Audit of adherence to National Institute of Clinical Excellence guidelines for the use of drotrecogin alfa (activated)

Introduction

Activated protein C (APC) is an endogenous protein, which has fibrinolytic and anti-inflammatory properties. This is available as human recombinant APC and is used in the treatment of patients with severe sepsis [1]. The National Institute of Clinical Excellence (NICE) suggested guidelines for the use of APC [2]. We retrospectively audited the records of patients who received APC during their admission to our ICU between January 2003 and August 2006. We audited our practice against three parameters: compliance with the NICE guidelines, accuracy of data forms, and outcomes of treatment.

Materials and methods

From January 2003 to August 2006 we used APC to treat 44 severely septic patients in our ICU. We obtained complete data for 37 patients. We collected data from the case notes, ICU charts and drotrecogin alfa (activated) data forms and recorded relevant data on an Excel spreadsheet proforma.

Results

NICE guidelines

We were 100% compliant with patient selection criteria for APC administration, which included a known or suspected site of infection, SIRS criteria and organ dysfunction criteria. All prescriptions were made by intensive care consultants. We were not fully compliant in excluding patients who met exclusion criteria (2/37 patients), although these cases were justified clinically by the consultants prior to administration.

Data entry

In 90% of cases the patient selection fields were completed, but only 30% of the exclusion and outcome fields were completed. In 30% of patients where a lactate ≥ 1.5 times normal was listed as one of the inclusion criteria, it was not associated with a pH ≤ 7.30 or a base deficit ≥5.0; however, all these patients had ≥3 organ-dysfunction criteria and hence still met the inclusion criteria.

Outcomes

Seven patients (15.9%) died during or within 28 days of APC administration. The standardised mortality ratio (SMR) was lower in patients receiving APC when compared with the rest of patients admitted over the same period (SMR ~0.5 vs ~1.0). Twenty-eight patients had an APACHE II score <25 and the effective cost per survivor was ~€16,800. Patients with APACHE II scores ≥25 had an effective cost per survivor of ~€22,400. Nine patients (20.5%) had their drotrecogin alfa (activated) infusions interrupted or discontinued for various reasons (including seven patients who had hemorrhagic complications, three of which were serious).

Conclusions and recommendations

We use APC in compliance with the NICE guidelines. APC is cost-effective in patients with an APACHE II score <25 in our ICU.