The Future of Drug Safety Promoting and Protecting the Health of the Public (2007) / Chapter Skim
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6 Communicating About Safety
6 Communicating About Safety
Pages 177-192
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From page 177... ...
prescription drug advertising, ever wider Internet and e-mail access and breadth of information, a shift in the formerly passive role of patient, and the emergence of a powerful patient advocacy movement (Atkin and Wallack, 1990; Dupuits, 2002; Pew Internet and American Life Project, 2003, 2004, 2005)
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From page 178... ...
THE FUTURE OF DRUG SAFETY communication efforts at FDA, discuss some of the challenges that have complicated those activities, and to suggest two specific areas for improvement and makes appropriate recommendations. Pharmaceutical products constitute 11 percent of the health care dollar (Smith et al., 2005)
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From page 179... ...
First, FDA has authority over prescription drug advertising developed and published or broadcast by sponsors, and CDER's Division of Drug Marketing and Communication sends untitled letters2 and warning letters to sponsors whose advertisements do not convey a fair balance of risk and benefit information. Second, all of FDA's advisory committees include consumer representatives.
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From page 180... ...
network -- prescription drug outcomes are one focus of the network -- and other material on evidencebased practice. NIH conducts or sponsors clinical trials and does make
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From page 181... ...
COMMUNICATING ABOUT SAFETY medication self-management support. Such efforts require standardization of pharmacy medication information leaflets, improvement of online medication resources, establishment of a national drug information telephone helpline, the development of personal health records, and the development of a national medication safety dissemination plan.
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From page 182... ...
THE FUTURE OF DRUG SAFETY providers in great detail. The IOM report Preenting Medication Errors (2007)
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From page 183... ...
COMMUNICATING ABOUT SAFETY the committee learned about a wide variety of communication opportunities and challenges related to involving the general public and disease groups (such as online support groups) in reporting drug-related adverse events, about a movement to counteract commercial pharmaceutical company "detailing" with neutral "academic detailing" (Avorn, 2005)
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From page 184... ...
How Industry Communicates to the Public and Patients The frequently dangerous patent medicines that led to the Pure Food and Drugs Act of 1906 and the Food, Drug, and Cosmetic Act of 1938 were advertised directly to consumers with their colorful labels and claims, but modern prescription drugs, as products of biomedical science are promoted largely to health care providers, mostly to physicians. About 86 percent of industry promotional budgets still pay for "sampling" (providing free samples to providers)
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From page 185... ...
. Consumer Medication Information It may surprise many Americans to know that most prescription drugs have only a physician package insert and lack patient package inserts (also known as patient information leaflets)
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From page 186... ...
In 1979 and 1980, FDA published in the Federal Register the draft, and then the final rule requiring written patient information for prescription drugs (CDER and CBER, 2006)
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From page 187... ...
. Improing Communication with the Public CDER uses the expertise of 17 advisory committees (and the Drug Safety and Risk Management advisory committee)
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From page 188... ...
. The presence of consumer representatives in FDA's advisory committee process is limited to one member per committee, and communication issues understandably constitute just a small component of advisory committees' work.
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From page 189... ...
7The Advisory Committee Oversight and Management Staff in the Office of the Commis sioner works in collaboration with FDA centers to ensure consistent development, implementation, and operations of the FDA advisory committees (FDA, 2003)
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From page 190... ...
The 15 members include advocates, survivors, family members, and health care professionals and are chosen by the NCI director from a pool of ap plicants. The DCLG complies with the provisions of the Federal Advisory Committee Act.
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From page 191... ...
, CDER (Center for Drug Evaluation and Research)
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From page 192... ...
2004. Prescription Drugs Online: One in Four Ameri cans Hae Looked Online for Drug Information, But Few Hae Ventured into the Online Drug Marketplace.
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