PRIME

Pharmacogenomics for the Prevention of Adverse Drug Reactions in Mental Health

Background

Undesirable effects of (adverse drug reactions to) medications are a major burden on the health of Albertans and other Canadians. For example, it has been estimated that the adverse drug reaction (ADR) rate on antidepressants is more than 25%; moreover, many of these are preventable. Pharmacogenomics (PGx), the study of how DNA-level variation affects response to pharmacologically active agents, is an emerging technology positioned to reduce the number of ADRs and provide cost savings to the healthcare system. This is particularly the case in the delivery of mental health care, where there are 23 commonly used medications for which PGx information in published clinical guidelines either already could or should be used to tailor prescribing practice. In fact, 64% of people carry at least one actionable (functional) genetic variant relevant to these 23 mental health medications. Despite the availability of PGx testing in some therapeutic areas (e.g., oncology), such testing is not yet available for mental health in a publicly funded health care system.

Objectives & Deliverables

In partnership with an Alberta technology-based small to medium enterprise (SME, Neogen Corporation) as well as Alberta Public Laboratories and clinical services (e.g., Clinical Pharmacology Consultation Service), our interdisciplinary team of researchers from theUniversities of Alberta and Calgary, clinicians, and highly qualified personnel will: develop a clinical PGx service relevant to mental health care via identifying and validating a core set of variants and genotyping methodology with reference samples for clinical laboratory implementation (Objective 1a, Deliverables 1-2) and design PGx resources to guide interpretation and enhance uptake and utilization of PGx testing (Objective 1b, Deliverables 3-5). We will then collect performance and outcome indicators on a pilot clinical PGx service in an addiction and mental health (AMH) clinic (Objective 2, Deliverables 6-8).

Activities

The development and pilot of our PGx testing service in Alberta will be guided by a PGx Service Implementation Process Framework. This framework includes two parallel activity streams (test development and clinical decision support development), which are aligned with objectives 1a and 1b, respectively. These activity streams interact with each other as well as stakeholders, ultimately leading to the launch of a pilot PGx testing service (Objective 2) from which performance and outcome indicators are collected and used to optimize the service.

The PRIME Team

Principal Investigators

Prof. Katherine J. Aitchison, PhD FRCPsych, Associate Director, Neuroscience and Mental Health Institute, University of Alberta

Dr. Chad Bousman, MPH, PhD, Assistant Professor, Medical Genetics, University of Calgary


Collaborators

Dr. Stacey Hume, PhD FCCMG, Alberta Public Laboratories

Prof. SM Hossein Sadrazdeh, PhD, DABCC, FACB, Alberta Public Laboratories

Dr. Jessica Boyd, PhD, Alberta Public Laboratories

Dr. Mark Yarema, MD, FRCPC, Lead, Calgary Clinical Pharmacology Consultation Service and Section Chief, Clinical Pharmacology and Toxicology, Alberta Health Services

Dr. Sudhakar Sivapalan, MD MSc FRCPC, Psychiatrist/Engineer

Dr. Jennifer Terpstra, PhD, Implementation Scientist

Dr. Michael Demas, MD, Psychiatrist

Dr. Adam Abba-Aji, MD, Psychiatrist


Partners

Neogen Corporation

Addiction & Mental Health Strategic Clinical Network



Objectives and Deliverables


Pharmacogenomics Service Implementation Process Framework

CDS, Clinical decision support; HQPs, Highly Qualified Personnel; IT, Information Technology; PGx, Pharmacogenomics. Adapted from Arwood et al., Cts-Clin Transl Sci 9, 233-245, 2016.

Funding Partner