Inspection Policy Project

Project Background

PSI inspectors conduct unannounced routine inspections to assess compliance with the Pharmacy Act, PSI guidance and other pharmacy and medicines legislation, in the interests of patient safety and public protection.

A review of the PSI's policy on unannounced routine pharmacy inspections was carried out in January 2014. It was decided to continue with the current PSI policy of unannounced inspections for the remainder of this cycle of inspections. The Council also decided to undertake an overall strategic review to consider PSI inspection policy into the future. The PSI completed the first full cycle of community pharmacy inspections in December 2014.

Why did the PSI carry out an inspection policy project?

In anticipation of completion of the first cycle of inspections, the Council of the PSI set up an independent Project Expert Group to carry out a strategic review of the existing inspection policy. The Expert Group commenced a review of the system and processes of inspection in place and their findings and recommendations for a new inspection policy for routine inspections was approved by the Council. In 2015, the Council updated the policy for routine pharmacy inspections, to include the following:

  1. The introduction of self-audits for pharmacies (Pharmacy Assessment System) to facilitate self-evaluation and ongoing performance improvement in pharmacies.
  2. The use of risk assessment to determine whether a pharmacy will be notified of a routine inspection.

As a result of Council’s decision, work commenced on a project to implement these changes. The first part of the project focused on the development of a self-audit or Pharmacy Assessment System. This Assessment System facilitates pharmacies in their evaluation and ongoing performance improvement.

Development of the Pharmacy Assessment System

The Pharmacy Assessment System was introduced in January 2017. In its development, the PSI engaged with  pharmacists, pharmacy owners and other key stakeholders. One part of this engagement involved five focus group meetings hosted by the PSI in July and August 2015. At these meetings, information on the project and an introduction to self-audit for pharmacies was given to participants.

Feedback from each of the meetings and consultations, steered the design and content of the final Pharmacy Assessment System and its accompanying resources.

In January 2016, the PSI invited all supervising pharmacists to pilot the newly drafted Pharmacy Assessment System in their pharmacies. Over 250 supervising pharmacists, from pharmacies all around the country, participated in this pilot. In addition, a broader public consultation invited comment on the Assessment System. The consultation results are available in our closed consultations section.

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