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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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