Methodological challenges when evaluating potential off-label prescribing of drugs using electronic health care databases: A case study of dabigatran etexilate in Europe.
Pharmacoepidemiol Drug Saf
; 27(7): 713-723, 2018 07.
Article
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| MEDLINE
| ID: mdl-29570897
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.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Trombosis
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Antitrombinas
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Uso Fuera de lo Indicado
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Registros Electrónicos de Salud
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Dabigatrán
Tipo de estudio:
Etiology_studies
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Observational_studies
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Prevalence_studies
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Prognostic_studies
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Risk_factors_studies
Límite:
Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
País como asunto:
Europa
Idioma:
En
Año:
2018
Tipo del documento:
Article