Inspection Findings - Overview

Here we provide an overview of the findings from pharmacy visits carried out in the first half of 2026.  We highlight several areas of concern identified by our Inspectors, where potential risks to the health and safety of patients and the public were noted/observed. Inspectors have noted a particular increase in non-compliance with the management and record keeping of Controlled Drugs, premises requirements and storage of medicinal products within pharmacies.

1. Records relating to the destruction of controlled drugs

Inspectors identified a range of deficiencies in the recording of controlled drug destruction. Common issues included missing witness signatures, missing dates of destruction, failure to record the quantity destroyed, incomplete details of the medicine destroyed and destruction records that did not correspond with stock removed from the active controlled drug register.

In some cases, expired or non-conforming Schedule 2 controlled drugs had been segregated pending destruction, but the corresponding witnessed destruction record had not been completed. Inspectors also identified instances where destruction records were incomplete or where the method of destruction recorded was not appropriate.

Learning and insights for improvement

Pharmacies should ensure that all controlled drug destruction records are completed at the time of destruction and contain all required information. Records relating to the destruction of Schedule 2 controlled drugs should include the name, strength and form of the controlled drug, the quantity destroyed, the date of destruction and the signature of the authorised person in whose presence the medicine was destroyed.

Practical tips for pharmacies

• Review controlled drug destruction records regularly to ensure all required fields have been completed.
• Reconcile medicines awaiting destruction against destruction records and stock balances.
• Ensure medicines awaiting destruction are clearly segregated from active stock and labelled appropriately.
• Periodically audit destruction records to identify omissions, inaccuracies or recurring errors.
• Ensure all pharmacists involved in the destruction process are familiar with the pharmacy's procedures and the relevant legislative requirements.

Further guidance on the record keeping requirements for controlled drugs is available in the PSI's Guidelines on the Keeping of Records in Respect of Medicinal Products when Conducting a Retail Pharmacy Business, Guidelines on the Disposal of Medicinal Products for a Retail Pharmacy Business and in the Advice on Segregation and Destruction of Controlled Drugs.

2. Maintenance of Controlled Drugs Registers 

Inspectors identified instances where the same class of controlled drug were recorded across multiple live controlled drug registers. Common issues included the use of more than one active register for the same class of controlled drug, unclear transfer of balances between registers, inadequate cross referencing between registers and registers that were not clearly labelled. In some cases, it was difficult to determine when entries had ceased in one register and transferred to another, making it challenging to verify stock balances and establish a complete audit trail.

Maintaining records for the same class of controlled drug across multiple live registers can increase the risk of recording errors and make stock reconciliation more difficult. PSI guidance highlights the importance of maintaining controlled drug records in a manner that supports accurate running balances, traceability and effective monitoring of controlled drug stock.

Learning and insights 

Each class of controlled drug should be recorded in a single live register. Where a new register is introduced, balances should be transferred accurately and supported by clear cross references to the previous register. Good record keeping practices support accountability, facilitate reconciliation activities and help maintain an effective audit trail for controlled drugs.

Practical tips for pharmacies

• Maintain only one live register for each class of controlled drug.
• Clearly label registers and indicate when a register has been closed and replaced.
• Record transferred balances clearly when commencing a new register.
• Include cross references in both the old and new registers when balances are transferred.
• Periodically review controlled drug registers to ensure entries for each class of controlled drug are being recorded in the correct section.
• Carry out regular accuracy checks of controlled drug balances and investigate discrepancies promptly. 

3. Premises, layout and maintenance

A range of issues relating to pharmacy premises, layout and maintenance were noted during inspections. Common findings included pharmacy layouts that did not adequately support the personal supervision of the sale and supply of medicinal products by a registered pharmacist.

Inspectors also noted refurbishment works and alterations to registered pharmacy premises that had been undertaken without notification of material changes to the PSI. In some pharmacies, patient consultation rooms were being used for storage or other non-pharmacy activities. Deficiencies in the maintenance and upkeep of pharmacy premises were also observed, with some areas not meeting the standards expected of a healthcare facility.

Learning and insights for improvement

Pharmacy premises should be maintained and operated in a manner that supports the safe and effective delivery of pharmacy services. The layout of the pharmacy should support appropriate pharmacist supervision and help ensure that patients can access pharmacy services in a safe and suitable environment.

Practical tips for pharmacies

• Review the pharmacy layout to ensure it supports appropriate pharmacist supervision of the sale and supply of medicinal products. 
• Notify the PSI of material changes to the pharmacy premises where required. 
• Ensure patient consultation rooms are available for consultations and are not used for storage or other non-pharmacy activities. 
• Carry out regular premises checks to identify and address maintenance issues promptly.

Further guidance on premises requirements is available in the PSI Guidelines on the Premises Requirements of a Retail Pharmacy Business. Information on notifying the PSI of material changes to a pharmacy premises is available.

4. Storage of medicinal products

During inspections, a range of issues relating to the storage of medicinal products were observed. Common findings included the storage of patient records, patient returned medicines and other pharmacy related items in unsuitable and, in some cases, unregistered areas of the pharmacy premises.

Concerns were also noted in relation to temperature monitoring procedures and the storage of medicinal products, including cold chain medicines. Pharmacy only medicinal products were found stored in locations accessible to members of the public. Patient returned medicines and out of date stock were, in some cases, stored alongside, or in close proximity to, active stock.

Learning and insights for improvement

Medicinal products should be stored in a manner that maintains their quality, safety and efficacy. Appropriate storage arrangements should ensure medicinal products are stored securely, under appropriate environmental conditions and in locations that support effective supervision and segregation of stock.

Practical tips for pharmacies

• Review medicines storage areas to ensure all medicinal products are stored securely and in appropriate locations within the pharmacy premises. 
• Ensure patient returned medicines and out of date stock are clearly segregated from active stock. 
• Ensure pharmacy only medicines are stored in areas that are not accessible to members of the public. 
• Review temperature monitoring procedures and investigate any temperature excursions promptly. 
• Ensure cold chain medicines are stored in appropriately maintained pharmaceutical grade refrigerators.

Further guidance on the storage of medicinal products is available in the PSI's Guidelines on the Storage of Medicinal Products within a Retail Pharmacy Business. Additional information is available in Advice on Storage Conditions of Medicines and Guidelines on the Disposal of Medicinal Products for a Retail Pharmacy Business.