The EpiPen that cost $75 in 2001 costs over $300 today

[bcla]

I noticed the 1mL vials after I posted that, so that's good news.

Yeah there is an art to opening ampules. Taking some gauze and snapping away from you usually does the trick. If you know a pharmacist that doesn't know ampules must be used with a filter needle, find another one. I question their knowledge. I'm not sure where those nurses were that had to tell pharmacists that. Unacceptable in my book.

Ampules seem like more trouble than they're worth. The idea is hundreds of years old and breaking glass seems like a poor system.

 

[Pea-n-Me]

OK. Apparently there is a 1 ml alternative that doesn't come in glass ampules. Nurses seem to universally hate ampules after cutting themselves breaking them open, and some worry about tiny glass shards (some use filters). At least one company sells them in vials with the foil top, and I'm pretty sure they're cheap.

Still, preparing one of these things on the spot would seem to be difficult when seconds count.

OK, how to explain this?

There is no room for error with the m, in this concentration, pictured. (1:1000.) That is for use by medical professionals ONLY, and even then, there can be mistakes in an emergency. And unfortunately, with this, mistakes can be deadly. (See stories in Comments section of article listed below.)

That's why ampules are still sometimes used for metered doses, or more commonly, autojets, like this, below. (Note the concentration is diluted AND it comes with a luer lock and protected needle so nurses and others administering it don't stick themselves by accident or it doesn't go into a vein or IV line any way other than purposefully):



To help you understand, you can read this:

https://acls-algorithms.com/acls-drugs/acls-and-epinephrine/

"The 1 mg dose can typically come in two forms 1:10,000 (most common). 1:10,000 is the dilution. This means that there is 1 mg in 10 mL of fluid.

The other concentration is 1:1,000. This means that there is 1 mg in 1 mL of fluid. For intravenous purposes, this needs to be diluted with 9 mL of fluid to make the concentration 1:10,000."

_____________________________________________________________________________________________

By comparison, the EpiPen delivers Epinephrine in these concentrations (and remember, it is injected into a large muscle in the leg, not directly into the vein, like the ones above are):

Table 1. EpiPen Auto-Injector dosing 1
Auto-Injector Epinephrine Concentration Patient Weight
EpiPen® Auto-Injector 0.3 mg (0.3 mL, 1:1000) ≥30 kg (≥66 pounds)
EpiPen Jr® Auto-Injector 0.15 mg (0.3 mL, 1:2000) 15-30 kg (33-66 pounds)
EpiPen® (epinephrine injection) Auto-Injector | Administration
_____________________________________________________________________________________________

So really, there's no way those vials you listed should ever be circulating among the general public.

 

[Tuffcookie]

So, I just read this:

http://money.cnn.com/2016/08/29/investing/generic-epipen-mylan-discount/index.html

Are they serious? $300 for a generic? What is wrong with this company?

TC

 

[bcla]

OK, how to explain this?

There is no room for error with the m, in this concentration, pictured. (1:1000.) That is for use by medical professionals ONLY, and even then, there can be mistakes in an emergency. And unfortunately, with this, mistakes can be deadly. (See stories in Comments section of article listed below.)

That's why ampules are still sometimes used for metered doses, or more commonly, autojets, like this, below. (Note the concentration is diluted AND it comes with a luer lock and protected needle so nurses and others administering it don't stick themselves by accident or it doesn't go into a vein or IV line any way other than purposefully):

View attachment 190489

To help you understand, you can read this:

https://acls-algorithms.com/acls-drugs/acls-and-epinephrine/

"The 1 mg dose can typically come in two forms 1:10,000 (most common). 1:10,000 is the dilution. This means that there is 1 mg in 10 mL of fluid.

The other concentration is 1:1,000. This means that there is 1 mg in 1 mL of fluid. For intravenous purposes, this needs to be diluted with 9 mL of fluid to make the concentration 1:10,000."

_____________________________________________________________________________________________

By comparison, the EpiPen delivers Epinephrine in these concentrations (and remember, it is injected into a large muscle in the leg, not directly into the vein, like the ones above are):

Table 1. EpiPen Auto-Injector dosing 1
Auto-Injector Epinephrine Concentration Patient Weight
EpiPen® Auto-Injector 0.3 mg (0.3 mL, 1:1000) ≥30 kg (≥66 pounds)
EpiPen Jr® Auto-Injector 0.15 mg (0.3 mL, 1:2000) 15-30 kg (33-66 pounds)
EpiPen® (epinephrine injection) Auto-Injector | Administration
_____________________________________________________________________________________________

So really, there's no way those vials you listed should ever be circulating among the general public.

