Manufacturer Pfizer confirmed on Tuesday (March 28) that it had applied to the Medicines and Healthcare products Regulatory Agency (MHRA) to reclassify sildenafil 50mg film-coated tablets from prescription-only medicine (POM) to P medicine status.

“The availability of the pharmacist-supplied, non-prescription sildenafil could offer men an additional way to access a legitimate, long-established and well-studied treatment for erectile dysfunction,” Pfizer's UK medical director Dr Berkeley Philips said.

Pfizer said it will provide pharmacists with “specific training to support them in dispensing sildenafil to appropriate patients only”, if the switch goes ahead.

RPS “fully supports” move

The Royal Pharmaceutical Society (RPS) welcomed the potential reclassification, and added that if agreed, pharmacists will also receive further advice and guidance from the RPS on erectile dysfunction.

“Sildenafil is one of the most counterfeited medicines,” said RPS president Martin Astbury, with many men “resorting to the internet to buy medication".

“Discussing health problems with patients and advising on the benefits and risks of treatment options is an integral part of the role of a pharmacist."

“The potential switch of sildenafil from POM to P status increases access to a medicine that has been proven to be safe and effective when used appropriately," Mr Astbury added.

New packaging proposals

The MHRA consultation – which includes a copy of the updated patient information leaflet and packaging proposed (see image below) – is open to the public until April 18.

A final decision on whether sildenafil will be reclassified will be made after the MHRA has “carefully analysed” the results of the public consultation, the watchdog said yesterday.

If the reclassification goes ahead, sildenafil 50mg will still remain available on prescription under the Viagra brand name, Pfizer added.

Read the consultation document and submit your views here.