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KMID : 1011320170090010018
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Journal of Pharmacoepidemiology and Risk Management
2017 Volume.9 No. 1 p.18 ~ p.26
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Analysis of Adverse Drug Reactions Related Analgesics Collected by Spontaneous Reporting Program within a Hospital
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Kwon Ji-Sun
Han Ye-Seul
Kim Jae-Song
Kim Soo-Hyun
Park Jung-Won
Son Eun-Sun
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Abstract
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Objective: This study was conducted in order to contribute to the reduction of analgesic adverse drug reactions (ADRs) by referring to drugs, characteristics of patients, and types of ADRs through analysis of analgesic ADRs cases collected by spontaneous reporting program within hospital.
Methods: A total of 11,943 cases registered and completed all of the assessments after being reported to ADRs reporting mechanisms of Severance Hospital from July 1st in 2014 to June 30th in 2015 were covered. Of all cases, drugs that represent analgesics, opium alkaloids, and designer drugs were extracted based on pharmaceutics classification system of Ministry of health & welfare. Causality assessment of ADRs cases were conducted according to the World Health Organization-The Uppsala Monitoring Center (WHO-UMC) criteria and only those that had been assigned “Possible” among 6 categories were considered as significant ADRs and analyzed.
Results: Among analgesic ADRs (4,948 reports, 41.43%) of total 11,943 reports, 4,907 cases (99.17%) were significant. The average age of patients that showed signs of significant ADRs were 54, and the proportion of women was 66.25%, higher than that of men. There were more narcotic analgesics (3,121 reports, 63.60%) than non-narcotic analgesics (1,786 reports, 36.40%) and appeared highest in gastrointestinal system (56.16%), followed by nervous system (25.68%) and cardiovascular system (5.81%). Fentanyl (21.36%), propacetamol (19.94%), and meperidine (5.42%) were the most threatening drugs that caused 221 cases of serious ADRs. The most common ADRs symptoms were found in cardiovascular system (58.82%), respiratory system (9.14%), and nervous system (7.22%).
Conclusion: The results of this study will help minimize possible adverse effects caused by analgesics administration by predicting them, and contribute to the safe drug use by reminding people of the importance of monitoring after analgesics administration and collecting data through the report of ADRs.
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KEYWORD
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Drug-Related Side Effects and Adverse Reactions, Analgesics, Adverse Drug Reaction Reporting Systems
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