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

- Rogue Medic

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

.

Is it wrong to use expired drugs? Part I

Is it wrong to use expired drugs?

Well, . . .

When paramedics ran out of a critical drug used to treat irregular heartbeats, the Bend Fire Department in Central Oregon dug into its stash of expired medications, loaded up the trucks and kept treating patients.[1]

 

Is this safe?
 

The first concern related to expired drugs is whether they are potentially harmful if consumed. Reassuringly, there is no published data to suggest harms from use of drug formulations after their expiry data.[2]

Rather than ask that question, EMS agencies have generally assumed that the expiration date is sacred and that giving drugs past the expiration date is evil. This is CYA vs. competent patient care.

I don’t know what I’m doing, but there is a rule that could be trouble for me, so I will enforce it as if it is more important than the things that cannot be as easily measured, such as competence.

Some EMS agencies are recognizing that this is not good for patients.

What is the potency of expired medications?

That is not a simple question.

Do we even know the potency of our medications that have not yet expired?

What is the mean kinetic temperature that they have been stored at?

If we have not controlled the mean kinetic temperature, haven’t we violated something much more important than an expiration date?

What changes about a medication, when the medication expires?

Emergency responders in various jurisdictions have reported turning to last resort practices as they struggle to deal with a shortage of drug supplies created by manufacturing delays and industry changes. Some are injecting expired medications or substituting alternatives. Others are simply going without.[1]

Oh, No! Don’t tell the lawyers, because the patients will own the EMS organizations!

What happens in the real work, rather than in the fevered imaginations of the whiners, who use a fear of lawyers to argue against everything except incompetence?

For some reason, these whiners do not see incompetence as something that carries any legal liability.
 

“We’ve never (before) had to go diving back into the bin to try to retrieve expired boxes of drugs,” said Tom Wright, emergency medical services coordinator for the Bend Fire Department, which has been administering outdated medicines for about a year. “We had the backing of our insurance company that giving expired drugs is better than giving no drugs at all.”

He said that medics have not reported any adverse reactions.[1]

No bad outcomes means no justification for a law suit to go to trial.

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?

To be continued in Part II.

Footnotes:

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

[2] Should you take expiry dates seriously?
Science-Based Pharmacy
Thursday, May 10th, 2012
Article

.

Medication Storage and the Heat

It has been hot with no real expectation of a cool rest of the Summer or even the Autumn.

What do we do to keep medications in the recommended storage range?
 


Image credit.
 

Do we need to refrigerate our drug boxes/bags?

According to these recorded temperatures in a cooled drug compartment, an uncooled drug compartment, and ambient temperature, the answer is that we do need to cool our drugs.
 


Click on images to make them larger.

The results indicate that drug storage temperatures in some prehospital rescue vehicles exceed USP guidelines.[1]

Without cooling, we are not protecting our medications from the harmful effects of high temperatures.

Mechanical cooling of the storage compartment results in drug storage temperatures within the USP guidelines.[1]

 

Mechanical cooling of drug storage compartments on vehicles is technologically and financially possible.[1]

Do we refrigerate/cool our drug compartments?

Do we monitor the temperature in the drug compartments, or the temperature of the individual drugs?

There is an excellent presentation on the topic at Free Emergency Medicine Talks.[2]

The medication most notable for needing refrigeration is insulin. Fortunately, insulin is not often used in EMS. The EMS drugs most often refrigerated are succinylcholine (suxamethonium in commonwealth countries, brand name Anectine) and lorazepam (Ativan). One alternative to refrigeration is to rotate stock every 30, or 60, or 90 days.

This seems as if it would be the most practical and affordable, but depends on having a hospital to exchange stock with. If we keep a medication on an ambulance for 30 days, then exchange it with the hospital, it is because we are expecting the hospital to use the medication quickly.

Lorazepam should be used frequently in an ICU – as long as there is not a drug shortage. The lorazepam drug shortage continues.[3]

Footnotes:

[1] Drug storage temperatures in rescue vehicles.
DuBois WC.
J Emerg Med. 2000 Apr;18(3):345-8.
PMID: 10729674 [PubMed – indexed for MEDLINE]

[2] Prehospital Medications – How Well Do They Store – Brian Walsh (New Jersey)
Brian W. Walsh, MD FAAEM
Free Emergency Medicine Talks
September 13, 2011
MEMC-VI (Sixth Mediterranian Emergency Medicine Conference)
Kos, Greece
Page with link to Mp3 Download

[3] Lorazepam
FDA
Current Drug Shortages
Drug shortage information page

.

