The DEA’s 2025 quotas for opioids will leave seriously ill patients in pain

A woman sat in our emergency department in agonizing pain, feeling shaky, nauseous, and weak — drug withdrawal was setting in. But she wasn’t a “junkie” or even a recreational drug user. She was in her mid-60s with advanced cancer in her ovaries that had spread to her abdomen, causing unbearable pain. She was my patient — let’s call her Teresa.

As her palliative medicine doctor, my role was to treat Teresa’s pain as she endured the burdens of her cancer treatment. Only her prescription morphine gave her the relief she needed to function and enjoy some small pleasures, like walking her dog in the park. But one day, her pharmacy didn’t have her morphine in stock, nor did five other neighborhood pharmacies that she went to. I called another three pharmacies before finding one with a two-week supply available — but it was a 40-minute drive from her home.

advertisement

This didn’t solve the problem. Ten days later, when her prescription ran low again, the refrain was the same: “We don’t have that in stock.” Pharmacies either had no supply or could provide only a few days’ worth. I eventually changed her morphine to another opioid called oxycodone after finding a pharmacy that had it in stock. This switch required a new prior authorization from her insurance, an authorization that didn’t clear before Teresa’s prescription ran out again. Exhausted and in pain, she called 911. Teresa, like so many others in this country, had fallen victim to a broken system that makes it increasingly difficult for people like her to access the medication they need to survive.

Unfortunately, Teresa’s situation is common — and about to get worse. The Drug Enforcement Administration (DEA) has proposed further cuts to the aggregate production quotas (APQs) for opioid medications in 2025. These quotas determine how much opioid medication can be legally manufactured in the U.S. each year. The DEA has been reducing them steadily since 2017 to combat the opioid overdose epidemic, and patients like Teresa are paying the price.

The opioid crisis is real, and addressing it is critical. More than half a million Americans died from an opioid overdose between 1999 and 2020, and though deaths have recently decreased, the epidemic continues to grow.

advertisement

But today, the real culprits in the opioid epidemic are illicit street drugs like fentanyl. While earlier waves of the opioid epidemic were driven by commonly prescribed opioids like Oxycontin, today, they are only a drop in the bucket compared to the flood of illicit fentanyl driving overdose deaths.

The reality is that hundreds of thousands of seriously ill patients in the U.S. rely on opioids as a first-line treatment for pain. For people with advanced cancer, chronic organ failure, or other life-limiting conditions, opioids are often the only medications that can effectively control pain and allow them to function. The American Society of Clinical Oncology and the Centers for Disease Control and Prevention both recommend opioids as first-line treatment for moderate to severe cancer pain. The World Health Organization has classified opioids like morphine, hydromorphone, oxycodone, and fentanyl as essential medicines for decades.

Yet in recent years, accessing these medications has become a herculean task. Pharmacies routinely run out of stock. Doctors like me spend hours on the phone trying to find enough supply to treat our patients and keep them out of the emergency room — time that would be better spent caring for patients. At my own institution, our palliative medicine physicians report regular opioid shortages leading to poorly controlled pain for their patients.

A recent survey of 2,800 people across the country living with chronic pain paints an even grimmer picture: 90% reported delays or difficulties in filling their opioid prescription, mainly because pharmacies didn’t have the medication in stock. The Food and Drug Administration and the American Society of Health Pharmacists are also reporting widespread shortages of essential opioids, including morphine and hydromorphone. The proposed 2025 reductions to opioid production quotas will only deepen this crisis.

As a palliative medicine doctor, I know the complexities and risks of opioid use. That’s why we now have careful monitoring and safeguards to ensure these medications are used appropriately. These safeguards are working.

advertisement

Let’s also be clear: Quotas and resulting shortages of prescription pain medicines are not helping to prevent overdose deaths. The real problem is illicit fentanyl being smuggled into the U.S. from other countries like China and Mexico. Quotas are simply turning vulnerable patients with serious illness into collateral damage in a misguided effort to address the opioid epidemic. For most people with serious illness, pain is inevitable, but suffering doesn’t have to be. The DEA needs to reconsider the proposed 2025 cuts in opioid production to make sure that patients with serious illness don’t become the innocent victims of the war on drugs.

Dr. Rebecca Rodin is a clinician scientist and assistant professor of geriatrics and palliative medicine at the Icahn School of Medicine at Mount Sinai. She is board-certified in hospice and palliative medicine and internal medicine and conducts population-level research to improve symptom burden and quality of life among older adults with serious illness.