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Checklist For Pharmacy and Its Quality Indicators

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The document discusses various legal, safety and quality requirements for a hospital pharmacy as per NABH accreditation standards.

The legal requirements discussed include qualifications of pharmacists, availability of prescription drugs, storage and dispensing of schedule drugs, sale of physician samples, storage permits for spirits/narcotics, record keeping for narcotics etc.

Safety measures discussed include appropriate storage conditions, temperature monitoring of refrigerators, identification of look-alike/sound-alike drugs, labeling of medicines, checking prescriptions etc.

Checklist for Pharmacy and its

quality indicators
A significant number of standards and objective elements of NABH are applicable to
Pharmacy of a hospital. Most of these requirements are given under the chapter of
‘Management of Medication’, but there are objective elements under other chapters
also, which are applicable to pharmacy. The checklist below has been prepared after
taking in consideration all such requirements. Objective of this checklist is that the
hospital should be able to prepare and quickly evaluate everything that is applicable
to pharmacy under NABH accreditation preparation.

A. Legal requirements
1. The person dispensing the medicine in pharmacy is a qualified pharmacist (B.
Pharm or D. Pharm). The qualification certificate should preferably be displayed in
pharmacy.

2.  List of prescription drugs is available (Schedule H drugs) and is dispensed only


against doctor’s prescription

3.  Schedule ‘X’ drugs are dispensed against valid medical prescription and a copy
of prescription is retained for about 2 years. (If the hospital’s pharmacy sells medicine
to others who are not the patient of hospital)

4.  Physician sample should not be sold by the pharmacy

5. If spirit is stored in pharmacy, there is permit (excise) available for storage and


sale of spirit with defined quantity

6. If Narcotics Drugs and Psychotropic Substances are used, there is a license


for the NDPS drugs with defined quantity

7. NDPS drugs are stored in a locked container, and there is a register to record
each and every issuance of NDPS drugs. The record must have name of patient for
which drug has been issued, quantity, date and the name and signature of issuer

8. Vials of used NDPS drugs are collected back in pharmacy and discarded as per
BMW rules

9. All legal documents are renewed within validity period

(Read all legal documents required by a hospital)

B. Medicine availability (applicable at pharmacy


store and those involved in medicine purchase)
10. Pharmacy store should have medicines as per the hospital’s formulary. A copy
of formulary (or its online version) be available with the pharmacy in-charge. The
formulary should be in consonance to ‘National List of Essential Medicines’ and
‘WHO model list of essential medicines’.

11. Pharmacy in-charge should be aware about what to do if there is a demand or


request of a medicine that is not listed in hospital’s formulary

12. All medicines in hospital’s pharmacy (store) is classified as per ABC analysis


and VED analysis

13. There is a policy in place for each category of medicine (Category A, B, C


and Category V, E, D) and the staff of pharmacy aware of the policy

14.  Stock level to be maintained, buffer level, and re-order level is defined for each
medicine

15. The standard process of acquisition of medicine is in place and pharmacy in-
charge aware about it

16.  Vendor evaluation method is established and records of evaluation is available 

17. Records of purchase and Goods Receipt Notes are available

18. Records of periodic stock audit, including physical verification is in place

19. Room and area used for medicine storage is clean, un-cluttered and devoid of
pests and rodents. Medicines should be stored on floor. Records of regular pest
control should be available.

20. Appropriate security arrangement (like CCTV, restricted entry) are in place to


prevent pilferage of medicines.

21. In-charge should be aware about protocol for issuance of implant and


necessary records to be maintained

C. Medicine safety
22. Medicines are stored in a condition as described by manufacturer (conditions
generally written on packets, and they are usually related to temperature, humidity,
sunlight etc.)

23. Refrigerator used for storing medicine should have a temperature monitoring
system. The device or thermometer used for recording temperature should be
calibrated. A temperature range is defined for the refrigerator and it should be
maintained. The temperature of the refrigerator should be recorded at-least 3 times a
day.

24. Staff should be aware on what to do if temperature of refrigerator is not


within the defined limit. (Time limit within which medicines to be shifted to another
refrigerator)

25. Inside refrigerator, location of storing various medicines should be specified.


(for eg. Vaccines should be stored in the location most appropriate temperature is
maintained)

26. Refrigerator used for storing medicines should not be used for storing any
personal items like food, beverages etc.

27.  Look alike and sound alike (LASA) medicines are identified and a list is
available. 
28. Pairs of LASA medicines are stored separately, or are colour coded to avoid
any confusion. (including inside refrigerator)

29.  High risk medicines should be identified and a list is available

30. High risk medicines should be stored in a protected place to avoid wrongly
dispensing it to patient

31. Medicine being sold should have a label clearly mentioning its name, dose and
expiry date. This is specifically required if pharmacy sells loose medicines, cut strip
medicines, or prepared formulations of certain medicines.

32. Pharmacists should be aware on things to check before dispensing a


medicine (right medicine, right dose, expiry date)

33. Pharmacists are aware on what to do if prescription is not clear or


legible (policy of confirmation of medicine from the prescribing doctor)

34. Pharmacists are aware on policy on verbal order of prescription medicine 

35. Staff at pharmacy are aware on practice of preventing expiry of


medicine (FIFO method, identifying near expiry medicine, identifying medicine with
short shelf life)

36. Staff at pharmacy are aware of situation when medicine recall is warranted and
the procedure of recall 

D. Other safety requirements


37.  Fire safety arrangement should be there in pharmacy and store (such a fire
extinguisher within inspection date, emergency evacuation route

38. Staff aware about what to do in case of fire

39. List of all hazardous materials stored in pharmacy is available. MSDS for each


hazardous material are kept available for ready reference of staff

40. Staff is aware about chemical spill management and whom to call for help in
case of major spills

E. Quality Indicators for Pharmacy


1. Incidence of dispensing errors

2. Percentage of wastage of drugs (in terms of financial loss)

3. Percentage of medicine expiring in a period

4. Percentage of stock out of drugs


5. Percentage of stock out of emergency drugs 

6. Percentage of stock out of V and E category drugs

7. Percentage of medicines procured through local purchase

8. Percentage of drugs rejected before preparation of goods receipt note

9. Percentage of variation from standard procurement process

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