99-659 / Pharmacy Inspection Process

GOP Information
Organisation sharing the GOP
Related practices from PaSQ database
The Pharmaceutical Society of Ireland (PSI)


Medication / IV Fluids
GOP Description
Implementation level
Clinical settings
There are over 1700 retail pharmacy business (RPBs) (“pharmacies”) in the Republic of Ireland.
The PSI seeks to inspect all RPBs by the end of 2015, to ensure that all pharmacies are compliant with legislation and practice guidelines and are safe and fit to operate pharmacy services to the public
All retail pharmacy businesses in Ireland will be inspected, prioritising inspections in those pharmacies where risk factors have been identified.
“Specialist Surveyors” carry out a preliminary review of pharmacies, identifying risk factors. This information aids the PSI in risk assessing pharmacies in order to target where inspections should be prioritised. Pharmacies of serious concern are classified as “Category 1 Risk” and an inspector is sent immediately to visit the pharmacy. Lower risk pharmacies are classed as “Category 2 Risk” and scheduled for inspection as soon as practicable. Inspectors of the PSI carry out routine inspections of pharmacies. The inspections seek to review the primary systems of the pharmacy and typically last 1-2 hours. A report is then issued outlining the required actions which must be taken in response to identified issues or concerns within a designated timeline. The PSI have provided a number of tools on the PSI website to help pharmacists improve their practice and to prepare for inspection. These include:
Inspection Checklist and podcast
Links to Legislation and PSI Guidance Documents
Newsletter Updates
The PSI has also engaged with the Irish Pharmaceutical Union in relation to difficulties pharmacists had encountered with the inspection process. It is hoped to launch an annual “self-assessment” tool for pharmacists by which pharmacists and pharmacy owners to help encourage regular “self-auditing” within pharmacies.
Timeframe implementation
It is hoped to inspect all pharmacies by year end 2015.
Implementation tools available
Inspection Software “Case Management System”
Specialist Surveyors (x 2)
Authorised Officers ( x 4 full time equivalents)Administrator ( x1)
PSI Website as communication tool
Implementation cost
The implementation costs are linked to the development of inspection software and staffing.
Method used to measure the results
Specialist Surveyors have visited all pharmacies in the country
Specialist Surveyors have visited Category 2 risk pharmacies on a minimum of two occasions
50% approximately of pharmacies have been visited by Authorised Officers as of 2012
Risk pharmacies have been identified and visited as a matter of priority by Authorised Officers
Through the report process, pharmacists are directed to address shortcomings in their practice and rectify all identified issues
In some circumstances, legal and disciplinary proceedings have commenced further to inspections. A log of disciplinary and legal actions taken is maintained.
Analysis of the results
Further to the development of inspection software, the most common shortcomings observed in pharmacies can be deduced. Education and information is then issued to pharmacists on these matters through the PSI newsletters. This information is also used to inform the Practice of Pharmacy Development Unit and areas where guidance may need to be issued.
Implementation barriers
Did you find implementation barriers?
Please describe implementation barriers
Recruitment Embargo
Delays in the development of inspection software “ Case Management System”
Many pharmacies had not been inspected or had been inspected once in the ten years preceding the implementation of The Pharmacy Act 2007. These pharmacies required greater assistance and time from the authorised officers. Legal and disciplinary proceedings were initiated in some cases, which also imposed greater demands on authroised officers and resulted in decreased availability of authorised officers to carry out inspections to annual targets.
Describe the strategies used to overcome the barriers (If needed)
Ongoing development of computerised systems to expedite inspection process and report writing to free up the availability of authorised officers
Review of inspection pro-forma and inspection strategy. Authorised Officers are now seeking to focus inspections on those pharmacy systems which have greatest impact on patient safety
Increased focus on assisting pharmacists prepare for inspection in the hope that this will improve compliance across all areas.
Other information
Other information about the GOP that you would like to add (Link or attached document)
It is hoped that the introduction of a self-assessment form will act as an additional tool to improve compliance with legislation and practice guidance.