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

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.