Drug Side Effects
Conditions
Keywords
Pharmacogenomics, Adverse Drug Reactions, Pharmacogenetics
Brief summary
The PREACT Registry aims to see whether data from Pharmacogenomic Testing (PGx) can help healthcare providers manage patient medication regimens and assess if the testing has an effect on reducing medication side effects, hospitalizations and emergency department visits. The way an individual processes a drug is in part determined by their genes, and there is known to be genetic variation between humans in the way drugs are metabolized. The study of the way genes affect a person's response to drugs is known as Pharmacogenomics.
Interventions
None listed
Sponsors
Companion Dx Reference Lab, LLC
Study design
Observational model
COHORT
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pharmacogenomic testing has been performed within 12-months prior to eligibility assessment for genes known to influence metabolism of at least one target drug * Subject is 2 years of age or older * Subject is not taking an investigational medication or in a clinical trial that would interfere with participation in the registry
Exclusion criteria
* Subject's medical and medication history is unavailable over the 90-day period preceding the receipt of pharmacogenomic test results * Subject (or subject's parent/guardian) is unable to provide an accurate history due to mental incapacity, in the Investigator's opinion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Meaningful Change | 90 day | Binary occurrence of meaningful change in drug regimen, defined for each subject as: * A genotype known to affect a target drug is identified by pharmacogenomic testing, and * The treating physician makes at least one target drug regimen change in dose, frequency, route of administration, drug discontinuation, addition or substitution. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in target drug regimen | 90 days retrospective; 90 days prospective | Changes in target drug regimen over the 90-day period preceding receipt of PGx results, compared to the changes made in the 90-day period thereafter. |
| Number of target drug adverse events (TDAE) | 90 day retrospective; 90 day prospective | Number of TDAE over the 90-day period preceding receipt of pharmacogenomics test results compared with the number over the 90-day period after the test |
| Target drug related emergency department visits | 90 day retrospective; 90 day prospective | Emergency department visits over the 90-day period prior to receipt of pharmacogenomics test results, compared to the number of visits over the 90-day period following receipt of test results. |
| Target drug related hospitalizations | 90 day retrospective; 90 day prospective | Hospitalizations over the 90-day period prior to receipt of pharmacogenomics test results, compared to the number of visits over the 90-day period following receipt of test results. |
Contacts
Primary ContactStudy Coordinator
Outcome results
None listed