The Royal Pharmaceutical Society (RPS) will issue a call for evidence ‘very shortly’ ahead of ‘any potential forthcoming changes’ to its professional guidance on self-selection of P medicines.

The Pharmacist understands that the society wants to understand how self-selection of P medicines is working in practice, and how risks are managed.

This follows concerns raised by the RPS that a ‘monumental change in practice’ regarding self-selection has been made ‘without wider communication from the regulator to the profession, patients and the public’.

A statement released by the RPS last night said 'hundreds of pharmacies' had been 'approved by the regulator to enable patients to self-select certain P medicines'.

Though it recognised that the 'sale of the P medicine is still required to take place within registered premises and under the supervision of a pharmacist'.

The regulatory approach to self-selection of P Medicines was discussed at an RPS board meeting this week, alongside presentations from the General Pharmaceutical Council (GPhC) and pharmacy multiple Boots, one of several pharmacies which have explored self-selection of P medicines.

Boots have trialled redesigned counter areas to allow patients ‘easy access to medicines’ with ‘expert advice on hand’, according to the multiple’s website.

Following the meeting, the RPS said it was ‘continuing to consider’ its current position on the issue, which it said was ‘now clearly at odds with regulator'.

‘We will be issuing a call for evidence very shortly to ensure any potential forthcoming changes to our professional guidance are truly evidence based,’ the RPS said.

GPhC ‘no longer requires’ advance notice of self-selection of P medicines

In a series of FAQs linked from an update posted on its website yesterday, the GPhC confirmed that pharmacies are no longer required to inform the regulator in advance of making pharmacy-only medications available for patients to self-select, under the supervision of a pharmacist.

And it stressed that any products believed be liable to abuse or misuse, particularly vulnerable to shoplifting or theft, or otherwise problematic - such as codeine-containing products, recent POM to P switches, some sleep aids or any high value medicines - should be considered in a risk assessment.

'You may choose to keep those products out of sight, or in a locked display cabinet', the GPhC said.

Roz Gittins, chief pharmacy officer at the GPhC, said the regulator’s ‘long-standing position’ has been ‘that self-selection of P medicines would not be compatible with our regulatory standards without key safeguards being in place'.

'This includes ensuring continued compliance with the current legal requirement for pharmacist supervision, and assurance that any arrangements put in place secure patient and public safety,’ she said.

She added: ‘The GPhC recognises that in order to meet patient needs, those providing pharmacy services may need to innovate and develop new ways of working. As the regulator, we don’t seek to stifle innovation, but to make sure that registered pharmacies meet our standards, as well as any relevant legal requirements, whilst maintaining the safety of their services.’

The GPhC would ‘continue to monitor developments’ through its normal inspection activity, she noted.

GPhC will say ‘facilitated self-selection’ instead of ‘open display’

Following the RPS meeting this week, the regulator had also recognised that ‘the language previously used for “self-selection” such as “open display” has not always been helpful, as it could be seen to suggest that the pharmacist and wider pharmacy team would not be involved in the selection and supply of P medicines to the person’, Ms Gittins said.

‘We think the term “facilitated self-selection” is more helpful, as it emphasises the crucial roles of the pharmacy team in facilitating the supply of the medicine to the person, and of the pharmacist in supervising the supply,’ she added.

Ms Gittins said that ‘subject to ongoing review and feedback’, the GPhC intended to use the term ‘facilitated self-selection’ going forward.

What was discussed at the RPS meeting around self-selection of P medicines?

At a board meeting this week in Bristol, RPS board members discussed potential plans to change the society’s position on the self-selection of pharmacy only (P) medicines.

One reason given for considering the change was that ‘an increasing number of providers’ sell P medicines online, ‘through websites that allow consumers to select a product and add it to a virtual basket’.

‘Having a barrier in physical premises that is not in place in digital structures may act as an impediment to brick-and-mortar pharmacies,’ the RPS suggested in a briefing document available ahead of the meeting.

Earlier in the week, the Pharmacists’ Defence Association (PDA) called for board members to reject the proposal, saying that self-selection of P medicines ‘could lead to a diminution in patient safety as well as a reduction in the ability of pharmacists to support patients by making professional decisions about how best to treat minor ailments’.

