Pharmacy Inspection Checklist

Pharmacists can use this pharmacy inspection check documentation demands, recordkeeping, and methods in a pharmacy. It helps you to efficiently investigate 9 important areas of pharmacy works such as registration certificates, prescription registers, and dispensing reports.

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Pharmacy Inspection Checklist

Registration Certificates

Is the current certificate of the supervising pharmacist at hand at the pharmacy and is it performed such that it is clear from the public pharmacy area?

Is the current certificate of registration for the pharmacy at hand at the pharmacy and is it performed such that it is legible from the public pharmacy area?

Storage of Medicinal Products

Are all medicines put in the pharmacy in date and is there an existing documented expiry date management system? The expiry dates of drugs may be checked.

Are all codeine-containing non-prescription medicines and other schedules 5 controlled drugs deposited in the dispensary?

Are all pharmacy-only medicines put behind the medicines counter?

Are all other non-prescription medicines deposited in a range of the pharmacy under the direction of the pharmacist?

Are all prescription-only medicines, containing veterinary prescription-only medicines stocked in the dispensary?

Is the fridge cleaned regularly and is food deposited in a separate fridge?

Are all medicines put in the fridge in good condition?

Does the fridge have a sufficient capacity to grant the correct storage of medicines?

Is the maximum/minimum fridge temperature-controlled, recorded and examined on a daily basis as per the PSI guidelines on the sourcing, storage and disposal of medicinal products within a local pharmacy business?

Does the pharmacy have a pharmaceutical standard fridge?

Is the fridge maintained annually?

Are medicinal products only transferred from their main packaging in exceptional circumstances? Have all the stability implications been recognised?

Is the maximum/minimum temperature in the dispensary and any further storage areas observed, recorded and reviewed on a daily base as per the PSI Guidelines on the sourcing, deposition and disposal of medicinal products in a retail pharmacy business?

Policies and Standard Operating Procedures

Select all performed procedures for methods carried out in the pharmacy:

Are dated policy and method training records ready for all staff for all related methods?

Is there an implementation date for all methods?

Have all policies and methods been recognised by the superintendent and controlling pharmacist?

Is there an examination date for all methods and is documentation correlating to previous reviews prepared?

Duty Register

Does the supervising pharmacist work in the pharmacy for a long part of the opening hours?

Is the duty log being served rightly?

Is the duty register checked regularly to ensure all details are correct?

Does the pharmacy have a responsibility register for this year?

Are all entries sustained contemporaneously, are they approved by the pharmacist and do they contain the pharmacists’ arrival times and departure times?

Is there a pharmacist overseeing the pharmacy for all opening hours and is this documented in the duty register?

Prescription Register/Daily Audit/Daily Dispensing Report

Is the prescription register/ daily dispensing record dated and approved by the pharmacist?

Are emergency supplies registered and is the reason for the emergency treatment recorded if a patient requests it?

Is the prescription register/ daily dispensing report concluded in the correct format?

Are all prescriptions for the last two years available for a survey at the premises?

Is the prescription register/ daily dispensing record printed daily?

Is the prescription register/ daily dispensing reports for the last two years available for study at the premises?

Controlled Drugs (CD) Register, Inventory & Safe

Is the CD register finished in accordance with legislation and guidance, i.e. is a dedicated page given for each product, are all necessary details listed, are the details listed in chronological order within 24 hours of stocks and are errors adjusted by marginal/ footnotes etc.?

Where controlled drugs have been expelled from the active balance and destroyed? Is there documentation linking to the witnessed destruction of these controlled drugs available for study?

Is there proof of the pharmacist regularly reviewing and checking stock balances?

Are all CD records for the previous two years ready for review?

Does the pharmacy have a regulated drugs record?

Does the CD safe have enough capacity to allow the orderly storage of all controlled drugs?

Is there a lockable safe for the storage of medicines in the dispensary?

Is the CD safeguarded (bolted to a solid wall/ floor) in accordance with guidance?

Has the CD safe been approved by authorities and is the document available for examination at the pharmacy?

Are expired/ patient declared controlled drugs stored in a selected part of the CD safe and properly labelled?

