Expert evaluation of the effectiveness of the anti-counterfeiting of medicines in Ukraine
Official statistics of the counterfeit medicines circulation significantly reduces the level of patient confidence not only to pharmacy specialists, but also to the healthcare system and even other government institutions. All stakeholders, from academics to politicians, point to the significant implications of this situation for the healthcare system. The relevance and complexity of the problems of combating the falsification of medicines requires an expert assessment of pharmacy specialists.The aim of the work is to evaluate the effectiveness of the anti-counterfeiting of medicines using a questionnaire of specialists of the State Service of Ukraine on Medicines and Drug Control and its territorial bodies.The object of the research was scientific publications, as well as the study of the opinions of specialists of the State Service of Ukraine on Medicines and Drug Control and its territorial bodies on the problems of anti-counterfeiting of medicines. The study was conducted using questionnaire survey methods, systematization and generalization.According to the results of the survey, respondents rated the work of the State Service of Ukraine and its territorial bodies on the prevention of the sale of counterfeit drugs as effective, but there are some problems – 67.16% and 76.12%; in general, as effective – 31.34% and 20.90% respectively. An assessment of the directions of inspection of pharmacies has showed that the majority of respondents to the first place belonged – the cancellation of a note of warning about planned inspection (86.57%), to the second and third – simplification of the inspection procedure in the presence of consumer complaints (without additional approvals), 64.18% and the introduction of the right to conduct «test purchases» of medicines by inspectors (56.72%), respectively. Effective methods that are appropriate to use to identify counterfeit drugs included: scanning 2-d barcodes using special equipment and software – 79.10%, a detailed study of supporting documents – 53.73%, a careful visual inspection of packages – 47,76%.Based on the results of the expert evaluation, the most important tools were established that minimize the problem of counterfeit medicines circulation: a significant increase in the powers of the regulatory body (according to the FDA) – 70.15%, independent serial quality control of imported and manufactured drugs and APIs – 64.18%, strengthening responsibility for admission to the pharmaceutical market of drugs with unproven effectiveness – 59.70%.According to the results of an expert evaluation of the pharmacy specialists, the most important priorities of state policy were established, that allows to increase the effectiveness of the medicines’ anti-counterfeiting, namely improving the system of state quality control and strengthening the responsibility for falsification of medicines.
Demchenko I. C., Soloviov O. C. Poperedzhennia poshyrennia falsyfikovanykh likarskykh zasobiv na mizhnarodnomu ta natsionalnomu rivniakh. – K.: TOV «Novyi druk», 2014. – 128 s.
Soloviov O. S. Mizhnarodnyi mekhanizm protydii falsyfikatsii medychnoi produktsii yak zasib pidvyshchennia yakosti u farmatsii Ukrainy // Upravlinnia, ekonomika ta zabezpechennia yakosti u farmatsii. – 2019. – № 3 (59). – S. 28–34.
Tolochko V., Medvedieva Yu. Vyvchennia dosvidu Yevropeiskoho Soiuzu shchodo borotby z falsyfikovanymy likarskymy zasobamy, yaki realizovuiutsia cherez internet apteky // Farmats. kurier. – 2012. – № 2. – S. 16–19.
Shmatenko O. P., Holub A. H., Rudenko V. V. ta in. Problemy rozpovsiudzhennia falsyfikovanykh likarskykh zasobiv ta shliakhy yikh vyrishennia // Viiskova medytsyna Ukrainy. – 2018. – T. 18, № 3. – S. 86–90.
Kovalenko I. A. Falsyfikatsiia ta obih falsyfikovanykh likarskykh zasobiv: kryminalno-pravove doslidzhennia : monohrafiia / Nauk. red. Ye. L. Streltsova. – Odesa: Vydavnychyi dim «Helvetyka», 2018. – 232 s.
Funestrand H., Liu R., Lundin S., Troein M. Substandard and falsified medical products are a global public health threat. A pilot survey of awareness among physicians in Sweden // J. Public. Health (Oxf). – 2019. – V. 41, N 1. – P. e95–e102. Published online 2019 Apr 11. https://doi.org/10.1093/pubmed/fdy092. PMCID: PMC6459355. PMID: 29860331.
Januszewicz P., Wolan M., Sobolewski M. et al. Counterfeit medicines in Poland: opinions of primary healthcare physicians, nurses and lay persons // JCN. https://doi.org/10.1111/j.1365-2702.2012.04166.x
Binkowska-Bury M., Wolan M., Januszewicz P. et al. What Polish hospital healthcare workers and lay persons know about counterfeit medicine products? // Central Eur. J. Public Health. – 2012. https://doi.org/10.21101/cejph.a3727
Daariimaa Khurelbat, Gereltuya Dorj, Enkhtuul Bayarsaikhan et al.. Prevalence estimates of substandard drugs in Mongolia using a random sample survey // Springerplus. – 2014. – V. 3. – P. 709. Published online 2014 Dec 2. https://doi.org/10.1186/2193-1801-3-709. PMCID: PMC4265637. PMID: 25525570.
This work is licensed under a Creative Commons Attribution 4.0 International License.