As the opioid crisis continues to claim lives in Buffalo and around the country, hospitals and hospices face an unnoticed and ironic crisis of their own: a shortage of injection opioids that threatens to leave patients in pain.
"The poor cancer patient is the collateral damage of this drug shortage," said Candace S. Johnson, chief executive officer at Roswell Park Comprehensive Cancer Center. "This could be a national disaster."
Roswell is burning through upwards of $150,000 a month coming up with makeshift solutions to the shortage of injection opioids and other drugs that are in short supply. Erie County Medical Center is hoarding painkillers and switching some surgery patients to other drugs. With opioids delivered in syringes in short supply, the company that runs Hospice Buffalo is delivering painkillers to some patients through anal tubes. And pharmaceutical experts nationwide worry that the shortage could lead to unnecessary suffering and even deadly medical errors.
Experts blame the shortage primarily on a problem at a Pfizer plant in Kansas – but also to some degree on the government's crackdown on opioid manufacturing.
“It is a shocking and unacceptable paradox to know that people having surgery in Buffalo, or sick children with cancer, are sitting in hospital beds right now, faced with the very real prospect of being in more pain than need be because of bureaucratic finger-pointing and lack of timely and effective action,” said Senate Minority Leader Charles E. Schumer, a New York Democrat who last week asked the Drug Enforcement Agency to lift production quotas that may be limiting the supply of legal opioids used at hospitals nationwide.
At issue is a shortage of pre-measured doses of hydromorphone, morphine and other injection opioids, which doctors in hospitals and hospices routinely use to treat the pain caused by some cancers and traumatic injuries.
Hospitals use these medications for in-patients only, so those drugs operate in a largely different market than the rogue prescription drugs, heroin and fentanyl fueling the nationwide opioid epidemic, which claimed 268 lives in Erie County alone last year.
That market for legal injection opioids is so tight that Johnson worries that Roswell Park's patients may eventually feel the shortage's pain.
Roswell Park typically has about 125 cancer inpatients at its facilities, and about 80 percent of them rely on opioids to manage the intense pain caused by many cancers. So far, Roswell Park has been able to cope with the shortage by putting its pharmacists to work remixing, dividing up and repackaging opioids that would normally come pre-packaged in individual doses.
"If what we need is not available, we have to get the raw materials and compound them," Johnson said.
Doing so is expensive. Roswell officials said the hospital has burned through nearly $2.7 million in 18 months to come up with in-house fixes to shortages of opioids and other drugs.
The drug shortage is causing similar troubles at all the region's hospitals, said Dr. Brian M. Murray, chief medical officer at ECMC.
As the region's only level one adult trauma center, ECMC uses opioids to treat everything from broken hips to gunshot wounds to injuries sustained in car crashes. In addition, the hospital does 10,000 surgeries a year – and amid an opioid shortage, it has to do things differently.
"The first thing you try to do is procure supplies," Murray said. "When things like this happen, people start scrambling, buying up every vial there is" of prescription opioids.
Beyond that, the hospital's pharmacy is compounding its own drugs the same way Roswell is, while adjusting the way it treats patients, Murray said. Patients who can take opioids orally get their medicine that way, because those painkillers are not in short supply. And the anesthesiology department is using alternatives to opioids, such as nerve-blocking agents, when possible.
Meantime, at the Center for Hospice & Palliative Care – which runs Hospice Buffalo – doctors are carefully parceling out opioids so that no patient is in pain, but sometimes switching to less-than-perfect alternatives. Thanks to the shortage of injection opioids and the fact that some patients can't take medicine orally, some people are now getting opioids delivered through the rectum, said Dr. Christopher Kerr, the organization's chief executive officer.
"Are these solutions ideal? No," said Kerr, whose organization serves between 900 and 950 people daily, with about half in pain management and half in end-of-life care. "Are we spending a significant amount of time and energy dealing with this? Yes."
By no means is the shortage exclusive to Buffalo. Five national medical groups, led by the American Hospital Association, recently wrote to the U.S. Drug Enforcement Agency to say that if the shortage gets any worse, medical care will be affected.
"With no appropriate opioids available, operations would have to be postponed or canceled. In some cases, this could prove life‐threatening to the patient," the letter said.
What's more, the hospital group and the other medical organizations warned that the shortage could lead to prescription errors. After all, it's much more risky for a pharmacist in a lab to concoct the right dose for a patient than it is for a nurse to use a pre-measured syringe of the same drug.
The shortage started to grow worse when Pfizer – the main supplier of injection opioids – trimmed back production at its plant in McPherson, Kansas, last June, as it began upgrading the facility.
Then one of Pfizer's suppliers of a key component of its pre-filled syringes experienced a quality-control problem, prompting Pfizer to place a temporary hold on its shipment of all such products. Pfizer is now working with the supplier to fix the problem, while also looking at other alternatives for bringing those prescription opioid products back on the market.
“We recognize the importance of these medicines to patients and physicians and are committed to resolving these shortages as quickly as possible," said Pfizer spokesman Steven Danehy.
It's important that Pfizer does so because the drug giant controls at least 60 percent of the market for prescription opioids and other producers don't have the capacity to fill the void that Pfizer left, said Erin R. Fox, senior director of drug information at the University of Utah School of Medicine.
"If Pfizer didn't have an issue with their plant, we wouldn't have a shortage," Fox said.
Lawmakers contend, though, that the federal government has made matters worse. To fight the opioid epidemic, the U.S. Drug Enforcement Agency has placed production quotas on the makers of legal prescription opioids. And that fact has prevented some other drug companies from at least partly filling the gap in the market caused by Pfizer's production problems.
"We have the manufacturers ready and willing to make the medications; we have hospitals begging for the supply and wringing their hands worried that they will run out," Schumer said. "It is unconscionable for the DEA not to act with the urgency that the situation requires."
Rep. Brian Higgins, a Buffalo Democrat, has been a leader on the issue, too, firing off letters this week to the DEA, its inspector general and the Food and Drug Administration to try to get some answers and action on the drug shortage.
"You've got a justifiably aggressive Drug Enforcement Agency playing a major role on the supply side, but there are legitimate and highly regulated dispensers of these prescription drugs that are in short supply," Higgins said. "There needs to be a balance, and that's what we're seeking."
The DEA has already been working to strike a better balance, said Katherine M. Pfaff, an agency spokeswoman.
"DEA allocates quotas for active ingredients and does not have the ability to dictate what product and in what form or strength a manufacturer will produce," she said. "However, we are communicating with those affected by ongoing production issues and have made accommodations to manufacturers to cover the medical need of prescription drugs as the market supplies have shifted. DEA is confident these steps will avoid any shortages.”
It's too soon, though, for medical professionals in Buffalo to notice those changes.
Asked if any patients had to go without painkillers they really need, Kerr, of the company that runs Hospice Buffalo, said: "We're on the fringe of that now – the fringe of not having enough drugs."