Saturday, April 6, 2024

The D.E.A. Needs to Stay Out of Medicine

Even when her pancreatic cancer began to invade her spine in the summer of 2021, my mother-in-law maintained an image of grace, never letting her pain stop her from prioritizing the needs of others. Her appointment for a nerve block was a month away, but her pain medications enabled her to continue serving her community through her church. Until they didn’t.

Her medical condition quickly deteriorated, and her pain rapidly progressed. No one questioned that she needed opioid medications to live with dignity. But hydrocodone and then oxycodone became short at her usual pharmacy and then at two other pharmacies. My mother-in-law’s 30-day prescriptions were filled with only enough medication to last a few days, and her care team required in-person visits for new scripts. Despite being riddled with painful tumors, she endured a tortuous cycle of uncertainty and travel, stressing her already immunocompromised body to secure her medications.

My mother-in-law’s anguish before she died in July 2022 mirrors the broader struggle of countless individuals grappling with pain. I’m still haunted by the fact that my husband and I, both anesthesiologists and pain physicians who have made it our life’s work to alleviate the suffering of those in pain, could not help her. It is no wonder that our patients are frustrated. They do not understand why we, doctors whom they trust, send them on wild goose chases. They do not understand how pharmacies fail to provide the medications they need to function. They do not understand why the system makes them feel like drug seekers.

Health care professionals and pharmacies in this country are chained by the Drug Enforcement Administration. Our patients’ stress is the result not of an orchestrated set of practice guidelines or a comprehensive clinical policy but rather of one government agency’s crude, broad-stroke technique to mitigate a public health crisis through manufacturing limits — the gradual and repeated rationing of how much opioids can be produced by legitimate entities. This is a bad and ineffective strategy for solving the opioid crisis, and it’s incumbent on us to hand the reins of authority over to public health institutions better suited to the task.

Since 2015, the D.E.A. has decreased manufacturing quotas for oxycodone by more than 60 percent and for hydrocodone by about 72 percent. Despite thousands of public comments from concerned stakeholders, the agency has finalized even more reductions throughout 2024 for these drugs and other commonly prescribed prescription opioids.

In theory, fewer opioids sold means fewer inappropriate scripts filled, which should curb the diversion of prescription opioids for illicit purposes and decrease overdose deaths — right?

I can tell you from the front lines that that’s not quite right. Prescription opioids once drove the opioid crisis. But in recent years opioid prescriptions have significantly fallen, while overdose deaths have been at a record high. America’s new wave of fatalities is largely a result of the illicit market, specifically illicit fentanyl. And as production cuts contribute to the reduction of the already strained supply of legal, regulated prescription opioids, drug shortages stand to affect the more than 50 million people suffering from chronic pain in more ways than at the pharmacy counter. (...)

Paradoxically, the D.E.A.’s production cuts may drive patients to seek opioids on the illicit market, where access is easy but drugs are laced unpredictably with fentanyl, xylazine and other deadly synthetics. My patients confide that they cannot go through cycles of pain relief and withdrawal and cannot spend hours in the emergency room; in their minds, they have no choice but to turn to the streets. (...)

The D.E.A. isn’t new to this criticism. As recently as January, it insisted that manufacturing issues or other supply-chain disruptions were the real issues limiting patient access to pain medication, not manufacturing quotas or the imposition of limits. And the agency suggested that action would be taken if the Food and Drug Administration told it about shortages, which the F.D.A. hasn’t so far. But when more than a third of health care professionals attest that their patients struggle to fill opioid scripts, something is clearly not working. The D.E.A.’s responses read more like a deflection of blame than a serious strategy.

My profession makes me acutely aware of opioid risks, including addiction and overdose, but at times and under careful dosing and monitoring, opioids are the right choice for our patients. Still, some health care providers are reluctant to prescribe them, even for cancer pain, for which opioids are a mainstay of treatment. Many cited opioid dispensing at pharmacies as a barrier.

This is concerning, since untreated pain is associated with decreased immunity, a worsening of depression, reduced mobility and adverse effects on quality of life. Ineffective pain management has also been associated with increased medical costs. Among people with sickle cell disease, for instance, 10 percent of patients account for 50 percent of emergency room visits. Although they suffer from other possibly contributing disorders, the common feature among them is chronic pain.

Dangerous prescription drugs require safeguards, but a scalpel has more promise than a sledgehammer. The D.E.A., an agency staffed with law enforcement officials, is not equipped to distinguish appropriate from inappropriate prescribing, and it has apparently confused inappropriate with criminal. Instead of defining medical aptness, the D.E.A. should pass the baton to our nation’s public health agencies.

Collaboratively, the Centers for Disease Control and Prevention, the Food and Drug Administration and the Department of Health and Human Services can take a tailored, more precise approach to opioids that is informed by medical and clinical acumen. The F.D.A., in particular, should strengthen existing risk evaluation and mitigation strategies programs, which place controls on individual medications and respond to signs of inappropriate prescribing. Although such programs have not always responded effectively, they can be improved with planning, time and resources. And lastly, the government should strip the D.E.A. of its authority to suspend providers’ controlled substance licenses when dangers arise and should hand that power over to these public health agencies.

by Shravani Durbhakula, NY Times | Read more:
Image: Ben Hickey
[ed. Hear, hear. Why is a drug enforcement agency in charge of pharmaceutical supply? Since the opioid hysteria started, the situation has only gotten worse - not because of prescription practices (which can be monitored and controlled, unlike street drugs) - but because patient needs are not being met. The "pill mills" and unethical doctors of yesterday were weeded out fairly quickly, but we continue to see legitimate pain patients (I was/am one of them) denied access to drugs that would allow pain maintenance and a productive life. There's a difference between addiction and dependency, and anyone who conflates the two is either misguided and/or uninformed at best. As one commenter put it: "How, as a society, have we gotten so far off-track, punishing patients for the abuse of addicts? If such a law were applied to driver’s licenses, we would take cars away from safe drivers to keep bad drivers off the road."]