Epidemiology and Benefit Risk, Global R&D, Sanofi, Toronto, Canada.
Real World Solutions, IQVIA, Courbevoie, France.
Pharmacoepidemiol Drug Saf. 2024 Nov;33(11):e70046. doi: 10.1002/pds.70046.
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.
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).
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.
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.
评估 2018 年欧洲附加风险最小化措施（aRMMs）对有生育能力的妇女（WCBP）和怀孕期间使用丙戊酸盐的影响。
这是一项在六个欧洲国家进行的横断面、非干预性调查，共纳入 1982 名医疗保健专业人员（HCPs）（2020 年 7 月至 10 月）和 779 名接受丙戊酸盐治疗癫痫、双相情感障碍或其他适应证的 WCBP（2020 年 8 月至 2021 年 2 月）。HCPs 包括处方医生（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、知识和行为维度（个人层面上答对≥80%的问题）和整体成功（行为维度和其他两个维度之一≥90%/80%的成功 HCPs/患者）方面，定义了成功的预设标准。
HCPs 和患者在整体或任何维度均未达到成功标准。妇科医生（71.7%）、药剂师（49.7%）和患者（51.2%）在行为维度的成功率最高，而处方医生（23.6%）在意识维度的成功率最高。HCPs 报告称不熟悉某些教育材料，且缺乏丙戊酸盐详细处方条件和无论性行为如何都需要避孕的知识。超过 50%的患者了解相关的患者材料，并了解丙戊酸盐的致畸风险。
HCP 类型和患者应答者的意识、知识和行为水平差异很大。需要进一步调查某些妊娠预防计划措施为何不为人所知和遵循，以提高其效果。这将在一项基于对 HCPs 和患者进行访谈的定性研究中进行探讨。
