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Effectiveness of the Additional Risk Minimisation Measures for Valproate Among Healthcare Professionals and Patients:
Sandrine Colas1, Tiffany Nishikawa2, Isabelle Dresco3
1Epidemiology and Benefit Risk, Global R&D, Sanofi, Toronto, Canada.
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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