Adverse Drug Reactions to First-line Anti-tubercular Drugs Based on Individual Case Safety Report in a Single Tertiary Hospital / 대한내과학회지

Background/Aims@#Tuberculosis has incidence and mortality rates that are among the highest for all communicable diseases. Adverse drug reactions (ADRs) to anti-tubercular drugs are common, and have a major impact on treatment maintenance and prognosis. It is important to understand the characteristics of ADRs and establish a suitable management plan. @*Methods@#We retrospectively reviewed patients with ADRs during treatment with first-line antitubercular drugs such as isoniazid, rifampicin, ethambutol, and pyrazinamide from 2009 to 2018. Age, sex, and total treatment period, and the onset, severity, seriousness, and system organ class of ADRs, were analyzed to understand the characteristics of first-line anti-tubercular drug-related ADRs. @*Results@#A total of 1,606 of 5,482 patients (29.3%) experienced ADRs after administration of first-line anti-tubercular drugs. The incidence of ADRs related to isoniazid, rifampicin, ethambutol, and pyrazinamide was 22.2%, 21.3%, 24.5%, and 29.6%, respectively. A total of 2,098 ADR reports were made (mean of 1.3 ± 0.6 per patient). The rates of mild, moderate, and severe ADRs were 32.4%, 61.1%, and 6.5%, respectively. There were 127 reports (6.1%) of serious ADRs. Skin and appendage disorders were most frequently reported (27.5%), followed by gastrointestinal disorders (17.5%), and liver and biliary system disorders (13.1%). The total treatment period was longer in patients who experienced ADRs (224.0 ± 3.1 days vs. 247.0 ± 4.7 days, p = 0.009). @*Conclusions@#The incidence of ADRs to first-line anti-tuberculosis drugs was 29.3%, and 6.5% were severe ADRS. ADRs prolonged the overall treatment duration, indicating the importance of their detection and management.

A 10-Year Single-Center Experience of Adverse Drug Reaction Monitoring / 대한내과학회지

Background/Aims@#Despite proper use of pharmaceuticals, adverse drug reactions (ADRs) can lead to problems related to patient safety. We analyzed the characteristics of ADRs, particularly serious adverse events (SAEs), in a single tertiary medical institution. @*Methods@#Spontaneous ADR report data collected from 2010 to 2019 in Seoul National University Hospital were assessed. Causality was evaluated according to the World Health Organization-Uppsala Monitoring Centre criteria. Age, sex, onset, severity, seriousness, and system organ class (SOC) of ADRs and SAEs were analyzed. @*Results@#During the study period, a total of 49,955 individual case safety reports were assessed as possible, probable, or certain. Although the number of gastrointestinal ADR reports was high (25.9%), severe cases were uncommon (2.6%). By contrast, the number of hematologic disorders was low (6.6%) but 39.2% of them were severe. Among ADRs, 10.2% were assessed as SAEs, the proportion of which was high at extreme ages and in males. Body as a whole-general disorders were the most frequently reported SOC for SAEs, followed by skin and appendage disorders. Antineoplastic agents and antibiotics were the most common causative agents of SAEs and ADRs. Anaphylactic reaction was the most frequent SAE (6.5%). @*Conclusions@#The proportion of SAE differs according to SOC and drug. Attention should be paid to SAEs in children and older adults because the rate of SAEs is significantly higher at extreme ages.

A 10-Year Single-Center Experience of Adverse Drug Reaction Monitoring / 대한내과학회지

Background/Aims@#Despite proper use of pharmaceuticals, adverse drug reactions (ADRs) can lead to problems related to patient safety. We analyzed the characteristics of ADRs, particularly serious adverse events (SAEs), in a single tertiary medical institution. @*Methods@#Spontaneous ADR report data collected from 2010 to 2019 in Seoul National University Hospital were assessed. Causality was evaluated according to the World Health Organization-Uppsala Monitoring Centre criteria. Age, sex, onset, severity, seriousness, and system organ class (SOC) of ADRs and SAEs were analyzed. @*Results@#During the study period, a total of 49,955 individual case safety reports were assessed as possible, probable, or certain. Although the number of gastrointestinal ADR reports was high (25.9%), severe cases were uncommon (2.6%). By contrast, the number of hematologic disorders was low (6.6%) but 39.2% of them were severe. Among ADRs, 10.2% were assessed as SAEs, the proportion of which was high at extreme ages and in males. Body as a whole-general disorders were the most frequently reported SOC for SAEs, followed by skin and appendage disorders. Antineoplastic agents and antibiotics were the most common causative agents of SAEs and ADRs. Anaphylactic reaction was the most frequent SAE (6.5%). @*Conclusions@#The proportion of SAE differs according to SOC and drug. Attention should be paid to SAEs in children and older adults because the rate of SAEs is significantly higher at extreme ages.