I do understand all that. I've mentioned the scene from Pulp Fiction where one of those pre filled syringes is shot into someone's heart.

Still, someone was talking about the 30 ml 1:1000 vials, where there a lot more chance for error. I have also read about people talking about preparing a syringe for use at home.

 

[Pea-n-Me]

Looks like Mylan is coming out with a generic.

http://arstechnica.com/science/2016/08/epipen-maker-mylan-reveals-generic-its-only-triple-the-price/

 

[Pea-n-Me]

I do understand all that. I've mentioned the scene from Pulp Fiction where one of those pre filled syringes is shot into someone's heart.

Still, someone was talking about the 30 ml 1:1000 vials, where there a lot more chance for error. I have also read about people talking about preparing a syringe for use at home.

I've seen the movie, but I don't understand your point about it. For emergency use by professionals it is almost always given intravenously, not shot directly into the heart.

From the link I posted:

Routes
During ACLS, epinephrine can be given 3 ways: intravenous; intraosseous, and endotracheal

Those 1:1000 vials will never be available to the public for treatment of anaphylaxis.

Not sure about a syringe for use at home (presumably prepared by a pharmacist based on a prescription and contained in a safety device), I guess time will tell. I, too, have explained that there is simply no room for error with this medication. Not trying to be difficult, just trying to explain how it is in the medical world.

 

[bcla]

I've seen the movie, but I don't understand your point about it. For emergency use by professionals it is almost always given intravenously, not shot directly into the heart.

From the link I posted:

Routes
During ACLS, epinephrine can be given 3 ways: intravenous; intraosseous, and endotracheal

Those 1:1000 vials will never be available to the public for treatment of anaphylaxis.

Not sure about a syringe for use at home (presumably prepared by a pharmacist based on a prescription and contained in a safety device), I guess time will tell. I, too, have explained that there is simply no room for error with this medication. Not trying to be difficult, just trying to explain how it is in the medical world.

I understand what you're saying. I also know Pulp Fiction was a movie.

I thought it's by prescription, but legally they (and hypodermic needles) can be dispensed to anyone with a prescription. Diabetics are drawing insulin and using needles daily, although I know they're shorter needles.

There have been medical studies testing the safety of a drawn syringe store for three months. Is it really that hard to pull out .3 ml into a syringe and put it away until needed? I know under stress it may be difficult.

 

[PollyannaMom]

Looks like Mylan is coming out with a generic.

http://arstechnica.com/science/2016/08/epipen-maker-mylan-reveals-generic-its-only-triple-the-price/

So they buy the rights to the original, jack up the price to a ridiculous amount, then manufacture a generic themselves (at a still ridiculous, but comparatively lower, price) and still make obscene amounts of money. They ought to be the new picture next to "evil genius" in the dictionary.

 

[bcla]

So they buy the rights to the original, jack up the price to a ridiculous amount, then manufacture a generic themselves (at a still ridiculous, but comparatively lower, price) and still make obscene amounts of money. They ought to be the new picture next to "evil genius" in the dictionary.

The article mentions that the "generic" will be functionally identical.

The main issue here isn't about the drug, which has been generic since before any auto injectors were ever made. The issue is the delivery mechanism, which is in part patented. It's pretty much a regulatory and prescribing issue. It's a regulatory issue when competitors have been pulled off the market and when potential competitors have had their versions denied approval. There is actually one competitor with limited availability. Some have mentioned that most states won't allow substitution without approval of the prescriber.

The odd thing is that it's unclear who makes them. Mylan doesn't even own it, and there have been some claims that they make them under license or that a division of Pfizer makes them. It's a contract issue involving marketing rights. Pfizer actually holds the ultimate rights.

 

[bcla]

There is no room for error with the m, in this concentration, pictured. (1:1000.) That is for use by medical professionals ONLY, and even then, there can be mistakes in an emergency. And unfortunately, with this, mistakes can be deadly. (See stories in Comments section of article listed below.)

Apparently a lot of medical professionals have gone the route of keeping around vials/ampules of epinephrine and needles for anaphylaxis. As with any injected drug, there have been mistakes made. This piece recommends that there should be a ready-made kit set aside with clear instructions for how much to draw and where to inject.

http://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=1145

Anaphylaxis kits and simulation training

If your organization has made the difficult decision to replace EPINEPHrine auto-injectors with ampuls and/or vials, please consider providing patient care areas with an anaphylaxis kit rather than stocking the ampuls and/or vials separately. The kit should contain a 1 mL vial or ampul of EPINEPHrine 1 mg/mL, a syringe, and any other needed supplies (e.g., alcohol wipe, needle), along with clear directions regarding measurement of the correct dose and administration by the correct route. Simulation training using the kit is highly recommended to ensure practitioners are comfortable with and understand how to prepare and administer EPINEPHrine from a vial or ampul.​

 

[Pea-n-Me]

I understand what you're saying. I also know Pulp Fiction was a movie.

