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Government Gazette No: 40522 Date Published: 23 December 2016 Board Notice No: 198 321301000 - Pharmacy Technician Curriculum Document Page 1 of 162 Curriculum Document: Pharmacy Technician Occupational Code: 321301000 Qualification Title: Pharmacy Technician Curriculum Document

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Page 1: Curriculum Document: Pharmacy Technician...321301000-PM-09, Compound sterile and non-sterile extemporaneous preparations, as per current legislation (Pharmacy Technician), NQF Level

Government Gazette No: 40522 Date Published: 23 December 2016 Board Notice No: 198

321301000 - Pharmacy Technician – Curriculum Document Page 1 of 162

Curriculum Document: Pharmacy Technician

Occupational Code: 321301000 Qualification Title: Pharmacy Technician – Curriculum Document

Page 2: Curriculum Document: Pharmacy Technician...321301000-PM-09, Compound sterile and non-sterile extemporaneous preparations, as per current legislation (Pharmacy Technician), NQF Level

Government Gazette No: 40522 Date Published: 23 December 2016 Board Notice No: 198

321301000 - Pharmacy Technician – Curriculum Document Page 2 of 162

Table of content SECTION 1: CURRICULUM SUMMARY .............................................................................................................. 4

1. Occupational Information ............................................................................................................................................................................................................... 4

2. Curriculum Information ................................................................................................................................................................................................................... 4

3. Assessment Quality Partner Information ....................................................................................................................................................................................... 6

4. Part Qualification Curriculum Structure ......................................................................................................................................................................................... 6

SECTION 2: OCCUPATIONAL PROFILE .................................................................................................................... 8

1. Occupational Purpose .................................................................................................................................................................................................................... 8

2. Occupational Tasks ........................................................................................................................................................................................................................ 8

3. Occupational Task Details ............................................................................................................................................................................................................. 8

SECTION 3: CURRICULUM COMPONENT SPECIFICATIONS ................................................................................... 11

SECTION 3A: KNOWLEDGE MODULE SPECIFICATIONS ................................................................................................... 11

1. 321301000-KM-01, Introduction to the pharmaceutical environment, NQF Level 4, Credits 10 ............................................................................................... 11

2. 321301000-KM-02, Stock distribution and control (Basic), NQF Level 4, Credits 4 .................................................................................................................. 14

3. 321301000-KM-03, Stock management (Post Basic), NQF Level 5, Credits 4 .......................................................................................................................... 16

4. 321301000-KM-04, Supply chain management (Pharmacy Technician), NQF Level 6, Credits 6 ............................................................................................. 17

5. 321301000-KM-05, Non-sterile medicine manufacture (Basic), NQF Level 4, Credits 6 ........................................................................................................... 20

6. 321301000-KM-06, Non-sterile and sterile medicine manufacture (Post Basic), NQF Level 5, Credits 6 ................................................................................. 23

7. 321301000-KM-07, Medicine manufacture (Pharmacy Technician), NQF Level 6, Credits ....................................................................................................... 25

8. 321301000-KM-08, Compounding of non-sterile extemporaneous preparations (Basic), NQF Level 4, Credits 3 .................................................................... 29

9. 321301000-KM-09, Compounding of sterile and non-sterile extemporaneous preparations (Post Basic), NQF Level 5, Credits 4 .......................................... 30

10. 321301000-KM-10, Compounding of sterile and non-sterile extemporaneous preparations (Pharmacy Technician), NQF Level 6, Credits 4 ......................... 31

11. 321301000-KM-11, Dispensing (Post Basic), NQF Level 5, Credits 12 ....................................................................................................................................... 32

12. 321301000-KM-12, Dispensing (Pharmacy Technician), NQF Level 6, Credits 11 ..................................................................................................................... 36

13. 321301000-KM-13, Screening and testing patients (Pharmacy Technician), NQF Level 6, Credits 2 ........................................................................................ 38

14. 321301000-KM-14, Managing pharmacy resources (Pharmacy Technician), NQF Level 6, Credits 10 ..................................................................................... 38

15. 321301000-KM-15, General housekeeping (Basic), NQF Level 4, Credits 2 ............................................................................................................................... 43

16. 321301000-KM-16, Administration and housekeeping (Post Basic), NQF Level 4, Credits 3 ..................................................................................................... 44

17. 321301000-KM-17, Body systems, disorders and commonly used medicines (Post Basic), NQF Level 5, Credits 15 .............................................................. 45

18. 321301000-KM-18, Pharmacological and non-pharmacological management of common communicable and non-communicable disease states and

conditions (Pharmacy Technician), NQF Level 6, Credits 18 ...................................................................................................................................................... 48

SECTION 3B: PRACTICAL SKILL MODULE SPECIFICATIONS ........................................................................................... 50

1. 321301000-PM-01, Distribute and control stock as per current legislation (Basic), NQF Level 4, Credits 4 ............................................................................. 50

2. 321301000-PM-02, Manage stock, as per current legislation (Post Basic), NQF Level 5, Credits 6 ......................................................................................... 53

3. 321301000-PM-03, Manage supply chain (Pharmacy Technician), NQF Level 6, Credits 5 ..................................................................................................... 55

4. 321301000-PM-04, Manufacture non-sterile medicines (Basic), NQF Level 4, Credits 6 .......................................................................................................... 56

5. 321301000-PM-05, Manufacture non-sterile and sterile medicines (Post Basic), NQF Level 5, Credits 8 ................................................................................ 59

6. 321301000-PM-06, Manufacture non-sterile and sterile medicines (Pharmacy Technician), NQF Level 6, Credits 8 .............................................................. 62

7. 321301000-PM-07, Compound non-sterile extemporaneous preparations (Basic), NQF Level 4, Credits 5 ............................................................................. 65

8. 321301000-PM-08, Compound sterile and non-sterile extemporaneous preparations, as per current legislation (Post Basic), NQF Level 5, Credits 6 ......... 68

9. 321301000-PM-09, Compound sterile and non-sterile extemporaneous preparations, as per current legislation (Pharmacy Technician), NQF Level 6,

Credits 7 ...................................................................................................................................................................................................................................... 69

10. 321301000-PM-10, Dispense medicines (Post Basic), NQF Level 5, Credits 14 ........................................................................................................................ 70

11. 321301000-PM-11, Dispense medicines (Pharmacy Technician), NQF Level 6, Credits 12 ..................................................................................................... 76

12. 321301000-PM-12, Perform general housekeeping and administrative tasks in the pharmacy (Basic), NQF Level 4, Credits 2 .............................................. 77

13. 321301000-PM-13, Perform general housekeeping and administrative tasks in the pharmacy (Post Basic), NQF Level 5, Credits 3 ...................................... 78

14. 321301000-PM-14, Conduct screening tests (Pharmacy Technician), NQF Level 6, Credits 3 .................................................................................................. 79

15. 321301000-PM-15, Manage pharmacy resources and self-development (Pharmacy Technician), NQF Level 6, Credits 10 .................................................... 80

16. 321301000-PM-16, Identify anatomical structures (Post Basic), NQF Level 5, Credits 15 ......................................................................................................... 86

17. 321301000-PM-17, Conduct practical activities to optimise therapy for patients (Pharmacy Technician), NQF Level 6, Credits 15 ........................................ 87

18. 321301000-PM-18, Operate computers and computer software (Basic), NQF Level 4, Credits 4 ............................................................................................. 88

SECTION 3C: WORK EXPERIENCE MODULE SPECIFICATIONS ...................................................................................... 92

1. 321301000-WM-01, Processes to distribute and control stock, as per legislation (Basic), NQF Level 4, Credits 5 .................................................................. 92

2. 321301000-WM-02, Processes to manage stock as per legislation (Post Basic), NQF Level 5, Credits 8 ............................................................................... 94

3. 321301000-WM-03, Processes to manage supply chain and supervise the supply chain (Pharmacy Technician), NQF Level 6, Credits 10 .............................

96

4. 321301000-WM-04, Processes to manufacture non-sterile medicines (Basic), NQF Level 4, Credits 4 ................................................................................... 98

5. 321301000-WM-05, Processes to manufacture non-sterile and sterile medicines (Post Basic), NQF Level 5, Credits 5 ......................................................... 99

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Government Gazette No: 40522 Date Published: 23 December 2016 Board Notice No: 198

321301000 - Pharmacy Technician – Curriculum Document Page 3 of 162

6. 321301000-WM-06, Processes to manufacture non-sterile and sterile medicines and to supervise select manufacturing activities (Pharmacy Technician),

NQF Level 6, Credits 6 ............................................................................................................................................................................................................... 104

7. 321301000-WM-07, Processes to compound non-sterile extemporaneous preparations (Pharmacist’s Assistant - Basic), NQF Level 4, Credits 5 ............ 111

8. 321301000-WM-08, Processes to compound sterile and extemporaneous preparations (Post Basic), NQF Level 5, Credits 6 ............................................ 113

9. 321301000-WM-09, Processes to compound and supervise the compounding of sterile and non-sterile extemporaneous preparations (Pharmacy

Technician), NQF Level 6, Credits 7 .......................................................................................................................................................................................... 116

10. 321301000-WM-10, Processes to dispense medicines (Post Basic), NQF Level 2, Credits 15............................................................................................... 117

11. 321301000-WM-11, Processes to dispense and supervise dispensing of medicines (Pharmacy Technician), NQF Level 6, Credits 15 .............................. 120

12. 321301000-WM-12, Processes to perform general housekeeping and administrative tasks in the pharmacy (Basic), NQF Level 4, Credits 2 .................... 123

13. 321301000-WM-13, Processes to perform general housekeeping and administrative tasks in the pharmacy (Post Basic), NQF Level 5, Credits 3 ............ 124

14. 321301000-WM-14, Processes to conduct screening tests (Pharmacy Technician), NQF Level 6, Credits 2 ........................................................................ 126

15. 321301000-WM-15, Management of pharmacy resources (Pharmacy Technician), NQF Level 6, Credits 10 ....................................................................... 127

SECTION 4: STATEMENT OF WORK EXPERIENCE ............................................................................................... 130

Page 4: Curriculum Document: Pharmacy Technician...321301000-PM-09, Compound sterile and non-sterile extemporaneous preparations, as per current legislation (Pharmacy Technician), NQF Level

Government Gazette No: 40522 Date Published: 23 December 2016 Board Notice No: 198

321301000 - Pharmacy Technician – Curriculum Document Page 4 of 162

SECTION 1: CURRICULUM SUMMARY 1. Occupational Information 1.1 Associated Occupation 321301: Pharmacy Technician

1.2 Occupation or Specialisation Addressed by this Curriculum 321301000: Pharmacy Technician

1.3 Alternative Titles used by Industry

None

2. Curriculum Information 2.1 Curriculum Structure This qualification is made up of the following compulsory Knowledge and Practical Skill Modules: Knowledge Modules:

321301000-KM-01, Introduction to the pharmaceutical environment, NQF Level 4, Credits 10

321301000-KM-02, Stock distribution and control (Basic), NQF Level 4, Credits 4

321301000-KM-03, Stock management (Post Basic), NQF Level 5, Credits 4

321301000-KM-04, Supply chain management (Pharmacy Technician), NQF Level 6, Credits 6

321301000-KM-05, Non-sterile medicine manufacture (Basic), NQF Level 4, Credits 6

321301000-KM-06, Non-sterile and sterile medicine manufacture (Post Basic), NQF Level 5, Credits 6

321301000-KM-07, Medicine manufacture (Pharmacy Technician), NQF Level 6, Credits 6

321301000-KM-08, Compounding of non-sterile extemporaneous preparations (Basic), NQF Level 4, Credits 3

321301000-KM-09, Compounding of sterile and non-sterile extemporaneous preparations (Post Basic), NQF Level 5, Credits 4

321301000-KM-10, Compounding of sterile and non-sterile extemporaneous preparations (Pharmacy Technician), NQF Level 6, Credits 4

321301000-KM-11, Dispensing (Post Basic), NQF Level 5, Credits 12

321301000-KM-12, Dispensing (Pharmacy Technician), NQF Level 6, Credits 11

321301000-KM-13, Screening and testing patients (Pharmacy Technician), NQF Level 6, Credits 2

321301000-KM-14, Managing pharmacy resources (Pharmacy Technician), NQF Level 6, Credits 10

321301000-KM-15, General housekeeping (Basic), NQF Level 4, Credits 2

321301000-KM-16, Administration and housekeeping (Post Basic), NQF Level 4, Credits 3

321301000-KM-17, Body systems, disorders and commonly used medicines (Post Basic), NQF Level 5, Credits 15

321301000-KM-18, Pharmacological and non-pharmacological management of common communicable and non-communicable disease states and conditions (Pharmacy Technician), NQF Level 6, Credits 18

Total number of credits for Knowledge Modules: 126 Practical Skill Modules:

321301000-PM-01, Distribute and control stock as per current legislation (Basic), NQF Level 4, Credits 4

321301000-PM-02, Manage stock, as per current legislation (Post Basic), NQF Level 5, Credits 6

321301000-PM-03, Manage supply chain (Pharmacy Technician), NQF Level 6, Credits 5

321301000-PM-04, Manufacture non-sterile medicines (Basic), NQF Level 4, Credits 6

321301000-PM-05, Manufacture non-sterile and sterile medicines (Post Basic), NQF Level 5, Credits 8

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Government Gazette No: 40522 Date Published: 23 December 2016 Board Notice No: 198

321301000 - Pharmacy Technician – Curriculum Document Page 5 of 162

321301000-PM-06, Manufacture non-sterile and sterile medicines (Pharmacy Technician), NQF Level 6, Credits 8

321301000-PM-07, Compound non-sterile extemporaneous preparations (Basic), NQF Level 4, Credits 5

321301000-PM-08, Compound sterile and non-sterile extemporaneous preparations, as per current legislation (Post Basic), NQF Level 5, Credits 6

321301000-PM-09, Compound sterile and non-sterile extemporaneous preparations, as per current legislation (Pharmacy Technician), NQF Level 6, Credits 7

321301000-PM-10, Dispense medicines (Post Basic), NQF Level 5, Credits 14

321301000-PM-11, Dispense medicines (Pharmacy Technician), NQF Level 6, Credits 12

321301000-PM-12, Perform general housekeeping and administrative tasks in the pharmacy (Basic), NQF Level 4, Credits 2

321301000-PM-13, Perform general housekeeping and administrative tasks in the pharmacy (Post Basic), NQF Level 5, Credits 3

321301000-PM-14, Conduct screening tests (Pharmacy Technician), NQF Level 6, Credits 3

321301000-PM-15, Manage pharmacy resources and self-development (Pharmacy Technician), NQF Level 6, Credits 10

321301000-PM-16, Identify anatomical structures (Post Basic), NQF Level 5, Credits 15

321301000-PM-17, Conduct practical activities to optimise therapy for patients (Pharmacy Technician), NQF Level 6, Credits 15

321301000-PM-18, Operate computers and computer software (Basic), NQF Level 4, Credits 4 Total number of credits for Practical Skill Modules: 133 This qualification also requires the following Work Experience Modules:

321301000-WM-01, Processes to distribute and control stock, as per legislation (Basic), NQF Level 4, Credits 5

321301000-WM-02, Processes to manage stock as per legislation (Post Basic), NQF Level 5, Credits 8

321301000-WM-03, Processes to manage supply chain and supervise the supply chain (Pharmacy Technician), NQF Level 6, Credits 10

321301000-WM-04, Processes to manufacture non-sterile medicines (Basic), NQF Level 4, Credits 4

321301000-WM-05, Processes to manufacture non-sterile and sterile medicines (Post Basic), NQF Level 5, Credits 5

321301000-WM-06, Processes to manufacture non-sterile and sterile medicines and to supervise select manufacturing activities (Pharmacy Technician), NQF Level 6, Credits 6

321301000-WM-07, Processes to compound non-sterile extemporaneous preparations (Pharmacist’s Assistant - Basic), NQF Level 4, Credits 5

321301000-WM-08, Processes to compound sterile and extemporaneous preparations (Post Basic), NQF Level 5, Credits 6

321301000-WM-09, Processes to compound and supervise the compounding of sterile and non-sterile extemporaneous preparations (Pharmacy Technician), NQF Level 6, Credits 7

321301000-WM-10, Processes to dispense medicines (Post Basic), NQF Level 2, Credits 15

321301000-WM-11, Processes to dispense and supervise dispensing of medicines (Pharmacy Technician), NQF Level 6, Credits 15

321301000-WM-12, Processes to perform general housekeeping and administrative tasks in the pharmacy (Basic), NQF Level 4, Credits 2

321301000-WM-13, Processes to perform general housekeeping and administrative tasks in the pharmacy (Post Basic), NQF Level 5, Credits 3

321301000-WM-14, Processes to conduct screening tests (Pharmacy Technician), NQF Level 6, Credits 2

321301000-WM-15, Management of pharmacy resources (Pharmacy Technician), NQF Level 6, Credits 10

Total number of credits for Work Experience Modules: 103

2.2 Entry Requirements Matric with Mathematics and Life Sciences

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Government Gazette No: 40522 Date Published: 23 December 2016 Board Notice No: 198

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3. Assessment Quality Partner Information

Name of body: South African Pharmacy Council Address of body: SAPC Building 591 Belvedere St Arcadia 0083 Contact person name: Vincent Tlala Contact person work telephone number: 012 319 8509/85

4. Part Qualification Curriculum Structure

Part Qualification 1: Title: Pharmacist’s Assistant (Basic), NQF Level 4, Credits 62 Purpose: The purpose of this part qualification is to prepare a learner to operate as a Pharmacist’s Assistant (Basic). This part qualification is the first in the trajectory for becoming a Pharmacy Technician. A Pharmacist’s Assistant (Basic) performs a range of assistive tasks in the various categories of pharmacy.

Applicable Modules (Rules of Combination) Knowledge Modules:

321301000-KM-01, Introduction to the pharmaceutical environment, NQF Level 4, Credits 10

321301000-KM-02, Stock distribution and control (Basic), NQF Level 4, Credits 4

321301000-KM-05, Non-sterile medicine manufacture (Basic), NQF Level 4, Credits 6

321301000-KM-08, Compounding of non-sterile extemporaneous preparations (Basic), NQF Level 4, Credits 3

321301000-KM-15, General housekeeping (Basic), NQF Level 4, Credits 2 Total number of credits for Knowledge Modules: 25 Practical Skill Modules:

321301000-PM-01, Distribute and control stock as per current legislation (Basic), NQF Level 4, Credits 4

321301000-PM-04, Manufacture non-sterile medicines (Basic), NQF Level 4, Credits 6

321301000-PM-07, Compound non-sterile extemporaneous preparations (Basic), NQF Level 4, Credits 5

321301000-PM-12, Perform general housekeeping and administrative tasks in the pharmacy (Basic), NQF Level 4, Credits 2

321301000-PM-18, Operate computers and computer software (Basic), NQF Level 4, Credits 4 Total number of credits for Practical Skill Modules: 21 This qualification also requires the following Work Experience Modules:

321301000-WM-01, Processes to distribute and control stock, as per legislation (Basic), NQF Level 4, Credits 5

321301000-WM-04, Processes to manufacture non-sterile medicines (Basic), NQF Level 4, Credits 4

321301000-WM-07, Processes to compound non-sterile extemporaneous preparations (Pharmacist’s Assistant - Basic), NQF Level 4, Credits 5

321301000-WM-12, Processes to perform general housekeeping and administrative tasks in the pharmacy (Basic), NQF Level 4, Credits 2

Total number of credits for Work Experience Modules: 16

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Government Gazette No: 40522 Date Published: 23 December 2016 Board Notice No: 198

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Part Qualification 2: Title: Pharmacist’s Assistant (Post Basic), NQF Level 5, Credits 130

Purpose: The purpose of this part qualification is to prepare a learner to operate as a Pharmacist’s Assistant (Post Basic). This part qualification is the second in the trajectory for becoming a Pharmacy Technician. A Pharmacist’s Assistant (Post Basic) performs a range of tasks in the various categories of pharmacy.

Applicable Modules (Rules of Combination) Knowledge Modules:

321301000-KM-03, Stock management (Post Basic), NQF Level 5, Credits 4

321301000-KM-06, Non-sterile and sterile medicine manufacture (Post Basic), NQF Level 5, Credits 6

321301000-KM-09, Compounding of sterile and non-sterile extemporaneous preparations (Post Basic), NQF Level 5, Credits 4

321301000-KM-11, Dispensing (Post Basic), NQF Level 5, Credits 12

321301000-KM-16, Administration and housekeeping (Post Basic), NQF Level 4, Credits 3

321301000-KM-17, Body systems, disorders and commonly used medicines (Post Basic), NQF Level 5, Credits 15

Total number of credits for Knowledge Modules: 44 Practical Skill Modules:

321301000-PM-02, Manage stock, as per current legislation (Post Basic), NQF Level 5, Credits 6

321301000-PM-05, Manufacture non-sterile and sterile medicines (Post Basic), NQF Level 5, Credits 8

321301000-PM-08, Compound sterile and non-sterile extemporaneous preparations, as per current legislation (Post Basic), NQF Level 5, Credits 6

321301000-PM-10, Dispense medicines (Post Basic), NQF Level 5, Credits 14

321301000-PM-13, Perform general housekeeping and administrative tasks in the pharmacy (Post Basic), NQF Level 5, Credits 3

321301000-PM-16, Identify anatomical structures (Post Basic), NQF Level 5, Credits 15 Total number of credits for Practical Skill Modules: 52 This qualification also requires the following Work Experience Modules:

321301000-WM-02, Processes to manage stock as per legislation (Post Basic), NQF Level 5, Credits 8

321301000-WM-05, Processes to manufacture non-sterile and sterile medicines (Post Basic), NQF Level 5, Credits 5

321301000-WM-08, Processes to compound sterile and extemporaneous preparations (Post Basic), NQF Level 5, Credits 6

321301000-WM-10, Processes to dispense medicines (Post Basic), NQF Level 2, Credits 15

321301000-WM-14, Processes to conduct screening tests (Pharmacy Technician), NQF Level 6, Credits 2

Total number of credits for Work Experience Modules: 36

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Government Gazette No: 40522 Date Published: 23 December 2016 Board Notice No: 198

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SECTION 2: OCCUPATIONAL PROFILE 1. Occupational Purpose

This occupational qualification is intended to equip the learner with the knowledge and skills required as Pharmacy Support Personnel (PSP) at the level of a Pharmacy Technician. The occupational certificate will allow for two part qualifications, Pharmacist’s Assistant Basic at NQF 4 and Pharmacist’s Assistant Post Basic at NQF 5, thus fulfilling the need for different levels of well-trained PSP. This occupational qualification will improve learner access to PSP qualifications and provide an opportunity to those learners who do not wish to pursue the academic (CHE) Pharmacy Technician qualification and/or wish to remain in the workplace while achieving the qualification. Successful completion of this qualification, and each of the part qualifications, may enable the learner to register in the relevant PSP category with the South African Pharmacy Council (PSP). Learners exiting with the Pharmacy Technician qualification will be able to assist with: medicine supply management; manufacturing of medicines; dispensing (supplying) of medicine to patients; providing patient care; managing pharmacy resources; apply health and safety regulations, human rights, relevant medical and pharmaceutical law and ethics in the performance of their pharmaceutical duties and housekeeping and administration relative to pharmaceutical services. A Pharmacy Technician is a generalist who can operate in the four categories of pharmacy (community, institutional (private or public), manufacturing and wholesale). While the Pharmacy Technician works under the direct personal supervision of a pharmacist in a pharmacy they may also work in a primary health care clinic or any other facility approved by Council under the indirect personal supervision of a pharmacist.

2. Occupational Tasks Manage medicine supply (NQF Level 6)

Manufacture, package and repackage medicines and scheduled substances (NQF Level 6)

Compound, manipulate and prepare extemporaneous preparations (NQF Level 6)

Dispense medicine to patient (NQF Level 6)

Manage pharmacy resources (NQF Level 6)

3. Occupational Task Details 3.1 Manage medicine supply (NQF Level 6) Unique Product or Service: Supply of the right medicine in the correct quantity and quality to the right place the time for which it was

requested Occupational Responsibilities:

Receive and store stock orders

Pick, pack and distribute orders

Perform stock counts and participate in stock taking

Pick, pack and dispatch orders for medicines in terms of current legislation

Control stock

Order medicine in terms of current legislation

Manage stock

Manage risks and anomalies during stock management Occupational Contexts:

Processes to distribute and control stock as per legislation (Basic) (NQF Level 4)

Processes to manage stock as per legislation (Pharmacist Assistant [Post Basic]) (NQF Level 5)

Processes to manage supply chain and supervise the supply chain (Pharmacy Technician) (NQF Level 6)

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3.2 Manufacture, package and repackage medicines and scheduled substances (NQF Level 6)

Unique Product or Service: Quality medicines that meet cGMP requirements Occupational Responsibilities:

Handle materials (Basic)

Manufacture non-sterile medicines or scheduled substances under guidance

Perform packaging processes

Handle materials (Post Basic)

Manufacture non-sterile and sterile medicines and scheduled substances

Package medicines

Manage materials

Manufacture non-sterile and sterile medicines or scheduled substances under supervision

Package and re-package medicines Occupational Contexts:

Processes to manufacture non-sterile medicines (Basic)

Processes to manufacture non-sterile and sterile medicines (Post Basic)

Processes to manufacture non-sterile and sterile medicines and to supervise select manufacturing activities (Pharmacy Technician) (NQF Level 6)

3.3 Compound, manipulate and prepare extemporaneous preparations (NQF Level 6) Unique Product or Service: Compounded extemporaneous preparations ready for use Occupational Responsibilities:

Compound a non-sterile medicine or scheduled substance, as per current legislation

Compound sterile and non-sterile products, as per current legislation

Compound sterile and non-sterile medicines, as per current legislation, at the level of the Pharmacy Technician

Perform general housekeeping and administrative tasks in the pharmacy

Operate a personal computer and install PC peripheral device

Create, edit and format GUI-based word processor documents

Create and edit GUI-based spreadsheets

Perform general housekeeping and administrative tasks in the pharmacy (Post Basic) Occupational Contexts:

Processes to compound non-sterile extemporaneous preparations (Pharmacist’s Assistant [Basic]) (NQF Level 4)

Processes to compound sterile extemporaneous preparations (Pharmacist’s Assistant [Post Basic]) (NQF Level 5)

Processes to compound and supervise the compounding of sterile and non-sterile extemporaneous preparations (Pharmacy Technician)

Perform general housekeeping and administrative tasks in the pharmacy (Basic)

Perform general housekeeping and administrative tasks in the pharmacy (Post Basic)

3.4 Dispense medicine to patient (NQF Level 6) Unique Product or Service: Appropriate provision of medicine to the patient, contributing towards positive health outcomes

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Occupational Responsibilities:

Verify prescription

Interact with patients

Prepare prescriptions

Perform Phase 3 of the dispensing process

Promote health

Perform Pharmacist Initiated Therapy (PIT)

Perform the dispensing process

Promote health

Perform screening tests

Occupational Contexts:

Processes to dispense medicines (Pharmacist’s Assistant [Post Basic]) (NQF Level 5)

Processes to dispense and supervise dispensing of medicines (Pharmacy Technician) (NQF Level 6)

Processes to provide screening tests (Pharmacy Technician) (NQF Level 6)

3.5 Manage pharmacy resources (NQF Level 6) Unique Product or Service: Effective and efficient use of resources to optimise productivity and minimise risk Occupational Responsibilities:

Supervise and manage staff

Manage pharmacy - related facility

Manage pharmacy-related facility operations

Manage financial aspects of the pharmacy-related facility

Manage conflict

Manage time

Manage diversity Occupational Contexts:

Management of pharmacy resources (Pharmacy Technician) (NQF Level 6)

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SECTION 3: CURRICULUM COMPONENT SPECIFICATIONS SECTION 3A: KNOWLEDGE MODULE SPECIFICATIONS List of Knowledge Modules for which Specifications are included

321301000-KM-01, Introduction to the pharmaceutical environment, NQF Level 4, Credits 10

321301000-KM-02, Stock distribution and control (Basic), NQF Level 4, Credits 4

321301000-KM-03, Stock management (Post Basic), NQF Level 5, Credits 4

321301000-KM-04, Supply chain management (Pharmacy Technician), NQF Level 6, Credits 6

321301000-KM-05, Non-sterile medicine manufacture (Basic), NQF Level 4, Credits 6

321301000-KM-06, Non-sterile and sterile medicine manufacture (Post Basic), NQF Level 5, Credits 6

321301000-KM-07, Medicine manufacture (Pharmacy Technician), NQF Level 6, Credits 6

321301000-KM-08, Compounding of non-sterile extemporaneous preparations (Basic), NQF Level 4, Credits 3

321301000-KM-09, Compounding of sterile and non-sterile extemporaneous preparations (Post Basic), NQF Level 5, Credits 4

321301000-KM-10, Compounding of sterile and non-sterile extemporaneous preparations (Pharmacy Technician), NQF Level 6, Credits 4

321301000-KM-11, Dispensing (Post Basic), NQF Level 5, Credits 12

321301000-KM-12, Dispensing (Pharmacy Technician), NQF Level 6, Credits 11

321301000-KM-13, Screening and testing patients (Pharmacy Technician), NQF Level 6, Credits 2

321301000-KM-14, Managing pharmacy resources (Pharmacy Technician), NQF Level 6, Credits 10

321301000-KM-15, General housekeeping (Basic), NQF Level 4, Credits 2

321301000-KM-16, Administration and housekeeping (Post Basic), NQF Level 4, Credits 3

321301000-KM-17, Body systems, disorders and commonly used medicines (Post Basic), NQF Level 5, Credits 15

321301000-KM-18, Pharmacological and non-pharmacological management of common communicable and non-communicable disease states and conditions (Pharmacy Technician), NQF Level 6, Credits 18

1. 321301000-KM-01, Introduction to the pharmaceutical environment, NQF Level 4, Credits 10

1.1 Purpose of the Knowledge Modules The main focus of the learning in this knowledge module is to build an understanding of the

pharmaceutical environment within the South Africa healthcare system. The learning will enable learners to demonstrate an understanding of:

KM-01-KT01: Overview of the South African healthcare system (10%)

KM-01-KT02: The pharmacy profession (30%)

KM-01-KT03: Medicines (30%)

KM-01-KT04: Legislative framework (30%) 1.2 Guidelines for Topics 1.2.1 KM-01-KT01: Overview of the South African healthcare system (10%) Topic elements to be covered include:

KT0101 Health and wellness

KT0102 Health care system (public and private health care systems; burden of disease (e.g. HIV and Aids, tuberculosis, smoking)

KT0103 Healthcare providers, healthcare professionals (multi-disciplinary health teams)

KT0104 Funding (medical schemes; Prescribed Minimum Benefits [PMBs], universal coverage; private and public sectors’ funding)

KT0105 National Core Standards (NCS)

KT0106 Primary health care (principles of ideal clinic concept)

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KT0107 Terminology

KT0108 Standard Treatment Guidelines (STG) and Essential Medicines List (EML) Internal Assessment Criteria and Weight

IAC0101 Explain the concepts of health and wellness and show its application to the scope of Pharmacy Support Personnel (PSP)

IAC0102 Describe the structure of and the inter-relationships within the South African health care system and demonstrate the impact of the burden of disease on the health system of the country

IAC0103 Explain the funding models of the healthcare system in the country

IAC0104 Explain the principles of the NCS

IAC0105 Discuss the principles and structure of the primary health care system

IAC0106 Describe the STG and EML framework and its relevance to healthcare (Weight 10%) 1.2.2 KM-01-KT02: The pharmacy profession (30%) Topic elements to be covered include:

KT0201 Pharmacy and the role of medicine in society

KT0202 Pharmacy environment (The regulatory bodies, professional associations, trade organisations and other related organisations and structures associated with the pharmacy discipline and their roles within the pharmacy environment)

KT0203 Categories of pharmacy

KT0204 Pharmacists and Pharmacy Support Personnel and their scopes of practice

KT0205 Current Good Manufacturing Practice (cGMP), or Good Wholesaling and Distribution Practice (GWDP), the Pharmaceutical Inspection Convention (PIC) guidelines; Standard Operating Procedures (SOPs); Good Pharmacy Practice (GPP)

KT0206 Ethical Rules, the Code of Conduct, the SA Code of Marketing Practice (The Marketing Code) and all relevant and current legislation

KT0207 Pharmaceutical terminology and abbreviations

KT0208 Quality assurance (key concepts and role-players) Internal Assessment Criteria and Weight

IAC0201 Discuss the role of medicine in society

IAC0202 Describe the pharmacy environment by identifying the various structures, bodies and disciplines impacting on the pharmacy profession and discussing the inter-relationships between them

IAC0203 Define the concept of a pharmacy in terms of the Pharmacy Act

IAC0204 Identify and describe the functions of the different sectors of pharmacy

IAC0205 Describe the categories of personnel in a pharmacy

IAC0206 Discuss the scopes of practice of PSP and their importance in terms of demarcating responsibilities of PSP

IAC0207 Explain the concepts of direct and indirect supervision in relation to the PSP

IAC0208 Explain the concepts and principles of GPP, cGMP, GWDP, the PIC guidelines and SOPs in terms of the role they play in the pharmacy profession

IAC0209 Discuss the ethical rules and codes that prescribe the functions of the PSP

IAC0210 Identify and explain pharmaceutical terminology and abbreviations

IAC0211 Explain the key concepts of quality assurance as they relate to pharmacy and identify the key role players

(Weight 30%) 1.2.3 KM-01-KT03: Medicines (30%) Topic elements to be covered include:

KT0301 History of pharmacy and medicines

KT0302 Origin of medicines

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KT0303 Physico-chemical properties of medicinal compounds

KT0304 Factors that affect medicines

KT0305 Active pharmaceutical ingredients

KT0306 Dosage forms and routes of administration

KT0307 Scheduling of medicines

KT0308 Classification of pharmaceutical products

KT0309 Fundamental pharmaceutics Internal Assessment Criteria and Weight

IAC0301 Discuss, briefly, the history of pharmacy and origins of medicines with reference to key historical figures and major discoveries in medicine

IAC0302 Explain environmental factors that affect medicines

IAC0303 Explain the terminology relating to physico-chemical properties of active pharmaceutical ingredients and excipients

IAC0304 Explain the classification of pharmaceutical products

IAC0305 Describe the control of medicines by and their relevance to the categories of PSP

IAC0306 Discuss the way scheduling works and the role of schedules in terms of access

IAC0307 Differentiate between the dosage forms of medicine and explain their routes of administration

IAC0308 Explain the fundamentals of pharmaceutics and the relationship of pharmaceutics in relation to the other disciplines of pharmacy

(Weight 30%) 1.2.4 KM-01-KT04: Legislative framework (30%) Topic elements to be covered include:

KT0401 The Pharmacy Act (No. 53 of 1974) and its related regulations and rules

KT0402 Scope of Practice for different categories of pharmacy personnel

KT0403 The Medicines and Related Substances Act (No. 101 of 1965) as amended, and its related regulations and guidelines

KT0404 National Health Act (Act No. 61 of 2003)

KT0405 Occupational Health and Safety Act (Act No. 85 of 1993) (universal precautions only)

KT0406 Consumer Protection Act (Act No. 68 of 2008)

KT0407 All other relevant and current legislation Internal Assessment Criteria and Weight

IAC0401 Discuss the Pharmacy Act and its related regulations and rules as primary current legislation for the pharmacy profession

IAC0402 Discuss the scopes of practice of PSP and the importance of these scopes in terms of demarcating responsibilities of PSP

IAC0403 Discuss the relevant aspects of the Medicines and Related Substances Act (No. 101 of 1965) as amended and its related regulations and guidelines, in terms of the PSP

IAC0404 List the Acts that impact on the pharmacy profession and discuss, briefly, their purposes (Weight 30%) 1.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements

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Legal Requirements:

Accredited/approved as provider with SAPC

Occupational Health and Safety requirements 1.4 Exemptions

None

2. 321301000-KM-02, Stock distribution and control (Basic), NQF Level 4, Credits 4 2.1 Purpose of the Knowledge Modules

The main focus of the learning in this knowledge module is to build an understanding of the procedures involved when the Pharmacist Assistant (Basic) receives and stores stock, picks, packs and dispatches orders, participates in stock takes and performs stock counts, with reference to GPP, GWDP and cGMP. The learning will enable learners to demonstrate an understanding of:

KM-02-KT01: Stock receipt and storage (40%)

KM-02-KT02: Picking, packing and dispatching of orders (30%)

KM-02-KT03: Stock takes and stock counts (30%) 2.2 Guidelines for Topics 2.2.1 KM-02-KT01: Stock receipt and storage (40%) Topic elements to be covered include:

KT0101 Delivery address and batch numbers

KT0102 Off-loading stock

KT0103 Checking procedures

KT0104 First-in first-out (FIFO) and first-expired first-out (FEFO)

KT0105 Administrative tasks relating to stock

KT0106 Items to be returned (discrepancies)

KT0107 Shrinkage (loss, theft, damage, expired and obsolete medicines)

KT0108 Storage (temperature control [including cold chain items]; handling of items [hazardous substances; special])

KT0109 Designated areas

KT0110 Data-capturing for received stock Internal Assessment Criteria and Weight

IAC0101 Explain why it is important to check delivery address and batch numbers

IAC0102 Describe the procedures for off-loading and checking received stock

IAC0103 Explain the purpose of designated areas and why received stock is placed in these areas

IAC0104 Explain the FIFO and FEFO principles and their application when unpacking, packing and storing stock

IAC0105 Describe the standard operating procedures when handling and storing cold chain items, hazardous and special substances

IAC0106 Describe the administrative procedures involved when receiving and storing stock

IAC0107 Describe the procedures to handle orders with discrepancies and the processing of items to be returned and credit

IAC0108 Explain the term ‘shrinkage’ in a pharmacy environment

IAC0109 Describe the processes for capturing stock either on electronic or stock card system

IAC0110 Explain the impact if the pharmacist or the PT is not notified about any stock discrepancies (Weight 40%) 2.2.2 KM-02-KT02: Picking, packing and dispatching of orders (30%)

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Topic elements to be covered include:

KT0201 Designated areas

KT0202 Documentation for picking, packing and dispatching of orders

KT0203 Packaging procedures (temperature control; method)

KT0204 Dispatch of stock

KT0205 Authorisation

KT0206 Automated Dispensing Units (ADUs) Internal Assessment Criteria and Weight

IAC0201 Describe designated areas and explain their purpose

IAC0202 Identify and describe the documentation for picking, packing and dispatching of orders

IAC0203 Describe the procedures for picking and packing medicines or scheduled substances, according to current legislation

IAC0204 Explain the importance of temperature control and processes in packaging procedures

IAC0205 Describe the procedures to dispatch stock

IAC0206 Explain the authorisation procedures in the context of picking, packing and dispatching medicines or scheduled substances, according to current legislation

IAC0207 Describe automated dispensing units

IAC0208 Describe the procedures to replenish stock in automated dispensing units (Weight 30%) 2.2.3 KM-02-KT03: Stock takes and stock counts (30%) Topic elements to be covered include:

KT0301 Expired/discontinued/slow moving/overstocked medicines or medical devices

KT0302 Stock takes and their schedules

KT0303 Stock counts (cyclic, monthly, quarterly and annually), stock rotation Internal Assessment Criteria and Weight

IAC0301 Describe the procedures to remove expired/discontinued/slow moving/overstocked medicines or medical devices

IAC0302 Describe the procedures to prepare expired stock for waste disposal

IAC0303 Describe the procedures to assess stockholding for overstocked items

IAC0304 Explain the essential difference between stock counts and stock takes

IAC0305 Describe the procedures to perform stock counts and participate in scheduled stock takes

IAC0306 Describe the procedures to perform a stock take of an automated dispensing units (Weight 30%) 2.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

As per SAPC requirements

Occupational Health and Safety requirements

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2.4 Exemptions

None

3. 321301000-KM-03, Stock management (Post Basic), NQF Level 5, Credits 4 3.1 Purpose of the Knowledge Modules

The main focus of the learning in this knowledge module is to build an understanding of the procedures involved when the Pharmacist Assistant (Post Basic) orders medicine and scheduled substances, performs stock takes and stock counts and receives stock, with reference GPP, GWDP and cGMP. The learning will enable learners to demonstrate an understanding of:

KM-03-KT01: Ordering of medicine and scheduled substances (40%)

KM-03-KT02: Stock takes and stock counts (Post Basic) (30%)

KM-03-KT03: Stock receipt (Post Basic) (30%) 3.2 Guidelines for Topics 3.2.1 KM-03-KT01: Ordering of medicine and scheduled substances (40%) Topic elements to be covered include:

KT0101 Average monthly consumption (AMC)

KT0102 Maximum and minimum stock level for each item (reorder level)

KT0103 Replenishment models

KT0104 Emergency orders

KT0105 Collection of required data for submission of Section 21 orders

KT0106 Approved vendors

KT0107 Quantification and demand planning

KT0108 Stock availability reporting Internal Assessment Criteria and Weight

IAC0101 Explain method of calculating AMC

IAC0102 Explain method of calculating and recording the maximum and minimum stock levels for each item

IAC0103 Explain the use of the replenishment models

IAC0104 Describe the procedures for handling emergency orders

IAC0105 Describe the process to collect required data for submission of Section 21 orders

IAC0106 Explain the criteria for identifying approved vendors

IAC0107 Explain the importance of quantification and demand planning and describe the methods of performing them

IAC0108 Explain the need for and the procedures to prepare a report for stock availability (Weight 40%) 3.2.2 KM-03-KT02: Stock takes and stock counts (Post Basic) (30%) Topic elements to be covered include:

KT0201 Stock counts and their schedules

KT0202 Stock taking

KT0203 Short-dated and slow-moving stock

KT0204 Quarantine of medicines

KT0205 Medicine disposal

KT0206 Transfers/borrowing of stock

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Internal Assessment Criteria and Weight

IAC0201 Explain the reasons for out-of-stock items

IAC0202 Describe the procedures to take stock

IAC0203 Describe the procedures to manage short-dated and slow-moving stock

IAC0204 Explain the assistive role of the PB in the quarantining of recalled and expired medicines

IAC0205 Explain the procedures to dispose of returned, recalled and expired medicines

IAC0206 Describe the processes to transfer/borrow stock

IAC0207 Describe the procedures to maintain stock levels of automated dispensing units (Weight 30%) 3.2.3 KM-03-KT03: Stock receipt (Post Basic) (30%) Topic elements to be covered include:

KT0301 Handling medicines belonging to the higher schedules, as per current legislation

KT0302 Suitability of received materials and stock Internal Assessment Criteria and Weight

IAC0301 Describe the procedures to unpack and arrange storage of the higher schedules of medicines, according to scope of practice and current legislation

IAC0302 Describe the procedures to reconcile received and ordered items

IAC0303 Explain why it is important to check materials and stock for retention and use (Weight 30%) 3.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

As per SAPC requirements

Occupational Health and Safety requirements 3.4 Exemptions

None

4. 321301000-KM-04, Supply chain management (Pharmacy Technician), NQF Level 6, Credits 6

4.1 Purpose of the Knowledge Modules

The main focus of the learning in this knowledge module is to build an understanding of the procedures involved in the management of stock of medicines or scheduled substances (according to current legislation), risk management and the ordering, receipt and storage of medicines or scheduled substances at the level of the Pharmacist Technician.

