The medical professional community knows that drugs with unknown safety are widely used in clinical practice, the use of which can be accompanied by adverse reactions, including serious adverse reactions. Globally, mortality from adverse drug reactions is the fourth largest. In Russia, only for the period 2011–2014. and in one federal district alone, over 1.2 thousand reports of serious adverse reactions were identified. Pharmacovigilance is one of the recognized effective tools for assessing the safety and quality control of commercially available drugs. The formation of periodic updated reports is carried out on a turnkey basis by specialized organizations.

Pharmacovigilance in general, as well as its effectiveness, in particular, is determined by the methods of collecting information about adverse reactions, one of which is the method of spontaneous reporting. The spontaneous reporting method makes it possible to collect important data on adverse drug events at a relatively low cost and postulates the right of healthcare workers or the population to transfer data on an adverse reaction that arose when taking medications to authorized state executive bodies. The more spontaneous messages enter the unified database of the Federal Service for Surveillance in Healthcare (Roszdravnadzor), which is empowered to exercise the supremacy of power in the Russian pharmacovigilance system, the more negative signals accumulate in relation to certain drugs, which allows the Ministry of Health of the Russian Federation take a range of restrictive measures to protect the health of Russian citizens. The spontaneous reporting method is used to generate periodic updated reports for turnkey pharmacovigilance and has more than half a century of development history.

For the first time, the requirement to provide a cheap report on an adverse reaction was introduced in Germany in 1963, then described in Great Britain in 1964. In the USSR, the first system for monitoring the safety of drug use began to form in 1969 with the organization of a department for accounting, systematization and express information about serious adverse reactions. Today, the spontaneous reporting method provides the “afferent link” of the international drug safety monitoring program, including that provided by the International Center for Drug Safety Monitoring in Uppsala (Sweden). The spontaneous message method is used by 147 countries, and its effectiveness worldwide is justified by its effectiveness of accumulated spontaneous messages, which already amounts to more than 9 million accounting units in the electronic database of spontaneous messages VigiBase. The spontaneous reporting method ultimately allows both organizations providing turnkey pharmacovigilance and the health care system to timely identify adverse reactions in the daily practice of the health care system at a low cost.