Katherine H. Capps
Co-Founder and Executive Director
February 23, 2022
Pharmacogenomics for Physicians and Pharmacists: Legality and Liability Implications
Integration of pharmacogenomic (PGx) testing into clinical practice has accelerated in select practice areas, moving it from a novelty to a standard part of patient care. That’s generally a good thing as it has proven in those areas to improve clinical outcomes. However, as PGx testing becomes a standard of care, failure to implement it could lead to instances where care may not be optimized, raising potential malpractice issues.
Two GTMRX executive members recently explored this issue in an excellent paper published in The Journal of Precision Medicine:
- Anthony P. Morreale, PharmD, MBA Associate Chief Consultant for Clinical Pharmacy and Policy Pharmacy Benefits Management Clinical Pharmacy Practice Office, Department of Veterans Affairs; and
- Shawn McFarland, PharmD, National Clinical Pharmacy Practice Program Manager, Clinical Practice Integration and Model Advancement, Clinical Pharmacy Practice Office, Pharmacy Benefits Management Services, Veterans Health Administration
First, a refresher
PGx is the study of how a person’s genetic makeup determines their responses to specific medications. It allows clinicians to choose a drug that is more likely to work for an individual, avoid those that might have serious side effects, adjust the dosage or determine that close monitoring of the patient is needed.
As a diagnostic companion in support of comprehensive medication management, PGx testing allows a provider to advance precise, personalized medicine. It gives providers insight into how an individual’s genes may affect their response to certain medications, thereby improving the precision of clinical decisions related to medication therapy. This can increase the likelihood that a medication will work as intended, reduce the chances of adverse reactions and may even reduce the duration of a treatment regimen. Simply put, PGx has the opportunity to improve the quality of patient care and has the potential to reduce the overall cost of care.
With better integrated EHRs, less costly PGx tests and better decision-support technology, PGx testing will soon be as routine as other lab tests, Morreale and McFarland predict.
As the body of literature grows and as patients become more aware of the power of PGx testing, we’ll see PGx being considered standard of care. “With the rapidly declining cost of pharmacogenomic testing, it will not be long until all patients have pre-emptive test results incorporated into the electronic medical record for all to see and act upon when necessary.” This may be most obvious in oncology, but PGx testing has become increasingly routine across many practice areas.
In addition, the FDA is now including PGx in package insert prescribing information. In fact, they point out that more than 350 therapeutic products have FDA-designated PGx labeling, including many common medications for depression and blood clots. And there are hundreds more.
As PGx tests are routinely incorporated into treatments and become a standard of care, significant liability implications may arise for the clinicians, primarily physicians and pharmacists, who are or will be responsible for oversight of the medications prescribed.
The risk of ignoring PGx testing
We’re already seeing this in certain cancers where, the authors explain, failure to test for tumor or patient genomic status is already a legal liability for providers.
“Simply stated, if a patient suffers an adverse drug reaction or ineffective treatment, and damages are incurred, the major legal hurdle is establishing a standard of care that may have been breached,” they write. And the thought that PGx testing is a “novelty” won’t be a strong defense:
“As with any newer technology or evidence, adoption is often slow so many clinicians and lawyers rest their case on the percentage of medical experts who might be utilizing the technology regardless of the strength of the evidence that it should be quickly incorporated into practice. This defense will be eroded as PGx is more commonly incorporated into care.”
Right now, Morreale and McFarland note, we’re in a period of transition.
Despite the rapid evolution of PGx, it has yet to have yet to be fully integrated at the point of care. One reason is that PGx still suffers from a lack of consistency, especially related to several key questions:
- When is testing necessary?
- Which patients should be tested?
- What types of tests are to be used?
- How do we use these tests?
- What is the impact of the application of test results to overall clinical outcomes?
A major hurdle, they point out, is “the lack of education and training of front-line clinicians about the availability of, and access to, decision support tools to assist with facilitation of PGx information into the electronic medical record complicates the implementation of PGx in all settings.”
It is anticipated that many of these issues will be resolved soon, and as a result the threat of liability related to PGx testing and interpretation of PGx test will continue to grow.
“Physicians have the responsibility to diagnose, treat, and inform patients of the risks and benefits of the proposed treatment and the fiduciary obligation towards their patients to act in their best interest utilizing the most current accepted and evidence-based practices. As a result, physicians face challenges to stay up to date on the latest developments in PGx-indicated medication use, especially given the accelerating volume of pharmacogenomic research.”
Clinicians and health care organizations must better understand what’s at stake. Both the medical and legal professions must rapidly improve their training and understanding of PGx to avoid such liabilities, argue Morreale and McFarland.
They call for more training and education for current pharmacists and physicians as well as students in both of these disciplines. This will improve patient care and reduce the potential legal liabilities.
Their paper is an important stake in the ground for physicians, pharmacists, other clinicians and health care systems. But at GTMRx, we’re also working to get the message out to a wider audience. Those who pay for health care—employers and public and private payors—must also understand the importance of widespread implementation of PGx testing and the risks of not moving forward.