The amount of opioids in post-surgery prescriptions increased after the Drug Enforcement Administration restricted the distribution of the opioid hydrocodone, according to a medical journal report published Wednesday.
In 2014, the DEA moved hydrocodone from its Schedule III to the more restrictive Schedule II to curb opioid abuse amid rising deaths from overdoses.
Yet in Michigan, the new restrictions didn’t have the intended effect, according to a study by researchers in the Department of Surgery at the University of Michigan in Ann Arbor.
The researchers found that following the new classification, the amount of hydrocodone and other, equally powerful opioids increased despite a decrease in the number of prescriptions written.
“Our main thought was that since surgeons were more limited in their ability to prescribe extra pain medications after the patient left the hospital, they prescribed more up-front to avoid the risk of patients running out,” Dr. Joe Habbouche, a study co-author and surgery resident at Michigan Medicine, said in an email to The Washington Times. “This is important because the goal of the restriction in 2014 was to decrease the amount of opioids prescribed by all types of health professionals.”
The study was published Wednesday in Journal of the American Medical Association Surgery. In an analysis of nearly 22,000 patients in Michigan between 2012 and 2015, the researchers noted that initial prescriptions increased the amount of opioids by an average of seven pills, despite a significant decline in refill rates following the reclassification.
Hydrocodone drugs, the most popular brand name being Vicodin, were the most frequently prescribed post-surgery pain relievers before and after the DEA reclassified the opioid. These drugs accounted for more than 72 percent of post-operative prescriptions.
The Schedule II restrictions required providers to write prescriptions for only a 30-day supply and refills to be made with a written prescription — removing the option of phoning or faxing a request to pharmacies. The restrictions aimed to increase oversight on prescribing rates.
“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,” the study says.
There was an observed increase in the amount of opioid pills in initial prescriptions specifically for patients naive about opioids and who had never filled a prescription for between one and 31 days before surgery, the study says.
This cohort often is cited as one of the more vulnerable populations in the opioid epidemic, in that 5 percent to 10 percent become addicted with an initial prescription after a routine surgical procedure, according to previous research that is highlighted in the new study.
At the time of the DEA reclassification, health officials were aware that drug overdose death rates had been rising since 1999. In Michigan in 2013, there were 9.4 opioid overdose deaths per 100,000 people. In 2016, the rate rose to 18.5 opioid deaths per 100,000 people — 678 deaths from prescribed opioids, 727 deaths from heroin and 921 deaths from synthetic opioids like fentanyl.
Today’s opioid epidemic is vastly different: Preliminary data from 2017 show that nearly half of the more than 61,000 opioid deaths are attributable to fentanyl.
But in 2014, prescription opioids were driving the overdose death rate. Deaths from natural and semisynthetic opioids, including oxycodone and hydrocodone, accounted for 12,159 deaths across the U.S. Overdose deaths from heroin tallied 10,574, and synthetic opioids accounted for 5,544 deaths.
The Michigan findings contradict previous research that found the schedule change had reduced prescriptions for opioids after common surgical procedures. This included a 2016 research letter published in JAMA by Christopher Jones of the Department of Health and Human Services, who observed 26.3 million fewer prescriptions for hydrocodone amounting to 1.1 billion fewer pills.
In 2017, researchers from the University of Massachusetts Medical School published data showing a decline in Medicaid claims for “hydrocodone combination products” in the period after the DEA reclassification.
The decision to reschedule hydrocodone was a campaign 15 years in the making, that started with a citizen petition by a general practitioner from upstate New York who entered into addiction medicine after delivering a baby in withdrawal from a mother addicted to heroin.
In 1999, Dr. Ronald J. Dougherty submitted a petition to the DEA to reschedule hydrocodone and its analogs as a Schedule II drug, according to a 2015 profile by the American Society of Addiction Medicine.
In an earlier petition to the New York State Board of Health, Dr. Dougherty outlined that as medical director of a drug treatment center, he saw 60 percent of patients referred for dependence on hydrocodone medications, such as Vicodin, Lortab, Meprobamate and Soma.
The DEA didn’t initiate proceedings to investigate the reclassification of hydrocodone until 2004, sending a request to the Department of Health and Human Services to evaluate the scientific and medical information on hydrocodone products to see if it was necessary to reschedule them. Four years after that HHS came back with its determination to keep hydrocodone as a Schedule III drug.
In 2009, the DEA asked HHS to re-evaluate its decision. That same year, 17,377 people died of a drug overdose related to opioids. By 2013, the year the Food and Drug Administration agreed and authorized to reschedule hydrocodone, opioid overdose deaths had increased to 18,042.
“Hydrocodone is the most prescribed opioid in the United States, including 137 million prescriptions in 2013,” the FDA wrote in a blogpost in 2014, the day the reclassification went into effect. “While it is useful in the treatment of pain, it has also contributed significantly to the very serious problem of opioid misuse and abuse in the United States.”
In their conclusion, the Michigan researchers acknowledged the limitation that their study only looked at prescribing rates in their state, yet it did highlight the need to focus on doctors in the clinical setting as a key intervention of opioid policy.
“Opioid-related policy is likely influenced by clinical context, and identifying the factors that motivate prescriber behaviors will be important to curb opioid prescribing and encourage opioid alternatives for surgical care,” they wrote.