Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
PRNewswire - Wednesday October 21, 1998
A state district court judge in Travis County ruled today in a lawsuit brought by Barr Laboratories, Inc. that the Texas Board of Pharmacy violated the state's Administrative Procedures Act in rulemaking intended to ensure doctors and patients are notified before NTI drugs are switched. The court did not rule on the merits of the law, which was unanimously passed by the Texas Legislature and signed into law by Governor Bush. The legislature passed this important patient safety law over Barr's opposition. The law called for the Board of Pharmacy to develop a list of dangerous drugs and a process for communication between physicians, pharmacists and patients. The Board of Pharmacy then adopted rules implementing the law. The court's ruling could leave Texas doctors and patients in the dark about the switching of dangerous drugs, and seriously jeopardizes many of the existing state agencies' rules and regulations.
``The court's ruling will keep a veil of secrecy over decisions to switch drugs where the difference between a safe and effective dose and a potentially dangerous one is very narrow,'' said Nicholas L. Teti, president of DuPont Pharmaceuticals. ``NTI drug switching without physician involvement is something we feel strongly is not in the best interests of elderly Americans who take this life-saving drug. Why is it wrong for patients and their doctors to know when a narrow therapeutic drug is switched? We urge the Board of pharmacy to reissue the rules in conformance with the Administrative Procedures Act.''
DuPont produces Coumadin(R) (Warfarin Sodium Tablets, USP) Crystalline, an anticoagulant used to prevent blood clots that can cause stroke*. It is one of the most frequently prescribed NTI drugs. Too little Coumadin will not prevent blood clots that can result in stroke, and too much can cause serious bleeding. A generic warfarin has been available in Texas since 1997.
DuPont said it continues to receive reports of patients who mistakenly take overdoses of warfarin when being switched from one manufacturer's product to another.
In the cases of overdosing reported to DuPont by physicians and other medical professionals, patients had some warfarin from the previous prescription left over when they were given a new prescription of warfarin from a different manufacturer. Because these are usually elderly patients, and because the tablets look different, the patients took both -- in effect, a double dose of a carefully monitored drug.
``We believe these potentially serious events can be avoided if the physician is involved whenever medications are changed,'' said Mr. Teti. ``We applaud the courage of the Board of Pharmacy in its attempt to ensure patients in Texas are informed when their drugs are switched.''
DuPont Pharmaceuticals, a unit of DuPont's Life Sciences Enterprise, is a world-wide business that focuses on research, development and delivery of pharmaceuticals to treat unmet medical needs in the fight against HIV, cardiovascular disease, central nervous system disorders, cancer and arthritis-related disorders. The company is also a leader in medical imaging.
* The most common adverse event and serious risk of oral anticoagulation therapy with Coumadin is bleeding in any tissue and organ.
COUMADIN is a registered trademark of DuPont Pharmaceuticals Co.
SOURCE: DuPont Pharmaceuticals Company
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