Let’s have some over-the-counter evidence

I have an editorial in The Pharmaceutical Journal on over the counter medicines and pharmacists relationship with them. Here’s part of it:

While the secret shopper work carried out by the consumer watchdog Which? in 2013 investigated[1] the quality of advice on OTC medicines given in pharmacies at the point of sale, an earlier report[2] in Which? published in 2012 focused on OTC products themselves. Among the products that were judged to be below par were sub-therapeutic doses of drugs, dubious herbal slimming tablets, oils that allegedly reduce scarring and some highly implausible alternative remedies. A pharmacist drawing up a local formulary of prescription drugs for a GP would take into account evidence of effectiveness, advice from evidence-based guidelines and a positive risk-benefit ratio. How many OTC products would reach the required standard?

Read more…

E-Cigarettes

Here’s a link to my brief piece on e-cigs in The Pharmaceutical Journal:

No drug is safer without regulation and that includes nicotine. Licensed e-cigarettes used as part of pharmacists’ smoking cessation role would be a step forward. Concern at the meeting that e-cigarettes were becoming an “easy fix” was supported by suggestions that smoking cessation services were not being renewed on the basis that e-cigarettes had solved the problem. Pharmacists need to defend the added value of those services and ensure e-cigarettes are an option when we have a licensed product.

In the meantime, we cannot support the sale of unlicensed e-cigarettes in pharmacies. This places pharmacists in a difficult position of selling an essentially recreational product with no licensed medicinal claim. There is potential for variation in dosing with unlicensed e-cigarettes, without the regulatory oversight of quality and safety the MHRA provides.

 

Ecigs and pharmacist autonomy

The surge in the use of ecigs has taken the health sector, including professional bodies, the pharmaceutical industry and regulators, by surprise. It’s a fascinating rise of a novel new delivery system, which has happened outside of the normal regulatory process.

This post isn’t about the evidence as to whether ecigs are harmful, whether they are a gateway to smoking, or whether they are an effective form of smoking cessation therapy (in future, they may have a role, but that should be after normal scientific evaluation and regulatory processes), but about the issues of professional autonomy they raise for pharmacists, and whether they are a good test case for exerting that autonomy.

Yesterday the Chief Pharmacists of the UK published an open letter raising concerns about ecigs. Their main points were:

  1. Health, safety and well-being of patients must be the first concern of pharmacy owners and superintendent pharmacists (as it is for pharmacy staff)
  2. Pharmacy staff should be empowered to exercise their professional judgement in the best interest of patients and public
  3. They point out ecigs are unlicensed and have limited scientific evidence
  4. They say they do not support their use as smoking cessation aids and that they should not be presented as having any therapeutic value

The response from companies who have decided to stock ecigs is interesting. Boots have agreed with concerns, suggesting that their decision to spend two years developing a ecig offering with a company is a responsible way forward. They hope to be the first to get a licensed preparation. Before that happens, Boots seem happy to sell an unlicenced product with no proven therapeutic value. Lloyds has said it is not selling ecigs as nicotine replacement therapy. Which begs the question what are they selling them for? None of this counters the concerns of chief pharmacists about the suitability for ecigs as a product pharmacy sells. At best, it is mitigation for a wrong decision to stock an unlicensed ecig in the first place.

Individual pharmacists are faced with the fact that their companies, and their superintendent pharmacists,  are happy to stock a product that is:

  • Not proven to have a therapeutic benefit
  • Is unlicensed
  • Is unsupported by the Royal Pharmaceutical Society
  • Is strongly felt should be a licensed product by the government and the MHRA
  • Is a matter of concern for all the Chief Pharmacists in the UK
  • Is also a matter of concern to the GPhC, who feel the RPS and MHRA guidance should be considered.

They should ask themselves if they are equally happy about this (and some may be).

They could of course, just ignore the ecigs and follow the advice that they tell patients they are not a smoking cessation aid. That still leaves them in the position of supplying a product they might not have personally stocked in the first place.

It is arguable that if acting as the responsible pharmacist within a pharmacy you could make a good case for removing any ecigs from display within the registered pharmacy premises on the grounds of maintaining the health, safety and well-being of patients. Certainly, you have the GPhC, the RPS, the MHRA, and all the Chief Pharmacists to support your stance. The fact that the superintendent of the company has a different opinion, does not invalidate your own professional judgement. In reality, it isn’t that simple. There may be local pressure from non-pharmacist managers who do not feel it is the place of pharmacists to make this decision – after all they have material from head office saying this is a perfectly OK product. The pharmacist may be putting themselves in a difficult position in terms of future performance reviews.  It would be nice if superintendent pharmacists actually issued a statement that such action would be permissible, that the professional autonomy of individual pharmacists on stocking such products was key and that no detriment would come to pharmacists who made this professional judgment.

As for regulators, in a recent case of MUR fraud the GPhC recently said:

“What we have to ask ourselves is whether, when there are pressures [and] mistakes, as inevitably there will be, can we have confidence that the registrant might be able to stand up and not ‘buckle’?”

Should it always be down to individual pharmacists having to exert their professional independence in a battle of wills? Is that the best we can do? Hope people don’t “buckle” when they are under immense work pressures? Is it time for regulators to regulate the industry in a manner that reduces the toxicity of this commercial environment, and help create a more supportive environment for individual acts of professionalism? Of course individuals need to take responsibility, but it is naive to think that the environment they practice in has no influence. Recent NHS scandals note both the role of individuals and the culture of organisations. Could the GPhC exert more control over superintendents? Could they make it clear that employee pharmacists should have the professional autonomy as individual pharmacy owners to remove items from sale they feel are incompatible with the best interests of patients and the public? Ecigs make a great test case for what actual control pharmacists over the materials they provide to the public, just as GPs have control over what they prescribe to the public.

And from there we might make some other steps forward on OTC medicines and homeopathy….

Photograph: Creative Commons from Vap in Liberty.