New restrictions for hydroxychloroquine

doctor makes "stop" gesture with hand - ama

The Department of Health has placed new restrictions on hydroxychloroquine initiation after a spate of ‘just in case’ overprescribing for COVID-19, and warned against use outside of current indications after a man died in the US

Following US President Donald Trump’s announcement last week that hydroxychloroquine will be fast-tracked by the US Food and Drug Administration as a treatment for COVID-19 infection after showing “very encouraging early results”, Australian community pharmacies saw unprecedented demand for the drug.

PSA strongly advised pharmacists to refuse dispensing of hydroxychloroquine outside of approved indications, and urged prescribers to stop writing prescriptions as a ‘just in case’ measure.

Reports of increased off-label prescribing of medicines containing hydroxychloroquine raised concerns of creating a potential shortage of the product in Australia.

MedAdvisor and IQVIA data shows that in the last week in Australia, around 6,600 healthcare practitioners prescribed hydroxychloroquine to 11,000 patients – nearly three times the usual volume. Prescribing came from both GPs and specialists, said MedAdvisor.

Meanwhile pharmacy academics pointed out there is currently no way to draw solid conclusions about the clinical benefits of hydroxychloroquine based on early data, and that a rigorous and sufficiently large randomised clinical trial is needed.

The Department of Health has moved quickly to place new restrictions on who can initiate therapy, to limit use of hydroxychloroquine to currently approved indications.

Only specialists in the following areas will be able to prescribe hydroxychloroquine to new patients: dermatology; intensive care medicine; paediatrics and child health; physician; and emergency medicine.

General practitioners and other medical practitioners (e.g. hospital Resident Medical Officers [RMOs] and doctors in training) can continue to prescribe repeats for hydroxychloroquine to patients in line with the registered indications for patients in whom the medication was prescribed prior to 24 March 2020.

From 24 March 2020, general practitioners and doctors in training can only prescribe these medicines for continued treatment of patients where initial treatment has been authorised by one of the specialists.

The TGA highlights that clinical trials are underway around the world examining the potential of hydroxychloroquine to treat COVID-19.

PSA national president Chris Freeman welcomed the decision by the TGA, telling AJP that the PSA looks forward to the results of the clinical trials to provide some robust evidence of the effect – or not – of hydroxychloroquine.

In addition, the TGA warns that medicines such as hydroxychloroquine and the similar compound chloroquine (which is not marketed in Australia)  pose well-known serious risks to patients including cardiac toxicity (potentially leading to sudden heart attacks), irreversible eye damage and severe depletion of blood sugar (potentially leading to coma).

“Given the limited evidence for effect against COVID-19, as well as the risk of significant adverse effects, the TGA strongly discourages the use of hydroxychloroquine outside of its current indications at this time other than in a clinical trial setting or in a controlled environment in the treatment of severely ill patients in hospital,” it says.

The advice comes after a man in the US died and his wife left in critical care after the couple, both in their 60s, ingested chloroquine phosphate, an additive commonly used at aquariums to clean fish tanks, according to Banner Health.

Within thirty minutes of ingestion, the couple experienced immediate effects requiring admittance to a nearby Banner Health hospital.

They took the chemical as a preventative measure against COVID-19 after seeing Trump on TV saying hydroxychloroquine was safe and may be useful as therapy.

“We were afraid of getting sick,” she told NBC News.

Medical toxicologists and emergency physicians are now warning the public against the use of inappropriate medications and household products to prevent or treat COVID-19.

In particular, Banner Health experts emphasised that chloroquine, a malaria medication, should not be ingested to treat or prevent this virus.

“We are strongly urging the medical community to not prescribe this medication to any non-hospitalised patients,” said Dr Daniel Brooks, Banner Poison and Drug Information Center medical director.

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1 Comment

  1. Ron Batagol

    The restrictions and TGA advice are very relevant.

    With regard to potential for the ocular toxicity, one of many recent references is:
    University of Iowa “Eye”
    “Hydroxychloroquine (Plaquenil) Toxicity and Recommendations for Screening
    John J. Chen, MD, PhD; Ryan M. Tarantola, MD; Christine N. Kay, MD; Vinit B. Mahajan, MD, PhD
    Updated by Jason P. Kam, MD,

    One relevant key point in the didcussion section of this study refers to the risk of ocular toxicity, with the following comments:
    “Chloroquine and hydroxychloroquine both belong to the quinolone family and share similar clinical indications and side effects, including retinal toxicity.Hydroxychloroquine has significantly less retinal toxicity and has largely replaced chloroquine as a treatment of inflammatory disease.”
    “Unfortunately, the retinal damage from these medications is largely irreversible, so it is critical to detect early retinal toxicity in the hopes of limiting the extent of visual loss.”

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