The Implementation of Pharmacogenomics Into Primary Care in British Columbia (IPPC)

University of British Columbia

Status: Completed

Conditions: Pharmacogenetics

Treatments: Other: Decision support

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02383290

H14-02979

Details and patient eligibility

About

Certain parts of the gene can predict how an individual person will respond to medication (pharmacogenetics). We will invite 250 individuals to give a sample of saliva. This sample will be sent to a laboratory for limited genomic analysis relating to pharmacogenetics. When personal data held by the participants, family physician, or pharmacist is joined with the genetic data personalized prescription recommendations are formed. The family physicians/pharmacists can view these recommendations through their electronic record. This should result in prescriptions that may be more beneficial and cause fewer adverse events.

Full description

We wish to develop and test a decision support tool, TreatGx. Using genetic information (single nucleotide polymorphisms - SNPs) and patient biophysical characteristics this tool creates drug and dose recommendations.

Each year in Canada, there are approximately 200,000 severe adverse drug events, claiming 10,000 to 22,000 lives, and costing $13.7 to $17.7 billion. Physicians cannot predict whether a patient will gain the desired benefit from a prescribed medication or whether they will experience harmful side effects. Genetic tests may reduce this potential harm for many medications; however there is currently no way of incorporating genetic information into routine prescribing processes.

We see a need to pilot test a, genetic based, prescribing decision support (TreatGx) for feasibility and usability.

Five Family Physicians and one pharmacy will be invited to participate. They will be requested to identify a total of 250 adults with chronic diseases to participate in the study.

Each participant will be invited to give a saliva sample for the SNP test. This sample will be sent to the laboratory for genetic testing; whole genome testing is not being undertaken. We have identified from published evidence a small panel of SNPs that will give information to guide prescribing. A genetic report will be fed back into the family physician's or pharmacist's electronic health record. The electronic health record will be linked to TreatGx; the next time the participant is seen by the family physician/pharmacist prescribing recommendations will be available for use. The family physician will be able to use TreatGx to give the participant a prescription that is personalized.

We will track how many times the system is used, gain feedback on usability, record timing between receiving samples, time to the laboratory, time to analysis, and time to electronic record.

Enrollment: 190 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• People attending specified pharmacy or Family Physicians.
• Aged 18 years or over, with a chronic disease that requires medication.
• Chronic diseases include: gout, chronic obstructive pulmonary disease, depression, osteoarthritis, hypertension, hyperlipidemia, atrial fibrillation, asthma, osteoporosis and epilepsy.

Exclusion criteria

• Pregnant
• Breast feeding.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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190 participants in 1 patient group

Decision support

Experimental group

Description:

This is a feasibility trial so all patients will give a saliva sample and the pharmacist/ Family Physician will use the decision support for generating prescription recommendations

Treatment:

Other: Decision support