Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on Utilisation and Prescribing Trends of Medicinal Products Containing Valproate: An Interrupted Time Series Study.
Shahab AbtahiRomin PajouheshniaCarlos E DuránJudit Riera-ArnauMagdalena GambaEma AlsinaVjola HoxhajMorten AndersenClaudia BartoliniSarah Brøgger KristiansenJeremy BrownChristine Erikstrup HallgreenPatricia Garcia-PozaHelga GardarsdottirRosa GiniAnna GirardiEmily HolthuisConsuelo HuertaLuisa IbánezGiorgio LimoncellaMar Martín-PérezOlga PaolettiGiuseppe RobertoPatrick SouvereinKarin M A SwartKevin WingMiriam SturkenboomOlaf KlungelPublished in: Drug safety (2023)
There was a small impact of the 2018 RMMs on valproate use in the studied European countries/regions. The substantial number of concurrent pregnancies with valproate exposure warrants a careful monitoring of implementation of the existing PPP for valproate in clinical practice in Europe, to see if there is any need for additional measures in the future.