Valproate Restrictions in Sweden and Norway: Online survey suggests implementation deficit.

Abstract

To assess knowledge among neurologists in Sweden and Norway on the restrictions issued by the European Medicines Agency (EMA) regarding use of valproic acid (VPA) to female patients of childbearing potential, their use of the pregnancy prevention programme and their VPA prescription habits. We conducted an online survey from May through September 2021 inviting neurologists in Sweden and Norway to participate. The questions assessed familiarity with the EMA restrictions, knowledge and use of the information material issued by Market Authorization Holders (MAH) of VPA, and experience of VPA prescriptions to women of childbearing age in the last 2years. The survey received 202 responses (response rate≈20%). Of the responders, 51% were well acquainted with the EMA restrictions, and 49% were aware of the MAH-issued educational material. Eighty-eight (44%) had prescribed VPA to women of childbearing age in the last 2years, and of these, only a small minority (n=13) regularly used the information brochure for patients, and even fewer (n=8) the VPA risk acknowledgement forms. We found limited penetrance of the new EMA restrictions on VPA use as well as limited acceptance and use among prescribers of the current company-issued information material and risk acknowledgment forms. More information campaigns and closer collaboration with treating physicians are likely needed.