DEA Plans Further Cuts in Rx Opioid Supply

By Pat Anson, PNN Editor

For the seventh consecutive year, the U.S. Drug Enforcement Administration is planning to cut the supply of prescription opioids, reducing them in 2023 to levels not seen in nearly two decades.

DEA sets production quotas for opioids and other controlled substances annually, after consulting with the CDC, FDA and individual states about their projected medical and research needs. Based on that input, the DEA is lowering the supply of Schedule II opioids such as oxycodone and hydrocodone by about 5 percent next year.

“FDA predicts that levels of medical need for schedule II opioids in the United States in calendar year 2023 will decline on average 5.3 percent from calendar year 2022 levels. These declines are expected to occur across a variety of schedule II opioids including fentanyl, hydrocodone, hydromorphone, oxycodone, and oxymorphone,” the DEA said in a notice published in the Federal Register.   

The production cut in Schedule II opioids is not as steep as in prior years, but continues a trend that began a decade ago. Since their peak in 2013, production quotas have fallen by 65% for oxycodone and 73% for hydrocodone, the two most widely prescribed opioids.

OXYCODONE PRODUCTION QUOTAS (KILOGRAMS)

SOURCE: DEA

The primary goal of the DEA in lowering opioid production is to reduce the risk of diversion, abuse and overdose, but it’s hard to find any evidence the policy is working. Prescription opioid use has fallen by 48% in the last five years, but opioid overdose deaths have climbed to record levels, fueled primarily by street drugs made with illicit fentanyl, a synthetic opioid 50 to 100 times stronger than morphine.

Although DEA is arresting and prosecuting illicit fentanyl dealers, it also continues to actively target doctors who prescribe high doses of opioids. This month it suspended the DEA license of a California doctor for unknown reasons, which led to the death of a chronic pain patient and his wife in a double suicide.

“It’s the end of the road for me with doctors,” Danny Elliott posted on Twitter a few days before his death. Elliott had lived with severe headaches for over two decades and was despondent that he was out of pain medication and unable to find a new doctor.

Low Risk of Diversion    

DEA is required under federal law to estimate the amount of prescription opioids that will be diverted through loss or theft, and then subtract it from the annual production quota. But those estimates reveal just how small the opioid diversion problem actually is.

Using information gathered from prescription drug monitoring programs (PDMPs), pharmacies, hospitals and others in the drug supply chain, DEA estimates that less than one percent of oxycodone (0.3%) and hydrocodone (0.42%) will be diverted for use by someone they were not intended for.

The DEA’s 2023 production quotas are also based on an old recommendation from the CDC that prescribers should “avoid increasing dosages of opioids beyond 90 MME for patients with chronic pain.”  CDC recently revised its opioid guideline to remove the 90 MME dosage threshold. The new guideline is more flexible and encourages doctors to make treatment decisions based on the individual needs of the each pain patient and not on any hard limits.

The DEA is accepting public comments on its production quotas until Thursday, November 17. The public response so far has been muted – only 47 comments as of this writing -- likely because the quotas have received little publicity from the media or the DEA itself.

Most of the comments that have been received are critical of DEA plans to reduce the supply of amphetamines and other stimulants used in treating attention deficit hyperactivity disorder (ADHD).  Some of those drugs are already in short supply, but DEA said it has “grown increasingly concerned” that ADHD medications are being diverted and abused by young adults.

To leave your comment on the DEA’s 2023 production quotas, click here.

Public Officials Ignorant About Overdose Crisis

By Christopher Piemonte, Guest Columnist

A recent Washington Post article highlights an ongoing debate between the Drug Enforcement Administration and some public officials, who are demanding that DEA further reduce the supply of opioid medication. DEA has responded that, without more precise data, such a reduction would be ineffective and dangerous for Americans that need opioids.

At the center of the debate is the Aggregate Production Quota (APQ) for Schedule I and II opioids and other controlled substances. Every year, the DEA sets the maximum amount for each substance that can be produced. DEA began cutting the opioid supply in 2017 and has proposed further cuts in 2020.  

Congressional lawmakers and state attorneys general argue that the APQ for opioid medication is still too high, and the excess supply leads to overdose deaths. In a recent letter to the Acting Administrator of DEA, six attorneys general claim that the APQ does not account for opioids diverted to the black market, which “factor in a substantial percentage of opioid deaths.”

