• Journal of Pharmaceutical Investigation
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• v.39 no.4
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• pp.299-307
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• 2009

Data exclusivity is one of the most important intellectual property rights of pharmaceuticals. During data exclusivity period, third parties are prohibited from relying on the data which the original company has submitted to regulatory authority for drug application. I investigated data exclusivity systems for pharmaceuticals in the US, EU, Canada and Korea. New chemical entities were usually given the longest periods of data exclusivity compared to drugs with new indication or new formulation, although the protection periods varied by country. For new drugs to be entitled to a data exclusivity, strict conditions should be met. Data exclusivity has also been provided as an incentive to promote clinical investigation and drug development for pediatric population or orphan diseases. In Korea, data exclusivity was adopted in 1995 as an additive provision to "drug re-examination" which is to investigate post-marketing safety information of new drugs. It was introduced with few discussion on the purposes or effects of data exclusivity on pharmaceutical industry and pharmaceutical market in this country. I found that Korea's data exclusivity system falls short of considerations on valuing innovation of pharmaceutical research. It is necessary to improve data exclusivity system in order to promote innovative pharmaceutical development and to balance intellectual property rights protection and access to drugs in this country.

• Journal of Trauma and Injury
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• v.27 no.3
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• pp.43-49
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• 2014

Purpose: Trauma is one of the most common causes of death for children, and identifying severely injured children quickly in an overcrowded emergency room (ER) is difficult. Therefore, severe injury must be prevented, and the severity of injuries in children must be determined easily from their general characteristics and pre-hospital factors. Methods: Injured children younger than 15 years of age who visited the ER from June 2011 to May 2013 were enrolled. According to the revised trauma score (RTS) of the patients, the study population was divided in two groups, a severe group (RTS<7) and a mild group ($RTS{\geq}7$). The general characteristics and the pre-hospital factors were compared between the two groups. Results: Six hundred seventy-three children were enrolled, their mean age was 8.03 (${\pm}4.45$) years, and 476 (70.73%) patients were male. Of these patients, 22 patients (3.27%) were in the severe group, and 651 patients (96.73%) were in the mild group. Fewer males were in the severe group than in the mild group (50.00% vs. 71.43%, p=0.030), and children in the severe group were younger than children in the mild group (3.50 vs. 8.00 years, p=0.049). In the severe group, toddlers (54.55%, p=0.036) were the most common age group. Severe injuries occurred more often in spring (32.81%) and summer (54.56%) than in autumn (9.09%) and winter (4.55%) (p=0.026). The most common places of injury in the severe group were roads (50.00%, p=0.009), and the most common mechanisms of injury in the severe group were traffic accidents (50.00%), followed by falls (31.82%) (p=0.011). Most severely injured children were transferred by ambulance (72.73%, p=0.000). Conclusion: The results of this study may be helpful for identifying severely injured children quickly in the field and the ER. To prevent severe pediatric injuries, precautions and policies based on these results should be established.

• Journal of Trauma and Injury
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• v.22 no.1
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• pp.87-96
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• 2009

Purpose: Injuries are the most important cause of morbidity and mortality in the childhood population worldwide. Thus, this study was down to investigate the type and the severity of injuries according to the age group in childhood. Methods: A survey of injury information and a chart review were done on 378 children (257 boys, 121 girls) who visited the Emergency Departments of Asan Medical Center from March 1, 2009, to March 31, 2009. To determine differences in injury mechanism, accident place, injury site, New Injury Severity Score (NISS) and Pediatric Trauma Score (PTS), we divided the 378 patients into 4 group: under 1 year, 1 to 4 years, 5 to 9 years, and 10 to 15 years. Results: The mean (${\pm}SD$) age of the study group was 5.1 (${\pm}4.4$) years. Two year olds formed the largest group of injured children, with 77 cases (20.4% of the total). The most common cause of injury in childhood was being hit by an object (26.2%). Falls were frequent in the under-1-year group (22.2%) and slip downs (30.1%) were more frequent in 1-to-4-year group. More than half (53.4%) of the injuries occurred in the home, and the most common places of home-related injuries were the living room (41.1%) and the bedroom (31.2%). The mean (${\pm}SD$) NISS was 1.5 (${\pm}1.8$), and traffic accidents had the highest NISS ($2.8{\pm}5.1$). Injuries occurred most frequently during the evening. The peak period was 4:00 PM to 8:00 PM (33.7%). Conclusion: Patterns of childhood injury by age group were considerably different, and less severe and nonhospitalized injuries were common. Thus, need to improve surveillance of a variety of injuries, promote intersectional collaboration, build institutional capacities and mobilize community support and policy as an investment in prevention.

