RISPERIDONE USE IN A TEACHING HOSPITAL DURING ITS FIRST YEAR AFTER MARKET APPROVAL - ECONOMIC AND CLINICAL IMPLICATIONS

Risperidone, a new antipsychotic drug, was recently approved by the Fo od and Drug Administration (FDA) on the basis of its having comparable efficacy and less toxicity than haloperidol. In a preliminary study t o evaluate the therapeutic efficiency of this drug, we conducted a sur vey of risperidone utilization, cost, and safety during its first year of availability at an academic psychiatric hospital. Data were obtain ed from a computerized, centralized medical record system, from an adv erse drug reaction monitoring system, and from pharmacy purchasing rec ords. In Its first year of availability, risperidone became the second most widely used antipsychotic agent at our institution. Most of this use extended beyond the adult schizophrenia population, for whom pre- marketing safety and efficacy data are available. The direct instituti onal cost of risperidone treatment exceeded the entire budget for anti psychotic drugs during the year before its release. Results from the a dverse drug reaction reporting system did not indicate a strong advant age of risperidone over more established antipsychotic agents with res pect to extrapyramidal side effects. Furthermore, the mean dose of ris peridone associated with extrapyramidal symptoms was 3.5 mg/day, consi derably lower than that suggested by pre-marketing studies in a more s elect patient group. These results confirm that new pharmacological ag ents are generally used in much broader patient populations than those for which efficacy and safety have been established prior to FDA appr oval. This study also raises questions about the therapeutic efficienc y of risperidone compared with other antipsychotic drugs. We conclude that systematic studies of outcome, safety, and cost of new pharmaceut icals in naturalistic settings are needed to provide the data necessar y to establish local standards of cost-effective care.