Welcome, my name is Anthony Cox. I’m an academic pharmacist, with a specialised interest in adverse drug reactions, pharmacovigilance, patients’ views of risks and benefits of medicines, and evidence based medicine. I’m also interested in quackery, and the anti-vaccine movement. My twitter handle is drarcox.
The new EU Pharmacovigilance definition of an adverse drug reaction now includes medication errors. This is welcome news. It is impossible to separate the regulation of medicines from medication errors; the boundaries between a medication error and an adverse drug reaction are too fuzzy. Long before the UK’s decision to create a separate agency on medication errors, the MHRA was reporting on adverse drug reactions caused by medication errors. There is now a great opportunity for some joined up thinking.
To that end the European Medicines Agency has issued six key recommendations to tackle the issue of medication errors. One of these is the following:
the systematic assessment and prevention of the risk of medication errors during the life-cycle of a medicine, including prior to granting marketing authorisation
You don’t have to look far to see an example of where that can go wrong. Earlier this month the US Food and Drug Administration sent an alert out about the risk of confusion between the cancer drug Kadcyla (ado-trastuzumab emtansine – the FDA approved non-propriety name) and Herceptin (trastuzumab). The risk arises because some computer systems are using the United States Adopted Name (USAN) for Kadcyla which is “trastuzumab emtansine”. As the drugs have differing dosing schedules this could cause real harm to patients. So top marks to the FDA for this warning.
No medication errors related to confusion between Kadcyla and Herceptin have been reported to FDA since approval of Kadcyla on February 22, 2013; however medication errors did occur during the clinical trials that evaluated its safety and efficacy prior to approval.
So medication errors occurred before approval, and it was still approved with that name and no warning was issued when it was approved? Oh dear.
Today saw the release of another Which? report on advice obtained from pharmacies, which was widely reported in the media and, shudder, The Daily Mail. After the Panorama story about pharmacists illegal selling prescription medicines 6 months ago, it is another blow to pharmacy’s reputation, and some have defended pharmacy.
Pharmacy Voice chief executive Rob Darracott argued that the sample size was “not enough to make any meaningful comparisons between pharmacy groups, or types”. Chemist & Druggist
There have been other criticisms of the Which? report, most of them similar to the complaints made when similar secret shopper studies have been undertaken, including lack of transparency with regard to methods and an insufficient sample to make the study in any way representative of the general pharmacy experience. While some of these criticisms may be academically valid, and there have been academic studies with smaller samples, I’m less convinced by their utility in PR terms after large scale failures in healthcare like Mid Staffs.
As a profession we have argued that we are the experts in medicine, and over the years welcomed increasingly powerful medicines as pharmacy only medicines. Is it really acceptable 7 out of 10 pharmacy staff failed to ask enough questions on supplying pantoprazole to discover the patient was on warfarin and might suffer a potential drug interaction? What would we think of the equivalent results from a survey of prescribing?
Which? do note the increasing role pharmacists are having in health, referring to services like MURs, and suggest that such services are pulling pharmacists away from the counter. In the face of rising pressures on pharmacists, and extended roles such as travel vaccines, with no fall in prescriptions to manage, there are dangers. Hannah Family is researching the effect of the mental workload that pharmacists carry on their dispensing activities. Some of her work is here [PDF]; it it seems unlikely that such negative effects are restricted to dispensing.
Interestingly, Which? found poorer advice was seen from counter-assistants who did not consult with pharmacists (2/3s of visits handled poorly), compared with sales where the pharmacist was involved (1/4 sales handled poorly). This is at least heartening news, and perhaps means the problem is aligned with training and supervision of counter staff, rather than widespread failure of pharmacists – although for the patient should be the same. Some may make the argument that the GPhC’s suggestion of allowing the self-selection of P medicines may worsen the situation pharmacists find themselves in.
So what should the response of the profession be? Back in 2008 the Royal Pharmaceutical Society (RPS) accepted there was room for improvement, but did argue the sample size was too small. This time Martin Astbury has stated:
‘The pharmacists I know won’t recognise their own practice in the results Which? have shared with us.‘The RPS wants to understand the underlying reasons for the differences highlighted by this report and how to improve consistency of the advice the public receive when they purchase medicines from a pharmacy. There are some areas which require improvement.
‘We have commissioned the University of Nottingham to look internationally for best practice on the sale of medicines through pharmacy. We will use the outcomes of this to make recommendations as to how pharmacists’ skills can be used most effectively in Great Britain to ensure the public get the best possible advice.’
