Application of Failure Mode and Effects Analysis Method in Risk Management of the Entire Process of Pharmacy Intravenous Admixture Service Antitumor Drugs Formulation

OBJECTIVE To improve the dispensing quality of antitumor drugs in pharmacy intravenous admixture service (PIVAS), and ensure the safety and effectiveness of clinical medication.

METHODS Performed failure mode and effects analysis(FMEA) on the entire process of PIVAS antitumor drugs formulation, identified risk points and calculate their risk priority value(RPN). Listed high-risk points with high RPN values as priority improvement targets, proposed improvement measures, and evaluated the improvement results.

RESULTS In the entire process of PIVAS antitumor drugs dispensing, a total of 16 risk points that need to be prioritized for improvement were identified. The research team rectified them from several main aspects, including medical order review, clinical education, environmental monitoring, packaging and delivery, and drip time management. After intervention, the total RPN values of 16 high risk points decreased from 808 to 318, all of which were reduced to low-risk, with a decrease of 60.6%. Among them, the number of errors in medical orders, the number of errors in the dispensing process, unsuitable environmental requirements, and delivery errors had been significantly improved after improvement(P<0.05). CONCLUTION Applying FMEA to the entire process risk management of PIVAS antitumor drug admixture can effectively improve the quality of anti-tumor drug formulation and reduce error rates.