Omeprazole could be first in wave of blockbuster switches

Omeprazole, the blockbuster ulcer drug discovered by AstraZeneca, could soon be dispensed by pharmacists without a prescription, pending final approval by regulators.

The drug was marketed exclusively by AstraZeneca as Losec until a number of generic manufacturers launched their own versions following UK patent expiry last year.

The Committee on the Safety of Medicines has already concluded the POM-P switch can be made safely, and is now seeking views from stakeholders before giving the final go-ahead.

Losec is one of the biggest selling drugs of all time earning AstraZeneca $5.7 billion in 2000 and would be one of the biggest POM-P switches ever.

Since its patent expired in April last year, Losec sales in the UK have been decimated by generic competition, with the majority of England's 4.5 million prescriptions in 2002 being generic.

The Medicines and Healthcare products Regulatory Agency has agreed with generics manufacturer Galpharm that patients' long-term use of the drug without consultation with the pharmacist will be discouraged, including limiting packet sizes to 28 tablets.

The MHRA says pharmacists are already familiar with the diagnosis of gastro-oesophageal reflux disease (GORD) following the switch of GlaxoSmithKline's treatment Zantac some years ago, and the same guidelines for referring patients to doctors will be used in this instance.

The Royal Pharmaceutical Society is particularly keen to see more prescription medicines switched and last year drew up a radical list of medicines that could be made available as pharmacy products, including Viagra and the cholesterol-lowering statin drugs.

While many people have dismissed statins as unsuitable for OTC sale because of issues of safety and medicines management, the Department of Health has signalled its support for the move.

Merck Sharpe and Dohme's statin Zocor (simvastatin) bears many similarities with Losec it is one of the most prescribed medicines, is proven to be very highly effective and safe and has also recently gone off-patent.

MSD has refused to comment on whether or not it is applying for a POM-P switch, but the patent expiry opens up the possibility of another company marketing a consumer version.

Early indications are that the idea has split opinion NHS professionals.

Prof Chris Packard, Head of Clinical Biochemistry at Glasgow Royal Infirmary, told the Sunday Telegraph: "This is a good option. It is a good way forward for expanding the prevention of coronary heart disease".

But Norman Evans, Chief Pharmacist at Wandsworth PCT, said that while statins were probably as safe as other OTC drugs available, he remained sceptical about allowing them to be dispensed without a prescription.

Some concern does remain about the safety profile of statins, however, following the withdrawal of Bayer's Lipobay in 2001. Muscle wasting and other serious side-effects are seen occasionally in all statins, but simvastatin in particular has a wealth of data to show its overwhelmingly sound safety profile.

"We won't be able to monitor patients very easily and theyl be putting themselves on these statins without a proper assessment of their risk", said Norman Evans. "If these statins become available with a considerable level of advice then fine, but I suspect that won't happen. It'll just be the affluent, worried well buying these things unnecessarily".

He added that the availability of OTC cholesterol-kits would not prove to be of great use, given that a cholesterol test in itself is not a particularly good indicator of clinical risk.

"The pharmacist should also look at smoking habits, weight, diet and alcohol intake, not just a cholesterol figure", he said.