Download - PHARMACY PRACTICE & DEVELOPMENT QAP INDICATORS 2010 … · PHARMACY PRACTICE & DEVELOPMENT QAP INDICATORS 2010 MANUAL Version 1/2011 PHARMACY PRACTICE AND DEVELOPMENT DIVISION, QUALITY

PHARMACY PRACTICE & DEVELOPMENT

QAP INDICATORS 2010 MANUAL Version 1/2011

PHARMACY PRACTICE AND DEVELOPMENT DIVISION,

QUALITY AND STANDARD SECTION

The Pharmacy Practice & Development QAP Indicators Manual Version 1/2011 Ministry of Health Malaysia Page 1

QAP INDICATOR 1 :

PERCENTAGE OF PRESCRIPTIONS WRONGLY FILLED AND

DETECTED BEFORE DISPENSING

1.0 BACKGROUND The drug dispensing service is an important function of the pharmacy department in

hospitals and health clinics. At all times, accuracy in the drugs dispensed to the

patients must be upheld, as wrong drug given to the patient could result in dire

consequences. This indicator refers to the number of prescriptions that are wrongly

filled and detected on counterchecking before being dispensed to the patient. This

indicator is not meant to be punitive but for remedial action to be taken.

2.0 RATIONALE FOR DEVELOPMENT OF INDICATOR

This indicator is developed to measure and monitor the incidence of errors during the

medication preparation process. It is also to ensure correct dispensing of medications

to the correct patients as prescribed (in terms of types of drugs, quantity, frequency

and dosages).

3.0 OBJECTIVES

3.1 To detect / document each occurrence / incidence of prescription wrongly

filled but detected before dispensing.

3.2 To identify weaknesses in the system and to take remedial action to prevent

its recurrence.

3.3 To instill patient’s confidence in receiving the right medication.

4.0 STANDARD

0%

5.0 DEFINITION OF TERMS

Prescriptions - All prescriptions received at out-patient, in-patient (unit of use/unit dose) and discharge prescriptions

For all in-patient (unit of use/unit dose) prescriptions, each filling or refill of the same prescription is recorded as a new prescription

Counterchecking - Prescriptions re-checked by a pharmacist or pharmacist assistant.


Yes No

Wrongly filled prescriptions

- Incorrect data/information of patient on the label Incorrect medication instructions on the label Incorrect medication filled in terms of type of

medications, quantity and dosage.

6.0 MODEL OF GOOD CARE 6.1 FLOW CHART - WORK PROCESS

Receive Prescription

Screen the prescription

Prescription

Error

Detected?

Contact the Prescriber

Problem solved Fill & Label prescription

Supply medication

to patient

Error

Detected

?

Investigate &

Correct the error

End

No Yes

Countercheck filled & labelled

prescription

Start

Yes No


6.2 WORK PROCEDURE FOR MEDICATION PREPARATION

Activities Responsibility

1. Interpret the prescription carefully.

2. Prepare appropriate label for medication.

3. Identify the correct medication.

4. Fill the correct quantity of medication.

5. Recheck labels and items filled.

6. Counterchecked with regards to:

- drug identification

- strength and dosage

- frequency and method of administration

- total quantity supplied.

7. Initial the prescription and put into the appropriate container

8. Hand over filled prescription to dispensing counter.

9. Countercheck filled prescription upon dispensing. Refer to P1 / PA1

for correction if any discrepancy detected and record in FORM 1A

immediately.

10. Rectify the error and dispense medication

11. Investigate and record error in Form 1B

12. Compile the total records from Form 1A & 1B daily.

13. Send the compiled information to the Pharmacist monthly using

Form 1A & 1B.

14. Summarize the statistics from all counters into Form QAP1.

15. Determine and analyze the percentage of prescriptions wrongly

filled and detected before dispensing.

P1 / PA1

P1 / PA1

P1 / PA1

P1 / PA1

P1 / PA1

P1 / PA1

P1 / PA1

P1 / PA1

P2 / PA2

P / PA

P2 / PA2

PA

PA

P

P

P – Pharmacist PA – Pharmacist Assistant


7.0 METHODOLOGY 7.1 METHOD OF COLLECTING DATA

- Form QAP 1A - is used to collect data related to any errors detected

while Counter-checking.

- Form QAP 1B - is used to collect data related to factors contributing to

errors detected before dispensing.

- Use the following formula for calculation:

Percentage of prescriptions = wrongly filled and detected before dispensing

Number of prescriptions wrongly filled x 100 % Total prescriptions counterchecked

7.2 SAMPLING

7.2.1 Inclusion criteria

- All prescriptions received at out-patient, in-patient (unit of use / unit of

dose) and discharge prescriptions are considered for this indicator at all

Hospital and Health Clinics

- For all in-patient (unit of use / unit dose) prescriptions, each filling or

refill of the same prescription is recorded as a new prescription.

E.g.:

IV Meropenem 500mg tds x 1/52

If unit of use: 2 prescriptions (If supplied every 3 days)

If unit dose: 7 prescriptions (Supplied daily)

- Prescriptions filled and counterchecked by different pharmacy staffs before

dispensing. (At least 2 pharmacy staff are involved in the dispensing

process)

7.2.2 Exclusion criteria

- All Parenteral Nutrition (PN) cases

- All Cytotoxic Drug Reconstitution (CDR) cases


7.3 DATA COLLECTION / FORMS 7.3.1 HOSPITAL / HEALTH CLINIC LEVEL

- Form QAP 1A – Daily Recording Of Errors Detected Before Dispensing

- Form QAP 1B – Daily Recording of Factors Contributing to Errors

Detected Before Dispensing

- Form QAP 1 – This form is to be filled as a compilation of 3 months data

and submitted by the Hospital / Health Clinic to the State Pharmaceutical

Services Division every 3 months:-

Jan – Mac – by 7th April

Apr – Jun – by 7th July

July – Sept – by 7th Oct

Oct – Dec – by 7th Jan

- Protocol For Investigation Of Hospital / Health Clinics With

Shortfall In Quality (SIQ) For Indicator Percentage of Prescriptions

Wrongly Filled And Detected Before Dispensing– This form is to be

sent every three months to the State Pharmaceutical Services Division with

the Form QAP 1 if the Standard for this Indicator is not achieved.

- SIQ QAP 1(STATE PSD)- is to be sent every 3 months by the State

Pharmaceutical Services Division to the Pharmaceutical Services Division,

Ministry of Health.

7.3.2 STATE PHARMACEUTICAL SERVICES DIVISION

- Data collected from Form QAP1A, Form QAP1B and the SIQ form must

be analysed by the State Pharmaceutical Services Division.

- SIQ QAP 1(STATE PSD)- is a summary of the SIQ analysis of all the

facilities within the jurisdiction of the state and this form is to be sent every

3 months by the State Pharmaceutical Services Division to the

Pharmaceutical Services Division, Ministry of Health. [refer to the

attachment SIQ QAP 1(STATE PSD)]






7.4 DATA ANALYSIS

- Data collected from Form QAP1A is analysed by the Hospital / Health Clinic

Pharmacist and reported in Form QAP 1.

