'Drug Shortage Action Plans for EMS' Webcast Q & A


 
 

Jeff Beeson, DO | | Tuesday, May 8, 2012


Editor's Note: If you missed the webcast, don't stress! You can watch the archived event and even share it with your colleagues!

Question: We carry morphine, Valium and Versed. What do we do/substitute?
Answer: Morphine is an opiate analgesic. You can substitute Fentanyl but it is also on the shortage list. There are some non-narcotic analgesics like toradol, or use an agonist-antagonist opiate like nubain or stadol.
Valium and Versed are benzodiazepines and the only other in that class that can be given IV is lorazepam (Ativan). One option if needing a benzo for seizures is the valium auto injectors used in the nerve agent (CANA) kits.

Question: Why is it important to put pressure on the local and state governments? Is it because the federal government will take too long?
Answer: The local governments regulate the practice of EMS. Each state licenses the EMT/Medics and Physician’s and the local regulatory bodies will be the ones that fine/charge you if some law is not followed. Certain states have specific drug lists that you must or can only carry. If those medications are not available, you must have them allow the deviation. If we have to use a medication past the expiration date, the local authorities will be the ones who have to support us. The federal government has no oversight over these issues.

Question: Should the EMS system be given priority for supplies of critical medications? Conversely, are there medications that should be prioritized for hospital supply?
Answer: We are all in the same business. An argument could be made for either side. I do know that most hospitals purchase in large groups and are usually given preference due to the amounts purchased. This should be approached on a local level working with your distributors and hospitals.

Question: What was the system mentioned early in the presentation which facilitated the sharing of drugs between agencies?
Answer: The San Antonio Regional Trauma Advisory Council in south Texas uses EM Systems, a web based emergency management program, to locally track needs and offers an area if you have something to provide for some other agency.

Question: The Dallas VA Medical Center has case after case of saline and ringers that they are auctioning off due to printed expiration dates. Shelf life is questionable on them. Is there a rule of thumb on their use if the fluids are clear and free of visible contaminates or particulate matter?
Answer: There is no rule of thumb. The FDA approves the shelf life based upon information the manufacturer presents to them. We do know if any medication is stored outside of the manufacturer’s temperature ranges, chemical decomposition is accelerated. There are some companies that will test potency to assist in the use by date extension but they do not extend the expiration dates.

Question: In a critical situation, is there any viable application of antibiotics marketed for fish? Most are the drug with no other added chemicals (i.e., Amoxicillin, epinephrine auto-injectors, etc., are extremely cheap).
Answer: I am not a veterinarian so I am unaware of animal medications. The only medications approved for use in humans are those approved by the FDA for that purpose.

Question: What would you recommend prehospital providers do when they are faced with a hospital that does not replace their medications due to shortages?
Answer: Start looking into EMS distributors. There are many who specifically sell to EMS agencies. You may also work with a local pharmacy in your area who can also help find medications you need.

Question: We have been told that we cannot exchange controlled substances, morphine for example, between providers. How are you addressing exchanging controlled substances between providers while still meeting the DEA requirements for tracking?
Answer: Any movement of a controlled substance must follow DEA regulations. If you have questions about what forms to use and policies concerning that, I would refer you to your local DEA office as each region has different interpretations of the rules.

Question: There's a large variability in how regional DEA agencies interpret and enforce their rules. There's often additional conflict between State Board of Pharmacy and the regional DEA. Do you have any suggestions for EMS to get consistent response from the DEA?
Answer:
NO response from the DEA. Contact your local DEA office for guidance.

Question: There's been discussion about accessing the Strategic National Stockpile (SNS), particularly for benzodiazepines. Has there been any movement on that?
Answer: I am unaware of specifics but know that has been discussed. If that decision were to be made, it would first be on a local level that would then advance the request up to higher authorities so once again, work on a local level.

Question: Have any states had any progress on declaring a public health emergency and tapping into any federal supplies?
Answer: I know that Oregon and Utah have put our public health notices. I am not aware of any movement into federal supplies.

Question: We pull our mediations based on a 90-day period due to temperature variations. Is that really a necessary step?
Answer: Each medication has different temperature requirements. I would refer you back to the manufacturer’s information about that medication. I do know that temperature greatly affects the potency life of the medications so yes, it is probably a necessary step.