Drug Shortage Update Affecting a Lot of the Ex-Code Drugs

Today’s drug shortage update from the FDA (Food and Drug Administration) includes a lot of drugs that used to be routine drugs for cardiac arrest.

Once upon a time, I was a code drug.

Atropine is the most recent drug to be dumped by the AHA (American Heart Association). In the past week, two manufacturers have stated that they have atropine available. FDA Update.

It was nice to see the AHA admit that there is not a good reason to keep treating every PEA (Pulseless Electrical Activity) or asystole patient with a drug that has never had good evidence that it improves survival. The next revision of the ACLS (Advanced Cardiac Life Support) guidelines will provide more opportunity to get rid of some drugs that are routinely used for cardiac arrest, even though there is no evidence that they improve survival – lidocaine (farther down on this list), amiodarone, and the everybody’s favorite drug to not improve survival – epinephrine (also farther down on the list).

Calcium Chloride has increased availability from one manufacturer, but decreased availability from another. Calcium is still the best drug for hyperkalemia, but it was once used routinely in cardiac arrest, as if there has been a lot of sudden onset hypocalcemia. FDA Update.

Epinephrine 1:10,000 has not yet been dumped by the FDA, but the recent evidence suggests that we are decreasing survival by using epinephrine – and those who do survive the epinephrine are more likely to have significant brain damage. FDA Update

Tomorrow, I will be talking about the evidence for and against epinephrine at the EMS Web Summit.

Lidocaine has new manufacturing delays. Lidocaine is still just barely in the ACLS guidelines –

Amiodarone may be considered when VF/VT is unresponsive to CPR, defibrillation, and vasopressor therapy (Class IIb, LOE A). If amiodarone is unavailable, lidocaine may be considered, but in clinical studies lidocaine has not been demonstrated to improve rates of ROSC and hospital admission compared with amiodarone (Class IIb, LOE B).[1]

Maybe lidocaine is there to make amiodarone look good, because nothing else makes amiodarone look good.

For victims of witnessed VF arrest, early CPR and rapid defibrillation can significantly increase the chance for survival to hospital discharge.128,–,133 In comparison, other ACLS therapies such as some medications and advanced airways, although associated with an increased rate of ROSC, have not been shown to increase the rate of survival to hospital discharge.31,33,134,–,138 [2]

In other words, these drugs are probably only as effective as atropine, and maybe less harmful than atropine, but the AHA has not given up on them, yet. FDA Update.

Magnesium Sulfate is another once-promising code drug, now used for the ever-impressive torsades and for the less impressive hypomagnesemia. FDA Update

Sodium Bicarbonate used to be given almost as much as epinephrine.

Now, Sodium Bicarbonate is only given when it is specifically indicated – the way that real medicine should be used. 😯

Sodium Bicarbonate is second line for hyperkalemia and probably is just the hypertonic saline (5.8% saline) that is working, rather than treatment of acidosis, but acidotic patients may benefit from that, too – if they are well ventilated. Sodium Bicarbonate is CO2 in a syringe.

FDA Update.

Vasopressin is now available, again. Not useful in cardiac arrest, but we feel we need to inject something, so this permits some variety. FDA Update.

Important non-code EMS drugs on the FDA Current Drug Shortages list are:

Alfentanyl – Possibly substituting for fentanyl, but not having enough to make up for the lack of fentanyl. Probably also due to increased realization that the side effects of opioids are easily managed by competent medical personnel.

Atracurium (Tracrium).

Diazepam (Valium).

Digoxin.

Diltiazem (Cardizem).

Diphenhydramine (Benadryl).

Etomidate (Amidate).

Fentanyl (Sublimaze).

Hydromorphone (Dilaudid).

Ketorolac (Toradol).

Lorazepam (Ativan).

Mannitol.

Metoclopramide (Reglan).

Midazolam (Versed).

Morphine.

Multi-vitamin injection (banana bags?).

Naloxone (Narcan).

Naltrexone.

Ondansetron (Zofran).

Oxytocin (Pitocin).

Pancuronium (Pavulon).

Phentolamine (Regitine).

Procainamide (Pronestyl) – the only ventricular antiarrhythmic that works (of those commonly available in the US – [sotalol also works]).

Prochlorperazine (Compazine).

Promethazine (Phenergan)

Propofol (Diprivan).

Sufentanyl (Sufenta).

