Schedule change proposed for ED drug

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New proposal put forward for Pharmacist-Only sildenafil category

The TGA’s Advisory Committee on Medicines Scheduling is set to again review the possibility of creating an S3 category for sildenafil (Viagra).

There have been two previous requests for the drug to be down-scheduled in Australia. It has been available over the counter in New Zealand since 2014 and in the UK it is set to be available OTC later this year. 

The latest request called for the creation of a new Schedule 3 entry for sildenafil in oral preparations containing 50 mg of sildenafil per dosage unit in packs containing not more than 8 dosage units.

It also requested the drug be included in Appendix H to permit advertising; and to “include sildenafil in Appendix M to provide additional controls or supply requirements to allow sildenafil to be supplied by a pharmacist”.

Supply of Schedule 3 sildenafil would be contingent on the sponsor making CPD-accredited training available to pharmacists and providing a patient assessment tool to facilitate screening and counselling by the pharmacist.

The new proposal claims the move will increase access to sildenafil for men suffering from erectile dysfunction and will help de-stigmatise the condition.

It also claims the risks with non-prescription sildenafil are similar to those with the prescription product and can be “effectively managed in the pharmacy setting”.

It is set to be considered at the June 2018 meeting of the ACMS, alongside a number of other high-profile scheduling changes.

The full list of reasons provided by the proposals sponsor are:

  • Non-prescription availability of sildenafil 50 mg with appropriate informative consumer and pharmacist educational programmes, and advertising of Schedule 3 sildenafil 50 mg, will help to reach many men with erectile dysfunction (ED) who currently do not seek help from their doctor about their condition. It will also direct men away from the unregulated supply of purported ED medications.
  • The proposed re-scheduling will help destigmatise ED, raise awareness of the causes of ED and its association with more chronic conditions such as cardiovascular disease (CVD) and diabetes, encourage treatment seeking behaviour, and will offer the potential for earlier and more frequent interaction with the primary healthcare system.
  • The important risks for non-prescription sildenafil 50 mg are consistent with those that have been established for sildenafil in the prescription setting. These risks can be effectively managed in the pharmacy setting through routine risk minimisation measures that have been specifically tailored for non-prescription use. Benefits outweigh the risks, and all risks can be appropriately managed through Schedule 3 availability. Any incremental risks associated with non-prescription availability and advertising of sildenafil 50 mg can be effectively managed in the pharmacy setting through key measures such as pharmacist intervention at the point of sale, pharmacist training and consumer education.

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