View Full Version : Possible Fix to ADHD Drug Shortages


hdboyad
03-05-12, 10:59 AM
As most of you know, it seems that every year there are multiple shortages that occur. This seems to be the result of strict DEA quotas on how much active ingredient pharmaceutical companies get for their medications not keeping up with the increased demand of ADHD patients that need these medications.

Basically, the quotas that the DEA gives to pharmaceutical companies give them a total amount of active ingredients like methylphenidate, amphetamine, etc. that they can use to make brand only formulations and generics. As you can guess, these quotas that the DEA sets are much to strict to keep up with demand. Evidence of this is the fact that there are always shortages every year. The DEA blames pharmaceutical companies for not making enough generics with their set quotas of active ingredient, and the pharma companies blame the DEA for setting quotas that are too low to keep up with the increased demand for these drugs.

Either way you look at it, the reason for these shortages results from the DEA quotas. If there were no quotas or the quotas were not as strict, the pharma companies could have enough active ingredient to keep up with demand for generics AND brand drugs, leading to little or no shortages.

If you are like me and you think that it is unacceptable for anyone to not be able to get drugs they depend on due to shortages in the 21rst century, then I encourage you to email your congress person and senator about your concern of these strict DEA quotas and drug shortages. Enough is enough. The DEA is literally playing with peoples lives here; people depend on this medication to function normally in their daily lives.

Downix
03-08-12, 12:10 AM
As most of you know, it seems that every year there are multiple shortages that occur. This seems to be the result of strict DEA quotas on how much active ingredient pharmaceutical companies get for their medications not keeping up with the increased demand of ADHD patients that need these medications.

Basically, the quotas that the DEA gives to pharmaceutical companies give them a total amount of active ingredients like methylphenidate, amphetamine, etc. that they can use to make brand only formulations and generics. As you can guess, these quotas that the DEA sets are much to strict to keep up with demand. Evidence of this is the fact that there are always shortages every year. The DEA blames pharmaceutical companies for not making enough generics with their set quotas of active ingredient, and the pharma companies blame the DEA for setting quotas that are too low to keep up with the increased demand for these drugs.

Either way you look at it, the reason for these shortages results from the DEA quotas. If there were no quotas or the quotas were not as strict, the pharma companies could have enough active ingredient to keep up with demand for generics AND brand drugs, leading to little or no shortages.

If you are like me and you think that it is unacceptable for anyone to not be able to get drugs they depend on due to shortages in the 21rst century, then I encourage you to email your congress person and senator about your concern of these strict DEA quotas and drug shortages. Enough is enough. The DEA is literally playing with peoples lives here; people depend on this medication to function normally in their daily lives.
Um, you do realize that the DEA does not set quotas, right? The pharms do. They file with the DEA for how much of the medication they will produce/use/import for the year. The DEA does not set that limit except in extreme cases, and they have not on ADHD related medication for several years.

hdboyad
03-08-12, 09:06 PM
Well I already emailed my senator and he said he too was concerned about the DEA's strict quotas. . .

hdboyad
03-08-12, 09:14 PM
Downix,
check out this article from the NYtimes:
http://www.nytimes.com/2012/01/01/health/policy/fda-is-finding-attention-drugs-in-short-supply.html?_r=2&scp=1&sq=adhd%20dea%20shire&st=cse

Maybe this will clear up some confusion

salleh
03-08-12, 11:11 PM
Just read that article .,...is it me or is that DEA agent more than a little bit of a jerk ....

It is not our problem that other people might abuse the drugs we HAVE to take .....

tough noogies DEA if you can't control it



STOP TRYING TO CONTROL PEOPLE ON OUR BACKS !!!!!!


enough is enoiugh ......I am gonna go and be unmedicated at him ......


and I hope everyone he ever knew, loved, stood next to, heard of , smelt, felt, or dreamed about in his life or any of his descendants lives .....gets or is born with ADHD ....severely ......


