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

- Rogue Medic

Do Drug Shortages Really Impact EMS? – Answer 1

Wed, 08 Sep 2010 18:39:51 -0400 by
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Here is part 1 of the details from the points I raised in commenting on the discussion of the drug shortages and the way these affect EMS. I already gave the short answers in Do Drug Shortages Really Impact EMS? – EMS Office Hours. These will be a bit longer, so I broke it up by answer. There are many points covered for a podcast that lasts less than 40 minutes. Do Drug Shortages Really Impact EMS?

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1. Do the drugs help patients?

I have recently written about why these drugs are inappropriate here, here, here, and here.

These drugs are based on either, or both, of 2 bad ideas.

First – Expired expert opinion. Opinion that is not supported by good research. When the research has been done, the research has not supported these treatments.

By expired, I do not mean that the expert has expired, but that the opinion has been kept in use long past any possible justification. If this were canned food in your cupboard, the can would be bulging at both ends from the disgusting growth on this very dead opinion.

Second – Not just expired expert opinion, but opinion that is not based on any research. There is the possibility that research will someday demonstrate that these treatments are effective, if anyone ever appropriately studies these ideas. It is also possible that the parts of the moon that have not been examined actually are made out of cheese. This is the morass of Class IIb level of evidence.

Class II: Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a procedure or treatment.

IIa. Weight of evidence/opinion is in favor of usefulness/efficacy

IIb. Usefulness/efficacy is less well established by evidence/opinion.[1]

There is no requirement for any evidence.

The highlighting is mine, but the wording is 100% ACC/AHA (American College of Cardiology/American Heart Association). The people who thought antiarrhythmics were the answer to everything, until research showed an antiarrhythmic fatality rate several times higher than placebo.[2]

Oopsy.

Perhaps I am putting too positive a spin on the Class II levels of evidence. Some of what is classified as IIa is not much different from IIb, because there is still the allowance for expert opinion. Any reading of this research should be preceded by the words, Wouldn’t it be nice if . . .

However, that is not the way to decide what chemicals to test on a patient.

Let’s be honest. That is all we are doing. We are testing chemicals and/or procedures on patients. We are not treating patients, because treatment implies some sort of concern for the patient. This is just a bunch of large scale never-to-be-published, uncontrolled, unregistered, unreasonable experiments on patients who are not informed of their guinea pig status.

I want to know the real risks and benefits of this treatment.

Wouldn’t it be nice if . . .

How far do we need to go to demonstrate that bad ideas really are bad ideas?

We need to demand that medical directors base their EMS protocols on research.

Why are medical directors ignoring what is best for their patients?

Why are medical directors ignoring what is best for our patients?

Why should we tolerate this ignorance?

I’m a doctor.

Wouldn’t it be nice if . . .

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Continued in –
Do Drug Shortages Really Impact EMS? – Answer 2
Do Drug Shortages Really Impact EMS? – Answer 3
Do Drug Shortages Really Impact EMS? – Answer 4

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Footnotes –

[1] Manual for ACC/AHA Guideline Writing Committees
Methodologies and Policies from the ACC/AHA Task Force on Practice Guidelines
Section II: Tools and Methods for Creating Guidelines
Step Six: Assign Classification of Recommendations and Level of Evidence
Free Full Text Article

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[2] C A S T and Narrative Fallacy
Rogue Medic
Article

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Filed Under: Critical Judgment, Drug Shortages, EMS Office Hours, Heresy, Physician Oversight, Research Tagged With: , , ,

Inadequate needle thoracostomy rate in the prehospital setting for presumed pneumothorax: an ultrasound study – abstract

Tue, 07 Sep 2010 17:22:22 -0400 by

ResearchBlogging.org
Also posted over at Paramedicine 101 (now at EMS Blogs) and at Research Blogging.

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Go check out the rest of the excellent material at both sites.

Over at 510 Medic, there is an interesting abstract of a new article on treatment of tension pneumothorax. Frequency of Inadequate Needle Decompression in the Prehospital Setting.

CONCLUSIONS: In this study, 26% of patients who received needle thoracostomy in the prehospital setting for a suspected PTX appeared not to have had a PTX originally, nor had 1 induced by the needle thoracostomy. It may be prudent to evaluate such patients with bedside ultrasound instead of automatically converting all needle thoracostomies to tube thoracostomies.[1]

I have not read the full text. I do not have access to this journal. If anyone can send me the full text, I would like to address some of the details, rather than just speculate about them. Late entry – I have received the article. Thank you to Jeff Williams and Jeremy Blanchard. I will write more about the full text later on.

