AMA opposes down-scheduling of Sildenafil
The Australian Medical Association has strongly opposed a proposal to make Sildenafil, the prescription drug more commonly known as Viagra, available over-the-counter.
This is the fourth application to downschedule the drug since 2017, however no new information has been provided to justify the change. The risk profile for Sildenafil remains significant given the broad range of contraindications, particularly among the key consumer market of older men.
The AMA submission highlighted that the prescription of sildenafil requires a comprehensive medical assessment to address the causes, contraindications and potential risks.
There are a range of potential causes of ED, including use of other prescription medicines and psychological issues.
The AMA’s position is that the downscheduling of prescription drugs should only occur when patient benefits and safety are demonstrated and supported by data.
The submission also contends that allowing the drug to be accessible over the counter sends a signal to consumers that it is low risk when there is no evidence to support this.
The application notes that downscheduling would minimise the numbers of patients likely to order it from unregulated online sources. However, there is no evidence making the drug available over the counter will discourage this activity, particularly when this solution would require to discuss the issue with a pharmacists in a public retail setting.