- Data collected from Form QAP1B is analysed by the Hospital / Health Clinic

Pharmacist and reported in the SIQ form in the event of non-conformance.

- Data collected from Form QAP1A, Form QAP1B and the SIQ form is

analysed, summarized and reported by the State Pharmaceutical Services

Division to the Pharmaceutical Services Division, Ministry of Health.


HOSPITAL / HEALTH CLINIC : ______________________________

MONTH / YEAR : ______________________________

Date

Total Number

Of Prescriptions

With Error

(a)

Types of Error Total Number Of

Prescriptions

Counterchecked

(d)

Labelling Error (b) Filling Error (c)

(c)

Wrong Quantity

Unfilled Drug

Wrong Drug

Wrong Strength

Wrong Quantity Patient

name

Drug data (name,

instruction)

Eg:

6/5/09

llll lll ll llll llll l llll l ll 100

Total

Percentage of prescriptions wrongly filled but detected before dispensing (%)

= a / d x 100

Total number of errors= b + c * Multiple errors in one prescription are counted as ONE PRESCRIPTION with error.

Form QAP1A – Daily Recording Of Errors Detected Before Dispensing


HOSPITAL / HEALTH CENTRE : ______________________________

MONTH / YEAR : ______________________________

Date & Time

Peak Hour Personnel Involved Factors Contributing to Errors (May Tick √ more than one factor)

Yes No P

har

mac

ist

PR

P

Ph

arm

acis

t A

ssis

tan

t

Trai

nee

Dru

g A

rran

gem

en

t

Dis

turb

ance

s at

W

ork

Sta

tio

n

Wo

rk

Envi

ron

me

nt

Ph

ysic

al P

rod

uct

Human Factor

CA

REL

ESS

FATI

GU

E

STR

ESS

INEX

PER

IEN

CE

PER

SON

AL

PR

OB

LEM

OTH

ERS

e.g: 12/8/09 9.00am

√ √ √ √ √ √

* PRP : Provisionally Registered Pharmacist

Drug Arrangement - Unsystematic drug arrangement

Disturbances at Work Station - Phone Calls, Power Supply Shortage, etc Work Environment - Noise, Cramped area, Disorganised, Humid, Lighting, etc

Physical Product - Shape, Color, Similar Product Packaging, etc

Human Factor - Careless, Fatigue, Stress, Inexperience, Personal Problem, etc

Form QAP1B - Daily Recording Of Factors Contributing to Errors Detected Before Dispensing


FORM QAP 1

QAP 1 For the following indicator: State :

Percentage of prescriptions wrongly filled and detected before dispensing

to the total number of prescriptions counter-checked Period:

(All prescriptions received at Out-Patient and In-Patient Pharmacy) Year:

No.

Hospital /

Health Clinic

Unit

Total number of prescriptions

received

Total no. of prescriptions

counterchecked (a)

No. of prescriptions wrongly filled and detected before

dispensing (b)

No. of errors that

require corrections

Percentage of prescriptions wrongly filled and detected before dispensing

(b) / (a) x 100 % * up to 4 decimal points

e.g: Hospital ABC

OPD 100 98 2 15 0.0200%

IPD 200 195 8 8 4.1000%

Standard Not more than 0%

Formula: Percentage of prescriptions wrongly filled = No. of prescriptions wrongly filled x 100 %

No. of prescriptions counterchecked

This form is to be sent to State Pharmaceutical Services Division every three (3) months : Jan-Mac - by 7th April

Apr- Jun - by 7th July

July-Sept - by 7th Oct Oct - Dec - by 7th Jan The State Pharmaceutical Services Div. will send this form to the Pharmaceutical

Services Div. M.O.H every three (3) months : Jan – Mac Apr– Jun July –Sept Oct – Dec

- by 15th April - by 15th July - by 15th Oct - by 15th Jan

The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010

Ministry of Health Malaysia Page 10

PROTOCOL FOR INVESTIGATION OF INSTITUTION WITH SHORTFALL IN QUALITY (SIQ) FOR INDICATOR PERCENTAGE OF

PRESCRIPTIONS WRONGLY FILLED AND DETECTED BEFORE DISPENSING ________________________________________________________

* To be filled by Hospital / Health Clinic * Please fill ONE SIQ form/Unit

1.0 General Information

1.1 Unit: OPD / IPD / Satellite / Others : ____________________________

1.2 Name of hospital / health clinic : ____________________________

1.3 State / District : ____________________________

1.4 Reporting for the period from : ______________ to ____________

2.0 Information on Errors Detected

2.1 Total number of prescriptions with errors : _______________

2.2 Total number of errors on:

i. Labelling of Patient’s name : _______________

ii. Labelling of Drug data : _______________

iii. Unfilled drug : _______________

iv. Wrong drug : _______________

v. Wrong strength : _______________

vi. Wrong quantity : _______________

2.3 Number of errors contributed by :

i. Pharmacist : _____________

ii. Provisional Registered Pharmacist : _____________

iii. Pharmacist Assistant : _____________

iv. Trainee : _____________

2.4 Factors contributing to errors :

(Please state number of errors for each factor)

i. Arrangement of product : _____________

ii. Distractions : _____________

iii. Working environment : _____________

SIQ QAP 1



iv. Physical product : _____________

v. Human Factors

a. Careless : ___________

b. Fatigue : ___________

c. Stress : ___________

d. Inexperience : ___________

e. Personal problems : ___________

f. Others : ___________

2.5 Number of errors occurring during peak hours: _____________

3.0 Information on workload at pharmacy counter

3.1 Average Number of Prescriptions per day: _____________

1.0 Information on manpower at

OPD / IPD / OTHERS: ________ pharmacy department

4.1 Number of post for a) Pharmacist * : _____________

b) Pharmacist Assistant : _____________

4.2 Number of post filled for a) Pharmacist * : _____________

b) Pharmacist Assistant : _____________

* Provisionally Registered Pharmacists are excluded.