510 Medic makes some important points and asks some good questions. Then 510 Medic asks –

So if we subscribe to the goal of “first do no harm” and those 15 patients didn’t have a pneumothorax induced by the procedure, is their discomfort worth proper treatment for the remaining 42 patients?[2]

I think that there is a more important question.

Should we assume that the presence of a pneumothorax is an indication for needle decompression?

A pneumothorax is not the same as a tension pneumothorax. Even the definition of a tension pneumothorax is not easy to agree on. I tend to treat with opioids what many others would treat with needle decompression. I have not had any of these patients deteriorate, while in my care. They received chest tubes in the trauma center.

Should we assume that the presence of a pneumothorax is an indication for needle decompression?

57 patients with a prehospital diagnosis of tension pneumothorax. Yes, EMS does diagnose, but that is a discussion for elsewhere. Yes, these patients were diagnosed by EMS with tension pneumothorax, unless we are suspecting acupuncture, because what other prehospital indication is there for sticking a needle into a patient’s chest?

Out of 57 patients diagnosed with tension pneumothorax, only 42 patients had a pneumothorax.

How many patients had a tension pneumothorax at the time the needle was stuck into the chest wall?

How many of those patients would have been better off if treated with something other than a needle?

How many complications were there from the needle decompression?

Am I wrong to use italics to highlight the word decompression, since so many of the patients did not have anything to decompress?

We rush to perform procedures that we have little experience with. Isn’t this a situation likely to lead to misdiagnosis?

Isn’t the infrequent use of needle decompression for suspected tension pneumothorax likely to lead to operator error?

The actual occurrence of tension pneumothorax appears to be much less frequent than the prehospital diagnosis of tension pneumothorax. Isn’t that an indication of a failure to properly educate medics?

Footnotes:

[1] Inadequate needle thoracostomy rate in the prehospital setting for presumed pneumothorax: an ultrasound study.
Blaivas M.
J Ultrasound Med. 2010 Sep;29(9):1285-9.
PMID: 20733183 [PubMed – in process]

Free Full Text from J Ultrasound Med.

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[2] Frequency of Inadequate Needle Decompression in the Prehospital Setting
510 Medic
Article

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Blaivas M (2010). Inadequate needle thoracostomy rate in the prehospital setting for presumed pneumothorax: an ultrasound study. Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine, 29 (9), 1285-9 PMID: 20733183

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Filed Under: Critical Judgment, Heresy, Paramedicine 101, Research Blogging, Tension Pneumothorax Tagged With: , , ,

Do Drug Shortages Really Impact EMS? – EMS Office Hours

Tue, 07 Sep 2010 14:18:49 -0400 by
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There is a discussion of the drug shortages and the way these affect EMS. There are many points covered for a podcast that lasts less than 40 minutes. Do Drug Shortages Really Impact EMS?

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1. Do the drugs help patients?

Short answer – No.

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2. If the protocols insist that we give these drugs, how do we convince doctors that doctors should act as if they learned something in medical school?

Short answer – Ridicule.

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3. Should we switch from Lasix (furosemide) to Bumex (bumetanide)?

Short answer – No.

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4. Should CPAP (Continuous Positive Airway Pressure) be ALS only (Advanced Life Support only)?

Short answer – No.

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Continued in –
Do Drug Shortages Really Impact EMS? – Answer 1
Do Drug Shortages Really Impact EMS? – Answer 2
Do Drug Shortages Really Impact EMS? – Answer 3
Do Drug Shortages Really Impact EMS? – Answer 4

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Filed Under: Critical Judgment, Drug Shortages, EMS Office Hours, Heresy, Physician Oversight, Research Tagged With: , ,

Too Much Information and Risk Management

Tue, 31 Aug 2010 20:23:42 -0400 by
Steve Whitehead discusses the problem of Too Much Information the problem of people avoiding learning by claiming that they are being presented with Too Much Information.

He gives 3 examples:

1) We like to keep the bar low.

2) We fear the limitless and undefined.

3) We are inherently insecure.

These are all genuine problems.

I do not want to be treated by someone who embodies these three problems.

I know too many people who do make these mistakes and they are scary.

The people, who complain about Too Much Information, let’s call them TMIs, for the purposes of this post.

