Use of unlicensed drugs and off-label drug use: focus on COVID-19

Introduction . In a crisis, like the COVID-19 outbreak, the strategy of experimental drug use in clinical practice increases the availability of potentially effective drugs that have not yet proven the opposite for patients with life-threatening diseases, despite the fact that such use is «off-label» for unregistered indications. The choice of drugs for «off-label» use is most difficult when a large potential benefit justifies higher risks, because the use of drugs for unapproved indications increases the frequency of adverse drug reactions and thereby reduces their clinical value. Goal . Clinical and pharmacological analysis of the «off-label» features of drug use for etiotropic and pathogenetic therapy of COVID-19, description of new opportunities for state registration of medicines in the fight against a new coronavirus infection. Materials and methods . From the Russian temporary guidelines for the treatment of COVID-19 were identified 14 international non-generic names (INN) of drugs. We analyzed the data obtained for the corresponding INN in the State register of medicines of the Ministry of health of the Russian Federation. Results . There is a widespread violation of the requirements of various sections of the current instructions for the medical use of the considered drugs, which requires additional analysis of real-word data. Conclusions . For this purpose, we can use thematic reports, patient registers, and active post-marketing pharmacovigilance.