Adverse drug events (ADEs) claim approximately 275,000 American lives annually, a staggering figure that equates to the daily loss equal to four full 737 plane crashes. This significant public health issue often goes unnoticed due to its dispersed occurrence across various settings including homes, clinics, and hospitals, and through outdated surveillance and reporting systems that fail to catch many instances. Unlike common misconceptions, most ADEs occur even when medications are used correctly rather than through non-adherence. The impact disproportionately affects women, who are twice as likely as men to experience ADEs, and non-White patients due to historical clinical trials primarily involving European ancestry males.
Current medical practices reveal a dire need for improvement, especially considering the $528 billion spent in 2016 on non-optimized medication use—the cost exceeding that of any major chronic disease. As populations age and polypharmacy becomes more common, the risk of ADEs increases, highlighting an urgent requirement for change. The introduction of precision medicine, like pharmacogenomics (PGx) testing, serves as a promising solution by aligning medication prescriptions with individual genetic profiles to enhance safety and efficacy. PGx testing, beneficial in various medical fields such as mental health and cardiology, remains underutilized due to several systemic hurdles.
Despite evident advantages including reduced healthcare costs and minimized emergency visits, PGx testing faces challenges including inconsistent insurance coverage and a lack of comprehensive education and clinical support for healthcare providers and patients. Moreover, pharmacists—key figures in medication management—are not recognized as healthcare providers on a federal level in the United States, which further complicates the implementation of PGx practices due to reimbursement issues.
Legislative action is imperative to normalize and enhance the accessibility of PGx testing. Several U.S. states have enacted biomarker legislation mandating insurance coverage for medically essential tests, with hopes of national adoption encouraged by endorsements from influential legistlative bodies like the National College of Insurance Legislators. Education plays a crucial role as well; providing resources and learning platforms for healthcare professionals about PGx could vastly improve patient care and safety.
Prominent efforts to support the integration of PGx into routine medical care include the potential enactment of the Right Drug Dose Now Act of 2024 and the Pharmacy and Medically Underserved Areas Enhancement Act. These legislative measures aim to update the National Action Plan for Adverse Drug Event Prevention, fund educational campaigns on PGx, modify electronic health record systems for better drug-gene interaction alerts, and enable pharmacists to deliver Medicare-recognized services.
The healthcare system’s imperative “first do no harm” extends beyond direct patient care to systemic improvements in medication safety and public health priorities. Equipped with advanced tools like PGx testing, the healthcare industry is positioned to significantly reduce medication-related harm if supported by comprehensive and common-sense legislative, educational, and clinical advancements.
Kristine Ashcraft, a notable figure in the field of pharmacogenomics and an advocate for precision medicine, emphasizes the necessity for systemic reform in her roles across various PGx committees and as a founder of a clinical decision support tool integrating personalized prescribing. Her extensive experience and advocacy exemplify the ongoing push towards a safer, more efficient medical practice tailored to individual genetic profiles, aiming to transform and enhance patient care on a broad scale.
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