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. 2021 Mar;30(3):283-291.
doi: 10.1002/pds.5119. Epub 2020 Nov 20.

Effectiveness of risk minimisation measures for valproate: A cross-sectional survey among physicians in Europe

Massoud Toussi  1 , Bardoulat Isabelle  1 , Stephanie Tcherny-Lessenot  2 , Hanka de Voogd  3 , Vasilis Dimos  4 , Sigal Kaplan  5
Affiliations

Effectiveness of risk minimisation measures for valproate: A cross-sectional survey among physicians in Europe

Massoud Toussi et al. Pharmacoepidemiol Drug Saf. 2021 Mar.

Abstract

Purpose: This study evaluated the effectiveness of risk minimisation measures (RMMs) implemented following the 2014 referral for valproate in Europe.

Methods: Cross-sectional survey was conducted over 2-month period in 2016 among physicians who prescribed valproate in France, Germany, the United Kingdom, Spain and Sweden. The web-based questionnaire included five endpoints to evaluate physicians' knowledge on (a) prescribing valproate only for epilepsy and bipolar disorder in women if other treatments were ineffective or not tolerated; (b) ensuring supervision by experienced physicians while treating these conditions; (c) considering alternative treatments for women planning pregnancy, regular review of treatment needs and re-assessing the benefit-risk balance in women and girls reaching puberty; (d) informing patients about the risks of taking valproate during pregnancy and (e) advising women on effective contraception during their treatment.

Results: Among 1153 physicians, 95.5% responded prescribing valproate for epilepsy and bipolar disorder in women only if other treatments are ineffective/not tolerated; 66.5% supervised while treatment; 76.6% considered alternative treatments for women planning pregnancy; 92.1% informed patients about the risks of taking valproate during pregnancy and 94.4% advised patients on the use of effective contraception during its treatment. Overall, 25.8% physicians recalled receiving both educational material (EM) and Dear Healthcare Professional Communication (DHPC). All endpoint rates were higher for physicians who acknowledged receipt of both DHPC and EM compared to physicians who did not receive them.

Conclusions: Although results varied across geography and physician speciality, majority of physicians had good knowledge about the indication and safety aspects of prescribing and using valproate.

Keywords: Direct Healthcare Professional Communication; pharmacoepidemiology; prescribing behaviour; risk minimisation measures; valproate.

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Conflict of interest statement

M. Toussi, I. Bardoulat are salaried employees of IQVIA (La Défense, France) a human data science company which received funds for the conduct of the study. Stephanie Tcherny‐Lessenot is an employee of Sanofi Aventis R&D (France). Sigalit Kaplan is an employee of Teva Pharmaceutical Industries Ltd. (Israel). Hanka de Voogd is an employee of Mylan EPD (The Netherlands). Vasilis Dimos is an employee of DEMO S.A. (Greece).

Figures

FIGURE 1
FIGURE 1
Knowledge that valproate should not be prescribed to pregnant women or women of child‐bearing potential unless other treatments are ineffective or not tolerated. WCBP, women of child‐bearing potential
FIGURE 2
FIGURE 2
Benefits vs risk for valproate/related substances. GP, general practitioner; WCBP, women of child‐bearing potential
FIGURE 3
FIGURE 3
Analysis of success with results on the five key primary endpoints separately for the overall weighted sample according to physician's speciality. GP, general practitioner; endpoint 01: Understanding on prescribing valproate for epilepsy and bipolar disorder in women if other treatments are ineffective or not tolerated; endpoint 02: Ensuring that a doctor experienced in treating these conditions supervises the treatment of epilepsy or bipolar disorder; endpoint 03: Taking into consideration alternative treatments if a woman becomes or plans to become pregnant during valproate treatment, regularly review the need for treatment and re‐assess the balance of the benefits and risks for women and also for girls reaching puberty who are taking valproate; endpoint 04: Informing patients of the risks of taking valproate during pregnancy; endpoint 05: Advising women taking valproate medicines about effective contraception during their treatment
FIGURE 4
FIGURE 4
Analysis of success with results on the five key primary endpoints separately for the overall weighted sample according to country. Endpoint 01: Understanding on prescribing valproate for epilepsy and bipolar disorder in women if other treatments are ineffective or not tolerated; endpoint 02: Ensuring that a doctor experienced in treating these conditions supervises the treatment of epilepsy or bipolar disorder; endpoint 03: Taking into consideration alternative treatments if a woman becomes or plans to become pregnant during valproate treatment, regularly review the need for treatment and re‐assess the balance of the benefits and risks for women and also for girls reaching puberty who are taking valproate; endpoint 04: Informing patients of the risks of taking valproate during pregnancy; endpoint 05: Advising women taking valproate medicines about effective contraception during their treatment
FIGURE 5
FIGURE 5
Acknowledgement of receipt of DHPC and/or EM related to valproate. DHPC, Dear Healthcare Professionals Communication; EM, educational material
See this image and copyright information in PMC

References

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