I thought it's by prescription, but legally they (and hypodermic needles) can be dispensed to anyone with a prescription. Diabetics are drawing insulin and using needles daily, although I know they're shorter needles.

There have been medical studies testing the safety of a drawn syringe store for three months. Is it really that hard to pull out .3 ml into a syringe and put it away until needed? I know under stress it may be difficult.

Yes, it would be that difficult. And there is no room for error.

To use your example. Diabetics are given and inordinate amount of teaching when using insulin. Part of their teaching includes making sure they are safe to self-administer, by a nurse watching them do it and "signing off" on their competency. Additionally, insulin is a very high use item - they give themselves injections daily or more, so in a relatively short time, they become very good at it.

In contrast, epinephrine is an extremely low use item, and may not ever be administered by the patient himself, despite initial teaching being done. Literally years could go by before the first use (as I believe we've read can be common with this). Imagine grandma fumbling around with a vial of epinephrine - disaster waiting to happen! Then we'd have outrage and sayings of why and how did this ever happen?

What I am trying to say is that there is a reason for the EpiPen safety apparatus.

These things aren't just done according to people's whims, either - these medications are highly regulated by overseers of hospitals and pharmacies, etc. because of safety issues. As you can see from the articles, even in medical areas mistakes can be made, so they try to minimize those whenever possible. This is what's being done with the EpiPen, the way it's designed.

 

[bcla]

Yes, it would be that difficult. And there is no room for error.

To use your example. Diabetics are given and inordinate amount of teaching when using insulin. Part of their teaching includes making sure they are safe to self-administer, by a nurse watching them do it and "signing off" on their competency. Additionally, insulin is a very high use item - they give themselves injections daily or more, so in a relatively short time, they become very good at it.

In contrast, epinephrine is an extremely low use item, and may not ever be administered by the patient himself, despite initial teaching being done. Literally years could go by before the first use (as I believe we've read can be common with this). Imagine grandma fumbling around with a vial of epinephrine - disaster waiting to happen! Then we'd have outrage and sayings of why and how did this ever happen?

What I am trying to say is that there is a reason for the EpiPen safety apparatus.

These things aren't just done according to people's whims, either - these medications are highly regulated by overseers of hospitals and pharmacies, etc. because of safety issues. As you can see from the articles, even in medical areas mistakes can be made, so they try to minimize those whenever possible. This is what's being done with the EpiPen, the way it's designed.

Again, I get that, but a lot of decisions are made based on costs. I think a school nurse could safely administer an injection, but it would of course require training. There are a lot of place where errors can creep in, but separate vials and hypodermic needles are still being used.

At least a page back I did mention someone giving a class presentation about "clear instructions", where the examples were an EpiPen vs a traditional pre-filled hypodermic needle. I believe it was originally sterile with some sort of lock on the plunger. If he had needed to use it, he was expected to remove the cap, stick it into his thigh, and push down the plunger. It was a lot of steps, and it also came with a string "tourniquet". Maybe he didn't have to draw the drug himself.

The negative publicity around all this is probably going to spur action, whether it's the alternative delivery device makers working harder to allay FDA concerns or the FDA looking at their applications with more urgency. In the meantime, I'm almost sure a few medical professionals are going to prescribe vials and needles for those patients who they believe can handle it.

 

[DizBelle]

I have no dog in this fight but what did people do before the epi-pen?

 

[Pea-n-Me]

Here is the position statement from the National Association of School Nurses

https://www.nasn.org/ToolsResources...axis/EpinephrinePoliciesProtocolsandReporting



A sample protocol from the NASN

https://www.nasn.org/portals/0/resources/Sample_Anaphylaxis_Epinephrine_Administration_Protocol.doc



and the official statement about food allergies, anaphylaxis and epinephrine use from CDC

http://www.cdc.gov/healthyschools/foodallergies/pdf/13_243135_A_Food_Allergy_Web_508.pdf

___________________________________________________________________________________________

Most talk about administration of epinephrine through an autoinjector like the EpiPen

However each state has its own laws and policies for epinephrine usage.

 

[Magpie]

I have no dog in this fight but what did people do before the epi-pen?

The simplest answer: They died.

