We can’t get our ADD meds and we’re losing focus faster than a defective camera lens. What gives?
First, everyone (OK, doctors) convinced us that we should take meds for our ADD. So we get our prescription filled, our brains come to attention, we get things done and then … and then … no medication!!!!
Is it a conspiracy? Is it corporate manipulation? Is it ghosts on Halloween?
Well, it’s probably not ghosts but there aren’t clear reasons for the shortage of ADHD medications, especially mixed amphetamine salts (a.k.a. Adderall and its ilk) and methylphenidate (a.k.a. Ritalin).
The FDA website reports that the Adderall shortages are caused by a variety of issues, mostly about “API” shortages. API stands for “Active Pharmaceutical Ingredient.” According to Drug Store News more than 80% of the API needed to manufacture drugs in the US comes from OUTSIDE the United States! Most of the active ingredients come from Italy, China and India. So if the supply slows down abroad, our meds in the US are affected.
It is truly a global world of pharmaceuticals these days. The FDA requires that the API produced outside the US meet the same high standards for quality as those produced domestically. But … and here’s the shocking fact … drugs produced overseas are NOT highly regulated, even for export to the US and other countries. As recently as 2008, there was a single FDA inspector assigned to China. As in one person. One.
OK, don’t get me sidetracked into a discussion about the purity of drugs. This is about shortages. However, concerns about the purity of the API can delay production, too. The FDA took action against a Mexican API production facility in June 2011, which delayed manufacturing (this was not an ADHD drug API).
So…as of October 28, 2011, the FDA reported that Immediate Release Mixed Amphetamine Salts (Adderall and generics) are delayed because of API shortages (brand name Adderall), higher demand and manufacturing delays.
For Adderall ER, the picture is similar, but Shire Pharmaceuticals (who also produces Vyvanse) claims there is no shortage at the manufacturing level. There are some distribution inequities, though. So one part of the country might have a plentiful supply, while other areas may experience a shortage … sigh.
Ritalin/methyphenidate – things are grim. As of October 11, 2011, Sandoz (which manufactures generic Ritalin) predicts “sporadic backorders” for the next couple of months. The only manufacturer who has plenty of generic Ritalin (methylphenidate) is Watson Pharmaceuticals which apparently has a lock on the market right now.
Metadate, a branded formulation of methyphenidate that comes in the CD, IR and ER variations, is at full supply from UCB Pharmaceuticals.
The other formulation that is bountiful at the moment is Daytrana, a brand name formulation that is administered via a time release transdermal patch (applied to the skin). Noven is the manufacturer of Daytrana.
Bottom line is that some important meds are missing from our ADHD arsenal right now and nobody seems to be talking about it … unless you are one of the unlucky ones who can’t get a prescription filled.
What’s your experience? Let us know where you live and whether you can get meds in your area. We need to help each other on this vital issue!