A public consultation is open until April 18, 2017 in connection with the reclassification of sildenafil – more commonly known as Viagra or Kamagra – as a medicine for the treatment of erectile dysfunction.
Sildenafil – the Viagra prescription drug or Kamagra OTC drug for the treatment of erectile dysfunction – could become a pharmacy drug (P) if government proposals go ahead.
The Medicines and Medical Devices Regulatory Agency (MHRA) in the United Kingdom, which regulates drugs and medical devices in the United Kingdom, recommends that the drug, which was first made available in the United Kingdom in 1998 , Should be reclassified as medicament P.
The recommendation, which is now in public consultation until April 18, 2017, follows a request from the drug maker Pfizer that the product should be more easily accessible.
The MHRA proposes that 50 mg of sildenafil citrate tablets should be available in pharmacies for use by adult men with erectile dysfunction. The consultation document also says that the recommended maximum pack size is eight tablets and the drug should be taken as a maximum daily dose of 50 mg.
It adds, however: “This proposal does not change any of the supply conditions of presently available prescription products for erectile dysfunction – which will remain available on prescription.”
Pfizer has developed a checklist for pharmacists to use when delivering the product, which includes a recommendation that it should not be sold to men with diagnosed cardiovascular disease.
The consultation document states: “The availability of sildenafil tablets pharmacy would be of value to men suffering from erectile dysfunction. Patients can be evaluated for suitability by a pharmacist and be aware of the risks, situations where the supply does not Is appropriate and possible interactions with other medicinal products.
“The risks of an indirect hazard arising from the misdiagnosis of the underlying disease are minimized through the use of its professional judgment and checklist to identify the patients for whom the product is not suitable, and refer those patients to A doctor, “he adds. “It is also considered that there is a low risk of direct danger and intentional abuse that will lead to a danger to human health.”
The MHRA highlights the benefits that the sildenafil pharmacy supply would bring, which it outweighs the risks involved, “bringing a group of difficult access into the health environment with the potential to increase early identification of heart disease and Also reduce the risks associated with the use of counterfeits obtained through the Internet. ”
Berkeley Phillips, chief medical officer of Pfizer UK, says it would reclassify the product as a “P medicine could offer men a new and additional way of accessing a legitimate, well-established and well-studied treatment for erectile dysfunction.”
“This could have more benefits, since the condition may be an early warning sign of a more serious underlying disease, such as heart disease, which otherwise may go undetected,” he adds.
The company confirmed that if the proposal goes ahead, the product will also be available with a prescription.
The Royal Pharmaceutical Society (RPS), the professional leadership body for pharmacists in Britain, supports the proposed reclassification of the MHRA. Martin Astbury, its president, says: “Potential change … increases access to a medicine that has proven to be safe and effective when used properly through more than a decade of real-world use by millions of men.”
He adds that the measure will help identify more men who may be at risk for cardiovascular disease that pharmacists may refer to GPs. “It will also help improve drug safety, as sildenafil is one of the most counterfeit drugs.”
If the product is reclassified, Astbury says the RPS will provide advice and guidance to pharmacists on the treatment of erectile dysfunction.