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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  1. The industry makes me mad

    How ridiculous! Are they supporting the pornography industry as well because a large percentage of Ed problems would be related to pornography use !

    • Jarrod McMaugh

      I am assuming that your opening words “How Ridiculous!” are describing the point you then follow with…. because your point is completely ridiculous.

      • The industry makes me mad

        I honestly believe this is the wrong thing for pharmacy to push for. Yes there are true medical reasons for ED but a large % of the problems in men would be related to psychological reasons, such as pornography use and medicating is not the answer. Many GPs would also miss this as a cause. Do some research and see how easy access online to sites and images is sadly affecting many young boys through to older men. It’s not a ridiculous point. It’s very real and very valid and I’m not surprised the incidence of ED is becoming more common. Bayer and other drug companies are very clever at providing a quick fix for people when the problem may be corrected by addressing psychological issues, without medication use.

        • Guy Callum-Power

          It seems there isn’t a skerrick of evidence to support your theory;

          “Most people experience no harm from porn use”

        • Jarrod McMaugh

          If you had a patient with diabetes presenting with symptoms that could be alleviated with medication, would you deny them this medication while they had their lifestyle and diet addressed to reverse the issue?

          You aren’t aware of the protocols being developed for this proposal. This group of medications aren’t available without a medical consultation, and if they are available OTC, they will not be available without a pharmacist consultation.

          These medications are extremely safe, and differential diagnosis of conditions that can cause the symptoms do not include conditions that are imminently dangerous or life threatening.

          Making this group of medications available to people who are experiencing the onset of symptoms will increase access, and also increase referral at an earlier stage – many men put off seeing a GP about ED until the problem is will developed. With availability in primary care pharmacy by consultation, more men will seek help early.

    • Nicholas Logan

      ED is not becoming more common. It’s treatment has been thwarted by the stigma attached. John Bell is spot on in identifying this down scheduling as an excellent opportunity for pharmacy to screen and refer CV disease, diabetes and depression for which we know early diagnosis can be life saving.

  2. GM

    I don’t necessarily agree with the issue with porn industry..that’s going to be black market anyway. I just don’t think all purchases will be for legitimate reasons. People don’t just buy online due to embarrassment.(pharmacies don’t exactly provide much privacy either) or suffer from ED. It’s just because they can.

  3. Elvy Donathon

    Buying potency-oriented drugs online makes process completely anonymous. But when you buying for example levitra, each man in line knows that u are having troubles with your sexual life.

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