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Medicines regulation

Pharmacists oppose Pfizer’s plan to make Nexium Control more widely available

Pharmacists are opposing proposals to allow Pfizer’s proton pump inhibitor (PPI) Nexium Control to be made available through non-pharmacy outlets.

The Guild of Healthcare Pharmacists (GHP), supported by the Royal Pharmaceutical Society (RPS), says changing the medicine’s status from a pharmacy (P) to a general sale list (GSL) product would lead to uncontrolled access, exposing patients to the increased risk of avoidable side effects.    

The GHP says Pfizer’s argument that product labelling would ensure appropriate use is “questionable”.

“Not everyone who experiences heartburn needs a PPI. The use of PPIs would be increased through greater accessibility of Nexium as a GSL medicine, leading to increased profitability to Pfizer but not necessarily appropriate or safe treatment for patients and with greater cost to the public,” the GHP says in its response to a consultation by the Medicines and Healthcare products Regulatory Agency (MHRA), which ran from 2 July to 23 July 2014.

The consultation followed the decision by the European Commission in August 2013 to allow Nexium Control to become a non-prescription medicine. That decision, according to Pfizer, relied on product information as the main risk minimisation tool, and not an intervention by a pharmacist. Pfizer told the MHRA that the product’s active ingredient esomeprazole had been sold safely elsewhere in the world in non-pharmacy outlets.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.20066006

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