Without evidence of benefit, an intervention should not be presumed to be beneficial or safe.

- Rogue Medic

Drug Shortages Affecting EMS


 

The most recent FDA (Food and Drug Administration) listing of drug shortages, editing out the many cancer drugs, and other non-EMS drugs, includes the following:
 

Generic Name or Active Ingredient                                                 Status
 

Albuterol Sulfate Inhalation Solution (0.5%)         Resolved

This is important, but one way of dealing with a nebulized albuterol shortage is to alternate albuterol with nebulized saline. this prevents giving too much albuterol to the patient who is maintaining a reasonable oxygen saturation and keeping the airway humidified.
 

Atropine Sulfate Injection         Currently in Shortage

We should be accumulating atropine, since we no longer use atropine for asystole. Atropine maintains its strength, even when stored for extended periods, so we should only discard atropine when there is contamination.
 

Calcium Chloride Injection, USP         Currently in Shortage

Calcium (chloride or gluconate) appears to be the best drug for hyperkalemia. We are fortunate in EMS to not have to deal with sodium polystyrene (Kayexalate), which is just a means of creating the appearance of clostridium difficlie. Senna glycoside (ex-lax) can be just as effective at causing diarrhea and anything that causes diarrhea will cause some removal of potassium.
 

Calcium Gluconate Injection         Currently in Shortage

See above.
 

Cromolyn Sodium Inhalation Solution, USP         Currently in Shortage
 

Dexamethasone Sodium Phosphate Injection         Resolved
 

Dextrose 50% Injection         Currently in Shortage

We should be using 10% dextrose, rather than 50%, but we are slow to learn from our mistakes.

Comment on 10% Dextrose vs 50% Dextrose.
 

Epinephrine Injection, 0.1 mg/mL         Currently in Shortage

Maybe we will be using less epinephrine after the results of the Paramedic2 trial are published. I expect that some patients will be shown to benefit from epinephrine in cardiac arrest. I hope that the results will help us to identify which patients benefit from epinephrine in cardiac arrest and which patients have worse outcomes because of receiving epinephrine in cardiac arrest. I don’t really expect these answers, because we seem to be trying to avoid asking appropriate questions about drug treatment.
 

Epinephrine Injection, 1 mg/mL         Resolved
 

Fentanyl Citrate (Sublimaze) Injection         Currently in Shortage

There are other drugs that are effective for pain management. Hydromorphone (Dilaudid) can be used safely by EMS.
 

Labetalol Hydrochloride Injection         Currently in Shortage
 

Lidocaine Hydrochloride (Xylocaine) Injection         Currently in Shortage

EMS should have disposed of our supplies of lidocaine and amiodarone following the ALPS and PROCAMIO.

Dr. Kudenchuk is Misrepresenting ALPS as ‘Significant’

The PROCAMIO Trial – IV Procainamide vs IV Amiodarone for the Acute Treatment of Stable Wide Complex Tachycardia
 

Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine         Currently in Shortage

This is more for wilderness EMS, than urban.
 

Methylprednisolone Sodium Succinate for Injection, USP         Currently in Shortage

This is an important drug for reactive airway conditions.
 

Nitrous Oxide, Gas         Currently in Shortage

A lot of people are uncomfortable with the idea of using nitrous oxide, but it is safe – as long as there is good circulation of fresh air.
 

Pantoprazole (Protonix) Powder for Injection         Currently in Shortage

This is usually not the part of allergic reaction that EMS treats, but it can be helpful.
 

Potassium Chloride Injection         Currently in Shortage

Not generally prehospital EMS, but interfacility.
 

Procainamide Hydrochloride Injection, USP         Currently in Shortage

This is an antiarrhythmic drug that actually works, but we tend to avoid it out of a lack of understanding and a lack of familiarity with the evidence.
 

Promethazine (Phenergan) Injection         Currently in Shortage
 

Ranitidine Injection, USP         Currently in Shortage
 

Rocuronium Bromide Injection         Currently in Shortage

Succinylcholine may end up as a shortage because of the rocuronium shortage.
 

Sodium Bicarbonate Injection, USP         Currently in Shortage

After calcium, sodium bicarbonate can be effective for hyperkalemia. Flush the line. Even better, use a different line for these incompatible medications.

We should not be wasting sodium bicarbonate in cardiac arrest patients, since it is not going to do anything to make things better, but it will make it more difficult to get sodium bicarbonate for the patients who can actually benefit.
 

Sodium Chloride 0.9% Injection Bags         Currently in Shortage

Do we really need to start as many IV (IntraVenous) lines with a drip?
 

Sodium Chloride 23.4% Injection         Currently in Shortage

Also effective for hyperkalemia, since it is the sodium that moves the potassium, not any myth of alkalinizing the patient.

.

