[Reasons to report or not report side effects of drugs to the national monitoring system in the Netherlands].

Abstract

To assess the awareness of medical practitioners in the Netherlands regarding the national voluntary reporting scheme for adverse reactions to drugs, and the reasons for non-reporting. Questionnaire. Netherlands Centre for Monitoring of Adverse Reactions to Drugs. A questionnaire was sent to a random sample of 500 practitioners aged under 65 in the database of the Dutch Inspectorate for Health Care. Of the 500 questionnaires 265 (53%) were returned and completely filled in. Sixty-seven (25%) practitioners had reported a suspected adverse reaction on one or several occasions during their practising career; 229 (86%) would report a serious adverse reaction, 190 (72%) an unknown one, 185 (70%) an adverse reaction to a new product, and 83 (31%) a proven adverse reaction. Almost 20% said they had had difficulties reporting because they could not find the telephone number or reporting forms. Forty practitioners (15%) claimed that they were too busy to report adverse reactions. Almost all practitioners (94%) were aware of the fact that the reporting scheme serves the early detection of unknown adverse reactions.