Pharmacy Inspection Checklist

• Site

• Registered Address
  Address

• Pharmacist-in-charge

• Conducted on

  Date

Registration Certificates

• Is the current certificate of registration for the pharmacy available at the pharmacy and is it displayed such that it is legible from the public pharmacy area?

  Yes

  No

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

  Yes

  No

Storage of Medicinal Products

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

  Yes

  No

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

  Yes

  No

• Are all pharmacy only medicines stored behind the medicines counter?

  Yes

  No

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

  Yes

  No

• Does the pharmacy have a pharmaceutical grade fridge?

  Yes

  No

• Is the fridge clean and is food stored in a separate fridge?

  Yes

  No

• Are all medicines stored in the fridge in good condition?

  Yes

  No

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

  Yes

  No

• Is the fridge serviced annually?

  Yes

  No

• 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?

  Yes

  No

• Are all medicines stored in the pharmacy in date and is there an active documented expiry date management system in place? The expiry dates of medicines may be checked.

  Yes

  No

• 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?

  Yes

  No

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

  Yes

  No

Policies and Standard Operating Procedures

• Select all implemented procedures for processes carried out in the pharmacy:

  Select Dispensing Sourcing of Medicines Storage of Medicines Expiry Date Checking Sale & Supply of Non-prescription of Medicinal Products Sale & Supply of Non-prescription Codeine-containing Medicines Management of Controlled Drugs Disposal of Medicines & Destruction of Controlled Drugs Management of Additional Services Provided Error & Incident Management Locum Procedure Housekeeping & Cleanliness Use of the Patient Consultation Area Pest Control Policy Use of Child-Resistant Containers Management of Emergency Situations Keyholding Policy Other

  • Dispensing
  • Sourcing of Medicines
  • Storage of Medicines
  • Expiry Date Checking
  • Sale & Supply of Non-prescription of Medicinal Products
  • Sale & Supply of Non-prescription Codeine-containing Medicines
  • Management of Controlled Drugs
  • Disposal of Medicines & Destruction of Controlled Drugs
  • Management of Additional Services Provided
  • Error & Incident Management
  • Locum Procedure
  • Housekeeping & Cleanliness
  • Use of the Patient Consultation Area
  • Pest Control Policy
  • Use of Child-Resistant Containers
  • Management of Emergency Situations
  • Keyholding Policy
  • Other

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

  Yes

  No

• Is there an implementation date for all procedures?

  Yes

  No

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

  Yes

  No

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

  Yes

  No

Duty Register

• Does the pharmacy have a duty register for the current year?

  Yes

  No

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

  Yes

  No

• Is the duty log being maintained correctly?

  Yes

  No

• Are all entries maintained contemporaneously, are they signed by the pharmacist and do they include the pharmacists’ arrival and departure times?

  Yes

  No

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

  Yes

  No

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

  Yes

  No

Prescription Register/Daily Audit/Daily Dispensing Report

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

  Yes

  No

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

  Yes

  No

• Is the prescription register/ daily dispensing report completed in the correct format in accordance with the requirements of regulation 10 of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (as amended)?

  Yes

  No

• Are emergency supplies recorded and if at the request of a patient is the reason for the emergency supply recorded?

  Yes

  No

• Is the prescription register/ daily dispensing reports for the previous two years available for review at the premises?

  Yes

  No

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

  Yes

  No

Controlled Drugs (CD) Register, Inventory & Safe

• Does the pharmacy have a Controlled Drugs register?

  Yes

  No

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

  Yes

  No

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

  Yes

  No

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

  Yes

  No

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

  Yes

  No

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

  Yes

  No

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

  Yes

  No

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

  Yes

  No

• Has the CD safe been certified by the Gardaí and is the certificate available for review at the pharmacy?

  Yes

  No

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

  Yes

  No

• Are all schedule 2 and 3 controlled drugs stored in the CD safe? Is the CD safe reserved solely for the storage of medicines?

  Yes

  No

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

  Yes

  No

Prescriptions

• Are the original prescriptions available for review?

  Yes

  No

• 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)?

  Yes

  No

• Do they meet the handwriting requirements for controlled drugs?

  Yes

  No

• Have they been entered correctly into the CD register (CD2 only) and prescription register?

  Yes

  No

• Have they been endorsed with the date of dispensing and the word 'dispensed'/ quantity dispensed?

  Yes

  No

• Are the original prescriptions available for review?

