Hospitals are experiencing an ongoing shortage of clinical injectable opioids—and providers say it's limiting them from treating severe, acute pain to the best of their ability.
About the shortage
The opioids in short supply are not prescription pills but rather packaged vials, patches, and syringes that are distributed to hospitals and other medical providers, according to STAT News. The medications are intended to treat pain in patients who are undergoing major surgery or are experiencing severe pain due to trauma or cancer. The specific medications include injectable morphine, Dilaudid, and fentanyl, Kaiser Health News reports.
The shortage, which industry experts largely attribute to manufacturing issues at Pfizer, comes amid a federal push to reduce the use of prescription opioids. As part of that effort, the Drug Enforcement Administration (DEA) last year sought a 25% reduction in production of all opioids and a 20% additional reduction this year.
Pfizer spokesperson Steve Danehy said the shortage of clinical injectable opioids began in June 2017 when the company scaled down production of the drugs while upgrading a plant in Kansas. Pfizer, which holds at least 60% of the injectable opioids market, also said it is experiencing "technical and process issue[s]" with an unnamed third-party supplier, and is not currently distributing prefilled syringes "to ensure patient safety."
The lack of competition and additional manufacturing capacity also has exacerbated the shortage, STAT News reports. Michael Cotugno, director of pharmacy services at Brigham and Women's Hospital, said production margins are a concern for providers. "In this case, the production margins were so slim that one company undergoes modernization of their plants, and the whole system is in disarray," he said.
How hospitals are mitigating the shortage
According to KHN, hospitals and health systems around the country are adopting multiple strategies to cope with the shortage.
For instance, Brigham and Women's has launched an incident command system in which doctors, nurses, and pharmacists meet every morning to discuss the shortage issue. While the hospital has not had to scale back services or ration medicines, providers are taking efforts to conserve what they have by emphasizing alternative pain management options, STAT News reports. In addition, Brigham and Women's regularly reaches out to wholesalers to stock up when additional supply is available.
Scott Knoer, chief of pharmacy at the Cleveland Clinic, said the system is tracking inventory closely and using alternatives when possible. According to Knoer, such strategies include using oral opioid medications for patients or using IVs to deliver Tylenol—a drug that costs $37 per vial compared with morphine's cost of $2 per vial. "There is a real cost to drug shortages," Knoer said. "This month it's opiates. It's going to be something else next month. This revolving door means something is always going to be short. You're never over it."
Other affected hospitals, including Kaiser Permanente and Dignity Health, said staff are making efforts to be more conservative with what they have and use alternatives when needed. And Shalini Shah, head of pain medication at UC Irvine Health, said Irvine has established a 20-person team that meets for an hour twice a week to assess the shortage and has established several alternative pain treatment options, such as using oral opioids or local anesthetics.
Howie Mell, an emergency physician and spokesperson for the American College of Emergency Physicians, said some EDs also have considered using nitrous oxide—also known as laughing gas—for pain patients. And some hospitals have postponed elective surgeries because of the shortage, according to the American Society of Anesthesiologists.
Providers warn about shortages effect on patient care
Providers and medical groups have raised concerns about the drug shortage's effect on patient care, KHN reports.
A coalition of professional medical organizations—including the American Hospital Association, the American Society of Clinical Oncology, and the American Society of Health-System Pharmacists—in a February letter to the DEA warned that drug shortages "increase the risk of medical errors" and are "potentially life-threatening."
Marchelle Bernell, a nurse at St. Louis University Hospital in Missouri, separately said a shortage makes it easier for mistakes to occur. In a fast-paced environment, a nurse might forget to program an electronic pump for the right dose when given an unfamiliar mix of medication, KHN reports.
Beverly Philip, a Harvard University professor of anesthesiology who practices at Brigham and Women's, explained, "The system has been set up safely for the drugs and the care processes that we ordinarily use," adding, "[If] you change those drugs, and you change those care processes, … the safety that we had built in is just not there anymore."
Providers ask DEA to ease controls
To help mitigate the current shortage, the medical groups asked the DEA to ease quotas on opioid production for liquid opioids. Under current regulations, if a major drug maker, such as Pfizer, hits a roadblock in production, smaller manufactures have to petition DEA to boost their own levels of production, KTAR News reports.
The shortage also has gained congressional attention, with a group of senators recently filing a bill that would make it easier for DEA to change its quotas and respond to new production problems.
DEA spokesperson Katherine Pfaff said the agency is working to address the issue as fast as possible. "We are communicating with those affected and are considering all possible solutions, including the adjustment of production quota," she said.
At Pfzier, Danehy said that the company "recognize[s] the importance of these medicines to patients and physicians and [is] committed to resolving these shortages as quickly as possible." He continued, "To that end, we are exploring the feasibility of increasing capacity within the global Pfizer manufacturing network and potential third party suppliers" (Ross, STAT News, 3/15; KTAR, 3/16; Bartolone, Kaiser Health News/Washington Post, 3/16).
Learn more: How to combat the opioid epidemic
Opioid misuse and abuse is one of the most pressing public health issues in the U.S., and hospitals and health systems are on the front lines. Currently, most health systems focus their opioid management efforts on select medical specialties.
This report outlines three imperatives to guide hospitals and health systems in their efforts to reduce the impact of inappropriate opioid prescribing and misuse.