• Korean Journal of Clinical Pharmacy
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• v.28 no.2
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• pp.81-87
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• 2018

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.

• The Korean Journal of Pain
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• v.13 no.1
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• pp.60-66
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• 2000

Background: For terminal cancer pain management, controlled-release oral morphine (morphine sulfate tablet, MST) is a simple and convenient regimen. Recently, fentanyl transdermal therapeutic system (F-TTS, transdermal fentanyl) has been developed and became one of the alternative ways of providing adequate pain relief. This open prospective study was designed to compare the analgesic efficacy and safety of MST and transdermal fentanyl in the management of terminal cancer pain. Methods: In this open comparative and randomized study, 64 terminal cancer patients received one treatment for 15 days, controlled-release oral morphine (MST group) or fentanyl transdermal therapeutic system (F-TTS group). Daily diaries about the vital sign, visual analogue scale (VAS) for pain, opioids requirement, co-anagesics, adjuvant drugs and adverse effects were completed with 24 patients in MST group, 18 patients in F-TTS group. Results: The majority of patients in both treatment groups were late-stage cancer and their distribution was not different in both groups. Daily opioids requirement was 126.4 mg in MST uced in F-TTS group (P<0.05). The incidence of nausea, vomiting and constipation was lower in F-TTS group (P<0.05). Patients satisfaction was similar, but F-TTS patient group favored continous use of same treatment compared with MST group after the study was finished. Conclusions: Transdermal fentanyl seems to be safe and similar analgesic effect to controlled-release oral morphine for the control of the terminal cancer patients. However, transdermal fentanyl provides a simpler and more convenient especially in respect to constipation, nausea & vomiting. To determine the exact analgesic effect, cost-effectiveness and complications, controlled trials should be followed.

• Journal of Hospice and Palliative Care
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• v.7 no.2
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• pp.238-247
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• 2004

Purpose: Pain management is often needlessly suboptimal. Health care professionals are seldom trained in pain management, may not realize the importance of pain management or recognize that a patient is in pain, and may fear prescribing opioid medications. Noting that one of the problems related to health care professionals is poor assessment of pain, we studied a trend of pain severity and satisfaction with pain controls after using TTS-fentanyl in order to determine whether a regular pain assessment was effective for controlling cancer pain. Methods: We assessed the pain as a $5^{th}$ vital sign after using TTS-fentanyl in 471 hospitalized cancer patients during 4 days. The data were collected from September, 2003 to December, 2003. Pain severity was assessed by using a numeric pain intensity scale($0{\sim}10$) by ongoing pain assessment. Results: Pain assessment as a $5^{th}$ vital sign had led to reduce patient's pain scores. High degrees of satisfaction scores in both patients and doctors with TTS-fentanyl were observed. They were also negatively correlated with the pain severity. Conclusion: Regular pain assessment was effective in the management of cancer pain.

• Radiation Oncology Journal
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• v.24 no.4
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• pp.263-271
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• 2006

$\underline{Purpose}$: To evaluate the effectiveness and safety of fentanyl-TTS in the management of radiotherapy induced acute pain and cancer pain treated with radiotherapy. $\underline{Materials\;and\;Methods}$: Our study was open labelled prospective phase IV multi-center study. the study population included patients with more 4 numeric rating scale(NRS) score pain although managed with other analgesics or more than 6 NRS score pain without analgesics. Patients divided into two groups; patients with radiotherapy induced pain (Group A) and patients with cancer pain treated with radiotherapy (Group B). All patients received 25 ug/hr of fentanyl transdermal patch. Primary end point was pain relief; second end points were change in patient quality of life, a degree of satisfaction for patients and clinician, side effects. $\underline{Results}$: Between March 2005 and June 2005, 312 patients from 26 participating institutes were registered, but 249 patients completed this study. Total number of patients in each group was 185 in Group A, 64 in Group B. Mean age was 60 years and male to female ratio was 76:24. Severe pain NRS score at 2 weeks after the application of fentanyl was decreased from 7.03 to 4.01, p=0.003. There was a significant improvement in insomnia, social functioning, and quality of life. A degree of satisfaction for patients and clinician was very high. The most common reasons of patients' satisfactions was good pain control. Ninety six patients reported side effect. Nausea was the most common side effect. There was no serious side effect. $\underline{Conclusion}$: Fentanyl-TTS was effective in both relieving pain with good tolerability and improving the quality of life for patients with radiotherapy induced acute pain and cancer pain treated with radiotherapy. The satisfaction of the patients and doctors was good. There was no major side effect.