If the topic were TMI‘s favorite team, he would hardly be complaining that there is Too Much Information.

If the topic were TMI‘s favorite centerfold, he would hardly be complaining that there is Too Much Information.

The problem seems to be that TMI doesn’t care enough to obtain more information. Why have such a person in a job that involves caring.

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A different problem with Too Much Information is in the ability to prioritize that information. This is not deciding that there is Too Much Information, rather determining how much information is important right now.

When we are on scene with a stable patient, how much information do we obtain before transport? What if the only source of the information is a family member – someone who cannot accompany the patient?

How much is too little information?

How much is enough information?

How much is too much information?

Are there other ways of obtaining the information? Can a nurse call from the hospital to gather more information after the patient is in the ED (Emergency Department)? How long do we delay transport to obtain more information?

Part of this can be dealt with by asking questions in a way to best obtain the most relevant information. However, we don’t always know what that way is. Which of the patient’s chronic illnesses – each with repeated complications that end with ED admissions – which of these do we not obtain a thorough history about with this stable patient?

We can come up with all sorts of BS excuses for not obtaining information, such as the need to get back in service quickly, but should we do an incompetent job just to keep to some imaginary schedule?

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What about when we are on scene with an unstable patient? A lot of the information we would like is only available on scene. What do we do?

How much is too little information?

How much is enough information?

How much is too much information?

Since the patient is unstable, the option of camping out until we have all of the information we would like, is not one that will lead to the survival of the patient. We need to make certain decisions about how much is enough information right now.

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What will a TMI do in that situation?

How would a TMI possibly understand?

TMIs are not understanding people.

TMIs are the people who should be working at jobs that do not require any decision making skill or any understanding of risk management, because TMIs are dangerous when permitted these responsibilities.

On what do TMIs base their decisions, if they have intentionally limited their preparation for the job?

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Risk management has a lot to do with making decisions based on limited information.

Risk management requires an understanding of what is enough information given the limitations of the job.

Risk management for EMS involves working with limited equipment. limited personnel, and limited information.

Risk management for EMS cannot work with arbitrary traditional restrictions on the ability to exercise critical judgment, not if we are interested in doing what is best for the patient.

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Some of us believe in luck.

Some of us pray to luck.

I prefer to make my own luck.

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How do we make our own luck?

We don’t just prepare, we over-prepare.

That is luck?

No. That is preparation. That is having more than the lowest common denominator amount of information.

We do not know what we will be presented with on each call, so how do we know which information we will not need? How would we know, ahead of time, what is not necessary – what is too much?

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Some people like using the 5 Ps to describe how to approach this.

Proper Planning Prevents Poor Performance.

Some extend it to 6 Ps.

Proper Planning Prevents Piss Poor Performance.

Either way, you get the idea. This is completely incompatible with claiming, Oh no. That is Too Much Information.

How do we know which information we will not need?

We don’t.

Only a fool would believe that he is smart enough to know what information he does not need, when he is still learning. Because of this prejudice, some never learn.

The problem seems to be that TMI doesn’t care enough to obtain more information. Why have such a person in a job that involves caring.

How do we know what we need to know?

Can someone, especially someone who intentionally limits the information he has, ever know?

From the quotes I have in the sidebar –

In the fields of observation chance favors only the prepared mind. – Louis Pasteur.

What these TMIs are saying is that they are too good to prepare to take care of patients, because the patients are not important to the TMIs.

EMS is not about the First Responder.

EMS is not about the EMT.

EMS is not about the Medic.

EMS is not about the Nurse.

EMS is not about the Doctor.

EMS is about the patient.

Competent EMS personnel insist on being prepared with more than enough information, in order to be best prepared for as much as is practical.

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Filed Under: Critical Judgment, Heresy Tagged With: , , ,

Helicopter Crash vs. Ambulance Crash

Tue, 31 Aug 2010 15:14:15 -0400 by
In the past week there have been a couple of EMS crashes that have made the news.

The first crash is from Maryland on Friday, August 27.

Captain Oscar Garcia, spokesperson for Montgomery County Fire and Rescue, says the ambulance had just refueled after dropping off a patient at Shady Grove Hospital and was heading back to Station 3 when for some reason, the ambulance went off the road and down a hill into a ravine on Falls Road near Liberty Lane.[1]

Elsewhere it was reported that the crash was a rollover –

MOI OMG Panic! Double Panic!

Get Me A Helicopter, Yesterday!!!11!!!!

