Next year marks 20 years since 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 prescription items for sildenafil. However, a large market in illegal erectile dysfunction medicines has also emerged as some men turn to the internet to avoid talking to their GP about sexual problems. In 2016–2017, UK drugs regulator the Medicines and Healthcare products Regulatory Agency (MHRA) seized unlicensed and counterfeit erectile dysfunction drugs valued at £15.7m, accounting for 56% of all medicines seized in the UK. The vast majority of these were unlicensed medicines.
A large market in illegal erectile dysfunction medicines has also emerged
At Pfizer’s request, the MHRA is now considering whether to make sildenafil available from all pharmacies without a prescription in the hope that this will reduce the risks associated with use of counterfeits obtained via the internet, as well as increase the number of men with erectile dysfunction who seek treatment. A public consultation on the reclassification ran from 27 March 2017 to 18 April 2017, and the MHRA is currently evaluating feedback.
It is not the first time that Pfizer has sought to make sildenafil available over the counter. In 2007, the company applied to the European Medicines Agency (EMA) to switch Viagra to non-prescription status throughout the EU. But it withdrew the application in 2008 after an EMA committee expressed concerns that there would be no medical supervision, which could delay diagnosis of possible cardiovascular disease. The EMA’s Committee for Medicinal Products for Human Use (CHMP) was also concerned that availability of the drug through pharmacies could lead to an increase in its recreational use, particularly among younger people.
It is not the first time that Pfizer has sought to make sildenafil available over the counter
But in the MHRA’s recent consultation, the regulator recommended that sildenafil 50mg tablets should be reclassified as a pharmacy medicine in the UK. It believes that wider availability should lead to earlier diagnosis of erectile dysfunction by a healthcare professional, along with earlier diagnosis of potential underlying conditions, such as cardiovascular disease or diabetes. Although the MHRA acknowledges there is evidence that sildenafil, often obtained illegally, is used by healthy men to counteract the effects of recreational drugs, it says there appears to be little harm caused by this intentional incorrect use.
In fact, sildenafil has been available from pharmacies for specific patient groups since 2007, when Boots became the first pharmacy in the UK to offer Viagra through a private patient group direction (PGD), an agreement between a doctor and a pharmacist to allow medicines to be supplied without a prescription. Boots piloted the service in the north west of England, rolling it out to other branches in 2009. Many other pharmacies have since followed suit, offering sildenafil and other phosphodiesterase-5 inhibitors, such as tadalafil (Cialis; Eli Lilly), vardenafil (Levitra; Bayer) and avanafil (Spedra; Menarini), to eligible men via PGDs.
So reclassifying sildenafil as a pharmacy medicine would not be such a huge leap. Pharmacists would use their professional judgment, as they do for all medicines, when deciding whether to supply sildenafil to a patient, taking into account any risks, contraindications and drug interactions. Of course, training may be needed to help pharmacists recognise patients who could be suffering from underlying cardiovascular disease, depression, anxiety and alcohol use, and to counsel, support, and refer these patients appropriately.
At the centre of any request to switch a medicine must be the patients, and allowing pharmacists to sell sildenafil over the counter would offer men a convenient, safe, and perhaps less intimidating, channel through which to seek professional advice and treatment for a problem that affects the lives of such a large number of men and women.