Canada's Adverse Drug Reaction Reporting System: A Failing Grade.

An article in the National Post on suicidal effects associated with varenicline (Champix) highlights deficiencies in the Canadian spontaneous reporting system (SRS) for adverse drug reactions (ADRs). The issues of under-reporting, poor quality information, duplication of reports and lack of a population denominator of drug use are discussed. Canada's SRS is deficient. There are immediate and medium-term actions that could be instituted that would improve pharmacovigilance in Canada. However, education about appropriate prescribing, the recognition of ADRs, and the duty to report them is a key long-term strategy to improving the pharmacovigilance system and should be included at every opportunity in the training of healthcare professionals so that life-long habits are developed. In addition to changes at Health Canada, greater emphasis needs to be placed on training in therapeutics, understanding drug safety, and the responsibility of healthcare providers in reporting risks in the curricula of medical and nursing schools.