The learning will enable learners to demonstrate an understanding of:

KM-04-KT01: Management of stock as per current legislation (40%)

KM-04-KT02: Risk management (40%)

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KM-04-KT03: Ordering, receipt and storage of medicines or scheduled substances (20%)

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4.2 Guidelines for Topics 4.2.1 KM-04-KT01: Management of stock as per current legislation (40%) Topic elements to be covered include:

KT0101 cGMP, GPP and GWDP

KT0102 Recall of stock

KT0103 Returned medicines

KT0104 Quarantine of recalled and expired, dormant medicines

KT0105 Safe disposal of medicines

KT0106 Legality governing disposal

KT0107 Stock reconciliation Internal Assessment Criteria and Weight

IAC0101 Explain the importance and application of GMP, GPP and GWDP to the management, dispatch and disposal of medicines, schedules substances and medical devices

IAC0102 Demonstrate an understanding of the role of the PT in the recall of stock

IAC0103 Explain the management of or returned medicines

IAC0104 Explain the management of quarantining recalled and expired medicines

IAC0105 Describe the safe disposal procedures for returned and expired medicines

IAC0106 Explain the process to create an action plan to manage out-of-stock items

IAC0107 Describe the procedures to disseminate out-of-stock information to relevant healthcare providers

IAC0108 Identify, analyse and resolve stock discrepancies

IAC0109 Explain the procedure to analyse stock reconciliation documents to achieve effective stock management

(Weight 40%) 4.2.2 KM-04-KT02: Risk management (40%) Topic elements to be covered include:

KT0201 Anomalies

KT0202 Financial impact (shrinkage, out of stock, excess stock)

KT0203 Error management

KT0204 Legal risks and legislative considerations within risk management Internal Assessment Criteria and Weight

IAC0201 Describe the kinds of risks and anomalies that will need to be managed by the Pharmacy Technician

IAC0202 Explain the financial impact of aspects such as shrinkage, out of stock medicines and excess stock

IAC0203 Discuss ways of mitigating risks, managing errors and reducing financial impact

IAC0204 Explain the legislative considerations within risk management (Weight 40%) 4.2.3 KM-04-KT03: Ordering, receipt and storage of medicines or scheduled substances (20%) Topic elements to be covered include:

KT0301 Environment control

KT0302 Hazardous substances

KT0303 Supervision of the sampling of raw materials, medicines or scheduled substances

KT0304 Approved vendors

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Internal Assessment Criteria and Weight

IAC0301 Explain the procedures and parameters to control the environment at which medicines are stored

IAC0302 Describe the unpacking and storage procedures for hazardous substances

IAC0303 Discuss the activities when supervising sampling of raw materials, medicines or scheduled substances

IAC0304 Explain the importance of procuring stock and/or materials from approved vendors (Weight 20%) 4.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Accredited as provider with SAPC

Occupational Health and Safety requirements 4.4 Exemptions

None

5. 321301000-KM-05, Non-sterile medicine manufacture (Basic), NQF Level 4, Credits 6 5.1 Purpose of the Knowledge Modules

The main focus of the learning in this knowledge module is to build an understanding of handling materials, manufacturing processes, packing/packaging processes and quality control at the level of the Pharmacist Assistant (Basic), with reference to cGMP and current legislation. The learning will enable learners to demonstrate an understanding of:

KM-05-KT01: Handling materials (Basic) (40%)

KM-05-KT02: Manufacturing processes (25%)

KM-05-KT03: Packing/packaging processes (35%) 5.2 Guidelines for Topics 5.2.1 KM-05-KT01: Handling materials (Basic) (40%) Topic elements to be covered include:

KT0101 Active and inactive (excipient) raw materials

KT0102 Types of packing materials

KT0103 Types of cleaning materials

KT0104 Procedures for checking incoming stock

KT0105 Quarantine store/area

KT0106 Principles of stock/materials rotation (FEFO and FIFO)

KT0107 Batch records and batch tracking

KT0108 Stock taking and stock counting

KT0109 Destruction of goods/stock

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KT0110 Security and access control

KT0111 Rejected, recovered and returned product and recalls

KT0112 Record keeping requirements for scheduled substances as per current legislation

KT0113 Storage conditions and expiration dates of materials

KT0114 Approved vendors

KT0115 Packaging materials

KT0116 Documentation for handling materials

KT0117 Applicable cGMP guidelines Internal Assessment Criteria and Weight

IAC0101 Explain the importance and basic principles of cGMP at the level of the Basic Pharmacist Assistant

IAC0102 Differentiate between active and inactive (excipient) raw materials

IAC0103 Identify and describe types of packing materials

IAC0104 Identify and describe types of cleaning materials

IAC0105 Describe methods of checking incoming stock against purchase order

IAC0106 Explain the concept of quarantining store/area

IAC0107 Explain the principles of stock rotation and shelf life

IAC0108 Explain the concepts of batches and batch control

IAC0109 Explain the importance of the link between finished product dispatch records and batch manufacturing records through batch numbers

IAC0110 Describe the processes for stock taking and stock counting

IAC0111 Describe the processes for the destruction of goods/stock

IAC0112 Describe the record keeping requirements for scheduled substances as per current legislation

IAC0113 Explain the importance of security and access control with respect to materials used in manufacture of medicines

IAC0114 Explain the importance and the principles of appropriate storage conditions for stock (including hazardous substances) and bulk manufactured stock

IAC0115 Explain the effects of light, moisture and temperature on medicines

IAC0116 Differentiate between rejected, recovered and returned product and recalls (as per cGMP)

IAC0117 Explain the concept of an approved vendor and the importance of using approved vendors

IAC0118 Explain the principles of storage and the destruction of unused packaging materials

IAC0119 Explain the importance of documentation in handling raw materials (Weight 40%) 5.2.2 KM-05-KT02: Manufacturing processes (25%) Topic elements to be covered include:

KT0201 System of weights and measures

KT0202 Transferring raw materials in a manufacturing environment

KT0203 Cross contamination

KT0204 Weighing and manufacturing equipment

KT0205 Principles of in-process and other controls

KT0206 In-process controls

KT0207 Personal protective equipment (PPE, hygiene and health and safety requirements

KT0208 Documentation (batch manufacturing document and batch manufacturing records, manufacturing specifications, standard operating procedures [SOPs], records, site master file)

Internal Assessment Criteria and Weight

IAC0201 Describe the system of weights and measures and the processes to conduct preliminary steps of weighing

IAC0202 Explain the principles governing the receipt of raw materials into the weighing area, the return of unfinished materials and the transfer of weighed material to the manufacturing area

IAC0203 Explain the importance of preventing cross contamination

IAC0204 Describe the operation of weighing and manufacturing equipment

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IAC0205 Explain the addition of materials to the mix after the pharmacist has checked each mass or volume

IAC0206 Demonstrate understanding of the relevance of deviations in a process and the impact of changes in processes and equipment on a product

IAC0207 Explain the importance of cleaning and checking equipment according to SOPs and describe the procedures to clean equipment

IAC0208 Explain the principles of in-process controls in terms of the final product release

IAC0209 Explain the importance and the purpose of documentation

IAC0210 Explain the role of the pharmacist/pharmacist technician in the manufacturing process

IAC0211 Describe PPE, hygiene and health and safety requirements for manufacturing (Weight 25%) 5.2.3 KM-05-KT03: Packing/packaging processes (35%) Topic elements to be covered include:

KT0301 Packaging line

KT0302 Packaging materials

KT0303 Over-printing of packaging materials

KT0304 Packaging equipment

KT0305 Controls for line opening, line closing and in-process controls for packaging line

KT0306 Packaging and re-packing operations

KT0307 Mislabelling, incorrect packaging inserts, leaflets

KT0308 Documentation for packaging Internal Assessment Criteria and Weight

IAC0301 Describe the procedures and controls for clearing, cleaning and checking a line for packaging

IAC0302 Describe the procedures to receive packaging materials for stores and to receive bulk material

IAC0303 Describe the procedures for setting-up equipment for overprinting packaging materials

IAC0304 Explain the controls for line opening, line closing and in-process controls for packaging line

IAC0305 Describe packaging and re-packing operations

IAC0306 Identify and describe packaging components

IAC0307 Describe the system of labelling material, in process materials, finished product and equipment

IAC0308 Explain the risks involved in mislabelling of products, incorrect packaging inserts and leaflets

IAC0309 Describe the procedures for over-printing material and give the reason for this action

IAC0310 Describe the documentation for packing/packaging processes

IAC0311 Describe the role of the quality department in the release of the finished product

IAC0312 Describe the procedures to transfer finished product to finished product warehouse (Weight 35%) 5.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Accredited as provider with SAPC

Occupational Health and Safety requirements

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5.4 Exemptions

None

6. 321301000-KM-06, Non-sterile and sterile medicine manufacture (Post Basic), NQF Level 5, Credits 6

6.1 Purpose of the Knowledge Modules

The main focus of the learning in this knowledge module is to build an understanding of handling materials used in the manufacture of medicines; pharmaceutical manufacturing processes and procedures for non-sterile or sterile medicines, packing/packaging processes and quality control leading to the final release of the product, with reference to cGMP and current legislation.

The learning will enable learners to demonstrate an understanding of:

KM-06-KT01: Handling materials (Post Basic) (25%)

KM-06-KT02: Pharmaceutical manufacturing processes and procedures for non-sterile or sterile medicines (45%)

KM-06-KT03: Packing/packaging processes (30%) 6.2 Guidelines for Topics 6.2.1 KM-06-KT01: Handling materials (Post Basic) (25%) Topic elements to be covered include:

KT0101 cGMP and current legislation

KT0102 Storage conditions

KT0103 Systems for environment control (heating, ventilation and air conditioning [HVAC])

KT0104 Handling and controlling recalled batch/es

KT0105 Batch documentation

KT0106 Handling and controlling returned stock

KT0107 Storage of bulk manufactured products

KT0108 Storage, issue and return of excess materials and destruction of over-printed packaging materials

KT0109 Materials/stock reconciliation Internal Assessment Criteria and Weight

IAC0101 Explain the general principles of cGMP and their application in manufacturing

IAC0102 Explain the legislative oversight requirements for manufacturing

IAC0103 Describe the procedures to monitor and record storage conditions for raw materials and packed products

IAC0104 Describe the processes to maintain the systems for environmental control

IAC0105 Explain the processes to handle and control recalled batch/es

IAC0106 Explain the principles and procedures of batch tracking

IAC0107 Demonstrate understanding of classes of recalls (risks)

IAC0108 Explain the processes to handle and control returned stock

IAC0109 Explain the implementation of bulk manufactured products storage requirements as per batch documentation

IAC0110 Explain the principles of returning excess materials into stock after weighing and packaging processes

IAC0111 Explain the method and/or the calculations to reconcile quantities of materials/stock (Weight 25%) 6.2.2 KM-06-KT02: Pharmaceutical manufacturing processes and procedures for non-sterile or sterile

medicines (45%)

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Topic elements to be covered include:

KT0201 Equipment taring, calibration, cleaning and maintenance

KT0202 Principles of manufacture of and basic dosage form manufacturing (e.g. liquids, semi-solids, and solid dosage forms)

KT0203 Active pharmaceutical ingredients and inactive ingredients/excipients

KT0204 Pharmaceutical calculations

KT0205 Production planning

KT0206 Specification tests and in-process control testing and checks, interpretation of results (e.g., pH, conductivity, spectrophotometry, viscosity, friability, spreadability, hardness testing) and raising any deviation to the appropriate supervisory person

KT0207 Aseptic technique (preparation and maintenance of a sterile area, access controls, personnel protection, filling techniques, sterilisation techniques, packaging techniques etc.)

KT0208 Change control

KT0209 Sampling procedures and retention samples

KT0210 Water usage, storage and processing

KT0211 Documentation Internal Assessment Criteria and Weight

IAC0201 Describe procedures for taring, calibrating, cleaning and maintain manufacturing equipment

IAC0202 Define active pharmaceutical ingredients and inactive ingredients/excipients

IAC0203 Explain the pharmaceutical calculations for manufacturing and reconciliation and describe how they are used in the production of medicines

IAC0204 Explain the principles of manufacture and basic dosage form manufacturing processes

IAC0205 Describe the procedures and controls of assisting with addition of raw materials to the mix

IAC0206 Explain the production planning process

IAC0207 Describe the methods for specification tests, in-process control testing and in-process checks for the various dosage forms

IAC0208 Describe aseptic techniques with regards to preparation and maintenance of a sterile area, access controls, personnel protection, filling techniques, sterilisation techniques, packaging techniques etc.

IAC0209 Explain the concept of change control

IAC0210 Describe sampling procedures and the assistive role played by the Post Basic in sampling

IAC0211 Explain the principles of retaining retention samples

IAC0212 Explain the principles of deviation and change control and the processes for reporting deviations and errors

IAC0213 Explain the importance and purpose of batch documentation in the manufacturing process and describe the method of completing batch records

IAC0214 Describe the method of assisting with the drafting of SOPs for manufacturing

IAC0215 Explain the importance of quality water, storage and water processing during manufacturing (Weight 45%) 6.2.3 KM-06-KT03: Packing/packaging processes (30%) Topic elements to be covered include:

KT0301 Packaging line opening and closure

KT0302 Packaging techniques

KT0303 Disposal of unused, damaged or rejected labels bearing a particular batch number and packaging date

KT0304 Sampling of medicines or scheduled substances

KT0305 Documentation collation, reconciliation and storage Internal Assessment Criteria and Weight

IAC0301 Describe the operation of packaging equipment and explain the importance of correct equipment settings

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IAC0302 Explain the checking processes for packaging line opening and closure

IAC0303 Describe packaging techniques

IAC0304 Identify relevant documentation and processes for packaging and explain their purpose and importance in packing/packaging processes

IAC0305 Describe the procedures for collating and reconciling batch documentation

IAC0306 Describe the responsibilities of the pharmacist in in-process control testing

IAC0307 Describe the techniques used to sample medicines or scheduled substances

IAC0308 Describe the disposal processes for unused, damaged or rejected labels bearing a particular batch number and packaging date

IAC0309 Describe the procedures to clean/sterilise packaging equipment (Weight 30%) 6.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Accredited as provider with SAPC

Occupational Health and Safety requirements 6.4 Exemptions

None

7. 321301000-KM-07, Medicine manufacture (Pharmacy Technician), NQF Level 6, Credits 7.1 Purpose of the Knowledge Modules

The main focus of the learning in this knowledge module is to build an understanding of the implementation and monitoring of cGMP and relevant current legislation, handling materials at the level of the Pharmacy Technician, manufacturing and packaging processes for non-sterile or sterile medicines and scheduled substances. The learning will enable learners to demonstrate an understanding of:

KM-07-KT01: cGMP and current legislation (25%)

KM-07-KT02: Materials handling (Pharmacy Technician) (15%)

KM-07-KT03: Manufacturing process for non-sterile or sterile medicines (35%)

KM-07-KT04: Packaging processes (25%) 7.2 Guidelines for Topics 7.2.1 KM-07-KT01: cGMP and current legislation (25%) Topic elements to be covered include:

KT0101 Implementation, monitoring of and compliance to cGMP and relevant current legislation

KT0102 Responsibilities as per site master file

KT0103 Management of change in facilities, equipment or processes (principles of qualification of new equipment and validation principles and methods)

Internal Assessment Criteria and Weight

IAC0101 Explain the implementation and monitoring of cGMP and current legislation

IAC0102 Explain what is meant by cGMP compliance

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IAC0103 Explain the importance of ensuring the accuracy and safe retention of cGMP records

IAC0104 Explain ways of identifying non-compliance and resolving problems

IAC0105 Explain the importance of assuming responsibility in terms of the site master file

IAC0106 Explain the management of change in facilities, equipment or processes in terms of the cGMP

(Weight 25%) 7.2.2 KM-07-KT02: Materials handling (Pharmacy Technician) (15%) Topic elements to be covered include:

KT0201 Feedback to production planning

KT0202 Complying with recall procedures

KT0203 Reconciliation of returned stock

KT0204 Control of stored manufactured product and control over returns, destruction and reconciliation of excess packaging materials and raw materials

KT0205 Batch records Internal Assessment Criteria and Weight

IAC0201 Explain the importance of and procedures for providing feedback to production planning on stock levels and out of stock situations

IAC0202 Describe the assistive role played by the PT on developing the recall strategy

IAC0203 Describe the method of reconciling returned stock

IAC0204 Explain the method to control stored manufactured product and returns

IAC0205 Discuss the procedures to destroy and reconcile printed packaging materials and raw materials

IAC0206 Describe the process to complete batch records (Weight 15%) 7.2.3 KM-07-KT03: Manufacturing process for non-sterile or sterile medicines (35%) Topic elements to be covered include:

KT0301 Operation, calibration and maintenance of weighing equipment

KT0302 Preparation for manufacturing (including verifying receipt of product; taring scales and entering information into log book, or similar record)

KT0303 Calculations (including purity; percent yield; expiration dates; proportions; mass [w/v, w/w]; molar concentrations; ratios; dilutions)

KT0304 Authorisation processes of line clearance, opening line, line closure (including cleaning equipment and area; swabbing samples; reconciling components)

KT0305 Weighing materials

KT0306 Specification tests and in-process checks, interpretation of results

KT0307 Sampling of medicines (purpose and procedures)

KT0308 Resolution and reporting of deviations

KT0309 Destruction or disposal of waste products

KT0310 Documentation Internal Assessment Criteria and Weight

IAC0301 Explain the importance of regular calibration and maintenance of weighing equipment

IAC0302 Describe the preparatory activities when manufacturing medicines

IAC0303 Explain the concepts of purity, percent yield, expiration dates, proportions, mass (w/v, w/w), molar concentrations, ratios and dilutions

IAC0304 Explain the types of calculations necessary in the manufacturing environment

IAC0305 Explain the authorisation processes to conduct line clearance, and to open and close the line

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IAC0306 Describe the procedures to weigh materials and explain the importance of signing for every step of the process

IAC0307 Describe the procedures to operate weighing equipment, aseptic equipment and in process controls within the manufacturing environment

IAC0308 Explain the use and maintenance of the register for registers for certain scheduled products and explain the importance of the register

IAC0309 Explain the methods for conducting specification tests and in-process checks

IAC0310 Explain the method of interpreting results

IAC0311 Identify problems that may arise in the manufacturing process suggest possible solutions

IAC0312 Explain the purpose and methods of sampling and the methods for supervising sampling of medicines or scheduled substances

IAC0313 Explain the method of controlling manufacturing and aseptic processes

IAC0314 Describe the process of sterilising an aseptic area

IAC0315 Discuss the methods to destroy or dispose of waste products

IAC0316 Describe the handling and completion of batch documentation and records throughout the manufacturing process

IAC0317 Explain the approach for preparing an SOP for manufacturing

IAC0318 Explain how to supervise the preparation of aseptic manufacture and filling and how to prevent and monitor contamination

(Weight 35%) 7.2.4 KM-07-KT04: Packaging processes (25%) Topic elements to be covered include:

KT0401 Preparation for packaging (including verifying receipt of bulk product and components; checking and signing seals; calibrating scales and entering into log book)

KT0402 Line clearance, opening and closing packing line Internal Assessment Criteria and Weight

IAC0401 Describe the preparatory procedures for packaging products, including over-printing of packaging materials

IAC0402 Explain the authorisation processes for line clearance, open packing line and close packing lines

IAC0403 Explain the method of controlling packaging processes

IAC0404 Explain the control of and responsibility for batch documents and relevant documentation

IAC0405 Explain the security and access controls for packaging (Weight 25%) 7.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Accredited as provider with SAPC

Occupational Health and Safety requirements

7.4 Exemptions

None

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8. 321301000-KM-08, Compounding of non-sterile extemporaneous preparations (Basic), NQF Level 4, Credits 3

8.1 Purpose of the Knowledge Modules

The main focus of the learning in this knowledge module is to build an understanding of compounding of non-sterile extemporaneous preparations undertaken under the direct the supervision of a Pharmacy Technician or a pharmacist, with reference to cGMP and GPP. The learning will enable learners to demonstrate an understanding of:

KM-08-KT01: Compounding of non-sterile extemporaneous preparations (100%) 8.2 Guidelines for Topics 8.2.1 KM-08-KT01: Compounding of non-sterile extemporaneous preparations (100%) Topic elements to be covered include:

KT0101 Fundamental principles of extemporaneous compounding of simple solutions, suspensions, semi-solids and powders

KT0102 SOPs, formulae and extension of formulae

KT0103 Units and concentration

KT0104 Environment and equipment

KT0105 Materials, containers and labels

KT0106 Weighing and mixing procedures

KT0107 Documentation, batch numbers and expiry dates

KT0108 Labelling and documentation

KT0109 Recall, storage and disposal

KT0110 Principles of GMP, GPP and scope of practice Internal Assessment Criteria and Weight

IAC0101 Explain the fundamental principles of extemporaneous compounding of simple solutions, suspensions, semi-solids and powders

IAC0102 Explain the importance of working according to SOPs and formulae

IAC0103 Describe the use of different units used to describe quantities of liquids and solids and their importance in describing concentration

IAC0104 Explain the need for conversion of units of concentration from a % m/v to v/v notation to g/ml

IAC0105 Describe the processes to eliminate cross contamination of bulk stock

IAC0106 Describe the procedures to prepare equipment and the environment for compounding

IAC0107 Describe the operation and cleaning of equipment and apparatus used in compounding

IAC0108 Describe the use of a formula in compounding

IAC0109 Describe weighing and mixing procedures for compounding

IAC0110 Explain how batch numbers are allocated and expiry dates determined

IAC0111 Describe labelling and documentation procedures

IAC0112 Explain the procedure to recall a product

IAC0113 Describe waste disposal procedures

IAC0114 Describe the role of the pharmacist or pharmacist technician in compounding

IAC0115 Explain the importance of ethical principles and SOPs in compounding (Weight 100%) 8.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements

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Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Accredited as provider with SAPC

Occupational Health and Safety requirements

8.4 Exemptions

None

9. 321301000-KM-09, Compounding of sterile and non-sterile extemporaneous preparations (Post Basic), NQF Level 5, Credits 4

9.1 Purpose of the Knowledge Modules

The main focus of the learning in this knowledge module is to build an understanding of compounding a non-sterile products and sterile products by the admixture of sterile components using aseptic techniques. The learning will enable learners to demonstrate an understanding of:

KM-09-KT01: Extemporaneous compounding of non- sterile and sterile products according to SOPs and the principles of cGMP and GPP (100%)

9.2 Guidelines for Topics 9.2.1 KM-09-KT01: Extemporaneous compounding of non- sterile and sterile products according to

SOPs and the principles of cGMP and GPP (100%) Topic elements to be covered include:

KT0101 Equipment preparation, use, cleaning and sterilisation

KT0102 Calculation of quantities of required ingredients and the checking of calculations for the compounding of products

KT0103 Aseptic technique and the maintenance of sterility

KT0104 Compounding of non-sterile and sterile products (including intravenous admixtures, parenteral solutions, total parenteral nutrition) according to GMP, SOPs and GPP

KT0105 Quality control and assurance in compounding

KT0106 Personal hygiene and health in sterile product compounding Internal Assessment Criteria and Weight

IAC0101 Explain the fundamental principles of extemporaneous compounding of non-sterile and sterile products

IAC0102 Describe the preparation, use, cleaning and/or sterilisation of equipment and apparatus used in compounding

IAC0103 Describe the method of checking and confirming the prescribed formula

IAC0104 Explain how to calculate the quantities of the required ingredients for the compounding of products

IAC0105 Explain the calculations and the method of extending quantities of materials required to compound non-sterile and sterile products according to the relevant formula

IAC0106 Describe aseptic technique

IAC0107 Describe the importance of personal health and hygiene in the compounding of sterile and non-sterile products

IAC0108 Describe the role of the pharmacist or pharmacist technician in compounding

IAC0109 Discuss quality control and quality assurance requirements for the pharmacy technician (Weight 100%)

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9.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Accredited as provider with SAPC

Occupational Health and Safety requirements

9.4 Exemptions

None

10. 321301000-KM-10, Compounding of sterile and non-sterile extemporaneous preparations (Pharmacy Technician), NQF Level 6, Credits 4

10.1 Purpose of the Knowledge Modules

The main focus of the learning in this knowledge module is to build an understanding of the compounding of non-sterile and sterile products and the supervision of other assistants involved in the compounding process. The learning will enable learners to demonstrate an understanding of:

KM-10-KT01: Extemporaneous compounding of sterile and non-sterile medicines or scheduled substances, as per current legislation (100%)

10.2 Guidelines for Topics 10.2.1 KM-10-KT01: Extemporaneous compounding of sterile and non-sterile medicines or scheduled

substances, as per current legislation (100%) Topic elements to be covered include:

KT0101 cGMP, GPP and compounding, manipulating and preparation of sterile and non-sterile medicines (including scheduled medicines, as per current legislation)

KT0102 Compounding, manipulation and preparation processes and procedures for sterile and non-sterile medicines

KT0103 Recording procedures including manufacture and keeping of registers for specified scheduled medicines/substances

KT0104 Inspection processes for assessing the quality of all compounded medicines

KT0105 Calculations

KT0106 Quality control and assurance, checking procedures in a supervisory role

KT0107 Storage, expiry dates and distribution of non-sterile compounded medicines and sterile admixtures

KT0108 Recall procedures for compounded medicines

KT0109 Supervision of extemporaneous compounding

KT0110 Extemporaneous compounding of scheduled medicines, as per current legislation

KT0111 Legal control of scheduled substances Internal Assessment Criteria and Weight

IAC0101 Explain the principles of GMP and GPP in relation to the extemporaneous compounding, manipulation and preparation of non-sterile and sterile medicines, (including scheduled medicines, as per current legislation)

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IAC0102 Discuss the compounding, manipulation and preparation of sterile admixtures and non-sterile medicines, according to SOPs, process documentation, aseptic techniques and principles of GMP and/or GPP for specific patients

IAC0103 Discuss the compounding, manipulation and preparation of non-sterile medicines according to SOPs and process documentation, and in accordance with aseptic techniques and principles of GMP and/or GPP for specific patients

IAC0104 Describe the procedures to generate records for each of the preparations produced in accordance with legal requirements and organisational policies and procedures

IAC0105 Explain the calculations relevant to compounding of medicines and explain the conversions and calculations of concentrations of ingredients

IAC0106 Explain the role of the PT in quality assurance and supervision of compounding procedures undertaken by others

IAC0107 Describe the storage procedures for compounded medicines and discuss the expiry dates and distribution of sterile admixtures

IAC0108 Explain the method for supervising extemporaneous compounding

IAC0109 Explain the recall procedures for compounded medicines

IAC0110 Explain the method to extemporaneously compounding scheduled medicines, as per current legislation

IAC0111 Explain the importance of inspection processes for all compounded products

IAC0112 Explain the importance and implications of legal control of scheduled substances (Weight 100%) 10.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Accredited as provider with SAPC

Occupational Health and Safety requirements

10.4 Exemptions

None

11. 321301000-KM-11, Dispensing (Post Basic), NQF Level 5, Credits 12 11.1 Purpose of the Knowledge Modules

The main focus of the learning in this knowledge module is to build an understanding of the dispensing of medicines including all activities carried out by the Post Basic under strict and direct supervision of the pharmacist with reference to GPP, Code of Conduct and ethical rules. The learning will enable learners to demonstrate an understanding of:

KM-11-KT01: Dispensing prescriptions (45%)

KM-11-KT02: Patient interaction (15%)

KM-11-KT03: Pharmacist Initiated Therapy (PIT) (10%)

KM-11-KT04: Professional communication (12%)

KM-11-KT05: Health and wellness (8%)

KM-11-KT06: Medicine safety (10%) 11.2 Guidelines for Topics

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11.2.1 KM-11-KT01: Dispensing prescriptions (45%) Topic elements to be covered include:

KT0101 Phases of dispensing

KT0102 Type of prescriptions (including inpatient or discharge medications, acute and repeat prescriptions)

KT0103 Patient information on prescription and identity of the patient

KT0104 Standard Treatment Guidelines (STG) and Essential Medicines List (EML)

KT0105 Prescribers and relevant registration numbers

KT0106 Validation and verification procedures

KT0107 Types/classification of medical conditions

KT0108 Picking, selecting and labelling items for prescriptions, including warning labels

KT0109 Common potential medication interactions

KT0110 Calculations for appropriate number of dosage units

KT0111 Consent for generic substitution

KT0112 Medicine Utilisation Evaluation (MUE)

KT0113 Therapeutic classes

KT0114 Dispensing using patient ready packs in a PHC

KT0115 GPP principles

KT0116 Prescription records

KT0117 Error-avoidance mechanisms

KT0118 Pharmacovigilance (adverse drug reactions and reporting systems) Internal Assessment Criteria and Weight

IAC0101 Explain the phases of dispensing and discuss the responsibilities of the Pharmacist Assistant (Post Basic) in the dispensing process

IAC0102 Distinguish between the types of prescriptions and state the reasons why it is importance to know the differences

IAC0103 Describe the procedures to check patient identity and information on prescriptions

IAC0104 Explain verification procedures to validate prescribers and their registration numbers

IAC0105 Explain verification procedures for legality of prescriptions and prescriptions according to current legislation

IAC0106 Explain the procedures to check compliance with EML and STG

IAC0107 Describe procedures to pick items, select appropriate containers for items and label items

IAC0108 Explain the reason for and the importance of signing and getting a pharmacist to counter-sign the prescription

IAC0109 Explain the calculations to be performed for number of dosage units

IAC0110 Explain what is meant by potential medication interactions and adverse drug events

IAC0111 Explain the process and importance of obtaining consent for generic substitution

IAC0112 Explain the importance of checking expiry dates of medicines

IAC0113 Explain the concept Medicine Utilisation Evaluation (MUE) and describe the method of collecting information for the MUE

IAC0114 Describe role of pharmacist in dispensing procedures

IAC0115 Explain the identification of medications according to therapeutic classes

IAC0116 Explain the importance of complying with GPP standards

IAC0117 Explain the principles when distributing medication to wards

IAC0118 Describe prescription recording procedures

IAC0119 Describe the procedures for re-ordering items that have a balance to follow

IAC0120 Explain the use of error-avoidance mechanisms in dispensing

IAC0121 Discuss the concept of pharmacovigilance

IAC0122 Explain the types of information that must be provided to the patient (including but not limited to indications, storage instructions, side effects, directions, usage)

(Weight 45%) 11.2.2 KM-11-KT02: Patient interaction (15%)

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Topic elements to be covered include:

KT0201 Patient trust, confidentiality, consent

KT0202 Patient information

KT0203 Patient’s conditions (acute, chronic, minor or self-limiting, co-morbidities and medicine allergies)

KT0204 Communication skills

KT0205 Electronic communication etiquette Internal Assessment Criteria and Weight

IAC0201 Discuss how a trusting relationship can be established with the patient

IAC0202 Explain the importance of patient confidentiality, consent and patient rights

IAC0203 Describe the process of obtaining information pertaining to the patient’s health care needs

IAC0204 Explain the importance of consulting with the pharmacist, regarding the patient’s symptoms

IAC0205 Explain the importance of communication skills especially in situations where there are language or cultural barriers

(Weight 15%) 11.2.3 KM-11-KT03: Pharmacist Initiated Therapy (PIT) (10%) Topic elements to be covered include:

KT0301 Identification of patients’ minor/common medical conditions

KT0302 Abuse potential

KT0303 Scheduled medicines (as per current legislation) for PIT items Internal Assessment Criteria and Weight

IAC0301 Describe procedures to collect information to appropriately identify and manage patients’ common medical conditions

IAC0302 Explain the importance and method of monitoring abuse potential

IAC0303 Demonstrate an understanding of the principles of Pharmacist Initiated Therapy in accordance with GPP

IAC0304 Explain the process of selecting appropriate PIT medicine (Weight 10%) 11.2.4 KM-11-KT04: Professional communication (12%) Topic elements to be covered include:

KT0401 Professional etiquette (professional communication with, health team, healthcare professionals and patients)

KT0402 Principles and concepts of health and illness behaviour

KT0403 Customer service skills

KT0404 Patient referral

KT0405 Direct and indirect supervision Internal Assessment Criteria and Weight

IAC0401 Describe how to communicate professionally and effectively with members of the health team, healthcare professionals and patients

IAC0402 Explain how to apply principles of health and illness behaviour when communicating with patients

IAC0403 Discuss effective customer service skills

IAC0404 Describe patient referral procedures

IAC0405 Explain the concepts of direct and indirect supervision as it relates to PSPs (Weight 12%)

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11.2.5 KM-11-KT05: Health and wellness (8%) Topic elements to be covered include:

KT0501 Direct and indirect supervision

KT0502 Socio-economic factors

KT0503 Preventative measures and lifestyle modification options Internal Assessment Criteria and Weight

IAC0501 Explain the concepts of health and wellness in terms of disease and disability

IAC0502 Identify and discuss socio-economic factors that contribute to health and wellness dysfunction and give examples

IAC0503 Explain preventative measures and lifestyle modification options in relation to the identified condition

