Pharmaceuticals: Management Safety of Circulation of Drugs
DOI:
https://doi.org/10.53933/sspmpm.v4i2.148Keywords:
pharmaceuticals, management, safety, circulation of drugs, proper GxP practices, pharmaceutical lawAbstract
The adoption and implementation of EU pharmaceutical directives and regulatory documents in Ukraine will significantly enhance the level of public health protection. Establishing a unified pharmaceutical market with EU countries will also improve the safety, quality, and accessibility of medications in Ukraine. To achieve these objectives, a comprehensive system for managing drug circulation safety has been proposed, with detailed functions and roles elaborated. Key components of this safety management system include robust monitoring mechanisms, stringent regulatory compliance measures, and effective communication channels among stakeholders. By implementing these measures, Ukraine can ensure that drugs are safe, effective, and of high quality, thereby fostering greater public trust in the healthcare system. Additionally, the integration of advanced technologies and best practices from EU countries can streamline drug approval processes, reduce counterfeit medications, and enhance pharmacovigilance. Efforts to improve the circulation of drugs will not only guarantee their safety and quality but also make them more readily available to the population. This will involve upgrading infrastructure, enhancing regulatory frameworks, and fostering collaboration with international pharmaceutical organizations. Overall, these initiatives are crucial for aligning Ukraine's pharmaceutical sector with European standards, ultimately leading to better health outcomes for its citizens and a more resilient healthcare system.
References
Pignattі F., Boone H., Moulon I. Overview of the European regulatory approval system. J. Ambul. Care Manage. 2004. Vol. 27. No. 2. P. 89-97. DOI: 10.1097/00004479-200404000-00003 DOI: https://doi.org/10.1097/00004479-200404000-00003
Pharmaceuticals: EU Regulations [6.0 RAC]. RAPS. 2024. URL: https://www.raps.org/products/pharmaceuticals-eu-regulations-60-rac
Health and social responses to drug problems: a European guide. EMCDDA. October 2021. URL: https://www.emcdda.europa.eu/publications/health-and-social-responses-a-european-guide_en
Medicine in the UK: from each – whenever possible, for everyone – on demand. https://www.vz.kiev.ua/medytsyna-velykoyi-brytaniyi-vid-kozhnogo-po-mozhlyvosti-kozhnomu-po-potrebi/
Shapovalov V.V.(Jr.), Shapovalova V.O., Shapovalov V.V. Experience of Great Britain in organization of healthcare system for pharmaceutical provision with medicines for privileged categories of citizens. Health of society. 2019. Vol. 78. No. 1. P. 36–40. URL: https://health-society.zaslavsky.com.ua/index.php/journal/article/view/188
Shapovalov V.V.(Jr.), Gudzenko A.A., Shapovalova V.A. et al. Experience of the USA concerning and organization of healthcare system for the pharmaceutical provision for privileged categories of citizens. Annals of Mechnikov Institute. 2019. No. 1. Р. 81–87. DOI: 10.5281/zenodo.2639521. URL: https://zenodo.org/records/2639521
Shapovalov V.V.(Jr.), Gudzenko A.O., Shapovalova V.A. et al. Experience of Poland concerning and organization of healthcare system for the pharmaceutical provision for privileged categories of citizens. The International scientific conference «Advance of Science». Czech Republic, Karlovy Vary: Skleněný Můstek – Ukraine, Kyiv: MCNIP, 2019. P. 16-22.
Shapovalov V.V., Tairova K.Y., Shapovalova V.A. et al. Introduction to pharmaceutical law: parameters of the control regime and stages of medicines circulation. 9th International youth conference “Perspectives of science and education”. New York, USA. 2019. P. 133-142.
Shapovalova V.A., Datkhayev U.M., Shapovalov V.V. et al. Introduction to pharmaceutical law and forensic pharmacy. The Third International scientific congress of scientists of Europe. Vienna. 2019. P. 43-49.
