CDC Guidelines Prescribe Controls on Opioid Therapy

By Larry K. Houck –

The Centers for Disease Control and Prevention (“CDC”) has released its final guidelines for prescribing opioids for chronic pain. CDC Guideline for Prescribing Opioids for Chronic Pain-United States, 2016, Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, Mar. 15, 2016. We blogged on the draft guidelines on October 12, 2015 and December 16, 2015. The guidelines represent the CDC’s contribution to the ongoing debate about the appropriate treatment of pain and, while the guidelines are voluntary, they will be very influential on opioid therapy for chronic pain.

The guidelines are intended for primary care clinicians (e.g., family physicians and internists) and provide recommendations for prescribing opioid pain medication for chronic pain (pain conditions that typically last longer than three months or past the time of normal tissue healing) in outpatient settings. The guidelines apply to patients eighteen years of age 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 ensure that clinicians and patients consider safer and more effective treatment, improve patient outcomes such as reduced pain and improved function, and reduce the number of persons who develop opioid use disorder, overdose, or experience other adverse events related to these drugs.” CDC Guideline, 2.

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 final guidelines are with slight variation, the same as the draft guidelines published in December 2015. The final guidelines are:

Determining When to Initiate or Continue Opioids for Chronic Pain

1. Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. If opioids are used, they should be combined with nonpharmacologic therapy and nonopioid pharmacologic therapy, as appropriate.
2. Before starting opioid therapy for chronic pain, clinicians should establish treatment goals with all patients, including realistic goals for pain and function, and should consider how opioid therapy will be discontinued if benefits do not outweigh risks. Clinicians 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, clinicians should discuss with patients known risks and realistic benefits of opioid therapy and patient and clinician responsibilities for managing therapy.

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

4. When starting opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extended-release/long acting (ER/LA) opioids.
5. When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when considering increasing dosage to ≥ 50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ≥ 90 MME/day or carefully justify a decision to titrate dosage to ≥ 90 MME/day.
6. Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, clinicians 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 days or less will often be sufficient; more than seven days will rarely be needed.
7. Clinicians should evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy for chronic pain or of dose escalation. Clinicians 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, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids.

Assessing Risk and Addressing Harms of Opioid Use

8. Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms. Clinicians 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, higher opioid dosages (≥ 50 MME/day), or concurrent benzodiazepine use, are present.
9. Clinicians 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 opioid dosages or dangerous combinations that put him or her at high risk for overdose. Clinicians 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.
10. When prescribing opioids for chronic pain, clinicians 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.
11. Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible.
12. Clinicians 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.

Id. at 16.

As we noted previously, the guidelines are reasonable and the recommendations are commonsensical, constitute good medical practice, and apply to the prescribing of any medication, not just opioids or controlled substances. Primary clinicians in the field should familiarize themselves with the guidelines and detailed explanation for each. The guidelines will further the public discussion on appropriate pain treatment. The guidelines will have a significant impact on practitioners and patients so it was appropriate that in addition to seeking input from a “Core Expert Group” that the CDC provided stakeholders and the public with an opportunity to comment on the guidelines. The CDC received more than 4,350 comments from patients, clinicians, families who lost loved ones to overdose, medical associations, professional organizations, academic institutions, state and local governments and industry. Id. at 7. We wonder about the extent of the CDC’s review and incorporation of the public comments into the final guidelines because they are so similar to the draft guidelines.

There has been increased enforcement against physicians for failing to adhere to their primary responsibility to ensure that prescriptions must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. See, e.g., Henri Wetselaar, M.D.; Decision and Order, 77 Fed. Reg. 57,126 (Sept. 17, 2012). And there has been action against pharmacies that have failed in their corresponding responsibility to ensure that the prescriptions they dispense are 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 help clarify these standards for physicians, pharmacies and regulators. However, there may be occasions when legitimate medical treatment conflicts with strict adherence to the guidelines. For example there may be instances when opioid therapy is required for more than seven days or a patient requires more than 50 or 90 morphine milligram equivalents per day. The CDC recognizes that the recommendations in the guidelines are “voluntary, rather than prescriptive standards” and cautions clinicians to “consider the circumstances and unique needs of each patient when providing care.” Id. at 2. But we again question whether the Drug Enforcement Administration will take enforcement action against practitioners who it believes prescribed opioids for other than legitimate medical purpose if they did not follow the CDC guidelines?

The CDC plans to follow-up by disseminating materials based on the guidelines to health systems, medical professional societies, insurers, public health departments, health information technology developers and clinicians. Id. at 33. In addition, the CDC plans to support clinician education on pain management options, opioid therapy and risk mitigation strategies. Id. at 34.

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