A Rollover!

The four firefighters had minor injuries and were taken to the hospital to be checked out, but they are expected to be ok. The car failed to stop and left the scene.[2]

It seems that somebody on scene decided to actually assess the patients, rather than triage them according to Mechanism Of Idiocy.

The second crash, this morning, did not have such a positive an outcome.

The Air Evac Lifeteam helicopter was flying to pick up a traffic accident victim when it went down near the Scotland community in Van Buren County at about 4:30 a.m., Federal Aviation Administration spokesman Lynn Lunsford said.[3]

Air Evac has experienced several fatal crashes in recent years.

In 2008, an Air Evac helicopter crashed in an Indiana cornfield killing three people. In 2007, another three-member crew was killed when an Air Evac helicopter crashed in Colbert County, Ala.

In 2006, an Air Evac helicopter crashed in Gentry in northwest Arkansas, killing the three-member crew.

Last month, an Air Evac helicopter made a forced landing near Tulsa, Okla., after the aircraft’s hydraulics failed. No one was hurt.

(This version corrects to delete information on a crash in western Tennessee; that helicopter did not belong to Air Evac.)[3]

At least the patient was not yet on board.

There is no information provided about what kind of injuries the patient was being flown for – that is assuming the patient actually was injured and not being flown for MOI (Mechanism Of Idiocy) by a protocol monkey.

Maybe the patient did have serious injuries, but considering that most patients sent to the trauma center by helicopter do not have serious injuries, betting on serious injuries would be a bad bet.

Our study demonstrated that the majority of trauma patients transported by medical helicopter from the scene had nonlife-threatening injuries.[4]

Our findings are similar to other studies that have documented that a significant number of trauma patients transported from the scene to a hospital by medical helicopter do not receive any added benefit from helicopter transport.[4]




Even though these patients receive no benefit from being transported by helicopter, these patients are exposed to significant risk and exaggerated costs.

This is the difference in outcome between a rollover crash of an ambulance and a crash of a helicopter.

Rollover crash –

Minor injuries. None of the patients transported by helicopter.

Helicopter crash –

Dead Pilot.

Dead Flight Medic.

Dead Flight Nurse.

The patient being transported by someone else.

Air Evac has identified the crew members who died in the crash as pilot Ken Robertson, flight paramedic Gayla Gregory, and flight nurse Kenneth Meyer, Jr.[5]

Helicopter services do not even seem to care how many of their employees and patients they kill.[6]

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Footnotes:

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[1] Four Hurt In Maryland Ambulance Accident – All onboard suffered non life-threatening injuries.
JEMS.com
Article

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[2] Ambulance Rollover Injures 4
Firegeezer
Article

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[3] Three Dead In Arkansas Medical Chopper Crash – Medevac was enroute to pick up a patient.
Chuck Bartels
Associated Press
Tuesday, August 31, 2010
Article at JEMS.com

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[4] Helicopter scene transport of trauma patients with nonlife-threatening injuries: a meta-analysis.
Bledsoe BE, Wesley AK, Eckstein M, Dunn TM, O’Keefe MF.
J Trauma. 2006 Jun;60(6):1257-65; discussion 1265-6. Review.
PMID: 16766969 [PubMed – indexed for MEDLINE]

Full Text PDF

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[5] Medical helicopter went down near Scotland in Van Buren Co.
todaysthv.com
Pictures are also from here.
Article

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[6] Not Clear On The Concept
Too Old To Work, Too Young To Retire
Article

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Filed Under: Critical Judgment, Heresy Tagged With: , , ,

That’s not Klingon It’s One Word Dyspnea: EMS Garage Episode 98

Tue, 10 Aug 2010 06:54:36 -0400 by
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We were supposed to be talking about the potential harm from the way we use oxygen in EMS, but we ended up with That’s not Klingon It’s One Word Dyspnea.

First, I mentioned that I am blogging at a new location – here. Also at EMS Blogs will be Black Hearts Incorporated, EMS Bloggers, EMS Office Hours, Medical Author Chat, Ready Fodder, The Social Medic, and Too Old To Work, Too Young To Retire. So far, EMS Office Hours, Too Old To Work, Too Young To Retire, and I are posting while things are being worked out. The blog transfer has not been fun, but it has been educational. I expect to learn a lot more. And I have to thank David Konig, who has been putting his blog, The Social Medic, on hold and guiding us through this. He has also come up with a nice simple design for my blog that I like a lot.

