A Drug Utilisation Study extension (DUS ext.) of valproate and related substances, in Europe, using databases (VALNAC09343)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48966
• EU PAS number:
  EUPAS34519
• Study ID:
  48966
• Official title and acronym:
  A Drug Utilisation Study extension (DUS ext.) of valproate and related substances, in Europe, using databases (VALNAC09343)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Netherlands

  Spain

  Sweden

  United Kingdom
• Study description:
  The aim of this study is to describe the prescribing practices before and after the dissemination of the new risk minimization measures (RMMs) (planned over Q2 2018 – Q4 2018, depending on approval by National Competent Authorities) in Europe and to assess the effectiveness of these measures. ; ; Primary objectives: ; • To describe and compare the prescribing practices in women of child bearing potential (WCBP) receiving valproate during the pre- and/or post-implementation period with respect to elements of the PPP (where available in each of the data sources) separately: ; o Use of contraceptives without interruption during treatment o Laboratory pregnancy tests before treatment o Treatment reviews by a specialist at least once per year (using a proxy of consultation by a specialist as a marker for treatment review),; o Specialty of prescribing physician at initiation.; • To describe and compare proportion of patients for which all elements of the PPP measurable with this DUS are fulfilled, during the pre- and/or post-implementation period,; • To describe and compare the incidence of valproate exposed pregnancies, and characteristics of exposed pregnancies during the pre and post implementation period.; ; This is a non-interventional longitudinal retrospective cohort study of WCBP exposed to valproate, conducted with secondary data obtained from electronic medical records or administrative healthcare databases in different European countries (i.e. France, Germany, the Netherlands, Spain, Sweden, and the UK). The study population will include all WCBP receiving valproate prescriptions during the pre-defined periods (pre- and post-implementation periods). The analyses will be mainly descriptive and will be conducted by country, database, and study time periods.
• Study status:
  Planned

Research institution and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 16/10/2018

Study start date

Planned: 01/08/2020

Date of final study report

Planned: 28/02/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

A Consortium of Marketing Authorization Holders for valproate and related substances

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)
• Regulatory procedure number:
  EMEA/H/A-31/1454