Viagra Connect (sildenafil) granted reclassification by the UK MHRA as a non-prescription, pharmacy-supplied treatment for erectile dysfunction in men aged 18 and over

Pfizer Ltd, Walton Oaks, UK – 28 November 2017Pfizer announced today that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted the reclassification of Viagra Connect (sildenafil) as a non-prescription, Pharmacy (P) medicine for the treatment of the symptoms of erectile dysfunction in men aged 18 and over.

Viagra Connect is the first medicine for erectile dysfunction to be reclassified from Prescription Only Medicine (POM) to Pharmacy (P) status in the UK; following an extensive and detailed review process, which included a public consultation (medicines in the UK are classified as POM; P; or General Sales List [GSL] which means they are available in retail stores such as supermarkets and newsagents).

Pfizer is currently working on plans for the launch of Viagra Connect in the UK 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).

Dr Berkeley Phillips, UK Medical Director, Pfizer Ltd said: “The availability of Viagra Connect in pharmacies from next year will offer men who are eligible for the product a new and convenient way to access sildenafil, a commonly prescribed treatment for erectile dysfunctioni. We understand some men may avoid seeking support and treatment for this condition ii,iii, 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. As erectile dysfunction may be a sign of an underlying condition such as diabetes, high blood pressure, or heart disease2, there could also be a wider benefit to public health in the long termiv. We hope that this forthcoming new opportunity to purchase a genuine treatment via pharmacy will also reduce the likelihood of men turning to potentially ineffective and dangerous counterfeits from illicit sources.”

Dr David Edwards, GP with a special interest in sexual dysfunction and past President of the British Society of Sexual Medicine said: “In my clinical experience a man’s ability to attain and maintain an erection is of paramount importance to him. When erection difficulties do occur, emotional and physical closeness between a man and his partner can diminish, leaving a man with a sense of isolation and lacking confidence in day to day life.

A new initiative that enables men to go to a pharmacy to get help for their ED is welcome. The Royal Pharmaceutical Society has pointed out that pharmacists are ideally placed to handle conversations with men about the condition. Almost all pharmacies already have a consulting room that is private making it an ‘okay place’ for men to attend. Anything that will deter men from buying ‘dodgy’, often counterfeit drugs without any contact with a healthcare professional, is to be applauded.”

Additional information

  • In order to purchase Viagra Connect, men aged 18 and over will need to answer questions from the pharmacist about their symptoms, their general health, and any other medications they are taking, so that the pharmacist can determine whether Viagra Connect is suitable for them
  • Pharmacists should advise men to follow up with their doctor at their earliest convenience within 6 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
  • Pfizer is committed to patient safety, and to ensuring that Viagra Connect is supplied in a way that supports patient safety and improves patient health
  • In addition to Viagra Connect, Viagra (VIAGRA 25mg, 50mg, 100mg film-coated tablets) will remain available as a prescription medicine

References

i IMS Global and UK Sildenafil Ranking MAT Q1 2017 Units and Scripts

ii Kubin M, Wagner G, Fugl-Meyer AR. Epidemiology of erectile dysfunction. Int J Impot Res. 2003;15:63–71

iii Fisher, William A., et al. “The multinational Men’s Attitudes to Life Events and Sexuality (MALES) Study Phase II: Understanding PDE5 inhibitor treatment seeking patterns, among men with erectile dysfunction.” Journal of sexual medicine 2004;1(2): 150-160.

iv Pastuszak AW, Hyman DA, Yadav N, Godoy G, Lipshultz LI, Araujo AB et al. Erectile dysfunction as a marker for cardiovascular disease diagnosis and intervention: a cost analysis. J Sex Med 2015; 12: 975–984.

v Viagra Connect Summary of Product Characteristics 2017

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