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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.  

Readers' comments (8)

  • Good decision.

    A great drug.

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  • Una Coales. Retired NHS GP.

    I welcome this decision. Would free up GP appointments. I wouldn't undermine the public. They know when to seek help if an OTC drug does not work and symptoms persist or worsen.

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  • At £18.50 for 28 tablets plus chemist profit, I think most people will still try and get it prescibed anyway (certainly here in Scotland where prescriptions are free and the people "careful" with their finances.

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  • This is a really positive step in helping to reduce the burden on GPs.

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  • I cannot believe most of the comments so far. There is a big campaign to identify early oesophageal cancer and we are now releasing one of the more powerful PPIs for general sale. I think this is dangerous and misguided.

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  • I find myself in agreement with Peter Mcevedy. Working as a primary care pharmacist with a focus on helping practices with their unplanned admissions patients and reviewing their medication, one of the major interventions our team tends to make is advising on reducing doses of long-term PPI therapy.

    The association with atypical fracture risk, as well as masking potential signs and symptoms of cancers, make me quite concerned to see these products become available as GSL items, with no healthcare professional intervention. Time will tell.

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  • If you're going to think like that then paracetamol shouldn't be GSL as this could potentially mask a brain tumour. All medicines have the potential for side effects. What we should be doing is encouraging people to look after themselves sensibly, whilst looking out for alarm symptoms, instead of running to the GP for an ailment that could be treated with a short course of a PPI. Our healthcare system is unsustainable and without switches like this it won't survive.

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  • Whew, what a relief. I hope they give all contientious meds to patients over the counter. Would like to see how many of them still want to buy a medicine with brand name for 5x the generic price as the lady with whom have wrestled a whole week for this stupid Esomperazole.
    Iwas a simple case: Mum had omeprazole 20mg in hospital and was discahrged on this as tolerated well. Daughter insisted to GP that Mum doesn't tolerate 'plastic' ( capsules). As a docile GP, I succumbed to pressure and prescribed the generic esomeprazole. Daughter wants the brand name which is 5x costier than the generic - it's not about plastic anymore. Hospital sent a fax today refusing to prescribe this as not on formulary. I could only advise the irate family who felt 'GP doesn't care' to put in a written complaint to the CCG.
    This is where part payment is going to play a highly educative role in the future.

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