(Weight 8%) 11.2.6 KM-11-KT06: Medicine safety (10%) Topic elements to be covered include:

KT0601 Forged prescriptions

KT0602 Dispensing containers

KT0603 Re-use of containers

KT0604 Re-use of medicines

KT0605 Re-calls

KT0606 Personal hygiene

KT0607 Expiry dates Internal Assessment Criteria and Weight

IAC0601 Explain the implications of forged prescriptions

IAC0602 Explain the use and re-use of dispensing containers

IAC0603 Explain how and under what circumstances medicines are re-used

IAC0604 Explain how are when medicines are re-called

IAC0605 Explain the importance of personal hygiene in the dispensing process

IAC0606 Explain why it is important to monitor the expiry dates of medicines (Weight 10%) 11.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

Related Qualification at a higher NQF level

Assessor registered with SAPC

As per SAPC requirements Legal Requirements:

Accredited as provider with SAPC

Occupational Health and Safety requirements

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11.4 Exemptions

None

12. 321301000-KM-12, Dispensing (Pharmacy Technician), NQF Level 6, Credits 11 12.1 Purpose of the Knowledge Modules

The main focus of the learning in this knowledge module is to build an understanding of dispensing procedures, health promotion activities and patient care undertaken by the PT with reference to GPP, Code of Conduct and ethical rules. The learning will enable learners to demonstrate an understanding of:

KM-12-KT01: Dispensing (50%)

KM-12-KT02: Health promotion (15%)

KM-12-KT03: Patient care (35%)

12.2 Guidelines for Topics 12.2.1 KM-12-KT01: Dispensing (50%) Topic elements to be covered include:

KT0101 Calculations (dosages (e.g., mg per kg prescribed and body surface area); quantities to be dispensed; percentage concentrations (i.e., w/w, w/v, v/v); flow rates and infusion times for intravenous medications; ratios and proportions; conversion between measurement units (i.e., mg to g to kg) for dilutions and allegation)

KT0102 Interaction with the patient (effects of medicines; instructions, warning)

KT0103 GPP

KT0104 Dispensing in a PHC or any other facility (including approval by Council and according to STG EML)

KT0105 Queuing of prescriptions as a part of prescriptions/dispensing

KT0106 Checking prescriptions dispensed by other Mid-Level Workers (MLWs)

KT0107 Sale of S1 medicines

KT0108 Error identification Internal Assessment Criteria and Weight

IAC0101 Explain percentage concentrations, flow rates and infusion times for intravenous medications, ratios and proportions, conversion between measurement units for dilutions and allegation

IAC0102 Explain how these calculations are performed

IAC0103 Describe the elements relevant to patient interaction

IAC0104 Explain the importance and application of GPP in the dispensing process

IAC0105 Discuss dispensing in a PHC or any other facility

IAC0106 Discuss the checking of prescriptions dispensed by other MLWs

IAC0107 Discuss the sale of self-care medicines

IAC0108 Describe the various categories of dispensing errors and discuss the avoidance and management of errors

(Weight 50%) 12.2.2 KM-12-KT02: Health promotion (15%) Topic elements to be covered include:

KT0201 Basic hygiene, infection control and healthy lifestyle

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KT0202 Community health projects

KT0203 Health deficiencies in the community Internal Assessment Criteria and Weight

IAC0201 Describe the ways to promote basic hygiene, infection control and healthy lifestyle

IAC0202 Describe ways of initiating and participation in community health projects

IAC0203 Describe the ways of identifying health deficiencies within the local community and conducting programmes to address the deficiencies

(Weight 15%) 12.2.3 KM-12-KT03: Patient care (35%) Topic elements to be covered include:

KT0301 Patient care skills

KT0302 Patient confidentiality

KT0303 Patient rights charter

KT0304 Patient consent

KT0305 Therapeutic outcomes

KT0306 Adherence and compliance

KT0307 Medicine storage for patients

KT0308 Medication history taking and referral

KT0309 Patient counselling techniques

KT0310 Special patient populations (paediatrics; geriatrics) Internal Assessment Criteria and Weight

IAC0301 Discuss patient care skills and the application thereof in a pharmacy environment

IAC0302 Explain the importance of patient confidentiality

IAC0303 Discuss the patient right charter in terms of its applicability to a pharmacy technician

IAC0304 Explain the importance of obtaining patient consent before taking any decisions

IAC0305 Explain the identification of medications according to therapeutic classes and outcomes

IAC0306 Describe the method of taking a patient’s history

IAC0307 Discuss the patient referral process

IAC0308 Explain what information must be given to patients regarding safe storage of medicines

IAC0309 Discuss patient counselling techniques and their application in the context of the occupation of pharmacy technician

(Weight 35%) 12.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Accredited as provider with SAPC

Occupational Health and Safety requirements

12.4 Exemptions

None

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13. 321301000-KM-13, Screening and testing patients (Pharmacy Technician), NQF Level 6, Credits 2

13.1 Purpose of the Knowledge Modules

The main focus of the learning in this knowledge module is to build an understanding of screening and testing patients. The learning will enable learners to demonstrate an understanding of:

KM-13-KT01: Screening and testing patient (100%) 13.2 Guidelines for Topics 13.2.1 KM-13-KT01: Screening and testing patient (100%) Topic elements to be covered include:

KT0101 Patient demographic data

KT0102 Clinical tests (including, but not limited to: blood pressure; blood glucose; cholesterol; HbA1c; urine screen; pregnancy test; HIV antibody test; peak flow assessment)

KT0103 Medical waste

KT0104 Testing preparation and procedures Internal Assessment Criteria and Weight

IAC0101 Describe methods of collecting information for patient demography data

IAC0102 Explain the procedures of the clinical tests that pharmacist technicians perform

IAC0103 Explain the importance of the aspects that must be covered during the interaction between the PT and the patient prior to performing the test

IAC0104 Describe the preparation and the procedures for the test and demonstrate the importance of applying them correctly

IAC0105 Describe the documentation of the testing process

IAC0106 Explain the application of the procedures to deal with medical wastes

IAC0107 Describe the role of the pharmacist in screening tests (Weight 100%) 13.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

Related Qualification at a higher NQF level

Assessor registered with SAPC

As per SAPC requirements Legal Requirements:

Accredited as provider with SAPC

Occupational Health and Safety requirements 13.4 Exemptions

None

14. 321301000-KM-14, Managing pharmacy resources (Pharmacy Technician), NQF Level 6, Credits 10

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14.1 Purpose of the Knowledge Modules

The main focus of the learning in this knowledge module is to build an understanding of managing pharmacy resources, using management related theory. The learning will enable learners to demonstrate an understanding of:

KM-14-KT01: Staff supervision and management (14%)

KM-14-KT02: Time management (8%)

KM-14-KT03: Problem-solving (8%)

KM-14-KT04: Basic financial management in a pharmacy environment (11%)

KM-14-KT05: Facilities management (10%)

KM-14-KT06: Operational management (10%)

KM-14-KT07: Quality assurance (QA) (12%)

KM-14-KT08: Conflict management (8%)

KM-14-KT09: Diversity management (8%)

KM-14-KT10: Research and report-writing (11%) 14.2 Guidelines for Topics 14.2.1 KM-14-KT01: Staff supervision and management (14%) Topic elements to be covered include:

KT0101 Basic principles of Human resource management (HRM)

KT0102 Categories of staff (in cleaning but not limited to cleaning staff, front shop assistants, and other mid-level workers)

KT0103 Schedule for staff training

KT0104 Workflow in team situations

KT0105 Meetings

KT0106 Audit team queries

KT0107 Staff productivity

KT0108 Continuing professional development (CPD)

KT0109 Types of training (including safety training)

KT0110 Teamwork (other health care professionals)

KT0111 Leadership and mentorship Internal Assessment Criteria and Weight

IAC0101 Discuss the principles of HRM as they pertain to PSP

IAC0102 Describe the different types and levels of staff in a pharmacy environment

IAC0103 Discuss the principles of supervision in the context of a pharmacy and ways of applying these principles

IAC0104 Discuss ways of managing, monitoring, supervising and motivating staff

IAC0105 Discuss the importance and the method of scheduling staff training

IAC0106 Describe how to monitor workflow in team situations and identify ways of improving productivity

IAC0107 Discuss how meetings are conducted and describe the constituent elements of meetings procedure

IAC0108 Discuss how to assist in responding to audit team queries

IAC0109 Discuss how to delegate and conduct performance appraisal

IAC0110 Explain the importance of CPD

IAC0111 Describe the different types of training PSP could undergo

IAC0112 Describe ways of orientating new employees (induction process)

IAC0113 Describe how to use problem-solving techniques to resolve problems within the scope of a PT

IAC0114 Discuss the principles of team building in the context of a pharmacy and ways of applying these principles

IAC0115 Discuss the concepts of leadership and mentorship as they pertain to PSP

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(Weight 14%) 14.2.2. KM-14-KT02: Time management (8%) Topic elements to be covered include:

KT0201 Concept of time management

KT0202 Identify and discuss the principles of time management

KT0203 Time management techniques (prioritisation of tasks etc.)

KT0204 Time wasters Internal Assessment Criteria and Weight

IAC0201 Explain the concept and importance of time management

IAC0202 Identify and discuss the principles of time management

IAC0203 Discuss ways in which to prioritise tasks

IAC0204 Identify and discuss the top time wasters that impact on the organisation's productivity (Weight 8%) 14.2.3 KM-14-KT03: Problem-solving (8%) Topic elements to be covered include:

KT0301 Analytical thinking skills

KT0302 Techniques to deconstruct problems

KT0303 Techniques to generate possible solutions Internal Assessment Criteria and Weight

IAC0301 Discuss what is meant by analytical thinking

IAC0302 Discuss other problem solving techniques (Weight 8%) 14.2.4 KM-14-KT04: Basic financial management in a pharmacy environment (11%) Topic elements to be covered include:

KT0401 Business maths and financial concepts (including but not limited to consistency, accountability, transparency, integrity, financial stewardship, accounting standards)

KT0402 Budgeting in a PHC

KT0403 Reporting periods and reporting formats (reporting including types of reports, generating reports, assessing and using the information effectively)

KT0404 Source documents (storage and retrieval)

KT0405 Financial risks in a pharmacy environment

KT0406 ABC and VEN analysis of medicine usage

KT0407 Time value of money Internal Assessment Criteria and Weight

IAC0401 Explain business maths and financial concepts relevant to a Pharmacy Technician

IAC0402 Explain budgeting in a pharmacy environment

IAC0403 Describe the aspects associated with reporting

IAC0404 Describe the source documents in the pharmacy and explain their importance

IAC0405 Discuss the financial risks in a pharmacy environment and ways of mitigating them

IAC0406 Explain the ABC and VEN analysis of medicine usage

IAC0407 Explain the concept time value of money

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(Weight 11%) 14.2.5 KM-14-KT05: Facilities management (10%) Topic elements to be covered include:

KT0501 PHC dispensary management; pharmacy management; thermolabile products and cold chain management

KT0502 Assets (equipment etc.)

KT0503 Health and safety; fire safety; security; maintenance, testing and inspections; space allocation and changes, cleaning; etc.

Internal Assessment Criteria and Weight

IAC0501 Explain what is meant by PHC dispensary management, pharmacy management and thermolabile products and cold chain management

IAC0502 Discuss what facilities management entails in the context of a Pharmacy Technicians’ scope of activities

(Weight 10%) 14.2.6 KM-14-KT06: Operational management (10%) Topic elements to be covered include:

KT0601 Concept of operational management in a pharmacy environment

KT0602 Decision-making

KT0603 Forecasting

KT0604 Inventory management

KT0605 Operations scheduling

KT0606 Materials requirements planning (MRP) Internal Assessment Criteria and Weight

IAC0601 Discuss what facilities management entails in the context of a Pharmacy Technicians’ scope of activities

IAC0602 Explain decision-making processes in a pharmacy environment

IAC0603 Explain the concept of forecasting

IAC0604 Explain aspects related to inventory management

IAC0605 Discuss the scheduling of operations in a pharmacy environment

IAC0606 Discuss materials requirements planning in a pharmacy environment (Weight 10%) 14.2.7 KM-14-KT07: Quality assurance (QA) (12%) Topic elements to be covered include:

KT0701 Definition of terms (quality assurance versus quality control and cGMP)

KT0702 Key elements of QA

KT0703 Quality assurance tools

KT0704 Consequences of QA breaches

KT0705 Quality improvement plan Internal Assessment Criteria and Weight

IAC0701 Define quality assurance in the various categories of pharmacy

IAC0702 Describe the characteristics of quality assurance throughout the pharmaceutical management system

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IAC0703 Explain the effects of inadequate pharmaceutical management quality assurance

IAC0704 Describe the characteristics of a good QA programme and the tools for achieving this

IAC0705 Describe the entities responsible for QA and their respective roles at various levels of the supply chain

IAC0706 Explain the importance of implementing a quality improvement plan (Weight 12%) 14.2.8 KM-14-KT08: Conflict management (8%) Topic elements to be covered include:

KT0801 Conflict generators (prejudice, stressors, deadline pressures, unmet expectations, conflict in creative vision, miscommunication and absence of communications)

KT0802 Conflict management techniques (listening skills, ignoring, imposing a solution, finding a solution through a consultative process)

KT0803 Teamwork

KT0804 Organisational culture (code of conduct and disciplinary procedures; respect and integrity) Internal Assessment Criteria and Weight

IAC0801 List the potential causes of interpersonal tensions and conflict in a pharmacy

IAC0802 Explain how conflict management techniques can be employed to mitigate pharmacy tensions

IAC0803 Describe the role of teamwork in maintaining good cooperative relationships, and the individual behaviours that contribute to effective teamwork

IAC0804 Describe how the law and own workplace code define and deal with sexual harassment, prejudicial speech and behaviour and other forms of inappropriate workplace conduct

IAC0805 Describe the individuals and processes that deal with these issues in own workplace

IAC0806 Discuss the formal and informal measures that a newsroom can employ to foster a positive working climate and evaluate the potential effectiveness of different measures

(Weight 8%) 14.2.9 KM-14-KT09: Diversity management (8%) Topic elements to be covered include:

KT0901 Diversity (includes differences in culture, language, ideology, philosophy, age, race, prejudice, stereotypes, sexual orientation, gender, faith, class, socialisation, nationality, personality and education on a macro and/or micro scale)

KT0902 Identities (include, but are not limited to social [ethnicity], professional, national, corporate, cultural, race, class, gender and religious identities)

KT0903 Community is about groups of people with at least one thing in common including, but not limited to, geographic location, faith, interest, common values, common concerns, needs and goals

KT0904 Socialisation institutions including, but not limited to, family, school, faith based organisations, workplaces, sectors, communities and social networks

KT0905 Entrenched, recurring patterns of behaviour in a group or sub-group

KT0906 Power and privilege (power includes power vested in groups and individuals, entrenched power and specialised or expert power)

KT0907 Stereotyping, discrimination, exclusion

KT0908 Framework for diversity management (programmes, business plans, performance management process

Internal Assessment Criteria and Weight

IAC0901 Explain the concept of diversity in terms of South African society

IAC0902 Explain the concept of identities and multiple and intersecting identities

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IAC0903 Explain the concept of community with respect to South Africa

IAC0904 Analyse the role of socialisation institutions in influencing perceptions and stereotypes of other people

IAC0905 Discuss the concepts of power and privilege with reference to a specific community/organisation

IAC0906 Explain how stereotyping, discrimination, exclusion impact on interpersonal relationships in an organisation

IAC0907 Explain how a framework can be developed for effective diversity management in an organisation

(Weight 8%) 14.2.10 KM-14-KT10: Research and report-writing (11%) Topic elements to be covered include:

KT1001 Data collection and collation techniques (mainly for MUE)

KT1002 Research techniques relevant to the work of a Pharmacy Technician (internet usage etc.)

KT1003 Report writing skills

KT1004 SOPs Internal Assessment Criteria and Weight

IAC1001 Explain data collection and collation techniques used by the Pharmacy Technician in relation to the MUE

IAC1002 Discuss research techniques required by the Pharmacy Technician

IAC1003 Identify report writing skills useful to a Pharmacy Technician

IAC1004 Explain the techniques of obtaining feedback from Pharmacy Assistants on SOPs

IAC1005 Explain the process of updating SOPs (Weight 11%) 14.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements

Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Accredited as provider with SAPC

Occupational Health and Safety requirements

14.4 Exemptions

None

15. 321301000-KM-15, General housekeeping (Basic), NQF Level 4, Credits 2 15.1 Purpose of the Knowledge Modules

The main focus of the learning in this knowledge module is to build an understanding of general housekeeping in a pharmacy. The learning will enable learners to demonstrate an understanding of:

KM-15-KT01: General housekeeping (100%)

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15.2 Guidelines for Topics 15.2.1 KM-15-KT01: General housekeeping (100%) Topic elements to be covered include:

KT0101 Administrative tasks (including electronic administrative tasks)

KT0102 General cleaning and merchandising

KT0103 Dispensary consumables

KT0104 Cleaning procedures Internal Assessment Criteria and Weight

IAC0101 Identify the administrative tasks conducted by the Basic in a pharmacy environment

IAC0102 Explain the importance of good housekeeping in a pharmacy environment

IAC0103 Describe the general cleaning and merchandising procedures

IAC0104 Describe the procedures to maintain the supply of dispensary consumables (Weight 100%) 15.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Accredited as provider with SAPC

Occupational Health and Safety requirements

15.4 Exemptions

None

16. 321301000-KM-16, Administration and housekeeping (Post Basic), NQF Level 4, Credits 3

16.1 Purpose of the Knowledge Modules

The main focus of the learning in this knowledge module is to build an understanding of administration and housekeeping performed by the Pharmacy Technician. The learning will enable learners to demonstrate an understanding of:

KM-16-KT01: Administration and housekeeping (60%)

KM-16-KT02: Information and Communication Technology (ICT) (40%) 16.2 Guidelines for Topics 16.2.1 KM-16-KT01: Administration and housekeeping (60%) Topic elements to be covered include:

KT0101 Patient profiles

KT0102 Self-inspection and internal audits

KT0103 SOPs

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Internal Assessment Criteria and Weight

IAC0101 Describe the procedures to update patient profiles

IAC0102 Describe how self-inspection and internal audits are conducted

IAC0103 Describe the procedures to update SOPs (Weight 60%) 16.2.2 KM-16-KT02: Information and Communication Technology (ICT) (40%) Topic elements to be covered include:

KT0201 Computer peripherals

KT0202 Computer software applications

KT0203 Inventory reports

KT0204 Orders

KT0205 Inventory projections and quantification

KT0206 Inventory expenditure Internal Assessment Criteria and Weight

IAC0201 Explain the installation, configuration and operation of relevant computer peripherals in accordance with manufacturer’s specifications and instructions

IAC0202 Explain the installation, configuration and operation of relevant computer software applications in accordance with manufacturer’s specifications and instructions

IAC0203 Describe how to produce relevant inventory reports in the required format according to the software functions and applications and how to interpret them

IAC0204 Describe how to generate inventory projections and quantification in the required format according to the software functions and applications

IAC0205 Describe how orders are generated in the required format using the relevant report application

IAC0206 Describe how inventory expenditure is tracked and produced using the relevant software application

(Weight 40%) 16.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Accredited as provider with SAPC

Occupational Health and Safety requirements

16.4 Exemptions

None

17. 321301000-KM-17, Body systems, disorders and commonly used medicines (Post Basic), NQF Level 5, Credits 15

17.1 Purpose of the Knowledge Modules

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The main focus of the learning in this knowledge module is to build an understanding of body systems and disorders and commonly used medicines.

The learning will enable learners to demonstrate an understanding of:

KM-17-KT01: Anatomy, physiology & pathophysiology (40%)

KM-17-KT02: Basic Pharmacology (30%)

KM-17-KT03: Top 200 medicines based on usage (30%)

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17.2 Guidelines for Topics 17.2.1 KM-17-KT01: Anatomy, physiology & pathophysiology (40%) Topic elements to be covered include:

KT0101 Dental and oral

KT0102 Gastro-intestinal

KT0103 Endocrine system

KT0104 Nutrition and blood

KT0105 Cardiovascular conditions

KT0106 Skin

KT0107 Reproductive

KT0108 Renal

KT0109 Infections and related conditions

KT0110 Immune system

KT0111 Musculoskeletal

KT0112 Central and peripheral nervous systems

KT0113 Respiratory system

KT0114 Eye, ear, nose and throat Internal Assessment Criteria and Weight

IAC0101 Explain and discuss basic concepts of anatomy and physiology

IAC0102 Explain and describe basic pathophysiology in terms of conditions listed in the Primary Care STG and EML

(Weight 40%) 17.2.2 KM-17-KT02: Basic Pharmacology (30%) Topic elements to be covered include:

KT0201 Pharmacodynamic

KT0202 Pharmacokinetics

KT0203 Toxicology

KT0204 Pharmacovigilance

KT0205 Package inserts and Patient Information Leaflets (PILs) Internal Assessment Criteria and Weight

IAC0201 Explain basic principles and concepts of pharmacodynamics

IAC0202 Explain basic principles and concepts of pharmacokinetics

IAC0203 Define toxicology and list medicines commonly taken in overdose

IAC0204 Define pharmaco-vigilance and know the procedure for reporting of adverse drug events

IAC0205 Define elements found in package inserts and Patient Information Leaflets (Weight 30%) 17.2.3 KM-17-KT03: Top 200 medicines based on usage (30%) Topic elements to be covered include:

KT0301 Acute, Chronic and OTC treatable conditions

KT0302 Standard Treatment Guidelines (STG) and Essential Medicines List (EML)

KT0303 Basic classification of medical conditions (ICD 10)

KT0304 Basic pharmacological classification of medicines

KT0305 Medicine related reference skills

KT0306 Clinical uses of Top 200 medicines

KT0307 Adverse Drug reactions, Contraindications, Special precautions

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Internal Assessment Criteria and Weight

IAC0301 Differentiate between acute, chronic and OTC treatable conditions

IAC0302 Explain principles embedded in the STG and EML

IAC0303 Classify medical conditions in the STG and EML according to ICD10

IAC0304 Classify Top 200 medicines according to therapeutic class

IAC0305 List therapeutic uses of Top200 medicines

IAC0306 Identify important adverse drug reactions, contraindications and special precautions of Top 200 medicines

IAC0307 Use reference skills to acquire information about medicines (Weight 30%) 17.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Accredited as provider with SAPC

Occupational Health and Safety requirements

17.4 Exemptions

None

18. 321301000-KM-18, Pharmacological and non-pharmacological management of common communicable and non-communicable disease states and conditions (Pharmacy Technician), NQF Level 6, Credits 18

18.1 Purpose of the Knowledge Modules

The main focus of the learning in this knowledge module is to build an understanding of communicable and non-communicable disease states and conditions, their treatment and OTC condition management processes. The learning will enable learners to demonstrate an understanding of:

KM-18-KT01: Communicable and non-communicable disease states and conditions (80%)

KM-18-KT02: Management of minor ailments (20%) 18.2 Guidelines for Topics 18.2.1 KM-18-KT01: Communicable and non-communicable disease states and conditions (80%) Topic elements to be covered include:

KT0101 Communicable and non-communicable disease states and conditions

KT0102 Clinical properties of medicines used to treat communicable and non-communicable disease states and conditions

KT0103 Application of pharmacological concepts Internal Assessment Criteria and Weight

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IAC0101 Identify, describe and differentiate between communicable and non-communicable disease states and conditions found in the STG and EML

IAC0102 Identify, describe and differentiate between clinical properties of medicines for conditions found in the STG and EML and Primary Care

IAC0103 Apply pharmacological concepts in terms of evaluating medicines used in the management of communicable and non-communicable disease states and conditions

(Weight 80%) 18.2.2 KM-18-KT02: Management of minor ailments (20%) Topic elements to be covered include:

KT0201 Chronic conditions

KT0202 Clinical properties of medicines used to treat chronic conditions

KT0203 Application of pharmacological concepts Internal Assessment Criteria and Weight

IAC0201 Identify, describe and differentiate between chronic conditions found in the STG and EML

IAC0202 Identify, describe and differentiate between clinical properties of medicines for conditions found in the STG and EML, Primary Care

IAC0203 Apply pharmacological concepts in terms of evaluating medicines used in the management of acute and chronic conditions

(Weight 20%) 18.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Accredited as provider with SAPC

Occupational Health and Safety requirements

18.4 Exemptions

None

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SECTION 3B: PRACTICAL SKILL MODULE SPECIFICATIONS List of Practical Skill Module Specifications

321301000-PM-01, Distribute and control stock as per current legislation (Basic), NQF Level 4, Credits 4

321301000-PM-02, Manage stock, as per current legislation (Post Basic), NQF Level 5, Credits 6

321301000-PM-03, Manage supply chain (Pharmacy Technician), NQF Level 6, Credits 5

321301000-PM-04, Manufacture non-sterile medicines (Basic), NQF Level 4, Credits 6

321301000-PM-05, Manufacture non-sterile and sterile medicines (Post Basic), NQF Level 5, Credits 8

321301000-PM-06, Manufacture non-sterile and sterile medicines (Pharmacy Technician), NQF Level 6,

Credits 8

321301000-PM-07, Compound non-sterile extemporaneous preparations (Basic), NQF Level 4, Credits 5

321301000-PM-08, Compound sterile and non-sterile extemporaneous preparations, as per current

legislation (Post Basic), NQF Level 5, Credits 6

321301000-PM-09, Compound sterile and non-sterile extemporaneous preparations, as per current

legislation (Pharmacy Technician), NQF Level 6, Credits 7

321301000-PM-10, Dispense medicines (Post Basic), NQF Level 5, Credits 14

321301000-PM-11, Dispense medicines (Pharmacy Technician), NQF Level 6, Credits 12

321301000-PM-12, Perform general housekeeping and administrative tasks in the pharmacy (Basic),

NQF Level 4, Credits 2

321301000-PM-13, Perform general housekeeping and administrative tasks in the pharmacy (Post

Basic), NQF Level 5, Credits 3

321301000-PM-14, Conduct screening tests (Pharmacy Technician), NQF Level 6, Credits 3

321301000-PM-15, Manage pharmacy resources and self-development (Pharmacy Technician), NQF

Level 6, Credits 10

321301000-PM-16, Identify anatomical structures (Post Basic), NQF Level 5, Credits 15

321301000-PM-17, Conduct practical activities to optimise therapy for patients (Pharmacy Technician),

NQF Level 6, Credits 15

321301000-PM-18, Operate computers and computer software (Basic), NQF Level 4, Credits 4

1. 321301000-PM-01, Distribute and control stock as per current legislation (Basic), NQF Level 4, Credits 4

1.1 Purpose of the Practical Skill Modules

The focus of the learning in this module is on providing the learner an opportunity to receive and store stock, pick, pack and distribute orders and to participate in stock counts and stock takes, with regards to GWDP and GPP and financial principles. The learner will be required to:

PM-01-PS01: Receive and store stock orders

PM-01-PS02: Pick, pack and distribute orders

PM-01-PS03: Perform stock counts and participate in stock taking 1.2 Guidelines for Practical Skills 1.2.1 PM-01-PS01: Receive and store stock orders Scope of Practical Skill Given a delivery of stock, the learner must be able to:

PA0101 Conduct the relevant checks according to SOP (checks include delivery address, order number, batch numbers, invoice numbers, cold chain)

PA0102 Place received stock order in a separate designated receiving area

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PA0103 Unpack, check and store all items that require special handling conditions, according to SOPs

PA0104 Check that all items received match what was invoiced and what was ordered

PA0105 Check that all items delivered are suitable to retain and use (expiry dates, damage)

PA0106 Handle and pack all items in the correct location using FEFO and FIFO principles

PA0107 Capture all received stock/supplies on electronic or stock card system

PA0108 Balance, use and interpret electronic or manual stock record (including performing calculations)

PA0109 File all documents appropriately

PA0110 Notify the pharmacist/pharmacy technician about discrepancies (including, short-dated, damaged, under or over-supply, incorrect item)

PA0111 Process credits for items to be returned Applied Knowledge

AK0101 Off-loading, receiving, checking, unpacking, packing, handling, information (data) capturing, storing, filing procedures

AK0102 Designated areas

AK0103 Handling and storage of medicines requiring special handling

AK0104 Reconciliation procedures for ordered and received stock

AK0105 Electronic and manual capturing systems (including stock card calculations)

AK0106 FEFO and FIFO principles

AK0107 Management of stock receipt discrepancies

AK0108 Administrative procedures (including recordkeeping)

AK0109 Processes for items to be returned

AK0110 Role of pharmacist/PT

AK0111 Current legislation (Medicines ACT, GPP) Internal Assessment Criteria

IAC0101 All relevant checks pertaining to receipt and storage of stock are conducted according to SOPs

IAC0102 Packing and handling procedures for stock are performed according to FEFO and FIFO principles, where applicable

IAC0103 Received stock/supplies are captured on electronic and manual systems

IAC0104 Calculations that enable stock reconciliation are performed and pharmacist is informed about discrepancies

IAC0105 All administrative requirements pertaining to receipt, storage and return of stock are conducted according to relevant SOPs

1.2.2 PM-01-PS02: Pick, pack and distribute orders Scope of Practical Skill Given a picking list and stock (schedules appropriate for the scope of a basic assistant), the learner must

be able to:

PA0201 Pick and pack orders for medicines or scheduled substances (in terms of current legislation), according to picking list

PA0202 Despatch checked orders for stock and scheduled substances

PA0203 Complete appropriate documentation for picking, packing and dispatching orders

PA0204 Ensure that appropriate authorisation is obtained from pharmacist/pharmacy technician for picking, packing and dispatching orders

PA0205 Stock automated dispensing units (ADUs) Applied Knowledge

AK0201 Picking and packing procedures

AK0202 Dispatch procedures

AK0203 Documentation

AK0204 Authorisation procedures

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AK0205 ADUs

AK0206 GWDP

AK0207 Current legislation (Medicines Act, GPP) Internal Assessment Criteria

IAC0201 Orders are picked, packed, checked and despatched according to relevant procedures, SOPs and authorisation from pharmacist

IAC0202 Documentation pertaining to picking, packing, checking and despatching is completed according to SOPs

IAC0203 Obtain validation, as legally required for certain schedules, from pharmacist/pharmacy technician prior to dispatching orders

IAC0204 ADUs are stocked according to SOPs 1.2.3 PM-01-PS03: Perform stock counts and participate in stock taking Scope of Practical Skill Given stock, the learner must be able to:

PA0301 Identify and remove expired and discontinued medicines or medical devices (where applicable)

PA0302 Participate in stock takes as scheduled

PA0303 Perform stock counts (including FEFO and FIFO principles)

PA0304 Identify medicines and medical related items to be ordered

PA0305 Report out-of-stock items and elevate to pharmacist

PA0306 Identify slow moving and overstocked items and report to the pharmacist technician/pharmacist

Applied Knowledge

AK0301 Expired/discontinued/slow moving/overstocked medicines or medical devices

AK0302 Stock taking procedures

AK0303 Stock counting procedures (cyclic, monthly, quarterly and annually)

AK0304 Stock rotation

AK0305 Reporting procedures Internal Assessment Criteria

IAC0301 Expired and discontinued medicines or medical devices are removed according to SOPs

IAC0302 Stock takes and stock counts are carried out according to schedules and FEFO and FIFO principles are applied

IAC0303 Items to be ordered, out-of-stock items, slow moving stock and overstocked items are dealt with according to procedures and reported

1.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Accredited as provider with SAPC

Occupational Health and Safety requirements

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1.4 Exemptions

None

2. 321301000-PM-02, Manage stock, as per current legislation (Post Basic), NQF Level 5, Credits 6

2.1 Purpose of the Practical Skill Modules

The focus of the learning in this module is on providing the learner an opportunity to pick, pack and dispatch orders for medicines in terms of current legislation, control stock and order medicines and scheduled substances appropriate to the scope of a post basic, with regards to GWDP, GPP and financial principles. The learner will be required to:

PM-02-PS01: Pick, pack and dispatch orders for medicines in terms of current legislation

PM-02-PS02: Control stock

PM-02-PS03: Order medicine in terms of current legislation 2.2 Guidelines for Practical Skills 2.2.1 PM-02-PS01: Pick, pack and dispatch orders for medicines in terms of current legislation Scope of Practical Skill Given picking list and stock, the learner must be able to:

PA0101 Pick and pack orders for medicines provided that orders that contain scheduled substances that require authorisation

PA0102 Despatch checked orders Applied Knowledge

AK0101 Picking and packing procedures

AK0102 Dispatch procedures

AK0103 Documentation

AK0104 Authorisation procedures by pharmacist Internal Assessment Criteria

IAC0101 Orders for medicines (as per current legislation) are picked, packed, checked and despatched according to relevant procedures/ SOPs and after authorisation from pharmacist

IAC0102 Documentation pertaining to picking, packing, checking and despatching medicines (as per current legislation) is completed according to SOPs

IAC0103 Authorisation is obtained from pharmacist for picking, packing and despatching orders 2.2.2 PM-02-PS02: Control stock Scope of Practical Skill Given stock, the learner must be able to:

PA0201 Receive medicines returned from patients and assist with disposal

PA0202 Quarantine expired, damaged and recalled medicines and ensure safe disposal, according to SOPs

PA0203 Maintain stock levels of the ADUs

PA0204 Perform stock takes as scheduled

PA0205 Use appropriate stock control system Applied Knowledge

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AK0201 Medicine disposal procedures

AK0202 Medicine quarantining procedures

AK0203 Procedures to maintain stock levels of ADUs

AK0204 SOPs

AK0205 Stock control system Internal Assessment Criteria

IAC0201 Medicines are disposed according to SOPs

IAC0202 Medicines are quarantined according to SOPs

IAC0203 Stock levels of ADUs are maintained according to SOPs

IAC0204 Stock control system is used according to SOPs 2.2.3 PM-02-PS03: Order medicine in terms of current legislation Scope of Practical Skill Given list of medicines and substances to be ordered, the learner must be able to:

PA0301 Calculate average monthly consumption (AMC)

PA0302 Calculate maximum and minimum stock levels for each item (reorder level)

PA0303 Use the replenishment model to order stock

PA0304 Place emergency orders

PA0305 Collect required data for submission of Section 21 orders

PA0306 Identify approved vendors

PA0307 Perform quantification and demand planning

PA0308 Report on stock availability Applied Knowledge

AK0301 Calculations for AVG and maximum and minimum stock levels for each item

AK0302 Replenishment model

AK0303 Emergency orders

AK0304 Section 21 orders

AK0305 Vendors

AK0306 Quantification and demand planning

AK0307 Reporting procedures Internal Assessment Criteria

IAC0301 Calculations are performed correctly

IAC0302 The replenishment model is used correctly to order stock

IAC0303 Emergency orders are placed using appropriate procedures

IAC0304 Required data for submission of Section 21 orders is collected using appropriate procedures

IAC0305 Approved vendors are identified according to procedures

IAC0306 Quantification and demand planning are conducted according to procedures

IAC0307 Reports on stock availability are produced according to appropriate format and SOPs 2.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

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As per SAPC requirements

Occupational Health and Safety requirements 2.4 Exemptions

None

3. 321301000-PM-03, Manage supply chain (Pharmacy Technician), NQF Level 6, Credits 5 3.1 Purpose of the Practical Skill Modules

The focus of the learning in this module is on providing the learner an opportunity to manage the medicine supply chain, and mitigate risks and to identify, analyse and solve anomalies during stock management, with regards to GWDP and GPP and financial principles. The learner will be required to:

PM-03-PS01: Manage stock and supervise supply chain

PM-03-PS02: Manage risks and anomalies during stock management 3.2 Guidelines for Practical Skills 3.2.1 PM-03-PS01: Manage stock and supervise supply chain Scope of Practical Skill Given stock, the learner must be able to:

PA0101 Capture all received stock/supplies on electronic system or stock card and sign the specified schedule register requesting authorisation by a pharmacist when required

PA0102 Manage recall of stock and return of medicines

PA0103 Manage quarantining of recalled, expired and discontinued medicines

PA0104 Dispose of medicines according to SOPs under supervision when required

PA0105 Disseminate out-of-stock information to relevant management and healthcare providers at PHC facilities, under indirect supervision

PA0106 Check orders prior to the packing and despatch thereof

PA0107 Delegate functions to other Pharmacy Support Personnel (PSPs)

PA0108 Supervise other PSPs Applied Knowledge

AK0101 Specified schedule register

AK0102 Procedures to recall stock

AK0103 Quarantining of recalled, expired and dormant medicines

AK0104 Disposal procedures for medicines

AK0105 Communication skills

AK0106 PHC, manufacturing pharmacy, wholesale pharmacy or bulk store of an institutional pharmacy

AK0107 Closed packs

AK0108 Delegation skills

AK0109 Supervisory skills Internal Assessment Criteria

IAC0101 All received stock/supplies are captured on an electronic system or stock card according to SOPs

IAC0102 Recall of stock and return of medicines are managed according to procedures

IAC0103 Quarantining of recalled, expired and dormant medicines is managed according to procedures

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IAC0104 Medicines are disposed according to SOPs

IAC0105 Orders are checked and despatched according to SOPs, as per current legislation

IAC0106 Stock-related functions are delegated to other PSPs as per SOPs

IAC0107 PSPs are supervised as required 3.2.2 PM-03-PS02: Manage risks and anomalies during stock management Scope of Practical Skill Given stock, the learner must be able to:

PA0201 Identify and analyse risks and anomalies

PA0202 Determine the financial impact of stock losses (shrinkage, damaged, discontinued, expired, theft)

PA0203 Mitigate risks, problem solve anomalies and implement error management techniques and solutions

Applied Knowledge

AK0201 Types of risks and anomalies

AK0202 Risk analysis and problem-solving techniques

AK0203 Method of determining financial impact of stock losses

AK0204 Error management techniques Internal Assessment Criteria

IAC0201 Risks and anomalies are identified and analysed and measures to mitigate them are implemented

IAC0202 The financial impact of stock losses is calculated

IAC0203 Error management techniques are implemented according to SOPs 3.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

As per SAPC requirements

Occupational Health and Safety requirements 3.4 Exemptions

None

4. 321301000-PM-04, Manufacture non-sterile medicines (Basic), NQF Level 4, Credits 6 4.1 Purpose of the Practical Skill Modules

The focus of the learning in this module is on providing the learner an opportunity to handle materials, assist with the manufacture of non-sterile medicines or scheduled substances and assist with post manufacturing processes, with reference to cGMP and current legislation. The learner will be required to:

PM-04-PS01: Handle materials (Basic)

PM-04-PS02: Manufacture non-sterile medicines or scheduled substances under guidance

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PM-04-PS03: Perform packaging processes 4.2 Guidelines for Practical Skills 4.2.1 PM-04-PS01: Handle materials (Basic) Scope of Practical Skill Given raw and packaging materials, the learner must be able to:

PA0101 Demonstrate ability to comply with cGMP and current legislation requirements

PA0102 Record environmental conditions under supervision

PA0103 Quarantine products as instructed under supervision

PA0104 Handle stock under supervision

PA0105 Handle batch documents and records under supervision

PA0106 Monitor storage conditions under supervision

PA0107 Ensure the security of product under supervision

PA0108 Manage stock of packaging materials under supervision

PA0109 Transport materials under supervision Applied Knowledge

AK0101 Storage conditions and expiration dates of materials

AK0102 Quarantining procedures

AK0103 Environmental conditions (e.g. temperature, humidity, pressure ventilation)

AK0104 Stock control

AK0105 Restrictions and special procedures with regards to Schedule 5 and 6 substances and medicines

AK0106 Batch records

AK0107 Packaging materials Internal Assessment Criteria

IAC0101 cGMP and current legislation requirements are applied in all manufacturing - related activities

IAC0102 Environmental and storage conditions are monitored and recorded under guidance

IAC0103 Raw material and packaging stock is controlled and transported under guidance

IAC0104 Batch documents and records are handled under guidance

IAC0105 Security of product is managed under guidance

IAC0106 Quarantine products are handled under guidance 4.2.2 PM-04-PS02: Manufacture non-sterile medicines or scheduled substances under guidance Scope of Practical Skill Given raw materials, cGMP, equipment, batch manufacturing document and SOPs, the learner must be

able to:

PA0201 Comply with cGMP and current legislation related to manufacturing

PA0202 Conduct preliminary steps of weighing medicines and substances as per current legislation, under supervision

PA0203 Transport weighed materials in the presence of a pharmacist/pharmacy technician

PA0204 Check and clean equipment and manufacturing areas before and after a run

PA0205 Transfer bulk product to quarantine area under supervision

PA0206 Participate in water treatment under supervision

PA0207 Adhere and promote access control and restrictions

PA0208 Use appropriate PPE Applied Knowledge

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AK0201 Manufacturing and packaging operations

AK0202 Movement of personnel and material through the factory

AK0203 Access control and security issues

AK0204 cGMP and current legislation

AK0205 Water treatment

AK0206 Equipment

AK0207 Bulk products Internal Assessment Criteria

IAC0201 cGMP and current legislation requirements are complied with in all manufacturing - related activities

IAC0202 Preliminary steps of weighing Schedule 0 to 6 substances are conducted under supervision

IAC0203 Weighted materials are transported according to appropriate protocols

IAC0204 Bulk product is transferred to quarantine area under supervision

IAC0205 Water treatment is conducted under supervision

IAC0206 Access control and restrictions are strictly adhered to

IAC0207 Manufacturing equipment and manufacturing areas are checked and cleaned before and after a run

IAC0208 Appropriate PPE is used in the manufacturing 4.2.3 PM-04-PS03: Perform packaging processes Scope of Practical Skill Given bulk medicines, packaging documents and materials, the learner must be able to:

PA0301 Comply with cGMP and current legislation related to packaging

PA0302 Clear and clean packaging line and equipment

PA0303 Pack medicine in appropriate packaging under supervision

PA0304 Clean equipment and apparatus

PA0305 Transport packaging materials Applied Knowledge

AK0301 Packaging and re-packing operations

AK0302 Clearing and cleaning procedures

AK0303 Transporting procedures

AK0304 Packaging materials and documentation Internal Assessment Criteria

IAC0301 cGMP and current legislation requirements are applied in all manufacturing - related activities

IAC0302 Packaging line and equipment are cleared and cleaned according to SOPs

IAC0303 Medicines are packed in appropriate packaging under supervision

IAC0304 Equipment and apparatus are cleaned and stored as per equipment manufacturer’s instructions

IAC0305 Packaging materials are transported according to procedures 4.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements

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Legal Requirements:

Accredited as provider with SAPC

Occupational Health and Safety requirements 4.4 Exemptions

None

5. 321301000-PM-05, Manufacture non-sterile and sterile medicines (Post Basic), NQF Level 5, Credits 8

5.1 Purpose of the Practical Skill Modules

The focus of the learning in this module is on providing the learner an opportunity to handle materials, assist with the manufacture of non-sterile and sterile medicines and scheduled substances, package medicines and perform packaging processes, with reference to cGMP and current legislation.

