By Pat Anson, PNN Editor-in-Chief

Tomorrow, the U.S. Drug Enforcement Administration is hosting another Prescription Drug Take Back Day, a nationwide effort that encourages people to fight drug addiction and overdose by throwing away their unnecessary drugs at thousands of drop-off locations.

It’s also a day the DEA is using to further stigmatize the prescription drugs that millions of Americans rely on for pain control and functional lives.

“The majority of opioid addictions in America begin with prescription pills found in home medicine cabinets. Worse yet, criminal drug networks are exploiting the opioid crisis by falsely manufacturing and marketing deadly fake pills as legitimate prescriptions, which are now flooding American communities, ”DEA Administrator Anne Milgram said, in a press release. “I urge Americans to do their part to prevent prescription drug abuse: just take your unnecessary drugs to a local collection site.”

The DEA’s campaign to reduce the supply of opioid drugs goes well beyond the drug withdrawal days. In 2022, the agency plans to reduce production quotas for oxycodone, hydrocodone and other widely used opioid pain relievers. If the proposed quotas published this week in the Federal Register are passed – and history indicates they will – it will be the sixth year in a row that the DEA has reduced the supply of opioid drugs.

During this period, production quotas fell by 63% for oxycodone and 69% for hydrocodone. And opioid prescribing has fallen to unprecedented levels in 20 years.

But with drug overdoses reaching record levels, critics say there is no evidence the DEA’s strategy is working. And they’re alarmed that a law enforcement agency is putting in place policies that affect Americans’ health care choices – in fact, to practice medicine without a license.

“I think there can be a very strong argument that the DEA is inappropriately exercising its medical judgment based on its reasoning to support further reduction in the production of opioid pain relievers,” says Dr Chad Kollas, palliative care specialist in Florida. “Federal policy has encouraged indiscriminate reductions in opioid prescribing, so for the DEA to cite this trend as evidence of a reduced need for the medical supply of opioid pain relievers is a self-fulfilling prophecy.

“The reduction in prescriptions has not resulted in a reduction in overdose deaths involving opioids, but rather has been associated with an increase in overdose deaths and suicides in patients with chronic pain who have been forced to stop their medication. pain medication. The federal opioid policy calling for untargeted and reduced prescribing of opioids has been a dismal failure. ”

18.88% decrease in “medical needs”

Federal law requires the DEA to set quotas for the production of opioids and other controlled substances each year. It does so after consulting with the Food and Drug Administration, the Centers for Disease Control and Prevention, and other federal agencies to establish the amount of drugs needed for medical, industrial, and scientific purposes.

“The responsibility for providing these estimates of legitimate medical needs rests with the FDA. The FDA provides the DEA with its predicted medical use estimates for selected controlled substances based on information it has at a specific time to meet legal requirements, ”DEA explained in the Federal Register.

“With respect to the medical use of Schedule II opioids, the FDA predicts that medical need levels for the United States will decline by an average of 18.88% between calendar years 2021 and 2022. These declines are expected to occur. for a variety of Table II opioids, including fentanyl, hydrocodone, hydromorphone, oxycodone, and oxymorphone. “

Asked to comment on the DEA statement, an FDA spokesperson said the agency sent a letter to the DEA in April 2021 using pharmaceutical sales data from previous years to create “models of statistical forecast to estimate medical needs for the next two years “. The FDA letter never used the 18.88% estimate, a figure apparently calculated by the DEA’s crystal ball.

“In the letter, the FDA provided an estimate of the need for each active ingredient in various opioid drugs for 2021 and 2022. It appears that the DEA has estimated the decrease of 18.88% on average on the list of active opioid ingredients, presumably based on the estimates we provided. We do not disagree with their predictions for this declining trend in opioid requirements, ”the FDA spokesperson wrote in an email to PNN.

