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A Metadata Extraction Approach for Clinical Case Reports to Enable Advanced Understanding of Biomedical Concepts
Published on: September 20, 2018
'Off-label' prescribing, the Physician's Desk Reference and the court
Richard A Spector1, Eva Marquez
1Eli Lilly and Company, Indianapolis, Indiana, USA.
Summary
Physicians, not the Physician's Desk Reference (PDR), should determine drug usage. The medical community believes off-label prescribing decisions require physician judgment, not rigid guidelines.
Area of Science:
- Medical Law
- Pharmacology
- Clinical Practice
Background:
- Off-label prescribing involves using drugs outside Food and Drug Administration (FDA)-approved indications.
- Some legal interpretations rely on the Physician's Desk Reference (PDR) to define the standard of care for prescribing.
- This reliance may override a physician's clinical judgment.
Purpose of the Study:
- To investigate the medical community's perspective on off-label prescribing.
- To compare legal standards with medical practice regarding drug usage guidelines.
- To analyze the role of the PDR in establishing the standard of care.
Main Methods:
- Survey of leaders within the United States medical community.
- Review of medical literature on drug prescribing practices.
- Analysis of legal cases concerning off-label drug use.
Main Results:
- The medical community does not view the PDR as an exhaustive guide to all drug applications.
- Physicians' judgment is considered paramount in determining appropriate drug use.
- The PDR is not recognized by medical leaders as the definitive standard of medical care.
Conclusions:
- Physician expertise, not the PDR, should guide off-label prescribing decisions.
- Legal standards that equate the PDR with the standard of care are misaligned with medical practice.
- Clinical judgment remains central to patient care and pharmacology.
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