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14 Articles in Volume 18, Issue #2
Ask the Expert: Is there evidence to prescribe cyclobenzaprine long-term?
Challenging the Chronic Pain Personality Profile
Designer Peptide May Prevent Chemo-Induced Neuropathy
Inside the Cancer Pain Research Consortium
Intrathecal Drug Therapy for Cancer-Related Pain
Managing Cancer Pain in an Era of Modern Oncology
Mapping Complex Pain: A Case Study
Medication Overuse Headache: Inaccurate and Overdiagnosed
Pain and Fall Risk in the Elderly
Reporting Quality of Care in Cancer Pain Management
Sharing the Risk: An Update to DEA & Doctors Working Together
The Intensifying Conflict Between Opioid Control and Pain Control
Two Mobile Apps Aim to Target Patient Compliance & Safety
Why Prescribers Need to Adopt Abuse-Deterrent Opioids

The Intensifying Conflict Between Opioid Control and Pain Control

Two years after their release, the CDC’s opioid prescribing guidelines continue to plague pain management practices.

John, a former cable company salesman, successfully used OxyContin for years to treat the severe back pain caused by injuries he sustained during a mugging in 2011. Before he found a medication that worked for him, he recalled, “My wife was about to leave me, because I was a miserable bastard. When you’re in that much pain, you want to just go to sleep and not wake up.”

Last fall, John said, a physician’s assistant told him his dose, 60 mg, three times per day, was too high and would have to be dramatically reduced under a new rule setting a limit of 90 morphine milligram equivalents (MME) per day. “My whole life turned upside down in a matter of 30 days,” he said. “I’m back in bed now. I can’t really get up very much, and I’m right back where I started in 2011.”

Although John was told that exceeding 90 MME a day was “no longer legal,” pain practitioners largely recognize that the MME ceiling is officially just a suggestion based on the opioid prescribing guidelines published by the US Centers for Disease Control and Prevention (CDC) in 2016.1 Some clinicians, however, have interpreted the recommendation as a hard-and-fast rule, leaving patients like John to suffer needlessly from pain that had previously been under control.

More generally, many medical experts say the CDC guidelines play up the hazards of opioids while playing down their benefits. The overall message is that clinicians should be stingy with these medications, prescribing them only as a last resort and maintaining the lowest possible doses. Despite the CDC’s protestations to the contrary, the mission of preventing abuse and diversion seems to be interfering with the average pain practitioner’s duty to provide appropriate care, leading in extreme cases to suicides by patients who are unable to get the pain relief they need.

Unintended Consequences

After the CDC guidelines were published, Dan Carr, MD, then the president of the American Academy of Pain Medicine (AAPM), worried about unintended consequences. “The CDC guideline makes disproportionately strong recommendations based upon a narrowly selected portion of the available clinical evidence,” he said in an AAPM statement at the time.2 “It is incumbent upon us all to monitor the deployment of the guideline to ensure that it does not inadvertently encourage under-treatment, marginalization, and stigmatization of the many patients with chronic pain that are using opioids appropriately.”

Two years later, Carr’s warning is proving prescient. “There are many pain clinics flooded with patients who have been treated previously by their primary care physician,” said AAPM President-Elect Jianguo Cheng, MD. These refugees include patients who “have been functional” and “responding well” to opioids for “many years,” he said.

Sidney Schnoll, MD, PhD, an addiction and pain treatment specialist who is vice president of pharmaceutical risk management services at the consulting firm Pinney Associates, has witnessed similar problems. “I get calls from patients whom I treated years ago, who were on stable doses of medication, doing very well, who have chronic pain conditions, and they can’t get medication to treat their pain,” he said. “They’re being taken off medication on which they had done very well for years.”

