Drug Shortages: Your 20-Step Guide to Survival

Editor’s note: For the latest drug shortage information, see the latest reports from Bound Tree Medical.

A broken femur with no pain control. A seizure prolonged for want of Valium. An octogenarian’s nausea unabated for lacking Zofran.

Welcome to EMS vs. the drug shortage. What’s previously bedeviled less populous corners of American healthcare has spread deep and wide into the prehospital world, where accounts like those above are amassing at a disquieting pace. Nearly 16% of respondents to an April NAEMT survey believed they’d seen patients suffer adverse outcomes due to lack of a needed medication.

Beyond EMS, people are dying. At least 15 known deaths in healthcare facilities have been linked to errors associated with recent medication shortages. No one in their right mind thinks that can’t happen to us.

But for EMS, ensuring stable and sufficient supplies of the common, frequently used drugs we’re now jonesing to get seems a long way off.

“A key difference with this crisis, as opposed to some of the low-intensity skirmishes we’ve had with other drugs in the past, is that there doesn’t really seem to be an end in sight this time,” says Eric Epley, executive director of the Southwest Texas Regional Advisory Council (STRAC), which manages emergency and trauma care in a 22-county region that includes San Antonio. “The other times it seemed like there would be some endpoint—‘By mid April we’ll have it solved, and you’ll be back in shape.’ It felt temporary. This time seems like, ‘Yeah, we’re running out, and there’s not going to be a solution.’”

With that, you know there are steps you need to take. You’ve probably acted already to pinch down par levels and find alternative supplies and therapeutic substitutes and other work-arounds for things you can’t get. You’ll need to keep doing that. But there’s other stuff you can and should be doing too, for both the immediate and long terms. We’ve rounded that up in the following guide.

Much will depend on your circumstances, of course—things like state law and the policies of pertinent governing bodies. All of it may not apply to everyone. We can’t fix the complicated causes of this overnight.

But consider this: You’re acting for the long haul. You want to ensure enough drugs into the future. Building long-term resilience isn’t easy, and changing law and policy isn’t fast. But apparently we’re going to have some time.

Best Practices Anytime

Let’s start at the beginning. These are basic measures you may already have taken. Frankly they’re best practices even if your drugs are abundant. If you haven’t already, consider them soon, no matter your current situation.

1. Awareness—There may be, in isolated pockets of good fortune, providers or services not yet touched by the drug shortage. More likely there are some in affected services who aren’t fully aware of its scope and dimensions beyond what’s different in their drug box today. They should be.

“The most important thing you can do is communicate with your staff,” says Scott Matin, vice president of clinical and business services for New Jersey’s Monmouth Ocean Hospital Service Corp. (MONOC), a hospital consortium whose EMS arm fields more than 100 ambulances. “We want to make sure they’re completely aware of the situation. Not to scare anybody, but they need to know there may be a day when there are no substitutes and we can’t get anything from a compounding pharmacy. If everybody understands that, they’ll be more careful about waste and expiration dates and things like that. They’ll have more buy-in. If you don’t really see something as a crisis, you may not work as hard to find solutions and help avoid catastrophe.”

Keep up with what’s short and what else is happening through the FDA (www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm), American Society of Health-System Pharmacists (www.ashp.org/shortages) and BoundTree.

2. Know what you use and have—Situational Awareness 101. The rate at which your service goes through medications is largely predictable. Past use is a barometer of future use and will tell you, based on what you have on hand, how long you can operate with current stocks.

“History is a pretty good predictor,” says Jeff Beeson, DO, RN, EMT-P, medical director for the Emergency Physicians Advisory Board, which provides medical direction for Ft. Worth’s MedStar system. “Obviously things can arise, but for the most part, you should know you have a 30-, 60-, 90-day supply of whatever medication. Taking into account expiration dates, it really should not be a surprise to anyone that you’re running short on something. You should know it’s happening before it happens.”

If you have trouble obtaining, that will also buy time to compensate.

3. Reduce par levels—As supplies dwindle, toting around extra drugs you won’t use is a luxury you don’t have. Knowing what you use, adjust what you carry.

In 2010, by way of example, Oklahoma’s Emergency Medical Services Authority (EMSA) ran low on 50% dextrose. After crunching numbers on what they used, carried and kept in store, leaders found they actually required less than they thought. They cut ambulance stocks from 10 amps to 4, freeing up hundreds of amps to return to an inventory that was less than a week from running out. EMSA then repeated the process for other meds.

First-Line Measures

As they began running short, many systems have turned to first-line compensation measures like these.

4. Rotate stock—Prudent even in bountiful times, this has become vital to preventing waste.
“We’re trying to keep a much tighter rein on expiration dates,” says Matin. “Some medics are great about making sure the one that’s going to expire first is at the top of your drug bag; others aren’t so good at that. We’re really emphasizing it so we don’t have things expire.”

