USE OF INNOVATIVE TECHNOLOGIES TO PREVENT FALSIFICATION OF MEDICINES
DOI:
https://doi.org/10.11603/2312-0967.2020.3.11425Keywords:
falsification of medicines, identification, authenticity, technology of protection, 2D barcode, packaging, markingAbstract
The aim of the work. Research of modern technologies of protection of medicines against falsification and analysis of the state and prospects of introduction of an effective system of prevention of falsification of medicines in Ukraine as an important factor in improving the quality and safety of medicines.
Materials and Methods. The objects of the study were scientific publications of domestic and foreign scientists, domestic regulations in the field of control of medicines, international legal acts, European Union Directives. In the study there were used logical, structural and comparative methods of analysis, expert evaluation, generalization and systematization.
Results and Discussion. It is established that one of the effective means of preventing the spread of counterfeit drugs in the global and national pharmaceutical markets is the development and implementation of technologies for the protection of drug packaging, which allow tracking and obtaining the necessary information at all stages of life cycle of drug from manufacturer to consumer. The article show the international experience of using the safety of packaging of medicines, which provide the opportunity to confirm their authenticity at all stages of life cycle, identifies options and characteristics of the most promising modern technologies for the protection of medicines.
Conclusions. Preventing the circulation of counterfeit medicines is a priority at both the international and national levels. Modern technologies make it possible to organize effective control of medicines throughout the supply chain from manufacturer to consumer and prevent the appearance of counterfeit medicines in the legal supply system. Today, the use of 2D barcodes is a good tool to prevent falsification of medicines at all stages of life cycle, which is introduced by more and more pharmaceutical manufacturers around the world.
References
Substandart and falseified medicinal products. [Electronic resource]. Available from: http://www.who.int/medicines/services/counterfeit/en/ [Accessed June 2020].
Council of Europe Convention on the Counterfeiting of Medical Devices and Similar Crimes Threatening Health from 28.10.2011. [Electronic resource]. Available from: https://zakon.rada.gov.ua/laws/show/994_a91 /. [Accessed June 2020]. Ukrainian.
State service of Ukraine on medicines and drugs control. [Electronic resource]. Available from: http://dls.gov.ua /. [Accessed June 2020]. Ukrainian.
Lebed S. O. Historical aspects and current state of drug falsification in Ukraine [ Історичні аспекти та сучасний стан фальсифікації лікарських засобів в Україні ] Rivne: Volyn. Oberehy; 2018. Ukrainian.
Law of Ukraine “On ratification of the Council of Europe Convention on Counterfeiting of Medical Devices and Similar Crimes Threatening Health” from June, 2012 № 4908-VI. [Electronic resource]. Available from: https://zakon.rada.gov.ua/laws/show/4908-17#n2. [Accessed June 2020]. Ukrainian.
World Health Organization. Substandard and Counterfeit Medicines. [Electronic resource]. Available from: http://www. who.int/mediacentre/factsheets/2003/fs275/en/. [Accessed July 2020].
World Health Organization. Global Surveillance and Monitoring System for substandard and falsified medical products. [Electronic resource]. Available from: https://www.who.int/medicines/regulation/ssffc/publications/GSMSreport_EN.pdf?ua [Accessed June 2020].
World Health Organization. Seventieth World Health Assembly. [Electronic resource]. Available from: http://www.who.int/mediacentre/news/releases/2017/dementia-immunization-refuguees/en/ [Accessed June 2020].
International Medical Products Anti-Counterfeiting Taskforce. Anti-counterfeit Technologies for the Protection of Medicines. [Electronic resource]. Available from:http://www.who.int/impact/events/IMPACTACTechnologhiesv3LIS.pdf. [Accessed June 2020].
PQM: Promoting the Quality Medicines in Developing Countries. [Electronic resource]. Available from: http://www.usp.org/global-health-impacprograms/promoting-quality-medicines-pqmusaid. [Accessed June 2020].
FDA's Anti-Counterfeit Device, 2013. [Electronic resource]. Available from: http://www.hhs.gov/open/initiatives/hhsinnovates/round6/fda-anti-counterfeit-device.html. [Accessed June 2020].
Kovacs S., Hawes S., Maley S., Mosites E., Wong L., Stergachis A. Technologies for detecting falsified and substandard drugs in low and middle-income countries [Electronic resourse]. PLoS Med. 2014;9(3). Available from: http://journals.plos.org/plosmedicine/article?id=10.1371/ journal.pmed.1001388. [Accessed June 2020]. DOI: https://doi.org/10.1371/journal.pone.0090601
Global Health Observatory (GHO) data. [Electronic resource]. – Available from: https://www.who.int/gho/database/en/.[Accessed June 2020].
Mackey T. K., Nayyar G. A review of existing and emerging digital technologies to combat the global trade in fake medicines. [Electronic resource]. Expert Opin. Drug Saf.2017;16:587-602. Available from: https://pubmed.ncbi.nlm.nih.gov/28349715/ [Accessed June 2020]. DOI: https://doi.org/10.1080/14740338.2017.1313227
US Food and Drug Administration. Radio Frequency Identification (RFID). [Electronic resource]. Available from: https://www.fda.gov/radiation-emittingproducts/radiationsafety/electromagneticcompatibilityemc/ucm116647.htm. [Accessed June 2020].
World Health Organization. A Study on the Public Health and Socioeconomic Impact of Substandard and Falsified Medical Products. [Electronic resource]. Available from: www.who.int/medicines/regulation/ssffc/publications/Layout-SEstudy-WEB.pdf?ua=1. [Accessed June 2020].
Directive 2011/62/EU of The European Parliament and of the Council of 8 June 2011 Amending Directive 2001/83/EC on the Community Code Relating to Medicinal Products for Human Use. [Electronic resource]. Available from: ec.europa.eu/health/sites/health/files/files/eudralex/vol1/dir_2011_62/dir_2011_62_en.pdf. [Accessed June 2020].
Downloads
Published
How to Cite
Issue
Section
License
The authors who publish their materials in this journal agree with the following terms:
- Authors reserve the right to authorship of their work and assign to the journal the right to first publish this work under the terms of the Creative Commons Attribution License, which allows other persons to freely distribute the published work with a mandatory reference to the authors of original work and the first publication of work in this journal .
- Authors have the right to make independent extra-exclusive work agreements in the form they are published by this journal (for example, posting work in an electronic repository of an institution or publishing as part of a monograph), provided that the link to the first publication of the work in this journal is maintained.
Journal policy allows and encourages publication of manuscripts on the Internet (for example, in institutions repositories or on personal websites), both before the publication of this manuscript and during its editorial review, as it contributes to productive scientific discussion and positively affects the efficiency and dynamics of the citation of the published work (see The Effect of Open Access).