National EMS Drug Shortage Increases

 

 
 
 

Jeff Beeson, DO, David Lehrfeld, MD, Ray Fowler, MD & Craig Manifold, DO | | Thursday, February 23, 2012


We’re running out of essential medications for the care of our patients. A national shortage currently exists for many of the commonly used medications in EMS today.

What is the cause of this shortage? The federal agencies seem to be blaming each other, support organizations seem to be blaming the manufacturers, and most seem to blame the regulators. All this makes us—administrators of EMS systems—want to go swallow some Mentos and a Diet Coke.

Whoever is to blame for these shortages, everyone is EMS is feeling the effects. Patient safety is at risk because of the non-availability of many medications.

The first indication of the problem began in 2010 when cardiac epinephrine and Dextrose 50% (D50) were in short supply. It happened quickly. We suddenly found that we would have been out of these medications in less than a month, with no future delivery date in sight. At that time, many services chose to use substitutions, such as multi-dose epinephrine vials, have crews dilute 1:1000 epinephrine with saline or using D10% in water.

These options come with risks due to changes in concentration and usual practices. In hospitals, nurses commonly work with different physicians who order various dosages of the same medication. In the hospital, however, a pharmacist is generally available to change the concentration of a drug in a vial to some other concentration in that setting … carefully and meticulously.

In the chaotic environment of EMS though, we become creatures of habit. Just rearrange the medics’ jump kits and feel the wrath of the troops. We want the epinephrine to be in the same place, in the same box, at the same concentration—every time.

It’s often difficult for an EMS operation to completely change any single drug. With providers working different shifts and locations, similarity and consistency is a necessity. Multiple training challenges exist and frequent changes are a recipe for disaster, often at the patient’s expense.

There are many anecdotal stories of medication errors when drug concentrations, methods of delivery (carpujet vs. ampule) or packaging and labeling change. To reduce risk, we must to take all steps to maintain consistency in drug dosages and packaging, including the training and protocol re-writing that goes into making these changes. It’s very hard to do this overnight.

Crisis Worsens
An Internet search for drug shortages illustrates the extent of the problem. High-cost cancer drugs and therapeutics have the federal officials on the news addressing the shortage issues and acknowledging that this is an unacceptable practice. These medications typically affect only a small fraction of the population. However, the prehospital population far exceeds this population, and from an EMS perspective, we’re experiencing critical shortages of medications that cost less than $1 a dose (e.g., epinephrine, dextrose and benzodiazepine). These medications are essential to treat perhaps the most common life-threatening conditions that we manage.

It appears that there’s no easy fix for this problem and that shortages will continue. At this writing, the most recent report from a national vendor reveals shortages in morphine, fentanyl, midazolam, magnesium sulfate, lidocaine, versed and ketamine, with uncertain future delivery dates. This is a huge problem for us in our industry.

These shortages affect the treatment of some of the most critical emergency medical conditions for which EMS is requested. The inability to be able to treat severe pain, for example, due to the unavailability of narcotic analgesics presents a serious obstacle to EMS systems tasked with mitigating such situations as fractured femurs encountered by young children injured while roller-skating in the park, or the elderly with broken hips who are writhing in agony.

The public, our lawmakers and pharmaceutical company officials need to be aware that EMS crews may soon arrive at homes in which a child is actively seizing, in critical need of midazolam or diazepam to eradicate their condition, and not have these life-saving drugs available to treat them.

These are real shortages, affecting real people, putting our citizens in harm’s way.

It’s important that this drug shortage be corrected immediately to avoid forcing EMS systems, and their field personnel, to administer medications in concentrations that vary from existing treatment practices and protocols.

We’re putting both our patients and our providers at risk when we place new concentrations of familiar drugs—or emergently substitute unfamiliar medications—on a continuous basis within our systems. This isn’t acceptable to EMS medical directors.

We must insist on maintaining the same drug concentrations to decrease the potential for errors. To address these shortages, we EMS administrations, have at times had to trade, promise, cajole and beg to obtain these essential medications. Many EMS systems have been forced to extend expiration dates for a few weeks at a time to avoid a public healthcare crisis. These actions are being taken to be able to treat patients in critical need of these medications.

The Major Metropolitan Medical Directors Coalition feels this is an action that EMS medical directors must consider because it’s our responsibility to properly treat our patients and protect our crews and agencies.

