Generic Olanzapine: Health Authority Opportunity or Nightmare?

A. Aleksander Araszkiewicz; Katarzyna Szabert; Brian Godman; Magdalena Wladysiuk; Corrado Barbui; Alan Haycox

Disclosures

Expert Rev Pharmacoeconomics Outcomes Res. 2008;8(6):549-555. 

In This Article

Methodology

The records of all outpatients prescribed Zyprexa or generic olanzapine to treat schizophrenia in the University Department of Psychiatry in Bydgoszcz between January 2000 and September 2007 were reviewed by Katarzyna Szabert. No Ethical Committee approval was sought as this was not necessary under local regulations.

Three different branded generic formulations were available in Poland during the study period in addition to the originator product, with the first formulation launched in October 2003. Datasets for each patient included their age, sex, time diagnosed with schizophrenia, length of follow-up since first prescribed olanzapine, whether they were prescribed olanzapine monotherapy or olanzapine plus other antipsychotics at any time, the extent of switching form Zyprexa to generic formulations and vice versa, side-effects while prescribed atypical antipsychotics as well as whether they relapsed.

Relapses were defined as any change in the patient's mental state, such as a recurrence of psychotic symptoms or changes in antipsychotic medication due to worsening of the patient's mental state as reported in the notes. If patients relapsed, the rationale for the relapse including poor compliance and subsequent management was also analyzed.

All outpatients were typically monitored monthly with patient follow-up lasting years in some cases. All patients were managed by psychiatrists working in the Medical Academy. Psychoeducation was also given routinely to patients and their family by the psychiatrists during their outpatient visit to help further improve their health.

No statistical analysis was performed in view of the heterogeneity of the outpatient population. In addition, we could not be sure that all the patients' characteristics were contained in the notes. This further reduces the possibility of undertaking any statistical analyses.

Polish Zloties are used in this paper as the principal currency (£1 = 4.2zl, €1 = 3.33 zl; as of 9 September 2008).

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