Pharmacoepidemiol Risk Manage.  2024 Sep;16(2):172-181. 10.56142/perm.24.0019.

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

• Kim SM
• Jung HS
• Jang HW
• Baek JH
• Lee JY
• Ah YM

• KMID: 2564481
• DOI: http://doi.org/10.56142/perm.24.0019

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.

Keyword

Investigational product; Medication error; Clinical trial; Contributing factor; Human error