And no, I'm not joking. It really was that simple. My mum remembers growing up in the 50's and hearing about children dying of "asthma". Babies often died of "croup". By and large, people with anaphylaxic reactions to something in their environment (bees, peanuts, milk) died well before adulthood. If you had a severe allergic reaction and couldn't get treatment in time, you died. Your death might be attributed to allergies, or your family might think you just choked, were poisoned, or got sick.

Diabetes also used to be a death sentence, once upon a time.

 

[Pea-n-Me]

I have no dog in this fight but what did people do before the epi-pen?

The EpiPen has been around since the 1970s.

https://en.m.wikipedia.org/wiki/Epinephrine_autoinjector

Food allergies have been on the rise in certain populations.

http://www.cdc.gov/nchs/data/databriefs/db121.htm

 

[bcla]

The simplest answer: They died.

And no, I'm not joking. It really was that simple. My mum remembers growing up in the 50's and hearing about children dying of "asthma". Babies often died of "croup". By and large, people with anaphylaxic reactions to something in their environment (bees, peanuts, milk) died well before adulthood. If you had a severe allergic reaction and couldn't get treatment in time, you died. Your death might be attributed to allergies, or your family might think you just choked, were poisoned, or got sick.

Diabetes also used to be a death sentence, once upon a time.

I've personally seen a anaphylaxis kit that included a traditional locked hypodermic needle as well as other items. This existed alongside the EpiPen. It had more steps, but it didn't require measuring the dose. More common usage of the EpiPen seems to have resulted in this going off the market. I think the EpiPen was also price competitive back in the early 90s.

 

[Pea-n-Me]

I looked up my own state's law reads in regards to epinephrine administration for anaphylaxis in schools. One thing in our law I haven't seen in any of the other links is that we require a "consulting pharmacist" to work in partnerships with schools.

How does your own state's law read? (All)

Bill Textclick to collapse contents
Chapter 71 of the General Laws, as appearing in the 2010 Official Edition, is hereby amended by adding the following section after Section 54B.



Section 54C. The Use of Emergency Epinephrine in Schools.



(a) Any person who is a school nurse or an employee of an accredited school, authorized by a prescriber and trained in the administration of epinephrine, who provides, administers, or assists in the administration of epinephrine to a student believed in good faith to be having an anaphylactic reaction, or is the prescriber of the epinephrine, shall not be liable for any civil damages for ordinary negligence in acts or omissions resulting from the rendering of such treatment.



(b) By the beginning of the 2013-2014 school year, local school boards and nonpublic accredited schools may adopt and implement policies for the possession and administration of epinephrine in every school, to be administered by a school nurse or an employee of the school board who is authorized and trained in the administration of epinephrine to any student believed to be having an anaphylactic reaction.



(c) The school district or nonpublic school may maintain at a school in a locked, secure and accessible location an epinephrine kit. An epinephrine kit may consist of one or more doses of epinephrine auto-injectors. A physician may prescribe epinephrine auto-injectors in the name of the school district or nonpublic school to be maintained for use when necessary.



(d) Pursuant to an order or standing protocol issued by the prescriber within the course of his professional practice, a school nurse, or any school board employee who is authorized and trained in the administration of epinephrine, may possess and administer epinephrine in emergency cases of anaphylactic shock.



(e) Epinephrine from an epinephrine kit shall be used only in emergency situations when the person administering the epinephrine reasonably believes that the signs and symptoms of an anaphylactic reaction are occurring and, if administered, at school, on school property or at a school-sponsored event.



(f) A school may not maintain an epinephrine kit unless the school has consulted a pharmacist licensed by the state board of pharmacy. The consultant pharmacist shall have supervisory responsibility for maintaining the epinephrine kit. The consultant pharmacist shall be responsible for developing procedures, proper control and accountability for the epinephrine kit. Periodic physical inventory of the epinephrine kit shall be required.

https://malegislature.gov/Bills/188/House/H1905

 

[kimblebee]

I have no dog in this fight but what did people do before the epi-pen?

I have an allergy to tree nuts..it closes my throat. I don't carry an epi pen because I am very careful and I know I have time to get to a hospital. I imagine that's what people did before epi pens were around.

 

[Christine]

I've personally seen a anaphylaxis kit that included a traditional locked hypodermic needle as well as other items. This existed alongside the EpiPen. It had more steps, but it didn't require measuring the dose. More common usage of the EpiPen seems to have resulted in this going off the market. I think the EpiPen was also price competitive back in the early 90s.

I remember this too. We've been getting an Epi-Pen since 1995. I remember the other kit back then.