Post-Authorization Safety Study to Assess the Effectiveness of the Newly Implemented Risk Minimization Measures for Topiramate: Drug Utilization Study

ENCePP Code of conduct

Yes

Data sources

• Data source(s):
  Système National des Données de Santé (French national health system main database)

  German Pharmacoepidemiological Research Database

  The Information System for Research in Primary Care (SIDIAP)

  Landspatientregisteret (National Patient Register)

  Sweden National Prescribed Drugs Register / Läkemedelsregistret

  Clinical Practice Research Datalink

  Hospital Episode Statistics

  Swedish Cause of Death Register
• Data source(s), other:
  National Medical Birth Register (MBR) Sweden; Total Population Register (TPR) Sweden; Office for National Statistics (ONS) United Kingdom; Données de Consommation Inter-régimes, (DCIR) France; Programme de Médicalisation des Systèmes d’Information, (PMSI) France; Inserm's CépiDc Causes of Deaths database (BCMD) France
• Data sources (types):
  Administrative healthcare records (e.g., claims)

  Electronic healthcare records (EHR)

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

• Check conformance:
  Unknown
• Check completeness:
  Unknown
• Check stability:
  Unknown
• Check logical consistency:
  Unknown

Data characterisation

• Data characterisation conducted:
  Unknown