A deluge of public comment and stakeholder input on a federally issued guideline for primary care prescribing of opioids for chronic pain offers testament to how sensitive this issue has become in the healthcare community. The volume of input is especially noteworthy in light of the fact that compliance with Centers for Disease Control and Prevention (CDC) guideline will remain voluntary.
“It is kind of odd having a clinical document open to public comments,” says Susan E. Awad, director of advocacy and government relations at the American Society of Addiction Medicine (ASAM), though she adds that there is support for “anything that will add credibility” to physician guidance for opioid prescribing.
Publication of the proposed guideline, limited to prescribing in primary care settings for chronic pain lasting longer than three months and not in the context of palliative care, occurred in mid-December; a comment period on the proposed guideline ended last week. Some medical organizations, including the American Medical Association (AMA), complained when earlier drafts circulated that some key stakeholder groups in the medical community had been excluded from the guideline development process.
That in part led to this month's appointment, by the CDC's Board of Scientific Counselors for the National Center for Injury Prevention and Control, of a 10-member expert panel to review and comment on the guideline, a process that should culminate with a presentation at a board meeting later this month. Pain and addiction specialists, general physicians and pain patients are all represented on the panel.
The proposed guideline covers treatment initiation, dosing, duration of treatment, tapering, and risk assessment and mitigation. The first of the CDC's dozen numbered recommendations states that non-opioid pharmacologic therapy and nonpharmacologic therapy should be the preferred treatment avenues for chronic pain, based on the presence of limited or insufficient evidence of opioids' effectiveness in treating conditions such as low back pain or fibromyalgia. The recommendation states that given the substantial risks associated with opioids, they should not be considered first-line or routine treatment for chronic pain that is not associated with cancer or end-of-life care.
Extended-release/long-acting opioids should be avoided in favor of immediate-release formulations at the start of opioid therapy for chronic pain, the guideline states. The extended-release drugs “should be reserved for severe, continuous pain and should be considered only for patients who have received immediate-release opioids daily for at least 1 week,” the document states. It adds that methadone, which it says produces more variable effects than other opioids, should not be a first choice when an extended-release medication is used.
The guideline recommends that additional precautions be taken whenever opioid dosages reach 50 morphine milligram equivalents (MMEs) a day, and that dosages of 90 MMEs a day and higher be avoided altogether.
The guideline also states, “Providers should evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy for chronic pain or of dose escalation,” and should evaluate the benefits of continued therapy at least every three months.
It is recommended that prescribers also ask pain patients about alcohol and drug use, through one-question screening methods and/or validated tools such as the Alcohol Use Disorders Identification Test (AUDIT) and the Drug Abuse Screening Test (DAST). Authors of the proposed guideline stated that while there is insufficient evidence defining how levels of opioid-related harm differ based on past or current substance use disorders, a substance use disorder history is associated with opioid misuse. They added that there is agreement among experts that providers should offer the overdose reversal drug naloxone to opioid patients who present an increased risk of overdose.
Among the recommendations regarding drug testing, the guideline states, “Providers should not terminate patients from care based on a urine drug test result because this could constitute patient abandonment and could have adverse consequences for patient safety, potentially including the patient obtaining opioids from alternative sources and the provider missing opportunities to facilitate treatment for substance use disorder.”
ASAM's official comment to the CDC credits the agency for developing the guideline and urges for rapid finalization of the document, stating, “This guidance is urgently needed by primary care practitioners.”
ASAM also suggests in the letter several additions or changes that it believes would strengthen the guideline, including:
Broadening its scope to include all practitioners who at least occasionally prescribe opioids for chronic pain, including dentists and pain management specialists.
Emphasizing functional improvement as a primary goal of opioid treatment; ASAM believes the current document reflects an overemphasis on pain ratings in outcome evaluation.
Specifying that physical dependence and tolerance are predictable phenomena with opioid treatment and should be distinguished from addiction.
Including more information on formulations of the drug naltrexone in the guideline's section on medication-assisted treatment for addiction, as the text presently focuses nearly exclusively on methadone and buprenorphine.
ASAM's Awad adds that the society is pleased that the CDC included in its section on opioid use disorder a reference to ASAM's practice guideline on medication-assisted treatment.