The learner will be required to:

PM-05-PS01: Handle materials (Post Basic)

PM-05-PS02: Manufacture non-sterile and sterile medicines and scheduled substances

PM-05-PS03: Package medicines 5.2 Guidelines for Practical Skills 5.2.1 PM-05-PS01: Handle materials (Post Basic)

Scope of Practical Skill Given a range of materials, SOPs, quality manual and equipment in a manufacturing environment, the learner must be able to:

PA0101 Select and implement cGMP-based SOPs

PA0102 Implement environmental conditions for materials and product

PA0103 Select and implement procedures to quarantine products and materials

PA0104 Implement stock control under guidance or in an assistive role

PA0105 Apply legal and special requirements for scheduled substances under guidance of the PT and the Pharmacist

PA0106 Complete batch records under guidance or in an assistive role

PA0107 Assist the pharmacist/PT with the destruction of goods

PA0108 Monitor and control storage conditions for bulk product prior to packing under guidance or in an assistive role

PA0109 Adhere to implemented security measures

PA0110 Control stock of packaging materials

PA0111 Issue packaging materials, with the exception of printed packaging materials Applied Knowledge

AK0101 Environmental and storage conditions for materials and bulk products

AK0102 Processes to quarantine and destroy materials

AK0103 Stock control of materials

AK0104 Legal and special requirements for scheduled substances

AK0105 Security measures for materials and products

AK0106 Issuing of packaging materials Internal Assessment Criteria

IAC0101 cGMP-based SOPs are implemented during manufacturing

IAC0102 Environmental conditions for materials and product are implemented according to SOPs

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IAC0103 Procedures to quarantine products and materials are implemented according to SOPs and under guidance of a PT or pharmacist

IAC0104 Procedures to destroy materials and goods are implemented according to SOPs and under guidance of a PT or pharmacist

IAC0105 Stock control measures are implemented for raw and packaging materials

IAC0106 Apply legal and special requirements for scheduled substances under supervision of the PT and the Pharmacist

IAC0107 Complete batch records under guidance of PT or the Pharmacist

IAC0108 Storage conditions for bulk product prior to packing are managed according to SOPs

IAC0109 Security measures for materials and products are implemented according to SOPs

IAC0110 The processes to issue packaging materials are implemented 5.2.2 PM-05-PS02: Manufacture non-sterile and sterile medicines and scheduled substances Scope of Practical Skill Given ingredients, materials and equipment, the learner must be able to:

PA0201 Apply cGMP and current legislation to manufacturing process

PA0202 Weigh non-active raw materials

PA0203 Perform pharmaceutical calculations used in the manufacture of medicines

PA0204 Use aseptic techniques

PA0205 Manufacture dosage forms under guidance

PA0206 Check, record and sign for the addition of non-active materials to the mix with the pharmacist

PA0207 Detect deviations and raise deviation to appropriate supervisory person

PA0208 Use PPE and hygienic procedures

PA0209 Clean and/or sterilise and maintain equipment

PA0210 Perform in-process control testing and in-process checks

PA0211 Label products Applied Knowledge

AK0201 Material weighing processes

AK0202 Active pharmaceutical ingredients and non-active materials

AK0203 Pharmaceutical calculations

AK0204 Deviations and reporting procedures

AK0205 Procedures to add non-active materials to the mix

AK0206 Aseptic techniques

AK0207 Equipment cleaning and maintenance

AK0208 PPE and hygiene procedures

AK0209 In-process control testing and checks

AK0210 cGMP and current legislation

AK0211 Labelling procedures Internal Assessment Criteria

IAC0201 cGMP-based SOPs are implemented during manufacturing

IAC0202 Non-active raw materials are weighed according to SOPs

IAC0203 The addition of non-active materials to the mix is conducted according to SOPs and with the pharmacist

IAC0204 Pharmaceutical calculations used in the manufacture of medicines are performed

IAC0205 A range of steps, aseptic techniques and appropriate documentation are used to manufacture dosage forms under guidance

IAC0206 Deviations are detected during the manufacture of medicines, under guidance, and appropriate corrective measures are implemented

IAC0207 Equipment is cleaned and maintained as per equipment manufacturer’s instructions

IAC0208 In-process control testing and in-process checks are conducted, results are interpreted and deviations reported to supervisory personnel according to SOPs

IAC0209 Manufacturing documentation is generated according to SOPs

IAC0210 Appropriate PPE and hygienic procedures are applied

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IAC0211 Products are labelled according to SOPs 5.2.3 PM-05-PS03: Package medicines Scope of Practical Skill Given manufactured medicine, the learner must be able to:

PA0301 Check that conditions are suitable for packaging, such as temperature, humidity and ventilation, according to standard operating procedures (SOPs)

PA0302 Receive packaging materials

PA0303 Check packing materials against works order/batch record

PA0304 Check correct batch number of medicine packed in accordance with SOPs

PA0305 Check and clear packaging line and obtain authorisation to proceed

PA0306 Open packaging line under guidance

PA0307 Clean and/or check that all apparatus and equipment is clean/sterilised and label accordingly

PA0308 Use master document for packing and re-packing each product

PA0309 Carry out, under guidance, in process control testing during packaging and re-packaging of medicines as per current legislation

PA0310 Secure all stored labels and over-printed material to prevent a possible mix-up

PA0311 Discard any unused, damaged or rejected labels bearing a particular batch number and packaging date in accordance with the SOPs

PA0312 Collate, under guidance, documents and records of each batch of medicine packed

PA0313 Sign all documentation, which must be countersigned by the pharmacist Applied Knowledge

AK0301 Conditions for packaging (temperature, humidity and ventilation)

AK0302 Receipt and checking of packaging materials

AK0303 Packaging line checking, clearing and opening

AK0304 In-process control testing during packaging and re-packaging

AK0305 Method of assigning batch numbers to each batch of medicines

AK0306 Procedures to handle unused, damaged or rejected labels and over-printed material

AK0307 Equipment and apparatus

AK0308 Documentation Internal Assessment Criteria

IAC0301 Conditions required for packaging are checked to ensure integrity of the packaging process

IAC0302 Packaging materials are received and checked against works order/batch record

IAC0303 Batch number of medicine packed is checked according to SOPs

IAC0304 Packaging line is checked, cleared and opened after obtaining authorisation

IAC0305 Apparatus and equipment is checked, cleaned/sterilised and labelled according to SOPs

IAC0306 Packing and re-packing each product is completed in line with documentation

IAC0307 In process control testing is conducted during packaging and re-packaging according to SOPs

IAC0308 Labels and over-printed material are appropriately secured and unused, damaged or rejected labels are discarded according to SOPs

IAC0309 Documentation is collated under guidance, signed and counter-signed according to SOPs 5.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements

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Legal Requirements:

Accredited as provider with SAPC

Occupational Health and Safety requirements 5.4 Exemptions

None

6. 321301000-PM-06, Manufacture non-sterile and sterile medicines (Pharmacy Technician), NQF Level 6, Credits 8

6.1 Purpose of the Practical Skill Modules

The focus of the learning in this module is on providing the learner an opportunity to manage materials, assist with the manufacture of non-sterile and sterile medicines and scheduled substances and the packaging of medicines, with reference to cGMP and current legislation. The learner will be required to:

PM-06-PS01: Manage materials

PM-06-PS02: Manufacture non-sterile and sterile medicines or scheduled substances under supervision

PM-06-PS03: Package and re-package medicines 6.2 Guidelines for Practical Skills 6.2.1 PM-06-PS01: Manage materials Scope of Practical Skill Given materials for manufacturing, the learner must be able to:

PA0101 Exercise control over cGMP requirements

PA0102 Monitor and control environmental conditions for materials

PA0103 Monitor and control the quarantining of materials

PA0104 Monitor and control stock rotation

PA0105 Apply special requirements for Scheduled substances and medicines under guidance of a pharmacist

PA0107 Monitor and control the issuing of raw materials

PA0108 Manage batch documents and records and implement batch tracking

PA0109 Destroy goods under guidance of the Pharmacist

PA0110 Monitor, implement and control storage conditions for bulk product prior to packaging

PA0111 Monitor, implement and control security measures for bulk product prior to packaging

PA0112 Destroy and rework material under guidance of a Pharmacist

PA0113 Monitor and control handling of packaging materials

PA0114 Delegate materials management-related functions to other PSPs

PA0115 Supervise other PSPs Applied Knowledge

AK0101 Environmental and storage conditions for materials

AK0102 Quarantining of materials

AK0103 Stock rotation

AK0104 Issuing of raw materials

AK0105 Special requirements for Scheduled substances and medicines

AK0106 Destruction of goods

AK0107 Destruction and reworking of materials

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AK0108 Packaging materials

AK0109 Delegation skills

AK0110 Supervisory skills Internal Assessment Criteria

IAC0101 Environmental conditions for materials, quarantining of materials, stock rotation, issuing of raw materials are monitored and implemented as per SOPs

IAC0102 Special requirements for Scheduled substances and medicines are applied under guidance of a pharmacist

IAC0103 Goods are destroyed in accordance with SOPs and under guidance of a Pharmacist

IAC0104 Batch documents and records are managed and batch tracking is implemented according to SOPs

IAC0105 Storage conditions and security measures for bulk product are monitored, implemented and controlled as per SOPs

IAC0106 Materials are destroyed and reworked according to SOPs and under guidance of a Pharmacist

IAC0107 Handling of packaging materials is monitored and controlled according to SOPs

IAC0108 Materials management -related functions are delegated to other PSPs as per SOPs

IAC0109 PSPs are supervised as required 6.2.2 PM-06-PS02: Manufacture non-sterile and sterile medicines or scheduled substances under

supervision Scope of Practical Skill Given ingredients, materials and equipment, the learner must be able to:

PA0201 Monitor and control cGMP during manufacture

PA0202 Monitor and control weighing of non-active ingredients

PA0203 Perform calculations and check calculations performed by other PSPs

PA0204 Initiate line clearance, opening line and line closure as per documented procedure, detailed checklist and signed authorisation by the supervising pharmacist

PA0205 Apply any special or legal requirements for certain scheduled products

PA0206 Monitor, control and implement the adding of non-active materials to the mix

PA0207 Monitor and control the manufacturing of various dosage forms

PA0208 Monitor, control and implement in process controls

PA0209 Monitor and control HVAC conditions

PA0210 Perform sampling or supervision of the sampling of medicines or scheduled substances, in accordance with rules relating to current good manufacturing practice (cGMP)

PA0211 Destroy or dispose of waste products

PA0212 Monitor and control water usage, storage and processing

PA0213 Monitor and control packaging and labelling

PA0214 Delegate manufacturing-related functions to other PSPs

PA0215 Supervise other PSPs Applied Knowledge

AK0201 cGMP principles

AK0202 Weighing procedures

AK0203 Line clearance, opening line, line closure

AK0204 Calculations

AK0205 Special requirements for S5 and S6 products

AK0206 HVAC

AK0207 In-process checks

AK0208 Medicine sampling

AK0209 Destruction or disposal of waste products

AK0210 Delegation skills

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AK0211 Supervisory skills Internal Assessment Criteria

IAC0201 Pharmaceutical and cGMP principles are applied in the manufacture of non-sterile and sterile medicines and scheduled substances

IAC0202 Weighing procedures are monitored and controlled

IAC0203 Preparations for manufacturing (including performing calculations) are carried out as per cGMP and SOPs

IAC0204 Line clearance, line opening and line closing for manufacturing are initiated according to relevant SOPS and under supervision of a Pharmacist

IAC0205 Special requirements for S5 and S6 products are applied as per SOPs

IAC0206 Adding of non-active materials to the mix and in process controls are monitored, implemented and controlled

IAC0207 The manufacturing of various dosage forms, HVAC conditions, water usage, storage and processing, packaging and labelling are monitored and controlled as per cGMP and SOPs

IAC0208 Sampling of medicines or scheduled substances is conducted or supervised according to cGMP and SOPs

IAC0209 Destruction and disposal of waste products are conducted according to cGMP and SOPs

IAC0210 Manufacturing -related functions are delegated to other PSPs as per SOPs

IAC0211 PSPs are supervised as required 6.2.3 PM-06-PS03: Package and re-package medicines Scope of Practical Skill Given manufactured medicines, the learner must be able to:

PA0301 Prepare for the packing/repacking products

PA0302 Check expiration dates

PA0303 Monitor and control cGMP in relation to packaging

PA0304 Initiate start-up line clearance and opening of the packaging line in accordance with cGMP and SOPs and signed authorisation by the supervising pharmacist

PA0305 Monitor and control receipt of bulk product and check batch number and expiry date

PA0306 Monitor and control receipt of packaging materials

PA0307 Monitor and control packaging materials against works order/batch document

PA0308 Monitor and control checking of line clearance

PA0309 Monitor and control setting-up of packaging equipment

PA0310 Monitor and control checking of over printing of packaging materials against batch document

PA0311 Open packaging line after approval by pharmacist

PA0312 Monitor, control and implement in process controls

PA0313 Monitor and control final batch reconciliation for approval by pharmacist

PA0314 Ensure that documentation complies with cGMP

PA0315 Control the processes according cGMP and SOPs and generate new SOPs under guidance of a pharmacist

PA0316 Delegate packaging and repackaging-related functions to other PSPs

PA0317 Supervise other PSPs Applied Knowledge

AK0301 Preparation procedures for the packing/repacking products

AK0302 Expiration dates

AK0303 cGMP for packaging

AK0304 Line clearance, line opening and line closing for packaging

AK0305 Receipting processes for bulk product and packaging materials

AK0306 Works order/batch document

AK0307 In-process controls

AK0308 Over printing of packaging materials

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AK0309 Final batch reconciliation

AK0310 Documentation

AK0311 SOPs

AK0312 Delegation skills

AK0313 Supervisory skills Internal Assessment Criteria

IAC0301 Preparations for packing and repacking medicines are completed according to SOPs

IAC0302 Expiration dates are checked

IAC0303 cGMP principles are applied in packaging

IAC0304 Line clearance, line opening and line closing for packing and re-packing medicines and scheduled substances are initiated according to cGMP, SOPS and under the supervision of a pharmacist

IAC0305 Receipt of bulk product and packaging materials is monitored and controlled according to SOPs

IAC0306 Packaging materials are monitored and controlled against works order/batch document

IAC0307 Checking of line clearance and setting-up of packaging equipment are monitored and controlled according to SOPs

IAC0308 Packaging line is opened according to SOPs and after approval by pharmacist

IAC0309 In process controls are monitored, controlled and implemented according to SOPs

IAC0310 Checking of over printing of packaging materials against batch document is monitored and controlled and final batch reconciliation is completed for approval by a pharmacist

IAC0311 All documentation complies with cGMP

IAC0312 All processes are controlled according cGMP and SOPs

IAC0313 New SOPs are generated under the guidance of a pharmacist

IAC0314 Packaging and repackaging -related functions are delegated to other PSPs as per SOPs

IAC0315 PSPs are supervised as required 6.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Accredited as provider with SAPC

Occupational Health and Safety requirements 6.4 Exemptions

None

7. 321301000-PM-07, Compound non-sterile extemporaneous preparations (Basic), NQF Level 4, Credits 5

7.1 Purpose of the Practical Skill Modules

The focus of the learning in this module is on providing the learner an opportunity to compound, manipulate or prepare a non-sterile medicine or scheduled substance (as per current legislation), with reference to cGMP and GPP. The learner will be required to:

PM-07-PS01: Compound a non-sterile medicine or scheduled substance, as per current legislation

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7.2 Guidelines for Practical Skills 7.2.1 PM-07-PS01: Compound a non-sterile medicine or scheduled substance, as per current legislation Scope of Practical Skill Given apparatus, equipment, formula, quantities and labels, the learner must be able to:

PA0101 Check, clean and prepare the environment, apparatus and equipment for compounding

PA0102 Work according to SOPs

PA0103 Receive the formula that has been checked by the pharmacist/PT

PA0104 Receive the calculated quantities for the required ingredients as per prescription/formula

PA0105 Eliminate any possibility of cross-contamination

PA0106 Prepare, weigh and mix the ingredients, each step to be checked by a pharmacist/PT

PA0107 Compound simple solutions, suspensions and semi-solids

PA0108 Label as per current legislation

PA0109 Document the compounding procedure

PA0110 Clean equipment and environment after compounding

PA0111 Sign the document as compounder with signature of supervising pharmacist/PT indicating that the procedure has been authorised and checked

Applied Knowledge

AK0101 Apparatus and equipment

AK0102 Compounding formula

AK0103 Calculated quantities for the required ingredients

AK0104 Procedures to prepare, weigh and mix the ingredients

AK0105 Legislative requirements for labelling

AK0106 Documentation for compounding

AK0107 Non-sterile medicine or scheduled substance

AK0108 SOPs

AK0109 Units to quantify liquids and solids

AK0110 Concentrations

AK0111 Cross-contamination

AK0112 cGMP and GPP requirements Internal Assessment Criteria

IAC0101 Environment, apparatus and equipment are checked, cleaned and prepared before and after the compounding process according to SOPs

IAC0102 The formula and the calculated quantities for the required ingredients are received

IAC0103 Contamination is preventing according to SOPs

IAC0104 Ingredients are prepared, weighed and mixed according to SOPs and checked by pharmacist/PT

IAC0105 Product is compounded according to procedure

IAC0106 Labelling- is completed as per SOPs

IAC0107 Documentation completed and signed as per SOPs 7.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

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Accredited as provider with SAPC

Occupational Health and Safety requirements 7.4 Exemptions

None

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8. 321301000-PM-08, Compound sterile and non-sterile extemporaneous preparations, as per current legislation (Post Basic), NQF Level 5, Credits 6

8.1 Purpose of the Practical Skill Modules

The focus of the learning in this module is on providing the learner an opportunity to to compound sterile and non-sterile products and scheduled substances according to current legislation and with reference to cGMP and GPP. The learner will be required to:

PM-08-PS01: Compound sterile and non-sterile products, as per current legislation 8.2 Guidelines for Practical Skills 8.2.1 PM-08-PS01: Compound sterile and non-sterile products, as per current legislation Scope of Practical Skill Given apparatus, equipment and formula, the learner must be able to:

PA0101 Check and confirm the prescribed formula

PA0102 Clean and/or sterilise equipment and apparatus

PA0103 Calculate the quantities of the required ingredients as per prescription/formula and check calculations for sterile and non-sterile compounding of products

PA0104 Ensure that calculations are checked by the pharmacist/PT

PA0105 Prepare, weigh, check and mix the ingredients

PA0106 Use aseptic techniques

PA0107 Prepare sterile products

PA0108 Compound semi-solids and liquid emulsions

PA0109 Label as per current legislation and attach assigned expiry date

PA0110 Document the compounding procedure

PA0111 Sign the document as compounder with signature of supervising pharmacist/PT indicating that the procedure has been authorised and checked

PA0112 Adhere to cGMP and GPP requirements

PA0113 Maintain personal hygiene and health in sterile product compounding Applied Knowledge

AK0101 Compounding techniques for sterile products

AK0102 Calculations of required quantities

AK0103 Procedures to prepare, weigh, check and mix the ingredients

AK0104 Labelling procedures

AK0105 Aseptic techniques

AK0106 Equipment and apparatus sterilisation procedures

AK0107 Documentation

AK0108 GPP and cGMP requirements Internal Assessment Criteria

IAC0101 The prescribed formula is checked and confirmed

IAC0102 Equipment and apparatus are sterilised according to SOPs

IAC0102 Quantities of the required ingredients as per prescription/formula are calculated and the calculations are checked by pharmacist/PT

IAC0104 Ingredients are prepared, weighed and mixed according to SOPs and checked by pharmacist/PT

IAC0105 Sterile products are prepared using aseptic techniques

IAC0106 Labelling and assigning of expiry date is completed as per SOPs

IAC0107 Documentation completed and signed as per SOPs

IAC0108 cGMP and GPP requirements are adhered to

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8.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Accredited as provider with SAPC

Occupational Health and Safety requirements 8.4 Exemptions

None

9. 321301000-PM-09, Compound sterile and non-sterile extemporaneous preparations, as per current legislation (Pharmacy Technician), NQF Level 6, Credits 7

9.1 Purpose of the Practical Skill Modules

The focus of the learning in this module is on providing the learner an opportunity to to compound sterile and non-sterile medicines, with reference to cGMP and GPP.

The learner will be required to:

PM-09-PS01: Compound sterile and non-sterile medicines, as per current legislation 9.2 Guidelines for Practical Skills 9.2.1 PM-09-PS01: Compound sterile and non-sterile medicines, as per current legislation Scope of Practical Skill Given apparatus, equipment and formula, the learner must be able to:

PA0101 Check and confirm the prescribed formula

PA0102 Calculate the quantities of the required ingredients as per prescription/formula

PA0103 Ensure that calculations are checked by the pharmacist

PA0104 Prepare, weigh, check and mix the ingredients

PA0105 Compound, manipulate and prepare sterile and non-sterile medicines

PA0106 Make the necessary entries in the relevant register

PA0107 Inspect the compounded medicines for quality

PA0108 Calculate and assign an appropriate expiry date as per SOPs

PA0109 Supervise the extemporaneous compounding of medicines, according to current legislation

PA0110 Label as per current legislation

PA0111 Document the compounding procedure

PA0112 Sign the document as compounder with signature of supervising pharmacist indicating that the procedure has been authorised and checked

PA0113 Adhere to cGMP and GPP requirements Applied Knowledge

AK0101 Compounding techniques for sterile products

AK0102 Calculations of required quantities

AK0103 Procedures to prepare, weigh, check and mix the ingredients

AK0104 Calculation of expiry dates

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AK0105 Labelling procedures

AK0106 Documentation (including relevant register)

AK0107 GPP and cGMP requirements Internal Assessment Criteria

IAC0101 The prescribed formula is checked and confirmed

IAC0102 Quantities of the required ingredients as per prescription/formula are calculated and the calculations are checked by pharmacist/PT

IAC0103 Expiry dates are calculated and assigned as per SOPs

IAC0104 Sterile and non-sterile medicines and scheduled substances are compounded, manipulated and prepared

IAC0105 Documentation, including relevant registers for medicines/scheduled substances, is completed

IAC0106 Labeling is completed as per SOPs

IAC0107 Documentation completed and signed as per SOPs

IAC0108 GPP requirements are adhered to 9.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

As per SAPC requirements

Occupational Health and Safety requirements 9.4 Exemptions

None

10. 321301000-PM-10, Dispense medicines (Post Basic), NQF Level 5, Credits 14 10.1 Purpose of the Practical Skill Modules

The focus of the learning in this module is on providing the learner an opportunity to verify, prepare and dispense prescriptions. The learner will also interact with patients for a variety of purposes, inter alia, to promote health and assist in pharmacist initiated therapy. All these activities will be guided by the GPP, Code of Conduct and ethical rules, under the supervision of a pharmacist. The learner will be required to:

PM-10-PS01: Verify prescription

PM-10-PS02: Interact with patients

PM-10-PS03: Prepare prescriptions

PM-10-PS04: Perform Phase 3 of the dispensing process

PM-10-PS05: Promote health

PM-10-PS06: Assist with Pharmacist Initiated Therapy (PIT) 10.2 Guidelines for Practical Skills 10.2.1 PM-10-PS01: Verify prescription Scope of Practical Skill

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Given a prescription, the learner must be able to:

PA0101 Identify the patient, the prescriber and the entity responsible for payment (as applicable)

PA0102 Check legality of the prescription

PA0103 Read the prescription

PA0104 Screen prescription for medicines which appear on the Primary Health Care Essential Medicines List and which are prescribed in accordance with Standard Treatment Guidelines, in a PHC facility

PA0105 Identify the medicine, and check the pharmaceutical form, strength, appropriate dose and frequency, presentation, method of administration and duration of treatment

Applied Knowledge

AK0101 Method of reading and screening prescriptions

AK0102 Method or reading a prescription

AK0103 Standard Treatment Guidelines (STG) and Essential Medicines List (EML) Internal Assessment Criteria

IAC0101 The legality of the prescription is checked using appropriate procedures

IAC0102 Prescription is read using appropriate procedures

IAC0103 Patient details, prescriber and entity responsible for payment are verified, using appropriate procedures

IAC0104 Prescriptions are screened as per procedures applicable to PHC facility purposes 10.2.2 PM-10-PS02: Interact with patients Scope of Practical Skill Given a range of patients, the learner must be able to:

PA0201 Establish a trusting relationship with the patient by making him/her feel comfortable and relaxed

PA0202 Maintain patient confidentiality

PA0203 Communicate with patients professionally in terms of sensitivity to patients’ needs and adversity

PA0204 Collect information from patient for Medicine Utilisation Evaluation (MUE)

PA0205 Communicate effectively to ensure that information relating to ‘to follow’

or outstanding items, preventative measures, storage of medication, instructions, reporting problems with medication, is understood to ensure optimal outcomes

PA0206 Explain preventative measures and lifestyle modification options in relation to the identified conditions

PA0207 Instruct patient how to take and store medication

PA0208 Ensure that patient understands instructions

PA0209 Instruct patients to report problems with medication

PA0210 Inform patient about chronic medication process

PA0211 Monitor patients and follow-up, if necessary Applied Knowledge

AK0201 Ways of building a trusting relationship

AK0202 Communication skills

AK0203 Importance of patient confidentiality, patient consent and patient rights

AK0204 Information collection process

AK0205 Generic substitution

AK0206 Preventative measures and lifestyle modification options

AK0207 Reporting problems with medication

AK0208 Management of chronic medication supply

AK0209 Medicine Utilisation Evaluation (MUE)

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Internal Assessment Criteria

IAC0201 A trusting relationship with the patient is developed using appropriate skills

IAC0202 Confidentiality and ethical dimensions of relationship with patient are maintained

IAC0203 Communication with patient is professional

IAC0204 Information for MUE is collected using appropriate techniques

IAC0205 The necessary and relevant instructions about medications are shared with patient and confirmation obtained that patient understands instructions

IAC0206 Preventative measures and lifestyle modification options are explained and confirmation obtained that patient understands the options

IAC0207 Management of chronic medication supply is explained to patient and confirmation obtained that patient understands the explanation

10.2.3 PM-10-PS03: Prepare prescriptions Scope of Practical Skill Given a verified and validated prescription, the learner must be able to:

PA0301 Capture details on patient profile

PA0302 Record the diagnosis or symptom complex (ICD 10 code where provided)

PA0303 Inform the patient of the benefits and implications of the substitution for a branded medicine with an interchangeable multi-source medicine, in case of a prescription

PA0304 Assist the patient to resolve the problem when the prescription cannot be dispensed in consultation with the pharmacist or in accordance with SOPs

PA0305 Pick, pack, select and label items for prescriptions according to current legislation

PA0306 Check expiry dates for medicines

PA0307 Check for drug allergies

PA0308 Perform calculations for dosage and appropriate number of dosage units

PA0309 Sign the prescription and obtain counter-sign from pharmacist

PA0310 Make the necessary entries in the prescription book or other record

PA0311 Record the items to be re-ordered or that have a balance ‘to follow’

PA0312 Record the dispensed medicines as well as those not dispensed

PA0313 Document interventions

PA0314 High standards of personal and environmental cleanliness and hygiene are applied in dispensing

Applied Knowledge

AK0301 Picking, selecting and labelling procedures for prescriptions items

AK0302 Expiry dates

AK0303 Drug allergies

AK0304 Unit calculations

AK0305 Recording and signing procedures

AK0306 ICD 10 code

AK0307 Implications of the substitution for a branded medicine

AK0308 Computer literacy

AK0309 Patient-ready packs/pre-packed medicines

AK0310 High standards of personal and environmental cleanliness and hygiene Internal Assessment Criteria

IAC0301 Preparation of prescriptions is conducted according to SOPs

IAC0302 Protocols for signing and countersigning documentation are adhered to in terms of SOPs

IAC0303 All recording and documentation activities pertaining to prescription preparation are conducted according to SOPs

IAC0304 Patient interactions during prescription preparations are conducted professionally

IAC0305 High standards of personal and environmental cleanliness and hygiene are maintained during prescription preparation

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10.2.4. PM-10-PS04: Perform Phase 3 of the dispensing process Scope of Practical Skill Given selected and labelled medicines, the learner must be able to:

PA0401 Provide instructions on how to use medicines

PA0402 Explain effects of the medicine to the patient/caregiver/agent

PA0403 Describe possible side effects which may occur

PA0404 Provide indications, and give warnings and storage instructions as needed

PA0405 Advise the patient to consult the pharmacist should the symptoms persist beyond the period as stated in patient information leaflet/package insert

PA0406 Check with patient/caregiver/ agent that the instructions and information have been understood

PA0407 Maintain prescription records

PA0408 Implement error-avoidance mechanisms

PA0409 Assist in the management of common chronic conditions

PA0410 Explain items ‘to follow’ or outstanding items

PA0411 Explain preventative measures and lifestyle modification options in relation to the identified conditions

PA0412 Instruct patient how to take and store medication

PA0413 Ensure that patient understands instructions

PA0414 Instruct patients to report problems with medication

PA0415 Inform patient about chronic medication process

PA0416 Monitor patients and follow-up, if necessary Applied Knowledge

AK0401 Dispensing procedures (including ward prescriptions)

AK0402 Error-avoidance mechanisms

AK0403 GPP

AK0404 Aetiology and epidemiology of the common acute conditions

AK0405 Pharmacy Assistant Post Basic may only dispense medicines as listed in the Primary Health Care Essential Medicines List or approved formularies which are prescribed in accordance with Standard Treatment Guidelines. Only re-packaged medicines or patient ready packs may be dispensed

AK0406 Management of common acute conditions

AK0407 Information to patients (items ‘to follow’ or outstanding items; preventative measures and lifestyle modification options; instructions how to take and store medication; instructions to report problems with medication)

Internal Assessment Criteria

IAC0401 All the steps for Phase 3 of the dispensing process are conducted according to SOPs

IAC0402 Communication with patient is conducted according to protocols and comprises of all the necessary instructions and information

IAC0403 Prescription records are maintained according to SOPs

IAC0404 Error-avoidance mechanisms are implemented according to SOPs

IAC0405 Common acute conditions are managed according to SOPs/protocols 10.2.5 PM-10-PS05: Promote health Scope of Practical Skill Given relevant information, the learner must be able to:

PA0501 Promote basic hygiene and infection control

PA0502 Promote healthy life style

PA0503 Present health education information

PA0504 Conduct programmes to identify health deficiencies in the community

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Applied Knowledge

AK0501 Hygiene

AK0502 Infection control

AK0503 Health education Internal Assessment Criteria

IAC0501 Basic hygiene, infection control and healthy life style are promoted according to SOPs

IAC0502 Health education information is presented to patient according to requirements

IAC0503 Programmes to identify health deficiencies in the community are conducted according to requirements

10.2.6 PM-10-PS06: Assist with Pharmacist Initiated Therapy (PIT) Scope of Practical Skill

Given patients presenting with a range of common minor ailments and PIT medicines, the learner must be able to:

PA0601 Collect information pertaining to the patients’ health care needs

PA0602 Consult with the pharmacist to determine whether the symptoms may be associated with a serious condition

PA0603 Provide appropriate therapy and advice if illness is a minor, self-limiting health problem

PA0604 Dispense the medicines if the recommended therapy is pharmacological

PA0605 Assist in Pharmacist Initiated Therapy (PIT)

PA0606 Identify and monitor potential misuse, overuse and abuse of medicines Applied Knowledge

AK0601 Symptoms for various conditions

AK0602 Calculations of required quantities

AK0603 Procedures to prepare, weigh, check and mix the ingredients

AK0604 Labelling procedures

AK0605 Documentation

AK0606 OTC medicines

AK0607 Potential misuse, overuse and abuse of medicines Internal Assessment Criteria

IAC0601 Information is collected using appropriate communication and patient interaction skills

IAC0602 The pharmacist is consulted as and when required

IAC0603 Appropriate therapy and advice is provided and medicines are dispensed under specific circumstances

IAC0604 Medicines are dispensed as part of PIT

IAC0605 Potential misuse, overuse and abuse of medicines are monitored 10.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Accredited as provider with SAPC

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Occupational Health and Safety requirements 10.4 Exemptions

None

11. 321301000-PM-11, Dispense medicines (Pharmacy Technician), NQF Level 6, Credits 12 11.1 Purpose of the Practical Skill Modules

The focus of the learning in this module is on providing the learner an opportunity to perform all phases of the dispensing process to ensure correct patient care, and to promote health. All these activities will be conducted with reference to GPP, Code of Conduct and ethical rules. The learner will be required to:

PM-11-PS01: Perform the dispensing process

PM-11-PS02: Promote health 11.2 Guidelines for Practical Skills 11.2.1 PM-11-PS01: Perform the dispensing process Scope of Practical Skill Given prescriptions, the learner must be able to:

PA0101 Dispense according to legislative requirements

PA0102 Check prescriptions prepared by other PSPs

PA0103 Perform calculations

PA0104 Provide information to patient to optimise therapeutic outcomes

PA0105 Manage the queuing of prescriptions Applied Knowledge

AK0101 Calculations (dosages (e.g., mg per kg prescribed and body surface area); quantities to be dispensed; percentage concentrations (i.e., w/w, w/v, v/v); flow rates and infusion times for intravenous medications; ratios and proportions; conversion between measurement units (i.e., mg to g to kg) for dilutions and allegation)

AK0102 GPP

AK0103 Dispensing in a PHC or any other facility

AK0104 Pre-packs

AK0105 Patient counselling

AK0106 Queuing of prescriptions Internal Assessment Criteria

IAC0101 Calculations are performed

IAC0102 Medicines are dispensed in a PHC or any other facility as per SOPs

IAC0103 Patient are given information to optimise therapeutic outcomes, as per SOPs

IAC0104 Prescription queues are managed as per SOPs 11.2.2 PM-11-PS02: Promote health Scope of Practical Skill Given relevant information, the learner must be able to:

PA0201 Provide information on communicable and non-communicable disease

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PA0202 Support public health programmes (generic skills e.g. developing pamphlets, presenting using one of several formats, accessing correct information)

PA0203 Promote healthy lifestyle Applied Knowledge

AK0201 Communicable and non-communicable disease

AK0202 Public health programmes

AK0203 Healthy lifestyle Internal Assessment Criteria

IAC0201 Information provided on communicable and non-communicable disease is correct and appropriate

IAC0202 Evidence for support for at least one public health programme is produced

IAC0203 A healthy lifestyle is promote using appropriate language and information 11.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

As per SAPC requirements

Occupational Health and Safety requirements

11.4 Exemptions

None

12. 321301000-PM-12, Perform general housekeeping and administrative tasks in the pharmacy (Basic), NQF Level 4, Credits 2

12.1 Purpose of the Practical Skill Modules

The focus of the learning in this module is on providing the learner an opportunity to perform general housekeeping and administrative tasks in the pharmacy.