4.3 Number of Provisionally Registered Pharmacists (average) : __________

4.4 Number of Pharmacist Assistant Trainees (average) : __________



5.0 Conclusion

5.1 Main factors contributing to non-conformance

i) ___________________________________

ii) ___________________________________

iii) ___________________________________

5.2 Remedial actions taken based on the main factors mentioned above

i) ___________________________________

ii) ___________________________________

iii) ___________________________________

5.2 Other comments.

i) ___________________________________

ii) ___________________________________

iii) ___________________________________

Investigated and reported by Name : _________________________________

Designation : _________________________________

Hospital / Health Clinic : _________________________________

Date : _________________________________

Report Verified by :

Name : _________________________________

Designation : _________________________________

Hospital / Health Clinic : _________________________________

Date : _________________________________



FORM SIQ QAP 1 (STATE PSD)

PROTOCOL FOR INVESTIGATION OF INSTITUTION WITH SHORTFALL IN QUALITY (SIQ) FOR INDICATOR PERCENTAGE OF PRESCRIPTIONS WRONGLY FILLED AND DETECTED BEFORE DISPENSING

HOSPITAL OUT-PATIENT DEPARTMENT (OPD) INCLUDES FEEDBACK FROM :

1. SPECIALIST CLINIC PHARMACY 2. OUT-PATIENT PHARMACY 3. EMERGENCY DEPARTMENT PHARMACY STATE :

REPORTING PERIOD :

HOSPITAL HOSPITAL 1 HOSPITAL 2 HOSPITAL 3 HOSPITAL 4 TOTAL

Total number of prescriptions with errors

TYPES OF ERRORS

Labelling of Patient’s name

Labelling of Drug data

Unfilled drug

Wrong drug

Wrong strength

Wrong quantity

TOTAL 0 0 0 0 0

PERSONNEL INVOLVED

Pharmacist

Provisional Registered Pharmacist

Pharmacist Assistant

Trainee

FACTORS CONTRIBUTING TO ERROR

1. Arrangement Of Drugs

2. Distractions

3. Work Environment

4. Physical Product

5. HUMAN FACTOR

5.1 Careless

5.2 Fatigue

5.3 Stress

5.4 Inexperience

5.5 Personal Problems

5.6 Others

TOTAL HUMAN FACTORS 0 0 0 0 0

TOTAL FACTORS 0 0 0 0 0

No. of errors occurring during peak hours

Average Number Of Prescriptions per day



HOSPITAL HOSPITAL 1 HOSPITAL 2 HOSPITAL 3 HOSPITAL 4 TOTAL

Information on manpower (excluding PRP)

No. of post for Pharmacist

No. of post FILLED for Pharmacist

No. of post for Pharmacist Assistant

No. of post FILLED for Pharmacist Assistant

No. of PRP

No. of Trainee

SUMMARY OF REMEDIAL ACTIONS TAKEN :

1) BY HOSPITAL

2) BY STATE




PROTOCOL FOR INVESTIGATION OF INSTITUTION WITH SHORTFALL IN QUALITY (SIQ) FOR INDICATOR PERCENTAGE OF PRESCRIPTIONS WRONGLY FILLED AND DETECTED BEFORE

DISPENSING IN-PATIENT DEPARTMENT (IPD) INCLUDES FEEDBACK FROM :

1. WARD SUPPLY 2. SATELLITE 3. DISCHARGE STATE :

REPORTING PERIOD :

HOSPITAL HOSPITAL

1 HOSPITAL

2 HOSPITAL

3 HOSPITAL

4 TOTAL


TYPES OF ERRORS



Unfilled drug

Wrong drug

Wrong strength

Wrong quantity

TOTAL 0 0 0 0 0

PERSONNEL INVOLVED

Pharmacist



Trainee



2. Distractions

3. Work Environment

4. Physical Product

5. HUMAN FACTOR

5.1 Careless

5.2 Fatigue

5.3 Stress

5.4 Inexperience


5.6 Others


TOTAL 0 0 0 0 0




HOSPITAL HOSPITAL

1 HOSPITAL

2 HOSPITAL

3 HOSPITAL

4 TOTAL







No. of PRP

No. of Trainee


1) BY HOSPITAL

2) BY STATE




PROTOCOL FOR INVESTIGATION OF INSTITUTION WITH SHORTFALL IN QUALITY (SIQ) FOR INDICATOR PERCENTAGE OF PRESCRIPTIONS WRONGLY FILLED AND DETECTED BEFORE DISPENSING

HEALTH CLINIC OUT-PATIENT DEPARTMENT (OPD) INCLUDES FEEDBACK FROM :

1. SPECIALIST CLINIC PHARMACY

2. OUT-PATIENT PHARMACY

3. EMERGENCY DEPARTMENT PHARMACY

STATE :

HEALTH CLINIC HC 1 HC 2 HC 3 HC 4 TOTAL


TYPES OF ERRORS



Unfilled drug

Wrong drug

Wrong strength

Wrong quantity

TOTAL 0 0 0 0 0

PERSONNEL INVOLVED

Pharmacist



Trainee



2. Distractions

3. Work Environment

4. Physical Product

5. HUMAN FACTOR

5.1 Careless

5.2 Fatigue

5.3 Stress

5.4 Inexperience


5.6 Others


TOTAL 0 0 0 0 0



HEALTH CLINIC HC 1 HC 2 HC 3 HC 4 TOTAL








No. of PRP

No. of Trainee


1) BY HOSPITAL

2) BY STATE



QAP INDICATOR 2:

PERCENTAGE OF CLINICAL PHARMACOKINETIC SERVICE (CPS)

RECOMMENDATIONS ACCEPTED BY THE REQUESTING DOCTOR / UNIT

1.0 BACKGROUND

Since the role of the Clinical Pharmacokinetic Service (CPS) pharmacist is to

monitor and give consultation on Therapeutic Drug Monitoring, an indicator to

examine the quality of service should be determined. Acceptance of the

pharmacist’s recommendation by the doctors not only reflects the quality of the

CPS unit and it also ensures that the CPS unit is in step with the current medical

practice of the doctors. This indicator will be useful to gauge the level of

competency expected for the service.

2.0 RATIONALE FOR THE DEVELOPMENT OF INDICATOR

The acknowledgement and acceptance of the pharmacist’s recommendations

from medical practitioners reflects the quality of Clinical Pharmacokinetic Service.

This indicator will also further establish the communication and cooperation

between pharmacists and other health care professionals.

3.0 OBJECTIVE

To obtain the level of acceptance from doctors based on the CPS

recommendations given by pharmacists.

4.0 STANDARD

More than 85% of the CPS recommendations are accepted by the requesting

doctor / unit.




Recommendation – Any suggestions based on drug assay interpretation and

patient assessment. Number of recommendations should

be equivalent to the number of drug requested.

E.g. Drugs requiring pre and post assay is considered as 1

recommendation

Acceptance – The interpretations and recommendations are accepted

by the requester.

Requesting

doctor / unit

– Refers to requesters in hospitals / institutions which

require Clinical Pharmacokinetic Service.



Receive the CPS request form

Register the request

Screen the request and conduct

initial patient assessment in the

ward (CLERK CASE)

Send first copy of CPS form to

requester, record & file the second copy

Prepare carousel, reagent

and sample for assay

Run the assay

6.0 MODEL OF GOOD CARE (PHARMACIST BASED / LAB BASED)

6.1 FLOW CHART

Yes

No

Start

Consult the requester

and rectify the problem

Interpret the results

Discuss results and recommendations with prescriber

Any problems?



6.2 WORK PROCEDURE

Activities

Responsibility

1. Receive the CPS request form. 2. Screen the CPS form and conduct initial patient

assessment in the ward. 3. Consult the requester if there are any problems/queries

and rectify the problems. 4. Register the request in the CPS Record Book. 5. Prepare carousel, reagent and sample for assay. 6. Run the assay. 7. Interpret the results and make recommendations. 8. Discuss the results and recommendations with the

prescriber. 9. Send the first copy of CPS form to Prescriber / unit. 10. Record and file second copy of the CPS form

P / PA P P

PA

P / PA / LT

P / PA / LT P P

PA

PA

CPS – Clinical Pharmacokinetic Service

P – Pharmacist

PA – Pharmacist Assistant

LT – Lab Technician



7.0 METHODOLOGY 7. 1 METHOD OF COLLECTING DATA

- Compile all monthly requests.

