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Amendments to the new restrictions on prescribing hydroxychloroquine for COVID-19

26 August 2020

Update

26 August 2020

Further to the information published below, the TGA reiterates its advice that it strongly discourages the use of hydroxychloroquine to treat COVID-19 (including in hospitalised patients) or prevent COVID-19, unless the patient is enrolled in a clinical trial, which will have safety monitoring protocols and oversight by a Human Research Ethics Committee.

The National COVID-19 Clinical Evidence Taskforce upgraded the strength of its recommendation against the use of hydroxychloroquine to treat COVID-19 outside of clinical trials (pdf,248kb) on 7 August 2020. The Taskforce comprises 29 peak health professional bodies whose members treat people with COVID-19.

The TGA is closely monitoring clinical studies in Australia and around the world investigating the use of hydroxychloroquine for the treatment of COVID-19. The interim results of a large trial conducted by the World Health Organization (the SOLIDARITY trial) found that hydroxychloroquine produced little or no reduction in the death of hospitalised patients with COVID-19, leading to halting of the hydroxychloroquine arm of that study. Similar studies by the US National Institutes of Health (the ORCHID study) and Oxford University (the RECOVERY trial (pdf,471kb)) were halted after showing no benefit of hydroxychloroquine.

These studies were all randomised controlled trials that are less prone to bias compared to non-randomised trials. Recent media commentary claiming that hydroxychloroquine, on its own or in combination with azithromycin or zinc, is effective for the treatment of COVID-19 has tended to refer to research findings from clinical studies that were non-randomised and therefore provide less reliable evidence.

Similar to the TGA’s current position on the use of hydroxychloroquine in patients with COVID-19, the US Food and Drug Administration (FDA) has cautioned against the use of hydroxychloroquine outside of clinical trial settings and has revoked the Emergency Use Authorisation that was previously in effect. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has suspended recruitment to all studies of hydroxychloroquine for the treatment or prevention of COVID-19.

Update

27 May 2020

The TGA is updating the below advice regarding hydroxychloroquine use in treating COVID-19. Based on the latest international data, use of hydroxychloroquine to treat COVID-19 is strongly discouraged, including in hospitalised patients, unless the patient is enrolled in a clinical trial which will have safety monitoring protocols and oversight by a Human Research Ethics Committee. It is important to note that the number of COVID-19 patients currently hospitalised in Australia is very low.

Update - PBS changes and supplier letter reinforce prescribing guidance

8 May 2020

To reflect Therapeutic Goods Administration (TGA) regulatory changes regarding hydroxychloroquine (described below), the Department of Health adjusted the Pharmaceutical Benefits Scheme (PBS) listing for hydroxychloroquine from 1 May 2020. This change will help minimise the risk of PBS prescriptions being supplied to patients accessing hydroxychloroquine for unapproved uses and ensure that patients who rely on this medication for approved uses will have continued access.

As of 1 May 2020, the general unrestricted benefits listing of hydroxychloroquine on the PBS was split into separate initial and continuing treatment listings for the TGA-approved uses of malaria and autoimmune disorders. Under both listings the prescribing health professional is required to seek PBS authority (streamlined). Under the initial PBS listing, initial therapy must be authorised by a medical practitioner of any of the specialities defined in the clinical criteria (listed below).

Sanofi, the supplier of one of the hydroxychloroquine products marketed in Australia (Plaquenil), has also written to health professionals reinforcing that hydroxychloroquine is not approved for use in Australia for treatment of COVID-19 outside the confines of a clinical trial. Sanofi also reinforced some of the known risks of prescribing hydroxychloroquine, in particular potentially serious cardiac issues. Globally, Sanofi has received an increased number of reports of serious cardiac issues, including deaths, in patients treated with hydroxychloroquine, This appears to be more common in patients also treated with other medicines that can affect the heart.

Amendments to the new restrictions

6 April 2020

On 24 March 2020, new restrictions came into effect limiting the health practitioners who could initiate therapy with hydroxychloroquine. These were introduced following reports of increased off-label prescribing of medicines containing hydroxychloroquine, which had the potential to create a shortage of the product in Australia. You can read the 24 March announcement relating to prescribing restrictions for hydroxychloroquine at New restrictions on prescribing hydroxychloroquine for COVID-19.

From 3 April 2020, dental board practitioners who are registered specialists in oral medicine have been added to the list of specialist health practitioners who are permitted to initiate treatment with hydroxychloroquine.

Information for consumers

If you are currently taking hydroxychloroquine for a chronic condition and are worried about being able to access this medicine, please speak to your health professional.

The TGA is working with the pharmaceutical industry to help ensure supply of hydroxychloroquine is maintained for patients needing it to treat chronic conditions for which it is indicated.

Information for health professionals

Effective 3 April 2020, the Poisons Standard has been amended to include oral medicine specialists registered with the Australian Dental Board to the list of specialist health practitioners authorised to supply and initiate treatment with hydroxychloroquine. This in addition to the categories of specialist medical practitioners currently permitted to authorise the supply of hydroxychloroquine.

Drugs and Poisons control legislation in the states and territories will be updated as required to reflect this change to the Poisons Standard.

Authorisation of initial treatment with hydroxychloroquine by listed specialists

Under the Appendix D Item 8 entry for hydroxychloroquine, medical practitioners that are not one of the listed specialists cannot initiate treatment with hydroxychloroquine.

Authorisation of initial treatment by one of the listed specialists could include documented instruction from a listed specialist to a general practitioner (GP) which would enable the GP to write the initial and continuing prescriptions.

Documented instruction could include verbal instruction that are recorded in the patient's medical record, or written correspondence from the relevant specialist.

Repeat scripts for patients already on treatment with hydroxychloroquine are not restricted to the listed specialists.

Please contact your relevant state or territory for information on their implementation of the Poisons Standard. Contact details for the Drugs and Poisons Units for each state and territory are available on the TGA website at Contacts for State/Territory medicines & poisons regulation units.

Further information