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What lies behind the OTC drugs drive?

Switching medicines from POM to P may be more convenient for patients, but is it medically sound? By Lilian Anekwe investigates

By Lilian Anekwe

Switching medicines from POM to P may be more convenient for patients, but is it medically sound? By Lilian Anekwe investigates

Brightly lit, and crammed with enticingly colourful pills, vials and bottles, a modern pharmacy lies somewhere on the spectrum from superstore to alchemist's laboratory.

That tension between the commercial imperative of pharmacies, and the powerful and potentially dangerous products they sell, is rarely more obvious than in the debate over the Government's drive to make more medicines available over the counter.

There are implications for both patient safety and public health, as the recent proposals to make antibiotics available OTC - which drew an outraged response from the country's leading infectious disease experts – aptly demonstrate.

Plans by the Medicines and Healthcare Products Regulatory Agency for pilots of the first OTC mainstream antibiotic - trimethoprim, a drug 30% of UTI-causing bacteria are already resistant to – have led to questions over whether commercial gains are being put ahead of public health.

Back in August, the British Society for Antimicrobial Chemotherapy condemned proposals for OTC antibiotics (the MHRA also plans a consultation on nitrofurantoin) as ‘entirely commercially driven'.

Professor Roger Finch, chair of the Department of Health's Advisory Committee on Antimicrobial Resistance and Healthcare Associated Infection, says the committee also has serious reservations, which he hopes will be heeded by the MHRA.

‘We are in receipt of several requests to consider prescription-only medicine to pharmacy switches from the pharmaceutical industry. This has raised significant professional concern in that it's not a strategic move, it's a commercial one that comes at a crucial time when we are trying to communicate the importance of prudent antibiotic use.

‘We have made appeals to the appropriate regulatory bodies and hope those have been heard. It's reached an impasse and the MHRA has paused for further consideration.'

But a senior pharmaceutical industry expert, speaking to Pulse on condition of anonymity, suggests the pharmaceutical industry might be getting implicit encouragement from ministers.

‘The Government wants people to be more self-reliant and responsible for their own health and less dependent on NHS services – so to some extent this is how they are making that policy manifest.

‘Some people think the pharmaceutical industry is terribly wicked and money driven, but that's a bit unfair. Companies wouldn't do it to make a loss, but they're getting encouragement from sentiments from the MHRA and the Government.'

These ‘sentiments' can be traced back to a response to a consultation titled Choice in the NHS, published in 2003, in which the Government pledged to ‘expand the range of medicines pharmacists can provide without prescription'.

They were echoed in a MHRA business plan for 2004-5, which stated: ‘We aim to expand the range of treatments available without prescription in for example, eye infections.'

And again in 2005/6: ‘We will continue to encourage companies to submit applications. New applications we expect during 2005/6 include a popular anti-infective eye drop [and] an antibiotic for recurrent urinary tract infections in women.'

MHRA figures show the stream of applications has continued unabated. Fifteen applications for reclassification have been made since the beginning of 2006, and since April 2002 18 drugs, including antibiotics, emergency contraceptives, NSAIDs and statins, have gone on sale OTC.

Just this week, the MHRA launched a consultation on a POM to P switch for a drug to treat the symptoms of benign prostatic hyperplasia. At a European level applications have also been approved and rejected by the EMEA for orlistat and sildenafil, respectively.

But while it is still unclear whether trimethoprim will be made available OTC nationally, it is already on sale in some areas as part of patient group directions, and the PCTs involved insist there has been no spike in demand. PGDs are also in operation in several PCTs to treat common minor ailments such as impetigo and thrush.

John Radford is director of public health at Rotherham PCT, where trimethoprim is available for free to women who have had a previous GP-diagnosis of UTI and who meet criteria set out in a diagnostic protocol.

Since its introduction two years ago, 31 of the PCT's 54 pharmacies have signed up to the PGD, and issue around 80 courses of the antibiotic a year.

Many more women access the service than are prescribed drugs, with some being given advice or referred back to their GP, and pharmacists are paid £4 per assessment and another £1 dispensing fee.

‘We've had no problems – no adverse effects, and no complaints. It's simply about making it more convenient for women to access the antibiotics they need more easily.'

Freeing up GP consultations is regularly trotted out as a justification for POM to P switches, but Dr Bill Beeby, chair of the GPC's prescribing committee, isn't entirely sold.

‘I'm not convinced simplistically saying "there are X million GP consultations for minor ailments" justifies switches drugs from POM to P. The treatment for some of these minor ailments might be simple but the diagnostic process is not always that simple.