To help its providers do that more easily during the tumult of a call, MedStar’s logistics team began sticking red-dot labels to stuff needing used first. Says Associate Director for Operations Matt Zavadsky, “It’s an easy way to tell them, if you have three Carpujects to choose from, pick the one with the red dot, because it’s close to expiration.”

5. Flexibility in purchasing—Some lucky folks have never had to deal with multiple drug suppliers. Now it’s time to cast a wider net. Look for alternative sources, in particular hospitals. Be open to alternative packagings and concentrations. Consider emergency purchasing procedures to streamline the process and let you move quickly if you find a score.

Those good relationships with area hospitals you should have been cultivating anyway can cushion the blows here.

“Some hospitals may still have medications on the shortage list,” says Carol Cunningham, MD, state medical director for the Ohio Division of EMS, “and EMS may be able to get some from those stashes. Someplace like the Cleveland Clinic has huge stores of medications because of its size.”

Hospital-based EMS services have an advantage in tapping those stocks, and to be sure, many hospitals face scarcities too. And all sorts of regulations cover the buying and selling and transfers of hard drugs. But desperate is desperate, and taking a big-picture approach—i.e., it’s not my problem or your problem, but a patient problem and community problem—is the best way to muster a coordinated, comprehensive response.

“We’ve used various measures,” says emergency physician Jim Augustine, MD, FACEP, a medical director for several services who has lectured on the issue, “but our biggest relief to date has been in coordinating with hospitals to develop cooperative methods for stretching medications in the community.”

6. Alternative medications—If a needed med is unavailable, no caregiver has to be told to look to the next-best thing. But next-best things are next-best for a reason: not as effective, too expensive, side effects, etc. And shortages of one drug can create runs on and shortages of its replacement.

What’s worse, much of what we’re short on now has no good alternative. So, as your docs determine and states permit, use ’em if you got ’em, but this point is really about departments’ agility in obtaining and deploying viable replacements they can find, training providers in their use and following up with QA.

7. Just-in-time protocols—To that end, have a mechanism to incorporate changes quickly as evolving drugs, dosages and delivery mechanisms dictate.

“We’ve been really pushing EMS medical directors to create just-in-time protocols,” says Cunningham. “With any new medication, EMS practitioners need to have training—potential side effects, how to give it. It can be a challenge if you have something like a different concentration. In order to prevent medication errors, the more time you have for training, the better.”

8. Define ‘need’—Beyond what you carry, the new tightfistedness can extend to what you administer. This doesn’t mean denying a med to a patient in distress, just keeping a gimlet eye on what’s really necessary.

“The other thing to start looking at is whether something’s a lifesaving medication or a medication of convenience,” says Beeson. “Then you have a decision to make: Do you even look for an alternative, or is this just something you carry, you’ve used it once in 10 years, and maybe you don’t need to carry it because in the 20 minutes it takes to get to the hospital, it’s not really going to be life-altering? Those are decisions clinical and operations and medical direction teams have to discuss.”

The Next Level

These are strategies you may not have embraced yet, but that could help you fare better as shortages continue.

9. Incident action plans and management teams—This is a crisis. Treat it as you would a more conventional long-duration crisis.

“Developing an incident action plan and incident command structure to deal with this is kind of a novel idea,” says Augustine. “It’s where a number of our regions are headed to ensure there’s cooperation among agencies and develop rapid teams for addressing shortages as they change week to week. Outside of disaster settings, we’ve never had to put together incident action teams to make sure we had enough backboards or ambulances or anything else. But it’s an effective way of looking at supplies of medicines available in communities and deciding how we best can share and exchange them.”

10. Strive for consistency—The more you change in your drug box, the greater your risk for error. Change may be inevitable, but work for as much sameness—in concentrations, delivery methods, packaging and labeling—as possible.

“What we’re seeing throughout the country are errors,” says Beeson. “You may run out of a medication you’ve traditionally had in concentration A, and a logistics person finds it, but it’s in concentration Z. Paramedics are creatures of habit. It’s the only solo practice of medicine that exists. So when you grab your epi or whatever out of the box, you expect it to be the same all the time.”

To reduce error risk, the policy at MedStar is that any medication that goes out must be in the same concentration providers are used to using. If something is acquired in another concentration, the service has a pharmacy change it.

“You can’t have three concentrations of the same drug throughout your system just because each day you’re buying it from a different distributor,” Beeson adds. “If you have multiple concentrations out there, you’re inevitably going to have a medication error, just because you’re putting the providers at risk.”

11. Go slow—Related to that, it’s a good time to remind personnel giving meds to take their time and remain watchful. Err in haste, repent at leisure, as they say.

