The Pharmacy Act 2007 gives the PSI significant powers of inspection, investigation and enforcement.
The PSI inspects retail pharmacy businesses (pharmacies) to assess compliance with the Act and with other pharmacy and medicines legislation, in the interests of patient safety and public protection.
The PSI's Inspection and Enforcement Policy is outlined in this policy document.
Inspections and investigations are carried out by Authorised Officers of the PSI. Authorised Officers operate under the PSI Code of Practice, which sets out the conduct and performance that is required of Authorised Officers in carrying out their statutory functions.
The PSI carries out two main types of inspections:
The PSI has introduced a Pharmacy Assessment System to be completed in all pharmacies every six months, and which will be verified by PSI inspectors during pharmacy inspections.
The PSI also conducts investigations which typically involve an inspection or series of inspections, as well as speaking with the pharmacy owner, pharmacist or other staff of a pharmacy, and review and seizure of records or other items, as part of the investigation process.
The PSI also uses ‘mystery shopper’ type surveillance to assist with its risk-based approach to inspection and enforcement.
Typically these surveillance visits are to check for important key requirements which might indicate a significant risk to patient safety, such as a pharmacist not being present in a pharmacy if it is open or if it possible to get prescription-only medicines without a prescription outside of legal emergency supply rules, or to assess general compliance with specific requirements or guidelines.
The PSI has also developed a Security Assessment Template, in conjunction with An Garda Síochána, to aid pharmacy owners and superintendent pharmacists in assessing the security of their pharmacies.