S S Sansgiry1, P S Cady, S Patil. 1. Department of Pharmacy Practice and Administrative Sciences, College of Pharmacy, Idaho State University, Pocatello 83209, USA.
Abstract
OBJECTIVE: This study evaluated information on over-the-counter (OTC) medication labels. Brand-name OTC products were examined to determine compliance with the Label Readability Guidelines recommended by the Nonprescription Drug Manufacturers Association (NDMA). Additionally, the use of pictures on OTC medication labels was assessed. The effect of pictures on other aspects of label design that may affect comprehension was also evaluated. DESIGN: We evaluated 100 OTC medication labels (20 analgesics and 80 cold/cough products). Assessment of label content was based on certain aspects of label design, such as package size, font size of written information, format of information on warnings and indications, use of pictures, and use of advertising claims on product labels. RESULTS: Many products evaluated did not meet NDMA guidelines. Even when font size of product name increased with increase in package size, font size on warnings and indications remained constant at 6 points. Lack of boldface (63%), use of all uppercase font (30%), use of hyphenation (49%), lack of paragraph breaks (19%), and the small font size of 6 points or less (98%) could reduce readability. Packages containing pictures were significantly larger than packages without pictures. Several packages (30%) contained pictures in the indications section. Many products contained advertising claims that were classified as "green" or "quality" (41%) and "free" (38%). Additionally, 43 different advertising claims were identified; some of these may be difficult for patients to interpret. CONCLUSIONS: The findings may help FDA develop specific regulations to improve label readability. Pharmacists who recommend OTC products to consumers should be aware of these issues and evaluate requests by consumers regarding OTC drugs accordingly.
OBJECTIVE: This study evaluated information on over-the-counter (OTC) medication labels. Brand-name OTC products were examined to determine compliance with the Label Readability Guidelines recommended by the Nonprescription Drug Manufacturers Association (NDMA). Additionally, the use of pictures on OTC medication labels was assessed. The effect of pictures on other aspects of label design that may affect comprehension was also evaluated. DESIGN: We evaluated 100 OTC medication labels (20 analgesics and 80 cold/cough products). Assessment of label content was based on certain aspects of label design, such as package size, font size of written information, format of information on warnings and indications, use of pictures, and use of advertising claims on product labels. RESULTS: Many products evaluated did not meet NDMA guidelines. Even when font size of product name increased with increase in package size, font size on warnings and indications remained constant at 6 points. Lack of boldface (63%), use of all uppercase font (30%), use of hyphenation (49%), lack of paragraph breaks (19%), and the small font size of 6 points or less (98%) could reduce readability. Packages containing pictures were significantly larger than packages without pictures. Several packages (30%) contained pictures in the indications section. Many products contained advertising claims that were classified as "green" or "quality" (41%) and "free" (38%). Additionally, 43 different advertising claims were identified; some of these may be difficult for patients to interpret. CONCLUSIONS: The findings may help FDA develop specific regulations to improve label readability. Pharmacists who recommend OTC products to consumers should be aware of these issues and evaluate requests by consumers regarding OTC drugs accordingly.
Authors: Terry C Davis; Michael S Wolf; Pat F Bass; Mark Middlebrooks; Estela Kennen; David W Baker; Charles L Bennett; Ramon Durazo-Arvizu; Anna Bocchini; Stephanie Savory; Ruth M Parker Journal: J Gen Intern Med Date: 2006-08 Impact factor: 5.128