Wednesday, November 2, 2016

Back To EpiPens -- November 2, 2016

Updates

July 3, 2018: today, from The WSJ, Novartis will rollout EpiPen competitor.
Novartis’s Sandoz generic-drug unit acquired the U.S. commercial rights for an emergency shot called Symjepi from Adamis Pharmaceuticals Corp.
Symjepi contains the same active ingredient, epinephrine, as EpiPen, which is used to treat anaphylaxis caused by insect bites and foods, among other allergic reactions. Symjepi comes in a prefilled syringe, which Adamis says could make it cheaper than EpiPen, which comes in an auto-injector device that conceals the needle.
U.S. regulators approved Symjepi in June 2017 but Adamis, a San Diego startup, never launched the product and instead hired an investment banker to find a commercial partner for it. Sandoz, one of the biggest generic-drug makers, plans to begin selling it in the U.S.
Mylan came under criticism in 2016 for boosting the list price for an EpiPen two-pack to more than $600, up 550% since acquiring the product in 2007. The company has since started selling a generic version for about $300.
Mylan also has experienced supply shortages for EpiPen this year because of problems at a Pfizer Inc. manufacturing plant that makes the product.
Cheaper than $10? See original post below.
 
Original Post 

Back on August 27, 2016,  I wrote:

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The EpiPen Story

Holman W. Jenkins, Jr. has a great opinion piece on the $600 hammer EpiPen. He provided the obvious answer. Why pay $600 for an American two-pack of EpiPens, when you can get them for about $100 each in Canada (the internet will work just fine)?  By the way, it would be an interesting science project to see exactly how widely used EpiPens really are. In my 30+ years being in the business of medicine, I have never seen a layperson use an EpiPen. I've worked with school nurses for decades and I've never seen a school nurse (or even heard of a school nurse) using an EpiPen. Anyway, here's a Canadian site offering EpiPens for about $160/pen which is probably the "standard" price in Canada.

By the way, the EpiPen story gets crazier the more one looks at it. The standard EpiPen delivers 0.3 ml of 1:1000 epinephrine. One can buy a 1-ml amp (enough for three doses) of epinephrine for $4.49.

Three doses is one more dose than the standard 2-pack epinephrine provides. Three doses for $4.49 vs two doses for $600.

Syringes and needles are virtually free: every insulin-dependent diabetic has ample supplies of syringes and needles, and most jurisdictions provide the homeless and drug addicts with syringes and needles for free, it seems. Whatever the expense, it has to be nominal. The challenge of administering epinephrine in an emergency is not the "physical" action but the "mental" action. The "mental" action is recognizing an emergency; recognizing that it is an allergic reaction; knowing that epinephrine is needed; and knowing where that epinephrine is. Snapping open an ampule, "drawing up" 0.3 ml in a standard little syringe, and then using one's own fist to push the needle into the thigh (by holding onto the syringe) and using one's own thumb to push in the plunger is the entirety of the "physical" action. This is not rocket science. If one has the time to complete the "mental" action, one has ample time to complete the "physical" action. Emergency room physicians do not use EpiPens; they use syringes, generally handed to them by nurses or technicians.

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Good For Those Mormons
 
NOW GET THIS: according to NPR this morning (November 2, 2016), a hospital in Utah has finally done that. They are getting rid of Mylan EpiPens. They are putting two syringes and two vials of epinephrine in a zip-lock bag -- cost of the kit: $10. Good for those Mormons. 

As I said before: the Mylan EpiPen story is a non-story. If anything, it's a first-world problem.

By the way, the Utah hospital includes two alcohol wipes in their packages. Mylan does not. LOL. So, in the moment, when one is about to die due to anaphylaxis, the emergency responder can take a few seconds to "sterilize" the injection site.

By the way, it has been proven that a) there is no need to sterilize an injection site; and, b) alcohol swabs do NOT sterilize an injection site. The only time, generally speaking, where sterilization is needed is when donating blood and then for those who have donated blood note that the technician uses copious amount of disinfectant (usually povidone iodine) and swabs for several minutes with multiple cotton balls soaked in disinfectant held by forceps/tongs and holding the instrument with gloved hands. 

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