중증피부과민반응에 대한 약물이상반응 보고자료의 분석
Analysis of ADR Reports of Severe Cutaneous Adverse Reactions
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Background : Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction/rash with eosinophilia and systemic symptoms (DRESS) are part of severe cutaneous adverse reaction (SCAR), generally induced by drugs. The symptoms include adverse systemic skin damage and impairment of internal organs that can result in death. Therefore, Samsung Medical Center (SMC) Regional Drug Safety Center analyzed the reported hospital cases of adverse drug reaction (ADR) related to SCAR to evaluate the current status and develop a management plan. Methods : The hospital’s SCAR cases reported spontaneously through the ADR reporting system from January 2011 to June 2014 were reviewed for causative drugs, severity, re-administration, etc. During the investigation period, all cases of patients with SJS, TEN, and DRESS were extracted through the electronic medical record (EMR) to analyze the ratio of reported ADR cases. Results : Among the 38 cases reported in the ADR reporting system, 30(78.9%) were assessed as severe. Of the 30 severe cases, 3(7.9%) were re-administered the causative drug. The main causative drugs were allopurinol, carbamazepine, and antibiotics which are in accordance with previous studies. In total, 103 patients with records of SJS, TEN, and DRESS were included in the EMR. Among the 103 cases, 28(27.2%) were reported spontaneously through the ADR reporting system. Conclusion : The study shows that the spontaneous reporting ratio is low for SCAR, which is a severe form of ADR. Therefore, continuous training and promotion is necessary to change the perception of hospital staff regarding spontaneous reporting of SCAR in the ADR reporting system.
Abstract
Background : Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction/rash with eosinophilia and systemic symptoms (DRESS) are part of severe cutaneous adverse reaction (SCAR), generally induced by drugs. The symptoms include adverse systemic skin damage and impairment of internal organs that can result in death. Therefore, Samsung Medical Center (SMC) Regional Drug Safety Center analyzed the reported hospital cases of adverse drug reaction (ADR) related to SCAR to evaluate the current status and develop a management plan. Methods : The hospital’s SCAR cases reported spontaneously through the ADR reporting system from January 2011 to June 2014 were reviewed for causative drugs, severity, re-administration, etc. During the investigation period, all cases of patients with SJS, TEN, and DRESS were extracted through the electronic medical record (EMR) to analyze the ratio of reported ADR cases. Results : Among the 38 cases reported in the ADR reporting system, 30(78.9%) were assessed as severe. Of the 30 severe cases, 3(7.9%) were re-administered the causative drug. The main causative drugs were allopurinol, carbamazepine, and antibiotics which are in accordance with previous studies. In total, 103 patients with records of SJS, TEN, and DRESS were included in the EMR. Among the 103 cases, 28(27.2%) were reported spontaneously through the ADR reporting system. Conclusion : The study shows that the spontaneous reporting ratio is low for SCAR, which is a severe form of ADR. Therefore, continuous training and promotion is necessary to change the perception of hospital staff regarding spontaneous reporting of SCAR in the ADR reporting system.
참고문헌 (12)
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