Risk analysis by the FMECA method of the pharmaceutical circuit of injectable experimental drugs

23 November 2020

A. Raphard , A-L. Yailian, M. Dubuisson, D. Laleye, C. Riou, E. Jousselme, J-P. Koehler, C. Pivot, C. Dhelens - Pharmacie, Hôpital Édouard Herriot, CHU de Lyon, France

In our hospital pharmacy, the preparation of injectable experimental drugs (EDs) is carried out by the centralized pharmaceutical preparation unit (UPCP) after pharmaceutical validation of the prescription by the pharmaceutical clinical trials unit (UPEC). In a context of continuous quality improvement and in the perspective of the ISO9001 certification of the UPEC unit, a multi-professional risk assessment has been performed using the FMECA (Failure Mode, Effects and Criticality Analysis) method.

To map the process of management, preparation and dispensation of injectable EDs, in order to assess possible risks and propose corrective actions (CAs) to optimize the injectable ED circuit.

Material and method
The FMECA was conducted between March and May 2020 over 5 sessions of the multi-professional working group (UPEC/UPCP pharmacists, pharmacy resident, pharmacy technicians and their managers). Each stage of the process was initially described. For each of them, failure modes (FMs), causes and their effects were then identified. The scoring of the frequency (F) of occurrence, severity (G) and detectability (D) was established for each FM using scales from 3 to 5 levels1. The assessment of criticality (C) (C = F*G*D) allowed the identified risks to be classified into 3 categories: low (C < 12), moderate (13 < C < 21) and major (C > 21) criticality.

The FMECA analysis highlighted 50 risks: 2 of a major level (4%), 8 of a moderate level (16%) and 40 of a low level (80%). The 2 risks of major level concerned the specific training of UPCP staff in preparation of injectable EDs requiring volume removal or not. Dispensing stage involved 4 risks of moderate level (incorrect storage of preparations, dispensation of preparation without validation by UPEC pharmacist, dispensation for another patient included in the same clinical trial, lack of traceability). The other steps of the process were of a low level of criticality.

This analysis identified steps with highest risk and proposed improvement solutions. Priority CAs must be carried out on the 2 risks of major level. The provided CAs are: improving the continuous training of all staff involved in preparation of injectable EDs, updating preparation forms (by emphasizing volume removal), validation of preparation forms by UPCP technicians and pharmacists, a reminder of ED specificities preparation by UPEC pharmacist before preparation for technicians when it is considered necessary. After the implementation of these CAs, a new FMECA will be conducted to assess their impact in the process.

[1] Analysis of the risks related to the circuit of management and dispensing of products in clinical trials by "FMECA" - Hurtrel & al., 2012

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