Inspection Findings - Overview

From July to December 2024, 183 pharmacy inspections were conducted by our Quality Assessors, comprising of:

• 10 new opening inspections 
• 30 full pharmacy inspections (known as ‘Systems inspections’)
• 18 visits to review the professional cover provided at the pharmacy

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. Fridge temperature monitoring and maintenance

It was noted at a number of inspections visits that the fridge and temperature monitoring records are not always maintained consistently.

Learning and insights for improvement

• In order to ensure the efficacy of medicines supplied to patients, strict adherence to the manufacturers' recommended storage conditions must be observed. 
• Medicines requiring storage at between 2˚C and 8°C must be stored in a pharmaceutical grade fridge. 
• The maximum and minimum temperatures of the dispensary, fridge 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 fridge should have adequate capacity to allow for the 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. 
• A written procedure outlining the temperature monitoring process at the pharmacy and the action to be taken if temperatures fall outside the range should also be available at the pharmacy. Find out more in the PSI Guidelines on the Storage of Medicinal Products within a Retail Pharmacy Business.

2. Record keeping of controlled drug products

At pharmacy inspections, PSI Quality Assessors will always review records relating to the receipt and supply of Schedule 2 Controlled Drugs (CD2), including the Controlled Drugs Register (CD Register).

At some inspections, it was observed that the running stock balances in the CD Register were not always maintained accurately. 

• Entries in the CD Register were not made in a chronological sequence. 
• Entries for wholesaler invoices did not always record the supplier’s address. 
• Errors were not always corrected by way of marginal or foot note. 
• Records of the witnessed destruction of Controlled Drugs were not always available for review at the back of the CD Register.

Learning and insights for improvement 

• The running balance of CD2 medicines in the CD Register must accurately reflect the physical stock located in the controlled drugs safe at all times. 
• The running stock balance in the CD Register should be regularly and systematically checked against the physical controlled drug stock at the pharmacy to ensure the balances in the CD Register are reconciled with the contents of the CD safe. 
• Incorrect stock balances identified during such checks should be fully investigated by the supervising pharmacist (or pharmacist on duty) and all relevant details noted in the CD Register.
• The CD Register should be completed at the time of the receipt of, or the dispensing of, the controlled drug and must legally be completed on the day of dispensing or the following day. 
• A record for receipt of a controlled drug must include the name and address of the supplier. It is good practice to record the supplier’s invoice number for each supply received. 
• In the event of an error in an entry, no cancellation, obliteration or alteration of the entry should be made. A correction must only be made by way of a dated note, preferably in the footnote section at the bottom of the page. This note should be signed by the relevant pharmacist. 
• The witnessed destruction of expired or non-conforming Schedule 2 Controlled Drugs should be recorded in the Controlled Drugs Witnessed Destruction Record section which is located at the back of the CD Register. 
• The destruction of Schedule 3 and 4 Controlled Drugs and patient-returned Schedule 2, 3 and 4 Controlled Drugs should be included in the controlled drugs destruction record book.

Further guidance on the record keeping requirements is available in the PSI's Guidelines on the Keeping of Records in Respect of Medicinal Products when Conducting a Retail Pharmacy Business - Version 4 March 2024, Guidelines on the Disposal of Medicinal Products for a Retail Pharmacy Business and the Inspectors Advice Article on Controlled Drug compliance. 

3. Accessibility of records

It was noted at a number of inspections visits that a number of pharmacy records are being kept in a digital format, such as standard operating procedures (SOPs), staff training logs, error and incident logs, temperature records and expiry date checking records. On several occasions, staff present in the pharmacy were unable to access these records for the Quality Assessor to conduct their review.

Learning and insights for improvement 

• Standard operating procedures (SOPs) stored digitally including all staff training logs and other policies must be accessible to all staff, including locum pharmacists. Please ensure all digital documents are saved in a format that can only be edited/amended by authorised personnel. 
• If an electronic error and incident management system is implemented in a pharmacy, it must be accessible to all staff who may need to log an error/ incident or access previous records when working in a pharmacy, including locum pharmacists. 
• Where any records are stored digitally it is important that they are accessible and readily available for review at an inspection by PSI Quality Assessors. Staff must be able to demonstrate to the Quality Assessor that they are familiar with the systems in place and how to access/utilise/navigate the records.

