Off-label Drug Prescription Pattern and Related Adverse Drug Reactions in the Medical Intensive Care Unit

Asawari Raut; Kavita Krishna; Utkarsha Adake; Apurva A Sharma; Anitta Thomas; Jignesh Shah

doi:10.5005/jp-journals-10071-23909

Off-label Drug Prescription Pattern and Related Adverse Drug Reactions in the Medical Intensive Care Unit

Indian J Crit Care Med. 2021 Aug;25(8):872-877. doi: 10.5005/jp-journals-10071-23909.

Authors

Asawari Raut¹, Kavita Krishna², Utkarsha Adake¹, Apurva A Sharma¹, Anitta Thomas¹, Jignesh Shah³

Affiliations

¹ Department of Clinical Pharmacy, BVDU Poona College of Pharmacy, Pune, Maharashtra, India.
² Department of Internal Medicine, Bharati Hospital, Pune, Maharashtra, India.
³ Department of Critical Care Medicine, Bharati Vidyapeeth [Deemed to be University] Medical College, Pune, Maharashtra, India.

Abstract

Introduction: The utilization of prescription drugs as off-label is common. While this practice can be beneficial to some patients, it can raise a safety concern when scientific evidence is lacking; hence, this study was conducted to evaluate the off-label drug consumption and its adverse drug reactions (ADRs) in the medical intensive care unit (ICU). Materials and methods: In the prospective cohort study conducted for a duration of 6 months, data pertaining to ICU patients' (age ≥18 years) demography, diagnosis, treatment, and laboratory investigation were collected to assess for off-label use as well as the strength of evidence and the occurrence of ADRs by using MICROMEDEX 2017 version (Healthcare Series Thomson Reuter, Greenwood, CO). Results: Of total 3574 drugs prescribed, 1453 (41%) were off-label indications and 65 (1.81%) were off-label dose. On the evaluation of off-label indication use, 1279 (88%) were evidence-based and 174 (12%) were low/no evidence-based medications (EBMs); 59 (91%) were evidence-based and 6 (9%) were low/no EBMs for off-label dose. Most commonly prescribed evidence-based off-label drug belonged to the gastrointestinal class while low/no evidence drugs were mostly of anti-infective class. A total of 383 ADRs were identified and 139 (36.2%) were implicated due to off-label medications, of which ADRs with evidence off-label medications (87.8%) were higher than low/no evidence off-label medication (12.2%) (P < 0.001). Conclusion: Widespread presence of off-label use was observed in medical ICU. Although incidence of ADRs was similar to the FDA-approved use, ongoing monitoring of such practice is needed. How to cite this article: Raut A, Krishna K, Adake U, Sharma AA, Thomas A, Shah J. Off-label Drug Prescription Pattern and Related Adverse Drug Reactions in the Medical Intensive Care Unit. Indian J Crit Care Med 2021;25(8):872-877.

Keywords: Adverse drug reactions; Cohort study; FDA-approved drug; Intensive care unit; Off-label drug prescription.