- Determine the number of assays received.

- Determine the number of recommendations that are accepted by the

requester.

- Use the following formula for calculation:

Percentage of CPS recommendations accepted by the requesting doctor / unit =

X 100%

Total number of CPS recommendations

- For Out-sourced cases, the referring center is supposed to

make the CPS recommendations based on the sample

analysis and follow up the case in the ward. The hospital that

made the CPS recommendation should report it in QAP 2.

7.2 SAMPLING

- All Clinical Pharmacokinetic Service (CPS) recommendations.

7.2.1 Inclusion criteria

- In-patient cases only

- Out-sourced CPS assay

7.2.2 Exclusion criteria

- Discharged or absconded patients

- Toxicity screening request

Number of CPS recommendations Accepted by the requesting doctor / unit



7.3 DATA COLLECTION / FORMS 7.3.1 HOSPITAL / HEALTH CLINIC LEVEL

- CLINICAL PHARMACOKINETIC SERVICE REQUEST FORM

- FORM QAP 2 - This form is to be filled as a compilation of 3

months data and submitted to the State Pharmacy Division every 3

months:-

Jan – March - by 7th April

Apr – June - by 7th July

July - Sept - by 7th Oct

Oct - Dec - by 7th Jan

- Protocol for Investigation of Hospitals with Shortfall in

Quality (SIQ) For Indicator Percentage of CPS

Recommendations Accepted By the Requesting Units /

Doctors.

- This form is to be sent to the State Pharmacy Division whenever there

is a shortfall in quality for this indicator.


- Data collected from Form QAP 2 and the SIQ form must be

analysed by the State Pharmaceutical Services Division. A summary of

the analysis [refer to the Form SIQ QAP 2 (STATE PSD)] must be

submitted to the Pharmaceutical Services Division, Ministry of Health

every 6 months.





7.4 DATA ANALYSIS

- Data collected is analyzed by the Pharmacist and reported in FORM

QAP 2.

- Data collected from Form QAP 2 and the SIQ form is analysed and

reported by the State Pharmaceutical Services Division. Appropriate

remedial actions based on root cause analysis must be conducted by

both Hospital and State PSD based on the outcome of the QAP report

analysis.



FORM QAP 2

QAP 2 For Clinical Pharmacokinetic Service QA indicator: State :

Percentage of Clinical Pharmacokinetic Service (CPS) recommendations accepted by Period :

the requesting Doctor / Unit Year :

No. Hospital Total no.

recommendations (a)

No. of CPS recommendations accepted by the requesting Doctor / Unit

(b)

Percentage of CPS recommendations accepted by the requesting Doctor / Unit

(b) / (a) x 100%

Standard Not less than 85 %

Formula: Percentage of recommendations accepted = No. of assays interpreted and recommendations accepted by the requesting Doctor / Unit X 100%

Total number of recommendation

Definition: Recommendation refers to number of samples / assays done

This form is to be sent to State Pharmaceutical Services Division every three (3) months : Jan - Mar - by 7th April

Apr - Jun - by 7th July



The State Pharmaceutical Services Div. will send this form to the Pharmaceutical Services Div. M.O.H. every three 93) months

Jan - Mar - by 15th April





PROTOCOL OF INVESTIGATION FOR HOSPITAL WITH SHORTFALL IN

QUALITY (SIQ) FOR INDICATOR PERCENTAGE OF CLINICAL

PHARMACOKINETIC SERVICE (CPS) RECOMMENDATIONS ACCEPTED BY THE

REQUESTING DOCTOR / UNIT

1.0 General Information 1.1 Name of Hospital / Institution :__________________________________

1.2 State : ______________________________________________________

1.3 Reporting for the period : _________________to ___________________

1.4 Total number of recommendations made done : ____________________

1.5 Total number of cases not complying with the indicator :______________

2.0 Factors associated with the pharmacy

No. % 2.1 Incomplete biodata

2.2 Incomplete lab data

2.3 Incomplete dosing regimen

2.4 Incomplete prescribing information

2.5 Patient’s latest condition not reviewed

2.6 Delay in notifying requester (Please specify reason) _______________

2.7 Pharmacist is not available / Staff constraints

2.8 Wrong type of assay done

2.9 Outdated / Invalid result

2.10 Incomplete / inappropriate / incorrect interpretation and recommendation

SIQ QAP 2


3.0 Factors associated with the medical / nursing staff No. %

3.1 Communication inadequacy

3.2 Unavailability of prescriber

3.3 Uncooperative attitude

3.4 Medication changed / withhold

3.5 Disease condition has changed / stabilized / worsen

3.6 Misinterpretation of suggested recommendation

3.7 Others, please specify: _______________

4.0 Corrective action taken by pharmacist with regard to the problems Yes No 4.1 Advise and rectify problem with the pharmacist

4.2 Advise and rectify problem with prescriber / nurse

4.3 Advise and rectify problems with pharmacy staff 4.4 Initiate continuous education program for prescriber / nursing staff / pharmacy staff 4.5 Initiate bedside counseling services 4.6 Improve Pharmacist and Doctors communication during rounds 4.7 Others, please specify :______________


5.0 Conclusion

5.1 Main factors contributing to non-conformance (based on highest percentage mention above) i. _________________________________

ii. _________________________________ iii. _________________________________

5.2 Remedial actions taken based on the main factors mentioned above.

i. __________________________________

ii. __________________________________ iii. __________________________________

5.3 Other comments. i. ___________________________________ ii. ___________________________________ iii.___________________________________

Investigated and reported by Name : _________________________________

Designation : _____________________________

Hospital / Institution: _____________________

Date : ___________________________________


Name : _________________________________

Designation : _____________________________

Hospital / Institution : _____________________

Date : ___________________________________



PROTOCOL FOR INVESTIGATION OF INSTITUTION WITH SHORTFALL IN QUALITY (SIQ) FOR INDICATOR PERCENTAGE OF CLINICAL PHARMACOKINETIC SERVICE (CPS) RECOMMENDATIONS

ACCEPTED BY THE REQUESTING DOCTOR / UNIT

STATE :

REPORTING PERIOD :

