Medicines to treat attention deficit hyperactivity disorder are in such short supply that hundreds of patients complain daily to the Food and Drug Administration (FDA) that they are unable to find a pharmacy with enough pills to fill their prescriptions
Medicines to treat attention deficit hyperactivity disorder are in such short supply that hundreds of patients complain daily to the Food and Drug Administration (FDA) that they are unable to find a pharmacy with enough pills to fill their prescriptions.
The shortages are a result of a troubled partnership between drug manufacturers and the Drug Enforcement Administration (DEA), with companies trying to maximize their profits and drug-enforcement agents trying to minimize abuse by people, many of them college students, who use the medications to get high or to stay up all night.
Caught in between are millions of children and adults who rely on the pills to help them stay focused and calm. Shortages, particularly of cheaper generics, have become so endemic that some patients say they worry almost constantly about availability.
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While the FDA monitors the safety and supply of the drugs, which are sold both as generics and under brand names like Ritalin and Adderall, the DEA sets manufacturing quotas that are designed to control supplies and thwart abuse.
Every year, the DEA accepts applications from manufacturers to make the drugs, analyzes how much was sold the previous year and then allots portions of the expected demand to various companies.
How each manufacturer divides its quota among its own ADHD medicines — preparing some as high-priced brands and others as cheaper generics — is left up to the company.
Now, multiple manufacturers have announced that their medicines are in short supply. The FDA has included these pills on its official shortages list, as has the American Society of Health-System Pharmacists, which tracks the problem for hospitals. And the American Academy of Child and Adolescent Psychiatry has told the more than 8,000 doctors in its membership that shortages seem to be “widespread across a number of states” and are “devastating” for children.
Officials at the FDA say the shortages are a result of overly strict quotas set by the DEA, which, for its part, questions whether there really are shortages or whether manufacturers are simply choosing to make more of the expensive pills than the generics, creating supply and demand imbalances.
The situation has made for a rare open disagreement between two federal agencies.
“We have reached out to the DEA and told them that there are shortage issues,” said Valerie Jensen, associate director of the FDA’s drug shortage program. “But the quota issues are outside of our area of responsibility.”
Still, Special Agent Gary Boggs of the DEA’s Office of Diversion Control, said in an interview, “We believe there is plenty of supply.”
Some high-priced pills are indeed readily available, and DEA officials said that so long as that is the case, they believe that ADHD drug supplies are adequate. Boggs attributed any supply disruptions to decisions made by manufacturers.
Novartis, for instance, makes both branded and generic versions of Ritalin; Shire Pharmaceuticals does the same for Adderall XR. In both cases, the companies have ensured that supplies of branded drugs are adequate while allowing generic versions to go wanting.
“We are working diligently to ensure our supply of these products meets demand, including discussions with DEA regarding our quota levels for these controlled substances,” said Kathy Bloomgarden, a spokeswoman for Novartis.
But those who rely on the drugs can react very differently to apparently similar medicines, so an adequate supply of one drug does them no good when their preferred medicine is unavailable, patients and their doctors say. And prices can vary so much that some patients say they cannot afford to switch.
Erin Fox, manager of the drug-information service at the University of Utah, said problems arise when there is a mismatch between what manufacturers choose to make and what patients are prescribed.
And, Fox said, while manufacturers sometimes use their limited quotas to ensure adequate supplies of high-priced branded drugs at the expense of low-profit generics, all of the issues would be resolved if the DEA were simply more generous with its quotas, particularly since sales of ADHD medicines have risen so rapidly.
In 2010, doctors wrote 51.5 million prescriptions for ADHD drugs, with a total sales value of $7.42 billion — an increase of 83 percent from the $4.05 billion sold in 2006, according to IMS Health, a drug information company.
Boggs, of the DEA, said his agency was concerned that ADHD drug abuse was on the rise. “We see people abuse it in college and then continue to abuse it nonmedically once they leave,” he said.
Since the drugs have been shown to improve concentration, and not just in people with ADHD, they have become popular among students who are seeking a study aid. And since they can impart a euphoria that users have likened to a cocaine high, the pills are sometimes ground up by people who snort them for a thrill.
On the other hand, there are people like Sheryl Greenfield, of Bryn Mawr, Pa., an ADHD patient who spent days calling dozens of pharmacies to find a generic substitute for Adderall XR. She finally gave up and bought the brand, and her co-pay went to $200 from $10. “I can afford the difference, but I know some people who can’t,” she said.