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  1. NeuroChi

    Nationwide drug shortage causing problems in Michigan.



    GRAND RAPIDS, Mich. (WOOD) - Many who have valid prescriptions for Adderall can't get them filled because pharmacies across West Michigan can't get enough of the drug in stock.
    Adderall is prescribed for, among other things, attention deficit hyperactive disorder (ADHD).

    "It's one of the worst [drug shortages] I've ever seen," said pharmacist and Kay Pharmacy President Mike Koelzer. "It's been weeks -- now going into months -- of not having the Adderall prescriptions available."

    Koelzer said they've had a problem keeping Adderall on their shelves at Kay Pharmacy.

    "We've had customers coming in crying when they find out the drug's unavailable or they've gone to many different pharmacies and finally came to us because they've heard that we have it, and we don't in many of the cases, and they have tears running down their face," said Koelzer.

    Koelzer said that's because not being able to get Adderall will affect people's behavior differently than if they can't get other medicines.

    "I think [Adderall] changes your biochemistry, and I think that if someone, perhaps, if they can't get their blood pressure medicine, it's something that they may get upset about, but it may not occupy their every thought," said Koelzer.

    He said the shortage came without much warning or any explanation from suppliers.

    "In the last few months, we've been getting a lot of phone calls from people saying, 'Do you have Adderall?' The reason is we are having trouble getting it from our wholesaler, as well as any other pharmacy in town is also having that problem," said Koelzer.

    Meijer pharmacies across the region are seeing 30-day backorders on the drug. A local Wal-Mart is completely out and several other area pharmacies are also having trouble meeting the drug demand.

    The FDA's website has a list of drug shortages on its website. It lists four different suppliers with shortages.

    The list cites "increased demand" and "supply issues" as the source of the shortages. At this point, experts told 24 Hour News 8, it doesn't look like there's any end in sight.

    "Where do we go from here? Two weeks from now, if the drugs aren't here or three months from now, where do we go? I don't think it's premature to be talking about that because we've already had the problem for months, and I just don't know when its going to clear up," said Koelzer.

    Koelzer said it might be a good idea to talk with your doctor to see if there's another alternative drugs to treat your condition.
    Adderall is a highly addictive drug that is sold illegally.

    When 24 Hour News 8 spoke with one Adderall user about the trouble she's had filling her prescription, she said it would be easier for her to get the drugs on the street than in the pharmacy at this point.


    By Dani Carlson. Monday, 31 Oct 2011, 11:38 PM EDT
    Wood8 tv news.
    http://www.woodtv.com/dpp/news/local/grand_rapids/Adderall-shortage-one-of-the-worst

Comments

  1. redn8
    I too am unable to find Adderall. My Doctor changed my scrip to Vyvanse and it seems to work for me, the same as Adderall.
  2. Emin
    I get my Adderall from a mail-in pharmacy through my insurance luckily. It sucks to hear this is going on for people. Explains why I've been getting name brand Adderall.
  3. somnitek
    I suppose this is for time-release as well as instant? I used to take Adderall, but switched to Dexedrine Spansules. I don't really bother to get 'em perscribed, except when I'm in school.
  4. NeuroChi
    How does this explain why you're getting name brand Adderall? This is the one out of stock...
  5. staples
    I ran into this with Dexedrine Spansules just about a week ago. None of the pharmacies in the area had it, most pharmacists generalized that there is a shortage of 'amphetamine-based' medications, and only one pharmacist mentioned that they haven't had a problem with lisdexamfetamine (Vyvanse).

    The last pharmacy in the area I went to, upon a local pharmacists's suggestion, was the hospital pharmacy. They, too, could only order name-brand dexedrine spansules, but said they could not order from generic manufacturers (anytime soon). Not wanting to chance having insurance refuse to cover name-brand when it wasn't specified by the doctor, and without certainty if the doctor could submit prior authorization to get insurance to cover it at that point, I declined to place the $700ish order.

    Having recently moved, I used to have my prescription filled in another town, about an hour away. As I started heading in that direction, I called my roommate and asked him to look up my old pharmacy's number, and to start calling other pharmacies that would be on my way to my old pharmacy, to see if a closer one could fill my prescription. It turned out that the pharmacy an hour away did have (apparently plenty of) d-amph spansules. Once I had passed any familiar area I called my roommate to let him know I didn't need him to continue calling pharmacies, by then he had called 26, none of them had Dexedrine Spansules. He only asked about half of them if they had Vyvanse, but still a whopping 0 "yes" responses (I asked him to ask about Vyvanse as well, since I could potentially just stop by my doctor's and ask to be switched back, given the situation).

    Once I returned home, I checked the FDA's list of shortages and neither dextroamphetamine (extended-release or not) nor lisdexamfetamine were listed. Since this was inconsistent with what any nearby pharmacy had reported, I went ahead and called the FDA--2 Minutes after they were done doing business, apparently, so I left a message.

    The FDA called me back earlier today and I explained my experience above, the contrasting information on their site, and asked where I could get any farther information (I need to know if I should ask my doctor to write a different prescription, after all). She explained that the FDA only gets minimal information from the manufacturers when a shortage is reported, and that the FDA isn't, in fact, the best source of this information. She explained that a more comprehensive list is maintained by the American Society of Health-System Pharmacists (http://ahsp.org/), and this list reported a shortage of two manufacturers for at least the instant-release tablet form of dextroamphetamine. Given this, she suggested that my experience may have been a side effect of a sudden increase in demand for the extended-release version due to shortage of the other stimulant medications.

    While I was satisfied with the explanation, there's still some uncertainty so I may call some pharmacies before my doctor writes my next prescription, or just ask for two prescriptions in case one cannot be filled. I suggest others prescribed to stimulant medication at least check with their pharmacies beforehand as well.
  6. runnerupbeautyqueen
    Man, I bet lots of people are wishing they sold adderall right about now. Does this mean the whole world is out of adderall? Or if you lived next to, say the Mexico border for example, could you just run across it and pick up your script there?

