[ot] The Missing Voice of Patients in Drug-Safety Reporting

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The Missing Voice of Patients in Drug-Safety Reporting

The New England Journal of Medicine . March 10th, 2010

Ethan Basch, M.D.

A patient wants to know about symptoms she may have from a prescription drug she

is taking. Consulting the label's " Adverse 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

Full story

http://healthcarereform.nejm.org/?p=3140 & query=TOC

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