ON THE ISSUE OF SAFETY OF NON-STEROIDAL ANTI-INFLAMMATORY DRUGS
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 phar...
Saved in:
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | Russian |
| Published: |
Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2018-09-01
|
| Series: | Безопасность и риск фармакотерапии |
| Subjects: | |
| Online Access: | https://www.risksafety.ru/jour/article/view/113 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849343334483492864 |
|---|---|
| author | N. Yu. Velts T. M. Bukatina E. O. Zhuravleva G. V. Kutekhova M. A. Darmostukova Yu. V. Olefir B. K. Romanov S. V. Glagolev V. A. Polivanov |
| author_facet | N. Yu. Velts T. M. Bukatina E. O. Zhuravleva G. V. Kutekhova M. A. Darmostukova Yu. V. Olefir B. K. Romanov S. V. Glagolev V. A. Polivanov |
| author_sort | N. Yu. Velts |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-b3869af2c9fe40c2b3003e88c81032d6 |
| institution | Kabale University |
| issn | 2312-7821 2619-1164 |
| language | Russian |
| publishDate | 2018-09-01 |
| publisher | Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
| record_format | Article |
| series | Безопасность и риск фармакотерапии |
| spelling | doaj-art-b3869af2c9fe40c2b3003e88c81032d62025-08-20T03:43:01ZrusMinistry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Безопасность и риск фармакотерапии2312-78212619-11642018-09-016312312910.30895/2312-7821-2018-6-3-123-129112ON THE ISSUE OF SAFETY OF NON-STEROIDAL ANTI-INFLAMMATORY DRUGSN. Yu. Velts0T. M. Bukatina1E. O. Zhuravleva2G. V. Kutekhova3M. A. Darmostukova4Yu. V. Olefir5B. K. Romanov6S. V. Glagolev7V. A. Polivanov8Scientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsScientific Centre for Expert Evaluation of Medicinal ProductsFederal Service for Surveillance in Healthcare (Roszdravnadzor)Federal State Dudgetary Institution «Information and Methodological Centre for Expert Evaluation, Recording and Analysis of Circulation of Medicinal Products» of RoszdravnadzorNon-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.https://www.risksafety.ru/jour/article/view/113non-steroidal anti-inflammatory drugsoff-labelover-the-counter drugsdrug safetypharmacovigilance |
| spellingShingle | N. Yu. Velts T. M. Bukatina E. O. Zhuravleva G. V. Kutekhova M. A. Darmostukova Yu. V. Olefir B. K. Romanov S. V. Glagolev V. A. Polivanov ON THE ISSUE OF SAFETY OF NON-STEROIDAL ANTI-INFLAMMATORY DRUGS Безопасность и риск фармакотерапии non-steroidal anti-inflammatory drugs off-label over-the-counter drugs drug safety pharmacovigilance |
| title | ON THE ISSUE OF SAFETY OF NON-STEROIDAL ANTI-INFLAMMATORY DRUGS |
| title_full | ON THE ISSUE OF SAFETY OF NON-STEROIDAL ANTI-INFLAMMATORY DRUGS |
| title_fullStr | ON THE ISSUE OF SAFETY OF NON-STEROIDAL ANTI-INFLAMMATORY DRUGS |
| title_full_unstemmed | ON THE ISSUE OF SAFETY OF NON-STEROIDAL ANTI-INFLAMMATORY DRUGS |
| title_short | ON THE ISSUE OF SAFETY OF NON-STEROIDAL ANTI-INFLAMMATORY DRUGS |
| title_sort | on the issue of safety of non steroidal anti inflammatory drugs |
| topic | non-steroidal anti-inflammatory drugs off-label over-the-counter drugs drug safety pharmacovigilance |
| url | https://www.risksafety.ru/jour/article/view/113 |
| work_keys_str_mv | AT nyuvelts ontheissueofsafetyofnonsteroidalantiinflammatorydrugs AT tmbukatina ontheissueofsafetyofnonsteroidalantiinflammatorydrugs AT eozhuravleva ontheissueofsafetyofnonsteroidalantiinflammatorydrugs AT gvkutekhova ontheissueofsafetyofnonsteroidalantiinflammatorydrugs AT madarmostukova ontheissueofsafetyofnonsteroidalantiinflammatorydrugs AT yuvolefir ontheissueofsafetyofnonsteroidalantiinflammatorydrugs AT bkromanov ontheissueofsafetyofnonsteroidalantiinflammatorydrugs AT svglagolev ontheissueofsafetyofnonsteroidalantiinflammatorydrugs AT vapolivanov ontheissueofsafetyofnonsteroidalantiinflammatorydrugs |