CDC Finds a Cure and Publishes Draft Opioid Prescribing Guidelines, Seeks Comments

December 16, 2015

By Larry K. Houck

The Centers for Disease Control and Prevention (“CDC”) have published draft guidelines for prescribing opioids for chronic pain and opened a docket seeking public comment. Proposed 2016 Guideline for Prescribing Opioids for Chronic Pain, 80 Fed. Reg. 77,351 (Dec. 14, 2015). The docket will accept comments until January 13, 2016. We blogged on the draft guidelines on October 12, 2015, listing the guidelines that the CDC presented during the September 16, 2015 webinar. At that time we noted that the CDC did not intend to make the draft guidelines available to the public. CDC Opioid Prescribing Guidelines; Excluding Stakeholders is Wrong Path. The CDC has now cured this obvious shortcoming and agreed to publish the draft guidelines for public comment. The CDC guidelines are just the latest contribution to the ongoing debate about the appropriate treatment of pain and, while they are voluntary, we expect them to be very influential on opioid therapy for chronic pain. We therefore believe that the CDC has made the right decision in publishing the guidelines and providing stakeholders with the opportunity to weigh in before they are finalized.

The CDC states physicians across all treatment specialties “believe that opioid pain medication can be effective in controlling pain but agree that physical dependence, tolerance, and addiction are common consequences of prolonged use” and that opioids are often overprescribed for patients with chronic noncancer pain. CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016. Primary care providers (family physicians and internists), says the CDC, are concerned about the misuse of opioid pain medication and patient addiction, and opine that they have received insufficient training on prescribing opioids. Id.

The draft guidelines provide opioid prescribing recommendations for primary care healthcare professionals who are treating patients with chronic pain, that is, pain lasting longer than three months or past the time of normal tissue healing, in outpatient settings. The guidelines apply only to patients eighteen years or older with chronic pain unrelated to active cancer treatment, and outside of palliative and end-of-life care. The CDC states that the guidelines are intended to improve communication between providers and patients about the benefits and risks of opioid therapy for chronic pain, improve the safety and effectiveness of pain treatment, and reduce the risks, including abuse, dependence, overdose, and death, associated with long-term opioid therapy. Id. The Federal Register notes that “The Guideline is not a federal regulation; adherence to the Guideline will be voluntary.” 80 Fed. Reg. at 77,351.

The draft guidelines are generally the same as those presented during the September 16th webinar with minor variations. The differences appear to be mostly the addition of the qualifier “for chronic pain” as if to reiterate that the guidelines do not apply in all circumstances. CDC has organized the guidelines into three general areas: (1) when to initiate or continue opioids for chronic pain; (2) opioid selection, dosage, duration, follow-up, and discontinuation; and (3) assessing risk and addressing harms of opioid use. The current draft guidelines are:

Determining When to Initiate or Continue Opioids for Chronic Pain

  1. Nonpharmacologic therapy and nonopioid pharmacological 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.
  2. 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.
  3. 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.

Opioid Selection, Dosage, Duration, Follow-Up, and Discontinuation

  1. When starting opioid therapy for chronic pain, providers should prescribe immediate-release opioids instead of extended-release/long acting (ER/LA) opioids.
  2. 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.
  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.
  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.

Assessing Risk and Addressing Harms of Opioid Use

  1. 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.
  2. 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.
  3. 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.
  4. Providers should avoid prescribing opioid pain medication for patients receiving benzodiazepines whenever possible.
  5. 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. CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016.

The CDC has also cured another criticism of the draft guidelines by making a number of relevant documents and materials available as part of the docket. The documents and materials provide needed transparency to the CDC’s development of the guidelines and should promote a much needed discussion in this complicated area. These documents include the Peer, Stakeholder and Constituent Review Summaries and the Clinical and Contextual Evidence Review Appendices.

As we noted in October, the draft guidelines are reasonable and should help progress the public discussion on appropriate pain treatment. Some of them are commonsensical, constitute good medical practice, and apply to the prescribing of any medication, not just opioids or controlled substances. However, they are not without controversy and other stakeholders have been critical of the CDC’s position. See, e.g., Letter to the Honorable Fred Upton, Chairman, House Energy and Commerce Committee, U.S. House of Representatives, from Robert Twillman, Executive Director, American Academy of Pain Management (Oct. 20, 2015). We questioned the CDC’s lack of transparency and not allowing input from interested stakeholders including prescribers, pharmacists, regulators, and especially patients. The final guidelines will potentially greatly influence practitioners and patients so it is appropriate that the CDC provide stakeholders and the public with an opportunity to comment on the draft guidelines.

There has been increased enforcement against physicians for failing to adhere to their primary responsibility to ensure that a prescription must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. See, e.g., 21 C.F.R. § 1306.04(a). The same is true for action against pharmacies that have failed in their corresponding responsibility to ensure that prescriptions are dispensed only for a legitimate medical purpose. See, e.g., The Medicine Shoppe; Decision and Order, 79 Fed. Reg. 59,504 (Oct. 2, 2014). The CDC guidelines at one level could be viewed as providing criteria or clarifying these standards. However, we would caution physicians, pharmacists, and regulators that legitimate medical treatment may on occasion conflict with strict adherence to the guidelines. There may, for example, be instances where a patient requires more than 50 or 90 morphine milligram equivalents per day. Thus, stakeholders will need to evaluate to the extent that these voluntary guidelines are consistent with appropriate medical practice.