Stockpiling of dexamethasone is being “strongly discouraged” after preliminary findings from the UK found it could play a role in helping treat people with severe COVID-19
The PSA has posted new advice from the TGA on its website pertaining to the preliminary findings of the Randomised Evaluation of COVID-19 Therapy (RECOVERY) Trial, which found that the drug reduced deaths by one-third in ventilated patients and by one fifth in other patients receiving oxygen.
The researchers, from the University of Oxford, included a range of potential treatments in the trial, including low-dose dexamethasone for 2,104 patients in one arm of the trial.
There was no benefit found among patients who did not require preliminary support.
The TGA’s advice is aimed at supporting pharmacists and mitigating against stockpiling.
It notes that the trial has not yet been published, and the promising findings are preliminary only.
It also highlights that the trial reportedly showed benefit only for ventilated or oxygenated COVID-19 patients in hospital, not for mild cases or prophylactic use.
“There is no evidence to support use of this medicine for COVID-19 in the outpatient setting,” it notes.
“There is currently no national shortage of dexamethasone injection or tablets reported to the TGA. Based on information provided to the TGA by sponsors, there is currently sufficient stock of dexamethasone tablets and injection to meet normal demand.
“Sponsors and wholesalers are closely monitoring the demand for their dexamethasone products and will implement appropriate measures if necessary to mitigate the risk of shortages.
“Unnecessary stockpiling of dexamethasone tablets and injections is strongly discouraged as it could create supply issues and prevent patients who require treatment with dexamethasone from accessing this medicine.”
The TGA says that it is working closely with both sponsors of dexamethasone and the wholesalers, monitoring demand and implementing measures to mitigate the risk of shortages, if necessary.
In March, when limits were placed on dispensing and sales of prescription and OTC medicines due to concerns about stockpiling and before dexamethasone began to emerge as having a potential role in treating COVID-19, it was listed as a drug which could be subject to shortage due to the then spike in demand for medicines.
NPS MedicineWise has also produced a “consumer-friendly” article on the medicine, which explains what is known about it and its potential role in treating COVID-19.
“For some people, the body overreacts when fighting COVID-19, causing such strong inflammation that it damages the lungs and other organs, sometimes leading to death,” says Nerida Packham, Medicines Line manager at NPS MedicineWise and pharmacist.
Ms Packham and the article note that dexamethasone is “not for everyone” and should not be taken in less-severe cases, or as a preventative.
“Like with all medicines, dexamethasone can have unwanted side effects, so it should only be used when the potential benefits outweigh the risks,” she told consumers.
“Never take this, or indeed any medicine in an attempt to prevent or treat COVID-19 without talking to your doctor. Dexamethasone can cause changes in the immune system and in some situations increase the frequency and seriousness of infections. For this reason, it should only be taken exactly as prescribed.”
The National COVID-19 Clinical Evidence Taskforce also issued a statement on the preliminary findings out of the University of Oxford.
“As soon as peer-reviewed data from this study are available, the Taskforce will incorporate this evidence into its rapid guideline development process and make appropriate recommendations about use of this treatment in patients with COVID-19 in Australia,” it says.
“The Taskforce acknowledges that this is a very promising finding, as this is the first randomised controlled trial to suggest that a drug can reduce COVID-19 mortality.
“We are hopeful that the initial reports of benefit are confirmed in a peer-reviewed publication in the very near future.
“At this time, the living evidence approach employed by the Taskforce will enable us to respond rapidly to provide evidence-based recommendations about the use of dexamethasone in COVID-19.”