Red flag opioids

In its statement to the Federal Register, the DEA also said it relies heavily on data from Prescription Drug Monitoring Programs (PDMPs) to find “red flags” that may indicate a drug is on target. abuse or misappropriation. The DEA is particularly concerned about daily doses of opioids that exceed 240 milligram equivalents of morphine (MME). That’s a very high dose for most people – and well above the limit of 90 EMA recommended by the CDC’s guidelines on opioids.

“DEA estimates that taking into account amounts greater than 240 MME per day allows for the consideration of oncology patients with legitimate medical needs for prescriptions of controlled controlled substances greater than 90 MME per day. Higher doses put individuals at a higher risk of overdose and death. Many dispensing prescriptions at doses exceeding 240 EMS per day may indicate diversion such as illegal distribution of controlled substances or prescribing outside the ordinary course of professional practice, ”the DEA said.

Where does the threshold of 240 MME come from? This is apparently another case where the DEA comes up with its own estimates to determine whether a dose is medically necessary. It certainly didn’t come from the CDC guideline, which was never meant to include patients with cancer pain or those in hospice care.

“The DEA is misapplying CDC guidelines on opioids, which were explicitly not meant to apply to patients receiving palliative care,” Dr. Kollas told PNN. “Further, it is misleading for the DEA to infer that patients receiving higher doses of opioid painkillers are turning them away, when the vast majority of opioid overdose deaths are due to illicit fentanyl in counterfeit pills.”

How serious is the drug diversion problem? Not that bad at all, according to the DEA’s own National Drug Threat Assessment, an annual report that has shown for years that less than 1% of legally prescribed opioids are diverted.

“The number of opioid dosage units available in the retail market and the thefts and losses of opioids
hit their lowest level in nine years, ”the DEA’s 2020 report revealed.

The same report also found that illicit fentanyl, and not prescription opioids, is “primarily responsible for fueling the current opioid crisis.” This is a view shared by the American Medical Association, which said in 2020 that “the nation no longer has a prescription opioid-related epidemic.”

“Stop punishing pain patients”

If this makes you wonder why the DEA is so determined to further reduce the supply of opioids, you are not alone.

“This is sheer madness. Scientific data from the CDC and the National Institutes of Health (NIH) shows that the overdose crisis is NOT due to prescription opioid pain relievers, ”wrote Chuck Robertson, one of hundreds of people who left comments in the Federal Register on the DEA’s proposal. “We’re in the midst of the worst supply chain crisis in modern history, so you want to keep cutting production? All of this puts hospitals and pharmacies at risk of being short medications that people need for pain control. “

“Please do not reduce the production quotas for the opioids listed. There are hundreds of stories of people who need opioid drug therapy to live with even the most basic functionality, ”said Michelle Stifle, a 22-year chronic pain patient. “This inhuman treatment is discriminatory. Stop punishing pain patients for the mistakes of others.

“Please don’t cut the quotas anymore. My wife has several autoimmune diseases that cause horrible pain. She was completely cut off from her pain medication after almost 20 years of use, ”said Jeffrey Smith. “She never took more than prescribed and never abused it. This allowed him to live a little normally. Now she is in pain every day and has no more life. I’m afraid the time will come, she won’t be able to take the pain anymore.

“I was forced to stop my pain medication after taking it responsibly for 17 years. I now spend 75 percent of the time in bed. I cannot function and I am in constant pain, ”said Shelly Allen. “I recently tore my rotator cuff and couldn’t even get a few days worth. Where there may have been overprescribing, there is now underprescribing. It’s my body, why can’t I choose my own pain relief in reasonable doses? “

“We do not need further reductions in the supply of opiates. It does not help to avoid or cure addiction. Any further reduction in supply will only promote rationing of health care, ”Amber Smith wrote. “Opiates are needed for surgery and other medical needs. Would the DEA ever suggest cutting off chemotherapy or insulin supplies? No, but these are just as necessary for patients as opiates. “

To leave a comment on the production quotas proposed by the DEA for 2022, click here. Comments must be received by November 17th.