Dextrose 10% in the Treatment of Out-of-Hospital Hypoglycemia

ResearchBlogging.org
 

Is 50% dextrose as good as 10% dextrose for treating symptomatic hypoglycemia?

If the patient is disoriented, but becomes oriented before the full dose of dextrose is given, is it appropriate to continue to treat the patient as if the patient were still disoriented? If your protocols require you to keep giving dextrose, do the same protocols require you to keep giving opioids after the pain is relieved? Is there really any difference?

50% dextrose has problems.
 

Animal models have demonstrated the toxic effect of glucose infusions in the settings of cardiac arrest and stroke.2 Experimental data suggests that hyperglycemia is neurotoxic to patients in the setting of acute illness.1,3 [1]

 

Furthermore, extravasation can cause necrosis.
 


Image credit.[2]
 

I expect juries to look at this kind of image and say, Somebody has to take one for the 50% dextrose team. We can’t expect EMS to change.

Is 10% dextrose practical?
 

Won’t giving less concentrated dextrose delay treatment?
 

The median initial field blood glucose was 38 mg/dL (IQR = 28 mg/dL – 47 mg/dL), with subsequent blood glucose median of 98 mg/dL (IQR = 70 mg/dL – 135 mg/dL). Elapsed time after D10 administration before recheck was not uniform, with a median time to recheck of eight minutes (IQR = 5 minutes – 12 minutes).[1]

 

If that is going to slow your system down, is it because you are transporting patients before they wake up?

Did anyone require more than 10 grams of 10% dextrose, as opposed to 25 grams of 50% dextrose?
 

Of 164 patients, 29 (18%) received an additional dose of intravenous D10 solution in the field due to persistent or recurrent hypoglycemia, and one patient required a third dose.[1]

 

18% received a second dose, which is 20 grams of dextrose and still less than the total dose of 25 grams of dextrose given according to EMS protocols that still use 50% dextrose.

Only one patient, out of 164 patients, required a third dose. That is 30 grams of dextrose.

Only one patient, out of 164 patients, received as much as we would give according to the typical EMS protocol, which should be a thing of the past. If we are routinely giving too much to our patients, is that a good thing? Why?
 

Maybe the blood sugars were not that low to begin with.
 


 

The average was 38 mg/dL, which is not high.
 

Maybe the change in blood sugar was small after just 10 grams of dextrose, rather than 25 grams.
 


 

The average (mean) change was 67 mg/dL, which is enough to get a patient with a blood sugar of 3 up to 70.
 

Maybe the blood sugar was not high enough after just 10 grams of dextrose, rather than 25 grams.
 


 

The average (mean) repeat blood sugar was 106 mg/dL, which is more than enough.
 

Maybe it took a long time to treat patients this way.
 


 

The average (mean) time was 9 minutes, which is not a lot of time.
 

Is this perfect?
 

Three patients had a drop in blood glucose after D10 administration: one patient had a drop of 1 mg/dL; one patient had a drop of 10 mg/dL; and one patient had a drop of 19 mg/dL.[1]

 

All patients, even the three with initial drops in blood sugar (one had an insulin pump still pumping while being treated) had normal blood sugars at the end of EMS contact.

10% dextrose is cheaper, just as fast, probably less likely to cause hyperglycemia, probably less likely to cause rebound hypoglycemia, probably less likely to cause problems with extravasation, less of a problem with drug shortages, . . . .

Why are we still resisting switching to 10% dextrose?
 

Other articles on 10% dextrose.

Footnotes:

[1] Dextrose 10% in the treatment of out-of-hospital hypoglycemia.
Kiefer MV, Gene Hern H, Alter HJ, Barger JB.
Prehosp Disaster Med. 2014 Apr;29(2):190-4. doi: 10.1017/S1049023X14000284. Epub 2014 Apr 15.
PMID: 24735872 [PubMed – indexed for MEDLINE]

[2] Images in emergency medicine. Dextrose extravasation causing skin necrosis.
Levy SB, Rosh AJ.
Ann Emerg Med. 2006 Sep;48(3):236, 239. Epub 2006 Feb 17. No abstract available.
PMID: 16934641 [PubMed – indexed for MEDLINE]

Kiefer MV, Gene Hern H, Alter HJ, & Barger JB (2014). Dextrose 10% in the treatment of out-of-hospital hypoglycemia. Prehospital and disaster medicine, 29 (2), 190-4 PMID: 24735872

Levy SB, & Rosh AJ (2006). Images in emergency medicine. Dextrose extravasation causing skin necrosis. Annals of emergency medicine, 48 (3) PMID: 16934641

.

DC Fire and EMS Being Sued for Retaliation After Problems Were Reported

 

Big city EMS departments like to brag about how good they are, but are they good?
 

