CDC Issues Opioid Prescribing Guideline for Chronic Pain

On March 18, 2016, the Centers for Disease Control and Prevention (“CDC”) issued a Guideline for Prescribing Opioids for Chronic Pain (i.e., pain lasting longer than three months or past the time of normal tissue healing) geared toward primary care physicians (“CDC Recommendations”). The CDC Recommendations do not apply to prescribing practices for active cancer, palliative and end-of-life care or to children or adolescents under age 18. They address the use of opioid pain medication in the general population as well as in certain special populations such as pregnant women and seniors and in populations with conditions posing special risks such as those with a history of substance use disorder or prior nonfatal overdose.  The CDC Guidelines are voluntary but may come to represent best practices for the responsible management of chronic pain.

The epidemic of addiction and drug abuse tied to opioids, including prescription opioids such as morphine, oxycodone and hydrocodone, drove the development of the CDC Recommendations. Related, the CDC responded to primary care physicians’ concerns regarding opioid pain medication misuse, insufficient training in good opioid prescribing practices and inconsistency in the prescribing practices recommended by professional organizations and state and federal agencies. In publishing its Recommendations, the CDC sought to improve the way opioids are prescribed through clinical practice guidelines that ensure safe, effective chronic pain treatment while reducing the number of people who misuse, abuse or overdose from the use of these powerful drugs. To formulate its guidelines, the CDC conducted a clinical systematic review of the scientific evidence to identify the effectiveness, benefits and harms of long-term opioid therapy for chronic pain. The three central themes of the CDC Recommendations are:

1. Don’t Routinely Use Opioids for Every Patient. Physicians should use non-pharmacologic therapies (e.g., exercise, cognitive behavioral therapy) and non-opioid drugs (e.g., anti-inflammatory agents) for chronic pain. When opioids are necessary, they should be augmented with non-pharmacologic or non-opioid drugs, as appropriate, to achieve the greatest benefit.
2. Start Low and Go Slow. Physicians should prescribe the lowest possible effective dose and start with immediate release instead of extended-release/long-acting opioids. They should also only provide the quantity needed for the expected duration of pain.
3. Follow Up and Provide Ongoing Monitoring of the Efficacy of Treatment. Physicians should regularly monitor their chronic pain patients to ensure opioid therapy is decreasing pain and improving function without causing harm. Where the benefits of therapy do not outweigh the harms, other therapies should be optimized and the physician should taper or discontinue opioid therapy.

The CDC Recommendations can be found here.

Detailed Recommendations

The CDC divided its 12 Recommendations into three main categories for consideration.  The Recommendations are excerpted below (bold emphasis added).

1. 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 the expected benefits for both pain and function are anticipated to outweigh the 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 consider how therapy will be discontinued if the benefits do not outweigh the 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.
2. Opioid Selection, Dosage, Duration, Follow-Up and Discontinuation
   1. When starting opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extended-release/long-acting opioids.
   2. 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 increasing dosage to greater than or equal to 50 morphine milligram equivalents (“MME”)/day and should avoid increasing dosage to greater than or equal to 90 MME/day or carefully justify a decision to titrate dosage to greater than or equal to 90 MME/day.
   3. 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.
   4. Clinicians should evaluate the benefits and harms with patients within one to four weeks of starting opioid therapy for chronic pain or of dose escalation. Clinicians should evaluate the benefits and harms of continued therapy with patients every three months or more frequently. If the benefits do not outweigh the 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.
3. Assessing Risk and Addressing the Harms of Opioid Use
   1. 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 (greater than or equal to 50 MME/day) or concurrent benzodiazepine use, are present.
   2. 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 three months.
   3. 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.*
   4. Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible.
   5. 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.

*All 12 Recommendations apply to all patients outside of active cancer treatment, palliative care and end-of-life care except Recommendation 10 where individual decision making is required.

Practical Takeaways

Although many states have implemented prescription drug monitoring programs designed to eliminate “pill mills” and to alert prescribers and pharmacists regarding a patient’s controlled substance prescription history, these efforts have not been enough to stem the tide of opioid abuse, addiction and overdose in the U.S. Given what the CDC calls an “epidemic” of drug overdose deaths in the United States¹, it is timely and crucial that the CDC has issued its opioid prescribing guidelines for chronic pain. The CDC Recommendations offer practical and concrete guidance to primary care physicians who must decide how to treat patients with chronic pain in a safe, effective manner. Here are a few practical takeaways:

• The CDC Recommendations are voluntary. As CDC Director, Dr. Tom Frieden has said, the “CDC does not regulate the practice of medicine,” therefore it would not have the authority to make the Recommendations mandatory. They may over time, however, be determined by professional societies, hospitals, health systems, primary care clinics and primary care physicians to be “best practices” for the management of chronic pain patients facilitating broad adoption of the Recommendations.
• The CDC Recommendations do not apply to pain management for active cancer, palliative and end-of-life care.
• Primary care physicians, hospital outpatient departments, community health centers, FQHCs and other outpatient provider settings should review relevant policies, practices and protocols addressing the treatment of chronic pain patients and consider modifying these to conform with the CDC Recommendations.

• Facilities that employ/engage primary care physicians should ensure that physicians become familiar with the new Recommendations.  The CDC offers additional educational resources including a checklist for prescribing opioids for chronic pain patients and a website with additional tools to guide clinicians to implement the Recommendations. Finally, for those interested, a transcript for the CDC’s telebriefing on its Guidelines can be found here.

If you have any questions, would like additional information about this topic, please contact:

• Adele Merenstein at amerenst@wp.hallrender.com or (317) 752-4427;
• Charise Frazier  at cfrazier@wp.hallrender.com or (317) 977-1406; or
• Your regular Hall Render attorney.

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¹ According to the CDC, more people died from drug overdoses in 2014 than in any year on record.  The majority of these deaths (greater than six out of ten) involved an opioid.  Since 1999, the rate of overdose deaths involving both prescription opioid pain relievers and heroin almost quadrupled, and the amount of prescription opioids sold in the U.S. nearly quadrupled as well. http://www.cdc.gov/drugoverdose/epidemic/