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

Pharmacoepidemiology and Drug Safety
Massoud ToussiSigal Kaplan

Abstract

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

References

Mar 15, 1994·Statistics in Medicine·J H Ellenberg
Sep 15, 2005·Journal of Neurology, Neurosurgery, and Psychiatry·J MorrowJ Craig
May 5, 2009·Epilepsy & Behavior : E&B·Kimford J MeadorUNKNOWN NEAD Study Group
Jul 12, 2016·Drugs -- Real World Outcomes·Jerzy DanilukAnna Kowalczyk
Aug 30, 2016·Annals of Indian Academy of Neurology·Unnikrishnan Krishnan Syam, Sanjeev V Thomas
Mar 4, 2018·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Sieta T de VriesUNKNOWN SCOPE work package 6
Apr 20, 2018·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Wally LandsbergMirza Rahman

❮ Previous
Next ❯

Methods Mentioned

BETA
contraception

Software Mentioned

OneKey
IQVIA OneKey
SAS

Related Concepts

Related Feeds

Bipolar Disorder

Bipolar disorder is characterized by manic and/or depressive episodes and associated with uncommon shifts in mood, activity levels, and energy. Discover the latest research this illness here.