Its decision to approve the reclassification of sildenafil 50mg film-coated tablets – to be manufactured by Pfizer under the brand Viagra Connect – from a prescription-only medicine (POM) to a P medicine, was announced by the medicines watchdog yesterday (November 28).

The reclassification follows a consultation – which ran from March 27-April 18 – prompted by an application by Pfizer.

Checklist for pharmacists

Pharmacists will receive a non-compulsory checklist to determine whether a patient is eligible for sildenafil, with questions around cardiovascular health, other medicines being taken, and medical conditions, the MHRA said.

Packs will be limited to a maximum size of eight tablets, it continued, while patients with severe cardiovascular disorders, uncontrolled hypertension, increased susceptibility to vasodilators, or who feel “very breathless” after light physical activity, will not be eligible.

“Patients can be assessed for suitability by a pharmacist and made aware of the risks, situations where supply is not appropriate, and potential interactions with other drugs,” the MHRA explained.

Training for pharmacies

Pfizer said it plans to launch Viagra Connect in the spring of 2018. Before this, the company will implement “an extensive training and education programme” within pharmacies, it said.

Pfizer’s UK medicine director Berkeley Phillips said giving patients the option to speak to a pharmacist “could be a real step forward in encouraging more men into the healthcare system”.

RPS and NPA support switch

The Royal Pharmaceutical Society (RPS) welcomed the move, pointing out that “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”.

President Ash Soni said the switch will help put men at risk from cardiovascular disease – one underlying cause of erectile dysfunction – within reach of a pharmacist's advice.

The National Pharmacy Association (NPA) also approved of the reclassification, stressing that purchasing sildenafil in a pharmacy is “far safer” than buying it online, due to the risk of counterfeit products.

“Pharmacies provide the right combination of access to healthcare advice and access to the medicine,” NPA chief pharmacist Leyla Hannbeck said.