The P medicines category serves a vital role and the controlled environment of community pharmacies has proven beneficial for patients, pharmacists, and the healthcare system. This controlled setting ensures that P medicines are managed and sold safely and responsibly. A practice that should be upheld.
The RPS paper on the ‘Open Sale of P Medicines in Community Pharmacy’
The PDA became aware of a debate to be held by RPS board members on 19 June 2024. A publicly available paper written by the RPS Director of England can be found here (p. 50-56). There were no early indications from the RPS that this contentious topic would be discussed at the first meeting after the RPS elections, where all three countries were present, along with the newly elected board members – some with little experience working in a community pharmacy. Due to the location of the meeting, many PDA members, who are also RPS members, found it impossible to attend the meeting with no remote dial-in facilities provided. Those who did manage to attend the meeting were given observer status only and, therefore, could not participate in the debate.
PDA members have raised several concerns about the paper presented on the day. For example:
1. The tone of the paper is written in such a way that a decision was to be made on the day about the future direction of the RPS policy concerning the open sale of pharmacy medicines in community pharmacies, asking for ‘clarity’ on the RPS policy position and outlining reputational and member risks.
Considering such a contentious topic of discussion, with a recognition of the risks involved, the PDA is astounded that the wider profession and community pharmacy sector had not been involved before this meeting to allow for a balanced and unbiased debate.
2. The paper outlines the current position in the Medicines Ethics and Practice, a guide of the RPS, stating that P medicines ‘must not be accessible to the public by self-selection’. It further suggests that the decision on whether P medicines should be on self-selection ought to be a local decision, made by the pharmacy owner or superintendent pharmacist. The GPhC indicates that there are no barriers to owners and superintendents who wish to make P medicines available to self-selection and that they no longer need to be notified, providing a documented comprehensive risk assessment identifying where things might go wrong as well as specific actions that have been taken to mitigate or otherwise minimise each of the individual risks has been identified, before allowing P medicines on open display.
The PDA does not support a decision where pharmacy owners, who may not be involved in the day-to-day operations of a pharmacy nor be proximate to the circumstances of the pharmacy, can set the principles where a responsible pharmacist may be asked to allow the open selection of P medicines in a pharmacy. Often, owners are also not registered pharmacists with little to no knowledge of the clinical implications of transactions involving the sales of P medicines to patients. There is also a risk of commercial targets being introduced over professional considerations.
In 2013, the RPS expressed a concern that pharmacists may find themselves trying to retrieve an unsuitable drug from a patient’s hands rather than guiding a patient to the best option available based on their clinical judgment and existing patient conditions. There must never be a situation where pharmacists should be placed under any pressure to supply or allow a supply of medicines to a patient because they feel they have no other choice. All supplies of P medicines must, and should, always be made using a clinical assessment of the patient’s condition.
3. The arguments for and against change from the RPS are riddled with flaws and risks. They even go so far as recognising that commercially minded owners may dilute the role of the pharmacists as being the guardians of healthcare, ‘ensuring the safe use of medicines’ and see a change in policy as a way for pharmacies to increase their sales to bridge the gap in the downfall of NHS related income.
The PDA has already seen how applying ‘targets’ to NHS services to achieve additional payments could contribute to bad behaviours and lead to inappropriate supplies being made. Considering ways of bridging an NHS funding gap by a change in policy regarding the sale of P medicines is not the role of a professional leadership body.
4. A recent NHS report indicated that around half of the population struggles to understand information that can help them manage their health and care. They rely on healthcare professionals to explain what they read and how it relates to their health conditions. Understanding health information (health literacy) is essential for taking medications correctly, knowing which health services to use, and managing long-term conditions. Having access to potentially potent medicines and not understanding the consequences these may have on co-morbidities may pose many risks to some people.
The PDA strongly believes that a professional leadership body for healthcare professionals, like the RPS, should never refer to patients as ‘consumers’ or ‘customers.’ Allowing patients to select medicines for purchase with only the information provided on the packaging is akin to searching for treatment on a search engine and does not allow a pharmacist to make the final assessment. This approach is unsafe and opens patients up to harm, as demonstrated by recent incidents related to the unsafe supply of weight loss medication such as Wegovy.
