Omeprazole, one of the biggest selling prescription drugs ever, which as the brand Losec made AstraZeneca's name, has been launched as an over-the-counter medicine in the UK by GlaxoSmithKline.

Pharmafocus was the first to break the news last November that GSK was to take the now off-patent omeprazole through the prescription only medicine to pharmacy  (POM-P) status and break new ground in consumer medicines.

GSK is one of the country's biggest consumer medicines companies and seized the opportunity to make omeprazole an extension of its top-selling Zantac range of gastrointestinal brands, re-naming it Zanprol.

The proton pump inhibitor (PPI) drug is far more powerful than existing over-the-counter heartburn remedies such as GSK's own Zantac and Reckitt Benckiser's Gaviscon, and the company has had to convince regulators the MHRA that pharmacists will be sufficiently trained to restrict sales to patients who can safely benefit from the drug.

On prescription, omeprazole is indicated for Gastro Oesophagitis Reflux Disease (GORD) and a range of clinical symptoms, including more advanced problems such as oesophageal damage, but Zanprol will be licensed purely for heartburn, a less serious complaint.

GSK has used an expert panel of GPs, gastroenterologists, pharmacists and academics to produce a package of educational materials to help pharmacists manage the treatment of heartburn, including a simple treatment algorithm to differentiate patients with more serious symptoms from those who can be treated with the OTC medicine.

"Years of experience with omeprazole and its ubiquitous use in general practice makes it a good candidate for non-prescription use," said Dr Robert Walt, consultant gastroenterologist, Birmingham Heartlands Hospital. "It is one of the most effective treatments for heartburn and is well tolerated. In addition, a pharmacist should be perfectly able to identify potential alarm symptoms so as to ensure certain patients get to their GPs when necessary."

The PPI class of drugs represents one of the biggest areas of NHS prescribing expenditure, with £403 million spent on the drugs in England in 2002, representing 6% of the total drugs budget. The government says its more liberal policy towards POM-P switches is to allow greater access to medicines through pharmacies and not to shift NHS costs to consumers - but GSK says it is an opportunity to do just that.

"The availability of OTC omeprazole from pharmacies represents a significant opportunity to ease the financial burden on the NHS and the time burden of GPs, as well as benefiting patients who will be able to gain easier access to effective heartburn therapy," added Dr Walt.

In the US, AstraZeneca entered into a deal with consumer products giant Procter & Gamble and the drug was launched in the market last September as Prilosec OTC.

Reporting on the company's full year sales in January, AstraZeneca chief financial officer Jonathan Symonds said the OTC launch had not, as some had anticipated, hurt sales of branded POMs, but had only affected sales of the now generic omeprazole.  The news was a relief for AstraZeneca and its shareholders, who were relying on the continued growth of its second generation PPI Nexium to make up for the rapid loss of revenue from Losec following its US patent expiry.

During the consultation, some stakeholders expressed their concern about the ability of pharmacists to adequately diagnose and manage the gastrointestinal condition. Last June the Royal College of General Practitioners said it was opposed to the switch, and suggested that profits from OTC sales could deter pharmacists from referring patients to their doctor.

Despite these concerns, the Government has backed the omeprazole switch, and is also supporting the even more significant proposal to make cholesterol-lowering drug simvastatin available through pharmacies.

pharmafocus@pharmafile.co.uk