Does active surveillance of serious and life-threatening adverse drug reactions improve reporting?

1Patient Safety Section, Therapeutic Effectiveness and Policy Bureau, Marketed Health Products Directorate, Health Canada; 2Canadian Paediatric Surveillance Program, Canadian Paediatric Society; 3Interdisciplinary School of Health Sciences and Department of Political Studies, University of Ottawa, Ottawa, Ontario Correspondence: Canadian Paediatric Surveillance Program, 2305 St Laurent Boulevard, Ottawa, Ontario K1G 4J8. Telephone 613-526-9397 ext 239, fax 613-526-3332, e-mail [email protected] Accepted for publication July 11, 2011 Adverse drug reactions (ADRs) are an important cause of illness and death (1). Of particular concern is the alarming lack of ADR data in the paediatric population, which, therefore, limits the ability to avoid or prevent these occurrences. Only a minority of prescribed pharmaceuticals on the market in North America have been tested in paediatric populations, and most of them are used without the benefits of adequate guidelines for safety or efficacy (2). Postmarketing surveillance is, therefore, essential for early detection of ADRs, and relies mainly on voluntary reporting. A major criticism of current voluntary surveillance by health professionals has been the high level of under-reporting. Healthrelated accreditation bodies estimate that 95% of all ADRs are not reported (3). The Canadian Paediatric Surveillance Program (CPSP) launched a specific study to enhance reporting of serious and lifethreatening ADRs in children, and has been collecting data since 2004. The first study objective is the identification of products most frequently causing ADRs in children, of the type of reactions encountered, and of any ADRs not currently captured by existing spontaneous reporting systems. Further objectives are quality data collecting, using ‘ADR Tips of the Month’ to build support and awareness of the study, facilitating case ascertainment, and impacting new information relating to the study or broader ADR surveillance topics. In 2008 and 2009, evaluations were conducted to collect more information on reporting practices of participants, and to assess the value of the CPSP surveillance methodology in supporting recognition/reporting of serious and life-threatening ADRs. Information was gathered on the ability of the CPSP to overcome documented barriers to reporting associated with passive surveillance, and the effectiveness of collaborative models in identifying solutions to improve ADR recognition and reporting. The current article presents study findings and results of the evaluative surveys.