HOSPITAL HOSPITAL

A HOSPITAL

B HOSPITAL

C HOSPITAL

D TOTAL

Total number of recommendations made done

Total number of cases not complying with the indicator

Factors associated with the pharmacy

Incomplete biodata

Incomplete lab data

Incomplete dosing regimen

Incomplete prescribing information

Patient’s latest condition not reviewed

Delay in notifying requester

Pharmacist is not available/ Staff constraints

Wrong type of assay done

Outdated/Invalid result

Incomplete/inappropriate/incorrect interpretation and recommendation

TOTAL 0 0 0 0 0

Factors associated with the medical/nursing staff

Communication inadequacy

Unavailability of prescriber

Uncooperative attitude

Medication changed/withhold

Disease condition has changed/stabilized/worsen

Misinterpretation of suggested recommendation

Others

TOTAL 0 0 0 0 0

Corrective action taken by pharmacist with regard to the problems

Advise and rectify problem with the pharmacist

Advise and rectify problem with prescriber/nurse


HOSPITAL HOSPITAL

A HOSPITAL

B HOSPITAL

C HOSPITAL

D TOTAL

Advise and rectify problems with pharmacy staff

Initiate continuous education program for prescriber /nursing staff/pharmacy staff

Initiate bedside counseling services

Improve Pharmacist and Doctors communication

Others


1) BY HOSPITAL

2) BY STATE


QAP INDICATOR 3:

PERCENTAGE OF TOXICITY CASES INTERPRETED AND RECOMMENDATIONS

COMMUNICATED WITHIN TWO HOURS TO THE REQUESTING DOCTOR / UNIT

1.0 BACKGROUND

Although less than 5% of all Clinical Pharmacokinetic Service (CPS) requests are

for toxicity cases, the prompt reporting of assay result is vital to ensure that

timely initiation of the most appropriate therapy can be given to the patient. The

CPS pharmacist’s role in monitoring appropriateness of therapy and giving

consultation on Pharmacokinetic Services is critical. Fast and reliable reporting is

a valuable tool and is the indicator to determine the quality of service. Hence it is

of utmost importance for the doctor to notify the pharmacist upon receiving

alleged poisoning / toxicity cases.


The time at which assay result is communicated (either verbally or in written

format) to the requesting doctor / unit will indicate the reliability and impact of

the CPS to the patient care system.

3.0 OBJECTIVE

To minimize the extent of toxicity effects towards the patients, by monitoring the

time taken for the results and recommendations to be communicated to the

requesting doctor / unit.



Toxicity – Suspected overdose / Poisoning with drugs

Recommendation – Suggestion of appropriate drug regime based on interpretation

and patient assessment.

Requesting

doctor / unit

– Refers to requesters in hospitals / institutions which require

Clinical Pharmacokinetic Service.

Communicated – Informed the requesters in hospital / institutions of the results

and recommendations either verbally or in a written report

–

–

The time the requesting doctor / unit inform the pharmacy

department of the toxic case.

The time limit (upon case notification) for the pharmacy

department to communicate the recommendation back to the

requesting doctor / unit

5.0 STANDARD 100% of the toxicity cases interpreted and recommended


Case Notified (Verbally / Written): Receive the toxicology CPS request

Screen the request

Send first copy of CPS form to

requesting doctor/ unit, record & file the second copy

Prepare carousel, reagent

and sample for assay

Run the assay

6.0 MODEL OF GOOD CARE

6.1 FLOW CHART

Yes

No

Start

Interpret the toxicology results

Discuss results and recommendations with prescriber

Any problem?

Consult the requesting

doctor/ unit and rectify

the problem

Register the request


6.2 WORK PROCEDURE

Activities

Responsibility

1. Case Notified : Receive the toxicity CPS request form.

2. Screen the CPS form

3. Consult the requesting doctor / unit if there are any

problems/queries and rectify the problems.

4. Register the request in the CPS Record Book.

5. Prepare carousel, reagent and sample for assay.

6. Run the assay.

7. Interpret the toxicity results and make recommendations.

8. Discuss the results and recommendations with the

prescriber.

9. Send the first copy of CPS form to

Prescriber / unit.

10. Record and file second copy of the CPS form

Pharmacist / PA

Pharmacist

Pharmacist

PA

Pharmacist / PA / LT

Pharmacist / PA / LT

Pharmacist

Pharmacist

PA

PA

CPS – Clinical Pharmacokinetic Service

PA – Pharmacy Assistant

LT – Lab Technician


7.0 METHODOLOGY

7. 1 METHOD OF COLLECTING DATA

Compile all monthly requests.

Determine the number of toxicity cases received.

Determine the number of toxicity cases interpreted and

recommendations communicated to the requesting doctor/ unit within 2

hours

Use the following formula for calculation:

Percentage of toxicity cases interpreted and

recommendations communicated to the requesting doctor / unit within 2

hours =

_____________________________________________________ x 100% Total number of toxicity cases interpreted and recommended

7.2 SAMPLING

All toxicity cases interpreted and recommendations communicated to the requesting doctor / unit by the pharmacy department.

Exclusion criteria

Out-sourced CPS assays Rejected sample

7.3 DATA COLLECTION / FORMS

7.3.1 HOSPITAL / HEALTH CLINIC LEVEL

FORM QAP 3A- Daily / monthly statistics of toxicity cases interpreted and recommendations communicated to the requesting doctor / unit within 2 hours, based on the Clinical Pharmacokinetic Services Request Form.

FORM QAP 3 - This form is to be filled as a compilation of 3 months data and submitted to the State Pharmaceutical Services Division every 3 months:-



Number of toxicity cases interpreted and recommendations communicated to the requesting doctor / unit within 2 hours


July – Sept - by 7th Oct

Oct – Dec - by 7th Jan

Protocol For Investigation Of Hospitals With Shortfall in Quality

(SIQ) For Indicator Percentage Of Toxicity Cases Interpreted

And Recommendations Communicated Within Two Hours To The

Requesting Doctors / Unit To The Total Number Of Toxicity

Cases - This form is to be sent to the State Pharmaceutical Services

Division whenever there is a shortfall in quality for this indicator.


- Data collected from FORM QAP 3 and the SIQ form must be

analysed by the State Pharmaceutical Services Division. A Summary

of the analysis (refer to the Form SIQ QAP 3) must be submitted to

the Pharmaceutical Services Division, Ministry of Health every 3

months.



July – Sept - by 15th Oct

Oct – Dec - by 15th Jan

7.4 DATA ANALYSIS

Data collected from FORM QAP3A is analysed by the Pharmacist and

reported in FORM QAP 3.


FORM QAP 3A : Daily / monthly statistics of toxicity cases interpreted and

recommendations communicated to the requesting doctor / unit within 2 hours.

