25 July 2017

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


Other checklists that may be of interest to you (click to access) – Facility safety inspectionHRDAmbulanceEmergencyOTMRDICUIPDInfrastructure, Imaging

All checklists

Other posts of interests (click to access) – Preparing for NABH accreditationHow not to prepare for NABH accreditation