GP wins bid to 'COVID–19 remedy' green

A MEDICATION that a local GP says is proven to prevent and treat COVID–19 overseas, will become available in Australia again after he successfully appealed to the Therapeutic Goods Administration (TGA) to have it reinstated. Wangaratta GP Dr Julian Fidge made a submission last year to the TGA to have ivermectin deleted from the Poisons Standard. After two rounds of public consultation and 24 submissions, the TGA has this week made an amendment to allow GPs to prescribe the medication from June 1. The restrictions were originally implemented in September 2021 due to concerns regarding the significant increase in off–label prescribing of ivermectin for the prevention and treatment of COVID–19 and the risk of shortages of ivermectin for its approved indications. In his application that instigated the review, Dr Fidge claimed that the effective banning of ivermectin posed a serious threat to public safety as it "may prevent more than 85 per cent of COVID–19 infections and may prevent serious illness and death caused by COVID–19 infections". With ivermectin unable to be prescribed by GPs, Dr Fidge said it forces patients to access the drug on the black market or use veterinarian ivermectin. He said it prevented the safe prescribing of the medication by doctors and safe dispensing by pharmacists. "There was never any evidence that specialist general practitioners have been prescribing ivermectin unsafely, or that the prescribing by general practitioners was undesirable," Dr Fidge said. "The use of ivermectin by Australians will be safer if the listing is deleted, because doctors and pharmacists can then be involved in the use of ivermectin by patients. "Ivermectin is extremely cheap, especially compared to the current vaccines and treatments for COVID–19. "It would remain cheap and accessible for vulnerable patients if the listing is removed." Dr Fidge said patients will still be protected by the Australian Scheduling Policy Framework (SPF) and other medical and pharmaceutical safety regulations if the listing is deleted. In its final decision published this week, the TGA has removed the restriction through its scheduling in the Poisons Standard "because there is sufficient evidence that the safety risks to individuals and public health is low when prescribed by a general practitioner in the current health climate". "This considers the evidence and awareness of medical practitioners about the risks and benefits of ivermectin, and the low potential for any shortages of ivermectin for its approved uses. "Also, given the high rates of vaccination and hybrid immunity against COVID–19 in Australia, use of ivermectin by some individuals is unlikely to now compromise public health." However, the TGA reported that "it does not endorse off–label prescribing of ivermectin for the treatment or prevention of COVID–19". "A large number of clinical studies have demonstrated ivermectin does not improve outcomes in patients with COVID–19," it said. "The National Covid Evidence Taskforce (NCET) and many similar bodies around the world, including the World Health Organization, strongly advises against the use of ivermectin for the prevention or treatment of COVID–19." Ivermectin for oral use is a prescription only (Schedule 4) medicine in the Poisons Standard. Up until June 1 it is only approved by the TGA for the treatment of river blindness (onchocerciasis), threadworm of the intestines (intestinal strongyloidiasis), and scabies.

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