Pharmacy Internal Audit

Updated: over a week ago

Pharmacy Internal Audit

Pharmacist

1. Is a notice conspicuously displayed on the premises detailing the name and registration number of the responsible pharmacist?


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2. Does the notice also clearly display the fact that the pharmacist is currently charge of the registered pharmacy?


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Pharmacy Procedures

1. Is there adequate and up-to-date SOP in place for arrangements to ensure that medicinal products are ordered, stored, prepared, sold by retail, supplied in circumstances corresponding to retail sale, delivered outside the pharmacy and disposed in a safe and effective manner?


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2. Is there adequate and up-to-date SOP in place for circumstances in which a member of pharmacy staff who is not a pharmacist may give advice about medicinal products?


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3. Is there adequate and up-to-date SOP in place for the identification of members of pharmacy staff who are competent to perform specified tasks related to the pharmacy business?


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4. Is there adequate and up-to-date SOP in place for proper recordkeeping?


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5. Is there adequate and up-to-date SOP in place for applicable arrangements in the absence of the responsible pharmacist from the premises?


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6. Is there adequate and up-to-date SOP in place for steps to be taken when there is a change of responsible pharmacist at the premises?


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7. Is there adequate and up-to-date SOP in place if a complaint is made about the pharmacy business?


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8. Is there adequate and up-to-date SOP in place in case an incident occurs which may indicate that the pharmacy business is not running in a safe and effective manner?


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9. Is there adequate and up-to-date SOP in place for the manner in which changes to the pharmacy procedures are to be notified to the staff?


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10. Is there evidence that the pharmacy procedures are reviewed?


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Pharmacy Record

1. Is there evidence that the pharmacy records are accurate?


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2. Are the pharmacy records maintained for at least 5 years?


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Absence

1. Is the responsible pharmacist absent from the registered pharmacy only after prior notice?


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Staff Training

1. Are staff appropriately trained for the tasks undertaken?


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Service Provision

1. Are SOPs available where required?


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2. Do service provisions comply with best practices?


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Dispensing

1. Examine a random sample of medicines awaiting collection to ensure, for example, the use of appropriate advisory and cautionary warning labels, appropriate container, etc. Is the sample compliant with the Medicines Act 1968?


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2. Is there an adequate audit trail to identify the pharmacist responsible for the supply?


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3. Is there an adequate audit trail to identify other staff involved in the dispensing process?


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4. Are there adequate procedures in place for handling medication or dosage changes occurring mid-cycle?


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5. Are medicines supplied in MDS for domiciliary patients? If yes, are records maintained for the same?


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6. Are medicines supplied in MDS for patients in care homes? If yes, are records maintained for the same?


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Medicine Stock, Containers & Storage

1. Are medicines stored appropriately (i.e., in original boxes, fully labelled, no loose blisters, mixed batches and in an organised fashion)?


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2. Are only licensed medicines stocked?


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3. Are medicines stored in appropriate conditions (e.g., temperature, humidity etc.)?


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4. Are there adequate date checking procedures in operation?


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5. Are dispensing containers appropriately stored?


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Recordkeeping

1. Are private prescription records legally compliant?


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2. Are emergency supply records legally compliant?


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3. Are poison records legally compliant (including permits and other documentation where necessary)?


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4. Are records of sales of veterinary medicines legally compliant (Veterinary Medicines Regulations)?


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5. Are specials records legally compliant?


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6. Are there appropriate records of extemporaneously prepared products (incl. Methadone)?


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7. Does the pharmacy maintain an error log and systems for documenting and auditing dispensing errors that have reached the patient?


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8. Does the pharmacy maintain incident or near miss logs and systems for documenting and auditing errors picked up during the dispensing process?


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9. Does the pharmacy maintain records of clinical interventions / significant events?


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Waste Disposal

1. Are procedures in place for the safe disposal of returned medicines from individuals or households (includes care homes), including hazardous waste?


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2. Are medicines returned by patients clearly segregated before disposal?


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3. Are there procedures for the management of expired (out-of-date) pharmacy stock?


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4. Are staff trained to deal with waste and is appropriate protective equipment available (including gloves, overalls and materials to deal with spillages)?


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Chemicals

1. Are chemicals stored, labelled and supplied in compliance with the Chemicals (Hazard Information and Packaging for Supply) Regulations 2002?


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2. Are COSHH assessments available for hazardous chemicals stocked or supplied?


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Information Sources

1. Are accurate and adequate information services available?


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2. Is there a system for dealing with Drug Alerts?


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3. Is an information pack available for locums?


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Computer

1. Is the computer software regularly updated?


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2. Is the use of data registered in accordance with the legal Data Protection regulations?


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3. Are patient confidential computer records accessible only to staff who need access?


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4. Are computer records regularly backed up?


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General Premises Check

1. Fascia and front access to premises clean and regularly maintained?


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2. Shop area clean and well maintained?


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3. Dispensary area(s) clean and well maintained?


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4. Consultation room clean and well maintained?


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5. Is the pharmacy secure at all times?


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6. Stock rooms clean and well maintained?


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7. Other areas (e.g., toilets, external stores) clean and well maintained?


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Is this sample what you are looking for?
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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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