CDC Opioid Prescribing Guidelines; Excluding Stakeholders is Wrong Path

By Larry K. Houck –

The Centers for Disease Control and Prevention (“CDC”), the nation’s premier agency focusing on public health and safety through disease prevention and control, and a component within the U.S. Department of Health and Human Services, is developing guidelines “to provide recommendations for the prescribing of opioid pain medication for patients 18 and older in primary care settings” that focus on treating chronic pain outside end-of-life care.  Draft CDC Guideline for Prescribing Opioids for Chronic Pain.  The CDC observes on its website that existing opioid guidelines vary and that primary care providers do not receive sufficient opioid prescribing training.  Id.  The CDC further notes that its guidelines will address determining initiation or continuing opioid therapy; opioid selection, dosage, duration, follow-up and continuation; and assessing associated risk and harm.  Id.

The CDC provided limited public access to the draft guidelines during a webinar on September 16th but is providing no further access or participation in their development.  The independent online chronic pain and pain management news source Pain News Network, reported that CDC anticipates finalizing the guidelines next month, and submitting them to the Department of Health and Human Services for publication in January 2016.  Pat Anson, CDC: Opioids Not ‘Preferred’ Treatment for Chronic Pain, Pain New Network, (Sept. 16, 2015).  It is unclear what form the publication of the guidelines will take.

The CDC is not making the guidelines available, but the Pain News Network lists the dozen guidelines provided during the webinar as follows:

1. Non-pharmacological therapy and non-opioid 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.
2. Before starting long term opioid therapy, providers should establish treatment goals with all patients, including realistic goals for pain and function.  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 risks and realistic benefits of opioid therapy and patient and provider responsibilities for managing therapy.
4. When starting opioid therapy, providers should prescribe short-acting opioids instead of extended-release/long acting opioids.
5. When opioids are started, providers should prescribe the lowest possible effective dosage.  Providers should implement additional precautions when increasing dosage to 50 or greater milligrams per day in morphine equivalents and should avoid increasing dosages to 90 or greater milligrams per day in morphine equivalents.
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 short-acting opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids.  Three or fewer days will usually be sufficient for non-traumatic pain not related to major surgery.
7. Providers should evaluate patients within 1 to 4 weeks of starting long-term opioid therapy or of dose escalation to assess benefits and harms of continued opioid therapy.  Providers should evaluate patients receiving long-term opioid therapy every 3 months or more frequently for benefits and harms of continued opioid therapy.  If benefits do not outweigh harms of continued opioid therapy, providers should work with patients to reduce opioid dosage and to discontinue opioids when possible.
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-related harms are present.
9. Providers should review the patient’s history of controlled substance prescriptions using state Prescription Drug Monitoring Program data to determine whether the patient is receiving excessive opioid dosages or dangerous combinations that put him/her at high risk for overdose.  Providers should review Prescription Monitoring Program data when starting opioid therapy and periodically during long-term opioid therapy (ranging from every prescription to every 3 months).
10. Providers should use urine drug testing before starting opioids for chronic pain and consider urine drug testing at least annually for all patients on long-term opioid therapy to assess for prescribed medications as well as other controlled substances and illicit drugs.
11. Providers should avoid prescribing of opioid pain medication and benzodiazepines concurrently whenever possible.
12. Providers should offer or arrange evidence-based treatment (usually opioid agonist treatment in combination with behavioral therapies) for patients with opioid use disorder.  Id.

The guidelines provided during the webinar are reasonable and public health benefits could result from clarifying opioid prescribing.  However, we question CDC’s process for developing the guidelines.  The Pain News Network noted that the Food and Drug Administration (“FDA”), not CDC, normally sets prescription drug guidelines, and that an FDA official responsible for opioid issues was unaware that CDC was drafting the opioid prescribing guidelines.  Id.  Knowledgeable and responsible FDA officials are not providing meaningful input to the guidelines. 

Secondly, the guidelines have ramifications for activities in which many stakeholders hold strong interests-healthcare professionals including prescribers and pharmacists, regulators and especially patients.  How will the American Medical Association and state medical boards react to the final guidelines?  Will the Drug Enforcement Administration take enforcement action against practitioners who it believes issued opioid prescriptions for other than legitimate medical purpose because they did not following the guidelines?  Or, in the alternative, will following the guidelines strengthen a practitioner’s defense that the opioid prescriptions they issued were legitimate?

CDC should not draft the guidelines in isolation until finalized, but instead make them available for public comment prior to their becoming final.  We agree with Edith Rosato, CEO of the Academy of Managed Care Pharmacy, who in a letter to CDC Director Tom Frieden, “strongly urges the CDC to formally release the draft guidelines and provide for a sufficient public comment period to ensure the perspective of all parties, including those of managed care pharmacy, are taken into consideration.”  Letter from Edith A. Rosato, RPh, Academy of Managed Care Pharmacy, to Tom Frieden, CDC, (Sept. 18, 2015).