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?
According to EMS1, an online resource for emergency medicine providers, states are likely to resist making changes to their own opioid regulations.
“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,” EMS1 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 net negative for public health. States have a tangled mess of opioid prescribing regulations and changing them won’t be easy.
“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 “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.”
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.
