자발적 약물 이상반응 보고 분석을 통한 수술 후 통증 조절에 사용된 Fentanyl의 약물사용적정성

초록

Objective: There have been many cases of spontaneous adverse drug reactions to fentanyl at a regional pharmacovigilance centerin the hospital. To assess the factors causing the adverse drug reactions reported in patients receiving fentanyl patient-controlledanalgesia (PCA) monotherapy or in combination with fentanyl transdermal therapeutic system (TTS) for acute post-operative painmanagement. Methods: We conducted a retrospective cohort study with all patients prescribed fentanyl PCA for pain managementafter orthopedic surgery at a single university hospital from June 2012 to May 2013. We analysed the factors causing adverse drugreactions reported by a spontaneous reporting system in patients receiving fentanyl PCA monotherapy and those receiving fentanylTTS in combination with fentanyl PCA. Results: Based on the spontaneous adverse drug reaction reporting, the risk ratio for theincidence rate of adverse drug reaction in the fentanyl TTS combination therapy group was 3.04 (95 % CI: 2.4-4.00, P < 0.0001),which was approximately 3-fold higher than that reported for fentanyl PCA monotherapy. Only 60 % of the adverse drug reactionswere reported. Conclusion: It is inappropriate to add fentanyl TTS to fentanyl PCA to manage post-operative acute pain. There isa need to improve adverse drug reaction reporting. We expect that regular analysis of adverse drug reactions reported at regionalpharmacovigilance centre would aid in appropriate drug utilization by patients.

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