Sildenafil to be made available over-the-counter
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that sildenafil 50mg tablets (Viagra Connect) will be reclassified from a prescription-only medicine (POM) to a pharmacy medicine (P) for the treatment of erectile dysfunction in men aged 18 years and over. This means that Viagra Connect can now be made available over-the-counter from pharmacies without a prescription.
The decision was made following an assessment of the safety of the medicine and advice from the Commission on Human Medicines. A public consultation conducted last spring received 47 responses; 33 respondents supported the proposal for sildenafil to be reclassified, 13 did not support it, and one was unsure. While the majority of respondents were in favour of the proposal, there was some concern that reclassification would further the abuse potential of the drug.
Manufacturer Pfizer said it is planning the launch of over-the-counter Viagra Connect in the UK in spring 2018. In preparation for the launch, it will implement an extensive training programme within pharmacies, and supply of the product will depend on pharmacists’ assessment of its suitability for the men requesting it. It will not be sold to men with severe cardiovascular disorders or at high risk of cardiovascular disease, those with liver or severe kidney failure, or those taking interacting medicines (eg nitrates).
Pharmacists should also advise men to follow up with their doctor within six months of first being supplied the product, so that any potential underlying conditions associated with erectile dysfunction can be investigated. The maximum pack size available will contain eight tablets and the maximum daily dose will be one 50mg tablet.
In addition to pharmacy-only Viagra Connect, Viagra 25mg, 50mg and 100mg tablets will remain available as a prescription-only medicine.
The MHRA said that making the medicine more widely available will help to encourage men who might not otherwise seek help into the healthcare system, while reducing the risks that come with buying unlicensed or counterfeit erectile dysfunction medicines online.