“If you think about how much progress we’ve made in the last two years, I’m very pleased with the deployment we have now. Are we 100 percent yet? No, but we’re working on it,” Miramontes said. [1]

 

No sensible person should argue with progress, but –

How bad were things?

How bad are things now?

How much work needs to be done to get to the level of competent?

What are the problems?
 


If this does not play, it is available at the link in the first footnote.
 

According to D.C. paramedic Gene Ryan, there has been mismanagement, but according to David A. Miramontes MD, FACEP, NREMT, Assistant Fire Chief, things have dramatically improved. Dr./Asst. Fire Chief Miramontes is management.

Whom should we believe?
 

“If you’re a burn patient with agonizing pain I could fix that, I could take your pain away, but hopefully you live in the right neighborhood,” Ryan said. “Hopefully it’s the neighborhood that carries that medication, and that’s hit or miss.”

In response, Assistant Fire Chief David Miramontes told News4 control drugs are deployed to more than 90 percent of the department’s units.[1]

 

Well, morphine and diazepam (Valium) are probably hard to come by, so the problems are to be expected, right?

No.

DCFEMS also carries fentanyl (Sublimaze) and midazolam (Versed) according to their protocols from 2012.[2] Why the failure to provide these basic ALS (Advanced Life Suopport) medications on the ALS ambulances?

Is there any reason why any fire department EMS service should not have excessive amounts of pain medicine on every ALS ambulance? If there is one thing fire departments should be familiar with, it is burns.

Burns mean pain – a lot of pain.

Anyone who has dealt with significant burns knows that more than 100 mg of morphine or more than 1,000 mcg (more than 1 mg) of fentanyl is not an unreasonable dose.

How can a medical director who is also an Asst. Fire Chief tolerate that? Or is the medical director the problem?
 


 

The dose for burns is half of what is permitted for every other painful condition.

What possible legitimate reason is there for not adequately stocking overstocking pain medicine?
 

Half a year ago, there was a problem with ambulances catching fire and running out of fuel. Management blamed the employees and claimed to be unaware of problems. In other words, management was failing to manage. The job of management is to help the employees to do their job well, not to make excuses.
 

Fire officials say they are trying to address various problems in the department. They hired a private consultant for $182,000 to audit the fleet after the inspector general found that they had lost track of reserve vehicles, listing many fire engines as ready for duty when they had, in fact, been stripped and sent to scrap yards.

After more than 60 ambulances had mechanical issues last month, including many with broken air conditioning during a heat wave, . . . .[3]

 

More than 60?

Out of how many ambulances?
 

Ambulances and Medic Units

  • 14 ALS Medic Units
  • 25 BLS Ambulances[3]

 

More than 60 out of 39 in just one month.

Time to replace some ambulances.

But ambulances are expensive. We can’t afford them.
 


 

14 Heavy Mobile Equipment Mechanics plus 3 foremen in the top 25 DCFEMS overtime earners.[4]

Maybe the heavy mobile equipment they work on does not include ambulances, but this suggests that there is a problem with the management of equipment. Is the equipment too old. Is the department understaffed? Is there some other reason for these employees being over-represented?
 

But top fire officials have accused the rank and file of contributing to the breakdowns and staffing shortages through neglect or incompetence,[3]

 

Our employees are out of control and we are powerless to do anything?

That excuse does not appear to be valid.

DCFEMS has gone through a bunch of medical directors, but adequate stocking of ambulances is still just something to dream about? Is the medical director able to make decisions independently, or is he being not able to exercise authority?

I do not know the answers, but the more people keep failing to fix the problems, the more it looks like DCFEMS needs to be scrapped and remade from scratch with new management. The duct tape is not working.

Mismanagement and retaliation vs. out of control employees?

Management is not making a persuasive case.

Footnotes:

[1] D.C. Paramedic Plans to Sue Fire Department
By Mark Segraves
Saturday, Feb 22, 2014 | Updated 5:00 AM EST
News4 NBC Washington
Article

[2] Emergency Medical Services Manual and Pre-hospital Treatment Protocol
David Miramontes, MD FACEP, Assistant Chief, Medical Director
Kenneth B. Ellerbe, Fire & EMS Chief
Effective Date: September 14th, 2012
Revision Date: September 24th, 2012
Version: 1.1
Page 146/303
Protocols at DC.gov in PDF Download format.

[3] Two D.C. ambulances catch fire while on call
By Peter Hermann
Published: August 13, 2013
Washington Post
Article

[4] Response to Questions Asked by the Committee for “Fiscal Year 2011 and 2012 Performance Oversight”
Government of the District of Columbia Fire and EMS Department
Council of the District of Columbia
Committee on Public Safety and the Judiciary
Phil Mendelson, Chair
February 3, 2012
Document in PDF Download format.

.