Do the number of CDs listed in the register match the quantities placed in the CD safe?

Are all schedule 2 and 3 controlled drugs put in the CD safe? Is the CD safe kept solely for the storage of medicines?

Prescriptions

Are there original prescriptions in place for review?

Are they correct and in date (administered within 14 days of the date on the prescription and not dispensed earlier to the date on the prescription)?

Have they been entered rightly into the CD record (CD2 only) and prescription record?

Have they been approved with the date of dispensing and the term 'dispensed'/ quantity dispensed?

Do they match the handwriting demands for controlled drugs?

Have they been validated with the date of dispensing and the term 'dispensed'/ number dispensed?

Are the original prescriptions ready for review?

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

Are they accurately written? Have they been entered accurately into the prescription record?

Premises

Is the premises complete?

Is the trading name of the pharmacy presented at all entries to the premises?

Has the PSI/Garda security evaluation been finished and are there adequate security arrangements, e.g. alarm, shutters, CCTV, panic buttons, as appropriate? Have any/all suggestions made by the crime prevention officer been performed?

Is the external and the internal bases in a good condition of repair and decoration, and are all appliances and fittings of an acceptable standard?

Are all storage areas in the bases in a good condition of repair and decoration, and are all fixtures and fittings of an adequate standard?

Are all entrances to the premises well sustained, clear and open?

Does the layout allow the pharmacist to both support patient confidentiality and exercise supervision of the purchase and supply of medicine in the dispensary, at the medicines counter and while in the patient consultation range?

Is the dispensary area clearly identifiable by signage?

Are there dedicated ranges for preparing extemporaneous products/ monitored dosage systems (if relevant)? Is enough lighting/ ventilation given in the dispensary?

Is a dispensing bench with a smooth indifferent & washable surface and enough space for the expected volume of activity?

Is there a dedicated dispensary sink with admittance to hot and cold water?

Is the entrance to the dispensary/ non-prescription medicines area and all places where medicines or confidential records are deposited restricted to authorised staff?

Does the place of the medicines counter restrict admittance to pharmacy only medicinal products?

Is a proper waiting area given for patients?

Is housekeeping in the whole pharmacy kept at an adequate standard?

Do the bases have a separate, designated, conveniently positioned private patient consultation area, which is immediately approachable from the public area of the store?

If the seasonal flu vaccination service is provided in the pharmacy does the patient consultation area match the conditions of the PSI's Guidelines?

Does the patient consultation area comply with the PSI's Guidelines on patient discussion areas, in terms of size, wheelchair accessibility, signage, the requirement of a table/ desk & at least three chairs?

Is there a clean and well-kept staff toilet room and a break room implemented at the premises?

Are all areas of the bases where medicines or records are deposited included in the floor plan of the recorded premises presented to the PSI?

Miscellaneous

Are extemporaneous medicinal products administered?

Is the pharmacy in a residential care environment?

Are veterinary medicinal products in place and veterinary prescriptions performed?

Does the pharmacy have proper reference books such as Martindale or other comprehensive drug references, current BNF and current BNF for kids, current Stockley’s and medicine interaction software, access to important current PSI guidelines, and further references if additional services are implemented, e.g. veterinary reference, if implementing veterinary services?

Does the pharmacy have all needed equipment such as general equipment, a computer with internet access, electronic dispensing system and medicine interaction software, managing equipment, dispensing containers, child-resistant containers (CRCs), disposable plastic cups, and improvised equipment?

Does the pharmacy have a medicinal product waste can and an assigned storage area for the waste?

Does the pharmacy have a methylated spirits file and license (if relevant) and is there an area for the storage of methylated spirits?

Is proof of waste collections by an allowed waste management company in place?

Does the pharmacy have a confidentiality policy for all personnel?

Are all waste and patient returned medication put in a selected area of the pharmacy separated from active stock pending timely processing?

Does the pharmacy have a poisons file (if relevant) and are poisons deposited in an appropriately designated place of the pharmacy?

Is there a shredder for confidential paper waste?

Is the pharmacy filed with the Data Protection Commissioner and is there a policy which includes all electronic and manual records?

Completion

Further comments:

Pharmacist (name and signature):