Prescribtion of off-label drugs to adult patients

Lipatnikova V.S.

City Clinical Hospital No. 52 of the Moscow Healthcare Department, Russia

The article examines the issue of legal regulation of off-label drug prescriptions to adult patients.
The author analyzed current legislative documents regulating the use of off-label drugs. Shortcomings in the legal framework including the lack of a unified procedure regulating the use of drugs outside the instructions in adults were identified. The identified uncertainty in the procedures for prescribing such drugs emphasizes the need to improve the regulatory system. The legislation regarding the prescription of drugs outside the instructions to children is analyzed. The role of medical commissions in making decisions on prescribing off-label therapy is considered. The need for a unified assessment of the actions of healthcare workers who prescribe drugs outside the instructions to adult patients in the context of the growth of new, poorly studied diseases is emphasized. The judicial practice on disputes related to off-label drug prescriptions to patients was also studied, including civil and criminal liability measures applied to doctors and medical organizations.
Based on the results of the analysis, author made a conclusion about the possibility of extending the procedures in force for off-label drug prescriptions to children to the adult population, as well as creating flexible adaptive legal solutions for the use of such drugs before their official inclusion in clinical guidelines, which will help minimize legal risks for healthcare workers and provide patients with access to the novel therapeutic approaches.

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About the Authors

Valentina S. Lipatnikova - Member of the New York State Bar Association, Member of the World Association of Medical Law (WAML), Member of the Association of Lawyers of Russia, Head of the Legal Department of City Clinical Hospital No. 52 of the Moscow Healthcare Department. Address: 3 Pekhotnaya St., Moscow, 123182;
e-mail: valentinalipatnikova@yahoo.com. ORCID: 0009-0000-3964-635X