Let the drug shortages help us make better patient care decisions


Image credit.[1]

 

Maryland made smart changes to their protocols because of the drug shortages.[2]

50% dextrose is not as good as 10% dextrose at treating hypoglycemia.[3],[4],[5]

Switching to 10% dextrose is an obvious solution, but not used by everyone.
 

Sedgwick County EMS workers administer about 80 doses of the stuff (50% dextrose) a month, but the county has only received 30 pre-filled doses so far this year through its normal vendor, Braithwaite said.[6]

 

We have research that shows that 10% dextrose is a better choice for EMS, but we continue to use the inferior treatment.

We have trouble obtaining the inferior treatment, but we refuse to change to the better treatment.

Is there a state law that prevents the use of different concentrations of dextrose?

If so, go to the government, explain the problem, and get the law changed. If that does not work, go to the press and point out that the failure to act by the legislature is endangering patients.
 

“We’re now looking at compounding of those medications,” he said.

But that’s an expensive alternative. A pre-filled dose of dextrose costs $6.99. A vial costs $1.81. Pre-filled doses are preferred, Hadley said, because there is one less step for emergency personnel.

Compound dextrose costs $14 per dose and has a much shorter shelf life, 90 days compared with two years.[6]

 

50 ml of 50% dextrose contains 25 grams of dextrose.

A 250 ml bag of 10% dextrose contains 25 grams of dextrose.

The cost of the bag of 10% dextrose is about $2.50, which is much less than the $7 cost of and amp of 50% dextrose.

Is there a difference in shelf life? If they are giving 80 doses a month, how much does that matter?

The only advantage to the 50% dextrose is familiarity, which is due to our failure to change to a better treatment when it becomes the right thing to do.

The drug shortages do not affect 10% dextrose.

Isn’t it time we cut costs, improved safety, improved care, and eliminated 50% dextrose?

Footnotes:

[1] Images in emergency medicine. Dextrose extravasation causing skin necrosis.
Levy SB, Rosh AJ.
Ann Emerg Med. 2006 Sep;48(3):236, 239. Epub 2006 Feb 17. No abstract available.
PMID: 16934641 [PubMed – indexed for MEDLINE]

[2] Drug shortages leading to better EMS protocols
Fri, 19 Oct 2012
Rogue Medic
Article

[3] Dextrose 10% or 50%: EMS Research Episode 10
Tue, 05 Jul 2011
Rogue Medic
Article

[4] Dextrose 10% or 50% in the treatment of hypoglycaemia out of hospital? A randomised controlled trial.
Moore C, Woollard M.
Emerg Med J. 2005 Jul;22(7):512-5.
PMID: 15983093 [PubMed – indexed for MEDLINE]

Free Full Text from PubMed Central

[5] A review of the efficacy of 10% dextrose as an alternative to high concentration glucose in the treatment of out-of-hospital hypoglycaemia
Ziad Nehme, Daniel Cudini
2009; Volume 7 : Issue 3; Article Number: 990341
Journal of Emergency Primary Health Care
Free Full Text with link to PDF Download

[6] Sedgwick County EMS warns of national drug shortages
By Deb Gruver
The Wichita Eagle
Published Tuesday, May 14, 2013, at 8:41 p.m
Article

.

Not Carrying Essential Drugs on an Ambulance

 

A paramedic responded to dispatch that he did not have any seizure medicines and that no other medics have seizure medicines.
 


 

How does this happen?

Is it a result of the drug shortage?[1]
 

Paramedic: “We don’t have any seizure medication?”
Dispatcher: “You don’t have any seizure medication?”
Paramedic: “That’s affirmative. No paramedic unit does.”
[2]

 

This was in January. A similar conversation occurred in December.

The article makes it seem as if the medics only carry lorazepam (Ativan) for seizures – when they carry seizure medication.

Why not any IM (IntraMuscular) seizure medication?[3],[4],[5],[6]

Unreasonable optimism?

Inability to keep up with research?

Inability to understand research?

There is a lot of that in EMS.

Do they carry a dose that will be effective?

4 mg IV lorazepam for an adult and 2 mg IV for a small child – if the goal is to actually stop the seizure, rather than just document the administration of sub-therapeutic doses of something.[7],[8]

If the dose is inadequate or if the dose cannot be given because of a failure to obtain an IV – then the drug is not a life saving drug.

Does Rural Metro/Clark County have these under-dosing problems with their seizure medications? I don’t know.

As it turns out, the reason the medics do not have lorazepam is that the DEA (Drug Enforcement Administration) is investigating.
 

It’s because of a DEA investigation into Rural Metro Ambulance when they worked out of Louisville. There was morphine and Valium missing from ambulances and the DEA was trying to figure out who took the drugs. Because of that investigation their paramedics were banned from carrying certain medications, medications used to stop seizures.[9]

 

Diazepam (Valium) is also a seizure medication. Diazepam can be given IM, but EMS usually gives it rectally.

