Tetracyclines: analysis of the Ukrainian pharmaceutical market and consumption compared to European countries
Keywords:antibiotic resistance, tetracyclines, consumption, assortment
Tetracyclines are a class of antibiotics discovered over 50 years ago. These are relatively inexpensive drugs with a wide spectrum of action. Therefore, they are quite often used for the prevention and treatment of infectious diseases of humans and animals, as well as stimulants of the animal growth. The active use of antibiotics of the Tetracycline group for various indications in the 50s of the twentieth century led to the emergence of resistant microorganisms. After a long pause in the development of the tetracycline class antibiotics they are now being used more and more often for the treatment of infectious diseases caused by multidrug-resistant bacteria, for example, in osteoporotic/osteopenic bone loss, topically for the treatment of skin lesions, including acne. In 2005 and 2018 (3INN), the U.S. Food and Drug Administration (FDA) approved the use of new drugs of the Tetracycline group – Tigecycline, Omadacycline, Sarecycline and Eravacycline.
Aim. To study the range of antibiotics of the Tetracycline group at the pharmaceutical market ofUkraine, as well as the volumes of their consumption in 2013-2018.
Materials and methods. To analyze the assortment of Tetracycline antibiotics at the pharmaceutical market of Ukraine and worldwide, the resources of the WHO Collaborating Centre for Drug Statistics Methodology and the State Register of Medicines of Ukraine were used. Consumption was calculated using the standard ATC / DDD methodology recommended by the WHO.
Results. According to theWHOCollaborationCenter for the Methodology of Statistical Analysis of Medicines, there are 17 international non-proprietary names (INNs) of the Tetracycline group antibiotics; among them 2 INNs are combined drugs. InUkraine, during six years of studies from 2013 to 2018, only 3 INNs were present at the market – Doxycycline, Tetracycline and Tigecycline, which in 2018 were represented by 14 trade names (TNs). The share of domestic drugs at the Ukrainian market decreased from 54 % in 2013 to 50 % (2018) due to the expansion of the assortment of imported TNs. The consumption of antibiotics of the Tetracycline group during the study period increased by almost 0.026 DDDs/1000 inhabitants/day. Comparing the consumption of tetracycline antibiotics inUkraine and in Europe it can be noted that inUkraine there is a slight upward trend. At the same time, inEurope in 2018, there was a insignificant decrease in consumption by an average of 0.1 DDDs/1000 inhabitants/day.Conclusions. Of the 17 INNs antibiotics of the Tetracycline group in the world, only 3 INNs are presented at the pharmaceutical market of Ukraine. On average, from 2013 to 2018, 13-14 TNs tetracyclines were presented at the pharmaceutical market of Ukraine. The consumption of tetracycline antibiotics in Ukraine over the study period increased by almost 0.026 DDDs/1000 inhabitants/day, while in Europe it remained at the same level during 2015-2017, and in 2018 it decreased slightly.
Fleming, A. Penicillin. Nobel Lecture, December 11, 1945. Available at: https://www.nobelprize.org/prizes/medicine/1945/fleming/lecture/ (date of access: 11.12.2019).
World Health Organization. (2015). Global Action Plan on Antimicrobial Resistance.Switzerland,Geneva, 28. Available at: https://apps.who.int/iris/bitstream/handle/10665/193736/9789241509763_eng.pdf?sequence=1 (date of access: 11.12.2019).
Melnykowycz J., Johansson K. R. (1955). Formation of amines by intestinal microorganisms and the influence of chlortetracycline. The Journal of experimental medicine, 101 (5), 507–517. doi: 10.1084/jem.101.5.507.
Chopra, I., Roberts, M. (2001). Tetracycline antibiotics: mode of action, applications, molecular biology, and epidemiology of bacterial resistance. Microbiology and molecular biology reviews, 65 (2), 232–260. doi: 10.1128/MMBR.65.2.232-260.2001.
