The Tangled Mess of Prescription Opioid Guidelines
/By Roger Chriss, PNN Columnist
The opioid overdose crisis has impacted medical practice in unanticipated and unfortunate ways. A recent JAMA study warned that efforts to reduce opioid prescribing through tapering raises the risk of overdose and mental health crises in pain patients on stable, long-term opioid therapy.
This study is the latest to find that opioid tapering is fraught with risks. Amid this, the American Medical Association has issued a call to revamp the CDC’s problematic 2016 opioid prescribing guideline because of its “devastating” impact on pain patients.
“The CDC should remove arbitrary thresholds, restore balance and support comprehensive, compassionate care as it revises the guideline,” wrote AMA news editor Kevin O’Reilly.
But revising the CDC guideline may not have much effect. The guideline is voluntary and doesn’t have the force of law, but many states have implemented their own guidelines in ways that make them enforceable. They are often paired with requirements and regulations covering everything from daily dose and prescription duration to drug testing, pain management agreements, and tapering. These state guidelines do not necessarily follow the CDC guideline on even basic issues of dose, duration or recommended use.
Some states, including Minnesota and Oregon, have adopted the CDC’s recommended threshold of 90 morphine milligram equivalents (MME) as a maximum daily dose not requiring consultation with a pain management specialist or a special exemption. Other states make their own rules. Washington has kept to 120 MME in its latest guideline update, as has Tennessee.
State policies also differ on the merits of using opioids for chronic pain. The Medical Board of California recommends that physicians and patients “develop treatment goals together” for long-term use of opioids, while Arizona’s opioid guideline flatly warns physicians: “Do not initiate long-term opioid therapy for most patients with chronic pain.”
On tapering, states do not agree much at all and generally do not follow federal HHS guidelines that tapering be individualized and “slow enough to minimize opioid withdrawal symptoms.”
Minnesota’s opioid guideline recommends that physicians “routinely discuss tapering with patients at every face to face visit” and allows for forced, rapid tapers or discontinuation under some circumstances.
Tennessee’s guideline notes that there are “many reasons to discontinue chronic opiate therapy” and “several different weaning protocols outlined by various sources.” It does not recommend any specific one, leaving it up to individual doctors to decide how to taper their patients.
The VA and Department of Defense have their own guideline, which contains a complex set of treatment algorithms that span several pages and effectively exclude almost all patients from long-term opioid use. Further, according to a separate algorithm, the VA is clearly aiming to taper or discontinue opioids in as many patients as possible. The guideline states "If prescribing opioid therapy for patients with chronic pain, we recommend a short duration.”
The Trouble With Algorithms
Many of the state guidelines are paired with a prescription drug monitoring programs (PDMPs) and use NarxCare, a private analytics system that gives individual risk scores to every patient based on their medical and prescription drug history. PNN first covered NarxCare in 2018, noting that patients can be automatically “red flagged” by the system for seeing too many doctors or using multiple pharmacies.
Maia Szalavitz recently wrote about Narxcare in Wired, noting that legitimate patients were being denied medications or abandoned by doctors because of their Narxcare scores.
“A growing number of researchers believe that NarxCare and other screening tools like it are profoundly flawed,” Szalavitz wrote. “None of the algorithms that are widely used to guide physicians’ clinical decisions — including NarxCare — have been validated as safe and effective by peer-reviewed research.”
A similar problem exists for data from PDMPs. A well-documented analysis by Terri Lewis, PhD, found that “machine learning” algorithms are often based on untested assumptions and financial incentives for providers, not on patient care.
“The worst part of machine learning (ML) snake-oil isn’t that it’s useless or harmful — it’s that ML-based statistical conclusions have the veneer of mathematics, the empirical facewash that makes otherwise suspect conclusions seem neutral, factual and scientific,” wrote Lewis. “What the PDMP is NOT designed to do, is detect patients who are using their opioids correctly from patients who are misusing their medications.”
All of the above imposes a significant risk and burden on patients, in particular if they relocate for work or school, or seek medical care outside of their state of residence.
In essence, patients are subjected to a set of federal recommendations from the CDC that may inform some state laws or regulations that are then implemented in a privatized process with little transparency or accountability. Patients simply cannot tell what is happening at the time of implementation, and if they see a problem after the fact, it is usually too late to fix it.
The AMA’s current effort to improve the CDC guideline for opioids is a laudable step forward. But the mess is far larger and more complex, and the role of the CDC is smaller than is generally appreciated amid an abundance of contradictory guidelines and regulations.
Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.