Historically, P medicines have only been available behind the counter or in locked cabinets, but in recent years, it appears that some pharmacies' practice and GPhC enforcement on the issue has changed. The regulator issued new guidance on self-selection on P medicines this week.

What are the arguments for and against self-selection of P medicines?

At the meeting this week, RPS board members heard a presentation from a Boots representative about the multiple’s trial of self-selection of P medicines, which includes redesigned counter areas to allow patients ‘easy access to medicines’ with ‘expert advice on hand’, according to the Boots website.

Arguments listed in a briefing document given to board members ahead of the meeting in favour of self-selection of P medicines included:

  • Being ‘in the interests of consumers and patients as it allows them access a medication to consider a potential purchase’
  • Allowing patients to read information on the packaging and ‘enhancing their choice and understanding’ and providing ‘greater patient empowerment’
  • Still giving pharmacists ‘an opportunity to refuse a sale if it would not be appropriate’
  • Potentially helping pharmacies ‘to increase their over-the-counter sales, to maximise business and help bridge the gap created by the downfall in income in the sector in recent years’

But the Pharmacists' Defence Association (PDA) said it was ‘astounded’ that the RPS had referred to an increase in income as one of the reasons to consider changing its position, and also condemned a later use of the term ‘customers’ rather than ‘patients’.

‘It should never be the role of a professional leadership body for pharmacists to reflect on ways to improve the commercial interests of business owners, this is a role for others. Its role should be about supporting the professional fulfilment of its pharmacist members, helping them to practice with competence and confidence and supporting the interests of patient safety in relation to their use of medicines,’ the PDA said.

The RPS briefing document also outlined potential reasons to oppose self-selection of P medicines, including:

  • That P medicines carry the ‘potential for harm’ and require an ‘additional level of protection’ to ‘protect the public’
  • That open sale could increase the risk of shoplifting of P medicines
  • That ‘putting them onto open display and into the hands of customers may make the decision not to sell, more challenging’
  • That the public might be confused by variation between pharmacy policies
  • That ‘the more commercially minded owners may dilute the reputation of pharmacies as being guardians of healthcare and ensuring the safe use of medication.’

It also highlighted that while many online pharmacies ‘effectively’ allow self-selection, the RPS ‘has previously called out concerns about “product led” websites, instead calling for such approach to focus on the condition and consultation’.

And it noted that upcoming changes to supervision legislation ‘may allow for the sale of P medicines under the supervision of a pharmacy technician operating with delegated authority’, suggesting that the board ‘may wish to consider’ the ‘possible implications’ of this.

'Long history of tension' around self-selection of P medicines

In background information given to board members ahead of the meeting, the RPS outlined the ‘long history of tension regarding the self-selection of P medicines’.

In 1951, a high court and court of appeal held that a Boots customer putting a P product in a basket and taking it to the till which is staffed by a pharmacist was a lawful sale under supervision.

But the regulator RPSGB - then part of the RPS - ruled that ‘pharmacy medicines must not be accessible to the public by self-selection’, preventing this practice from continuing.

‘This was generally understood to mean that medicines are not available for self-selection and must be out of reach to the public, behind the medicines counter or in locked cabinets,’ the RPS papers said.

In 2013, the GPhC, now the pharmaceutical regulator and separate from the RPS, moved to an 'outcome based approach' that suggested that a decision on whether or not P medicines should be on self-selection should be made locally by owners or superintendents.

According to a statement shared by the PDA in 2013, at the time the GPhC stated that this would be under three pre-conditions:

  1. Pharmacies would need to notify the GPhC of their intention to allow P medicines on self-selection.
  2. Guidance on compliance for pharmacies would need to be developed and communicated in advance.
  3. The current arrangements (no P medicines on self-selection) would remain in place until new enforcement rules came into effect.

It is unclear when GPhC enforcement on the issue changed, but it appears that over recent years, some pharmacies have been allowed to display P medicines in different ways and begin some form of self-selection. Although The Pharmacist understands that guidance has not been issued to the sector at large until this week.