Skip to main content
construction release_alert
Scholars@Duke will be undergoing maintenance April 11-15. Some features may be unavailable during this time.
cancel
Journal cover image

Managing the risks of therapeutic products: proceedings of a workshop.

Publication ,  Journal Article
Kramer, JM
Published in: Pharmacoepidemiol Drug Saf
September 2005

Traditional tools available to the Food and Drug Administration for managing known risks of therapeutic products (drugs, devices and biological products) have limited effectiveness. This report presents the recommendations of a multidisciplinary workshop focused on managing these risks. This is the last in a series of five workshops coordinated by the Centers for Education and Research on Therapeutics (CERTs) on assessing, communicating and managing the risks and benefits of therapeutic products. Workshop participants included experts from government, academia, industry and healthcare organizations, including consumers. Using a modified nominal group process, participants developed a consensus on principles that should govern future risk management (RM) programs, specifically: in order to protect the public health, risk management programs (RMPs) should be evidence-based, science-driven and patient-focused. A plan to manage the risks of each new therapeutic product should be developed prior to its approval. Evaluation of both the processes and outcomes of RM is essential; these evaluations should be in the public domain. Participants also identified and prioritized research and policy gaps related to RM. Recommended research areas included determining the effectiveness of each element of RMPs, finding the best ways to inform healthcare consumers and determining the best way to present risk information in drug labeling. Policy questions included defining the criteria for requiring a RMP, determining the effect of privacy legislation on RMPs and determining how the continuum of risk across therapeutic products should be classified. As this workshop demonstrated, it is possible to develop a prioritized research and policy agenda to meet the needs of all constituencies. Collaboration across diverse government, academic, industry and constituency-based organizations can lead to solutions for the perplexing problems involved in balancing the risks and benefits of therapeutic products. Patients deserve no less as we strive to protect their safety.

Duke Scholars

Published In

Pharmacoepidemiol Drug Saf

DOI

ISSN

1053-8569

Publication Date

September 2005

Volume

14

Issue

9

Start / End Page

619 / 628

Location

England

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Treatment Outcome
  • Risk Management
  • Research
  • Public Policy
  • Pharmacology & Pharmacy
  • Legislation, Drug
  • Information Dissemination
  • Evidence-Based Medicine
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Kramer, J. M. (2005). Managing the risks of therapeutic products: proceedings of a workshop. Pharmacoepidemiol Drug Saf, 14(9), 619–628. https://doi.org/10.1002/pds.1060
Kramer, Judith M. “Managing the risks of therapeutic products: proceedings of a workshop.Pharmacoepidemiol Drug Saf 14, no. 9 (September 2005): 619–28. https://doi.org/10.1002/pds.1060.
Kramer JM. Managing the risks of therapeutic products: proceedings of a workshop. Pharmacoepidemiol Drug Saf. 2005 Sep;14(9):619–28.
Kramer, Judith M. “Managing the risks of therapeutic products: proceedings of a workshop.Pharmacoepidemiol Drug Saf, vol. 14, no. 9, Sept. 2005, pp. 619–28. Pubmed, doi:10.1002/pds.1060.
Kramer JM. Managing the risks of therapeutic products: proceedings of a workshop. Pharmacoepidemiol Drug Saf. 2005 Sep;14(9):619–628.
Journal cover image

Published In

Pharmacoepidemiol Drug Saf

DOI

ISSN

1053-8569

Publication Date

September 2005

Volume

14

Issue

9

Start / End Page

619 / 628

Location

England

Related Subject Headings

  • United States Food and Drug Administration
  • United States
  • Treatment Outcome
  • Risk Management
  • Research
  • Public Policy
  • Pharmacology & Pharmacy
  • Legislation, Drug
  • Information Dissemination
  • Evidence-Based Medicine