Member Alert
Attention AACE Members In Florida
A recent ruling by a Florida State judge will affect the way you prescribe levothyroxine sodium to your patients. In an order signed January 28, 2008, the judge ordered levothyroxine sodium off of the negative formulary list. That means pharmacists now have the ability to substitute generic levothyroxine sodium without your or your patients' consent. The only way to ensure your prescription or refill order is honored to your specifications is to write "Medically Necessary" on the prescription.
The brand names removed from the negative formulary include: Levothyroid, Levoxyl, Synthroid, and Unithroid. Click here to view the complete order.
In 2004, the FDA approved the use of generic levothyroxine preparations as equivalent to branded preparations. At that time, AACE, along with the American Thyroid Association (ATA) and The Endocrine Society (TES) issued a joint statement warning about the flawed methodology used to determine bio-equivalency, and the potential harm it could bring to patients. The groups also developed guidelines for the use of levothyroxine sodium which can be found here.
Since 2004, all three professional societies have twice gone before the FDA, once in 2005, and again in 2006, to dispute the methodology of determining "bioequivalence" based on the following concerns:
- The sensitivity of the "pharmacokinetic" methodology employed by the FDA to compare levothyroxine products,
- The cost and inconvenience of the required blood tests and dose adjustments after changing levothyroxine preparations, and
- The FDA’s failure to employ measurements of serum Thyroid Stimulating Hormone (TSH), the most reliable indicator of thyroid hormone action, as the principal parameter to compare bioequivalence of levothyroxine preparations.
In 2006, AACE, along with the ATA and TES, issued a strong statement that the substitution of so-called "bio-equivalents" could lead to adverse outcomes in some patients. AACE, TES and The American Society for Reproductive Medicine (ASRM) co-sponsored a resolution adopted by the AMA House of Delegates in November of 2006 calling for more strict enforcement of these products.