"The Narrow Therapeutic Index drug
state-by-state challenge that started with Coumadin versus generic warfarin sodium continues and has expanded to include critical care drugs." Dey noted.
The controversy centers on whether warfarin sodium, used to treat complications associated with atrial fibrillation (a disease that affects 3 million Americans, particularly the elderly), should be designated a Narrow Therapeutic Index drug
These and other narrow therapeutic index drugs
should not be split.
* Narrow Therapeutic Index drugs
are drugs that must be closely monitored by a physician because too much or too little medicine could produce serious adverse health conditions; this is true regardless of whether the product is brand or generic.
On a monthly basis, medication use and cost was measured and reported the number of medications and medication doses per nursing home resident per month; the number of laboratory measurements for narrow therapeutic index drugs
per nursing home resident per month; and the cost of all oral medications per nursing home resident per month.
In a related matter, they criticized automatic generic substitution of critical-dose drugs, also known as narrow therapeutic index drugs
, and asked the AMA to help states stop the practice of automatic substitution.
"The question that must be answered is, 'Is there a scientific basis for treating narrow therapeutic index drugs
differently than non-narrow therapeutic index drugs when making prescribing or dispensing decisions between bioequivalent products?' The answer to that question is unequivocal -- no."
The question of Narrow Therapeutic Index drugs
and what to do about them in terms of legal substitutions is probably not an issue that pops up first on the radar screens of retail pharmacy executives.