Pharmacogenomics Testing for Overmedication

Overseen By Ryley Uber, Pharm.D.

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Geisinger Clinic

Disqualifiers: Liver transplant, Stem cell transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

2000 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary goal of this study is to conduct pharmacogenomics testing (a type of DNA test) within an aging population and measure the impact of this test on medication selection, dosing, healthcare utilization, and costs of care.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop your current medications. However, since the study involves testing the impact of DNA testing on medication selection and dosing, it's possible that changes to your medication regimen could occur.

What data supports the effectiveness of the treatment Multigene pharmacogenomics test for overmedication?

Research shows that pharmacogenetic testing can improve health outcomes by reducing side effects and the number of drugs used, especially in patients taking multiple medications. This suggests that using pharmacogenomics tests can help manage overmedication by tailoring drug treatments to individual genetic profiles. ^{1 2 3 4 5}

Is pharmacogenomics testing generally safe for humans?

Pharmacogenomics testing is generally considered safe and can help predict adverse drug reactions (unwanted side effects) by using a person's genetic information. Studies have shown that using pharmacogenomics can reduce the risk of harmful drug reactions, as seen in a European study where it lowered the risk of toxicities by 30%. ^{1 6 7 8 9}

How does the multigene pharmacogenomics test differ from other treatments for overmedication?

The multigene pharmacogenomics test is unique because it uses genetic testing to understand how a person's body processes different drugs, helping to prevent overmedication by tailoring drug prescriptions to individual genetic profiles. This approach is different from standard treatments, which often do not consider genetic differences in drug metabolism. ^{1 4 10 11 12}

Research Team

Ryley Uber, Pharm.D.

Principal Investigator

Geisinger Clinic

Eligibility Criteria

This trial is for older adults who are patients at Geisinger 65 Forward clinics and take five or more medications. It's not open to those who've had liver transplants, stem cell transplants, or were part of the eMERGE pharmacogenomics study.

Inclusion Criteria

I am currently taking 5 or more medications.

Follows at a Geisinger 65 Forward clinic location

Exclusion Criteria

I have had a stem cell transplant from a donor.

Previous enrollment in the Electronic Medical Records and Genomics (eMERGE) pharmacogenomics cohort

I have had a liver transplant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization

Participants are randomly assigned to either the pharmacogenomics testing group or the standard care group

1 week

Pharmacogenomics Testing

Participants in the experimental arm undergo a multigene pharmacogenomics test with results reported in the medical record

1 month

1 visit (in-person for blood draw)

Follow-up

Participants are monitored for changes in medication therapy, healthcare utilization, and costs of care

Up to 5 years

Treatment Details

Interventions

• Multigene pharmacogenomics test

Trial Overview The trial is testing a multigene pharmacogenomics test that examines DNA to guide medication choices and dosages for geriatric patients, aiming to improve healthcare outcomes and reduce costs.

Participant Groups

Group I: Pharmacogenomics Testing Experimental Treatment 1 Intervention

Patients in the experimental arm will be ordered a multigene pharmacogenomics test. This DNA test requires a blood draw, with the results expected to be reported in the medical record approximately 7 to 14 calendar days after the blood draw. These results will be made available to Geisinger healthcare professionals that have a treatment relationship with study participants.

Group II: Standard of Care Active Control 1 Intervention

A multigene pharmacogenomics test will not be ordered for patients in this study arm, as is the standard of care.

Who Is Running the Clinical Trial?

Geisinger Clinic

Lead Sponsor

Trials

159

Recruited

1,976,000+

Findings from Research

A staggering 99% of veterans using VHA pharmacy services are projected to carry at least one actionable pharmacogenetic variant, indicating a high potential for personalized medicine to improve drug prescribing.

Over half of the veterans (54.8%) received at least one level A drug that could be influenced by these genetic variants, suggesting that pharmacogenetic testing could significantly impact treatment decisions for commonly prescribed medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Projected Prevalence of Actionable Pharmacogenetic Variants and Level A Drugs Prescribed Among US Veterans Health Administration Pharmacy Users. Chanfreau-Coffinier, C., Hull, LE., Lynch, JA., et al.[2020]

Pharmacogenomics can help predict adverse drug reactions (ADRs) by identifying genetic variations that affect how individuals respond to medications, addressing a significant issue in drug safety.

The review highlights successful examples of pharmacogenomics influencing clinical practice and discusses future areas where it could improve drug safety, while also acknowledging the challenges in implementing these tests in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The emerging era of pharmacogenomics: current successes, future potential, and challenges. Lee, JW., Aminkeng, F., Bhavsar, AP., et al.[2021]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Clinical use of pharmacogenomic tests in 2009. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The impact of pharmacogenetic testing in patients exposed to polypharmacy: a scoping review. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Implementation of pharmacogenetic testing in medication reviews in a hospital setting. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Implementation of Pharmacogenomics and Artificial Intelligence Tools for Chronic Disease Management in Primary Care Setting. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Projected Prevalence of Actionable Pharmacogenetic Variants and Level A Drugs Prescribed Among US Veterans Health Administration Pharmacy Users. [2020]

6. Denmark pubmed.ncbi.nlm.nih.gov

The emerging era of pharmacogenomics: current successes, future potential, and challenges. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Applying pharmacogenomics to enhance the use of biomarkers for drug effect and drug safety. [2015]

8. Israel pubmed.ncbi.nlm.nih.gov

Pharmacogenomic testing and antithrombotic therapy: ready for prime time? [2021]

9. England pubmed.ncbi.nlm.nih.gov

Implementation of preemptive testing of a pharmacogenomic panel in clinical practice: Where do we stand? [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Pharmacogenomic Approaches for Automated Medication Risk Assessment in People with Polypharmacy. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Pharmacogenomic biomarkers: new tools in current and future drug therapy. [2011]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Frequencies of Combined Dysfunction of Cytochromes P450 2C9, 2C19, and 2D6 in an Italian Cohort: Suggestions for a More Appropriate Medication Prescribing Process. [2023]