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s:drive/policies/techcheckaudit policy Windsor Regional Hospital Pharmacy Department Policy and Procedure of Dispensing & Compounding Tasks to Non-Pharmacists Preamble Under the Regulated Health Professions Act (RHPA), only authorized professionals can perform a “controlled act”. Controlled acts that pertain to hospital pharmacy services include compounding, dispensing, and selling of a drug. The Ontario College of Pharmacists has specified that only the technical aspects of the medication process can be performed by a Regulated Pharmacy Technician. Cognitive functions must not be delegated. Technical functions that can be delegated include: “Dispensing a Drug” The tasks within “dispensing a drug” which can be performed are: - receiving prescriptions in person, electronically, verbally and by fax (see NAPRA Model Standards of Practice for Pharmacy Technicians - #19 Pharmacy technicians, when distributing drugs, see Appendix 1) - interpreting (i.e., reading) a prescription - adjusting an order according to an approved policy (e.g., therapeutic interchange) - order entry - selecting the drug (i.e., determining product to dispense) - reconstituting a product - determining expiry date of product - repackaging medications (into vial, unit-dose package, syringe, etc.) - labeling a product - final physical check for accuracy of finished product - maintaining (not interpreting) patient profiles - maintaining, preparing and operating equipment “Compounding a Drug” Drugs which may be “compounded” include non-sterile topical and oral preparations as well as IV admixtures and other sterile preparations. The tasks within “compounding a drug” which can be performed are: - selecting ingredients - performing calculations of quantities - determining equipment to be used - physically preparing product according to approved formula and protocol - carrying out established quality control assessments on product - final physical check of finished product Cognitive functions that must be performed by a pharmacist include: Assessing the therapeutic appropriateness of a medication order (allergies, drug interactions, efficacy, adverse effects, therapeutic duplication) Making a recommendation to a prescriber regarding therapy Developing the compounding formula for an extemporaneously prepared product Policy: Pharmacy technicians, pharmacy support staff, and other health professionals governed by the Regulated Health Professions Act (RHPA) are permitted to perform specified controlled acts provided that the act is specifically performed by the individual in accordance with the RHPA and the Ontario College of Pharmacists. Procedures: A. Delegation Authority 1. The Director of Pharmacy has the authority to delegate the technical aspects of dispensing and compounding of medications to pharmacy technicians, pharmacy support personnel, and other health professionals regulated by the RHPA. The Director may extend this authority to other pharmacists providing that the pharmacist has sufficient knowledge and expertise to ensure that the delegation is done safely and effectively. 2. Individuals to whom the tasks are delegated must be qualified to perform the specified tasks and accept the delegation.

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Page 1: Windsor Regional Hospital Pharmacy Department Policy and ... · Windsor Regional Hospital Pharmacy Department Policy and Procedure of Dispensing & Compounding Tasks to Non-Pharmacists

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Windsor Regional Hospital Pharmacy Department Policy and Procedure

of Dispensing & Compounding Tasks to Non-Pharmacists Preamble Under the Regulated Health Professions Act (RHPA), only authorized professionals can perform a “controlled act”. Controlled acts that pertain to hospital pharmacy services include compounding, dispensing, and selling of a drug. The Ontario College of Pharmacists has specified that only the technical aspects of the medication process can be performed by a Regulated Pharmacy Technician. Cognitive functions must not be delegated.

Technical functions that can be delegated include:

“Dispensing a Drug”

The tasks within “dispensing a drug” which can be performed are:

- receiving prescriptions in person, electronically, verbally and by fax (see NAPRA Model Standards of Practice for Pharmacy Technicians - #19 Pharmacy technicians, when distributing drugs, see Appendix 1) - interpreting (i.e., reading) a prescription - adjusting an order according to an approved policy (e.g., therapeutic interchange) - order entry - selecting the drug (i.e., determining product to dispense) - reconstituting a product - determining expiry date of product - repackaging medications (into vial, unit-dose package, syringe, etc.) - labeling a product - final physical check for accuracy of finished product - maintaining (not interpreting) patient profiles - maintaining, preparing and operating equipment

“Compounding a Drug”

Drugs which may be “compounded” include non-sterile topical and oral preparations as well as IV admixtures and other sterile preparations. The tasks within “compounding a drug” which can be performed are:

- selecting ingredients - performing calculations of quantities - determining equipment to be used - physically preparing product according to approved formula and protocol - carrying out established quality control assessments on product - final physical check of finished product

Cognitive functions that must be performed by a pharmacist include: Assessing the therapeutic appropriateness of a medication order (allergies, drug interactions, efficacy,

adverse effects, therapeutic duplication) Making a recommendation to a prescriber regarding therapy Developing the compounding formula for an extemporaneously prepared product

Policy:

Pharmacy technicians, pharmacy support staff, and other health professionals governed by the Regulated Health Professions Act (RHPA) are permitted to perform specified controlled acts provided that the act is specifically performed by the individual in accordance with the RHPA and the Ontario College of Pharmacists.

