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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.

Descriptive Analysis of Medication Errors and Contributing Factors in Clinical Trials at a Single Institution

단일기관 임상시험에서 의약품 사용과오 및 기여요인 분석

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

1Department of Pharmacy, Seoul National University Hospital, Seoul, Korea
2College of Pharmacy, Seoul National University, Seoul, Korea
3College of Pharmacy, Yeungnam University, Gyeongsan, Korea

1서울대학교병원 약제부, 2서울대학교 약학대학, 3영남대학교 약학대학

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

Received: September 2, 2024; Revised: September 19, 2024; Accepted: September 19, 2024

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.

Abstract

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

Korean Society for Pharmacoepidemiology and Risk Management

Vol.16 No.2
September, 2024

eISSN 2982-5954

Frequency: Bimonthly

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