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Healthy Skepticism Library item: 11855

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Journal Article

Brown JS, Kulldorff M, Chan KA, Davis RL, Graham D, Pettus PT, Andrade SE, Raebel MA, Herrinton L, Roblin D, Boudreau D, Smith D, Gurwitz JH, Gunter MJ, Platt R.
Early detection of adverse drug events within population-based health networks: application of sequential testing methods.
Pharmacoepidemiol Drug Saf 2007 Oct 22;
http://www3.interscience.wiley.com/cgi-bin/abstract/116833324/ABSTRACT?CRETRY=1&SRETRY=0


Abstract:

PURPOSE: Active surveillance of population-based health networks may improve the timeliness of detection of adverse drug events (ADEs). Active monitoring requires sequential analysis methods. Our objectives were to (1) evaluate the utility of automated healthcare claims data for near real-time drug adverse event surveillance and (2) identify key methodological issues related to the use of healthcare claims data for real-time drug safety surveillance.

METHODS: We assessed the ability to detect ADEs using historical data from nine health plans involved in the HMO Research Network’s Center for Education and Research on Therapeutics (CERT). Analyses were performed using a maximized sequential probability ratio test (maxSPRT). Five drug-event pairs representing known associations with an ADE and two pairs representing ‘negative controls’ were analyzed.

RESULTS: Statistically significant (p < 0.05) signals of excess risk were found in four of the five drug-event pairs representing known associations; no signals were found for the negative controls. Signals were detected between 13 and 39 months after the start of surveillance. There was substantial variation in the number of exposed and expected events at signal detection.

CONCLUSIONS: Prospective, periodic evaluation of routinely collected data can provide population-based estimates of medication-related adverse event rates to support routine, timely post-marketing surveillance for selected ADEs.

Jeffrey S. Brown (jeff_brown@harvardpilgrim.org)

Keywords:
adverse drug event • methodology • sequential analysis • drug safety surveillance • SPRT

 

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909