Abstract
Risk management represents a fundamental shift in the traditional paradigm of the healthcare system from a passive, information-oriented role, communicating warnings and side effects, to one of action and accountability for the safe use of drugs within the marketplace. To further the healthcare system’s goal of developing better risk management programs to ensure safe pharmaceutical use and protect public health, a risk-management advisory council, composed of 25 experts, was convened in late 2001. The objectives were to: 1. discuss the utility of available data resources for risk management efforts, identifying strengths, limitations, and lessons learned; 2. identify gaps in systems, data elements, and methodologies; and 3. outline principles of good practice to reliably assess risk. This paper describes the deliberations and conclusions from the one and a half-day meeting of the council; it includes a brief update on Food and Drug Administration risk management activities since that time.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Anonymous. Office of Drug Safety Annual Report. Center for Drug Evaluation and Research 2001. http://www.fda.gov/cder/Offices/ODS/annrep2001/annualreport2001.htm. (Accessed on 09/27/02.)
Hubbard WK. Drug Safety and Risk Management; Notice of Meeting. Federal Register. 2002 July 11; 63(133).
US Department of Health and Human Services. PDUFA Reauthorization Good For American Patients. HHS News. June 18, 2002.
Butler. Mary Ellen. Congress Reauthorizes PDUFA. US Medicine Institute for Health Studies. July; 1, 2002.
Centers for Education and Research on Therapeutics. Overview: Fact Sheet. http://www.ahcpr.gov/clinic/certsovr.htm. (Accessed on 10/01/02)
Duke Center for Education and Research on Therapeutics. Duke CERTs Program. http://www.dcri.duke.edu/research/fields/certs/index.html. (Accessed on 09/27/02)
US Food and Drug Administration. Accutane Risk Management Program Strengthened. FDA Consumer. 2002; 36(1).
US Department of Health and Human Services. FDA Approves Restricted Marketing of Lotronex. FDA News. June 7, 2002.
Author information
Authors and Affiliations
Corresponding author
Additional information
Executive Public Health Risk Management Advisory Council: Susan Ackermann, PhD, Director, Hoffmann-La Roche. Inc.; William H. Campbell, PhD. Dean, School of Pharmacy, The University of North Carolina at Chapel Hill: Joseph W. Cranston, PhD, Director of Science. Research & Technology, American Medical Association; Wanju Dai, MD, DrPH, Vice President & Global Head. Aventis Pharmaceuticals; Gretchen Dieck, MD, Vice President. Pfizer, Inc.; Russell H, Ellison, MD, Vice President, Medical Affairs. Chief Medical Officer, Roche Laboratories. Inc.; Kathleen Gondek, MD, Director of Health Economics and Outcomes Research, Bayer Corporation; Harry Guess. MD, PhD. Vice President. Epidemiology, Merck Research Laboratories; Peter Honig, MD. MPH. Director. U.S. Food & Drug Administration; Linda S. Hostelley, Executive Director. Merck & Co., Inc.; Mark Hurwich. Partner, Monitor Group; Kenneth Kassler-Taub, MD. Vice President. Bristol-Myers Squibb Company; James Kotsanos, MD. MS, Director, Eli Lilly & Company; Robert C. Nelson, PhD, RCN Associates Inc.; Eleanor M. Perfetto, PhD, Independent Consultant; Edith Rosato, Vice President, National Association of Chain Drug Stores: Margie Sherr, Director. IMS Health; Judith Sills. PharmD, Vice President, Director New Jersey Office, The Degge Group: Bertram A. Spilker, MD, PhD. Senior Vice President, PhRMA; Paul Stang, PhD, Executive Vice-President, Galt Associates, Inc.; Patricia Tennis, PhD, Director, GlaxoSmithKline; Victor G. Villagra. MD. National Medical Director. CIGNA Healthcare; Susan C. Winckler, RPh, JD, Group Director, The American Pharmaceutical Association: Songlin Xue, MD, PhD, Assistant Vice President, Wyeth-Ayersl Research: and Ana-Maria Zaugg, Vice President, IMS Health (organizational affiliations as of November 2001).
Rights and permissions
About this article
Cite this article
Perfetto, E.M., Ellison, R., Ackermann, S. et al. Evidence-Based Risk Management: How Can We Succeed?: Deliberations from a Risk Management Advisory Council. Ther Innov Regul Sci 37, 127–134 (2003). https://doi.org/10.1177/009286150303700115
Published:
Issue Date:
DOI: https://doi.org/10.1177/009286150303700115