Why?

Because giving a drug in a socially inappropriate way that is also less effective than other ways of giving the drug is what EMS does. Does Rural Metro/Clark County give rectal seizure medications? I don’t know.

Who should be notifying Clark County when required drugs are pulled from the ambulance?

The DEA apparently gave the order, so they should be notifying Clark County of the DEA’s change to the medications carried by medics.

Rural Metro appears to be required to carry the medications, so they should notify Clark County that they are not satisfying the drug requirements. The contract should be specific about what minimum standards any company must meet and what notification must be made when the minimum standards are not met. If the contract does not require notification, then Clark County is being willfully ignorant. Especially with the drug shortages, Clark County (and any EMS agency) should be keeping aware of any supply problems ambulance companies are having.

Maryland changed their protocols because of the drug shortages, so this is affecting EMS in other places.[10]

It looks as if all three (Clark County, Rural Metro, and the DEA) failed to act responsibly toward the citizens of Indiana.

Footnotes:

[1] Drug Shortages
FDA
Drug Safety and Availability
Current Drug Shortages Index

[2] Paramedics say area Ambulance service not carrying needed medicine
WHAS11.com
Posted on February 5, 2013 at 6:22 PM
Updated Tuesday, Feb 5 at 6:41 PM
Article

[3] Midazolam in treatment of epileptic seizures.
Lahat E, Aladjem M, Eshel G, Bistritzer T, Katz Y.
Pediatr Neurol. 1992 May-Jun;8(3):215-6.
PMID: 1622519 [PubMed – indexed for MEDLINE]
 

Midazolam (Versed), the first water-soluble benzodiazepine, has had widespread acceptance as a parenteral anxiolitic agent. Its antiepileptic properties were studied in adult patients with good results. Midazolam was administered intramuscularly to 48 children, ages 4 months to 14 years, with 69 epileptic episodes of various types. In all but 5 epileptic episodes, seizures stopped 1-10 min after injection. These results suggest that midazolam administered intramuscularly may be useful in a variety of epileptic seizures during childhood, specifically when attempts to introduce an intravenous line in convulsing children are unsuccessful.

That is from 1992 – over two decades ago.

[4] Midazolam in treatment of various types of seizures in children.
Yakinci C, Müngen B, Sahin S, Karabiber H, Durmaz Y.
Brain Dev. 1997 Dec;19(8):571-2.
PMID: 9440805 [PubMed – indexed for MEDLINE]
 

No side effects were observed. These results suggest that i.m. administration of midazolam may be useful in a variety of seizures during childhood, especially in case of intravenous (i.v.) line problem.

That is from 1997 over a decade and a half ago.

[5] A prospective, randomized study comparing intramuscular midazolam with intravenous diazepam for the treatment of seizures in children.
Chamberlain JM, Altieri MA, Futterman C, Young GM, Ochsenschlager DW, Waisman Y.
Pediatr Emerg Care. 1997 Apr;13(2):92-4.
PMID: 9127414 [PubMed – indexed for MEDLINE]
 

CONCLUSIONS:
IM midazolam is an effective anticonvulsant for children with motor seizures. Compared to IV diazepam, IM midazolam results in more rapid cessation of seizures because of more rapid administration. The IM route of administration may be particularly useful in physicians’ offices, in the prehospital setting, and for children with difficult IV access.

That is also from 1997 over a decade and a half ago.

[6] Use of intramuscular midazolam for status epilepticus.
Towne AR, DeLorenzo RJ.
J Emerg Med. 1999 Mar-Apr;17(2):323-8. Review.
PMID: 10195494 [PubMed – indexed for MEDLINE]
 

The pharmacodynamic effects of midazolam can be seen within seconds of its administration, and seizure arrest is usually attained within 5 to 10 min. Case reports and a recent randomized trial that demonstrate the successful use of i.m. midazolam in the termination of epileptic seizures are reviewed.

That is from 1999 – still over a decade ago. There have been more studies of IM midazolam (Versed) in this century.

[7] Lorazepam (lorazepam) Injection, Solution
[Baxter Healthcare Corporation]

DailyMed
NLM
FDA label
 

For the treatment of status epilepticus, the usual recommended dose of Lorazepam Injection is 4 mg given slowly (2 mg/min) for patients 18 years and older. If seizures cease, no additional Lorazepam Injection is required. If seizures continue or recur after a 10- to 15- minute observation period, an additional 4 mg intravenous dose may be slowly administered.

