The TGA has knocked back applications for the drugs to go OTC, citing need for medical practitioners to be involved
Applications were submitted for both sildenafil (50 mg) and PDE5 inhibitor vardenafil (up to 10mg) by their respective sponsors for the TGA to consider downscheduling the drugs from S4 to S3.
But this month both applications have been knocked back, even though each had majority support through submissions received.
According to the Advisory Committee on Medicines Scheduling, there were significant reasons for the decision to keep the drugs prescription only, including the potential for incorrect assessment of erectile dysfunction (ED) and lack of screening of underlying and asymptomatic chronic conditions if supplied through pharmacy alone.
The “risk of worsened health outcomes is heightened by the possibility of men never going to their doctor for assessments and obtaining repeat supplies from pharmacists,” said the scheduling committee.
It also shared concerns surrounding the serious nature of adverse events and drug interactions of sildenafil, and possible misuse and/or abuse by men who do not have ED, or by men who take other drugs.
The decision will be disappointing for the Australian Self-Medication Industry, which has argued that Australia has been slow to switch suitable medicines to OTC.
“While other nations with similar health systems have forged ahead with switch, Australia has fallen behind,” said ASMI.
“In New Zealand, specially trained pharmacists can supply sildenafil under strict criteria to men aged 35-70 with ED. In Australia, sildenafil medicines remain prescription-only.”
ASMI says evidence shows three years of prescription-free access to sildenafil in New Zealand has been a positive for men’s health issues, and that pharmacy protocol for supplying the medicine has successfully identified men who were suspected of having possible underlying health conditions.
Sydney pharmacist John Bell, who had consulted with Bayer in their submission regarding vardenafil, said a lot of men don’t feel comfortable going to their GP to enquire about ED drugs, and pharmacists were “well positioned” to fill this gap if the drug goes S3.
“The reality is … many [men] access these drugs online or overseas, where there’s no counselling, quality control, or ability for a doctor to follow up,” said Mr Bell.
“I think there’s a role for pharmacists to not only provide advice but provide screening and medical referral.”
However the scheduling committee disagreed, saying it did not consider increased access through downscheduling an appropriate mechanism to address the issue of online purchasing and counterfeiting.
“Consumer education and information is a better avenue to help overcome the stigma of ED and improve treatment rates,” it concluded.