A comparative analysis of the innovator and generic package inserts for selected central nervous system medication in South Africa
Date
2016
Authors
Moodley, Kerusha
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Abstract
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.
Description
Research Report in partial fulfillment of MSc (Med) Pharmaceutical Affairs
Department of Pharmacy and Pharmacology
University of Witwatersrand
Faculty of Health Sciences