ADHD drug shortage leaves physicians with few choices

Patients of Chicago child and adolescent psychiatrist Louis Kraus, MD, have traveled to as many as 10 pharmacies in recent months trying to fill a prescription for attention-deficit/hyperactivity disorder medication.

In many instances, the patients return home empty-handed because of a shortage of ADHD drugs that is impacting patients and health professionals across the country.

"This is a significant concern," said Dr. Kraus, chief of child and adolescent psychiatry at Rush University Medical Center in Chicago. "ADHD is one of the more common psychiatric diagnoses [among youths]. We're talking about hundreds of thousands of children who are not going to be able to get the appropriate medical treatment."

Though much attention has been paid to the recent supply problems for chemotherapy drugs and pain medicine, health professionals say there has been less publicity about shortages of ADHD medications.

Supply issues for such drugs began in the fall of 2011, said Erin Fox, PharmD, director of the University of Utah Health Care Drug Information Service, which tracks national medication shortages.

The ADHD drugs most significantly affected are amphetamine mixed salts, which include Adderall, dextroamphetamine tablets and methylphenidate, which includes Ritalin, Dr. Fox said.

Overall, there were more than 250 drug shortages in the U.S. in 2011, the Food and Drug Administration said. That is up from the record of 178 shortages reported to the FDA in 2010. The agency said it is not clear whether the problem will improve this year.

Contributing to the shortage of ADHD medications are supply issues for raw materials and increased demand for the drugs, the FDA said.

Complicating matters is that the Drug Enforcement Administration tries to limit the production of these substances to prevent their use for nonmedical reasons, said pediatrician Mark Wolraich, MD, professor of pediatrics at the University of Oklahoma Health Sciences Center. The result is that primary care physicians increasingly are receiving phone calls about patients unable to fill their ADHD prescriptions because the drugs are not available, Dr. Wolraich said.

Among the challenges for physicians is trying to locate a nearby pharmacy that has the drug or identifying another medication that will appropriately treat the patients' symptoms, he said.

"It frequently takes some time to determine what is the most effective medication for children with ADHD. So it's not easy to just jump to another medication," Dr. Wolraich said.

Also concerning health professionals are the consequences of patients abruptly stopping their ADHD treatment. Suddenly discontinuing such medicine can decrease youths' ability to focus and function in school, Dr. Kraus said. It also can lead them to be more impulsive and ultimately increase their risk of having a serious incident, he said.

Dealing with these supply problems "is tremendously time-consuming for physicians, and [the drug shortage] places patients at a potential risk" of injury, Dr. Kraus said.

Working to prevent shortages

In 2007, more than 5 million U.S. children 4 to 17 years old (9.5%) had been diagnosed with ADHD, according to the most recent data from the Centers for Disease Control and Prevention. That year, about 66% of youths in that age group (2.7 million) received medication to treat the disorder, the CDC said.

Dr. Fox said it is difficult to gauge the extent of the drug shortage's impact on those who depend on the medication, because supply problems vary from one community to the next. But she said it is clear the issue is affecting people across the country.

In areas with shortages, Dr. Kraus encourages primary care physicians to talk to patients about the potential health risks of stopping their ADHD medication and educate them about other drugs that are available.

Beyond that, however, he said there is little physicians can do.

In an effort to prevent drug shortages and lessen their impact when they do occur, President Obama issued an executive order in October 2011 that directs the FDA to require manufacturers to report drug discontinuances in advance.

The AMA House of Delegates addressed the issue at its Interim Meeting in November 2011 in New Orleans. The house adopted policy that recommends offering tax incentives to manufacturers that produce critical drugs and changing the FDA definition of a "medically necessary" drug in shortage to expand the agency's authority to act.

"If we have some advanced knowledge of what medications are not going to be available, we can at least attempt trials with different types of medicine that might be effective for our patients," Dr. Kraus said. "The problem is we don't have that information."