The CDC guidelines in themselves are not legally binding. Congress, however, has imposed the recommendations on the Department of Veterans Affairs (VA), and at least 18 states have enacted elements of them. In 2016 and 2017, according to a tally by the National Conference of State Legislatures,3 14 states imposed limits on the duration of initial prescriptions for acute pain, ranging from three days (Kentucky) to two weeks (Nevada), with seven days the most common. Arizona enacted a five-day limit in January. Four states (Arizona, Maine, Nevada, and Rhode Island) have imposed daily dose ceilings, while Maryland has limited opioid prescriptions to “the lowest effective dose” and a quantity “not greater than needed for the expected duration of pain.”3

In seven other states, the legislature authorized or directed another body to impose limits on opioid prescriptions. In addition to these statutory changes, the guidelines are shaping the policies and practices of regulators, insurers, and law enforcement agencies, leading to an industry-wide perception that departing from them is bad medical practice.

Stefan Kertesz, MD, MSc, an internist and professor of preventive medicine at the University of Alabama at Birmingham who specializes in pain and addiction, said physicians are facing “pressure from many directions.” He said the burdens include “scrutiny from state officials,” “barriers from insurance and pharmacy benefit plans,” “more restrictive guidelines from state licensing boards,” “stories of some physicians losing their livelihoods and being shut down,” and “super-intense rhetoric from thought leaders and journalists,” who tend to blame physicians for causing the “opioid epidemic” through careless prescribing. “Under that kind of pressure,” said Dr. Kertesz, “who wouldn’t change what they’re doing, even if it hurts a few patients?”

Too Much Left to Interpretation

The CDC has implied there is something special about the 90 MME cap, as well as 50 MME per day, the level at which the agency urges extra caution. But the authors of a 2015 study4 of opioid-related deaths in North Carolina reported that “dose-dependent opioid overdose risk among patients increased gradually and did not show evidence of a distinct risk threshold.” Critics have called the CDC’s cutoffs arbitrary, since patients vary widely in the way they metabolize and respond to opioids, especially if they have developed a tolerance after years of effective opioid management.

“There seems to be no clear clinical evidence that opioid risks increase with 50 MME per day or that doses should never exceed 90 MME per day in any patient,” according to Pergolizzi et al.5 “It seems unnecessary and counterproductive to decrease a patient’s dose of opioids just to achieve an arbitrary limit.”

CDC officials have said they do not want doctors to impose dose reductions on patients. “We do hear stories about people being involuntarily taken off opioids,” Deborah Dowell, MD, MPH, a co-author of the guidelines and senior medical advisor/chief medical officer at the CDC’s Division of Unintentional Injury Prevention, said at a prescription drug abuse summit in 2017.6 “We specifically advise against that in the guidelines.”

That language is hard to find in the guidelines,1 but the recommendations do describe tapering as a consensual process, saying “clinicians should work with patients to reduce opioid dosage or to discontinue opioids when possible” if they determine that the risks of the medication outweigh the benefits. The CDC notes that “tapering opioids can be especially challenging after years on high dosages” but says “these patients should be offered the opportunity to re-evaluate their continued use of opioids at high dosages.”1

In many cases, that “opportunity” has become a unilateral decision. “Even though it is not specified in the CDC guidelines to do this,” said Dr. Kertesz, “I am seeing many physicians in my region and across the country taper patients against their will. They’re tapering stable patients who were not violating the rules of the practice, who were basically functional. Physicians are tapering them without consent, often in a draconian fashion, and in many cases simply discharging the patient from the practice, and just ending the clinical relationship.”

Lynn Webster, MD, former AAPM president and current vice president of scientific affairs for PRA Health Sciences, said it was predictable that doctors would view the CDC’s recommendations as mandatory because of the agency’s stature in the medical community. “If something comes from the CDC as a guideline, it is more than a guideline,” he said. “The CDC bears full responsibility for how these arbitrary dose levels are being implemented throughout the country and the consequences for the people in pain.”

The Harsh Reality

Dr. Webster said he receives emails from desperate patients almost every day. Many had been taking doses of opioids that controlled their pain well enough for them to work and “have a reasonable life…maybe for a decade or more.” Now they are bedridden “because they’re being forced to take a dose far less than what has been necessary to keep them functional,” he said. Other patients “have been told by their doctors that they’re taking them off all of their medicines.” These people, who “don’t have any idea where to go to get help,” often state that “the only option they have is suicide.”

