Centre issues fresh advisory for use of Remdesivir in COVID-19 treatment. Details here

Union Health Ministry has issued an advisory for rational use of Remdesivir in treating Covid-19 patients on Monday. The recommendations calls for extreme caution in prescribing the drug to Covid-19 patients and regular review of its use at hospitals.

"The MOHFW, AIIMS and the ICMR had jointly issued treatment guidelines for management of COVID-19 patients in the form of a guidance/algorithm on April 23... But this guidance/algorithm does not prevent misuse/overuse of Remdesivir," the advisory said.

The document mandates that medication should be prescribed by senior doctors directly involved in the patient's care.

The latest advisory cautions that doctors should practise "extreme caution" in using Remdesivir as this experimental drug can be potentially harmful, is relatively costlier and has limited availability.

"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 Authorisation only based on limited scientific evidence globally," advises the Health Ministry. "It is not indicated in mild Covid-19 patients who are in home care or Covid care centres."

In the event of Remdesivir being prescribed, it should be procured and provided by the hospitals; the patient's relatives or attendants should not be asked to procure it from the retail market, the adviosory adds.

To further ensure rational use of Remdesivir, the ministry recommended that if the drug has to be advised or ordered during odd hours, it should be done by the duty doctor after a telephonic consultation with a senior faculty member, specialist or a unit in-charge. The advice or order to administer Remdesivir must be written and it should bear the name, signature and stamp of the concerned doctor.

The advisory further stated that every hospital needs to set up a special drug committee (SDC) to review the use of Remdesivir at the facility periodically. It would be preferable to have a pharmacology professor or faculty as a member of the SDC wherever available. This committee should share its findings with the clinicians periodically to ensure rational and judicious use of Remdesivir, the ministry states.

Health Ministry states that the purpose of this document is to stop irrational use or over-prescription of "the reserve/experimental/emergency-use authorisation drug Remdesivir".

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 considered by the JMG include 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.

"Remdesivir 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 advisory cited the study.

The group also took note of 'Solidarity Trial' conducted by WHO in 30 countries from March 2020 at 405 hospitals - 11,330 adults underwent randomisation; 2,750 were assigned to receive Remdesivir.

"The interim 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," the advisory notes.