Three studies published this year have examined the risks when patients with chronic pain abruptly stop taking opioids.
When the CDC issued guidelines to slow opioid prescribing in 2016, the hope was to slow the epidemic of deaths that began in the 1990s when oxycodone hit the market.
Surely, the guidelines stopped many from starting the path to addiction—there are early signs that the death rate from opioids is finally coming down. But for those who were already taking opioids for pain, there were different risks, and a recent study from the University of Washington shows they are deadly.
Patients tapering off opioids for pain were 3 times more likely to die of an overdose in the years that followed the CDC directive. The authors note theirs is the third study published this year to highlight the risks of suddenly stopping opioids. In April, the FDA issued a label change and warned physicians not to abruptly cut doses but to instead slowly taper patients off these powerful drugs.
The lead author of the University of Washington study, Jocelyn James, MD, assistant professor of general internal medicine, warned that better systems are needed to protect patients from the effects of the 2016 guidelines.
“We are worried by these results, because they suggest that the policy recommendations intended to make opioid prescribing safer are not working as intended,” James said in a statement.
The new study, published last week in the Journal of General Internal Medicine, looked at data from 572 patients with chronic pain who were enrolled in an opioid registry. Chronic opioid therapy was stopped for 344 of them, while 187 continued to visit a primary care clinic. Over the study period, 119 registry patients died (20.8%), including 21 who died of an overdose or possible overdose. Of this group, 17 were patients who had stopped seeing the primary care clinic and 4 were still being seen.
“Discontinuing chronic opioid therapy was associated with increased risk of death,” the investigators concluded.
Tapering patients off opioids can often lead to an end to regular care for the patient, a separate study published last month found. The psychological fallout of ending therapy is something that must be taken into account when easing patients off opioids, the FDA warned in its notice.
“When you and your patient have agreed to taper the dose of opioid analgesic, consider a variety of factors, including the dose of the drug, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient,” the FDA notice states. “No standard opioid tapering schedule exists that is suitable for all patients.”
The FDA encouraged an individualized plan that addresses withdrawal symptoms and psychological distress.
Alongside the FDA warning, CDC published a commentary in the New England Journal of Medicine clarifying that the 2016 guidelines were not to be used as a reason to abruptly cut off patients from needed medication, or for enforcement of “hard limits.” But in daily clinical practice, enforcement may be coming not from agencies but from health plans, which coordinate with pharmacy benefit managers to track which physicians are prescribing opioids and which patients are receiving them, perhaps from more than one doctor.
In addition, 33 states passed laws to encourage or require health plans to track opioid prescribing or limit the pill count in initial opioid prescriptions. New Jersey limits the initial prescription to just 5 pills. Critics of the movement say this has caused patients with chronic pain to turn to heroin or fentanyl instead.
Is there a good way to ease patients off opioids? The time frame of the data collection—2010 to 2015—came before laws in Washington state allowed for multimodal pain management and treatment for opioid use disorder. Rules are different today, study co-author Joseph Merrill, MD, MPH, professor of General Medicine at the University of Washington School of Medicine, said in a statement.
Addiction clinics can now treat patients with medication for opioid use, Merrill said, so high-risk patients are more carefully managed.
James JR, Scott JM, Klein JW, et al. Mortality after discontinuation of primary care—based chronic opioid therapy for pain: a retrospective cohort study [published online August 29, 2019]. J Gen Intern Med. doi: 10.1007/s11606-019-05301-2.