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Showing posts with label patients voice drug safety. Show all posts
Showing posts with label patients voice drug safety. Show all posts

Thursday, March 11, 2010

The Missing Voice of Patients in Drug-Safety Reporting - New England Journal of Medicine



The Missing Voice of Patients in Drug-Safety Reporting

Ethan Basch, M.D.
A patient wants to know about symptoms she may have from a prescription drug she is taking. Consulting the label’sAdverse Reactions section, she finds a wealth of data. Little does she realize that this information, largely collected during clinical trials, is based almost entirely on clinicians’ impressions of patients’ symptoms — not on patients’ own firsthand reports of their experiences with the drug.
The current drug-labeling practice for adverse events is based on the implicit assumption that an accurate portrait of patients’ subjective experiences can be provided by clinicians’ documentation alone. Yet a substantial body of evidence contradicts this assumption, showing that clinicians systematically downgrade the severity of patients’ symptoms, that patients’ self-reports frequently capture side effects that clinicians miss, and that clinicians’ failure to note these symptoms results in the occurrence of preventable adverse events.1,2...continued