    If this kind of shortage can happen with adderall can it also happen with pain medication? People going to in to get their oxycodone or whatever and then they get told "oh sorry, it's gonna be 1-3 months." I would predict a riot except everyone would be too sick to riot.
  7. YIPMAN
    Study finds U.S. drug shortage problem concentrated

    * Study combines sales data with official shortage reports

    * Most affected are generic injectables, many cancer drugs

    * Declining supply found for 75 of 168 drugs in shortage

    * Just one or two companies supply many of those medicines


    A shortage of medicines in the United States that recently gained the attention of President Barack Obama is worst among about 75 products while supplies of other scarce drugs are either stable or have improved, according to a report released Monday, Researchers at the IMS Institute for Healthcare Informatics took 168 drugs officially reported in shortage as of Oct. 7 and combined that list with IMS Health sales data to find that the problem is more concentrated than overall figures suggest.

    Of the drugs that come up short, drugmakers have been providing stable supplies of 56 of them, 31 medicines became more available, but 75 products have been on a steep decline.

    More than 80 percent of all affected drugs were generic injectable medications, meaning drugs without patent protection that generally treat acute disease. In fact, half of the generic injectable drugs sold in the United States were on the shortages list, according to the report.

    Although all major therapy areas were affected, cancer drugs took the biggest hit, accounting for 16 percent of all medications in shortage and putting more than a half million patients at risk for unexpectedly losing access to potentially life-saving treatments, the report said.
    "It's a finite and relatively small number of products that are causing the disruption," said Murray Aitken, executive director of the IMS Institute for Healthcare Informatics. "Not to diminish the issue of disruption because these products are very important ... it's useful to be more specific and focused in looking at the part of the market that is especially affected."

    The problem has authorities and experts perplexed and led Obama late last month to sign an executive order to address it. Just 56 drugs were reported as scare in 2006, the FDA has said. The IMS report found great volatility in the availability of some drugs in recent years, likely linked to the simple fact that some drugmakers just stopped making those medicines.

    Although almost 100 companies in all were supplying the 168 products in short supply, half of those drugs were made by only one or two suppliers, the report found. Of the troubled 75, a single company or two companies were supplying 65 percent of them, Aitken said.
    "Some (companies) have decided to stop production of these types of drugs, and if it leaves one or two suppliers, that doesn't provide a lot of flexibility when one might have a manufacturing problem of some sort," he said.
    "Part of the story is there may not be sufficient economic incentive currently in this sector of the market."

    The corporations supplying the most number of drugs from the shortage list were Hospira Inc and Teva Pharmaceuticals USA. Others included Novartis AG , Watson Pharmaceuticals, Pfizer and Baxter Healthcare, according to the report. The companies most commonly report manufacturing problems, discontinuation or suspension of production and increased demand as the cause of drug shortages, said the report by IMS, a healthcare research company.

    Researchers in the report based their analysis on the lists of drugs in shortage compiled by the Food and Drug Administration and American Society of Health-System Pharmacists.


    Source: Business - msnbc.com
    By Alina Selyukh

    Copyright 2011 Thomson Reuters


    http://www.msnbc.msn.com/id/45288418/ns/business/t/study-finds-us-drug-shortage-problem-concentrated
  8. YIPMAN
    Doctors’ Lobby Declares Drug Shortages a National Emergency

    Growing shortages of cancer drugs and other life-saving medicines are a national public health emergency, the American Medical Association declared yesterday.
    The nation’s largest lobby group of doctors voted to ratchet up the tone of a resolution prompted by shortages of anesthetics, cardiovascular drugs such as epinephrine and cancer treatments including Johnson & Johnson (JNJ)’s Doxil.

    “In America, this should not be happening,” said Leah McCormack, a Forest Hills, New York, dermatologist who joined other New York physicians to amend a resolution on drug shortages that the AMA’s governing body then adopted at a meeting in New Orleans.

    The amendment declaring the problem an emergency was approved by 51 percent of AMA delegates voting. The physicians also debated organ-transplant policies of Medicaid, the federal- state health program for the poor.
    The AMA’s leadership refused to endorse the New York drug- shortage amendment, instead proposing language calling on the Food and Drug Administration to require drugmakers to develop plans to ensure the supply of “vital and life-sustaining medications and vaccines.”
    “I don’t think there’s anyone that doesn’t think it’s an urgent situation,” said Jeremy Lazarus, a Greenwood Village, Colorado, psychiatrist who is the AMA’s president-elect, in an interview. “The largest physician organization in the United States is saying it’s a big, big problem.”

    Anecdotal Evidence
    The stronger language was inspired by a colleague whose wife had trouble finding appropriate chemotherapy to treat her ovarian cancer, said Thomas Madejski, an internist from Medina, New York, who worked with McCormack on the measure.

    He said that pharmacists at his hospital, Medina Memorial, keep a running list of drugs in short supply, including furosemide, a diuretic used on patients with heart failure, and methylprednisolone, a steroid used to treat lung diseases such as emphysema.
    The group rejected an amendment to the drug shortage resolution that would have called for the government to fine drug manufacturers that don’t rectify shortages within 30 days. An amendment directing AMA researchers to examine regulatory causes of the shortages, in addition to any economic causes, was adopted.

    Causes Debated
    Public insurance program regulations on how treatments are priced are exacerbating shortages, said David McKalip, a neurosurgeon in St. Petersburg, Florida.
    “That’s why we have shortages now in drugs, because of government price controls,” he told the delegates.
    Two-thirds of the medicines experiencing shortages are made by three or fewer companies, said Bona Benhamin, director of medication-use quality improvement for the American Society of Health-System Pharmacists, in a presentation to AMA delegates earlier in the day.
    “These companies maximize efficiency and have very tight production schedules that are very carefully calculated,” she said. One glitch can cause a shortage because “there are no redundancies” in the manufacturing process, she said.

