• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail


Table of Contents: Managing the Risks From Medical Product Use: Creating a Risk Management Framework

Previous Section : Members of the Task Force

Ball, L.K., G. Evans, and A. Bostrom, "Risky Business: Challenges in Vaccine Risk Communication," Pediatrics, 101:453-458, 1998.

Bates, D.W., D.L. Boyle, M.B. Vander Vliet, J. Scheider, and L.L. Leape, "Relationship Between Medication Errors and Adverse Drug Reactions," J Gen Intern Med., 10:199-205, 1995.

Bates, D.W., D.J. Cullen, N. Laird et al., "Incidence of Adverse Drug Events and Potential Adverse Drug Events: Implications for Prevention," JAMA, 274:29-34, 1994.

Bates, D.W., L.L. Leape, and S. Petrycki, "Incidence and Preventability of Adverse Drug Events in Hospitalized Adults," J Gen Intern Med., 8:289-294, 1993.

Bates, D.W., N. Spell, D.J. Cullen et al., "The Costs of Adverse Drug Events in Hospitalized Patients," JAMA, 277:307-311, 1997.

Burkhart, G.A., M.J. Sevka, R. Temple, and P. Honig, "Temporal Decline in Filling Prescriptions for Terfenadine Closely in Time With Those for Either Ketoconazole or Erythromycin," Clin Pharm Ther., 61:93-96, 1997.

Cavuto, N.J., R.L. Woosley, and M. Sale, "Pharmacies and Prevention of Potentially Fatal Drug Interactions," JAMA, 275:1086, 1996.

Claycamp, H.G., "Industrial Health Risk Assessment: Industrial Hygiene for Technology Transition," AIHA Journal, 57:423-435, 1996.

Covello, V.T., D.B. McCallum, and M.T. Pavlova, Effective Risk Communication: The Role and Responsibility of Government and Nongovernment Organizations, Proceedings of the Workshop on the Role of Government in Health Risk Communication and Public Education (Volume 4), Plenum Press, 1989.

Evans, G., A. Bostrom, R.B. Johnston, B.L. Fisher, and M.A. Stoto, Risk Communication and Vaccination, Workshop Summary," Institute of Medicine, National Academy Press, 1997.

Faich, G.A., "National Adverse Drug Reaction Reporting," Arch Intern Med., 151:1645-1647, 1991.

Fischhoff, B., "Risk Perception and Communication Unplugged: Twenty Years of Progress," Risk Analysis, 15:137-142, 1995.

Fischhoff, B., A. Bostrom, and M.J. Quadrel, "Risk Perception and Communication," Ann Rev Pub Health., 14:183-203, 1993.

Fisher, A., and Y.C. Chen, "Customer Perceptions of Agency Risk Communication," Risk Analysis, 16:177-184, 1996.

Fisher, A., A. Chitose, and P.S. Gipson, "One Agency's Use of Risk Assessment and Risk Communication," Risk Analysis, 14:207-212, 1994.

Food and Drug Administration, Center for Drug Evaluation and Research, 1998 Report to the Nation, May 1999.

Friedman, M.A., J. Woodcock, M. Lumpkin, J. Shuren et al., "The Safety of Newly Approved Medicines: Do Recent Market Removals Mean There Is a Problem?" JAMA, Vol. 281, No. 18, May 12, 1999.

Glickman, T.S., and M. Gough, Readings in Risk, distributed by Johns Hopkins University Press, 1990.

Government Accounting Office, FDA Drug Review - Postapproval Risks 1976-1985, GAO/PEMD-90-15, April 1990.

Hance, B.J., C. Chess, and P.M. Sandman, "Improving Dialogue with Communities: A Risk Communication Manual for Government," Environmental Communication Research Program, New Jersey Agricultural Experiment Station, Rutgers University, 1991.

Johnson, J.A., and J.L. Bootman, "Drug-Related Morbidity and Mortality: A Cost-of-Illness Model," Arch Intern Med., 155:1949-1956, 1995.

Kasperson, R., and P.J. Stallen, Communicating Risks to the Public: International Perspectives, Kluwer Academic Publishers, 1991.

Leape, L.L., T.A. Brennan, N. Laird et al., "The Nature of Adverse Events in Hospitalized Patients: Results from the Harvard Medical Practice Study II," N Engl J Med., 324:377-384, 1991.

Leape, L.L., A.G. Lawthers, T.A. Brennan, and W.G. Johnson, "Preventing Medical Injury," Qual Rev Bull., 19:144-149, 1993.

Lazarou, J., B. H. Pomeranz, and P.N. Corey, "Incidence of Adverse Drug Reactions in Hospitalized Patients: A Meta-analysis of Prospective Studies," JAMA, 279:1200-1205, 1998.

Leviton, L.C., C.E. Needleman, and M.A. Shapiro, Confronting Public Health Risks: A Decision Maker's Guide, SAGE Publications, Inc., 1998.

Lowrance, W.W., Of Acceptable Risk: Science and the Determination of Safety, William Kaufmann, Inc., 1976.

Lundgrun, R., Risk Communication: A Handbook for Communicating Environmental, Safety, and Health Risks, Battelle Press, 1994.

McCallum, D.B., "Risk Communication: A Tool for Behavior Change," NIDA Research Monograph, 155:65-89, 1995.

National Research Council, Improving Risk Communication, National Academy Press, 1989.

Ng, K.L., and D.M. Hamby, "Fundamentals for Establishing a Risk Communication Program," Health Physics, 73:473-482, 1997.

Ostrove, N.M., and L.A. Morris, "Use and Perceptions of Drug Product Labeling: A Survey of Physicians," unpublished manuscript, U.S. Food and Drug Administration.

Patton, D.E., "The NAS Risk Paradigm as a Medium for Communication," Risk Analysis, 14:375-378, 1994.

Philley, J.O., "Acceptable Risks?," Professional Safety, 36:32-36, 1991.

Powell, D., and W. Leiss, Mad Cows and Mother's Milk: The Perils of Poor Risk Communication, McGill-Queen's University Press, 1997.

Presidential/Congressional Commission on Risk Assessment and Risk Management, Framework for Environmental Health Risk Management - Final Report, Volume 1, 1997.

Rowan, F., "The High Stakes of Risk Communication," Preventive Medicine, 25:26-29, 1996.

Tonn, B.E., C.B. Travis, R.T. Goeltz, and R.H. Phillippi, "Knowledge-Based Representations of Risk Beliefs," Risk Analysis, 10:169-184, 1990.

Wood, A.J.J., and R.L. Woosley, "Making Medicines Safer - The Need for an Independent Drug Safety Board," N Eng J Med., 339:1851-1854, 1998.


Next Section : Acronym List