Then the topic turned to the recent medical helicopter crashes and Ambulance Driver’s post Is that helicopter really necessary? in response to the M.D.O.D. post Do You REALLY Need the Helicopter? Before the podcast, I wrote a post mostly about the comments on Ambulance Driver’s post. Fly Everyone, Let the NTSB Accident Investigators Sort ‘Em Out.

It should come as no surprise to people who are familiar with any of the participants, that we were very critical of the abuse of helicopter EMS by medical directors, by ED physicians, and by ground EMS personnel.

Why should we try to justify abuse?

The comments in support of helicopter abuse (on Ambulance Driver’s post) are depressing for those of us trying to improve the quality of EMS. These comments do point out the problems I wrote about in Confirmation Bias and EMS. Many of us do not appear to make any attempt to be objective in evaluating what we do in EMS. We only seem to look at things through the filter of our biases. The people writing these comments seem to have decided that helicopters always save lives and they deny that helicopter crashes are a problem.

The purpose of the helicopter is to make a significant difference in transport time for the patient who really is unstable. These patients are not as common as many suggest. They seem to be most commonly encountered by the least experienced people. In other words, as people become more skilled, they panic less and fly fewer patients. The people denying the problems with helicopters seem to be trying to demonstrate that they cannot assess patients well enough to recognize which patients are unstable, which are stable, and which were never even injured.

The people denying the problems with helicopters also seem to demonstrate that they do not understand that they are not saving significant amounts of time. They often are delaying a patient’s arrival at a trauma center just so they can put the patient in a helicopter.

Finally, we did briefly mention harm from oxygen, but that should be covered in an upcoming podcast. Preferably a show with at least one physician on it. There is a lot to discuss, when considering the over-use of oxygen, and it does appear that we use too much oxygen. We have too many patients receiving oxygen without any evidence of hypoxia.

In the absence of hypoxia, there is not evidence of benefit from oxygen, but there is evidence of harm. This goes back to at least 1950, so the idea that oxygen is harmful is not at all new. This is another example of what I write about in Confirmation Bias and EMS.

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Filed Under: EMS Garage, Ethics, Fraud, Helicopters, Heresy Tagged With: , , , , ,

Current Drug Shortages

Fri, 30 Jul 2010 09:05:08 -0400 by

The drug shortages updates from the FDA have included a lot of drugs commonly used in emergency medicine, but some of the recent shortages may be more likely to point out the lack of importance and misuse of these drugs.

I apologize for the formatting. Formatting is not my strength. The link above will take you to the original document. All of my further comments are in blue on the page below.

Drug Name Company
Information		 Reason for Shortage Related Information
Amikacin injection

updated
7/8/2010

 Bedford
Customer service
1- 800-562-4797		 Manufacturing delays Bedford anticipates availability by mid-August, 2010.

RSI (Rapid Sequence Induction/Intubation) medication. Rocuronium and succinylcholine are still available.

Drug Name Company
Information		 Reason for Shortage Related Information
Calcium Chloride Injection

New!

7/20/2010

 Hospira Inc.

1-877-946-7747



American Regent, Inc.

1-800-645-1706

 Unanticipated Increased Demand Information on Anticipated Availability for Syringes (PDF – 15KB)


American Regent, Inc. currently has Calcium Chloride Injection, USP 100 mg/mL in a 10 mL vial available. Due to increases in demand, American Regent, Inc. may not be able to fill all orders. Contact your wholesaler regarding product availability.

Calcium chloride can be replaced by calcium gluconate, which is one third as strong as calcium chloride.

Drug Name Company
Information		 Reason for Shortage Related Information
Dextrose 50% injection

updated
7/13/2010

 Hospira Inc.
1-877-946-7747		 Unanticipated Increased Demand Information on Anticipated Availability (PDF – 18KB)

Dextrose 50% can be, and should be replaced with Dextrose 10%. The studies of the use of 10% Dextrose, rather than 50% dextrose, for acute hypoglycemia make it clear that 10 Dextrose is no less effective, but is less likely to cause complications. I will write about this in another post.

