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Almut G. Winterstein, PhD; Stephan Linden, BSPharm; Abigail E. Lee, PharmD; Erica M. Fernandez, PharmD; Carole L. Kimberlin, PhD

Arch Intern Med. 2010;170(15):1317-1324. doi:10.1001/archinternmed.2010.263

Background  United States retail pharmacies are key sources of written consumer medication information (CMI) through leaflets dispensed with prescription drugs. The content and format of this CMI are unregulated. Public Law 104-180 stipulates that by 2006, 95% of prescriptions be accompanied by "useful" CMI.

Methods  Professional shoppers filled prescriptions for lisinopril and metformin in a national sample of 365 pharmacies. Dispensed CMI was evaluated according to explicit criteria (77 for lisinopril and 78 for metformin) adapted from Food and Drug Administration guidelines.

Results  Six percent of pharmacies did not provide any written CMI. A mean (SD) of 60.2% (20.7%) and 57.7% (20.1%) of the criteria for useful CMI were met for lisinopril and metformin prescriptions, respectively. Shortcomings concerned especially "directions about use" with means of 53.4% (95% confidence interval [CI], 51.4%-56.5%) and 45.6% (43.7%-47.6%), and "comprehensibility/legibility," with means of 43.8% (42.6%-44.9%) and 42.6% (41.1%-43.7%) for lisinopril and metformin, respectively. The CMI leaflets ranged from 33 to 2482 words, with more than 1000-word differences among those meeting higher than 80% of the content criteria, suggesting large variations in conciseness. Chain pharmacies had better adherence to content criteria than did independent stores, with mean differences of 22.1% (95% CI, 15.8%-28.4%) for lisinopril and 21.1% (95% CI, 14.9%-27.3%) for metformin.

Conclusions  Although distribution through pharmacies seems effective, the content, format, reading level, and excessive length of CMI are disconcerting. Private sector initiatives to provide useful CMI have failed. Research is needed on effective information selection and presentation in terms of effects on comprehension, retention, and appropriate patient actions to derive optimal drug benefit.

Author Affiliations: Pharmaceutical Outcomes and Policy, College of Pharmacy, Epidemiology and Biostatistics, College of Public Health and Health Professions, and University of Florida Food and Drug Administration/Center for Drug Evaluation and Research Graduate Program in Pharmaceutical Outcomes and Policy Research (Dr Winterstein), Pharmaceutical Outcomes and Policy, College of Pharmacy (Mr Linden and Dr Kimberlin), and College of Pharmacy (Drs Lee and Fernandez), University of Florida, Gainesville.

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