The reclassification of erectile dysfunction drug sildenafil as a pharmacy medicine would not be a big leap
Allowing pharmacists to sell sildenafil would offer men a convenient, safe and perhaps less intimidating channel for seeking professional advice and treatment for erectile dysfunction.
Next year marks 20 years since the pharmaceutical company Pfizer launched Viagra (sildenafil), the first oral medicine to treat erectile dysfunction. Since it was licensed in 1998, Viagra has been prescribed for more than 64 million men worldwide. In 2015-2016, pharmacists in England dispensed 2.7 million sildenafil prescriptions. However, a large market for illegal drugs for erectile dysfunction has also emerged as some men turn to the Internet to avoid talking to their GP about sexual problems. In 2016-2017, UK drug regulator, the Medicines and Health Care Products Regulatory Agency (MHRA), seized unlicensed and falsified erectile dysfunction drugs valued at £ 15.7m, representing 56% of all drugs seized in the United Kingdom. The vast majority of these were unlicensed medications.
At the request of Pfizer, MHRA is considering whether to make sildenafil available from all non-prescription pharmacies in the hope that this will reduce the risks associated with the use of counterfeits obtained through the Internet, as well as increase the number Of men with erectile dysfunction looking for treatment. A public consultation on the reclassification took place from March 27, 2017 to April 18, 2017, and the MHRA is evaluating feedback.
It is not the first time Pfizer has tried to make sildenafil available without a prescription. In 2007, the company asked the European Medicines Agency (EMA) to switch Viagra to non-prescription status throughout the EU. However, it withdrew the application in 2008 after an EMA committee expressed concern that there would be no medical supervision, which could delay the diagnosis of possible cardiovascular diseases. The Committee for Medicinal Products for Human Use (CHMP) of the EMA was also concerned that the availability of the drug through pharmacies could lead to an increase in its recreational use, particularly among young people.
However, in the recent MHRA consultation, the regulator recommended that sildenafil 50mg tablets be reclassified as pharmacy medicine in the UK. He believes that increased availability should lead to an earlier diagnosis of erectile dysfunction by a health professional, together with an earlier diagnosis of possible underlying conditions such as cardiovascular disease or diabetes. Although the MHRA acknowledges that there is evidence that sildenafil, often illegally obtained, is used by healthy men to counteract the effects of recreational drugs, it says there appears to be little harm caused by this wrongful intentional use.
In fact, sildenafil has been available in pharmacies for specific patient groups since 2007 when Boots became the first pharmacy in the UK to offer Viagra through a privately managed group of patients (DGP), an agreement between a doctor and a pharmacist to allow medicines to be supplied without a prescription. Boots piloted the service in northwest England and sent it to other branches in 2009. Since then, many other pharmacies have followed suit by offering sildenafil and other phosphodiesterase-5 inhibitors such as Tadalafil (Cialis, Eli Lilly), Vardenafil (Levitra, Bayer) and Avanafil (Spedra, Menarini), to eligible men through PGD.
Therefore reclassifying sildenafil as a pharmacy medicine would not be a big leap. Pharmacists would use their professional judgment, as for all drugs, in deciding whether to deliver sildenafil to a patient, taking into account the risks, contraindications and interactions with other medications. Of course, training may be necessary to help pharmacists recognize patients who might suffer from underlying cardiovascular disease, depression, anxiety and alcohol consumption, and to advise, support and refer these patients adequately.
At the heart of any drug change request should be patients and allowing pharmacists to sell sildenafil without a prescription would offer men a convenient, safe and perhaps less intimidating channel through which to seek professional advice and treatment for a problem that It affects the lives of so many men and women.