How to optimise the robustness and safety of a hospital compounding by monitoring relevant indicators?

M-L. Brandely-Piat (Paris - France)
L. Escalup (Paris - France)
P. Odou (Lille - France)

Within internal use pharmacies, hospital compounding, which are increasingly frequent, are made using various production processes. We must therefore take into account in our organisations the fact that a process, whatever its initial validation, can go wrong. The method used to control the evolution of these processes must be preventive, with the objective of bringing them to a required level of quality and then maintaining them there through appropriate monitoring. This method must quickly identify and effectively correct any drift. The workshop aims to define the bases of this control, by applying it to situations encountered in hospital compounding unit, around examples such as the production of hard capsules, injectables, realized manually or automatically, in individual or batch compounding.

The workshop will address the notion of variability based on examples from the life of current hospital pharmacies, such as automated control of anti-cancer chemotherapy based on the infrared or RAMAN technique, manual preparation of capsules, automated compounding of liquid injectables, volumes dispensed by pump, etc... Before drug preparation, and then during preparation, it is necessary to work on a "process" approach, which consists of using well-known tools that are now widely used in our hospitals by the quality departments. These include the Cause and Effect Diagram (Fish Bone), the Cause Influence Probability Matrix, the 5 Whys method, etc. Another qualitative approach is to be able to identify the 2 types of variability: variability resulting from random causes and variability resulting from causes that can be assigned to a problem.

When this qualitative approach is achieved, it is possible to work on a quantitative approach based on the use of indicators of the process and/or the end product. Simple indicators to check that the process is correctly adjusted will be given during the workshop, using examples of drug preparations currently encountered in hospital pharmacies. Finally, it is possible by using sampling to check that the whole production is in conformity with the specifications sought, making it possible to reduce the units used within the control and/or the sample bank. The most commonly used representation technique is the control chart. As we shall see, this name covers a very heterogeneous set of representations which apply to a great many situations.

Participants will leave this workshop with tools that can be easily applied in their daily practice.

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