An advisory has been issued by the government for rational use of Remdesivir in COVID-19 treatment, underlining that the anti-viral drug must be advised by senior faculty members directly involved in the patient’s care.
The advisory said the drug should be provided by the hospitals and the patient’s relatives should not be asked to obtain it from the retail market. Hence, to stop the misuse of Remdesivir the has been recommended by the government that if the drug is to be advised or ordered during odd hours, it should be done only by the duty doctor after a telephonic consultation with a senior faculty member, specialist or a unit in-charge, and that advise or order must be in a written form, therefore it should bear the name, signature and stamp of the doctor concerned.
A special drug committee needs to be set up by every hospital in order to review the use of Remdesivir at the facility periodically, according to the advisory. “Remdesivir should be procured and provided by the hospitals only; the patient’s attendants/ relatives should not be asked to procure Remdesivir from retail market,” the advisory underlined.
The committee should share its findings with the clinicians periodically to ensure rational and judicious use of Remdesivir. It would be preferable to have a pharmacology professor or faculty as a member of the SDC wherever available.
The MOHFW, AIIMS and the ICMR had jointly issued treatment guidelines for management of coronavirus patients in the form of a guidance/algorithm on 23rd April. But this guidance/algorithm does not prevent misuse/overuse of Remdesivir, the advisory noted.
To stop the irrational use or over prescription of the reserve/ experimental/emergency-use authorisation drug Remdesivir is the major purpose behind making this document.
For this reason, the Joint Monitoring Group, under the chairmanship of the Director General of Health Services, took into consideration findings of some studies to issue the advisory.
The studies he took note of are — The ‘Adaptive COVID-19 Treatment Trial’ that found Remdesivir is useful in cases of COVID-19 with SpO2 lesser than 94 per cent on room air (moderate to severe cases) if it is administered within seven to 10 days of illness.
It showed that the drug has led to a shorter median time from randomisation to recovery (10 days versus 15 days with placebo) and may have reduced the time to hospital discharge (12 days versus 17 days) but did not show a mortality benefit.
The WHO conducted the ‘Solidarity Trial’ in 30 countries from March 2020 at 405 hospitals: 11,330 adults underwent randomisation; 2,750 were assigned to receive Remdesivir.
The provisional results of the ‘WHO Solidarity trial’ published in December 2020 showed that Remdesivir had little or no effect on hospitalised patients with COVID-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay.
In this view, Remdesivir is to be used only in select moderate/severe hospitalised COVID-19 patients on supplemental oxygen as it is a reserve drug approved under Emergency Use Authorization only based on limited scientific evidence globally.
However, Remdesivir is not prescribed to the mild Covid-19 patients who are under home covid care centres. Remdesivir is relatively of high cost and has limited availability hence it has been advised by the physicians and doctors to exercise extreme caution in using the drug and to stop its misuse as this is only an experimental drug with potential to harm.