TGA looks at sildenafil
This article was originally published in OTC Bulletin & The Rose Sheet
Australia’s Therapeutic Goods Administration (TGA) is to consider making sildenafil – the active ingredient in Pfizer’s blockbuster erectile dysfunction drug Viagra – available without a prescription.
At its June meeting, the TGA’s scheduling committees will consider an application to make 50mg sildenafil available via a pharmacist in packs of no more than 8 tablets and add the product to Appendix H list, meaning it would be able to advertised to the public.
Furthermore, the applicant has asked for sildenafil to be placed in Appendix M – which is reserved for schedule 3 medicines that might require additional controls or supply requirements – noting that it would provide continued professional development accredited training and a patient assessment tool to allow pharmacists to screen and counsel potential users.
In September last year, the TGA rejected applications to switch 50mg sildenafil and another erectile dysfunction drug vardenafil citing concerns around misuse of the drugs, pack size and the potential for underlying health conditions to go unnoticed (OTC bulletin, 22 September 2017, page 10).
Earlier in 2017, the TGA rejected an application from Bayer to switch vardenafil to pharmacist-only status, claiming that the reclassification was predicated on the providing pharmacists with additional training and introducing a new supply protocol (OTC bulletin, 17 February 2017, page 14).
Sildenafil is already available without a prescription in New Zealand (OTC bulletin, 24 October 2015, page 1), while Pfizer launched an OTC version of the drug under the Viagra Connect name in the UK earlier this month (OTC bulletin, 23 March 2018, page 1).