DATE PATIENT

RN DRUG NAME

TIME

DURATION COMMENTS CASE

NOTIFIED

RECCOMENDATION

COMMUNICATED

TO REQUESTOR

1/1/2010 12345 Paracetamol 3am 4:30am 1 hr 30 min comply Salicylate 3am 4:30am 1 hr 30 min comply

2/1/ 2010 87599 Paracetamol 8am 10:30am 2 hr 30min Non compliance (delay from lab)

Total cases received:

2


FORM QAP 3

QAP 3 For Clinical Pharmacokinetic Service QA indicator: State :

Percentage of toxicity cases interpreted and recommendations communicated Period:

within two hours to the requesting Doctor/Units to total number of toxicity cases received Year:

No. Hospital

No. of

toxicity cases received

(a)

No. of toxicity cases interpreted and recommendations communicated within two

hours to the requesting Doctor / Units (b)

Percentage of toxicity cases interpreted and recommendations communicated within two

hours to the requesting Doctor / Units (b) / (a) x 100%

Standard 100%

Formula: Percentage of toxicity cases interpreted & recommendations communicated =

No. of toxicity cases interpreted and recommendations communicated within two hours to the requesting Doctor / Units X 100%

Total number of toxicity cases received

Definition: Cases means number of patients

This form is to be sent to State Pharmaceutical Services Division every three (3) months : Jan - Mac - by 7th April




The State Pharmaceutical Services Div. will send this form to Jan - Mac - by 15th April

Pharmaceutical Services Div. M.O.H. every three (3) months Apr - Jun - by 15th July




PROTOCOL OF INVESTIGATION FOR HOSPITAL WITH

SHORTFALL IN QUALITY (SIQ) FOR INDICATOR

PERCENTAGE OF TOXICITY CASES INTERPRETED AND RECOMMENDATIONS

COMMUNICATED WITHIN TWO HOURS TO THE REQUESTING DOCTOR / UNIT

________________________________________________________

1.0 General Information 1.1 Name of Hospital / Institution :__________________________________

1.2 State : _____________________________________________________

1.3 Reporting for the period : _________________to __________________

1.4 Total number of toxicity cases interpreted and recommended :_________

1.5 Total number of case not complying with the indicator :_______________

2.0 Factors associated with the pharmacy Problems No. % 2.1 Problem with the reagent

(expired, out of stock, etc.)

2.2 Problem with machine

(out of order, not calibrated etc.)

2.3 Unavailability of pharmacist

2.4 Delay in analyzing sample by pharmacist

2.5 Delay in tracing result

2.6 Delay in interpreting results

2.7 Incomplete case clerking by pharmacist

2.8 Others, please specify: ____________________________________

__________________________________ 3.0 Factors associated with the lab

No. %

3.1 Problem with the reagent

(expired, out of stock, etc.)

SIQ QAP 3


No. %

3.2 Problem with machine

(out of order, not calibrated etc.)

3.3 Unavailability of lab personnel

3.4 Incomplete lab data

3.5 Others, please specify: _____________________________________

______________________________________ 4.0 Factors associated with the medical / nursing staff

No. % 4.1 Incomplete sampling information 4.2 Delay in sending sample 4.3 Unattended by medical officer in-charge 4.4 Incomplete case clerking by medical officer 4.5 Others, please specify: _____________________________________ ______________________________________ 5.0 Corrective actions taken by the pharmacist in charge with regards to

the problem

Yes No 5.1 Advise and rectify problem with the pharmacist 5.2 Advise and rectify problem with the lab 5.3 Advise and rectify problem with doctor / nurse 5.4 Others, please specify: ______________________________________ ______________________________________


6.0 Conclusion 6.1 Main factors contributing to non-conformance. i. _______________________________ ii. _______________________________ iii. _______________________________ 6.2 Remedial actions taken based on the main factors mentioned above. i. _________________________________ ii. _________________________________ iii. _________________________________ 6.3 Other comments. i. _________________________________ ii. _________________________________ iii. _________________________________

Investigated and reported by : Name : _________________________________

Designation : _________________________________

Hospital / Institution : ___________________________

Date : _________________________________


Name : _________________________________

Designation : _________________________________

Hospital / Institution : ___________________________

Date : _________________________________



PROTOCOL FOR INVESTIGATION OF INSTITUTION WITH SHORTFALL IN QUALITY (SIQ) FOR INDICATOR PERCENTAGE OF CLINICAL PHARMACOKINETIC SERVICE (CPS) RECOMMENDATIONS

ACCEPTED BY THE REQUESTING DOCTOR / UNIT

STATE : REPORTING PERIOD :

HOSPITAL HOSPITAL

A HOSPITAL

B HOSPITAL

C TOTAL

Total number of toxicity cases interpreted and recommended

Total number of cases not complying with the indicator

Factors associated with the pharmacy

Problem with the reagent (expired, out of stock, etc.)

Problem with machine (out of order, not calibrated etc.)

Unavailability of pharmacist

Delay in analyzing sample by pharmacist

Delay in tracing result

Delay in interpreting results

Incomplete case clerking by pharmacist

Others

TOTAL 0 0 0 0

Factors associated with the lab

Problem with the reagent (expired, out of stock, etc.)

Problem with machine (out of order, not calibrated etc.)

Unavailability of lab personnel

Incomplete lab data

Others

TOTAL 0 0 0 0

Factors associated with the medical/nursing staff

Incomplete sampling information

Delay in sending sample

Unattended by medical officer in-charge

Incomplete case clerking by medical officer

Others

TOTAL 0 0 0 0


HOSPITAL HOSPITAL

A HOSPITAL

B HOSPITAL

C TOTAL

Corrective action taken by pharmacist with regard to the problems

Advise and rectify problem with the pharmacist

Advise and rectify problem with the lab

Advise and rectify problem with prescriber/nurse

Others

TOTAL 0 0 0 0

SUMMARY OF REMEDIAL ACTIONS TAKEN : 1) BY HOSPITAL

2) BY STATE


INDICATOR QAP 4 :

PERCENTAGE OF VALUE OF STOCKS DISPOSED AND WRITTEN OFF TO

VALUE OF STOCKS HANDLED ANNUALLY

1.0 BACKGROUND

The drug expenditure of the Ministry of Health (MOH) runs into almost RM 2 billion each year,

constituting about 10% of the MOH annual budget. In MOH hospitals, the value of drugs and

medical consumables that are purchased through the hospital pharmacy stores amounts to a

significant percentage of the hospital budget. Stocks written-off and disposed can amass up to

millions of Ringgit Malaysia (RM) in losses every year. Stocks disposed are usually due to

preventable circumstances such as drug expiry, obsolesce, deterioration and damage due to

poor storage condition can be avoided by efficient hospital pharmacy store management. Stocks

are written-off due to unpreventable circumstances such as disaster, deterioration or theft

contribute a considerable amount to the pharmacy financial losses yearly and must be

accounted for as well. Hence the role of the pharmacy store management is to minimize

wastage due to preventable circumstances, ensure adequate supply and improve the cost

effectiveness of the healthcare service.


This indicator is developed to improve stock management by the pharmacy store as the amount

of stocks written-off annually and the justifications for writing off these items are captured and

analysed. This will enable corrective and preventive measures to be taken to enhance the cost

effectiveness of the health care system.

3.0 OBJECTIVE

1. To measure the wastage due to stocks written-off and disposed.

2. To improve pharmacy store management

4.0 STANDARD

0% of the value of stocks handled annually.



*Store

– A designated place for receiving, recording, storing, maintaining,

managing and supplying stock.

*Main Store – A Hospital/ Integrated store that process, manage and supplies stocks

for Unit Stores.

*Unit Store

(Sub-store)

– Pharmacy managed store that keeps and supplies stocks to end users

for short term and direct usage, for operational purposes.