Question: Is it even a possibility to use medication besides benzodiazepines in the field to control seizures?
Answer: There are a few antiepileptic medications available for IV use. Benzodiazepines remain the first line treatment and have shown to be most effective. If those aren’t available, other considerations may be IV valproic acid or levetiracetam. Both of these have not been shown to be as effective as benzodiazepines and are not routinely used for active seizures.

Question: Any problems trying to get medications from other counties that can be used in the U.S.?
Answer: There are federal regulations concerning medications being imported from other countries. The FDA has very strict manufacturer’s requirements where other countries do not. I would not advise this due to the fact we have no way of insuring what is actually in the vial.

Question: Do you know of any new benzodiazepines currently in production that will make their way to the prehospital field and emergency department to make up for some of the shortages?
Answer: I am unaware of any new benzodiazepines in the IV form. There are newer antiepileptic medications that have IV formulations but they are not routinely used for actively seizing patients.

Question: Have you seen any indication that drug companies have been conspiring to drive up prices through creation of artificial shortages, such as many believe occurs with the oil companies?
Answer: I have no information on companies price gouging. I do know the federal government is looking into these types of complaints.

Question: What do you do when you have shortages in both opiate pain medications you carry?
AnswerConsider the use of non-opiate pain medications. The options are limited but there are other forms of pain medications available.

Question: Currently, our providers are responsible for acquiring their own drugs. We have put out a survey and found that very few of the provider agencies have any idea how often and what medications they use. Is this a larger problem or is it isolated to our area?
Answer: This is a routine finding now due to the fact operators are looking. For years we have ordered what was missing off our shelves. Now that certain things are in short supply, we are all monitoring our usage and we are developing programs for all our disposable supplies.

Question: Are there any legal avenues available to "force" manufacturers to produce these medications?
Answer: I am not a lawyer but I am unaware of any legal avenues. There are no obligations they have to produce the products. Most of our shortages are generics and any manufacturer can produce them if they so desire.

Question: Is there an action plan or strategy to mediate the cause of the shortage. Is there a nationwide move to push drug companies to produce medications?
Answer: There are federal movements for this cause. They are focusing more on preventing these shortages in the future more than fixing our current issues.

Question: At the EMS Today Conference & Exposition, one of the medical directors who was presenting spoke about obtaining medications through a local compounding pharmacy that were otherwise unavailable. What are your thoughts?
Answer: Here in Fort Worth we are using a compound pharmacy. They are a great resource for us. Look for an accredited compound pharmacy in your area and make a call. Provide them with your shortages and ask them how they can help you.

Question: Would you recommend retaining our expired medications at this time in case of later need?
Answer:
We are holding on to all our expired medicines currently. We have not had to use them but if the time comes, we are ready. I would advise everyone to not dispose of any expired medicines that are on the shortage list.

Question: Who is making all the money from these shortages?
Answer: I am not sure there is money to be made. These medicines are all very inexpensive.

Question: How much of the shortages depend on the amount of money being made by the drug companies?
Answer: I am not sure there is money to be made. These medicines are all very inexpensive.

Question: We are a small service. What advice would you give for making an agreement with agencies to swap out drugs that are about to expire?
Answer: I doubt anyone will be willing to swap drugs during this shortage. I would contact your local EMS agencies and form some local group or task force to develop a local plan of action. Here in Texas we have regional advisory councils that are working on this. I know of other larger organizations that are treating this like a major incident and utilizing an ICS type of strategy. The best advice I have is a local solution.

Question: Do we know if there is an end in sight?
Answer: Every day is new. I have a medical control team meeting every Monday to develop a plan of action for this week. There are many advisory lists available with dates when a certain delivery is to occur but I find these are often more of a hope than reality.

Question: I realize you cannot give a definitive general answer. But can you discuss the most obvious issues with giving an out-of-date medication (e.g., efficacy, amount to give, expectations or results to expect)?
Answer: It is very difficult to answer this. We know from military experiences that medications can be used past the expiration date. If the medicine is stored in a controlled environment, the potency is good well past that date. It is possible the dose will be less effective. It is also possible that chemical breakdown could cause an unwanted reaction. That is why no regulatory agency will permit the administration of an expired medicine. There is just very limited science on this topic.




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Related Topics: Administration and Leadership, Operations and Protcols

Jeff Beeson, DOJeff Beeson , DO, is the associate medical director for the Emergency Physician Advisory Board of Fort Worth, which provides medical oversight for MedStar Ambulance and the 15 first responder organizations of the system. He's an emergency physician, a licensed paramedic and a registered nurse.

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