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Healthy Skepticism Library item: 8519

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

Lexchin J.
Is there still a role for spontaneous reporting of adverse drug reactions?
CMAJ 2006 Jan 17; 174:(2):191-2


In an age of large, linked databases, is there still a role for a system of spontaneous reporting of adverse drug reactions? The problems associated with reports are well-known: poor quality of submitted reports; significant underreporting of adverse reactions; difficulty in calculating rates because of incomplete numerator data along with unreliable denominators; and limited ability to establish cause and effect.1

In this commentary I discuss the importance of reporting adverse reactions and possible ways to increase the rate of reporting. How to analyze signals that are generated through reporting and what action to take on these signals are outside my scope, since these are issues that will exist in any type of postmarketing surveillance system.

Modern computer technology, which allows linking of multiple databases, could easily be used to record prescriptions filled for selected products and then follow people receiving these prescriptions through records of physician visits and hospital admissions, and through cancer and death registries. Integrated databases have been used for well over a decade in Saskatchewan to investigate safety issues around drugs. Their use in other provinces is more recent, but they were instrumental in discovering the increase in hospital admissions and death rates in Ontario associated with hyperkalemia and the use of spironolactone in treating congestive heart failure.2 Even with these capabilities, I believe that there is still a role for spontaneous reporting of adverse drug reactions…

MeSH Terms: Adverse Drug Reaction Reporting Systems* Canada Data Collection Databases, Factual* Humans Quality Control


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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