  Yes

  No

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

  Yes

  No

• Are they correctly written? Have they been entered correctly into the prescription register?

  Yes

  No

• Have they been endorsed with the date of dispensing and the word 'dispensed'/ quantity dispensed?

  Yes

  No

Premises

• Is the premises self-contained?

  Yes

  No

• Has the PSI/Garda Security Assessment been completed and are there adequate security arrangements in place, e.g. alarm, shutters, CCTV, panic buttons, as applicable? Have any/all recommendations made by the crime prevention officer been implemented?

  Yes

  No

• Is the external and the internal premises in a good state of repair and decoration, and are all fixtures and fittings of an acceptable standard?

  Yes

  No

• 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?

  Yes

  No

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

  Yes

  No

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

  Yes

  No

• Dispensary - Is the dispensary area easily identifiable by signage?

  Yes

  No

• 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?

  Yes

  No

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

  Yes

  No

• Is there a dedicated dispensary sink with access to hot and cold (potable) water?

  Yes

  No

• Are dedicated areas for preparing Extemporaneous Products/ Monitored Dosage Systems in place (if applicable)? 12.12 Is adequate lighting/ ventilation provided in the dispensary?

  Yes

  No

• Does the location of the medicines counter restrict access to pharmacy only medicinal products?

  Yes

  No

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

  Yes

  No

• Is a suitable waiting area provided for patients?

  Yes

  No

• Does the premises have a separate, designated, conveniently located private patient consultation area, which is directly accessible from the public area of the pharmacy?

  Yes

  No

• 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?

  Yes

  No

• If the seasonal influenza vaccination service is provided in the pharmacy does the patient consultation area meet the requirements of the PSI's Guidelines?

  Yes

  No

• Is there a clean and well maintained staff toilet with wash hand basin and a staff break area provided at the premises?

  Yes

  No

• 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?

  Yes

  No

• Is housekeeping in all areas of the pharmacy maintained at an acceptable standard?

  Yes

  No

Miscellaneous

• Are Extemporaneous Medicinal Products offered?

  Yes

  No

• Are there procedures in place for preparing extemporaneous products?

  Yes

  No

• Are detailed records of products prepared maintained?

  Yes

  No

• Is all required equipment available in the pharmacy?

  Yes

  No

• Is all equipment clean and appropriately calibrated?

  Yes

  No

• Is the pharmacy in a Residential Care Setting?

  Yes

  No

• Are there procedures in place which address the management of the supply of medication to<br>patients in residential care homes?

  Yes

  No

• Are records of the patient consent, medicines delivery, pharmacist visits, patient counseling, and interdisciplinary medicine therapy review available for review for all patients in residential care settings?

  Yes

  No

• Are Veterinary Medicinal Products available and Veterinary Prescriptions made?

  Yes

  No

• Are veterinary medicinal products stored in a designated area(s) of the pharmacy?

  Yes

  No

• Are prescription medicines, prescription only exempt medicines, pharmacy only medicines, licensed merchant medicines, companion animal remedies and veterinary medicines requiring refrigeration stored appropriately?

  Yes

  No

• Does the pharmacy have a veterinary register?

  Yes

  No

• Are records of all incoming and outgoing veterinary medicines (VPOM, VPOM (E), PS and LM) recorded in the veterinary register in accordance with legislative requirements?

  Yes

  No

• Are veterinary prescriptions available, correctly written, and up-to-date (dispensed within one year of the date on the prescription)?

  Yes

  No

• Have they been entered correctly into the veterinary register and endorsed with the date of dispensing and signed by the pharmacist?

  Yes

  No

• Are all records (register and prescriptions) for the last five years available for review at the premises?

  Yes

  No

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

  Yes

  No

• Does the pharmacy have appropriate reference books such as Martindale or other complete drug reference, current BNF & current BNF for children, current Stockley’s and drug interaction software, access to relevant current PSI guidelines, and additional references if additional services are provided, e.g. veterinary reference, if providing veterinary services?

  Yes

  No

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

  Yes

  No

• Is all waste and patient returned medication stored in a designated area of the pharmacy segregated from active stock pending timely processing?

  Yes

  No

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

  Yes

  No

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

  Yes

  No

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

  Yes

  No

• Does the pharmacy have a shredder for confidential paper waste?

  Yes

  No

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

  Yes

  No

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

  Yes

  No

Completion

• Additional Comments

• Pharmacist-in-charge Name & Signature

  Sign