Health and Medical News and Resources

General interest items edited by Janice Flahiff

Communicating Health Risk Is A Risky Task For FDA

 

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Communicating Health Risk Is A Risky Task For FDA

From the 23 January Medical News Today article

The impact of efforts by the U.S. Food and Drug Administration to notify the general public and health care providers about unanticipated risks from approved medications has been “varied and unpredictable,” according to a systematic review of published studies about FDA warnings and alerts over the last 20 years.

Although some communication efforts had a strong and immediate effect, many had little or no impact on drug use or health behaviors and several had unintended consequences, researchers report in the journal Medical Care. …

…The FDA has several standard tools to disseminate new evidence about drug safety. These include “Dear Healthcare Provider” letters to prescribers*, “public health advisories” and “Safety Alerts” targeting the general public, and “black box warnings”** added to a label when a drug’s risks may be particularly severe or affect a large population. Despite numerous studies examining single alerts, advisories and label changes, no prior study has systematically examined the effect of these risk communications….

[Article summarizes the effectiveness of 4 categories of communication]

…Part of the problem, the authors emphasize, is the challenge of communicating complex risk messages to a large, diverse audience. “The most effective communications were the simplest, those that were specific, where alternatives were available, and where the messaging was reinforced over time,” said Stacie Dusetzina, PhD, lead author from Harvard Medical School.

 

Read the entire Medical News Today article

*No direct links to “Dear Healthcare Provider” letters at http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/default.htm
However, individual letters can be found through using search engines, as a recent one for the drug Promacta

**Recent black box warnings are listed at Drug Safety Communications . If a drug has a black box warning, it will be part of its label. Drug information by name of drug is located at Drugs@FDA.

January 30, 2012 - Posted by | Consumer Health | , , , , , ,

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