First, Do No Harm: Support legislative efforts to combat the epidemic of adverse drug events

If four full-sized 737 aircraft crashed every day, resulting in a total loss of life, there would be a public outcry and immediate government intervention. Yet we lose just as many people every day – 275,000 Americans annually – to adverse drug reactions (ADRs). This public health crisis goes largely unnoticed as it happens to one mother, one son, one sister and one friend at a time in homes, clinics, emergency rooms, nursing homes and hospitals. Outdated monitoring and reporting systems result in many more ADEs going unreported. Most ADEs occur when medications are administered and taken correctly, contrary to popular belief that this is most often due to nonadherence. The effects are worse in women, who are twice as likely to develop ADEs, and in non-white patients. This is because clinical trials for the generics we primarily prescribe were conducted years ago and largely included only white men of European descent.

While some harm from medications may be unavoidable, studies suggest that half or more can be prevented by prioritizing education, equal access to health care, and technology, which requires legislative action.

The Growing Public Health Crisis

In 2016, the last time this was measured, we spent $528 billion on unoptimized drugs, a staggering number that exceeds the cost of the drugs themselves or a serious chronic disease. The more medications a patient takes, the higher the risk of ADEs. Currently, over 40 million patients take five or more medications every day. With the “silver tsunami” of baby boomers aging into Medicare, that number is expected to double by 2040. Now is the time to act.

Despite investments in precision medicine, pharmacogenomics testing (PGx) remains underutilized as a tool to reduce preventable drug harm. PGx testing helps determine which medications and dosages are likely to be safe and/or effective based on each patient's genetic makeup. It is precision medicine for drugs. Unlike other genetic variations, which are typically rare, PGx variations occur in over 99% of patients. A single, comprehensive multi-gene test can help maximize the safety and effectiveness of many commonly prescribed medications used in mental health, pain management, cardiovascular treatment, cancer treatment and more. Drug-gene interactions are very similar to drug-drug interactions – in fact, the FDA has stated in its drug development guidance that they are similar in scope and therefore should receive similar attention. The main differentiator is that, unlike drugs, genetics cannot be changed.

Consider the 1,300 patients who die each year, not from cancer, but from treatment with fluorouracil or capecitabine itself. In 5-7% of patients with DPYD-PGx variants, standard doses of these drugs may be toxic and at risk of treatment-related death increase by 25.6 times. Or consider the 8% of patients with certain PGx variations that affect the metabolism of citalopram and escitalopram who are 34.3% more likely to commit suicide because the drugs are eliminated too quickly to to produce a treatment benefit, or so slowly that they increase side effects leading to treatment discontinuation. Perhaps also think about the patients who continue to receive clopidogrel without a PGx test, despite an FDA black box first added in 2010 warning that patients with certain PGx variants are more likely to have another heart attack or stroke.

The promise of PGx testing

Biomarker testing, including PGx testing, can help turn this tide. Numerous studies have confirmed that optimizing prescribing with PGx testing reduces emergency room visits, hospitalizations, and healthcare costs. A large study in several European countries in various specialties and care areas showed a 30% reduction in clinically significant adverse drug reactions in just 12 weeks. A recent meta-analysis in adult cancer patients demonstrated a 53% reduction in significant adverse events with the use of PGx testing. And despite the lack of widespread adoption, medical liability risks increase when evidence-based PGx testing is not discussed with and offered to patients. So why is it not a standard of care? Numerous hurdles stand in the way of making PGx testing a standard of care, including:

• Inconsistent insurance coverage: A significant barrier to equitable access and adoption of biomarker testing, including PGx testing, is inconsistent insurance coverage that has not kept pace with professional guidelines and advances in evidence. This has led to further socioeconomic, racial and ethnic disparities in access to quality health care.
• Lack of education and clinical decision support: Both provider and patient education and prioritization of integrated clinical decision support are needed to realize the benefits of genomic medicine, including PGx-guided drug management.
• Lack of recognition of pharmacists as healthcare providers: Although many states recognize pharmacists as health care providers, they are not yet recognized as providers at the federal level. This lack of federal recognition hinders reimbursement for pharmacists, even though they provide numerous and essential direct care services to patients consistent with their training, including PGx-guided medication management.

Support biomarker legislation and prioritize PGx training

To address barriers to insurance coverage, biomarker laws have been enacted in sixteen states, including Arizona, California, Georgia, Illinois, Maryland, Texas, and New York, and have been implemented in eleven additional states. The National College of Insurance Legislators (NCOIL) approved model biomarker legislation in the summer of 2023, laying the foundation for expected nationwide rollout. Typically, this legislation requires government insurance providers, including Medicaid and commercial payers, to cover tests that guide treatment decisions based on medical and scientific evidence, including tests established by CMS NCDs, Medicare Administrative Contractor LCDS, or nationally recognized guidelines and consensus statements for the clinical practice are covered. Medicare LCDs began covering certain evidence-based PGx tests in 2020.

Physicians must prioritize learning about and incorporating PGx testing into their practice to improve patient safety and care. Free resources can be found at the NIH Inter-Society Coordinating Committee for Practitioner Education in Genomics (ISCC-PEG). Healthcare professionals in states that have not enacted biomarker legislation can learn how to support states' ACS CAN efforts.

Additional legislative action and advocacy efforts to improve drug safety and reduce ADRs are also in the works. This includes:

• Right Drug Dose Now Act of 2024 – You can urge your members of Congress to support this legislation – learn more and sign your support at Fourth Cause. This bipartisan bill, reintroduced by Swalwell and Crenshaw in late March, would:
  • Require an assessment and updating the National Action Plan for the Prevention of Adverse Drug Events;
  • Create an educational campaign for healthcare providers to prevent adverse drug events, in part through the use of evidence-based PGx information.
  • Incentivize updates to electronic health record systems ensure that healthcare providers are made aware of drug-gene interactions when making prescribing decisions;
  • Improve reporting systems This would be helpful in reporting PGx-associated adverse drug events
  • A second associated invoice Approves sustained funding for PGx implementation research and policy development.
• Pharmacy and Medically Underserved Areas Improvement Act – The bill would allow pharmacists to provide Medicare Part B services that are already authorized by their state’s laws. Find out more at ASHP.

The Hippocratic oath of “First do no harm” cannot stop at direct patient care; The healthcare industry and its key stakeholders must systematically address ongoing public health issues. We have the tools to reduce the harm caused by medications by half or more; It is long past time to make this a public health priority. Sensible legislation must be passed to ensure we move beyond an outdated medication management and safety system that no longer serves providers or the patients they serve.

Editor's Note: The author serves on the PGx Committee of the NIH Inter-Society Coordinating Committee for Practitioner Education in Genomics (ISCC-PEG), a member of the PGx Working Group for the American Cancer Society Cancer Action Network (ACS CAN), and serves on the Steering Committee for STRIPE, the FDA collaborative community for PGx.

Photo: z_wei, Getty Images

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