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Should pharmacists sell antibiotics OTC?

The decision to supply an OTC antibiotic will be made in exactly the same way a GP would, claims pharmacist Colette McCreedy, but Dr Maureen Crown argues pharmacists are not diagnosticians may miss something.

The decision to supply an OTC antibiotic will be made in exactly the same way a GP would, claims pharmacist Colette McCreedy, but Dr Maureen Crown argues pharmacists are not diagnosticians may miss something.

Yes

Before I consider the suitability of pharmacists to supply azithromycin for chlamydia - already licensed - or trimethoprim for uncomplicated UTIs, currently under consideration, it's worth looking at how these decisions are made.

All decisions on whether a medicine is suitable for classification as a pharmacy medicine are taken by the Medicines and Healthcare products Regulatory Agency. The MHRA takes advice from the Commission on Human Medicines, which is made up of experts in the field who scrutinise the licence applications of all medicines whether prescription only (POM), pharmacy medicines (P) or general sales list (GSL).

The regulator's overarching objective is to ensure that medicines work and are acceptably safe. The classification of medicines is based on weighing up the benefits of widening access to the public within a framework that manages the risks of untoward effects to individual and public health.

The supply of medicines 'over the counter' is often misrepresented as a simple transaction. This is not the case.

Medicines with a P licence can only be supplied under the supervision of a pharmacist and from a registered pharmacy and the conditions for its authorisation may be very different to its POM counterpart. That means there may be tighter rules on the quantity that can be supplied, the conditions it can be used to treat and the upper and lower age of people who can be treated.

As part of the marketing authorisation, training support must be provided that is approved by the MHRA. In addition the Royal Pharmaceutical Society will issue practice guidance that, through the code of ethics, imposes further restrictions on how a P medicine may be supplied.

In the case of azithromycin, pharmacists will only supply this as a treatment for asymptomatic chlamydia infection. This will be diagnosed by the gold standard nucleic acid amplification test, exactly the same test that is used by GPs and other health professionals to diagnose chlamydia.

As all pharmacists will be using the same test result database, it will be impossible for the same patient to obtain multiple treatments of azithromycin - although I have yet to find a convincing reason why someone would want to do this.

Pharmacists are medicines experts and well aware of both the benefits and risks of antibiotic therapy and of the need to manage it responsibly to avoid long-term problems with antimicrobial resistance. Also, experience has shown pharmacists will treat any new 'off-prescription' medicine with great care and caution.

Turning to trimethoprim, if the MHRA decides to allow this antibiotic to be made available without prescription, the professional guidance from pharmacists' regulatory body will be that supplies must only be made personally by a pharmacist. Again, support training will be developed as well as protocols, which will be in keeping with national guidance for the treatment of acute bacterial cystitis.

Under these conditions we believe pharmacists have the competence to ensure that the product is supplied safely and effectively.

I would like to emphasise that the National Pharmacy Association is keen that pharmacists and GPs work together at a local level to ensure both fully understand the limits of the market authorisation for a non-prescription antibiotic product and agree referral pathways for cases presenting in the pharmacy that would require referral.

Colette McCreedy is chief pharmacist at the National Pharmacy Association

No

My first instinct on hearing pharmacists were to be able to sell oral antibiotics over the counter was that they must surely be having a laugh. But that quickly turned to alarm when I realised they weren't.

The line in the sand has, unfortunately, already been breached, with azithromycin available OTC for chlamydia.

Now there is no doubt that a flood of other antibiotics will follow, especially with the pharmaceutical industry using its leverage. One already being considered by the Medicines and Healthcare products Regulatory Agency is OTC trimethoprim for 'uncomplicated UTIs'.

Let's take this as an example of why the idea is so wrong. It sounds reasonable on the face of it. Miss A goes to the pharmacy with acute dysuria, frequency and nocturia but is otherwise well. The pharmacist asks 'Are you pregnant?'- no. 'Are you allergic?'- no. It appears quite straightforward that antibiotics will solve the problem, save the doctor's time and be more convenient for the patient. So why not?

As all first-year med students are taught, a full history is imperative in establishing the differential diagnoses. Then a relevant examination is needed to clarify this. Then and only then can appropriate treatment be given.

With all due respect, pharmacists simply don't have the time, facilities, diagnostic skills or expertise to do this.

Will they have Miss A up on a couch, legs akimbo to look for signs of thrush, atrophic vaginitis, lichen sclerosis or urethral polyps? How about an internal exam to assess pelvic tenderness?

I don't think so. Will they ask her in the middle of a busy pharmacy whether she has had unprotected intercourse and whether her period is late? Will they send her to the loo for a sample to dipstick? If positive, can they get an MSU to hospital to be processed?

Worst of all, I believe, is the risk that a cancer diagnosis could be missed.

A patient can present with what appears to be a simple UTI but on dipstick there is only haematuria and the MSU is negative. This needs to be rechecked as, if persistent, must be investigated by fast track to exclude cancer. How many diagnoses would be missed by patients self-medicating, thinking they have a simple infection and never having their urine dipsticked?

In reality Miss A might well get her three days of bd trimethoprim, but feel better after only three tablets and stop taking them, thinking she can save money next time. Using different chemists means she may have many shortened courses and, of course, can generously lend them to a friend who seems to have the same problem.

The chance of wrong and missed diagnoses with inadequate courses of treatment will lead to long-term problems, and the increase in antibiotic resistance does not bear thinking about.

And that brings me to another point. Surely the mantra from microbiologists and the Department of Health is that GPs are the villains, because we prescribe antibiotics inappropriately and profusely? It's therefore our fault that there is so much microbial resistance and so many superbugs.

So why, in heaven, are they considering a free-for-all? Because that is what it will be and it won't stop with trimethoprim. How about a five-day course of amoxicillin if you are feeling a bit chesty?

More importantly, the pharmaceutical industry realises there are huge profits to be made from OTC antibiotics. There is already enormous pressure for more antibiotics to be considered for sale. The patients will be the losers with no holistic care, missed diagnoses and potential deaths. The only winners will be the pharmaceutical companies.

Dr Maureen Crown is a GP in South Woodford, Essex

Should pharmacists sell antibiotics OTC? yes quote

Pharmacists are medicines experts and well aware of risks and benefits

'no' quote

What about five days of amoxicillin if you're feeling a bit chesty?

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