Approaches to the deactivation of cytostatic drugs: degradation, mineralization, and toxicological assessment (literature review)

Introduction. Cytostatic drugs are widely used in oncology practice; however, their handling is associated with occupational and environmental exposure risks. In the Russian Federation, requirements for the management of medical waste generated during the use of cytostatic and other hazardous medicinal products are established by Federal Laws No. 52-FZ “On the Sanitary and Epidemiological Welfare of the Population”, No. 89-FZ “On Production and Consumption Waste”, and No. 323-FZ “On the Fundamentals of Public Health Protection in the Russian Federation”, as well as by Sanitary Rules SanPiN 2.1.3684–21, which regulate sanitary and epidemiological requirements for waste management and provide for the need for its decontamination.

At the same time, the current regulatory and methodological documents of the Russian Federation mainly regulate the organizational, sanitary and epidemiological aspects of handling such waste, but do not contain scientifically justified criteria for selecting deactivation methods and/or clear instructions depending on the chemical nature of the substances and their transformation products. This creates certain difficulties for practical services, control and supervisory authorities in implementing the provisions of the sanitary legislation of the Russian Federation.

The purpose of the study was to summarize data on current approaches to the deactivation of cytostatic drugs, taking into account the assessment of their effectiveness, limitations, and the completeness of chemical-analytical and toxicological evidence confirming the absence of hazardous properties after degradation.

Materials and methods. A review of scientific publications, regulatory and methodological documents, international guidelines on the handling of hazardous medicinal products, and materials indexed in the open scientific databases PubMed, Scopus, Web of Science, eLIBRARY.RU, RSCI and CyberLeninka was conducted. The analysis took into account the chemical nature of the drug, the deactivation method, the degree of degradation of the parent compound, data on the identification of transformation products, mineralization parameters, and the results of mutagenicity, cytotoxicity and ecotoxicity assessments.

Results. Cytostatic drugs represent a toxicologically significant group of drugs; some of their representatives adversely affect the endocrine system in humans and animals and are classified by the expert community as carcinogens, mutagens and reproductive toxicants of hazard category 1. At the same time, both Russian and international regulatory and methodological documents contain substantial gaps regarding their deactivation.

Current approaches include oxidative, photochemical, photocatalytic and electrochemical methods, as well as complexation. The choice of an appropriate method is determined by the chemical structure of the parent compound, the composition of the matrix, treatment conditions and the properties of the resulting transformation products.

Assessment of the effectiveness of an approach to the deactivation of medicinal products should include the following stages: selection of an appropriate degradation method, chemical-analytical assessment of the degree of parent compound degradation and identification of transformation products, assessment of mineralization degree, evaluation of the toxicity of degradation products, and interpretation of the results obtained.

Limitations. The study was limited to the analysis of open literature, regulatory, methodological and guidance sources. Closed industrial data, unpublished reports and original experimental verification of the effectiveness of deactivation methods were not included. Data comparability was limited by differences in matrix composition, cytostatic drug concentrations, treatment conditions and the completeness of chemical and toxicological assessment of transformation products.

Conclusion. Taking into account the widespread use of cytostatic drugs in medical practice, as well as their toxicity and hazard, including when present in waste, it appears appropriate to develop and incorporate into the regulatory and methodological framework of the Russian Federation documents, including methodological guidelines and guidance documents, that contain criteria for selecting appropriate deactivation methods, as well as lists of recommended methods, procedures and reagents.

Authors’ contribution:
Khamidulina Kh.Kh.,Tarasova E.V. – concept and design of the study, editing, approval of the final version of the article, responsibility for the integrity of all parts of the article;
Kurpedinov K.S., Nazarenko A.K. – collecting and processing material, writing text, editing.

Conflict of interest. The authors declare no apparent and potential conflicts of interest in relation to the publication of this article.

Funding. The study had no sponsorship.

Received: March 20, 2026 / Accepted: June 1, 2026 / Published: June 30, 2026

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