Methodological challenges when evaluating potential off-label prescribing of drugs using electronic health care databases: A case study of dabigatran etexilate in Europe

Miguel Cainzos-Achirica, Cristina Varas-Lorenzo, Anton Pottegård, Joelle Asmar, Estel Plana, Lotte Rasmussen, Geoffray Bizouard, Joan Forns, Maja Hellfritzsch, Kristina Zint, Susana Perez-Gutthann, Manel Pladevall-Vila

Research output: Contribution to journalArticle

4 Scopus citations

Abstract

Purpose: To report and discuss estimated prevalence of potential off-label use and associated methodological challenges using a case study of dabigatran. Methods: Observational, cross-sectional study using 3 databases with different types of clinical information available: Cegedim Strategic Data Longitudinal Patient Database (CSD-LPD), France (cardiologist panel, n = 1706; general practitioner panel, n = 2813; primary care data); National Health Databases, Denmark (n = 28 619; hospital episodes and dispensed ambulatory medications); and Clinical Practice Research Datalink (CPRD), UK (linkable to Hospital Episode Statistics [HES], n = 2150; not linkable, n = 1285; primary care data plus hospital data for HES-linkable patients). Study period: August 2011 to August 2015. Two definitions were used to estimate potential off-label use: a broad definition of on-label prescribing using codes for disease indication (eg, atrial fibrillation [AF]), and a restrictive definition excluding patients with conditions for which dabigatran is not indicated (eg, valvular AF). Results: Prevalence estimates under the broad definition ranged from 5.7% (CPRD-HES) to 34.0% (CSD-LPD) and, under the restrictive definition, from 17.4% (CPRD-HES) to 44.1% (CSD-LPD). For the majority of potential off-label users, no diagnosis potentially related to anticoagulant use was identified. Key methodological challenges were the limited availability of detailed clinical information, likely leading to overestimation of off-label use, and differences in the information available, which may explain the disparate prevalence estimates across data sources. Conclusions: Estimates of potential off-label use should be interpreted cautiously due to limitations in available information. In this context, CPRD HES-linkable estimates are likely to be the most accurate.

Original languageEnglish (US)
JournalPharmacoepidemiology and Drug Safety
DOIs
StateAccepted/In press - 2018
Externally publishedYes

Keywords

  • Atrial fibrillation
  • Dabigatran
  • Drug utilization
  • NOACs
  • Off-label
  • Pharmacoepidemiology

ASJC Scopus subject areas

  • Epidemiology
  • Pharmacology (medical)

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