Suggestions to Survive
First, we recommend that all EMS agencies monitor the usage of every medication deployed in their system. Historical data is very reliable on usage and can give you some guiding insight on the “par levels” that you set for each drug box.

You might consider reducing the par level for the drug box on certain medications, carrying three ampules of a medication rather than five, thus providing some extra medication to distribute throughout the agency. How much do you keep on hand? What’s your projected time until you run out? Having these answers will help you keep in close contact with your distributor.

Many EMS agencies are negotiating purchase arrangements with area hospitals. Often hospitals are the biggest purchasers of certain medications, and building relationships with the local hospitals may help manage drug shortages. State pharmacy statutes typically allow these purchasing arrangements, as does the Drug Enforcement Administration (DEA) regulations. On the other hand, don’t expect hospitals to be much help if they’re also running out of medications.

Inform your purchasing department that new emergency procedures need to be in place. If a non-approved vendor has a supply of a needed medication, you don’t have weeks to go out for bids. You need to purchase now.

A useful Internet site for monitoring shortages can be found at www.fda.gov/Drugs/DrugSafety/DrugShortages, last accessed February 14, 2012.

Second, assign someone to make sure that your “soon to expire medications” are used first. Don’t place the newest medications into the drug kit when the stock on the truck, for example, is near expiration. Swap them out, and place the drugs nearer expiration into the drug kit.

Third, consider extending expiration dates, though that is a decision that ultimately falls to the Medical Director to authorize. Some companies can examine your medications and extend the manufacturer’s expiration dates based on chemical testing and potency. Consultation with state agencies may be beneficial in the area of extending expirations dates, but even then, what’s the alternative?

Finally, medical directors can explore the possibility of using a pharmacy accredited by the Pharmacy Compounding Accreditation Board (PCAB) that can “compound” medications for their EMS agency.

Consult www.PCAB.org for accredited “compounding pharmacies” that may be able to provide many of the medications in short supply or unobtainable from existing supply sources. Compounding pharmacies have the ability to turn around orders from approved EMS agencies within one week of an order.

However, you must verify with state officials that such a practice is allowed in your state or Commonwealth. You must also be aware that compounding pharmacies, by law, must deliver controlled substances directly to the agency or medical director licensed by the DEA to oversee the EMS vehicles that will receive and use these medications.

Compounding pharmacies also need to ensure that a mechanism is in place within your agency to identify and recall compounded drugs in the event of a problem experienced in the field.

One of the authors’ agencies recently approached a compounding pharmacy to attempt to resolve a critical shortage of epinephrine and D50. Their local pharmacy took multi-dose epinephrine and packaged Epi 1:10,000 for them. They also took a 3 L bag of D50 to provide 50 mL vials. They’re now having this compounding pharmacy package other medications that they’re having difficulty obtaining.

Many areas are developing a regional approach to assist in dealing with this issue. There is safety in numbers, as well as using a multidisciplinary approach. Ensure hospital pharmacists, vendors, EMS agencies, medical directors and others have an understanding of the issue and its affect on patient care to develop local practices and guidance.

Despite the fact that the shortage of critical drugs is apparently not the result of a lack of raw materials, government agencies are reluctant to investigate and resolve this issue with pharmaceutical companies. And you can’t expect regulatory agencies to formally state that it’s OK to administer expired medications. Therefore, a regional approach may be best to ensure collective protection.

Pending some larger systemic solutions or government intervention to resolve these problems, the key is to think outside the box. Look for alternatives that aren’t normally used by our supply chains. Do you have a cache of Valium auto-injectors that could be used?

The American College of Emergency Physicians, National Association of EMS Physicians, National Association of EMTs, National Association of EMS Officials and others are feverishly working to find solutions. Legislature is being drafted to prevent these shortages from occurring again. But the problem will not end any time soon.

In the meantime, we must assess our issues while maintaining close communication with our crews, continually striving to ensure that we’re protecting our patients in a clinically sound and safe manner.

To minimize errors, avoid frequent changes to medications carried on the rigs. A strong emphasis on the basics is so important, such as concentrating on the five “rights” of medications administration: right drug, at the right dose, by the right route, at the right time for the right patient.

During this period of shortages—and if changes have been made—remind your clinicians to slow down, review the supplies and take extra precautions to prevent errors, checking and double-checking before administering anything.

It has been said that the Chinese curse is “may you live in interesting times.” Without a doubt, the crisis that’s occurring across the EMS industry regarding the shortages of critical medications will keep things “interesting” in our field for a long time to come.

 




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