[8] Intramuscular versus intravenous therapy for prehospital status epilepticus.
Silbergleit R, Durkalski V, Lowenstein D, Conwit R, Pancioli A, Palesch Y, Barsan W; NETT Investigators.
N Engl J Med. 2012 Feb 16;366(7):591-600.
PMID: 22335736 [PubMed – in process]

Free Full Text from N Engl J Med.
 

All adults and those children with an estimated body weight of more than 40 kg received either 10 mg of intramuscular midazolam followed by intravenous placebo or intramuscular placebo followed by 4 mg of intravenous lorazepam.

 

The relationships among benzodiazepine dose, respiratory depression, and subsequent need for endotracheal intubation are poorly characterized, but higher doses of benzodiazepines may actually reduce the number of airway interventions. Our data are consistent with the finding that endotracheal intubation is more commonly a sequela of continued seizures than it is an adverse effect of sedation from benzodiazepines.11

[9] Rural Metro Ambulance responds about carrying meds on their vehicles
by Renee Murphy
WHAS11.com
Posted on February 6, 2013 at 7:02 PM
Updated Wednesday, Feb 6 at 8:49 PM
Article

[10] Drug shortages leading to better EMS protocols
Fri, 19 Oct 2012
Rogue Medic
Article

.

Drug shortages leading to better EMS protocols

MIEMSS (Maryland Institute for Emergency Medical Services Systems) has posted some changes to their protocols that are in response to the drug shortages affecting EMS.

This is good news, even though two of the three drugs being used as replacements are also subject to drug shortages. That is one of the problems with the drug shortage – the replacements end up suffering from increased demand to replace the original drugs.

Some of the drugs do not need any replacement, such as IV (IntraVenous) furosemide (Lasix) for CHF/ADHF (Congestive Heart Failure/Acute Decompensated Heart Failure) patients. The best thing we can do is to stop giving the drug and to stop giving any other diuretic for a medical condition that is not effectively treated with diuretics.[1]

Pain management drugs are important and availability is important.
 

The continuing medication shortage continues to affect Maryland EMS Operational Programs (EMSOPs). Morphine is among the medications that EMSOPs have had difficulty restocking.

Because of the importance of successfully managing pain in out-of-hospital medicine, the Protocol Review Committee has looked into alternatives to Morphine for Maryland EMS. MIEMSS has emergently included fentanyl in the 2012 Maryland Medical Protocols effective immediately. Please see the attached protocol pages.[2]

 

Unfortunately, the obvious substitutes are also in short supply – fentanyl (Sublimaze), hydromorphone (Dilaudid), and other opioids.[3]

One interesting part of the Maryland protocols is the addition of abdominal pain to their standing orders for morphine or fentanyl administration. The Maryland protocols have leapfrogged past Pennsylvania’s protocols with a couple of big changes.
 


Image credit.

Even a surgical journal has research showing that treating undifferentiated abdominal pain with opioids does not make diagnosis more difficult.
 

CONCLUSION:
The literature addressing early pain relief for abdominal pain is characterized by weaknesses, but there is a common theme suggesting that analgesia is safe. Pending further research, which should address some of the shortcomings of extant studies, a practice of judicious provision of analgesia appears safe, reasonable and in the best interests of patients in pain.
[4]

 

A much more recent Cochrane Review comes to the same conclusion.

MAIN RESULTS:
Eight studies fulfilled the inclusion criteria. Differences with use of opioid analgesia were verified in variables: Change in the intensity of the pain, change in the patients comfort level.

AUTHORS’ CONCLUSIONS:
The use of opioid analgesics in the therapeutic diagnosis of patients with AAP does not increase the risk of diagnosis error or the risk of error in making decisions regarding treatment.
[5]

 

If we were to ask the patients what they prefer, I expect that a lot would choose to decrease their pain, even if there is the minimal possibility of alteration in physical assessment. That alteration may be for the better – if the patient is not in severe pain at the slightest touch, the patient may be able to localize the pain, which is a big part of the physical assessment of undifferentiated abdominal pain.

Footnotes:

[1] Drug Shortages Affect Those Still in the Dark Ages – Furosemide
Rogue Medic
Thu, 26 Aug 2010
Article

[2] NEW (June 2012) – Emergency Medication Addition Due to Medication Shortage: FENTANYL
Maryland Institute for Emergency Medical Services Systems
June 12, 2012
MIEMSS page with links to this and other updates and to current protocols

There is also information at that page about the following two changes because of the drug shortage –

NEW (April 2012) – Emergency Medication Addition Due to Medication Shortage: KETAMINE

NEW (May 2012) – Emergency Medication Addition Due to Medication Shortage: DIAZEPAM

[3] Current Drug Shortages Index
FDA
Current Drug Shortages Index

[4] Effect on diagnostic efficiency of analgesia for undifferentiated abdominal pain.
Thomas SH, Silen W.
Br J Surg. 2003 Jan;90(1):5-9. Review.
PMID: 12520567 [PubMed – indexed for MEDLINE]

[5] Analgesia in patients with acute abdominal pain.
Manterola C, Vial M, Moraga J, Astudillo P.
Cochrane Database Syst Rev. 2011 Jan 19;(1):CD005660. Review.
PMID: 21249672 [PubMed – indexed for MEDLINE]

.

