Naloxone Debate: FDA Hears Testimony

[mds275]

Naloxone Debate: FDA Hears Testimony About Making an Overdose Antidote Nonprescription
Maia Szalavitz
TIME.com
April 13, 2012

“Why didn’t I know about this when my child was alive?” That was the question raised over and over at a U.S. Food and Drug Administration (FDA) hearing on Thursday by parents whose families make up the terrible statistics on opioid overdose, which now kills some 15,000 Americans each year.

Parents testified at an open meeting called by the FDA to consider whether the lifesaving antidote to opioid overdose — a non-addictive, non-toxic drug called naloxone (Narcan) — should be made available over-the-counter, so that everyone can keep it in their first aid kit, just in case.

The meeting was sponsored by the FDA, the Centers for Disease Control and Prevention (CDC) and the National Institute on Drug Abuse, whose director, Dr. Nora Volkow, has said that she supports making the drug available without a prescription.

http://healthland.time.com/2012/04/13/naloxone-debate-fda-hears-testimony-about-making-an-overdose-antidote-nonprescription/

 

[mds275]

I've been advocating for more naloxone availability for years and I couldn't be happier that the US Feds are starting to pay attention.

One thing that I am not sure if it deserves more debate is promoting naloxone availability as something that parents, average citizens, police officers should be the target audience for. Those of us who spend time distributing and refilling naloxone rescue kits know that the considerable majority (though not all) of the lives saved with narcan are the result of drug users taking care of drug users.

Is it a problem that this is gaining momentum without that being overtly explicit? Or is just reality that the media and the general public don't really want to think about drug users as capable people who can save some else's life and any press is good press when it comes to making narcan/naloxone more widely available?

 

[23536]

I am an occasional IV heroin user and I required CPR once. Nevertheless I don't possess naloxone because it isn't around. Needle exchanges are illegal in my area.

If naloxone were available at Walgreens, I'd probably go ahead and get a vial or two.

You can go up to any pharmacist and get ipecac; you should be able to do the same with naloxone.

Moreover, naloxone should be handed out, even to people who don't ask for it. Methadone clinics and NA/AA fellowships should distribute it. Don't leave it up to the user to have initiative: be pyroactive.

Also: users caught with heroin and naloxone should be granted immunity from punishment. Dealers who distribute naloxone with their heroin should be given some leeway (as long as they're not violent).

 

[Nexus298]

Don't get me wrong I think this would be a wonderful thing if Narcan were available without a prescription, but it would only be a matter of time before some parents and authority figures would abuse this and administer it to users in a nonoverdose situation to throw the user in to withdrawals as punishment for using. I don't think this would be common place, but it would happen.

 

[Crankinit]

Don't get me wrong I think this would be a wonderful thing if Narcan were available without a prescription, but it would only be a matter of time before some parents and authority figures would abuse this and administer it to users in a nonoverdose situation to throw the user in to withdrawals as punishment for using. I don't think this would be common place, but it would happen.

I'm sure it would happen, but that's still a worthwhile tradeoff for the lives saved.

 

[panic_the_digital]

I am an occasional IV heroin user and I required CPR once. Nevertheless I don't possess naloxone because it isn't around. Needle exchanges are illegal in my area.

If naloxone were available at Walgreens, I'd probably go ahead and get a vial or two.

You can go up to any pharmacist and get ipecac; you should be able to do the same with naloxone.

Moreover, naloxone should be handed out, even to people who don't ask for it. Methadone clinics and NA/AA fellowships should distribute it. Don't leave it up to the user to have initiative: be pyroactive.

Also: users caught with heroin and naloxone should be granted immunity from punishment. Dealers who distribute naloxone with their heroin should be given some leeway (as long as they're not violent).

FYI, good luck on getting ipecac, as it is no longer available due to the fact it causes more harm than it fixes. Naloxone on the other hand, that's some good stuff to have around. I hope this makes headway and I will gladly stock it on my shelves.

 

[23536]

FYI, good luck on getting ipecac, as it is no longer available due to the fact it causes more harm than it fixes.

I don't know much about the dangers of ipecac, but hospitals aren't very understanding of "I swallowed a huge amount of heroin when the cops stopped me". Is there another high-yield method of inducing vomiting?

 

[mds275]

Naloxone on the other hand, that's some good stuff to have around. I hope this makes headway and I will gladly stock it on my shelves.

AMEN! The US FDA just held a meeting that included conversations about making it available OTC- this is a recent article about that meeting. Help it make some headway & submit coment to the FDA on this topic, they are accepting PUBLIC (meaning you "the public" can comment, and also that it will be part of publicly available govnt docs) comment until June 12, 2012- submit here. Internationally, the UN Commission on Narcotic Drugs unanimously endorsed overdose prevention, including naloxone! Headway is happening, but elected officials and policy makers need to keep hearing that people think it's a good idea!

Handing out narcan is happening more often- if you live in the USA, search here for a program, this is a list of programs in other countries.

 

[Captain.Heroin]

You can get naloxone prescribed to you for free here in Los Angeles.

If it stays a prescription, it is pretty irrelevant to me now.

The reason it isn't OTC: if a dope user on probation fucks up, overdoses, and needs medical attention, they will live but go back to jail. Think about the people who stand to gain from this. The US government is not concerned about our lives.

 

[panic_the_digital]

I don't know much about the dangers of ipecac, but hospitals aren't very understanding of "I swallowed a huge amount of heroin when the cops stopped me". Is there another high-yield method of inducing vomiting?

