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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a personalized medication review (PMR) by a pharmacist, which includes discussing pharmacogenomic (PGx) test results, can improve medication effectiveness for patients. PGx tests examine how a person's genes affect their drug response. Participants will be divided into two groups: one will receive their PGx results during the PMR, while the other will receive them a year later. Individuals who participated in the Pitt+Me Discovery study and are taking multiple high-cost prescription medications might be suitable for this trial. The researchers aim to determine if incorporating PGx results in the PMR can lead to better medication outcomes and reduce medical costs. As an unphased trial, this study offers the opportunity to contribute to innovative research that could enhance personalized medicine.

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 prior data suggests that this pharmacist-provided personalized medication review is safe?

Research has shown that pharmacist medication reviews are both safe and beneficial. For example, one study found that these reviews reduced death rates by 3.8%, meaning fewer people died when pharmacists checked their medications. Another study demonstrated that reviewing a patient's medication list can prevent drug interactions, leading to fewer side effects or adverse reactions.

Overall, pharmacist medication reviews are well-received. They aim to enhance medication safety by identifying potential problems early. No evidence suggests that these reviews cause harm; instead, they improve medication effectiveness for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how personalized medication reviews by pharmacists, combined with pharmacogenomic (PGx) results, can optimize drug interactions management. This approach is unique because it integrates genetic information to tailor medication plans, potentially reducing adverse drug reactions more effectively than standard medication reviews without PGx data. By comparing immediate and delayed access to genetic results, the trial aims to demonstrate how timely PGx information can enhance patient outcomes, paving the way for more personalized and precise healthcare strategies.

What evidence suggests that this trial's treatments could be effective for improving medication outcomes?

Research has shown that when pharmacists review medications using genetic test results, treatment effectiveness can greatly improve. In this trial, participants will be randomized to receive either an immediate or delayed return of pharmacogenomic results. The immediate group will receive a pharmacist Personalized Medication Review with these genetic test results, which customize drug treatments based on a person's unique genetic makeup, leading to fewer medication issues. Studies have found that when pharmacists discuss these test results with patients, drug interactions are better managed, and medications become more effective. Additionally, using these test results helps identify the right medication and dosage for each person, reducing side effects and potentially lowering medical costs. Overall, combining pharmacist reviews with genetic testing offers a promising approach to personalizing medicine. ^{1 3 6 7 8}

Who Is on the Research Team?

Philip Empey, PharmD, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06660264

Study Details | NCT06660264 | An Evaluation of the Impact ... The goal of this prospective randomized clinical trial is to learn if a pharmacist-provided personalized medication review (PMR) that discusses pharmacogenomic ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11333096/

Implementing a Pharmacist-Led Primary Care ... A pharmacist-led pharmacogenomics medication management service is now offered at all primary care sites within the health system.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0010482523007941

A precision medicine approach to personalized prescribing ... The approach focuses on raising the performance of four potential interaction screenings in the prescribing process, including drug–drug interactions, drug–gene ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11168213/

Precision medicine in pharmacy Individuals often have variable responses to different medications. This variability can result in individuals having less favourable outcomes ...

5. mdpi.com mdpi.com/2075-4426/12/3/421

Real-World Impact of a Pharmacogenomics-Enriched ... The results were distilled by a clinical pharmacist to create a medication action plan (MAP) that summarized the proposed changes for the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10950891/

Personalized Drug Therapy: Innovative Concept Guided With ... Personalized drug therapy can anticipate and prevent possible drug interactions by analyzing the patient's medication list, thus minimizing the chances of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12286251/

Enhancing the Role of Community Pharmacists in ... Most notably, the pharmacist-driven medication safety reviews were associated with a 3.8% reduction in mortality rates, emphasizing the ...

8. bps.ac.uk bps.ac.uk/getmedia/b43a3dca-1bbf-4bff-9379-20bef9349a8c/Personalised-prescribing-full-report.pdf.aspx

Using pharmacogenomics to improve patient outcomes Ample supply of adverse outcomes Case brought on the basis that an adverse drug efficacy or safety outcome could have been prevented, treated or minimised ...