Bob Noel of Altoona started taking Adderall for severe attention deficit hyperactivity disorder in second grade.
"It lets you focus," said Noel, now 27. "So you're not so uptight all day long."
But he quit taking Adderall in mid-2011 - not because it stopped working, but because he couldn't get it.
Now he's on Klonopin, a different kind of medication designed for different kinds of issues. It helps, but not nearly as much as Adderall, according to Noel and his doctor, Zane Gates.
Noel is the victim of a drug shortage - he can't get Adderall because the government allocates only a limited amount of its ingredients to manufacturers every year, based on demand, and the government has repeatedly underestimated demand, according to Gates.
Similarly, Amy Hanna, 44, of Altoona started having sporadic trouble getting desmopressin acetate, which she has taken since 1988 to replace the fluid-retention hormone her body doesn't produce because of a pituitary gland tumor.
Without it, she has unquenchable thirst and must drink constantly and then go to the bathroom constantly.
"[The drug] allows me to live a productive life, a normal life," Hanna, marketing manager at the Mirror, said.
But in February, a pharmacist said there was none available at all.
"My heart just stopped," she said.
It turned out the manufacturer had suspended production and wasn't resuming until June. She contemplated "the end of my life as [I] know it," she said.
Her pharmacist contacted distributors all over the U.S., located one bottle and had it shipped overnight. That took care of the problem, but only for 21 days.
"That's when I started asking for help," Hanna said. "This is bigger than me."
Factors
The factors causing shortages are "complex and multidimensional," according to a statement on the problem from John Castellani, CEO of Pharmaceutical Research and Manufacturers of America.
Generics account for about 85 percent of the problem, said Kaelan Hollon, a spokeswoman for PhRMA.
Multi-source generics are the biggest issue, said Nick Genovese, pharmacy director at Altoona Regional.
Most shortages are with specific drugs, according to a report provided by Hollon - "An Economic Analysis of the Causes of Drug Shortages," published by the Department of Health and Human Services.
But sometimes a whole class is in short supply. Older sterile injectable drugs - especially for cancer treatment - are such a class, according to the report.
Generally, classwide shortages occur when companies start making more kinds of drugs without increasing production capacity, according to the HHS report.
In recent times, companies expanded their generic drug offerings, because an unusually high number of brand patents have expired, beginning in 2008, according to the report.
Attempting to produce new drugs in large quantities quickly can lead to quality problems, according to the report. That leads to Food and Drug Administration-ordered shutdowns.
Low inventories based on "lean" manufacturing principles also contribute to the problem, according to FDA spokeswoman Sarah Clark-Lynn.
There's also the profit issue.
Often, companies elect to discontinue making a drug, because they're not making much of a profit, Genovese said.
"It's a problem of supply and demand in the purest form," said Pete Kreckel, pharmacist at Broad Avenue Pharmacy. "They quit making it, and when you want to pay [their] price, [they] start again."
Executive order
An executive order from President Barack Obama in October has helped with early notifications, as evidenced by the posting of 80 new shortages this year, according to Clark-Lynn.
The Senate and House have been working on the issue, also. They passed the Food and Drug Administration Reform Act of 2012, which would require manufacturers to provide early notification of shortages, enable FDA to expedite applications for manufacturing changes for drugs in short supply and improve FDA's recordkeeping for such drugs, according to U.S. Rep. Bill Shuster, R-9th District.
A committee will reconcile differences in the House and Senate versions, according to Shuster spokeswoman Gretchen Gailey. The bill has bipartisan support, and the president should sign it, she said.
The bill includes authorization of the Generic Drug User Fee Act, which would require the generic drug industry to pay $1.5 billion over five years to support faster and more predictable review of generic drug applications - helping to reduce shortages and bring drugs to market faster, according to thepharmaletter, a news and analysis service.
Manufacturers have already stepped up voluntary reporting of potential shortages, according to Castellani.
Patients should beware drugs from "gray market" secondary wholesalers - whose products can be problematic, because of questions about product integrity, according to Castellani.
Altoona Regional
Most times, Altoona Regional can't get 25 or 30 different drugs, Genovese said.
"We're used to it," he said.
When it happens, the hospital must find an alternate source or an alternate product, he said.
Genovese knows of facilities that have had to postpone elective surgery due to a shortage of propofol, a hypnotic. It hasn't happened at Altoona Regional, but "there are times when I left Friday where I'm not sure we would have enough to get through Monday," he said.
The past year has been the worst that Genovese has experienced for shortages - although recently, things have gotten a little better.
Still, Genovese doesn't recall a situation where the hospital couldn't provide something that worked. Nor does he know of someone growing seriously ill or dying as a result of a shortage, he said.
The realities
Noel would go back to Adderall if he could. He could take an equivalent drug, but his insurance won't cover it, and it's expensive, Gates said.
When Hanna got desperate, she contacted the media and area federal lawmakers.
Sen. Bob Casey's office put her in touch with a representative of the firm that makes her drug, and she has been able to get enough to keep her going through July.
Shuster's office provided a company phone number in case of an emergency shortfall in her personal supply.
"I'm hoping this legislation makes [drug companies] a little more accountable," Hanna said. "It might give me an opportunity to make plans."
But she's still worried. After all, the FDA can't require a firm to keep making a drug it wants to stop making, the FDA states on its website Q&A.
"I think this is going to be a constant problem," Hanna said. "I will have to live the rest of my life refill to refill, wondering."
Mirror Staff Writer William Kibler is at 949-7038.
