Stability issues of parenteral chemotherapy drugs.

ABSTRACT

The pharmacist often needs to have all the information required to prepare and to assign an expiry date for parenteral products of antineoplastic agents. The pharmaceutical manufacturers usually provide data on how to prepare their products and the associated physicochemical stability. Standard reference texts also provide additional summary information of other primary data. However, it is not uncommon to find knowledge gaps in this area. Hence, additional extrapolation and consensus on interpretation is often needed to address issues not covered by data from the pharmaceutical manufacturers, standard reference texts, or official guidelines. Some of the key issues have been identified in our recent development of a chemotherapy preparation and stability chart. These include use of data from different brands, expiry date of original vial and final products, risk of contamination, infusion volume and stability, multi-day home-use products, syringe preparations, and products to be used immediately. Potential approaches to address these common issues are described in this article.