Inducing vomiting is largely useless as the GI starts moving a food (or heroin) bolus within 30 minutes of ingestion, which is highly unlikely. Inducing vomiting increases ones risk for aspiration pneuminitis, which docs would rather not deal with. They would likely give you some activated charcoal if the ingestion occurred within the hour, but they will most likely keep the narcan flowing if they know what you ingested.

 

[IHateOpiophobes]

Don't get me wrong I think this would be a wonderful thing if Narcan were available without a prescription, but it would only be a matter of time before some parents and authority figures would abuse this and administer it to users in a nonoverdose situation to throw the user in to withdrawals as punishment for using. I don't think this would be common place, but it would happen.

My dad who is now a suboxone MD.....before he understood addiction, used to give me Narcan Challenges if he suspected me of using. Not pretty....yikes that was horrible.

 

[IHateOpiophobes]

You can get naloxone prescribed to you for free here in Los Angeles.

If it stays a prescription, it is pretty irrelevant to me now.

The reason it isn't OTC: if a dope user on probation fucks up, overdoses, and needs medical attention, they will live but go back to jail. Think about the people who stand to gain from this. The US government is not concerned about our lives.

Sad, but I agree with you. The war on drugs is fought because all the snotty nosed kids who were picked on and grew up to became cops to stop the evils of drugs, would lose their ungodly amount of wasted funding. Its all about the benjamins. Not the people.

 

[Captain.Heroin]

I still think it is a great thing I was able to get naloxone prescribed to me.

My dad who is now a suboxone MD.....before he understood addiction, used to give me Narcan Challenges if he suspected me of using. Not pretty....yikes that was horrible.

I would have called CPS.

 

[Tommyboy]

I wonder what way it would be available in. I know they have the nasal sprays of it which are easy for family members to administer without having to worry about using a syringe, but I'm thinking that IM naloxone would be more or just as efficient compared to nasal administration, and most people are capable of jamming a person in the leg with a syringe, and pushing the plunger down.

One of the reasons why I am curious about this is because I wonder how this would effect state laws on pharmacies selling syringes without prescription if they are selling narcan OTC that requires a syringe. Would people in states with tight syringe regulations have to buy narcan everytime they wanted to get a syringe, or would they relax the laws in light of the harm reduction progess being made?

 

[Crankinit]

I think the nasal administration is probably a better option, overall. There's so much stigma around needles and so many people are uncomfortable with them, even when it's a device like an epi-pen (I have one for peanut allergy and before I started IVing opiates I used to be seriously freaked out about the concept of having to jam that thing into my leg if I accidentally ate peanuts). Nasal administration isn't much slower than IM, if at all.

 

[ro4eva]

I remember reading about an IV smack user who'd load up his gear in one syringe and naloxone in another. He'd then stick both into opposite arms and shoot the smack. This way he was able to reverse two ODs.

 

[mds275]

One of the reasons why I am curious about this is because I wonder how this would effect state laws on pharmacies selling syringes without prescription if they are selling narcan OTC that requires a syringe. Would people in states with tight syringe regulations have to buy narcan everytime they wanted to get a syringe, or would they relax the laws in light of the harm reduction progess being made?

The FDA is not going to approve an injectable drug for OTC. During the public meeting on April 12, someone asked about that since certain forms of insulin are available OTC and they basically said "forget it- not a chance". Kind of a bummer- I would have liked to see what it would mean for what you are talking about, Tommyboy.

There are pros and cons to both injected and nasally administered naloxone- IMO what would be "best" is for people to be able to choose which form they want. Drawing up medication for injection is something that we have all seen before and it is really easy, the current formulation of naloxone used intranasally requires some assembly and is a teensy bit confusing. This is what it looks like disassembled:

 

[i against i]

hope it does become available OTC, i'm in the UK but progressive drug laws anywhere make me happy.

 

[23536]

The FDA is not going to approve an injectable drug for OTC. During the public meeting on April 12, someone asked about that since certain forms of insulin are available OTC and they basically said "forget it- not a chance".

I mean, they're deciding on whether to approve the chemical, right? It's all naloxone HCl. Once people have that, they can decide on which ROA to use.

If a syringe-naive person finds himself in a position to save an overdose victim, he may appreciate a pre-loaded nasal pump.

Or, like those epi pens and the migraine one-shot packages (name escapes me), the naloxone can come in tubes with pins.

edit: like the imitrex self-injection pen: press the blue button and the needle pops out:

 

[mds275]

^It's annoyingly complicated, even though it should be as simple as you explain. Currently, the naloxone HCL products produced in the US are approved chemicals for administration by IV, IM and SC routes. Other than insulin, which was apparently a special situation, there are no drugs that are OTC as injectable. So it means that naloxone and it's intranasal devicewould have to be approved for IN ROA and then a separate application to make that approved IN naloxone product available OTC. This would probably involve clinical trials and $$$ from a pharma company in addition to the support from the FDA.
The photo of the autoinjector could totally work, but the medicine to fill it it will probably remain available only by prescription. There's no reason, however, that a doctor can't prescribe naloxone- and insurance should pay for it, too. In Italy (and Sweden, I think) injectable naloxone is available OTC, but I think those are the only places. I don't think there is anywhere where nasal naloxone is officially approved (but there are clinical trials IN v IM v IV underway in Australia).
IMO, lobbying local health departments and prescribers to start distribution programs is a good short term solution to making naloxone more available while the FDA figures out what they want to do.