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美国通用药物替代的决定因素

Determinants of Generic Drug Substitution in the United States.

作者信息

Segal Jodi B, Onasanya Oluwadamilola, Daubresse Matthew, Lee Chia-Ying, Moechtar Mischka, Pu Xia, Dutcher Sarah K, Romanelli Robert J

机构信息

Department of Medicine, Johns Hopkins School of Medicine, 624 N. Broadway Room 644, Baltimore, MD, 21205, USA.

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.

出版信息

Ther Innov Regul Sci. 2020 Jan;54(1):151-157. doi: 10.1007/s43441-019-00039-9. Epub 2020 Jan 6.

Abstract

BACKGROUND

Some classes of drugs have lower than optimal uptake of generic products. We aimed to understand the determinants of generic drug substitution across classes.

METHODS

We conducted a cross-sectional analysis of data from the 2013 MarketScan Commercial Claims and Encounters Database from Truven Health Analytics. We quantified generic substitution rates (GSR) for 26 drug classes, choosing one representative week in November 2013. We used mixed-effects logistic regression to estimate the independent relationship between the determinants of interest and generic substitution for 8 classes with low generic utilization.

RESULTS

The GSRs for most classes exceeded 90%, although some were much lower including thyroid hormones (64%), androgens (74%), estrogens (71%), and hydantoin-type anticonvulsants (72%). The determinants of generic substitution varied across classes, albeit with important patterns. Patients using a mail order pharmacy had significantly less generic substitution than patients filling at retail pharmacies for 5 of the 8 studied classes; two additional classes showed no relationship between pharmacy type and generic use. Men relative to women and patients taking more medications were more likely to use generics for most classes. State substitution laws and patient consent laws were largely inconsequential regarding generic substitution.

CONCLUSIONS

Policies are needed to support the use of safe, effective and often lower cost generic drugs, when available. Mail order pharmacies, as often required by pharmacy benefits managers, lessen generic use for many classes. These pharmacies may require additional regulatory oversight if this adversely impacts patients.

摘要

背景

某些种类的药物通用产品的使用率低于最佳水平。我们旨在了解各类药物通用替代的决定因素。

方法

我们对来自Truven Health Analytics公司2013年市场扫描商业理赔与病历数据库的数据进行了横断面分析。我们在2013年11月选取了一个代表性周,对26类药物的通用替代率(GSR)进行了量化。我们使用混合效应逻辑回归来估计感兴趣的决定因素与8类低通用利用率药物的通用替代之间的独立关系。

结果

大多数类别的GSR超过90%,尽管有些类别要低得多,包括甲状腺激素(64%)、雄激素(74%)、雌激素(71%)和乙内酰脲类抗惊厥药(72%)。通用替代的决定因素因类别而异,尽管存在重要模式。在8个研究类别中的5个类别中,使用邮购药房的患者的通用替代率明显低于在零售药房取药的患者;另外两个类别显示药房类型与通用药物使用之间没有关系。相对于女性,男性以及服用更多药物的患者在大多数类别中更有可能使用通用药物。州替代法和患者同意法在很大程度上与通用替代无关。

结论

需要制定政策来支持在有可用药物时使用安全、有效且通常成本较低的通用药物。如药房福利管理人员经常要求的那样,邮购药房会减少许多类别的通用药物使用。如果这对患者产生不利影响,这些药房可能需要额外的监管。

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Determinants of Generic Drug Substitution in the United States.美国通用药物替代的决定因素
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