Background: Food and Drug Administration (FDA) regulations mandate that package inserts (PIs) include observed or predicted clinically significant drug-drug interactions (DDIs), as well as the results of pharmacokinetic studies that establish the absence of effect.
Objective: To quantify how frequently observed metabolic inhibition DDIs affecting US-marketed psychotropics are present in FDA-approved PIs and what influence the source of DDI information has on agreement between 3 DDI screening programs.
Methods: The scientific literature and PIs were reviewed to determine all drug pairs for which there was rigorous evidence of a metabolic inhibition interaction or noninteraction. The DDIs were tabulated noting the source of evidence and the strength of agreement over chance. Descriptive statistics were used to examine the influence of source of DDI information on agreement among 3 DDI screening tools. Logistic regression was used to assess the influence of drug class, indication, generic status, regulatory approval date, and magnitude of effect on agreement between the literature and PI as well as agreement among the DDI screening tools.
Results: Thirty percent (13/44) of the metabolic inhibition DDIs affecting newer psychotropics were not mentioned in PIs. Drug class, indication, regulatory approval date, generic status, or magnitude of effect did not appear to be associated with more complete DDI information in PIs. DDIs found exclusively in PIs were 3.25 times more likely to be agreed upon by all 3 DDI screening tools than were those found exclusively in the literature. Generic status was inversely associated with agreement among the DDI screening tools (odds ratio 0.11; 95% CI 0.01 to 0.89).
Conclusions: The presence in PIs of DDI information for newer psychotropics appears to have a strong influence on agreement among DDI screening tools. Users of DDI screening software should consult more than 1 source when considering interactions involving generic psychotropics.
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