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Deputy CMO requests GP assistance
Professor Paul Kelly has written to RACGP President Dr Harry Nespolon to ask for general practice’s help in managing the current supply shortage of hydroxychloroquine.
Deputy CMO Professor Paul Kelly said the number of PBS prescriptions of hydroxychloroquine doubled in March.
As you know, hydroxychloroquine is approved by the Therapeutic Goods Administration (TGA) for rheumatoid arthritis, mild systemic and discoid lupus erythematosus and the suppression and treatment of malaria.
Hydroxychloroquine is also listed on the Pharmaceutical Benefits Scheme (PBS) as an unrestricted benefit. In recent months, the number of PBS prescriptions supplied of hydroxychloroquine has doubled, from the usual number of 23,000–25,000 per month to 49,000 in March 2020.
This unanticipated and likely off-label use is adversely impacting access to this medicine for patients who regularly use it.
To try and limit the use of hydroxychloroquine to currently approved indications, an amendment to the current Poisons Standard under paragraph 52D(2)(a) of the Therapeutic Goods Act 1989 was made from 24 March 2020 to restrict initiation of therapy to certain specialists.
Please note that there are no changes to the prescribing of continuing therapy. Further information is available from the TGA.
The Department of Health is working towards making changes to the current PBS listing for 1 May 2020 to align the PBS listing with the TGA changes, to minimise the risk of PBS prescriptions being supplied to those accessing hydroxychloroquine for unapproved indications, and to ensure that those who regularly rely on this medication will be able to continue accessing it.
These changes include the PBS restriction being split into two separate listings for autoimmune conditions and malaria in line with the registered TGA indications, as well as a change from an unrestricted listing to a Authority Required (STREAMLINED) listing, with both an initial and a continuing treatment phase.
In line with the recent changes to the Poisons Standard the initial prescription must be authorised by specialist physicians or specialists in dermatology, intensive care medicine, paediatrics and child health, and emergency medicine. However, treatment can be initiated by GPs where it has been authorised by one of these specialists by either written or oral advice, and this is recorded in the medical file.
As you know, hydroxychloroquine has been the subject of clinical trials internationally for the management of COVID-19. To date there has been no conclusive evidence demonstrating clinical benefit for the use of hydroxychloroquine in the management of COVID-19 or in its prevention.
However, clinical trials continue and Australia is contributing to this research effort.
To this end, the Australian Government has secured supply of hydroxychloroquine for the National Medical Stockpile, with the intention of using this supply to support clinical trials and clinical use, should these trials demonstrate benefit.
I ask that medical practitioners continue to exercise clinical judgement, balancing the risk of benefits and harms, and confine prescribing to PBS listed and TGA approved indications. I also ask that you circulate this request to your members to ensure that adequate supplies of hydroxychloroquine can be maintained.
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