A comparative analysis of the innovator and generic package inserts for selected central nervous system medication in South Africa

Moodley, Kerusha
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The evolution of generic medicines has provided greater access to healthcare for the general population. But this has also given rise to disparities with respect to information that needs to accompany generic medicines. Generic companies face a major problem when bringing a new product to the market place. Access to the originators’ clinical and post surveillance data is prohibited and not easily attainable. This data provides the basis of the labelling information and if copied, generic companies run the risk of copyright infringement which creates tension on how appropriate information is delivered. Consequently, generic manufacturers are forced to develop PIs. Previous studies indicate that this process yields a package insert of substandard quality with questionable quality, which leaves the impression that the pharmaceutical industry is more profit-driven than patient-driven. This is a comparative study of innovator and generic package inserts for molecules; fluoxetine, citalopram, sertraline, venlafaxine and risperidone. A textual analysis was used to compare package inserts. Key findings from this novel study demonstrate that there are considerable differences between the originator PI and the generic brands. Side effects experienced solely by women who are twice more likely than males to administer antidepressants were found to be omitted from two out of three generics. Limited access to correct information impedes the decision making process for the healthcare professional as well as the patient resulting in lack of confidence in the product itself. Other significant findings highlighted in this study revealed inconsistencies with respect to the use of words with opposing meanings, incorrect use of prefixes which ultimately shifts the meanings of words as well as the alteration of nouns which downplays the severity of side effects further emphasizing the variability of prescribing information currently available in South Africa. Ordering of risk within a package insert is an important factor in determining the risk profile conveyed by text. Deciphering the most important information from the less important information proves to be difficult with the package inserts analysed. The on-going trend depicts gaps in the South African registration system with respect to labelling of medicines and thus warrants urgent attention.
Research Report in partial fulfillment of MSc (Med) Pharmaceutical Affairs Department of Pharmacy and Pharmacology University of Witwatersrand Faculty of Health Sciences