Pharmacy Inspection

This checklist aims to help pharmacists to efficiently inspect key areas of retail pharmacy operations including registration certificates, prescription registers, dispensing reports, etc.

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Pharmacy Inspection



Registration Certificates

1. Is the current certificate of registration for the pharmacy available on the premises?


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2. Is the certificate of registration displayed such that it is legible from the public pharmacy area?


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3. Is the current certificate of the supervising pharmacist available and is it displayed such that it is legible from the public pharmacy area?


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Storage Of Medicinal Products

1. Are all prescription-only medicines, including veterinary prescription-only medicines stored in the dispensary?


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2. Are all codeine containing non-prescription medicines and other schedule 5 controlled drugs stored in the dispensary?


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3. Are all pharmacy only medicines stored behind the medicines counter?


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4. Are all other non-prescription medicines stored in an area of the pharmacy under the control of the pharmacist?


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5. Does the pharmacy have a pharmaceutical-grade fridge?


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6. Is the pharma-grade fridge cleaned regularly?


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7. Are all medicines stored in the fridge in good condition?


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8. Is the fridge of an adequate capacity to permit the orderly storage of medicines?


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9. Is the fridge serviced annually?


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10. Is the maximum/minimum fridge temperature monitored, recorded and reviewed on a daily basis as per the PSI Guidelines on the Sourcing, Storage and Disposal of Medicinal Products within a Retail Pharmacy Business?


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11. Is a separate fridge available to store food and beverages?


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12. Are all medicines stored in the pharmacy in date and is there an active documented expiry date management system in place?


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13. Is the maximum/minimum temperature in the dispensary and any additional storage areas monitored, recorded and reviewed on a daily basis as per the PSI Guidelines on the Sourcing, Storage and Disposal of Medicinal Products within a Retail Pharmacy Business?


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14. Are medicinal products only removed from their primary packaging in exceptional circumstances? Have all stability implications been considered?


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Policies And Standard Operating Procedures

1. Have all policies and procedures been approved by the Superintendent and Supervising Pharmacist?


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2. Is there an implementation date for all procedures?


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3. Is there a review date for all procedures and is documentation relating to previous reviews available?


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4. Are dated policy and procedure training records available for all staff for all relevant procedures?


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Duty Register

1. Does the pharmacy have a duty register for the current year?


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2. Is there a pharmacist supervising the pharmacy for all hours of opening and is this recorded in the duty register?


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3. Is the duty log maintained correctly?


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4. Are all duty log entries maintained accurately?


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5. Are the duty log entries signed by the pharmacist and do they include the pharmacists’ arrival and departure times?


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6. Does the supervising pharmacist work in the pharmacy for a significant proportion of the opening hours?


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7. Is the duty register reviewed regularly to ensure all details are correct?


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Prescription Register / Daily Audit / Daily Dispensing Report

1. Is the prescription register / daily dispensing report printed on a daily basis (within 24 hours)?


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2. Is the prescription register / daily dispensing report dated and signed by the pharmacist?


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3. Is the prescription register / daily dispensing report completed in the correct format in accordance with the legal requirements?


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4. Are emergency supplies recorded?


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5. If emergency supplies are requested by a patient is the reason for the emergency supply recorded?


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6. Is the prescription register/ daily dispensing report for the previous two years available for review at the premises?


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7. Are all prescriptions for the previous two years available for review at the premises?


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Controlled Drugs (CD) Register, Inventory & Safe

1. Does the pharmacy have a Controlled Drugs (CD) register?


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2. Is the CD register completed in accordance with legislation and instructions i.e., is a dedicated page provided for each product where all required details are entered in chronological order within 24 hours of supply and are errors corrected by footnotes etc.?


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3. Is there evidence of the pharmacist routinely reviewing and checking stock balances?


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4. Are all CD registers for the last two years available for review?


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5. Where controlled drugs have been removed from the active balance and destroyed is documentation relating to the witnessed destruction of controlled drugs available for review?


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6. Do the quantities of CDs recorded in the register match the quantities located in the CD safe?


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7. Is there a lockable safe for the storage of medicines (schedule 2 and 3 controlled drugs) in place in the dispensary?


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8. Is the CD safe secured (bolted to a solid wall/ floor) in accordance with regulations?


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9. Has the CD safe been certified and is the certificate available for review at the pharmacy?


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10. Does the CD safe have sufficient capacity to permit the orderly storage of all schedule 2 and 3 controlled drugs?


