At 510 Medic, there is a post called Lack of Accountability.

Read it.

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Here is what I think about the topic.

It is a sad thing that so many people in positions of responsibility are so interested in avoiding responsibility.

If we had to choose, would we choose to be treated by a doctor, nurse, EMT, et cetera, who avoids responsibility?

Let me rephrase that.

Would we choose to be treated by someone who is irresponsible?

Would we get in a plane flown by a pilot, who is irresponsible?

ir·re·spon·si·ble (r-spns-bl)
adj.
1. Marked by a lack of responsibility: irresponsible accusations.
2. Lacking a sense of responsibility; unreliable or untrustworthy.
3. Law Not mentally or financially fit to assume responsibility.
4. Not liable to be called to account by a higher authority.

http://www.thefreedictionary.com/irresponsible

Definition 4. is important.

4. Not liable to be called to account by a higher authority.

Isn’t that exactly the goal of our training in EMS – at least the way some teach it?

If we just follow the protocol, we can’t get in trouble.

If we get permission from medical command, we can’t get in trouble.

If we just follow orders, we can’t get in trouble.

Why do we let anyone get away with telling these lies?

A question we often hear is –

Who is going to take responsibility for this?

The EMS response seems to be –

I’m not doing anything unless somebody else takes responsibility for what I do.

EMS agencies not only tolerate this – EMS agencies encourage this irresponsible behavior.
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The CDC’s latest MMWR (Morbidity and Mortality Weekly Report) includes a graph of the change in life expectancy from 1970 to 2007. It is broken down by race (black/white) and gender (you can guess the categories). We continue to increase life expectancy. Unfortunately, there is no way I know of to graph changes in quality of life. That would be interesting.

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5651a7.htm

I was curious about the way this compares with earlier years. I only included the data from each year that ended in a zero.

Section 6 – Life Tables
Page 19
Table 6-5. Estimated Average Length of Life in Years, by Race and Sex: Death-Registration States, 1900-28, and United States, 1929-93
Free Full Text PDF from CDC page 25/28 in the PDF page counter

As you can see, the slope (you remember that term from math) of the increase changes at about 1950. This does not mean that anything bad was happening in 1950. Maybe all of the dramatic increases had already been made.

For comparison I decided to look at the land speed records from 1900 to 2010.

Why land speed records?

It was the first thing that popped into my head when I thought about something that would have improvements well documented over time. I used the highest speed recorded at the end of each year that ended in a zero.

There were actually a bunch of records in 1899 – from 39.3 to 69.8. There was no new record in 1900, so I included the record that everyone was trying to beat. You can see that there are some flat spots on the chart. That means that no new record had been set since the last record.

All Out Land Speed Record List

Do the flat parts of this chart indicate that no progress was being made? No.

One difference is that this is a chart of the fastest speed up until that time, so it will never go down.

The life expectancy chart will go whichever way the average life expectancy goes.

During this time – 1900 to 2007 – life expectancy has continually increased.

There has never been a decrease.

The fastest speed recorded in any year has often been less than the land speed record. Yet both show dramatic increases.

Just more evidence that there is no such thing as The Good Old Days.

This continual improvement has come about by rejecting tradition.

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Updated 19:15 9-16-10 – I added a title (I changed the link to match the title, too) and links for the chart information.

The first chart is from the CDC. The others were created with data from the locations linked.

I was rushing out the door and “oopsy.”

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A press release from the FDA (Food and Drug Administration).

The U.S. Food and Drug Administration has approved the pediatric use of Protopam Chloride (pralidoxime chloride), a drug used to treat poisoning by organophosphate pesticides and chemicals (e.g., nerve agents). The drug is approved to be administered either by intravenous (IV) or intramuscular (IM) injections.^[1]

I did a quick search for pediatric versions of the pralidoxime autoinjector. I did not find anything. That does not mean that they do not exist. I tried to contact the FDA and AAP (American Academy of Pediatrics) about this. The press release was at 16:24 during a holiday week. It is not surprising that I got voice mail at the FDA (at about 17:05) and an out of office email auto reply from the AAP later on.

This is not a press release that appears to be well thought out.

While there is a lot of useful information in there, there is not any mention of pediatric versions of the pralidoxime autoinjectors.

There is not any mention of pediatric dosage of pralidoxime.

