Implementation of Bevacizumab hospital preparation in syringes at hospital pharmacy department: Conducting an internal audit

EH. Diouf, Q. Bessonnat, D. Salmon, V. Lebreton, D. Laleye, C. Pivot, F. Pirot

Aim

Department of pharmacy prepares syringes of Bevacizumab within framework of recommendation to temporary utilization (RTU) of AVASTIN ® in DMLA treatment. An internal audit was carried out in order to first check application of procedures and then to prepare healthcare regional agency (ARS) inspection for this activity.

Materials and method

A frame of reference for this audit included French good manufactured practice (BPP), French hospital good manufactured practice (BPPH), and AVASTIN ® RTU in DMLA therapy as well as the internal procedures of the compounding unit. From this frame of reference, an audit grid was drafted by basing itself on various preparation stages. These were made up of material preparation, personal access to cloakroom and airlock, syringes production, controls, visual inspection and syringes storage in anti-UV bags between 2°C and 8°C. The various stages of this audit were audit preparation, opening meeting, audit conduct, closing meeting and audit report.

Results

To 57 audited criteria, only 4 non-conformities were recorded. These non-conformities concern especially personal flow, hygiene rules for area controlled atmosphere access and update of procedures.

Discussion

After completion of audit, corrective and improvement actions were proposed: planning of days and schedules of preparation, installation of pictograms in front of every place for reminding access conditions to staff and update of procedures. Some observations allowed implementation to recommendations improvement.

Indeed, realization of internal audit on syringes preparation of Bevacizumab made it possible to identify process failures and set up corrective actions. Moreover, it also made it possible to better preparation of ARS inspection for this activity.

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