AMN submission to the TGA

Submission and support for the application under section 52EAA of the Therapeutic Goods Act 1989 (the Act) to delete the Appendix D, item 10, listing for Ivermectin Application

Enable general practitioners to safely and effectively prescribe ivermectin

AMN has lodged a submission to the TGA in full support of the initiating applicants proposal to delete the Appendix D, item 10, listing for Ivermectin.
Tuesday 27th September 2022

On September 11, 2022, the TGA restricted the prescribing of oral ivermectin on the advice of the

Advisory Committee on Medicines Scheduling (ACMS). It was decided that ivermectin could only be prescribed by general practitioners for TGA-approved conditions. Ivermectin prescriptions for further unapproved conditions were also allowed by some experts, including infectious disease doctors, dermatologists, gastroenterologists, and hepatologists.

Submission Summary

  • In 2013, the TGA published a report titled, ‘Australian Public Assessment Report for Ivermectin’ (AUSPAR). The report highlighted the safety characteristics of ivermectin especially when recommended by doctors and given by pharmacists. If the listing is removed, Australians' usage of ivermectin will be safer because doctors and pharmacists can then monitor the patients progress and suggest other complimentary treatment suggestions.
  • To date, close to fifteen thousand Australians have died from or with COVID and over ten million have had the COVID virus. The initiating applicant argued that ivermectin treatment may prevent 44% of infections, this suggests that ivermectin may have a positive impact on the SARS-CoV-2 virus if used in conjunction with other approved and safe therapies.
  • Removing this restriction will help the government, the public and private health systems and patients, whether they are vaccinated or unvaccinated. The Appendix D listing for ivermectin was made during a period of uncertainty. Moving to a multi-therapy approach strategy, would potentially help decrease infections and deaths, boost public health confidence and move Australia forward to deal with emerging economic, geo-political, mental health and societal issues.

Please read AMN's submission to the TGA below and share wide.