Generic substitution--comparing the clinical efficacy of a generic substitute for fluphenazine decanoate with the original product.

UNLABELLED: Long-acting neuroleptics have become the mainstay of the long-term treatment of schizophrenia, improving compliance and thus preventing relapse. Since schizophrenia is a common condition and treatment is usually long-term, this has important financial implications.

OBJECTIVE

Generic substitution is an important cost-saving measure and generic psychopharmacological agents are also currently available in South Africa. There have been concerns about the quality of these products, but these often arise from anecdotal reports. This study was undertaken to compare the clinical efficacy of a generic substitute of fluphenazine decanoate with the original product.

DESIGN AND

SETTING

The study was a double-blind randomised trial involving two parallel groups--generic substitution v. original product. Chronic schizophrenics, aged between 18 and 65 years, who had been on a constant dose of fluphenazine decanoate for at least 3 months preceding the trial, all treated as outpatients in the community, were studied. The Positive and Negative Syndrome Scale (PANSS) (positive scale) was used as measuring scale and patients were evaluated at inclusion and then every 2 weeks for the next 12 weeks.

RESULTS

Both groups had a median change of zero in PANSS scores over the 12-week period. No clinically significant differences between the change in PANSS score were found in respect of the two products.

CONCLUSIONS

Generic substitution could play an important role in containing the costs of health care in South Africa. Concerns about the quality and efficacy of these drugs should be investigated. In this study, no significant differences in the efficacy of the two products were found.