Prevalence and relationship with health of off-label and contraindicated drug use in the United States: a cross-sectional study
Background: Off-label and contraindicated prescription drug use can result in adverse health outcomes. Despite concerns, the extent and characteristics of such usage patterns remain underexplored in the American population. We conducted a cross-sectional study analysing outpatient prescription data...
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| Main Authors: | , |
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| Format: | Article |
| Language: | English |
| Published: |
Taylor & Francis Group
2025-12-01
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| Series: | Journal of Pharmaceutical Policy and Practice |
| Subjects: | |
| Online Access: | https://www.tandfonline.com/doi/10.1080/20523211.2025.2472221 |
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| Summary: | Background: Off-label and contraindicated prescription drug use can result in adverse health outcomes. Despite concerns, the extent and characteristics of such usage patterns remain underexplored in the American population. We conducted a cross-sectional study analysing outpatient prescription data between 2016 and 2021 to determine the prevalence of off-label and contraindicated drug use.Methods: The study used labelling information from DrugCentral and the Medical Expenditure Panel Survey, focusing on the American non-institutionalised population. We analysed 9872 drug-indication and 34,138 drug-contraindication pairs among 46,770 patients and 1,596,753 prescriptions. Linear and probit regressions, and a double machine learning approach, were employed to assess associations between off-label/contraindicated use, health status, and healthcare utilisation, adjusting for demographic and health-related factors.Results: Overall, 75% of prescriptions were for labelled indications, while 25% were off-label; 54% were contraindicated. Only 33% of prescriptions were both indicated and not contraindicated. Off-label prescriptions had a lower contraindication rate (48.8%) compared to indicated prescriptions (56.2%). Improved health status and reduced medical expenditure correlated with lower off-label prescription rates. Notably, newer drugs (post-1997) had a higher rate of prescriptions that were both indicated and not contraindicated (43%) compared to older drugs (pre-1979, 21%). Patterns of off-label and contraindicated use were consistent across racial and educational demographics.Conclusion: Off-label and contraindicated drug use is prevalent in outpatient prescriptions and is associated with worse health outcomes and increased healthcare utilisation. These findings suggest a need for enhanced monitoring and regulatory measures to minimise risks associated with inappropriate prescription practices. |
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| ISSN: | 2052-3211 |