Abstract
Objective: To investigate the knowledge and perceptions of final-year medical students in the Yemeni universities about generic medicines.Methods: A two-month cross-sectional survey was conducted among final-year medical students in three Yemeni universities; Sana’a University, University of Science and Technology and Thamar University in 2013.Results: One hundred and sixty-five medical students out of 270 responded to the present study, with a response rate of 61.1%. More than 60% of medical students were not introduced to bioequivalence of generic medicines during their undergraduate study, and 80.0% of them had a low desire to inquire about it during their study. In addition, more than 60.0% of them were unaware of the similarity of generic medicines to their brand equivalents in dosage form and dose. More than three-quarters of the medical students incorrectly perceived that generic medicines are inferior in quality (80.0%), less effective (58.0%) and with more side-effects (47.8%) than their brand equivalents. The medical students in the present disagreed about the need for more information on the safety and efficacy of generic medicines.Conclusions: Yemeni students need to further enhance their awareness and expand their knowledge about the concepts and principles of bioavailability and bioequivalence of generic medicines if they are to contribute appropriately to generic medicine use.
Highlights
Utilizing generic medicines in place of their brands has been suggested as one area of health to reduce annual healthcare expenditure without compromising its delivered quality [1,2,3]
Registration of generic drugs as new products and their subsequent marketing require bioequivalence studies. These bioequivalence studies of generic medicines are mainly based on maximum plasma concentration (Cmax) and area under the plasma concentration curve (AUC) from administration to last observed concentration
For generic medicines to be accepted for sale in the Yemeni markets, they must be bioequivalent to the reference product, and their AUC and Cmax values must be within an acceptance range of 0.80– 1.25 of those of the reference product according to the U.S Pharmacopeia, or these generic medicines have been accepted by two Middle East countries [5]
Summary
Utilizing generic medicines in place of their brands has been suggested as one area of health to reduce annual healthcare expenditure without compromising its delivered quality [1,2,3]. Bioequivalent, to brand medicines in dosage form, safety, efficacy, route of administration, quality and intended medical use [4]. Registration of generic drugs as new products and their subsequent marketing require bioequivalence studies. These bioequivalence studies of generic medicines are mainly based on maximum plasma concentration (Cmax) and area under the plasma concentration curve (AUC) from administration to last observed concentration. In Yemen, prior to being introduced to the market, generic medicines have to be approved by the Supreme Board for Drugs & Medical Appliances [5]. For generic medicines to be accepted for sale in the Yemeni markets, they must be bioequivalent to the reference product, and their AUC and Cmax values must be within an acceptance range of 0.80– 1.25 of those of the reference product according to the U.S Pharmacopeia, or these generic medicines have been accepted by two Middle East countries [5]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
