New TGA restrictions on prescribing hydroxychloroquine for COVID-19

Pharma News: In recent days there has been considerable focus on the potential for hydroxychloroquine and the similar compound chloroquine (which is not marketed in Australia) to help in treating COVID-19.

Hydroxychloroquine is used for treatment of malaria and certain autoimmune diseases such as rheumatoid arthritis. Sanofi and Arrotex are among the companies that manufacture this drug.

Recent reports of increased off-label prescribing of medicines containing hydroxychloroquine have raised concerns that this will create a potential shortage of this product in Australia.

Clinical trials are underway around the world examining their potential to treat COVID-19. However, these medicines 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).

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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.

Prescribing Restrictions

To limit use of hydroxychloroquine to currently approved indications, there have been new restrictions placed on who can initiate therapy using it. Only certain types of specialists will be able to prescribe hydroxychloroquine to new patients (see information for health professionals below).

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.

There are no medicines that have been approved by the TGA for treatment of COVID-19, therefore prescribing of any medicine for the treatment of COVID-19 is considered off-label use. There is currently no clear data to inform clinical guidance on the use, dosing, or duration for COVID-19 treatment.

To help maintain the supply of hydroxychloroquine in Australia and discourage inappropriate prescribing, effective from 24 March 2020 the TGA is implementing changes to the Poisons Standard to place restrictions on the medical specialists who can initiate prescribing of the medication. Initiation of hydroxychloroquine is restricted to the following medical specialties as per the Medical Board list: 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. General practitioners and doctors in training can prescribe these medicines for continued treatment of patients where treatment was previously initiated by one of the specialists.

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