Skip to main content

Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary

View Cover

Purchase Options
Purchase Options MyNAP members save 10% online. Login or Register
Overview

Contributors

Description

All pharmaceutical products have inherent risks, and their use involves trade-offs between their therapeutic benefits and their risks. However, the public has a limited understanding of the benefits and risks of drugs, and many individuals believe that drugs approved by the U.S. Food and Drug Administration (FDA) carry no risks. The FDA is responsible for evaluating and balancing the potential risks of drugs with their potential benefits. Assessing, managing, and communicating the benefit-risk profile of a pharmaceutical product is a complex and nuanced scientific, political, and sociological challenge. Once the assessment is made, the FDA is then responsible for managing how to communicate these risks and make healthcare decisions based on them.

To explore these issues, the Forum on Drug Discovery, Development, and Translation conducted a public workshop entitled Understanding the Benefits and Risks of Pharmaceuticals, with the broad goals of gaining a better understanding of the current system used to evaluate benefit and risk, and to identify opportunities for improvement. This workshop was held in Washington, D.C., on May 30-31, 2006. The benefit-risk profiles of pharmaceuticals are constantly evolving as new data are collected throughout the life cycle of a drug. Discussions during the workshop focused on the following: (1) premarket assessment, during which clinical trial data are used to assess benefit and risk; (2) communication of that information to prescribing physicians and their patients; (3) healthcare decisions made by prescribing physicians and their patients; and (4) the accumulation of benefit-risk information from postmarketing experience, which feeds back into the other phases. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary explains in detail the discussions during this workshop.

Topics

Suggested Citation

Institute of Medicine. 2007. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary. Washington, DC: The National Academies Press.https://doi.org/10.17226/11910.

Import this citation to:

Publication Info

98 pages |6 x 9
ISBNs:
  • Paperback: 978-0-309-10738-9
  • Ebook: 978-0-309-17976-8
DOI: https://doi.org/10.17226/11910
Contents
Rights

Copyright Information

The National Academies Press and the Transportation Research Board have partnered with Copyright Clearance Center to offer a variety of options for reusing our content. You may request permission to:

  • Republish or display in another publication, presentation, or other media
  • Use in print or electronic course materials and dissertations
  • Share electronically via secure intranet or extranet
  • And more

For most Academic and Educational uses no royalties will be charged although you are required to obtain a license and comply with the license terms and conditions.

Click here to obtain permission forUnderstanding the Benefits and Risks of Pharmaceuticals: Workshop Summary.

Translation and Other Rights

For information on how to request permission to translate our work and for any other rights related query please click here.

Copyright.com Customer Service

For questions about using the Copyright.com service, please contact:

Copyright Clearance Center
22 Rosewood Drive
Danvers, MA 01923
Tel (toll free): 855/239-3415 (select option 1)
E-mail: info@copyright.com
Web: https://www.copyright.com
Stats

Loading stats for Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary...