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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.
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