From July to December 2024, 125 Falsified Medicines Directive (FMD) themed inspections. 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.

Ensuring compliance with the Falsified Medicines Directive (FMD) requirements

In 2024, our Quality Assessors carried out 228 FMD themed inspections across all counties in Ireland. We would like to thank all pharmacies for their cooperation throughout the inspection process. Between July and the end of 2024, a total of 125 FMD themed inspections were carried out. Below, we provide an overview of our compliance data along with recommendations to enhance compliance.

In case you missed it, we also published an overview of our findings from FMD themed inspections that took place between January and June 2024. which can be found below.

For further information, guidance and FAQs, visit our Falsified Medicines Directive webpage.

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 July to the end of 2024.

Compliance data for July to the end of 2024

FMD Compliance 

• 88% of pharmacies had low compliance rates for the period reviewed when the IMVO scanning and decommissioning data was compared with the daily audit figures during the inspection.

Standard Operating Procedure (SOP) for FMD Operational Management 

• 43% of pharmacies did not have an SOP for FMD Operational Management

Staff Training Records 

• 64% of pharmacies did not have up to date and signed staff training records maintained at the pharmacy.

Recommendations for improvement

To support better compliance with FMD legislative requirements, we recommend improvements in two main areas based on our inspections and engagement with pharmacy teams: 

1. Effective Governance: 

a) Develop a comprehensive SOP for FMD Operational Management

It was observed that in a majority of cases where an SOP was either not available or not comprehensive, overall compliance levels were significantly lower. This highlights the importance of having a comprehensive SOP, which accurately reflects the pharmacy’s operations. It will promote consistent practice by guiding the pharmacy team to work in a way that reflects the practice at the pharmacy and complies with legislation.

b) Ensure Staff Training and Maintain up-to-date Training Records

It was observed that compliance levels were consistently low in cases where staff training records were not maintained. In certain instances, staff were unaware of the FMD legislative requirements, and others were using the incorrect mode on the FMD software, such as scanning under the ‘Verify’ tab instead of the ‘Decommission/Dispense’ tab. This contributed to overall low compliance with FMD legislative requirements.

This highlights the importance of staff training and maintaining up-to-date training records. Doing so ensures that staff receive the necessary role-specific training to understand the legislation and correct use of the FMD software.

Effective governance is important for ensuring compliance with FMD legislative requirements. Developing an SOP and ensuring staff training are essential steps not only to promote consistent practice and adherence to legislation but also to ensure staff are well informed and competent in their roles. The supervising pharmacist must ensure that any system or procedure put into place is followed on a day-to-day basis in the pharmacy.

For further guidance on governance in pharmacy, please see our Guidance on Pharmacy Governance Roles.

2. Effective Operational Management

a) Seamlessly Integrate FMD systems into the dispensary workflow

In certain cases where compliance was low, it was observed that the FMD system was not well integrated into the dispensary workflow.

This highlights the need for seamless integration whereby there are an adequate number of FMD scanners placed in convenient locations within the dispensary. This will help ensure the system becomes a seamless part of the dispensary workflow, enabling staff to use it as intended and reducing barriers to compliance.

b) Resolve FMD Software Issues promptly

In certain cases, staff explained that timely resolution of software issues and possible delays in troubleshooting were contributing factors to low compliance.

This highlights the importance of regularly maintaining FMD software systems. Conducting regular checks and promptly contacting your software provider to address any issues will help ensure ongoing and consistent compliance.

Effective governance and operational management are important for maintaining ongoing and consistent compliance. We would encourage individuals in pharmacy governance roles to proactively review their practices to ensure compliance with the FMD legislative requirements. When issues are identified, you should promptly take the necessary corrective actions to uphold the highest standards of pharmacy practice.

Taking prompt corrective action shows a commitment to compliance, minimises potential risks, and helps maintain patient and public safety.

From January to June 2024, 182 pharmacy inspections were conducted by our Quality Assessors, comprising of:

• 8 new opening inspections 
• 44 full pharmacy inspections (known as ‘Systems inspections’) 
• 26 visits to review the professional cover provided at the pharmacy 
• 1 inspection to assess the Internet Supply of non-prescription medicines 

Below you will find an overview of the findings from the 44 full pharmacy inspections carried out. 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.

From January to June 2024, 103 Falsified Medicines Directive (FMD) themed inspections. 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.