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.
Franks
Andrea S
AS
Departments of Clinical Pharmacy and Family Medicine, College of Pharmacy and Graduate School of Medicine, University of Tennessee, Knoxville, TN 37920, USA. afranks@utmem.edu
Ray
Shaunta' M
SM
Wallace
Lorraine S
LS
Keenum
Amy J
AJ
Weiss
Barry D
BD
D032882:Comprehension; D004348:Drug Labeling / Q000379:methods* / Q000592:standards*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology / Q000517:prevention & control; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D010353:Patient Education as Topic / Q000379:methods / Q000592:standards; D004364:Pharmaceutical Preparations / Q000145:classification
D004364:Pharmaceutical Preparations