Comment from Yvonne Helmick

NarxCare Recommendations • Regulate NarxCare as a medical device, requiring transparency, validation, and error rate disclosure. • Investigate its real-world harms, particularly for pain patients and those with SUDs/MOUD. • Establish federal guidelines for CDS algorithms to prioritize fairness and patient-centered care. • Consider the Center for U.S. Policy’s recall request until NarxCare’s safety is proven. NarxCare’s unregulated use undermines patient safety and trust. I urge the FDA to act swiftly to protect vulnerable populations NarxCare, developed by Bamboo Health, is a clinical decision support (CDS) system integrated into prescription drug monitoring programs (PDMPs) across 42 states. It scores patients based on factors such as prescription history, overdose records, and addiction treatment, aiming to identify risks related to opioid misuse. However, growing concerns highlight its lack of transparency, potential for harm, and need for regulatory oversight. NarxCare operates by analyzing PDMP data to generate risk scores, which are used by healthcare providers to make decisions about patient care, particularly regarding opioid prescriptions. While intended to combat the opioid crisis, its proprietary algorithm lacks transparency, meaning neither patients nor providers fully understand how scores are calculated. This opacity raises concerns about accuracy, bias, and fairness, especially given its widespread adoption without independent validation. A 2017 article in Modern Healthcare noted NarxCare’s integration into state PDMPs, describing it as a tool that “visualizes” patient data, but it did not discuss validation studies or error rates, highlighting a gap in scientific scrutiny (Patient drug use data at your fingertips). Harms to Patients Research suggests NarxCare’s risk scores can lead to significant harm, particularly for vulnerable populations. The evidence leans toward the following impacts: • Pain Patients: Patients with chronic pain often face delayed or denied care due to high risk scores. The 2022 CDC Clinical Practice Guideline for Prescribing Opioids for Pain warns that misapplication of PDMP tools, including similar systems, can result in “untreated and undertreated pain, serious withdrawal symptoms, psychological distress, overdose, and suicidal ideation” (CDC Clinical Practice Guideline). A 2023 study in JAMA Internal Medicine found that rapid opioid tapering, often prompted by high scores, increases overdose risk by 1.5 times and mental health crises by 2 times (Association of Opioid Tapering With Overdose). • Patients with Substance Use Disorders (SUDs): Individuals with SUDs, especially those on medication for opioid use disorder (MOUD) like methadone or buprenorphine, are particularly affected. NarxCare flags these patients as high-risk, even when stable in recovery, making it harder to access pain relief during surgery or emergencies. A 2024 study in the Journal of General Internal Medicine argues that NarxCare’s scores “weaponize” biases, stigmatizing SUD patients and eroding trust in healthcare (Paths Forward for Clinicians). The Recovery Review blog (2023) recounts cases where patients were terminated from care due to inflated scores, including one where pets’ prescriptions were mistakenly attributed to the patient (AI, Substance Misuse, Addiction). • Expanding Methadone Access: As methadone access expands into more settings, NarxCare’s influence could further restrict compassionate care, amplifying these harms unless regulated. Health Disparities and Bias The evidence leans toward NarxCare exacerbating health disparities. A 2021 study in Health Affairs found that Black and Hispanic patients receive fewer opioid prescriptions than White patients, and tools like NarxCare may amplify these inequities by reinforcing provider biases (Racial and Ethnic Disparities in Pain Management). Patients in underserved communities, who may visit multiple pharmacies due to stock shortages, are also at risk of being flagged, perpetuating systemic inequities. Lack of Transparency and Validation NarxCare’s proprietary algorithm has not been independently validated, raising concerns about its reliability. The Center for U.S. Policy’s 2023 FDA Citizen Petition called for a recall, citing “meaningful harm” due to unvalidated scores, echoing calls for transparency (CUSP FDA Citizen Petition). The FDA’s cautious approach to abuse-deterrent formulations, requiring post-market studies, sets a precedent for similar scrutiny of NarxCare (Abuse-Deterrent Opioid Analgesics).