Prescribing Restrictions for Hydroxychloroquine

The Therapeutic Goods Administration (TGA) has issued an alert advising of new prescribing restrictions for hydroxychloroquine. These restrictions have been introduced following reports of increased off-label prescribing for the management of coronavirus disease (COVID-19), which have led to concerns of supply interruptions.

Several small studies suggest that hydroxychloroquine and the similar agent chloroquine (not marketed in Australia) could be effective against COVID-19. Interest in chloroquine for COVID-19 may stem from a study that found the agent to be effective in preventing the replication of coronavirus (SARS-CoV) in vitro. However, the evidence for effectiveness in COVID-19 is considered limited and clinical trials are continuing around the world. Clinical trials are also set to begin in Australia following announcements by the University of Queensland and the Walter and Eliza Hall Institute in Melbourne.

To prevent stock shortages related to a sudden increase in demand, the TGA has amended the Poisons Standard. As of 24 March 2020, hydroxychloroquine can only be initiated by medical practitioners specialising in the following fields:

• Dermatology;
• Intensive care medicine;
• Paediatrics and child health;
• Physician; or
• Emergency medicine.

Other medical practitioners can continue to prescribe repeats for hydroxychloroquine for patients initiated on therapy prior to 24 March 2020, in line with the registered indications. Hydroxychloroquine is currently registered in Australia for the treatment of rheumatoid arthritis, mild systemic and discoid lupus erythematosus, and the suppression and treatment of malaria.