More Than Just CDC Opioid Guideline Needs Changing
/By Roger Chriss, PNN Columnist
The CDC’s draft revisions to its 2016 opioid guideline are generally seen as an improvement by pain management experts because they give doctors more flexibility to prescribe opioids. But how much will prescribing really change?
Forty states have enacted laws that limit the supply or dose of opioid prescriptions, according to the Pew Charitable Trust. Some states may resist making changes.
“For the eased guidelines to have their intended effect, states would need to amend or repeal existing statutes that limit opioid prescriptions to three to seven days and set ceilings on the daily dose doctors can prescribe,” Stateline reported.
The reasons are simple. Amid a deteriorating drug overdose crisis and a complex prescribing landscape, the proposed changes in the CDC guideline are likely to be seen at the state level as a negative for public health. There’s a tangled mess of different opioid regulations that vary from state to state.
“Relaxing those regulations now would wreak havoc on states. They won’t know what to do,” says Gary Franklin, MD, who is Vice-President of State Regulatory Affairs for Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.
“We’ve made quite a dent in prescription painkiller use,” Franklin told EMS1. “But we’ve still got a lot of work to do.”
Lewis Nelson, MD, Chair of Emergency Medicine at Rutgers New Jersey Medical School, is concerned about plans to drop the guideline’s recommended dose limit of 90 morphine milligram equivalents (MME) per day. Nelson says the CDC’s “watered down recommendations” will lead to more addiction and overdoses.
“By removing this recommended cap … prescribers may feel it is appropriate to prescribe longer initial prescriptions to their patients,” Nelson told The Daily Targum, a student newspaper at Rutgers. “This is one of the key factors that created the opioid crisis in the early 1990s that lasted through today.”
Nelson and Franklin were both key advisors to the CDC during the drafting of its 2016 guideline, serving on a panel known as the “Core Expert Group.” They did not have a similar role in the drafting of the revised guideline.
Federal Agencies and States Do Their Own Thing
Because they are controlled substances, prescription opioids are not regulated the same way as other medications. Manufacturing levels are determined by the DEA, which annually determines production quotas for opioids based on input from the FDA, CDC, Centers for Medicare and Medicaid Services (CMS), and individual states. The DEA has been steadily reducing production quotas for prescription opioids for almost a decade and seems unlikely to change course anytime soon.
Drug approval falls to the FDA, which says one of its “highest priorities” is reducing the number of Americans addicted to opioids. “This may be achieved by ensuring that only appropriately indicated patients are prescribed opioids and that the prescriptions are for durations and doses that properly match the clinical reason for which the drug is being prescribed in the first place,” the FDA says on its website.
Federal programs like Medicare, Medicaid and VA/Tricare, as well as private insurers and pharmacies, exert considerable influence on clinical practice via formularies, guidelines, and prior authorizations.
States ignore the CDC, FDA and other federal regulations when it suits their ends, as seen with Florida’s new “Buck the CDC” effort against federal mask mandates and covid guidelines.
States also set their own regulations for legalizing cannabis or decriminalizing hallucinogens.
When it comes to healthcare and public health, each state does its own thing, even if they conflict with federal policy and are detrimental to other states.
Patient advocate Richard “Red” Lawhern deftly summarizes the many nuances of the CDC’s draft guidance with “the devil is in the details.” And the National Pain Advocacy Center has a detailed analysis of the draft, with suggestions for further advocacy.
The CDC has been a convenient scapegoat for the rapid opioid tapering, patient abandonment, and even suicides that have occurred in recent years. But the reality of regulating prescription opioids and treating chronic pain is complex. Even if CDC does finalize the proposed changes in its draft guideline, there is still a long way to go to restore some semblance of order and stability in pain management.
The CDC is one part of a much larger system that probably needs to change as much as the 2016 guideline need to be updated.
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.
