Inspection Findings - Overview

Here we provide an overview of the findings from the 44 full pharmacy inspections carried out in the first half of 2024. We highlight several areas of concern identified by our Quality Assessors, where potential risks to the health and safety of patients and the public were noted/observed.

1. Absence of a Registered Pharmacist on the Pharmacy Premises

At two inspections, pharmacies were open and operating to the public in the absence of a registered pharmacist/ pharmaceutical assistant.  It is an offence under Section 28(c) of the Pharmacy Act 2007 for a person carrying on a retail pharmacy business (for the pharmacy owner, superintendent and/or supervising pharmacist) to sell and supply a medicine other than under the personal supervision of a registered pharmacist. References in the Act to the term sale and supply include references to the keeping of the medicinal product. 

Learning and insights for improvement

• In the absence of professional cover, a pharmacy must not open to the public.
• Pharmacies must have a key holding policy in place that outlines that that non-pharmacists (including staff) do not have access to the pharmacy except in the presence of the pharmacist or pharmaceutical assistant. In the event of pharmacist absence robust procedures must be in place.

2. Temperature monitoring and fridge maintenance

It was noted at a number of inspections visits that temperature records are not always maintained consistently.  In addition, instances of ice accumulation in fridges were noted by PSI Quality Assessors at a number of inspections. 

Learning and insights for improvement

• In order to ensure the continued therapeutic effectiveness of medicines supplied to patients, strict adherence to the manufacturers' recommended storage conditions must be observed.
• Medicines requiring storage between 2˚C and 8°C must be stored in a pharmaceutical grade refrigerator, and the ambient room temperature should be less than 25°C. 
• The maximum and minimum temperatures of the dispensary, refrigerator and any additional medicines storage areas should be recorded at least once daily in a log. The thermometer should be reset after the temperatures are checked. 
• The refrigerator should have adequate capacity to allow for organised, well-spaced storage of all medicinal products. 
• If ice is accumulating in a pharmacy fridge, this requires immediate attention from an appropriate refrigeration service engineer.
• There should also be a written procedure outlining temperature monitoring and the action to be taken if temperatures fall outside the range. Find out more in the PSI Guidelines on the Storage of Medicinal Products within a Retail Pharmacy Business.

3. Storage of controlled drug products

At full pharmacy inspections, PSI Quality Assessors will always review the storage of controlled drug (CD) medicines in the pharmacy, i.e., Schedule 2 CDs (CD2) and Schedule 3 CDs (CD3).

At some inspections, it was observed that CDs are not always stored in the CD safe as per legislation. In some cases, we noted that the CD safes do not have sufficient capacity to permit the orderly storage and safe keeping of all CD2 and CD3 medicines kept at the pharmacy, including active, expired, non-conforming and patient-returned stock.

Learning and insights for improvement

• All CD2 and CD3 medicines must be stored in the CD safe, including methadone preparations.
• Pharmacy owners and superintendent pharmacists are requested to review CD safe capacity and compliance with storage regulations, to ensure that all CD2 and CD3 medicines can be securely stored at all times under the supervision of a pharmacist.
• Expired or non-conforming (e.g. damaged) Schedule 2 and 3 CDs should be stored in the CD safe, recorded in the controlled drug witnessed destruction record at the back of the CD Register (page 201), segregated from ‘live’ stock, and clearly labelled ‘CDs for destruction'. Destruction should be destroyed in the presence of an authorised person i.e. member of An Garda Siochana.
• Patient-returned CDs should be promptly destroyed. While awaiting destruction, patient-returned Schedule 2 and 3 CDs should be stored in the CD safe, recorded in the Controlled Drugs Destruction Record Register, segregated from ‘live’ stock and clearly labelled ‘Patient-returned CDs for destruction'. The destruction of patient returned controlled drugs (CD2, CD3 and CD4) should be witnessed by a second pharmacist or another responsible member of the pharmacy staff.
• If there are expired controlled drugs or patient returns awaiting destruction, they must be promptly destroyed in accordance with legislative requirements and should not be allowed to accumulate in the controlled drug safe. 

Further information and frequently asked questions about controlled drug is provided on the PSI website and the Inspectors Advice Article on Controlled Drug compliance. 

4. Error and Incident Record keeping

At all full pharmacy inspections conducted in the first half of 2024, our Quality Assessors reviewed the pharmacy’s medication error management records. This review includes checking that the pharmacy has policies and procedures to assist all members of staff in dealing with medication errors, and that records of medication errors are maintained at the pharmacy.

It was noted at some inspection visits that comprehensive records of medication errors are not being maintained on an ongoing basis. In particular, records did not outline the corrective action and preventative action that have taken place to ensure appropriate action is taken to safeguard the health of the patient and to minimise the risk of future errors taking place at the pharmacy. 

