Contradictions in legislation on medical waste management in the manufacturing of medicinal products

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Abstract

Introduction. The rapid development of the pharmaceutical industry makes the impact on the environmeте to be very important. The solution of the problem is related to waste management and, accordingly, the legislative regulation of waste management at medicinal products enterprises.

Materials and methods. The methods of the scientific hypothetical-deductive cognition, general logical methods,  and methods of research: analysis, synthesis, abstraction, generalization, induction were applied. The objects of research were laws and regulations governing relations in the field of waste management in the production of medicines, as well as departmental letters.

Results. This article analyzes the contradictions occurring in federal laws and departmental regulations related to the management of medical waste in medicinal products manufacturing, which, on the one hand, may cause the violation of citizens' rights to a healthy environment and sanitary and epidemiological well-being, on the other hand to become the reason of restrictions in development of business. The legislative definition of medical waste was shown to include, besides other things, wastes from medicinal products manufacturing, which leads to the withdrawal of pharmaceutical enterprises waste from the general field of waste legislation. At the same time, there is a transfer of regulation of medicinal products manufacturing waste management to the sanitary legislation field. However, in practice, there is a situation of double regulation by the departmental acts of the Federal Service for Supervision of Consumer Rights Protection and Human Welfare and Federal Service for Supervision over Natural Resource Management. 

Discussion. The analysis of the experience in the field of the organization of pharmaceutical waste management in the foreign practice (WHO, EPA) has been introduced, where the concept of pharmaceutical waste was introduced, within which hazardous chemical waste, controlled substances (narcotic, psychotropic, hormones) and biomedical wastes are selected.

Conclusion. The analysis of federal regulations, sanitary norms, and rules, norms of Federal Service for Supervision over Natural Resource Management  affecting the management of waste (medical waste) in the production of medicines, shows their limited applicability to modern high-tech industries, which requires bringing the regulatory and legal acts in line and improving the standardization.

About the authors

Natalya A. Mozzhukhina

Ltd Company “Institute of Design, Ecology, and Hygiene”; I.I. Mechnikov North-West State Medical University

Author for correspondence.
Email: Natalya.Mozzhukhina@szgmu.ru
ORCID iD: 0000-0002-8051-097X

MD, Ph.D.Candidate of Medical Sciences, Docent of the Preventive medicine and health protection department of the I.I. Mechnikov North-West State Medical University, Saint Petersburg, 191015, Russian Federation. 

e-mail: Natalya.Mozzhukhina@szgmu.ru

Russian Federation

G. B. Yeremin

North-West Public Health Research Center

Email: noemail@neicon.ru
ORCID iD: 0000-0002-1629-5435
Russian Federation

A. Yu. Lomtev

Ltd Company “Institute of Design, Ecology, and Hygiene”

