Prevalence and relationship with health of off-label and contraindicated drug use in the United States: a cross-sectional study.

IF 3.3 Q1 HEALTH POLICY & SERVICES

Journal of Pharmaceutical Policy and Practice Pub Date : 2025-03-06 eCollection Date: 2025-01-01 DOI:10.1080/20523211.2025.2472221

Katharina E Blankart, Frank R Lichtenberg

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Abstract

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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美国超说明书用药和禁忌症用药的流行程度及其与健康的关系：一项横断面研究

背景：说明书外和禁忌症的处方药使用可导致不良的健康结果。尽管令人担忧，但这种使用模式的范围和特征在美国人口中仍未得到充分研究。我们进行了一项横断面研究，分析了2016年至2021年的门诊处方数据，以确定超说明书和禁忌症药物使用的患病率。方法：该研究使用来自DrugCentral和医疗支出小组调查的标签信息，重点关注美国非机构人口。我们分析了46,770例患者和1,596,753张处方中9872对药物适应症和34138对药物禁忌症。采用线性和概率回归以及双重机器学习方法来评估标签外/禁忌症使用、健康状况和医疗保健利用之间的关联，并根据人口统计学和健康相关因素进行调整。结果：总体而言，75%的处方是针对标签适应症的，而25%的处方是标签外的；54%为禁忌症。只有33%的处方既有指征又无禁忌症。超说明书处方的禁忌率（48.8%）低于适应症处方（56.2%）。改善健康状况和减少医疗支出与较低的超说明书处方率相关。值得注意的是，较新的药物（1997年以后）有更高的处方率，既指征又非禁忌症（43%）比旧的药物（1979年以前，21%）。标签外和禁忌症的使用模式在种族和教育人口统计中是一致的。结论：超说明书和禁忌症药物的使用在门诊处方中很普遍，并且与较差的健康结果和增加的医疗保健利用有关。这些发现表明需要加强监测和管理措施，以尽量减少与不适当的处方做法相关的风险。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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