Open sales do not just increase the risk of shoplifting and diversion. It also increases the risk of items being abandoned in other sections of the premises. This allows some other members of the public to acquire these opportunistically and other aspects affecting the stability and integrity of the medicines, such as storage conditions not being maintained for temperature-sensitive medication. Some P medicines are subject to misuse, and some people will take extreme measures to obtain these. The pharmacist must be able to make the final decision regarding the sale and supply of the medicine in terms of safety and suitability.
5. The RPS compares online transactions, where ‘consumers’ can place products in virtual baskets as similar to transactions happening in brick-and-mortar pharmacies. This process has also driven some organisations to recommend using algorithms to supply prescription medicines online. These approaches could have disastrous effects on medicines safety, with healthcare professionals calling for urgent regulations to be put in place to safeguard patients.
Further, the Competition and Markets Authority’s decision to classify all pharmacies as ‘interchangeable’ could have significant implications for brick-and-mortar pharmacies if the current policy on P medicines was to align with the arrangements of distance-selling pharmacies. Not only could it mean patients will be assessed by algorithms online, but when presenting at a physical pharmacy, patients may get access to potent medication without the necessary checks and balances for clinical appropriateness by pharmacists being in place. The RPS itself has called out concerns about ‘product-led’ websites. However, changing the policy in relation to the open sale of P medicines in community pharmacies is precisely that, just in a physical setting.
The PDA has significant concerns that the discussion paper used by the RPS to support the boards discussion refers to the now closed consultation on pharmacy supervision. It states that, ‘’this may allow for the sale of P medicines under the supervision of a pharmacy technician operating with delegated authority.’ This statement is contrary to what was actually concluded in the report by the Supervision Practice Group (of which the RPS was a member and co-signatory), which specifically stated on the supply of P medicines:
‘In relation to the supply of P medicines, the group agreed that further work would need to be undertaken in consultation with the Medicines and Healthcare Products Regulatory Authority (MHRA). This was discussed as a large and wide-ranging subject area that required in-depth discussion and debate to consider the ramifications for various future scenarios. That discussion is outside the remit of the Supervision Practice Group in the time available.’
In light of this much more considered view on P medicines, which was articulated by all of the organisations that participated in the sector group on supervision, it was inappropriate for the RPS board meeting to consider P medicines on self-selection in this way and was indeed a mistake.
Conclusion
For the RPS to renew the debate, or for the Boards to even re-consider whether the current RPS position which is that ‘Pharmacy medicines must not be accessible to the public by self-selection’ is still a valid position to hold and maintain’ is both premature and disingenuous. Having seen the responses of some RPS members and others to the debate, and perhaps recognising the strength of feeling on this issue, the RPS country board Chairs released a statement to members within hours of the discussion, indicating that they have decided to issue a call for evidence on the self-selection of P medicines.
Get involved
Despite the unexpected nature of this development, the PDA is ready and insists that a broader debate within the profession must take place if substantial proposals on changes to practice are being considered. The PDA has launched a survey of all members to share their views. The survey is open until 2 August and will help inform the PDA’s views. All pharmacists are encouraged to have their say in this crucial debate.
Learn more
- P medicines for self-selection, are you concerned?
- PDA challenges RPS on its ‘open display of P medicines’ policy review
- P meds on self-selection. GPhC decision must be challenged
- Self-selection of P medicines – not in the public interest!
- RPS Cross Board Open Business Meeting
- FAQ: self-selection and open display of Pharmacy medicines
- Health literacy
- ‘It terrifies me’: Girl landed in A&E after buying Wegovy from Boots
- Wegovy: Online weight loss drugs need ‘urgent regulation’, doctor leaders warn
- Decision on relevant merger situation and substantial lessening of competition
- Supervision in community pharmacy
- RPS statement on the self-selection of P medicines
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