The streets of America may be awash in opioids, but there's one surprising group of users that is having trouble getting hold of them: doctors.
Local health officials said the injectable versions of morphine, hydromorphone (Dilaudid), and fentanyl — staples of pain control and sedation in hospitals and hospices — are in short supply.
"The shortage of hydromorphone is beyond acute," said Beverly Philip, vice president of scientific affairs for the American Society of Anesthesiologists.
As a result, pharmacists are scrambling daily to find more and to figure out alternative dosing regimens. The constant changes put extra stress on hospital pharmacists, increase the risk of mistakes, and lead to waste and higher costs. Nishaminy Kasbekar, director of pharmacy at Penn Presbyterian Medical Center, said her hospital has had to turn to more expensive alternatives at an extra cost of $30,000 over the last three months. Three months ago, she said, the hospital could get 20 percent to 30 percent less of those three drugs than it wanted. Now, it's 50 percent to 60 percent less.
There are plenty of opioid pills, but they are often not appropriate for hospitalized patients or those in hospice.
Erin Fox, senior director of drug information at University of Utah Health, said the hard-to-get drugs are "absolutely essential, and hospitals use a very, very large amount of these."
The shortage stems from manufacturing problems and may be exacerbated by government regulations meant to prevent street sales of addictive drugs. A coalition of medical organizations on Tuesday urged the Drug Enforcement Administration to loosen its rules to help combat the shortages. The letter, signed by the American Hospital Association, the American Society of Anesthesiologists, the American Society of Clinical Oncology, the American Society of Health-System Pharmacists, and the Institute for Safe Medication Practices, raised the specter of postponed or canceled surgeries. "In some cases," it said, "this could prove life-threatening to the patient."
Small syringes and vials are in most demand, because they are safest and have long shelf lives. Pharmacies can split larger vials in a clean room, but drugs may be wasted and the resulting syringes expire much more quickly than the preloaded syringes that are in short supply.
Health officials said that so far, they have been able to avoid mistakes and keep patients' pain under control, but Louis Iobbi, pharmacy director at Doylestown Hospital, said he is worried. The hospital has enough opioids to care for patients for the next 2½ to three months, he said, but Pfizer, the dominant manufacturer, has told health-care providers that "some of this stuff might not be available until July, and that's a nightmare."
Pfizer has said its "full recovery date" is in early 2019, the letter to the DEA said.
At the Visiting Nurse Association of Greater Philadelphia's inpatient hospice, medical director Stanley Savinese said his morphine supply will last about two weeks. His supplier can find enough hydromorphone to get the hospice through March. The hospice is switching patients to oral drugs whenever possible and may soon have to rely more on suppositories. "The staff is not that crazy about that, and neither are our patients or the families," he said.
Terri Maxwell, vice president of clinical education at Philadelphia-based Enclara Pharmacia, which supplies medications to the VNA and other hospices, said her company was asking clients to "ration" injectable morphine and hydromorphone. Enclara can get the liquid morphine that caregivers give hospice patients at home, but people in inpatient hospice often need stronger stuff. "We have been strongly recommending that people reserve [injectables] for only people who have intractable and rapidly escalating pain," she said.
The shortage of opioids comes on top of a national shortage of intravenous solutions. Like other hospital pharmacy leaders, Kasbekar has a daily meeting — at 7:30 a.m. — to discuss what will and will not be available. While the IV-solutions shortage has been attributed largely to plant problems in Puerto Rico in the wake of Hurricane Maria, the opioids shortage is more complicated.
In some ways, it is a typical drug shortage. These are happening more and more, Fox said, when a dominant producer has manufacturing problems and smaller companies can't ramp up enough to meet demand. In this case, Pfizer controls 65 percent to 70 percent of the market for the injectable opioids now in short supply, she said. Steven Danehy, a Pfizer spokesman, said there is a "technical and process issue" with a supplier that makes a "key component" of the pre-filled syringe systems Pfizer uses.
What complicates the picture further is that these drugs are controlled substances, and the DEA limits how much can be sold. Over the last two years, the DEA has reduced the annual quotas for morphine, hydromorphone, and fentanyl by 35 percent to 46 percent. Barbara Carreno, a DEA spokeswoman, said the rules are meant to reduce diversion to illicit drug users and reflect actual medical usage of the drugs. The limits, she said, should not be causing shortages.
However, each producer gets its own quota. Danehy said Pfizer still expects to be able to meet its annual allotment eventually. It clearly isn't meeting expectations now. Meanwhile, Fox said two smaller companies that make the same products have said they asked the DEA to produce more but received lower increases than they wanted. The DEA considers data on individual companies' quotas "proprietary" and doesn't release it, Carreno said. Fresenius Kabi and West-Ward Pharmaceuticals, the two firms, did not respond to requests for comment.
Tuesday's letter to the DEA asked it to "temporarily reallocate or revise" its quotas.
The shortage comes at a time when many medical providers have been working to reduce opioid usage to prevent patients from becoming dependent on them.
"We will learn a lot from these shortages," said Michael Ganio, director of pharmacy practice and quality for the American Society of Health-System Pharmacists. "We may find that some of these efforts to conserve or use alternative treatments are just as effective."
Jeanmarie Perrone, an emergency medicine physician at Penn Medicine, said the shortage has given another reason to stress to residents that some patients may get some pain relief from non-opioids. But, she added, "it's pretty hard to run an emergency department without IV opioids."
Fox doesn't see much of a silver lining in the shortage. The last time there was a shortage of these drugs two people died because of dosing errors, she said. "It's just a huge amount of work for hospitals to deal with this," she said. "All that labor takes away from other things."