Shapovalov V. V. Pharmaceutical law as a component of the system of postgraduate training of pharmacy and medicine specialists in the light of harmonization of national legislation with EU countries. Scientific and pedagogical internship "Social sciences education as a component of the education system in Ukraine and EU countries". Republic of Poland: Wloclawek, 2019. P. 62-66.
Shapovalov V. Multidisciplinary study of medical errors in the system of legal relations between "Doctor-Patient-Pharmacist-Advocate" during the circulation of drugs. SSP Modern Pharmacy and Medicine. 2023. Vol.3. No.2. P.1-11. URL: https://doi.org/10.53933/sspmpm.v3i2.88 DOI: https://doi.org/10.53933/sspmpm.v3i2.88
Constitution of Ukraine. Verkhovna Rada of Ukraine. 1996. No. 30, Art. 141. URL: https://zakon.rada.gov.ua/laws/show/254%D0%BA/96-%D0%B2%D1%80#Text/
Law of Ukraine "Basics of Ukrainian legislation on health care". Verkhovna Rada of Ukraine. 1993. No. 4, Article 19. URL: https://zakon.rada.gov.ua/laws/show/2801-12#Text
Decree of the Cabinet of Ministers of Ukraine of December 22, 2023 No. 1324 "Some issues of implementation of the program of state guarantees of medical care for the population in 2024." Verkhovna Rada of Ukraine. Edition of April 16, 2024. URL: https://zakon.rada.gov.ua/laws/show/1394-2023-%D0%BF#Text
Gryzodoub O., Shapovalov V. Quality systems in Pharmacy: multidisciplinary context of the State Pharmacopoeia of Ukraine. SSP Modern Law and Practice. 2023. Vol.3. No.1. P.1-23. DOI: https://doi.org/10.53933/sspmlp.v3i1.81 DOI: https://doi.org/10.53933/sspmlp.v3i1.81
Shapovalova V., Shapovalov V., Osyntseva A. et al. Organization of the pharmaceutical business, industrial pharmacy and forensic pharmacy concerning the competences of quality management during the circulation of medical products: GxP standards. Actual problems of medicine and pharmacy. 2022. Vol.3. No.2. P.1–20. URL: https://doi.org/10.52914/apmp.v3i2.44 DOI: https://doi.org/10.52914/apmp.v3i2.44
Shapovalova V. Forensic and pharmaceutical risks in the organization of pharmacotherapy of covid, post-covid and long-covid disorders. COVID-19 and vaccination practice standards. SSP Modern Pharmacy and Medicine. 2022. Vol. 2. No. 4. P.1–24. URL: https://doi.org/10.53933/sspmpm.v2i4.69 DOI: https://doi.org/10.53933/sspmpm.v2i4.69
Osyntseva A., Shapovalov V. Management and marketing of circulation of first-line antituberculosis medicines: use of innovative research technologies. SSP Modern Pharmacy and Medicine. 2023. Vol.3. No.4. P.1-13. URL: https://doi.org/10.53933/sspmpm.v3i4.114 DOI: https://doi.org/10.53933/sspmpm.v3i4.114
Shapovalova V. The ICD-11 for the Twenty-First Century: the first view from the organizational, legal, clinical and pharmacological aspects. SSP Modern Pharmacy and Medicine. 2022. Vol. 2. No. 1. P. 1-13. URL: https://doi.org/10.53933/sspmpm.v2i1.37. DOI: https://doi.org/10.53933/sspmpm.v2i1.37
Shapovalov V. (Jr.), Gudzenko A., Shapovalova V. et al. Concerning the importance of forensic and pharmaceutical researches to improve patients’ accessibility to medicines. Pharmacia. 2017. Vol. 65. No. 2. Р. 23-29. URL: http://bsphs.org/wp-content/uploads/2017/07/Shapovalov.pdf
