McCauley Superintendent Pharmacist Audit

• Site conducted

  Select

• Conducted on

  Date

• Audit Conducted by

• PSI Registration Number of Superintendent

• Supervising Pharmacist

• PSI Registration Number of Supervising Pharmacist
  Address

• Checklist for a Pharmacy Inspection by The Pharmaceutical Society of Ireland

• The following is a non-exhaustive list of what may be reviewed by an Authorised Officer of the PSI during a Pharmacy Inspection. This checklist is intended as a self-assessment tool to assist you in preparing for an inspection. In addition, you should be familiar with pharmacy and medicines legislation, accessible via the PSI website and and PSI guidelines accessible via the PSI website and the links below

• SI REQUIRES ACCESS TO DUTY REG; DAILY AUDIT;SOPs; DATE CHECKING LOG; CD REGISTER; CD KEY; MEDICINES COMPLETE; PHARMAPOD;END OF MONTH PAPERWORK & VET REG TO COMPLETE AUDIT

• Registration Certificates

  Yes

  No

  N/A

• 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?

• 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

  N/A

• Storage of Medicinal Products

• Are all prescription-only medicines, including veterinary prescription-only medicines (if applicable) stored in the dispensary?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Does the pharmacy have a pharmaceutical grade fridge?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Is the fridge serviced annually?

  Yes

  No

  N/A

• 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

  N/A

• 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

  N/A

• 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

  N/A

• Are medicinal products only removed from their primary packaging in exceptional circumstances? If they have been removed are they labelled with all information required as per the PSI Guidelines on the Sourcing, Storage and Disposal of Medicinal Products within a Retail Pharmacy Business? Have all stability implications been considered?

  Yes

  No

  N/A

Policies and Standard Operating Procedures

• Has the pharmacy a full suite of procedures for all processes carried out in the pharmacy?

  Yes

  No

  N/A

• At a minimum, the following procedures should be in place:

• a) Dispensing: This includes the entire process from the receipt of the prescription, through therapeutic review to the transfer of the medicine to the patient and patient counselling. Dispensing procedures should address the dispensing of different types of medicines, including high-risk medicines (,etc.)

  Yes

  No

  N/A

• d) Expiry Date checking

  Yes

  No

  N/A

• e) Sale and supply of non-prescription medicinal products. These procedures should address the general supply of non-prescription medicines and the supply of specific products (EllaOne ,,,,etc.)

  Yes

  No

  N/A

• f) Sale and supply of non-prescription codeine containing medicines

  Yes

  No

  N/A

• g) Management of controlled drugs (including storage and record keeping)

  Yes

  No

  N/A

• h) and destruction of controlled drugs

  Yes

  No

  N/A

• i) Management of additional services provided, including (as applicable):

  Yes

  No

  N/A

• , monitored dosage systems, , etc

  Yes

  No

  N/A

• j) Error and incident management. There should be error records in place and corrective actions should be recorded. Please see which includes templates that can be downloaded and used in your pharmacy

  Yes

  No

  N/A

• k) Locum Procedure

  Yes

  No

  N/A

• l) Housekeeping and cleanliness of the dispensary (including equipment), public pharmacy area and all other areas of the pharmacy. There should be a cleaning schedule or sign off sheet in place

  Yes

  No

  N/A

• m) Use of the This should address directing patients to the area and supervision of the pharmacy while a pharmacist is engaged in a consultation

  Yes

  No

  N/A

• n) Pest control policy

  Yes

  No

  N/A

• o) Policy on use of child resistant containers

  Yes

  No

  N/A

• p) Management of emergency situations, e.g. loss of electricity/ power

  Yes

  No

  N/A

• q) Keyholding Policy for the premises and CD Safe and security procedures. Is access to the pharmacy and medicines only permitted in the presence of the pharmacist?

