Analysis of the prescription of Valproat and related substances over time

>Federal Institute for Drugs and Medical Devices BfArM

PharmacotherapyClaims data

Antiepileptic drugs and especially valproate and valproate-related substances have a high risk of teratogenicity. Doctors were made aware of this in 2014 and 2018 through Red Hand Letters after completion of various risk assessment procedures and in 2018 through training materials and documents for patients.

Authorisation holders of medicinal products containing valproate and related substances are required to conduct post-authorisation safety evaluations to verify the effectiveness of these risk reduction measures. These studies have now been approved by the PRAC.

The aim of this study was to determine whether the above-mentioned measures have led to a change in prescribing behaviour and thus to an improvement in drug therapy safety. In a first approximation, a descriptive analysis of the prescription development and prescription pattern of antiepileptic drugs as a whole and by substance class for women in the last 10 years between 2008 and 2017 as well as in an update up to 2020 will be carried out.

Of particular interest here was the question of which oral antiepileptic drugs were used for which indications in women of childbearing age. In addition it must be investigated whether channeling, i.e. a decrease in valproate and related substances, can be observed when other antiepileptic drugs with a known, possibly lower or even unknown teratogenic risk increase. Moreover, it will be investigated which diagnoses were present when valproate and related substances were first prescribed.

Information on prescription behaviour over long periods of time can be obtained by evaluating health insurance data. For the project described here the data of the research institute of AOK were used. 

Duration: 2020–2022
Methods: Statistical Analyses
Topics: Pharmacotherapy, Supply curves, Disease incidence
Data: Claims data


Scholz K, Köster I, Meyer I, Selke GW, Schubert I.
Brief Report: Prescribing of valproate and oral antiepileptics for women of childbearing age and during pregnancy in Germany between 2010 and 2020. Pharmacoepidemiology and Drug Safety 2023; 32: 1306–1314

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