Procedures:

A. Delegation Authority

1. The Director of Pharmacy has the authority to delegate the technical aspects of dispensing and compounding of medications to pharmacy technicians, pharmacy support personnel, and other health professionals regulated by the RHPA. The Director may extend this authority to other pharmacists providing that the pharmacist has sufficient knowledge and expertise to ensure that the delegation is done safely and effectively.

2. Individuals to whom the tasks are delegated must be qualified to perform the specified tasks and accept the delegation.

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3. Other regulated health professionals (e.g. RN, RPN) accepting the delegated functions from the Director of Pharmacy or designate must do so in accordance with any applicable regulations established by that profession’s College.

4. Only technical aspects of dispensing may be delegated to non-pharmacists, and then only after written procedures and control checks are established.

5. Once an individual is authorized to perform a delegated function, he/she may perform the function at anytime, regardless if he/she is scheduled for that job on a particular day.

6. A licensed pharmacist must be readily available to answer questions, and provide directions and supervision when non-pharmacists are performing delegated functions.

B. Qualification Process

1. To qualify for performing the Tech Check process , the Regulated Pharmacy Technician must meet the following requirements:

1.1 employed continuously as a Regulated Pharmacy Technician at Windsor Regional Hospital and worked 1000 hours rotating through those duties that require tech-check

1.2 OR through inter campus transfers, has worked 150 hours in those duties that require tech check. 1.3 complete educational session reviewing policies and procedures for task to be delegated 1.4 correctly check the required number of orders (per appropriate Appendix 3 or 4), within the specified

time, with 100% accuracy – confirmed by pharmacist or designated Technician (RPhT) 1.5 random unannounced spot checks will be performed through out the year by the delegating

pharmacist or designate 2. All pharmacy technicians will be evaluated and/or re-certified annually and upon their return from an extended

LOA with respect to delegated tasks, or sooner at the discretion of the Director. 3. Staff who have not passed the initial certification process are not entitled to receive the responsibility

allowance associated with performing the delegated functions.

C. Accountability

1. The Director or designate is responsible for assessing the competency and ensuring that staff has the required knowledge, technical skill and ability to perform all the functions required of a Regulated Pharmacy Technician.

To assess competency, the Director or designate will: 1.1 Review medication incidents and discrepancies for all technicians to note trends and educate where

appropriate. If an individual (pharmacist or technician) has a higher number of medication incidents compared to the departmental average, the individual may be required to complete remediation activities.

1.2 Require all delegated technicians to undergo an initial and subsequent annual tech-check-tech audit (see Appendix 2 - Manager Operational check list). The accepted standard for tech-check-tech error rate is <0.5% as measured by the annual audit. In addition, for every error noted by the pharmacist, manager, or designate who is checking the audit, that section of the audit will be repeated to achieve 100% accuracy. Any individual who does not meet this standard of <0.5% will be required to repeat the entire audit. If the second audit does not achieve the <0.5% error rate, the Director or designate may remove the individual from performing the tech check function, along with loss of responsibility allowance, until an appropriate remediation plan is completed and a re-assessment demonstrates the individual’s ability to meet the standard.

2. The technician has the right to refuse to perform a task if he/she believes that additional training is required. 3. Individuals accepting the duty of tech check are fully responsible and accountable for his/her work. Any Near-

Miss Incidents must be reported to the Director, Managers and/or delegating pharmacist. 4. If an error/near miss incident is made/reported with respect to a delegated task, the individual and delegating

pharmacist will review the error/near miss incident. Corrective action will be taken where necessary. 5. If errors/near-miss incidents are reported regularly, the individual and the Director, Managers, and/or

delegating pharmacist will implement a Remediation Plan as follows: Week One: Review “The Dispensing” policy/procedures. Week Two: Re-training week. Week Three/Four: Random spot checks confirmed by the Manager or designated

pharmacist End of Week Four: Re-evaluate the performance of the technician.

The Director/Manager has the right to withdraw the task of tech check if the individual does not meet the required competencies and may be putting patients at risk of potential medication incidents.

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D. The Medication Processes at Windsor Regional Hospital

1. In-patient Department Pharmacy Technicians may be responsible for the final check of the following:

- PacMED canister refills - PacMED UTC fills - Re-packaged medications into unit-dose format (non-PacMED packaged) - Stock oral syringe refills (including narcotics and controlled-medications) - Batched IV products (including narcotics and controlled-medications) - kits and trays - Patient specific Narcotic fills – i.e Methadone - Wardstock requests - NICU oral batch - Chemo check of trayed up orders prior to mixing (see Appendix 3) - Adult TNA checks (see Appendix 4) - Compounding – non-sterile topical and oral preparations (see Appendix 5)

- Pyxis refills - IV batch refills (patient-specific orders using spiked, premixed IV meds) - IV refills of daily manufactured IV meds (patient specific orders mixed in hood) - manufactured NICU TPNs and adult/pediatric TNAs - Unit dose carts (cassettes) / oral batch

- New orders filled (First-fill area) - Manufactured medication refill

See Appendix 5 - WRH In-patient Department Final Check procedure.