These authors read far too much into their limited study – Part II

ResearchBlogging.org

Continuing from Part I.

The authors do not find dramatic differences between fentanyl and morphine in their ability to relieve pain in patients who are not hypotensive. In the discussion, they begin to give their reasons for not wanting to use fentanyl.

Why?

I don’t know why they are not fond of fentanyl, but this is what they write in their discussion.

Our study opens the door for debate regarding the value of including fentanyl in limited formularies such as medical helicopters and ambulances given its higher cost and lack of any detectable advantages when compared to morphine. Whereas at our institution fentanyl costs approximately the same as morphine, costs may vary widely in other institutions.[1]

The authors state that their cost is about the same for morphine and for fentanyl, but they think that the possibility that someone somewhere might be paying a lot more for fentanyl is reason enough to limit their choices to morphine.

Both drugs are available as generics, so there does not appear to be any reason to bring a hypothetical difference in price into the discussion. Both generic drugs are affected by the current drug shortages.

If we are much more concerned about giving morphine to hypotensive patients, than we are about giving fentanyl to hypotensive patients, is that worth a bit of a premium in the price of fentanyl?

I think so. More on fentanyl and hypotensive patients in a little bit.

There is also the question of whether including fentanyl in prehospital formularies is worth the risk given its abuse potential among medical staff. Although surveillance data suggest that nationally, fentanyl is one of the least abused drugs in the non-physician population, fentanyl abuse by physicians is a well-recognized concern (24,25).[1]

The first reference does not even mention fentanyl abuse. the second reference appears to be there as a reference for the lack of abuse by non-physicians.

There is no reference for the statement that fentanyl abuse by physicians is a well-recognized concern.

Is fentanyl more of a concern than morphine?

Is fentanyl less of a concern than morphine?

There is nothing in this paper to answer that question. Are the authors using a traditional doctors’ tale an old wives’ tale?

It looks that way.

There was no detectable difference with the limited number of patients, the limited dosing of medication, and the refusal to include patients with a blood pressure that was not at least 10 points above where hypotension begins.

Patients were excluded if they reported an allergy to morphine or fentanyl, or if they were hypotensive before receiving the first dose of the study drug (systolic blood pressure < 100 mm Hg).[1]

It isn’t as if they would have been giving large doses.

It isn’t as if there is a significant concern that fentanyl will cause hypotension.

Fentanyl appears to be one of our most effective treatments for getting rid of hypotension.

There was a 47% chance that a hypotensive patient would no longer be hypotensive after a dose of fentanyl.

the safety of fentanyl as demonstrated in the current study may be related to more conservative dosing in unstable patients, but the parallel message is that experienced EMS crews are able to exercise judgment in determining which patients should receive cautious drug dosing.[2]

Should we assume that there is no judgment going into the dosing of patients?
 

experienced EMS crews are able to exercise judgment in determining which patients should receive cautious drug dosing.
 

When should we expect hypotension after giving a dose of fentanyl?

When the patient is already hypotensive.

I have written more about this study.[3]
 

The study is not a bad idea, since the information on the lack of hypotensive effect of fentanyl[2] was not yet published. However, the conclusions are not justified by the results of this study.

The conclusions may best be described as imaginative.

The authors seem to be experiencing a case of the vapors and might want to consider taking some anti-anxiety medication.

According to the available research, which is much more extensive than this study, fentanyl is very safe, even when the patient is hypotensive.

There is less evidence to demonstrate that the morphine is safe for treating hypotensive patients with pain, but that does not appear to be a concern of the authors, even though the pain of hypotensive patients should be the concern of all of us who treat hypotensive patients.

Is fentanyl expensive?

No.

Is fentanyl effective?

Yes.

Is fentanyl dangerous?

Fentanyl is one of the safest drugs we use.

The ignorance of those on the pushing end of the fentanyl syringe is what is dangerous.

The problem is not the fentanyl, but the ignorance.

Footnotes:

[1] The Effectiveness and Adverse Events of Morphine versus Fentanyl on a Physician-staffed Helicopter.
Smith MD, Wang Y, Cudnik M, Smith DA, Pakiela J, Emerman CL.
J Emerg Med. 2012 Jul;43(1):69-75.
PMID: 21689900 [PubMed – in process]

There is one unusual aspect to the study that does not appear to affect the outcome, but raises questions about how many obstacles to research we create, when the obstacles may not be valid.

