1. Konrad Rokita 1, 3, Grzegorz Cessak 1,2, Ewa Bałkowiec-Iskra 1,2,3 1 Department of Experimental and Clinical Pharmacology, Medical University of Warsaw 2 The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Warsaw, Poland 3 Nowowiejski City Hospital, Warsaw, Poland Introduction of a specific set of rules that enabled registration of generic medicinal products constituted one of the major breakthroughs in pharmacotherapy of mental disorders. Generic drugs currently available on the market meet the criteria of bioequivalence, that have been agreed upon by registration agencies all over the world. They allow treatment that is as effective and safe, as the one achieved with reference products. Lower prices of generic medicinal products are due to the reduced costs of obtaining the marketing authorization; and these drugs meet the same quality requirements as the reference products. Similarly to reference products, they are a subject to postmarketing surveillance of adverse drug reactions. However, despite regulatory declaration, switching from reference to generic drugs is often associated with concerns of healthcare providers about decreased treatment effectiveness or occurrence of adverse drug reactions. The aim of the present research was to retrospectively study therapeutic equivalence of selected reference and generic psychotropic drugs in patients treated in Nowowiejski Hospital (Warsaw, Poland). INTRODUCTION MATERIALS AND METHODS RESULTS CONCLUSIONS: Therapeutic equivalence of psychotropic drugs Medical histories of patients treated in Psychiatric Ambulatory in Nowowiejski Hospital were analyzed. Therapeutic response was assessed in period of twelve months after the switch from reference or generic antipsychotics or antidepressants to the other generic. Included were only cases of patients in psychiatric stable state for the period of minimum two months. Cases where lack of compliance in the period of one year before the switch was documented were excluded from the analysis. Moreover, impossibility of history identification and patient’s addiction were the causes of exclusion. 720 medical histories were analyzed, identifying 140 cases fulfilling inclusion criteria. Only 9 adverse events were reported. This included: 3 cases of weight gain and single cases of hyperglycemia, hypercholesterolemia, akathisia, xerostomia in patients after olanzapine switch. Quetiapine switch caused weight gain in one patient. Only one adverse effect was observed after antidepressant switch – restlessness in patient treated with sertraline. The detailed results are presented in the graphs below. Changes in efficacy and adverse effects of treatment with generic antipsychotic and antidepressive drugs are rare, however, as reasons for these rare phenomena remain unknown and impossible to predict in individual cases, a careful clinical patient monitoring should be performed during at least the first few weeks after the conversion. In case of any mental state deterioration, psychological factors and the resulting decreased compliance should be considered and discussed with the patient. A dose adjustment of a newly introduced generic drug may be required. If serious adverse effects or deterioration of the mental state occur, reference treatment should be reintroduced. All cases of a therapeutic inequivalence should be carefully monitored and made available to the public. Medical professionals should be encouraged to publish observations associated with the drug switch in their own patients. Stability or improvement of mental state Worsening a mental state New adverse events after switch Drug switch or discontinuation

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