Additionally the RPS will be running a joint event with the GPhC to discuss these issues with companies – something that Which? has welcomed. This response is proportionate; even with caveats the Which? report is a signal of a potential problem. It’s not all doom and gloom. In the very same article Which? offers some advice on making the most of pharmacies, and welcomes the statements of both the GPhC and the RPS, so we do have goodwill.
As the RPS develops. most notably the development of the Faculty, it will increasingly act as a professional body able to support pharmacists to be the best they can be. The faculty should enable pharmacists of all branches to achieve the highest possible professional standards, and the RPS should fight for an environment in which professionalism thrives.
Medicines are our turf, we shouldn’t be continually kicked round the pitch.
I’ve been active in pharmacy politics for over 13 years, and long before there were plans to split the regulatory and professional functions of The Royal Pharmaceutical Society I wrote an editorial about why that should be done. Howard Fox and I were called radicals for this proposal at the time, but now it seems nonsensical to imagine having the two roles together. This article is no longer on The Pharmaceutical Society’s website, so I thought it might be of some interest for people who are considering voting me.
I think we are on the way to creating the body that we envisioned in this editorial.
That is why I am standing now. Please lend me your vote.
Split and merge: a way forward for the Royal Pharmaceutical Society
The Pharmaceutical Journal Vol 265 No 7110 p263
August 19, 2000 Broad Spectrum
By Anthony Cox and Howard Fox
The publication of the NHS national plan for England is now a reality, and serious consideration is being given to the future of the regulatory functions of the Royal Pharmaceutical Society of Great Britain. We believe its days as a combined regulatory and representative body are clearly numbered, and the profession should have the self-confidence to separate these functions. Professional self-regulation is under the microscope at the moment, following several high-profile failures by regulatory bodies to spot poor practice and to deal effectively with individuals. At the Guild of Healthcare Pharmacists weekend school – “Practising to perfection” – in April, Baroness Audrey Emerton expressed the view that health care professionals were “not good” generally at external scrutiny. She also warned about the discussion in government about the wisdom of continuing self-regulation. On July 17, the Independent newspaper forewarned that the national plan for the NHS would include a proposal to create an NHS disciplinary body which would cover all professions. In the wake of the NHS plan it has now been announced that the Society is to be part of the new UK Council of Health Regulators, which is to be formed to fulfil the need for formal co-ordination between the health regulatory bodies. This new body will also include the General Medical Council, the successor bodies to the UK Central Council for Nursing, Midwifery and Health Visiting, and the Council for Professions Supplementary to Medicine, as well as the General Dental Council, the General Optical Council, the General Chiropractic Council and the General Osteopaths Council.
The end of self-regulation?
One particular note within the NHS plan could spell the end of professional self-regulation: “Were concerns to remain about the individual self-regulatory bodies, its [UK Council of Health Regulators] role could evolve.” Perhaps pharmacy is in a good position, as throughout the years the Society’s inspectorate and the Statutory Committee have shown an exemplary dedication to duty. Indeed, had the GMC adopted the Statutory Committee model, it is likely that self-regulation would not have become the issue that it is today. Following the Independent’s report, the Society’s Secretary and Registrar stated: “One of the great strengths of the Society’s arrangements is our inspectorate. This allows us to handle complaints personally and to resolve many informally, to the satisfaction of complainants.” Also the Secretary expressed the view: “Our proposals for reform of our legislation, prepared in 1998, provide for greater lay representation, wider powers and more flexible sanctions. We believe that they would meet the justifiable demands of the public.” The announcement of the national plan has been welcomed by the Society and it looks forward to working with the new UK Council of Health Regulators.
