Across the nation, EMS agencies are grappling with what is becoming an increasingly worrisome situation: shortages of medications that are crucial for saving lives. Many in EMS report that, for the most part, needed drugs are still in their drug boxes. But stocks are running low, and they’ve been told by their suppliers that it’s unclear when the next shipment is coming in.
In Roanoke, Va., all members of Roanoke County Fire and Rescue were recently retrained to use midazolam instead of diazepam to control seizures. “Versed [midazolam] looks identical, but it’s twice as potent,” says Stephen Simon, division chief for the department. “So you can’t just send an e-mail out. You have to retrain each person individually.” And even that may be a temporary measure—midazolam, along with others in the benzodiazepine class of medications, is also running short.
The Southern Nevada Health District, the regulatory authority for EMS in Clark County, Nev., is trying to figure out what to do about its dwindling supply of morphine. EMS authorities there considered switching to fentanyl—only that drug is on the shortage list, too. And at American Medical Response, Chief Medical Officer Ed Racht, M.D., is working with his team to figure out if they can move medications to different AMR locations around the country, filling in where supplies are running low.
“It’s affecting us all across the country in various practices in different ways depending on local supply, local supplier and local utilization,” Racht says. “We’re like everyone else, looking at options, including changes in protocol and repositioning our drug stocks so we can get them to higher utilization areas. The worrisome drugs from our standpoint are shortages of the drugs used to treat or reverse a condition in which seconds or minutes make a difference.”
How did this happen?
The drug shortage crisis first emerged as an issue in 2010, when 178 “medically necessary” drugs ran short, according to the U.S. Food and Drug Administration (FDA). Since then, the problem has gotten worse: The number of drugs on shortage in 2011 hit at least 232, and 2012 is looking just as bad.
Initially, many of the drugs that garnered attention were cancer drugs, such as doxorubicin, used to treat ovarian and other cancers, and methotrexate, used to treat acute lymphoblastic leukemia in children. Today, the list includes a wide range of drugs, including anesthetics and lifesaving drugs used by EMS. They include the following:
- Atropine, used to increase heart rate
- Midazolam, lorazepam and diazepam, used to treat seizures
- Magnesium sulfate, used for eclampsia, or high blood pressure and seizures in pregnant women
- Ondansetron, to combat nausea
- Etomidate, used in conjunction with benzodiazepines to help with intubation
The reasons for the shortages are varied, and in some cases, murky. More than 80 percent of the drugs in short supply are generic, and more than 80 percent are injectables, according to a November 2011 report from the IMS Institute, a health care research group.
According to the FDA, consolidation in the pharmaceutical industry has left only a few manufacturers making generic—and less profitable—medications. In some instances, manufacturers have cited issues with quality assurance at their plants, leading production to be delayed; some drug makers have said they’ve had difficulty getting raw materials and components from suppliers. But others have simply decided to discontinue making drugs that are less profitable, and the FDA can’t require them to keep making them.
“Sometimes these older drugs are discontinued by companies in favor of newer, more profitable drugs …,” the FDA explains on its website. “This small number of manufacturers and limited production capacity for older sterile injectables, combined with the long lead times and complexity of the manufacturing process for injectable drugs, results in these drugs being vulnerable to shortage. When one company has a problem or discontinues, it is difficult for the remaining firms to increase production quickly and a shortage occurs.”
The federal government is trying to address the problem. On Oct. 31, 2011, President Obama issued an executive order requiring that drug-makers notify the FDA six months in advance for disruptions of sole source, medically necessary drugs. The advance warning has enabled the FDA to work with manufacturers to avoid shortages of some 100 drugs, according to the FDA. Importing the drugs from abroad is another stopgap fix: On Feb. 21 of this year, the FDA approved the importation of methotrexate and doxorubicin. Bills are also pending in Congress that would require manufacturers to notify the FDA well in advance of potential interruptions in supply.
Challenges for EMS
For EMS, dealing with the shortage poses particular difficulties, says David Slattery, M.D., EMS medical director for Las Vegas Fire & Rescue. While a hospital pharmacy, for example, might be able to move quickly to come up with an alternative drug, EMS follows specific protocols that can’t be changed overnight. And training a workforce that’s spread out over a large region and works different shifts poses logistical challenges.
“In a hospital environment, we have a huge cache of multiple medications that do the same thing. We can often easily replace one medication with another that does the same thing. In the field, we don’t have that option,” Slattery says. “We don’t have multiple medications that serve the same function. We have one nausea medication. One pain medication. There are many reasons for it. More medications mean more training. But it’s also the nature of the field—you just have to limit to the essentials.”