Stocks – All drugs and non-drugs purchased and stored by the hospital

pharmacy managed stores (Main and Unit Stores)

*Written-off

stocks

– Stocks loss due to natural disasters, fire, theft and deterioration which

are beyond the management’s control within the same fiscal year.

Stocks

disposed

– Stocks identified for disposal in the store within the same fiscal

year due to preventable circumstances such as expiry, deterioration,

damage or obsolesce of stocks.

Stocks

received

annually

– All stocks received within the same fiscal year by the pharmacy

managed stores.

Opening

Stock

– Stocks held at 1st January

Closing Stock – Stocks held at 31st Dec (excluding expired stock in hand)

Life Saving

Items

– Medications which require immediate administration in a medical

emergency. These medications have the potential to sustain life and /

or prevent further complications.

Life Saving

Item List

– A list of Emergency, Antidote and Anti-venom items identified and

approved by the PSD, MOH. This list will be updated annually / when

necessary.

National

Pandemic

Items

– Items such as stock pile medications and vaccines used solely for

pandemic activities.

FIFO – First In First Out


FEFO – First Expired First Out

TPS – Tatacara Pengurusan Stor

*PEKELILING PERBENDAHARAAN BIL. 5 TAHUN 2009 (Tatacara Pengurusan Stor)

6.0 MODEL OF GOOD CARE

Determine the stock(s) to be disposed

(Form QAP 4A)

Compile the data into QAP 4

Determine total value of stock(s) to be disposed

Analyse and implement remedial actions

Report SIQ when necessary and submit

report


6.0 WORK PROCEDURE FOR QAP 4 REPORTING

STEPS PROCEDURE

1. Determine stocks to be disposed.

2. For main store:

Isolate stocks to be disposed from the store’s system and remove these stocks from

the holding stock value.

For sub store:

Isolate stocks to be disposed from the sub store’s system.

3. Record identified stocks to be disposed in QAP 4A.

4. Main store:

The data collected in QAP 4A shall then be translated into form QAP 4B and QAP 4.

Sub-store:

The data collected in QAP 4A shall then be translated into form QAP 4C.

5. Main store shall be responsible to compile QAP 4, QAP 4B, QAP 4C, SIQ and submit

to state PSD.

6. State PSD shall analyse and take necessary remedial action.

7. State PSD shall then submit reports to MOH.


7.0 METHODOLOGY 7.1 METHOD OF COLLECTING DATA - Prepare a list of items for disposal and write-off as per schedule using the prescribed

form (KEW.PA-17, KEW.PS-19 & 21) and proceed to fill in Form QAP 4A and Form QAP

4B or 4C.

- Determine the value of written-off stocks, disposed stocks and value of stocks received

annually.

- All stocks identified for disposal / written off must be approved for disposal / written off

within the same fiscal year.

- Use the following formula for calculation :-

% of Value of Stocks Disposed & Written Off =

Total Value of Stocks Handled Annually = Value of Opening Stock + Value of stocks

received annually - Value of Closing Stock

- The Form QAP 4A, Form QAP 4B and Form QAP 4C will include the items listed in the

exclusion criteria, as the management of these items need to be reported to the

Pharmaceutical Services Division.

- However, in the calculation of the Percentage of Value of Stocks Disposed and Written

Off in Form QAP 4, the items listed in the exclusion criteria will not be included (e.g:

Life Saving Items and National Pandemic Items)

7.2 SAMPLING

7.2.1 Inclusion :

Stocks that has been approved for disposal and those pending for approval.

7.2.2 Exclusion :

Item purchased under development projects, assets, domestic, reagent, uniform,

stationeries and medical gases.

Returned medication from patients and wards.

Total Value of Stocks Disposed & Written Off for the year

Total Value of Stocks Handled Annually

X 100%


7.3 DATA COLLECTION FORMS - Roles and Responsibilities

Unit

FORMS

QAP 4 QAP 4A QAP 4B QAP 4C SIQ (when

needed)

KEW PS / PA

(when needed)

Sub

store

- Fill and

Submit to

Main Store

- Fill and

Submit to

Main Store

- -

Main

store

Fill and

Submit to

State PSD

Fill and

file

Fill and

Submit to

State PSD

Submit to

State PSD

Fill and

Submit to

State PSD

Fill and Submit

to State PSD

State

PSD

Fill and

Submit to

PSD,MOH

- Submit to

PSD,MOH

Submit to

PSD,MOH

Submit to

PSD,MOH

-

- The Main Store Pharmacist compiles all the forms 4B, 4C & QAP 4 (value from Form 4B

only) from the Main and Unit Stores and submits it to the State Pharmaceutical Services

Division annually by:

Jan – Dec - by 7th January the following year.

- Protocol For Investigation of Hospital With Shortfall In Quality (SIQ) For

Indicator Percentage Of Value Of Stocks Disposed and Written-off To Value of

Stocks Handled Annually – This form and all relevant documents are to be filled and

sent by the Main Store Pharmacist whenever there is a shortfall in quality for this indicator

to the State Pharmaceutical Services Division.

- Form KEW.PA-17, KEW.PS 19 and KEW.PS-21 are to be attached with the SIQ forms.

- The State Pharmaceutical Services Division will send the compiled data of Form QAP 4,

Form QAP 4B, Form QAP 4C and SIQ (when necessary) to the Pharmaceutical Services

Division, Ministry of Health annually by:

Jan – Dec - by 15th January the following year.

7.4 DATA ANALYSIS

The pharmacist is responsible to analyse all the data collected and fill in the relevant forms mentioned above.


LIST OF ITEMS DISPOSED & WRITTEN OFF

Hospital : Year :

Store: Main Store Sub Store

*Category Code:

Life Saving Items Emergency Items

Antidote Anti-venom

: : :

EI AD AV

National Pandemic items : NPI

Non-Drug : ND

Others : O

*Category

Items Reason for disposal & written off (Pls √ one)

Unit cost

(RM)

Quantity Total cost

(RM) Disposed Written Off Deterioration Damage Obsolete Expired

Deterioration Disaster Theft

e.g: EI Atropine Inj. √ x y xy

Raw material e.g.

menthol

crystal

√ Change of

physical

appearance

Alcohol 96% √

Due to evaporation

TOTAL COST

Life Saving Items : RM Others : RM

National Pandemic items

: RM Non-Drug : RM

Total cost (RM) : Total cost (RM) :

FORM QAP 4A



QAP 4 : Percentage Of Value Of Stocks Disposed and Written Off To Value of Stocks Handled Annually

Hospital : Unit: Main Store Year :

Important Note : Total (a1) = Total (a2)

This form is to sent to the State Pharmaceutical Services Division every January of the following year : by 7th Jan

Category

Total value of stocks Disposed and Written Off for the year (a) (RM) *Please fill in the value of stocks(RM) in the relevant categories

Value of Stocks (a1) (RM) Reasons (a2) (RM)

Main store (Pharmacy) Sub- Total (RM) Damage Obsolete Expired Deterioration

Disaster

(Flood,

Fire, etc)

Theft Sub- Total

(RM) Written off Disposed

DR

UG

S

Life Saving Items List

National Pandemic

Items

Others ( O)

NON-DRUG (ND)

TOTAL (a1) TOTAL (a2)

Formula: % of Value of Stocks Disposed and Written-Off

= Total value of stocks disposed and written-off for the year x 100% Total value of stocks handled annually

Total value of stocks disposed and written-off for the

year (A)

=

Subtotal O + Subtotal ND

*Value of stocks handled annually (B)

*Note: i) To exclude value of all items listed in the exclusion criteria

ii) For Main Pharmacy Store ONLY.