Tromethamine (Tham).

Vecuronium (Norcuron).

and something new –

Sodium Chloride 0.9% (5.8mL and 20mL) (Initial Posting Date) – 5/4/2012. FDA Update.

Footnotes:

[1] Drug Therapy in VF/Pulseless VT
2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science
Part 8: Advanced Life Support
Part 8.2: Management of Cardiac Arrest
Free Full Text from Circulation

[2] Overview
2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science
Part 8: Advanced Life Support
Part 8.2: Management of Cardiac Arrest
Free Full Text from Circulation

.

How Bad are the Drug Shortages

I rant a bit about the misuse of many of these drugs, but there are a lot of drugs used in EMS on the current drug shortage list.

There is a lot written about the drug shortages, but what drugs are affected right now? I copied a list of what drugs are currently experiencing shortages as of today from the FDA (Food and Drug Administration).[1], [2]

What about EMS drugs?

Alfentanil Injection (Alfenta, Rapifen) – An opioid that may be used in some EMS systems as a substitute for fentanyl. Or another reason for EMS to use ketamine.[7]

Atracurium besylate (Tracrium) – A paralytic used in RSI (Rapid Sequence Induction/Intubation).

Atropine Sulfate Injection – Amphastar lists no delays, but other manufacturers list manufacturing delays and an increase in product demand. One manufacturer temporarily suspended production in April 2011.

The FDA search shows that there were drug shortages updates for atropine on 12/11/2008, 4/07/2009, and 9/30/2011 (the current shortage?), but all of the cached pages are the most recent, so the original information is not there.[3]

Following concerns about possible terrorist attacks using poisons that may be treated with atropine, the long term stability of atropine, and the continuing lack of evidence of benefit of atropine in treating cardiac arrest.[4]

How much did each of those contribute to another magic treatment biting the dust?

Caffeine, anhydrous (125 mg/mL) and Sodium benzoate (125 mg/mL) (Starbucks, Dunkin’ Donuts) – OK, that is not the kind of caffeine they are referring to. There might be true rebellion among EMS and hospital personnel if caffeine were not available.

What does that tell us about sleep deprivation, medicine, and the need for naps on the job?

Calcium Chloride Injection – If we are treating emergency hyperkalemia (which I recently saw written as hyperpotassiumemia :oops:) with anything other than calcium chloride as the first line drug, we are not providing good patient care.[5]

But calcium is dangerous!!

The danger of calcium is just another EMS myth.

What is dangerous is using much less effective treatments, such as sodium bicarbonate.

What is even more dangerous is using harmful, but ineffective treatments, such as sodium polystyrene sulfonate (Kayexalate)

Calcium Gluconate – A less concentrated form of calcium, that is safer in IV (IntraVenous) lines of questionable patency, not that this is the biggest concern in treating peri-arrest patients. IO (IntraOsseous) works for calcium chloride.[6]

Desmopressin Injection (DDAVP, Stimate, Minirin) – Similar to vasopressin.

Dexamethasone Injection (Decadron) – Methylprednisolone (Medrol, Solu-Medrol) is a good alternative that is not listed as a current drug shortage.

Diazepam Injection (Valium, Diastat) – The common alternative benzodiazepine sedatives (lorazepam [Ativan] and midazolam [Versed]) are also listed as current drug shortages.

Maybe this is a good reason to start carrying ketamine.[7]

Digoxin Injection – An inotrope alternative to catecholamines. The only inotrope not supposed to raise heart rate or myocardial oxygen demand at therapeutic levels. On the other hand, there is debate about whether digoxin improves outcomes.[8], [9]

Diltiazem Injection (Cardizem) – Verapamil (Calan, Isoptin, and Verelan) is the common alternative calcium channel blocker that should be used in the place of diltiazem for A Fib (Atrial Fibrillation) or SVT (SupraVentricular Tachycardia).

Diphenhydramine Hydrochloride Injection (Benadryl) – A medication to treat dystonic reactions. For dystonia, it can be replaced by benztropine (Cogentin). The more common use of diphenhydramine is as an antihistamine, such as after IM (IntraMuscular) epinephrine for anaphylaxis. It may sedate and decrease itching, but do not expect diphenhydramine to reverse anaphylaxis.


An example of dystonia. Image credit.

