Korean J Clin Pharm.  2018 Jun;28(2):81-87. 10.24304/kjcp.2018.28.2.81.

Fentanyl PCA Monotherapy and Fentanyl TTS Combination Therapy in Post-Operative Pain Management: Analyses of Spontaneous Adverse Drug Reaction Reports

• Park SJ
• Jeong KH
• Kim EY

• KMID: 2416665
• DOI: http://doi.org/10.24304/kjcp.2018.28.2.81

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.

Keyword

Fentanyl PCA; fentanyl TTS; adverse drug reactions; postoperative pain management

MeSH Terms

Acute Pain
Analgesia, Patient-Controlled
Cohort Studies
Drug Utilization
Drug-Related Side Effects and Adverse Reactions*
Fentanyl*
Humans
Incidence
Odds Ratio
Orthopedics
Pain Management*
Passive Cutaneous Anaphylaxis*
Pharmacovigilance
Retrospective Studies
Fentanyl