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)
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.