2. Windsor Regional Cancer Center Pharmacy Technicians may be responsible for the final check of the following: - Batched IV bags - Chemotherapy infusion bags - Non-chemotherapy infusion bags - Chemotherapy syringes - Non-chemotherapy syringes - Intrathecal preparations See Appendix 6 - WRCC Pharmacy Department Final Check procedures.

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Appendix 1

GUIDELINES FOR THE DELEGATION OF FUNCTIONS TO PHARMACY TECHNICIANS

PREFACE This is the 2006 edition of the Canadian Society of Hospital Pharmacists (CSHP) Guidelines for the Delegation of

Functions to Pharmacy Technicians. It replaces the 1992 Guidelines for the Delegation of Functions to Pharmacy

Technicians and other Support Personnel. This document was approved as an official CSHP publication by CSHP Council

in February 2007. The delegation of drug-product preparation and distribution functions to pharmacy technicians is

essential to allow the pharmacist time for patient care functions. With well-trained technicians, clearly defined policies

and procedures, and quality control procedures to ensure ongoing competency, such functions can be delegated without

compromising patient safety. These Guidelines were developed to assist hospital pharmacists in determining which

functions may be delegated to pharmacy technicians under the direction or supervision of a pharmacist. If provincial or

territorial pharmacy regulatory bodies have specific definitions for a pharmacy technician or rules governing the

supervision or delegation of duties, these must be respected.

1. SCOPE These Guidelines set forth methods for evaluating a task to determine if it may be delegated to pharmacy technicians.

Note: Hospital pharmacy practice continues to evolve, and it is recognized that sections 3.2 and 3.3 do not provide a

complete list of all functions performed in hospital pharmacies.

2. DEFINITION The following definition describes a pharmacy technician for the purpose of these Guidelines:

Pharmacy technicians — Personnel who assist pharmacists and other health care professionals in the provision of

pharmaceutical products and services for delivery to a patient or a patient care area. The responsibilities that a pharmacy

technician may undertake are clearly described by the job description/profile in place within a specific institution. The

institution is responsible for ensuring that its pharmacy technicians have received appropriate training and certification

and that all applicable regulations relating to pharmacy technicians are adhered to.

3. DELEGATION OF FUNCTIONS TO PHARMACY TECHNICIANS

3.1 General Principles of Delegation 3.1.1

A pharmacist shall perform clinical functions involving patient-specific monitoring and the evaluation of drug therapy, as

well as functions requiring professional expertise. A pharmacist shall perform all functions restricted to a pharmacist by

provincial or federal law.

3.1.2

It is recommended that all pharmacy technicians should have completed a formal training and/or certification program.

3.1.3

A departmental orientation and training program should be developed for pharmacy technicians. A more intensive

training program may be required for pharmacy technicians who have not completed a formal training program.

3.1.4

The Director of Pharmacy or pharmacist designate shall be responsible for approving policies and procedures for all

departmental activities.

3.1.5

Policies and procedures regarding delegation of duties shall be written and shall outline:

(a) requirements for training and/or assessment of individual personnel before they are

permitted to undertake delegated functions; and

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(b) requirements and responsibilities for quality monitoring, such as documentation and

interim and final checks.

3.1.6

When pharmacy technicians are performing delegated functions, a pharmacist shall be readily

available to answer questions and to provide direction and supervision.

3.1.7

Functions shall be delegated only if there is sufficient opportunity for technicians to practice and

maintain the necessary skills.

3.2 Pharmacy Service Functions Routinely Performed by Pharmacy Technicians It is expected that the following functions will be performed routinely by pharmacy technicians:

(a) repackaging and labelling medication;

(b) preparing, labelling, and checking medication pursuant to a written order or prescription;

(c) selecting and applying auxiliary labels according to an approved list;

(d) filling and checking unit-dose carts according to a manual or computerized fill list;

(e) restocking and checking emergency boxes, cardiac arrest kits, and night cupboard supplies in accordance with an

approved list of contents;

(f) restocking cupboards or exchange carts on nursing units according to an approved list;

(g) reconstituting or diluting sterile and nonsterile medications, including checking diluents and volumes, in accordance

with an approved list;

(h) preparing and labelling products requiring specialized techniques, including IV admixtures, compounded products,

total parenteral nutritional products, and chemotherapy agents, in accordance with approved procedures;

(i) performing bulk compounding in accordance with approved procedures, when specific formulation and method or

preparation are provided in writing for the individual product;

(j) recycling usable medication into active stock;

(k) delivering narcotics and controlled drugs to patient care areas, obtaining signatures of authorized persons as proof of

receipt, and maintaining records accordingly;

(l) manually transcribing or performing computer entries of prescriptions for dispensing purposes;

(m) providing routine maintenance of departmental equipment;

(n) collecting workload measurement statistics;

(o) documenting drug distribution processes and outcomes (e.g., medication errors, missing doses);

(p) performing quality assurance audits on technical functions and activities;

(q) performing periodic quality assurance inspections of all areas of the institution where pharmaceuticals are stored; and

(r) orienting and training new staff and students.

