- From 1 May 2020 the unrestricted PBS listing was changed to reduce risks associated with off-label prescribing
It was changed to Authority required (streamlined) for patients with autoimmune disorders and malaria and split into two items, initial and continuing treatment.
- The PBS listing change aims to help ensure continued access to hydroxychloroquine for patients with autoimmune disorders and malaria during the COVID-19 pandemic
It also helps reduce the risk of significant adverse effects due to prescribing of hydroxychloroquine to patients with COVID-19 outside of clinical trials.
- Initial PBS prescribing is only allowed by specialists in dermatology, intensive care medicine, physician, emergency medicine or paediatrics and child health
General practitioners can only prescribe for continuing treatment where initial treatment has been authorised by one of the specialists listed above.
On 1 May 2020, the unrestricted PBS listing for hydroxychloroquine was:1
- changed to Authority required (streamlined)
- split into two items, initial and continuing treatment.
The initial treatment must be for patients who have:1
- an autoimmune disorder, or
- malaria and require treatment for an acute attack or as suppressive therapy.
The initial treatment also must be authorised by medical practitioners recognised under State or Territory legislation that forms part of the Health Practitioner Regulation National Law as a specialist in dermatology, intensive care medicine, physician, emergency medicine or paediatrics and child health.1
Continuing treatment must be for patients who have previously been treated with PBS-subsidised therapy with hydroxychloroquine for autoimmune disorders and malaria. There is no requirement for the continued treatment to be authorised by the specialists in the initial treatment listing. It may also be prescribed by nurse practitioners where care of a patient is shared between a nurse practitioner and medical practitioner in a formalised arrangement with an agreed management plan.1
Why were the changes made?
The TGA amended the Poisons Standard Appendix D to include a new listing for hydroxychloroquine. This amendment (item 8) restricted who could authorise initial treatment with hydroxychloroquine to those recognised in the specialist areas of dermatology, emergency medicine, intensive care medicine, physician or paediatrics and child health.4
The amendment was made in response to reports of increased off-label prescribing of hydroxychloroquine.3 At that time clinical interest was growing in hydroxychloroquine as a potential agent for the treatment of COVID-19.5,6
There was concern such prescribing activity would create potential shortages of the medicine and impact the health of Australians who use it for approved indications, and potential harms to patients with COVID-19 due to the risk of significant adverse effects.3
On 3 April 2020, dental board practitioners registered as specialists in oral medicine were added to the list of specialist health practitioners permitted to initiate treatment with hydroxychloroquine.7 However, this group is not included in the PBS listing of practitioners able to authorise an initial prescription.1
What else should health professionals know?
Medical practitioners who are not one of the listed specialists cannot initiate a PBS prescription of hydroxychloroquine. General practitioners and doctors in training can only prescribe hydroxychloroquine for continuing treatment under the PBS for patients where initial treatment has been authorised by one of the listed specialists.1
The changed listing to Authority required (streamlined) requires that prescribers and pharmacists ensure that any relevant scripts have a valid streamlined authority code, which needs to be valid at the date of prescribing.2
What should patients know?
Health professionals should advise patients with autoimmune disorders and malaria that there have been changes to the way hydroxychloroquine is prescribed under the PBS, including which medical practitioners can initiate a PBS prescription and prescribe continuing treatment.
They should let them know that the changes assist to minimise the risk of PBS prescriptions being supplied to patients accessing hydroxychloroquine for unapproved indications, and ensure that patients who are regularly on this medicine for the approved indications are able to have continued access.2
Patient should also be advised that medicines containing hydroxychloroquine are in Schedule 4, meaning they are available only with a prescription, and their use for the prevention or treatment of COVID-19 outside of clinical trial research is off-label and not recommended due to the risk of significant adverse effects.3,8
An FAQ titled Can hydroxychloroquine be used to treat or prevent COVID-19? has been published to answer current questions patients might have about this medicine.
Hydroxychloroquine is currently of interest as a potential treatment for COVID-19. An NPS MedicineWise summary of the medicine within this context is available.
An editorial in Australian Prescriber considers Principles of ethical prescribing for self and others: hydroxychloroquine in the COVID-19 pandemic.
- Pharmaceutical Benefits Scheme. Summary of changes (May 2020). Canberra: Australian Government Department of Health, 2020. (accessed 1 May 2020).
- Pharmaceutical Benefits Scheme. Revised hydroxychloroquine PBS listings for the treatment of autoimmune disorders and malaria from 1 May 2020. Canberra: Australian Government Department of Health, 2020. (accessed 29 April 2020).
- Therapeutic Goods Administration. New restrictions on prescribing hydroxychloroquine for COVID-19. Canberra: Australian Government Department of Health, 2020. (accessed 30 April 2020).
- Therapeutic Goods Administration. Notice of an amendment to the current Poisons Standard under paragraph 52D(2)(a) of the Therapeutic Goods Act 1989. Canberra: Australian Government Department of Health, 2020. (accessed 1 May 2020).
- Zhou D, Dai SM, Tong Q. COVID-19: a recommendation to examine the effect of hydroxychloroquine in preventing infection and progression. J Antimicrob Chemother 2020. https://www.ncbi.nlm.nih.gov/pubmed/32196083. (accessed 1 May 2020).
- Gao J, Tian Z, Yang X. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. Biosci Trends. 2020; 14: 72-3. (accessed 6 April 2020).
- Therapeutic Goods Administration. Amendments to the new restrictions on prescribing hydroxychloroquine for COVID-19. Canberra: Australian Government Department of Health, 2020. (accessed 1 May 2020).
- Australian National COVID-19 Clinical Evidence Taskforce. Australian guidelines for the clinical care of people with COVID-19. Melbourne: National COVID-19 Clinical Evidence Taskforce, 2020. (accessed 1 May 2020).