Reporting Patterns Indicative of Adverse Drug Interactions

Johanna Strandell, Ola Caster, Andrew Bate, Niklas Norén, I. Ralph Edwards
2011 Drug Safety  
Adverse drug interaction surveillance in collections of Individual Case Safety Reports (ICSRs) remains underdeveloped. Most efforts to date have focused on disproportionality analysis, but the empirical support for its value is based on isolated examples. Additionally, too little attention has been given to the potential value of the detailed content of ICSRs for improved adverse drug interaction surveillance. Objective: The aim of the study was to identify reporting patterns indicative of
more » ... cted adverse drug interactions before the drug interactions are generally established. Methods: A reference set of known adverse drug interactions and drug pairs not known to interact was constructed from information added to Stockley's Drug Interactions Alerts between the first quarter of 2007 and the third quarter of 2009. The reference set was used to systematically study differences in reporting patterns between adverse drug interactions before they are generally established and adverse drug reactions (ADRs) to drug pairs that are not known to interact, in the WHO Global ICSR Database, VigiBase. The scope of the study included pharmacological properties such as common cytochrome P450 metabolism, explicit suspicions of drug interactions as noted by the reporter, clinical details such as dose and treatment overlap, and the lower limit of the 95% credibility interval of a three-way measure of disproportionality, Omega 025 (O 025 ), based on the total number of reports on two drugs and one ADR together. Analyses were carried out including and excluding concomitant medicines. Results: Five reporting patterns were highlighted as particularly strong indicators of adverse drug interactions before they are known: suspicion of interactions as noted by the reporter in a case narrative, the assignment of the two drugs as interacting or through an ADR term; co-reporting of effect ORIGINAL RESEARCH ARTICLE
doi:10.2165/11586990-000000000-00000 pmid:21332249 fatcat:agh37hhdfzgrvpkeiyzm4op2aa