3.3 Additional Pharmacy Service Functions that may be Delegated to Pharmacy

Technicians The following functions may be delegated to pharmacy technicians in accordance with the

principles described in section 3.1:

(a) developing departmental policies and procedures for approval by pharmacy management;

(b) ensuring that pharmacy technicians adhere to policies and procedures;

(c) communicating with nurses and others about drug distribution issues, e.g., missing doses, refill notices, allergy status;

(d) reviewing medication orders for legibility and completeness and taking corrective action as appropriate (i.e., drug,

dose, route, frequency, duration, and allergies);

(e) with the assistance of clinical information software, identifying potential interactions, therapeutic duplications, and

incompatibilities within patient profiles;

(f) collecting information on suspected adverse drug reactions for review by a pharmacist;

(g) verifying accurate entry of medication orders into a computer or other record system;

(h) with assistance of department-approved list or reference, verifying compatibilities of ingredients in compounded

products;

(i) performing final product checks of all ingredients and quantities for all compounded products, including sterile

products, IV admixtures, total parenteral nutritional products, and chemotherapy agents;

(j) controlling and managing inventory, including the selection of manufacturers;

(k) monitoring financial reports;

(l) verifying accuracy of pharmaceutical calculations and arithmetic;

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(m) developing formulation instructions and stability and compatibility information for compounded products and

forwarding this information to a pharmacist for review; and

(n) performing quality assurance audits involving the drug distribution system and forwarding the results to Pharmacy

Department managers.

4. SUPERVISORY RESPONSIBILITIES THAT MAY BE PERFORMED BY

PHARMACY TECHNICIANS The Pharmacy Department may designate supervisory and/or management roles for pharmacy technicians.

Responsibilities could include the following:

(a) participating in recruitment and retention of pharmacy technicians;

(b) participating in performance management functions (e.g., performance appraisals, working with Human Resources to

monitor sick time usage);

(c) organizing and conducting staff and student educational programs;

(d) participating on or leading pharmacy or hospital committees related to pharmacy services; and

(e) collaborating with other health care disciplines on pharmacy service delivery and quality assurance.

5. QUALITY ASSURANCE A quality assurance program shall be established to ensure that delegated tasks are consistently performed at the expected

level as defined by the Pharmacy Department’s policies and procedures.

BIBLIOGRAPHY Accreditation standard for pharmacy technician training programs. Bethesda (MD): American Society of Health-

System Pharmacists; 2002.

Akers E. Proposed standards of practice for registered pharmacy technicians. Toronto (ON): Ontario College of

Pharmacists; 2004.

American Association of Pharmacy Technicians; American Pharmaceutical Association; American Society of Health-

System Pharmacists; National Association of Chain Drug Stores; Pharmacy Technician Educators' Council. Model

curriculum for pharmacy technician training [Internet]. 2nd ed. Bethesda (MD): American Society of Health-System

Pharmacists; 2001 [cited 2006 Dec 11]. Available from: http://www.ashp.org/technician/model_curriculum/

Academy of Managed Care Pharmacy. White paper on pharmacy technicians 2002: needed changes can no longer

wait. Am J Health-Syst Pharm. 2003; 60(1):37-51.

Blackburn J. Environmental scan of pharmacy technicians. Ottawa (ON): Canadian Pharmacists Association; 2006.

Competency profile for pharmacy technicians [Internet]. Pharm Connect 2003 [cited 2006 Dec 11];10(5):8-17.

Available from: http://www.ocpinfo.com/client/ocp/OCPHome.nsf/object/PCxSeptOct03/$file/PCxSeptOct2003.pdf

Lifshin L, Nimmo C. Developing and maintaining up-to-date training for pharmacy technicians. Am J Health Syst

Pharm 2001;58:968-70.

MacInnis M, Power B, Cooper J. Environmental scan of pharmacy technicians. Ottawa (ON): Canadian Pharmacists

Association; 2001.

Regulations on accreditation of hospital pharmacy technicians training programs. Bethesda (MD): American Society

of Health-System Pharmacists; 2003.

White paper on pharmacy technicians. Vancouver (BC): College of Pharmacists of British Columbia; 2006.

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Appendix 2 – Manager Operational Checklist

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Appendix 3 – Windsor Regional Hospital In-patient Department – Final Check Procedure

Policy: All medications filled by a pharmacy technician must be checked by a pharmacist or another pharmacy technician who is

authorized to perform this function.

Procedure: A. Patient specific medications:

1. Each product must be checked for accuracy of the following: 1.1 correct medication 1.2 correct dosage form 1.3 correct dosage strength 1.4 correct quantity supplied / volume used in preparation for IV prepared products the volume of drug will be checked prior to injection into solution 1.5 expiry date 1.6 correct label applied

2. Each label must be checked for accuracy and legibility of the following: 2.1 patient’s name, first and last 2.2 patient’s location, unit and bed 2.3 medication name 2.4 dosage form 2.5 dosage strength 2.6 admin/dose quantity 2.7 DIN checked by filler … in cases of a DIN discrepancy (i.e. brand change) 2.8 auxiliary labels per defined list 2.9 expiry date indicated

3. Errors should be brought to the attention of the filler where possible, and corrected.

4. After the check is completed and any errors are corrected, the checking technician shall sign the hardcopy.

5. To improve efficiencies and reduce risk to the patient, near-miss incidents should be reported through the Medication Incident reporting system. (i.e . RL6)

B. Bulk Packaging: 1. Each product must be checked for accuracy of:

1.1 medications and diluents 1.2 dosage form 1.3 dosage strength 1.4 volume of all drugs and diluents

for IV prepared products the volume of drug will be checked prior to injection into solution

1.5 quantity of supplies used corresponds to batch requirements 1.6 correct devices used (eg. bags, syringe tip caps, etc.) 1.7 expiry date of all drugs, solutions, and products 1.8 storage conditions 1.9 correct label applied

2. Each label must be checked for accuracy and legibility of: 2.1 drug name and volume

2.2 dosage strength 2.3 expiry date 2.4 lot number

2. Errors should be brought to the attention of the filler where possible, and corrected.

3. After the check is completed and any errors are corrected, the checking technician shall sign the hardcopy.

4. To improve efficiencies and reduce risk to the patient, near-miss incidents should be reported through the Medication Incident reporting system. (ie. RL6)

Final Check Audit requirements: In-Patient Pharmacy (Initial Requirements)

FINAL CHECKS NUMBER OF CHECKS REQUIRED DATE COMPLETED WITNESSED BY

STOCK items

PACMED canister refills 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 (15)

PACMED UTC fill 1 1 1 1 1 1 1 1 1 1 (10)

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Pyxis refills (1 nursing station = 1 check) 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 (20)

Prepackaged Meds - “batching down” of bulk items into smaller packaging (1 bulk container = 1 check) i.e. creams, kayexalate, PEG, blister card narcotics/controlled-substances) Stock unit-dose oral syringes (i.e. wall stock and narcotic/controlled-substance stock)

1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 (20)

Batched IV products - Ancef, Zantac, stock of docked mini-bag

plus meds **product to be checked prior to placement in IV prep area and volume/pump setting to be checked prior to injection

- Narcotics/controlled-substance IVs prepared from a worksheet **drug volumes to be checked prior to injection into solution

- Adult TNA (1 batch = 1 check) **drug volumes to be checked prior to injection into solution (see appendix 5)

1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 (15)

1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 (15) 1 1 1 1 1 1 1 1 1 1 (10)

Kits and Trays i.e. crash cart trays, malignant hyperthermia kits, etc

1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 (15)

FILL LIST items

Patient specific IV Batch refills - orders using spiked, or premixed IV bags (eg. pull an Ancef bag from stock for the batch fill, pull a docked product for the batch fill) (1 order = 1 check)

5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 (75)

Manufactured Patient Specific IV refills – IVs that are manufactured from the daily batch i.e. penicillin IV, vancomycin, gravol, dexamethasone, etc

5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 (75)

Patient Specific Oral batch (1 patient = 1 check)

5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 (75)

OTHER items

Extemporaneous Compounds Pt Refills (eg. Topical compounds [i.e. 1% HC in clotrimazole], compounded oral liquids [i.e. NICU preps])

1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 (15)

New Orders (First fill area – includes 1st

dose IVs) (1 order = 1 check)

2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 (50)

Wardstock – from nursing units 1 1 1 1 1 1 1 1 1 1 (10)

Chemo – checking all products prior to manufacturing (volume and final check is RPh

1 1 1 1 1 1 1 1 1 1 (10)

Methadone – PT specific liquid doses 1 1 1 1 1 (5)

NICU/PEDS oral batch (1 order = 1 check)

1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 (25)

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Aseptic technique test (completed test to be

attached)

Aseptic technique audit (completed audit to be attached)

“Near miss” events found during audit of tech-check: (document on back)

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Appendix 4 – Windsor Regional Hospital WRCC/Outpatient Department – Final Check Procedure

Policy: All medications filled by a pharmacy technician must be checked by a pharmacist or another pharmacy technician who is

authorized to perform this delegated function.

Procedure: A. Batched IV Packaging:

1. Each product must be checked for accuracy of: 1.1 medications and diluents 1.2 dosage form 1.3 dosage strength 1.4 volume of all drugs and diluents (volume of drug to be checked prior to injection into solution) 1.5 quantity of supplies used corresponds to batch requirements 1.6 correct devices used (eg. bags, syringe tip caps, etc.) 1.7 expiry date of all drugs, solutions, and products 1.8 storage conditions 1.9 correct label applied

2. Each label must be checked for accuracy and legibility of: 2.1 drug name and volume 2.2 dosage strength 2.3 expiry date 2.4 lot number

3. Errors should be brought to the attention of the filler immediately, where possible, and corrected.

4. After the check is completed and any errors are corrected, the checking technician shall write the expiry date on the hardcopy and sign the hardcopy.

5. To improve efficiencies and reduce risk to the patient, near-miss incidents should be reported through the RiskMonitor Pro reporting system.

