Viagra Connect (sildenafil) granted reclassification by the U.K. MHRA as a non-prescription, pharmacy-supplied treatment for erectile dysfunction.
The U.K.’s Medicines and Healthcare Regulatory Agency (MHRA) has reclassified Viagra Connect (sildenafil) as a non-prescription, Pharmacy (P)-supplied medicine for the treatment of erectile dysfunction in men aged 18 and over.
The move has been taken by the healthcare agency in part to thwart online sales of counterfeit Viagra in the country.
Viagra Connect is the first medicine for erectile dysfunction to be reclassified from Prescription Only Medicine (POM) to Pharmacy (P) status in the U.K. following an extensive and detailed review process, which included public consultation
Medicines in the U.K. are classified as POM; P; or General Sales List (GSL), the latter meaning they are available at retail stores such as supermarkets and news stands.
Pfizer is currently working on plans for the launch of Viagra Connect in the U.K. in the spring of 2018. In the interim, the company will be implementing an extensive training and education program within pharmacies. When available, supply of the product will depend on pharmacists’ assessment of its suitability for patients with symptoms of erectile dysfunction.
“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 dysfunction1,” Dr. Berkeley Phillips, U.K. medical director at Pfizer Ltd., said in a press statement. “We understand some men may avoid seeking support and treatment for this condition 2,3, 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 term4,” Phillips continued. “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.”
Viagra Connect contains the active ingredient sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE 5) inhibitors.
The Royal Pharmaceutical Society indicates that pharmacists are ideally placed to handle conversations with men about the condition.
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References:
1 IMS Global and UK Sildenafil Ranking MAT Q1 2017 Units and Scripts
2 Kubin M, Wagner G, Fugl-Meyer AR. Epidemiology of erectile dysfunction. Int J Impot Res. 2003;15:63–71
3 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.
4 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.
(Source: Pfizer Ltd.)