The learner will be required to:

PM-12-PS01: Perform general housekeeping and administrative tasks in the pharmacy 12.2 Guidelines for Practical Skills 12.2.1 PM-12-PS01: Perform general housekeeping and administrative tasks in the pharmacy Scope of Practical Skill Given appropriate cleaning materials, the learner must be able to:

PA0101 Perform administrative tasks

PA0102 Clean and tidy shelves, equipment, and specialised storage areas

PA0103 Maintain supply of dispensary consumables (e.g., bottles, poly-vials and tablet boxes) Applied Knowledge

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AK0101 Administrative tasks

AK0102 Cleaning and tidying procedures

AK0103 Method of maintaining supply of dispensary consumables

AK0104 Merchandising (FEFO and FIFO principles) Internal Assessment Criteria

IAC0101 Administrative tasks are performed according to SOPs

IAC0102 Cleaning and tidying activities are performed according to SOPs

IAC0103 Supply of medicine containers is maintained according to SOPs 12.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

As per SAPC requirements

Occupational Health and Safety requirements 12.4 Exemptions

None

13. 321301000-PM-13, Perform general housekeeping and administrative tasks in the pharmacy (Post Basic), NQF Level 5, Credits 3

13.1 Purpose of the Practical Skill Modules

The focus of the learning in this module is on providing the learner an opportunity to perform general housekeeping and administrative tasks in the pharmacy. The learner will be required to:

PM-13-PS01: Perform general housekeeping and administrative tasks in the pharmacy (Post Basic) 13.2 Guidelines for Practical Skills 13.2.1 PM-13-PS01: Perform general housekeeping and administrative tasks in the pharmacy (Post

Basic) Scope of Practical Skill Given patient information, adverse drug reaction form, medicine quality complaint form, SOPs, the learner

must be able to:

PA0101 Update, maintain and store patient information in terms of legislative requirement

PA0102 Communicate with third-party payers to determine or verify coverage for products and services (e.g. medical aid updates, cash out)

PA0103 Perform administrative tasks in support or under the direct supervision of a pharmacist

PA0104 Complete an adverse drug reaction form and submit to a pharmacist, in terms of SOPs

PA0105 Complete a medicine quality complaint form, and submit to a pharmacist, in terms of SOPs

PA0106 Assist with updating SOPs in operations

PA0107 Coordinate the dissemination of written, electronic, and oral communications throughout the sector

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Applied Knowledge

AK0101 Patient information

AK0102 Medicine quality complaint form

AK0103 Dissemination of information

AK0104 Adverse drug reaction form Internal Assessment Criteria

IAC0101 Patient information is updated, maintained and stored according to SOPs

IAC0102 Appropriate communication and professional skills are used during communication with third-party payers

IAC0103 Adverse drug reaction forms and medicine quality complaint forms are completed according to SOPs

IAC0104 All relevant administrative tasks are performed according to SOPs

IAC0105 Input is provided to either the PT of the pharmacist to improve SOPs 13.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

As per SAPC requirements

Occupational Health and Safety requirements 13.4 Exemptions

None

14. 321301000-PM-14, Conduct screening tests (Pharmacy Technician), NQF Level 6, Credits 3

14.1 Purpose of the Practical Skill Modules

The focus of the learning in this module is on providing the learner an opportunity to conduct screening tests, with reference to GPP, Code of Conduct and ethical rules. The learner will be required to:

PM-14-PS01: Conduct screening tests 14.2 Guidelines for Practical Skills 14.2.1 PM-14-PS01: Conduct screening tests Scope of Practical Skill Given non-sterile examination gloves and screening instrument, the learner must be able to:

PA0101 Explain the procedure

PA0102 Give the patient an opportunity to ask questions

PA0103 Obtain written informed patient’s consent to conduct the test

PA0104 Document the patient history including medication used for previously diagnosed conditions and illnesses

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PA0105 Wash hands and put on examination gloves

PA0106 Check instrument for correct code and re-code instrument used if necessary

PA0107 Check with patient when last he/she had food or drink

PA0108 Conduct the test using appropriate infection control measures

PA0109 Document and record the result of the test, together with details of the test equipment, batch number and advice/referral given

PA0110 Refer the patient to pharmacist for interpretation of the results

PA0111 Dispose of medical waste Applied Knowledge

AK0101 Procedures to perform screening tests

AK0102 Patient’s written consent

AK0103 Ways to interact with patient, including effective communication skills

AK0104 Gloves and reliable instruments

AK0105 Documentation

AK0106 Protocols for recording and objective validation of quality of method and equipment

AK0107 Patient confidentiality Internal Assessment Criteria

IAC0101 Screening test is performed according to SOPs

IAC0102 Patient results are referral to pharmacist are handled according to SOPs

IAC0103 Documentation is handled and stored according to SOPs

IAC0104 Medical waste is disposed according to SOPs 14.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

As per SAPC requirements

Occupational Health and Safety requirements

14.4 Exemptions

None

15. 321301000-PM-15, Manage pharmacy resources and self-development (Pharmacy Technician), NQF Level 6, Credits 10

15.1 Purpose of the Practical Skill Modules

The focus of the learning in this module is on providing the learner an opportunity to supervise and manage staff and manage pharmacy-related facility. The learner will be required to:

PM-15-PS01: Supervise and manage staff

PM-15-PS02: Manage pharmacy - related facility

PM-15-PS03: Manage pharmacy-related facility operations

PM-15-PS04: Manage financial aspects of the pharmacy-related facility

PM-15-PS05: Manage conflict

PM-15-PS06: Manage time

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PM-15-PS07: Manage diversity

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15.2 Guidelines for Practical Skills 15.2.1 PM-15-PS01: Supervise and manage staff Scope of Practical Skill Given a group of individuals, the learner must be able to:

PA0101 Prepare and implement work schedules

PA0102 Allocate duties and manage staff rosters

PA0103 Orientate Pharmacy Technician trainees, PA (basic and post basic) and pharmacy students

PA0104 Organise and document staff meetings

PA0105 Monitor workflow in team situations while identifying, resolving, and reporting problems

PA0106 Monitor staff in terms job descriptions and established objectives

PA0107 Encourage staff productivity, participation in the activities of their professional bodies and inter-professional activities

PA0108 Work with staff to resolve audit team queries

PA0109 Identify staff training needs

PA0110 Prepare and implement staff training schedule (including CPD programmes)

PA0111 Arrange training or train staff according to identified needs

PA0112 Review work of pharmacist’s assistants

PA0113 Record staff training activities, and maintain and store staff’s personal records

PA0114 Handle complaints and, if needed, refer appropriately

PA0115 Demonstrate leadership among staff

PA0116 Mentor staff

PA0117 Perform appropriate workload calculations

PA0118 Collaborate with other health care providers (working within a multi-disciplinary team) Applied Knowledge

AK0101 Types of staff (cleaning staff, healthcare aisle assistants/front shop assistants, and other mid-level workers)

AK0102 Current legislation (LRA and BCEA)

AK0103 Job descriptions

AK0104 Schedule for staff training

AK0105 Workflow in team situations

AK0106 Meetings

AK0107 Audit team queries

AK0108 Staff productivity

AK0109 Continuing professional development (CPD)

AK0110 Types of training (including safety training)

AK0111 Problem-solving

AK0112 Teamwork (other health care professionals)

AK0113 Leadership and mentorship Internal Assessment Criteria

IAC0101 Work schedules and staff duty rosters for mid-level workers are managed to ensure efficiency in the pharmacy

IAC0102 Time management techniques are applied in preparing staff schedules, rosters and activities

IAC0103 Staff are orientated according to company policies and SOPs

IAC0104 Staff meetings are organised, conducted and documented as per SOPs

IAC0105 Staff, staff workflows and staff productivity are monitored and problems identified are resolved

IAC0106 Staff are encouraged and motivated to conduct themselves professionally, ethically and efficiently and to participate in professional activities, including CPD plans

IAC0107 Staff training needs are identified and staff training is implemented as per prepared training schedule

IAC0108 Work of staff is reviewed according to criteria and KPIs

IAC0109 Problems amongst staff members are identified and resolved using conflict management and problem-solving techniques

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IAC0110 Leadership is demonstrated and staff mentorship is conducted in an organised way

IAC0111 Workload calculations are performed as required

IAC0112 All staff training activities are recorded and staff records are maintained and stored according to procedures

15.2.2 PM-15-PS02: Manage pharmacy - related facility

Scope of Practical Skill Given a pharmacy-related facility, the learner must be able to:

PA0201 Manage equipment and infrastructure

PA0202 Manage health, safety, hygiene and security within a facility

PA0203 Manage space allocation

PA0204 Manage cleaning and maintenance activities

PA0205 Solve problems related to facility management

PA0206 Prepare SOPs for managing a pharmacy-related facility

PA0207 Manage the quality issues related to the facility

PA0208 Conduct audits to ensure correct patient care

PA0209 Record, report and manage dispensing errors and incidents Applied Knowledge

AK0201 Techniques/methods for managing equipment, infrastructure, space allocation, cleaning and maintenance

AK0202 Problem-solving techniques

AK0203 SOPs

AK0204 Quality assurance

AK0205 Audits for patient care

AK0206 Dispensing errors and incidents

AK0207 Recording and reporting procedures Internal Assessment Criteria

IAC0201 Pharmacy facility management related activities are performed according to appropriate procedures and SOPs

IAC0202 Problem-solving techniques are used to manage the pharmacy facility

IAC0203 SOPs for the facility are prepared according to procedures and in conjunction with the pharmacist

IAC0204 Quality issues are managed as per quality management processes

IAC0205 Audits to ensure correct patient care are conducted according to procedures

IAC0206 Dispensing errors and incidents are recorded, reported and managed as per SOPs 15.2.3 PM-15-PS03: Manage pharmacy-related facility operations Scope of Practical Skill Given a pharmacy-related facility, the learner must be able to:

PA0301 Monitor and manage the delivery and storage of patient-specific pre-dispensed and packaged medicines

PA0302 Manage stock and stock rotation

PA0303 Prepare for or assist in disposal of medicines

PA0304 Manage inventory and stock forecasting

PA0305 Manage operations scheduling

PA0306 Develop SOPs Applied Knowledge

AK0301 Stock rotation principles

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AK0302 Queues for prescriptions

AK0303 Medicine disposal

AK0304 Receipt and storage of medicines Internal Assessment Criteria

IAC0301 The delivery and storage of patient-specific pre-dispensed and packaged medicines are monitored and managed

IAC0302 Pharmacy-related facility operation schedules, inventory and stock forecasting are managed according to procedures

IAC0303 Preparations for the disposal of medicines are managed according to SOPs

IAC0304 SOPs for pharmacy-related facility operations are developed in accordance with procedures and in conjunction with the pharmacist

15.2.4 PM-15-PS04: Manage financial aspects of the pharmacy-related facility Scope of Practical Skill Given a pharmacy-related facility, the learner must be able to:

PA0401 Manage budget

PA0402 Perform ABC and VEN analyses

PA0403 Manage source documents

PA0404 Manage financial reporting process

PA0405 Identify and mitigate financial risks Applied Knowledge

AK0401 Budgets

AK0402 ABC and VEN analyses

AK0403 Time value of money

AK0404 Source documents

AK0405 Financial risks

AK0406 Financial reporting process Internal Assessment Criteria

IAC0401 The budget is managed according to sound financial principles

IAC0402 ABC and VEN analyses are performed to determine medicine usage

IAC0403 Source document are stored appropriately to enable quick retrieval

IAC0404 Financial risks are identified and mitigated

IAC0405 The financial reporting process is managed and adhered 15.2.5 PM-15-PS05: Manage conflict Scope of Practical Skill Given a simulated conflict situation, the learner must be able to:

PA0501 Identify conflict generator

PA0502 Interpret the nature and dynamics of the conflict

PA0503 Defuse or calm the situation respectfully and firmly

PA0504 Apply conflict management techniques and ethical considerations to resolve the conflict

PA0505 Escalate problem to higher level in the organisation for resolution, if necessary Applied Knowledge

AK0501 Conflict generators

AK0502 Dynamics of the conflict

AK0503 Techniques to defuse of calm a situation

AK0504 Conflict management techniques

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AK0505 Procedures to escalate the conflict to higher level Internal Assessment Criteria

IAC0501 Conflict generator is identified to enable conflict resolution

IAC0502 The nature and dynamics of the conflict are interpreted

IAC0503 Emotions are managed to promote clear-thinking

IAC0504 Situation is defused using appropriate procedures and ethical considerations

IAC0505 Conflict management techniques are applied to resolve the conflict

IAC0506 Problem is escalated to higher level in the organisation if necessary 15.2.6 PM-15-PS06: Manage time Scope of Practical Skill Given a simulated pharmacy environment, the learner must be able to:

PA0601 Highlight points in the workflow where time management is particularly crucial or difficult

PA0602 Select from a range of different time-management techniques those most appropriate for self and the specific circumstances of working in a pharmacy

PA0603 Prioritise own tasks decisively and flexibly in the context of a pharmacy

PA0604 Communicate effectively with team to ensure that work is completed within given timeframes Applied Knowledge

AK0601 Repertoire of time planning and management techniques

AK0602 Production or workflow, deadline structure, and responsibilities of colleagues and other role-players

AK0603 Workflow timeframes and how these may create conflict

AK0604 Time wasters Internal Assessment Criteria

IAC0601 A flowchart of the production or work cycle is drawn and bottlenecks and stress points are highlighted and analysed

IAC0602 Different time-management techniques are employed to achieve targets

IAC0603 Tasks are prioritised using ‘urgent’ and ‘important’ categories

IAC0604 Time wasters are identified and measures are taken to prevent them 15.2.7 PM-15-PS07: Manage diversity Scope of Practical Skill Given a simulated pharmacy environment, the learner must be able to:

PA0701 Check policies, practices and ways of thinking within organisational culture

PA0702 Identify organisational changes that should be made to reflect the diversity of SA society

PA0703 Design a personal plan to contradict any occurrence of ideologies of superiority in his/her life

PA0704 Make people work in diverse groups

PA0705 Conduct an educational programme on diversity Applied Knowledge

AK0701 Organisational culture and the policies and practices of the organisation

AK0702 Organisational change

AK0703 Method of designing personal plan to deal with ideologies of superiority

AK0704 Planning and presenting educational programmes Internal Assessment Criteria

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IAC0701 The policies and practices of an organisation are checked with a view to identifying possible organisational changes

IAC0702 A personal plan is prepared to deal with ideologies of superiority

IAC0703 Group work and educational programmes are conducted to encourage recognition and acceptance of diversity

15.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Accredited as provider with SAPC

Occupational Health and Safety requirements

15.4 Exemptions

None

16. 321301000-PM-16, Identify anatomical structures (Post Basic), NQF Level 5, Credits 15 16.1 Purpose of the Practical Skill Modules

The focus of the learning in this module is on providing the learner an opportunity to identify anatomical structures and therapeutic - related information for the top 200 medicines. The learner will be required to:

PM-16-PS01: Identify anatomical structures 16.2 Guidelines for Practical Skills 16.2.1 PM-16-PS01: Identify anatomical structures Scope of Practical Skill Given a simulated anatomical model and posters, the learner must be able to:

PA0101 Identify and describe the musculoskeletal system

PA0102 Identify and describe the dental and oral system

PA0103 Identify and describe the gastro-intestinal system

PA0104 Identify and describe the cardiovascular system

PA0105 Identify and describe the components of the skin system

PA0106 Identify and describe the reproductive system

PA0107 Identify and describe the endocrine system

PA0108 Identify and describe the renal system

PA0109 Identify and describe the immune system

PA0110 Identify and describe the central and peripheral nervous system

PA0111 Identify and describe the respiratory system

PA0112 Identify and describe the eye, ear, nose and throat Applied Knowledge

AK0101 Anatomical systems of the human body

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Internal Assessment Criteria

IAC0101 The anatomical structures that constitute the systems of the human body are identified and described

16.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

As per SAPC requirements

Occupational Health and Safety requirements

16.4 Exemptions

None

17. 321301000-PM-17, Conduct practical activities to optimise therapy for patients (Pharmacy Technician), NQF Level 6, Credits 15

17.1 Purpose of the Practical Skill Modules

The focus of the learning in this module is on providing the learner an opportunity to manage and optimise patient therapy and perform pharmacovigilance. The learner will be required to:

PM-17-PS01: Provide appropriate management of minor ailments

PM-17-PS02: Manage and optimise patient therapy pertaining to communicable and non-communicable disease states and conditions and perform pharmacovigilance when appropriate

17.2 Guidelines for Practical Skills 17.2.1 PM-17-PS01: Provide appropriate management of minor ailments Scope of Practical Skill Given a patient and PIT medicine, the learner must be able to:

PA0101 Collect information

PA0102 Assess and decide on appropriate action plan

PA0103 Select appropriate therapy (which may include assisting with PIT)

PA0104 Refer to pharmacist where appropriate

PA0105 Provide instructions and advice to the patient

PA0106 Follow-up and monitor

PA0107 Complete documentation Applied Knowledge

AK0101 Action plan

AK0102 Therapy (pharmacological or not)

AK0103 Documentation

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Internal Assessment Criteria

IAC0101 Accurate information is collected from patient

IAC0102 Appropriate action plan is decided upon and appropriate therapy is selected

IAC0103 The pharmacist is consulted where appropriate

IAC0104 Instructions and advice are given to patient

IAC0105 Documentation is competed according to procedures 17.2.2 PM-17-PS02: Manage and optimise patient therapy pertaining to communicable and non-

communicable disease states and conditions and perform pharmacovigilance when appropriate Scope of Practical Skill Given a patient and a prescription, the learner must be able to:

PA0201 Gather and assess patient health information

PA0202 Read prescription

PA0203 Confirm compliance of the prescribed medication with STG and EML

PA0204 Perform pharmacovigilance

PA0205 Determine multiple co-morbidities, contra-indications and possible drug-drug interactions

PA0206 Identity patients that require PT to consult with pharmacist prior to dispensing Applied Knowledge

AK0201 STG and EML

AK0202 Multiple co-morbidities, contra-indications and interactions Internal Assessment Criteria

IAC0201 Patient health information is collected and assessed according to procedure

IAC0202 Patient and prescription are compared to identify anomalies

IAC0203 Compliance of the prescribed medication with STG and EML is confirmed according to procedure

IAC0204 Pharmacovigilance is performed as per procedure

IAC0205 Multiple co-morbidities, contra-indications and possible drug-drug interactions are determined according to procedures

IAC0206 Patients that require PT to consult with pharmacist prior to dispensing are identified 17.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Accredited as provider with SAPC

Occupational Health and Safety requirements

17.4 Exemptions

None

18. 321301000-PM-18, Operate computers and computer software (Basic), NQF Level 4, Credits 4

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18.1 Purpose of the Practical Skill Modules

The focus of the learning in this module is on providing the learner an opportunity to operate computers and computer software (Basic). The learner will be required to:

PM-18-PS01: Operate a personal computer and install PC peripheral device

PM-18-PS02: Create, edit and format GUI-based word processor documents

PM-18-PS03: Create and edit GUI-based spreadsheets 18.2 Guidelines for Practical Skills 18.2.1 PM-18-PS01: Operate a personal computer and install PC peripheral device Scope of Practical Skill Given computer, peripherals and applicable software, the learner must be able to:

PA0101 Start up and shut down a personal computer system using standard and non-standard methods (includes login, use of mouse and keyboard, non-standard start-up and non-standard shut-down)

PA0102 Change the configuration of a personal computer (date, time, volume controller, display properties, desktop theme, screen saver, screen pixel resolution, keyboard language)

PA0103 Use personal computer operating system functions (install software, install hardware, uninstall software, print screen [screen print])

PA0104 Physically connect a peripheral device directly to a PC (including printers, external hard drives, modems)

PA0105 Set-up device drivers for a peripheral device in a GUI environment Applied Knowledge

AK0101 Manufacturer instructions

AK0102 Computer installation procedures

AK0103 Computer configurations

AK0104 Operating system functions

AK0105 Types of devices

AK0106 Software for devices Internal Assessment Criteria

IAC0101 The personal computer is started p and shut down according to procedure

IAC0102 Configuration of a personal computer are changed according to manufacturer’s instructions

IAC0103 Personal computer operating system functions are used according to manufacturer’s instructions

IAC0104 A peripheral device directly to a PC and the device drivers are set-up according to manufacturer’s instructions

18.2.2 PM-18-PS02: Create, edit and format GUI-based word processor documents Scope of Practical Skill Given a computer and word processor software, the learner must be able to:

PA0201 Create, open and save documents

PA0202 Produce a document from given text

PA0203 Format a document (including alignment, justification, line spacing, indentation, paragraph spacing, line and page break control, hyphenation; font (type, size, style - italic, bold, underlined), font colour, font effects (shadow, small capitals, outline, strike-through, superscript, subscript)

PA0204 Edit a document

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PA0205 Check spelling and grammar in a document Applied Knowledge

AK0201 Creating, naming and saving documents

AK0202 Text, HTML, other software versions, other software types Internal Assessment Criteria

IAC0201 Documents are created, opened, saved, produced from given text, edited and formatted according to software operating procedures

IAC0202 Spelling and grammar in the document is checked using the appropriate software functions 18.2.3 PM-18-PS03: Create and edit GUI-based spreadsheets Scope of Practical Skill Given a computer and spreadsheet processor software, the learner must be able to:

PA0301 Create, open and save spreadsheets

PA0302 Produce a spreadsheet from a given specification

PA0303 Edit a spreadsheet

PA0304 Format a spreadsheet

PA0305 Check spelling in a spreadsheet

PA0306 Print a spreadsheet using features specific to spreadsheets Applied Knowledge

AK0301 Properties of spreadsheets (rows, columns, cells, cell cursor)

AK0302 Creating, naming and saving spreadsheets

AK0303 Formulae: addition, subtraction, division, multiplication, sum

AK0304 Text, CSV, HTML, other software versions, other software types

AK0304 Formatting features include the following: style, alignment, font, background colour. At least one option listed out of each formatting feature must be performed: style (text, number, date, currency, percentage), alignment (left, centre, right, justified, text direction), font (type, size, style - italic, bold, underlined, colour, strike-through, superscript, subscript), background colour)

Internal Assessment Criteria

IAC0301 Spreadsheets are created, opened, saved, produced from given specifications, edited and formatted according to software operating procedures

IAC0302 Spelling in the document is checked using the appropriate software functions

IAC0303 Basic spreadsheet formulae are used correctly 18.3 Provider Programme Accreditation Criteria Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Accredited as provider with SAPC

Occupational Health and Safety requirements

18.4 Exemptions

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None

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SECTION 3C: WORK EXPERIENCE MODULE SPECIFICATIONS List of Work Experience Module Specifications

321301000-WM-01, Processes to distribute and control stock, as per legislation (Basic), NQF Level 4,

Credits 5

321301000-WM-02, Processes to manage stock as per legislation (Post Basic), NQF Level 5, Credits 8

321301000-WM-03, Processes to manage supply chain and supervise the supply chain (Pharmacy

Technician), NQF Level 6, Credits 10

321301000-WM-04, Processes to manufacture non-sterile medicines (Basic), NQF Level 4, Credits 4

321301000-WM-05, Processes to manufacture non-sterile and sterile medicines (Post Basic), NQF Level

5, Credits 5

321301000-WM-06, Processes to manufacture non-sterile and sterile medicines and to supervise select

manufacturing activities (Pharmacy Technician), NQF Level 6, Credits 6

321301000-WM-07, Processes to compound non-sterile extemporaneous preparations (Pharmacist’s

Assistant - Basic), NQF Level 4, Credits 5

321301000-WM-08, Processes to compound sterile and extemporaneous preparations (Post Basic), NQF

Level 5, Credits 6

321301000-WM-09, Processes to compound and supervise the compounding of sterile and non-sterile

extemporaneous preparations (Pharmacy Technician), NQF Level 6, Credits 7

321301000-WM-10, Processes to dispense medicines (Post Basic), NQF Level 2, Credits 15

321301000-WM-11, Processes to dispense and supervise dispensing of medicines (Pharmacy

Technician), NQF Level 6, Credits 15

321301000-WM-12, Processes to perform general housekeeping and administrative tasks in the

pharmacy (Basic), NQF Level 4, Credits 2

321301000-WM-13, Processes to perform general housekeeping and administrative tasks in the

pharmacy (Post Basic), NQF Level 5, Credits 3

321301000-WM-14, Processes to conduct screening tests (Pharmacy Technician), NQF Level 6, Credits

2

321301000-WM-15, Management of pharmacy resources (Pharmacy Technician), NQF Level 6, Credits

10

1. 321301000-WM-01, Processes to distribute and control stock, as per legislation (Basic), NQF Level 4, Credits 5

1.1 Purpose of the Work Experience Modules

The focus of the work experience is on providing the learner an opportunity to: gain structured experience under guidance of a qualified and/or experienced Pharmacy Technician or Pharmacist to distribute and control stock at the level of the Pharmacist’s Assistant (Basic), within expected time frames and according to SOPs. Work experience providers are to ensure that learners get as much exposure to the work activities listed in this module as possible. The learner will be required to:

WM-01-WE01: Observe and assist a Pharmacist’s Assistant (Basic), Pharmacist’s Assistant (Post Basic), Pharmacy Technician or Pharmacist to distribute and control stock

WM-01-WE02: Distribute and control stock under supervision of a Pharmacy Technician or Pharmacist

WM-01-WE03: Distribute and control stock independently but subject to quality checks by Pharmacy Technician or Pharmacist

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1.2 Guidelines for Work Experiences 1.2.1 WM-01-WE01: Observe and assist a Pharmacist’s Assistant (Basic), Pharmacist’s Assistant (Post

Basic), Pharmacy Technician or Pharmacist to distribute and control stock Scope of Work Experience The person will be expected to engage in the following work activities:

WA0101 Discuss and review the work activities outlined in this scope with a Pharmacy Technician or Pharmacist

WA0102 Receive, process and pack stock as per company/organisational SOPs (includes packing stock according to FEFO & FIFO principles)

WA0103 Notify the Pharmacist/ Pharmacy Technician about discrepancies (including, short-dated, damaged, under or over-supply, incorrect item)

WA0104 Pick, pack and distribute orders with appropriate checks and authorisation from a Pharmacist/ Pharmacy Technician

WA0105 Complete appropriate documentation for picking, packing and dispatching orders

WA0106 Perform stock counts

WA0107 Report out-of-stock items, over-stocked items and medicines and medical related items to be ordered

WA0108 Process credits for items to be returned Supporting Evidence

SE0101 Checklists

SE0102 Signed-off log book 1.2.2 WM-01-WE02: Distribute and control stock under supervision of a Pharmacy Technician or

Pharmacist Scope of Work Experience The person will be expected to engage in the following work activities:

WA0201 Receive, process and pack stock as per company/organisational SOPs (includes packing stock according to FEFO & FIFO principles)

WA0202 Notify the Pharmacist/ Pharmacy Technician about discrepancies (including, short-dated, damaged, under or over-supply, incorrect item)

WA0203 Pick, pack and distribute orders with appropriate checks and authorisation from a Pharmacist/ Pharmacy Technician

WA0204 Complete appropriate documentation for picking, packing and dispatching orders

WA0205 Perform stock counts

WA0206 Report out-of-stock items, over-stocked items and medicines and medical related items to be ordered

WA0207 Process credits for items to be returned Supporting Evidence

SE0201 Signed-off log book 1.2.3 WM-01-WE03: Distribute and control stock independently but subject to quality checks by

Pharmacy Technician or Pharmacist Scope of Work Experience The person will be expected to engage in the following work activities:

WA0301 Receive, process and pack stock as per company/organisational SOPs (includes packing stock according to FEFO & FIFO principles)

WA0302 Notify the Pharmacist/ Pharmacy Technician about discrepancies (including, short-dated, damaged, under or over-supply, incorrect item)

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WA0303 Pick, pack and distribute orders with appropriate checks and authorisation from a Pharmacist/ Pharmacy Technician

WA0304 Complete appropriate documentation for picking, packing and dispatching orders

WA0305 Perform stock counts

WA0306 Report out-of-stock items, over-stocked items and medicines and medical related items to be ordered

WA0307 Process credits for items to be returned Supporting Evidence

SE0301 Signed-off log book 1.3 Contextualised Workplace Knowledge

(a) Company specific standard operating procedures (b) Safety, health, environmental and quality requirements and procedures (c) Company specific quality management systems

1.4 Criteria for Workplace Approval Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Compliant with Safety, Health, Environmental, Risk and Quality (SHERQ) requirements

Compliant with Compensation for Occupational Injuries and Diseases Act (COIDA) requirements

Accredited by the AQP

1.5 Additional Assignments to be Assessed Externally None

2. 321301000-WM-02, Processes to manage stock as per legislation (Post Basic), NQF Level 5, Credits 8

2.1 Purpose of the Work Experience Modules

The focus of the work experience is on providing the learner an opportunity to: gain structured experience under guidance of a Pharmacy Technician or Pharmacist to manage stock (medicines or scheduled substances), within expected time frames and according to SOPs. Work experience providers are to ensure that learners get as much exposure to the work activities listed in this module as possible. The learner will be required to:

WM-02-WE01: Observe and assist a Pharmacist’s Assistant (Post Basic), Pharmacy Technician or Pharmacist to manage stock

WM-02-WE02: Manage stock under supervision of a Pharmacy Technician or Pharmacist

WM-02-WE03: Manage stock independently but subject to quality checks by Pharmacy Technician or Pharmacist

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2.2 Guidelines for Work Experiences 2.2.1 WM-02-WE01: Observe and assist a Pharmacist’s Assistant (Post Basic), Pharmacy Technician or

Pharmacist to manage stock Scope of Work Experience The person will be expected to engage in the following work activities:

WA0101 Discuss and review the work activities outlined in this scope with a Pharmacy Technician or Pharmacist

WA0102 Pick, pack and dispatch orders according to legislation

WA0103 Control stock

WA0104 Quarantine expired, damaged and recalled medicines, according to SOPs

WA0105 Perform calculations (Average Monthly Consumptions [AMC]: maximum and minimum)

WA0106 Order stock using relevant replenishment model

WA0107 Identify approved vendors

WA0108 Perform quantification and demand planning

WA0109 Report on stock availability Supporting Evidence

SE0101 Checklists

SE0102 Signed-off log book 2.2.2 WM-02-WE02: Manage stock under supervision of a Pharmacy Technician or Pharmacist Scope of Work Experience The person will be expected to engage in the following work activities:

WA0201 Pick, pack and dispatch orders according to legislation

WA0202 Control stock

WA0203 Quarantine expired, damaged and recalled medicines, according to SOPs

WA0204 Perform calculations (Average Monthly Consumptions [AMC]: maximum and minimum)

WA0205 Order stock using relevant replenishment model

WA0206 Identify approved vendors

WA0207 Perform quantification and demand planning

WA0208 Report on stock availability Supporting Evidence

SE0201 Signed-off logbook 2.2.3 WM-02-WE03: Manage stock independently but subject to quality checks by Pharmacy Technician or Pharmacist Scope of Work Experience The person will be expected to engage in the following work activities:

WA0301 Pick, pack and dispatch orders for Schedule 1 to 6

WA0302 Control stock

WA0303 Quarantine expired, damaged and recalled medicines, according to SOPs

WA0304 Perform stock takes as scheduled

WA0305 Perform calculations (Average Monthly Consumptions [AMC]: maximum and minimum)

WA0306 Use the replenishment model to order stock

WA0307 Identify approved vendors

WA0308 Perform quantification and demand planning

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WA0309 Report on stock availability Supporting Evidence

SE0301 Signed-off logbook 2.3 Contextualised Workplace Knowledge

(a) Company specific standard operating procedures (b) Safety, health, environmental and quality requirements and procedures (c) Company specific quality management systems

2.4 Criteria for Workplace Approval

Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Compliant with Safety, Health, Environmental, Risk and Quality (SHERQ) requirements

Compliant with Compensation for Occupational Injuries and Diseases Act (COIDA) requirements

Accredited by the AQP 2.5 Additional Assignments to be Assessed Externally

None

3. 321301000-WM-03, Processes to manage supply chain and supervise the supply chain (Pharmacy Technician), NQF Level 6, Credits 10

3.1 Purpose of the Work Experience Modules

The focus of the work experience is on providing the learner an opportunity to: gain structured experience under guidance of a Pharmacist to manage stock, within expected time frames and according to SOPs. Work experience providers are to ensure that learners get as much exposure to the work activities listed in this module as possible. The learner will be required to:

WM-03-WE01: Observe and assist a Pharmacy Technician or Pharmacist to manage supply chain

WM-03-WE02: Manage supply chain under the supervision of a Pharmacy Technician or Pharmacist

WM-03-WE03: Manage supply chain independently but subject to quality checks by a Pharmacist 3.2 Guidelines for Work Experiences 3.2.1 WM-03-WE01: Observe and assist a Pharmacy Technician or Pharmacist to manage supply chain Scope of Work Experience The person will be expected to engage in the following work activities:

WA0101 Discuss and review the work activities outlined in this scope with the Pharmacy Technician or Pharmacist

WA0102 Manage recall of stock and return of medicines

WA0103 Manage quarantining of recalled or expired or discontinued medicines

WA0104 Sign specified schedule register

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WA0105 Check orders, prior to the packing and despatch thereof

WA0106 Mitigate risks and manage anomalies during stock management

WA0107 Implement error management techniques

WA0108 Supervise Basics and Post Basics in the medicine supply chain Supporting Evidence

SE0101 Checklist

SE0102 Signed-off logbook 3.2.2 WM-03-WE02: Manage supply chain under the supervision of a Pharmacy Technician or

Pharmacist Scope of Work Experience The person will be expected to engage in the following work activities:

WA0201 Manage recall of stock and return of medicines

WA0202 Manage quarantining of recalled or expired or discontinued medicines

WA0203 Sign specified schedule register

WA0204 Check orders, prior to the packing and despatch thereof

WA0205 Mitigate risks and manage anomalies during stock management

WA0206 Implement error management techniques

WA0207 Supervise the Basics and Post Basics in the medicine supply chain Supporting Evidence

SE0201 Signed-off logbook 3.2.3 WM-03-WE03: Manage supply chain independently but subject to quality checks by a Pharmacist Scope of Work Experience The person will be expected to engage in the following work activities:

WA0301 Manage recall of stock and return of medicines

WA0302 Manage quarantining of recalled or expired or discontinued medicines

WA0303 Sign specified schedule register

WA0304 Check orders prior to the packing and despatch thereof

WA0305 Mitigate risks and manage anomalies during stock management

WA0306 Implement error management techniques

WA0307 Supervise the Basics and Post Basics in the medicine supply chain Supporting Evidence

SE0301 Signed-off logbook 3.3 Contextualised Workplace Knowledge

(a) Company specific standard operating procedures (b) Safety, health, environmental and quality requirements and procedures (c) Company specific quality management systems

3.4 Criteria for Workplace Approval Physical Requirements:

As per SAPC requirements

Human Resource Requirements:

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As per SAPC requirements Legal Requirements:

Compliant with Safety, Health, Environmental, Risk and Quality (SHERQ) requirements

Compliant with Compensation for Occupational Injuries and Diseases Act (COIDA) requirements

Accredited by the AQP 3.5 Additional Assignments to be Assessed Externally None

4. 321301000-WM-04, Processes to manufacture non-sterile medicines (Basic), NQF Level 4, Credits 4

4.1 Purpose of the Work Experience Modules

The focus of the work experience is on providing the learner an opportunity to: gain structured experience under the guidance of a Pharmacist’s Assistant (Basic), Pharmacist’s Assistant (Post Basic), Pharmacy Technician or Pharmacist to manufacture non-sterile medicines, within expected time frames and according to SOPs. Work experience providers are to ensure that learners get as much exposure to the work activities listed in this module as possible. The learner will be required to:

WM-04-WE01: Observe and assist within their scope of practice a Pharmacist’s Assistant (Basic), Pharmacist’s Assistant (Post Basic), Pharmacy Technician or Pharmacist to manufacture non-sterile medicines

4.2 Guidelines for Work Experiences 4.2.1 WM-04-WE01: Observe and assist within their scope of practice a Pharmacist’s Assistant (Basic),

Pharmacist’s Assistant (Post Basic), Pharmacy Technician or Pharmacist to manufacture non-sterile medicines

Scope of Work Experience The person will be expected to engage in the following work activities:

WA0101 Discuss and review the work activities outlined in this scope with a Pharmacy Technician and/or a Pharmacist

WA0102 Apply cGMP and GPP and current legislation requirements

WA0103 Use appropriate PPE

WA0104 Assist in a range of material handling and recording activities (record environmental conditions, handle quarantining products, control stock, handle documents and records, monitor storage conditions, ensure security of product, manage stock of packaging materials and transporting materials)

