The world has until 11:59 pm EST today (January 13, 2016) to comment on the proposed United States Centers for Disease Control Guideline and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain. I got my two cents in just under the wire…

Here are the twelve draft “Recommendations” from the CDC website along with my suggestions in italics.

 CDC RECOMMENDATIONS

Section (1) Determining When to Initiate or Continue Opioids for Chronic Pain

 

1. 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.

The phrase “pain and function” should be “pain or function.” Sometimes pain relief is reason enough to prescribe opioids. And “risks to the patient” should be “harm to the patient.” (The word “benefit” is very often coupled with “risk” when it more correctly should be coupled with “harm.”)

 

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.

The last phrase should be “…only if there is meaningful improvement in pain or function that outweighs harm to the patient.” The word “clinically” is ambiguous and unnecessary.

 

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.

The word “known” is unnecessary and ambiguous (i.e. Known by whom?)

 

Section (2) Opioid Selection, Dosage, Duration, Follow-Up, and Discontinuation

 

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

The phrase “providers should prescribe” should be “providers should strongly consider prescribing…” (When starting opioid therapy there can be clinical scenarios where prescribing a ER/LA opioid would be the best course of action.)

 

5. 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.

The use of the arbitrary thresholds (50 mgms and 90 mgms) is acceptable here because the flexible helping verb “should” is used instead of the inflexible verb “shall.” This allows the provider some flexibility for clinical judgment.

 

6. 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.

This is reasonable as written.

 

7. Providers should evaluate benefits and harms with patients within 1–4 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.

Change the first two sentences to: “Soon after starting or escalating opioid therapy, providers should evaluate patients in order to gauge any benefits or harms associated with the treatment plan. This initial reevaluation is usually within the first four weeks. Providers generally should evaluate benefits and harms of continued opioid therapy every 3 months – and more frequently or less frequently depending upon the clinical course.”

 

Section (3) Assessing Risk and Addressing Harms of Opioid Use

 

8. 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 dosage (≥50 MME) are present.

The second sentence should read: “Providers should incorporate into the management plan strategies to mitigate risk. One such risk mitigation strategy worth of consideration is offering naloxone when…”

 

9. 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.

Change to: “Providers should review the patient’s history of controlled substance prescriptions by way of prescription drug monitoring program (PDMP) data, such as those offered by most states. This data can allow insight into aberrant and risky behaviors, such as when a 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 or longer – depending upon clinical and regulatory circumstances.”

 

10. 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.

Change to: “When prescribing opioids for chronic pain, providers should consider appropriate biologic tissue drug testing before starting opioid therapy. Additional drug testing should occur randomly and when clinically indicated.”

 

11. Providers should avoid prescribing opioid pain medication for patients receiving benzodiazepines whenever possible.

Change to: “Providers should exercise caution when prescribing opioid pain medication for patients receiving benzodiazepines.”

 

12. 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.

Change to: “Providers should offer or arrange evidence-based treatment (such as medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder.”

 

Overall, I am impressed with the amount of detail and collaborative effort that went into creating this impressive document. There are no easy answers and no universally accepted dictums – all the more reason to allow flexibility for clinical judgment. I hope we can continue to seek truth with open minds and open hearts. That’s my real recommendation, my two cents worth. 
The CDC draft is available at:
http://www.cdc.gov/drugoverdose/prescribing/guideline.html

My comments were posted to the CDC website and can be viewed at:
http://www.regulations.gov/#!documentDetail;D=CDC-2015-0112-4296

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