Open AccessON THE ISSUE OF SAFETY OF NON-STEROIDAL ANTI-INFLAMMATORY DRUGS
Author(s) -
Н. Ю. Вельц,
Т. М. Букатина,
Е. О. Журавлева,
Г. В. Кутехова,
М. А. Дармостукова,
Ю. В. Олефир,
Б. К. Романов,
С. В. Глаголев,
В. А. Поливанов
Publication year - 2018
Publication title -
bezopasnostʹ i risk farmakoterapii
Language(s) - English
Resource type - Journals
eISSN - 2619-1164
pISSN - 2312-7821
DOI - 10.30895/2312-7821-2018-6-3-123-129
Subject(s) - medicine , drug , ibuprofen , over the counter , medical prescription , pharmacy , pharmacovigilance , pharmacology , adverse effect , antipyretic , analgesic , intensive care medicine , anesthesia , family medicine
Non-steroidal anti-inflammatory drugs (NSAIDs) are liders in selling both in the Russian Federation and worldwide. The combination of analgesic, anti-inflammatory and antipyretic effects make the drugs of this group very popular in patients with various diseases. The realization of NSAIDs in pharmacies occurs both by prescription and over-the-counter, so the safety assessment of the use of this group of drugs remains relevant. In the current practice, self-administration (responsible selfmedication) of drugs of the NSAID group is an additional factor affecting the safety of their intake. According to the studies, about 40 % of patients taking NSAIDs consider that NSAIDS are absolutely safe, and more than 30 % of those taking OTC NSAIDs use them in excess of the recommended dosages. We analyzed 3963 individual case safety reports (ICSR) in the federal database «Pharmacovigilance» from 07.12.2008 to 31.08.2017. The inclusion criterions was the presence of information on the off-label application of NSAIDs in the ICSR, reports of adverse effects that may be associated with the use of this drug or erroneous reports on the active substance, which was not present in this drug. The most frequent mistakes in the application were an increase of the daily dose, a change in the method of administration to patient who are contraindicated with this drug. There were 9 ICSR of burning sensation in the anus with the introduction of ibuprofen suppositories (not in the label), and 7 ICSR of ineffectiveness of the active substance, which was not present in this drug.