The PROWESS trial delineated a role for the use of drotrecogin-α in severe sepsis. However, this drug is associated with significant cost, which was projected to be $1.5 million annually in our university hospital setting, based on charts coded for septicemia. Therefore, a protocol to allow its appropriate use but discourage misappropriation was needed. A group of pharmacists, critical care physicians and nurses developed a protocol using data from the trial.
Physicians prescribing drotrecogin were required to complete a standardized order form which required that the infected patient display ≥2 signs of the systemic inflammatory response syndrome (SIRS), and a minimum of one organ dysfunction. Also, an intensivist was required to approve the use. Exclusion criteria were left at the discretion of the intensivist. These forms were collected over a 40 month period and demographics, associated costs, and adverse events were compiled.
122 patients were prescribed drotrecogin between 12/01 and 04/05. Of these patients, 53.3% were in the medical ICU, 30.3% were surgical, and 16.4% were in the burn ICU. The average age was 49.1 years (range 18 - 91. 55.1% were male, 44.9% female. Mean APACHE II at time of infusion in 82 patients was 25.6 (range 12 - 45). The most frequent adverse events in this population were death during infusion (14.9% or 18 patients) and bleeding (6% or 7 patients). Total hospital cost of the drug was $806,669, or an average of $7333 per patient. Overall 28 day all cause mortality was 33.6%.
Drotrecogin in our institution was used in patients with a high severity of illness as assessed by APACHE II. Complications were comparable to previous studies. Drug costs were well below anticipated numbers.
A prescribing protocol for the use of drotrecogin in severe sepsis which indicates inclusion criteria but not exclusion criteria, and is approved by a critical care specialist, can aid in guiding the use of this drug while promoting cost containment.
Sonja Bartolome, Consultant fee, speaker bureau, advisory committee, etc. Simpson is a member of the Lilly Lecture Bureau and has received consulting fees from Eli Lilly.