(2000; 28 pages) [French]
Under-reporting is a common phenomenon in all countries. Correcting for under-reporting is difficult, however, because its extent is unknown and very variable. Even at established centres the reported proportion of serious reactions may not be more than 10%. Several of the countries participating for many years in the WHO Drug Monitoring Programme receive 200 or more adverse reactions per million inhabitants annually from about 10% of physicians. In many other countries, however, the reporting rates are much lower.
Under-reporting may delay signal detection and cause underestimation of the size of a problem. However, in signal detection not only the quantity but also the relevance of case reports and the quality of data are important.
There are also a number of more elusive issues which require attention. Sometimes healthcare professionals fear that the acknowledgement of adverse reactions may reflect negatively on their competence or put them at risk of litigation. Some are reluctant to report adverse reactions because of doubts regarding the causal role of the drug (although, of course, it is essential that suspected reactions are reported). Under-reporting is both a technical and a psychological issue. Clarity of criteria for reporting, simple procedures and good motivational practice are all influential in addressing the problem.