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Umesh Modi is a chartered accountant, and Pamini Jatheeskumar is a chartered certified accountant at Silver Levene...
  Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead...
Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead pharmacist, Health and Wellbeing Directorate, Public Health England
More inWhite Papers  

a sildenafil molecule image November 29 2017

Pfizer has announced that it will launch Viagra Connect as a Pharmacy (P) medicine, following approval for reclassification from Prescription Only Medicine (POM) status.

The medicines regulator, the MHRA, has approved the application to make the product containing sildenafil 50mg available as an over the counter medicine for men aged 18 years and over who have erectile dysfunction. It followed a consultation earlier this year proposing the reclassification.

Pfizer has said it is working on plans to launch the OTC product in the spring of 2018. “In the interim, the company will be implementing an extensive training and education programme within pharmacies. When available, supply of the product will depend on pharmacists’ assessment of its suitability for each man presenting with symptoms of erectile dysfunction (ED).”

Pharmacists will be expected to advise men to have a follow-up consultation with their doctor within six months of first being supplied the product, so that any potential underlying conditions or risk factors associated with erectile dysfunction can be investigated. “In cases where pharmacists believe the product is unsuitable for clinical reasons, they should advise men to see their doctor for further assistance,” said Pfizer.

In addition, the MHRA said: “Viagra Connect will not be sold to those with severe cardiovascular disorders; at high cardiovascular risk; liver failure; severe kidney failure; or taking certain interacting medicines. Use of Viagra Connect in these groups of men must continue to be under the supervision of a doctor.”

One of the reasons for granting an OTC product licence was that it would address concerns that men who might not otherwise seek help from health professionals have been buying medicines from websites operating illegally. “Erectile dysfunction medicines are a popular target for criminals selling unlicensed and counterfeit medicines. Over the past five years, investigators from MHRA have seized more than £50 million of unlicensed and counterfeit erectile dysfunction medicines,” said the MHRA.

The PAGB, representing the branded OTC medicines manufacturers, has welcomed the announcement. John Smith, PAGB Chief Executive, said: “Over-the-counter availability offers people faster and easier access to effective medicines, reduces pressure and costs on GPs and the NHS and encourages more people to self care. In this specific case, we also believe that enabling men to access Viagra Connect from their local pharmacy will reduce the likelihood of them accidentally purchasing counterfeit products online.”

The Royal Pharmaceutical Society’s President, Ash Soni, said: “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 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. 

“One of the underlying causes of ED is cardiovascular disease, so this move will also bring more men into the healthcare system where they can get proper advice and referral to their GP if necessary for further treatment.”

The Men’s Health Forum was also pleased by the reclassification announcement. Its Chief Executive, Mark Tod, said: “If this means more men find it easier to get advice and help for erection problems, that can only be a good thing.

“Erection problems can be very distressing. Sometimes men end up buying fake drugs online without talking to anyone to try and do something about it. Erection problems can also be a sign of other health issues like heart disease, diabetes, mental health problems or high blood pressure.”

Links:
MHRA announcement    
Pfizer statement                 
PAGB statement                 
RPS statement   
Men’s Health Forum statement  
MHRA Consultation documents                  

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