CNS Drugs 2004; 18 (12): 769-775 CURRENT OPINION 1172-7047/04/0012-0769/$31.00/0  2004 Adis Data Information BV. All rights reserved. The Generic Alternative in Schizophrenia Opportunity or Threat? Philippe Nuss, 1 David Taylor, 2 Marc De Hert 3 and Martina Hummer 4 1 Psychiatry Department, H ˆ opital St Antoine, Paris, France 2 Pharmacy Department, Maudsley Hospital, London, UK 3 University Psychiatric Centre St Jozef, Catholic University of Louvain, Kortenberg, Belgium 4 Department of Biological Psychiatry, Innsbruck University Clinics, Innsbruck, Austria Pharmacological treatment of schizophrenia often requires careful dosage Abstract titration to achieve satisfactory symptom control whilst minimising the risk of adverse effects. Relapses requiring hospitalisation are an important potential source of additional cost for the health service and any inadequate symptom control increases the indirect costs of schizophrenia relating to, for example, the need for sheltered accommodation or intensive social services support. The availability of generic drugs is widely regarded as an opportunity to reduce expenditure on drug costs and deploy limited resources more widely and effec- tively. However, generic drugs may differ from branded drugs in their formulation and may not show precise bioequivalence with the branded product. This may have consequences for the pharmacokinetic profile of the generic drug. A higher maximum plasma concentration (Cmax) could lead to increased or emergent adverse effects, whereas a decreased absorption or minimum plasma concentra- tion (Cmin) may result in a reduced therapeutic effect. For example, plasma levels of clozapine are critical to therapeutic response. Symptom aggravation occurred in approximately 10% of patients switched from branded to generic clozapine in a small, randomised, crossover study. Patients with schizophrenia may also show suspicion and hostility regarding their treatment. This may result in unwillingness to take an unfamiliar medication and decreased compliance, thus increasing the risk of a relapse. Thus, great care should be taken by psychiatrists when switching patients with schizophrenia from branded to generic antipsychotic drugs; this entails monitor- ing clinical outcome closely and adjusting the treatment in case of symptom aggravation or emergence of adverse effects. Schizophrenia is a chronic debilitating mental adjustments of treatment regimens and often fre- disorder that is associated with a lifetime risk of quent episodic hospitalisation, if not long-term insti- about 1% in the adult population and usually devel- tutional care, and consumes significant public health ops during adolescence or early adulthood. [1] Treat- service financial resources. However, appropriate ment involves long-term drug therapy with multiple pharmacotherapy allows many patients to be treated