Surveys among Health Care Professionals and Patients to assess their knowledge and behaviour with respect to the new (2018) Risk Minimization Measures for valproate use in Europe. (VALNAC09348)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/34466
• EU PAS number:
  EUPAS34465
• Study ID:
  34466
• Official title and acronym:
  Surveys among Health Care Professionals and Patients to assess their knowledge and behaviour with respect to the new (2018) Risk Minimization Measures for valproate use in Europe. (VALNAC09348)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Poland

  Spain

  Sweden

  United Kingdom
• Study description:
  This survey aims to measure the awareness, knowledge and behaviour of prescribing physicians, gynaecologists and pharmacists with respect to the new (2018) RMMs for valproate, as well as of patients treated with valproate in France, Germany, Poland, Sweden, Spain and UK. The new RMMs include new prescribing and dispensing conditions, Pregnancy Prevention Program (PPP), educational materials (EM) i.e. Healthcare Professionals (HCPs) guide, Patient Card, Patient Guide, and Annual Risk Acknowledgement form. Objectives for HCPs - To assess HCPs awareness related to both receipt and reading of the new (2018) RMMs including direct healthcare professional communication (DHPC) and educational materials (EMs) for valproate-containing medicines. - To assess HCPs knowledge with respect to the new (2018) RMMs including measures of PPP, prescribing/dispensing conditions and risks associated with exposure to valproate-containing medicines during pregnancy. - To assess HCPs behaviour with respect to the new (2018) RMMs regarding the measures of the PPP. Objectives for Patients - To assess the awareness of women of child bearing potential (WCBP) treated with valproate-containing medicines related to both receipt and reading of the new (2018) RMMs including the educational materials provided by the HCPs. - To assess the knowledge of WCBP treated with valproate-containing medicines with regards to risks associated with use of valproate-containing medicines during pregnancy and measures to avoid exposed pregnancies. - To assess the behaviour of WCBP treated with valproate-containing medicines with respect to the new (2018) RMMs including measures of the PPP. Data collection Mainly web questionnaire, paper version proposed to patients, pharmacists not be surveyed in France. Sample size: - 1328 completed questionnaires from physicians who have prescribed valproate, 215 from gynaecologists having seen patients treated with valproate, - 384 completed questinnaires
• Study status:
  Finalised

Research institutions and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Actual: 16/10/2018

Study start date

Planned: 01/06/2020

Actual: 01/12/2020

Date of final study report

Planned: 01/02/2021

Actual: 28/07/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

A Consortium of Marketing Authorization Holders for valproate and related substances

Study protocol

Initial protocol

VALNAC09348 HCP Patients Surveys Protocol V6.0 04NOV2020 clean

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