B. Chemotherapy Infusion Bags: 1. Each product must be checked for accuracy of:

1.1 Medication, diluent, and solution 1.2 volume and expiry date of drug, diluent, and solution (volume of drug to be checked prior to injection into solution)

1.3 diluent transferred if insufficient volume for drug 1.4 drug reconstituted correctly 1.5 correct device used (eg. bag, transfer device, needles, syringes, infusion line, etc.) 1.6 prepared when patient has arrived 1.7 ingredients from clinical trial used when required and documented 1.8 correct label applied

2. Each label must be checked for accuracy and legibility of:

2.1 patient name and date of treatment 2.2 drug name, dose, and volume 2.3 solution type and volume 2.4 total volume 2.5 rate of infusion

3. Lines are to be primed where required. 4. Errors should be brought to the attention of the filler immediately, where possible, and corrected.

5. After the check is completed and any errors are corrected, the checking technician shall write the expiry date of the drug on

the order and sign the drug order next to the volume column

6. All infusions will be dispensed to the holding unit in a chemo-bag.

7. The pharmacist on duty will be informed immediately of any discrepancy that leaves the pharmacy.

8. To improve efficiencies and reduce risk to the patient, near-miss incidents should be reported through the Medication Incident Reporting system.

C. Chemotherapy Syringes: 1. Each product must be checked for accuracy of:

1.1. medication, volume and expiry date 1.2. diluent, volume and expiry date 1.3. drug reconstituted correctly

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1.4. syringe size, and tip cap 1.5. correct label applied

2. Each label must be checked for accuracy and legibility of: 2.1. patient name and date of treatment 2.2. drug name, dose, and volume 2.3. label does not occlude volume increments 2.4. intended route

3. Errors should be brought to the attention of the filler immediately, where possible, and corrected.

4. After the check is completed and any errors are corrected, the checking technician shall write the expiry date of the drug on the order and sign the drug order next to the volume column

5. All syringes will be dispensed to the holding unit in a chemo-bag.

6. The pharmacist on duty will be informed immediately of any discrepancy that leaves the pharmacy.

7. To improve efficiencies and reduce risk to the patient, near-miss incidents should be reported through the RiskMonitor Pro reporting system.

D. Non-Chemotherapy Infusion Bags:

1. Each product must be checked for accuracy of: 1.1. medication, diluent, and solution 1.2. volume and expiry date of drug, diluent, and solution (volume of drug to be checked prior to injection into solution)

1.3. dose and volume calculations 1.4. drug reconstituted correctly 1.5. correct label applied

2. Each label must be checked for accuracy and legibility of: 2.1. patient name and date of treatment 2.2. drug name, dose, and volume 2.3. volume and type of solution 2.4. total volume 2.5. rate of infusion

3. Errors should be brought to the attention of the filler immediately, where possible, and corrected.

4. After the check is completed and any errors are corrected, the checking technician shall write the expiry date of the drug on the order and sign the drug order next to the volume column

5. The pharmacist on duty will be informed immediately of any discrepancy that leaves the pharmacy.

6. To improve efficiencies and reduce risk to the patient, near-miss incidents should be reported through the RiskMonitor Pro reporting system.

E. Non-Chemotherapy Syringe:

1. Each product must be checked for accuracy of:

1.1 medication, expiry date and volume 1.2 diluent, expiry date and volume 1.3 dose and volume calculations 1.4 drug reconstituted correctly 1.5 tip cap or syringe 1.6 correct label applied

2. Each lable must be checked for accuracy and legibility of: 2.1 patient name and date of treatment 2.2 drug name, dose, and volume 2.3 intended route

3. Errors should be brought to the attention of the filler immediately, where possible, and corrected.

4. After the check is completed and any errors are corrected, the checking technician shall write the expiry date of the drug on the order and sign the drug order next to the volume column

5. The pharmacist on duty will be informed immediately of any discrepancy that leaves the pharmacy.

6. To improve efficiencies and reduce risk to the patient, near-miss incidents should be reported through the RiskMonitor Pro reporting system.

F. Intrathecal Preparations: 1. Each product must be checked for accuracy of:

1.1. medication, expiry date and volume 1.2. diluent, expiry date and volume 1.3. preservative-free ingredients 1.4. syringe size, and tip cap

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2. Each label must be checked for accuracy and legibility of:

2.1. patient name and date of treatment 2.2. drug name, dose, and volume 2.3. label does not occlude volume increments 2.4. marked “for intrathecal use – preservative-free” and highlighted in YELLOW 2.5. appropriate auxiliary labels attached

3. It is recommended to verbalize the checking process to ensure preservative-free ingredients

4. Errors should be brought to the attention of the filler immediately, where possible, and corrected.

5. After the check is completed and any errors are corrected, the checking technician shall write the expiry date of the drug on the order and sign the drug order next to the volume column

6. All syringes will be dispensed to the holding unit in a chemo-bag.

7. The pharmacist on duty will be informed immediately of any discrepancy that leaves the pharmacy.

8. To improve efficiencies and reduce risk to the patient, near-miss incidents should be reported through the RiskMonitor Pro reporting system.

