After months of complaints about a lack of transparency by some physician groups, patients, and patient advocates, the Centers for Disease Control and Prevention (CDC) has published a draft guideline on opioid prescribing, but many are still concerned.
The guideline appears in the December 14 Federal Register and is open for comment until January 13.
The CDC's National Center for Injury Prevention and Control's Board of Scientific Counselors will create a working group in early January to review the comments and make recommendations to the Board on revisions, a CDC spokesperson told Medscape Medical News. The group will include the core experts who helped write the guideline, members of the Board, and pain patients, said the spokesperson.
There is still no timeline for when the final guideline will be published, but it is "a priority for our agency," the spokesperson added.
The guideline's recommendations are only for prescribing in primary care settings, and only in treating chronic pain lasting longer than 3 months that is outside of end-of-life care.
It was written by Deborah Dowell, MD, and Tamara Haegerich, PhD, from the CDC's Division of Unintentional Injury Prevention, along with an outside expert, Roger Chou, MD, from Oregon Health and Sciences University, Portland, said the CDC spokesperson.
The recommendations were reviewed by a panel of experts that included representatives from the Society of General Internal Medicine, American Academy of Family Physicians (AAFP), and American College of Physicians.
Although the AAFP was involved, it is not a given that it will back the final guideline, said AAFP president-elect John Meigs Jr, MD. Evidence-based guidelines can help combat the opioid abuse problem but are not a guarantee, he told Medscape Medical News.
Once the CDC's guideline is published, "the AAFP's Commission on Health of the Public and Science will review it in its entirety and determine whether we will endorse it," Dr Meigs said.
The American College of Physicians has no official comment for now but will weigh in after it has collected comments from its members, a spokesperson told Medscape Medical News.
The American Medical Association (AMA) submitted comments to the CDC on October 1, as it was one of almost two dozen organizations that was given a review of the draft in September.
AMA, Others Cry Foul
The guideline was also shared via CDC webinars on September 16 and 17 that included 700 participants, resulting in 1200 comments, said the CDC spokesperson. The second webinar was held reportedly because of complaints from pain patients and others who said technical problems prevented them from getting into the first, according to Pain News Network.
The patient community has expressed alarm about the transparency of how the opioid guideline was developed. The CDC spokesperson said that after the webinar, the draft was shared with stakeholders, including several professional societies, including the American Pain Society, the American Cancer Society Action Network, and Physicians for Responsible Opioid Prescribing.
The guideline was going to be finalized and published without further outside comment. In its October letter, the AMA objected. That move would be "disappointing, given the stature of the CDC as a public agency, the serious nature of the problem, and likely impact of the specific guidance that may be released," wrote James L. Madara, MD, Executive Vice President and CEO of the AMA.
The AMA also took issue with the guideline-writing committee's methods and said that the expert review panel should have included more physician specialties.
Further, patients were all but ignored, said Dr Madara. "The guidelines and supporting discussion are devoid of a patient-centered view and any real acknowledgment or empathy of the problems chronic pain patients may face," he said.
The organization offered revisions to many of the guideline's 12 core recommendations, noting that in some cases they conflicted with other federal guidance on opioid prescribing.
The AMA has not been alone in its objections. In a meeting in early December, some members of the federal Interagency Pain Research Coordinating Committee criticized the process, according to Pain News Network.
In a survey conducted by that publication, 95% of pain patients said that the CDC guideline discriminated against them, and 93% said that if published as is, the guideline would be harmful to pain patients.
The 12 recommendations in the draft are as follows.
Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Providers should only consider adding opioid therapy if expected benefits for both pain and function are anticipated to outweigh risks to the patient (recommendation category: A, evidence type 3).
Before starting opioid therapy for chronic pain, providers should establish treatment goals with all patients, including realistic goals for pain and function. Providers should not initiate opioid therapy without consideration of how therapy will be discontinued if unsuccessful. Providers should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety (recommendation category: A, evidence type: 4).
Before starting and periodically during opioid therapy, providers should discuss with patients known risks and realistic benefits of opioid therapy and patient and provider responsibilities for managing therapy (recommendation category: A, evidence type: 3).
When starting opioid therapy for chronic pain, providers should prescribe immediate-release opioids instead of extended-release/long-acting (ER/LA) opioids (recommendation category: A, evidence type: 4).
When opioids are started, providers should prescribe the lowest effective dosage. Providers should use caution when prescribing opioids at any dosage, should implement additional precautions when increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should generally avoid increasing dosage to ≥90 MME/day (recommendation category: A, evidence type: 3).
Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, providers should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three or fewer days usually will be sufficient for most nontraumatic pain not related to major surgery (recommendation category: A, evidence type: 4).
Providers should evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy for chronic pain or of dose escalation. Providers should evaluate benefits and harms of continued therapy with patients every 3 months or more frequently. If benefits do not outweigh harms of continued opioid therapy, providers should work with patients to reduce opioid dosage and to discontinue opioids (recommendation category: A, evidence type: 4).
Before starting and periodically during continuation of opioid therapy, providers should evaluate risk factors for opioid-related harms. Providers should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, or higher opioid dosages (≥50 MME), are present (recommendation category: A, evidence type: 4).
Providers should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving high opioid dosages or dangerous combinations that put him or her at high risk for overdose. Providers should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months (recommendation category: A, evidence type: 4).
When prescribing opioids for chronic pain, providers should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs (recommendation category: B, evidence type: 4).
Providers should avoid prescribing opioid pain medication for patients receiving benzodiazepines whenever possible (recommendation category: A, evidence type: 3).
Providers should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder (recommendation category: A, evidence type: 3).
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Cite this: CDC Opioid Guideline Lands, Controversy Continues - Medscape - Dec 18, 2015.