Diagnosing Adverse Drug Reactions Registry

Study Overview
=================
Brief Summary
-----------------
This multicenter Registry is to assess whether the use of pharmacogenomic data results in a meaningful change in a subject's drug or dose regimen. In addition, the Registry will evaluate the relationship between adverse drug reactions (ADR) and genotype and assess resource utilization (emergency department visits and hospitalizations) associated with ADR.

Official Title
-----------------
DART Registry: Diagnosing Adverse Drug Reactions Registry

Conditions
-----------------
Genetics of Drug Metabolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has care coordinated at the treating physician's outpatient clinic; Subject has provided written informed consent; Subject is taking at least three (3) regularly scheduled medications, excluding as needed (PRN) medications, over the counter medications and nutritional supplements; two (2) of which are known to be affected by genetic allelic variation. Subject's treating physician has a clinical suspicion that the subject is experiencing adverse signs or symptoms related to a prescribed medication or is not achieving the intended effect from the medication. Exclusion Criteria: Subject has a history of chronic renal dysfunction, Chronic Kidney Disease Stage 4 or 5; Subject has a history of abnormal hepatic function within the last 2 years (INR >1.2 not attributable to anticoagulant medications, AST (aspartate aminotransferase) or ALT (alanine aminotransferase) >1.5x normal, or suspected cirrhosis); Subject has a history of malabsorption (short gut syndrome); Subject has a history of any gastric or small bowel surgery; Subject is currently hospitalized; Subject is currently being treated with intravenous medication; Subject underwent prior pharmacogenomic testing with results reported within the last 12 months. Subjects may be eligible within 60 days from the date of pharmacogenomic testing.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of meaningful change in drug regimen | The primary endpoint of the study is the binary occurrence of meaningful change in drug regimen, defined in each subject when: A genotype known to affect a drug the subject is taking is identified, and The subject's treating physician makes at least one drug regimen change in concordance with the PharmD recommendations. | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the regimen of drugs controlled by genes of interest over the 12 months prior to enrollment and change in the regimen of drugs controlled by genes of interest over the 60 days following receipt of pharmacogenetic test results. |  | 60 days | 
| Number of ADR per month over the 12 months prior to enrollment and number of ADR per month over the 60 days following receipt of pharmacogenomic test results. |  | 60 days | 
| Frequency of genome-based PharmD recommendations to alter drug or dose. |  | 60 days | 
| Emergency department visits and hospitalizations | Emergency department visits over the 12 months prior to enrollment, emergency department visits over the 60 days following receipt of test results, hospitalizations over the 12 months prior to enrollment, and hospitalizations over the 60 days following receipt of test results. | 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adverse Drug Reactions, Emergency Department Visits, Hospitalizations, Pharmacogenomic