The PDA is urging pharmacists to sign a petition against proposals that will allow the owners of pharmacies to display P medicines on self-selection.
In 2012, the GPhC undertook a consultation about the regulation of pharmacy premises. On one of its pages an incidental reference was made as to how medicines could be available on self-selection. Few respondents read deeply into this but those that did, like the PDA, concluded that P medicines on self-selection may be up for debate and submitted a very robust defence of the P category.
“The suggestion that P medicines should be sold on self-selection is an argument that we would expect to see coming from a large retailing lobby group and not from a health profession regulator which should have a better understanding of medicines,”
said the PDA’s submission.
“We urge the GPhC to think again about this intention as it will be met with significant resistance from the wider profession.”
However, by far the vast majority of respondents understandably, did not spot this bombshell as they made no reference to it. Following the consultation the GPhC confirmed that it was going to move to outcome based regulation. Under this approach, the final outcomes would be set and the profession would be allowed to find its own way(s) of achieving them. The GPhC then argued that as a consequence, the prohibition of the sale of P medicines from open display should no longer apply. Instead, a decision on whether or not P medicines should be on self-selection should be made locally by owners or superintendents.
The GPhC stated that there were to be three pre-conditions:
- Pharmacies would need to notify the GPhC of their intention to allow P medicines on self-selection.
- Guidance on compliance for pharmacies would need to be developed and communicated in advance.
- The current arrangements (no P medicines on self-selection) would remain in place until new enforcement rules came into effect in October 2013 (now moved to 2014).
The PDA’s concerns
Almost immediately the PDA heard from alarmed members, with some reporting that their employers had already moved P medicines onto the open shelves. The PDA promptly raised its concerns with the GPhC. It is difficult to understand how a regulator whose main role was to protect the interests of the public could have made such a decision. The PDA requested copies of minutes of meetings and any policy papers that its Council had been considering and issued an urgent press release registering serious concerns.
The PDA and the Royal Pharmaceutical Society jointly held a meeting with officials from the GPhC to explain from a pharmacy practice point of view why this policy needed to be withdrawn. The GPhC however, refused to do so.
The 2012 GPhC consultation was about standards for registered pharmacies – not about P medicines on self-selection. It is not acceptable for the GPhC to reach conclusions on a matter of such fundamental importance through a consultation on a different matter. Consequently, the GPhC has been asked to hold a consultation on this specific matter allowing the profession to have a say. In 2007, when the then regulator; the RPSGB considered this matter, it held a consultation which lasted six weeks and which received hundreds of responses not only from pharmacists, but also from pharmacy and non-pharmacy organisations, other healthcare professions, patient representative organisations and individual patients. The majority of respondents were in favour of maintaining the current safety measures.
However, the GPhC officials explained that no such consultation would be held on this occasion.
Recently, the GPhC explained that;
“Our expertise is not around pharmacy at all – it’s about regulation”
The profession is now faced with the prospect of a new regulator that lacks expertise in pharmacy, proposing a fundamental change in practice despite formal protestations and warnings about patient safety from organisations that are steeped in pharmacy practice and risk management (PDA and RPS). Additionally it denies the public and practitioners – those that these changes will affect a consultation on this matter. These behaviours are a cause of great concern, they do not represent transparent modern regulation and these are questions that the regulator must answer.
PDA meets with pharmacists
In May, the PDA organised a series of engagement meetings in England, Scotland and Wales to gauge the extent of feeling amongst pharmacists and the results were unequivocal. Practicing pharmacists believe that the current arrangements represent an important cornerstone of pharmacy practice which, should it be removed would reduce the prospects for patient safety and make the pharmacists role of ensuring that the public get the right P medicines significantly more difficult to deliver.
There are many concerns about this proposal, including;
- Reducing the opportunity for prevention of improper sales, placing the public, pharmacists and staff at greater risk.
- Causing even greater tension between commercial and patient safety considerations in community pharmacy.
- Many PDA members face disciplinary action by employers because they have refused to sell patients the P medicine of their choice even though this is the right clinical decision.
- Damaging the ability of the pharmacist to ensure that the right P-Medicine is taken for any particular condition.
- How can a pharmacist properly supervise the sale of P Medicines ensuring that the safest and correct medicine is purchased if the patient has access to the medicine, has selected it and presents with it in their hand prior to purchase?
- Increasing the amount of medicines in circulation increasing the risk of harm to the public.
- Extreme pressure already exists encouraging the public to unnecessarily buy as many medicines as possible – such as three for the price of two promotions.
- Previous pilots (as part of the RPSGB 2007 consultation) have shown that when P medicines are available via self-selection, there is an increase in sales of more than 50%.
- The pharmaceutical industry has already welcomed these proposals. Recently a senior industry representative indicated that making P medicines available on self-selection would remove pharmacists as a hurdle to improved sales. An aggressive manufacturer led advertising campaign would potentially increase the volume of P-Medicines sales even further and would effectively by pass the safety measures currently delivered by the existing arrangements.
- Self-selection would exacerbate the tendency for medicines to be treated like normal items of commerce.
- Creating confusion amongst the public in an area where too much confusion already exists.
- The idea to allow self-selection in one pharmacy and not another would create frustration amongst the public and undermine the professionalism and standing of pharmacy.
- Damaging the control that currently supports the safe de-regulation of medicines from POM to P.
- The P medicine is a special category of medicines which enables de-regulation of products from POM to P. It ensures that newly deregulated medicines can be sold under a restricted and controlled format. If P medicines went on self-selection this assurance would be diluted and the de-regulation programme harmed.
- Allowing owners and their business managers to decide whether P medicines should be sold on self-selection undermines the pharmacists who are responsible for sales of medicines and for securing the safe and effective running of the pharmacy.
- Plenty of examples of what happens when the professional autonomy of pharmacists in community pharmacy is undermined by their employers already exist. Such as the operation of MUR’s in community pharmacy and the use of the 2 hour absence permitted under the RP regulations to operate the pharmacy before the arrival to work of the pharmacist
- A recent European Court of Justice Ruling highlighted the dangers to the public when the decisions and independence of the pharmacist are circumvented by non-pharmacist employers. Giving employers and their business managers the decision as to whether P-medicines are to be sold on self-selection or not is riven with such a risk.
- Harming operational practices that improve patient safety
- Currently, a pharmacist can choose to temporarily suspend P medicine sales (perhaps due to temporary absence, or because of severe staff shortages), but not if these medicines go on self-selection.
There are to name but a few.
What is going to be done?
The GPhC is at odds with many in the profession on a matter which is core to the profession’s identity – that of guardian of the nation’s medicines.
The recent PDA P-Medicines meetings held around the whole of the UK provided a rich vein of information from pharmacists and gave a good foundation of ideas upon which to build a robust campaign based on patient safety and public interest.
The full campaign to seek a change in the current GPhC policy will be developed in a stepped up fashion throughout 2013 and if necessary into 2014. This petition is just the start, but it is very important, and will be used amongst other measures in subsequent discussions with the GPhC, with its supervising body and ultimately in representations to Parliament.
The PDA is seeking a withdrawal of the current GPhC policy and we appeal to all pharmacists to sign the petition and encourage your colleagues to do likewise. We thank you for your support.