GENERIC SUBSTITUTION SHOULD BE GROUNDED ON PHARMACIST FAMILIARITY WITH LITERATURE, ATTORNEY CAUTIONS NARD; THERAPEUTIC SUBSTITUTION PROBLEMATIC
Executive Summary
Generic substitution decisions by pharmacists should be based on a familiarity with the literature in order to avoid liability suits, D.C. attorney Jonah Shacknai (Royer, Shacknai & Mehle) told the Natl. Assn. of Retail Druggists at its annual meeting in NYC Oct. 22. Shacknai noted that the Drug Price Competition and Patent Term Restoration Act will double the number of drugs eligible for generic competition and also "double the opportunities for pharmacists to be exposed to potential liability for injuries arising out of substitution." He added that "the scope of that liability has not been fully defined by the courts, although clearly it is greater in some states than in others." The pharmacist should "be familiar with the drug product selection law of his state," Shacknai said. "He should also keep current on bioavailability issues relating to drugs, and particularly on bioequivalence problems between generic drugs and their brandname counterparts. Any scientific data suggesting such problems, no matter how preliminary, may haunt him in a professional liability action." Specifically addressing the issue of therapeutic substitution, i.e. substituting one drug for another drug which is in the same therapeutic class but which is not generically equivalent to the prescribed drug, Shacknai stated: "I see enormous potential for legal liability for pharmacists under such a system and frankly question whether it would be more troublesome to pharmacists than it is worth. Chart omitted.
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth