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Readability of over-the-counter medication labels
S S Sansgiry1, P S Cady, S Patil
1Department of Pharmacy Practice and Administrative Sciences, College of Pharmacy, Idaho State University, Pocatello 83209, USA.
Journal of the American Pharmaceutical Association (Washington, D.C. : 1996)
|February 28, 1998
Summary
Many over-the-counter (OTC) medication labels fail to meet readability guidelines, with small fonts and poor formatting hindering comprehension. This impacts patient understanding and pharmacist recommendations for OTC drugs.
Area of Science:
- Pharmaceutical Sciences
- Health Communication
- Consumer Product Safety
Background:
- Over-the-counter (OTC) medications are widely used, necessitating clear and understandable product labeling for safe and effective self-medication.
- The Nonprescription Drug Manufacturers Association (NDMA) provides Label Readability Guidelines to enhance consumer comprehension of OTC medication information.
- Assessing compliance with these guidelines is crucial for identifying potential barriers to safe medication use.
Purpose of the Study:
- To evaluate the compliance of brand-name OTC medication labels with NDMA Label Readability Guidelines.
- To assess the utilization and impact of pictures on OTC medication labels.
- To investigate how label design elements, including pictures, affect overall comprehension.
Main Methods:
- A review of 100 OTC medication labels (20 analgesics, 80 cold/cough products) was conducted.
- Label content and design were assessed based on package size, font characteristics, information formatting, use of images, and advertising claims.
- Readability was evaluated against specific NDMA guidelines and general principles of clear communication.
Main Results:
- A significant number of OTC labels did not adhere to NDMA guidelines, particularly concerning font size for warnings and indications (often 6 points or less).
- Common readability issues included lack of boldface (63%), excessive use of all uppercase font (30%), and absence of paragraph breaks (19%).
- Labels with pictures were larger, and 30% included images within the indications section; numerous potentially confusing advertising claims were also identified.
Conclusions:
- Current OTC medication label designs present challenges to readability, potentially impairing consumer understanding.
- Findings can inform the U.S. Food and Drug Administration (FDA) in developing regulations to improve label clarity.
- Pharmacists should be aware of these labeling deficiencies when advising consumers on OTC medication choices.