Monday, June 25, 2012

Stimulant Medication Shortages Update: You Helped CHADD to Make a Difference



It has been a very long year of dealing with medication shortages across the country. The information you shared with us last winter was often heartbreaking, as you described the incredible steps you were forced to take to obtain medication for yourself or your child, the skyrocketing prices charged by some pharmacies, and the awful consequences of not having medication.

CHADD has worked hard to address the shortages, and we are seeing some real changes take place—both in resolving the immediate shortages and in solving the problem long-term. We have been working closely with legislators, peer associations, government agencies, and pharmaceutical companies to get to the causes and to address them.

The Drug Enforcement Agency appears to have a key role in the shortages. Their mission is to ensure stimulant medications are not abused or misused. Every year they set a quota for each pharmaceutical company, and the company may not manufacturer even a single pill above this limit. If the quota does not accurately reflect the legitimate need, or if medications are diverted for nonmedical use, then a shortage can occur. Until now there has been no mechanism for a shortage to be addressed once it occurs. That is about to change.

Over the last six months, CHADD has been busy addressing this serious problem:
  • CHADD’s survey in January collected more than 5,500 responses. Forty-nine percent of our respondents were having serious difficulty getting prescriptions filled, and eighteen percent were forced to change to a new medication. Your participation in the survey gave us more information on the shortage than anyone else in the country. Thank you.
  • CHADD and the American Academy of Child and Adolescent Psychiatry formed a coalition of concerned associations, which included several pharmacist groups as well as the American Academy of Pediatrics, the American Psychiatric Association, and a number of mental health and ADHD groups.
  • CHADD has been in regular communication with all the major pharmaceutical companies to understand the obstacles to manufacturing sufficient quantities of medication.
  • CHADD leadership has met with staff for every key committee in both the US House of Representatives and the US Senate to make them aware of the seriousness of the problem.
  • CHADD leadership and members of the coalition met with the staff of the Food and Drug Administration to determine their role.
  • CHADD worked with the media to get the story out to the larger community. Literally hundreds of media outlets covered the story.
  • And the coalition repeatedly asked for a meeting with the Drug Enforcement Agency. We are still waiting.
Have we made a difference? You bet we have.
  • In January, the DEA increased the quota for stimulant medications significantly. Because the pharmaceutical companies need time to then manufacture the medications, an increase in the availability of medications did not begin until this spring.
  • The House Energy and Commerce Health Subcommittee is investigating the role of the DEA in the shortage and has not yet released a report.
  • Senator Chuck Grassley from Iowa has asked the General Accounting Office to investigate the DEA’s role and report on their findings. While such a report can take up to a year, the GAO is known for even-handed, nonpartisan reports and good recommendations.
  • The Prescription Drug User Fee Act of 2012 (PDUFA) was approved by the House last week and now faces one last vote in the Senate before going to the President. It instructs the Secretary of Health and Human Services to address medication shortages within thirty days. When the shortage involves a controlled medication, like stimulants, the Secretary has the authority to contact the Attorney General (the Secretary’s counterpart in the Department of Justice, which includes the DEA) and ask that the quota be increased. The Attorney General and the DEA must respond by either taking action or responding with a clear rationale for not increasing the quota. And all of this information must be made public. This is the first time a mechanism has been put in place to address a shortage before it becomes chronic.
But we want to be really, really sure that all of CHADD’s members and all people with ADHD have access to their medication. So we are asking each of you to take five minutes and fill out another survey. It is just as important to know that the problem has disappeared as it is to know whether you are still having difficulty getting prescriptions filled. We will not trust that the crisis has passed until you tell us. Please take a moment to let us know.

Ruth Hughes, PhD

Ruth Hughes, PhD, is the CEO of CHADD.

22 comments:

Ron Sterling, M.D. said...

One huge, widespread and firmly embedded belief that has a very significant effect on the lax attitude about the continuing availability of the very few medications that are known to be very effective for increasing working memory (the real and most important deficit in ADD) is the BELIEF THAT ALL THE MEDS ARE ESSENTIALLY INTERCHANGEABLE SO, IF YOU LOSE ONE, NO BIG DEAL, SWITCH TO ANOTHER.

