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12 Articles in Volume 17, Issue #1
A Brief History of the FDA’s Role in the Ongoing Effort to Ensure Safe Opioid Use
Distinguishing Neuropathic, Non-Neuropathic, and Mixed Pain
How Can Healthcare Providers Better Advocate for Patients With CRPS?
Ketamine for the Treatment of CRPS?
Letters to the Editor: Opioid Calculator; Metformin
Living With CDC Opioid Guidelines
Neurohormones in Pain and Headache Management: New and Emerging Concepts
Optimizing Neuropathic Pain Relief With Scrambler Therapy
Pain Management and the Elderly
Spinal Cord Stimulation: What Clinicians Need to Know
The Association Between Depressive Disorder and Chronic Pain
Updates in Management of Complex Regional Pain Syndrome

Living With CDC Opioid Guidelines

Editor's Memo January/February 2017

Not quite a year has passed since the Centers for Disease Control and Prevention (CDC) published its guidelines for opioid prescribing.1 Although the guidelines may have been drafted and published with the sincere intent of reducing opioid overdoses, the consequences of the guidelines have been profound.

Among its recommendations, the CDC noted that “clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when increasing dosage to 50 morphine milligrams equivalents [MME] or more per day, and should avoid increasing dosage to 90 MME or more per day.” The maximum of 90 MME is a guideline, not law or even a regulation. Thus, the guidelines don’t restrict opioid dosages above 90 MME. They also do not cover use of opioids in the palliative, end-of-life, and cancer settings. It is, therefore, fitting that my Editor’s Memo to start 2017 concerns the consequences of CDC opioid guidelines.

Growing Distrust

The first consequence of the guidelines is a growing distrust that pain patients and their advocates feel toward the CDC and other governmental agencies. Although a year has passed since the CDC held public hearings on the guidelines, claims of fraud, deceit, and hidden agendas are a continued focus of investigations. Most recently, a report published in JAMA Internal Medicine suggested that some of the opposition to the CDC guidelines expressed by professional groups may have been influenced by existing financial interests with opioid manufacturers and other stakeholders.2

Pain News Network, a patient advocacy website, surveyed more than 2,200 chronic pain patients before the release of the CDC guidelines.3 Many of the respondents predicted there would be unintended consequences if the guidelines were adopted: 

  • 90% thought more people would suffer from than be helped by the guidelines
  • 78% thought there would be more suicides 
  • 76% thought doctors would prescribe opioids less often or not at all
  • 60% thought pain patients would get opioids through other sources or off the street 
  • 70% thought use of heroin and other illegal drugs would increase

There is hardly a patient I see who fails to express similar concerns. Whether these perceptions have any merit seems less important than the reality that setting limits on opioids have created a wall of mistrust and a perception that some government officials care more about the addict than a suffering pain patient.

Dissemination of Nonscientific Information

Another consequence is that a small group of medical practitioners who bill themselves as “pain experts” have attempted to capitalize on the new guidelines. Some of the unscientific claims I’ve recently heard include:

  • No pain patient ever needs over 90 MME 
  • Anyone taking over 90 MME has hyperalgesia
  • Severe risks and complications are inevitable with dosages over 90 MME
  • There are no “long-term” benefits of doses over 90 MME

In addition, some 3rd-party payors are misinformed about opioid dosing and side effects. I recently received a telephone call from a 3rd-party payor who admonished me to give patients naloxone, since “every” patient prescribed over 90 MME “will eventually overdose.”

My fundamental answer to all these nonscientific, often hysterical beliefs is to recommend a visit to any pain practice in the country to seek out a couple of patients who have been on a fentanyl patch for a few years. Any patch above 25 mcg/h exceeds 90 MME. Don’t be shocked when you find out that patients using dosages of greater than 25 mcg/h are functioning well, with no known complications or hyperalgesia. Why should they throw away their patches just to meet a 90 MME recommendation?

