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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.
The Pharmacy Practice & Development QAP Indicators Manual Version 1/2011 Ministry of Health Malaysia Page 2
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
The Pharmacy Practice & Development QAP Indicators Manual Version 1/2011 Ministry of Health Malaysia Page 3
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
The Pharmacy Practice & Development QAP Indicators Manual Version 1/2011 Ministry of Health Malaysia Page 4
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
The Pharmacy Practice & Development QAP Indicators Manual Version 1/2011 Ministry of Health Malaysia Page 5
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)]
Jan – Mac – by 15th April
Apr – Jun – by 15th July
July – Sept – by 15th Oct
Oct – Dec – by 15th Jan
The Pharmacy Practice & Development QAP Indicators Manual Version 1/2011 Ministry of Health Malaysia Page 6
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.
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010 Ministry of Health Malaysia Page 7
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
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010 Ministry of Health Malaysia Page 8
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
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010 Ministry of Health Malaysia Page 9
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
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010
Ministry of Health Malaysia Page 11
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) : __________
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010
Ministry of Health Malaysia Page 12
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 : _________________________________
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010
Ministry of Health Malaysia Page 13
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
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010
Ministry of Health Malaysia Page 14
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
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010
Ministry of Health Malaysia Page 15
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 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
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 0 0 0 0 0
No. of errors occurring during peak hours
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010
Ministry of Health Malaysia Page 16
HOSPITAL HOSPITAL
1 HOSPITAL
2 HOSPITAL
3 HOSPITAL
4 TOTAL
Average Number Of Prescriptions per day
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
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010
Ministry of Health Malaysia Page 17
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
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
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 0 0 0 0 0
No. of errors occurring during peak hours
Average Number Of Prescriptions per day
HEALTH CLINIC HC 1 HC 2 HC 3 HC 4 TOTAL
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010
Ministry of Health Malaysia Page 18
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
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010
Ministry of Health Malaysia Page 19
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.
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010
Ministry of Health Malaysia Page 20
5.0 DEFINITION OF TERMS
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.
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010
Ministry of Health Malaysia Page 21
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?
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010
Ministry of Health Malaysia Page 22
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
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010
Ministry of Health Malaysia Page 23
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
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010
Ministry of Health Malaysia Page 24
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.
7.3.2 STATE PHARMACEUTICAL SERVICES DIVISION
- 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.
Jan – Mac – by 15th April
Apr – Jun – by 15th July
July – Sept – by 15th Oct
Oct – Dec – by 15th Jan
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.
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010
Ministry of Health Malaysia Page 25
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
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 93) months
Jan - Mar - by 15th April
Apr - Jun - by 15th July
July - Sept - by 15th Oct
Oct - Dec - by 15th Jan
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010 Ministry of Health Malaysia Page 26
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
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010 Ministry of Health Malaysia Page 27
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 :______________
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010 Ministry of Health Malaysia Page 28
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 : ___________________________________
Report Verified by :
Name : _________________________________
Designation : _____________________________
Hospital / Institution : _____________________
Date : ___________________________________
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010 Ministry of Health Malaysia Page 29
FORM SIQ QAP 2 (STATE PSD)
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
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010 Ministry of Health Malaysia Page 30
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
SUMMARY OF REMEDIAL ACTIONS TAKEN :
1) BY HOSPITAL
2) BY STATE
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010 Ministry of Health Malaysia Page 31
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.
2.0 RATIONALE FOR DEVELOPMENT OF INDICATOR
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.
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010 Ministry of Health Malaysia Page 32
4.0 DEFINITION OF TERMS
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
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010 Ministry of Health Malaysia Page 33
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
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010 Ministry of Health Malaysia Page 34
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
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010 Ministry of Health Malaysia Page 35
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:-
Jan – March - by 7th April
Apr – June - by 7th July
Number of toxicity cases interpreted and recommendations communicated to the requesting doctor / unit within 2 hours
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010 Ministry of Health Malaysia Page 36
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.
7.3.2 STATE PHARMACEUTICAL SERVICES DIVISION
- 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.
Jan – March - by 15th April
Apr – June - by 15th July
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.
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010 Ministry of Health Malaysia Page 37
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
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010 Ministry of Health Malaysia Page 38
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
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 Jan - Mac - by 15th April
Pharmaceutical Services Div. M.O.H. every three (3) months Apr - Jun - by 15th July
July - Sept - by 15th Oct
Oct - Dec - by 15th Jan
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010 Ministry of Health Malaysia Page 39
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
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010 Ministry of Health Malaysia Page 40
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: ______________________________________ ______________________________________
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010 Ministry of Health Malaysia Page 41
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 : _________________________________
Report Verified by :
Name : _________________________________
Designation : _________________________________
Hospital / Institution : ___________________________
Date : _________________________________
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010 Ministry of Health Malaysia Page 42
FORM SIQ QAP 3 (STATE PSD)
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
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010 Ministry of Health Malaysia Page 43
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
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010 Ministry of Health Malaysia Page 44
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.
2.0 RATIONALE FOR DEVELOPMENT OF INDICATOR
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.
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010 Ministry of Health Malaysia Page 45
5.0 DEFINITION OF TERMS
*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
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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
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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.
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010 Ministry of Health Malaysia Page 48
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%
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010 Ministry of Health Malaysia Page 49
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.
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010 Ministry of Health Malaysia Page 50
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
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Ministry of Health Malaysia Page 51
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
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Ministry of Health Malaysia Page 52
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
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Ministry of Health Malaysia Page 53
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
The Pharmacy Practice & Development QAP Indicators Manual Version 2/2010
Ministry of Health Malaysia Page 54
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
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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?
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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 : _______________
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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
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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 : ___________________________________
Report Verified by :
Name : _________________________________
Designation : _____________________________
Hospital : ________________________________
Date : ___________________________________
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