Rare diseases

New advice on hydroxychloroquine usage

People with autoimmune diseases who rely on hydroxychloroquine have been reassured that the manufacturer and pharmacy wholesalers have sufficient stocks of the drug to cover those who have a genuine clinical need for it.

Last week the Department of Health restricted use of the drug to specialists such as rheumatologists and dermatologists, following a spike in prescribing triggered by media reports that hydroxychloroquine could be used as prophylaxis against COVID19.

The drug is a TGA licensed treatment for patients with RA and mild systemic and discoid lupus erythematosus, but has gained widespread attention as a potential treatment for COVID19 following the release of preliminary results from a small French trial.

In response to anxious patient inquiries about the continuing supply of hydroxychloroquine, Associate Professor Glenn Reeves, Medical Director of the Autoimmune Resource and Research Centre (ARRC) in NSW said the new restrictions on dispensing should preserve supplies for patients with a clinical need.

“GPs will not be able to initiate treatment with hydroxychloroquine for a patient, but will be able to authorise (prescribe) continuing supply of hydroxychloroquine for a patient (after specialist initiation),” he wrote in a statement released on 25 March.

“I am also assured by Sanofi and the PSA that there is a national stockpile of the drug with PSA stating that they will continue to work with governments and regulators to help address issues relating to medicine stock supply,” he added.

Manufacturer Sanofi said that prior to the restrictions there had been high demand from wholesalers and hospitals for its brand of hydroxychloroquine, Plaquenil ,and it had seen increased sales at pharmacies.

“ Our Australian supply team is continuing to work across Sanofi’s global network to secure ongoing deliveries of Plaquenil. We are also actively assessing orders and will allocate existing stock to wholesalers and customers to support appropriate distribution.

The global upsurge in demand for hydroxychloroquine has prompted recommendations from the American College of Rheumatology on how to manage patients if there are shortages

Adequate supplies of hydroxychloroquine should be allocated for patients with SLE, especially pregnant SLE patients and those in whom even brief drug holidays would be reasonably expected to cause a flare of their disease.

It noted that in the case of SLE, including pregnant women with SLE, “hydroxychloroquine is the cornerstone of medical therapy…. It should be used in every patient unless there is a clear contraindication. It is the only medication shown to increase survival in lupus patients. It has been shown to reduce lupus flares and prevent organ damage including cardiovascular events

Continuing supplies are crucial because withdrawal of hydroxychloroquine from SLE patients for as short as two weeks, even in those with previously clinically stable disease, is associated with flares, the ACR statement noted.

Its suggestions for managing shortages of hydroxychloroquine include:

  • Hydroxychloroquine dose reductions and extended hydroxychloroquine dosing intervals tailored to an individual patient’s needs when faced with hydroxychloroquine shortages.
  • Restricting new starts of hydroxychloroquine in the outpatient setting, pending approval by a rheumatologist [or dermatologist where hydroxychloroquine is prescribed for cutaneous manifestations of SLE].
  • A limit on hydroxychloroquine refills to 30 days for patients prescribed hydroxychloroquine prior to the COVID-19 pandemic.
  • Allocation of adequate supplies of hydroxychloroquine to COVID19 trials for preexposure prophylaxis, post-exposure prophylaxis, and therapy.


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