Impact of Regulatory Interventions on Immediate Release Fentanyl and Alternatives Use in Spain: An Interrupted Time Series Analysis.

IF 2.4 4区医学 Q3 PHARMACOLOGY & PHARMACY

Pharmacoepidemiology and Drug Safety Pub Date : 2025-04-01 DOI:10.1002/pds.70145

Elvira Rubio-Esparza, Diana González-Bermejo, Eva Angela Segovia-Muñoz, Edurne Lázaro-Bengoa

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引用次数: 0

Abstract

Purpose: Immediate release fentanyl (IRF) is approved for breakthrough cancer pain. In February 2018, the Spanish Agency of Medicines and Medical Devices (AEMPS) issued a communication reminding the authorized conditions and risks. In July 2021, a prescription-controlled system was implemented to avoid use in non-cancer patients. We assessed the impact of these regulatory interventions on IRF use and alternatives such as immediate release morphine (IRM).

Methods: Ecological study using national data of defined daily dose (DDD) dispensed per 100 000 inhabitants and day (DID). Segmented regression analysis was conducted to quantify the impact of the regulatory interventions. Furthermore, inflection points identified through sensitivity analysis using joinpoint regression were incorporated to capture potential trend changes more accurately and enhance the robustness of the analysis.

Results: The AEMPS communication was associated with an immediate decrease in IRF use (-1.57 DID), although it did not influence the trend, which had previously stabilized since 2017. The prescription-controlled system was associated with a substantial decline in level (-5.01 DID) and slope (-1.64 DID per quarter). IRM use increased continuously throughout the study period. After the last intervention, a rise was observed (0.27 DID), but no trend changes.

Conclusions: The prescription-controlled system was associated with a sharp decline in IRF use and a slight increase in IRM use, which can be attributed to restrictions applied to non-cancer patients. The increase in IRM use does not compensate for the decrease in IRF consumption, suggesting that other therapeutic strategies with opioids and non-opioid alternatives should be explored in these patients.

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监管干预对立即释放芬太尼和替代品使用在西班牙的影响：中断时间序列分析。

目的：立即释放芬太尼（IRF）被批准用于突破性癌症疼痛。2018年2月，西班牙药品和医疗器械管理局（AEMPS）发布了一份通知，提醒授权条件和风险。2021年7月，实施了一个处方控制系统，以避免在非癌症患者中使用。我们评估了这些监管干预措施对IRF使用和替代品如立即释放吗啡（IRM）的影响。方法：采用国家每10万居民每日限定剂量（DDD）数据进行生态学研究。进行分段回归分析以量化监管干预的影响。此外，通过结合点回归的敏感性分析确定的拐点，更准确地捕捉潜在的趋势变化，增强分析的稳健性。结果：AEMPS通信与IRF使用的立即减少（-1.57 DID）相关，尽管它没有影响自2017年以来之前稳定的趋势。处方控制系统与水平（-5.01 DID）和斜率（-1.64 DID /季度）的大幅下降有关。在整个研究期间，IRM的使用持续增加。在最后一次干预后，观察到上升（0.27 DID），但没有趋势变化。结论：处方控制系统与IRF使用急剧下降和IRM使用略有增加相关，这可归因于对非癌症患者的限制。IRM使用的增加并不能弥补IRF消耗的减少，这表明应该在这些患者中探索其他使用阿片类药物和非阿片类药物替代的治疗策略。

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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来源期刊

Pharmacoepidemiology and Drug Safety 医学-药学

CiteScore

4.80

自引率

7.70%

发文量

173

审稿时长

3 months

期刊介绍： The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report. Particular areas of interest include: design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology; comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world; methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology; assessments of harm versus benefit in drug therapy; patterns of drug utilization; relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines; evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.