Pharmacogenomics and Active Surveillance for Serious Adverse Drug Reactions in Children

Abstract

Juxtaposing clinical pharmacology with human genetics, pharmacogenomics utilizes a patient‘s genetic information to identify genetic variants that have the potential to provide clinically relevant predictions of toxicity and efficacy. The goal is to develop personalized and genetic-based predictions of an individual‘s drug response and likelihood of experiencing an adverse drug reaction. The Canadian Pharmacogenomics Network for Drug Safety (CPNDS) has implemented active adverse drug reaction surveillance to monitor and discover genetic markers related to serious adverse drug reactions in the pediatric population. Evidence-based pharmacogenomics research will inform public policy and influence drug benefit–risk decision-making. Regulatory processes and future challenges in pharmacogenomics research will be discussed.

KEYWORDS::

• ADR
• adverse drug reaction
• children
• clinical guidelines
• drug regulation
• drug safety
• pediatrics
• pharmacoeconomics
• pharmacogenomics
• pharmacovigilance
• surveillance

Acknowledgements

The authors would like to acknowledge and thank patients and families as participants in CPNDS for their important role in reducing drug harm in children. The authors are also indebted to their fellow CPNDS investigators, surveillance clinicians and collaborators.

Financial & competing interests disclosure

Financial support for this research was primarily provided by Genome Canada ON, Canada. The University of British Columbia has received matching funds from a variety of sources as required by the grant competition: Genome British Columbia, Canada; Child & Family Research Institute, Vancouver, Canada; Faculties of Pharmaceutical Sciences and Medicine, University of British Columbia, BC, Canada; University of Western Ontario, Canada; Canada Gene Cure Foundation, BC, Canada; Canadian Society of Clinical Pharmacology, Quebec, Canada; C17 Research Network, Childhood Cancer Foundation, Candlelighters Edmonton, AB, Canada; The Canadian Paediatric Society, Ottawa Canada; Merck Frosst, Quebec, Canada; Janssen-Ortho, Toronto, Canada; Illumina, CA, USA; IBM; Eli Lilly, Liverpool, UK; Pfizer, NY, USA. Grant Number (Clinical Trials.gov Number): NCT00414115. New grant funds have been received from the Canadian Institutes of Health Research and the Canada Foundation for Innovation, Child & Family Research Institute/Michael Cuccione Foundation Graduate Studentship, and Canadian Institutes of Health Research (Frederick Banting and Charles Best Canada Graduate Scholarships). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Additional information

Funding

Financial support for this research was primarily provided by Genome Canada ON, Canada. The University of British Columbia has received matching funds from a variety of sources as required by the grant competition: Genome British Columbia, Canada; Child & Family Research Institute, Vancouver, Canada; Faculties of Pharmaceutical Sciences and Medicine, University of British Columbia, BC, Canada; University of Western Ontario, Canada; Canada Gene Cure Foundation, BC, Canada; Canadian Society of Clinical Pharmacology, Quebec, Canada; C17 Research Network, Childhood Cancer Foundation, Candlelighters Edmonton, AB, Canada; The Canadian Paediatric Society, Ottawa Canada; Merck Frosst, Quebec, Canada; Janssen-Ortho, Toronto, Canada; Illumina, CA, USA; IBM; Eli Lilly, Liverpool, UK; Pfizer, NY, USA. Grant Number (Clinical Trials.gov Number): NCT00414115. New grant funds have been received from the Canadian Institutes of Health Research and the Canada Foundation for Innovation, Child & Family Research Institute/Michael Cuccione Foundation Graduate Studentship, and Canadian Institutes of Health Research (Frederick Banting and Charles Best Canada Graduate Scholarships). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.