Protecting Patients’ Rights in the Off-Label Use of Medicines Containing Psychoactive Substances (Example: Ketamine-Assisted Therapy)

Abstract

In Ukraine, off-label use of medicines containing psychoactive substances, including ketamine-assisted therapy, is widespread. This is due to a sharp increase in the number of people suffering from mental disorders during wartime and the search for effective treatment methods. The purpose of the study is to identify problematic issues and develop recommendations to ensure patients' rights when using off-label medicines containing psychoactive substances (using the example of ketamine-assisted therapy). The study used legal analysis, induction and deduction, system-structural and comparative analysis, content analysis of information from open sources, and analytical research methods. It was found that the off-label use of registered medicines is not prohibited by current legislation. Still, consideration must be given to the existing risks caused by the lack of clinical trial results on the safety and effectiveness of medicines. The specificity of the off-label use of medicinal products containing psychoactive substances is that it requires more meticulous attention to ensuring patients' rights. This is because: a) such use creates an increased risk to patients' life and health both during use and in the long term, as it may result in dependence on this substance; b) when obtaining informed consent from a competent patient for such use, the doctor must ensure not only that the patient is familiar with the possible short-term and long-term risks of using such an off-label medicinal product, but also, in the case of treating patients with mental disorders, that the patient can understand the content of such consent. In cases of off-label use of a medicinal product containing a psychoactive substance prescribed by an anesthesiologist for approved indications, in particular the medicinal product "Ketamine" when conducting ketamine-assisted therapy, such therapy must be carried out with the participation and under the supervision of an anesthesiologist. Unlike the off-label use of drugs containing psychoactive substances, their advertising is prohibited, and therefore the current practice of such advertising is illegal.