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11. Are all schedule 2 and 3 controlled drugs stored in the CD safe?


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12. Is the CD safe reserved solely for the storage of medicines?


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13. Are expired/ patient returned controlled drugs stored in a designated part of the CD safe and appropriately labelled?


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Prescriptions

1. Are the original prescriptions available for review?


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2. Are they valid and in date (dispensed within 14 days of the date on the prescription and not dispensed prior to the date on the prescription)?


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3. Do they meet the handwriting requirements for controlled drugs?


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4. Have they been entered correctly into the CD register and prescription register?


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5. Have they been endorsed with the date of dispensing and quantity dispensed?


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6. Are they valid and in date (dispensed within 6 months of the date on the prescription)?


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7. Have they been entered correctly into the prescription register?


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Premises

1. Are the premises self-contained?


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2. Has the security assessment been completed and are there adequate security arrangements in place e.g., alarm, shutters, CCTV, panic buttons, as applicable?


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3. Have any / all recommendations made by the crime prevention officer been implemented?


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4. Are the external and the internal premises in a good state of repair and decoration and are all fixtures and fittings of an acceptable standard?


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5. Are all storage areas in the premises in a good state of repair and decoration and are all fixtures and fittings of an acceptable standard?


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6. Are all entrances to the premises well maintained, clear and accessible?


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7. Is the trading name of the pharmacy displayed at all entrances to the premises?


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Dispensary

1. Is the dispensary area easily identifiable by signage?


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2. Does the layout enable the pharmacist to both maintain patient confidentiality and exercise supervision of the sale and supply of medicinal products in the dispensary, at the medicines counter and while in the patient consultation area?


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3. Is a dispensing bench with a smooth impervious and washable surface and adequate space for expected volume of activity in place?


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4. Is there a dedicated dispensary sink with access to hot and cold water?


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5. Are dedicated areas for preparing Extemporaneous Products/ Monitored Dosage Systems in place (if applicable)?


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6. Is adequate lighting / ventilation provided in the dispensary?


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7. Does the location of the medicines counter restrict access to pharmacy-only medicinal products?


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8. Is access to the dispensary/ non-prescription medicines area and all areas where medicines or confidential records are stored restricted to authorised personnel?


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9. Is a suitable waiting area available for patients?


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10. Do the premises have a designated private patient consultation area, which is directly accessible from the public area of the pharmacy?


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11. Does the patient consultation area comply with the PSI's Guidelines on Patient Consultation Areas, in terms of size, wheelchair accessibility, signage, provision of a table/ worktop & three chairs?


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12. If the seasonal influenza / flu vaccination service is provided in the pharmacy, does the patient consultation area meet the requirements of the PSI's Guidelines?


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13. Is there a clean and well-maintained staff toilet with sink?


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14. Is a staff break area provided at the premises?


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15. Are all areas of the premises where medicines or records are stored included in the floor plan of the registered premises submitted to the PSI?


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16. Is housekeeping in all areas of the pharmacy maintained at acceptable standards?


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Miscellaneous

1. Are extemporaneous medicinal products offered?


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2. Is the pharmacy in a residential care setting?


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3. Are veterinary medicinal products available?


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4. Does the pharmacy have all required equipment such as a computer with internet access, electronic dispensing system and drug interaction software, dispensing equipment, dispensing containers, child-resistant containers (CRCs), disposable plastic cups and extemporaneous equipment?


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5. Does the pharmacy have appropriate reference books and additional references if additional services are provided e.g., veterinary reference, if providing veterinary services?


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6. Does the pharmacy have a medicinal product waste bin and a designated storage area for the bin?


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7. Is all waste and patient returned medication stored in a designated area of the pharmacy and segregated from active stock?


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8. Is evidence of waste collections by an authorised waste management company available?


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9. Does the pharmacy have a methylated spirits register and license (if applicable) and is there a designated area for the storage of methylated sprits?


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10. Does the pharmacy have a poisons register (if applicable) and are poisons stored in an appropriate designated area of the pharmacy?


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11. Does the pharmacy have a shredder for confidential paper waste?


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12. Is the pharmacy registered with the Data Protection Commissioner and is a policy which covers all electronic and manual records in place?


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13. Does the pharmacy have a confidentiality policy in place for all staff?


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Checklist by GoAudits.com – Please note that this checklist is intended as an example. We do not guarantee compliance with the laws applicable to your territory or industry. You should seek professional advice to determine how this checklist should be adapted to your workplace or jurisdiction.

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