Compliance and Enforcement

We know that the current inspection model will need to change. To sit alongside the new inspection model, a new framework will be used to make decisions about whether the standards we are proposing have been met and how to secure compliance if there have been failures to meet the standards. Before developing and testing this new model, we want to hear the feedback from the consultation on the proposed standards.

This section sets out our current thinking and the proposed direction of travel. It is intentionally more discursive than the rest of the consultation but we would welcome feedback on this section as we continue to explore how best to inspect and regulate registered pharmacies in a way that is proportionate and based on risk. It is right that we are able to use powers to take urgent action against registered pharmacies where there is an immediate threat to patient safety.

However we believe that in the vast majority of cases, it is going to be in patients’ best interest for us as the regulator to work with pharmacy owners and superintendent pharmacists to secure compliance with our standards rather than moving to a more adversarial and expensive legal enforcement approach.

 

Compliance guidance

We recognise that pharmacy owners, superintendents and registrants may require additional information about how best to achieve and to demonstrate compliance, particularly as what we are proposing is to move away from a prescriptive rules based approach to outcome-focused standards. For this reason, under each standard we have included a section called ‘showing compliance’.

These are examples of how you can show you have met the standards. This is not an exhaustive list and these examples are indicative only – they are not mandatory, although achieving the standard is. We recognise that the standards can sometimes be met in more than one way and showing compliance will often differ depending on the activities being undertaken in a registered pharmacy. Whether owners and superintendents use these examples or a different approach, you must be able to demonstrate that our standards have been met.

We are exploring as part of this consultation, what additional information is needed for owners and superintendents to support them in meeting our standards. Recognising our desire to avoid an overly prescriptive ‘one size fits all’ approach, it is not currently our intention to provide a comprehensive guidance document covering all the standards. We do not feel that this would be proportionate and could lead to a check box approach to compliance. However, we do believe that there may be a need for additional guidance on compliance for certain specific areas either because of the complexity of process or where the model of service may be new or technology based. Potential topics may include:

  • Compliance guidance for pharmacy owners operating an internet pharmacy
  • Compliance guidance for registered pharmacies working under an exemption from MHRA licensing requirements.

Comments are closed.