Sepsis in Critically Ill Patients at a Community Acute Care Hospital: DISCUSSION part 2
The ICU mortality rate and the 28-day mortality rate in the present study were higher than those reported in the PROWESS study. This difference may be due in part to the higher severity of illness among patients in the current study. The 28-day mortality rate was also higher than the hospital—ICU mortality rate of 45% observed in a previous Canadian study, in which the average APACHE II score was 31 and the mean number of dysfunctional organs was 3.4. Of note, the patients in the earlier Canadian study3 who had failure of 3 or more organs were at increased risk of death (odds ratio [OR] 3.3, 95% confidence interval [CI] 1.6-7.0, p = 0.002). The fact that half of the deaths in the current study occurred within 8 h of initiation of DAA suggests that these patients may have been moribund and therefore not suitable for DAA therapy. However, the first organ or system dysfunction had to have developed no more than 48 h before DAA therapy was started, so it is unlikely that DAA was being used as a heroic measure in patients for whom conventional therapy was failing and whose first organ failure had developed many days previously.
Rates of serious bleeding associated with DAA use appeared to be higher in clinical practice than those reported in the PROWESS study. A higher incidence of this adverse effect may be expected when a medication is administered on a broader clinical scale than is the case in a study setting. The rate of serious bleeding during infusion observed in the current study (7%) was similar to rates reported previously for Canada (7.3%) and Italy (10.9%). At the author’s institution, all of the PROWESS exclusion criteria were incorporated in the preprinted order, whereas 20% of patients in the earlier Canadian study had relative contraindications to DAA. Information about contraindications was not published in the Italian study. The use of DAA in patients with a relative contraindication to therapy was associated with a greater risk of a serious bleeding event (OR 2.7, 95% CI 1.1-6.5, p = 0.028) in the earlier Canadian study. This illustrates the importance of a risk-benefit assessment for each patient who is considered for therapy with DAA and the potential need to re-evaluate the use of this agent for patients with relative contraindications to therapy.
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Wastage of DAA can be minimized by not preparing additional supplies of the drug in advance of completing the current bag. Implementing this recommendation may be difficult in institutions where the drug is prepared in pharmacy dispensaries that are not open 24 h/day; in this situation, it may be necessary to call back pharmacists outside pharmacy hours to prepare the medication, or it may be necessary to prepare additional supplies of the medication in advance of need. The potential risk of inappropriate use of DAA if this medication were to be readily available on the ward (i.e., the risk associated with not ensuring that patients meet all institutional criteria for usage) was felt to outweigh the potential limitations associated with the need for therapy when the pharmacy was closed. In addition, there is a risk of mixing errors if nurses are responsible for mixing the drug, which could lead to negative patient outcomes or further wastage, particularly given that the medication is used infrequently. Most of the potentially preventable wastage identified in this study occurred when the pharmacy was open, which indicates an easily correctable area for improvement. Since completion of the study, pharmacists have been informed of the importance of not preparing additional supplies of DAA in advance of need once therapy has been initiated, and the ICU pharmacist stays in close contact with the dispensary regarding the need for and timing of subsequent supplies of DAA for each patient. The wastage data from this study are unique, as no previous evaluations of wastage associated with DAA use were identified in the literature.
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The institution now has information about the patients who receive DAA, as well as information about efficacy, toxicity, and wastage associated with this drug. This drug-use evaluation indicates higher mortality and bleeding rates than originally estimated during randomized controlled trials. Given the retrospective design of the study, these data may be limited because of incomplete data collection or inaccurate reporting of data in patients’ health care records. In addition, the sample size was small, despite a lengthy data collection period, because use of this agent is limited. Although there are limitations to the conclusions that can be drawn from single-centre evaluations of the efficacy and safety of DAA, the results of this drug-use evaluation are in keeping with the results from other larger evaluations. They illustrate the importance of drug-use evaluations and of institutional guidelines to facilitate appropriate use of DAA. Institutions should also evaluate wastage associated with DAA use, to minimize potentially preventable wastage of this costly drug.