Analysis of individual case safety reports of drug-induced anaphylaxis to the Korea Adverse Event Reporting System

PURPOSE: To identify causative agents of the drug-induced anaphylaxis (DIA) by using the Korea Institute of Drug Safety & Risk Management-Korea Adverse Event Reporting System (KIDS-KAERS) database (Ministry of Food and Drug Safety) in Korea and to check their labeling information regarding anaphylaxis.METHODS: Among Individual Case Safety Reports from January, 2008 to December 2017, cases of DIA were analyzed for demographics, causative agents and fatal cases resulting in death. The domestic drug labeling, Micromedex and U.S. Food and Drug Administration (FDA) drug package insert, were reviewed to check if the labeling information on suspected causative agents contains anaphylaxis.RESULTS: A total of 4,700 cases of DIA were analyzed. The mean age was 49.85±18.32 years, and 2,642 patients (56.2%) were females. Among 8,664 drugs reported as causative agents, antibiotics (27.4%) accounted for the largest portion. There were 18 fatal cases: antibiotics (7 cases), antineoplastic agents (4 cases) were the major causative drugs for the mortality cases. Of 513 drugs reported as suspected causative agents, 103 (20.1%) did not list anaphylaxis as an adverse effect on domestic drug labeling and 16 (3.1%) did not reflect anaphylaxis in any of 3 adverse drug information.CONCLUSION: Analysis of 10-year data showed that antibiotics were the main cause of DIA and the mortality rate was 0.7%. In 3.1% of suspected drugs, there was no description of anaphylaxis in any of the drug labeling.

Comparison of one-bag and multibag desensitization protocols for the prevention of rituximab hypersensitivity

Purpose@#Rituximab is prone to infusion-related reactions, which commonly requires desensitization to maintain its administration. Conventional desensitization protocols are using multistep infusion by diluting solutions. However, the process of diluting drugs and stepwise delivery needs additional time and effort. The objective of this study was to investigate the safety and efficacy of a nondiluting, one-bag protocol of rituximab desensitization. @*Methods@#A retrospective study was performed by reviewing the medical records of patients who underwent rituximab desensitization between 2009 and 2018. The completion rate, occurrence and severity of breakthrough reactions (BTR), and time required to complete the therapy were compared between one-bag protocol and multibag protocol. Results were analyzed by generalized estimation equation method, and odds ratios (ORs) of completion rate and BTR incidence were estimated. @*Results@#Total 190 cases of desensitization therapy were performed in 49 patients; the incidence of BTR was 16.84% and the overall completion rate was 96.32%. No significant difference in completion rate was found (OR, 3.58; 95% confidence interval [CI], 0.79– 16.38) and there was no significant difference in BTR incidence (OR, 0.81; 95% CI, 0.23–2.82) in one-bag protocol. BTR in the one-bag protocol tended to occur even through entire steps, whereas most of the BTR in the multibag protocol occurred at later steps of the process. The average time spent in the desensitization was 60 minutes shorter in the one-bag than the multibag protocol (258.15 minutes vs. 329.81 minutes, P< 0.001). @*Conclusion@#One-bag desensitization protocol showed no significant difference in safety and efficiency compared to the conventional multibag protocol, with shortening the time required for completion.

Establishment and Operation of Wartime Health Care System in North Korea during the Korean War and Support from the Korean Society in Yanbian / 의사학

