PMID- 32604192 OWN - NLM STAT- MEDLINE DCOM- 20210222 LR - 20210506 IS - 1549-8425 (Electronic) IS - 1549-8417 (Linking) VI - 16 IP - 4 DP - 2020 Dec TI - Prevalence and Seriousness of Analgesic-Induced Adverse Events in Korea: A 10-Year Nationwide Surveillance. PG - e215-e224 LID - 10.1097/PTS.0000000000000742 [doi] AB - OBJECTIVES: The objectives of this study were to describe the prevalence and seriousness of analgesic-induced adverse events (AEs) and to identify factors associated with serious analgesic-related AEs in Korea. METHODS: Voluntarily reported analgesic-induced AEs to the Korea Adverse Event Reporting System from 2007 to 2016 were retrospectively reviewed. Analgesic medications were classified into nonopioids and opioids based on the Anatomical Therapeutic Chemical classification system. All AEs were grouped using System Organ Classes according to the World Health Organization-Adverse Reaction Terminology. Logistic regression was performed to identify factors associated with serious AEs. RESULTS: Overall, 194,566 AEs (32.2% for nonopioids, 67.8% for opioids) were included in this analysis. The most common causative nonopioid and opioid analgesics was ketorolac (n = 10,789) and tramadol (n = 53,727), respectively. The most frequent AEs were skin and appendage disorders for nonopioids (31.8%) and gastrointestinal disorders (59.5%) for opioids. Serious AEs occurred in 6102 (9.7%) and 3326 (2.5%) cases of the nonopioid and opioid groups, respectively. The most common serious AEs were skin and appendage disorders (33.2%) for nonopioids and neurologic disorders (19.3%) for opioids. Serious AEs were significantly associated with male (odds ratio [OR] = 1.423), advanced age (OR = 1.570), certain causality (OR = 2.304), nonopioid analgesics (OR = 4.182), and polypharmacy (OR = 1.009; P <0.001 for all). CONCLUSIONS: In Korea, analgesic-induced AEs are prevalent with opioids more commonly implicated. Tramadol is the most common etiologic medication. Serious AEs are more frequently caused by nonopioids with skin and appendage disorders most common. FAU - Choi, Yeo Jin AU - Choi YJ AD - From the Clinical Trial Center, Hallym University Sacred Hospital, Anyang, Gyeonggi-do. FAU - Kim, Myoung-Hee AU - Kim MH AD - Department of Pharmacy, College of Pharmacy, Kyung Hee University, Seoul. FAU - Chung, Eun Kyoung AU - Chung EK FAU - Lee, Jun Kyu AU - Lee JK AD - Department of Internal Medicine, Dongguk University Ilsan Hospital, Goyang, Gyeonggi-do, South Korea. FAU - Yoon, Jimin AU - Yoon J FAU - Yug, Ji Seob AU - Yug JS AD - Department of Pharmacy, College of Pharmacy, Kyung Hee University, Seoul. FAU - Jang, Dong Kee AU - Jang DK AD - Department of Internal Medicine, Dongguk University Ilsan Hospital, Goyang, Gyeonggi-do, South Korea. LA - eng PT - Journal Article PL - United States TA - J Patient Saf JT - Journal of patient safety JID - 101233393 RN - 0 (Analgesics) RN - 0 (Analgesics, Opioid) SB - IM MH - Adolescent MH - Adult MH - Analgesics/*adverse effects MH - Analgesics, Opioid/*adverse effects MH - Child MH - Drug-Related Side Effects and Adverse Reactions/*epidemiology MH - Female MH - Humans MH - Male MH - Middle Aged MH - Prevalence MH - Republic of Korea MH - Retrospective Studies MH - Young Adult EDAT- 2020/07/01 06:00 MHDA- 2021/02/23 06:00 CRDT- 2020/07/01 06:00 PHST- 2020/07/01 06:00 [pubmed] PHST- 2021/02/23 06:00 [medline] PHST- 2020/07/01 06:00 [entrez] AID - 01209203-202012000-00019 [pii] AID - 10.1097/PTS.0000000000000742 [doi] PST - ppublish SO - J Patient Saf. 2020 Dec;16(4):e215-e224. doi: 10.1097/PTS.0000000000000742.