Failure mode and effect analysis of the risk management of non-integral-dosage drug dispensing in PIVAS

doi:10.5246/jcps.2024.07.044

Abstract

Abstract:

To mitigate risks associated with the prescription examination, marking, dispensing, checking, and review of non-integral-dosage drugs in Pharmacy Intravenous Admixture Service (PIVAS), we formed a project team. Employing the failure mode and effect analysis (FMEA) management method, we identified potential risks in four critical steps of the non-integral-dosage drug dispensing process within PIVAS drug management: prescription verification, mixed allocation, and verification. For each step, we assigned scores for severity, incidence, and detectability, subsequently calculating the Risk Priority Number (RPN) to prioritize identified risks. Targeted measures for improvement were developed for steps with the highest RPN values. A total of 31 risk factors were documented in the management of non-integral-dosage drugs, with the dispensing process being particularly vulnerable. Specific measures were devised for eight high RPN risks. Following a 3-month optimization and improvement period, RPN values and incidences of internal differences were significantly reduced. The implemented measures demonstrated effective risk control. Notably, we established a comprehensive conversion system for partial-dose drug dispensing, directly translating into a volume of suction fluid for dispensing personnel based on doctor orders. This eliminated the need for manual secondary calculations, thereby standardizing and automating the dispensing of non-integral-dosage drugs in PIVAS. Simultaneously, our project team conducted a dissolution test on 23 types of drugs with non-integral dosage, revealing that the solvent volume increased for 11 types after dissolution. The dosage conversion for partial dosage was recalibrated based on the volume of the final solution to ensure dosage accuracy. Through the application of failure mode and effect analysis, we systematically managed the risks associated with non-integral-dosage drugs in PIVAS. This approach addressed safety concerns in the dispensing process, reduced errors, and ensured the safe and precise administration of medication to patients.

Key words: PIVAS, FMEA, The non-integral-dosage drugs, Risk management, Dispensing

Supporting:

Kuikui Geng, Juan He, Sheng Rong, Zhaohu Jia, Xiangxiang Zhang, Tianlu Shi. Failure mode and effect analysis of the risk management of non-integral-dosage drug dispensing in PIVAS[J]. Journal of Chinese Pharmaceutical Sciences, 2024, 33(7): 597-608.

Figures/Tables 8

Table 1. Statistical table of project team members.

Table 2. Scoring standards of risk points S, O, and D of non-whole dose drug allocation.

Table 3. Statistical table of S, O, D, and RPN values of non-integral drug dispensing risk points before and after the implementation of measures.

Table 4. Statistical table of solvent dissolution test results of 23 kinds of powder varieties for injection used in non-whole doses.

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