2020-2022 年限制性监管框架对法国普瑞巴林配药的全国性影响

IF 4.4 2区医学 Q1 SUBSTANCE ABUSE

International Journal of Drug Policy Pub Date : 2024-11-23 DOI:10.1016/j.drugpo.2024.104660

Julia de Ternay , Claire Meley , Patrick Guerin , Sébastien Meige , Nicolas Grelaud , Benjamin Rolland , Mathieu Chappuy

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引用次数: 0

摘要

背景普瑞巴林是一种获准用于治疗神经性疼痛、癫痫和一般焦虑症的药物。然而，普瑞巴林也日益成为被转移和滥用的原因，因此，法国卫生当局决定在 2021 年将其列为麻醉药品，要求使用安全的处方笺。我们的研究旨在评估这一措施对普瑞巴林配药模式的影响。方法我们利用具有全国代表性的 12,690 家法国社区药房的样本数据，通过中断时间序列 (ITS) 分析，评估了 2021 年 6 月实施的新监管框架对普瑞巴林每月配药总量的影响。我们建立了一个反事实模型，以预测在没有干预措施的情况下会发生什么。我们对普瑞巴林配药量超过每天 600 毫克最高推荐剂量的子样本进行了同样的分析。此外，我们还比较了（1）普瑞巴林的配药次数（2）法规实施前一年和法规实施后一年阿片类药物和/或苯二氮卓类药物的联合配药情况。结果法规实施后，普瑞巴林的配药次数立即大幅下降了 38,475,375 毫克（95 %CI [-66,931,799 毫克；-10,018,951 毫克]）。这种下降趋势在接下来的几个月中仍在继续，每月减少 4,788,107 毫克（95 %CI：[-8,888,326 毫克；-687,888 毫克]）。根据反事实模型预测，如果不采取干预措施，普瑞巴林的用量将不会发生显著变化。ITS 分析表明，在新法规实施后，每日剂量超过 600 毫克的亚样本的普瑞巴林配药量没有发生显著变化。同时，阿片类药物（监管前为 18.4%，监管后为 11.6%，p <0.001）和苯二氮卓类药物（监管前为 21.4%，监管后为 11.7%，p <0.001）的联合配药量大幅减少。我们的研究结果强调了限制滥用处方药的监管措施的重要性。

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National impact of a constraining regulatory framework on pregabalin dispensations in France, 2020–2022

Background

Pregabalin is a drug approved for neuropathic pain, epilepsy and general anxiety disorder. However, pregabalin is also an increasing cause of diversion and misuse, and, for this reason, the French health authorities have decided in 2021 to classify it as a narcotic drug, requiring secured prescription pads. Our study aimed to evaluate the impact of this measure on pregabalin dispensation patterns.

Methods

Using data from a national representative sample of 12,690 French community pharmacies, we assessed the impact of the new regulatory framework, implemented in June 2021, on the total monthly quantity of pregabalin dispensed by conducting an interrupted time-series (ITS) analysis. We built a counterfactual model to predict what would have happened without the intervention. We conducted the same analyses in the subsample of pregabalin dispensations exceeding the maximum recommended dosage of 600 mg per day. Additionally, we compared (1) the number of pregabalin dispensations (2) the co-dispensing of opioids and/or benzodiazepines one year before and one year after the regulation.

Results

Following the regulatory change, there was an immediate and significant drop of 38,475,375 mg (95 %CI [-66,931,799 mg; -10,018,951 mg] in pregabalin dispensations. This decline continued in the following months, with a decrease of 4,788,107 mg (95 %CI: [-8,888,326 mg; -687,888 mg] per month. The counterfactual model predicted that, without the intervention, there would have been no notable change in pregabalin dispensations. The ITS analyses showed no significant change in pregabalin dispensations following the new regulation for the subsample with doses exceeding 600 mg per day. Concurrently, there was a significant decrease in co-dispensing of opioids (18.4 % pre-regulation versus 11.6 % post-regulation, p < 0.001) and benzodiazepines (21.4 % pre-regulation versus 11.7 % post-regulation, p < 0.001).

Conclusion

The constraining regulation adopted in 2021 by the French health authorities significantly curtailed total pregabalin dispensing in community pharmacies. Our findings underscore the importance of regulatory measures to limit the misuse of a prescribed medication.

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来源期刊

International Journal of Drug Policy SUBSTANCE ABUSE-

CiteScore

7.80

自引率

11.40%

发文量

307

审稿时长

62 days

期刊介绍： The International Journal of Drug Policy provides a forum for the dissemination of current research, reviews, debate, and critical analysis on drug use and drug policy in a global context. It seeks to publish material on the social, political, legal, and health contexts of psychoactive substance use, both licit and illicit. The journal is particularly concerned to explore the effects of drug policy and practice on drug-using behaviour and its health and social consequences. It is the policy of the journal to represent a wide range of material on drug-related matters from around the world.