The MHRA has reclassified Nexium Control from a P medicine to a GSL item despite concerns from the Royal Pharmaceutical Society (RPS) and British Medical Association (BMA).

The MHRA announced its decision last week (January 27), following a consultation last year. The medicines watchdog said concerns raised by health bodies in their consultation responses about the long-term use of the gastroresistant tablets, which contain 20mg of esomeprazole, would be addressed by clear labelling on the product.

The European Commission had authorised the sale of Nexium Control without a prescription in all EU member states in 2013, the MHRA said. As a result, the product was classified as a P medicine, although the product had not been available to buy in pharmacies, the MHRA told C+D. 

The RPS told C+D that its views on the reclassification had not changed since its consultation response, in which it claimed that GSL status would not ensure that patients received advice from a health professional when they bought the drug. At the time, it urged the MHRA to ensure that the drug was classified as a P medicine.

“Pharmacy sale of medicines is usually the first step in widening public access and offers added safety for patients, as pharmacists and trained healthcare advisors are on hand to counsel patients on their medicines. We believe that this added safety measure is needed for Nexium 20mg,” the RPS said in its response.
 

Opposition to the change

The RPS's consultation response was one of four that opposed the reclassification, out of a total of 11. Only two responses had supported the move, said the MHRA, which launched the consultation last July at the request of Nexium’s manufacturer Pfizer. 

In its own response, the BMA requested “further consideration” to be made, stating it could not support the reclassification to GSL status without a period of pharmacist-only availability.

But the MHRA said last week that its Commission on Human Medicines (CHM) had found "no new issues of concern" as a result of the consultation. The risk of an overdose or prolonged treatment with the drug was considered low and there was sufficient information in the drug's packaging and leaflet to alert patients that it should not be taken by pregnant or lactating women or by children, it said.

The product was clearly labelled for a maximum use of two weeks and carried advice for people aged over 55 about when to seek medical advice, the MHRA said. This allowed people to use the medicine safely without the need for pharmacist input, it stressed.

The CHM had also been reassured by advice in the product's information leaflet which directed patients to a pharmacist if symptoms persisted or another course of treatment was needed, the MHRA said.

As a result of the consultation, the CHM had decided that Nexium Control should be switched to a GSL item for the treatment of heartburn and acid regurgitation in maximum pack sizes of 14 tablets and for no longer than two weeks without consulting a doctor, the MHRA added.
 

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