U.S. agencies warn doctors not to abruptly cut off the
medications for long-time users
By Claudia Wallis on April 19, 2019
Pain Patients Get Relief from War on Opioids
Credit: Getty Images
Ever since U.S. health authorities began cracking down on opioid prescriptions about five years ago, one vulnerable group has suffered serious collateral damage: the approximately 18 million Americans who have been taking opioids to manage their chronic pain. Pain specialists report that desperate patients are showing up in their offices, after being told by their regular physician, pharmacy or insurer that they can no longer receive the drugs or must shift to lower doses, no matter how severe their condition.
Abrupt changes in dosage can destabilize patients who have relied for many years on opioids, and the consequences can be dire, says Stefan Kertesz, an expert on opioids and addiction at the University of Alabama at Birmingham School of Medicine. “I’ve seen deaths from suicide and medical deterioration after opioids are cut.”
Last week, after roughly three years of intensive lobbying and alarming reports from the chronic pain community, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) took separate actions to tell clinicians that it is dangerous to abruptly curtail opioids for patients who have taken them longterm for pain. The FDA did so by requiring changes to opioid labels specifically warning about the risks of sudden and involuntary dose tapering. The agency cited reports of “serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide” among patients who have been inappropriately cut off from the painkillers.
One day later, CDC director Robert Redfield issued a clarification of the center’s 2016 “Guideline for Prescribing Opioids for Chronic Pain,” which includes cautions about prescribing doses above specific thresholds. Redfield’s letter emphasized that these thresholds were not intended for patients already taking high doses for chronic pain but were meant to guide first-time opioid prescriptions. The letter follows another recent clarification sent by the CDC to oncology and hematology groups, emphasizing that cancer patients and sickle cell patients were largely exempt from the guideline.
Taken together, these actions represent a significant victory for the chronic pain community. “The combination of the FDA and CDC speaking out reconfigures the conversation going forward in a very, very helpful way,” says Kertesz, who was one of five doctors associated with the advocacy group Health Professionals for Patients in Pain (HP3) who received Redfield’s letter.
Tougher rules on opioid prescriptions from federal and state authorities, health insurance companies and pharmacies, were an understandable response to the nation’s “opioid crisis,” an epidemic of abuse and overdose that led to a 345 percent spike in U.S. deaths related to legal and illicit opioids between 2001 and 2016. Since 2016, most fatal overdoses have involved illegally produced fentanyl sold on the street, according to CDC data, but past research has shown that many victims got started with a prescription opioid such as oxycodone.
The CDC’s 2016 guideline was aimed at reining in irresponsible prescribing practices. (The agency’s own analysis showed that prescriptions for opioids had quadrupled between 1999 and 2010.) The guideline stressed that the first-line treatments for chronic pain are non-opioid medications and non-drug approaches such as physical therapy. When resorting to opioids, the guideline urged doctors to prescribe “the lowest effective dosage,” to carefully size up risks versus benefits when raising doses above 50 morphine milligram equivalents (MME) a day, and to “carefully justify a decision” to go to 90 MME or above.
That advice on dosage was widely misinterpreted as a hard limit for all patients. Kertesz has collected multiple examples of letters from pharmacies, medical practices and insurers that incorrectly cite the guideline as a reason to cut off long-term opioid patients.
Frank Gawin, a retired psychiatrist in Hawaii, is one of many chronic pain sufferers ensnared by that kind of mistake. For 20 years he took high-dose opioids (about 400 MME daily) to
manage extreme pain from complications of Lyme Disease.
Gawin, an expert on addiction himself, was well aware of the risks but notes that he stayed on the same dose throughout those 20 years. “It helped me profoundly and probably extended my career by 10 to 15 years,” he says. About five months ago, his doctor, a pain specialist he prefers not to name, informed Gawin and other patients that she would be tapering everyone below 80 MMEs because she was concerned about running afoul of medical authorities. Gawin has not yet reached that goal, but his symptoms have already returned with a vengeance. “As I am talking to you, I am in pain,” he said in a phone interview. “I’m having trouble concentrating. I’m depleted. I’m not myself.”
Last week’s federal actions could go a long way in informing physicians not to cut off patients like Gawin. Of particular value, say patient advocates and experts, is the emphasis on working together with patients on any plan to taper the drugs. “It’s finally about patient consent,” says Andrea Anderson, former executive director of the Alliance for the Treatment of Intractable Pain, an advocacy group. She notes that the FDA urged doctors to create an individualized plan for patients who do wish to taper and that the agency stated that “No standard opioid tapering schedule exists that is suitable for all patients.”
The CDC is relying on pain advocacy groups to get the word out about its clarification. [Editor’s note: After this story was published, he CDC took additional steps by issuing a press release on April 24 that warned against “misapplication” of the 2018 guideline and pointed to an editorial on the subject in the New England Journal of Medicine.] Any formal update to the guideline will await the results of a systematic review of chronic pain research currently underway, said Debbie Dowell, chief medical officer of the CDC’s Injury Center, in an email; Dowell is the lead author of the 2016 guideline.
Gawin hopes the federal actions will persuade his doctor that forced tapering is wrong for him. “The only way I can see getting back to normal,” he says, “is to get back to the medication that worked for me.”
[Editor’s note: Andrea Anderson has stepped down from her position, and this story was updated on April 19, 2019, to reflect that change.]
LINK TO ORIGINAL ARTICLES:
Pain Patients, War on Opioids, Claudia Wallis, Food and Drug Administration, FDA, Centers for Disease Control and Prevention, CDC, Guideline for Prescribing Opioids for Chronic Pain,