“Maybe one of the benefits of all this,” notes Zavadsky, “is that everybody learns to just take a minute, take a deep breath, slow down, and make sure what you have in your hand is what you’re desiring to administer to the patient. That could actually be a positive outcome.”

12. Go public—In March, when MONOC was out of Ativan and etomidate and nearly out of the Versed that replaced them, Matin went public. He issued a press release and got face time and ink locally and nationally, calling attention to the situation.

“My intent,” he says, “was to let the people of New Jersey, particularly the people we serve, know there’s a crisis, and in a short time we may not have the drugs someone needs when we come to their house. I think that was the responsible thing to do. We’re being as proactive as possible.”

Make sure the first your local media hears of the drug shortage isn’t from the outraged parents of a baby whose seizure your crew couldn’t stop.

13. Monitor errors and near-misses—Being able to report errors and close calls confidentially is an important safety measure with or without a drug shortage. With it, it becomes more so.

“In the systems where I work, we’ve tried to instill in our people that we really need to hear about near-misses related to this shortage,” Augustine says. “I think we’ll see systems developing some form of no-fault safety reporting process, so that we’ll be looking at both near-misses and misses prompted by this drug shortage. That would be a silver lining. Where errors or near-misses occur, we’d like to hear about them so we can attempt to address both the current issue and future risk management.”

14. Expired medications?—Drug expiration dates are generally pretty conservative, but your state will have to guide you here. Some are at this point: In April Utah moved to allow 18 different medications to be used up to six months post-expiration. Others have been more resistant, so don’t expect blanket permissions to give expired drugs, even if no alternatives are available. Some states have indicated they may not sanction those who have no other options. Some services have moved to test expired medications for potency, and some medical directors have authorized their use. The NAEMT survey found 22.5% of providers approved to use meds past their expiration dates.

“I think you really hate to waste something that’s in short supply when in your heart you know, and if scientifically it can be proven, it still works and will still benefit patients,” says Cunningham. “Wouldn’t you rather be able to give it and have it be 90% effective than not have it at all?”

“We know the effects of an untreated seizure,” adds Beeson. “We really don’t know the effects of using a medication that’s expired by a week or 30 days. So that’s a difficult decision medical directors must make, obviously keeping patient safety as their primary concern.”

Weigh this carefully if you’re pushed into a corner, and confer with your relevant state bodies, medical director and legal counsel now.

Bigger Tickets

Finally, here are some bigger-ticket, longer-term ideas that may take some time to establish, but can help systems weather the current crisis (however long it lasts) and any future recurrences.

15. Work collaboratively—The post-9/11 emphasis on regionalization, collaboration, mutual aid and helping each other out will pay off here.

In Texas, where they’ve recently dealt with things like hurricanes and H1N1, the regional structure is robust. STRAC is one of 22 such regional bodies across the state, and represents 71 EMS agencies and 53 hospitals. That’s provided a framework for cooperative response among a lot of people, sharing not only meds, but information, ideas, economics and the burden of coping.

“We had the table to sit at,” says Craig Manifold, DO, medical director for the San Antonio Fire Department. “It let us get the right participants together and brainstorm. We came together as agency directors and medical directors and said, ‘These are what we think the best practices are.’ As people had good ideas, we could incorporate them, and instead of individuals and specific agencies, we could put those best practices out on a regional basis, with direct communication with the people making the changes. That’s what really cements those processes in place.”

“We’re on the same charting product, and we meet together monthly, so we’re able to fall back on that when a crisis happens,” says Dudley Wait, EMS director for the city of Schertz. “If one of us is having trouble, it helps us get connected up, even 100 miles away.”

16. Regional buying—Collective approaches like the one in the San Antonio region also bring purchasing power. This will be especially important as you forge new relationships with people like compound pharmacists, whose services will be increasingly in demand (more on that in a moment).

“Instead of an individual organization contacting a compounding pharmacy, it’s better for a large group or region, because it decreases the cost significantly,” says Jeff Carson, RPh, chief of staff for San Antonio-based Oakdell Pharmacy, which is handling compounding needs for STRAC members. “If we were dealing with an individual EMS organization, the prices per unit would have been higher. With a regional group, we had some assurance there’d be a certain level of volume that allowed us to purchase raw ingredients at a much larger quantity, which lowered the cost.”

That means, for smaller services without big monetary clout, it’s time to find some big friends, or at least a lot of little ones. Adds SAFD Assistant Medical Director Emily Kidd, MD: “I think there’s no question, particularly for the smaller agencies that need smaller amounts to keep their stocks up, being able to purchase these drugs as a region has made a huge difference.”

17. Regional tracking—Meetings and e-mails and list-servers are great, but for real-time tracking of who’s got what, the STRAC group capitalized on its existing Web-based crisis information management system, ESi’s WebEOC. The tracking board it developed shows all members who’s in need of what and who might be able to help, allowing efficient allocation of limited stocks.