Citing data from the CDC, they assert that in 2016 “opioids obtained through a prescription were a factor in over 66% of all drug overdose deaths.”

There’s a problem with these claims: They’re wrong.

When asked about the accuracy of the letter, a spokesperson for CDC said prescription opioids were a factor in “approximately 27% of all drug overdose deaths,” a figure nearly 40% lower than that presented in the letter.

It would be one thing if this error were simply a typo or miscalculation. But these state officials, as well as many lawmakers, are insisting on a specific policy response without having made the effort to dig into the data and understand the nature of the problem itself. Specifically, they cite inaccurate data to support the incorrect notion that “prescription opioids have been a dominant driver in the growing crisis.” What’s worse, that false notion is the basis for their intransigent insistence on a blanket reduction in the supply of all prescription opioids.

Experts in law enforcement, medicine and policy agree that the attorneys general made an erroneous factual conclusion, and that an arbitrary opioid quota reduction would be both ill-informed and dangerous.

“There is no question that the DEA, or any agency, attempting to come up with valid quotas for controlled substances will find it difficult if not impossible. One of the problems with interpreting overdose death information is that illicit fentanyl and heroin deaths are frequently lumped together with oxycodone- and hydrocodone-related deaths,” said John Burke, President of the International Health Facility Diversion Association and a former drug investigator for the Cincinnati Police Department.

“The vast majority of people prescribed controlled substances take them as directed. Proposed cuts in quotas will negatively impact Americans who have a legitimate medical need for opioids, causing them even more discomfort and distress. These patients are routinely overlooked when considering the prescribing and dispensing of controlled substances, and it is a tragedy.”

Increased Demand for Street Drugs

Other experts warn that further reducing the supply of opioid medication will lead to drug shortages and increase demand for illicit drugs.   

“On the surface, it appears that limiting the quotas…could, in fact, provide a means to address the overdose crisis,” said Marsha Stanton, a pain management nurse, clinical educator and patient advocate. “That, however, will do nothing more than to minimize or eliminate access to those medications for individuals with legitimate prescriptions. We have already seen the effects of back-ordered medications, which create significant barriers to appropriate patient care.”

“Patients who lose access to prescriptions for opioids, have, in some cases, turned to street drugs as an alternative. This has led to increased morbidity and mortality since street drugs have uncertain content and are often used in a comparatively uncontrolled manner,” said Stuart Gitlow, MD, an addiction psychiatrist and past president of the American Society of Addiction Medicine.

“We, therefore, cannot afford to use a crude blunt instrument such as a quota change to address the drug abuse problem. Rather, we must focus on each patient individually and, through education of clinical professionals, ensure that each patient receives medically reasonable treatment.”

By continually insisting on cuts in opioid production, public officials demonstrate a lack of understanding of America’s overdose crisis. Put simply, they’ve failed to do their homework.

“For more than a decade, experts have urged government officials to focus on much more than reducing the opioid-medication supply. Yet, they remain fixated in intellectual laziness,” said Michael Barnes, Chairman of the Center for U.S. Policy and a former presidential appointee in the Office of National Drug Control Policy.

“Policy makers must reduce demand by prioritizing drug abuse prevention, interventions, and treatment. Prevention is the biggest challenge because it will require public officials to realize and respond to the socioeconomic underpinnings of drug abuse. The time is long overdue for politicians to get serious and do the work necessary to save lives and solve this crisis.”   

The disturbing reality is this: Despite rising death tolls and the shortcomings of recent responses, many officials involved in overdose-response policy misunderstand the complexity of America’s overdose crisis.

Until those individuals are educated about the nuances of the issue, they will continue to demand policy that does not adequately address the problem, and the crisis will carry on. Continued ignorance on the part of government officials would truly be, as Mr. Burke put it, a national tragedy.

Christopher Piemonte is a policy manager for the Center for U.S. Policy (CUSP), a non-profit dedicated to enhancing the health, safety and economic opportunity of all Americans. CUSP is currently focused on identifying and advancing solutions to the nation’s substance abuse, mental health and incarceration crises.