Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Establishment of a failure mode and effects analysis for high-risk breviscapine-based traditional Chinese medicine injection

Yingying Mei^1,2, Tiandong Zhang^1,2 , Xu Zuo^1,2, Ziyun Bu^1,2

¹Department of Pharmacy, Xinxiang Central Hospital, Xinxiang, Henan Province 453000, China; ²The Fourth Clinical College of Xinxiang Medical University, Xinxiang, Henan Province 453000, China.

For correspondence:- Tiandong Zhang Email: zhangtd_2021@163.com

Accepted: 5 May 2024 Published: 29 May 2024

Citation: Mei Y, Zhang T, Zuo X, Bu Z. Establishment of a failure mode and effects analysis for high-risk breviscapine-based traditional Chinese medicine injection. Trop J Pharm Res 2024; 23(5):893-901 doi: 10.4314/tjpr.v23i5.12

© 2024 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..

Abstract

Purpose: To assess the failure modes and effects of clinical application of breviscapine-based traditional Chinese medicine injection (TCMI).

Methods: 229 reports on clinical application errors, medication errors or management measures relating to breviscapine injection were collected by searching various databases. A clinical application and safety evaluation questionnaire was formulated for use in the failure mode and effects analysis (FMEA) of breviscapine injection. The questionnaire survey was then distributed to 100 doctoral, nursing and pharmaceutical personnel in Xinxiang Central Hospital who were randomly chosen to participate.

Results: A total of 81 (83.5 %) valid questionnaires were retrieved. A total of 29 potential failure types, failure causes and failure effects were identified. Mean values of all risk priority numbers (RPN) of the 29 failure modes were ranked comprehensively. The failure modes identified as top 10 risk factors include; detailed information regarding the patient’s medical, allergy and family disease history not being provided to physicians (75.22); incorrect choice of drug manufacturer and lot number (74.95), drugs not being dispensed on the spot (72.16); inappropriate choice of solvent (71.31); drugs not suitable for combination therapy (70.81); inappropriate choice of solvent dosage (69.14); individual patient differences not taken into consideration (67.07); infusion rate too fast (67.00); off-label drug use (65.32); and age of the patient not taken into consideration (64.96).

Conclusion: As a risk management tool, the FMEA conducted in this study reduces potentially dangerous clinical application of high-risk TCMI, standardizes the medication process and significantly reduces occurrence of adverse reactions to TCMI. Future studies are required to validate these claims.

Keywords: Breviscapine, High-risk traditional Chinese medicine injection, Failure mode, Adverse reaction, Pharmacology