Dec. 16, 2011 at 8:22 AM ET
After nearly 10 months, the nationwide shortage of ADHD drugs has taken a toll on Kate Skinn.
The 32-year-old Ohio woman had to take a medical leave from college because she can’t focus on her reading. She’s lost income from her job as a waitress because she’s distracted at work. And she’s had to struggle even harder than usual juggling the needs of her boyfriend and their four children, all because she can’t reliably get the Adderall that helps her cope.
“It’s impossible to manage all the facets of my life and do my schoolwork,” said Skinn, of Sheffield Lake, Ohio, who was diagnosed with attention-deficit hyperactivity disorder three years ago. “When I can’t take my medicine, I can’t concentrate. I’ll start everything I need to do, but never complete any of it.”
She’s among millions of Americans struggling to deal with the worst drug shortage in United States history. ADHD drugs such as Adderall and Ritalin, first reported as scarce last spring, are only a fraction of the 251 medications in short supply so far this year, up from 211 in 2010, according to University of Utah Drug Information Service.
The issue drew renewed attention Thursday, when the White House issued an interim rule that requires drugmakers that are the only producers of certain critical medications to report to the Food and Drug Administration all manufacturing interruptions that could disrupt supplies.
It follows an October executive order in which President Barack Obama directed the FDA and the Department of Justice to take bolder steps to resolve the worsening scarcity.
Shortages of life-saving drugs, such as those used to treat cancer, and medically necessary drugs, such as anesthetics and painkillers, have sparked the most dire concerns, experts say.
But shortages of the ADHD drugs widely used to help an estimated 5.4 million children and 1.5 million adults concentrate daily are also worrisome, especially as the problem continues.
“We get those reports from patients saying I had to drive three hours to get my ADHD prescription and this is the third, fourth or fifth time,” said Erin Fox, manager of the Drug Information Service, which tracks drug supply issues. “We’re hearing from moms who are so worried and upset about not getting the drugs their kids need every day.”
FDA officials, too, say the ADHD drug shortage has drawn a lot of attention.
“We’re hearing the same thing: that patients aren’t able to get these drugs,” said Valerie Jensen, associate director of the FDA’s drug shortage program. “We’re continuing to check with the companies about their expected resolution dates.”
Drugmakers say that increased demand and difficulty obtaining supplies of the raw materials used to manufacture the drugs are behind the ongoing ADHD pill shortages. But an official with the government agency that allocates those controlled substances says from his vantage, there’s plenty of raw material out there.
The DEA allocates an aggregate amount of medically necessary supplies of controlled drugs -- for instance, 56 million grams of methylphenidate in 2011 -- and then doles out confidential portions to each drugmaker.
“We’ve given them quota sufficient to meet the needs and then it’s up to them how they manufacture their product,” said Gary Boggs, a supervisory special agent for the Office of Diversion for the federal Drug Enforcement Agency.
Company business decisions surrounding competition, marketing -- and profit margins -- are behind many of the troubles that patients have encountered, Boggs added. Manufacturers might make more of an expensive brand-name drug and not enough of a generic version. Or they may distribute too much product in one place, causing a shortage somewhere else.
“This isn’t just a clean there is either product or not product,” Boggs said. “There’s a whole lot of different dynamics in here.”
Drugmakers declined to discuss specifics of their DEA allocations.
Still, those dynamics have reshaped Kate Skinn’s life.
In the past 10 months, she’s had to drive to multiple pharmacies trying to get the different ADHD drugs used by four members of her family, including her 4-year-old son, Markus.
“I have to actually block out a whole day of my life to figure out if I’m going to have medication for the next day,” said Skinn.
Because the drugs are controlled substances, she and other patients have to follow strict rules governing prescriptions and refills. Skinn sometimes skips a dose at night in order to hoard them for times when she might run out.
“For people with ADHD, there’s already a stigma attached to it,” she said. “You end up feeling like you’re drug-seeking. It doesn’t make you feel good.”
In recent weeks, the ADHD shortage has shown signs of easing. Brand-name Adderall XR, the extended-release version produced for the drug company Shire Pharmaceuticals, has been logged as available in “adequate” supplies. Company spokesman Matt Cabrey said that’s because the DEA granted an increase in the firm’s allocation of amphetamine mixed salts used to make the drug.
Other firms, as well, say that as they receive their new DEA allocations in the new year, the shortages may subside.
That would be welcome news for patients like Skinn, but drug supply experts say they've heard that before -- and no one should count on it.