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Physicians' liability for adverse drug reactions
M B Kaufman1, C A Stoukides, N A Campbell
1University of Rhode Island Drug Information Center, Roger Williams Medical Center, Providence.
Abstract:
Although the Food and Drug Administration's spontaneous reporting system for adverse drug reactions has been collecting reports since 1960, the number of adverse drug reactions reported is low. One of the perceived deterrents to reporting adverse drug reactions is physicians' fear of involvement in litigation. We discuss the basis for physicians' liability and review the standard of care concept regarding physicians' liability associated with adverse drug reactions. Examination of the elements of a professional negligence case and "informed consent" shows what physicians can do to avoid malpractice related to adverse drug reactions.
Insights
Physicians fear litigation when reporting adverse drug reactions, leading to low reporting rates. Understanding liability and informed consent can help prevent malpractice related to drug safety.
Area of Science:
- Medical Law
- Pharmacovigilance
- Patient Safety
Background:
- The Food and Drug Administration's adverse drug reaction reporting system has collected data since 1960.
- Low reporting rates of adverse drug reactions persist despite the system's longevity.
- Physicians' apprehension regarding litigation is a significant perceived barrier to reporting.
Purpose of the Study:
- To explore the legal underpinnings of physician liability concerning adverse drug reactions.
- To review the standard of care in medical malpractice cases involving adverse drug events.
- To identify strategies for physicians to mitigate malpractice risks associated with adverse drug reactions.
Main Methods:
- Discussion of legal principles governing physician liability.
- Analysis of the "standard of care" in adverse drug reaction contexts.
- Examination of professional negligence elements and informed consent doctrines.
Main Results:
- Physicians' fear of litigation is a key factor in underreporting adverse drug reactions.
- Understanding legal standards and informed consent is crucial for managing liability.
- Specific actions can be taken by physicians to reduce malpractice risks.
Conclusions:
- Addressing physicians' litigation fears is essential for improving pharmacovigilance.
- Adherence to informed consent and understanding of professional negligence can protect physicians.
- Enhanced reporting of adverse drug reactions contributes to overall patient safety and drug efficacy.