Blog | Thursday, December 15, 2011

Is the adderall shortage a harbinger of future drug supply problems?


Today, most if not all doctor's offices are strained by the shortage of some prescription medication or vaccine. A month ago, President Obama signed his executive order directing the FDA to take steps to reduce drug shortages as the White House stated that drug shortages have nearly tripled over the past five years, reaching the stunning number of 178 in 2010. These shortages make regular news: Cancer patients without the chemotherapy needed to keep them alive, antibiotics unavailable to treat life-threatening infections, or intravenous nutrition to support the critically ill fighting to live while medical teams and families search for elusive remedies.

As this new reality plays out in hospitals and homes the media is provided a steady stream of drama for our morning paper or evening news. Meanwhile, time and focus is repeatedly stolen from physicians, patients, and parents in a myriad of ways. Currently, my medical practice in primary care internal medicine has been negatively affected by the shortage of Adderall, a medication used to treat attention deficit hyperactivity disorder (ADHD). What this medical condition may lack in dramatic news worthiness it more than makes up for in sheer numbers, with an estimated 4.5 million Americans living with this condition today.

I had my first inkling several months ago of the affect the Adderall shortage would have on my practice after one of my patients called frustrated that their pharmacy did not have their Adderall at the prescribed dosage. By calling several pharmacies I was able to find their medication at a smaller dose. Advising my patient to "double-up," I wrote another prescription and had to direct my patient to return to my office to pick up the rewritten prescription, a time-consuming process that doctors and patients can ill afford to repeat on a regular basis.

Unfortunately, this scenario, initially thought an exception, has now become the rule, monopolizing my own time while draining the daily resources of my staff, nurse and medical partner. Most ironically though, it forces a population of patients unable to concentrate without medication to focus on precisely the type of task that would challenge them the most in order to obtain their medication, a classic "Catch-22".

Last week, I had the opportunity to attend the Capitol Hill forum, "Is ADHD Ailing our Economy," in the Rayburn office building. From a panel of experts I heard evidence regarding the prevalence of ADHD in our country as well as the economic impact ADHD has on our nation's economy. I had previously thought in economic terms limited to drug costs alone, but during this forum I heard compelling evidence of the economic impact of untreated ADHD, such as the cost last year somewhere between $87 billion and $138 billion dollars in lost productivity or the expense of $3 billion dollars in burden to the judicial system in 2010 alone.

Against this backdrop of economic impact my curiosity as to the cause of the Adderall shortage was piqued. If the economic impact of untreated ADHD is so expensive, then how can we allow the shortage of Adderall to continue? I spoke with a representative for Shire pharmaceuticals, makers of Adderall XR, and was assured that the shortage did not extend to their product line, as the shortage was limited to the generic rapid release version of Adderall. He stated that the actual cause of the shortage was complicated, but Shire's quarterly report dated Mach 31, 2011 stated that "Shire's ability to supply this product is limited by quota restrictions that the U.S. DEA places on amphetamine use."

The FDA blames increased demand (legal and illegal), while the DEA has not released any official statement on the shortage, but does offer a "Drug Fact Sheet" comparing Adderall to cocaine and crack. Further confusing the reasons for this shortage are lawsuits filed over the last two years by Teva pharmaceuticals and Impax Laboratories, makers of generic Adderall, against Shire regarding shortages of the parent compounds in making Adderall as Shire is under contract to provide the parent compound to both of these companies.

While the specific reasons for the Adderall shortage remain elusive and the finger pointing continues, I fear this shortage will continue unchecked for many more months before a solution is found. Adderall is but one of many drugs now difficult to find and I am most worried that these shortages are a symptom of a growing dysfunction between government and the medical industry. Today's shortages may pale in comparison to tomorrow's deficiencies.

Dr. Simmons' travel and participation in the Capitol Hill briefing was made possible by sponsorship from Shire Pharmaceuticals.

This post by Steve Simmons, MD, appeared at Get Better Health, a network of popular health bloggers brought together by Val Jones, MD. Better Health's mission is to support and promote health care professional bloggers, provide insightful and trustworthy health commentary, and help to inform health policy makers about the provider point of view on health care reform, science, research and patient care.