The current state of legal regulation of waste management of medicines in Russia and abroad (analytical review)

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Abstract

Intensive production and use of medicines (drugs) leads to their release into the environment. To assess the situation and determine the tactics of safe handling of this type of medical waste, it is necessary to assess the legislative regulation of the issue.

In this analytical review there were analyzed currently in force regulatory documents concerning the treatment of pharmaceutical waste and their proper disposal. The relevant European standards and recommendations are given. A number of contradictions and unresolved issues have been identified. The analysis of the regulatory framework revealed the incoordination of sanitary and environmental legislation, which hinders the establishment of a safe pharmaceutical waste management system, leading to practical difficulties with their treatment (difficulties of disposal, legal disputes, etc.). The regulatory regulation of the same composition of pharmaceutical waste varies depending on the place of formation, and not on the composition and the perceived danger.

The absence of regulation of specific methods of disposal and neutralization of drug waste, depending on their composition as well as absence of the control over the effectiveness of these processes in terms of environmental impact has been revealed. There is no established requirements for specifying the methods of disposal of the released drugs by manufacturer. The determination of the hazard class by the environmental impact of pharmaceuticals formed during the implementation of medical activities is currently not necessary. The lack of a regulated system for collecting pharmaceuticals from the citizens does not allow individuals safely disposing this type of waste and centrally monitor their quantity. These circumstances can lead to uncontrolled destruction of pharmaceuticals with unknown consequences for both nature and public health.

There is needed A comprehensive solution to the problem of reducing the impact of pharmaceutical waste on the environment and the prevention of antimicrobial resistance with the adoption of a number of practical managerial and regulatory measures and the possible use of European experience.

Contribution: Balakaeva A.V. — the concept and design of the study, collection and processing of material, statistical processing, writing a text;
Skopin A.Yu. — collection and processing of material, writing a text;
Sinitsyna O.O. — editing;
Rusakov N.V. — editing.
All authors are responsible for the integrity of all parts of the manuscript and approval of the manuscript final version.

Conflict of interest. The authors declare no conflict of interest.

Acknowledgement. The study had no sponsorship.

Received: November 11, 2023 / Revised: May 24, 2024 / Accepted: July 19, 2024 / Published: July 31, 2024

About the authors

Alisa V. Balakaeva

Federal Scientific Center of Hygiene named after F.F. Erisman; Centre for Strategic Planning of FMBA of Russia

Author for correspondence.
Email: Balakaeva.AV@fncg.ru
ORCID iD: 0000-0003-4217-4300

Ph.D. in Biology, senior researcher of the Department of Scientific Support for Laboratory Research of Products and Environmental Objects of the Federal Scientific Center for Hygiene named after F.F. Erisman, 141014, Mytishchi, 141000, Russian Federation

e-mail: Balakaeva.AV@fncg.ru

Russian Federation

Anton Yu. Skopin

Federal Scientific Center of Hygiene named after F.F. Erisman

Email: skopin.ayu@fncg.ru
ORCID iD: 0000-0001-7711-9489

MD, Ph.D., Head of the Department of Scientific Support for Laboratory Research of Products and Environmental Objects of the Federal Scientific Center for Hygiene named after F.F. Erisman, 141014, Mytishchi, 141000, Russian Federation

e-mail: skopin.ayu@fncg.ru

Russian Federation

Oksana O. Sinitsyna

Federal Scientific Center of Hygiene named after F.F. Erisman

Email: Sinitsyna.oo@fncg.ru
ORCID iD: 0000-0002-0241-0690

MD, PhD, DSci., professor, Corresponding Member of the Russian Academy of Sciences, Deputy Director for Scientific Work of the Federal Scientific Center for Hygiene named after F.F. Erisman, 141014, Mytishchi, Russian Federation

e-mail: sinitsyna.oo@fncg.ru

Russian Federation

Nikolay V. Rusakov

Centre for Strategic Planning of FMBA of Russia

Email: rusakovnv39@yandex.ru
ORCID iD: 0000-0002-3754-009X

MD, PhD, DSci., professor, academician of Russian Academy of Sciences, Leading specialist of Hygiene Department of the Centre for Strategic Planning, 119121, Moscow, Russian Federation

e-mail: rusakovnv39@yandex.ru

Russian Federation

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Copyright (c) 2024 Balakaeva A.V., Skopin A.Y., Sinitsyna O.O., Rusakov N.V.


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