Bayer pushes for downscheduling of vardenafil

Making ED drugs available through pharmacists could prevent men resorting to dangerous online versions, says the company

Bayer has applied to the TGA to consider downscheduling the PDE5 inhibitor vardenafil (Levitra) up to 10mg from prescription only to pharmacist only.

The move could provide men with greater access to safe erectile dysfunction (ED) drugs, says the company.

While an estimated one in five Australian men aged over 45 are dealing with ED, less than 20% of men under the age of 65 consult their doctor about symptoms and look elsewhere for help, says a Bayer spokesperson.

“Online purchases of ED products are widespread in Australia. This could be a concern with 30% of TGA safety alerts (to May 2016) relating to unapproved ED product alerts and reflect the ongoing ease of access to unregistered ED options containing unevaluated ingredients.”

Several Australian-based and overseas websites are currently selling what they claim to be PDE5 inhibitors, including Levitra, Cialis, Viagra and their generic alternatives.

Bayer’s Levitra, which has been available since 2003, has a “known manageable safety and tolerability profile, established through studies in more than 52,000 men,” says the spokesperson.

“The self-care controlled environment within pharmacy represents an important step forward in providing men with greater accessibility to TGA-registered ED medications.”

Sydney pharmacist John Bell, who consulted with Bayer in their submission, says a lot of men don’t feel comfortable going to their GP to enquire about ED drugs, and pharmacists are “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,” says Bell.

“In general, ED is not a disease but a sign or symptom of a health issue such as cardiovascular disease, diabetes or depression.

“I think there’s a role for pharmacists to not only provide advice but provide screening and medical referral.

“It would certainly be a consultative process – there would definitely need to a consultation and appropriate history taken and referral if necessary,” says Bell, adding that the same process could be applied to oral contraceptives in the future.

The AMA has voiced concerns about public pharmacies not being confidential environments in which to discuss ED, but Bell points out most pharmacies now have private consultation rooms.

He adds that pharmacists would need additional training or a refresher course beforehand.

“We expect if this submission is approved there would certainly be training to prepare pharmacists for understanding when these ED drugs are suitable or not, or when they’d need referral.

 “It would be up to the PSA and the Pharmacy Guild of Australia to support their members by providing that training,” he says.

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