Basic Emergency Department Meds in Short Supply

Emergency physicians are spending time devising workarounds for shortages of IV solution and at least one life-saving drug because suppliers can't meet demand—in part because of manufacturing problems.

Like lots of emergency physicians, Carol A. Cunningham, MD, is used to occasional medical supply shortages and knows how to adapt. Finding workarounds and making modifications in the moment is simply a part of her job.

But her patience was sorely tried last winter when supplies of saline solution ran short.

Cunningham, who is state medical director for the Ohio Department of Public Safety's division of emergency medical services and emergency physician at Akron General Medical Center, says "It became really scary when we didn't have saline. I felt like we were practicing medicine in a third-world country. There was just no way of giving fluid resuscitation or treating dehydration intravenously."

While the saline and IV solution shortages have been among the most noticeable to clinicians and hospital staff over the last year, they have not been isolated supply chain problems. Basic supplies such as epinephrine, dextrose-filled syringes, and nitroglycerin injections have also been scarce.

"People think, 'we can use another drug,'" says Cunningham. "But… not all drugs are appropriate for all patients." Besides allergies or interactions, many drugs that are safe for adults are completely inappropriate for children. For some supplies, such as epinephrine, there is no clinically acceptable substitute. "For pediatric resuscitation, this is the drug," says Cunningham.

IV Fluids Shortage Continues in Hospitals

Room for Error
The experiences of William Jaquis, MD, chief of the department of emergency medicine at LifeBridge Health in Baltimore, mirror Cunningham's. "Sometimes, not even second-choice drugs have been available," he says. Jaquis says his team is often forced to figure out a substitute on-the-fly, then scramble to find supplies and calculate the correct dose.

"It delays the patient's treatment, and in the emergency room, minutes have impact. Those few minutes in these situations can be crucial," he says.

Jaquis also says he fears being held liable should a patient suffer a poor outcome as a result of being treated with a non-first choice medication, or due to delayed treatment. "It's a possibility we face every day anyway, and with the extra levels of complexity caused by dealing with these shortages, it creates even more potential for that to happen."

Quality Concerns
"The number of [medical product] shortages have increased, and it's concerning," says Curtis Rooney, president of the Healthcare Supply Chain Association (HSCA). He says serious quality issues have slowed down production and that has kept basic medical supplies such as saline out of stock over the last year.

"There have been manufacturing challenges. Upon inspection of IV bags, particles, and sometimes fungus or glass were found by inspectors. These are some serious issues you really don't want on market," he says. Rooney reports similar quality issues in the manufacturing of epinephrine and dextrose.

Bona Benjamin, director of medication use quality improvement at the Center on Medication Safety and Quality at the American Society of Health-System Pharmacists agrees that there have been major quality problems.

"We've held several meetings with stakeholders to try to figure out what's going on, but it's hard to say overall." She says that each manufacturer has stated a different reason for coming up short.

Benjamin uses a popular non-opioid anesthetic, Ketorolac, as an example. Its current shortage is caused by crystals having been found in vials of the product. "It's not of [the] quality you would want to see issued from a plant. This is now considered to be a contamination… You can't have injectable medications with crystals in them," she says.

With Saline in Short Supply, Hospitals Look for Alternatives

Having plants taken offline to remedy production issues has cut down on manufacturers' ability to supply the basics. "When you have a small number of manufacturers in a market and one drops, it increases the likelihood of a shortage. Other manufacturers just can't pick up the slack fast enough," says Rooney. His organization recently wrote a letter to the Food and Drug Administration urging a faster process for approving new manufacturers.

"We're very interested in bringing new entrants into the market," he says. "State and federal government entities are very limited in what they can do, which is why we've suggested new abbreviated new drug application approach."

In the meantime, Rooney's advice to hospitals is to attempt to work with their suppliers to see if they can get more of the supplies they might be low on. "I would call your [group purchasing organization]. If that doesn't work, you can try calling another local hospital, ask if they have anything to spare. Also, try wholesale distributors."

No End in Sight
Cunningham was surprised and relieved when the FDA began allowing saline from Europe to be imported to the United States last year, but she and the other leaders at her hospital felt the sticker shock. "The price went way up—it was five, maybe six times what we were accustomed to paying per bag. But at least we had some access to it," she says.

Cunningham also worries that community hospitals are especially vulnerable to shortages because suppliers might overlook them in favor of larger health systems, who are larger accounts. "If you are running a pharmaceutical company and there are not enough drugs to go around, and you if have one contract with a large, well known healthcare system and one contract with a small community hospital, who do you want to make happy? The winner will be the big-money client," she says.

Jaquis is also concerned about cost to his hospital and availability of these supplies. "There's generally a secondary market for these commonly used medications. It's a more competitive market than when you go through normal channels. It's like going to a ticket dealer the night before Ohio State plays Michigan for a Big Ten Championship. They have a limited supply of these basic materials, and your buyer is competing with a bunch of other people to get same medications."

Jaquis says his hospital tries to avoid doing this unless it's absolutely necessary, but sometimes, it's "something that we absolutely have to have."

Rooney hopes the FDA will consider approving more manufacturers in the near future, but he says it will be a long time before emergency department staff can breathe a sigh of relief. "Everyone is doing the best they can with what they have, but I'm not seeing the light at the end of the tunnel here."