PDA respond to the GPhC’s Consultation on Developing its Approach to Regulating Registered Pharmacies

The GPhC have recently consulted on developing an approach to regulating registered pharmacies. This would include publishing inspection reports for the first time.

Wed 15th August 2018 The PDA

Findings from a recent Freedom of Information (FOI) request show that whilst carrying out routine inspections, the GPhC identified major patient safety concerns in 667 pharmacy inspections across Great Britain. Read more.

The following changes have been proposed:

  1. Changes to the types of inspections – moving to a new model that includes three types of inspection: routine inspections, intelligence-led inspections and themed inspections.
  2. Moving to unannounced inspections – future inspections will be unannounced, as a general rule.
  3. Changing inspection outcomes – there would 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 would result in a ‘standards not all met’ outcome overall.
  5. Publishing inspection reports – publishing inspection reports and improvement action plans when relevant, on a new website.
  6. Sharing examples of notable practice – that are identify through inspections in a ‘knowledge hub’ on the new website. This will help encourage continuous learning and improvement in pharmacy.

The PDA are generally supportive of the six key changes proposed and believe they will lead to improved standards. However, the PDA feel the proposals do not go far enough and there is still much to do to improve the regulation of registered pharmacies.

In its official consultation response, the PDA have made various recommendations to help the GPhC to develop a new approach to regulating registered pharmacies. This includes:

  • The website where the GPhC publishes its inspection reports should provide an option to allow people to easily submit information to the GPhC about the pharmacy.
  • For the overall outcome and at principle level, there should be an additional annotation for pharmacies to denote a “major patient safety risk” (which is currently denoted by a “poor” rating in its inspection model).
  • Not meeting one standard should result in the pharmacy receiving an overall outcome of ‘standards not all met’ because it is likely to provide an effective incentive for pharmacy owners to try to meet all standards, which in turn should benefit patients.
  • The GPhC must not reduce the level of detail and frankness provided in its published reports relative to its current inspection reports. Reports must include details of public-interest matters, for example in relation to staffing levels, raising concerns and the impact of corporate incentives or targets on health, safety or wellbeing of patients and the public, or the professional judgement of staff.
  • The GPhC should publish all inspection reports produced since 1 November 2013, which provide a useful source of information.

Download the full consultation response below

thumbnail of GPhC Regulating Reg Pharms FINAL 09-08-2018



thumbnail of consultation-on-developing-our-approach-to-regulating-registered-pharmacies-may-2018

The Pharmacists' Defence Association is a company limited by guarantee. Registered in England; Company No 4746656.

The Pharmacists' Defence Association is an appointed representative in respect of insurance mediation activities only of
The Pharmacy Insurance Agency Limited which is registered in England and Wales under company number 2591975
and is authorised and regulated by the Financial Conduct Authority (Register No 307063)

The PDA Union is recognised by the Certification Officer as an independent trade union.

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