Drug Name Company
Information		 Reason for Shortage Related Information
Epinephrine 0.1 mg/mL Emergency Syringes 10 mL LifeShield Abboject syringe with 1.5 inch, 21-gauge needle (NDC 00409-4921-34)
updated
7/16/2010		 Hospira Inc.,
1-877-946-7747		 Unanticipated increased demand Hospira Supplies (PDF – 15KB)

Please see the American Society of Health Systems Pharmacists link below for important safety information regarding the use of alternate epinephrine injectables during the shortage: Epinephrine 0.1 mg/mL Emergency SyringesExit Disclaimer

This is 1:10,000 epinephrine. There is no research to show epinephrine produces any improvement in cardiac arrest outcomes that matter.

1:1,000 epinephrine for anaphylaxis is a whole different story, but there is no shortage of 1:1,000 epinephrine. There are warnings about the confusion between 1:1,000 and 1:10,000 epinephrine. Since we should only be giving epinephrine IV (IntraVenous) to dead people, the warnings of arrhythmia and/or death are pointless. If you are in the habit of giving 1:10,000 epinephrine to living patients, you are in the wrong business. The only appropriate routes of administration to living patients are IM (IntraMuscular), SC/SQ (SubCutaneous, or SubQ for the hard of writing), and IV Drip. The IV drip is usually 1 mg epinephrine in 250 ml NS (Normal Saline) or D5W (Dextrose 5% in Water).

There is no significant difference between the concentrations, when diluted in 259 ml. If you add 1 mg of 1:1,000 epinephrine to 250 ml, you end up with 1 mg in 251 ml or 3.98 mg mcg/ml. That is micrograms/ml – not milligrams/ml. If you think that you should not round that off to 4 mg/ml, you do not understand dosages. If you add 1 mg of 1:10,000 epinephrine to 250 ml, you end up with 1 mg in 260 ml or 3.85 mg mcg/ml. This should also be rounded off to 4 mg/ml, even though it is a much bigger difference from the 4 mg mcg/ml. The reason is that both are not significant differences.

When administering epinephrine by IV, we should only be giving it as a slow infusion. The rate is 2 mcg/minute to 10 mcg/minute (I did write these down correctly). The maximum rate is 4 times more than the starting dose. That is 400% more than the starting dose. That is compared to a difference of less than 4%, which is the difference between 3.98 mg mcg/ml and 3.85 mg mcg/ml.

400% more vs. less than 4% more. If you think that the difference of less than 4% is significant, please stop treating patients. Your patients deserve better.

If you are worried about the resuscitations, don’t. The only reason we get away with giving such large doses of epinephrine to these patients is that they are already dead.

It is not safe to give 1 mg epinephrine IV to somebody if it is 1:,1,000 epinephrine (1 ml of 1:1,000).

It is not safe to give 1 mg epinephrine IV to somebody if it is 1:,10,000 epinephrine (10 ml of 1:10,000).

If you do not know this, consider the exciting world of fast food order satisfaction. TOTWTYTR should be able to get you an application. He claims that he carries them with him for people making the wrong career choices. He isn’t doing this for you. He is doing this for the patients. Maybe he has an extra one for me.

Edited 8/02/10 at 05:50 also see More on Drug Calculations for more details on problems with my drug calculation. Thank you to Matt J for pointing out my error.

For more on epinephrine.[1] [2] [3] [4] [5]

Drug Name Company
Information		 Reason for Shortage Related Information
Furosemide Injection 10mg/ml

updated
7/29/2010

 Hospira Inc.
1-877-946-7747

American Regent, Inc.
1-800-645-1706

APP
1-888-386-1300

 Manufacturing delays

Increase in demand

Increase in demand

 Hospira is working to restore availability.

American Regent, Inc., the distributor of Furosemide Injection, USP 10 mg/mL manufactured by Luitpold Pharmaceuticals, Inc., will continue to notify its wholesalers of the product release dates for all three presentations of Furosemide Injection, USP 10 mg/mL (2 mL vial, 4 mL in a 5 mL vial and 10 mL vial) so they can communicate product availability and appropriately allocate to the end user..

APP has the 10 mg/mL injection 4 mL vial (NDC 63323-0280-04) available. APP anticipates that the 2 mL vials will be released by end of July and the 10 ml vials by late-September, 2010.

Furosemide (Lasix) is not an important emergency medicine drug, either. If your patient has an onset of ADHF/CHF (Acute Decompensated Heart Failure/Congestive Heart Failure), then there are several treatments that may decrease the likelihood that your patient will end up intubated. CPAP (Continuous Positive Airway Pressure), High-dose nitrates (usually NTG – NiTroGlycerin), and/or ACE Inhibitors (Angiotensin Converting Enzyme Inhibitors, such as enalapril [Vasotec]).

