The fight is on — can proposals for self selection of P medicines be defeated?

One February day in 2012, a regulator still in its toddler stages, with no more than 17 months of experience, launched a major rehaul of how pharmacy (P) medicines should be sold to the public.

With the stroke of a pen, the General Pharmaceutical Council sought to change pharmacy’s traditional practice where customers have first asked for advice at the pharmacy counter, before a P medicine is recommended by the pharmacy staff. Now it will become topsy-turvy: a customer will select a medicine, and pharmacy staff will have to provide advice if the medicine is appropriate or take it from the customer if it is not.

By September 2012 it was a done deal, despite protestations from pharmacy’s professional body, the Royal Pharmaceutical Society (PJ 2012;289:315). But the wheel is still turning and the pharmacy profession is fighting back.

The Pharmacists’ Defence Association held roadshows this year with hundreds of pharmacists all over Britain to gather feedback. Following this, the PDA will be launching a petition against self-selection this week (www.the-pda.org/pmedspetition). RPS President Martin Astbury says the Society is hoping to endorse the petition “once we have seen the details”. Separately, the RPS will be launching its own consultation on over-the- counter medicines, which will include self-selection and professional standards in community pharmacy, early next year, following the results of the models of care work due to be completed in the autumn.

Mr Astbury told The Journal that it would be “helpful” if the GPhC did not act “unilaterally” and produce guidance on self- selection until this has happened.The RPS has argued that there is no evidence to justify a change to the current system. Such evidence will only be gathered after patient harm has occurred. “This puts patients at unacceptable risk,” the RPS says.

Mark Koziol, the chairman of the PDA, said two main concerns were raised by “coalface” pharmacists during the roadshows.The first was that self-selection would harm the public’s safety and, secondly, participants called into question the role of the GPhC.

“Pharmacists are being regulated in a way that is not transparent and completely ignores what pharmacists want across the land.” He said that it is “inconceivable” that the GPhC should bring in self-selection, when a consultation on the same subject held by the previous regulator only a few years earlier had said it should remain banned.

John Murphy, director of the PDA and general secretary of the PDA Union, said that since self-selection would be voluntary, “there will be different standards applied and so it will confuse pharmacy customers”. He is also worried how for-profit companies will respond to the move. “Give commercial organisations an inch [and] they will take a mile in terms of commercial sales,” Mr Murphy added.

Lack of transparency?

What is considered unreasonable by the PDA is that the GPhC ran a consultation on premises standards and included a “throw- away line in it about self-selection”. Indeed, the 51-page consultation contained only 17 words on self-selection.

The GPhC received 456 responses, of which 106 were from organisations. It has not published the responses, only providing them “on request”. Yet publishing responses is generally considered good practice. A spokeswoman for Transparency International, the UK’s leading anticorruption organisation, said: “If the subject of the consultation impacts [on] the general public (and particularly if commissioned by the Government), we would expect the following to be made public: the names of the people/ organisations who made submissions; each individual submission should be made public unless that respondent has specifically asked to remain anonymous.”

Considering its impact on vulnerable patients, who may not have the skills to self-select, it is surprising to learn that only two organisations representing the patient and charity sectors (the Patients Association and National Voices) responded to the consultation. Perhaps more groups would have responded if the GPhC had highlighted the self-selection issue more clearly in the consultation.

Patients’ groups that The Journal contacted have differing views on the issue, but all are concerned about the risks to patients.

Jo Cumming, head of helplines and information for Arthritis Care, said: “Arthritis Care is concerned that people who are experiencing chronic pain may be put at risk by this proposal by the GPhC. Medication for the relief of musculoskeletal pain should not be easily accessible to be bought inappropriately over the counter without the advice of a skilled pharmacist.”

Katherine Murphy, chief executive of the Patients Association, said the risks to patients could be quite significant.

She told The Journal: “[Self-selection] does not help vulnerable patients, who will need help and advice on selecting medicines for themselves. Under the new scheme the patient will select their medication and then they can only have a discussion with the pharmacist at the till point when the patient is ready to pay, which can create problems.

