Impact of EU label changes and pregnancy prevention programme for medicinal products containing valproate and related substances: risk awareness and adherence (ValproateRiskAware)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49662
• EU PAS number:
  EUPAS32405
• Study ID:
  49662
• Official title and acronym:
  Impact of EU label changes and pregnancy prevention programme for medicinal products containing valproate and related substances: risk awareness and adherence (ValproateRiskAware)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Denmark

  Greece

  Latvia

  Netherlands

  Portugal

  Slovenia

  Spain
• Study description:
  This is a multi-country study in eight European countries: Belgium, Denmark, Greece, Latvia, Portugal, The Netherlands, Slovenia and Spain. In each country a web-based questionnaire will be conducted among users and former users of valproate and related products, and among health care professionals. An electronic survey including questions on the influence of regulatory recommendations on HCP awareness about the teratogenic and neurodevelopment effects of valproate and related substances will be used to gauge their perspective and to assess effects on knowledge, attitudes and practices. Similary a patient questionnaire will measure awareness about regulatory recommendations as well as uptake of pregnancy prevention measures, and investigate their effect on valproate use. Data from the survey and questionnaire will be anonymised and analysed for differences between countries. Determinants for adherence to the measures implemented per country will be analysed. Additionally, in two countries (Netherlands and Portugal) semi-structured telephone interviews will be held with 6-8 patients with a range in age and varied educational background.
• Study status:
  Finalised

Research institutions and networks

Institutions

Division of Pharmacoepidemiology & Clinical Pharmacology (PECP), Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University

Netherlands

Division of Pharmacoepidemiology & Clinical Pharmacology (PECP), Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University

Netherlands

Porto Pharmacovigilance Centre, Faculty of Medicine, University of Porto (UFPorto)

Portugal

Department of Medicine/Laboratory of Hygiene and Environmental Protection, Democritus University of Thrace

Greece

The Institute of Public Health of Riga Stradins University Riga, Latvia, University of Copenhagen, Faculty of Health and Medical Sciences, Department of Pharmacy (Social and Clinical Pharmacy) Copenhagen, Denmark, Sección de Innovación y Organización, Servicio Navarro de Salud Pamplona, Spain, Pharmaceutical Care Unit – Ghent University Ghent, Belgium, Centre for Health Protection, National Institute for Public Health and the Environment Bilthoven, Netherlands

Networks

Pharmacoepidemiology and Pharmacovigilance Network

Study timelines

Date when funding contract was signed

Planned: 25/02/2019

Actual: 25/02/2019

Study start date

Planned: 25/10/2019

Actual: 25/10/2019

Data analysis start date

Planned: 25/12/2019

Date of interim report, if expected

Planned: 24/07/2020

Date of final study report

Planned: 28/08/2020

Actual: 01/04/2021

Sources of funding

EMA

Study protocol

Initial protocol

29-01-2020 Protocol valproate study version 2.0 final with annexes

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable