The addition of benzodiazepines to the triplicate prescription program in New York State was successful in reducing the use of benzodiazepines in a nursing home population, but the use of alternative agents was substantially increased. The reduction in benzodiazepine use could not be shown to be associated with any reduction in risk of adverse events during a retrospective review. In order to evaluate the impact of a triplicate prescription program on patient care, endpoints of efficacy as well as toxicity must be identified prior to the implementation of new legislation. It should be incumbent upon those States considering implementation of triplicate legislation to realize that the imposition of these regulations is tantamount to forced enrollment in a clinical trial for the patients affected by the legislation. A mechanism must be available to prospectively assess changes in prescribing patterns and their clinical consequences in order to determine objectively whether the legislative intervention was a success.