Late addition – Late this morning (9-10-2010) there was a link to the Baxter label that was approved 9-08-2010. I added the parts in red at 12:48 on 9-10-2010

PEDIATRIC DOSING (FOR PATIENTS 16 YEARS AND UNDER)

PEDIATRIC INTRAVENOUS DOSING:

Refer to the Preparation for Administration section for instructions on reconstitution
and dilution of PROTOPAM that result in a 10-20 mg/mL solution for intravenous
infusion.

PROTOPAM can be given as intermittent intravenous infusions or as a loading dose
followed by continuous intravenous infusion, depending upon the patient’s clinical
condition. The specific dose given should depend upon the severity of the symptoms.

Loading Dose Followed By Continuous Infusion

Administer a loading dose of 20-50 mg/kg (not to exceed 2000 mg/dose) over 15-30
minutes followed by a continuous infusion of 10-20 mg/kg/hour.

Intermittent Infusion Dosing
Administer an initial intermittent infusion of 20-50 mg/kg (not to exceed 2000 mg/dose)
over 15-30 minutes. A second dose of 20-50 mg/kg may be indicated after about one
hour if muscle weakness has not been relieved. Repeat dosing is permissible every 10-12
hours as needed.

If it is not practical to administer intermittent or continuous intravenous infusions, or if
pulmonary edema is present, the 20-50 mg/kg dose should be given slowly (over not less
than five minutes) by intravenous injection as a 50 mg/mL solution in water (see
Preparation for Administration section). Additional doses may be given every 10-12
hours if muscle weakness persists.

PEDIATRIC INTRAMUSCULAR DOSING:

Refer to the Preparation for Administration section for instructions on reconstitution of
PROTOPAM that result in an approximate 300 mg/mL solution for intramuscular
administration.

Intramuscular injections in children should be administered in the anterolateral aspect of
the thigh to avoid the nerve, artery and vein, as well as the femur.

Pharmacokinetic modeling using published data from the scientific literature was
conducted to derive intramuscular dosing recommendations in the pediatric population.
The specific intramuscular dose of PROTOPAM should depend upon the severity of the
symptoms.

MILD SYMPTOMS
• For treatment of mild symptoms, administer a weight-appropriate intramuscular
dose (see Table 1 below) of PROTOPAM. Wait 15 minutes for PROTOPAM to
take effect.

• If, after 15 minutes, mild symptoms persist, then administer a second weight-
appropriate intramuscular dose of PROTOPAM.

• If after an additional 15 minutes, mild symptoms continue to persist, a third
weight-appropriate intramuscular dose of PROTOPAM may be administered.

• The three PROTOPAM injections together are considered a single course of
treatment, and the total amount of PROTOPAM administered per course of
treatment (i.e., 3 weight-appropriate injections) should not exceed the total
amounts listed in Table 1 below.

• If at any time after the first dose, the patient develops severe symptoms,
administer two additional weight-appropriate intramuscular doses of
PROTOPAM in rapid succession.

SEVERE SYMPTOMS
• For treatment of severe symptoms, administer the weight-appropriate
intramuscular dose (see Table 1 below) of PROTOPAM as three injections, in
rapid succession, into the patient’s anterolateral thigh (see Table 1 below).

PERSISTENT SYMPTOMS
• If symptoms persist after administering a complete course (3 injections of the
weight-appropriate dose each), the series may be repeated beginning
approximately 1 hour after administration of the last injection.^[*]

This chart is from the same source as the information in red above.^[*]

This is something that the AAP has been pushing for since 2008, so an extra day to address these, and other, issues is not unreasonable. I would say that we should wait until after the weekend, so that there is a full work week to address this, but with the fear of attack that goes with 9/11, this probably satisfies those who do not seem to get enough Ativan in their diets. Oh, joy.

What else does the press release say?

Protopam Chloride was approved by the FDA in 1964 to treat various types of pesticide and chemical poisoning in adults. The drug works as an antidote to pesticides and chemicals of the organophosphate class by slowing the attachment of the chemical to nerve endings.^[1]

Apparently, the FDA has felt that no pediatric dosage is appropriate, because as far as I can tell, none of their material includes any pediatric dosage. 1964 approved for adults. Children are never on farms (where organophosphates are most often found), so there would be no reason to consider having pediatric dosage recommendations.