Shapovalova V. System of drugs circulation based on medical and pharmaceutical law. Actual Problems of Medicine and Pharmacy. 2021. Vol.1. N.1-1. URL: https://apmplmi.com/index.php/apmp/article/view/12 DOI: https://doi.org/10.52914/apmp-2021-1-6
Shapovalova V. Extemporaneous preparations in the pharmacotherapy of nervous system disorders: pharmaceutical management, marketing, analysis, application. SSP Modern Pharmacy and Medicine. 2023. Vol.3. No.4. P.1-7. URL: https://doi.org/10.53933/sspmpm.v3i4.111 DOI: https://doi.org/10.53933/sspmpm.v3i4.111
Shapovalova V. Post-Traumatic Stress Disorder: administration, clinical and pharmacological, organizational and legal, pharmaceutical management, recent case studies. SSP Modern Pharmacy and Medicine. 2024. Vol.4. No.1. P.1-8. URL: https://doi.org/10.53933/sspmpm.v4i1.123 DOI: https://doi.org/10.53933/sspmpm.v4i1.123
Shapovalov V., Shapovalov V. Management of Prescription Medicines in Ukraine: Continuation of the Experimental Study on the Organization of Pharmaceutical Provision. SSP Modern Pharmacy and Medicine. 2024. Vol.4. No.2. P.1-11. URL: https://doi.org/10.53933/sspmpm.v4i2.143 DOI: https://doi.org/10.53933/sspmpm.v4i2.143
Shapovalov V., Shapovalova V., Osyntseva A. et al. The Relevance of acquiring of legal knowledge concerning labor protection, fire safety, sanitary and epidemiological regime for health care professionals. SSP Modern Law and Practice. 2024. Vol.4. No.1. P.1-15. URL: https://doi.org/10.53933/sspmlp.v4i1.127 DOI: https://doi.org/10.53933/sspmlp.v4i1.127
Shapovalova V.O., Chernykh V.P. The physiological properties of the action of a new analgesic and antipyretic preparation. Fiziol. Zh. 1997. Vol. 43. No.1-2. P. 117-121. URL: https://pubmed.ncbi.nlm.nih.gov/9221112/
Decree of the Cabinet of Ministers of Ukraine of August 17, 1998 No. 1303 "On regulation of free and subsidized dispensing of medicinal products according to doctors' prescriptions in the case of outpatient treatment of certain population groups and for certain categories of diseases." Verkhovna Rada of Ukraine. Editorial from April 05, 2023. URL: https://zakon.rada.gov.ua/laws/show/1303-98-%D0%BF#Text
Ivanishyn-Hayduchok L., Shapovalova V., Shapovalov V. ICD-11: Organizational and legal, medical and pharmaceutical, social and economic issues of implementation of the program of state guarantees of medical care in 2022 in Ukraine, based on the fundamental principles of the European Union. SSP Modern Pharmacy and Medicine. 2022. Vol.2. No.2. P.1-14. URL: https://doi.org/10.53933/sspmpm.v2i2.53 DOI: https://doi.org/10.53933/sspmpm.v2i2.53
Shapovalov (Jr.) V., Gudzenko A., Shapovalova V. et al. Organizational and legal aspects of the use of pharmacoeconomic analysis of multivitamin complexes for pharmaceutical provision of military personnel. The Pharma Innovation Journal. 2018. Vol.7. Iss.10. P.166–169. URL: http://www.thepharmajournal.com/archives/2018/vol7issue10/PartD/7-7-147-579.pdf
