Researchers Question DEA Hydrocodone Schedule Change in Light of Postoperative Prescribing Practice Data
The impact of the policy change in the postoperative setting is, according to researchers, “not understood.”
Despite the best intentions, the 2014 US Drug Enforcement Administration (DEA) change of hydrocodone-containing analgesic products from schedule III to the more-restrictive schedule II has been linked with an increase in the quantity of opioids filled by patients in a postoperative setting, according to research published in JAMA Surgery.1
The DEA initiated the scheduling change as a response to the ongoing opioid crisis. Although recent studies2,3 suggest that this shift in policy did lead to a reduction of overall hydrocodone fills, the impact of the policy change in the postoperative setting is, according to researchers, “not understood.”
Jennifer Waljee, MD, MPH, of the Michigan Opioid Prescribing Engagement Network at the University of Michigan in Ann Arbor and colleagues performed an interrupted time series analysis of outpatient opioid prescriptions in an effort to examine the trend in postoperative opioid prescribing at 75 Michigan hospitals (5120 providers) before and after the DEA schedule change.
The primary study outcome was the trend in opioid prescription fills for initial postoperative prescriptions both before and after the schedule change, which took place on October 6, 2014. Secondary outcomes included the total amount of opioids filled as well as the refill rate within the 30-day postoperative period.
Data were included for 21,955 adult inpatients between 18 and 64 years of age. Participants underwent 1 of 19 common elective surgical procedures and filled an opioid prescription within 14 days of hospital discharge.
The investigators' analysis indicated an increase of 35 oral morphine equivalents (OMEs) per initial postoperative prescription immediately following the schedule change. Mean OME at the beginning of the study period was 371.36, with a decrease of 1.15 OMEs per month; following the schedule change, an 35.11 increase in mean OMEs — the equivalent of 7 additional hydrocodone tablets — was noted.
Researchers stratified the results by type of opioid prescription, noting an increase of 30 OMEs per prescription for hydrocodone but not for other opioid types.
Following the schedule change, there were “no significant differences” in total OMEs filled during the 30-day postoperative period either before or after the schedule change, although a decrease in refill rate among those who had not previously taken opioid medications was noted.
“In contrast to the findings of the present study, prior studies have shown that hydrocodone fills have declined following the schedule change…across many types of care,” the researchers noted. “[W]e observed an increase in the amount of opioid provided in the initial prescription following surgery. It is plausible that a policy that is broadly targeted to all types of care may not entirely address the nuances of surgical prescribing.”
“It is possible that, in the absence of clear prescribing guidelines for postoperative care, restricting opioid prescribing may inadvertently motivate surgeons to prescribe greater amounts to ensure adequate pain treatment,” they added.
Dr Waljee and colleagues note several limitations of the study, including limited data generalizability and lack of knowledge about patient insurance status, elective surgery type, and prior opioid use.
“Our findings highlight the need to couple policy alongside robust evidence regarding average consumption and the prescriber factors that drive opioid prescribing,” Dr Waljee and colleagues concluded.
- Habbouche J, Lee J, Steiger R, et al. Association of hydrocodone schedule change with opioid prescriptions following surgery [published online August 22, 2018]. JAMA Surg. doi:10.1001/jamasurg.2018.2651
- Jones CM, Lurie PG, Throckmorton DC. Effect of US Drug Enforcement Administration's rescheduling of hydrocodone combination analgesic products on opioid analgesic prescribing. JAMA Intern Med. 2016;176(3):399-402.
- Tran S, Lavitas P, Stevens K, et al. The effect of a federal controlled substance act schedule change on hydrocodone combination products claims in a Medicaid population. J Manag Care Spec Pharm. 2017;23(5):532-539.