The General Pharmaceutical Council has agreed an updated approach to the regulation of registered pharmacies, with “operational changes” such as unannounced inspections and binary inspection outcomes set to follow.

The principles underpinning the GPhC’s new approach were agreed at its Thursday December 6 council meeting, and were the subject of a recent consultation that included a public YouGov survey.

Among other things, these principles stipulate that the regulator should be “flexible, agile and responsive” to intelligence it receives, that inspections should reflect everyday working practices, that inspection outcomes should be clear and that information regarding inspections should be publicly accessible (see below).

The GPhC says it will now work on bringing forward the “operational changes” that follow on from these principles, including switching to a new inspection model, introducing unannounced inspections and binary (‘standards met’ or ‘standards not all met’) outcomes, requiring a pharmacy to meet all standards in order to pass, and publishing inspection reports.

Some of these changes may be seen as controversial, with the consultation responses suggesting that some in the sector were concerned that changes such as requiring all standards to be met to receive an overall ‘standards met’ outcome would not be fair on pharmacy professionals.

The GPhC says that based on the consultation feedback it has “identified a number of additional operational actions it will take when implementing the new approach,” such as providing information to help stakeholders understand the changes.

Some of the operational measures are being tested and refined by a reference group of responsible pharmacists, superintendent pharmacists and representatives from pharmacy bodies in England, Scotland and Wales.

GPhC chief executive Duncan Rudkin said the changes “will help us to provide greater assurance to the public that pharmacy services are safe and effective, and to drive continuous improvement in the quality of care that people receive when using pharmacy services.”

GPhC's new principles

The six defining principles the GPhC will refer to in its regulation of registered pharmacies in future are:

  • To be flexible, agile and responsive to the information the regulator holds, intelligence it receives and issues it identifies within pharmacy
  • Inspections should reflect as closely as possible how patients and the public experience pharmacy services day to day
  • The overall outcome of an inspection is clear and understandable to members of the public and enables pharmacy owners to be held to account against the standards
  • All standards for registered pharmacies need to be met every day
  • That the outcome of an inspection is open, transparent and accessible to members of the public (including where improvement action or regulatory enforcement action is required as a result
  • That insights from inspection activities are accessible to everyone in the pharmacy sector.

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