Do medication samples jeopardize patient safety?

BACKGROUND: Medication samples are commonly dispensed by prescribers. Written consumer medication information (CMI) provided with sample packaging is an important source of patient information. Although one-third of Americans have health literacy deficiencies, previous studies have found that CMI is often too complex for many patients to understand. This may prevent patients from using these medications appropriately. OBJECTIVE: To evaluate readability and formatting characteristics of CMI included with nonsolid (ie, topical cream/lotion, inhalation, transdermal) drug samples. METHODS: We collected a convenience sample of nonsolid dosage sample medications (N = 55) from several different private and university-affiliated primary care and specialty physician practices at a large academic medical center in the southeastern US. We noted whether CMI was present and, if it was, we assessed it for instruction presentation, reading level, text size, format/layout, and comprehensibility. RESULTS: Most (43 of 55) products included CMI, either as a separate leaflet or directly on the packaging. Reading level of CMI leaflets ranged from the 6th- to 14th-grade level, with just 4 (16.0%) written at the recommended 6th-grade level. Text font point size was 9.48 ± 2.14 (mean ± SD; range 5-12). Text printed directly on sample packaging averaged 6.61 point ± 2.62 (4-11) font size. Ninety-two percent of CMI leaflets included a combination of text and pictures; only 11.1% of CMI printed directly on the packaging used pictorial aids. CONCLUSIONS: Most CMI accompanying nonsolid medication samples is written at a reading level that exceeds that of many consumers and does not meet recommended standards for readability and comprehensibility of patient education material.