Learning and insights for improvement

• The maintenance and review of error records as part of an error management system will facilitate the identification of any patterns or repeated errors, help identify learning needs, and contribute to the continuous review and improvement of the policies and procedures of the pharmacy.
• If an electronic error management system is implemented in a pharmacy, it must be accessible to all staff who may need to log an error or access previous records when working in a pharmacy, including locum pharmacists. 

Further information including record templates is provided in the Inspectors' Advice on Medication Error Management which may be useful when reviewing your error management processes.

As part of our ongoing commitment to transparency and supporting pharmacies to maintain regulatory compliance, here we provide an overview of the findings from our FMD themed inspection visits from January to June 2024.  

Introduction 

The Falsified Medicines Directive (2011/62/EU) (“FMD”) is a patient safety initiative. It is designed to ensure that falsified (or counterfeit) medicines do not enter the pharmaceutical supply chain. The PSI is responsible for supervising compliance with the Commission Delegated Regulation on Safety Features (EU) 2016/161 by pharmacies. 

FMD requirements for pharmacies 

It is the responsibility of those in pharmacy governance roles to ensure that the legal requirements of FMD are being met within their pharmacy. The FMD requirements include: 

• Verification of medicines. Community pharmacies are obliged to verify the authenticity of medicines with safety features and decommission them at the point of dispensing. 
• Handling alerts. Pharmacists are responsible for managing any alerts generated during the verification process. Any alerts generated by the FMD system in a pharmacy should be investigated and closed out in a timely manner. The IMVO have further supports to help you in resolving alerts. 

Findings and insights from FMD inspection visits

The PSI conducted FMD inspections across 103 community pharmacies from January to June 2024. We would like to thank those pharmacies for their cooperation throughout the inspection process.  Following our FMD inspections, we carry out a follow-up assessment to track the progress in addressing areas of non-compliance identified during inspections. This process ensures that any issues identified are addressed and that the corrective measures put in place are achieving the desired outcomes.   

Compliance data

FMD Compliance

• 82% of pharmacies had low compliance rates when the IMVO decommissioning data was compared with the daily audit figures during the inspection.

SOP for FMD Operational Management

• 69% of pharmacies had an SOP for FMD Operational Management

Staff Training Records

• 48% of pharmacies had staff training records

Recommendations for improvement 

Consistent scanning and decommissioning

• Those in pharmacy governance roles must have well defined processes and arrangements to ensure consistent compliance with FMD legislative requirements. Here are some tips to enhance compliance in this area

Seamless integration of FMD systems 

• Ensure that FMD software systems are seamlessly integrated into the dispensary workflow.
• Ensure an adequate number of FMD scanners are available and place these scanners in convenient locations within the dispensary. Proper placement enhances accessibility and streamlines workflow processes. 

Maintenance and issue resolution 

• Continuously maintain the functionality of FMD software systems and promptly address any software issues that may arise during usage. 
• If you encounter any issues with your FMD software system, contact your software provider directly. They can assist with troubleshooting and resolving technical problems. 

FMD software mode verification 

• Before scanning, pharmacists should verify that the FMD software is in the correct mode (either decommission, dispense or supply). This step prevents errors during product verification. 
• It is important that all relevant staff, including locums, are familiar with the functionalities of the software system, and are trained on its usage. 

Management of lending/borrowing of medicines subject to FMD requirements

• Implement procedures and practices for borrowing and lending practices in the context of the FMD within the pharmacy.  
• Training should be provided to staff involved in borrowing and lending to ensure they understand their roles and responsibilities.  Further information on borrowing/lending of medicines is available in the IMVO FAQ document. 

Staff training

• Pharmacists and pharmacy staff involved in the dispensing process must undergo training on FMD legislative requirements and pharmacy FMD procedures, including the using of FMD software to ensure ongoing and consistent compliance. Up to date training records should be maintained and available for review. 

Regular compliance review

• Those in pharmacy governance roles should: 
• Schedule regular reviews of the pharmacy’s FMD compliance practices and procedures to align with any changes in legislation and/or practices at the pharmacy.   
• Identify areas for improvement and implement corrective actions to enhance compliance and efficiency. 

Further information

Staying informed and following up to date advice helps to ensure FMD compliance within your pharmacy and contributes to patient safety by maintaining the integrity of the medicines supply chain. 

• Visit our dedicated information for pharmacists on the Falsified Medicines Directive. 
• The IMVO (www.imvo.ie) has published extensive information to support pharmacies with their compliance and to enhance understanding of the processes involved in meeting these responsibilities in pharmacies. 
• The Irish Institute of Pharmacy (IIOP) offers educational resources and webinars focused on FMD.  
• The Health Products Regulatory Authority (HPRA) also have dedicated information on their website.