Etomidate Injection (New!!) (Amidate) – Etomidate is commonly used for pseudo-RSI or DFI (Drug Facilitated Intubation). In Pennsylvania, we have a dose of 0.3 mg/kg, that is often restricted even more by some medical command doctors out of an apparent fear of giving a dose that might be effective. Should they want to give orders for more, the maximum dose listed in the protocol is 30 mg. The medical command doctor can order more, but few seem to realize that this is not a restriction on what they can order. Etomidate is only supposed to be used with a paralytic for RSI, but is expected to be both sedative and paralytic, when EMS uses it in Pennsylvania. 😳

Why use a not-very-effective drug at a dose that is not expected to be effective?

Fentanyl Citrate Injection (Sublimaze) – The shortage of both benzodiazepines and opioids are just more reasons for EMS to use ketamine.[7]

Furosemide Injection (Lasix) – A drug that EMS should not use. Furosemide is so far down on the list of treatments for CHF (Congestive Heart Failure), that it suggests we have been digging a grave for the patient, if we stay on scene long enough to give furosemide. A worthless EMS treatment.[10], [11] Pennsylvania is ahead of most states in moving furosemide to medical command order only, but the better move is to remove it from EMS use completely.

Ketorolac Injection (Toradol) – A pain medicine related to aspirin, so not a good idea for trauma, but some people are less worried about interfering with the ability of trauma patients to stop bleeding than they are about the possibility that the 10/10 severe pain patient might stop screaming and, without anyone noticing, stop breathing. 😳

One possible superiority is for calculi (kidney stones and gall stones). Of course, this is just another reason for EMS to use ketamine.[7]

Labetalol Hydrochloride Injection (Normodyne, Trandate) – A beta blocker. Beta blockers have been de-emphasized since the CRUSADE trial, but there are still EMS indications in heart attack. Patients with signs of dramatic catcholamine release (they look as if someone gave them epinephrine) except for patients with tachycardia (greater than 110 beats per minute).

Lorazepam Injection (Ativan) – Not the best, or even the second best, EMS sedative, but one that is preferred by a lot of people. A much better idea is midazolam, because aggressive doses can be given and they should be wearing off at about the time the patient is being transferred to the ED (Emergency Department), so that one-on-one observation of a heavily sedated patient is not required and flumazenil (Romazicon) is not given. Another reason for EMS to use ketamine.[7]

Magnesium Sulfate Injection – A safer antiarrhythmic than amiodarone and a treatment for some of the arrhythmias caused by amiodarone, such as torsades des pointes.-

Mannitol Injection – An osmotic diuretic used in some EMS systems.

Methylphenidate HCl (Ritalin) – Possibly the second most common EMS drug – after caffeine.

Metoclopramide injection (Reglan) – Anti-nausea medication.

Midazolam Injection (Versed) – This used to be my favorite EMS sedative, but this is one more reason for EMS to use ketamine.[7]

Morphine Sulfate Injection – For pain management and another reason for EMS to use ketamine.[7]

Nalbuphine Injection (Nubain) – A poor substitute for morphine and a pathetic excuse for risk management. Just another reason for EMS to use ketamine.[7]

Naltrexone Oral Tablets (New!!) (Depade, ReVia) – With the use of nebulized naloxone, who knows what might be next? As long as we are treating something other than respiratory depression (patients unlikely to be able to use a nebulizer), maybe oral tablets will be next and the longer acting opioid antagonist may appeal to those terrified of any potential for respiratory depression.

NeoProfen (ibuprofen lysine) Injection – For treatment of PDA (Patent Ductus Arteriosus) in premature babies. Some EMS may use this, but it is more likely to be found in the ED or neonatal ICU.

Ondansetron Injection 2 mg/mL (Zofran) – One effective antiemetic.

Ondansetron Injection 32 mg/50 mL premixed bags (Zofran) – Same thing, different preparation.

Oxytocin Injection, USP (synthetic) (Pitocin) – For post-partum hemorrhage that is not otherwise controlled. Massage the fundus and consider direct pressure. Direct pressure is not in EMS protocols, but when the alternative is the death of the patient, do we want to stop the bleeding, or do we want to follow protocols?

Pancuronium Bromide Injection (Pavulon) – A paralytic used in RSI.

Phentolamine Mesylate for Injection (Regitine) – For treatment of extravasation of catecholamines (epinephrine, dopamine, dobutamine). Not usually carried by EMS (after all, it only happens in other EMS systems), but used in the ED (even to treat the extravasation of catecholamines from EMS IVs – but only from those other EMS systems). 😎

Procainamide HCL Injection (Pronestyl) – An antiarrhythmic that is very effective, but it has a lot of side effects – just like the much less effective drugs that are used in its place.

