Pharmacist Medication Review for Drug Interaction Management

(MyPGx Trial)

Overseen By Philip E Empey, PharmD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Metastatic cancer, Transplant, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 1

600 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on reviewing your medications and discussing test results, so it's likely you can continue your current medications.

What data supports the effectiveness of this treatment?

Research shows that pharmacist-led medication reviews can significantly improve patient management and outcomes by identifying and addressing drug interactions more effectively than standard care. For example, a study found that using a drug interaction test led to better management of drug interactions and improved patient symptoms. ^{1 2 3 4 5}

Is the Pharmacist Medication Review for Drug Interaction Management generally safe for humans?

The research articles focus on identifying and managing drug interactions, which is a key part of ensuring medication safety. Pharmacist reviews help detect and prevent risky drug combinations, contributing to safer medication use. ^{1 2 6 7 8}

How does the Pharmacist Personalized Medication Review (PMR) differ from other treatments for managing drug interactions?

The Pharmacist Personalized Medication Review (PMR) is unique because it involves a pharmacist conducting a detailed review of a patient's medications to identify and manage potential drug interactions, especially after hospital discharge. This personalized approach is distinct from standard treatments as it focuses on optimizing medication safety and effectiveness through direct pharmacist intervention, rather than relying solely on computerized alerts or prescriber decisions. ^{1 8 9 10 11}

What is the purpose of this trial?

The goal of this prospective randomized clinical trial is to learn if a pharmacist-provided personalized medication review (PMR) that discusses pharmacogenomic test results will improve medication outcomes. The primary aim is to identify patients within the Pitt/UPMC employee health programs who are most likely to benefit from PGx testing based on prescription history. The second aim is to determine the effect of the pharmacist-provided PMR including PGx test results. Participants 18 years of age and older who have undergone PGx testing through a independent biobanking study (Pitt+Me Discovery) will be randomly assigned to receive PMR with a discussion of PGx test results or PMR without PGx results. Those who receive PMR only will receive PGx results one year after their PMR. Researchers will compare the groups to see if a pharmacist-provided PMR using PGx test results will lead to better medication outcomes and lower medical costs.

Research Team

Philip Empey, PharmD, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for adults over 18 who are part of the Pitt/UPMC employee health programs and have had pharmacogenomic (PGx) testing. It's designed to see if discussing PGx test results during a medication review with a pharmacist can improve how well their medications work.

Inclusion Criteria

Enrolled in the UPMC insurance plan for at least 1 year

I am part of Pitt+Me Discovery and chose to get my pharmacogenomics results.

I am identified by UPMC as likely to benefit from genetic testing due to my medication use and costs.

Exclusion Criteria

I am able to understand and agree to the study's requirements.

I have had genetic testing for drug response.

Terminal illness (specifically metastatic cancer, palliative care, or hospice)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pharmacogenomic Testing

Participants undergo pharmacogenomic testing through an independent biobanking study

Baseline

Personalized Medication Review (PMR)

Participants receive a pharmacist-provided personalized medication review with or without PGx test results

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for changes in healthcare costs, medication adherence, and other outcomes

12 months

Treatment Details

Interventions

• Discussion of Pharmacogenomic results during the PMR
• Pharmacist Personalized Medication Review (PMR)

Trial Overview The study tests whether personalized medication reviews by pharmacists that include discussion of patients' genetic test results lead to better outcomes than reviews without this information. Participants will be randomly placed in one of two groups, comparing the effectiveness of these approaches.

Participant Groups

Group I: Immediate Return of Pharmacogenomic Results Experimental Treatment 2 Interventions

Participants will be randomized to immediate versus delayed return of pharmacogenomic results obtained from testing conducted by an independent biobanking study (Pitt+Me Discovery). Participants in the immediate group will receive a pharmacist Personalized Medication Review with PGx results.

Group II: Delayed Return of Pharmacogenomic Results Experimental Treatment 1 Intervention

Participants will be randomized to immediate versus delayed return of pharmacogenomic results obtained from testing conducted by an independent biobanking study. Participants in the delayed group with receive a pharmacist Personalized Medication Review without PGx results. The delayed group will receive results from the independent biobanking study (Pitt+Me Discovery) at 12 months after the Personalized Medication Review.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

University of Pittsburgh Medical Center

Collaborator

Trials

78

Recruited

77,600+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Drug-related problems identified in post-discharge medication reviews for patients taking warfarin. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

[Prevalence of potential drug-drug interactions in ambulatory patients with statin therapy]. [2008]

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

Retrospective drug utilization review: incidence of clinically relevant potential drug-drug interactions in a large ambulatory population. [2023]

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

Randomized Trial to Improve Primary Care Patient Management and Patient Outcomes Using a Drug-Drug Interaction Test: Confirmation of the DECART Simulated Patient Clinical Utility Trial Results. [2021]

5. Japan pubmed.ncbi.nlm.nih.gov

Efficacy of a Pharmacist Team Clinical Medication Review in Older Adults: A Prospective and Retrospective Observational Study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Prevalence and typology of potential drug interactions occurring in primary care patients. [2015]

7. Brazil pubmed.ncbi.nlm.nih.gov

Drug interactions among older adults followed up in a comprehensive medication management service at Primary Care. [2020]

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

Community pharmacy managers' perception of computerized drug-drug interaction alerts. [2019]

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

Pharmacist recognition of potential drug interactions. [2022]

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

Reasons provided by prescribers when overriding drug-drug interaction alerts. [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Visualization of Drug Interactions for Supporting Medication Review. [2020]