WA0105 Assist in the manufacture of non-sterile medicines or scheduled substances (e.g. transport weighed materials in the presence of a pharmacist/pharmacy technician, check and clean equipment and manufacturing areas before and after a run, transfer bulk product to quarantine area under guidance, and participate in water treatment)

WA0106 Adhere to and promote access control and restrictions

WA0107 Assist in packaging activities (apply cGMP and current legislation related to packaging, clear and clean packaging line and equipment, pack medicine in appropriate packaging, transport packaging materials)

Supporting Evidence

SE0101 Checklist

SE0102 Signed-off log book

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4.3 Contextualised Workplace Knowledge

(a) Company specific standard operating procedures (b) Safety, health, environmental and quality requirements and procedures (c) Company specific quality management systems

4.4 Criteria for Workplace Approval Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Compliant with Safety, Health, Environmental, Risk and Quality (SHERQ) requirements

Compliant with Compensation for Occupational Injuries and Diseases Act (COIDA) requirements

Accredited by the AQP

4.5 Additional Assignments to be Assessed Externally None

5. 321301000-WM-05, Processes to manufacture non-sterile and sterile medicines (Post Basic), NQF Level 5, Credits 5

5.1 Purpose of the Work Experience Modules

The focus of the work experience is on providing the learner an opportunity to: gain structured experience under the guidance of a Pharmacist’s Assistant (Post Basic), Pharmacy Technician or Pharmacist to manufacture non-sterile and sterile medicines, within expected time frames and according to SOPs. Work experience providers are to ensure that learners get as much exposure to the work activities listed in this module as possible. The learner will be required to:

WM-05-WE01: Observe a Pharmacist’s Assistant (Post Basic), Pharmacy Technician and/or Pharmacist manufacture non-sterile medicines

WM-05-WE02: Assist in the manufacture of non-sterile medicines under the supervision of a Pharmacy Technician and/or a Pharmacist

WM-05-WE03: Observe a Pharmacist’s Assistant (Post Basic), Pharmacy Technician or Pharmacist package and re-package non-sterile medicines

WM-05-WE04: Assist in packaging and re-packaging of non-sterile medicines under the supervision of a Pharmacy Technician and/or a Pharmacist

WM-05-WE05: Observe a Pharmacist’s Assistant (Post Basic), Pharmacy Technician or Pharmacist manufacture sterile medicines

WM-05-WE06: Assist in the manufacture of sterile medicines under the supervision of a Pharmacy Technician and/or a Pharmacist

WM-05-WE07: Observe a Post Basic, Pharmacy Technician or Pharmacist package sterile medicines

WM-05-WE08: Assist in the packaging of sterile medicines under the supervision of a Pharmacy Technician and/or a Pharmacist

5.2 Guidelines for Work Experiences 5.2.1 WM-05-WE01: Observe a Pharmacist’s Assistant (Post Basic), Pharmacy Technician and/or Pharmacist manufacture non-sterile medicines Scope of Work Experience

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The person will be expected to engage in the following work activities:

WA0101 Discuss and review the work activities outlined in this scope with a Pharmacy Technician and/or a Pharmacist

WA0102 Implement cGMP and GPP -based SOPs

WA0103 Monitor environmental conditions for materials and product

WA0104 Implement procedures to quarantine products and materials

WA0105 Assist in stock control, completing batch records, destroying goods, managing storage conditions for bulk product prior to packing

WA0106 Apply legal and special requirements for scheduled substances

WA0107 Manage stock of packaging materials and issue packaging materials, with the exception of printed packaging materials

WA0108 Perform some manufacturing activities (e.g. weigh non-active raw materials, perform pharmaceutical calculations used in the manufacture of medicines, assist in the manufacture dosage forms, check, record and sign for the addition of non-active ingredients to the mix with the pharmacist)

WA0109 Assist in performing in-process control testing and in-process checks

WA0110 Detect deviations and raise deviation to appropriate supervisory person

WA0111 Use PPE and implement hygienic procedures for all procedures Supporting Evidence

SE0101 Signed-off logbook

SE0102 Learner journal 5.2.2 WM-05-WE02: Assist in the manufacture of non-sterile medicines under the supervision of a

Pharmacy Technician and/or a Pharmacist Scope of Work Experience The person will be expected to engage in the following work activities:

WA0201 Implement cGMP-based SOPs

WA0202 Monitor environmental conditions for materials and product

WA0203 Implement procedures to quarantine products and materials

WA0204 Assist in stock control, completing batch records, destroying goods, managing storage conditions for bulk product prior to packing

WA0205 Apply legal and special requirements for scheduled substances

WA0206 Manage stock of packaging materials and issue packaging materials, with the exception of printed packaging materials

WA0207 Perform manufacturing activities (weigh non-active raw materials, perform pharmaceutical calculations used in the manufacture of medicines, assist in the manufacture dosage forms, check, record and sign for the addition of non-active ingredients to the mix with the pharmacist)

WA0208 Assist in performing in-process control testing and in-process checks

WA0209 Detect deviations and raise deviation to appropriate supervisory person

WA0210 Use PPE and implement hygienic procedures for all procedures Supporting Evidence

SE0201 Signed-off logbook

SE0202 Learner journal 5.2.3 WM-05-WE03: Observe a Pharmacist’s Assistant (Post Basic), Pharmacy Technician or Pharmacist package and re-package non-sterile medicines Scope of Work Experience The person will be expected to engage in the following work activities:

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WA0301 Check environmental conditions for packaging

WA0302 Manage packaging materials (receive and check against batch record, check correct batch number of medicine packed)

WA0303 Check and clear packaging line after obtaining authorisation and assist in opening the line

WA0304 Clean and/or check that all apparatus and equipment are cleaned, sterilised and labelled accordingly

WA0305 Use master document for packing and re-packing each product

WA0306 Assist in carrying out process control testing during packaging and re-packaging of medicines as per legislation

WA0307 Label product and secure all stored labels and over-printed material to prevent a possible mix-up

WA0308 Discard any unused, damaged or rejected labels bearing a particular batch number and packaging date in accordance with the SOPs

WA0309 Assist in collating documents and records of each batch of medicine packed

WA0310 Sign all documentation, which must be countersigned by the pharmacist Supporting Evidence

SE0301 Signed-off logbook

SE0302 Learner journal 5.2.4 WM-05-WE04: Assist in packaging and re-packaging of non-sterile medicines under the

supervision of a Pharmacy Technician and/or a Pharmacist Scope of Work Experience The person will be expected to engage in the following work activities:

WA0401 Check environmental conditions for packaging

WA0402 Manage packaging materials (receive and check against batch record, check correct batch number of medicine packed)

WA0403 Check and clear packaging line after obtaining authorisation and assist in opening the line

WA0404 Clean and/or check that all apparatus and equipment are clean, sterilised and labelled accordingly

WA0405 Use master document for packing and re-packing each product

WA0406 Assist in carrying out process control testing during packaging and re-packaging of medicines as per legislation

WA0407 Label product and secure all stored labels and over-printed material to prevent a possible mix-up

WA0408 Discard any unused, damaged or rejected labels bearing a particular batch number and packaging date in accordance with the SOPs

WA0409 Assist in collating documents and records of each batch of medicine packed

WA0410 Sign all documentation, which must be countersigned by the pharmacist Supporting Evidence

SE0401 Signed-off logbook

SE0402 Learner journal 5.2.5 WM-05-WE05: Observe a Pharmacist’s Assistant (Post Basic), Pharmacy Technician or

Pharmacist manufacture sterile medicines Scope of Work Experience The person will be expected to engage in the following work activities:

WA0501 Implement cGMP-based SOPs

WA0502 Monitor environmental conditions for materials and product

WA0503 Implement procedures to quarantine products and materials

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WA0504 Assist in stock control, completing batch records, destroying goods, managing storage conditions for bulk product prior to packing

WA0505 Apply legal and special requirements for scheduled substances

WA0506 Manage stock of packaging materials and issue packaging materials, with the exception of printed packaging materials

WA0507 Perform manufacturing activities (weigh non-active raw materials, perform pharmaceutical calculations used in the manufacture of medicines, use aseptic techniques, assist in the manufacture dosage forms, check, record and sign for the addition of non-active ingredients to the mix with the pharmacist)

WA0508 Assist in performing in-process control testing and in-process checks

WA0509 Detect deviations and raise deviation to appropriate supervisory person

WA0510 Use PPE and implement hygienic procedures for all procedures Supporting Evidence

SE0501 Signed-off logbook

SE0502 Learner journal 5.2.6 WM-05-WE06: Assist in the manufacture of sterile medicines under the supervision of a Pharmacy

Technician and/or a Pharmacist Scope of Work Experience The person will be expected to engage in the following work activities:

WA0601 Implement cGMP-based SOPs

WA0602 Monitor environmental conditions for materials and product

WA0603 Implement procedures to quarantine products and materials

WA0604 Assist in stock control, completing batch records, destroying goods, managing storage conditions for bulk product prior to packing

WA0605 Apply legal and special requirements for scheduled substances

WA0606 Manage stock of packaging materials and issue packaging materials, with the exception of printed packaging materials

WA0607 Perform manufacturing activities (weigh non-active raw materials, perform pharmaceutical calculations used in the manufacture of medicines, use aseptic techniques, assist in the manufacture dosage forms, check, record and sign for the addition of non-active ingredients to the mix with the pharmacist)

WA0608 Assist in performing in-process control testing and in-process checks

WA0609 Detect deviations and raise deviation to appropriate supervisory person

WA0610 Use PPE and implement hygienic procedures for all procedures Supporting Evidence

SE0601 Signed-off logbook

SE0602 Learner journal 5.2.7 WM-05-WE07: Observe a Post Basic, Pharmacy Technician or Pharmacist package sterile

medicines Scope of Work Experience The person will be expected to engage in the following work activities:

WA0701 Check environmental conditions for packaging

WA0702 Manage packaging materials (receive and check against batch record, check correct batch number of medicine packed)

WA0703 Check and clear packaging line after obtaining authorisation and assist in opening the line

WA0704 Clean and/or check that all apparatus and equipment are cleaned, sterilised and labelled accordingly

WA0705 Use master document for packing and re-packing each product

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WA0706 Assist in carrying out process control testing during packaging and re-packaging of medicines as per legislation

WA0707 Label product and secure all stored labels and over-printed material to prevent a possible mix-up

WA0708 Discard any unused, damaged or rejected labels bearing a particular batch number and packaging date in accordance with the SOPs

WA0709 Assist in collating documents and records of each batch of medicine packed

WA0710 Sign all documentation, which must be countersigned by the pharmacist

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Supporting Evidence

SE0701 Signed-off logbook

SE0702 Learner journal 5.2.8 WM-05-WE08: Assist in the packaging of sterile medicines under the supervision of a Pharmacy

Technician and/or a Pharmacist Scope of Work Experience The person will be expected to engage in the following work activities:

WA0801 Check environmental conditions for packaging

WA0802 Manage packaging materials (receive and check against batch record, check correct batch number of medicine packed)

WA0803 Check and clear packaging line after obtaining authorisation and assist in opening the line

WA0804 Clean and/or check that all apparatus and equipment are cleaned, sterilised and labelled accordingly

WA0805 Use master document for packing and re-packing each product

WA0806 Assist in carrying out process control testing during packaging and re-packaging of medicines as per legislation

WA0807 Label product and secure all stored labels and over-printed material to prevent a possible mix-up

WA0808 Discard any unused, damaged or rejected labels bearing a particular batch number and packaging date in accordance with the SOPs

WA0809 Assist in collating documents and records of each batch of medicine packed

WA0810 Sign all documentation, which must be countersigned by the pharmacist Supporting Evidence

SE0801 Signed-off logbook

SE0802 Learner journal 5.3 Contextualised Workplace Knowledge

(a) Company specific standard operating procedures (b) Safety, health, environmental and quality requirements and procedures (c) Company specific quality management systems

5.4 Criteria for Workplace Approval Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Compliant with Safety, Health, Environmental, Risk and Quality (SHERQ) requirements

Compliant with Compensation for Occupational Injuries and Diseases Act (COIDA) requirements

Accredited by the AQP

5.5 Additional Assignments to be Assessed Externally None

6. 321301000-WM-06, Processes to manufacture non-sterile and sterile medicines and to supervise select manufacturing activities (Pharmacy Technician), NQF Level 6, Credits 6

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6.1 Purpose of the Work Experience Modules

The focus of the work experience is on providing the learner an opportunity to: gain structured experience under the guidance of a pharmacist to manufacture non-sterile and sterile medicines, within expected time frames and according to SOPs. Work experience providers are to ensure that learners get as much exposure to the work activities listed in this module as possible. The learner will be required to:

WM-06-WE01: Observe and assist a Pharmacy Technician and/or Pharmacist to manage materials for the manufacture of non-sterile medicines

WM-06-WE02: Manage materials in the manufacture of non-sterile medicines under supervision of a Pharmacy Technician and/or Pharmacist

WM-06-WE03: Observe and assist a Pharmacy Technician and/or Pharmacist to manage materials for the manufacture of sterile medicines

WM-06-WE04: Manage materials in the manufacture of sterile medicines under supervision of a Pharmacy Technician and/or Pharmacist

WM-06-WE05: Observe and assist a Pharmacy Technician and/or Pharmacist manufacture non-sterile medicines

WM-06-WE06: Manufacture non-sterile medicines under supervision of a Pharmacy Technician and/or Pharmacist

WM-06-WE07: Observe and assist a Pharmacy Technician and/or Pharmacist manufacture sterile medicines

WM-06-WE08: Manufacture sterile medicines under supervision of a Pharmacy Technician and/or Pharmacist

WM-06-WE09: Observe and assist a Pharmacy Technician and/or Pharmacist to package and re-package non-sterile medicines

WM-06-WE10: Package and re-package non-sterile medicines under supervision of a Pharmacy Technician

WM-06-WE11: Observe and assist a Pharmacy Technician and/or Pharmacist to package and re-package sterile medicines

WM-06-WE12: Package and re-package sterile medicines under supervision of a Pharmacy Technician

6.2 Guidelines for Work Experiences 6.2.1 WM-06-WE01: Observe and assist a Pharmacy Technician and/or Pharmacist to manage materials

for the manufacture of non-sterile medicines Scope of Work Experience The person will be expected to engage in the following work activities:

WA0101 Discuss and review the work activities outlined in this scope with the Pharmacy Technician or Pharmacist

WA0102 Monitor and control environmental conditions for materials and stock rotation

WA0103 Monitor and control the issuing of raw materials

WA0104 Monitor and control the quarantining of materials

WA0105 Apply special requirements for Schedule 5 and 6 substances and medicines under guidance of a pharmacist

WA0106 Manage batch documents and records and implement batch tracking

WA0107 Destroy goods under guidance of the Pharmacist

WA0108 Monitor and control the application of cGMP while managing materials

WA0109 Supervise the Basics and Post Basics to manage materials for the manufacture of non-sterile medicines

Supporting Evidence

SE0101 Signed-off checklists

SE0102 Signed-off logbooks

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SE0103 Learner journal 6.2.2 WM-06-WE02: Manage materials in the manufacture of non-sterile medicines under supervision of

a Pharmacy Technician and/or Pharmacist Scope of Work Experience The person will be expected to engage in the following work activities:

WA0201 Monitor and control environmental conditions for materials and stock rotation

WA0202 Monitor and control the issuing of raw materials

WA0203 Monitor and control the quarantining of materials

WA0204 Apply special requirements for scheduled substances and medicines according to legislation, under guidance of a pharmacist

WA0205 Manage batch documents and records and implement batch tracking

WA0206 Destroy goods under guidance of the Pharmacist

WA0207 Monitor and control the application of cGMP during materials management

WA0208 Supervise the Basics and Post Basics to manage materials for the manufacture of non-sterile medicines

Supporting Evidence

SE0201 Signed-off checklists

SE0202 Signed-off logbooks

SE0203 Learner journal 6.2.3 WM-06-WE03: Observe and assist a Pharmacy Technician and/or Pharmacist to manage materials

for the manufacture of sterile medicines Scope of Work Experience The person will be expected to engage in the following work activities:

WA0301 Monitor and control environmental conditions for materials and stock rotation

WA0302 Monitor and control the issuing of raw materials

WA0303 Monitor and control the quarantining of materials

WA0304 Apply special requirements for Schedule 5 and 6 substances and medicines under guidance of a pharmacist

WA0305 Manage batch documents and records and implement batch tracking

WA0306 Destroy goods under guidance of the Pharmacist

WA0307 Monitor and control the application of cGMP while managing materials

WA0308 Supervise the Basics and Post Basics to manage materials for the manufacture of sterile medicines

Supporting Evidence

SE0301 Signed-off checklists

SE0302 Signed-off logbooks

SE0303 Learner journal 6.2.4 WM-06-WE04: Manage materials in the manufacture of sterile medicines under supervision of a

Pharmacy Technician and/or Pharmacist Scope of Work Experience The person will be expected to engage in the following work activities:

WA0401 Monitor and control environmental conditions for materials and stock rotation

WA0402 Monitor and control the issuing of raw materials

WA0403 Monitor and control the quarantining of materials

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WA0404 Apply special requirements for scheduled substances and medicines according to legislation, under guidance of a pharmacist

WA0405 Manage batch documents and records and implement batch tracking

WA0406 Destroy goods under guidance of the Pharmacist

WA0407 Monitor and control the application of cGMP during materials management

WA0408 Supervise the Basics and Post Basics to manage materials for the manufacture of sterile medicines

Supporting Evidence

SE0401 Signed-off checklists

SE0402 Signed-off logbooks

SE0403 Learner journal 6.2.5 WM-06-WE05: Observe and assist a Pharmacy Technician and/or Pharmacist manufacture non-

sterile medicines Scope of Work Experience The person will be expected to engage in the following work activities:

WA0501 Monitor and control cGMP during manufacture

WA0502 Monitor and control weighing of non-active ingredients

WA0503 Perform calculations

WA0504 Initiate line clearance, opening line and line closure as per documented procedure, detailed checklist and signed authorisation by the supervising pharmacist

WA0505 Apply any special requirements for scheduled substances and products (as per legislation) during manufacturing

WA0506 Monitor, control and implement the adding of non-active materials to the mix

WA0507 Monitor and control the manufacturing of various dosage forms

WA0508 Monitor, control and implement in process controls

WA0509 Perform sampling or supervise the sampling of medicines or scheduled substances, in accordance with rules relating to current good manufacturing practice (cGMP)

WA0510 Monitor and control water usage, storage and processing

WA0511 Supervise the Basics and Post Basics to manufacture non-sterile medicines Supporting Evidence

SE0501 Signed-off checklists

SE0502 Signed-off logbooks

SE0503 Learner journal 6.2.6 WM-06-WE06: Manufacture non-sterile medicines under supervision of a Pharmacy Technician

and/or Pharmacist Scope of Work Experience The person will be expected to engage in the following work activities:

WA0601 Monitor and control cGMP during manufacture

WA0602 Monitor and control weighing of non-active ingredients

WA0603 Perform calculations

WA0604 Initiate line clearance, opening line and line closure as per documented procedure, detailed checklist and signed authorisation by the supervising pharmacist

WA0605 Apply any special requirements for scheduled substances or products during manufacturing

WA0606 Monitor, control and implement the adding of non-active materials to the mix

WA0607 Monitor and control the manufacturing of various dosage forms

WA0608 Monitor, control and implement in process controls

WA0609 Perform sampling or supervise the sampling of medicines or scheduled substances, in accordance with rules relating to current good manufacturing practice (cGMP)

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WA0610 Monitor and control water usage, storage and processing

WA0611 Supervise the Basics and Post Basics to manufacture non-sterile medicines Supporting Evidence

SE0601 Signed-off logbook

SE0602 Learner journal 6.2.7 WM-06-WE07: Observe and assist a Pharmacy Technician and/or Pharmacist manufacture sterile

medicines Scope of Work Experience The person will be expected to engage in the following work activities:

WA0701 Monitor and control cGMP during manufacture

WA0702 Monitor and control weighing of non-active ingredients

WA0703 Perform calculations

WA0704 Initiate line clearance, opening line and line closure as per documented procedure, detailed checklist and signed authorisation by the supervising pharmacist

WA0705 Apply special requirements for scheduled substances and products (as per legislation) during manufacturing

WA0706 Monitor, control and implement the adding of non-active materials to the mix

WA0707 Monitor and control the manufacturing of various dosage forms

WA0708 Monitor, control and implement in process controls

WA0709 Monitor and control HVAC conditions

WA0710 Perform sampling or supervise the sampling of medicines or scheduled substances, in accordance with rules relating to current good manufacturing practice (cGMP)

WA0711 Monitor and control water usage, storage and processing

WA0712 Supervise the Basics and Post Basics to manufacture sterile medicines Supporting Evidence

SE0701 Signed-off checklists

SE0702 Signed-off logbooks

SE0703 Learner journal 6.2.8 WM-06-WE08: Manufacture sterile medicines under supervision of a Pharmacy Technician and/or

Pharmacist Scope of Work Experience The person will be expected to engage in the following work activities:

WA0801 Monitor and control cGMP during manufacture

WA0802 Monitor and control weighing of non-active ingredients

WA0803 Perform calculations

WA0804 Initiate line clearance, opening line and line closure as per documented procedure, detailed checklist and signed authorisation by the supervising pharmacist

WA0805 Apply any special requirements for scheduled substances or products during manufacturing

WA0806 Monitor, control and implement the adding of non-active materials to the mix

WA0807 Monitor and control the manufacturing of various dosage forms

WA0808 Monitor, control and implement in process controls

WA0809 Monitor and control HVAC conditions

WA0810 Perform sampling or supervise the sampling of medicines or scheduled substances, in accordance with rules relating to current good manufacturing practice (cGMP)

WA0811 Monitor and control water usage, storage and processing

WA0812 Supervise the Basics and Post Basics to manufacture sterile medicines Supporting Evidence

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SE0801 Signed-off logbook

SE0802 Learner journal 6.2.9 WM-06-WE09: Observe and assist a Pharmacy Technician and/or Pharmacist to package and re-

package non-sterile medicines Scope of Work Experience The person will be expected to engage in the following work activities:

WA0901 Prepare for the packing/repacking products and check expiration dates

WA0902 Monitor and control cGMP in relation to packaging

WA0903 Monitor and control checking of line clearance, initiate start-up of line clearance and opening of the packaging line in accordance with cGMP and SOPs and signed authorisation by the supervising pharmacist

WA0904 Monitor and control receipt, storage conditions and security measures of bulk product and check batch number and expiry date

WA0905 Monitor and control receipt of packaging materials and check packaging materials against works order/batch document

WA0906 Monitor and control setting-up of packaging equipment

WA0907 Monitor and control checking of over printing of packaging materials against batch document

WA0908 Open packaging line after approval by pharmacist

WA0909 Monitor, control and implement in process controls

WA0910 Monitor and control final batch reconciliation for approval by pharmacist

WA0911 Ensure that documentation complies with cGMP

WA0912 Control the processes according cGMP and SOPs and generate new SOPs under guidance of a pharmacist

WA0913 Supervise the Basics and Post Basics to package and re-package non-sterile medicines Supporting Evidence

SE0901 Signed-off logbook

SE0902 Learner journal 6.2.10 WM-06-WE10: Package and re-package non-sterile medicines under supervision of a Pharmacy

Technician Scope of Work Experience The person will be expected to engage in the following work activities:

WA1001 Prepare for the packing/repacking products and check expiration dates

WA1002 Monitor and control cGMP in relation to packaging

WA1003 Monitor and control checking of line clearance, initiate start-up of line clearance and opening of the packaging line in accordance with cGMP and SOPs and signed authorisation by the supervising pharmacist

WA1004 Monitor and control receipt, storage conditions and security measures of bulk product and check batch number and expiry date

WA1005 Monitor and control receipt of packaging materials and check packaging materials against works order/batch document

WA1006 Monitor and control setting-up of packaging equipment

WA1007 Monitor and control checking of over printing of packaging materials against batch document

WA1008 Open packaging line after approval by pharmacist

WA1009 Monitor, control and implement in process controls

WA1010 Monitor and control final batch reconciliation for approval by pharmacist

WA1011 Ensure that documentation complies with cGMP

WA1012 Control the processes according cGMP and SOPs and generate new SOPs under guidance of a pharmacist

WA1013 Supervise the Basics and Post Basics to package and re-package non-sterile medicines

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Supporting Evidence

SE1001 Signed-off logbook

SE1002 Learner journal 6.2.11 WM-06-WE11: Observe and assist a Pharmacy Technician and/or Pharmacist to package and re-

package sterile medicines Scope of Work Experience The person will be expected to engage in the following work activities:

WA1101 Prepare for the packing/repacking products and check expiration dates

WA1102 Monitor and control cGMP in relation to packaging

WA1103 Monitor and control checking of line clearance, initiate start-up of line clearance and opening of the packaging line in accordance with cGMP and SOPs and signed authorisation by the supervising pharmacist

WA1104 Monitor and control receipt, storage conditions and security measures of bulk product and check batch number and expiry date

WA1105 Monitor and control receipt of packaging materials and check packaging materials against works order/batch document

WA1106 Monitor and control setting-up of packaging equipment

WA1107 Monitor and control checking of over printing of packaging materials against batch document

WA1108 Open packaging line after approval by pharmacist

WA1109 Monitor, control and implement in process controls

WA1110 Monitor and control final batch reconciliation for approval by pharmacist

WA1111 Ensure that documentation complies with cGMP

WA1112 Control the processes according cGMP and SOPs and generate new SOPs under guidance of a pharmacist

WA1113 Supervise the Basics and Post Basics to package and re-package sterile medicines Supporting Evidence

SE1101 Signed-off logbook

SE1102 Learner journal 6.2.12 WM-06-WE12: Package and re-package sterile medicines under supervision of a Pharmacy

Technician Scope of Work Experience The person will be expected to engage in the following work activities:

WA1201 Prepare for the packing/repacking products and check expiration dates

WA1202 Monitor and control cGMP in relation to packaging

WA1203 Monitor and control checking of line clearance, initiate start-up of line clearance and opening of the packaging line in accordance with cGMP and SOPs and signed authorisation by the supervising pharmacist

WA1204 Monitor and control receipt, storage conditions and security measures of bulk product and check batch number and expiry date

WA1205 Monitor and control receipt of packaging materials and check packaging materials against works order/batch document

WA1206 Monitor and control setting-up of packaging equipment

WA1207 Monitor and control checking of over printing of packaging materials against batch document

WA1208 Open packaging line after approval by pharmacist

WA1209 Monitor, control and implement in process controls

WA1210 Monitor and control final batch reconciliation for approval by pharmacist

WA1211 Ensure that documentation complies with cGMP

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WA1212 Control the processes according cGMP and SOPs and generate new SOPs under guidance of a pharmacist

WA1213 Supervise the Basics and Post Basics to package and re-package sterile medicines Supporting Evidence

SE1201 Signed-off logbook

SE1202 Learner journal 6.3 Contextualised Workplace Knowledge

(a) Company specific standard operating procedures (b) Safety, health, environmental and quality requirements and procedures (c) Company specific quality management systems

6.4 Criteria for Workplace Approval Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Compliant with Safety, Health, Environmental, Risk and Quality (SHERQ) requirements

Compliant with Compensation for Occupational Injuries and Diseases Act (COIDA) requirements

Accredited by the AQP 6.5 Additional Assignments to be Assessed Externally None

7. 321301000-WM-07, Processes to compound non-sterile extemporaneous preparations (Pharmacist’s Assistant - Basic), NQF Level 4, Credits 5

7.1 Purpose of the Work Experience Modules

The focus of the work experience is on providing the learner an opportunity to: gain structured experience under the guidance of a Pharmacy Technician or Pharmacist to compound non-sterile extemporaneous preparations, within expected time frames and according to SOPs. Work experience providers are to ensure that learners get as much exposure to the work activities listed in this module as possible. The learner will be required to:

WM-07-WE01: Observe and assist a Pharmacist’s Assistant (Basic), Pharmacist’s Assistant (Post Basic), Pharmacy Technician or Pharmacist compound non-sterile extemporaneous preparations

WM-07-WE02: Compound non-sterile extemporaneous preparations under supervision of a Pharmacy Technician or Pharmacist

7.2 Guidelines for Work Experiences 7.2.1 WM-07-WE01: Observe and assist a Pharmacist’s Assistant (Basic), Pharmacist’s Assistant (Post

Basic), Pharmacy Technician or Pharmacist compound non-sterile extemporaneous preparations Scope of Work Experience The person will be expected to engage in the following work activities:

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WA0101 Discuss and review the work activities outlined in this scope with Pharmacy Technician or Pharmacist

WA0102 Check, clean and prepare the environment, apparatus and equipment for compounding

WA0103 Work according to given SOPs

WA0104 Receive the formula that has been checked by the pharmacist/PT

WA0105 Receive the calculated quantities for the required ingredients as per prescription/formula

WA0106 Eliminate any possibility of cross-contamination

WA0107 Prepare, weigh and mix the ingredients, each step to be checked and monitored by a pharmacist/PT

WA0108 Label as per legislation

WA0109 Document the compounding procedure

WA0110 Clean equipment and environment after compounding

WA0111 Sign the document as compounder with signature of supervising pharmacist/PT indicating that the procedure has been authorised and checked

WA0112 Assist with the mixing simple solutions

WA0113 Assist with the mixing suspensions

WA0114 Assist with the mixing semi-solids Supporting Evidence

SE0101 Signed-off checklists

SE0102 Signed-off logbooks

SE0103 Learner journal 7.2.2. WM-07-WE02: Compound non-sterile extemporaneous preparations under supervision of a

Pharmacy Technician or Pharmacist Scope of Work Experience The person will be expected to engage in the following work activities:

WA0201 Check, clean and prepare the environment, apparatus and equipment for compounding

WA0202 Work according to given SOPs

WA0203 Receive the formula that has been checked by the pharmacist/PT

WA0204 Receive the calculated quantities for the required ingredients as per prescription/formula

WA0205 Eliminate any possibility of cross-contamination

WA0206 Prepare, weigh and mix the ingredients, each step to be checked and monitored by a pharmacist/PT

WA0207 Label as per legislation

WA0208 Document the compounding procedure

WA0209 Clean equipment and environment after compounding

WA0210 Sign the document as compounder with signature of supervising pharmacist/PT indicating that the procedure has been authorised and checked

WA0211 Mix simple solutions

WA0212 Mix suspensions

WA0213 Mix semi-solids Supporting Evidence

SE0201 Signed-off logbooks

SE0202 Learner journal 7.3 Contextualised Workplace Knowledge

(a) Company specific standard operating procedures (b) Safety, health, environmental and quality requirements and procedures (c) Company specific quality management systems

7.4 Criteria for Workplace Approval Physical Requirements:

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As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Compliant with Safety, Health, Environmental, Risk and Quality (SHERQ) requirements

Compliant with Compensation for Occupational Injuries and Diseases Act (COIDA) requirements

Accredited by the AQP 7.5 Additional Assignments to be Assessed Externally None

8. 321301000-WM-08, Processes to compound sterile and extemporaneous preparations (Post Basic), NQF Level 5, Credits 6

8.1 Purpose of the Work Experience Modules

The focus of the work experience is on providing the learner an opportunity to: gain structured experience under the guidance of a Pharmacy Technician or Pharmacist to compound sterile and extemporaneous preparations at the level of the Post Basic, within expected time frames and according to SOPs. Work experience providers are to ensure that learners get as much exposure to the work activities listed in this module as possible. The learner will be required to:

WM-08-WE01: Observe and assist a Pharmacist’s Assistant (Post Basic), Pharmacy Technician or Pharmacist compound sterile extemporaneous preparations

WM-08-WE02: Compound sterile extemporaneous preparations under supervision of a Pharmacy Technician and/or Pharmacist

8.2 Guidelines for Work Experiences 8.2.1 WM-08-WE01: Observe and assist a Pharmacist’s Assistant (Post Basic), Pharmacy Technician or

Pharmacist compound sterile extemporaneous preparations Scope of Work Experience The person will be expected to engage in the following work activities:

WA0101 Discuss and review the work activities outlined in this scope with Pharmacy Technician or Pharmacist

WA0102 Check and confirm the prescribed formula

WA0103 Clean and sterilise equipment and apparatus

WA0104 Calculate the quantities of the required ingredients as per prescription/formula and check calculations for non-sterile compounding of products

WA0105 Calculate the quantities of the required ingredients as per prescription/formula and check calculations for the compounding and manipulation of sterile products

WA0106 Ensure that calculations are checked by the pharmacist/PT

WA0107 Prepare, weigh, check and mix the ingredients

WA0108 Use aseptic techniques

WA0109 Prepare sterile products

WA0110 Label as per legislation

WA0111 Document the compounding procedure

WA0112 Sign the document as compounder with signature of supervising pharmacist/PT indicating that the procedure has been authorised and checked

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WA0113 Adhere to GPP requirements

WA0114 Maintain personal hygiene and health in sterile product compounding

WA0115 Compound semi-solids

WA0116 Compound liquid emulsions Supporting Evidence

SE0101 Signed-off checklists

SE0102 Signed-off logbooks

SE0103 Learner journal 8.2.2 WM-08-WE02: Compound sterile extemporaneous preparations under supervision of a Pharmacy

Technician and/or Pharmacist Scope of Work Experience The person will be expected to engage in the following work activities:

WA0201 Check and confirm the prescribed formula

WA0202 Clean and sterilise equipment and apparatus

WA0203 Calculate the quantities of the required ingredients as per prescription/formula and check calculations for non-sterile compounding of products

WA0204 Calculate the quantities of the required ingredients as per prescription/formula and check calculations for the compounding and manipulation of sterile products

WA0205 Ensure that calculations are checked by the pharmacist/PT

WA0206 Prepare, weigh, check and mix the ingredients

WA0207 Use aseptic techniques

WA0208 Label as per legislation

WA0209 Document the compounding procedure

WA0210 Sign the document as compounder with signature of supervising pharmacist/PT indicating that the procedure has been authorised and checked

WA0211 Adhere to GPP requirements

WA0212 Maintain personal hygiene and health in sterile product compounding

WA0213 Compound semi-solids

WA0214 Compound liquid emulsions Supporting Evidence

SE0201 Signed-off logbooks

SE0202 Learner journal 8.3 Contextualised Workplace Knowledge

(a) Company specific standard operating procedures (b) Safety, health, environmental and quality requirements and procedures (c) Company specific quality management systems

8.4 Criteria for Workplace Approval Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Compliant with Safety, Health, Environmental, Risk and Quality (SHERQ) requirements

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Compliant with Compensation for Occupational Injuries and Diseases Act (COIDA) requirements

Accredited by the AQP 8.5 Additional Assignments to be Assessed Externally None

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9. 321301000-WM-09, Processes to compound and supervise the compounding of sterile and non-sterile extemporaneous preparations (Pharmacy Technician), NQF Level 6, Credits 7

9.1 Purpose of the Work Experience Modules The focus of the work experience is on providing the learner an opportunity to: gain structured experience

under the guidance of a Pharmacist to compound and supervise the compounding of sterile and non-sterile extemporaneous preparations at the level of the Pharmacy Technician, within expected time frames and according to SOPs. Work experience providers are to ensure that learners get as much exposure to the work activities listed in this module as possible.

The learner will be required to:

WM-09-WE01: Observe a Pharmacist supervise extemporaneous compounding of non-sterile and sterile preparations by a Pharmacist’s Assistant (Post Basic) or Pharmacy Technician

WM-09-WE02: Supervise extemporaneous compounding of non-sterile and sterile preparations under supervision of a Pharmacist

9.2 Guidelines for Work Experiences 9.2.1 WM-09-WE01: Observe a Pharmacist supervise extemporaneous compounding of non-sterile and

sterile preparations by a Pharmacist’s Assistant (Post Basic) or Pharmacy Technician Scope of Work Experience The person will be expected to engage in the following work activities:

WA0101 Discuss and review the work activities outlined in this scope with Pharmacy Technician or Pharmacist

WA0102 Check and confirm the prescribed formula

WA0103 Calculate the quantities of the required ingredients as per prescription/formula

WA0104 Ensure that calculations are checked by the pharmacist

WA0105 Check that the compounding area and equipment are clean/sterile as per SOPs and cGMP

WA0106 Check the ingredients, weights of each ingredient and mixing process

WA0107 Check aseptic techniques

WA0108 Make the necessary entries in the relevant register in the case of certain Scheduled medicines/substances

WA0109 Inspect the compounded medicines for quality

WA0110 Check the labelling is correct and as per legislation

WA0111 Check documentation of the compounding procedure

WA0112 Sign the document as the supervising Pharmacy Technician after the compounder has signed as complete

WA0113 Ensure compounding of higher scheduled substances as per legislation is signed off by the supervising pharmacist

WA0114 Adhere to GPP requirements

WA0115 Observe the supervision and manufacture of different sterile medicines being compounded

WA0116 Observe the supervision and manufacture of non-sterile medicines being compounded (creams or ointments)

Supporting Evidence

SE0101 Signed-off checklists

SE0102 Signed-off logbooks 9.2.2. WM-09-WE02: Supervise extemporaneous compounding of non-sterile and sterile preparations

under supervision of a Pharmacist Scope of Work Experience The person will be expected to engage in the following work activities:

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WA0201 Check and confirm the prescribed formula

WA0202 Calculate the quantities of the required ingredients as per prescription/formula

WA0203 Ensure that calculations are checked by the pharmacist

WA0204 Check the reparation, weighing and mixing of the ingredients

WA0205 Supervise the extemporaneous compounding procedure

WA0206 Make the necessary entries in the relevant register in the case of higher schedules medicines/substances

WA0207 Inspect the compounded medicines for quality

WA0208 Check labelling is as per legislation

WA0209 Check documentation of the compounding procedure

WA0210 Sign the document as supervising PT ensuring that the procedure has been authorised and checked by a pharmacist when required by legislation

WA0211 Adhere to GPP requirements

WA0212 Supervise medicines being compounded until deemed competent

WA0213 Supervise the mixing of admixtures under supervision until deemed competent Supporting Evidence

SE0201 Signed-off checklists

SE0202 Signed-off logbooks 9.3 Contextualised Workplace Knowledge

(a) Company specific standard operating procedures (b) Safety, health, environmental and quality requirements and procedures (c) Company specific quality management systems

9.4 Criteria for Workplace Approval Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Compliant with Safety, Health, Environmental, Risk and Quality (SHERQ) requirements

Compliant with Compensation for Occupational Injuries and Diseases Act (COIDA) requirements

Accredited by the AQP 9.5 Additional Assignments to be Assessed Externally None

10. 321301000-WM-10, Processes to dispense medicines (Post Basic), NQF Level 2, Credits 15

10.1 Purpose of the Work Experience Modules

The focus of the work experience is on providing the learner an opportunity to: gain structured experience under the guidance of a Pharmacy Technician or Pharmacist to dispense medicines, within expected time frames and according to SOPs. Work experience providers are to ensure that learners get as much exposure to the work activities listed in this module as possible. The learner will be required to:

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WM-10-WE01: Observe and assist a Pharmacist’s Assistant (Post Basic), Pharmacy Technician or Pharmacist to dispense medicines

WM-10-WE02: Dispense medicines under the supervision of a Pharmacist

WM-10-WE03: Dispense medicines independently but subject to quality checks by a Pharmacist 10.2 Guidelines for Work Experiences 10.2.1 WM-10-WE01: Observe and assist a Pharmacist’s Assistant (Post Basic), Pharmacy Technician or

Pharmacist to dispense medicines Scope of Work Experience The person will be expected to engage in the following work activities:

WA0101 Verify prescription

WA0102 Receive and screen prescription for medicines which appear on the Primary Health Care Essential Medicines List and which is prescribed in accordance with Standard Treatment Guidelines, in a PHC facility.

