Objective  To explore the application effect of failure mode and effect analysis (FMEA) on the drug validity management of inpatient pharmacy.

Methods  Based on the FMEA method, risks in the drug quality management process were identified, all potential failure modes were explored and the causes of failure were analyzed. The quantitative scoring was carried out based on severity, occurrence and detection degree, the risk priority number (RPN) was calculated, and key failure modes were determined. Improvement plans were developed and implemented from three aspects: oral dismantling drugs management, other drugs management except for oral dismantling drugs, and cardinal drugs management in inpatient wards, and the effectiveness of the intervention was evaluated.

Results  Based on the values of RPN, 28 potential failure modes were identified, among which 20 were key failure modes that needed to be improved with priority. After taking corresponding measures, the RPN values of the 20 key failure modes all decreased, with 17 of them having a reduction of ≥50%. The variety number of drugs that were close to expiry in the ward was significantly reduced (P<0.05), and the qualified rates of cardinal drug management, drug validity management, and drug labeling management were significantly improved (P<0.05). The type number of  drugs that were close to expiry in the inpatient pharmacy, the drug turnover days in the repackaging machine, and the number of validity-verification adverse events all decreased to varying degrees.

Conclusion  The application of FMEA method can effectively identify and improve the risk points in the drug validity management process, enhance the quality of drug management, and ensure the safety of medication for inpatients.

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