  Yes

  No

  N/A

• Note: Non-pharmacist staff members should not have access to the dispensary and any other areas where medicines are stored in the absence on a pharmacist or pharmaceutical assistant

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

  Yes

  No

  N/A

• Is there an implementation date for all procedures?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

Duty Register

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Does the supervising pharmacist work in the pharmacy for a significant proportion of the opening hours? and forms for the are available on the PSI website

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Pharmaceutical Assistant (if applicable). If a pharmaceutical assistant is employed at the pharmacy and providing temporary cover in the absence of the pharmacist, are they operating in accordance with the Code of Practice Governing Temporary Absence?

  Yes

  No

  N/A

• This provides that the assistant who will be performing professional duties of the pharmacist in his/her temporary absence shall be employed in the pharmacy concerned on a permanent basis for not less than 15 hours per week. The assistant shall be entitled to cover short absences, such as lunch hours, two half days or one day off per week, unscheduled short absences or holiday cover

  Yes

  No

  N/A

Prescription Register/Daily Audit/ Daily Dispensing Report

SI to pick at random and follow through on – at least 1- Private , GMS, Z drug, High Tech, CD

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

Controlled Drugs (CD) Register

• Does the pharmacy have a Controlled Drugs register?

  Yes

  No

  N/A

• 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

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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

  N/A

Controlled Drug Inventory

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

  Yes

  No

  N/A

Controlled Drug Safe

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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

  N/A

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

  Yes

  No

  N/A

Extemporaneous Medicinal Products (if applicable) - on foot of prescriptions

• Are there procedures in place for preparing extemporaneous products?

  Yes

  No

  N/A

• Are detailed records of products prepared maintained?

  Yes

  No

  N/A

• Is all required equipment available in the pharmacy?

  Yes

  No

  N/A

• Is all equipment clean and appropriately calibrated?

  Yes

  No

  N/A

• Note: is only permissible on foot of prescriptions in limited circumstances

Prescriptions

• A number of controlled drug and medicinal product prescriptions will be requested and reviewed during the course of the inspection

Controlled drugs (CD2 and CD3) Prescriptions:

• Are the original prescriptions available for review?

  Yes

  No

  N/A

• 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

  N/A

• Do they meet the handwriting requirements for controlled drugs?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

Medicinal Product Prescriptions:

SI to pick at random and follow through on – at least 1- Private, GMS, Z drug, High Tech,

• Are the original prescriptions available for review?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Are they correctly written?

  Yes

  No

  N/A

• Have they been entered correctly into the prescription register?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

Premises

• Is the premises self-contained?

  Yes

  No

  N/A

• 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

  N/A

• 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

  N/A

• 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

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Is adequate lighting/ ventilation provided in the dispensary?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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

  N/A

• Is a suitable waiting area provided for patients?

  Yes

  No

  N/A

• Patient Consultation Area - 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

  N/A

• Does the patient consultation area comply with , in terms of size, wheelchair accessibility, signage, provision of a table/ worktop & three chairs?

  Yes

  No

  N/A

• Note: The area can't be the only access route to another area of the pharmacy

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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

  N/A

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

  Yes

  No

  N/A

Residential Care Settings (if applicable)

• Are there procedures in place which address the management of the supply of medication to patients in residential care homes? The procedures should address the entire process, including the receipt of prescriptions, the delivery of medicines, the management of controlled drugs, medicine therapy reviews and patient counselling etc

  Yes

  No

  N/A

• Letters to Superintendents on Residential Care Homes:

• Are records of the following available for review for all patients in residential care settings:

• Patient consent?

  Yes

  No

  N/A

• Medicines delivery?

  Yes

  No

  N/A

• Pharmacist visits?

  Yes

  No

  N/A

• Patient counselling?

  Yes

  No

  N/A

• Interdisciplinary medicine therapy review?

  Yes

  No

  N/A

Veterinary Medicinal Products (if applicable)

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• Note: A separate pharmaceutical grade fridge is required for veterinary medicines

• Does the pharmacy have a veterinary register?

  Yes

  No

  N/A

• 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

  N/A

Veterinary Prescriptions:

• Are they available?

  Yes

  No

  N/A

• Are they in date (dispensed within one year of the date on the prescription)?