Furosemide is good for filling the patient’s bladder, but the patient probably did not call for help filling his/her bladder. If you have a stable ADHF/CHF patient, you can mess around with furosemide. If you have an unstable patient with ADHF/CHF and you are considering giving furosemide, then call 911 and get the patient some emergency treatment. Furosemide isn’t it. I will write more about treatment of ADHF another time.

Drug Name Company
Information		 Reason for Shortage Related Information
Haloperidol Decanoate Injection

updated
7/14/2010

 Teva Pharmaceuticals
1-800-545-8800

Ortho-McNeil Janssen
1-800-526-7736

APP Pharmaceuticals
1-888-386-1300

Bedford Laboratories Customer Service
1-800-562-4797

 Manufacturing delays

See Related Information

See Related Information

Manufacturing delays

 Teva has all presentation on back order with an estimated release date of November of 2010.

Ortho-McNeil has Haldol Decanoate available in 50 mg/mL 1 mL ampoules in 3 count (NDC 00045-0253-03) presentations and 100 mg/mL 1 mL ampoules (NDC 00045-0254-14).

APP has haloperidol decanoate available in 50 mg/mL 1 mL vials (NDC 63323-0469-01), 50 mg/mL 5 mL vials (NDC 63323-0469-05), 100 mg/mL 1mL vials (NDC 63323-0471-01), and 100 mg/mL 5 mL vials (NDC 63323-0471-05). The dating on the haloperidol decanoate 50 mg/mL 1 mL is 8 months. Additional batches of 100 mg/mL 1mL and 50 mg/mL 5 mL will be available late-June.

Bedford has not yet reported an estimated date of availability.

Haloperidol decanoate is a long acting version of haloperidol (Haldol), so this is as relevant as furosemide. This is only for after the patient has been sedated and determined to need longer term sedation.

Drug Name Company
Information		 Reason for Shortage Related Information
Naloxone Injection

updated
7/29/2010

 Amphastar
1-800-423-4136

Hospira
1-877-946-7747

 See related information section

Manufacturing delays

 Amphastar-IMS has both naloxone 1mg/ml syringes in the needleless (NDC 0548-3369-00) and fixed needle (NDC 0548-1469-00) versions available for immediate shipment.

Hospira anticipates for NDC 0409-1215-01 (0.4 mg/mL, 1 mL vial) and NDC 0409-1219-01 (0.4 mg/mL, 10 mL vial) they will have releases in August with full recovery by late September. The NDC 0409-1782-69 (0.4 mg/mL, 1 mL Carpuject) is anticipated for release first quarter of 2011.

If you have a BVM (Bag Valve Mask resuscitator), you should not need naloxone. The problem is inadequate respiration, not inadequate naloxonation. Manage the airway first, then, if you have naloxone and desire to use appropriately titrated naloxone, go ahead.

Drug Name Company
Information		 Reason for Shortage Related Information
Pancuronium Injection

updated
7/29/2010

 Teva Pharmaceuticals
1-800-545-8800

Hospira
1-877-946-7747

 Teva initiated withdrawal of multiple lots of pancuronium injection from the market on 5/4/2010.

Increased demand

 Teva has no immediate plans to re-enter the market

Hospira plans to have their pancuronium 1 mg/mL, 10 mL vial, package of 25 (NDC 00409-4646-01) released in early August 2010 with anticipated full recovery in mid October 2010.

RSI (Rapid Sequence Induction/Intubation) medication. Rocuronium and succinylcholine are still available.

Drug Name Company
Information		 Reason for Shortage Related Information
Propofol Injection 10mg/ml, 20ml 25s, 50ml 20s, 100ml 10s
updated
6/10/2010		 Teva Pharmaceuticals
1-800-545-8800

Hospira Inc.
1-877-946-7747

APP
1-888-386-1300

 Teva Pharmaceuticals has discontinued their propofol injection.

Hospira Inc. recalled specific lots because some containers may contain particulate matter. Hospira has implemented improvements to its manufacturing process and is coordinating with the FDA to begin distribution of propofol manufactured under a new process as soon as possible.

APP has increased production in response to the increased demand. Please see additionalinformation on availability in the Related Information section

 Additional Information on Propofol Supplies

Questions and Answers on the Propofol Shortage

Please see the Dear Health Care Professional Letter (PDF – 41KB) from APP.

