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 journalArticlepeer-review

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 condi-tions 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 antico-agulant 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)
Pages (from-to)713-723
Number of pages11
JournalPharmacoepidemiology and Drug Safety
Volume27
Issue number7
DOIs
StatePublished - Jul 2018

Keywords

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

ASJC Scopus subject areas

  • Epidemiology
  • Pharmacology (medical)

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