Article Sidebar
Published:
Dec 1, 2016Article Details
Copyright remains in the Author’s name. The work is licensed under a Creative Commons Attribution - Noncommercial Works License. Authors are required to complete and sign an Author Agreement form that outlines Author and Publisher rights and terms of publication. The Agreement form should be uploaded along with other submissions files and any submission will be considered incomplete without it [forthcoming].
Material submitted for publication in the SAMJ is accepted provided it has not been published or submitted for publication elsewhere. Please inform the editorial team if the main findings of your paper have been presented at a conference and published in abstract form, to avoid copyright infringement. The SAMJ does not hold itself responsible for statements made by the authors.
Previously published images
If an image/figure has been previously published, permission to reproduce or alter it must be obtained by the authors from the original publisher and the figure legend must give full credit to the original source. This credit should be accompanied by a letter indicating that permission to reproduce the image has been granted to the author/s. This letter should be uploaded as a supplementary file during submission.
Main Article Content
Generic substitution comparing the clinical efficacy of a generic substitute for fluphenazine decanoate with the original product
Abstract
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.
