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Sujit S Sansgiry, PhD, Manjiri D Pawaskar, BS, and Monali J Bhosle, BS. Clinical Sciences and Administration, University of Houston, 1441, Moursund St, Houston, TX 77030, 7137958392, SSansgiry@uh.edu
Objectives: To determine the extent of manufacturers′ compliance with the guidelines published by the FDA titled ′Over the Counter (OTC) Human Drugs: Labeling Requirements′ in 1999. Methods: Content analysis of OTC medication packages (n= 100) in the categories of analgesics, cough and cold remedies and stomach remedies, were conducted. Data were collected pre (1996) and post (2001) guidelines to extract information such as package size, print type, and font size of written information. The font size of written information was measured using a compugraphic point system scale. Data were coded and analyzed to determine extent of compliance with the FDA guidelines. Results: The mean font size of warnings, uses, and directions was slightly more, around 6 points, yet small enough that many consumers may still find it difficult to read information of OTC labels. The Drug Facts panel, as required by the FDA guidelines, was included on only 52% of the packages evaluated in 2001. Certain improvements on various aspects of the label information included an increase in the use of toll free number (23%). Use of hyphenations decreased by 27%, use of paragraphs increased by 5 % and use of bullets increased by 58% as recommended by the FDA guidelines. Conclusions: Although manufacturers′ are complying with certain aspects of the FDA guidelines, many of them have not implemented them universally. The early adoption of standardized labeling format may promote safe and effective use of medications by helping consumers to make informed decisions in product purchase.
Learning Objectives:
Presenting author's disclosure statement:
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.