Pharmacists And Shire Spar Over Adderall Shortage

In the latest report from the frontlines in the ongoing battle against prescription drug shortages, a majority of pharmacists report that they lack one or more medicines at least every day and an overwhelming percentage say that shortages, on average, last three weeks or longer. Not surprisingly, most cite shortages of attention-deficit disorder pills, but also topical ointments and creams.

To be specific, 96 percent of pharmacists experienced a shortage in the past six months, with 59 percent reporting a problem daily and 23 percent on a weekly basis, according to the survey of 675 pharmacists who were queried by the National Community Pharmacists Association, a trade group for independent US drug stores. The survey also found that 80 percent of the pharmacists report the average shortage lasts three weeks or longer, and 78 percent of their customers are not taking their meds, which suggests many people are unable to obtain supplies from alternative pharmacies.

Of the 675 pharmacists surveyed last month, 81 percent pointed to shortages of ADHD meds, notably Ritalin and Adderall XR, and their generic equivalents. However, Shire Pharmaceuticals, which sells Adderall XR, disputes that a shortage exists. Late last week, the drugmaker issued a statement in an attempt to clarify what it calls 'misinformation' about the availability of its Adderall XR pill, [UPDATE: as well as the Adderall IR, which it no longer sells.]

"While IMS data indicate there is an Adderall IR shortage, the data does not show a widespread shortage of either Shire’s branded Adderall XR or authorized generic Adderall XR," according to Shire. Due to a settlement over patent litigation, by the way, Shire also makes and supplies the authorized generics distributed by Teva Pharmaceuticals and Impax Pharmaceuticals.

Shire has been on the defensive in recent weeks as reports intensify over Adderall XR shortages that actually began last spring, which the drugmaker acknowledged and described as 'spot outages' of both its brand and the authorized generics. "However, we believe these outages were temporary and that availability of brand and authorized generic Adderall XR quickly improved," Shire argued.

The statement comes shortly after four House Democrats launched a probe that also reflects fingerpointing between the FDA and the US Drug Enforcement Agency, which is responsible for setting quotas of controlled substances (back story). The FDA blamed strict DEA quotas, while the DEA blamed drugmakers for choosing to produce more of the higher-priced brand-name versions.

Shire blamed DEA quotas for the shortages last year, but now insists quotas have risen. "We believe there is currently sufficient product available to meet patient demand for branded and authorized generic Adderall XR," the drugmaker, while adding that "Shire does not control, or have visibility into, Teva and Impax’s distribution of authorized generic Adderall XR to wholesalers and pharmacies."

The current FDA list of shortages includes ADHD meds from Teva (see here), while the agency comments that "product availability for all dosage strengths is adequate" for Shire's Adderall XR, but that was as of last October. We asked Teva and Impax for a response and will update you accordingly. Novartis, by the way, sells Ritalin and we have also sought a comment.

Meanwhile, 31 percent of the pharmacists surveyed also reported shortages of prescription topical creams and ointments, notably methylphenidate and dextroamphetamine

Overall, 81 percent of the pharmacists also say price fluctuations caused higher acquisition costs, but 62 percent say that reimbursement from health plans and pharmacy benefit managers were not sufficiently updated to reflect increases in their acquisition costs. And 52 percent report that payers and PBMs do not cover alternative therapies when the prescribed drug is not available.

pic thx to joguldi on flickr

14 Comments

Feb 13, 2012 - 11:11am

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Feb 13, 2012 - 11:19am

May I observe that if you should read the package insert you will find that Adderall is "methamphetamine" as a psychotropic. How does that go again - "Speed kills" - I think?

NOT lack of speed - except, of course, if you are driving on the NJ TPK. Well, perhaps anywhwhere in NJ - at least some would say ...

Feb 13, 2012 - 12:24pm

As a result of the shortage the national GPA will drop by at least 1/2 per cent.

Feb 13, 2012 - 1:33pm

It's true. Speed does kill. ADHD drugs are bad drugs for a bogus disorder. Check out the "Beyond Meds" blog to learn how to safely withdraw from these and other lethal psychiatric drugs. Pot is much safer if you want to play with your mind.

Only because I am a stickler for accuracy I must correctly observe that the Adderall brands (and generics) are a mixture of 75% detroamphetamine and 25% levamphetamine. The latter compound is far less potent than the former, and may not be well-transported into the CSF/brain to have any action at all. This combination was originally developed as a diet pill.

Dextroamphetamine is the prototypical compound of these stimulants, and has the more familiar brand name of Dexedrine. As I recall the history, it was originally used in the military and commercially developed as a treatment for depression. I've not heard of signficant shortages with either formulation of this compound.

Dextroamphetamine naturally has a long half life, and despite the popularity of the extended-release formulation (Adderall XR), a skilled clinician who understands the pharmacology can provide the same duration of action with the standard release formulations of either dextroamphetamine or mixed amphetamine salts. This approach is much less expensive than treatment with the extended-release formulation.

Methamphetamine is an entirely different substance - with the addition of a methyl group to the terminal amine of dextroamphetamine. It was branded as Desoxyn (and an extended release formulation). It had use for narcolepsy more than ADD, and if it is used at all any more it is very rare. Of course now methamphetamine is more likely synthesized as a street drug, and more likely smoked rather than swallowed.

Interestingly, caffeine has similar pharmacologic effects to amphetamine stimulants, though not as much of the euphoric effects which seem to be addicting. Caffeine certainly has the same tendance to induce dependence.

Feb 13, 2012 - 2:42pm

Dr Helm, that's good information. However, if you put me back in organic chem lab I'll bet that by the end of the semester I can figure out the stereoisomeric synthesis of Adderrall and figure out a way to get rid of the levo isomer so that I can extract the pure D-isomer. Furthermore, if I were enterprising, since Adderrall currently goes for about $10 for a 30 mg pop, I could easily double that with the pure D Form.

