Monitoring of NSAIDs adverse effects based on spontaneous reports from Wrocław regional adverse drug reactions monitoring center.
The mechanism of action of non-steroidal anti-inflammatory drugs (NSAIDs) in majority of cases is responsible for adverse reactions of these therapeutic agents. Obtaining post-registration information on adverse drug reactions (ADRs) by means of the Yellow Card System is a significant element in the process of enhancing the safety of pharmacotherapy. The aim of the study was to analyze ADRs of NSAIDs (anti-inflammatory and analgesic drugs) reported to the Regional Centre for the Monitoring of Adverse Drug Reactions (RCMADR) in Wrocław in the years 2007-2009. The study material included 232 spontaneous reports, which were sent by physicians and pharmacists to the RCMADR in Wrocław, out of which 80 concerned mentioned drugs. Analysis of the obtained data revealed a relationship between the incidence and kind of ADRs and the age, gender of the patients, centre from which the data were supplied, geographical region of administered medication. A significant role of post-registration monitoring of adverse drug reactions during therapy with antiinflammatory and analgesic drugs was confirmed in view of geographically conditioned differences affecting the profile of instituted therapy and the source of information. With an increasing global use of these medications, only thorough monitoring of every adverse reaction, encouraging spontaneous reports, as well as analysis at a global level may increase the knowledge on adverse drug reactions and enable correction of the safety profile of every drug from this group.
Department of Clinical Pharmacology, Wrocław Medical University, Bujwida 44, 50-345 Wrocław, Poland. tje1@wp.pl
Ewa
E
Jaźwińska-Tarnawska
Anna
A
Wiela-Hojeńska
Anna
A
Wolańczyk-Medrala
Janusz
J
Patkowski
Marita
M
Nittner-Marszalska
Krystyna
K
Głowacka
D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010595:Pharmacists; D010820:Physicians; D055815:Young Adult
D000894:Anti-Inflammatory Agents, Non-Steroidal