Impact of EU label changes and revised pregnancy prevention programme for oral retinoid containing medicinal products: utilization and prescribing trends

ENCePP Seal

This study has been awarded the ENCePP seal

Composition of steering group and observers

Information DoI and steering group EUPAS31095

Signed code of conduct

Declaration of Compliance with the ENCEPP Code of Conduct

Signed code of conduct checklist

Checklist for the ENCEPP Code of Conduct

Signed checklist for study protocols

ENCEPP Checklist for Study Protocols

Data sources

• Data source(s):
  Danish registries (access/analysis)

  Caserta claims database

  PHARMO Data Network

  Base de Datos para la Investigación Farmacoepidemiológica en el Ámbito Público (Pharmacoepidemiological Research Database for Public Health Systems)

  ARS Toscana
• Data source(s), other:
  Danish Registries (access/analysis), Caserta database, PHARMO Data Network, BIFAP, ARS, FISABIO
• Data sources (types):
  Administrative data (e.g. claims)

  Disease registry

  Drug dispensing/prescription data

  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:
  No