DEA Revises Opioid-Quota Rules, Leaving Out Requested Change

Kerry Dooley Young

July 13, 2018

The Drug Enforcement Administration (DEA) will update its established procedures for setting production quotas for addictive drugs without heeding a recommendation from medical groups regarding shortages of injectable opioids. A new DEA rule also drew complaints about the general attitudes toward treatment of chronic pain.

The DEA on July 11 announced its final decision on changes to its regulations regarding aggregate production quotas (APQs), which it said were initially issued in 1971. The DEA annually sets APQs for controlled substances, including morphine and oxycodone. In April, the DEA unveiled a draft rule to revise the process for setting APQs as part of the federal government's attempt to curb abuse of opioids. On Wednesday, the DEA said it "is finalizing the rule as proposed without changes," despite having received more than 1500 comments on the draft version.

The new rule directs the DEA to consider the extent to which a drug can be diverted for abuse in setting annual opioid production limits. The rule also directs the DEA to share notices of proposed and final APQ orders with state attorneys general. The rule also directs the DEA to consider relevant information from the Department of Health and Human Services, the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention, and the Centers for Medicare & Medicaid Services in making its decision on quotas.

DEA Acting Administrator Uttam Dhillon said the changes will allow "increased communication and better information sharing between DEA and individual states, as we work together to address the opioid problem plaguing our country."

In a statement to Medscape Medical News, Roslyne Schulman, director of policy at the American Hospital Association (AHA) in Washington, DC, said the hospital group was "disappointed" that the DEA did not amend its final rule to ensure that drug shortages be considered in setting and adjusting APQs.

"We strongly recommend that the DEA routinely consult with the Food and Drug Administration's drug shortage staff, which collects and publishes relevant data on all national drug shortages, when establishing and adjusting quotas," she said.

Although the FDA is working with drugmakers to avoid shortages, physicians still have to scramble to find alternatives and work-arounds for low or missing supply of injectable opioid medications, including morphine, hydromorphone, and fentanyl.

In a May 4 comment on the DEA proposal, the AHA and five other medical groups asked the DEA to consider the formulation of opioids in making decisions on APQs and weighing the risk for shortages. They noted that the DEA's intent in setting these quotas is to provide adequate supplies for the United States' legitimate needs.

"Shortages create legitimate needs," wrote the AHA, the American Society of Clinical Oncology (ASCO), America's Health Insurance Plans, the American Society of Health-System Pharmacists, the American Society of Anesthesiologists, and the Institute for Safe Medication Practices.

"Injectable opioids dispensed in clinical settings pose a far lower risk of diversion than other dosage forms dispensed directly to patients," the groups said. "Proactively considering shortages when setting and adjusting APQs will safeguard patient health and safety and ensure critical needs are met."

In a Wednesday statement to Medscape Medical News on the final DEA rule, ASCO Chief Medical Officer Richard L. Schilsky, MD, said the cancer group hopes the DEA "can carry out this rule while being mindful of opioid shortages that jeopardize patient care.

"We strongly encourage the DEA to work with the Food and Drug Administration and other agencies to make sure legitimate patient needs for intravenous and oral opioids are met," Schilsky said.

The Association of American Medical Colleges (AAMC) had told the DEA in a May comment that limited supply of injectable opioids could result in postponement or even cancellation of operations, potentially putting lives at risk.

The AAMC asked the DEA to take steps to ensure current drug shortages "are alleviated, to guarantee a sufficient supply of opioid medications for legitimate needs," Mary Mullaney, director of hospital payment policies for the AAMC, told Medscape Medical News in an email. The shortage of injectable opioid products is not expected to be fully resolved until the middle of 2019.

The DEA acknowledges in the final rule that there's a need to ensure that quotas reflect legitimate medical need, Mullaney wrote. Still, a root cause for shortages remains outside of the DEA's control, she noted.

Manufacturers "cannot be compelled to produce more of that drug to meet the shortage," she wrote. Thus, the "drug may continue to be in shortage, which results in increased costs — for both the hospital and the patient — associated with care that requires such a drug."

A spokesman for the DEA offered a similar view.

"When situations arise where drug supply might not meet legitimate needs, we work with all stakeholders to address concerns while maintaining that balance," said Melvin S. Patterson, a DEA spokesman, in a statement to Medscape Medical News. "DEA allocates quota for active ingredients and does not have the ability to dictate what product and in what form or strength a manufacturer will produce."

"OpiodPhobia"

The DEA noted in the final rule that it received 23 comments concerning the shortages. The majority of the comments about the draft rule — about 1300 of 1561 — came from members of the public who expressed concerns about their ability to get necessary prescriptions due to limited production and societal disapproval of opioids.

One commenter wrote of difficulty in obtaining pain medication for degenerative disc disease. "I've had to wait some months up to 3 days to pick up my morphine extended relief 30 mg tablets that should of been available but weren't[,] throwing my schedule off," the commenter wrote. "I've never experienced what I'm going through till recently."

Many of these comments from the public addressed broader trends in attitudes about pain treatment, well beyond the narrow scope of the changes the DEA was making to the APQ procedures.

People with chronic pain "are being treated like criminals," wrote another commenter. "Our only crime is that we are sick, suffering and in pain."

Several commenters wrote to the DEA about having trouble finding physicians willing to prescribe them opiates. One commenter described this phenomenon as "OpioidPhobia." The DEA also received a number of comments suggesting that more focus is needed on heroin and illicit fentanyl.

In response to these comments, the DEA noted that the rule in question only revises the process for gathering information for quotas. Still, the agency offered its view that controlled prescription drugs (CPDs) remain "inextricably linked with the threat the United States faces from the trafficking of heroin and illicit fentanyl and fentanyl analogues.

"Roughly 75 percent of heroin users reported nonmedical use of prescription opioids before using heroin (though the vast majority of individuals misusing opioid CPDs do not go on to use heroin)," the DEA said. "Many stated that they first obtained these drugs for free from the family medicine cabinet or from friends but then sought street or black market drugs to maintain their addiction."

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