Prochlorperazine Injection (Compazine) – Another anti-nause medication. This is also one of the drugs that may cause dystonic reactions.

Promethazine Injection (Phenergan) – Still another anti-nause medication. Another drug that may cause dystonic reactions.

Vasopressin Injection (Pitressin) – An alternative to epinephrine as a pressor to treat cardiac arrest, even though there is no evidence of improved survival. Also goes by the name “pit,” so that it can be easily confused with Pitocin (“pit”) used in OB/GYN.

Vecuronium Injection (Norcuron) – A paralytic used in RSI.

That is it for the drugs that are used in some EMS systems. Fortunately, a lot can be replaced by ketamine, or their use can be reduced by the use of ketamine. Pain management, sedation, RSI, excited delirium, DSI (Delayed Sequence Intubation), et cetera. One long list of reasons for EMS to use ketamine.[7]

Also see Stressful Drug Shortage Update.

Footnotes:

[1] Current Drug Shortages
Drug Shortages
FDA
02/15/2012
Drug shortage Update

[2] List of medications from FDA drug shortages update on 02/15/2012

Acetylcysteine Inhalation Solution

Alcohol Dehydrated (Ethanol > 98%)

Alfentanil Injection

Amikacin Injection

Amino Acid Products (New!!)

Aminocaproic Acid

Ammonium Chloride Injection

Ammonium Molybdate Injection

Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10%

Amphetamine Mixed Salts, ER Capsules

Amphetamine Mixed Salts Immediate-Release Tablets

Anadrol-50 tablets (Oxymetholone Tablets)

Aquasol A

Atracurium besylate

Atropine Sulfate Injection

Avalide (irbesartan and hydrochlorothiazide)Tablets

Bleomycin Injection

Bupivacaine Hydrochloride Injection

Buprenorphine Injection

Butorphanol Injection

Caffeine, anhydrous (125 mg/mL) and Sodium benzoate (125 mg/mL)

Calcitriol 1 mcg/mL Injection

Calcium Chloride Injection

Calcium Gluconate

Cerezyme (imiglucerase for injection)

Chromic Chloride Injection

Cisplatin injection 1 mg/mL solution

Corticorelin Ovine Triflutate (New!!)

Cosyntropin Injection

Cyanocobalamin injection

Daunorubicin hydrochloride solution for injection

Desmopressin Injection

Dexamethasone Injection

Dexrazoxane Injection

Dextroamphetamine Tablets

Diazepam Injection

Digoxin Injection

Diltiazem Injection

Diphenhydramine Hydrochloride Injection

Doxorubicin (adriamycin) lyophilized powder

Doxorubicin Liposomal (Doxil) Injection

Doxorubicin Solution for Injection

Ethiodol (ETHIODIZED OIL) ampules

Etomidate Injection (New!!)

Etoposide solution for injection

Fabrazyme (agalsidase beta)

Fentanyl Citrate Injection

Fluorouracil Injection

Foscarnet Sodium Injection

Fosphenytoin Sodium Injection

Furosemide Injection

Haloperidol Decanoate Injection

Indigo Carmine Injection

Insulin glulisine [rDNA origin] injection) solution for injection (Apidra SoloStar)

Intravenous Fat Emulsion

Isoniazid Tablets

Ketorolac Injection

Labetalol Hydrochloride Injection

L-cysteine hydrochloride

Leucovorin Calcium Lyophilized Powder for Injection

Leuprolide Injection

Levaquin Injection

Levofloxacin Injection

Levoleucovorin (Fusilev) 50 mg single use vials

Lorazepam Injection

Magnesium Sulfate Injection

Mannitol Injection

Mesna 100 mg/mL Injection

Methotrexate Injection

Methylphenidate HCl

Methyldopate Injection

Metoclopramide injection

Mexiletine Capsules (150mg, 200mg, and 250mg)

Midazolam Injection

Mitomycin Powder for Injection

Morphine Sulfate Injection

Multi-Vitamin Infusion (Adult and pediatric)

Mustargen (mechlorethamine HCl) injection

Nalbuphine Injection

Naltrexone Oral Tablets (New!!)

NeoProfen (ibuprofen lysine) Injection

Neupro (rotigotine transdermal system)

Ondansetron Injection 2 mg/mL

Ondansetron Injection 32 mg/50 mL premixed bags

Ontak injection

Opana ER (oxymorphone hydrochloride) Extended-Release Tablets CII (New!!)