Final Check Audit requirements: WRCC Out-Patient Pharmacy

FINAL CHECKS NUMBER OF CHECKS REQUIRED DATE COMPLETED WITNESSED BY

Batched IV Bags (i.e. Decadron bags) 1 batch = 1 check

1 1 1 1 1 1 1 1 1 1 (10)

Chemotherapy Infusion bags

10 10 10 10 10 10 10 10 10 10 10 10 (120)

Chemotherapy Syringes

2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 (30)

Non-Chemotherapy Infusion bags

1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 (15)

Non-Chemotherapy Syringes

1 1 1 1 1 1 1 1 1 1 (10)

Intrathecal Preparations

1 1 1 1 1 (5)

Aseptic technique test (completed test to

be attached)

Aseptic technique audit (completed audit

to be attached)

Chemo review (completed review to be

attached)

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TECHNICIAN CHECKING AUDIT

STANDARD = 100% ACCURACY

NAME:

______________________

AUDIT START DATE:____________________ AUDIT DEADLINE

DATE:_________________

Last Audit

Date:________________

AUDIT COMPLETION DATE:________________

FINAL CHECKS NO. ORDERS COMPLETED DATE COMPLETED

Order Entry

5 5 5 5 5 5 5 5 5 5 (50)

I have read & understand the

Delegated Act for

**********************

found on the S-Drive

Signature: Date:

Pyxis Refills 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 (20)

PACMED Canister Refills 1 1 1 1 1 (5)

PACMED-STS tray fill 1 1 1 1 1 (5)

I have read & understand the

Delegated Act for Pyxis

refills, PACMED Canister

refills & PACMED-STS Tray

Fills found on the S-Drive

Signature: Date:

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Oral Syringes Refills 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 (25)

Methadone Oral Liquid Doses 1 1 1 1 1 (5)

I have read & understand the

Delegated Act for Bulk

Repackaging of Oral Meds

found on the S-Drive

Signature: Date:

Pre-Packaged Unit Dose Oral

Meds (syringes, bottles, etc-

packaged by P3 or Narc tech)

1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 (15)

I have read & understand the

Delegated Act for Bulk

Repackaging of Oral Meds

found on the S-Drive

Signature: Date:

Unit Dose Carts (Cassettes)

5 5 5 5 5 5 5 5 5 5 (50)

I have read & understand the

Delegated Act for Unit Dose

Cart Refills found on the S-

Drive

Signature: Date:

IV Batch Refills (spiked,

premix)

10 10 10 10 10 10 10 10 10 10 (100)

I have read & understand the Delegated Act for Premixed, Pre-packaged IV Products (**All Delegated Technicians)found on the

S-Drive

Signature: Date:

IV Refills (manufactured daily)--IV Team

ONLY-decreased from 50 to 25 July 4/13---

Includes patient specific Narcotic

Preparations 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 (25)

TPN Orders--IV Team ONLY 1 1 1 1 1 1 1 1 1 1 (10)

Batched IV Products (batches)e.g Ancef,

Zantac, Saline Syringes, Narcotic

Preparations--IV Team ONLY 1 1 1 1 1 1 1 1 1 1 (10) + 1 1 1 1 1 (5)-Narc preps

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I have read & understand the Delegated Act for IV Batches, TPN Orders & Daily Manufactured IV Refills (**IV Team Members**)

found on the S-Drive

Signature: Date:

New Orders (First-fill Area-including

previously batched/premixed IV meds, meds

required for Transferred patients) (# of

meds-orders counted must include meds

dispensed by tech)-100 required-eff.

0710/09 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 (100)

New Orders Con't

Note: New staff are required to be audited

on a total of 200 orders. 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 (100)

Home Medication Verification 1 1 1 1 1 1 1 1 1 1 (10)

I have read & understand the Delegated Act for 1ST Fill Area-includes: New In-Patient, Premixed IV's & Homemeds found on the

S-Drive

Signature: Date:

Manufactured Med Refills (topicals, oral

syringes)

1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 (25)

I have read & understand the Delegated Act

for Manufactured Med Refills (topicals, oral

syringes) found on the S-Drive

Signature: Date:

1 1 1 1 1 (5)

No Longer Required -eff.

June 18/13

I have read & understand the Delegated Act

for ICU/CCU Transfers found on the S-Drive

Signature: Date:

Weekend Pass Medication

5 5 5 5 5 5 5 5 5 5 (50)

Aseptic Technique Audit & Test--ALL

TECH'S (completed audit & test to be

attached to this audit tool)----NOTE: IF NO

IV shifts are EVER scheduled/worked IV

audit may be skipped --March 2012

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IV Room Test --IV TEAM (completed test to

be attached to this audit tool)

Annual Chemo Review--IV TEAM (completed

review to be attached to this audit tool)

PACMED Audit (Review to be signed off by

Joanne, Marilena or Sandra & completed audit

to be attached to this audit tool)

Annual Review of ISMP's List of High-Alert

Medications-Charlene

Annual Review of Unlocking Profiles &

Deleting Allergies- Charlene, Angel or Shelly

**GRAY AREAS ARE PENDING**

NOTES:

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ISMP’s List of High-Alert Medications High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients. We hope you will use this list to determine which medications require special safeguards to reduce the risk of errors. This may include strategies like improving access to information about these drugs; limiting access to high-alert medications; using auxiliary labels and automated alerts; standardizing the ordering, storage, preparation, and administration of these products; and employing redundancies such as automated or independent doublechecks when necessary. (Note: manual independent double-checks are not always the optimal error-reduction strategy and may not be practical for all of the medications on the list).