I have been trying to educate, educate, educate legislators and bureaucrats that this has been proven to be NOT TRUE. Once you find the correct medication for you, it is not interchangeable without significant side-effects and ineffectiveness and potential development of tolerance (addiction with withdrawal symptoms).

I could go on... but one set of examples from my practice is how often I see transferring clients who have been utilizing inappropriately high doses of Adderall because they are unaware of the fact that Adderall is made up of two different chemicals, and although similar, are NOT THE SAME. One can be correct, while the other is not.

Often, the dextroamphetamine part of Adderall is correct and the longer acting amphetamine part of Adderall is incorrect, causing side effects that are very noticeable during the last two or so hours of duration of the Adderall (In the IR preparation, the dextroamphetamine part is pretty much gone by the 3-4 hour mark and the remaining 2 or so hours of IR effectiveness is due to the remaining effects of the longer-acting amphetamine in Adderall).

So, these new clients get on the right med - dextroamphetamine by itself, not in combination with amphetamine -- and they can sleep again, etc.

THEN WHAT HAPPENS? Dextroamphetamine becomes totally unavailable (Washington State) and hey are forced back on Adderall because they can't find a dextroamphetamine-only preparation.

It's criminal! Period. There is no dextroamphetamine available anywhere in the Seattle area and no pharmacy can order it or expects to be able to order it anytime in the near future.

Yah, that's the ticket, get people addicted (make them develop a tolerance) to the long-acting part of Adderall, just to benefit from the dextroamphetamine in Adderall...

Bill Poorman said...

I understand why you are saying the DEA is the bottleneck, but why are they the bottleneck? Was their quota forecasting wrong, or are more stimulants going to non-medical (criminal) activities? Or is it something else entirely?

Thanks for everything you're doing to resolve this.

catalinakidsonthemove said...

I have read that one company who makes this medication bought the only other company who makes the same medication. Under the law, that company is to be blamed for the shortage. They bought the other company and were unable to produce the amounts needed due to the limit one company can produce.

Anonymous said...

My daughter continues to be uable to get dextrostat and has had to change to a more expensive, less effective medication! We are located in Spartanburg, SC.

Anonymous said...

I believe the shortage has improved here, but a change to IL state law now makes it so that I can no longer obtain a 90 day supply at the discounted rate of my insurance company. So now it is 75.00 every 90 days instead of 50.00 every 90 days, because a 30 day supply is 25.00 each and the discount is only allowed if you get a 90 day supply. That is a huge cost difference over the course of a year or years. I worry for my daughter who may need medication for ever! I think it is unconstitutional to not be allowed the discount simply because others abuse it! The punishment seems to be for those who need the drugs rather than the criminals!!!

Anonymous said...

Please help us in Washington state. I was told by June my pharmacy would be able to get Detrostat short acting tabs again. Now what's happened is the vendors that the pharmacies order from have decided not to carry any of the short acting dextroamphetimine medications. I have checked 4 different pharmacies that use different vendors and the answer is the same... Not going to carry the medication any more.

thanks.

Michelle Hammack said...

I agree with Dr. Sterling. The drugs are not interchangeable. I am very intolerant to any stimulant drugs. We found Atomoxetine to be the only helpful drug for my Adult ADD. I have had very few side affects and have been taking it for several years now.
Here is more information:

http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000222/

http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000222/

Cosmictadpole said...

Thank you for providing all of this information. Just today I'm about at my wits end over this problem. I took the CHADD survey, and I posted this in the comments section:

The generic version of Adderall that I usually take is the Barr version. Oftentimes, the pharmacy runs out of this version. This month, the pharmacy had again run out of the Barr version, so they gave me a generic which was new to me: the Sandoz generic. Since I've begun taking the Sandoz generic, I've felt like the medication is hardly working, I've felt extra spacey, foggy, and zoned out, and I cannot perform my work at my job. I also feel very anxious and hopeless - either from the medication itself, or from the fact that I can't focus and do my work.

