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Use for expired AV?
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by tigers9 on June 19, 2008
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What are the rules regarding expired AV for humans? So it is OK with FDA to use it for animals?
Z
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SNIP
Miami-Dade Fire Rescue's Venom Response Unit had two vials of recently-expired anti-venom, which they gave to the dog
SNIP
http://www.wctv.tv/APNews/headlines/20580124.html
Snake Bites Dog Save Email Print
Posted: 6:43 PM Jun 19, 2008
Last Updated: 6:43 PM Jun 19, 2008
Reporter: Angela Howard
Email Address: angela.howard@wctv.tv
0 comments
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A bite from a venomous snake sends this family pet to the vet.
Prince Charming's owner rushed him to the veterinarian's office yesterday after she noticed the American Bulldog's leg bleeding and swollen.
Turns out, he was bit by a snake from the pit viper family in the yard.
Thankfully, the Miami-Dade Fire Rescue's Venom Response Unit had two vials of recently-expired anti-venom, which they gave to the dog.
Prince Charming is expected to make a full recovery.
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RE: Use for expired AV?
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by Cro on June 20, 2008
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Some veternarians are known to obtain expired antivenin from hospitals and zoos for use on dogs, cats, and livestock that has been bitten by venomous snakes.
This greatly reduces the cost of the vet care, compared with the vet using newly bought unexpired antivenom.
The expired anitivenin tends to get a bit weaker over time, however, it will still work against snake bites, and some studies have shown some antivenins to still be able to nuturalize snake venoms 10 years after the expiry date. I think this would be most likely with the freeze dried antivenoms.
Most places that stock antivenins tend to hang onto them, even after the expiration date, as they know that expired antivenin is better than nothing.
As far as the FDA, they probably have strict rules about the use of expired medications.
One would hope that a Doctor would use some common sense, and still save a patient's life, and use the antivenin available, even if it was a bit past the expiration date. Especially, if the bite was from an exotic venomous snake.
Because antivenin for exotic venomous snakes is manafactured in other countries, its use might nor require the same FDA rules, and might fall under some sort of experimental / unapproved treatment.
I am sure the snakebite specialists here will be able to list FDA rules.
Best Regards John Z
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RE: Use for expired AV?
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by JoeCrotalid on June 20, 2008
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The General rule in the medical community is that expired AV is only used in last resort cases if unexpired AV can not be obtained. The theory is that once expired a medication or in this case AV loses a percentage of its effectiveness after the expiration date, and that percentage continues to drop with each passing period of time.
The other point here is that we live in a day an age where ambulance chasing lawyers make their living off just about anything they can. So if a patient was given expired AV and ad some adverse outcome-some lawyer would jump up and say it had to be the result of the expired AV and the hospital is at fault for for giving it rather than the hospital tryed everything to effectively treat the patient. Therefore many physicians would opt not to give it due to fear of lawsuit.
I had such a case a while back where I worked with Miami-Dade on a Cobra envenomation where we were sent 5 vials of Thai Red Cross Cobra and another 10 vials of an recently expired AV with instructions to only give the 10 vials if the patient developed symptoms. At that time the Local Poison Control advised to administer the expired AV despite no symptoms. I worked with Miami-Dade, and decided not to administer the AV because symptoms were not present. We did administer the Thai Red Cross AV and the patient was fine other than just some very localized tissue necrosis at the bite site.
With all of my envenomations who are receiving AV, I sit down and explain the risks and benefits of administration and have them sign an informed consent which not even many physicians will do. I now work for that same Poison Control Center as their specialist in Snakebites.
I did not read the full article-was the dog given CroFab or Wyeth Polyvalent that was left over. There is less legal liability in veterinary cases since it is an animal not to say they don't deserve the same high level of care, but lawyers don't tend to chase animal cases because they can't make the money so the use of expired AV tends not to be problem so much.
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RE: Use for expired AV?
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by JoeCrotalid on June 20, 2008
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John is correct about keeping AV past its expiration date. A perfect example is that I recently did a hospital wide survey of all the facilities covered by my poison control center to determine the amount of on-hand stock of Wyeth North American Coral Snake AV with the current concerns about shortage. In our coverage area, we have a total of 143 available vials at assorted facilities. I instructed each facility to maintain their supply past the expiration date to use in case of envenomation until the new Coralmyn AV becomes FDA approved and available for purchase. Although it has FDA approval for emergency use-the only agency currently stocking it is Miami-Dade although as the regional level 1 Trauma Center, we have submitted our request to stock the Coralmyn as well. According to my literature-Coralmyn is currently in phase 3 clinical study, and Elda Sanchez at the Natural Toxins Research Center has published that it has been proven to be very effective in neutralizing the venom of the North American Coralsnakes.
With regards to exotic AV-it does fall under a special FDA category as an orphan/experimental medication and are granted FDA approval for emergency use in exotic envenomations but are not officially FDA approved medications because they are manufactured in foreign counties, and do not always go through the excessive studies that US medications are subjected to.
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RE: Use for expired AV?
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by JoeCrotalid on June 20, 2008
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Hopefully Jeff (FLherp) can address the issue more thoroughly with regards to the exotic AV and the FDA since Miami-Dade has to deal with import and the exact rgulations with regards to administration.
Chris may have something to add to this as well.
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RE: Use for expired AV?
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by tigers9 on June 20, 2008
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I was never good at chemistry, but was always wondering about the expiration days on pills, like August 2008, so it is not like on Sept 1 2008 the drug is useless, right?
How much effort (or would it be possible) to have more expiration dates listing how the drug’s effectiveness decrease over the next 1,2,3 years ?
Like After August 2008, it would be at 75% effectiveness, etc…
Z
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RE: Use for expired AV?
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by LarryDFishel on June 20, 2008
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In my uneducated opinion, it would be technically possible to do that, but it would cost them millions of dollars in extra studies to find out something that would result in them selling LESS of their product. Probably not going to happen.
I also suspect that FDA rules require a specific exp date, but I could be wrong about that.
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RE: Use for expired AV?
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by Phobos on June 21, 2008
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I would certainly use expired A/V if no "fresh" a/v could be obtained quickly and I developed symptoms. Time is tissue! For instance, if you were bitten by a Gabby or Rhino Viper. Even if A/V was sent from the Philly Zoo it would take 2 hours or more, most experts (Venom Docs) say that in two hour major organ damage would occur from envenomation by these species. This is what killed the Firefighter in Ohio a few years ago when bitten by his Rhino viper. He got fresh A/V but way too late to save him. I would tell the ER Doc in this case to start me on expired A/V till fresh arrived. I would tell him that I would (or my family) would sue him and the hospital if he did not and I suffered organ damage or death.
Government agencies (globally) assign expiration dates although they are arbitrary numbers not based in real data or fact.
Al
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RE: Use for expired AV?
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by JoeCrotalid on June 21, 2008
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Al
Although I agree with you 100% about giving expired AV, just for the sake of arguement-say the physician gives you the expired AV, and it is ineffective. What is your legal stance then? Would you be willing to sign a waiver releasing the physician and hospital from liability if they give you the expired AV and it is ineffective or you have an adverse reaction to it? OR do you now sue because they gave you the AV you demanded and it proved ineffective and you had an adverse outcome? The physician is caught in the catch 22! If you would demand expired AV be given-then I would recommend a notarized waiver be included in your bite protocol to take to the hospital-then the MD is more likely to give that AV.
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