At the end of the day (and on the Ides of March, of all days), the Centers for Disease Control and Prevention’s (CDC’s) long-awaited advice to physicians faced with prescribing opioids for the treatment of chronic pain, in its “CDC Guideline for Prescribing Opioids for Chronic Pain-United States 2016,” is “don’t.”
There are 12 recommendations comprising the guideline (MMWR Early Release/March 15, 2016/65) for treating chronic pain (defined as “pain lasting longer than three months or past the time of normal tissue healing”), but three are considered by the CDC to be key to patient care:
- Nonopioid therapy is preferred for chronic pain outside of active cancer, palliative and end-of-life care.
- When opioids are used, the lowest possible effective dosage should be prescribed to reduce risks for opioid use disorder and overdose.
- Providers should always exercise caution when prescribing opioids and monitor all patients closely.
A Clear Message: “Don’t”
The recommendations will not be embraced by legitimate chronic pain patients who have found genuine benefit from the medications. The CDC simply was not convinced that the absence of data on long-term efficacy was worth the risks for opioid-related misuse, abuse, addiction, overdose and death to allow for their use in most medical situations.
The CDC was very clear in its view that the current opioid epidemic stems largely from too many doctors treating chronic pain by writing too many opioid prescriptions too quickly, for too many pills and for too long a time.
“More than 40 Americans die each day from prescription opioid overdoses. We must act now,” said CDC Director Tom Frieden, MD, MPH. “Overprescribing opioids—largely for chronic pain—is a key driver of America’s drug overdose epidemic. The guideline will give physicians and patients the information they need to make more informed decisions about treatment.”
The first-ever opioid prescribing guideline for primary care physicians (PCPs) ended up mostly unchanged from the draft that was released last fall and revised in December 2015, before being reopened for comment earlier this month. All versions were unveiled to great scrutiny, including questions regarding the financial (and nonfinancial in the case of opioid opponents) conflicts of interest of some stakeholders or guideline developers; why some stakeholders were included in the process and others were not; and concerns about whether nonprofit groups like Physicians for Responsible Opioid Prescribing had undue influence over the writing of the guideline (or actually authored them). These perceptions were fueled by the fact that the draft guideline was made public for only an hour and a half in mid-September, during a webinar, followed by a 48-hour window in which to send comments by email, as well as by the fact that the webinar was well attended by nonprofits focused on fighting addiction, insurers and pharmacies, and poorly attended by advocates of chronic pain patients.
Apart from its development, critics alleged at the time of its drafting that the new guideline would cause real harm to a significant subset of chronic pain patients for whom opioids do not pose a threat, and who often do not have any other options to treat their pain.
Now the final version has arrived on the physician’s doorstep, accompanied by strong pressure to justify any and all opioid prescriptions, and only after all nonopioid pharmacologic and nonpharmacologic options have been exhausted. (It will be interesting to see what the strident tone of the guideline will do for medical marijuana as a pain treatment.)
‘May Compromise Care’
Past president of the American Academy of Pain Medicine, Lynn Webster, MD, initially compared the guideline in an interview with “‘Mom and apple pie.’ They are sensible, rational, but aren’t really anything new. Most of the recommendations have been advocated by professional pain organizations for more than a decade. Importantly, I don’t anticipate they will improve outcomes, which was the stated goal.”
But overall, Dr. Webster described himself as being disappointed by the effort. “I think the CDC has missed an opportunity to make a real difference,” he said, adding that he has huge respect for the agency and expected the best from it.
In fact, the guideline may compromise care for some people, he noted, pointing to the daily dosage limits and limits on the number of days for prescriptions. “In most instances, acute pain treatment does not need more than seven days of medication,” said Dr. Webster.
He added that if a patient doesn’t need more than three days of medicine, then it shouldn’t be prescribed, and “in cases where doctors prescribe more medicine than the patient requires, the doctor needs more education.”
But Dr. Webster said there are many instances when limiting prescriptions to seven days will cause unnecessary burden and cost to patients. “Some patients will simply be denied medications because physicians will see the seven-day recommendation as a rule or standard of care. When patients need medication for more than seven days, their doctors may be unwilling to prescribe it because they feel at risk.”
He said the guideline doesn’t take into account real-world issues, such as that people “with acute trauma or post-op pain may have limited ambulation and find it difficult to return to an office for a refill.” This is particularly true for rural or elderly people who live alone. It is also likely to be an added cost to the patient for copayments and office visits if they are able to get refills, he pointed out.
Dr. Webster added that the suggested dose limit is “flawed thinking” and will create a false sense of safety if physicians are prescribing less than that. (The guidelines recommended keeping opioid doses under 50 morphine milligram equivalents [MME]/d total, and include a prescription for the opioid overdose drug naloxone if going up to 90 MME/d). “All doses are potentially dangerous,” he said. “Some data suggest there are nearly as many opioid overdose deaths with doses less than 50 MME [as] above.”
Charles Argoff, MD, director, Comprehensive Pain Program at the Albany Medical Center, in New York, said in an interview that he sees merit in the guideline if it is used appropriately, but is concerned that it will be used to block access to needed medications.
“I think these recommendations could be especially useful for physicians and other prescribers who don’t work in pain management, to help them be better guided to what constitutes reasonable, initial treatment with opioids. Many pain doctors could tell of patients who have come into their offices with a script for 120 Vicodin [hydrocodone/acetaminophen] after a tooth extraction, with refills allowed, for adolescents—16-year-olds. These are cases where the dentist simply just gave a patient a lot of medicine so he wouldn’t hear back from them. This is not generally appropriate prescribing behavior.”
“So, I am not naive that we are facing a national crisis of significant opioid-related adverse outcomes, and we are facing a national crisis with chronic pain. I would only hope that this is the spirit of this guideline—to enhance safe, effective therapy—and not to block access to medications to those who need them,” said Dr. Argoff.
The question quickly becomes, are PCPs up to the challenge? The CDC clearly believes they have been given the tools to succeed. The guideline also comes with a checklist that can take a physician through its criteria step by step for prescribing opioids (www.cdc.gov/drugoverdose/pdf/PDO_Checklist-a.pdf).
“Doctors want to help patients in pain and are worried about opioid misuse and addiction,” said Debra Houry, MD, MPH, director of CDC’s National Center for Injury Prevention and Control. “This guideline will help equip them with the knowledge and guidance needed to talk with their patients about how to manage pain in the safest, most effective manner.”
Dr. Webster said the guideline is likely to continue the “chilling effect” on opioid prescribing. “That will be welcomed by some,” he mused, “but I hope the guidelines don’t cause more harm than good.”