Warnings for drug-drug interactions in consumer medication information provided by community pharmacies.

Objectives: In 2006, the U.S. Food and Drug Administration (FDA) issued a draft guidance for pharmacies to provide consumer medication information (CMI) to patients receiving prescription medications. The objective of this study was to evaluate CMI leaflets provided by community pharmacies for accuracy and completeness regarding drug-drug interactions (DDIs).

Methods: CMI leaflets were obtained for 3 commonly prescribed medications (azithromycin, ciprofloxacin, and simvastatin) from 14 community pharmacies that are part of 6 chain organizations that operate in southern Arizona. Three to 4 salient interacting medications for each leaflet medication were identified with the use of 2 well recognized drug compendia. The content of the DDI information in the leaflets was evaluated for completeness. The font size and reading level of each leaflet were assessed as well.

Results: The CMI provided by 14 pharmacies appeared to be produced by 2 information vendors, Wolters Kluwer and First Databank. This was evident based on the identical wording and attribution (e.g., copyright statements) on the leaflets. The CMI from First Databank mentioned 5 of the 11 previously identified interactions with the target medications, although 1 chain in this group chose not to print the DDI section at all and as a result scored 0. The CMI developed by Wolters Kluwer mentioned only 2 of the 11 identified DDIs. The average reading grade level for First Databank leaflets was 10.6 (SD 2.87), and the reading level for the CMI from Wolters Kluwer was 5.0 (SD 1.02). The font sizes varied from 8 to 12 points; FDA recommends that the information be printed in 12-point size or larger.

Conclusion: Community pharmacies appear to be distributing CMI leaflets with limited warnings about serious and well known DDIs. The results of this study suggest that consumers are not being informed through the CMI about important known DDIs.