Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
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Fentanyl PCA Monotherapy and Fentanyl TTS Combination Therapy in Post-Operative Pain Management: Analyses of Spontaneous Adverse Drug Reaction Reports

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

  • Park, Soo Jung (Graduate School of Food and Drug Administration, College of Pharmacy, Chung-Ang University) ;
  • Jeong, Kyeong Hye (College of Pharmacy, Chung-Ang University) ;
  • Kim, Eun Young (Graduate School of Food and Drug Administration, College of Pharmacy, Chung-Ang University)
  • 박수정 (중앙대학교 의약식품대학원) ;
  • 정경혜 (중앙대학교 약학대학) ;
  • 김은영 (중앙대학교 의약식품대학원)
  • Received : 2018.04.18
  • Accepted : 2018.05.23
  • Published : 2018.06.29
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Abstract

Objective: There have been many cases of spontaneous adverse drug reactions to fentanyl at a regional pharmacovigilance center in the hospital. To assess the factors causing the adverse drug reactions reported in patients receiving fentanyl patient-controlled analgesia (PCA) monotherapy or in combination with fentanyl transdermal therapeutic system (TTS) for acute post-operative pain management. Methods: We conducted a retrospective cohort study with all patients prescribed fentanyl PCA for pain management after orthopedic surgery at a single university hospital from June 2012 to May 2013. We analysed the factors causing adverse drug reactions reported by a spontaneous reporting system in patients receiving fentanyl PCA monotherapy and those receiving fentanyl TTS in combination with fentanyl PCA. Results: Based on the spontaneous adverse drug reaction reporting, the risk ratio for the incidence 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 reactions were reported. Conclusion: It is inappropriate to add fentanyl TTS to fentanyl PCA to manage post-operative acute pain. There is a need to improve adverse drug reaction reporting. We expect that regular analysis of adverse drug reactions reported at regional pharmacovigilance centre would aid in appropriate drug utilization by patients.

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References

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