Is there still a role for spontaneous reporting of adverse drug reactions?
Joel Lexchin Joel Lexchin is associate professor, School of Health Policy and Management, York University; emergency physician, University Health Network; and associate professor, Department of Family and Community Medicine, University of Toronto, Toronto, Ont. Correspondence to: Dr. Joel Lexchin, 121 Walmer Rd., Toronto ON M5R 2X8; jlexchin{at}yorku.ca’ + u + ‘@’ + d + ”//–> 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 act