Department of Pharmaceutical Sciences, Utrecht University, Universiteitsweg 99, 3584 CG Utrecht, The Netherlands.
Department of Pharmacy, University of Copenhagen, 2100 Copenhagen, Denmark.
Int J Environ Res Public Health. 2023 Jan 26;20(3):2215. doi: 10.3390/ijerph20032215.
The European Medicine Agency (EMA) provided additional recommendations regarding the use of valproate during pregnancy in 2018 by introducing a pregnancy prevention program (PPP). This study aimed to investigate the adherence and the impact of the PPP and the awareness of valproate teratogenicity among Danish healthcare professionals (HCPs) and patients.
As part of the EMA initiated multi-country survey, web-based questionnaires were distributed among Danish general practitioners (GPs), medical specialists, pharmacists, and patients.
A total of 90 prescribers, 98 pharmacists, and 103 patients were included in the study. Some 95.0% of the prescribers, 78.6% of the pharmacists, and 81.6% of the patients were aware of the teratogenic risks of valproate. The patient guide (27.8%), the HCP guide (23.3%), direct healthcare professional communication (23.3%), and the warning sign on the outer medication package (23.5%) were the most applied measures from the PPP. A total of 54.4% of the prescribers and 32.7% of the pharmacists informed patients about the importance of effective contraception during the use of valproate.
The study showed that in Denmark HCPs and patients are highly aware of the teratogenic effects of valproate. However, adherence to and the impact of the measures included in the PPP were low.
欧洲药品管理局(EMA)在 2018 年通过引入妊娠预防计划(PPP),提供了关于孕期使用丙戊酸的额外建议。本研究旨在调查丹麦医疗保健专业人员(HCPs)和患者对 PPP 的依从性和影响,以及对丙戊酸致畸性的认识。
作为 EMA 发起的多国家调查的一部分,在线问卷调查分发给丹麦的全科医生(GPs)、医学专家、药剂师和患者。
共有 90 名处方者、98 名药剂师和 103 名患者参与了研究。95.0%的处方者、78.6%的药剂师和 81.6%的患者意识到丙戊酸的致畸风险。患者指南(27.8%)、HCP 指南(23.3%)、直接医疗保健专业人员沟通(23.3%)和外用药包装上的警告标志(23.5%)是 PPP 中应用最多的措施。共有 54.4%的处方者和 32.7%的药剂师告知患者在使用丙戊酸期间有效避孕的重要性。
研究表明,在丹麦,HCPs 和患者对丙戊酸的致畸作用高度认识。然而,对 PPP 中包含的措施的依从性和影响较低。