Esomeprazole made general sales drug despite GP concerns
The anti-acid treatment esomeprazole is to be made the first PPI available on general sale in the UK, after the drugs regulator agreed to switch it from pharmacy-only status – despite concerns from the GPC this could mean patients with serious underlying gastric problems ignore their symptoms.
The drug, which has the brand name Nexium, was only made a pharmacy (P) medicine in 2013, at the time bringing it in line with other a number of other PPIs available as P-medicines including the related drug omeprazole.
The Medicines and Healthcare products Regulatory Agency (MHRA) has now announced it has agreed to drug manufacturer Pfizer’s request to reclassify the drug so that people can buy it over the counter without being given pharmacy advice.
In its official assessment report, the MHRA said it ‘has agreed to reclassify Nexium Control from a pharmacy (P) medicine to a general sales list medicine (GSL) in the UK for the short-term treatment of reflux symptoms (eg heartburn and acid regurgitation) in adults’.
The move comes despite objections from the GPC, which said elderly people in particular may delay going to the GP about symptoms that could well indicate a serious underlying problem.
In an official consultation response, the GPC said: ‘We have concerns about the proposals to reclassify the Nexium Control 20 mg Gastro-Resistant tablets from prescription-only medication (POM) to a GSL produce and we would be unable to support this change without a period of pharmacist-only availability.
‘We also have specific concerns relating to some groups of patients, particularly elderly people with new-onset symptoms. It would be unusual for elderly patients to present with dyspeptic symptoms without prior history, and it would alert pharmacists to refer the patient to a GP to investigate more rapidly than in the general population.’
However, the MHRA said the risk of an underlying serious condition being missed was ‘no greater for esomeprazole than any other treatment for heartburn’ and that packet instructions would be sufficient to stop people misusing the drug.
The MHRA’s assessment report stated: ‘The risk of missing an underlying more serious condition is no greater for esomeprazole than with any other treatment for heartburn currently available. As treatment of heartburn symptoms is generally treated with a GSL product (95% of the sales volume falling into this category) there is no greater risk with taking Nexium Control than taking any other currently available GSL medicine for this condition on the market. Pharmacist intervention would not be available in these circumstances whichever product was chosen.’
It added: ‘To ensure correct use without pharmacist intervention, there are clear directions about dosing and treatment duration in the outer carton and patient leaflet which are further supported by the package size.’
The MHRA said it received 10 responses in total to the consultation of which two were in favour, four ‘raised issues’ and four were not in favour.