Shapovalov V., Veits O., Panchenko O. et al. Pharmacy and Dentistry: a multidisciplinary study of the risks of circulation of medicinal products. SSP Modern Pharmacy and Medicine. 2024. Vol.4. No.1. P.1-11. URL: https://doi.org/10.53933/sspmpm.v4i1.132 DOI: https://doi.org/10.53933/sspmpm.v4i1.132
Shapovalova V.O., Shapovalov V.V. Spasmophilia in children and the anticonvulsant properties of a new Ukrainian preparation containing a pyrimidine derivative. Fiziol. Zh. 1998. Vol. 44. No.5-6. Р.102-105. URL: https://pubmed.ncbi.nlm.nih.gov/9866032/. DOI: https://doi.org/10.1049/ir:19980309
Shapovalov (Jr.) V., Gudzenko A., Shapovalova V. et al. Organizational and legal aspects of the use of pharmacoeconomic analysis of multivitamin complexes for pharmaceutical provision of military personnel. The Pharma Innovation Journal. 2018. Vol.7. Iss.10. P.166–169. URL: http://www.thepharmajournal.com/archives/2018/vol7issue10/PartD/7-7-147-579.pdf
Shapovalov V., Osyntseva A., Veits O., Derkach A. Multidisciplinary Study of Alcohol Abuse from the Perspective of Pharmaceutical Law and Forensic Pharmacy. SSP Modern Law and Practice. 2024. Vol.4. No.1. P.1-16. URL: https://doi.org/10.53933/sspmlp.v4i1.133 DOI: https://doi.org/10.53933/sspmlp.v4i1.133
Zbrozhek, S. I. Analysis of the availability of drug circulation for various patient groups in healthcare institutions. Likars’ka Sprava. 2020. No. 7-8. P. 56-63. URL: https://doi.org/10.31640/JVD.7-8.2020(7) DOI: https://doi.org/10.31640/JVD.7-8.2020(7)
Shapovalov V. (Jr.), Gudzenko A., Shapovalova V. at. el. Forensic and pharmaceutical study of the presence of a causal link between the degree of alcohol abuse and qualification level of the respondents. Pharmacia. 2017. Vol. 66. No. 3. Р. 31–39. URL: http://bsphs.org/wp-content/uploads/2017/11/Shapovalov.pdf
Zbrozhek S.I., Shapovalova V.A., Shapovalov V.V. et al. Organizational and legal research of indicators of incidence and prevalence of diabetes mellitus in countryside areas. Annals of Mechnikov Institute. 2017. No.1. P.44–53. URL: http://www.imiamn.org.ua/journal/1_2017/zmist1_2017.html
Shapovalova V. Musculoskeletal health systematic review: clinical and pharmacological, organizational and legal, administration and pharmaceutical management aspects. SSP Modern Pharmacy and Medicine. 2024. Vol.4. No.2. P.1-12. URL: https://doi.org/10.53933/sspmpm.v4i2.134 DOI: https://doi.org/10.53933/sspmpm.v4i2.134
Shapovalova V. Monkeypox virus – new challenges of modernity: experimental organizational and legal, clinical and pharmacological studies. SSP Modern Pharmacy and Medicine. 2022. Vol.2. N.3. P.1–15. URL: https://doi.org/10.53933/sspmpm.v2i3.54. DOI: https://doi.org/10.53933/sspmpm.v2i3.54
Haiduchok І., Shapovalov V. Covid-19: multidisciplinary researches of forensic and pharmaceutical risks and causal relationships of unqualified medical care for patients during pandemic. 2022. SSP Modern Law and Practice. Vol.2. No.1. P.1-25. URL: https://doi.org/10.53933/sspmlp.v2i1.39. DOI: https://doi.org/10.53933/sspmlp.v2i4.74
AHRQ PSNet annual perspective: impact of the COVID-19 pandemic on patient safety. AHRQ. 30.03.2021. URL: https://psnet.ahrq.gov/perspective/ahrq-psnet-annual-perspective-impact-covid-19-pandemic-patient-safety.
