Analysis of notified adverse events: a tool for improving risk mapping related to the automatic repackaging and preparation of individual doses

5 October 2016

M. Cadart , B. Rousset, S. Armand-Branger CESAME (Centre de Santé Mentale Angevin), Ste Gemmes sur Loire,
BP 50089 49137 Les Ponts de Cé Cedex 9, France

CESAME’s pharmacy, a psychiatric hospital in France, bought an automatic dispensing machine (ADM) to implement drug safety management. A risk mapping was set up prior its launch to secure the new process.

The study aims to update this mapping based on notified adverse events during the first ten months of production.


  • Retroactive analysis of adverse events notified by nurses: events classification, observed frequencies computation.
  • Risk defined prior to the study : risk rating update based on frequency.
  • Undefined risk : risk introduction with its scoring.
  • The risk-rate is computed with the combination of two parameters : frequency and severity. It results in a criticality indexed on a 1 to 16 scale.


  • 1 new risky stage identified and scored in the field of software parameterization,
  • Rise in criticality of 4 risks: 2 concerning the production, 1 concerning the unpackaging and 1 the visual control of production,
  • 88% of pharmacy errors are linked to a failure at the stage of visual control of production by the pharmacy technician.


Controlling stage has a criticality scored 16, with means it’s urgent to set up corrective measures.
These consist in a new space organization by partitioning locals, removing the phone from the production area and team reviews of the procedure “Implementation of automatic individual dose preparation”. In the event of these actions being insufficient, purchase of a controlling automaton will be considered.

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