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Prevalence and Seriousness of Analgesic-Induced Adverse Events in Korea: A 10-Year Nationwide Surveillance.
J Patient Saf. 2020 Jun 26 [Online ahead of print]JP

Abstract

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.

Authors+Show Affiliations

From the Clinical Trial Center, Hallym University Sacred Hospital, Anyang, Gyeonggi-do.Department of Pharmacy, College of Pharmacy, Kyung Hee University, Seoul.Department of Pharmacy, College of Pharmacy, Kyung Hee University, Seoul. Department of Pharmacy, Kyung Hee University Hospital at Gangdong, Seoul.Department of Internal Medicine, Dongguk University Ilsan Hospital, Goyang, Gyeonggi-do, South Korea.Department of Pharmacy, College of Pharmacy, Kyung Hee University, Seoul. Department of Pharmacy, Kyung Hee University Hospital at Gangdong, Seoul.Department of Pharmacy, College of Pharmacy, Kyung Hee University, Seoul.Department of Internal Medicine, Dongguk University Ilsan Hospital, Goyang, Gyeonggi-do, South Korea.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32604192

Citation

Choi, Yeo Jin, et al. "Prevalence and Seriousness of Analgesic-Induced Adverse Events in Korea: a 10-Year Nationwide Surveillance." Journal of Patient Safety, 2020.
Choi YJ, Kim MH, Chung EK, et al. Prevalence and Seriousness of Analgesic-Induced Adverse Events in Korea: A 10-Year Nationwide Surveillance. J Patient Saf. 2020.
Choi, Y. J., Kim, M. H., Chung, E. K., Lee, J. K., Yoon, J., Yug, J. S., & Jang, D. K. (2020). Prevalence and Seriousness of Analgesic-Induced Adverse Events in Korea: A 10-Year Nationwide Surveillance. Journal of Patient Safety. https://doi.org/10.1097/PTS.0000000000000742
Choi YJ, et al. Prevalence and Seriousness of Analgesic-Induced Adverse Events in Korea: a 10-Year Nationwide Surveillance. J Patient Saf. 2020 Jun 26; PubMed PMID: 32604192.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Prevalence and Seriousness of Analgesic-Induced Adverse Events in Korea: A 10-Year Nationwide Surveillance. AU - Choi,Yeo Jin, AU - Kim,Myoung-Hee, AU - Chung,Eun Kyoung, AU - Lee,Jun Kyu, AU - Yoon,Jimin, AU - Yug,Ji Seob, AU - Jang,Dong Kee, Y1 - 2020/06/26/ PY - 2020/7/1/entrez PY - 2020/7/1/pubmed PY - 2020/7/1/medline JF - Journal of patient safety JO - J Patient Saf N2 - 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. SN - 1549-8425 UR - https://www.unboundmedicine.com/medline/citation/32604192/Prevalence_and_Seriousness_of_Analgesic-Induced_Adverse_Events_in_Korea:_A_10-Year_Nationwide_Surveillance L2 - https://doi.org/10.1097/PTS.0000000000000742 DB - PRIME DP - Unbound Medicine ER -
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