However, to many lay people the argument to remove self-regulatory powers from health professionals is persuasive, especially in the current climate. A desire by a profession to maintain self-regulation can be seen as self-interest to an outsider, especially when that regulatory function is maintained by a body, such as the Royal Pharmaceutical Society of Great Britain, which also serves a representative function. The Society was founded in 1841 in order to protect the interest of the profession, and the supplemental charter of 1953 sets out its functions clearly. There are four main objects, which are, in brief, to:
- Advance chemistry and pharmacy
- Promote pharmaceutical education
- Maintain the honour and safeguard and promote the interests of the members in the exercise of the profession of pharmacy
- Provide relief for distressed persons who are members, who are related to members or who are students
Although these do protect patients in an indirect way by promoting best practice and education, they are all concerned with the representation of pharmacy and pharmacists, not regulation. Since the Society was given its statutory function by the Pharmacy Act 1954, it has become increasingly confused about its role and has been unable to separate its regulatory function from its representative role. Can the Society even consider itself a representative body if it, for example, increases lay membership on its Council or has a Government-employed chief pharmacist on its Council as of right? Having wider powers, increased lay membership and more flexible sanctions would finally demolish the façade of its representative function: it will cease to be a representative body and become a regulatory body. Many members do not see the Society as a representative body, and the ongoing corporate governance battle could be attributed to this tension within the organisation. If the Society and the profession wish to take forward professional self-regulation, and have a continuing desire to go on representing pharmacists, there should be serious consideration of the option of splitting the Society into a regulatory body and a representative body. This would help to clarify the distinction between the two roles. We propose the Society should continue with plans to reform the inspectorate and the Statutory Committee but at the same time prepare to create the following bodies:
- The Royal Pharmaceutical Society of Great Britain – to represent pharmacists, and to promote and advance all branches of the profession
- The Regulatory Committee for Pharmacy – to provide a statutory function to protect the public (it should be formed from the Statutory Committee and the inspectorate and have greater lay representation, wider powers and more flexible sanctions)
Today, pharmacists are represented by a number of disparate bodies and our failure to promote the profession nationally is a result of this fractured lobby. Some in the Pharmaceutical Services Negotiating Committee and the National Pharmaceutical Association have recognised this and the two bodies recently attempted a merger. Although the attempt failed, a merger is still seen by some as the only viable way forward for pharmacy. Considering the small number of pharmacists in Britain, we are over-represented. Rationalisation would go some way towards improving the standard of representation that pharmacy and pharmacists obtain. Once the Society sheds its regulatory role it too will be in a position to merge, becoming the single parent body for all pharmacy organisations.
Missed the point
Some may feel threatened by our proposal to split the Society, but by planning to reform the inspectorate and the Statutory Committee without considering the problems associated with having both regulatory and representative functions combined, the Society has completely missed the point. This will be seen as a last-ditch effort to maintain the status quo by attempting to hold on to self-regulation come what may. The Society has missed the mood of the Government and the national plan. It should cease trying to maintain its present structure, grit its teeth and radically reform for the benefit of both patients and the profession.
Anthony Cox and Howard Fox are pharmacists from Sutton Coldfield, West Midlands, and Dorchester, Dorset, respectively
Members of the Royal Pharmaceutical Society are encourage to get involved in the debate at the RPS website, where there is a specific forum for the 2013 election. Here is the text of my initial responses.
How should pharmacists ensure that they are providing good quality p-meds supplies and how would self-selection affect this?
P Medicines are fundamentally no different from any other drugs. Patients should obtain safe and evidence-based prescribing of POMs, and the same applies to the supply of P medicines from pharmacies. Pharmacists, and the staff they supervise, must retain their professional oversight of the supply of P medicines. The recently published guiding principles of medicines optimisation are focused on prescribed medication, but they equally apply to P medicines: understanding the patient’s experience, making an evidence-based choice, maximising safety, and routinely doing so.
While self-selection might well enable increased patient choice and autonomy, there is a balance to be struck and a move to self-selection carries risks. While I have faith that pharmacists have the professionalism to carry out their role as best they can, this move may make it far harder in an increasingly pressurised commercial environment. I’d draw a parallel with the direct-to-consumer adverts for prescription drugs in the US. One would hope that doctors would still prescribe rationally in the face of this, but evidence suggests that such advertising does make their job harder and has not served patients well.
We already know some patients are using over-the-counter drugs sub-optimally. Without evidence that a move to self-selection carries no additional risks to public health there are legitimate concerns to be raised about such a move. In future, if it was found that self-selection had been detrimental to the safe and effective supply of P medicines, might it make other POM to P switches less likely? I am disappointed that there will be no specific consultation on self-selection from the GPhC, and perhaps a more considered evidence-based approach, with independently administered and evaluated trials of self-selection, would have been of use.
Are you a ‘follower’ or a ‘leader’?
I’m hoping to be elected to a team of individuals who want to work as an organisation to deliver a professional body that pharmacists can be proud of. I have no interest in a ranked hierarchy based on supposed “leaders” and “followers” jockeying for position. That’s the old model that failed the membership.