    Johnson & Johnson notifies the FDA when it anticipates a shortage and tells the agency how long the shortage will last and when additional supplies may be available, spokeswoman Lisa Vaga said in an e-mail.
    “We support prompt identification and reporting,” she said. The company, based in New Brunswick, New Jersey, is trying to “expedite” restoring the supply of Doxil, she said.

    Organ Transplants
    Delegates sparred earlier over organ-transplant policies in Medicaid. Arizona Governor Jan Brewer, a Republican, eliminated Medicaid coverage for some transplants in 2010 to control spending. She restored the coverage this year after advocates for the poor and transplant surgeons criticized the policy.
    Transplant surgeons proposed a resolution, endorsed by the AMA’s leadership, that would call for the U.S. to make transplants a guaranteed Medicaid benefit.

    Brewer “denied life-saving surgery from a group of patients simply because of a bureaucratic decision,” Thomas Peters, a Florida transplant surgeon, told the delegates. Many transplants save money over alternative treatments, such as dialysis for kidney-failure patients, he said.
    Arizona doctors defended Brewer, who eliminated coverage only for transplants that had a low chance of success, said Beth Purdy, an orthopedic surgeon.

    “Arizona shares the plight of many states; we have no money,” she said. “Hard choices result. Do we vaccinate our children and offer prenatal care or do we do transplants that, upon analysis, are deemed to have a near hopeless chance of success?”

    The 497 AMA delegates present voted by 70 percent to 30 percent to refer the transplant resolution to their board of directors, a move that delays the measure.



    By Alex Wayne - Nov 15, 2011 6:23 PM GMT

    http://www.bloomberg.com/news/2011-...drug-shortages-national-health-emergency.html

    ...

    related thread:
    nationwide adderall shortage
    http://www.drugs-forum.com/forum/showthread.php?t=170625
  9. YIPMAN
    Shortage Of ADHD Drugs Has Parents, Doctors Scrambling

    When it's time to renew her son's prescriptions for medicine to treat his attention-deficit/hyperactivity disorder, Roxanne Ryan prepares for another wild goose chase.

    The Philadelphia mother says she typically has to call around to 10 to 15 different pharmacies to find where the prescriptions can be filled. And when 10-year-old Sergey doesn't get his medication, he's a bundle of uncontained energy.

    "It's like having a hundred channels racing through your mind," Ryan says. "He can't sit still. He would interrupt the lesson. He can't complete a thought."

    It's hard enough to cope with ADHD without having to call around to find where his prescription can be filled, Ryan says. It's some sort of luck that she also suffers from the disorder. So she's been able to meet his needs so far by giving him some of her prescription – while she does without.

    The scarcity of ADHD medications is a problem faced by an untold number of children and adults with the disorder. For instance, in Chicago, Natalie Smith recently spent hours calling drugstores on behalf of her college-student son Andrew.

    "Then I had to quickly drive to those pharmacies," Smith told Shots. "A couple were already out when I got there. So it's kind of a game."

    In Boston, pediatric psychiatrist Joseph Gonzales-Heydrich says the problem requires him and his colleagues to do a lot of creative juggling of drug regimens for young patients who need combinations of drugs in different doses, some short-release, some intermediate- and some extended-release.

    "When a dosage is not available, nothing is going to be exactly equivalent," he says. "We're guessing at what might be good enough for now, and hoping that the kid is not going to suffer in school and what-not because of it."

    ADHD is not the only disorder for which drugs are in short supply. Many medications are increasingly in shortage, leading President Obama to issue an executive order on Oct. 31 to help unsnarl the supplies. But the problem has been concentrated on intravenous medications used in hospitals and cancer chemotherapy agents.

    However, for reasons that are unclear, in recent months the hard-to-get drugs include ADHD medications such as Adderall. Last week, methylphenidate, the active ingredient in Ritalin and generic equivalents, was officially declared in shortage.

    "We've literally had hundreds per week of inquiries about this, so we know it's impacting a lot of patients," says Valerie Jensen of the Food and Drug Administration's Office of Drug Shortages. "This has been throughout the nation. It's not a local issue. It's not a regional issue. Pharmacists are reporting it to us as well."

    The advocacy group Children and Adults with ADHD says lots of patients can't get any of the drugs they need at all.

    "People are going without. That's what we're hearing," says Ruth Hughes, the group's chief executive.

    She says the implications go beyond kids driving their parents and teachers nuts.

    "This isn't just 'Oh, I can't focus,' " Hughes says. "Because you can't focus, there are other very adverse circumstances that happen. Teen pregnancy or dropping out of school, drug abuse. Those are the kinds of things that happen when people have very poor impulse control."

    And young adults with ADHD have three times more car accidents.

    "So it's very important that they're taking their medication when they're driving, to control those symptoms," Hughes adds.

    Nobody knows how many people are affected by the shortages. Up to 15 million children and adults are thought to have ADHD, and more than half of children with the disorder take medication for it.

    Trying to figure out why there's a shortage is a big challenge. Different experts – even different federal agencies – give you very different reasons.

    The Drug Enforcement Administration doesn't think there's a shortage at all.
    "You know, I guess there's sort of an assumption out there that there is in fact a shortage," says Gary Boggs of the DEA's Office of Diversion Control.

    DEA is involved because these medications are classified as potential drugs-of-abuse, and thus are controlled substances. The DEA sets an annual ceiling on how much of these drugs can be made.

    The agency focuses on the aggregate amount of active ingredients being manufactured, not the number of pills sold under a specific company's label, dose or dosage form (such as "extended release"). And from that perspective, Boggs says, there is no shortage.