What does the AAP say?

Children are an especially vulnerable population when exposed to nerve agents. Because of the combination of greater dermal absorption (thinner, less keratinized skin), an increased minute volume, and increased CNS permeability to nerve agents, children have a much higher morbidity and mortality when compared to adults. For example, in experimental models the median lethal dose in juveniles is only 10% of that of adult counterparts.^[2]

However, pralixoxime auto-injectors and diazepam are labeled for adult use only; pediatric versions of the auto-injectors are not yet available in the United States.^[2]

We still do not know if pediatric pralixoxime auto-injectors are available in the US, but now we do have a press release.

Since 2001, pediatric experts have recommended the pralidoxime auto-injector be used in children after a nerve agent exposure. However, FDA has still not provided this approval. More importantly, FDA has not provided a pediatric indication to pralidoxime in any form.^[2]

Oops. I wrote that it was since 2008. I was wrong. The AAP approved this back in 2001.

Experts quickly agreed that in the absence of complete data, there was sufficient information to support pralidoxime auto-injector safety and efficacy in children weighing more than 10 kg; such a group would receive no more than 60 mg per kilogram of pralidoxime, which was judged to be the upper limits of its safety in children, when balanced against the risks of non-treatment. Additionally, when the alternative approach of treating children through administration of pralidoxime from multi-use vials was considered, the group was unanimous in recommending that the pralidoxime auto-injector be given to any child weighing more than 10 kg. The American Academy of Pediatrics Disaster Preparedness Advisory Council (AAP DPAC) has concurred with this view.^[2]

This wording can be confusing. The AAP are stating that children weighing 10 kg (22 pounds) or more should receive the adult pralixoxime auto-injector.

How do we know that this is what the AAP are stating?

such a group would receive no more than 60 mg per kilogram of pralidoxime, which was judged to be the upper limits of its safety in children.

The auto-injector form of pralidoxime found in the CHEMPACK contains 600 mg pralidoxime.^[2]

That is the adult pralixoxime auto-injector.

There is only an adult pralixoxime auto-injector manufactured, so this can only refer to the adult dose. Also –

When activated, each auto-injector dispenses 600 mg of pralidoxime chloride in 2 mL of a sterile solution containing 20 mg/mL benzyl alcohol, 11.26 mg/mL glycine in Water for Injection, USP. The pH is adjusted with hydrochloric acid. The pH range is 2.0-3.0. The product is pyrogen free.^[3]

How do we know that is the adult dose?

Pediatric Use:
Safety and effectiveness in children have not been established.^[3]

According to the press release, safety and effectiveness have even been established to the satisfaction of the FDA. Dosage probably has, too, but the FDA is keeping that a secret. The AAP is more comfortable providing dosage information.

And I should not forget the tricky math part – 600 mg divided by 10 kg (or more) = 60 mg/kg (or less). This results in the conclusion that children weighing 10 kg or more – would receive no more than 60 mg per kilogram of pralidoxime, which was judged to be the upper limits of its safety in children.

That is enough for one post. I sent emails to Life in the Fast Lane and The Poison Review about this. They are the toxicology gurus. I hope they will write something about treatment of pediatric organophosphate poisonings. They have different styles, so learning from people explaining the same thing differently is a great way to improve understanding.

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Footnotes:

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^[1] FDA approves pediatric use of chemical poisoning treatment
FDA NEWS RELEASE
For Immediate Release: Sept. 9, 2010
Media Inquiries: Sandy Walsh, 301-796-4669; sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
Press Release

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^[2] Pralidoxime auto-injector and Midazolam as Pediatric Countermeasures for Nerve Agent Exposure
American Academy of Pediatrics
David T. Tayloe, Jr., MD, FAAP
AAP President
December 18, 2008
Google Quick View of Letter . . . . . Full Text PDF of Letter

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^[3] PRALIDOXIME CHLORIDE injection
[Meridian Medical Technologies, Inc.]
DailyMed
Free Full Text FDA Label in HTML . . . . . Download of Free Full Text FDA Label in PDF

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^[*] PROTOPAM Chloride (pralidoxime chloride) for Injection
NDA 014134/S-022
FDA Approved Labeling Text dated September 8, 2010
label approved on 09/08/2010 (PDF)

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