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