The links in the box give a lot of information. Some of the replacements are benzodiazepines (such as lorazepam, diazepam, and midazolam) possibly mixed with an opioid (such as fentanyl, morphine, and hydromorphone), ketamine, etomidate, barbiturates , and other sedatives or anesthetics.

Drug Name Company
Information		 Reason for Shortage Related Information
Vecuronium Injection

updated
7/29/2010

 Bedford Laboratories Customer Service
1-800-562-4797

Sun Pharmaceutical Industries, Inc.
1-800-818-4555

Teva Pharmaceuticals
1-800-545-8800

Hospira, Inc.
1-877-946-7747

 Increase in demand

Increase in demand
On manufacturing hold
Manufacturing Delays

 Bedford has vecuronium available in 20 mg vials (NDC 55390-0039-10) and anticipates the 10 mg vials will be available by August. There is emergency supply available of the 10 mg vials.

Sun Pharmaceutical Industries (Distributor: Caraco Pharmaceutical Labs, Ltd.) is continuing to release product as it becomes available.
Vecuronium Bromide for Injection 10 mg 10 vials NDC 41616-0931-44
Vecuronium Bromide for Injection 20 mg 10 vials NDC 41616-0932-44

Teva has the 10mg/vial (NDC 00703-2914-03) and 20 mg/vial (NDC 00703-2925-03) on backorder and supply is anticipated to be available in September.

Hospira will be off-market for an undefined period.

RSI (Rapid Sequence Induction/Intubation) medication. Rocuronium and succinylcholine are still available.

Edited 8/02/10 at 05:50 also see More on Drug Calculations for more details on problems with my drug calculation. Thank you to Matt J for pointing out my error.

Footnotes:

[1] Risk for Serious or Fatal Medication Error.
National Alert Network Message. EPINEPHrine pre-filled syringe shortage.
American Society of Health System Pharmacists and the Institute for Safe Medication Practices.
Updated June 16, 2010.
Alert

[2] It doesn’t pay to play the percentages.
Medication Safety Alert.
Institute for Safe Medication Practices.
October 16, 2002.
Alert

[3] Epinephrine 0.1 mg/mL Emergency Syringes
American Society of Health-System Pharmacists
July 28, 2010
Alert

[4] Epinephrine
EMS Drugs
Street Watch: Notes of a Paramedic
Article

[5] Medication Errors – Epinephrine
Street Watch: Notes of a Paramedic
Article

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Filed Under: Drug Shortages, FDA, Heresy, Ketamine, NTG Tagged With:

Financial Reform – Health Care Reform – Improvement?

Thu, 29 Jul 2010 22:11:00 -0400 by
From Barry Ritholtz at The Big Picture, this insight –

“The answer is yes, it does. If it didn’t, I wouldn’t be able to justify getting out of bed in the morning and charging the outrageous fees that we charge our clients, which they willingly pay.”

-A former regulator, now corporate lobbyist, as to whether he had an inside edge in lobbying his ex-colleagues

>

Well, don’t let it be said that this Congress isn’t creating jobs: The 2,300 page financial reform bill seems to be generating demand for more of what we surely don’t need: Corporate Lobbyists.

He isn’t wrong. You should read the rest of the article, too.

Here is my point.

Is the Health Care Reform Bill is any different?

The lobbyists are only a part of these make work bills. Sarbanes-Oxley was a law that was supposed to improve accountability, which was considered to be somewhat of a failure on the part of the accountants. The result was that the demand for accountants went up – a lot.[1] [2]

As with putting a medic in every seat on every responding vehicle, when you create such demand that you cannot be selective about the people you hire, quality will suffer.

Will the Health Care Bill be any different?

As the pundits often say, just right up until the bubble bursts, in times of speculative excess – It’s different this time.

This will not redirect money from those who provide the actual patient care to those who get paid to rearrange the paperwork – to a lot more of the people who get paid to rearrange paperwork. People who will all be of the highest quality, because the health care organizations will be selective, when there are not enough people to fill the jobs. Right.

For a simpler view of the financial reform, that could just as easily be a view of health care reform, there is this cartoon in a different post at The Big Picture –

Footnotes:

[1] Sarbanes-Oxley puts accountants in high demand
Journal Record, The (Oklahoma City),
Apr 21, 2005
by Janice Francis-Smith
Article

[2] Accountant deficit: regulations, real estate fueling demand for high-end auditors.
The Free Library
2006
Article

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Filed Under: Heresy Tagged With:
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