Implications of the Pharmacist Prescribing Loophole (Opinion Piece)

Recently, there has been a buzz in pharmacy circles around pharmacist prescribing in the context of private clinics. Many of these are linked to registered pharmacies, which places them under the regulation of the GPhC, while a few are not. The following opinion piece was provided by one of our subscribers in relation to the current status around pharmacist-led private clinics. Let us know what you think via the comments below.

In England, the regulatory landscape surrounding prescribing pharmacist-run clinics has evolved significantly, driven by the expanding role of pharmacists in healthcare. Here’s my analysis of the current regulations and the implications for practice:

Expanded Role of Pharmacists

1. Prescribing Rights: Pharmacists in England have been granted independent prescribing rights, allowing them to prescribe medications following additional training and certification. This shift aims to enhance healthcare accessibility and efficiency, particularly in primary care settings.
2. Integration into Primary Care: Pharmacists are increasingly integrated into multidisciplinary teams within primary care networks (PCNs), helping to manage chronic conditions, conduct medication reviews, and provide patient education. Their role as prescribers helps to alleviate pressure on general practitioners (GPs).

Regulatory Framework

1. General Pharmaceutical Council (GPhC): The GPhC is the regulatory body overseeing the practice of pharmacists in England. It ensures that pharmacists meet professional standards and are competent to prescribe medications independently.
2. Care Quality Commission (CQC): The CQC regulates health and social care services in England. However, there exists a loophole where certain pharmacist-run clinics might not fall directly under the CQC’s stringent oversight, especially those primarily dispensing medication rather than providing a broader range of clinical services.

Loophole in Regulation

1. Scope of CQC Regulation: The CQC’s mandate typically covers services providing comprehensive medical care. Pharmacist-run clinics focused mainly on dispensing and limited prescribing may not require CQC registration if they do not offer a wider range of clinical services traditionally associated with GP practices.
2. Implications of the Loophole: This regulatory gap can lead to variability in the quality of care provided by pharmacist-run clinics. While pharmacists are trained professionals, the absence of CQC oversight could result in inconsistent service standards, potentially impacting patient safety and care quality.

Benefits and Challenges

1. Benefits:
   • Increased Access: Pharmacist-run clinics enhance healthcare access, particularly in underserved areas.
   • Efficient Care Delivery: They reduce the burden on GPs, allowing quicker service for minor ailments and chronic disease management.
   • Patient Convenience: Combining prescribing and dispensing in one location streamlines the patient experience.
   • Enhanced Patient Choice: Those who do not wish to wait for limited access to NHS primary care services can have the option of private health services directly from a qualified and registered professional.
2. Challenges:
   • Quality Assurance: Without CQC regulation, ensuring uniform quality and safety standards across all pharmacist-run clinics is challenging.
   • Professional Boundaries: Clarifying the scope of practice and ensuring pharmacists do not overstep their clinical expertise is crucial.
   • Uniformity: All other providers of regulated health activities fall under the remit of the CQC. The specific exemption for pharmacists is in relation to “primary pharmacy services”, hence pharmacists who are mainly providing prescribing services with the dispensing of a product as one of two possible outcomes might more accurately be described as providing “secondary pharmacy services”. “Primary” and “secondary” would have to be defined by law.
   • Potential Conflict of Interest: In 2020, the Royal College of Nursing and the Royal Pharmaceutical Society released a joint guidance on the prescribing, dispensing, supplying and administration of medicines. This stated that, “the prescribing and dispensing/supply and/or administration of medicines should normally remain separate functions performed by separate health care professionals in order to protect patient safety.” However, this is guidance and has no regulatory force.
   • Applying GPhC Best Practice: The GPhC, which is the regulatory body for pharmacists, provides an example of a community pharmacist in Scotland who was able to prescribe to meet local needs in the care of minor ailments, after suitable training. A notable statement in the report reads, “People using the service were free to take prescriptions to another pharmacy, although they were usually dispensed on site.” It appears that what made this an example of good practice, from the GPhC point of view, is the qualification in a subsequent paragraph that reads, “The pharmacist prescriber was not involved in any aspect of dispensing these prescriptions. Instead, the clinical check was always carried out by the checking pharmacist, who was then able to question the prescriptions issued by either the pharmacist prescriber or GP, if necessary.“

Future Directions

1. Enhanced Regulation: One possible approach is to have more comprehensive regulation to bridge the gap. Extending CQC oversight to all pharmacist-run clinics could potentially standardise care quality and ensure patient safety.
2. Collaboration and Integration: Promoting collaborative models where pharmacists work closely with GPs and other healthcare providers can enhance care coordination and patient outcomes.
3. Strengthening Regulations within the Current Framework: The Pharmacy Order 2010 gives the GPhC governing Council powers to make orders and rules, subject to approval by the Privy Council. In theory it should be able to create regulations that specify the terms under which registered pharmacists can run clinics, with inspection and regulation remaining with the GPhC.
4. Continued Professional Development: Ensuring pharmacists have access to ongoing education and training in clinical areas is essential to support their expanding role. The yearly revalidation could be tailored to reflect the areas of practice that the individual pharmacist engages in.

Conclusion

The evolving role of pharmacists in England, including their ability to run prescribing clinics, presents both opportunities and challenges. While it addresses key healthcare delivery issues such as accessibility and efficiency, the regulatory loophole regarding CQC oversight needs to be addressed to ensure consistent and safe patient care. Balancing expanded pharmacist roles with robust regulatory frameworks will be critical to maximising the benefits of this healthcare evolution.

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