Watanabe, T. (1963). Infective heredity of multiple drug resistance in bacteria. Bacteriological reviews, 27 (1), 87–115.
Aoki, T., Satoh, T., Kitao, T. (1987). New tetracycline resistance determinant on R plasmids from Vibrio anguillarum. Antimicrobial agents and chemotherapy, 31 (9), 1446–1449. doi: 10.1128/aac.31.9.1446.
Payne, J. B., Golub, L. M. (2011). Using tetracyclines to treat osteoporotic/osteopenic bone loss: from the basic science laboratory to the clinic. Pharmacological research, 63 (2), 121–129. doi: 10.1016/j.phrs.2010.10.006.
Tamarkin, D., Gazal, E., Keynan, R., Eini, M., Schuz, D. (2015). U.S. Patent Application No. 14/384,978.
FDA’s Center for Drug Evaluation and Research. (n.d.). New Approvals Report 2018. Available at: https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2018 (date of access: 10.12.2019).
Iakovleva, L. V., Tkacheva, O. V., Kosolapova, Ya. O. (2010). Proceeding from Farmakoekonomika v Ukraine: sostoianie i perspektivy razvitiia: Materialy III nauch.-prakt. konf., (25-26 fevralia 2010) (pp. 283-285). Kharkiv: NFaU.
Tkachenko, K. M. (2017). Eksperymentalne obgruntuvannia zastosuvannia kombinatsii hliukozaminu z doksytsyklinom pry zapalnykh zakhvoriuvanniakh suhlobiv. PhD thesis. Kharkiv.
Iakovlieva, L., Bahlai, T. (2019). Β-lactam antibiotics in Ukraine: market and consumption analysis in 2013–2018. ScienceRise. Pharmaceutical Science, 2, 16-21. Available at: http://nbuv.gov.ua/UJRN/texcfarm_2019_2_5 (date of access: 14.12.2019).
WHO Collaborating Centre for Drug Statistics Methodology Available at: https://www.whocc.no/atc_ddd_index/ (date of access: 12.12.2019).
Derzhavnyi reiestr likarskykh zasobiv Ukrainy. Departament farmatsevtychnoi diialnosti, Derzhavnyi ekspertnyi tsentr Ministerstva okhorony zdorovia Ukrainy. Available at: http://www.drlz.com.ua (date of access: 12.12.2019).
Systema doslidzhennia rynku likarskykh zasobiv “Farmstandart” kompanii “Morion”. Available at: http://www.pharmstandart.com.ua (date of access: 12.12.2019).
Morozov, A. M., Iakovlieva, L. V., Stepanenko, A. V. et al. (2013). Vyvchennia spozhyvannia likarskykh zasobiv za anatomo-terapevtychno-khimichnoiu klasyfikatsiieiu ta vstanovlenymy dobovymy dozamy (ATC/DDD-metodolohiia). Kyiv: NFaU; DETs MOZ Ukrainy, 32.
Derzhavna sluzhba statystyky Ukrainy. Available at: http://www.ukrstat.gov.ua/ (date of access: 12.12.2019).
European Surveillance of Antimicrobial Consumption Network. Publications & data. Reports for 2015, 2016, 2017, 2018. Available at: https://www.ecdc.europa.eu/en/publications-data (date of access: 14.12.2019).
Nakaz Ministerstva okhorony zdorovia Ukrainy No. 1317 vid 09.12.2016 “Pro provedennia klinichnykh vyprobuvan likarskykh zasobiv ta zatverdzhennia suttievykh popravok”. zakon.rada.gov.ua. Available at: https://zakon.rada.gov.ua/laws/show/z1010-09 (date of access: 15.12.2019).
Antimicrobial Medicines Consumption (AMC) Network. AMC Data 2011–2014. (2017). WHO Regional Office for Europe, 168. Available at: https://apps.who.int/medicinedocs/documents/s23195en/s23195en.pdf (date of access: 15.12.2019).
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