I asked the pharmacy if there was anything I could do, and they said that I could ask my doctor about writing me a new prescription and then seeing if the Barr version is back in stock by then. But, they said that if my doctor was willing to do that, my insurance would not pay for it, and it would cost me $150, which is completely infeasible for me at this time. I'm so upset about this, as I fear that I could lose my job, and I can't even focus well enough to remember to call my doctor during business hours. How can they do this to us? There must be something that can be done!

Due to these shortages, I've also experienced having to have prescriptions filled partially by one pharmacy and partially by another, having to try several different pharmacies, and having to use other generic versions that cause anxiety and jittery side-effects.

Thank you so much for all of your work to try to help with this problem!

Anonymous said...

I have had to go weeks even months without my medication due to shortages. The pharmacies where I live in Illinois claim that they are not allowed to partially fill my prescriptions so unless I go back to the doctor and get them to write a prescription for a lesser amount, I am unable to get any. When I complain I get the "look" like I'm just a druggie. I live in a rural area and it can take several weeks to get a new prescription from my doctor. I am so glad that someone is doing something about this. I get so frustrated traveling 60+miles round trip only to NOT get my medication. I take 20mg of Dextroamphetamine CR in the am and 10mg in the evening. I can't stay focused enough to be fully functional, or slow my head down to even be able to sleep without the meds.

Kenny Stanger said...

This crisis has most certainly NOT passed. It's certainly quite present for me on Long Island, NY. (as well as for my friend in Phili). I've called a number of pharmacies - none have it in stock, and none can tell me even if ordering it will be successful. (they can take the script, order it, hold the script for 3 days, then see if the order came in. If it didn't, I just lost 3 days of searching. Simply not practical).

For me this is dire, because I fly back to Berlin next week (where I currently live) with or without it. I likely won't be back in the states for maybe a year.

There is some good news coming (though it won't help me much in the immediate future). In case people here are not aware, there is another manufacturer (Mikart) that will very soon have their version of dexedrine on the market. I called them and then their distributor to get some info. The distributor said they did't have a release date yet, but when I pressed her she reluctantly guessed 30-90 days. I really hope having another manufacturer in the market will be a long-term solution.

Anonymous said...

It sure would be nice if CHADD would send out an informational pamphlet to pharmacies informing them of the shortage and the fact that people may be calling to check availability of the medicine.

And to Walgreens, CVS, Rite Aid et al. when people call your pharmacy to inquire on the availability of ADHD medicines, it would be nice if we weren't treated by your staff as junkies looking to "score" medicine. Trust me I have better things to do with my time than to call hundreds of pharmacies each month, and I'm sure your pharmacists have better things do, but the fact is I am not going to spend hundreds of dollars in gas going from pharmacy to pharmacy looking for my prescribed medicine. It would be nice if pharmacists and their staffs were informed that there is a massive shortage and should maybe exhibit a little compassion instead of being rude and completely unhelpful.

Patricia McLaughlin said...

I asked my doctor to change my prescription from generic Adderall 20 mg. tablets to generic Adderall 20 mg. extended-release capsules, because my Medicare part D insurer, AARP/United Healthcare, had moved the tablets to a higher tier. (Last year my copay for 180 tablets was $7; this year, it increased to $111.) However, according the website at Optum Rx (the mail-order pharmacy recommended by my insurer and, incidentally, a subsidiary of United Healthcare), the copay for the extended release capsules was (and only God knows why) still only $8. The doctor changed the prescription, and I mailed it in. OptumRx filled it on April 24. At first, the copay came up as $8 as I had expected. However, a few days later, it was changed, and I was instead charged $572.55; according to my claim history at Optum Rx, the insurance company paid $565.52. (Customer service reps at Optum Rx have told me these numbers are incorrect; if so, they haven’t been corrected on the website.)
In other words, the 90-day supply of 180 20 mg. extended-release generic Adderalls, which I had switched to purely to save money, had suddenly increased in price to a total of $1,138.07. (Last year, the price for 180 20 mg. generic Adderall tablets was $67.10; I paid a copay of $7 and the insurance company paid $60.10.)
OptumRx didn't notify me that the price of my medication had increased (by a factor of 17!). The $1,138.07 charge put me in the donut hole--with eight months of 2012 still to go.
How—outside of Alice in Wonderland—can this make sense??