WA0103 Interact with the patient, using professional communication skills and establish a trusting relationship

WA0104 Maintain patient confidentiality

WA0105 Inform the patient of the benefits and implications of the substitution for a branded medicine with an interchangeable multi-source medicine, in case of a prescription

WA0106 Assist the patient to resolve the problem when the prescription cannot be dispensed in consultation with the pharmacist or in accordance with SOPs

WA0107 Prepare the prescriptions

WA0108 Complete all the relevant administrative procedures (signing and counter-signing)

WA0109 Provide information on the indications, give instructions on how to store and use medicines, explain side effects, instruct patient to report problems with the medication, advise the patient to consult the pharmacist should the symptoms persist beyond the period as stated in patient information leaflet/package insert and explain medication ‘to follow’

WA0110 Ensure that the patient understands instructions and the chronic medication process

WA0111 Monitor adherence to medicine regimen Supporting Evidence

SE0101 Signed-off logbook 10.2.2 WM-10-WE02: Dispense medicines under the supervision of a Pharmacist Scope of Work Experience The person will be expected to engage in the following work activities:

WA0201 Verify prescription

WA0202 Receive and screen prescription for medicines which appear on the Primary Health Care Essential Medicines List and which is prescribed in accordance with Standard Treatment Guidelines, in a PHC facility

WA0203 Interact with the patient, using professional communication skills and establish a trusting relationship

WA0204 Maintain patient confidentiality

WA0205 Inform the patient of the benefits and implications of the substitution for a branded medicine with an interchangeable multi-source medicine, in case of a prescription

WA0206 Assist the patient to resolve the problem when the prescription cannot be dispensed in consultation with the pharmacist or in accordance with SOPs

WA0207 Prepare the prescriptions

WA0208 Complete all the relevant administrative procedures (signing and counter-signing)

WA0209 Provide information on the indications, give instructions on how to store and use medicines, explain side effects, instruct patient to report problems with the medication, advise the patient to

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consult the pharmacist should the symptoms persist beyond the period as stated in patient information leaflet/package insert and explain medication “to follow”

WA0210 Ensure that the patient understands instructions and the chronic medication process

WA0211 Monitor adherence to medicine regimen Supporting Evidence

SE0201 Signed-off logbook 10.2.3 WM-10-WE03: Dispense medicines independently but subject to quality checks by a Pharmacist Scope of Work Experience The person will be expected to engage in the following work activities:

WA0301 Verify prescription

WA0302 Receive and screen prescription for medicines which appear on the Primary Health Care Essential Medicines List and which is prescribed in accordance with Standard Treatment Guidelines, in a PHC facility

WA0303 Interact with the patient, using professional communication skills and establish a trusting relationship

WA0304 Maintain patient confidentiality

WA0305 Inform the patient of the benefits and implications of the substitution for a branded medicine with an interchangeable multi-source medicine, in case of a prescription

WA0306 Assist the patient to resolve the problem when the prescription cannot be dispensed in consultation with the pharmacist or in accordance with SOPs

WA0307 Prepare the prescriptions

WA0308 Complete all the relevant administrative procedures (signing and counter-signing)

WA0309 Provide information on the indications, give instructions on how to store and use medicines, explain side effects, instruct patient to report problems with the medication, advise the patient to consult the pharmacist should the symptoms persist beyond the period as stated in patient information leaflet/package insert and explain medication “to follow”

WA0310 Ensure that the patient understands instructions and the chronic medication process

WA0311 Monitor adherence to medicine regimen Supporting Evidence

SE0301 Signed-off logbook 10.3 Contextualised Workplace Knowledge

(a) Company specific standard operating procedures (b) Safety, health, environmental and quality requirements and procedures (c) Company specific quality management systems

10.4 Criteria for Workplace Approval Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Compliant with Safety, Health, Environmental, Risk and Quality (SHERQ) requirements

Compliant with Compensation for Occupational Injuries and Diseases Act (COIDA) requirements

Accredited by the AQP 10.5 Additional Assignments to be Assessed Externally

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None

11. 321301000-WM-11, Processes to dispense and supervise dispensing of medicines (Pharmacy Technician), NQF Level 6, Credits 15

11.1 Purpose of the Work Experience Modules

The focus of the work experience is on providing the learner an opportunity to: gain structured experience under the guidance of a Pharmacist to dispense and supervise the dispensing of medicines, within expected time frames and according to SOPs. Work experience providers are to ensure that learners get as much exposure to the work activities listed in this module as possible. The learner will be required to:

WM-11-WE01: Observe and assist Pharmacist Technician or Pharmacist to dispense medicines

WM-11-WE02: Dispense medicines under supervision of a Pharmacist

WM-11-WE03: Dispense medicines independently but subject to quality checks by a Pharmacist

WM-11-WE04: Prepare and present a patient education tool 11.2 Guidelines for Work Experiences 11.2.1 WM-11-WE01: Observe and assist Pharmacist Technician or Pharmacist to dispense medicines Scope of Work Experience The person will be expected to engage in the following work activities:

WA0101 Perform calculations

WA0102 Dispense according to legislation

WA0103 Provide information to the patient to optimise therapeutic outcomes

WA0104 Manage the queuing of prescriptions

WA0105 Complete all the relevant administrative procedures (signing and counter-signing)

WA0106 Check scripts prepared by relevant PSPs

WA0107 Check for errors in the dispensing process carried out by Post Basics and other Pharmacy Technicians

WA0108 Supervise dispensing by Post Basics and other Pharmacy Technicians Supporting Evidence

SE0101 Signed-off logbook 11.2.2 WM-11-WE02: Dispense medicines under supervision of a Pharmacist Scope of Work Experience The person will be expected to engage in the following work activities:

WA0201 Perform calculations

WA0202 Dispense according to legislation

WA0203 Provide information to the patient to optimise therapeutic outcome

WA0204 Manage the queuing of prescriptions

WA0205 Complete all the relevant administrative procedures (signing and counter-signing)

WA0206 Check scripts prepared by relevant PSPs

WA0207 Check for errors in the dispensing process carried out by Post Basics and other Pharmacy Technicians

WA0208 Supervise dispensing by Post Basics and other Pharmacy Technicians Supporting Evidence

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SE0201 Signed-off logbook

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11.2.3 WM-11-WE03: Dispense medicines independently but subject to quality checks by a Pharmacist Scope of Work Experience The person will be expected to engage in the following work activities:

WA0301 Perform calculations

WA0302 Dispense according to legislation

WA0303 Provide information to the patient to optimise therapeutic outcome

WA0304 Manage the queuing of prescriptions

WA0305 Complete all the relevant administrative procedures (signing and counter-signing)

WA0306 Check scripts prepared by relevant PSPs

WA0307 Check for errors in the dispensing process carried out by Post Basics and other Pharmacy Technicians

WA0308 Supervise dispensing by Post Basics and other Pharmacy Technicians Supporting Evidence

SE0301 Signed-off logbook 11.2.4 WM-11-WE04: Prepare and present a patient education tool Scope of Work Experience The person will be expected to engage in the following work activities:

WA0401 Identify the need or topic

WA0402 Obtain relevant information

WA0403 Decide on the mode of delivery of the message

WA0404 Present the topic using appropriate communication skills

WA0405 Evaluate feedback Supporting Evidence

SE0401 Signed-off logbook 11.3 Contextualised Workplace Knowledge

(a) Company specific standard operating procedures (b) Safety, health, environmental and quality requirements and procedures (c) Company specific quality management systems

11.4 Criteria for Workplace Approval Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Compliant with Safety, Health, Environmental, Risk and Quality (SHERQ) requirements

Compliant with Compensation for Occupational Injuries and Diseases Act (COIDA) requirements

Accredited by the AQP 11.5 Additional Assignments to be Assessed Externally None

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12. 321301000-WM-12, Processes to perform general housekeeping and administrative tasks in the pharmacy (Basic), NQF Level 4, Credits 2

12.1 Purpose of the Work Experience Modules

The focus of the work experience is on providing the learner an opportunity to: gain structured experience under the guidance of a Pharmacy Technician or Pharmacist to perform general housekeeping and administrative tasks, within expected time frames and according to SOPs. Work experience providers are to ensure that learners get as much exposure to the work activities listed in this module as possible. The learner will be required to:

WM-12-WE01: Observe and assist a Pharmacist’s Assistant (Basic), Pharmacist’s Assistant (Post Basic), Pharmacy Technician or Pharmacist to perform general housekeeping and administrative tasks in the pharmacy

WM-12-WE02: Perform general housekeeping and administrative tasks in the pharmacy under the supervision of a Pharmacy Technician or Pharmacist

WM-12-WE03: Perform general housekeeping and administrative tasks in the pharmacy independently but subject to quality checks by a Pharmacy Technician or Pharmacist

12.2 Guidelines for Work Experiences 12.2.1 WM-12-WE01: Observe and assist a Pharmacist’s Assistant (Basic), Pharmacist’s Assistant (Post

Basic), Pharmacy Technician or Pharmacist to perform general housekeeping and administrative tasks in the pharmacy

Scope of Work Experience The person will be expected to engage in the following work activities:

WA0101 Perform administrative tasks (filing, capturing information etc.)

WA0102 Clean and tidy shelves and specialised storage areas

WA0103 Maintain supply of medicine containers and dispensary consumables Supporting Evidence

SE0101 Signed-off logbook 12.2.2 WM-12-WE02: Perform general housekeeping and administrative tasks in the pharmacy under the

supervision of a Pharmacy Technician or Pharmacist Scope of Work Experience The person will be expected to engage in the following work activities:

WA0201 Perform administrative tasks (filing, capturing information etc.)

WA0202 Clean and tidy shelves and specialised storage areas

WA0203 Maintain supply of medicine containers and dispensary consumables Supporting Evidence

SE0201 Signed-off logbook 12.2.3 WM-12-WE03: Perform general housekeeping and administrative tasks in the pharmacy

independently but subject to quality checks by a Pharmacy Technician or Pharmacist Scope of Work Experience The person will be expected to engage in the following work activities:

WA0301 Perform administrative tasks (filing, capturing information etc.)

WA0302 Clean and tidy shelves and specialised storage areas

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WA0303 Maintain supply of medicine containers and dispensary consumables Supporting Evidence

SE0301 Signed-off logbook 12.3 Contextualised Workplace Knowledge

(a) Company specific standard operating procedures (b) Safety, health, environmental and quality requirements and procedures (c) Company specific quality management systems

12.4 Criteria for Workplace Approval Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Compliant with Safety, Health, Environmental, Risk and Quality (SHERQ) requirements

Compliant with Compensation for Occupational Injuries and Diseases Act (COIDA) requirements

Accredited by the AQP

12.5 Additional Assignments to be Assessed Externally None

13. 321301000-WM-13, Processes to perform general housekeeping and administrative tasks in the pharmacy (Post Basic), NQF Level 5, Credits 3

13.1 Purpose of the Work Experience Modules The focus of the work experience is on providing the learner an opportunity to: gain structured experience

under the guidance of a Pharmacy Technician or Pharmacist to perform general housekeeping and administrative tasks, at the level of a Post Basic, within expected time frames and according to SOPs. Work experience providers are to ensure that learners get as much exposure to the work activities listed in this module as possible.

The learner will be required to:

WM-13-WE01: Observe and assist a Pharmacist’s Assistant (Post Basic), Pharmacy Technician or Pharmacist to perform general housekeeping and administrative tasks in the pharmacy

WM-13-WE02: Perform general housekeeping and administrative tasks in the pharmacy under the supervision of a Pharmacy Technician or Pharmacist

WM-13-WE03: Perform general housekeeping and administrative tasks in the pharmacy independently but subject to quality checks by Pharmacy Technician or Pharmacist

13.2 Guidelines for Work Experiences 13.2.1 WM-13-WE01: Observe and assist a Pharmacist’s Assistant (Post Basic), Pharmacy Technician or

Pharmacist to perform general housekeeping and administrative tasks in the pharmacy Scope of Work Experience The person will be expected to engage in the following work activities:

WA0101 Update, maintain and store patient information in terms of legislative requirement

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WA0102 Perform administrative tasks in support or under the direct supervision of a pharmacist

WA0103 Complete an adverse drug reaction form and submit to a pharmacist

WA0104 Assist with updating SOPs in operations

WA0105 Coordinate the dissemination of written, electronic, and oral communications throughout the sector

Supporting Evidence

SE0101 Signed-off logbook 13.2.2 WM-13-WE02: Perform general housekeeping and administrative tasks in the pharmacy under the

supervision of a Pharmacy Technician or Pharmacist Scope of Work Experience The person will be expected to engage in the following work activities:

WA0201 Update, maintain and store patient information in terms of legislative requirement

WA0202 Perform administrative tasks in support or under the direct supervision of a pharmacist

WA0203 Complete an adverse drug reaction form and submit to a pharmacist

WA0204 Assist with updating SOPs in operations

WA0205 Coordinate the dissemination of written, electronic, and oral communications throughout the sector

Supporting Evidence

SE0201 Signed-off logbook 13.2.3 WM-13-WE03: Perform general housekeeping and administrative tasks in the pharmacy

independently but subject to quality checks by Pharmacy Technician or Pharmacist Scope of Work Experience The person will be expected to engage in the following work activities:

WA0301 Update, maintain and store patient information in terms of legislative requirement

WA0302 Perform administrative tasks in support or under the direct supervision of a pharmacist

WA0303 Complete an adverse drug reaction form and submit to a pharmacist

WA0304 Assist with updating SOPs in operations

WA0305 Coordinate the dissemination of written, electronic, and oral communications throughout the sector

Supporting Evidence

SE0301 Signed-off logbook 13.3 Contextualised Workplace Knowledge

(a) Company specific standard operating procedures (b) Safety, health, environmental and quality requirements and procedures (c) Company specific quality management systems

13.4 Criteria for Workplace Approval Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements

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Legal Requirements:

Compliant with Safety, Health, Environmental, Risk and Quality (SHERQ) requirements

Compliant with Compensation for Occupational Injuries and Diseases Act (COIDA) requirements

Accredited by the AQP 13.5 Additional Assignments to be Assessed Externally None

14. 321301000-WM-14, Processes to conduct screening tests (Pharmacy Technician), NQF Level 6, Credits 2

14.1 Purpose of the Work Experience Modules

The focus of the work experience is on providing the learner an opportunity to: gain structured experience under the guidance of a Pharmacist to conduct screening tests, within expected time frames and according to SOPs. Work experience providers are to ensure that learners get as much exposure to the work activities listed in this module as possible. The learner will be required to:

WM-14-WE01: Observe and assist a Pharmacy Technician or Pharmacist to conduct screening tests

WM-14-WE02: Conduct screening tests under the supervision of a Pharmacist

WM-14-WE03: Conduct screening tests independently but subject to quality checks by Pharmacy Technician or Pharmacist

14.2 Guidelines for Work Experiences 14.2.1 WM-14-WE01: Observe and assist a Pharmacy Technician or Pharmacist to conduct screening

tests Scope of Work Experience The person will be expected to engage in the following work activities:

WA0101 Explain the procedure and allow patient an opportunity to ask questions

WA0102 Obtain written consent

WA0103 Document the patient history including medication used

WA0104 Prepare for test (gloves, instruments etc.)

WA0105 Conduct the test

WA0106 Conduct post-test activities (excluding interpretation of results and informing patient about the outcome)

WA0107 Supervise the screening of patients conducted by Pharmacy Technicians Supporting Evidence 14.2.2 WM-14-WE02: Conduct screening tests under the supervision of a Pharmacist Scope of Work Experience The person will be expected to engage in the following work activities:

WA0201 Explain the procedure and allow patient an opportunity to ask questions

WA0202 Obtain written consent

WA0203 Document the patient history including medication used

WA0204 Prepare for test (gloves, instruments etc.)

WA0205 Conduct the test

WA0206 Conduct post-test activities (excluding interpretation of results and informing patient about the outcome)

WA0207 Supervise the screening of patients conducted by Pharmacy Technicians

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Supporting Evidence

SE0201 Signed-off logbook 14.2.3 WM-14-WE03: Conduct screening tests independently but subject to quality checks by Pharmacy

Technician or Pharmacist Scope of Work Experience The person will be expected to engage in the following work activities:

WA0301 Explain the procedure and allow patient an opportunity to ask questions

WA0302 Obtain written consent

WA0303 Document the patient history including medication used

WA0304 Prepare for test (gloves, instruments etc.)

WA0305 Conduct the test

WA0306 Conduct post-test activities (excluding interpretation of results and informing patient about the outcome)

WA0307 Supervise the screening of patients conducted by Pharmacy Technicians Supporting Evidence

SE0301 Signed-off logbook 14.3 Contextualised Workplace Knowledge

(a) Company specific standard operating procedures (b) Safety, health, environmental and quality requirements and procedures (c) Company specific quality management systems

14.4 Criteria for Workplace Approval Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Compliant with Safety, Health, Environmental, Risk and Quality (SHERQ) requirements

Compliant with Compensation for Occupational Injuries and Diseases Act (COIDA) requirements

Accredited by the AQP 14.5 Additional Assignments to be Assessed Externally None

15. 321301000-WM-15, Management of pharmacy resources (Pharmacy Technician), NQF Level 6, Credits 10

15.1 Purpose of the Work Experience Modules

The focus of the work experience is on providing the learner an opportunity to: gain structured experience in managing a number of systems and processes at a pharmacy-related facility, within expected time frames and according to SOPs. Work experience providers are to ensure that learners get as much exposure to the work activities listed in this module as possible. The learner will be required to:

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WM-15-WE01: Assist the pharmacist to supervise and manage staff

WM-15-WE02: Assist the pharmacist to manage pharmacy-related facility

WM-15-WE03: Assist the pharmacist to manage pharmacy-related facility operations

WM-15-WE04: Assist the pharmacist to manage financial aspects of the pharmacy-related facility 15.2 Guidelines for Work Experiences 15.2.1 WM-15-WE01: Assist the pharmacist to supervise and manage staff Scope of Work Experience The person will be expected to engage in the following work activities:

WA0101 Prepare and implement work schedules

WA0102 Allocate duties and prepare staff roster

WA0103 Organise and document staff meetings

WA0104 Monitor workflow in team situations while identifying, resolving, and reporting problems

WA0105 Draw up and implement team building exercise

WA0106 Monitor staff productivity

WA0107 Identify staff training needs

WA0108 Prepare and implement staff training schedule (including CPD programmes)

WA0109 Arrange training or train staff according to identified needs

WA0110 Handle complaints and, if needed, refer appropriately Supporting Evidence

SE0101 Signed-off logbook 15.2.2 WM-15-WE02: Assist the pharmacist to manage pharmacy-related facility Scope of Work Experience The person will be expected to engage in the following work activities:

WA0201 Manage equipment

WA0202 Manage health, safety, hygiene and security within a facility

WA0203 Manage cleaning and maintenance activities

WA0204 Identify, analyse and solve problems related to facility management

WA0205 Prepare SOPs for managing a pharmacy-related facility

WA0206 Manage the quality issues related to the facility

WA0207 Record, report and manage dispensing errors and incidents Supporting Evidence

SE0201 Signed-off logbook 15.2.3 WM-15-WE03: Assist the pharmacist to manage pharmacy-related facility operations Scope of Work Experience The person will be expected to engage in the following work activities:

WA0301 Monitor and manage the delivery and storage of patient-specific pre-dispensed and packaged medicines

WA0302 Manage the queuing of prescriptions

WA0303 Manage stock and stock rotation

WA0304 Manage inventory and stock forecasting

WA0305 Manage operations scheduling

WA0306 Develop and implement SOPs Supporting Evidence

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SE0301 Signed-off logbook 15.2.4 WM-15-WE04: Assist the pharmacist to manage financial aspects of the pharmacy-related facility Scope of Work Experience The person will be expected to engage in the following work activities:

WA0401 Develop budget

WA0402 Perform ABC and VEN analyses

WA0403 Manage source documents

WA0404 Manage financial reporting process

WA0405 Identify and mitigate financial risks Supporting Evidence

SE0401 Signed-off logbook 15.3 Contextualised Workplace Knowledge

(a) Company specific standard operating procedures (b) Safety, health, environmental and quality requirements and procedures (c) Company specific quality management systems

15.4 Criteria for Workplace Approval Physical Requirements:

As per SAPC requirements Human Resource Requirements:

As per SAPC requirements Legal Requirements:

Compliant with Safety, Health, Environmental, Risk and Quality (SHERQ) requirements

Compliant with Compensation for Occupational Injuries and Diseases Act (COIDA) requirements

Accredited by the AQP 15.5 Additional Assignments to be Assessed Externally None

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SECTION 4: STATEMENT OF WORK EXPERIENCE

Curriculum Number: 321301000

Curriculum Title: Pharmacy Technician

Learner Details

Name:

ID Number:

Employer Details

Company Name:

Address:

Supervisor Name:

Work Telephone:

E-Mail:

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321301000-WM-01, Processes to distribute and control stock, as per legislation (Basic), NQF Level 4, Credits 5

WM-01-WE01 Observe and assist a Pharmacist’s Assistant (Basic), Pharmacist’s Assistant (Post Basic), Pharmacy Technician or Pharmacist to distribute and control stock

Scope Work Experience Date Signature

WA0101 Discuss and review the work activities outlined in this scope with a Pharmacy Technician or Pharmacist

WA0102 Receive, process and pack stock as per company/organisational SOPs (includes packing stock according to FEFO & FIFO principles)

WA0103 Notify the Pharmacist/ Pharmacy Technician about discrepancies (including, short-dated, damaged, under or over-supply, incorrect item)

WA0104 Pick, pack and distribute orders with appropriate checks and authorisation from a Pharmacist/ Pharmacy Technician

WA0105 Complete appropriate documentation for picking, packing and dispatching orders

WA0106 Perform stock counts

WA0107 Report out-of-stock items, over-stocked items and medicines and medical related items to be ordered

WA0108 Process credits for items to be returned

Supporting Evidence Date Signature

SE0101 Checklists

SE0102 Signed-off log book

WM-01-WE02 Distribute and control stock under supervision of a Pharmacy Technician or Pharmacist

Scope Work Experience Date Signature

WA0201 Receive, process and pack stock as per company/organisational SOPs (includes packing stock according to FEFO & FIFO principles)

WA0202 Notify the Pharmacist/ Pharmacy Technician about discrepancies (including, short-dated, damaged, under or over-supply, incorrect item)

WA0203 Pick, pack and distribute orders with appropriate checks and authorisation from a Pharmacist/ Pharmacy Technician

WA0204 Complete appropriate documentation for picking, packing and dispatching orders

WA0205 Perform stock counts

WA0206 Report out-of-stock items, over-stocked items and medicines and medical related items to be ordered

WA0207 Process credits for items to be returned

Supporting Evidence Date Signature

SE0201 Signed-off log book

WM-01-WE03 Distribute and control stock independently but subject to quality checks by Pharmacy Technician or Pharmacist

Scope Work Experience Date Signature

WA0301 Receive, process and pack stock as per company/organisational SOPs (includes packing stock according to FEFO & FIFO principles)

WA0302 Notify the Pharmacist/ Pharmacy Technician about discrepancies (including, short-dated, damaged, under or over-supply, incorrect item)

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WA0303 Pick, pack and distribute orders with appropriate checks and authorisation from a Pharmacist/ Pharmacy Technician

WA0304 Complete appropriate documentation for picking, packing and dispatching orders

WA0305 Perform stock counts

WA0306 Report out-of-stock items, over-stocked items and medicines and medical related items to be ordered

WA0307 Process credits for items to be returned

Supporting Evidence Date Signature

SE0301 Signed-off log book

Contextualised Workplace Knowledge Date Signature

1. Company specific standard operating procedures

2. Safety, health, environmental and quality requirements and procedures

3. Company specific quality management systems

Additional Assignments to be Assessed Externally Date Signature

321301000-WM-02, Processes to manage stock as per legislation (Post Basic), NQF Level 5, Credits 8

WM-02-WE01 Observe and assist a Pharmacist’s Assistant (Post Basic), Pharmacy Technician or Pharmacist to manage stock

Scope Work Experience Date Signature

WA0101 Discuss and review the work activities outlined in this scope with a Pharmacy Technician or Pharmacist

WA0102 Pick, pack and dispatch orders according to legislation

WA0103 Control stock

WA0104 Quarantine expired, damaged and recalled medicines, according to SOPs

WA0105 Perform calculations (Average Monthly Consumptions [AMC]: maximum and minimum)

WA0106 Order stock using relevant replenishment model

WA0107 Identify approved vendors

WA0108 Perform quantification and demand planning

WA0109 Report on stock availability

Supporting Evidence Date Signature

SE0101 Checklists

SE0102 Signed-off log book

WM-02-WE02 Manage stock under supervision of a Pharmacy Technician or Pharmacist

Scope Work Experience Date Signature

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WA0201 Pick, pack and dispatch orders according to legislation

WA0202 Control stock

WA0203 Quarantine expired, damaged and recalled medicines, according to SOPs

WA0204 Perform calculations (Average Monthly Consumptions [AMC]: maximum and minimum)

WA0205 Order stock using relevant replenishment model

WA0206 Identify approved vendors

WA0207 Perform quantification and demand planning

WA0208 Report on stock availability

Supporting Evidence Date Signature

SE0201 Signed-off logbook

WM-02-WE03 Manage stock independently but subject to quality checks by Pharmacy Technician or Pharmacist

Scope Work Experience Date Signature

WA0301 Pick, pack and dispatch orders for Schedule 1 to 6

WA0302 Control stock

WA0303 Quarantine expired, damaged and recalled medicines, according to SOPs

WA0304 Perform stock takes as scheduled

WA0305 Perform calculations (Average Monthly Consumptions [AMC]: maximum and minimum)

WA0306 Use the replenishment model to order stock

WA0307 Identify approved vendors

WA0308 Perform quantification and demand planning

WA0309 Report on stock availability

Supporting Evidence Date Signature

SE0301 Signed-off logbook

Contextualised Workplace Knowledge Date Signature

1. Company specific standard operating procedures

2. Safety, health, environmental and quality requirements and procedures

3. Company specific quality management systems

Additional Assignments to be Assessed Externally Date Signature

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321301000-WM-03, Processes to manage supply chain and supervise the supply chain (Pharmacy Technician), NQF Level 6, Credits 10

WM-03-WE01 Observe and assist a Pharmacy Technician or Pharmacist to manage supply chain

Scope Work Experience Date Signature

WA0101 Discuss and review the work activities outlined in this scope with the Pharmacy Technician or Pharmacist

WA0102 Manage recall of stock and return of medicines

WA0103 Manage quarantining of recalled or expired or discontinued medicines

WA0104 Sign specified schedule register

WA0105 Check orders, prior to the packing and despatch thereof

WA0106 Mitigate risks and manage anomalies during stock management

WA0107 Implement error management techniques

WA0108 Supervise Basics and Post Basics in the medicine supply chain

Supporting Evidence Date Signature

SE0101 Checklist

SE0102 Signed-off logbook

WM-03-WE02 Manage supply chain under the supervision of a Pharmacy Technician or Pharmacist

Scope Work Experience Date Signature

WA0201 Manage recall of stock and return of medicines

WA0202 Manage quarantining of recalled or expired or discontinued medicines

WA0203 Sign specified schedule register

WA0204 Check orders, prior to the packing and despatch thereof

WA0205 Mitigate risks and manage anomalies during stock management

WA0206 Implement error management techniques

WA0207 Supervise the Basics and Post Basics in the medicine supply chain

Supporting Evidence Date Signature

SE0201 Signed-off logbook

WM-03-WE03 Manage supply chain independently but subject to quality checks by a Pharmacist

Scope Work Experience Date Signature

WA0301 Manage recall of stock and return of medicines

WA0302 Manage quarantining of recalled or expired or discontinued medicines

WA0303 Sign specified schedule register

WA0304 Check orders prior to the packing and despatch thereof

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WA0305 Mitigate risks and manage anomalies during stock management

WA0306 Implement error management techniques

WA0307 Supervise the Basics and Post Basics in the medicine supply chain

Supporting Evidence Date Signature

SE0301 Signed-off logbook

Contextualised Workplace Knowledge Date Signature

1. Company specific standard operating procedures

2. Safety, health, environmental and quality requirements and procedures

3. Company specific quality management systems

Additional Assignments to be Assessed Externally Date Signature

321301000-WM-04, Processes to manufacture non-sterile medicines (Basic), NQF Level 4, Credits 4

WM-04-WE01 Observe and assist within their scope of practice a Pharmacist’s Assistant (Basic), Pharmacist’s Assistant (Post Basic), Pharmacy Technician or Pharmacist to manufacture non-sterile medicines

Scope Work Experience Date Signature

WA0101 Discuss and review the work activities outlined in this scope with a Pharmacy Technician and/or a Pharmacist

WA0102 Apply cGMP and GPP and current legislation requirements

WA0103 Use appropriate PPE

WA0104 Assist in a range of material handling and recording activities (record environmental conditions, handle quarantining products, control stock, handle documents and records, monitor storage conditions, ensure security of product, manage stock of packaging materials and transporting materials)

WA0105 Assist in the manufacture of non-sterile medicines or scheduled substances (e.g. transport weighed materials in the presence of a pharmacist/pharmacy technician, check and clean equipment and manufacturing areas before and after a run, transfer bulk product to quarantine area under guidance, and participate in water treatment)

WA0106 Adhere to and promote access control and restrictions

WA0107 Assist in packaging activities (apply cGMP and current legislation related to packaging, clear and clean packaging line and equipment, pack medicine in appropriate packaging, transport packaging materials)

Supporting Evidence Date Signature

SE0101 Checklist

SE0102 Signed-off log book

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Contextualised Workplace Knowledge Date Signature

1. Company specific standard operating procedures

2. Safety, health, environmental and quality requirements and procedures

3. Company specific quality management systems

Additional Assignments to be Assessed Externally Date Signature

321301000-WM-05, Processes to manufacture non-sterile and sterile medicines (Post Basic), NQF Level 5, Credits 5

WM-05-WE01 Observe a Pharmacist’s Assistant (Post Basic), Pharmacy Technician and/or Pharmacist manufacture non-sterile medicines

Scope Work Experience Date Signature

WA0101 Discuss and review the work activities outlined in this scope with a Pharmacy Technician and/or a Pharmacist

WA0102 Implement cGMP and GPP -based SOPs

WA0103 Monitor environmental conditions for materials and product

WA0104 Implement procedures to quarantine products and materials

WA0105 Assist in stock control, completing batch records, destroying goods, managing storage conditions for bulk product prior to packing

WA0106 Apply legal and special requirements for scheduled substances

WA0107 Manage stock of packaging materials and issue packaging materials, with the exception of printed packaging materials

WA0108 Perform some manufacturing activities (e.g. weigh non-active raw materials, perform pharmaceutical calculations used in the manufacture of medicines, assist in the manufacture dosage forms, check, record and sign for the addition of non-active ingredients to the mix with the pharmacist)

WA0109 Assist in performing in-process control testing and in-process checks

WA0110 Detect deviations and raise deviation to appropriate supervisory person

WA0111 Use PPE and implement hygienic procedures for all procedures

Supporting Evidence Date Signature

SE0101 Signed-off logbook

SE0102 Learner journal

WM-05-WE02 Assist in the manufacture of non-sterile medicines under the supervision of a Pharmacy Technician and/or a Pharmacist

Scope Work Experience Date Signature

WA0201 Implement cGMP-based SOPs

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WA0202 Monitor environmental conditions for materials and product

WA0203 Implement procedures to quarantine products and materials

WA0204 Assist in stock control, completing batch records, destroying goods, managing storage conditions for bulk product prior to packing

WA0205 Apply legal and special requirements for scheduled substances

WA0206 Manage stock of packaging materials and issue packaging materials, with the exception of printed packaging materials

WA0207 Perform manufacturing activities (weigh non-active raw materials, perform pharmaceutical calculations used in the manufacture of medicines, assist in the manufacture dosage forms, check, record and sign for the addition of non-active ingredients to the mix with the pharmacist)

WA0208 Assist in performing in-process control testing and in-process checks

WA0209 Detect deviations and raise deviation to appropriate supervisory person

WA0210 Use PPE and implement hygienic procedures for all procedures

Supporting Evidence Date Signature

SE0201 Signed-off logbook

SE0202 Learner journal

WM-05-WE03 Observe a Pharmacist’s Assistant (Post Basic), Pharmacy Technician or Pharmacist package and re-package non-sterile medicines

Scope Work Experience Date Signature

WA0301 Check environmental conditions for packaging

WA0302 Manage packaging materials (receive and check against batch record, check correct batch number of medicine packed)

WA0303 Check and clear packaging line after obtaining authorisation and assist in opening the line

WA0304 Clean and/or check that all apparatus and equipment are cleaned, sterilised and labelled accordingly

WA0305 Use master document for packing and re-packing each product

WA0306 Assist in carrying out process control testing during packaging and re-packaging of medicines as per legislation

WA0307 Label product and secure all stored labels and over-printed material to prevent a possible mix-up

WA0308 Discard any unused, damaged or rejected labels bearing a particular batch number and packaging date in accordance with the SOPs

WA0309 Assist in collating documents and records of each batch of medicine packed

WA0310 Sign all documentation, which must be countersigned by the pharmacist

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Supporting Evidence Date Signature

SE0301 Signed-off logbook

SE0302 Learner journal

WM-05-WE04 Assist in packaging and re-packaging of non-sterile medicines under the supervision of a Pharmacy Technician and/or a Pharmacist

Scope Work Experience Date Signature

WA0401 Check environmental conditions for packaging

WA0402 Manage packaging materials (receive and check against batch record, check correct batch number of medicine packed)

WA0403 Check and clear packaging line after obtaining authorisation and assist in opening the line

WA0404 Clean and/or check that all apparatus and equipment are clean, sterilised and labelled accordingly

WA0405 Use master document for packing and re-packing each product

WA0406 Assist in carrying out process control testing during packaging and re-packaging of medicines as per legislation

WA0407 Label product and secure all stored labels and over-printed material to prevent a possible mix-up

WA0408 Discard any unused, damaged or rejected labels bearing a particular batch number and packaging date in accordance with the SOPs

WA0409 Assist in collating documents and records of each batch of medicine packed

WA0410 Sign all documentation, which must be countersigned by the pharmacist

Supporting Evidence Date Signature

SE0401 Signed-off logbook

SE0402 Learner journal

WM-05-WE05 Observe a Pharmacist’s Assistant (Post Basic), Pharmacy Technician or Pharmacist manufacture sterile medicines

Scope Work Experience Date Signature

WA0501 Implement cGMP-based SOPs

WA0502 Monitor environmental conditions for materials and product

WA0503 Implement procedures to quarantine products and materials

WA0504 Assist in stock control, completing batch records, destroying goods, managing storage conditions for bulk product prior to packing

WA0505 Apply legal and special requirements for scheduled substances

WA0506 Manage stock of packaging materials and issue packaging materials, with the exception of printed packaging materials

WA0507 Perform manufacturing activities (weigh non-active raw materials, perform pharmaceutical calculations used in the

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manufacture of medicines, use aseptic techniques, assist in the manufacture dosage forms, check, record and sign for the addition of non-active ingredients to the mix with the pharmacist)

WA0508 Assist in performing in-process control testing and in-process checks

WA0509 Detect deviations and raise deviation to appropriate supervisory person

WA0510 Use PPE and implement hygienic procedures for all procedures

Supporting Evidence Date Signature

SE0501 Signed-off logbook

SE0502 Learner journal

WM-05-WE06 Assist in the manufacture of sterile medicines under the supervision of a Pharmacy Technician and/or a Pharmacist

Scope Work Experience Date Signature

WA0601 Implement cGMP-based SOPs

WA0602 Monitor environmental conditions for materials and product

WA0603 Implement procedures to quarantine products and materials

WA0604 Assist in stock control, completing batch records, destroying goods, managing storage conditions for bulk product prior to packing

WA0605 Apply legal and special requirements for scheduled substances

WA0606 Manage stock of packaging materials and issue packaging materials, with the exception of printed packaging materials

WA0607 Perform manufacturing activities (weigh non-active raw materials, perform pharmaceutical calculations used in the manufacture of medicines, use aseptic techniques, assist in the manufacture dosage forms, check, record and sign for the addition of non-active ingredients to the mix with the pharmacist)

WA0608 Assist in performing in-process control testing and in-process checks

WA0609 Detect deviations and raise deviation to appropriate supervisory person

WA0610 Use PPE and implement hygienic procedures for all procedures

Supporting Evidence Date Signature

SE0601 Signed-off logbook

SE0602 Learner journal

WM-05-WE07 Observe a Post Basic, Pharmacy Technician or Pharmacist package sterile medicines

Scope Work Experience Date Signature

WA0701 Check environmental conditions for packaging

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WA0702 Manage packaging materials (receive and check against batch record, check correct batch number of medicine packed)

