GPhC Council agrees new approach to regulating registered pharmacies

At its meeting on Thursday 6 December, the Council of the GPhC agreed the principles that will underpin how the GPhC will regulate registered pharmacies in future.

The GPhC will now begin work on bringing forward a number of operational changes to how it regulates and inspects pharmacies in line with these principles. These changes include publishing reports from pharmacy inspections for the first time and a move to unannounced inspections. The changes follow a major consultation across the sector and with patients and the public.

Following the Council’s decision, Duncan Rudkin, Chief Executive of the GPhC, said:

“Over the last five years we have made significant improvements to how we regulate and inspect registered pharmacies. These further changes we are now making 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.

“I want to thank everyone who took part in our consultation for helping us to shape our future approach. What we heard has enabled us to refine our proposals and we will continue to engage with people and organisations across pharmacy as we work towards implementing the agreed principles.”

The Council of the GPhC have approved the following principles which will underpin our updated approach to regulating registered pharmacies: 

  1. To be flexible, agile and responsive to the information we hold, intelligence we receive and issues we identify within pharmacy.
  2. Inspections should reflect as closely as possible how patients and the public experience pharmacy services day to day.
  3. 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.
  4. All standards for registered pharmacies need to be met every day.
  5. 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).
  6. That insights from inspection activities are accessible to everyone in the pharmacy sector

These principles build on essential aspects of our current approach and learning, as well as incorporating feedback from our extensive consultation.

These principles have operational implications including:

  1. Changes to the types of inspections –the new model will include three types of inspection: routine inspections, intelligence-led inspections and themed inspections.
  2. Moving to unannounced inspections as a general rule in the future. This will make sure the outcomes of the inspection reflect whether the pharmacy is meeting the standards every day.
  3. Changing inspection outcomes –there will be two possible outcomes for an inspection overall (‘standards met’ or ‘standards not all met’), and four possible findings at the principle level (‘standards not all met’, ‘standards met’, ‘good practice’ and ‘excellent practice’).
  4. Requiring all standards to be met to receive an overall ‘standards met’ outcome – if any standard is found not to be met, this will result in a ‘standards not all met’ outcome overall.
  5. Publishing inspection reports – and improvement action plans when relevant, on a new website. This will be designed so that the information is easy to search and analyse. Pharmacy owners will also be expected to display inspection outcomes in their pharmacies.
  6. Sharing examples of notable practice –examples of notable practice identified through inspections will be published in a ‘knowledge hub’ on the new website. This will help encourage continuous learning and improvement in pharmacy.

The GPhC has identified a number of additional operational actions it will take when implementing the new approach in response to the feedback received through the public consultation.  These actions include providing a range of information to help pharmacy owners, pharmacy professionals and the public to understand the new approach, including information on the process of publishing inspection reports.

The GPhC is now bringing together an operational reference group of responsible pharmacists, superintendent pharmacists and representatives from pharmacy bodies from across the pharmacy sector in England, Scotland and Wales to test and refine some of the operational measures in further detail, using feedback from the consultation.

The GPhC plans to begin to publish inspection reports from the first quarter of 2019-2020 and will also implement the other changes in 2019-20.