    "There is plenty of the drug available out there," Boggs told NPR. "It's just how it's being marketed and how these companies make business decisions. And those business decisions that they make are completely outside of our control."

    One company may have run out of its quota; another has plenty. One company sells only to Rite-Aid, another only to CVS. There might be plenty of 30-milligram extended-release in one locale, but none of the 10-milligram quick-release. And so on.

    But ask some drug companies what the problem is, and you get a different answer. They say the DEA's annual quota hasn't been keeping up with demand, which has been escalating over the past decade as more people get diagnosed with ADHD and the previous stigma associated with the diagnosis fades.

    The DEA normally sets its aggregate ceiling on active ingredients once a year, although it may revise the quota once during the year if circumstances warrant. Individual manufacturers can (and do) apply to the agency for increases in their quotas.

    But companies say they can wait two or three months for the DEA to respond to their quota requests. Once they get it (if they do), it takes 12 weeks to turn the raw ingredients into finished pills ready for distribution.

    For one version of what really may be going on behind the scenes to cause (or exacerbate) the shortages – or market distortions, as the DEA would have it – read this.

    Whatever the root causes, for people like Roxanne Ryan in Philadelphia, it doesn't do much good to know there's plenty of medicine out there – somewhere. If she can't get what Sergey needs, she'll continue to give him the medication prescribed for her. (She was diagnosed with ADHD after he was – a not-uncommon story.)

    "It's sacrificing so that my son can have," she says. "Every parent does that."


    Monday, 11/21/11 12:01am - Morning Edition
    Richard Knox


    http://www.npr.org/blogs/health/201...gs-has-parents-doctors-scrambling?ps=sh_sthdl

    Audio for this story from Morning Edition will be available at approx. 9:00 a.m. ET
  10. Expat98
    Shortage of ADHD drug Adderall to continue in 2012

    A shortage of Adderall, which is used to treat attention deficit hyperactivity disorder, shows little sign of easing as manufacturers struggle to get enough active ingredient to make the drug and demand climbs.

    Adderall, a stimulant, is a controlled substance, meaning it is addictive and has the potential to be abused. The Drug Enforcement Administration tightly regulates how much of the drug's active pharmaceutical ingredient (API) can be distributed to manufacturers each year.

    The system is designed to prevent the creation of stockpiles that could be diverted for inappropriate use. Adderall and other stimulants are popular with students who may not have ADHD but are seeking to improve their test scores.

    The DEA authorizes a certain amount of the API in Adderall - mixed amphetamine salts - to be released to drugmakers each year based on what the agency considers to be the country's legitimate medical need.

    Increasingly that estimate is coming into conflict with what companies themselves say they need to meet demand for the drug, which is reaching all-time highs. In 2010, more than 18 million prescriptions were written for Adderall, up 13.4 percent from 2009, according to IMS Health, which tracks prescription data.

    Concerns are now rising among patient groups and doctors that the shortages seen in 2011 will continue into this year. Many orders remain unfilled, manufacturers say, and it may take several months before ingredient authorized under the new 2012 quota can be turned into new product.

    "I am very concerned about the future," said Ruth Hughes, chief executive of Children and Adults with Attention Deficit/Hyeractivity Disorder (CHADD). "No one seems to have much inventory to get us through the months ahead."

    ADHD is one of the most common childhood disorders. An average of 9 percent of children between the ages of five and 17 are diagnosed with ADHD per year, according to the Centers for Disease Control and Prevention.

    Symptoms include difficulty staying focused, hyperactivity and difficulty controlling behavior. If they are not properly medicated, children with ADHD may act out and be held back in class; adolescents might engage in impulsive, risky behavior; adults are at greater risk of being fired from their jobs.

    "There are real major life impacts for people not having access to medication," Hughes said. "Someone needs to own this problem and take the initiative to fix it."

    RIPPLE EFFECT

    Adderall is made in several dosages and formulations. Shire Plc makes Adderall XR, a more expensive extended release version of the drug. Authorized generic versions of Adderall XR are sold by Teva Pharmaceutical Industries and Impax Laboratories Inc.

    Shorter-acting instant release forms are made by Sandoz, a unit of Swiss drugmaker Novartis AG, as well as by CorePharma LLC and Teva. It is the shorter-acting versions of the drug that are currently in shortest supply.

    The full scope of the shortage is unclear. Patients have been scrambling since mid-year to find pharmacies carrying the drug. Some have been switched to other medications such as Adderall XR or Ritalin, a rival drug known also as methylphenidate. But companies do not always track which pharmacies have their product at any given time.

    "We don't monitor the distribution system, but we do know that all our customers are on back order right now," said Teva spokeswoman Denise Bradley. Teva sells to wholesalers and distributors as well as to some hospitals and specialty pharmacies - and all have orders placed but not filled.

    Hughes said CHADD, along with the American Academy of Child and Adolescent Psychiatry, another advocacy organization, has recently started to track where, geographically, the calls about shortages are coming from.

    Quantifying the problem is particularly urgent since the Adderall shortage is now also spilling over and causing shortages of Ritalin. Sandoz, which makes generic forms of both drugs, is straining to meet increased demand for both products.

    "There is currently not enough product to fill all of our customer orders at the wholesaler level," said Julie Masow, a spokeswoman for Novartis, in an email.

    TENSIONS FLARE

    The problem is particularly troublesome since no one really agrees on its cause.

    Under the quota system, drugmakers receive enough material to meet what the DEA estimates will meet the legitimate needs of American patients, but not enough to build inventory. The DEA says recent shortages were not caused by an insufficient quota but by marketing decisions taken by the companies.

    "Any shortage of these products is therefore a result of decisions made by industry regarding manufacturing or distribution," Barbara Carreno, a DEA spokeswoman said, though she declined to specify those decisions.

    She noted that there are currently more than 200 drugs in short supply in the United States, most of which do not contain controlled substances and have nothing to do with the DEA.

