Bioequivalence as the basis of generic replacement in the framework of pharmaceutical care
V Propisnova, I Zupanets and O Tarasenko
National University of Pharmacy, Ukraine
: J Pharm Sci Emerg Drugs
Abstract
In Ukraine, the choice of OTC-drug in case of relief of particular non-dangerous symptoms is regulated by the Order of the Ministry of Health No. 283 "About approval of the list of medicines permitted for use in Ukraine, which are dispensed without prescriptions from pharmacies and their structural units" and Order No. 875 "About approval of the Standards for the pharmacist ". However, there are only lists of recommended medicines, without any indications of their interchangeability and quality in the both documents. In this issue a reference book "Rxindex: a guide to the equivalence of medicines" is a good argument to Ukrainian pharmacists. The authors describe the characteristics of medicines from the point of view of the therapeutic (bio-) equivalence code. Information about the drugs, registered in Ukraine at the time of publication, according to the ATC classification, complete list of analogues with the indication of the manufacturer, dose and dosage forms, main indications and contraindications, information about the therapeutic equivalence, short and sufficient information for the prescribing are presented in this book. For a generic replacement, the pharmacist is recommended to choose preparations having the same composition, the same dosage form and code A (products, registered on the base of full dossier, including innovative medicines), B (products, the effectiveness of which was proved by bioequivalence research) or B1 (products, the equivalence of which is not subject to proof or proved by the dissolution test (biowaver). Thus, in Ukraine today there is a source of reliable information about the quality of the studies performed during the registration of drugs, which will help any pharmacist to perform correct generic replacement or qualitative pharmaceutical care.
Biography
Viktoriia Propisnova graduated in Pharmacy from Kharkov Institute of Pharmacy (Ukraine) in 1992 and completed her PhD in 1999. She is the Associate Professor of the Department of Clinical Pharmacology and Clinical Pharmacy of the National University of Pharmacy (Ukraine). The main area of her scientific activity is the development and practical implementation of ideas and fundamentals of pharmaceutical care in applied medicine and pharmacy.
E-mail: katyazupanets@gmail.com
