Stability of antineoplastic agents in use for home-based intravenous chemotherapy

Abstract

Aim of the review: The aim of this work was first to define which antineoplastic agents with sufficiently long stability could be eligible in the circuit of home-based therapy (centralised preparation, transport to the patient's home and administration by nurses) and, second, to propose a standardisation of the stability data of anticancer drugs in use for home hospitalisation.

Method: A survey carried out in six hospital pharmacies of the Assistance Publique-Hôpitaux de Paris (AP-HP) hospitals, with important activity in oncology, listed the stability data used locally by each site. The final goal is to reach a consensus for the stability of cytotoxic drugs, which was the result of an original collaboration between the pharmacists of the compounding unit and the quality control unit. These results were compared to marketing authorisation data.

Results: The survey showed that eight antineoplastic agents of 34 were prepared under identical conditions (infusion diluent, concentration range, protection from light, temperature) by all hospitals (3 < or = n < or = 6): the stability was identical between each site for only two cytotoxic drug preparations (fotemustine and gemcitabine) and varied by up to 168 h or 7 days for the preparations of dacarbazine, epirubicine and cisplatin. Stability validated by pharmacists and those provided by marketing authorisation ranged respectively from "extemporaneously prepared" at 1,344 h (median = 168 h) to "extemporaneously prepared" at 720 h (median = 4 h). For 11 antineoplastic drugs, no information about the stability after compounding was specified in the marketing authorisation. Of all cytotoxic drugs used in the Hospital at Home of AP-HP, stability after compounding validated by pharmacists was less than 30 h for six of them, between 30 and 78 h for four and exceeding 78 h for the remaining 24.

Conclusion: Considering the lack of data about cytotoxic drugs stability provided by the pharmaceutical companies and the difficulties in retrieving and interpreting the literature data, a consensus on the stability of cytotoxic drug preparations is essential for the current practice. With this approach, initiated for home hospitalisation, we propose in this study an initiative of the standardisation of stability data which offers a decision support for other centres.