    "There is no reason to think that the same market forces that are causing those shortages are not playing a part in these," Carreno said.

    President Barack Obama recently issued an executive order demanding that the Food & Drug Administration address these shortages, which mostly affect generic injectable drugs that companies are no longer making as they are not as profitable as newer products.

    For their part, Adderall manufacturers say they are working flat out to meet demand, and say the DEA does not always approve enough material in time for them to supply customers.

    "Our production facilities are currently running at maximum capacity for Adderall utilizing all available API," said Teva's Bradley. "The catalyst for the problem is the quota system, not the business."

    The DEA sets its aggregate quota at the beginning of each year, taking into account past quota levels, inventory levels and company sales forecasts. But the DEA's assessment of what a company needs may not be the same as the company's own estimates. It is an ongoing process of negotiation.

    "DEA can come back and say, 'we agree with your forecast and issue everything you want,' or they may come back and say 'we don't think you need that much,' and they give you 75 percent," said Matt Cabrey, a spokesman for Shire.

    Early last year, Shire suffered shortages of Adderall XR. "It was directly related to the API quota," Cabrey said. In June 2010, Shire calculated that API was running too low. It applied to the DEA for more, but did not receive the additional supply until December. It typically takes Shire three months to then make the product and get it to customers.

    As a result, Cabrey said, there were shortages of Adderall XR in January and February last year and supplies did not return to normal until March and April. The company said there are no shortages of Adderall XR, though some patients say even that is now hard to get hold of.

    Amy Alkon, 47, who writes a syndicated column on dating and manners, began taking Adderall for her ADHD about five months ago after Ritalin stopped working for her. This week she spent hours on the phone trying to find a pharmacy that could fill her prescription - and she couldn't find Adderall or Adderall XR.

    "I have gone to the biggest medical centers in the Los Angeles area, I've called countless pharmacies and they have no pills," she said. "Nobody has anything."

    For Alkon, the prospect of the shortage continuing is alarming. Adderall, she said, has changed her life, allowing her to organize her thoughts and tamp down what she calls a "tornado" of activity in her brain.

    CONTROLLED SUBSTANCES

    The DEA, while insisting its quota for 2011 was sufficient, nonetheless revised it upwards in December.

    "We increase the aggregate so that we will have enough to respond to specific companies if their requests for more amphetamine salts are justified and needed," said Carreno. "The companies can and do request more amphetamine salts, and we can and do respond to those requests throughout the year."

    Simply increasing the overall national quota, however, does not address company complaints that it takes DEA months to approve individual requests for new product.

    Asked why it might take the agency months to approve a company's request, the DEA said it is required by law to balance providing enough API to meet the legitimate needs of patients while protecting the public from any diversion of potentially lethal substances.

    "We do our best to accomplish both missions, and the quota system is part of the process for achieving this," Carreno said.

    That is not good enough for CHADD's Hughes or other advocacy groups, who plan to lobby both the DEA and drugmakers to find a solution to the shortages.

    "When you have a controlled substance problem, the DEA has to be involved in fixing it," said Hughes. "It is not sufficient to say it is an industry problem. We need to figure out how to build more flexibility into the system."

    The DEA controls roughly 400 basic substances, in addition to derivative products such as salts and ethers.

    The chemicals are divided into five schedules. Schedule 1 drugs include illegal substances such as heroin. Scheduled II drugs, such as Adderall and other stimulants, have a medical use but a high potential for abuse. Schedule III drugs have a somewhat lower abuse potential and include the painkiller Vicodin, while Schedule IV drugs include the tranquilizers Klonopin and Ativan. Schedule V substances include cough medicines such as Robitussin.

    Adderall is popular on college campuses, even among those who do not have ADHD but want a performance boost. Students may trade the drug or get it from their siblings or parents.

    Stimulants appear to work in patients with ADHD by increasing the availability in the brain of the chemicals dopamine and norepinephrine, which both appear to help regulate attention and executive function. Their effects differ slightly depending on the drug, and some people respond better to one than another.

    "In every suburban high school and in colleges there is a significant underground economy around stimulants," said Harry Tracy, a psychologist and publisher of NeuroPerspective, a monthly publication focusing on central nervous system disorders. "Adderall can go for $5 to $10 a pop."

    Physicians say it can be challenging to sort out who is a legitimate patient and who might seek the drug simply to enhance performance.

    "Trying to determine the best thing to do can be a quandary at times because there is this question of whether the person is trying to get the medication for nonmedical reasons," said Steven Cuffe, a child psychiatrist and Chairman of the Department of Psychiatry at the University of Florida College of Medicine.

    Right now patients are trying to scrape by, either by traveling long distances to fill prescriptions or switching to other products even if they don't work as well or are more expensive. But these are temporary workarounds and without a structural change manufacturers and advocate groups fear the problem will linger or even worsen.

    "This does not seem to be a short-term solvable problem," Hughes said.

    ---

    By Toni Clarke (REUTERS)
    Sun Jan 1, 2012 6:06pm EST

    http://www.reuters.com/article/2012/01/01/us-adhd-adderall-shortage-idUSTRE80009E20120101
  11. sassyspy
    Re: Shortage of ADHD drug Adderall to continue in 2012

    This was mentioned on the evening news today, and they also mentioned potential shortages of other drugs used for ADHD, including Ritalin and Concerta.

    The growing consensus according to what I read still points directly at the DEA and their "quota" system.
    Personally, I think perhaps the DEA is trying some manipulative measures on manufacturers, besides everything else they already control.

    It always comes back to the same old song: Control one substance, another is found and then another is controlled,... blah blah it is a never ending circle of attempts to control people, and what they do.
  12. Terrapinzflyer
    Mother's new little helper — Adderall
    Stressed-out women are turning to the ADHD drugs their children take.

