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Adverse drug reactions in elderly patients: alternative approaches to postmarket surveillance.
J Health Law. 2000 Summer; 33(3):383-454.JH

Abstract

In the last three years, the Food and Drug Administration has withdrawn seven prescription drugs from the market, and it has required intensified warnings for a number of others, all due to the discovery of previously unforeseen side effects associated with their use. Adverse drug reactions are a leading cause of death in the United States. For a variety of physiological and socio-medical reasons, the elderly are particularly susceptible to adverse drug reactions. Because the pre-approval process cannot expose all potential risks associated with a drug, the authors assert that policymakers should consider implementing a more extensive, and more integrated, post-approval surveillance and testing system. They conclude that the recent cluster of drug withdrawals due to safety problems raises legitimate questions about the rigor and effectiveness of the post-approval monitoring system for new drugs, and these questions extend beyond the obvious difficulties associated with the collection and analysis of risk data. Traditionally viewed as a regulatory problem for the FDA, the problem of adverse drug reactions implicates patient welfare and the provision of medical care more broadly, and a purely regulatory mind set unnecessarily constrains thinking about possible approaches to improving drug safety. Possible solutions to the problem ought to contemplate more formalized involvement of the medical community, pharmacists, and patients. This Article introduces a proposed systems approach to detecting and preventing adverse drug reactions, and discusses several other incremental reforms to existing systems that may help the medical community to improve the overall safety of prescription drug therapy for the elderly, and ultimately for all patients.

Authors+Show Affiliations

Center for Governmental Responsibility, University of Florida College of Law, USA.No affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

11184355

Citation

Noah, B A., and D B. Brushwood. "Adverse Drug Reactions in Elderly Patients: Alternative Approaches to Postmarket Surveillance." Journal of Health Law, vol. 33, no. 3, 2000, pp. 383-454.
Noah BA, Brushwood DB. Adverse drug reactions in elderly patients: alternative approaches to postmarket surveillance. J Health Law. 2000;33(3):383-454.
Noah, B. A., & Brushwood, D. B. (2000). Adverse drug reactions in elderly patients: alternative approaches to postmarket surveillance. Journal of Health Law, 33(3), 383-454.
Noah BA, Brushwood DB. Adverse Drug Reactions in Elderly Patients: Alternative Approaches to Postmarket Surveillance. J Health Law. 2000;33(3):383-454. PubMed PMID: 11184355.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Adverse drug reactions in elderly patients: alternative approaches to postmarket surveillance. AU - Noah,B A, AU - Brushwood,D B, PY - 2001/2/24/pubmed PY - 2001/2/28/medline PY - 2001/2/24/entrez SP - 383 EP - 454 JF - Journal of health law JO - J Health Law VL - 33 IS - 3 N2 - In the last three years, the Food and Drug Administration has withdrawn seven prescription drugs from the market, and it has required intensified warnings for a number of others, all due to the discovery of previously unforeseen side effects associated with their use. Adverse drug reactions are a leading cause of death in the United States. For a variety of physiological and socio-medical reasons, the elderly are particularly susceptible to adverse drug reactions. Because the pre-approval process cannot expose all potential risks associated with a drug, the authors assert that policymakers should consider implementing a more extensive, and more integrated, post-approval surveillance and testing system. They conclude that the recent cluster of drug withdrawals due to safety problems raises legitimate questions about the rigor and effectiveness of the post-approval monitoring system for new drugs, and these questions extend beyond the obvious difficulties associated with the collection and analysis of risk data. Traditionally viewed as a regulatory problem for the FDA, the problem of adverse drug reactions implicates patient welfare and the provision of medical care more broadly, and a purely regulatory mind set unnecessarily constrains thinking about possible approaches to improving drug safety. Possible solutions to the problem ought to contemplate more formalized involvement of the medical community, pharmacists, and patients. This Article introduces a proposed systems approach to detecting and preventing adverse drug reactions, and discusses several other incremental reforms to existing systems that may help the medical community to improve the overall safety of prescription drug therapy for the elderly, and ultimately for all patients. SN - 1526-2472 UR - https://www.unboundmedicine.com/medline/citation/11184355/Adverse_drug_reactions_in_elderly_patients:_alternative_approaches_to_postmarket_surveillance_ L2 - https://medlineplus.gov/drugreactions.html DB - PRIME DP - Unbound Medicine ER -