Orphenadrine Citrate Injection

Oxsoralen (methoxsalen) 1% topical lotion

Oxytocin Injection, USP (synthetic)

Paclitaxel Injection

Pancuronium Bromide Injection

Phentolamine Mesylate for Injection

Phytonadione Injectable Emulsion (Vitamin K)

Potassium Phosphate

Primaquine Phosphate Tablets

Procainamide HCL Injection

Prochlorperazine Injection

Promethazine Injection

Selenium injection

Sodium Acetate Injection

Sodium Chloride 23.4%

Sodium Phosphate Injection

Sulfamethoxazole 80mg/trimethoprim 16mg/ml injection (SMX/TMP)

Telavancin (Vibativ) Injection

Tetracycline Capsules

Thiotepa for Injection

Thyrogen (thyrotropin alfa) injection 1.1mg/vial

Thyrolar Tablets

Ticlopidine Tablets

Tobramycin Solution for Injection

Vasopressin Injection

Vecuronium Injection

Vinblastine Sulfate Injection

Voltaren gel 1% (Diclofenac Sodium Topical Gel) (New!!)

[3] Atropine Sulfate Injection
FDA
FDA Search

[4] What Will We Do With All of That Atropine
Rogue Medic
Fri, 22 Oct 2010
Article

[5] Management of severe hyperkalemia.
Weisberg LS.
Crit Care Med. 2008 Dec;36(12):3246-51. Review.
PMID: 18936701 [PubMed – indexed for MEDLINE]

Free Full Text PDF

[6] Comparison study of intraosseous, central intravenous, and peripheral intravenous infusions of emergency drugs.
Orlowski JP, Porembka DT, Gallagher JM, Lockrem JD, VanLente F.
Am J Dis Child. 1990 Jan;144(1):112-7.
PMID: 1688484 [PubMed – indexed for MEDLINE]

[7] Is Ketamine an EMS Wonder Drug
Rogue Medic
Sun, 01 Jan 2012
Article

[8] Update on digoxin therapy in congestive heart failure.
Haji SA, Movahed A.
Am Fam Physician. 2000 Jul 15;62(2):409-16. Review.
PMID: 10929703 [PubMed – indexed for MEDLINE]

Free Full Text from Am Fam Physician.

For many more years, digitalis continued to be an important part of heart failure management. The detrimental aspects of digoxin therapy were not considered important until excess mortality was reported in survivors of myocardial infarction who received digitalis.13,14 Uncontrolled observations that the withdrawal of digoxin produced no ill effects also raised concerns about the efficacy of the drug.15,16

[9] The effect of digoxin on mortality and morbidity in patients with heart failure. The Digitalis Investigation Group.
[No authors listed]
N Engl J Med. 1997 Feb 20;336(8):525-33.
PMID: 9036306 [PubMed – indexed for MEDLINE]

Free Full Text from N Engl J Med.

In conclusion, digoxin had no effect on overall mortality in patients receiving diuretics and angiotensin-converting–enzyme inhibitors, but it did reduce the overall number of hospitalizations and the combined outcome of death or hospitalization attributable to worsening heart failure. In clinical practice, digoxin therapy is likely to affect the frequency of hospitalization, but not survival.

On the other hand, that is not a study of digoxin for emergency use.

[10] Prehospital therapy for acute congestive heart failure: state of the art.
Mosesso VN Jr, Dunford J, Blackwell T, Griswell JK.
Prehosp Emerg Care. 2003 Jan-Mar;7(1):13-23. Review.
PMID: 12540139 [PubMed – indexed for MEDLINE]

Free Full Text PDF

[11] Modern management of cardiogenic pulmonary edema.
Mattu A, Martinez JP, Kelly BS.
Emerg Med Clin North Am. 2005 Nov;23(4):1105-25. Review.
PMID: 16199340 [PubMed – indexed for MEDLINE]

Free Full Text PDF

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Is the Drug Shortage an Excuse for Incompetence – Part II

Continuing from Part I.

A hospital, or ambulance company, should not allow doctors, nurses, or paramedics to give substitute medications without educating them about the medication. Different concentrations. Different dosages. Different side effects. Different drug interactions. Different indications. Different routes of administration. Et cetera. Even for nearly identical drugs.

Likewise, a doctor, nurse, or paramedic should not give any medication without being familiar with the drug – concentrations, dosages, side effects, drug interactions, indications, et cetera.