    All over the country in recent weeks, mothers of children with attention-deficit hyperactivity disorder have been scrambling to fill prescriptions for their kids' stimulant medications, due to suddenly scarce supplies.

    Drug firms blame the shortage on quotas of the psychoactive ingredients, set by the U.S. Drug Enforcement Administration to control abuse. Some DEA officials counter that the drug firms have chosen to use their limited allotments to make more of the pricey, brand-name drugs, causing a dearth of the cheaper generics.

    Manufacturing issues aside, however, the National Institute on Drug Abuse suggests there may be another, more ironic reason for the stimulant shortages: namely, a dramatic increase in their use — and abuse — by women of childbearing age.

    Over the last decade, the number of prescriptions written each year for generic and brand-name forms of Adderall, an amphetamine mix that has recently become the most popular ADHD remedy, has surged among women over 26, rising from a total of roughly 800,000 in 2002 to some 5.4 million in 2010. A particularly startling increase has been for women aged 26 to 39, for whom prescriptions soared by 750% in this time frame.

    Though part of this rise can be accounted for by an increase in population, officials at the National Institute on Drug Abuse are concerned that it is widening the pipeline for diversion and abuse.

    Many doctors recommend stimulants for children and adults who have symptoms of ADHD, including difficulty sustaining attention and maintaining self-control. Experts in the field say they help strengthen the parts of the brain involved in these functions by improving the utilization of dopamine, a key neurotransmitter.

    Yet amphetamines and other stimulants can also be abused, especially when crushed and snorted, providing a "rush" that has been compared to that of cocaine. The American Society of Health-System Pharmacists warns that even when taken as prescribed, the medications can be habit-forming, and also have possibly serious side effects, including seizures, paranoia, aggressive behavior and tics. In people with preexisting heart problems, there is an added danger of cardiac arrest.

    The upside of the medications — their ability to help those with attention-deficit disorders to focus — has nonetheless led to a continuing increase in their use, and in drug company revenue. In 2010, manufacturers sold $7.42 billion worth of the drugs, up from $4.05 billion just two years earlier.

    Many of these new prescriptions are warranted. When ADHD symptoms are severe, the disorder can be debilitating for children and adults. As stigma surrounding it has abated, it's not surprising that there has been an increase in adults, in particular, seeking treatment.

    The danger comes when people without ADHD take the meds to boost their productivity, a trap experts say has of late become especially tempting for young mothers. Remember that "Desperate Housewives" episode in which actress Felicity Huffman tries her kids' Ritalin and finds it's the perfect "mother's little helper" as she races to finish making costumes for the school performance of "Little Red Riding Hood"?

    "Much as kids are stressed by having to go through school and all their outside activities, their moms are right there with them," says Stephen Odom, a Newport Beach addiction specialist. "She's more tired than anyone, and coffee just doesn't do it."

    Like the Huffman character, many women start out by sampling their children's meds — a felony, by the way. Then they get prescriptions of their own, sometimes by faking ADHD symptoms, or find the pills by more underhanded means.

    This was the case for Sunny Morrisette, a 28-year-old woman in Logan, Utah, arrested last month for trading cigarettes to neighborhood schoolchildren in return for their ADHD drugs. Morrisette allegedly told police that she was under a lot of stress and had heard "good things about Adderall and wanted to try it." She was charged with several felony drug offenses and with contributing to the delinquency of a minor.

    "There's a lot of denial around these drugs, and the danger is easy to minimize because that prescription label can make you feel what you're doing is safe," warns Brad Lamm, the president of a New York intervention agency.

    The greatest rates of abuse continue to be found on college campuses, where students use the meds to study — and party — harder. Dee Owens, director of the Alcohol/Drug Information Center at Indiana University, says Adderall abuse has become "epidemic among young ladies" who are trying to keep their grades up and their weight down, and to drink more beer without falling asleep.

    More worrisome, and in what the National Institute on Drug Abuse calls a "cause for alarm," abuse of prescription stimulants is also becoming more prevalent in high school. An institute survey of 45,000 students found abuse of stimulants had increased among high school seniors, from 6.6% to 8.2%, just in the last two years.

    Full disclosure: I've been diagnosed with ADHD myself — by three different experts — and I've recently started to take Adderall on occasion, with some mixed feelings. The good part of this mix is a boost in my energy and mood, which makes sense, considering that back in the 1930s many doctors prescribed amphetamines to treat depression. Yet I worry about becoming dependent.

    That's one reason why, knowing just how many of my busy fellow mothers are relying on amphetamines, I've asked experts for their advice about how to watch for signs of addiction.

    Here's what they tell me: Make sure you take pills only under a doctor's supervision. Don't fall in the trap of boosting your dose. And get help right away if you catch yourself lying about your use or getting prescriptions from more than one doctor.

    "Just like with any drug, if you can't stop, despite adverse consequences, you have an issue," says Dee Owens, who has worked in addiction prevention for more than 20 years. "I've talked to hundreds — no — thousands of people, and not a single person ever meant to become an addict. They just wake up one day — and there they are."


    By Katherine Ellison
    January 13, 2012

    http://www.latimes.com/news/opinion...g-shortage-20120113,0,7444563.story?track=rss
  13. Pondlife
    Anatomy of the Great Adderall Drought

    Last May, Stephanie Lee couldn’t find a pharmacy in Atlanta that stocked Adderall, the prescription drug cocktail of amphetamine salts that helps her treat her attention deficit hyperactivity disorder, or ADHD. She called her local pharmacy. All amphetamine salts, as well as generic, extended release Adderall XR were nowhere to be found, thanks to a limit set on the amount of amphetamines produced every year by the federal government.

    Luckily, Stephanie’s insurance covered name-brand Adderall XR, so she was still intermittently able to get her prescription filled. At one point, she was trading some XR pills with her sister-in-law for amphetamine salts because pharmacies were all out. Another time, she went a month and a half without any medication at all. Signs started popping up at pharmacies saying, “No Adderall available until 2012.”

    When the shortage began, Stephanie had just begun a new job. I asked her how she functioned without her medication. She compared concentrating off of Adderall to the feeling of “someone who used to be super thin and fit who gains a ton of weight and then tries to run a marathon. Only imagine the weight gain happening overnight. You’re like, ‘Fuck! I just did this yesterday! Why is it so much harder now?’”

    Today, Adderall is only legal in the United States and Canada. Currently there’s a massive shortage of it in the U.S., leaving many ADHD sufferers like Stephanie without access to medication and leaving others stuck paying for higher-priced alternatives.

    Everybody’s favorite focus drug

    For many people with ADHD, Adderall is what best manages their symptoms. At the same time, a drug that reduces appetite, increases wakefulness, induces feelings of euphoria (side effects, or, rather, effects of Adderall)—all through flooding your brain’s reward system—has vast potential for abuse. Amphetamine salts, used in Adderall, are classified by the U.S. Government as a Class II Narcotic, the same as cocaine and Oxycontin.

    To prevent hoarding of materials and their potential for theft and illicit use, the Drug Enforcement Agency sets quotas for the chemical precursors to drugs like Adderall. The DEA projects the need for amphetamine salts, then produces and distributes the materials to pharmaceutical companies so that they can produce their drugs. But with the number of prescriptions for Adderall jumping 13 percent in the past year, pharmaceutical companies claim that the quotas are no longer sufficient for supplying Americans with their Adderall.

    ADHD affects a startling number of Americans—it’s estimated that nearly five percent of Americans are living with the disorder. Many of those affected use some type of stimulant drug to treat their symptoms. While various drug treatments—notably methylphenidate, better known as Ritalin—have been around since the early 1960s, the Jersey-registered, Ireland-headquartered global specialty biopharmaceutical company, Shire Pharmaceuticals’ introduction of Adderall in 1996 drastically changed the landscape of ADHD treatment. Today, only generic versions of the mixture of amphetamine salts are available. However, the extended release form, Adderall XR, is available in both generic and name-brand forms.

    Despite the millions of prescriptions written each year for ADHD, the scientific community isn’t entirely in agreement on how these drugs actually work. Ritalin increases focus and energy through inhibiting the re-uptake of both dopamine and norepinephrine in the brain. These neurotransmitters then remain in the synapse longer, and their effects are felt in the form of heightened focus and awareness. Adderall, however, works via a slightly different mechanism. While it’s postulated that Adderall also inhibits the re-uptake of these same neurotransmitters, amphetamines also trigger the release of dopamine. This affects the brain’s reward mechanisms, so it’s not only easier to focus on mundane or repetitive tasks, it can also feel positively delightful to do so.

    Without Adderall, you might feel bored by your math homework or unable to focus on the multiple steps needed to reach a solution, but on Adderall you might literally feel like you’re in love with math. The tricky thing about prescribing stimulant medications is that, ostensibly, the drugs will achieve their purpose (increased concentration and motivation) in pretty much anyone, regardless of whether they have ADHD or not.

    Quotas must be insufficient

    Doctors wrote over 18 million prescriptions for Adderall in 2010, and that number escalates every year. Increasing numbers of Americans being diagnosed with ADHD, coupled with a surge of others either feigning symptoms to get prescriptions or drying out their prescribed friends’ supplies, means there’s simply not going to be enough Adderall to satisfy everyone’s needs (and desires).

    It’s well known that many college students use Adderall to give themselves an extra edge for getting work done whether they’re prescribed or not. A 2005 study of students attending 119 colleges nationwide found that, on certain campuses—regardless of whether or not they had prescriptions—up to 25 percent of respondents had misused ADHD medications. Furthermore, a 2009 study on non-medical use (defined as use of a prescription drug without a doctor’s order) of Adderall among full-time college students showed that subjects aged 18 to 22 were twice as likely as their counterparts, who were not full-time college students, to have used Adderall.

    The DEA contends that their quotas do, in fact, meet demands, and that any shortages arise from pharmaceutical companies selectively producing only certain (typically name-brand) versions of ADHD medications. Yet it would seem that the quotas must be insufficient.

    Everyone I talked to about the Adderall shortage reported not being able to find generic or name-brand versions of their medication. I spoke with three people personally affected by the shortage, and they said that at times, there was literally nothing available anywhere.

    “Why is this so much harder now?”

    First I spoke with David, thirty-two. He was diagnosed with ADHD eight years ago, and was prescribed Adderall, but had taken it infrequently until this year. This past September, when he returned to school to pursue a Master’s degree, he began taking his medication daily for the first time. In only four months, he found himself manic, hypersexual, jittery, and feeling “crazy.” He craved cigarettes and coffee, began having difficulty sleeping and, ironically enough, concentrating.

    In the face of diminishing availability of the drug, matched with his extreme response, he opted to change medications entirely and switched, recently, to a newer ADHD medication, Vyvanse. Though he hasn’t been taking it long, he claims that the new medication has helped him focus while also helping him remain calm. But it’s when we start talking about Vyvanse that things start getting even more complicated. We’ll get that to that a bit later.

    Stephanie Lee found her freshman year of college unusually difficult. She had trouble adjusting to the levels of stress she encountered. Additionally, her mother, two brothers, and her sister had all been recently diagnosed with ADHD, so she, very reasonably, wondered if she might also have the disorder. Beginning in her sophomore year, armed with a prescription from her doctor, she took a combination of Adderall XR and amphetamine salts throughout college, and then completely ceased taking ADHD medication all together for a few years.

