TEXAS: Generic Drug Refills Restricted
The Texas Board of Pharmacy yesterday adopted restrictions that will limit pharmacists' ability to substitute certain generic drugs for brand-name equivalents. The restrictions would require pharmacists to obtain physician approval before choosing to refill certain drugs from the "Narrow Therapeutic Index" (NTI) list with a generic version. If the brand-name is not available, pharmacists must inform the patient and prescribing physician of the change. Nine drugs are included in the list; in NTI drugs "the levels at which the drugs are helpful and harmful [are] marginal," according to experts quoted by the AP/Dallas Morning News. However, on the same 5-4 vote, the board ordered a task force to reconsider the NTI list. The new restriction on generics will likely take effect next month; changes to the NTI list could come as soon as March.
Safety Or Market Share?
John Heiser, a lobbyist for DuPont Pharmaceuticals Co., said that although "[w]e've never said (generic drugs) aren't safe ... [w]e consider this to be a victory for patient safety." Bruce Downey, chair of generic drugmaker Barr Laboratories, countered that "generic drugs allowed to be used in Texas have been rated by the federal Food and Drug Administration as equivalent to the brand name drug" (8/5). C.A. Stubbs of Citizens Against Government Waste, who testified before the board in opposition to the change, said, "There is a concerted effort on the part of the big pharmaceutical companies to prevent people from gaining access to the lower-priced, but perfectly safe generic drugs. The issue is about protecting market share and profits. It has nothing to do with patient safety." Stubbs predicted that as "drugs near the end of their patent lives," drug companies will push to include them on the NTI (CAGW release, 8/4).
On The List
The following drugs are included on the NTI:
- Digoxin, a heart drug
- Phenytoin and Divalproex Sodium, anti-convulsants
- Warfarin Sodium, a blood thinner
- Theophylline, an asthma drug
- Leothyroxine, a thyroid drug
- Carbamazepine and Valproic Acid, epilepsy treatments
- Lithium, an anti-depressant (Elizondo, AP/Houston Chronicle, 8/5)