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POM-to-P switching

Sildenafil to be reclassified to P medicine

Sildenafil will be available through pharmacy outlets, following a discussion with the pharmacist, for adult men with erectile dysfunction.

Sildenafil pills

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Sildenafil will be available through pharmacy outlets, following a discussion with the pharmacist, for adult men with erectile dysfunction

Sildenafil (Viagra Connect, Pfizer) is to be formally reclassified from a prescription only medicine (POM) to a pharmacy medicine (P), the Medicines and Healthcare products Regulatory Agency (MHRA) has announced.

Sildenafil will be available through pharmacy outlets, following a discussion with the pharmacist, for adult men with erectile dysfunction. The drug will be sold at a maximum daily dose of 50mg and a maximum pack size of eight tablets.

The decision to reclassify the drug was made following an assessment of the safety of sildenafil, advice from the Commission on Human Medicines and a public consultation earlier this year. The drug will not be sold to those with severe cardiovascular disorders, liver failure, severe kidney failure or individuals taking certain interacting medicines.

“This decision is good news for men’s health,” said Mick Foy, MHRA group manager in vigilance and risk management of medicines.

“The move to make Viagra Connect more widely accessible will encourage men to seek help within the healthcare system and increase awareness of erectile dysfunction,” he added.

President of the Royal Pharmaceutical Society, Ash Soni, welcomed the MHRA’s decision to switch sildenafil to a P medicine.

“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,” he said.

“The switch will increase access to a medicine that has been proven safe and effective through over 15 years of use by many millions of men, and provides a genuine and safe source of supply of one of the world’s most counterfeited medicines,” he added.

Pfizer is currently working on plans to launch the drug in the UK in the spring of 2018. According to Pfizer, in the interim the company will be implementing an extensive training and education programme within pharmacies.

“We understand some men may avoid seeking support and treatment for this condition so we believe giving them the option to talk to a pharmacist and buy Viagra Connect could be a real step forward in encouraging more men into the healthcare system,” said Berkeley Phillips, UK medical director at Pfizer Ltd.

“As erectile dysfunction may be a sign of an underlying condition such as diabetes, high blood pressure, or heart disease, there could also be a wider benefit to public health in the long term,” he added.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20204025

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