Patterns and predictors of off-label prescription of psychiatric drugs.

Aishwarya Vijay,Joseph S Ross,Jessica E Becker,Andrea Romigi

doi:10.1371/journal.pone.0198363

Abstract

Off-label prescribing of psychiatric drugs is common, despite lacking strong scientific evidence of efficacy and potentially increasing risk for adverse events. The goal of this study was to characterize prevalence of off-label prescriptions of psychiatric drugs and examine patient and clinician predictors of off-label use. This manuscript presents a retrospective, cross-sectional study using data from the 2012 and 2013 National Ambulatory Medical Care Surveys (NAMCS). The study examined all adult outpatient visits to psychiatric practices for chronic care management with a single listed visit diagnosis in which at least one psychiatric drug was prescribed. The main outcome measure was off-label prescribing of at least one psychiatric drug, defined as prescription for a condition for which it has not been approved for use by the FDA. Among our sample representative of 1.85 billion outpatient visits, 18.5 million (1.3%) visits were to psychiatrists for chronic care management in which at least one psychiatric drug was prescribed. Overall, the rate of off-label use was 12.9% (95% CI: 12.2–15.7). The most common off-label uses were for manic-depressive psychosis treated with citalopram and primary insomnia treated with trazodone. Several patient and clinician characteristics were positively associated with off-label prescribing, including seeing a psychiatrist (OR: 1.06, 95% CI, 1.01–1.12; p = 0.03) instead of another type of clinician, the office visit taking place in the Western region of the country (OR: 1.09, 95% CI, 1.01–1.17; p = 0.02), and the patient having 3 or more chronic conditions (OR: 1.12, 95% CI, 1.02–1.14; p = 0.003). In contrast, having Medicare coverage (OR: 0.93, 95% CI, 0.84–0.97; p = 0.04) and receiving payment assistance from a medical charity (OR: 0.91, 95% CI, 0.88–0.96; p = 0.03) instead of private insurance were negatively associated with off-label prescribing. These results suggest that certain classes of psychiatric medications are being commonly prescribed to treat conditions for which they have not been determined by the FDA to be clinically efficacious and/or safe.

Highlights

Off-label prescribing is the prescription of an FDA-approved medication for a condition or in a manner different from that approved by the FDA
Multiple studies comparing adverse drug events among approved vs. off-label uses have found that adverse drug reactions occur at a higher rate among those prescribed for off-label uses [6,7,8,9]
We examined whether nine patient and clinician characteristics were associated with off-label use, selected based on limited previous work [11, 26] and availability from the data source

Summary

Introduction

Off-label prescribing is the prescription of an FDA-approved medication for a condition or in a manner different from that approved by the FDA. This practice is legal and common–a 2003 report showed that for the 3 leading drugs in each of the 15 leading drug classes, off-label use accounted for approximately 21% of prescriptions [1]. Off-label prescribing does have potential benefits in certain situations. It encourages innovation in clinical practice and allows approved therapies to be used for rare conditions that have not been as well studied. Multiple studies comparing adverse drug events among approved vs. off-label uses have found that adverse drug reactions occur at a higher rate among those prescribed for off-label uses [6,7,8,9]

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Conclusion