......I put a curse on him .......



time to get real ....can mail our congress people ......


it's bad enough being a woman in America right now, as far as health issues are concerned ......but they're messing with our brains too !

hdboyad
03-08-12, 11:30 PM
Doesn't it just make your blood boil? I mean we need these drugs to even be function somewhat normally!!! I just can't believe that our government let's the DEA do this!!!

purpleToes
03-09-12, 12:23 AM
Whether there's plenty of supply or not, the DEA's logic of setting quotas seems badly flawed, to be generous about it. The DEA should have to explain exactly how the quota policy achieves the goal of thwarting abuse, because I don't think they can. I doubt they can produce any evidence that limiting supply keeps ADD drugs out of the wrong hands.

I wonder, too, what exactly is it they're trying to prevent? The drug companies from supplying illicit drug dealers on the side? Doctors from overprescribing? Patients from faking ADD to get meds? Thieves from holding up pharmacies? Apart from the first one, I can't see how limiting the supply prevents any of these things.

Surely there are bright enough minds at the DEA to come up with some enforcement methods that are meaningful and actually work, instead of this punish-everyone approach.

purpleToes
03-09-12, 12:35 AM
If the DEA believes there's plenty of supply, shouldn't it be a straightforward matter to identify where all these extra pills are lying around somewhere? I mean, with all those DEA-issued serialized Rx pads, and extra strict rules about dispensing, they can't really account for every pill? Is it all "drug enforcement theater?"

Downix
03-09-12, 07:37 PM
Downix,
check out this article from the NYtimes:
http://www.nytimes.com/2012/01/01/health/policy/fda-is-finding-attention-drugs-in-short-supply.html?_r=2&scp=1&sq=adhd%20dea%20shire&st=cse

Maybe this will clear up some confusion

Yes, it pointed out what I said, that the drug companies are the ones deciding on what medications they will make, not the DEA.

Downix
03-09-12, 07:38 PM
If the DEA believes there's plenty of supply, shouldn't it be a straightforward matter to identify where all these extra pills are lying around somewhere? I mean, with all those DEA-issued serialized Rx pads, and extra strict rules about dispensing, they can't really account for every pill? Is it all "drug enforcement theater?"

Those pills are laying around as name-brand medications, such as name brand Vyvanse, instead of the generic adderalls. The companies set what they will produce.

hdboyad
03-09-12, 11:50 PM
Um, you do realize that the DEA does not set quotas, right? The pharms do. They file with the DEA for how much of the medication they will produce/use/import for the year. The DEA does not set that limit except in extreme cases, and they have not on ADHD related medication for several years.

I would like to point out to you Downix that you stated that the DEA does not set quotas, which is strictly wrong. . . they do. This thread was not created to argument with people, but rather inform people, so if you could stop doing otherwise I would greatly appreciate it.

Rebelyell
03-10-12, 12:34 AM
Amazingly the people who work in big Pharma dont have a clue and probably dont have adhd or any mental health issues.years ago my moms friend worked in pharmacy company maybe she still does.I was talking about neuro receptors when she overheard me and cut in and started explaining to me how they work,I shot bck and told her I know this does that and dopamine switches that etc.She was impressed I knew that much about it when I didnt have a college degree or was that smart.It kind of wrinkled my nose how I then looked at nts after that.Why does it have to be they have to be such damn know it alls or condescending buttholes?Just cause I have adhd and ts doesnt make me a dumb ***.I really really am starting to wonder who the real idiots are the more I look around and deal w people.

purpleToes
03-10-12, 12:44 AM
Yes, it pointed out what I said, that the drug companies are the ones deciding on what medications they will make, not the DEA.

I think Downix is mistaking my use of "supply" to mean finished product (pills), not raw material.

