The drugs company that markets the proton pump inhibitor (PPI) esomeprazole has applied for it to be made more freely available to buy over the counter, in a move the GPC warns could put patients at risk from potentially serious underlying gastrointestinal complaints.
The drug – brand name Nexium – has been available without prescription as a pharmacy-only medicine since last year, but now drugs firm Pfizer wants it switched to the general sales list (GSL) of drugs, so it can be bought over the counter from other retailers without advice from a pharmacist.
Pfizer – which recently struck a deal with the manufacturer of Nexium, AstraZeneca, to market the drug over the counter – argues esomeprazole is no more risky than other drugs for heartburn on general sale and wants to make it easier for people to access the treatment.
But the GPC said esomeprazole was already easy enough to buy and that without pharmacist checks, patients could take the drug inappropriately and ignore potentially serious underlying causes of their heartburn and indigestion such as peptic ulcers, cancer, or abnormality of the pancreas or bile ducts.
The Medicines and Healthcare Products Agency recently closed a consultation on Pfizer’s request for esomeprazole to be reclassified.
The application from Pfizer read: ‘Heartburn is a well established GSL indication within the UK environment… UK consumers suffering from heartburn and acid regurgitation are therefore very familiar with and experienced in self-diagnosis and self-selection of appropriate treatments for this condition, without the intervention of a pharmacist.
‘By enabling a new class of medicine to be self selected within the GSL category, it will allow those who are suffering from heartburn wider access and more choice to effectively treat their symptoms.’
The drug company also pointed to experience with the related PPI omeprazole, which it said has been sold without safety issues in non-pharmacy setting elsewhere in the world.
The application said: ‘US data on omeprazole in the GLS setting showed a low number of drug interactions and the likelihood of clinical significance was low. The data did not show any specific safety issues relating to misuse or accidental overdose as a result of the sale and supply of the PPI in a GSL environment.
‘Due to the similarity in profiles of the actives, it is likely that Nexium Control will have a similar safety profile to omeprazole if available in a GSL setting.’
But Dr Andrew Green, chair of the GPC’s clinical and prescribing subcommittee and a GP in Hedon, East Yorkshire, told Pulse the BMA was opposed to the move.
Dr Green said: ‘It is our opinion that there are no good grounds for this proposed change. The provision of PPIs as pharmacy only drugs allows patients to have good access to these medications while maintaining the overview of a pharmacist, who can direct the patient to their GP if indicated.’
Dr Green explained PPIs are more effective than other indigestion products and could mask more serious conditions.
He said: ‘PPIs are very good at stopping symptoms and the danger is that somebody has symptoms that require investigation but all they do is keep taking the stuff, if they can just get it over the counter, perhaps because they are afraid of what an investigation might show.’
Dr Richard West, chair of the Dispensing Doctors Association and a GP in Suffolk, said it would be a ‘difficult balance’ to widen access to PPIs while still minimising the risk to patients.
Dr West said: ‘It’s a difficult balance. Actually, we’ve always had a lot of indigestion remedies that have been general sales, both OTC and P, and people have generally used them sensibly but you can always find the odd example where something has gone wrong.’
He added: ‘It’s a matter of getting people to understand if their symptoms don’t settle on it they need to get further advice. If they take one esomeprazole having had a curry and six pints the night before that’s one thing, but if they’re taking it everyday then that’s very different.’
A Pfizer spokesperson said: ‘Pfizer has submitted an application to the MHRA to allow Nexium Control® to be supplied via the General Sales List (GSL). Proton Pump Inhibitors (PPIs) have a long safety history for the treatment of heartburn when used in accordance with the label instructions.’
‘Patient safety is the primary concern for Pfizer. Within the proposed GSL licence, the product has a clear maximum treatment period of 14 days, after which patients are instructed to consult a doctor if no symptom relief is obtained. In addition there are clear instructions in the patient leaflet and on the packaging to aid patients in identifying signs and symptoms for which they should seek advice from a healthcare professional.’
‘The availability of Nexium Control® as a GSL product would provide those with heartburn to have broader access to a medicine that doctors and patients have trusted for years, when often many people would continue to suffer in silence. Switching medicines from prescription to non-prescription status, improves consumer access to affordable healthcare options, empowers people to take charge of their health, and reduces the burden on the NHS.’