Use of Off-Label Drugs in COVID-19: Clinicians' Perceptions Based on a Cross-Sectional Observational Study.

Introduction The absence of a common National Treatment Guideline during the second wave of the COVID-19 pandemic in India resulted in different treatment strategies, and the use of "off-label drugs" (OfLDs) was one of them. Aims This study aimed to assess the proportion of doctors who prescribed OfLDs, their perceived appropriateness, and the factors leading to their use. Settings and design This is an undergraduate student research project, in which a web-based cross-sectional survey was conducted on doctors who delivered care to COVID-19 patients during the second wave of the pandemic in Uttarakhand, India. Materials and methods The minimum sample size was 370 (for a 95% confidence level, an alpha error of 0.5, and a power of 80%). Data were collected electronically using a validated questionnaire after institutional ethical clearance and the participants' consent. Statistical analysis This is a descriptive-analytical study. Results We received 419 completed responses; all specialties had seen COVID-19 patients, and 91.4% (383) of the doctors had provided care to COVID-19 patients in some way or the other. About 90.7% (380) of the doctors used OfLDs; 62.5% (262) agreed that OfLDs were beneficial, and 78.9% (331) disagreed on universal steroid use. Only 34.1% (143) felt that using OfLDs was ethical. About 16.9% (71) of the doctors believed that alternative medicine was a useful treatment adjunct, and 20% (84) of doctors prescribed OfLDs under duress. About 21.2% (89) believed that Remdesivir was the main treatment for the disease, and 18.6% (78) believed that Tocilizumab was the main treatment for the disease. Personal experience, conviction, or advice from peers were among the various reasons that were put forward for using OfLDs. Conclusions The use of OfLDs during the COVID-19 pandemic in India was extensive. It was done sometimes under pressure and was largely based on confusion (multiplicity of guidelines, many times at variance with each other) as well as on a personal or low level of scientific evidence forwarded to support the use. Copyright © 2023, Sagar et al.

Citation

Anubha Sagar, Taruna Sharma. Use of Off-Label Drugs in COVID-19: Clinicians' Perceptions Based on a Cross-Sectional Observational Study. Cureus. 2023 Jul;15(7):e41819

PMID: 37575703

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