Facilitated self‑selection of P medicines: absent evidence, present risk

As a long-standing member and Fellow of the Royal Pharmaceutical Society (RPS), I was concerned to read that the RPS has reversed its position on the open display of Pharmacy (P) medicines.

The RPS justifies this major policy shift primarily based on a literature review published as a non-peer-reviewed preprint on medRxiv. This alone is troubling. The review explicitly acknowledges that none of the included 55 studies examined the safety or outcomes of P medicine self-selection specifically. Instead, it draws broad inferences from research on over-the-counter (OTC) and general sales list (GSL) products, despite the fact that P medicines are, by definition, subject to stricter regulatory controls owing to their higher risk profile.

The review’s conclusions are equally as concerning. It notes a “lack of high-quality evidence evaluating patient safety in self-selection models” and calls for “more research… to fully understand the risks and benefits” of such models in relation to P medicines. Despite this, the RPS proceeded to endorse the policy. One has to question the wisdom and propriety behind making this far-reaching decision in haste, based on weak evidence, without opening up the discussion to members.

Risks outweigh benefits

While the review identifies access, autonomy and reduced pressure on healthcare services as potential benefits of self-selection, risks were reported more frequently and in greater thematic diversity, including:

  • Adverse events, particularly among vulnerable populations;
  • Inappropriate medicine selection owing to misdiagnosis or low health literacy;
  • Delayed diagnosis of serious conditions because of symptom masking;
  • Reduced opportunity for pharmacist intervention and counselling.

Removing medicines from behind the counter risks downgrading public perception of their potency and potential harms, thus encouraging their casual use.

From the documents disclosed by the RPS — namely minutes of its national pharmacy board meetings and Community Pharmacy Expert Advisory Group summaries — there is no evidence that the wider membership was formally consulted. Nor is there documentation of a robust risk assessment or a public health impact analysis.

The language used by the RPS — particularly the term “facilitated self-selection” — is open to misinterpretation. It risks contravening the intent, if not the letter, of the Human Medicines Regulations 2012, which require that P medicines be supplied under the supervision of a pharmacist. There is little clarity as to what “supervision” looks like in a model where the product may already be in the customer’s hand before any interaction occurs.

Professionally and publicly opposed

Pharmacists’ Defence Association data show that 93% of pharmacists oppose self-selection of P medicines. Their concerns are precisely those omitted from the RPS position: supervision gaps, inappropriate self-selection, legal responsibility and even workplace conflict arising from refused sales.

This opposition from frontline pharmacists highlights a disconnect between the RPS’s leadership and the views of those who will be expected to implement this policy.  

The RPS must not allow commercial pressures to override its central mission: to uphold professional standards and protect public health.

I urge the RPS to:

  • Suspend its current position, pending a transparent, profession-wide consultation;
  • Commission an independent, peer-reviewed safety assessment of the proposed model;
  • Provide a legal and ethical definition of “supervision” in this context;
  • Align any new policy with existing regulations, professional guidance and patient safety principles.

Until such steps are taken, this policy risks eroding the professional standing of pharmacists and undermining public trust in our duty to put patient safety first. Also noteworthy is the ongoing loss of confidence pharmacists (RPS members and non-members alike) have in our professional body. 

I was present at the birth of the RPS. I do not want to see it fail.

Graham Phillips, director and superintendent pharmacist of Manor Pharmacy Group

Response from the Royal Pharmaceutical Society:

We would like to thank the member for their correspondence and engagement with this position statement and guidance. We hope the response below gives some reassurance as to the robust and lengthy process undertaken by the three country boards before any decision was taken regarding whether to support the facilitated self-selection of P medicines, which was already in practice. We acknowledge the concerns raised and believe that, as recommended in our statement, ongoing research into the risk and benefits of the facilitated sale of P medicines in real-world practice could address some of these concerns. 

Healthcare is changing and pharmacy with it. The way patients access services, engage with clinicians and have an active say in their care and treatment has evolved.

Pharmacists and their teams play a crucial role in ensuring the safe and effective use of medicines. They perform a vital role as the first point of contact for people to access healthcare; dispensing medicines, providing counselling and ensuring that medicines are used appropriately and optimising outcomes from treatment.

P medicines are an essential category for self-care and treatment in the community, but they must still be used appropriately and with the correct advice. Models of sale and supply have evolved, legally and with GPhC regulatory approval, which allow patients to take a more active role in their treatment plan. This is still done in consultation with a trained member of healthcare staff, currently under the supervision of the pharmacist as is the case regardless of the display model used.

Representation was made to the three national boards of the RPS in June 2024 and consensus achieved on how this professional issue would be addressed after they became aware of this model of sale already being implemented in practice. They gathered information on the way the models work in practice, the view from the regulator, spoke with pharmacists in practice and considered all aspects of the models in use.

As requested by the boards, the science and research team, led by the chief scientist at the RPS, undertook a programme of work related to this. A call for evidence survey opened for eight weeks from July to September 2024 and, in parallel, a literature review was conducted. The findings of this are pre-print and currently under peer review. They were presented to the three national boards in February 2025. The elected members acknowledged that the facilitated self-selection of P medicines is already in operation within some community pharmacies.

Taking into consideration the evidence presented, as well as the other representations and information gathered, the conclusion of the boards is that this model must be operated within safe parameters that ensure no negative impact on patient safety and must retain the professional autonomy of the responsible pharmacist (RP). This change allowed the production of professional guidance, which will support contractors and employees working with this model to do so in the safest way possible.

The boards also recognised that, despite the research not evidencing any detrimental impact on patients, there is a need for more research in this area which, understandably, can only be carried out with the model in place. Any evidence gained could inform future risk assessments, which should be undertaken by those operating in this way. The RPS also recommend that mandatory training for all pharmacy teams operating this model is undertaken, which allows the identification and management of risk from facilitated self-selection.

Community pharmacies across the UK provide world-class patient care and services. Practice and ways of working evolve over time to meet patient need. With our professional support, guided by our three country boards, pharmacists and pharmacy teams can continue to deliver safe and effective person-centred care, under these lawful and regulatory enabled models of practice, while still upholding the highest professional standards.

Last updated
Citation
The Pharmaceutical Journal, PJ, August 2025, Vol 315, No 8000;315(8000)::DOI:10.1211/PJ.2025.1.370728

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