‘A legal switch opens up the market but does not necessarily shift care from doctors to pharmacists, especially if those patients just end up coming back to their GP anyway.'

Although PCTs where antibiotics are available as a PGD have seen no surge in demand, it takes longer for antibiotic resistance to emerge – particularly if records of women who have resistant infections are absent or incomplete.

There are concerns the increased availability of azithromycin tablets, which went on sale earlier this month as part of a chlamydia service, will encourage antibiotic resistance to gonorrhoea.

On the other hand, the prohibitive cost of the chlamydia service, at £45 – £25 for the test kit and £20 for the tablets – may mean patients shun the OTC option in favour of seeing their GP. So far, around 7,000 pharmacists have taken up the service, but there are no figures yet on how many patients have made use of it.

To learn the lessons of previous OTC switches we are reliant on academic research, which again takes time to generate.

The emergency hormonal contraceptive pill became available OTC in January 2000, and according to several analyses, there has been no increase in its use or in unprotected sex, and no decrease in the use of more reliable forms of contraception.

That evidence could prove part of the Government's thinking in plans to pilot the contraceptive pill over the counter, as part of a commitment to widen access to contraception.

But since the much publicised announcement by Lord Darzi in December to ‘work with PCTs over the next year to pilot the supply of contraception, including the contraceptive pill' through pharmacists, little progress has been made – much to the dismay of David Pruce, director of policy and communications at the Royal Pharmaceutical Society of Great Britain.

‘The contraceptive pill is something pharmacists should be able to do but we'd want to make sure there are appropriate training and processes to make sure it's done safely. But there's been no discussion with the DH and no movement.'

But it seems only a matter of time before there is movement on making the pill available OTC, at first in pilots and then potentially nationwide. And that may raise concerns that, as more and more drugs are switched, GPs may lose their gatekeeper role in frontline care.

Which is not something Dr Beeby thinks is necessarily a bad thing.

‘I'm all for patients taking a greater role in their own healthcare, I don't see much of my job is as a gatekeeper anyway. If we can make drugs available more safely elsewhere I'd be happy to signpost my patients towards them.'

As the range of drugs available in pharmacies continues to increase, access to medicines may increasingly be seen as a commercial transaction.

Case study: Cornwall & Isles of Scilly PCT

Paul Hughes, the PCTs pharmaceutical advisor, oversees a minor ailments scheme that makes five prescription only medicines available as part of a patient group direction.

"We have PGDs for 5 medicines – for impetigo, vaginal thrush, nappy rash and conjunctivitis, as well as trimethoprim for UTIs. It started off as a pilot in a couple of pharmacists, but then grew and grew, and now it is financed through a local enhanced service.

"There is a diagnostic protocol that is agreed by the PCT, and all pharmacists are trained and now to follow it. We don't offer trimethoprim to every woman – some women are referred back to the GP, some women are given advice on other possible things to try.

"In the last financial year the pharmacists gave 352 courses of trimethoprim under the PDG, so theoretically, that's 352 consultations avoided.

"Each pharmacist has to submit a monthly audit sheet, which documents exactly what was given under the PGD. Antibiotics are a major public health problem and here we have our own pharmaceutical guidelines to prevent them being prescribed inappropriately. There will be a review of resistance in 2009."


How are medicines classified in the UK, and what is a ‘switch'?
Medicines in the UK can either be a prescription-only medicine (POM) – traditionally could only be supplied on a prescription from a medical or dental practitioner, although this was widened in 2006 to include other health practitioners.
Medicines classified as Pharmacy (P) medicine – can be supplied by a registered pharmacist from a registered pharmacy.
General Sales List (GSL) medicine – can be sold from any commercial outlet.
A switch involves reclassifying drugs between categories.

What are the potential benefits for patients and the NHS?
There is now an increasingly wide choice of how patients can access treatment for common minor illnesses, which fits with the Government's agenda to give patient's more control over their healthcare and increase access and convenience. Self-care may relieve some of the burden of minor illnesses from GPs and enables them to do more complex work. There are also some direct financial savings to prescribing costs.

What are the potential public health impacts?
In the case of antibiotics, infectious disease experts are worried that the changes in access to antibiotics will have an impact on the prevalence of antimicrobial resistance, but so far there is little direct evidence so far There are concerns over access to drugs without medical assessment.

What lies behind the drive to make more drugs OTC, and is it safe? What lies behind the drive to make more drugs OTC, and is it safe?

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