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Use of national guidelines for the introduction of Drotrecogin alfa (activated)


The Scottish Medicines Consortium approved the use of Drotrecogin alfa (activated) (Xigris©) in October 2002 and recommended that a register of patients receiving the drug be kept. The Scottish Intensive Care Society (SICS) developed guidelines for the use of this innovative therapy, suggesting that patients should have three or more of the systemic inflammatory response syndrome (SIRS) criteria in the presence of infection, at least two acute organ failures and an APACHE score of at least 25 [1].


The Council of the SICS agreed that an audit of the use of Xigris© be conducted once it was licensed. The Scottish Intensive Care Society Audit Group (SICSAG) implemented this study on behalf of the SICS. Information manuals containing the guidelines and data collection methodology were introduced throughout Scottish ICUs. The guidelines were also made available in an interactive format on the ICU audit system (Ward Watcher, Critical Care Audit Ltd, Yorkshire, UK) and provided clinicians with an electronic tool to help determine fulfilment of criteria. Pharmacists and ICU staff informed the SICSAG whenever the drug was administered. Attempts to review records of all patients receiving the drug in the first 10 months were made by a nurse from the audit group.


Between October 2002 and August 2003, 102 patients received the drug. Complete records were available for data validation in 92 (90%) of the recipients. Of these recipients, 90 (97.8%) fulfilled the recommended criteria for SIRS, 87 (94.6%) for infection and 81 (88%) had at least two organ dysfunctions. The range in APACHE scores was wide, from 5 to 43. Over one-half (57.6%), however, had APACHE scores greater than 24 (mean 25.5, median 26). Overall, 49 recipients (53.3%) fulfilled all the criteria as suggested in the guidelines. Based on our prospective audit, conducted over a 5-month period in 2002 [2], we expected that in the region of 300 patients might meet the criteria in this time period.


Early use of this drug has been stable month-on-month. Overall use has been less than anticipated but has shown marked variation between units. Consultants generally follow those aspects of the guidelines relating to SIRS criteria and organ dysfunction but seem reluctant to base prescribing decisions on APACHE score.


  1. Scottish Intensive Care Society: Guidelines for use of activated protein C.[]

  2. MacKirdy F, Harris G, Mackenzie SJ: The epidemiology of sepsis in Scottish Intensive Care Units. Crit Care 2003, 7(Suppl 2):P27. 10.1186/cc1916

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Supported with a grant from Eli Lilly.

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Mackenzie, S., Patterson, L., Plenderleith, L. et al. Use of national guidelines for the introduction of Drotrecogin alfa (activated). Crit Care 8 (Suppl 1), P121 (2004).

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