Drug War?

The National Community Pharmacists Association surveyed 675 independent pharmacists. Their main concern was the shortage of Adderall XR (amphetamine mixed salts) and its generic equivalents, prescribed for attention-deficit hyperactivity disorder. As for drug shortages overall, some key results were:

• "96 percent of responding pharmacists experienced a drug shortage in the past six months.
• 82 percent have been experiencing drug shortages at least daily (59 percent) or weekly (23 percent).
• 80 percent said that the average shortage last [sic] three weeks or longer.
• 78 percent indicated that patients have to go without taking their medication(s) due to shortages, suggesting that patients are unable to obtain their needed supply from alternative pharmacies, either."

Amphetamine, amphetamine mixed salts, dextroamphetamine, and (rarely) methamphetamine are all approved ADHD treatments, and alleviate the symptoms in 70-80% of children. An excellent summary of the disease itself and the simultaneous treatments required is provided by the National Resource Center on ADHD. The disease may continue on into adulthood or the initial diagnosis may occur in adults.

As part of the War on Drugs, the Drug Enforcement Administration sets production quotas for these drugs. Note in my post last fall that the shortage of amphetamine mixed salts for immediate release reported in the ASHP bulletin was in part due to the fact that Teva had produced the quantity allowed by the DEA quota restrictions. The immediate release form is the only one approved for treatment of children 3-6 years of age. The FDA has asked the DEA to increase quotas to solve the problem, but the DEA maintains that its quotas are adequate to meet the demand and that the shortage is due to drug manufacturers (Shire in the case of Adderall XR) choosing to produce and sell the more expensive and more profitable brand name version of the drug. For example, since Shire supplies Teva with the active pharmaceutical ingredient, the more of the API that Shire uses to produce Adderall XR, the less there is for Teva to produce the generic immediate release formulation.

The three-sided dispute between the FDA, DEA and drug manufacturers has led to an investigation by US Congressional Representatives Henry Waxman, Diana DeGette, Frank Pallone, and Chris Van Hollen. More information about the investigation may be found in this post by Ed Silverman at Pharmalot. The Executive Branch has issued Executive Order 13588 -- Reducing Prescription Drug Shortages addressing actions that can be taken by the FDA, Department of Justice, and drug manufacturers. For example, Shire discontinued Adderall IR [immediate release], and supplies Teva with the API to produce the generic equivalent. Under the executive order, a discontinuation such as this would now require six months notice. Representative DeGette and Senator Amy Klobuchar introduced House and Senate companion bills (HR 2245/S 296) last summer to address drug shortages, and DeGette was interviewed on that topic by Sarah Kliff of the Washington Post. The American Society of Health-System Pharmacists has a legislative summary of these bills (PDF), which I believe remain pending in committee. Comments and updates on the bills' status will be welcome.