State regulatory positions concerning therapeutic substitutions in hospitals

Abstract

State regulatory agencies were surveyed to determine their views concerning hospital policies that allow therapeutic substitution. A questionnaire consisting of 10 close-ended questions was sent to the executive secretary of each board of pharmacy in the 50 states and District of Columbia. Agencies were contacted by telephone in four weeks if they did not respond. Of the 51 jurisdictions surveyed, 34 answered all of the questions, 13 answered some, and 4 did not respond. None of the 13 partial respondents expressed their views concerning the legality of therapeutic substitution in the institutional setting. Fifteen agencies indicated they would view this practice as illegal, 17 said it is in accordance with policies established by the P & T committee and therefore not subject to state or federal regulation, and two agencies gave qualified responses. Seven agencies indicated enforcement procedures would be initiated if they were to learn that therapeutic substitution was being practiced in a hospital within their jurisdiction. Three states were uncertain about what action would likely be taken, 23 indicated no action would be taken, and two gave qualified responses. All 39 agencies responding to the question indicated they had never taken action against the practice of a formulary system that allows therapeutic substitution. Few state laws address the practice of therapeutic substitution, and opinions of regulatory agencies vary. Moreover, the opinions rendered have not been tested in the courts.