    But she went back on the medication when she returned to school for a graduate program. She began taking the same combination of drugs she had as an undergraduate and was doing well until May 2011, when her pharmacy called to inform her that the 20 milligram Adderall XR pills she usually took were out of stock. In the eight months that followed, Stephanie switched to two 10 milligram pills of Adderall XR (the only dosage available) twice per day. Despite being the same total number of milligrams, taking the drugs this way was twice as expensive, so Stephanie soon had to pay her costly health insurance deductible, something that had never happened to her before.

    Hilary, twenty-six, was the one person I spoke with who had not been diagnosed with ADHD in adulthood. She began taking ADHD medications when she was five, and continued, basically uninterrupted until the Adderall shortage. Hilary lost her health insurance earlier this year. Unfortunately, this coincided with the beginning of the Adderall shortage. Suddenly, the generic version, which typically costs around thirty dollars for a month’s supply, was gone. She was left forking over three hundred dollars for a month’s supply of the name-brand medication, or simply going without. Hilary has now been off of her medication for two months and mentions she’s in the market for a sugar daddy to help her foot her medication bills. She’s only half joking.

    When I asked Stephanie about dealing with life off Adderall, she remarked that she “wasn’t one of those kids who grew up on the stuff. I hadn’t been diagnosed until much later in my life, so I knew how to get by.” But what about kids like Hilary, who have literally gone their entire lives medicated? Regardless of the legitimacy of ADHD and stimulant medications, it’s impossible to ignore the fact that those accustomed to medication will fare worse when off of it, at least for some period of time or, as in David’s case, until they are prescribed something else, like Vyvanse.

    Supplying the Competition

    In 2006, two pharmaceutical manufacturers, Teva Pharmaceuticals and Impax Laboritories, were awarded the rights to sell generic versions of Adderall XR when Shire lost its patent in 2009. However, the drug manufacturers didn’t have the production capacity to produce such a large amount of drugs, and Shire was awarded a subcontract from the government to produce for the other manufacturers until they were able to on their own. Though they had lost their cash cow patents on Adderall and Adderall XR, Shire would continue to profit from their manufacturing generic forms of Adderall XR.

    In the spring of 2009, after losing their patent on Adderall XR, Shire’s earnings predictably plummeted. Earnings for one quarter nosedived from $300 million to $67 million. But, oddly, in 2010, earnings began to creep upwards, surpassing $100 million in one quarter. Around this time, Impax and then Teva both filed lawsuits stating that Shire was intentionally botching their orders of generic Adderall XR, delivering too little of the drug or missing orders all together. Mysteriously, there still seemed to be enough brand name Adderall XR floating around to improve Shire’s profit margins. It would seem a simple lesson to not let a single entity produce both their own product and their chief competitor’s product, but that’s exactly what Shire was doing.

    The DEA contends that shortages arise from pharmaceutical companies selectively producing only certain versions of medications

    Oddly, around the same time, many insurance companies began to refuse to cover generic Adderall XR. Generic Adderall XR is not, in fact, FDA-approved to treat ADHD and insurance companies claimed that the therapeutic equivalence to Shire’s Adderall XR was unproven.

    The results of the shortage or lack of insurance coverage for generic Adderall XR forced many people to seek out name-brand Adderall XR, which, in turn, ran out. Then people, desperate for any ADHD medication, sought out the generic instant release amphetamine salts (formally Adderall). The increased demand on instant release dried up the supplies pretty quickly, and soon ADHD sufferers everywhere were unable to find any form of their medication. Luckily, Shire had magically possessed enough amphetamines from their DEA quota to produce plenty of their new ADHD medication, Vyvanse. In fact, Shire doubled its third quarter profits from 2010 to 2011, with most of that increase resulting from Vyvanse sales. During this time, coinciding nicely with the Adderall shortage, Shire hiked the price of Vyvanse.

    But, in medical trials Vyvanse proved no better at treating ADHD symptoms than generic Adderall XR. It’s not any easier to get either; its active chemical, Lisdexamfetamine, also a schedule II narcotic, precludes doctors from writing refills of the prescription. Add on that it’s much more expensive than either of the generic forms of amphetamine salts and its list of side effects mirror those of Adderall. So, why would anyone switch to Vyvanse? The answer is that they wouldn’t, at least not in such large numbers. Not unless they had to.

    So, is the DEA and its quota system really to blame for the shortage of drugs? Well, partially, yes. If the DEA didn’t restrict any manufacturer’s access to amphetamine salts, then everyone could manufacture Adderall in all of its versions, generic and name-brand, to their murmuring hearts’ content. But the government quotas are also a convenient scapegoat for pharmaceutical companies seeking to supply only the more expensive—and more profitable—of the ADHD medications.

    http://motherboard.vice.com/2012/2/16/anatomy-of-the-great-adderall-drought
  14. Trippery
    Re: Anatomy of the Great Adderall Drought

    I bet shire is sending a fat paycheck to congress in brib.. ERR campaign contributions to keep it this way...
  15. NeuroChi
    Re: Anatomy of the Great Adderall Drought

    What?? The exact same amphetamine compounds don't have the same pharmacological effect if not given the brand-name, Adderall? Does the FDA actually need to approve the brand, not just the drug?
  16. staples
    Re: Anatomy of the Great Adderall Drought

    Yes, the generic manufacturer must submit an Abbreviated New Drug Application. In the case of Adderall XR, generic companies have to demonstrate that their versions have the same time-release profile (within a certain statistical tolerance) as the name-brand version, not just the same active ingredient.

    It's even more complicated with pharmaceutical companies acquiring or suing one another: While it's true that there are FDA-approved generic forms of Adderall (the instant-release version), and apparently no generic forms of Adderall XR, Shire supplies Teva with Adderall XR as the result of litigations between the two companies; therefore Teva-distributed Adderall XR is labelled as an authorized generic form (without being listed as an approved generic formulation--because it's the exact same formulation, an already-authorized drug product--by the FDA). This obviously creates a needlessly confusing situation for patients, doctors, and insurance companies alike.
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