Key result
Russian off-label prescribing requires reasonable clinical need outside of minors, emergencies, and authorized research.
Why the study?
In Russia, off-label drug use is only regulated for minors, emergencies, and authorized scientific research, leaving other cases open to legal challenge despite clinical need.
This review highlights the regulatory and clinical challenges of off-label drug prescribing in the Russian Federation.
Restricts off-label prescribing to narrow contexts; leaves open development of broader guidelines and safety studies.
The instruction for a medicinal product is the main document regulating indications, contraindications and the method of its administration. Sometimes there are clinical situations when it is necessary to use the drug not according to indications or without taking into account contraindications. In medicine, such a practice has been assigned a foreign name — «off-label», in contrast to «in-label» — an appointment according to the instructions. Currently, Russia has regulations on the use of off-label drugs only for minors, in case of emergencies, as well as during scientific research authorized by the Ministry of Health of the Russian Federation. In other cases, the possibility of using the drug outside the instructions should be determined by a reasonable need for the patient, which can be challenged by experts and lawyers. The article provides an overview of the current state of the problem of prescribing off-label drugs in the Russian Federation, as well as clinical cases of prescribing drugs outside of compliance with the guidelines.
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Shnyakin et al. (2025) conducted a review in Off-label drug prescribing. Off-label drug prescribing was evaluated. Off-label drug prescribing in the Russian Federation is currently regulated only for minors, emergencies, and authorized research, with other uses requiring reasonable clinical need.
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