Detection of adverse drug reactions: evaluation of an automatic data processing applied in oncology performed in the French DRG database

This study focused on adverse drug reaction which required inpatient hospitalization (ADRh). All diagnoses coded in the DRG database for hospital stays that occurred within three months after OTT initiation were collected (potential ADRh). Filters (exclusion criteria) were automatically applied on potential ADRh in order to exclude diagnoses that were not adverse drug reactions (false positives). A pharmacovigilance review was carried out to identify ADRh in the medical records (reported ADRh). The sensitivity and specificity of the detection method were estimated for each filter combinations by comparison between potential and reported ADRh. This study included 129 patients. The medical records review led to identify 19 ADRh (all coded in the DRG database) in 14 patients. To maintain a one hundred percent sensitivity of the method detection, the best specificity obtained was 58.3% (95% IC: [55.2‐61.4]).The use of restrictive filters (“drug” in the diagnostic label, specific diagnosis code for adverse cancer drug reaction) resulted in a 97.8% specificity (95% IC: [96.6‐98.5]) with a 38.2% sensitivity (95% IC: [23.9‐55.0]). Our method has detected the third of ADRh with an excellent specificity. Complementary experimentations in pharmacovigilance centers are necessary to evaluate the interest of this tool in routine in addition to spontaneous reporting. This article is protected by copyright. All rights reserved.
Source: Fundamental and Clinical Pharmacology - Category: Drugs & Pharmacology Authors: Tags: Original Article Source Type: research