In recent postings in the New York Times, Time.com, and Reuters.com, correspondents report on the “troubled partnership” between attention deficit hyperactivity disorder drug manufacturers and the DEA, and the related “rare open disagreement” between the DEA and the FDA.
The DEA is rarely involved in the actual management or distribution of drugs, but in the case of ADHD drugs they tightly regulate how much of the drug’s active pharmaceutical ingredient (API) can be distributed to manufacturers each year. The system is designed to prevent the creation of stockpiles that could be diverted for inappropriate use.
Quotas Too Strict?
The agency lets each manufacturer decide how to divide its quota between high-priced brand names and cheaper generic versions, with what some say are predictable results: nationwide shortages of low-margin, inexpensive generic ADHD medicines.
Both the FDA and the American Society of Health-System Pharmacists have placed this type of medication on their official shortages lists. The FDA, which receives hundreds of complaints daily about the shortage, insists that the shortages are the DEA’s fault. The DEA questions whether there really are shortages and points the finger at the manufacturers, saying that they chose to make more of the brands than generics.
Further complicating matters are patients who take structured treatment interruptions, or “drug holidays”, for varying lengths of time over the course of a month, in effect stockpiling their medication and contributing to the shortage.
Oh, and there’s even more: demand for the drugs is reaching all-time highs. In 2010, more than 18 million prescriptions were written for Adderall, up 13.4% from 2009, according to IMS Health, which tracks prescription data.
The end result is a situation that is costing the public billions a year because they often have no choice but to switch to a branded product. The insurance companies are then hit with a wave of prior authorizations, and they have to approve these branded drugs.
What is TRICAST Doing About It?
While lobbyists, manufacturers, advocacy groups, and the government struggle to remedy the shortages, TRICAST is offering innovative solutions to our clients.
For example, we are proposing quantity limits that are more consistent with how patients are actually using their medications. Rather than a traditional 30-day supply, why not prescribe a 24-day supply to patients who only take their medication during the week?
Additionally, the data surveillance and FWA monitoring capabilities of some of our products can spot gaps in usage that might indicate stockpiling, and detect patterns of actual abuse by patients, pharmacists, and physicians.
While we can’t necessarily influence public policy, we can help our clients work more efficiently within the constraints that the various shortages have created.