Subcontracting of cytotoxic drug reconstitution : assessment and impact on our centralized unit after 5 months

Recently, SFPO and ARS guidelines promote a clustering of activities once production volume is lower than 5000 preparations per year. Within that context, our hospital committed itself in a subcontract in order to optimize our production unit capacities. The projected increase of activity is about 66,7%.

The aim of this study is to assess in qualitative and quantitative terms this outsourcing after 5 months of implementing and evaluate the impact on our production unit.

A retrospective study was conducted on the first 5 months, based on extracted data from CHIMIO® software. Data were analyzed by Excel®. In addition, a review of quality indicators and non-compliance (NC) observed was evaluated.

The activity increased by 67,7%, divided into 59,3% preparations for our unit and 40,7% for the external customer. The average time between customer’s medical validation and subcontractor’s pharmaceutical validation is 13min. The production record is edited 19min after customer’s medical validation and an average time of 46min is seen between the “on-demand” status and final preparation. Preparations realized in advance represent 47% of the customer orders. In 5 months of outsourcing, 13 preparations have been destroyed by the customer (0,9%), 13 NC relate to a medical validation outside the predefined time schedules, and 26 various NC have been recorded. The assessment on our production unit shows a time period for availability lengthened by 19min for our patients.

This study shows feasibility of cytotoxic drug reconstitution subcontracting which representing a significant increase of production, without a binding elongation of preparations availability for our unit.
The NC analysis led, among others, to a delivery schedule adaptation to enhance the process. Working with preparations in advance succeeded in reducing the time spent in hospital for the patients.