Australia left behind on Viagra, erectile dysfunction medicines

04 December 2017

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The UK has joined New Zealand in making sildenafil - the active ingredient in erectile dysfunction (ED) medicines such as Viagra - available from pharmacists without the need for a prescription from a doctor.

The move follows a recent decision by the Australian regulator to reject an application to make sildenafil available at a pharmacy in pack sizes of up to 8 dosage units, after consultation with a pharmacist. Another erectile dysfunction medicine, Bayer's Levitra (active ingredient vardenafil), has been rejected for rescheduling in Australia twice before.

In New Zealand, men suffering erectile dysfunction have been able to buy the sildenafil product Silvasta from specially trained pharmacists without a prescription from a GP since October 2014.

The Australian Self Medication Industry (ASMI) argues that this is another example which illustrates how Australia is out of step with other markets when it comes to access to medicines.

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has reclassified Viagra Connect (containing sildenafil 50mg) as a pharmacy medicine that is available to men over 18 after screening by a pharmacist for cardiovascular disease and risk, severe kidney failure, liver failure and the use of certain medications. The move comes after authorities assessed the safety of Viagra Connect and following public consultation.

By contrast, the Australian regulator, the TGA's Advisory Committee on Medicines Scheduling,  rejected applications for erectile dysfunction medications to be available from a pharmacist, based on the argument that there is a direct relationship between erectile dysfunction and cardiovascular risk, and that access from a pharmacist could potentially reduce the likelihood men would visit their GP.

Speaking at the World Self Medication Industry General Assembly held in Sydney in October this year, Alison Van Wyk, Executive in Professional Services for Green Cross Health, explained that the New Zealand experience with over-the-counter access to sildenafil over three years shows a positive influence on men's health. Furthermore, the indications are that this encourages men to have health conversations with their pharmacist, which in turn increases their interaction with their doctor for serious health issues.

By October, 2017, 58% of New Zealand pharmacists had undertaken the training required to supply sildenafil. Ms Van Wyk presented evidence and case studies from pharmacists who reported that approximately two thirds of their consultations resulted in the supply of sildenafil to the patient, while the remainder are referred on to doctors for further medical intervention. Ms Van Wyk argued that the reclassification of Sildenafil, and its advertising, increases the general discussion around the topic of erectile dysfunction by men, while also 'catching' suspected health issues such atrial fibrillation (irregular, often rapid heart rate that commonly causes poor blood flow) and obstructive sleep apnoea, which resulted in the patient being referred to a doctor. So while ED may prompt men who rarely see doctors to visit the pharmacy, they may leave with a greater understanding of their health status and consequently see their doctor about their cardiovascular health.

ASMI has stated that erectile dysfunction (ED) is a condition that is appropriate for self-treatment under the supervision of a pharmacist. Both UK and New Zealand regulatory authorities have been satisfied that these medicines have a good safety profile and that their suitability for supply through pharmacies is positive.

"Over-the-counter availability offers people faster and easier access to effective medicines, reduces pressure and costs on GPs and the PBS, and encourages more people to better self-manage their health," said ASMI CEO Deon Schoombie.