PROJECT SUMMARY
Preemptive pharmacogenetic (PGx) testing may be particularly beneficial in medically underserved
populations by reducing the number of appointments required to optimize drug therapy and increasing the
effectiveness of less expensive off-patent medications – the type most often with pharmacogenetic guidelines
available (PGx drugs). However, there is little data available to guide clinical implementation in these patient
populations. Our long-term goal is to contribute toward the efficient implementation of PGx into clinical
practice to improve the precision of medication prescribing. The overall objective for this application is to
identify PGx drug usage patterns in medically underserved patients, and assess the feasibility and
effectiveness of preemptive PGx testing in this patient population. The central hypothesis is that medically
underserved patients are prescribed more PGx drugs, and preemptive PGx testing is feasible as well as
effective in improving patient medication satisfaction. The rationale for the proposed research is that
identifying patient populations that can most benefit from PGx testing will facilitate clinical implementation that
may reduce medication treatment disparities.
We plan to test the central hypothesis and accomplish the overall objective of this application by pursuing
three specific aims. The first aim is to identify clinical, demographic and socioeconomic factors associated
with PGx drug prescribing patterns in a large, real-world, diverse patient population. We will accomplish this
aim by comparing clinical, demographic, and socioeconomic data with prescription data from millions of
patients across the State of Florida. The second aim is to develop a low-cost, ancestrally inclusive PGx testing
panel designed to inform commonly used PGx drugs. We will design a low-cost, clinically validated panel that
will include variants common in racial minorities in the U.S. We plan to leverage extensive batching of tests
and an already available genotyping platform that minimizes labor costs in order to achieve significant cost
savings. The third aim is to determine the feasibility of low-cost preemptive PGx testing in a medically
underserved population as well as its effect on patient medication satisfaction. We will accomplish this aim by
completing a randomized open-label clinical trial comparing medically underserved patients receiving
preemptive PGx testing to those receiving usual care. We will compare key implementation metrics and will
also conduct semi-structured interviews in both patients and healthcare providers to assess PGx perceptions
of feasibility and sustainability from stakeholders.
The proposed research is significant because it should contribute valuable preliminary data toward both
the real-world effectiveness of preemptive PGx testing as well as the feasibility of studying and implementing
this technology in medically underserved patients – an area of PGx research where few data are available. The
proposed research is innovative because this project will utilize additional demographic and socioeconomic
data that, with along with clinical data, should better identify patient populations most likely to benefit from PGx
testing and allow focused of implementation efforts to those populations. Ultimately, we expect to have
developed valuable data identifying patients most likely to benefit from preemptive PGx testing, particularly in
patients who are medically underserved and/or members of racial minorities. These results should have an
important positive impact because they can inform further clinical implementation efforts of PGx as well as
future large clinical trials of preemptive testing, ideally reducing healthcare disparities in the field of precision
medicine.