And there aren’t always alternatives. “The best example is the benzodiazepines—Ativan, Valium, Versed—the entire class is not available,” he adds.
In EMS, consistency is also important, says Rory Chetelat, EMS manager for the Southern Nevada Health District. In Clark County, for example, responders from all six fire departments and three EMS providers need to be using the same drugs, so that if a fire department starts the meds and an ambulance provider does the transport, everyone is following the same protocols.
“We don’t have the flexibility to change drugs willy-nilly,” Chetelat says. “Hospitals have pharmacists who are able to find substitutions, but we don’t have that luxury in the back of an ambulance, so we’re trying to find safe alternatives that don’t require switching drugs too frequently. When you switch drugs in EMS, it requires problems for training and education and increases the likelihood of medical errors.”
Another concern for EMS is that drugs have to be able to withstand high temperatures in the back of an ambulance compartment. A final consideration is cost, says Skip Kirkwood, deputy director and chief of Wake County EMS in Raleigh, N.C., and president of the National EMS Management Association. “In a hospital, if they have to use a brand-name drug, they can pass that cost through to the patient,” he says. “EMS agencies can’t do that.”
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So what can EMS do? Experts offer these tips for dealing with the shortage.
1. Don’t wait If you haven’t already, start coming up with contingency plans, because changing protocols and getting staff trained takes time.
2. Closely monitor what you have Make sure you know exactly what you have in your drug boxes, how it’s being used, and if you can shift supplies within your agency to make sure everyone has at least some of the medications in question. If you have several units or stations, consider moving supplies from less busy stations to keep the busiest ones stocked. Make sure soon-to-expire medications are used first.
3. Monitor changes daily Keeping track of which drugs are on shortage is a moving target, as shortages vary depending on what suppliers have been able to get their hands on. “One distributor may have Versed this week and another week they don’t, while another week someone else has it and the other doesn’t,” Chetelat says. The FDA maintains a frequently updated list of drugs that are currently experiencing shortages (see links at upper right). Keep tabs on it.
4. Get approvals to buy from other suppliers or distributors These are national shortages, but there is variation from region to region and supplier to supplier. If your purchasing agreements require that you buy from specific distributors, take steps to ensure that you can quickly buy from other suppliers if it turns out they have the drugs you need.
5. Extend expiration dates In Clark County, the EMS medical advisory board recently agreed to allow the use of eight drugs for six months past their expiration date. Those drugs are dopamine, adenosine, atropine, morphine, midazolam, magnesium sulfate, ondansetron and etomidate.
Research done by the FDA for the military years ago found that many drugs remain potent for years after their expiration dates, Slattery says. The research helped the board feel comfortable in allowing the drugs to be used past their manufacturer-determined shelf life. (The Wall Street Journal, which originally reported on the FDA research, quoted a former FDA official and director of the testing program as saying that some expiration dates are set to ensure there is turnover in the product, rather than “scientific” reasons.)
One study or one expert isn’t the final word, Slattery notes, and some medications lose potency faster than others. But the data suggest “they don’t go bad all of a sudden,” he says.
6. Carefully consider how you’re using drugs In Clark County, magnesium sulfate is used for three problems: eclampsia; toursades, a life-threatening heart arrhythmia; and severe asthma attacks. Because there are other asthma treatments and the research on magnesium sulfate in halting asthma attacks is mixed, EMS is looking at no longer using its dwindling supply of magnesium sulfate for asthmatic patients, Slattery says. “We are forcing ourselves to prioritize indications, if we get down to that critical level of medications,” he says.
Or, to help your morphine supplies last, consider “considerate use” protocols. Let’s say you have a patient with a badly broken ankle. It might be OK to use one vial on the patient, bringing the pain down from a 10 to a 4 or a 5, Slattery says, but hold off on breaking into a second vial. “We want to treat pain and give medications that are needed,” he says, “but if we’re dealing with a short transport time, maybe we don’t have to get the person completely pain-free.”
Another option, if supplies get low enough, is to not use the morphine on the patient with the broken ankle at all and first try to control the pain with splinting, elevation and ice, Chetelat says. “You might save the morphine for the woman with the broken hip who we can’t move because she’s in agony,” he says.
7. Find out about alternative medications Alternatives for the benzodiazepines are not ideal, Slattery says. They include propofol and barbiturates, neither of which has a great safety or side-effect profile. “We don’t want to go there unless we have to,” he says. “What we’re hoping to do is extend our supply and extend the amount of drugs we have by redistributing them and using ‘considerate use’ protocols to make them last as long as we can.”
