REMEDIUMREMEDIUM1561-59362658-3534Joint-Stock Company Chicot166310.32687/1561-5936-2023-27-4-344-349Original ArticleAccessibility of medical care for adult cancer diseases using off-label drugs: clinical recommendations and standards of medical care analysisLedovskikhYulia A.jledovskih@gmail.comCenter for Healthcare Quality Assessment and Control, Moscow, RussiaN. A. Semashko National Research Institute of Public Health, Moscow, Russian FederationRussian Medical Academy of Continuous Professional Education, Moscow, Russia15122023434434914102025Copyright © 2023,2023Currently, the use of off-label drugs is an actual problem all over the world. Use of off-label drugs are not fully regulated in Russian legal system. While the study, clinical guidelines for the treatment of cancer for the adult age group posted in the Rubricator of the Ministry of Health of Russia were analyzed for the presence of off-label anticancer drugs and an assessment was made of the consistency of the lists of anticancer drugs in clinical guidelines and standards of medical care. The results of the study showed that a number of clinical guidelines for the treatment of cancer describe the use of off-label drugs. However, due to legislative restrictions, these drugs are not included in the standards of medical care for adults with cancer developed on the basis of clinical guidelines. This creates a situation that leads to inconsistency between the standards of medical care for adults and clinical recommendations. For the healthcare system, the issue of regulating the procedure for including off-label drugs in the standards of medical care for adults on the basis of evidence-based information presented in clinical guidelines is an urgent issue in order to harmonize documents that regulate both the provision and financing of medical care in the healthcare system of the Russian Federation to improve its accessibility.drugsoff-labelclinical guidelinesstandards of medical carecancer diseasesregulationsлекарственные препаратыoff-labelклинические рекомендациистандарты медицинской помощионкологические заболеваниянормативные правовые акты1.Tsygankova O. V., Batluk T. I., Latyntseva L. D. et al. Legal and medical aspects of off-label medication use. Point of view. Rational Pharmacotherapy in Cardiology. 2019;15(1):130—134. (In Russ.) DOI: 10.20996/1819-6446-2019-15-1-130-1342.Khadartsev A. A., Ivanov D. V., Khadartseva K. A. Legal aspects off-label-use of drugs (literature review). Journal of New Medical Technologies, e-edition. 2020;(3):115—123. (In Russ.) DOI: 10.24411/2075-4094-2020-166543.Martsevich S. Y., Navasardjan A. R., Komkova N. A. Off-label prescribing. possible causes, types and consequences. Legal regulation in the Russian Federation. Rational Pharmacotherapy in Cardiology. 2017;13(5):667—674. (In Russ.) DOI: 10.20996/1819-6446-2017-13-5-667-6744.Saiyed M. M., Ong P. S., Chew L. Off-label drug use in oncology: a systematic review of literature. J. Clin. Pharm. Ther. 2017;42(3):251—258. DOI: 10.1111/jcpt.125075.Joerger M., Schaer-Thuer C., Koeberle D. et al. Off-label use of anticancer drugs in eastern Switzerland: a population-based prospective cohort study. Eur. J. Clin. Pharmacol. 2014;70(6):719—725. DOI: 10.1007/s00228-014-1662-56.Levêque D. Off-label use of targeted therapies in oncology. World J. Clin. Oncol. 2016;7(2):253—257. DOI: 10.5306/wjco.v7.i2.2537.Navasardyan A. R., Martsevich S. Y., Gabay P. G. Prescribing drugs not in accordance with the official instructions for medical use (offlabel), clinical guidelines, standards of medical care and legal regulation in the Russian Federation. Part 2. Rational Pharmacotherapy in Cardiology. 2021;17(2):286—293. (In Russ.) DOI: 10.20996/1819-6446-2021-04-01