  Yes

  No

  N/A

• Are they correctly written?

  Yes

  No

  N/A

• Have they been entered correctly into the veterinary register?

  Yes

  No

  N/A

• Have they been endorsed with the date of dispensing, the word 'dispensed' and signed by the pharmacist?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

Miscellaneous

• Does the pharmacy have all required equipment?

  Yes

  No

  N/A

• General Equipment (telephone, fax, label printer etc.)?

  Yes

  No

  N/A

• Computer, with pharmacy email and internet access?

  Yes

  No

  N/A

• Electronic dispensing system and drug interaction software?

  Yes

  No

  N/A

• Dispensing Equipment (tablet counter, dispensing containers (tablet vials, bottles, ointment jars, plastic bags/ cardboard cartons), child resistant containers (CRCs), disposable plastic cups etc.?

  Yes

  No

  N/A

• Extemporaneous equipment (graduated cylinders, ointment slab, electronic NAWI compliant balance (accurately measures 100mg to 200g), certified metric weights, mortars and pestles weighing boats, spatulas & stirrers etc.)?

  Yes

  No

  N/A

• Does the pharmacy have appropriate reference books?

  Yes

  No

  N/A

• Martindale or other complete drug reference (current or most recent edition)?

  Yes

  No

  N/A

• Current BNF & Current BNF for children (or other appropriate current children's reference)?

  Yes

  No

  N/A

• Current Stockley’s (or other detailed drug interaction reference) and drug interaction software?

  Yes

  No

  N/A

• Access to relevant current PSI guidelines, pharmacy and medicines legislation and SmPCs of medicinal products authorised in Ireland (hard copy or internet access)?

  Yes

  No

  N/A

• Additional references if additional services are provided, e.g. veterinary reference, if providing veterinary services?

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• 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

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

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

  Yes

  No

  N/A

• ADDITIONAL SI AUDIT REVIEW ITEMS

• LOANS – no more than 5 days supply as per emergency supply SOP

  Yes

  No

  N/A

• OWINGS – duplicate owings, SOP followed

  Yes

  No

  N/A

• POSTERS IN DISPENSARY

  Yes

  No

  N/A

• HIGH ALERT NEBULES

  Yes

  No

  N/A

• PATIENT CENTRED APPROACH

  Yes

  No

  N/A

• ZANTAC AND MONOTRIM SHELFTALKERS

  Yes

  No

  N/A

• MINIMISING RISK IN DISPENSARY

  Yes

  No

  N/A

• ETHICAL DECISION MAKING TEMPLATE POSTER

  Yes

  No

  N/A

• EHC – RECORDED ON PMR, DAILY AUDIT AND PAPERWORK FOR 2 YEARS

  Yes

  No

  N/A

• HIGH TECH SECTION OF DISPENSARY / FRIDGE

  Yes

  No

  N/A

• ULM AND HIGH RISK AREA OF DISPENSARY

  Yes

  No

  N/A

• ULM INVOICES

  Yes

  No

  N/A

• HIGH TECH INVOICES

  Yes

  No

  N/A

• FLU VACCINATION FOLDER, EQUIPEMENT AND SET UP

  Yes

  No

  N/A

• CHILD SAFE GAURDING POSTER AVAILABLE

  Yes

  No

  N/A

• CCTV SIGNAGE AVAILABLE

  Yes

  No

  N/A

• METHADONE FOLDER AND UP TO DATE PATIENT CONTRACTS

  Yes

  No

  N/A

• PHARMAPOD REVIEW

  Yes

  No

  N/A

• Review Errors & Near Miss logs and compare with industry standard and reasons review

  Yes

  No

  N/A

• PHARMACY ASSESSMENT SYSTEM REVIEW

  Yes

  No

  N/A

• OUTCOME OF AUDIT –

  Yes

  No

  N/A

• ACTIONS REQUIRED BY SUPERVISING PHARMACIST

  Yes

  No

  N/A

• DATE

  Date

• COMPLETE

  Yes

  No

  N/A