North Korea's health care system during the Korean War has a significant meaning in North Korean medical history and is also an appropriate research topic for understanding North Korea's wartime system. However, previous studies on North Korean medical history has been focused on before and after the war. This study traces the formation and operation of North Korea's wartime health system to fill the gap in the literature, aiming to identify that the support of the North Korean community in China's Yanbian community was key to North Korea's wartime health system.North Korea reorganized its health care system, centered on the military, such as establishing field hospitals concurrently with the outbreak of the war. However, as time went on, the North Korean health care project began to put an emphasis on protecting the lives and health of the civilians behind the frontline. In addition to the primary need to prevent infectious diseases, the hygiene and prevention project functioned as a means to control and mobilize the public by emphasizing broad public participation. Although North Korea tried to meet the demand for a large medical personnel through short-term training, medical personnel were always in short supply during the war.During the war, it was the Korean society in Yanbian that replenished medical personnel in North Korea and provided a space for a relatively stable hospital operation. Numerous Koreans in Yanbian participated in the Korean War as nurses, paramedic staff, transfusion donors, and army surgeons for North Korea. Such large-scale participation of medical personnel in Yanbian was based on the long-established medical exchanges between Yanbian and North Korea. Koreans in Yanbian also accommodated North Korean wounded, refugees, and war orphans and provided various medical assistance to them. During the war, Yanbian was a “secure rear” capable of performing medical actions that could not be done in North Korea.This study has confirmed that North Korea's current participation in public health projects, which is a characteristic of its health care sector, has its origins in the Korean War. Moreover, it demonstrates that North Korea's medical history needs to be viewed from an East Asian perspective, including the Korean society in Yanbian, rather than a national-only perspective. The application of this view to the analysis of North Korean’s health care system in other historical periods would facilitate richer discussions.

The Establishment and operation of Longjing Medical College(龍井醫科大學): The History of Longjing Medical College as Frontier History: Focusing on its ‘Disconnection’ and ‘Continuity’ / 의사학

Longjing Medial College(龍井醫科大學), established in Longjing, Yanbian, China on September 12, 1945, existed for about 1 year and 6 months until it was renamed as the Medical Department of Dongbei Junzheng Daxue Jilin Fenxiao(東北軍政大學吉林分校) in April 1947. However, there are only few records and studies on Longjing Medical College in Yanbian as well as in Korea. In order to fill the gap, this study attempted to restore the history of Longjing Medical College built in Yanbian, China immediately after the liberation. In particular, it analyzed how and why the Longjing Medical College was founded and operated, and which relations the college had with the post-war medical educational institutions, focusing on the ‘disconnection’ and ‘continuity’ in the historical sense. Since the establishment of Manchukuo(滿洲國), the Japanese colonial government had made it a major “frontier” and actively promoted the mass migration of Japanese and Koreans. For them, the government also set up three Exploitation Medical Schools in 1940. As a part of these three institutions, Longjing Exploitation Medical School(龍井開拓醫學院) educated more than 150 students by 1945, of which about one third was Korean. After the liberation, the Longjing Educational Alliance(龍井敎育同盟) decided to pursue the return-movement of the Longjing Exploitation Medical School and took over the institution. On September 12, 1945, Longjing Medical College opened at the school site of Longjing Exploitation Medical School. Longjing Medical College was founded by people who had ‘the perspective of Korean nationality’ in an atmosphere where the ‘ethnicity’ of the Koreans exercised considerable power. Nevertheless, in 1946, when the Chinese Civil War began and the Yanbian region became an important base of the Chinese Communist Party, the Party began to expand and strengthen their influences in the region. Accordingly, the operation rights of Longjing Medical College were transferred to the Yanbian Administrative offices of Supervision(延邊行政督察專員公署) and Government of Jirinsheng(吉林省政府) which were the administrative institution by the Chinese Communist Party in turns. In the end, Longjing Medical College was reorganized into the Medical Department of Dongbei Junzheng Daxue Jilin Fenxiao (1947. 3) and the first branch of the Chinese Medical College (1948. 1), a medical education institution focused on nurturing the medical personnel required for the Chinese Civil War. In January 1949, the first branch moved to Harbin, merged with the second branch there, and was transformed into Harbin Medical College. Afterwards, the Yanbian Koreans played a major role to establish Yanbian Medical College(延邊醫科專門學校) in a basis of the teachers and buildings left by the moving-out of the first branch(1948. 10. 1). Now, Yanbian Medical College is the official body of Yanbian University Medical Center. Longjing Medical College, which has such a complicated history, is partially ‘disconnected’ from the Yanbian medical educational institutions in the post-war era in terms of its possession, operation objective, and academic system. However, many of the early members of the Longjing Medical College were not only teachers and students of the Longjing Exploitation Medical School, but also a few of them continued to teach at the Medical Department of Dongbei Junzheng Daxue Jilin Fenxiao, the first branch of the Chinese Medical College, and Yanbian Medical College. Particularly, several members actively participated in the establishment of each school or in the position of the top leader of the school. Also, all the medical education institutions referred to above used the building and facilities of Longjing Exploitation Medical School until the period of Yanbian Medical College. As such, the history of Longjing Medical College as frontier history, gives us a difficult, but significant question on the meanings of ‘disconnection’ and ‘continuity’ in history and their implications.