Gosh, I’ve never given this before. Let’s play with it. It’s not like anything bad could happen.

Do doctors do this?

Do nurses do this?

Do paramedics do this?

Is this the kind of behavior that any hospital wants/accepts from its employees?

Is this the kind of behavior that any ambulance company wants/accepts from its employees?

“In our mind, that’s just the tip of the iceberg,” Vaida says of the 15 deaths. “No one may be attributing a death because they really aren’t aware that a drug actually caused the death. If someone is notaware of the potency of one medication and gives too much so that the patient goes into respiratory arrest and dies, they may attribute it to the fact that the patient came into the hospital with respiratory problems.”[1]

Ex-Dr. Conrad Murray is going to prison for similar behavior.

How can any administrator claim that Conrad Murray behavior is to be expected from their employees, but not end up being investigated.

If I give a medication and the patient stops breathing, I should still be able to ventilate and oxygenate the patient. The same is true for any first responder, or basic EMT.

 

If the problem is respiratory depression

 

and the result is death,

 

is the problem the drugs,

 

the people giving the drugs,

 

or the oversight of the people giving the drugs?

 

Why hire people who can tell the difference between one and 100?

How is a death, under these circumstances, any different from the death of Michael Jackson under similar circumstances?

What are the circumstances of these deaths?

So far, 15 deaths attributed to the drug shortage have occurred nationwide, an Associated Press study found.[1]

One code-blue patient in an undisclosed city died because the preloaded emergency syringe epinephrine wasn’t available.[2]

In cardiac arrest, epinephrine, does NOT save lives.

Epinephrine does help to just get a pulse back, but that is not saving a life. If just getting a pulse back were saving a life, then we would not have large awards to the families of patients who went in to the hospital without impairment, but came out with just a pulse. That would be considered a good outcome.

If the doctors, nurses, and medics do not know what medications they are using, they should not proceed until they do know what they are doing.

Footnotes:

[1] Shortage of Lifesaving Drugs Reaches Epic Proportions
Beverly Ford Source: Telegram & Gazette (Worchester, MA)
December 21, 2011
EMS World
Article

[2] Oklahoma EMS Face Drug Shortage
by Sonya Colberg
The Oklahoman
Monday, October 4, 2010
Article at JEMS.com

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Is the Drug Shortage an Excuse for Incompetence – Part I

Continuing from Shortage of Lifesaving Drugs Reaches Epic Proportions.

It’s how to provide the best patientcare while at the same time preventing medical mix-ups when administering drug substitutes, many of which have different potencies than their more commonly used counterparts. Fentanyl, for example, which isused as a substitute for morphine, is 10 times stronger than the opiate. A wrong dose, hospital officials worry, could cause death.[1]

Fentanyl is 100 times as potent per mg (not 10 times), but the packaging is generally single dose packaging. A syringe of fentanyl with 100 mcg is roughly the same strength as a syringe of morphine that contains 10 mg. I would need to get 99 more syringes of fentanyl to give the same dose in milligrams.

In what hospital is this not going to require a trip to the pharmacy? What ambulance company carries 10 mg fentanyl (10,000 mcg fentanyl) on any ambulance?

This 10 mg of morphine –


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Is not the same as this 10 mg of fentanyl –


Image credit. Click on images to make them larger.

Hold on. That isn’t 10 mg fentanyl. We need more –

We still need more –

We aren’t there yet –

Just a teensy-weensy bit more –

There is more than a subtle difference between the one syringe and the 100 syringes. If you missed it, go back and look again. Can you tell the difference between 100 syringes and 1 syringe? Are you sure?

Have carpal tunnel symptoms developed from repeatedly pushing the plunger on these syringes? Is each syringe being followed by a flush? If 2 ml fentanyl is followed by a 10 ml flush, that is 1,200 ml for what should have been 1 ml of morphine. The syringes are the same size, although the fentanyl syringes contain 2 ml each and the morphine syringes contain 1 ml each.

There may be other concentrations available, but 50 mcg/ml is the most common concentration of fentanyl. The variation in concentrations is much more common with morphine. The 10 mg/ml concentration is what I carry, which is 10 mg in one 1 ml syringe (as pictured). Everyone should check the concentration at least once before giving any medication.

To be continued in Part II.

