Journey to a Guideline: The Process and Overview of the Long-Awaited CDC Guideline on Opioid Prescribing for Primary Care

by Phil Walls, RPh, Chief Clinical Officer
Steven Stanos, DO

Will the New CDC Guideline Have an Impact on Opioid Prescribing?

Last week, myMatrixx released a blog providing a summary of key concepts gleaned from the CDC Guideline for Prescribing Opioids for Chronic Pain.  Since then, we have received numerous questions from clients and industry insiders regarding whether or not this latest set of guidelines will have an impact on opioid prescribing.  The answer is a qualified yes.  These guidelines will undoubtedly improve patient care and are finally getting the media attention that this subject has deserved for many years.  However, the full impact of this effort alone will be almost impossible to measure as this is just one more, albeit significant, in a long line of efforts aimed at this national epidemic.

In addition to clinical pharmacy management efforts in place today, prescription drug monitoring programs (PDMPs) have reduced controlled substance prescribing significantly in states that have mandated its use.  Limitations on physician dispensing of controlled substances have also decreased opioid dispensing by physicians without a coincident increase in dispensing by pharmacies.  The FDA’s Risk Evaluation and Mitigation Strategy has had an impact on drug abuse and the FDA continues to play an active role with the recent announcement that immediate-release opioids will now be required to carry a black box warning similar to those required for long-acting opioids.  Black box warnings are reserved for those drugs that may cause serious side effects, particularly death–and we would be remiss if we did not recognize the efforts of Operation Unite and their annual National Prescription Drug Abuse and Heroin Summit.  The list of efforts is almost endless, including the Official Disability Guidelines, American College of Occupational and Environmental Medicine and many state guidelines.

This brings us to the long-awaited CDC Guideline for Prescribing Opioids for Chronic Pain, which was released by the federal government March 15, 2015.  The controversial guideline was developed by a multi-professional group under the Centers for Disease Control and Prevention.  This is in response to rising opioid use for chronic pain and the ongoing struggle nationwide with prescription narcotic misuse, abuse and addiction (i.e. opioids, benzodiazepines) and the epidemic of heroin use and related deaths.  The document cites that in 2012 alone, health care providers wrote 259 million prescriptions for opioids. The guideline is 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 their use. The focus from a clinical decision-making standpoint should include a greater understanding of the patient’s clinical situation and level of function.

Development & Process

Much of the guideline is based on the Interagency Guideline on Prescribing Opioids for pain developed by the Washington State Agency Medical Directors in collaboration with providers, public stakeholders and state officials, the 3rd edition, published in June of 2015. The meta-analysis was based on the previously published Agency of Healthcare Research and Quality (AHRQ) systematic review of 2014 and subsequent re-evaluation and update of the evidence review.  The CDC gathered input from the Core Expert Group (CEG) to review the evidence and provide perspective and included various providers including primary care providers, subject matter experts, and representatives from professional societies and state agencies. A face-to-face meeting of the CEG took place in June of 2015, followed by a stakeholder comment period and review by the Stakeholder Review Group (SRG). Feedback from patients and clinicians took place as part of multiple webinars in September of 2015.

The draft document was released by a notice in the Federal Register (80 FR 77351) for public comment which closed on January 13, 2016. Four thousand three hundred and fifty comments were received from patients, family members, and clinicians.  In late December, the National Center for Injury Prevention and Control (NCIPC) Board of Scientific Counselors (BSC) and advisory committee taxed with reviewing policies were advised by CDC and recommended formation of an Opioid Guideline Workgroup (OGW) to provide additional input. The OGW focused on reviewing the quality of the evidence and the specific recommendations. The BSC convened a final meeting on January 28, 2016 to deliberate recommendations from the OGW report, a unanimous vote by the committee.

The guideline is intended for primary care clinicians who prescribe opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care. The document’s focus excludes those patients requiring opioid analgesics for acute pain.

12 Specific Recommendations Address 3 Broad Clinical Areas

Determine When to Initiate

1. Opioids are not first-line or routine therapy for chronic pain
2. Establish and measure goals for pain and function
3. Discuss benefits and risks and availability of non-opioid therapies with patients

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

4. Use immediate-release opioids when starting
5. Start low and go slow; when opioids are needed for acute pain, prescribe no more than needed
6. Do not prescribe ER/LA opioids for acute pain
7. Follow-up and re-evaluate risk of harm; reduce dose or taper and discontinue if needed

• Assessing Risk and Addressing Harms of Opioid Use

8. Evaluate risk factors for opioid-related harms
9. Check PDMP for high dosages and prescriptions from other providers
10. Use urine drug testing to identify prescribed substances and undisclosed use
11. Avoid concurrent benzodiazepine and opioid prescribing
12. Arrange treatment for opioid use disorder if needed

Read the full CDC guideline here.

What Is New or Controversial?

Most of the recommendations are in line with previous recommendations around assessment and monitoring, including the use of risk assessment tools for predicting misuse and abuse, use of urine toxicology testing and state PDMPs.  Some relatively controversial recommendations or those that may have differed from other guidelines are recommendations #5 and #6.

Recommendation #5 includes guidance on dosing and states that clinicians should “use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when considering increase 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.” Some stakeholders felt there is conflicting evidence regarding higher dose and adverse events and evidence to support a “tipping point” or threshold where risks increase.

Setting dose limits could lead to a false sense of security by providers since adverse events can occur at lower doses, especially in opioid naive or medically complex patients.

This dosing guidance is far more strict than similar guidelines such as Washington State which recommends referral to a pain specialist for those patients requiring higher than 120 MME/day. Other professional society groups, pain experts, and advocacy groups are concerned this recommendation could be misconstrued by payers and insurers as “dose limits” and potentially stigmatize patients requiring higher doses.

Recommendation #6 relates to “exercising caution” when initiating opioid management for acute pain conditions because in many cases, this may lead to chronic use. Besides recommending “prescribing the lowest effective dose of immediate release opioids for acute pain, providers should prescribe for 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.”  Some have argued that a 3 to 7-day range for “acute” pain condition is arbitrary and not based on scientific evidence.

A 3-day limit has been part of recent emergency medicine guidelines and protocols as a means to reduce ER doctor shopping and to bridge patients until further evaluation by non-ER clinicians, such as a patient’s primary care provider.

What Does This Mean For You?

1. Utilize the myMatrixx threshold report to identify when patients exceed the recommended guideline for MME (also referred to as MED or morphine equivalent dose)

2. Consult a clinical pharmacist at myMatrixx to determine if there may be factors contributing to the prescriber’s decision, i.e. evaluate risks vs. benefits

3. Review the myRisk Predictor with your myMatrixx pharmacist to identify at-risk patients as soon as possible and take action!