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Fast Facts:
ADHD diagnosis:
About 5.4 million children ages 4-17 have been diagnosed with ADHD, according to the federal Centers for Disease Control and Prevention. The rate of ADHD diagnosis has increased an average of 5.5 percent per year from 2003 to 2007, the most recent data available. It's unknown how many adults have ADHD, but estimates range from 1 to 5 percent of the population.
Facts About Shortage:
Why don't pharmaceutical firms just make more of the medication? Manufacturers often make drugs in large batches, in some cases enough to fulfill the expected demand for two to three years, Fucarino said. Then machines are retooled to make another drug, a process that can take several months. Hydrocodone
, which has a high potential for abuse, poses another complication since the federal government controls how much amphetamine manufacturers can have. It's not known when the shortage is expected to ease. Meanwhile, patients, doctors and pharmacists are scrambling for alternatives.
Mike DeAngelis, a spokesman for CVS, said that when a medication is not available, pharmacists often work with physicians to find another one. One option is the extended-release, name-brand version, which is not in short supply.
But it is more expensive, and its effect is not the same as the fast-acting variety. Or the patient can be moved to another ADHD drug such as Dexedrine or Ritalin, though these may work differently or not at all.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,
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 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 Morophine as well. "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 the medication 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 Morphine, 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 Hydrocodone 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 it
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