Messages about Black-Box Warnings
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- 作者：Dr Pierre L. Yong (1) (2) (3) (4)
Cabral Bigman (5)
David N. Flynn (6)
Danielle Mittermaier (5)
Judith A. Long (1) (3) (6) - 刊名：Drug Safety
- 出版年：2009
- 出版时间：December 2009
- 年：2009
- 卷：32
- 期：12
- 页码：1147-1157
- 全文大小：210KB
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Cabral Bigman (5)
David N. Flynn (6)
Danielle Mittermaier (5)
Judith A. Long (1) (3) (6)
1. Department of Medicine, Philadelphia Veterans Affairs Medical Center, Philadelphia, Pennsylvania, USA
2. Robert Wood Johnson Clinical Scholars Program, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA
3. Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania, USA
4. Center for Public Health Initiatives, University of Pennsylvania, Philadelphia, Pennsylvania, USA
5. Annenberg School of Communication, University of Pennsylvania, Philadelphia, Pennsylvania, USA
6. Division of General Internal Medicine, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA - ISSN：1179-1942
文摘
Background: The US FDA and lay media are important sources of information for the public about the risks of adverse events associated with drugs, yet the quality of FDA and US lay media reports about medication ‘black-box-warnings, which highlight potentially severe adverse events from medications, is unknown. Objective: To determine and compare the content of FDA and US lay media reports about medication black-box warnings. Methods: We assessed FDA and US lay media reports about medication black-box warnings published or aired between 1 January 2003 and 31 December 2007 for the presence of six core message components, including (i) the affected drug’s brand name; (ii) generic name; (iii) treatment indication; (iv) reason for the black-box warning; (v) clinical recommendations for patients, such as warning signs and symptoms of the adverse effect addressed by the black-box warning; and (vi) encouragement to discuss the issue with a healthcare provider, and additional characteristics. Results: FDA reports presented more core information than lay media reports (median 5 vs 3 message components; p < 0.001). FDA reports were more likely to mention generic names (84.6% vs 18.1%; p < 0.001) of affected drugs, while lay media reports less frequently detailed clinical recommendations for patients (43.9% vs 96.2%; p < 0.001). Only 10.6% of lay media reports encouraged patients to seek additional information from their healthcare provider, compared with 48.1% of FDA reports (p < 0.001). Conclusions: FDA and US lay media reports about medication black-box warnings presented different information. This may reflect a difference in underlying motivation for reporting of news about risks of adverse drug events. It may also indicate a lack of agreement and understanding about the best methods to communicate risk information to the public, thus indicating areas for future research.