Shapovalova V.A., Zbrozhek S.I., Shapоvalov V.V. et al. Coronavirus disease pandemia 2019: growth of epidemic dangers. Acta scientific pharmaceutical sciences. 2020. Vol.4. Iss.7. P.61–68. URL: https://www.actascientific.com/ASPS/ASPS-04-0559.php. DOI: https://doi.org/10.31080/ASPS.2020.04.0559
Shapovalova V. An Innovative multidisciplinary study of the availability of coronavirus vaccines in the world. SSP Modern Pharmacy and Medicine. 2022. Vol.2. N.2. P.1–17 URL: https://doi.org/10.53933/sspmpm.v2i2.45. DOI: https://doi.org/10.53933/sspmpm.v2i2.45
Krasnianska T., Ponomarenko M. Organization of the Pharmaceutical Business, Drug Technology and Forensic Pharmacy: Modern Trends in The Development of the Science of Pharmaceutical Law During the Covid-19 Pandemic. SSP Modern Pharmacy and Medicine. 2022. Vol. 2. No 3. Р. 1-15. DOI: https://doi.org/10.53933/sspmpm.v2i3.59 DOI: https://doi.org/10.53933/sspmpm.v2i3.59
Ponomarenko M.S., Solovyov O.S., Krasnyanska T.M. et al. The main stages of standardization and streamlining of training and use of the pharmaceutical personnel resource base. Current issues of pharmaceutical and medical science and practice. 2016. No. 2 (21). P. 1-10. DOI: https://doi.org/10.14739/2409-2932.2016.2.70698
Zbrozhek S.I., Shapovalova V.O., Shapovalov V.V. (Jr.) et al. Processing of the control regime of medicines for pharmacotherapy of chronic pain syndrome in the field of palliative aid. Likars'ka sprava. 2019. Nо 5-6. P.111-118. DOI: https://doi.org/10.31640/JVD.5-6.2019(15) DOI: https://doi.org/10.31640/JVD.5-6.2019(15)
Shapovalova V.O., Zbrozhek S.I., Shapovalov V.V. (Jr.) et al. Content analysis of pharmacies in Ukraine, which produce extemporaneous drugs. Public health. 2017. Vol. 6. Nо 3-4. P. 77-83. DOI: https://doi.org/10.22141/2306-2436.6.3.2017.123498 DOI: https://doi.org/10.22141/2306-2436.6.3.2017.123498
Shapovalova V.A., Sosyn I.K., Butenko G.M. et al. Pharmaceutical law in narcology. Kharkov: “Fact”. 2004. 800 p.
Shapovalov V.V. (Jr.), Shapovalova V.A., Shapovalov V.V. Forensic and pharmaceutical research on the impact of drugs on the safety, life, and health of road users within the organization of pharmaceutical business, drug technology, pharmaceutical and medical law in Ukraine. Health of Society. 2021. Vol. 10. Nо 4. P. 127-132. DOI: https://doi.org/10.22141/2306-2436.10.4.2021.246355. DOI: https://doi.org/10.22141/2306-2436.10.4.2021.246355
Gudzenko A., Shapovalov V., Shapovalov V. et al. Forensic pharmacy: analysis of complaints about the pharmaceutical provision for privileged categories of patients in Ukraine (experimental research). Science Review. 2021. Vol.2. Iss.37. P.1-6. DOI: https://doi.org/10.31435/rsglbal_sr/30042021/7517
Osyntseva A. Polydrug addiction: multidisciplinary forensic and pharmaceutical, organizational and legal, and technological study of factors of formation and development. SSP Modern Pharmacy and Medicine. 2022. Vol.2. No.4. P.1-14. URL: https://doi.org/10.53933/sspmpm.v2i4.72. DOI: https://doi.org/10.53933/sspmpm.v2i4.72
Shapovalova V.O., Vasina Y.V., Shapovalov V.V. et al. Study of turnover extemporaneous preparations in Ukraine on the basis of pharmaceutical law. Pharmaceutical Journal. 2016. No 1. Р. 77-85. URL: https://pharmj.org.ua/index.php/journal/article/view/155
What is the Pharmaceutical Regulatory System of the European Union and its Member States? Synapse. 18.04.2024. URL: https://synapse.patsnap.com/blog/what-is-the-pharmaceutical-regulatory-system-of-the-european-union-and-its-member-states.
Basics of medicines regulation. Eupati. 21.11.2016. URL: https://toolbox.eupati.eu/resources/basics-of-medicines-regulation/.
The dialogue between the EBA and the State Medical Service will contribute to solving problems with the import of medicines. Apteka.ua. 30.05.2024. URL: https://www.apteka.ua/article/695639
Law of Ukraine "On Medicinal Products". Verkhovna Rada of Ukraine. 1996. No. 22, Art. 86. Edition of January 01, 2024. URL: https://zakon.rada.gov.ua/laws/show/123/96-%D0%B2%D1%80#Text
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