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Methodological approaches to evaluate the impact of FDA drug safety communications.

Author: AvornJerry, BrownsteinJohn S, CampbellEric G, Dal PanGerald J, KesselheimAaron S, LappinBrian M, RauschPaula, SchneeweissSebastian, SchwartzLisa M, SeegerJohn D, ToomeyTimothy, WoloshinSteven, ZhouEsther H

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Research Support, U.S. Gov't, Non-P.H.S.Research funding provided by US government agencies other than the Public Health Service.

Overview

This article discusses the importance of post-approval drug safety communications (DSCs) issued by the FDA. It explores how DSCs convey information to patients and physicians and the factors that influence the effectiveness of communication.
Paper Details　
Original Abstract of the Article :
When the US FDA approves a new prescription drug there is still a great deal remaining to be learned about the safe and proper use of that product. When new information addressing these topics emerges post-approval, the FDA may issue a Drug Safety Communication (DSC) to alert patients and physicians...See full text at original site
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引用元：
https://doi.org/10.1007/s40264-015-0291-y

データ提供：米国国立医学図書館（NLM）

FDA Drug Safety Communications: Evaluating Their Impact

The FDA plays a vital role in ensuring the safety and effectiveness of medications. Once a drug is approved, the FDA continues to monitor its use and issue drug safety communications (DSCs) to alert patients and healthcare professionals about new information regarding safety and efficacy. This research explores the effectiveness of these DSCs in changing patient and prescriber behavior.

Evaluating the Effectiveness of FDA Drug Safety Communications

The study examines the factors that contribute to the effectiveness of FDA DSCs. It highlights the importance of understanding how physicians and patients receive, understand, and perceive the information conveyed in these communications. The researchers emphasize the need for effective communication strategies to ensure that DSCs reach their intended audience and lead to positive changes in prescribing and patient behavior.

Navigating the Desert of Drug Safety: Clear Communication is Key

This research underscores the importance of effective communication in navigating the complex landscape of drug safety. Clear and concise communication is essential for ensuring that patients and healthcare professionals have the information they need to make informed decisions about medication use. This study provides valuable insights into the challenges and opportunities of communicating drug safety information effectively.

Dr.Camel's Conclusion

The desert of drug safety can be vast and unpredictable. This research highlights the importance of effective communication in ensuring the safety and effectiveness of medication use. By studying the factors that influence the effectiveness of FDA DSCs, we can work towards a future where drug safety information is communicated clearly and effectively, empowering patients and healthcare professionals to make informed decisions about their health.

Date :
  1. Date Completed 2016-02-23
  2. Date Revised 2018-12-02
Further Info :

Pubmed ID

25968811

DOI: Digital Object Identifier

10.1007/s40264-015-0291-y

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English

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