RPS changes stance and signals support for facilitated self-selection of P meds

The Royal Pharmaceutical Society (RPS) has issued a position statement in support of facilitated self-selection of Pharmacy (P) medicines, alongside new professional guidance on the model.

The body stressed that pharmacies adopting facilitated self-selection must work in line with regulatory standards and have ‘robust processes’ in place, while ensuring appropriate supervision of P medicines sales.

The move from the RPS to publish a position statement and updated guidance comes after an FAQ from the General Pharmaceutical Council (GPhC) which last year set out what the regulator would expect to be in place when facilitated self-selection occurs.

The model refers to setups ‘where people can pick up P medicines themselves without having to ask a team member to either get it for them or open a cabinet’, with 'key safeguards' are in place, according to the FAQs.

Last summer, around the time of the FAQs being published, the RPS became concerned about 'significant challenges' for pharmacists surrounding facilitated self-selection of P medicines and said it had been ‘deeply disappointed’ about the lack of communication on self-selection from the regulator.

At the time, the RPS said it had become aware of ‘hundreds’ of pharmacies being enabled by the GPhC to allow patients to self-select some P medicines – which was at odds with its then position of ‘pharmacy medicines must not be accessible to the public by self-selection’.

The RPS then launched a call for evidence on the ‘benefits and harms’ of facilitated self-selection of P medicines in July 2024 – the findings of which are currently being peer reviewed.

In its new position statement issued this week, the RPS said it is ‘supportive’ of the adoption of models that enable facilitated self-selection of P medicines and that pharmacies choosing to implement this should consider ‘good practice guidance’ when doing so.

‘Pharmacies that operate a facilitated self-selection model must meet regulatory standards, all staff involved must be appropriately trained and supported, robust processes need to be in place and the Responsible Pharmacist (RP) must have confidence that the processes in place ensure any identified risks are mitigated or minimised and patient safety is maintained. This model may not be suitable to operate in all pharmacies,’ it said in a statement published today.

It added: ‘The facilitated self-selection of pharmacy (P) medicines must operate in an environment that is compliant with all regulatory standards and one which assures public and patient safety.

‘Regulatory standards must be met at all times and professional guidance should be followed.

‘The superintendent pharmacist (SI) must ensure arrangements are in place so that patient safety is maintained and that pharmacy team members involved in the facilitated self-selection of P meds are trained to the appropriate level and know when to refer patients.

‘Where pharmacies operate a model that enables the facilitated self-selection of P medicines, the Responsible Pharmacist (RP) must be confident that processes are in place to ensure they are able to appropriately supervise sales of P-Medicines.’

The RPS said it would work with other organisations to support ‘safe implementation of the self-selection of P medicines, including a public campaign to support the role of community pharmacy in self-care’.

And it recommending there be ongoing research into the ‘risks and benefits’ of the facilitated self-selection of P medicines in real-world practice; the implementation of mandatory training for pharmacy teams operating this model, and for the technological solutions to be explored and adopted to flag high-risk P medicines and minimise inappropriate sales.

Its new professional guidance, also published today, sets out risk assessment factors, roles and responsibilities, safeguards and raising concerns, development and training and the medicines that ‘may not be suitable’ for facilitated self-selection.

The guidance sets out a risk assessment which can be used to identify any P medicines which may not be appropriate for the model.

And it outlined some ‘higher-risk’ P medicines which may not be suitable, including medicines that:

Are liable to problematic use, abuse or misuse, e.g, laxatives, pseudoephedrine, sleep aids, opioids, cyclizine
Have an increased risk of more severe side effects or adverse drug reactions
Have an increased risk of serious harm if taken in overdose, including medicines referenced in patient safety reports and prevention of death reports.
Medicines susceptible to shoplifting or theft
High-value medicines.
Recent POM to P switches.

Roz Gittins, GPhC chief pharmacy officer, said: ‘We fully agree with the RPS that facilitated self-selection of P-medicines must operate in an environment that is compliant with all regulatory standards and one which assures public and patient safety.

‘Our position continues to be that open display of P-medicines is not compatible with regulatory requirements without key safeguards being in place.

‘This includes ensuring continued compliance with the current legal requirement for pharmacist supervision, and assurance that where facilitated self-selection is available, that the systems and processes put patient and public safety first.

‘We will continue to check for associated compliance as part of our usual regulatory processes, including during inspections of pharmacy premises.’

She added that the GPhC looked forward to ‘collaborating closely with the RPS and other organisations to support safe implementation of the self-selection of P medicines, and agree with the RPS on the need for associated further research’.

When concerns were raised about self-selection last year, the Pharmacists’ Defence Association launched a survey of its members to hear views on the topic.

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It revealed in February that more than nine in 10 pharmacists responding to the survey opposed the self-selection of pharmacy (P) medicines.

And the PDA launched a report making a case ‘against the liberalisation of P medicine sales'.