Better manging risks ? Carrying out risk mapping in a pharmacy production unit

11 October 2019

Manon Etis1, Mathieu Wasiak1, Yassine Bouattour1, Maily Devillers1, Mireille Jouannet1, Valérie Sautou1,2
1 : CHU Clermont-Ferrand, Pôle Pharmacie, F-63003 Clermont-Ferrand, France
2 : Université Clermont Auvergne, Institut de Chimie de Clermont- Ferrand. UMR CNRS 6296, F-63000 Clermont-Ferrand, France

Our pharmacy hospital produces non-sterile and sterile preparations. As this activity presents significant risks, we wanted to evaluate them by conducting a risk mapping to determine our control level and to define areas for improvement.

Materials and methods

A working group composed of 3 pharmacists, 3 pharmacy interns, 12 pharmacy technicians and a logistics operator was set up and 14 meetings were organized. The approach, according to the FMEA method, consisted of several steps: process description, identification and evaluation of the gross risks according to the institutional scale of our hospital which has 5 levels (possible causes, frequency, severity for the patients), description of control means for each risk, net risks assessment. The data treatement concerning the reliability, the relevance, the supervision, and the formalization of control means made it possible to calculate the control level on a scale with 4 levels.

26 risks were identified, 13 of which involved several steps in the process. The gross risks were divided into 4 major risks, 20 strong, 2 moderate and 0 low. The application of control means enabled us to obtain 0 major risk, 12 strong risks, 12 moderate risks and 2 low risks. Mean of control analysis gives the following results:
* 14 (53.8%) risks are very well controlled (level 4/4), including 2 (7.69%) among the strong risks: risks of absence of pharmaceutical analysis or risks of error in analysis.
* 10 (38.46%) are rated 3/4, of which 9 (34.61%) among the strong net risks: risks of microbiological or chemical contamination, calculation or weighing error, error in the choice of the preparation to be carried out , forgetfulness, error in the choice of raw materials, raw material or preparation shortage, delivery error.
* 2 (7.69%) are at a level 2/4 and are therefore poorly mastered, including 1 (3.84%) among the strong net risks: risks related to interpersonal / intersector communication.

This study confirms that the production activity generates significant risks, and shows that the majority of them are well mastered in our hospital pharmacy. The focus should begin on the strong net risks least well controled. The ongoing work on staff training and the requalification of areas and equipments should lead to rapid results improvement.

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