Monitoring a high-cost drug in critical care units

Recombinant human activated protein C (APC) (Drotrecogin-alfa activated) was licensed for the treatment of severe sepsis following the large randomised controlled trial, PROWESS [1]. Subgroup analysis of PROWESS and the subsequent ADDRESS [2] study have shown that only the sickest patients (at least two organ failures or APACHE II score >25) benefit from APC. Treatment is associated with an increased risk of serious bleeding, and so the use of APC is contraindicated in patients at high risk for this complication. The cost of using APC is high, both financially and in terms of possible adverse effects, thus appropriate patient selection is crucial. Upon European Licensing in 2002, the South East London Critical Care Network (SELCCN) successfully bid for funding to use APC on the understanding that the hospital Trusts would provide regular usage reports.