Despite FDA warnings regarding the risk for adverse effects from administering long-acting opioids to patients who had not developed opioid tolerance through prior usage, the initiation of potent long-acting fentanyl patches (Duragesic, Janssen) without first receiving an opioid analgesic persists for these residents (J Am Geriatr Soc 2016;64:1772-1778).
Of 12,278 long-stay Medicare-enrolled nursing home residents who were prescribed long-acting opioids within 30 days of admission in 2011, 9.4% had not received an opioid analgesic in the previous 60 days, according to the study.
“Our conclusion is that opioid-naive initiation of long-acting opioids is a rare occurrence in nursing homes, and there has been a decrease in this practice since it was first described in the mid-2000s,” said Camilla B. Pimentel, MPH, PhD, a postdoctoral associate at the University of Massachusetts Medical School, in Worcester, and the lead author of the study. “However, opioid-naive initiation of fentanyl patches persists despite FDA safety communications and other national efforts to increase awareness of safe use of opioids.”
The study’s authors were most surprised by their finding that were the most commonly prescribed long-acting opioid for nursing home residents who were opioid naive, she said.
“This is counter to FDA guidance, including black box warnings and public health advisory warnings,” Dr. Pimentel said. She questioned whether fentanyl patches, which are simply applied to the skin and provide analgesia for up to 72 hours, are frequently prescribed because they are easy to administer.
In July 2005 and December 2007, the FDA issued public health advisory warnings on the safe use of transdermal fentanyl patches. The FDA was particularly concerned about the use of long-acting opioids by individuals who had not received prior opioid analgesics.
The study found that 51.9% of opioid-naive nursing home residents—those who had not been prescribed opioids in the 60 days before administering a long-acting opioid—received the fentanyl patch. The study also found that 56.4% of non-naive residents received the long-acting fentanyl patch. Other commonly prescribed long-acting opioids were morphine and oxycodone.
Nursing home residents who were prescribed long-acting opioids had a mean age of 75 years (71.4% women). Most were admitted for at least 90 days and had moderate to severe functional impairment (73%); 19.3% also suffered moderate to severe cognitive impairment. The study excluded residents who were hospitalized during the seven days before nursing home admission. Arthritis, pulmonary disease, heart failure, osteoporosis and cancer were the most commonly diagnosed conditions.
Only 5% of all long-stay Medicare nursing home residents identified for the study were prescribed long-acting opioid medication.
Dr. Pimentel said the findings of the study are important because “the safe use of long-acting opioids, according to FDA safety warnings, means that they should only be given to patients who have developed a tolerance to opioid medications through regular treatment with other opioids. Otherwise, they are at higher risk of unintentional fatal overdose because of respiratory depression.”
“While the study indicates substantial improvement in ‘new initiation’ in 2011 compared with the prior study in 2004-2005, it remains concerning that greater than 9% of nursing home opioid-naive patients are receiving a long-acting opioid,” said Shaun C. Corbett, MD, medical director of rehabilitation services and the Rosomoff Comprehensive Rehabilitation Center at Miami Jewish Health Systems, who was asked to comment on the study.
“It is especially concerning, when one considers the reduced hepatic and renal function of many geriatric patients, that more than 50% of opioid-naive patients who received fentanyl patches received a dose of 25 mcg per hour or 50 mcg per hour, as opposed to a 12-mcg per hour patch,” Dr. Corbett said. “In my opinion, other than a few rare instances, short-acting formulations should be initiated prior to long-acting formulations, especially in the geriatric population.”
Dr. Pimentel said the study also found the “prevalence estimates do not significantly change when we vary the time in which we observe the nursing home residents’ medication use. Previous estimates of opioid-naive initiation of long-acting opioids were as high as 39.3%. Regardless of the way we varied our assumptions, our estimates were not as high.”
Dr. Pimentel said before another pain-related educational campaign is launched, “it’s important to first understand why opioid-naive initiation of long-acting opioids is occurring in nursing homes. It would be interesting to see if there are any anecdotal information out there about why long-acting opioids—including fentanyl patches—are used in nursing homes, and with very frail and ill older adults.”
—Thomas Rosenthal
Dr. Pimentel and her co-authors and Dr. Corbett reported no financial disclosures regarding the study.
All opioids have specific risks, and the fentanyl transdermal patch preparation has received a black box warning by the FDA to define opioid tolerance as a requisite needed before use. Fentanyl is labeled as such based on both its potency and delayed time to a maximal concentration of many hours when administered transdermally. The delay presents challenges in identifying its chief hazard of respiratory depression. Although prescribing outside the parameters established in a black box warning is not by default negligent, it does appear curious that this prescribing pattern would occur at such a frequency. Have those practicing in nursing homes gathered clinical expertise with the fentanyl patch that is unique to their practice environment, or are other factors influencing decision making? Further investigation appears warranted regarding the etiology of the prescribing patterns, the safety of practice and patient outcomes.