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

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.

Evaluation of efficacy and safety of fentanyl-TTS in adult patients with cancer-related pain / 대한내과학회지

The transdermal administration of narcotics is one of the alternative ways of providing adequate pain relief for the patients with chronic cancer pain. A Phase 4 trial was conducted to evaluate the efficacy and safety of Fentanyl-TTS in adult patients with cancer-related pain in Korea. METHODS: Patients with histologically confirmed malignancy, who have pain related to the cancer and/or therapy, pain necessitating the use of opoid analgesics, age of 18 yr or older, ability to communicate effectively with study personnel, and signed on informed consent were included. The patients were titrated with a short-acting narcotic to control their cancer pain before they are converted to a fentanyl-transdermal therapeutic system(TTS). Short acting parenteral morphine and MS contin were used as rescue medications. All patients were evaluated initially and were followed up with a pain visual analogue scale(VAS), quality of life(QOL)-VAS. Patients were asked to keep the daily record for 21 days about pain VAS, QOL-VAS, amount of rescue morphine used, and side effects. RESULTS: Twenth two patients were enrolled from January 1996 to October 1997. The dose of fentanyl-TTS required, ranged between 25 and 75 ug/hr (25 microgram/hr in 13, 50 microgram/hr in 4, and 75 microgram/hr in 2). The mean dose of morphine required before the use of the fentanyl-TTS was 135.3 mg (20-285 mg/day), but it was decreased after the use of the fentanyl-TTS. Pain VAS and QOL-VAS were in adquate level during the fentanyl- TTS treatment. Patients favored continuous use of fentanyl after the study was finished. Side effect of fentanyl-TTS was minimal. CONCLUSION: Transdermal fentanyl seems to be a convenient and effective analgesic for the control of cancer related pain in Korean. A controlled trial comparing fentanyl-TTS to morphine needs to be followed.