Drug Shortage Crisis Worsens for EMS

 

 
 
 

Jeff Beeson, DO, David Lehrfeld, MD, Ray Fowler, MD & Craig Manifold, DO | From the April 2012 Issue | Monday, April 2, 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.

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 1:1,000 epinephrine with saline or use 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.

Although, in the chaotic environment of EMS, 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 are necessities. 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, EMS must 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.

The prehospital population far exceeds the oncology 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 the ambulance drug box.
It appears that there’s no easy fix for this problem and that shortages will continue. The most recent report from a national vendor at press time reveals shortages in morphine, fentanyl, midazolam, magnesium sulfate, lidocaine, versed and ketamine, with uncertain future delivery dates. This is a huge problem for us.

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 lifesaving drugs available to treat them.
These are real shortages, affecting real people and 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, EMS administrators, 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 do 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.

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 that are 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.
—Jeff Beeson, DO; David Lehrfeld, MD; Ray Fowler, MD & Craig Manifold, DO

PRO BONO

If you missed the big show in Baltimore, you missed a great conference. Here’s a glimpse of just a few of the “hot topics” talked about in the EMS law and risk management sessions sponsored by Page, Wolfberg & Wirth, as well as some quick “respected practices” that came out of these sessions:

Slow Down. Vehicle crashes are the biggest risk for EMS liability. Studies show that shaving a few minutes off of response time rarely makes a difference in patient outcome. With the increase in distracted drivers, we need to be more diligent in our defensive driving practices. Remember: If you arrive 30 seconds late, no one will remember, but if you arrive 30 seconds early and kill someone in the process of getting there, no one will ever forget.

Don’t Leave Patients Behind. Refusals of care are one of the highest risk areas for liability after crashes. Take your time to ensure that the patient has the capacity to make a decision to refuse care and carefully document your explanations and the patient’s response. Short scene times and poorly written patient care reports and refusals are key indicators of a problem in your system. Consider a medical review of all patient refusal cases, which some EMS systems have already implemented.

Don’t Drop People. As patients get bigger, there’s an increase in injury to patients and providers when lifting and moving. Make sure you have a policy on when “extra manpower” should be called, have good preventive health screenings of your staff and follow safe lifting and moving practices. Interestingly, non-emergent ambulance transports and wheelchair van transports seem to place patients at a higher risk for injury, perhaps due to the smaller number of staff who may handle these calls.

Don’t Commit Fraud. The government has really stepped up its enforcement of the fraud and abuse laws. Ambulance documentation of the patient becomes a key element in these cases. We need to tune up our patient documentation so that it paints a clear, accurate and objective “picture” of the condition of the patient at the time of transport, including such reasons as the patient needs to be transported by ambulance and can’t be safely transported by other means (if that’s the case). Ambulance documentation should always be honest—never make things up or misrepresent the condition of the patient. But on the other hand, the documentation should be complete and unbiased. Don’t let your dislike of transporting a non-emergent patient selectively cloud your documentation.

Finally, it’s all about attitude. There was lots of discussion about how a negative attitude is often the “root cause” of most liability. The bottom line is people don’t sue you if they like you. We need to set and communicate expectations to all members of our staff and then call people out on bad behavior when we see it—even if we aren’t a supervisor. We all have a professional responsibility to ensure that safe, competent and patient-centered care is provided to our patients. “What happens in the truck stays in the truck” is an unacceptable approach to managing risk in today’s highly litigious environment.

 




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Related Topics: Administration and Leadership, EMS drug shortages, drug shortage, Jems Priority Traffic

 
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