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Labels May Need Explicit References To Consequences Of Misuse – Ganley

This article was originally published in The Tan Sheet

Executive Summary

Frequent occasions of drug-label comprehension not predicting appropriate use suggest that OTC drug labels need more explicit language, FDA's Office of Nonprescription Products director says

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Label comprehension guidance on list again

The Center for Drug Evaluation and Research continues developing its guidance on label comprehension studies for nonprescription drugs. The center Feb. 5 publishes its 2009 1agenda of guidances, a list that includes a total of 42 items in 14 CDER categories. Specifically, the list includes guidances on labeling dietary supplements for women who are or could be pregnant, dosage delivery devices for liquid OTCs and drug names and dosage forms. Publication of the guidance on label comprehension studies is anticipated by drug firms because questions on the design of such studies surfaced during FDA advisory committees' reviews of Rx-to-OTC switch applications (2"The Tan Sheet" Sept. 22, 2008, p. 6). CDER long has recommended improving OTC labeling and label comprehension studies to account for the growing complexity of nonprescription drugs and their indications (3"The Tan Sheet" Dec. 4, 2006, p. 9)

AHRQ agency announces new pharmacy tools

The Department of Health and Human Services' Agency for Healthcare Research and Quality offers two new tools for pharmacies aimed at better serving people with limited health literacy, AHRQ announces Oct. 30. The tools - "Is Our Pharmacy Meeting Patients' Needs? A Pharmacy Health Literacy Assessment Tool User's Guide" and "Strategies to Improve Communication between Pharmacy Staff and Patients: A Training Program for Pharmacy Staff" - are geared at raising awareness of health literacy limitations and training staff on ways to better assist pharmacy patients, according to a press release. AHRQ cites a study that found people with limited health literacy are more likely to be unable to identify their OTC as well as prescription medications, difficulty understanding instructions and less likely to understand potential side effects than the more health literate 1("The Tan Sheet" Dec. 4, 2006, p. 9). The tools are a result of an Emory University study funded by AHRQ and the Robert Wood Johnson Foundation...

Label Comprehension Studies Must Account For Drugs’ Complexity – Bull

The science behind creating OTC labeling and label comprehension studies needs to be improved to account for the increasing complexity of nonprescription drugs and their indications, stated Center for Drug Evaluation & Research Office of Drug Evaluation V Director Jonca Bull, MD

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