Conducting a change in practice: new procedure for the preparation of portable antibiotic dispensers

C.Villié(1); C.Duquenne(1) ; M. Durand(1) ; R.Mazet(1) ; MD. Desruet(1,2) ; P. Bedouch(1,3)
1. Department of Pharmacy, Grenoble University, F-38000, Grenoble France 2. Laboratory of Bioclinic Radiopharmaceutics, Grenoble University, Inserm, CHU Grenoble, France 3. University Grenoble Alpes, CNRS, TIMC-IMAG UMR 5525, ThEMAS, F-38000, Grenoble, France

Introduction
In our hospital center, portable antibiotic diffusers are prepared for patients at home. The process uses a manual filling of the diffusers by the agents leading to musculoskeletal disorders (MSD), a variability on the precision of the preparation and risks of filling errors. The objective of this work is to define and validate a new filling process for diffusers that limits RSI and improves the accuracy of preparations.

Method
Equipment used : BAXA Repeater® pump
The change management was carried out in 6 steps:
1) Define a process limiting compression and traction movements: team brainstorming and blank tests
2) Validate the accuracy of the critical points
* preparation of the mother bag (PoM): production of a batch (n°1) of 14 Ceftazidime dispensers at 1.3g QSP 110 mL and determination of the antibiotic (ATB) in the PoM (HPLC analysis), deviation < 5
* filling of the diffusers from the PoM: realization of a batch (n°2) of 14 diffusers of glucose solution and determination of the concentration of the diffusers n°1, 7 and 14 (enzymatic analysis), deviation < 5
* validation of the repeatability of the volume delivered by the pump: 14 volumes of 110 ml measured with a test tube, deviation < 1%.
3) Validate the sterility of the process: aseptic filling test (AFT) over 3 days including "worst cases
4) Process risk analysis (Speed AMDEC)
5) Elaboration of quality documents, manufacturing sheets, labels
6) Training and accreditation of new operators

Results
1) The new procedure uses a peristaltic pump to fill the diffusers and integrates a preparation step of a mother bag. The number of compression/pulling operations is reduced by 58% to 80% depending on the ATB treatments.
2) Process validation
* The dosage of the mother bag of batch n°1 is 11.7 mg/mL, i.e. < 1% of the theoretical value (VT) = 11.82mg/ml
* The glucose dosage of the diffusers 1-7-14 of batch n°2 is < 2% of the TV = 32 mM
* Pump delivery volumes range from 110-111 mL, or < 1%.
3) The sterility of the process is validated
4-6) The risk analysis allowed the detection of an uncontrolled risk in case of equipment failure and to define the appropriate course of action. All the personnel were trained and qualified on the process by companionship.

Discussion-Conclusion
This new process allows to homogenize the concentration of ATB in the diffusers and a precise filling of the batch. This work has improved the process by securing the formulation and preparation by empowering the agents.
The method used in this work to support a change in practice has made it possible to control the risks. The collaboration of the agents throughout the trials is a guarantee of success to perpetuate the involvement of the teams.

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