The Missing Voice of Patients in Drug-Safety Reporting - New England Journal of Medicine Ovarian Cancer and Us OVARIAN CANCER and US Ovarian Cancer and Us

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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


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