Drug being used to treat COVID-19 not for general use — health ministry
THE health ministry has stressed that the antiviral drug Remdesivir, when procured, will be used for COVID-19 patients who are hospitalised and under constant monitoring, and only with their consent.
At a COVID Conversations session yesterday, director of health services and planning in the Ministry of Health and Wellness Dr Nadine Williams emphasised that the supply of the antiviral drug, which clinical trials have so far found to be useful in preventing the multiplying of the novel coronavirus, will only be used under specified circumstances.
On Wednesday, the ministry advised that in response to the public call for greater access to Remdesivir, it will be procuring supplies of the antiviral drug, through the National Health Fund, for the treatment of coronavirus infections in public facilities.
Dr Williams noted yesterday that the drug has not received full approval in any country, as clinical trials on its use in the management of the disease are still ongoing, but that it is, however, being used under emergency-use authorisation in some jurisdictions.
She said that while Jamaica awaits full approval for registration, the drug can be used under a clinical trial or emergency licence. Dr Williams said, too, that the ministry decided to procure a small amount of drugs based on published evidence that there is some benefit in the use of Remdesivir.
“In addition, we were seeing a local increase [in COVID-19 cases] and there were requests by attending physicians to say, ‘We would like to have a drug that might have an impact on some of our patients’,” she said, pointing out that one of the reasons the ministry is seeking to get the drug is that the process of acquiring supplies may take some days, and delay importation.
The director of health services and planning said it was important to have a pool of the drug available upon physicians’ requests, and have the drug ready before rolling out a trial or definitive treatment.
“Before there is a distinct drug that has been put out to say, ‘This is the drug that has maximum effect on COVID-19 patients’, we would want to have something that has shown some benefit in our toolbox, to say, ‘Yes, we can actually help, in a context’,” she explained.
Dr Williams explained that “it is important to realise that the evidence is evolving, so there is nothing that is concrete... for the evidence that we have, this drug has been shown in one of the trials to have some [effect] on the recovery time; it was said that it reduces the recovery time by five days, that there is some effect on the mortality rate, and if used early enough in the course of the disease, that it may actually reduce the rate of progression or extent of the progression from the moderately ill to the critically ill”.
She pointed out, however, that there is no evidence that in the critically ill it affects recovery time or death rate from the disease. Dr Williams also added that the side-effect profile is wide and incomplete at this time.
Explaining the context in which the drug would be used when fully approved, she said patients would have to be moderately ill and hospitalised, are able to get an IV drug, and are under the care of a licensed clinician who is able to monitor them. Importantly, she said, there must be consent from the patient, and a physician must explain the objective of administering the drug, and the side effects. She said the outcome of the use of the drug must also be reported to health authorities.
“Therefore, this is not being rolled out for general use. It is a drug for which the Food and Drug Administration has given approval for use on an emergency basis,” she stated.
According to Minister of Health and Wellness Dr Christopher Tufton, the drug would be available for free.