Email: noemail@neicon.ru
ORCID iD: 0000-0003-3183-2582
Russian Federation

References

  1. Ershov A.G. Shubnikov V.A. Medical and biological waste: problems and solutions. Tverdye bytovye othody. 2011 (2): 16-19. (In Russian)
  2. Frolov V.N. Collection, disinfection and disposal of waste of classes “B” and “V”. Tverdye bytovye othody. 2012 (11): 42-3. (In Russian)
  3. Samutin N.M., Rusakov N.V., Butorina N.I., Kobzev N.S., Ustinov A.K. Approaches of the European and Russian legislation in the field of waste management. Gigiena i sanitariya. 2014 (6): 9-13. (In Russian)
  4. Soldatenko N.A., Karmanov V.V., Vajsman Ya.I., Samutin N.M. Ensuring safety in the thermal recycling of medical waste containing polyvinyl Chloride. Gigiena i sanitariya. 2013 (1): 42-6. (In Russian)
  5. Akimkin V.G., Timofeeva T.V., Mamontova L.S., Zudinova E.A. Modern trends in the dynamics of the volume of medical waste generation in major cities of the Russian Federation. Dezinfekcionnoe delo. 2015 (1): 17-24. (In Russian)
  6. Zudinova E.A., Balakaeva A.V., Timofeeva T.V., Mamontova L.S. Preimushchestva i nedostatki apparatnogo metoda obezzarazhivaniya medicinskih othodov. Advantages and disadvantages of the hardware method of disinfection of medical waste. Upravlenie kachestvom zdravoohraneniya. 2015 (31): 39-46. (In Russian)
  7. Zudinova E.A. Stages of introduction of a medical waste management system, based on the disinfection of epidemiologically hazardous waste by the hardware method. Menedzher zdravoohraneniya. 2015 (1): 40-6. (In Russian)
  8. Mironenko O.V., Bormashov A.V., Balakaeva A.V., Soprun L.A. Hygienic justification of the choice of waste treatment technology depending on the type of specialized medical care. Dezinfekciya. Antiseptika. 2012; 3 (11): 28-33. (In Russian)
  9. Timofeeva T.V., Balakaeva A.V., Zudinova E.A., Glazunova O.I. Hardware and chemical methods for disinfection of medical waste: a comparative analysis of the effectiveness. Dezinfekciya. Antiseptika. 2014; 3(19): 47-9. (In Russian)
  10. Samutin N.M., Butorina N.N., Starodubova N.Yu., Kornejchuk S.S., Ustinov A.K. Priority technologies of the medical waste management system. Gigiena i sanitariya. 2015 (7): 35-7. (In Russian)
  11. Balakaeva A.V., Rusakov N.V. Sanitary-epidemiological evaluation of the effectiveness of facilities for medical waste disinfection. Gigiena i sanitariya. 2016 (7): 611-4 (In Russian)
  12. Akimkin V.G., Timofeeva T.V., Mamontova L.S., Zudinova E.A. Modern features of the dynamics of the volume of generation and structure of medical waste in major cities of the Russian Federation. ZNiSO. 2015; 9 (270): 9-14. (In Russian)
  13. Mironenko O.V., Lomtev A.Yu., Ozerova E.M., Pan’kin A.V., Soprun L.A. Application of GIS-technologies for the creation of a management system for medical wastes of classes B and V in St. Petersburg. Poliklinika. 2013 (6): 60-6. (In Russian)
  14. Zudinova E.A., Timofeeva T.V., Akimkin V.G. Measures to introduce a centralized system of disinfection/detoxification of medical waste in Moscow. ZNiSO. 2016 (12): 40-2. (In Russian)
  15. Rossolovskij A.P., Mihajlov A.N., Nikonov V.A., Il’ina A.N., Rybakova E.V., Mozzhuhina N.A., Eremin G.B. Evaluation of the effectiveness of medical waste microwave disinfection. Problemy medicinskoj mikologii. 2016; 18 (2): 108-9. (In Russian)
  16. Mathur P., Patan S., Shobhawat A.S. Need of Biomedical Waste Management system in hospitals – An Emerging issue - A Review. Current World Environment. 2012; 7 (1): 117-24.
  17. Zimmermann K. Microwave as an emerging technology for treatment of biohazardous waste: A mini-review. Waste Management & Research. 2017; 35 (5): 471-9.
  18. Chen Y., Ding Q., Yang X. Application countermeasures of nonincineration technologies for medical waste treatment in China. Waste Management & Research. 2013; 31: 1217-41.
  19. Toktobaev N., Emmanuel J., Djumalieva G. An innovative health care waste management system in Kyrgyzstan. Waste Management & Research. 2015; 33: 130-8.
  20. De Titto E., Salvino A.A., Townend W.K. Healthcare waste management: Current issues in developing countries. Waste Management & Research. 2012; 30: 559-61.
  21. Windfeld E.S., Books M.S. Medical Waste Management – A Review. Journal on Environmental Management. 2015; 163: 98-108.
  22. Insa E., Zamorano M., Lopez R. Critical review of medical waste legislation in Spain. Resources, Conservation and Resycling. 2010; 54: 1048-58.
  23. Miyzaki M., Une H. Infectious waste management in Japan. A revised regulation and a management process in medical instirurions. Waste Management & Research. 2005; 26: 616-21.
  24. Qli A., Ekejinda C.C., Adjie D.U., Ezeobi I., Ojipfor O.S. Health waste management in selected govermenr and private hospitals in Southeast Nigeria. Asian Pacific Journal of Tropical Biomedicine. 2016; 6 (1): 84-9.
  25. Vaccari M., Terry T., Peteghella P. Costs associated with management of waste from healthcare facilities: An analysis at national and site level. Waste Management & Research. 2018; 36 (1): 39-47.
  26. Ugol’nikov V.V., Ugol’nikova O.D., Petrov A.P. Innovative economy: regional cluster initiatives. SPb. Publishing house SPb GUSE. 2010: 191. (In Russian)
  27. Dvorjashin Ju.S., Kolodjaznaja V.A. A systematic approach to the design of biopharmaceutical enterprises. In: V All-Russian. scientific and practical. conf. with international. participation of “Innovation in the health of the nation”, 8-9 November 2017. SPb. 2017: 146-8. (In Russian)
  28. Tatarkin A.I. Prospects for the development of the pharmaceutical industry in Russia: market conditions, trends and development factors in the context of the WTO. Tatarkin A.I., Petrov A.P. Biznes, menedzhment i pravo. 2013; 1(21): 24-8 (In Russian)
  29. Yeremin G.B. Questions of functional zoning when placing pharmaceutical companies. Yeremin G.B., Lomtev A.Ju., Mozzhuhina N.A., Sinil’shhikova I.A., Nikonov V.A. In: International Forum of the Scientific Council of the Russian Federation on Human Ecology and Environmental Hygiene “Ecological Problems of the Present: Identification and Prevention of the Adverse Impact of Anthropogenically Deterministic Factors and Climate Change on the Environment and Human Health”. 14-15 December 2017. M. 2017: 146-8. (In Russian)
  30. Safe management of wastes from health care activities. Ed. by Chatiere Y.et al. 2 ed. WHO. 2014: 129-30. Available at: http://www.who.int/water_sanitation_health/publications/wastemanag/en/ (date of the application 07.02.2018)
  31. Pharmaceutical Waste Guidelines. EPA. 2010: 10. Available at: http://www.ehs.ucsb.edu/units/envhlth/ehrsc/hazardouswaste/envdisppro.htm (date of the application 09.02.2018)
  32. Guidelines on Safe Disposal of Unwaned Pharmaceuticals in and after Emergencies. WHO-1999- 36p Available at: http://apps.who.int/medicinedocs/en/d/Jwhozip51e/ (date of the application 07.02.2018)

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