I was always raised to believe in Better Living Through Chemistry.

Feb 14, 2012 - 10:04am

And Grandma always said, "....first get rid of the drug dealors..."

Feb 14, 2012 - 10:44am

You know, there are some people who actually take Adderall for it's intended and prescribed purpose. Having been taking Adderall for approx. 10 years, and Ritalin for 10 years before that, it's really frustrating to have to go to 5 pharmacies before finding one that has any.

I need the medication to function normally, to make my brain work. I will not share my history, but I'm fairly certain that I would not be alive today had it not been for a doctor who listened to me and decided that Ritalin would help me. A doctor who was taking a risk, probably saved my life.

Although I'm sure some will say I am an addict, I still forget to take it at least once a week. In 20 years, I have never taken more than prescribed, and my quality of life has dramatically improved. Actually, that's an understatement.

So, markps2, Observer, and Nan off your soap boxes and do some research. We're not all speed freaks.

I'm an author and a nationally syndicated newspaper columnist. Adderall changes my writing day from torture to hard work I love. Because I actually need it to quiet the tornado that whirls in my brain without it, I am not "speedier" with it, but slower. I'm able to speak more slowly and to focus in a way I am not when I am not on this medication.

Feb 29, 2012 - 3:21pm

Amy, I agree with dz. I wrote a 237 page doctoral dissertation and many days I would also describe it as torture. My mind was swirling with ideas, facts charts, figures, and guess what? I took a step back, a day off here and there, cleared my head and got back on task without chemical assistance other than a strong pot of coffee.

I was on deadline as well. Get it done by the university deadline or pay for an extra semester. This is the first time I've ever heard of Adderall for writer's block. If you seriously need Adderall to make your daily or weekly deadline I suggest you consider long form exposition as less taxing to your nervous system.

Mar 5, 2012 - 1:40pm

For all the naysayers out there who are totally against meds for ADHD, I hope you never have any children with it. It's not a "disorder," it's a difference- but if you expect those of us who have the varying forms of it to function "acceptably" in a fast-paced world that is not geared towards us, then you better be ready to fork over the big bucks to provide one-on-one assistance to all of the children in school (and adults on the job) who will need that to stay on track without meds.

If you have never experienced the difference in thinking from not being able to have any level of executive functioning (see what needs to be done and figuring out the steps to do it) to suddenly feeling like something has clicked in your mind and everything works and you know what to do- then you can't possibly know what it's like, so don't judge other people who have benefited from the medication. This medication doesn't have to be forever, but until we can get to a point in our lives where we don't have loads of financial, interpersonal, parenting, etc., pressures that overwhelm us, then we should be allowed to have access to these meds. If somebody was addicted to this stuff, then I would seriously doubt that they truly have ADD/ADHD. Our reliance on having our meds in stock is not a physical addiction- it is the awareness of what it's like when we aren't taking the meds and how things go back to the way they were before when we don't have an adequate positive support system in place to help us. All of you naysayers ARE that lack of an adequate, positive support system. Just try being an ADD parent of an ADHD child and both of you have comorbid conditions to be managed. You would have a nervous breakdown and cry like a baby.

Be glad you are doing so well in your life that you can put down other people for seeking help. Your lack of empathy towards others will only come back to bite you in the end. What goes around, comes around.

And having "a pot of coffee" to maintain focus every day is a lot more dangerous to your health than what we take daily for ADD/ADHD. There is no single treatment for this difference in brain functioning, especially when you have comorbid conditions. We have to be our own advocates and be constantly vigilant about everything in our lives- we don't get that chance to kick back and relax. Not as long as we live in YOUR standardized, boxed up, labeled world.

Mar 5, 2012 - 3:48pm

Taxpayers don't need to pay anymore for 1-1 counseling. We already spend a bloated portion of our education budget on special education teachers, coaches, tutors, mentors and hand holders of varying sorts.

I will foot the bill to pay for an extra classroom and monitor when your kid needs all day to complete the SAT's, but with the $9500/year that comes out of my property tax bill each year to pay for things like special ed, my wallet is bursting at the seams.

In the old days we used to call ADHD "minimal brain dysfunction". Not PC, I realize, but maybe we should go back to calling it that, so that if it is a valid medical condition it will be regarded as such. Towards that end, I say bring back "The Ritalin Kid" advertising campaign, below:

http://amphetamines.com/methylphenidate/ritalinkid.html

Mar 19, 2012 - 12:54pm

It’s a waste of your time explaining what it's like trying to function "normally" with ADHD/ADD without medication... they just won't get it! But one thing that should be made perfectly clear is this: If you truly suffer from ADHD/ADD and take Adderall, you DO NOT feel the "buzzed", "speed" effects that those of you who do not need it feel when you take it! You also count EVERY pill, knowing that it's your life-line and would NEVER-EVER consider giving it to a friend or dealing them for cash!

The abuse by college kids who just want to stay up all night and cram hurts those of us who actually need it to be able to sleep at night!

Amy Alkon, I get it! Abusers use Adderall to give them energy, "speed" them and everything around them up. Sufferers use it to "normalize" everything. Take our thoughts from a jumbled chaotic mess and put them into perspective! REAL SUFFERS will get that... don't waste your time explaining to the abusers and close-minded individuals.

So the next time your popping Adderall and your feeling "buzzed", "high" or like you can stay up all night to write that paper and still go to class the next morning... Grow up! Stop abusing the drug and making it so difficult for those of us who NEED it!

Jun 18, 2012 - 7:56pm
Yeah. What "FinallyAbleToFunction" said!