We should be looking to build a robust organisation as a team, where both staff and board members talents are maximized to the best use of the membership.
As an organisation should the RPS be leading the profession? Yes.
Should the English National Board consist of a group of people elbowing each other to demonstrate their leadership? No.
If members of the profession do elect me, then I am keen to ensure that the English National Board spends time ensuring that leadership can be further developed and supported in localities, either through LPFs, or through the leaders we see every day in our work. The new Faculty appears to a way forward. Pharmacy has no shortage of leaders; I meet inspirational people in community pharmacy and hospital pharmacy all the time. The NHS changes mean that big battles have to be fought locally to deliver on medicines optimization and to ensure a rewarding future exists for pharmacists.
We need to support the leaders in those areas.
How would you encourage greater levels of member engagement with the Society and its initiatives?
The question asks about the “Society and its initiatives”, which paints the RPS as something separate from the membership, with its own interests and own initiatives. The key is ensuring that the RPS initiatives are the members’ initiatives.
Thirteen years ago I started a debate in The Pharmaceutical Journal about splitting the professional body of the Royal Pharmaceutical Society away from its regulatory function, which was impairing its ability to represent interests of the profession. The split became inevitable with time, and it is pleasing to see that the RPS has since become a more responsive organisation. Recently I worked with the RPS on the All Trials campaign for publication of clinical trial data, and it is clear they are not the same organisation.
It could be even better. Mechanisms for the membership to feed into the RPS outside of elections are less obvious. There is no AGM equivalent to those of some other professional organisations which provide the opportunity to direct policy, and while it may not be desirable to re-create the old branch representatives meeting, some mechanism along those lines may be a way forward. There is a need to look as much at how information flows up into the RPS, as well as ensuring that information flows out.
Boards need to keep in touch with the membership and ensure that their work programme is aligned with members concerns, but also need to continue to take the lead on key issues.
In support of this, LPFs should become a valuable mechanism for feeding into the centre. Is there a mechanism for them to feed into consultations at the RPS? There is considerable expertise on LPF committees that the RPS could tap into. Sometimes my LPF is surprised by initiatives, which we’d be keen to be engaged in. I would support an examination of how LPFs might feed into policy within the RPS.
As the new Faculty, and the networks it will create, is developed, there will hopefully be further ways of increasing engagement. This is a potentially great step forward for the profession, and should strengthen the RPS. Pharmacists do need to realise it isn’t just what the RPS can do for them, but also why it is crucially important that they engage with the professional body. We are a relatively small profession, facing technological and professional pressures that are both a challenge and an opportunity. We need a strong professional organisation with high membership engagement to fight our corner.
I am standing for election to the English National Board of the Royal Pharmaceutical Society. I have worked in community, hospital, and academia. My full election details are here [PDF].
Please take the time to consider me as one of your candidates.
Pharmacists in all sectors of the profession are facing professional challenges during this sustained period of economic, organisational, and technological change. We need an effective professional body working with organisations such as the PDA, the Guild, and the UKCPA to strengthen the ground we stand upon, and support pharmacists in their professional lives.
The RPS is a more responsive body since its separation from the regulator. It is still finding its feet. I support the RPS Faculty as a step forward, and will fight to help the RPS bring more value to its most valuable asset, its members. Our unique body of professional knowledge should define us. Every year, the problems associated with medicines become more clearly defined; the preventable harm from medication errors and adverse drug reactions, the problems of translating evidence based medicine into the rational use of medicines, and the adherence issues patients have. While we are a relatively small profession, there is no other group primarily concerned with medicines that matches us.
Our society should lead the other professions’ organisations on medicine-related issues. I was pleased to see the RPS sign the All Trials initiative on clinical trial data transparency. While such high level issues may not directly affect the pharmacist on the ward or the community pharmacist, taking the lead on medicines issues increases our credibility and stakes out our claim to be the medicines experts. Medicines are our turf. Our professional role needs to be supported with scientific evidence. That includes arguments for our extended roles, and evidence to counter some of the poor practice in target setting for pharmacists that is undermining professionalism.
Hard-working highly competent pharmacists are reduced to tears by unfair pressures to hit targets on services that were meant to increase our professional status. Other changes, like remote supervision, threaten both pharmacists and the patients we serve. Technology should enable us to deliver better, more professionally rewarding, care to our patients, not cut us out.
Give me your vote and I will work to make the RPS the organisation you deserve.