A shortage of Adderall, a medication to treat Attention Deficit Disorder, is likely to continue through 2012, raising concerns among patient groups and health care professionals in the U.S. according to a report in The New York Times (NYT).
Multiple manufacturers of the drug are struggling to cater to high demand from millions of Americans who rely on drugs like Adderall and Ritalin. These manufacturers are also finding it increasingly difficult to get enough of the Active Pharmaceutical Ingredient (API) to make Adderall, as the stimulant is tightly regulated by the Drug Enforcement Agency (DEA).
Adderall is a highly addictive drug and can lead to substance abuse problems. It is, therefore, no surprise the stimulant is especially popular among the student community, members of whom, although may not suffer from Attention Deficit Hyperactivity Disorder (ADHD), use the substance as a study aid to improve test scores. The drug is also used as a party drug since it can impart a wave of euphoria when consumed.
Meanwhile, the reasons for the shortage remain unclear. Reports link the scarcity to the DEA, which actively decides the amount of API to be mixed in Adderall and releases only that amount of mixed amphetamine salts to the manufacturers. The manufacturing quotas set each year by the federal agency are designed so as to combat illicit drug abuse.
The brunt of the problem is being borne by the Food and Drug Administration (FDA), with hundreds of complaints filed each day, from concerned patients, claiming the drug is in short supply in pharmacies across the country.
We have reached out to the DEA and told them that there are shortage issues, said Valerie Jensen, Associate Director of the FDA's Drug Shortage Program, in a statement reported by NYT. The statement however, also said quota issues were outside the FDA's area of responsibility.
However, the DEA claims there is an adequate stock of the drug and points to the supply and demand imbalances drug manufactures have created.
Meanwhile, while manufacturers maximize profits through production of brand-name pills, concerned patients are left scrambling to find generic alternatives.
Adderall XR is a more expensive substitute of the same drug (Adderall) manufactured and sold by Teva Pharmaceutical Industries and Impax Laboratories Inc. While some can afford to pay the difference, it is the poorer patients who are affected by the shortage.
I am very concerned about the future, Ruth Hughes, the Chief Executive of Children and Adults with Attention Deficit/Hyperactivity Disorder (CHADD) told Reuters, No one seems to have much inventory to get us through the months ahead.
According to Reuters, Adderall manufacturers cite the DEA's quotas as the reason for the shortage.
Our production facilities are currently running at maximum capacity for Adderall utilizing all available API, said a Teva spokesperson, adding, The catalyst for the problem is the quota system, not the business.
The addition of Adderall to the FDA's Drug Shortage List follows an Executive Order signed last October by President Obama, requiring the FDA to quickly address shortage of crucial prescriptions. The order also looks into illegal price gouging in the pharmaceuticals market. Incidentally, there was a shortage of 178 specific drugs, reported to the FDA, in 2010.
Adderall prescriptions shot up by 13.4 percent from 2009 to 2010, with more than 18 million prescriptions written for patients suffering from the disorder, according to IMS Health prescription data, the publication noted.