CLASSES / CATEGORIES OF MEDICATIONSl/Categories of Medications - adrenergic agonists, IV (e.g., epinephrine, phenylephrine, norepinephrine) - adrenergic antagonists, IV (e.g., propranolol, metoprolol, labetalol) - anesthetic agents, general, inhaled and IV (e.g., propofol, ketamine) - antiarrhythmics, IV (e.g., lidocaine, amiodarone) - antithrombotic agents (anticoagulants), including warfarin, low-molecular-weight heparin, IV unfractionated heparin, Factor Xa inhibitors (fondaparinux), direct thrombin inhibitors (e.g., argatroban, lepirudin, bivalirudin), thrombolytics (e.g., alteplase, reteplase, tenecteplase), and glycoprotein IIb/IIIa inhibitors (e.g., eptifibatide) - cardioplegic solutions - chemotherapeutic agents, parenteral and oral - dextrose, hypertonic, 20% or greater - dialysis solutions, peritoneal and hemodialysis - epidural or intrathecal medications - hypoglycemics, oral - inotropic medications, IV (e.g., digoxin, milrinone) - liposomal forms of drugs (e.g., liposomal amphotericin B) - moderate sedation agents, IV (e.g., midazolam) - moderate sedation agents, oral, for children (e.g., chloral hydrate) - narcotics/opiates, IV, transdermal, and oral (including liquid concentrates, immediate and sustained-release formulations) - neuromuscular blocking agents (e.g., succinylcholine, rocuronium, vecuronium) - radiocontrast agents, IV - total parenteral nutrition solutions

SPECIFIC MEDICATIONS

- colchicine injection - epoprostenol (Flolan), IV - insulin, subcutaneous and IV - magnesium sulfate injection - methotrexate, oral, non-oncologic use - oxytocin, IV - nitroprusside sodium for injection - potassium chloride for injection concentrate - potassium phosphates injection - promethazine, IV - sodium chloride for injection, hypertonic (greater than 0.9% concentration) - sterile water for injection, inhalation, and irrigation (excluding pour bottles) in containers of 100 mL or more Background BACKGROUND Based on error reports submitted to the USP-ISMP Medication Errors Reporting Program, reports of harmful errors in the literature, and input from practitioners and safety experts, ISMP created and periodically updates a list of potential high-alert medications. During February-April 2007, 770 practitioners responded to an ISMP survey

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designed to identify which of these medications were most frequently considered high-alert drugs by individuals and organizations. Further, to assure relevance and completeness, the clinical staff at ISMP, members of our advisory board, and safety experts throughout the US were asked to review the potential list. This list of drugs and drug categories reflects the collective thinking of all who provided input.

© ISMP 2007. Permission is granted to reproduce material for internal newsletters or communications with proper attribution. Other reproduction is prohibited without written permission. Unless noted, reports were received through the USP-ISMP Medication Errors Reporting Program (MERP). Report actual and potential medication errors to the MERP via the web at www.ismp.org or by calling 1-800-FAIL-SAF(E). ISMP guarantees confidentiality of information received and respects reporters’ wishes as to the level of detail included in publications.

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Windsor Regional Hospital Pharmacy Department

Performing of Controlled Acts by Regulated Pharmacy Technicians

I, __________________________________ (print name of designate/ Manager) allow the following controlled acts to

____________________________________________ (print name of technician).

********See attached Tech Check Audit for performed final checks.********* As the Manager/designate reviewing the tasks specified above, I have confirmed that the Pharmacy Technician has completed the required training

and demonstrated a level of proficiency that meets the standard for performing the tasks at Windsor Regional Hospital. He/She has read all the

procedures and understood the requirements. I will ensure that an audit process is in place to assess the ongoing level of competency in

performing these activities. I will ensure that a pharmacist is readily available to answer questions and provide direction as required.

Re-certification must be completed by ________________________________ (date must be within one year) in order for Tech to continue

with the responsibility of final checks past this date. Signature of Pharmacist __________________ Date ___________________________

I, ______________________________ (print name of technician), employed as a ____________ (position) at Windsor Regional Hospital, accept

the responsibility of performing the tasks listed above. I have read and understood the policies and procedures regarding the performance of these

tasks, and have completed the required training. I have received and reviewed “ISMP’s List of High Alert Medications”

(http://www.ismp.org/Tools/highalertmedications.pdf) and understand that an error with a high-alert medication has potentially more devastating

effects to a patient. I feel competent in performing these tasks and do not require additional training. I understand that I am responsible for

maintaining an acceptable level of performance. I understand that my competency and performance will be monitored and evaluated on a regular

basis. I also understand that I am accountable for any errors I commit in the performance of these activities and am committed to inform my

supervisor of a Near-Miss Incident.

Signature of Technician _______________________________ Date_______________________