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Fentanyl PCA Monotherapy and Fentanyl TTS Combination Therapy in Post-Operative Pain Management: Analyses of Spontaneous Adverse Drug Reaction Reports
Korean J Clin Pharm 2018;28(2):81-87
Published online June 30, 2018
© 2018 Korean College of Clinical Pharmacy.

Soo Jung Park1#, Kyeong Hye Jeong2#, and Eun Young Kim1,2*

1Graduate School of Food and Drug Administration, College of Pharmacy, Chung-Ang University, Seoul 06974, Republic of Korea
2College of Pharmacy, Chung-Ang University, Seoul 06974, Republic of Korea
Correspondence to: * Eun Young Kim, College of Pharmacy, Chung-Ang University 84, Heukseock-Ro, Dongjack-gu, Seoul 06974, Republic of Korea Graduate school of Food and Drug Administration, College of Pharmacy, Chung-Ang University, 84, Heukseok-ro, Dongjak-gu, Seoul 06974, Republic of Korea
Tel: +82-2-820-5791, Fax: +82-2-816-7338 E-mail:
#The authors equally contributed to this manuscript as first author.
Received April 18, 2018; Revised May 23, 2018; Accepted May 23, 2018.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
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.
Keywords : Fentanyl PCA, fentanyl TTS, adverse drug reactions, postoperative pain managemen

June 2018, 28 (2)
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