Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
Mongan Institute and Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, Boston.
JAMA Intern Med. 2021 Jan 1;181(1):16-22. doi: 10.1001/jamainternmed.2020.3588.
Brand-name drugs, including biologics, have been the primary source of increasing prescription drug spending in the US. Each state has drug product selection laws that regulate whether and how pharmacists can substitute prescriptions for brand-name drugs with more affordable equivalents, either small-molecule generic drugs or interchangeable biologics, but the details of these laws can vary.
To examine the variation in state drug product selection laws with regard to factors that may affect which version of a drug is dispensed.
DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional analysis was performed, using a legal database, to obtain information on state laws of all states plus Washington, DC, as they existed on September 1, 2019.
Whether substitution was mandatory or permissive, patient consent was needed prior to substitution, patient notification of substitution was required independent of the drug's packaging, and/or pharmacists were protected from special risk of liability for substitution.
For small-molecule and biologic drugs, descriptive statistics were generated for the 4 exposure variables. In addition, for small-molecule drugs, a generic substitution score with a maximum of 1 point was assigned for each exposure variable (range, 0-4 points), with higher scores indicating regulatory requirements limiting substitution.
This cross-sectional analysis of the generic drug substitution regulations in the 50 US states and Washington, DC, found that for small-molecule drugs, 19 states required pharmacists to perform generic substitution; 7 states and Washington, DC, required patient consent; 31 states and Washington, DC, mandated patient notification independent of the drug's packaging, and 24 states did not explicitly protect pharmacists from greater liability. Nine states and Washington, DC, had a generic substitution score for small-molecule drugs of 3 or higher, and 45 states had more stringent requirements for interchangeable biologic substitution, most commonly mandatory physician notification.
The findings of this study suggest that there is a need for optimizing state drug product selection laws to promote generic and interchangeable biologic substitution, which may help improve medication adherence and reduce drug spending.
包括生物制剂在内的品牌药物一直是美国处方药支出增长的主要来源。每个州都有药品选择法，规定药剂师是否可以以及如何用更实惠的替代药物替代品牌药物，这些替代药物可以是小分子仿制药或可互换的生物制剂，但这些法律的细节可能会有所不同。
研究各州药品选择法的差异，以了解影响药品发放版本的因素。
设计、地点和参与者：采用横断面分析，使用法律数据库获取截至 2019 年 9 月 1 日所有州和华盛顿特区的州法律信息。
替代是强制性的还是允许的，替代前是否需要患者同意，是否需要独立于药品包装向患者通知替代，以及/或药剂师是否免受替代的特殊责任风险保护。
对于小分子和生物制剂，对 4 个暴露变量生成描述性统计数据。此外，对于小分子药物，为每个暴露变量分配一个最高得分为 1 分的通用替代评分（范围 0-4 分），得分越高表示限制替代的监管要求越高。
这项对美国 50 个州和华盛顿特区的小分子药物通用替代法规的横断面分析发现，19 个州要求药剂师进行通用替代；7 个州和华盛顿特区要求患者同意；31 个州和华盛顿特区要求独立于药品包装向患者通知替代，24 个州没有明确保护药剂师免受更大的责任。9 个州和华盛顿特区的小分子药物通用替代评分得分为 3 或更高，45 个州对可互换生物制剂的替代要求更严格，最常见的是强制性医生通知。
本研究结果表明，需要优化州药品选择法，以促进通用和可互换生物制剂的替代，这可能有助于提高药物依从性和降低药物支出。
