Ex) Article Title, Author, Keywords
Ex) Article Title, Author, Keywords
Pharmacoepidemiology and Risk Management 2024; 16(2): 172-181
Published online September 30, 2024 https://doi.org/10.56142/perm.24.0019
Copyright © Korean Society for Pharmacoepidemiology and Risk Management.
Sae-Mi Kim1,2, Hyun-Suk Jung1, Hong-Won Jang1, Jin-Hee Baek1, Ju-Yeun Lee2, Young-Mi Ah3
김새미1,2, 정현숙1, 장홍원1, 백진희1, 이주연2, 아영미3
Correspondence to:Ju-Yeun Lee
College of Pharmacy, Seoul National University, 1 Gwanak-ro, Gwanak-gu, Seoul 08826, Korea
Tel: +82-2-3668-7472
Fax: +82-2-3668-2728
E-mail: jypharm@snu.ac.kr
Young-Mi Ah
College of Pharmacy, Yeungnam University, 280 Daehak-ro, Gyeongsan 38541, Korea
Tel: +82-53-810-2823
Fax: +82-53-810-4654
E-mail: ymah@ynu.ac.kr
This is an Open-Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Objective: This study aimed to classify medication errors during clinical trials by stage of medication use, identify error types, and analyze associated factors at a single institution. Methods: Data were collected from medication errorrelated reports, including ‘protocol violation reports’ and ‘near miss reports,’ from January 1, 2018, to December 31, 2022. Errors were categorized by severity using the Medication Error Index and classified by error type using the Sheikhtaheri and psychological classification methods. Contributing factors were analyzed in terms of human, organizational, investigational product, and clinical trial design factors. Results: A total of 62 medication errors from 46 reports were identified. Errors occurred across various stages: prescribing (19.4%), preparation (46.8%), administration (1.6%), site management (9.7%), and sponsor management (22.6%). Common errors included ‘wrong dose’ in prescribing (58.3%) and ‘wrong medication’ in preparation (31.0%). Severity classification showed that most errors were in categories B (45.7%) and C (52.2%). Near miss analysis revealed that 45.6% of errors were intercepted before reaching the patient. Contributing factors were primarily human (52.9%), followed by organizational (16.1%), investigational product (16.1%), and clinical trial design factors (14.9%). Psychological classification indicated 34.8% rule-based, 30.4% knowledge-based, 21.7% action-based, and 13.0% memorybased errors. Conclusion: Understanding medication errors and their contributing factors in clinical trials can provide valuable insights for improving medication safety strategies in the planning and execution of clinical trials.
KeywordsInvestigational product, Medication error, Clinical trial, Contributing factor, Human error