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Government intent on pushing more drugs OTC

Alarm at the over-the-counter revolution follows the controversial decision to allow direct-to-consumer advertising for reclassified drugs – Rob Finch reports

The Government's drive to expand the over-the-counter sale of drugs is gathering pace, with its drugs watchdog now openly intent on removing control of large sections of patient care from GPs.

Pulse has learned that the Medicines and Healthcare Products Regulatory Agency (MHRA) will 'encourage' companies to apply to reclassify drugs, making them available to the public without GP involvement.

Many doctors are alarmed at the over-the-counter revolution and the issue is bound to set sparks flying when it is debated at this week's BMA annual representatives meeting in Llandudno.

And in another controversial move, the MHRA announced last week that reclassified medicines for a range of disorders can be advertised directly to consumers, raising serious concerns among GPs about the implications for workload (Pulse, June 14).

The MHRA has said the Government intends to increase the number and range of products sold over the counter 'as quickly as possible'.

Along with the Royal Pharmaceutical Society, it has set out a list of candidates for reclassification (see above). A proton pump inhibitor on the list has already been reclassified, with the anti-flu drug zanamivir (Relenza), topical steroids for eczema and diuretics for hypertension among those others near the top of the list.

Inclusion of some of the drugs on the list does not worry GPs, but the Government's new agenda has already controversially seen simvastatin switch – a move that attracted strong criticism from the GPC.

And GPC prescribing subcommittee chair Dr Peter Fellows warned many of the other drugs on the list – particularly antihypertensives – were unsuitable for the switch because of the dangers of side-effects and the need for careful professional monitoring. He said: 'There's a huge question-mark over them. Patient safety is the paramount concern.'

While Dr Fellows said the GPC was very much in favour of supplementary prescribing by nurses and pharmacists, reclassifying drugs was 'a different kettle of fish'.

He added: 'We're in favour of liberalisation, but not down to general sales licence – so that patients could get these drugs in supermarkets and corner shops.'

Dr Stephen Kownacki, chair of the primary care dermatology society, cautioned against patients buying potent steroids for eczema and warned it would be difficult to monitor resistance to antibiotics on the list if patients were buying them from a number of different pharmacists.

There are also worries over the effect of the over-the-counter switch on GP workload.

Professor Tony Avery, professor of primary health care at the University of Nottingham and chair of the UK Drug Utilisation Research Group, said: 'GPs are working to set formularies – it creates not only added workload, but dissonance with the patient if they can't get the product they want.'

Such concerns have become particularly intense since the MHRA's announcement that companies will be able to advertise reclassified drugs for cardiovascular and respiratory diseases, mental illness and peptic ulcers directly to patients.

Helen Darracott, director of legal and regulatory affairs for the Proprietary Association of Great Britain, welcomed the move, saying advertising was one of the most important means of informing consumers and health professionals.

But Dr Fellows warned direct-to-consumer advertising of formerly prescription-only medicines had caused 'a major hike' in workload in the US, as patients visited their GP to get drugs cheaper than the over-the-counter cost.

The GPC is also worried about the effect of the over-the-counter trend on health inequalities. At the time of the simvastatin announcement, GPC chair Dr John Chisholm said: 'It's pushing provision into the private sector. If it's worth doing it should be equitably available to all patients.'

The suspicion remains that the Government's plans are heavily motivated by the desire to cut costs – and certainly the potential savings are huge.

Last week, the Association of the European Self-Medication Industry suggested the enlarged EU could save some £10.5 billion by reclassifying 5 per cent of prescription medicines. It said the UK was the only country in Europe with the political will to make the move.

Health Secretary John Reid has argued that reclassifying simvastatin from prescription-only to pharmacy status gave the public 'more choice about how they protect their health'.

To some extent Professor Avery, a GP in Nottingham, agrees, supporting the individual's right to make decisions about medication, even where the evidence for benefit is slight. 'For any government in the world it is probably not feasible to fund all health interventions,' he said.

But he added: 'We need to make sure this is not a backdoor way of not spending the money on the health service.'

Drugs the Government wants to see change

from prescription-only to pharmacy status

lAnti-flu drug zanamivir (Relenza)

lMalarial prophylactics

lb-blockers, calcium channel blockers and diuretics for hypertension

lPotent topical steroids for eczema

lInhaled selective b2-agonists and antimuscarinic bronchodilators for stable asthma and COPD

lOrlistat and sibutramine for obesity

lBroad-spectrum antibiotics for eye infections

List not exhaustive Source: Royal Pharmaceutical Society

How patient choice

agenda has driven

drug reclassification

lDecember 2001

Medicines Control Agency (now MHRA) reviews process of reclassification

of drugs

lEarly 2002

Royal Pharmaceutical Society sets out list of candidates for reclassification from prescription-only medicine

to pharmacy status

lMarch 2004

Zanprol (omeprazole 10mg) launched as a pharmacy medicine

lMay 2004

Health Secretary John Reid announces reclassification of simvastatin – Consumers Association warns that the public are being used as 'guinea-pigs'

lJune 2004

Advertising ban lifted on treatments for cardiovascular disease, respiratory conditions, peptic ulcers, serious skin disorders and rheumatic conditions

lJuly 2004

Zocor (simvastatin 10mg) expected to be sold in pharmacies

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