WA0703 Check and clear packaging line after obtaining authorisation and assist in opening the line

WA0704 Clean and/or check that all apparatus and equipment are cleaned, sterilised and labelled accordingly

WA0705 Use master document for packing and re-packing each product

WA0706 Assist in carrying out process control testing during packaging and re-packaging of medicines as per legislation

WA0707 Label product and secure all stored labels and over-printed material to prevent a possible mix-up

WA0708 Discard any unused, damaged or rejected labels bearing a particular batch number and packaging date in accordance with the SOPs

WA0709 Assist in collating documents and records of each batch of medicine packed

WA0710 Sign all documentation, which must be countersigned by the pharmacist

Supporting Evidence Date Signature

SE0701 Signed-off logbook

SE0702 Learner journal

WM-05-WE08 Assist in the packaging of sterile medicines under the supervision of a Pharmacy Technician and/or a Pharmacist

Scope Work Experience Date Signature

WA0801 Check environmental conditions for packaging

WA0802 Manage packaging materials (receive and check against batch record, check correct batch number of medicine packed)

WA0803 Check and clear packaging line after obtaining authorisation and assist in opening the line

WA0804 Clean and/or check that all apparatus and equipment are cleaned, sterilised and labelled accordingly

WA0805 Use master document for packing and re-packing each product

WA0806 Assist in carrying out process control testing during packaging and re-packaging of medicines as per legislation

WA0807 Label product and secure all stored labels and over-printed material to prevent a possible mix-up

WA0808 Discard any unused, damaged or rejected labels bearing a particular batch number and packaging date in accordance with the SOPs

WA0809 Assist in collating documents and records of each batch of medicine packed

WA0810 Sign all documentation, which must be countersigned by the pharmacist

Supporting Evidence Date Signature

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SE0801 Signed-off logbook

SE0802 Learner journal

Contextualised Workplace Knowledge Date Signature

1. Company specific standard operating procedures

2. Safety, health, environmental and quality requirements and procedures

3. Company specific quality management systems

Additional Assignments to be Assessed Externally Date Signature

321301000-WM-06, Processes to manufacture non-sterile and sterile medicines and to supervise select manufacturing activities (Pharmacy Technician), NQF Level 6, Credits 6

WM-06-WE01 Observe and assist a Pharmacy Technician and/or Pharmacist to manage materials for the manufacture of non-sterile medicines

Scope Work Experience Date Signature

WA0101 Discuss and review the work activities outlined in this scope with the Pharmacy Technician or Pharmacist

WA0102 Monitor and control environmental conditions for materials and stock rotation

WA0103 Monitor and control the issuing of raw materials

WA0104 Monitor and control the quarantining of materials

WA0105 Apply special requirements for Schedule 5 and 6 substances and medicines under guidance of a pharmacist

WA0106 Manage batch documents and records and implement batch tracking

WA0107 Destroy goods under guidance of the Pharmacist

WA0108 Monitor and control the application of cGMP while managing materials

WA0109 Supervise the Basics and Post Basics to manage materials for the manufacture of non-sterile medicines

Supporting Evidence Date Signature

SE0101 Signed-off checklists

SE0102 Signed-off logbooks

SE0103 Learner journal

WM-06-WE02 Manage materials in the manufacture of non-sterile medicines under supervision of a Pharmacy Technician and/or Pharmacist

Scope Work Experience Date Signature

WA0201 Monitor and control environmental conditions for materials and stock rotation

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WA0202 Monitor and control the issuing of raw materials

WA0203 Monitor and control the quarantining of materials

WA0204 Apply special requirements for scheduled substances and medicines according to legislation, under guidance of a pharmacist

WA0205 Manage batch documents and records and implement batch tracking

WA0206 Destroy goods under guidance of the Pharmacist

WA0207 Monitor and control the application of cGMP during materials management

WA0208 Supervise the Basics and Post Basics to manage materials for the manufacture of non-sterile medicines

Supporting Evidence Date Signature

SE0201 Signed-off checklists

SE0202 Signed-off logbooks

SE0203 Learner journal

WM-06-WE03 Observe and assist a Pharmacy Technician and/or Pharmacist to manage materials for the manufacture of sterile medicines

Scope Work Experience Date Signature

WA0301 Monitor and control environmental conditions for materials and stock rotation

WA0302 Monitor and control the issuing of raw materials

WA0303 Monitor and control the quarantining of materials

WA0304 Apply special requirements for Schedule 5 and 6 substances and medicines under guidance of a pharmacist

WA0305 Manage batch documents and records and implement batch tracking

WA0306 Destroy goods under guidance of the Pharmacist

WA0307 Monitor and control the application of cGMP while managing materials

WA0308 Supervise the Basics and Post Basics to manage materials for the manufacture of sterile medicines

Supporting Evidence Date Signature

SE0301 Signed-off checklists

SE0302 Signed-off logbooks

SE0303 Learner journal

WM-06-WE04 Manage materials in the manufacture of sterile medicines under supervision of a Pharmacy Technician and/or Pharmacist

Scope Work Experience Date Signature

WA0401 Monitor and control environmental conditions for materials and stock rotation

WA0402 Monitor and control the issuing of raw materials

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WA0403 Monitor and control the quarantining of materials

WA0404 Apply special requirements for scheduled substances and medicines according to legislation, under guidance of a pharmacist

WA0405 Manage batch documents and records and implement batch tracking

WA0406 Destroy goods under guidance of the Pharmacist

WA0407 Monitor and control the application of cGMP during materials management

WA0408 Supervise the Basics and Post Basics to manage materials for the manufacture of sterile medicines

Supporting Evidence Date Signature

SE0401 Signed-off checklists

SE0402 Signed-off logbooks

SE0403 Learner journal

WM-06-WE05 Observe and assist a Pharmacy Technician and/or Pharmacist manufacture non-sterile medicines

Scope Work Experience Date Signature

WA0501 Monitor and control cGMP during manufacture

WA0502 Monitor and control weighing of non-active ingredients

WA0503 Perform calculations

WA0504 Initiate line clearance, opening line and line closure as per documented procedure, detailed checklist and signed authorisation by the supervising pharmacist

WA0505 Apply any special requirements for scheduled substances and products (as per legislation) during manufacturing

WA0506 Monitor, control and implement the adding of non-active materials to the mix

WA0507 Monitor and control the manufacturing of various dosage forms

WA0508 Monitor, control and implement in process controls

WA0509 Perform sampling or supervise the sampling of medicines or scheduled substances, in accordance with rules relating to current good manufacturing practice (cGMP)

WA0510 Monitor and control water usage, storage and processing

WA0511 Supervise the Basics and Post Basics to manufacture non-sterile medicines

Supporting Evidence Date Signature

SE0501 Signed-off checklists

SE0502 Signed-off logbooks

SE0503 Learner journal

WM-06-WE06 Manufacture non-sterile medicines under supervision of a Pharmacy Technician and/or Pharmacist

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Scope Work Experience Date Signature

WA0601 Monitor and control cGMP during manufacture

WA0602 Monitor and control weighing of non-active ingredients

WA0603 Perform calculations

WA0604 Initiate line clearance, opening line and line closure as per documented procedure, detailed checklist and signed authorisation by the supervising pharmacist

WA0605 Apply any special requirements for scheduled substances or products during manufacturing

WA0606 Monitor, control and implement the adding of non-active materials to the mix

WA0607 Monitor and control the manufacturing of various dosage forms

WA0608 Monitor, control and implement in process controls

WA0609 Perform sampling or supervise the sampling of medicines or scheduled substances, in accordance with rules relating to current good manufacturing practice (cGMP)

WA0610 Monitor and control water usage, storage and processing

WA0611 Supervise the Basics and Post Basics to manufacture non-sterile medicines

Supporting Evidence Date Signature

SE0601 Signed-off logbook

SE0602 Learner journal

WM-06-WE07 Observe and assist a Pharmacy Technician and/or Pharmacist manufacture sterile medicines

Scope Work Experience Date Signature

WA0701 Monitor and control cGMP during manufacture

WA0702 Monitor and control weighing of non-active ingredients

WA0703 Perform calculations

WA0704 Initiate line clearance, opening line and line closure as per documented procedure, detailed checklist and signed authorisation by the supervising pharmacist

WA0705 Apply special requirements for scheduled substances and products (as per legislation) during manufacturing

WA0706 Monitor, control and implement the adding of non-active materials to the mix

WA0707 Monitor and control the manufacturing of various dosage forms

WA0708 Monitor, control and implement in process controls

WA0709 Monitor and control HVAC conditions

WA0710 Perform sampling or supervise the sampling of medicines or scheduled substances, in accordance with rules relating to current good manufacturing practice (cGMP)

WA0711 Monitor and control water usage, storage and processing

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WA0712 Supervise the Basics and Post Basics to manufacture sterile medicines

Supporting Evidence Date Signature

SE0701 Signed-off checklists

SE0702 Signed-off logbooks

SE0703 Learner journal

WM-06-WE08 Manufacture sterile medicines under supervision of a Pharmacy Technician and/or Pharmacist

Scope Work Experience Date Signature

WA0801 Monitor and control cGMP during manufacture

WA0802 Monitor and control weighing of non-active ingredients

WA0803 Perform calculations

WA0804 Initiate line clearance, opening line and line closure as per documented procedure, detailed checklist and signed authorisation by the supervising pharmacist

WA0805 Apply any special requirements for scheduled substances or products during manufacturing

WA0806 Monitor, control and implement the adding of non-active materials to the mix

WA0807 Monitor and control the manufacturing of various dosage forms

WA0808 Monitor, control and implement in process controls

WA0809 Monitor and control HVAC conditions

WA0810 Perform sampling or supervise the sampling of medicines or scheduled substances, in accordance with rules relating to current good manufacturing practice (cGMP)

WA0811 Monitor and control water usage, storage and processing

WA0812 Supervise the Basics and Post Basics to manufacture sterile medicines

Supporting Evidence Date Signature

SE0801 Signed-off logbook

SE0802 Learner journal

WM-06-WE09 Observe and assist a Pharmacy Technician and/or Pharmacist to package and re-package non-sterile medicines

Scope Work Experience Date Signature

WA0901 Prepare for the packing/repacking products and check expiration dates

WA0902 Monitor and control cGMP in relation to packaging

WA0903 Monitor and control checking of line clearance, initiate start-up of line clearance and opening of the packaging line in accordance with cGMP and SOPs and signed authorisation by the supervising pharmacist

WA0904 Monitor and control receipt, storage conditions and security measures of bulk product and check batch number and expiry date

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WA0905 Monitor and control receipt of packaging materials and check packaging materials against works order/batch document

WA0906 Monitor and control setting-up of packaging equipment

WA0907 Monitor and control checking of over printing of packaging materials against batch document

WA0908 Open packaging line after approval by pharmacist

WA0909 Monitor, control and implement in process controls

WA0910 Monitor and control final batch reconciliation for approval by pharmacist

WA0911 Ensure that documentation complies with cGMP

WA0912 Control the processes according cGMP and SOPs and generate new SOPs under guidance of a pharmacist

WA0913 Supervise the Basics and Post Basics to package and re-package non-sterile medicines

Supporting Evidence Date Signature

SE0901 Signed-off logbook

SE0902 Learner journal

WM-06-WE10 Package and re-package non-sterile medicines under supervision of a Pharmacy Technician

Scope Work Experience Date Signature

WA1001 Prepare for the packing/repacking products and check expiration dates

WA1002 Monitor and control cGMP in relation to packaging

WA1003 Monitor and control checking of line clearance, initiate start-up of line clearance and opening of the packaging line in accordance with cGMP and SOPs and signed authorisation by the supervising pharmacist

WA1004 Monitor and control receipt, storage conditions and security measures of bulk product and check batch number and expiry date

WA1005 Monitor and control receipt of packaging materials and check packaging materials against works order/batch document

WA1006 Monitor and control setting-up of packaging equipment

WA1007 Monitor and control checking of over printing of packaging materials against batch document

WA1008 Open packaging line after approval by pharmacist

WA1009 Monitor, control and implement in process controls

WA1010 Monitor and control final batch reconciliation for approval by pharmacist

WA1011 Ensure that documentation complies with cGMP

WA1012 Control the processes according cGMP and SOPs and generate new SOPs under guidance of a pharmacist

WA1013 Supervise the Basics and Post Basics to package and re-package non-sterile medicines

Supporting Evidence Date Signature

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SE1001 Signed-off logbook

SE1002 Learner journal

WM-06-WE11 Observe and assist a Pharmacy Technician and/or Pharmacist to package and re-package sterile medicines

Scope Work Experience Date Signature

WA1101 Prepare for the packing/repacking products and check expiration dates

WA1102 Monitor and control cGMP in relation to packaging

WA1103 Monitor and control checking of line clearance, initiate start-up of line clearance and opening of the packaging line in accordance with cGMP and SOPs and signed authorisation by the supervising pharmacist

WA1104 Monitor and control receipt, storage conditions and security measures of bulk product and check batch number and expiry date

WA1105 Monitor and control receipt of packaging materials and check packaging materials against works order/batch document

WA1106 Monitor and control setting-up of packaging equipment

WA1107 Monitor and control checking of over printing of packaging materials against batch document

WA1108 Open packaging line after approval by pharmacist

WA1109 Monitor, control and implement in process controls

WA1110 Monitor and control final batch reconciliation for approval by pharmacist

WA1111 Ensure that documentation complies with cGMP

WA1112 Control the processes according cGMP and SOPs and generate new SOPs under guidance of a pharmacist

WA1113 Supervise the Basics and Post Basics to package and re-package sterile medicines

Supporting Evidence Date Signature

SE1101 Signed-off logbook

SE1102 Learner journal

WM-06-WE12 Package and re-package sterile medicines under supervision of a Pharmacy Technician

Scope Work Experience Date Signature

WA1201 Prepare for the packing/repacking products and check expiration dates

WA1202 Monitor and control cGMP in relation to packaging

WA1203 Monitor and control checking of line clearance, initiate start-up of line clearance and opening of the packaging line in accordance with cGMP and SOPs and signed authorisation by the supervising pharmacist

WA1204 Monitor and control receipt, storage conditions and security measures of bulk product and check batch number and expiry date

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WA1205 Monitor and control receipt of packaging materials and check packaging materials against works order/batch document

WA1206 Monitor and control setting-up of packaging equipment

WA1207 Monitor and control checking of over printing of packaging materials against batch document

WA1208 Open packaging line after approval by pharmacist

WA1209 Monitor, control and implement in process controls

WA1210 Monitor and control final batch reconciliation for approval by pharmacist

WA1211 Ensure that documentation complies with cGMP

WA1212 Control the processes according cGMP and SOPs and generate new SOPs under guidance of a pharmacist

WA1213 Supervise the Basics and Post Basics to package and re-package sterile medicines

Supporting Evidence Date Signature

SE1201 Signed-off logbook

SE1202 Learner journal

Contextualised Workplace Knowledge Date Signature

1. Company specific standard operating procedures

2. Safety, health, environmental and quality requirements and procedures

3. Company specific quality management systems

Additional Assignments to be Assessed Externally Date Signature

321301000-WM-07, Processes to compound non-sterile extemporaneous preparations (Pharmacist’s Assistant - Basic), NQF Level 4, Credits 5

WM-07-WE01 Observe and assist a Pharmacist’s Assistant (Basic), Pharmacist’s Assistant (Post Basic), Pharmacy Technician or Pharmacist compound non-sterile extemporaneous preparations

Scope Work Experience Date Signature

WA0101 Discuss and review the work activities outlined in this scope with Pharmacy Technician or Pharmacist

WA0102 Check, clean and prepare the environment, apparatus and equipment for compounding

WA0103 Work according to given SOPs

WA0104 Receive the formula that has been checked by the pharmacist/PT

WA0105 Receive the calculated quantities for the required ingredients as per prescription/formula

WA0106 Eliminate any possibility of cross-contamination

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WA0107 Prepare, weigh and mix the ingredients, each step to be checked and monitored by a pharmacist/PT

WA0108 Label as per legislation

WA0109 Document the compounding procedure

WA0110 Clean equipment and environment after compounding

WA0111 Sign the document as compounder with signature of supervising pharmacist/PT indicating that the procedure has been authorised and checked

WA0112 Assist with the mixing simple solutions

WA0113 Assist with the mixing suspensions

WA0114 Assist with the mixing semi-solids

Supporting Evidence Date Signature

SE0101 Signed-off checklists

SE0102 Signed-off logbooks

SE0103 Learner journal

WM-07-WE02 Compound non-sterile extemporaneous preparations under supervision of a Pharmacy Technician or Pharmacist

Scope Work Experience Date Signature

WA0201 Check, clean and prepare the environment, apparatus and equipment for compounding

WA0202 Work according to given SOPs

WA0203 Receive the formula that has been checked by the pharmacist/PT

WA0204 Receive the calculated quantities for the required ingredients as per prescription/formula

WA0205 Eliminate any possibility of cross-contamination

WA0206 Prepare, weigh and mix the ingredients, each step to be checked and monitored by a pharmacist/PT

WA0207 Label as per legislation

WA0208 Document the compounding procedure

WA0209 Clean equipment and environment after compounding

WA0210 Sign the document as compounder with signature of supervising pharmacist/PT indicating that the procedure has been authorised and checked

WA0211 Mix simple solutions

WA0212 Mix suspensions

WA0213 Mix semi-solids

Supporting Evidence Date Signature

SE0201 Signed-off logbooks

SE0202 Learner journal

Contextualised Workplace Knowledge Date Signature

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1. Company specific standard operating procedures

2. Safety, health, environmental and quality requirements and procedures

3. Company specific quality management systems

Additional Assignments to be Assessed Externally Date Signature

321301000-WM-08, Processes to compound sterile and extemporaneous preparations (Post Basic), NQF Level 5, Credits 6

WM-08-WE01 Observe and assist a Pharmacist’s Assistant (Post Basic), Pharmacy Technician or Pharmacist compound sterile extemporaneous preparations

Scope Work Experience Date Signature

WA0101 Discuss and review the work activities outlined in this scope with Pharmacy Technician or Pharmacist

WA0102 Check and confirm the prescribed formula

WA0103 Clean and sterilise equipment and apparatus

WA0104 Calculate the quantities of the required ingredients as per prescription/formula and check calculations for non-sterile compounding of products

WA0105 Calculate the quantities of the required ingredients as per prescription/formula and check calculations for the compounding and manipulation of sterile products

WA0106 Ensure that calculations are checked by the pharmacist/PT

WA0107 Prepare, weigh, check and mix the ingredients

WA0108 Use aseptic techniques

WA0109 Prepare sterile products

WA0110 Label as per legislation

WA0111 Document the compounding procedure

WA0112 Sign the document as compounder with signature of supervising pharmacist/PT indicating that the procedure has been authorised and checked

WA0113 Adhere to GPP requirements

WA0114 Maintain personal hygiene and health in sterile product compounding

WA0115 Compound semi-solids

WA0116 Compound liquid emulsions

Supporting Evidence Date Signature

SE0101 Signed-off checklists

SE0102 Signed-off logbooks

SE0103 Learner journal

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WM-08-WE02 Compound sterile extemporaneous preparations under supervision of a Pharmacy Technician and/or Pharmacist

Scope Work Experience Date Signature

WA0201 Check and confirm the prescribed formula

WA0202 Clean and sterilise equipment and apparatus

WA0203 Calculate the quantities of the required ingredients as per prescription/formula and check calculations for non-sterile compounding of products

WA0204 Calculate the quantities of the required ingredients as per prescription/formula and check calculations for the compounding and manipulation of sterile products

WA0205 Ensure that calculations are checked by the pharmacist/PT

WA0206 Prepare, weigh, check and mix the ingredients

WA0207 Use aseptic techniques

WA0208 Label as per legislation

WA0209 Document the compounding procedure

WA0210 Sign the document as compounder with signature of supervising pharmacist/PT indicating that the procedure has been authorised and checked

WA0211 Adhere to GPP requirements

WA0212 Maintain personal hygiene and health in sterile product compounding

WA0213 Compound semi-solids

WA0214 Compound liquid emulsions

Supporting Evidence Date Signature

SE0201 Signed-off logbooks

SE0202 Learner journal

Contextualised Workplace Knowledge Date Signature

1 Company specific standard operating procedures

2 Safety, health, environmental and quality requirements and procedures

3 Company specific quality management systems

Additional Assignments to be Assessed Externally Date Signature

321301000-WM-09, Processes to compound and supervise the compounding of sterile and non-sterile extemporaneous preparations (Pharmacy Technician), NQF Level 6, Credits 7

WM-09-WE01 Observe a Pharmacist supervise extemporaneous compounding of non-sterile and sterile preparations by a Pharmacist’s Assistant (Post Basic) or Pharmacy Technician

Scope Work Experience Date Signature

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WA0101 Discuss and review the work activities outlined in this scope with Pharmacy Technician or Pharmacist

WA0102 Check and confirm the prescribed formula

WA0103 Calculate the quantities of the required ingredients as per prescription/formula

WA0104 Ensure that calculations are checked by the pharmacist

WA0105 Check that the compounding area and equipment are clean/sterile as per SOPs and cGMP

WA0106 Check the ingredients, weights of each ingredient and mixing process

WA0107 Check aseptic techniques

WA0108 Make the necessary entries in the relevant register in the case of certain Scheduled medicines/substances

WA0109 Inspect the compounded medicines for quality

WA0110 Check the labelling is correct and as per legislation

WA0111 Check documentation of the compounding procedure

WA0112 Sign the document as the supervising Pharmacy Technician after the compounder has signed as complete

WA0113 Ensure compounding of higher scheduled substances as per legislation is signed off by the supervising pharmacist

WA0114 Adhere to GPP requirements

WA0115 Observe the supervision and manufacture of different sterile medicines being compounded

WA0116 Observe the supervision and manufacture of non-sterile medicines being compounded (creams or ointments)

Supporting Evidence Date Signature

SE0101 Signed-off checklists

SE0102 Signed-off logbooks

WM-09-WE02 Supervise extemporaneous compounding of non-sterile and sterile preparations under supervision of a Pharmacist

Scope Work Experience Date Signature

WA0201 Check and confirm the prescribed formula

WA0202 Calculate the quantities of the required ingredients as per prescription/formula

WA0203 Ensure that calculations are checked by the pharmacist

WA0204 Check the reparation, weighing and mixing of the ingredients

WA0205 Supervise the extemporaneous compounding procedure

WA0206 Make the necessary entries in the relevant register in the case of higher schedules medicines/substances

WA0207 Inspect the compounded medicines for quality

WA0208 Check labelling is as per legislation

WA0209 Check documentation of the compounding procedure

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WA0210 Sign the document as supervising PT ensuring that the procedure has been authorised and checked by a pharmacist when required by legislation

WA0211 Adhere to GPP requirements

WA0212 Supervise medicines being compounded until deemed competent

WA0213 Supervise the mixing of admixtures under supervision until deemed competent

Supporting Evidence Date Signature

SE0201 Signed-off checklists

SE0202 Signed-off logbooks

Contextualised Workplace Knowledge Date Signature

1. Company specific standard operating procedures

2. Safety, health, environmental and quality requirements and procedures

3. Company specific quality management systems

Additional Assignments to be Assessed Externally Date Signature

321301000-WM-10, Processes to dispense medicines (Post Basic), NQF Level 2, Credits 15

WM-10-WE01 Observe and assist a Pharmacist’s Assistant (Post Basic), Pharmacy Technician or Pharmacist to dispense medicines

Scope Work Experience Date Signature

WA0101 Verify prescription

WA0102 Receive and screen prescription for medicine which appears on the Primary Health Care Essential Medicines List and which is prescribed in accordance with Standard Treatment Guidelines, in a PHC facility.

WA0103 Interact with the patient, using professional communication skills and establish a trusting relationship

WA0104 Maintain patient confidentiality

WA0105 Inform the patient of the benefits and implications of the substitution for a branded medicine with an interchangeable multi-source medicine, in case of a prescription

WA0106 Assist the patient to resolve the problem when the prescription cannot be dispensed in consultation with the pharmacist or in accordance with SOPs

WA0107 Prepare the prescriptions

WA0108 Complete all the relevant administrative procedures (signing and counter-signing)

WA0109 Provide information on the indications, give instructions on how to store and use medicines, explain side effects, instruct patient to report problems with the medication, advise the patient to consult the pharmacist should the symptoms persist

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beyond the period as stated in patient information leaflet/package insert and explain medication “to follow”

WA0110 Ensure that the patient understands instructions and the chronic medication process

WA0111 Monitor adherence to medicine regimen

Supporting Evidence Date Signature

SE0101 Signed-off logbook

WM-10-WE02 Dispense medicines under the supervision of a Pharmacist

Scope Work Experience Date Signature

WA0201 Verify prescription

WA0202 Receive and screen prescription for medicine which appears on the Primary Health Care Essential Medicines List and which is prescribed in accordance with Standard Treatment Guidelines, in a PHC facility

WA0203 Interact with the patient, using professional communication skills and establish a trusting relationship

WA0204 Maintain patient confidentiality

WA0205 Inform the patient of the benefits and implications of the substitution for a branded medicine with an interchangeable multi-source medicine, in case of a prescription

WA0206 Assist the patient to resolve the problem when the prescription cannot be dispensed in consultation with the pharmacist or in accordance with SOPs

WA0207 Prepare the prescriptions

WA0208 Complete all the relevant administrative procedures (signing and counter-signing)

WA0209 Provide information on the indications, give instructions on how to store and use medicines, explain side effects, instruct patient to report problems with the medication, advise the patient to consult the pharmacist should the symptoms persist beyond the period as stated in patient information leaflet/package insert and explain medication “to follow”

WA0210 Ensure that the patient understands instructions and the chronic medication process

WA0211 Monitor adherence to medicine regimen

Supporting Evidence Date Signature

SE0201 Signed-off logbook

WM-10-WE03 Dispense medicines independently but subject to quality checks by a Pharmacist

Scope Work Experience Date Signature

WA0301 Verify prescription

WA0302 Receive and screen prescription for medicine which appears on the Primary Health Care Essential Medicines List and which is prescribed in accordance with Standard Treatment Guidelines, in a PHC facility

WA0303 Interact with the patient, using professional communication skills and establish a trusting relationship

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WA0304 Maintain patient confidentiality

WA0305 Inform the patient of the benefits and implications of the substitution for a branded medicine with an interchangeable multi-source medicine, in case of a prescription

WA0306 Assist the patient to resolve the problem when the prescription cannot be dispensed in consultation with the pharmacist or in accordance with SOPs

WA0307 Prepare the prescriptions

WA0308 Complete all the relevant administrative procedures (signing and counter-signing)

WA0309 Provide information on the indications, give instructions on how to store and use medicines, explain side effects, instruct patient to report problems with the medication, advise the patient to consult the pharmacist should the symptoms persist beyond the period as stated in patient information leaflet/package insert and explain medication “to follow”

WA0310 Ensure that the patient understands instructions and the chronic medication process

WA0311 Monitor adherence to medicine regimen

Supporting Evidence Date Signature

SE0301 Signed-off logbook

Contextualised Workplace Knowledge Date Signature

1. Company specific standard operating procedures

2. Safety, health, environmental and quality requirements and procedures

3. Company specific quality management systems

Additional Assignments to be Assessed Externally Date Signature

321301000-WM-11, Processes to dispense and supervise dispensing of medicines (Pharmacy Technician), NQF Level 6, Credits 15

WM-11-WE01 Observe and assist Pharmacist Technician or Pharmacist to dispense medicines

Scope Work Experience Date Signature

WA0101 Perform calculations

WA0102 Dispense according to legislation

WA0103 Provide information to the patient to optimise therapeutic outcomes

WA0104 Manage the queuing of prescriptions

WA0105 Complete all the relevant administrative procedures (signing and counter-signing)

WA0106 Check scripts prepared by relevant PSPs

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WA0107 Check for errors in the dispensing process carried out by Post Basics and other Pharmacy Technicians

WA0108 Supervise dispensing by Post Basics and other Pharmacy Technicians

Supporting Evidence Date Signature

SE0101 Signed-off logbook

WM-11-WE02 Dispense medicines under supervision of a Pharmacist

Scope Work Experience Date Signature

WA0201 Perform calculations

WA0202 Dispense according to legislation

WA0203 Provide information to the patient to optimise therapeutic outcome

WA0204 Manage the queuing of prescriptions

WA0205 Complete all the relevant administrative procedures (signing and counter-signing)

WA0206 Check scripts prepared by relevant PSPs

WA0207 Check for errors in the dispensing process carried out by Post Basics and other Pharmacy Technicians

WA0208 Supervise dispensing by Post Basics and other Pharmacy Technicians

Supporting Evidence Date Signature

SE0201 Signed-off logbook

WM-11-WE03 Dispense medicines independently but subject to quality checks by a Pharmacist

Scope Work Experience Date Signature

WA0301 Perform calculations

WA0302 Dispense according to legislation

WA0303 Provide information to the patient to optimise therapeutic outcome

WA0304 Manage the queuing of prescriptions

WA0305 Complete all the relevant administrative procedures (signing and counter-signing)

WA0306 Check scripts prepared by relevant PSPs

WA0307 Check for errors in the dispensing process carried out by Post Basics and other Pharmacy Technicians

WA0308 Supervise dispensing by Post Basics and other Pharmacy Technicians

Supporting Evidence Date Signature

SE0301 Signed-off logbook

WM-11-WE04 Prepare and present a patient education tool

Scope Work Experience Date Signature

WA0401 Identify the need or topic

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WA0402 Obtain relevant information

WA0403 Decide on the mode of delivery of the message

WA0404 Present the topic using appropriate communication skills

WA0405 Evaluate feedback

Supporting Evidence Date Signature

SE0401 Signed-off logbook

Contextualised Workplace Knowledge Date Signature

1 Company specific standard operating procedures

2 Safety, health, environmental and quality requirements and procedures

3 Company specific quality management systems

Additional Assignments to be Assessed Externally Date Signature

321301000-WM-12, Processes to perform general housekeeping and administrative tasks in the pharmacy (Basic), NQF Level 4, Credits 2

WM-12-WE01 Observe and assist a Pharmacist’s Assistant (Basic), Pharmacist’s Assistant (Post Basic), Pharmacy Technician or Pharmacist to perform general housekeeping and administrative tasks in the pharmacy

Scope Work Experience Date Signature

WA0101 Perform administrative tasks (filing, capturing information etc.)

WA0102 Clean and tidy shelves and specialised storage areas

WA0103 Maintain supply of medicine containers and dispensary consumables

Supporting Evidence Date Signature

SE0101 Signed-off logbook

WM-12-WE02 Perform general housekeeping and administrative tasks in the pharmacy under the supervision of a Pharmacy Technician or Pharmacist

Scope Work Experience Date Signature

WA0201 Perform administrative tasks (filing, capturing information etc.)

WA0202 Clean and tidy shelves and specialised storage areas

WA0203 Maintain supply of medicine containers and dispensary consumables

Supporting Evidence Date Signature

SE0201 Signed-off logbook

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WM-12-WE03 Perform general housekeeping and administrative tasks in the pharmacy independently but subject to quality checks by a Pharmacy Technician or Pharmacist

Scope Work Experience Date Signature

WA0301 Perform administrative tasks (filing, capturing information etc.)

WA0302 Clean and tidy shelves and specialised storage areas

WA0303 Maintain supply of medicine containers and dispensary consumables

Supporting Evidence Date Signature

SE0301 Signed-off logbook

Contextualised Workplace Knowledge Date Signature

1. Company specific standard operating procedures

2. Safety, health, environmental and quality requirements and procedures

3. Company specific quality management systems

Additional Assignments to be Assessed Externally Date Signature

321301000-WM-13, Processes to perform general housekeeping and administrative tasks in the pharmacy (Post Basic), NQF Level 5, Credits 3

WM-13-WE01 Observe and assist a Pharmacist’s Assistant (Post Basic), Pharmacy Technician or Pharmacist to perform general housekeeping and administrative tasks in the pharmacy

Scope Work Experience Date Signature

WA0101 Update, maintain and store patient information in terms of legislative requirement

WA0102 Perform administrative tasks in support or under the direct supervision of a pharmacist

WA0103 Complete an adverse drug reaction form and submit to a pharmacist

WA0104 Assist with updating SOPs in operations

WA0105 Coordinate the dissemination of written, electronic, and oral communications throughout the sector

Supporting Evidence Date Signature

SE0101 Signed-off logbook

WM-13-WE02 Perform general housekeeping and administrative tasks in the pharmacy under the supervision of a Pharmacy Technician or Pharmacist

Scope Work Experience Date Signature

WA0201 Update, maintain and store patient information in terms of legislative requirement

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WA0202 Perform administrative tasks in support or under the direct supervision of a pharmacist

WA0203 Complete an adverse drug reaction form and submit to a pharmacist

WA0204 Assist with updating SOPs in operations

WA0205 Coordinate the dissemination of written, electronic, and oral communications throughout the sector

Supporting Evidence Date Signature

SE0201 Signed-off logbook

WM-13-WE03 Perform general housekeeping and administrative tasks in the pharmacy independently but subject to quality checks by Pharmacy Technician or Pharmacist

Scope Work Experience Date Signature

WA0301 Update, maintain and store patient information in terms of legislative requirement

WA0302 Perform administrative tasks in support or under the direct supervision of a pharmacist

WA0303 Complete an adverse drug reaction form and submit to a pharmacist

WA0304 Assist with updating SOPs in operations

WA0305 Coordinate the dissemination of written, electronic, and oral communications throughout the sector

Supporting Evidence Date Signature

SE0301 Signed-off logbook

Contextualised Workplace Knowledge Date Signature

1 Company specific standard operating procedures

2 Safety, health, environmental and quality requirements and procedures

3 Company specific quality management systems

Additional Assignments to be Assessed Externally Date Signature

321301000-WM-14, Processes to conduct screening tests (Pharmacy Technician), NQF Level 6, Credits 2

WM-14-WE01 Observe and assist a Pharmacy Technician or Pharmacist to conduct screening tests

Scope Work Experience Date Signature

WA0101 Explain the procedure and allow patient an opportunity to ask questions

WA0102 Obtain written consent

WA0103 Document the patient history including medication used

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WA0104 Prepare for test (gloves, instruments etc.)

WA0105 Conduct the test

WA0106 Conduct post-test activities (excluding interpretation of results and informing patient about the outcome)

WA0107 Supervise the screening of patients conducted by Pharmacy Technicians

WM-14-WE02 Conduct screening tests under the supervision of a Pharmacist

Scope Work Experience Date Signature

WA0201 Explain the procedure and allow patient an opportunity to ask questions

WA0202 Obtain written consent

WA0203 Document the patient history including medication used

WA0204 Prepare for test (gloves, instruments etc.)

WA0205 Conduct the test

WA0206 Conduct post-test activities (excluding interpretation of results and informing patient about the outcome)

WA0207 Supervise the screening of patients conducted by Pharmacy Technicians

Supporting Evidence Date Signature

SE0201 Signed-off logbook

WM-14-WE03 Conduct screening tests independently but subject to quality checks by Pharmacy Technician or Pharmacist

Scope Work Experience Date Signature

WA0301 Explain the procedure and allow patient an opportunity to ask questions

WA0302 Obtain written consent

WA0303 Document the patient history including medication used

WA0304 Prepare for test (gloves, instruments etc.)

WA0305 Conduct the test

WA0306 Conduct post-test activities (excluding interpretation of results and informing patient about the outcome)

WA0307 Supervise the screening of patients conducted by Pharmacy Technicians

Supporting Evidence Date Signature

SE0301 Signed-off logbook

Contextualised Workplace Knowledge Date Signature

1. Company specific standard operating procedures

2. Safety, health, environmental and quality requirements and procedures

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3. Company specific quality management systems

Additional Assignments to be Assessed Externally Date Signature

321301000-WM-15, Management of pharmacy resources (Pharmacy Technician), NQF Level 6, Credits 10

WM-15-WE01 Assist the pharmacist to supervise and manage staff

Scope Work Experience Date Signature

WA0101 Prepare and implement work schedules

WA0102 Allocate duties and prepare staff roster

WA0103 Organise and document staff meetings

WA0104 Monitor workflow in team situations while identifying, resolving, and reporting problems

WA0105 Draw up and implement team building exercise

WA0106 Monitor staff productivity

WA0107 Identify staff training needs

WA0108 Prepare and implement staff training schedule (including CPD programmes)

WA0109 Arrange training or train staff according to identified needs

WA0110 Handle complaints and, if needed, refer appropriately

Supporting Evidence Date Signature

SE0101 Signed-off logbook

WM-15-WE02 Assist the pharmacist to manage pharmacy-related facility

Scope Work Experience Date Signature

WA0201 Manage equipment

WA0202 Manage health, safety, hygiene and security within a facility

WA0203 Manage cleaning and maintenance activities

WA0204 Identify, analyse and solve problems related to facility management

WA0205 Prepare SOPs for managing a pharmacy-related facility

WA0206 Manage the quality issues related to the facility

WA0207 Record, report and manage dispensing errors and incidents

Supporting Evidence Date Signature

SE0201 Signed-off logbook

WM-15-WE03 Assist the pharmacist to manage pharmacy-related facility operations

Scope Work Experience Date Signature

WA0301 Monitor and manage the delivery and storage of patient-specific pre-dispensed and packaged medicines

WA0302 Manage the queuing of prescriptions

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WA0303 Manage stock and stock rotation

WA0304 Manage inventory and stock forecasting

WA0305 Manage operations scheduling

WA0306 Develop and implement SOPs

Supporting Evidence Date Signature

SE0301 Signed-off logbook

WM-15-WE04 Assist the pharmacist to manage financial aspects of the pharmacy-related facility

Scope Work Experience Date Signature

WA0401 Develop budget

WA0402 Perform ABC and VEN analyses

WA0403 Manage source documents

WA0404 Manage financial reporting process

WA0405 Identify and mitigate financial risks

Supporting Evidence Date Signature

SE0401 Signed-off logbook

Contextualised Workplace Knowledge Date Signature

1. Company specific standard operating procedures

2. Safety, health, environmental and quality requirements and procedures

3. Company specific quality management systems

Additional Assignments to be Assessed Externally Date Signature