“Rather unfairly, patients will need to take the responsibility for buying these
medicines — there will be risks to the patients in that some pharmacy staff may not have time, or indeed may not be aware of some of the side effects. The risks to patients could be quite significant. Patients will have to take the responsibility for buying these medicines, unless they are alerted by pharmacy staff, as not all people read the patient information leaflet contained within the package. There are also issues around safe storage of medicines and the proposed risks that this will add to patients.”

Jeremy Taylor, chief executive of National Voices, a coalition of health and social care charities, said: “Not all patients are aware that some over-the-counter remedies can be risky, so the onus must be on pharmacies to ensure that appropriate advice is always given.There is nothing in principle wrong with having medicines on display for self-selection but we would recommend that is only appropriate if pharmacies can demonstrate they have a failsafe system for ensuring appropriate advice is given, for example an electronic prompt triggered by barcode scanning.”

What do the multiples think?

According to industry sources, multiples like Morrisons, Tesco and Sainsbury, are supportive of self-selection, with some, like Boots and Lloyds, sitting on the fence.

Steve Banks, superintendent pharmacist for Boots UK, told The Journal: “We believe that anything that encourages customers to take responsible action to manage their own health should be looked at with a view to understanding how this could positively impact on them. That said, any professional challenges need to be very carefully considered, and we are undertaking our own research to understand how this could work in practice.”

A Tesco spokesman said the company was interested in “exploring this opportunity”. He added: “We’ll be considering issues such as managing the sale of pharmacy medicines safely and talking to our customers about the plans to get their feedback.”

Morrisons said it would be supportive of any move which makes it easier for customers to shop for medicines, so long as patient safety is maintained. A spokesman added: “In practice, this means that not all pharmacy medicines would be available for self-selection, particularly those with recognised safety issues or addiction potential. However, we need to recognise that customer shopping habits are changing and as a profession we must keep pace with that change while ensuring safety.”

OTC industry view: sales will rise

Unsurprisingly, the Proprietary Association of Great Britain, which represents the OTC pharmaceutical manufacturers, backs self- selection, claiming it is an “opportunity for pharmacy to showcase its USP”.

Helen Darracott, PAGB director of legal and regulatory affairs, said that sales of medicines in pharmacies could increase if the public could see the full range of medicines available, including the larger packs which offer an “economic incentive to buy in pharmacy”.

Although the PAGB supports self-selection, when asked what evidence there is that it is good practice, it declined to comment. “This is not a matter for PAGB or our members,” it said.

OTC medicines sales grew only slightly last year (Panel 1), so self-selection just may be the boon the sector is looking for, regardless of how pharmacists feel about it.

Legal risk

Pharmacists may be concerned that once P medicines are placed on open shelves, they will be exposed to increased risk. Does the PAGB agree that the manufacturer benefits yet the pharmacist has to carry all the increased risk for sales? It answered: “It is a matter for lawyers to determine whether there is any legal difference relating to changes in the location of P medicines within pharmacy premises.”

The Medicines and Healthcare products Regulatory Agency has no strong view on self- selection saying it is a “professional matter”, but since it is the adviser to the Government on POM-to-P switches, it can be expected that it will be monitoring the success of self- selection, because this will likely feed into future switching decisions.

Future battle-lines

The GPhC may back down on self-selection after this two-pronged lobbying effort: a PDA petition with the potential to be signed by thousands of pharmacists and an RPS consultation on OTC medicines.

But if that fails, there is always the prickly judicial review route.This would need to assess how the GPhC had gone about its consultation: did the GPhC consult properly, did it take account of the outcomes of the consultation, was it reasonable, lawful and fair? These factors need to be considered before any decision can be made on whether a judicial review could be successful.

Alternatively, a sympathetic ear at the MHRA may help the insertion of a line somewhere in the human medicines legislation to ban self-selection of anything other than general sale list medicines.

It is to be hoped that the lobbying works instead.