Background Increasing demand for hospital-prepared cytostatics has forced Danish hospital pharmacies to develop solutions which support effective work flow in decentralised and future centralised production units. One way to optimise the logistics is to hold stock of prepared cytostatics for 1-3 months. This requires documentation of extended shelf lives of the prepared products. This can be done in different ways but the authorities' opinion is crucial for the quality. The Danish Drug Agency in spring 2011 stated that stability data for prepared cytostatics should be delivered by the industry and stated in the summary of product characteristics (SPC).
Purpose The aim of this study was to conduct a survey of the shelf lives and the usefulness of the information stated in section 6.3 in the SPCs for 13 selected prepared cytostatics.
Results 150 SPCs were identified for 13 cytostatics. The longest shelf life identified for prepared cytostatics was 28 days for doxorubicin, epirubicin, gemcitabine and irinotecan. Great variation between the minimum and maximum shelf lives for the same drug substance was observed. One of the biggest discrepancies occurred for epirubicin with a minimum shelf life of ‘use immediately after preparation’ and a maximum shelf life of 28 days after preparation. Apart from a few exceptions the times for which the concentrations are stable, which can be applied to the shelf lives, are not stated in the SPCs. Often no shelf lives for the prepared product are stated but only for the original or reconstituted product, and consistent terminology is lacking in the SPCs.
Conclusions Due to the limited information on shelf lives in the SPCs it is not possible to produce cytostatics in DK for stock; the quality of the SPCs is deficient.
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