Proposal to change Poisons Standard

The TGA November meeting will discuss a proposal to charge Astodrimer Sodium from Schedule 3 to Schedule 2. The proposal states:

The applicant proposed an amendment to the entries relating to astodrimer sodium. The proposedamendment would include astodrimer sodium as Pharmacy medicine (Schedule 2) when used as avaginal gel for treatment, relief and prevention of bacterial vaginosis. These preparations are currently a Pharmacist Only medicine (Schedule 3). The proposed amendment to the Appendix H entry would permit advertising of all Schedule 3 preparations of astodrimer sodium. The current Appendix H entry only allows advertising of preparations for the treatment and relief of bacterial vaginosis and prevention of recurrent bacterial vaginosis.Astodrimer sodium is currently approved for use as an active ingredient in medical devices.

I have responded as follows:

I will not repeat the extensive published material (Phase 3 clinical trials) relating to the effectiveness of Astodrimer sodium as both a treatment and preventative for bacterial vaginosis. It would be true to say that it and antibiotics (particularly metronidazole (Flagyl)) are the only real alternatives.

It is also true that only Aastodrimer sodium is approved by TGA as a preventative.My point is that the medical profession has been slow to disseminate this. Clearly a prescription solution for what is a very common and unpleasant condition for women has significant financial benefits to the profession. Even though the dangers of widespread usage of antibiotics are well understood.

I would refer you to the various health web sites e.g. https://www.betterhealth.vic.gov.au/health/conditionsandtreatments/bacterial-vaginosis
which are controlled by the medical profession. I tried through the Victorian Department of Health to have astodrimer sodium listed as an alternative treatment, but to no avail.

The feedback evidence of users shows clearly that it works and it has been proved safe.Any move to allow women freer access to this knowledge and the product is to the benefit of the females f this country.