August 7, 2012

Patricia McLaughlin said...

I asked my doctor to change my prescription from generic Adderall 20 mg. tablets to generic Adderall 20 mg. extended-release capsules, because my Medicare part D insurer, AARP/United Healthcare, had moved the tablets to a higher tier. (Last year my copay for 180 tablets was $7; this year, it increased to $111.) However, according the website at Optum Rx (the mail-order pharmacy recommended by my insurer and, incidentally, a subsidiary of United Healthcare), the copay for the extended release capsules was (and only God knows why) still only $8. The doctor changed the prescription, and I mailed it in. OptumRx filled it on April 24. At first, the copay came up as $8 as I had expected. However, a few days later, it was changed, and I was instead charged $572.55; according to my claim history at Optum Rx, the insurance company paid $565.52. (Customer service reps at Optum Rx have told me these numbers are incorrect; if so, they haven’t been corrected on the website.)
In other words, the 90-day supply of 180 20 mg. extended-release generic Adderalls, which I had switched to purely to save money, had suddenly increased in price to a total of $1,138.07. (Last year, the price for 180 20 mg. generic Adderall tablets was $67.10; I paid a copay of $7 and the insurance company paid $60.10.)
OptumRx didn't notify me that the price of my medication had increased (by a factor of 17!). The $1,138.07 charge put me in the donut hole--with eight months of 2012 still to go.
How—outside of Alice in Wonderland—can this make sense??

Anonymous said...

Well it's not fixed yet. That's for sure. i haven't seen an IR tab in Phoenix in months. If there is a good thing to come out of the price increase it's that Shire not only manufactured the shortage but some competition as well. At last glance I read that two other companies were producing Dex in different varieties. I'm sure it's the same for Adderall.

The pharmacy employees are the ones that I really have a hard time with. The arrogance and absolutely uncalled for rudeness has pushed me to the end of my tolerance on several occasions. I don't care if they like, approve, or desire to help me. I just wish they'd do their jobs and maybe learn what the medications are used for. In conversation with one young pharmacy tech I mentioned I work nights. He asked if that's why I was prescribed dextoamphetamine. Really??? Are you kidding??? And you work here??? So with this type of ignorance in place the lack of anything resembling service is understandable. But not acceptable.

Best of all is that the ignorance and arrogance starts at the top and works it's way down. FDA guidelines state 60mg a day is the max for any stimulant medication. God help us. My grandson suffers from ADD as well as myself. He needs to focus in school and the rest of the time he functions pretty well. I on the other hand don't deal well with daily life responsibilities without it. Common sense would dictate that as I weigh almost 200 lbs. compared to the boys 70 lbs. I would need a higher dose. Adults have to focus for more than school hours as well. But somehow it's been determined that our maximum dose should be the same. And any doctor with the nerve to prescribe of label will be hearing from the DEA. Our government in action. Just plain stupid.

So I thank you from the out of focus bouncing around like lightning recesses of my brain for dealing with all these government types. It has to be the most trying experience of your lives. Trying to get big pharma and big government to do anything productive I imagine borders on the impossible.

amyb. said...

This discussion is so interesting to me. I just received an rx yesterday for my son for the daytrana patch...when I dropped it off at the Pharmacy, they had none in stock. After calling several other pharmacies--none of whom had it in stock--they ordered it and told me it would take 7-10 days to get here. Lucky for my son (and me) he has not yet started so will suffer no withdrawal symptoms. What a nightmare for all of the families who have to deal with this every month. Thank you for the heads up!

Anonymous said...

I waited, suffering, for 36 years for doctors to figure out what was going on with me! They finally diagnosed me with ADHD and put me on Adderal, life changing for my family. Now being unable to get my meds due to cost and lack of insurance because lay offs in Georgia my family suffers! I am at a loss for words to describe the anger and frustration that runs through myself and my husband and children! They say mommy you were doing so good what's the matter? What do you say to that! I haven't a clue! They already put up with so much, I feel so guilty at times!

