Practical implementation of a preliminary risk analysis on a regional scale relating to the introduction of a unit dose dispensing system with over-packaging within a hospital pharmacy

HAMIDOU F1, BOREL C1, MONIRUL S2, LE GONIDEC P1 1 Observatoire des médicaments, des dispositifs médicaux et de l’innovation thérapeutique d’Île-de-France, Paris, France
2 Hôpital Avicenne, AP-HP, Bobigny, France

Background and objectives
In 2019, a Preliminary Risk Analysis (PRA) was carried out on a segment of the drug distribution process: the automatized preparation of unit dose to be administrated by the over-packaging unit dose dispensing system. This regional PRA was based on the experience of 6 pharmacy teams. The wide range of possible scenarios identified (n=190), makes the PRA results hardly usable by hospital project teams.
The aim of this work was to implement this exhaustive risk matrix in a practical tool usable by actors involved or commencing in this new hospital pharmacy activity.

Methodology
The working group which elaborated the regional PRA (pharmacists and executive pharmacy technicians) analyzed the 190 accident scenarios with 3 filters (non-exclusives), called thematic. Then a standard factsheet template was elaborated with a summary section and a technical section based on detailed elements of the PRA. The double aim was to target both pharmacy teams as well as management teams.

Results
The aggregation of the information from the system sub-component’s, hazardous situations, primer causes, and feared events has highlighted keys points based on risk minimization actions identified in the PRA. Three factsheets were done with the following filters: “multisite operations” (49 scenarios); “suppliers/buyers” (44 scenarios) and “staff awareness of pharmacy and health care teams” (129 scenarios). Those represent respectively 26%, 14% and 64% of PRA accident scenarios. The major of criticality level on those 3 factsheets is level 2 (on a 3 levels scale). Among the generic types of hazards, the most important ones are the human factor and means and equipment. The factsheet is organized as follows: 2 quantitative sections containing the initial criticality data of accident scenarios and the generic types of hazards and 2 qualitative sections containing the summary table of keys points linked to the thematic as well as the detailed table of PRA scenarios.

Discussion, conclusion
The factsheets will be tested shortly by hospital project teams in order to evaluate the relevance and operational nature of the information. Others thematic might be implemented with the following filters: legal risks and hospital information systems risks.

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