The DEA sets a quota for how much raw material the drug companies can have, not which products or how many pills they can produce. The drug companies can allocate the raw material as they wish.

purpleToes
03-10-12, 12:46 AM
Those pills are laying around as name-brand medications, such as name brand Vyvanse, instead of the generic adderalls. The companies set what they will produce.

That's the DEA's position, roughly. My point was, if it's true, shouldn't they be able to prove it easily?

Downix
03-10-12, 01:17 AM
I think Downix is mistaking my use of "supply" to mean finished product (pills), not raw material.

The DEA sets a quota for how much raw material the drug companies can have, not which products or how many pills they can produce. The drug companies can allocate the raw material as they wish.

Somewhat. Companies do file with the DEA for how much of the raw material they wish to produce, and the DEA then can agree with them, or adjust the amount up or down. Incidentally, the DEA report on Schedule II quotas published on Jan 6th 2012 lists that they have had to push the amount of Methylphenidate that companies are authorized to produce from the requested 35,000,000 kg to 56,000,000 kg in 2011 alone. The drug producers wanted to produce 21 million kg *less* than the quota made them produce. Eliminating the quota system would have made the drug shortfall problems worse, not better, by the reports.

Downix
03-10-12, 01:28 AM
That's the DEA's position, roughly. My point was, if it's true, shouldn't they be able to prove it easily?

They publish full numbers. But the DEA had end-product juristiction removed 8 years ago as part of the reorganization under the various homeland security bills. So now you have two divisions, each one only handling one half of the problem. This issue is more at fault, this disconnect between raw material and end product, than any quota. The FDA retains end-product juristiction, while DEA is raw material juristiction. End result, you get a blame game.

Downix
03-10-12, 01:34 AM
And contrary to popular belief, not trying to start an argument, nor to be contrary, just trying to dispel a common misperception so we can get the real issue fixed which is a far bigger problem than just our medication (which is already a big enough problem for us as it is). This disconnect in federal agencies causes problems in many areas, each one pointing the finger at the others.

hdboyad
03-13-12, 12:29 AM
Somewhat. Companies do file with the DEA for how much of the raw material they wish to produce, and the DEA then can agree with them, or adjust the amount up or down. Incidentally, the DEA report on Schedule II quotas published on Jan 6th 2012 lists that they have had to push the amount of Methylphenidate that companies are authorized to produce from the requested 35,000,000 kg to 56,000,000 kg in 2011 alone. The drug producers wanted to produce 21 million kg *less* than the quota made them produce. Eliminating the quota system would have made the drug shortfall problems worse, not better, by the reports.

Downix,

Could you please cite your sources for this information? Thanks.

Downix
03-13-12, 02:41 AM
Downix,

Could you please cite your sources for this information? Thanks.

The DEA's website for prescription medication quotas includes all of the information given:

http://www.deadiversion.usdoj.gov/quotas/index.html

Also multiple articles, such as this one by Gloria Rood of Grove Ridge Consulting:

https://www.gplus.com/business-of-medicine/insight/adderall-drug-shortage-more-blame-on-shire-than-dea-53952

When dealing with an issue so critical, always go to the horses mouth, as it is.

salleh
03-13-12, 10:42 AM
my head is spinning trying to figure this out .....


a couple of things jump out at me .....

.>>> there's no shortages, nor has there ever been, of the expensive stimulant meds. ( i.e. Vyvanse....)


>>>>>there are yearly shortages of the affordable stumulant meds .......


>>>>>the drug manufacterers say it's the fault of the DEA, not enough raw materials dispensed to them


>>>>>>the DEA say that they dispense plenty of the raw material for the stim meds


>>>>>>the whole thing is complicated by one company making the Vyvanse, and the generic stim meds .....( does Shire also make the brand name Adderall ?)


and that's basically what the problem is .....



the who why and wherefor are still being muddied by all involved ......

hdboyad
03-13-12, 09:07 PM
Downix,

I saw the aggregrate quota for 2011, but I am not finding what the pharma companies requested in 2011. Where did you find this?