Footnotes:

[1] Shortage of Lifesaving Drugs Reaches Epic Proportions
Beverly Ford Source: Telegram & Gazette (Worchester, MA)
December 21, 2011
EMS World
Article

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Shortage of Lifesaving Drugs Reaches Epic Proportions

I did not come up with the title – Shortage of Lifesaving Drugs Reaches Epic Proportions – that was the title of the article I am criticizing, but not for any lack of hyperbole.

“It’s a perfect storm of conditions with a rapidly consolidating marketplace, a health care system that is trying to control costs, an issue with raw materials and a marketplace that doesn’t have a good redundancy system in place to handle things when a plant shuts down,” says Allen Vaida, executive vice president of the Institute for Safe Medication Practices. “No question about it. It’s a national crisis.”[1]

In EMS, we are worried about a shortage of drugs, when we should see this as an opportunity to improve patient care.

Among the drugs Fox found that were in short supply during 2011 were injectable versions of calcium gluconate, used by first responders to regulate heart rhythm in patients suffering cardiac arrest; succinylcholine, a muscle relaxer used to intubate patients; naloxone hydrochloride, which reverses drug overdoses; and propofol, an anestheticused in emergency surgery better known for causing the death of singer Michael Jackson. Most of those medications are older generic injectables that are widely used in emergency situations. Some of those shortages, among them propofol and succinylcholine, have since been resolved but others continually crop up, creating a gap in emergency drug stockpiles.[1]

calcium gluconate, used by first responders to regulate heart rhythm in patients suffering cardiac arrest

It could be, but that does not make sense. ACLS (Advanced Cardiac Life Support) discourages the routine use of calcium, but in true emergencies we should be using calcium chloride, rather than the slow infusion of calcium gluconate.

Routine administration of calcium for treatment of in-hospital and out-of-hospital cardiac arrest is not recommended (Class III, LOE B).[2]

naloxone hydrochloride, which reverses drug overdoses

Naloxone is only indicated for life-threatening respiratory depression due to an opioid overdose. However, a response to naloxone is definitely not diagnostic for an opioid overdose.

Suppose that EMS has no naloxone (Narcan), so what? The essential treatment for opioid overdose, and for benzodiazepine overdose, is just supportive care.

and propofol, an anesthetic used in emergency surgery better known for causing the death of singer Michael Jackson.

Propofol did not cause the death of Michael Jackson. The lack of airway management by Dr. Conrad Murray killed Michael Jackson. Opening his airway, and maybe some painful stimulus, would have kept Michael Jackson alive.

“Gray market” suppliers, usually small wholesalers or individuals who closely monitor and react to pharmaceutical trends, are scooping up medications as soon as a shortage becomes apparent then selling back the products to drug distributors, other wholesalers or hospitals at inflated prices that can sometimes top more than 1,000 percent of a drug’s original cost.[1]

What is the original cost used for these calculations? Is it the cost to the manufacturer? The list price? The wholesale price to hospitals? The cost per dose to the patient? Why use percentages? Do most people realize that 1,000% as much means ten times as much.


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“We’re not getting any complaints regarding any infringement on care because of the shortages,” she says. “That doesn’t guarantee it isn’t happening, but we usually see that fairly quickly when there seems to be an uptick in problems. What I surmise is that providers are doing what they are supposed to do under the circumstances.”[1]

Is it possible for people to actually do what they are supposed to do?

If we are not doing what we are supposed to be doing, why not?

“Patient access to innovative treatments is the cornerstone of our industry. That is why the critically important issue of drug shortages demands our collective attention to ensure patients can access themedicines they need in the most expeditious manner possible,” says John Castellani, chief executive officer and president of The Pharmaceutical Research and Manufacturers of America, a trade group comprised of pharmaceutical research and biotechnology companies.[1]

 

No.

 

“Patient access to innovative safe and effective treatments is the cornerstone of our industry.

Safe and effective are essential. Innovative is desirable, but not essential.

Dr. Conrad Murray killed Michael Jackson with incompetence, not with any drug. Is blaming deaths on a drug shortage any different from blaming deaths on a drug?

To be continued in Is the Drug Shortage an Excuse for Incompetence – Part I on 01/06/2012.


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Footnotes:

[1] Shortage of Lifesaving Drugs Reaches Epic Proportions
Beverly Ford Source: Telegram & Gazette (Worchester, MA)
December 21, 2011
EMS World
Article

[2] Interventions Not Recommended for Routine Use During Cardiac Arrest
Part 8: Adult Advanced Cardiovascular Life Support
2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care
Part 8.2: Management of Cardiac Arrest
Free Full Text Article with links to Free Full Text PDF download

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