GPhC consults on regulation of registered pharmacies

The GPhC is consulting until 9 August 2018 on changes to its approach to regulating registered pharmacies.

It is proposing the following key changes:

1. Introducing intelligence-led and themed inspections alongside routine inspections
2. Moving to unannounced inspections so the inspector’s experience is more likely to reflect that of a patient
3. Changing the inspection outcomes to either ‘standards met’ or ‘standards not all met’, with 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
5. Publishing inspection reports and improvement action plans when relevant, on a new website. These are different to an “improvement notice”, a statutory tool the GPhC can use for a breach of premises standards.
6. Sharing examples of notable practice identified through inspections in a ‘knowledge hub’ on the new website.

The GPhC has also explained some of the changes to its powers following the work of the Rebalancing Medicines Legislation and Pharmacy Regulation programme board (upon which it is represented).

Other notable details respondents should consider include:

• The GPhC has never issued any improvement notice or other sanction to a pharmacy owner where it identified that standards were not met (over 1900 occasions since November 2013). You can read more about that here https://www.the-pda.org/gphc_lack_of_action/.
• The GPhC intends to continue to use “action plans” rather than statutory “improvement notices” to deal with breaches of premises standards.
• Though it has called its action plans “improvement action plans”, these have no statutory force and must not be confused with “improvement notices”.
• Pharmacy owners will need to tell the GPhC whether the action plan has been implemented. Currently, they have to do so within two days (following a ‘poor’ rating) or five days (following a ‘satisfactory’ rating). The GPhC said it “may need to revisit the pharmacy to review whether the necessary improvements have been made” but may instead accept the assurances provided by the pharmacy owner. It has not said how often it expects a revisit to be required, or under what conditions. It is unclear if and how the GPhC currently makes that decision.
• The GPhC has not proposed any changes to the standards themselves or how its inspectors go about identifying breaches at individual standard level (for example, how it identifies the adequacy of staffing levels – Standard 2.1).
• 12,825 pharmacies were inspected from 1 November 2013 to 1 March 2018 under the GPhC’s current inspection model. The GPhC has found that 85% were meeting all of the standards.
• There are approximately 13,615 pharmacies in England, Scotland and Wales, suggesting that some pharmacies have not had an inspection in the past four and a half years under the current model.
• Breaches of improvement notices for breaches of premises standards are no longer to lead to criminal sanctions. Instead, the GPhC can refer non-compliance to its Fitness to Practise Committee (FtPC).
• Sanctions following such a referral can only be applied if the FtPC decides the pharmacy owner is unfit to carry on the relevant business safely and effectively. We believe this will set a high bar for any action ever being taken against pharmacy owners for a breach of the premises standards (as we said here).
• Sanctions available to the FtPC in such cases include disqualifying a pharmacy owner or removing one or more pharmacies from the register. The GPhC has not explained how this could be applied in practice to a body corporate (including which person(s) would be held accountable) or a non-pharmacist owner, for whom there is no register.
• The GPhC has said that inspection reports will not contain “commercially sensitive information”. It has not explained this term in any detail including whether this applies if the information is in the public interest.

The PDA will be responding as an organisation, but members may also wish to respond as individuals. The consultation documents can be found here:
https://www.pharmacyregulation.org/registered-pharmacies

If you would like to provide your views as to how the PDA should respond, please email consultations@the-pda.org