ADHD Drugs on Critical List as Medication Shortages Soar

The 178 drug shortages reported to the Food and Drug Administration (FDA) in 2010 have given way to more than 250 such shortages for 2011. Older injectables are still high on the list, but so are anesthetics, intravenous electrolytes, and stimulants used to treat patients with attention-deficit/hyperactivity disorder (ADHD).

The AMA declared at its 2011 annual meeting that the shortages are a national public-health emergency (Psychiatric News, December 16, 2010).

When Psychiatric News Update queried psychiatric professionals about the extent of the shortage of ADHD medications that they are experiencing, responses came from frustrated practitioners in states throughout the country. One respondent echoed the sentiments of most others when he wrote, “It is creating havoc for me and my patients.”

Multiple etiologies, including the Drug Enforcement Administration’s (DEA) drug importation restrictions, FDA oversight, and allegations that pharmaceutical companies are manipulating their allotted quantities of active drug ingredients to shift patient demand from generics to more expensive branded medications, have been proposed.

Valerie Jensen, R.Ph., associate director of the Drug Shortage Program at the FDA’s Center for Drug Evaluation and Research, discussed the extent of the problem and the importance of communication among FDA, drug manufacturers, health professionals, and the public in helping to reduce the impact on public health in a Webinar last September. She explained that the FDA’s response is constrained by its lack of authority to require manufacturers to report potential or current shortages to the agency.

Discontinuations are another source of the shortage. The FDA works with drug manufacturers to address manufacturing and quality problems and helps them ramp up production when other manufacturers experience problems— like equipment failure—that decrease their production. But the FDA cannot require a manufacturer to continue to produce a drug it wants to discontinue, and older drugs are sometimes discontinued in favor of newer, more profitable medications.

There may be other reasons for the shortage of drugs used to treat ADHD, however. Rising ADHD diagnosis and treatment rates have created unprecedented demand for the amphetamine and methylphenidate stimulants, which are subject to abuse and thus are under DEA control. The DEA has said “the increased use of these substances for treatment of ADHD has paralleled an increase in their abuse among adolescents and young adults who crush these tablets and snort the powder to get high.”

Multiple studies have also documented accounts of diversion and misuse of the stimulant medications by non-ADHD college students who claim the drugs allow them to focus more clearly on their studies, and score higher on tests.

The Government Accountability Office has urged Congress to give the FDA greater ability to respond to drug shortages by mandating that manufacturers report to the FDA any changes that could affect the supply of their drugs.

But could those changes come soon enough? “Many of the companies that manufacture the short-acting stimulant medications report they have no inventory left or limited inventory,” explained Lizbet Boroughs, deputy director of federal affairs in APA’s Department of Government Relations. “Given the manufacturing time lag of eight to 12 weeks, it is unlikely that the 2012 DEA-approved medications will get to market until March at the earliest. No one seems to be able to estimate the amount of medications currently in pharmacies across the country.”

Boroughs said APA is working with a coalition of patient, family, clinician and pharmacy-related organizations that includes the National Alliance on Mental Illness, Children and Adults With Attention Deficit/Hyperactivity Disorder, American Academy of Child and Adolescent Psychiatry, and American Academy of Pediatrics. “This coalition has been working with congressional leaders to bring attention to this issue and look for ways to solve the shortage,” she said.

On January 17, four members of the House of Representatives sent congressional letters of inquiry to medication manufacturers Shire and Novartis asking them to document shortages of stimulant medications, particularly generics. “We would be concerned if [your company] were taking action to create a shortage of a critical generic drug,” wrote Reps. Henry Waxman, Diana DeGette, Frank Pallone Jr., and Chris Van Hollen.

Information on the FDA’s response to drug shortages, including links to lists of current and resolved drug shortages, is posted at www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm. The American Society of Health-System Pharmacists lists shortages and estimated resupply dates at www.ashp.org.