Every day, the FDA gets hundreds of calls from attention-deficit/hyperactivity disorder (ADHD) patients who are a facing a near constant shortage in the prescription drugs prescribed for their disorder, according to a recent report in The New York Times.
The problem has become so prevalent that both the FDA and the American Society of Health-System Pharmacists currently lists the active pharmaceutical ingredients (API) of many common ADHD drugs—including methylphenidate HCl, dextroamphetamine tablets, and amphetamine mixed salts immediate-release tablets—on their drug shortages lists. The shortages have prompted a blame game among the FDA, the Drug Enforcement Administration (DEA), and drug manufacturers.
The crux of the problem is one that pharmacists encounter daily—balancing the needs of legitimate patients against the increase risk of drug diversion and abuse. The APIs in ADHD medications are Schedule II controlled substances, and the DEA is concerned about the rising abuse of stimulants on college campuses across the country. As a result, the agency sets limits on how much of each API can be used each year, assigning allotments to each drug manufacturer. The DEA maintains that their quotas are reasonable, and faults drug manufacturers that choose to produce lucrative name brand drugs instead of generics, leading in part to a more limited supply.
Pharmaceutical companies and the FDA claim that the DEA’s quotas are too low to meet the rising demand for these drugs. In 2010, prescriptions for Adderall (dextroamphetamine and amphetamine), for example, increased by 13.4% to a total of more than 18 million. New guidelines for the diagnosis of ADHD can help explain this increase in part; the percentage of children aged 4 to 17 diagnosed with ADHD has increased from 7.8% in 2003 to 9.5% in 2007
In 2012, the DEA-determined quotas will increase for methylphenidate for the first time since 2007 from 50,000 kg to 56,000 kg. The amphetamine quota will also increase from 18,600 kg (set in 2009) to 25,300 kg.
Until the agencies and drug manufacturers reach some agreement, pharmacists are likely to encounter patients who call or stop by the pharmacy to see if their preferred drug regimen is available. Pharmacists can take that opportunity to counsel patients on alternate treatment options and behavioral modifications that can help them cope with the current shortages. ~Pharmacy Times~