Professional Standards Authority Good Practice Guidance Consultation Response

Published: 11/04/24

The Professional Standards Authority (PSA) is an independent organisation, accountable to the UK Parliament. Its remit is to protect the public through work with organisations that register and regulate people working in health and social care. The PSA is seeking consultation on the good practice guidance documents they have produced in support of regulatory reform.

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The two guidance documents are;

• Guidance on the use of Accepted Outcomes in Fitness to Practise

• Guidance on Rulemaking

The PSA support the reforms to healthcare professional regulation but have also identified certain risks that may arise from the new ways of working. Developing the guidance that is being consulted on is one of the steps they are taking to help make the reforms a success, mitigate any potential risks and realise the opportunities of the reforms.

As an organisation, CPS are focussing on a consultation response to the ‘Guidance on Rulemaking’ document, as this is the area which will have the greatest impact on community pharmacy businesses and service delivery. As an organisation, CPS is not responsible for fitness to practice issues and therefore it is not relevant to respond to questions 4-21 of this consultation.

The PSA guidance on Rulemaking aims to help regulators make effective use of their new rulemaking powers in a way which prioritises public protection. It includes some principles to guide what good rules should aim to do or be, and the rulemaking process.

• 22. Do you think our guidance will help regulators exercise their rulemaking powers effectively?

  The guidance set out has given detail on principles which will guide robust rule making processes. This will allow for fair but flexible regulation of health and care. The guidance will help regulators exercise their rulemaking powers effectively, due to the clarity of the legislative requirements laid out and backed up by the evidence collected of good practice which is already being used across different regulatory bodies. As the Anaesthesia Associates and Physician Associates Order (AAPA Order) is acting as the template of reform for new powers for all health and care professional regulators, it is encouraging to understand there has been a collaborative but evidence-based approach taken to underpin this guidance.

• 23. Do you think that the principles outlined are the right ones?

  Yes

• 24. Do you have any comments to make on the principles listed or any additional principles to suggest?

  The ability for regulation to be agile is important in the current changing landscape of community pharmacy. With the role of a community pharmacist expanding along with the upskilling of pharmacy technicians, the ability to change the rules as service need grows must be a priority. The landscape will continue to evolve in the lead up to 2026 but will change dramatically when all newly qualifying pharmacists will have their independent prescribing qualification upon course completion. The responsible pharmacist regulations are becoming more limiting as a result, and what was originally intended to safeguard the public, is now resulting in a buildup of work due to restrictions around what can be done in a pharmacy when the responsible pharmacist is absent, ultimately increasing the risk of harm. Having the principles listed underpinning the regulator’s ability to make and develop rules, will allow for flexibility within the pharmacy sector to be exercised and new ways of working to be approached whilst maintaining public safety and service demand.

• 25. Do you think that the guidance on consistency between regulators (avoiding unjustifiable difference) is helpful?

  Yes

• 26. Do you have any comments to make on this section of the guidance?

  Ensuring consistency between regulators is achieved and maintained is of vital importance to protecting the public. Not only does this ensure all health and care professionals are to work to the same underlying principles but it also allows for an easier transition to fewer regulators in the future if this is desired.

  Future learning around consistency between regulators could also then be used to form further good practice guidance. Guidance should also be focused around achieving shared definitions in rule setting and not limiting it to professional guidance but working collaboratively as well.

• 27. Do you think that the guidance on consultation is helpful?

  Yes

• 28. Do you have any comments to make on this section of the guidance?

  The guidance set out clearly details how consultation ensures the regulator seeks all areas of opinion and remains accountable around rulemaking. The guidance helps to understand how findings from consultations will be used to develop regulation. This is important for community pharmacy in terms of future guidance, which will be set by the GPhC, around the role and responsibilities of the superintendent pharmacist and the responsible pharmacist. This will impact capacity, patient safety, and future development of clinical services within community pharmacy.

• 29. Do you think that the guidance on governance is helpful?

  No

• 30. Do you have any comments to make on this section of the guidance?

  The guidance on governance within regulatory organisations’ is clear and states the importance of governance for public safety. It’s not that it isn’t helpful but rather it is incomplete. There is a weakness in point 8.3 ‘Areas that regulators should consider when defining the governance pathway’, where it leaves regulators open to interpreting the guidance which could result in more difference rather than consistency amongst organisations. This could go against the spirit of the reforms. A suggestion would be to create a framework for governance which is more specific. Each profession should also have the ability to scrutinise their own organisation to ensure governance is robust.

• 31. Please set out any impacts that our guidance would be likely to have on you and/or your organisation, or considerations that we should take into account when assessing the impact of the proposals.

  Keeping guidance flexible so developments in modern healthcare can be assessed and supported in a timely manner is vital. Guidance will impact community pharmacy’s ability to engage with the public and provide services which are crucial to managing the health of our population appropriately. Guidance will shape the future of how community pharmacy businesses, as healthcare contractors, operate and their ability to work efficiently to support the NHS, therefore it is important that guidance is enabling whilst maintaining the safety of the public.

• 32. Are there any aspects of these proposals that you feel could result in different treatment of, or impact on, groups or individuals based on the following characteristics as defined under the Equality Act 2010?

  Age
  Disability
  Gender reassignment
  Marriage and civil partnership
  Pregnancy and maternity
  Race
  Religion or belief
  Sex
  Sexual orientation
  Other (please specify)

  - No to all.

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