There are numerous reports, both official and unofficial, of suicides related to reduced opioid regimens among patients suffering from chronic and intractable pain conditions, including those reported on a blog by North Carolina internist Thomas Kline, MD, PhD.7 Next month, Veterans Affairs representatives plan to discuss the impact of opioid discontinuation on suicide at the 2018 National Prescription Drug Abuse and Heroin Summit. Preliminary data from a VA Department examination of cases between 2010-2011 and 2013-2014 shows that while “opioid discontinuation was not associated with overdose mortality,” it was associated with “increased suicide mortality.”

These data were extracted from fiscal years prior to the release of the CDC’s guidelines, but they reflect the impact of the VA’s Opioid Safety Initiative, which began in October 2013. A 2017 VA fact sheet says the program reduced the number of patients receiving opioids by a third.8 “Despite recommendations within recent guidelines for patient-centered evaluation of the risks and benefits for prescribing opioids for chronic pain,” says the clinical track agenda for next month’s summit, “there are concerns regarding the potential iatrogenic effects of initiatives from state regulators, insurers, payers and healthcare organizations that have presented mandates to reduce opioid doses or to discontinue those in patients who currently receive them.”9

The CDC has made potentially deadly desperation more likely by encouraging prescribers to subordinate their patients’ interests to the government’s interest in preventing misuse or abuse of opioids. The guidelines state, for example, that, “when starting opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extended-release/long-acting (ER/LA) opioids.”1 This blanket rule makes no sense, according to Pergolizzi et al,5 if the CDC is serious when it states opioid prescribing should be guided by the risks and benefits for the patient. “It appears that this statement is asking physicians to make prescribing choices based on public health concerns…rather than the most appropriate course of therapy for the individual patient,” wrote the authors.5 “If prescribers must forego the use of ER/LA opioids in patients who could possibly benefit from them, it essentially punishes the chronic pain patient for offenses committed by drug abusers.”

Is There a Way Forward?

What might the conscientious physician do in the face of these conflicting demands? “Doctors are between a rock and a hard place,” said Dr. Webster. “To do the right thing, I think they have to have impeccable records. They have to be detailed in their documentation, and I believe that if they have people on doses that are above what the CDC has recommended, then they really need to have corroboration by another physician, preferably a specialist, that the dose they have them on is reasonable for this person and a reason why.”

Both Drs. Webster and Kertesz said they know of clinicians, including pain specialists, who have simply stopped prescribing opioids because it seems too risky. But then what happens to those patients who need opioids to keep the agony at bay? “We’re engaged in a stampede that is trampling people to death,” said Dr. Kertesz, “and those people need to be protected.”

The State of the Public Health Emergency

More than four months have passed since President Trump declared in late October 2017 a public health emergency surrounding opioids misuse, abuse, and diversion. Yet, efforts to end the crisis have been minimal, if not nonexistent. A few points to date:

  • Federal funds requested by the President to combat the epidemic: $0.00.
  • Confirmed appointees to direct the White House Office of National Drug Control Policy: none.
  • Confirmed appointees to head the Drug Enforcement Administration (DEA): none.
  • Recommended FY2018 budget cuts for the Office of National Drug Control Policy: 95%.

What has been done? The president issued another statement in early February suggesting that he intends to now focus on opioid law enforcement, rather than treatment. For instance, the signed January 2018 INTERDICT Act (officially known as the International Narcotics Trafficking Emergency Response by Detecting Incoming Contraband with Technology Act) provides federal agents with $9 million to acquire tools and personnel to screen for fentanyl and other synthetic opioids at US borders. In addition, the US Attorney General launched DEA tactics to focus on prescription drug diversion, with an eye toward pharmacies and physicians deemed to be dispensing unusual or disproportionate amounts of medication, including opioids.

Last updated on: April 12, 2019
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