Loss of Coverage

The next consequence is that insurance companies (including workers’ compensation carriers) and some state legislatures and medical boards now consider the 90 MME level a ceiling or maximal opioid dose. This has led to denial of claims for prescriptions over 90 MME. Pain News Network conducted a follow-up survey of 1,978 chronic pain patients and found that 68% said their opioid medication had been decreased or stopped since the CDC adopted its prescribing guidelines.4 In addition, 45% of respondents were warned by their doctor that additional decreases would be necessary. Most striking, just over 50% said they had considered suicide as a way to end their pain.4 Additional survey findings included: 

  • 75% of patients said they are not receiving adequate pain control
  • 57% said they had been discharged or abandoned by a doctor because they need opioid treatment
  • 44% said they had problems getting a prescription filled at a pharmacy 
  • 90% said their pain levels, activities, and social interactions have worsened
  • 97% said they have never been addicted to drugs or required treatment for drug abuse

Moreover, many doctors fear scrutiny by their medical boards (ie, medical license restriction or revocation) and the Drug Enforcement Agency if they prescribe above this level. Some physicians have informed me that they can’t get malpractice insurance or local hospital privileges if they prescribe above 90 MME. Given these developments it’s no wonder that physicians in primary care, as well as specialty sectors, are now simply refusing to prescribe opioids at all, and certainly not above 90 MME.

Forced Tapering

Another unfortunate consequence is growing, unconfirmed anecdotal reports on patient-oriented Internet sites of suicide or cardiovascular collapse among chronic pain patients who have had their opioids abruptly reduced because their physician refused to prescribe or an insurance company refused to pay for opioids above 90 MME. Many longtime chronic pain patients are resistant to attempts to lower their opioid dosage to 90 MME. Many of these patients were started many years ago on dosages considerably over 90 MME. They have not only functioned well but often found a good quality of life despite severe injury or disease, and they consider their opioids to not only be a right but their very lifeblood. New chronic pain patients usually are far less problematic since there are now many opioid alternatives that help keep the opioid dosages below 90 MME.

A great clinical disappointment is that there is no reliable, safe, consistent way to reduce a high opioid dosage down to 90 MME in every long-term chronic pain patient. Simple tapering may only work to a point before pain and withdrawal symptoms emerge. Withdrawal agents, such as clonidine, and opioid substitutes, such as ketamine, may or may not be helpful. The same applies to naloxone wash-out procedures. In-patient, controlled tapering is desirable but very expensive and not available in most locales or covered by insurance.

Recommendations

The CDC has had very little to say about the impact of these guidelines since their release. As Pain News Network has reported, a top CDC official wrote a letter to 1 patient saying the guidelines were only meant as a “guide” for primary care providers “as they work in consultation with their patients.”4 According to Debra Houry, MD, MPH, director of the CDC’s National Center for Injury Prevention, which oversaw the guidelines’ development, “The Guideline includes a recommendation to taper or reduce dosage only when patient harm outweighs patient benefits of opioid therapy. The Guideline is not a rule, regulation, or law. It is not intended to deny access to opioid pain medication as an option for pain management. It is not intended to take away physician discretion and decision-making.”5

At this time, it seems prudent to recommend that patients who are taking over 90 MME could consider a controlled taper if they feel that their function is not improving or the risks outweigh the benefits of their opioid medication. A dosage reduction of 5% to 10% a month is usually safe and tolerated.6

At the same time opioids are reduced, patients should be started on ancillary, nonopioid agents to aid in pain control and withdrawal suppression. However, don’t be surprised if your patients are resistant; many patients have tried adjuvant therapies—nonsteroidal anti-inflammatory drugs, gabapentin, and antidepressants—prior to being started on an opioid. In addition, many of the nonpharmaceutical options recommended by the CDC are not always readily available to every patient—including physical therapy, cognitive behavioral therapy, and exercise programs. If an intrathecal pump is indicated (ie, for patients on ultra-high opioid doses) and a patient can get insurance to cover it, he or she should seriously consider it.  

My 2 departing messages to all parties are these:

  • There are some patients with severe, chronic, intractable pain who require doses greater than 90 MME, and society should accommodate them or they will suffer pathologic and functional consequences; and
  • Physicians can only prescribe what government agencies allow (or face legal or financial consequences). For example, several states require (Indiana) or recommend (California, Ohio, South Carolina) that patients who are being prescribed more than 60 or 80 MME/day need to consult with a pain specialist, but these specialists often are unavailable. Patients who require more than low doses need to exercise their rights and advocate for their needs.

 

Last updated on: February 14, 2017
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1 comment.

By lynne.levitan on 02/18/2017
Thank you, Dr. Tennant, for the sensible, balanced comment on the madness being perpetrated across the US. Why can't the CDC see the tremendous harm being done by their so-called "guidelines" that are being adopted as hard and fast rules by state medical boards, insurance companies and the CMS? If they truly believe these are soft "guidelines" not intended to interfere with pain patients' appropriate and helpful therapy, then they need to do something: either retract the guidelines and reissue them with language that emphasizes that they are in no way to be construed as rules, or perhaps add a "black box warning" (!) that applying these rules indiscriminately may cause serious patient harm, including suicide.
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