What is an adverse drug reaction?
An adverse drug reaction is any unintended response to a drug, which includes prescription, non-prescription, biological, and herbal drug products. Drug abuse, drug interactions, and overdoses are also monitored using the reporting system. A possible link between a drug and an adverse reaction is sufficient to file a report. ADR reports do not imply a causal link between a reaction and a suspected drug. When should adverse drug reactions be reported? Adverse drug reactions (ADRs) should be reported when: 1) The reaction to a drug is unexpected, no matter how severe. This means there is no indication on the labelling or drug information that such a reaction might occur. 2) The reaction is serious. Health Canada defines a serious reaction in the following way: “A noxious and unintended response to a drug, which occurs at any dose and requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disabi
