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Pfizer applies to switch sildenafil from POM to P

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Pfizer applies to switch sildenafil from POM to P

Pfizer has applied to the Medicines and Healthcare products Regulatory Agency for sildenafil 50mg tablets to be reclassified from POM to P status.

Sildenafil, first launched as Viagra in 1998 for treating erectile dysfunction, has data from 15 years of prescription use, which demonstrates a good safety profile, according to the Proprietary Association of Great Britain (PAGB).

John Smith, PAGB chief executive, commented: “Erectile dysfunction [ED] is a condition that is easily self-diagnosed and suitable for self-treatment with the support of pharmacists, who are ideally placed to support men with ED and identify whether sildenafil is a suitable treatment for their condition. They will be able to identify any red flags or concerns which would need further investigation by a GP or specialist doctor.”

Safe and effective

The RPS also supports the move. President Martin Astbury said: “The potential switch of sildenafil from POM to P increases access to a medicine that has been proven to be safe and effective when used appropriately through over a decade of real world use by millions of men. 

“Erectile dysfunction can be a warning sign of cardiovascular disease, and increasing access to sildenafil via private consultations at pharmacies means more men will get the help they need.  Pharmacists will provide referral to local GPs when necessary, which could help detect the underlying cause of ED and potentially reduce heart attacks and strokes.

“Around two-thirds of men with erectile dysfunction will do nothing about their condition or resort to the internet to buy medication. Sildenafil is one of the most counterfeited medicines, which means at best they will be getting substandard treatment and at worst risking their health.  Men going to a community pharmacy can be assured of a safe and legitimate supply, as well as high quality advice which will ensure the medicine is right for them.”

Pfizer’s application will be supported by an extensive pharmacy education and training programme.

The consultation closes on April 17.

Men going to a pharmacy can be assured of a safe and legitimate supply

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