Anonymous said...

In 2000 I was diagnosed by my former co-worker-psychologist, with ADHD.I take medication for I was a troubled kid. I had learning difficulties especially math and English. I am a board certified health care provider in Maryland and the district and degree in psychology from Md ( special accomondations for ADHD). I believe my illness is affecting my work, not the patient care but learning electronic charting. I would like to know how to file for a disability and receive help re programming/wiring my brain??

Anonymous said...

Ruth,

Thank you for your hard work in this area! We are seeing supply get better as of late. However there has been a troubling price increase in the cost of dextroamphetamine. We are seeing sudden increases of 4x or more over the previous month. This drug was commonly prescribed to individuals without insurance due to the low cost. There is no reason for pricing to quadruple or more month-over-month. Especially for a medicine that has been around for nearly 100 years.

Yes we are now seeing a decent supply of dextroamphetamine, but the increase in price will lead to many, that rely on the medicine, to be priced out of affording it. I am asking you to please take a look at this. I know you have many things going as of late, but this is going to be the next ADD medication crisis. I myself rely on this medication and will no longer be able to afford it. Sometimes I suspect the powers that be would rather see me fail than be a successful member of society, which I have become, since being treated for ADHD.

Thank you for all you do!

Anonymous said...

The cost of dextroamphetamine has just increased here in Oregon by 400%. What can we do to stop these greed mongers from preying on us. I am not feeling reasonable about this. What hope can you give me?

Anonymous said...

I was shocked today to find out that my Dextroamphetamine prescription went from $63 to $300 last month, and was told that it was moved to another tier and taken off the generic list. This is not good news at all, as I cannot function without it, but can only afford it one time. I am forced to look into other medications.

Anonymous said...

I work for a physician, and I want to say that physicians are so highly regulated by the DEA on how they prescribe medications that often it is not possible for the physicians to write another prescription for different medication without fear of reprisal for practicing medicine. Physicians don't even understand why there's a shortage. There is also no good reason for the quadrupling of the price, other than someone is apparently trying to get rich . The shortages on all of the medications do not seem to be necessary but seem to be more an effort of the new socialized medicine to save money for someone however those of us who have to pay for anything are paying more and shortages make it seem like we are now a third world country. Something is really wrong with this system and we Americans need to stand up and find out why and get it fixed. Maybe Chadd can work on the other medication classes as well including antibiotics which for mini are either being discontinued in manufacture or there are shortages of those too.

Anonymous said...

It has now been over half a year since CHADD "took action" and "had an impace" on this problem, yet IMMEDIATELY after President Obama was re-elected, my prescription for DEX ER went from $447 to OVER $1500. This is no coincidence! Big Pharma TEVA is clearly profiteering in advance of what they believe will be Obamacare price controls on such drugs. Racemic amphetamine was synthesized as phenylisopropylaminne over 130 years ago! Dex has been manufactured over half a century in the U.S.!!! It is generic and thereis no rational explanation that Big Pharma or The Drug Enforcement Adminnistration can provide for what is going on with pricess and quotas. It is time to take the control out of the DEA's hands and put back into the department originally established by Congress to oversee such issues, the Food and DRUG Administration. The DEA has a vested interest in this and it is NOT to protecr our citizenry! A recent study of illicit amphetamine users found that over 50% tested as qualifying for a diagnosis of ADD/ADHD, yet only %17 had been previously diagnosed! This means that 333% of illegal amphetamine users are risking felony convictions, removal of children and prison sentences, all in the name of "justice" and the illegal WAR ON DRUGS. Illegal because the FDA was originally charged with regulating these substanes and NOT the Department of (in)Justice! The department of justice has no business being involved in regulating or enforcing what we put into our bodies, especially when PRESCRIBED BY A MEDICAL PROFESSIONAL WHO PERSONALLY KNOWS THE PATIENT!!! MORE ACTION IS NEEDED BY CHADD ON THIS AND THE FDA NEEDS TO PUT SOME PANTS ON AND STEP UP!