Krasheninnikov A.E., Matveev A.V.
Autonomous non-profit organization «National Scientific Center of Pharmacovigilance», 127051, Russia, Moscow, st. Malaya Sukharevskaya, pl. d. 2, p. 2.
It is known that the use of drugs in modern clinical practice is accompanied by the risk of side effects, the cause of which, in many cases, is the level of drug safety insufficiently established by the manufacturer. The use of such drugs in 19.8% of cases may be accompanied by adverse reactions from consumers, while 72.6% of them are classified as serious. Despite the high level of danger of serious adverse reactions and the risk of death due to their use, it has been proven that in 68% of cases they are preventable. The prevention of adverse drug reactions, as well as the growing desire of society to minimize the risks of drug use are the main driving force behind the development of the pharmacovigilance system. One form of preventing adverse drug reactions is the preparation of a RMP (Risk Management Plan). If the CSR is made to order by a third-party organization, then the preparation of a RMP (risk management plan) is also included in the assignment.
The term “pharmacovigilance”, coined back in the mid-1970s by a French group of pharmacologists and toxicologists, was defined as a range of measures that contribute to “assessing the risk of side effects potentially associated with drug treatment”. Activities include the preparation of an RMP (Risk Management Plan). Since its inception, the global pharmacovigilance system has undergone several stages in the formation and development of drug safety surveillance technologies. Conventionally, the following stages can be distinguished:
- the first stage — the formation of separate local institutes for the study of drug safety;
- the second stage — the emergence of the world institute of pharmacovigilance;
- the third stage is the integration of pharmacovigilance systems from different countries and the harmonization of legislative acts.
The growth of publicly known cases of the development of serious adverse reactions to drugs, as well as the results of research work in 1850 by a team of doctors (Thomas Walkley and Arthur Hill Hassall), who proved the facts of falsification of medicinal products, served as a catalyst for the adoption of the first legislative acts of the pharmacovigilance system. In Britain, the Adulteration of Food and Drink Act 1860 was passed in 1860, revised and amended by the appointment of public experts in 1872. In 1875, the Sale of Food and Drugs Act 1875 was drafted and the Society of Public Analysts was created. At the same time, the principles of preparing a RMP (risk management plan) were born, to order from third parties, or by the efforts of the marketing authorization holder. All these measures have enabled the counties and boroughs of London to take effective action to ensure food standards and drug safety. With the development of the pharmaceutical industry and the publication of high-profile deaths due to the development of adverse reactions, the FDA was given additional powers, for example, to approve drugs before they are introduced to the US market and to ensure safety control of drugs already in use.