The r-tPA is one of the therapeutic drugs to reduce the initial mortality and to enhance long-term survival rate in acute myocardial infarction. The r-tPA use need DUE(drug use evaluation). It is not only because its adverse effects such as intracranial hemorrhage or other bleeding but its high cost. Furthermore in order to use r-tPA unique dosing regimen and special patient condition must be satisfied. And the risk of adverse effects and the cost analysis should be considered before administration of the r-tPA. The purpose of this study is assuring the quality and the benefit of r-tPA use through evaluating the use of r-tPA.
This study was conducted through retrospective chart review of 16 adults who received r-tPA to manage myocardial infarction from jan. 1996 to Oct. 1997. We have optimised the criteria for our hospital, which is applicated from ASHP ´Audict Criteria for Drug Utilization Review (1990)´. The consist of four criteria; the justification of use, the process indicator, the complication and the outcome measure. In the analysis of justification the results showed the accepted level was 100%. In the process indicator including aPTT, CBC, CK/LDH, electrolyte, EKG and heparin administration the results showed the accepted level was 100%. Anticoagulation with heparin was continued for five days and this was consistent with the criteria. In the complication criteria, aPTTs were larger three times than control in eight cases (50%). Bleeding in the cutaneous puncture site occurred in two cases (12.5%). Although arrhythmnia occurred in eight cases (50%), most r-tPA were administered without any particular management except one case, in which lidocaine was administered to manage arrhythmia. However there had not been any fatal adverse effects like intracranial hemorrhage. In the criteria of outcome measure to evaluate the outcome after administration of the r-tPA, it was difficult to identify early reperfusion because of insufficient documentation. Sign of early reperfusion were identified in three cases. In our hospital the reperfusion of coronary artery was identified from coronary angiography after five or seven days. The rate of reperfusion was 92.3%.
From these results, we concluded that the r-tPA use in our hospital was appropriate and safe without any serious adverse events. And we founded that the elevation of aPTT has to be monitored closely. Especially, it is important to administer the r-tPA in earlier phase of myocardial infarction in order that it can be used effectively and safely. Pharmacists can contribute this through supplying more information about AMI and r-tPA.
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