According to the World Health Organization, non-steroidal anti-inflammatory drugs (NSAIDs) are the second most used after antibiotics. More than 30 million people in the world take NSAIDs every day, with 40% of patients over the age of 60. Considering that large quantities of these drugs are taken without a prescription and due control by a doctor, the organization and maintenance of the pharmacovigilance system is of particular importance. And building a pharmacovigilance system is the most important task of regulatory systems!
The first representative of NSAIDs appeared on the pharmacological market at the end of the 19th century, and at present this group of drugs is the leader among non-narcotic analgesics. It is known that the main element of the mechanism of action of NSAIDs is inhibition of the synthesis of prostaglandins (PG) from arachidonic acid by inhibiting the enzyme cyclooxygenase (COX). It has been established that there are at least two cyclooxygenase isoenzymes that are inhibited by NSAIDs. COX-1 controls the production of prostaglandins, which regulate the synthesis of factors that ensure the integrity of the gastrointestinal mucosa, platelet aggregation and renal blood flow, and COX-2 is involved in the synthesis of prostaglandins during inflammation. In this case, the activity of COX-2 under normal conditions is absent, but is expressed under the influence of certain tissue factors that initiate the inflammatory response. The combination of analgesic, anti-inflammatory and antipyretic effects, ease of use due to a variety of dosage forms, and the availability of drugs in the pharmacy network have determined the great popularity of NSAIDs among the population. A significant proportion of NSAIDs are available without a prescription. This factor largely determines the additional requirements for the safety of drugs and the requirements for the aforementioned organization and maintenance of the pharmacovigilance system. The availability of NSAIDs determines the high level of attention to integrative indicators of adverse reactions when using this pharmacological group.
As an example of building a pharmacovigilance system, you can take a retrospective analysis of spontaneous messages received in the AIS database of Roszdravnadzor «Pharmacovigilance» in the period from 07.12.2008 to 31.08.2017. A total of 6257 cases of adverse reactions were identified. It is not possible to estimate the true frequency of adverse reactions, since there is no information on the volume of consumption. However, it was possible to divide the drugs by the frequency of detected reactions and, in some cases, to analyze the timely included risk reduction programs, such as changes in the instructions for medical use, etc. Actually, the last point is the most important in organizing and maintaining the pharmacovigilance system.
* N. Yu. Velts, E. O. Zhuravleva, T. M. Bukatina, G. V. Kutekhova
* N. Yu. Velts, E. O. Zhuravleva, T. M. Bukatina, G. V. Kutekhova
Federal State Budgetary Institution «Scientific Center for Examination of Funds medical application «of the Ministry of Health of the Russian Federation, Russian Federation, 127051, Moscow, Petrovsky Boulevard, 8, bldg. 2,
* Safety and Risk of Pharmacotherapy 2018.6 (1) .pdf