The study was fully reviewed by our Institutional Review Board, and given that both treatment arms are considered acceptable practice with equal risk, informed consent was not deemed necessary for this study. Upon completion of participation, each patient was given a verbal and written debriefing of his or her study involvement.[1]

[2] Fentanyl in the out-of-hospital setting: variables associated with hypotension and hypoxemia.
Krauss WC, Shah S, Shah S, Thomas SH.
J Emerg Med. 2011 Feb;40(2):182-7. Epub 2009 Mar 27.
PMID: 19327928 [PubMed – in process]

Full Text PDF Download at medicalscg.

[3] Fentanyl in the out-of-hospital setting: variables associated with hypotension and hypoxemia
Rogue Medic
Fri, 27 May 2011
Article

Chart Version – Fentanyl in the out-of-hospital setting: variables associated with hypotension and hypoxemia
Rogue Medic
Sun, 05 Jun 2011
Article

Safety of prehospital intravenous fentanyl for adult trauma patients
Rogue Medic
Thu, 03 May 2012
Article

Smith MD, Wang Y, Cudnik M, Smith DA, Pakiela J, & Emerman CL (2012). The Effectiveness and Adverse Events of Morphine versus Fentanyl on a Physician-staffed Helicopter. The Journal of emergency medicine, 43 (1), 69-75 PMID: 21689900

Krauss WC, Shah S, Shah S, & Thomas SH (2011). Fentanyl in the out-of-hospital setting: variables associated with hypotension and hypoxemia. The Journal of emergency medicine, 40 (2), 182-7 PMID: 19327928

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Is it wrong to use expired drugs? Part II

Continuing from Part I

It was good fortune that no one around Mayer, Ariz., called 911 to report a seizure during the three weeks this year that the local fire district had no drugs to treat the condition.[1]

Consider the possibilities –

Are they required to carry the medication?

Was there a bad outcome?

Clearly, the only way to predict the future is by multiple choice exam –

A. They did not give the medication and there was a bad outcome that might have been prevented, or minimized by giving the appropriate medication that is commonly given by EMS.

B. They gave the medication – the appropriate medication that is commonly given by EMS was ineffective – possibly because of decreased potency. There is a maximum dose in the protocols that may not be exceeded.

C. They gave the medication and- the appropriate medication that is commonly given by EMS was ineffective – possibly because of decreased potency. There is a maximum dose in the protocols that may only be exceeded with medical command permission, which was inexplicably denied.

D. They gave the medication – the appropriate medication that is commonly given by EMS was ineffective – possibly because of decreased potency. They continued to give medication until they ran out, but they do not carry much, so the potency was not adequate to stop the seizures.

Or –

E. They gave the medication – the appropriate medication that is commonly given by EMS was effective – possibly because in spite of decreased potency, EMS continued to give medication until the medication was effective, so the potency was adequate to stop the seizures.

Why do we arbitrarily limit the amount of benzodiazepine that may be given for seizures, even though the side effects should be manageable by basic EMTs?

Why do we arbitrarily limit the amount of benzodiazepine that may be given for seizures, even though management of an overdose should be within the skills of basic EMTs?

This is the essence of the question –
 

Is giving an expired drug less safe than giving nothing?
 

Based on what?

Does anything change when we are treating an emergency that can cause permanent disability or death?

Assuming that the drug is the appropriate treatment, that there is no readily available substitute, and there is no sign of anything growing in the medication, is there any good reason to avoid using the expired drug(s)?[2]

If you answered yes, please stay out of EMS (or any other patient care setting).

What are we taught in EMS?

Exactly the opposite – until recently.

What is an indication of bacterial growth?
 

Image credit.

Epinephrine is supposed to be clear, regardless of expiration date.
 

Image credit.

Some anti-seizure medication, such as the diazepam (Valium) pictured, is not supposed to be clear. This greenish/yellowish tint is normal for diazepam. If there is no greenish/yellowish tint to the diazepam, there is probably only water in the syringe.

Diazepam is supposed to be the color of diazepam regardless of expiration date. We are supposed to know this.
 

Oregon health officials last week began allowing ambulances to carry expired drugs, and southern Nevada has extended the expiration dates for drugs in short supply. Arizona has stopped penalizing ambulance crews for running out of mandated medications.[1]

Is nothing better than something effective?

Is nothing better than something safe?

In Arizona, nine EMS agencies or the hospitals where they’re based have told the state they can’t get all the drugs they need to meet the state’s minimum supply that ambulances are required to carry. Before the state relaxed the rules last November, ambulances risked being taken out of service.[1]

Is nothing better than something effective?

Is nothing better than something safe?

To be continued in Part III and Part IV.

Footnotes:

[1] Paramedics turn to expired drugs due to shortages
boston.com
By Jonathan J. Cooper
Associated Press / July 12, 2012
Article

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