The authors declared no conflict of interest. The project received unrestricted research funds from Eli Lily, Pfizer, and Merck Frosst.
Article first published online: 8 JUN 2009
Copyright © 2009 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 18, Issue 8, pages 713–721, August 2009
How to Cite
Carleton, B., Poole, R., Smith, M., Leeder, J., Ghannadan, R., Ross, C., Phillips, M. and Hayden, M. (2009), Adverse drug reaction active surveillance: developing a national network in Canada's children's hospitals. Pharmacoepidem. Drug Safe., 18: 713–721. doi: 10.1002/pds.1772
The research was conducted at the University of British Columbia.
- Issue published online: 24 JUL 2009
- Article first published online: 8 JUN 2009
- Manuscript Accepted: 14 APR 2009
- Manuscript Revised: 1 APR 2009
- Manuscript Received: 19 DEC 2008
- adverse drug reaction;
Adverse drug reactions (ADRs) rank as the fifth leading cause of death in the western world. The nature and scope of these ADRs in children are not predictable based on post market surveillance reports that rely heavily on adult drug experience. The genotype-specific approaches to therapy in childhood (GATC) national ADR network was established to identify specific ADRs and to improve drug safety through identification of predictive genomic biomarkers of drug risk.
GATC set out to establish a national network of trained surveillance clinicians in pediatric hospitals across Canada. Surveillance clinicians identified, enrolled, and collected clinical data and biological samples from ADR cases and controls. Surveillance was targeted to three ADRs: anthracycline-induced cardiotoxicity, cisplatin-induced hearing impairment, and codeine-induced mortality in breastfed infants.
The initial surveillance site was established in September 2005, with 10 sites fully operational by 2008. In 3 years, GATC enrolled 1836 ADR cases and 13188 controls. Target numbers were achieved for anthracycline-induced cardiotoxicity. Modified target numbers were nearly attained for cisplatin-induced hearing impairment. Codeine-induced infant mortality in a breastfed infant was discovered by GATC investigators. A case–control study was subsequently conducted.
GATC has demonstrated a model of active and targeted surveillance that builds an important step toward the goal of personalized medicine for children. Effective communication, site-specific solutions and long-term sustainability across the network are critical to maintain participation and productivity. GATC may provide a framework of ADR surveillance that can be adapted by other countries and healthcare systems. Copyright © 2009 John Wiley & Sons, Ltd.