Emergency use of drugs authorised for COVID-19

US to allow hydroxychloroquine and chloroquine from national stockpile to be distributed and used for certain hospitalised patients infected with COVID-19

The Food and Drug Administration (FDA) in the United States has decided that the benefits of using hydroxychloroquine and chloroquine to treat COVID-19 patients outweigh the risks, despite clinical trials having not yet been completed.

On 28 March 2020, the FDA issued an Emergency Use Authorization to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the country’s Strategic National Stockpile to be distributed and used for certain hospitalised patients with COVID-19.

These drugs will be distributed from the stockpile to states for doctors to prescribe to adolescent and adult patients hospitalised with COVID-19, who weigh 50 kg or more, when a clinical trial is not available or feasible.

Administration as a treatment for COVID-19 infection is based on in-vitro evidence of activity against SARS coronavirus, as well as the preliminary results from a small French study showing that the combination of hydroxychloroquine and azithromycin reduced viral load in people with COVID-19 infection, explain Australian academics.

Clinical trials examining the potential of hydroxychloroquine and chloroquine to treat COVID-19 are currently underway, however their results are yet to be finalised.

The US Emergency Use Authorization requires that fact sheets that provide important information about using chloroquine phosphate and hydroxychloroquine sulfate in treating COVID-19 be made available to health care providers and patients, including the known risks and drug interactions.

Fact sheets for healthcare practitioners outline suggested doses for the drugs as well as warnings and drug interactions.

Health care providers are ordered to submit a report on all medication errors and all serious adverse events to use of the drugs.

Meanwhile patients or their caregivers must be informed of alternative treatments, that they have the option to accept or refuse administration of chloroquine phosphate or hydroxychloroquine sulfate, and be properly informed of the significant known and potential risks and benefits of the drugs.

However if providing this information will delay the administration of the drugs “to a degree that would endanger the lives of patients”, the information must be provided to the patients as soon as practicable after the drug is administered.

The FDA has also put out an urgent letter warning people not to use chloroquine phosphate intended for fish as treatment (or prevention) for COVID-19 in humans.

“While FDA is aware of the use of unapproved drugs to treat aquarium fish, our primary concern during the COVID-19 pandemic is the imminent threat to the health of consumers who may take animal drugs thinking they are interchangeable with approved human drugs,” it says.

“Chloroquine products sold for aquarium use have not been evaluated by the FDA to determine whether they are safe, effective, properly manufactured, and adequately labelled for use in fish—let alone humans.”

The warning comes after a man in the US died after he and his wife reportedly took chloroquine used to treat their fish in an attempt to prevent COVID-19. His wife also became very ill.

News of the potential benefit of hydroxychloroquine for COVID-19, particularly as promoted by US President Donald Trump, not only impacted people in the US but also led to a spate of ‘just in case’ overprescribing in Australia.

MedAdvisor and IQVIA data provided to AJP showed that during the second-last week of March, around 6,600 healthcare practitioners (both GPs & specialists) in Australia prescribed hydroxychloroquine to 11,000 patients – nearly three times the usual volume.

The Department of Health moved quickly to place new restrictions on who can initiate therapy, to limit use of hydroxychloroquine to currently approved indications – inflammatory conditions or the suppression and treatment of malaria – in order to prevent a nationwide shortage of the drug and ensure supply for patients currently being prescribed the medication.

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.

PSA had previously urged prescribers not to write prescriptions for this medicine as a ‘just in case’ measure.

“While the data may not yet be clear, if hydroxychloroquine is shown to be effective for COVID-19, we want every dose available to treat those who may require it,” A/Prof Freeman said.

The TGA has also warned 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.

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