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Written consent now mandatory for treating COVID-19 patients with remdesivir

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Umesh Isalkar    28 September 2020

On 23rd September, the state’s medical task force which comes under the Department of Medical Education and Research (DMER) had issued a notification making it mandatory for treating doctors and hospitals to seek written consent of patients or the patient’s relatives before administering the remdesivir, anantiviral drug.

The main objective is to include a patient’s relative in the medical management of coronavirus when they use expensive drugs and also to check the drug’s indiscriminate usage.

DMER director Tatyrao Lahane said that they had reinforced the guideline which has already been laid down by the Drug Controller General of India (DCGI) about the careful use of remdesivir. Getting the patient’s or their relative consent is mandatory and they want hospitals and doctors to follow it in letter as well in spirit.

At present, doctors are seeking consent only for patients with chronic kidney and liver diseases, or pregnant and breastfeeding women, in whom remdesivir is used.

Chiefintensivist of Sanjeevan hospital, Subhal Dixit said that they will follow the rule. Until now, they haven’t received any alert from any of the government body, and also the health department of Pune Municipal Corporation.

Sanjeev Wavare, Assistant medical officer of health, PMC said that the DMER’s notification is self-explanatory and there shouldn’t be any doubt about implementing the norm.

An office-bearer of the Indian Medical Association (IMA), on condition of anonymity stressed on more clarity regarding seeking written consent. He further said that the DMER’s notification has asked for written consent only in patients who are RT-PCR negative for COVID-19, however have severe acute respiratory illness and their radiological investigations show lung involvement that is typically seen in coronavirus infected patients.

Task force experts had requested doctors to use the drug in patients who are hypoxic i.e. blood oxygen saturation below 94%) and might require supplemental oxygen support.

The Food and Drug Administration made it clear that patients’ relatives should not approach any retail medical stores or wholesale distributors. The drug is directly supplied to hospitals as per the requirement.

FDA Pune joint commissioner S B Patil said that relatives must approach the hospital’s pharmacy or the chemists’ association helpline set up for remdesivir drugs.

Source: The Times of India

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