Effectiveness of the Additional Risk Minimisation Measures for Valproate Among Healthcare Professionals and Patients: A Cross-Sectional Survey in Six European Countries.

IF 2.4 4区医学 Q3 PHARMACOLOGY & PHARMACY

Pharmacoepidemiology and Drug Safety Pub Date : 2024-11-01 DOI:10.1002/pds.70046

Sandrine Colas, Tiffany Nishikawa, Isabelle Dresco, Sigal Kaplan, Karine Marinier, Aude Lachacinski, Marie-Laure Kürzinger, Massoud Toussi

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引用次数: 0

Abstract

Purpose: To assess the impact of the 2018 European additional risk minimisation measures (aRMMs) regarding the use of valproate in women of childbearing potential (WCBP) and during pregnancy.

Methods: A cross-sectional, non-interventional survey conducted in six European countries among 1982 healthcare professionals (HCPs) (July-October 2020) and 779 WCBP treated with valproate for epilepsy, bipolar disorder or other indications (August 2020-February 2021). HCPs were prescribing physicians (neurologists, psychiatrists, paediatricians and GPs), gynaecologists and pharmacists. Prespecified criteria were defined for success in the dimensions of awareness, knowledge and behaviour (correct answers to ≥ 80% of questions at individual level) and overall success (≥ 90%/80% successful HCPs/patients respectively, in the behaviour dimension and one of the two other dimensions).

Results: HCPs and patients did not meet the success criteria either overall or in any dimension. Highest success rates were in the behaviour dimension for gynaecologists (71.7%), pharmacists (49.7%) and patients (51.2%), and in the awareness dimension for prescribing physicians (23.6%). HCPs reported being unfamiliar with some educational materials and lacked knowledge of detailed prescribing conditions for valproate and the need for contraception regardless of sexual activity. More than 50% of patients were aware of the relevant patient materials and knew about the teratogenic risks of valproate.

Conclusion: Self-reported levels of awareness, knowledge and behaviour varied considerably by HCP type and among patient respondents. Further investigation is needed into why certain measures of the pregnancy prevention programme are not well known and followed, to improve their effectiveness. This will be addressed in a qualitative study which will be based on interviews with HCPs and patients.

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医护人员和患者对丙戊酸钠额外风险最小化措施的有效性：欧洲六国横断面调查。

目的：评估2018年欧洲额外风险最小化措施（aRMMs）对育龄妇女（WCBP）和孕期使用丙戊酸钠的影响：在六个欧洲国家对 1982 名医疗保健专业人员（HCPs）（2020 年 7 月至 10 月）和 779 名因癫痫、双相情感障碍或其他适应症而接受丙戊酸钠治疗的 WCBP（2020 年 8 月至 2021 年 2 月）进行了横断面、非干预性调查。HCP 为处方医生（神经科医生、精神科医生、儿科医生和全科医生）、妇科医生和药剂师。在意识、知识和行为方面的成功率（个人层面对≥80%问题的正确回答）和总体成功率（在行为方面和其他两个方面中的一个方面，HCP/患者的成功率分别≥90%/80%）定义了预先规定的标准：结果：医疗保健人员和患者在整体或任何方面都没有达到成功标准。妇科医生（71.7%）、药剂师（49.7%）和患者（51.2%）在行为维度上的成功率最高，处方医生（23.6%）在意识维度上的成功率最高。据报告，高级保健人员不熟悉某些教育材料，不了解丙戊酸钠的详细处方条件以及无论是否有性行为都需要避孕的知识。50%以上的患者了解相关的患者资料，并知道丙戊酸钠的致畸风险：不同保健医生类型和不同患者受访者自我报告的认知、知识和行为水平差异很大。需要进一步调查为什么预防妊娠计划中的某些措施没有被广泛知晓和遵循，以提高其有效性。这项定性研究将以对保健医生和患者的访谈为基础。

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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.