“WebEOC is something we use routinely for disaster response, and it’s relatively familiar,” says Epley. “We had the board built within about 3–4 hours of the conference call where the members spelled out what they wanted. That kind of flexibility is what has made WebEOC so valuable to us. You can build it to your specific needs.”

18. Compound pharmacies (today)—We’ve referred to these, and they’re already sustaining many EMS systems. The only reason they’re this far down the list is that they appear to be a major component of the solution going forward, and so merit inclusion in the “big” answers.

Compounding, of course, is the art of creating drugs and dosages. A compound pharmacist in New Jersey saved MONOC on its benzos. “We literally found one on Wednesday or Thursday,” says Matin, “and they turned it around for us by 8 p.m. on Friday, literally just in time for the weekend, when we for sure would have run out of benzodiazepines on some of our trucks. It was that close, and hence my suggestion to be proactive. Don’t think it can’t happen to you.”

Oakdell is a well-known pharmacy with four locations in the San Antonio area. It’s accredited, which is important. Kidd contacted Carson for help several months ago, and it was able to assist.

“Truthfully, many of those medications are not super difficult to make if you have the right facilities and staff,” says Carson. “The main issue we have is just the sheer volume of syringes and doses we put together. That involved a bit of ramping up and addition of staff and equipment, but to this point we’ve been able to handle it.”

The cons to compounding are shorter shelf lives and higher costs. But Carson notes that the shelf lives aren’t proven shorter, just not proven as long as manufactured drugs’. “As we go along and batches start to age,” he says, “we’ll have those times challenged and keep testing to validate them. It’s very likely those drugs are stable for as long as the manufactured drugs, but I can’t state that until I’ve proven it.”

Prices should come down over time, too, as per-unit costs drop with increased production and up-front costs for things like testing and evaluation are absorbed in initial orders.

19. Compound pharmacies (tomorrow)—Find compounding pharmacies by state at www.ecompoundingpharmacy.com, and get to know your local compounder—he’s likely to become a big part of your life.

“Unfortunately, the reality is, the drug shortage problem is not going to get better. It’s going to get worse. And it has to do with the inherent problem with the system,” says Carson. “If manufacturers continue to produce low-cost, high-volume drugs like morphine and fentanyl and Valium and Benadryl and things of that nature, they won’t get venture capital investment. They’re more interested in high-volume, high-dollar, large-target-patient-population drugs than the low-cost drugs that are common in EMS and other institutional uses. So I think we’re going to see involvement of compound pharmacies will only increase as time goes by.”

It’s true that the drugs scarce today aren’t big money-makers for manufacturers, and that would be sticky enough without all the complicating factors (production interruptions, lack of capacity, lack of advance reporting of discontinuations, reported raw material shortages, DEA quotas and more) also mucking up the current picture. Suffice it to say, this is the new normal, and if it’s pinching your pocketbook, well, at least you’re used to it.

“Short term, it’s not an issue,” says Wait. “If I have to get 40 syringes of Valium and spend $9 a syringe instead of $1, I can do that a couple of times. When I have to start doing that for Valium, Versed, fentanyl, morphine, amiodarone—when all of a sudden my entire drug inventory sees that kind of increased costs, or it continues for an extended period of time—then that is a cost in our industry that’s going to be very difficult to bear.”

“If morphine was $1 a vial and now is suddenly $9 a vial, so be it. But the reimbursement is lagging,” adds Epley. “We can’t charge for that and can’t get reimbursed for that. I think the market will eventually reset; the problem is, we’re having to live through the market figuring itself out. People will make drugs if they can make money at it; if they can’t make money at it, they’re not going to make them. The problem is, EMS and its patients are stuck in the middle. If it’s 36 months to reset, then it is, but during that time we have to figure something out so we can stop people’s seizures.”

20. Work to change the system—So we end up here. Don’t be misled by the terse summation or list-ending position. It’s as important in the end as anything you’ll do.

There are bills in Congress and executive orders and FDA activity and other federal efforts to address aspects of the problem. Learn about them and support them. State bodies have the authority to make some aspects of coping easier. Write, call and keep pressing them. EMS organizations at all levels are fiercely engaged too. Know what they’re doing and get behind them. This might not solve things quickly, but the alternative won’t solve them at all.

“We’re supposed to have one of the best healthcare systems in the world,” says Cunningham. “But imagine having a 40-year-old who has a sudden cardiac arrest, and you don’t have the epinephrine to treat him. Or a 5-year-old with seizures who’s in status, and you don’t have the medication to stop it. Then you look at the ground and think, My gosh, I’m standing in America?! That just shouldn’t happen.”