=

Value of Opening stock + Value of stocks received annually - Value of Closing

stock

% of Value of Stocks Disposed and Written-Off

=

A / B x 100%

FORM QAP 4B



QAP 4: Percentage of Value Of Stocks Disposed and Written Off To Value of Stocks Handled Annually

Hospital : __________________ Unit: OPD/ IPD/ Satellite/ Others:______________ Year : ____________

Important Note : Total (a1) = Total (a2)

This form is to be sent to the State Pharmaceutical Services Division every January of the year : by 7th Jan

Category

Total value of stocks Disposed and Written Off for the year (a) (RM) *Please fill in the value of stocks(RM) in the relevant categories

Value of Stocks (a1) (RM) Reasons (a2) (RM)

Unit-store (Pharmacy) Sub- Total (RM) Damage Obsolete Expired Deterioration

Disaster

(Flood,

Fire, etc)

Theft

Sub- Total

(RM) Written off Disposed

DR

UG

S

Life Saving Items List

National Pandemic

Items

Others ( O)

NON-DRUG (ND)

TOTAL (a1) TOTAL (a2)

Total value of stocks disposed and written-off for the

year (A)

= Subtotal O + Subtotal ND

FORM QAP 4C



FORM QAP 4

QAP 4 Percentage Of Value Of Stocks Disposed and Written-off To Value of Stocks Handled Annually State :

Period : Year :

No. Hospital Total value of stocks disposed

and written off (RM)* Total value of stocks handled

annually

Percentage Of Value Of Stocks Disposed and Written-off To Value

of Stocks Handled Annually

Hospital A 600,000 2,200,000 27.3%

TOTAL :

Standard : 0%

* Value taken from QAP 4B Formula: Percentage Of Value Of Stocks Disposed

and Written-off To Value of Stocks Handled Annually

= Total value of stocks disposed and written off Total value of stocks handled annually

x 100%

This form is to be sent to State Pharmaceutical Services Division every year

: Jan - Dec - by 7th Jan

The State Pharmaceutical Services Div. will send this form to the Pharmaceutical Services Div. M.O.H every year

: Jan - Dec - by 15th Jan



PROTOCOL FOR INVESTIGATION OF HOSPITAL WITH SHORTFALL IN QUALITY (SIQ) FOR INDICATOR PERCENTAGE OF VALUE OF STOCKS DISPOSED AND WRITTEN-OFF

TO VALUE OF STOCKS HANDLED ANNUALLY _______________________________________________________________________ 1.0 General Information 1.1 Name of Hospital / Institution :_________________________________

1.2 State :_____________________________________________________

1.3 Reporting for the year of :_____________________________________

1.4 Total value of stocks handled annually :__________________________

1.5 Total value of disposed: ______________________________________

1.6 Total value written-off: _______________________________________

1.7 Total value of stocks written-off for the year : _____________________

* Detailed reports on investigation on theft (including Police Report ) / damage / disaster

are to be attached

2.0 Investigation 2.1 Estimation of Requirement 2.1.1 Are purchases made by Re-Order Advice (ROA) done?

2.1.2 Is the ROA routinely revised according to the usage trend?

2.1.3 Are the Re-Order Advice (ROA) counter-checked by pharmacist ?

If no, please specify reason:______________________

2.2 Compliance to FIFO/FEFO in issue of stocks :

Yes

2.2.1 Do you follow TPS 135 on the issuance of stock based on

FIFO / FEFO?

2.2.2 Is there a system to monitor the expiry of stocks?

If yes, please specify :_______________________

Yes No

No

SIQ QAP 4



2.3 Adequacy of Monitoring

2.3.1 How do you monitor the physical conditions of stocks?

____________________________________________

2.3.2 How often are the stocks monitored within the year _________times

Yes No

2.3.3 Do you generate items near expiry date?

How often? _____________________/ year.

2.3.4 Time frame used to generate the items near expiry

report:___________month.

2.3.5 How often is the slow moving list of items circulated to users and other

hospital / institution within the year _____times

2.3.6 How much of the slow moving item which is circulated is taken up by other

institutions?

Value (RM) : _____________

Percentage : _____________

2.4 Condition of Stocks Received Yes No

2.4.1 Are guidelines available for inspection of goods on receipt? 2.4.2 How do you document the inspections of goods on receipt?

_______________________________________________ Yes No

2.4.3 For each of the items written-off, did the stocks

meet the specifications at the time of receipt?

2.4.4 Upon receipt, are there short expiry items

(expiry date in less than 1 year) involved?

2.4.4.1 If yes, is there a Letter of Undertaking

(LOU) given for all these items?



Yes No

2.4.4.2 If yes, do you monitor the LOU?

2.4.4.3 Is the LOU kept together with the respective

item (e.g: bin card)?

Please specify:________________________

2.5 Staff workload (* Please include a copy of the Organization chart for the hospital

concerned)

2.5.1 Total no. of pharmacists : ______________________________

2.5.2 No. of pharmacist involved in store management (include Grade):

U41: _______________ U48: _______________

U44: _______________ U52: _______________

2.5.3 Total no. of store administrative assistant : _______________

2.5.4 Total no. of other workers in the store:

i. General worker : ____________

ii. Contract workers : ____________

iii. Others : ____________

2.5.5 Value of items received for the year : RM ____________

2.5.6 Total no. of items issued for the year : _______________

2.5.7 No. of items in the stock inventory : _______________

2.5.8 Total no. of LPOs issued for the year : _______________



2.6 Security and Safety features in the Store:

2.6.1 What are the security features in the store?

a) Security guards?

b) CCTV?

c) Others (Please specify):_________________

2.6.2 What are the safety features in the store?

a. How often is maintenance of machinery done?

______________________________________

b. Are there routine checks on the fire extinguishers?

______________________________________

c. How often is the storage conditions reviewed?

______________________________________

2.7 Other factors contributing to non-compliance

i. ___________________________________

ii. ___________________________________

iii. ___________________________________

Yes No



3.0 Conclusion

3.1 Reasons For Shortfall In Quality (SIQ)

i. ___________________________________

ii. ___________________________________

iii. ___________________________________

3.2 Proposed remedial action to be taken

i. ___________________________________

ii. ___________________________________

iii. ___________________________________

3.3 Other comments ( if any)

i. ___________________________________

ii. ___________________________________

iii. ___________________________________

Investigated and reported by : Name : _________________________________

Designation : _____________________________

Hospital : ________________________________

Date : ___________________________________


Name : _________________________________

Designation : _____________________________

Hospital : ________________________________

Date : ___________________________________

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