• Journal of Preventive Medicine and Public Health
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• v.55 no.1
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• pp.19-27
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• 2022

This study estimated the direct and indirect socioeconomic costs of 238 diseases and 22 injuries from a social perspective in Korea from 2007 to 2015. The socioeconomic cost of each disease group was calculated based on the Korean Standard Disease Classification System. Direct costs were estimated using health insurance claims data provided by the National Health Insurance Service. The numbers of outpatients and inpatients with the main diagnostic codes for each disease were selected as a proxy indicator for estimating patients' medical use behavior by disease. The economic burden of disease from 2007 to 2015 showed an approximately 20% increase in total costs. From 2007 to 2015, communicable diseases (including infectious, maternal, pediatric, and nutritional diseases) accounted for 8.9-12.2% of the socioeconomic burden, while non-infectious diseases accounted for 65.7-70.7% and injuries accounted for 19.1-22.8%. The top 5 diseases in terms of the socioeconomic burden were self-harm (which took the top spot for 8 years), followed by cirrhosis of the liver, liver cancer, ischemic heart disease, and upper respiratory infections in 2007. Since 2010, the economic burden of conditions such as low back pain, falls, and acute bronchitis has been included in this ranking. This study expanded the scope of calculating the burden of disease at the national level by calculating the burden of disease in Koreans by gender and disease. These findings can be used as indicators of health equality and as useful data for establishing community-centered (or customized) health promotion policies, projects, and national health policy goals.

• Clinical and Experimental Pediatrics
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• v.65 no.4
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• pp.194-200
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• 2022

Background: Injury is the leading cause of death or disability in children and adolescents. Rates of deaths from injuries have recently declined, but studies of the occurrence of nonfatal injuries are lacking. Purpose: This study aimed to investigate nonfatal injuries in children and adolescents younger than 20 years based on data from the Korean National Health and Nutrition Survey, 2007-2018. Methods: A questionnaire survey was conducted to determine whether children and adolescents had experienced an injury requiring a hospital visit in the previous year. We investigated each injury's risk factors and characteristics. Results: Of a total of 21,598 children and adolescents, 1,748 (weighted percentage, 8.1%) experienced one or more injuries in the previous year. There was no yearly difference in the proportion of injuries experienced. Among the male subjects, 10.0% had an injury experience; among the female participants, 6.1% had an injury experience (P<0.001). The highest rate was 9.0% in children aged 1-4 years. In multivariate logistic regression analysis, male sex; having an urban residence; having restricted activity due to visual, hearing, or developmental impairment; and attention deficit/hyperactivity disorder were significant risk factors for injury experience. The characteristics of up to 3 injuries per patient were investigated, and 1,951 injuries were analyzed. Falls and slips accounted for 34.9%, collisions for 34.1%, and motor vehicle accidents for 11.3% of the total injuries. Ninety-six percent of injuries were unintentional, 20% caused school absences, and 10% required hospitalization. Conclusion: Among Korean children and adolescents, 8.1% experienced injuries at least once a year with no significant differences in incidence over the past 12 years. Greater attention and effort to prevent injuries are needed.

• Journal of Trauma and Injury
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• v.22 no.1
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• pp.51-56
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• 2009

Purpose: The purpose of this study was to investigate environmental factors contributing to childhood home slip-down injuries. Methods: Among a total of 2,812 injured children in our Customer Injury Surveillance System (CISS), we performed a prospective study on 262 children with home slip-down injuries who visited the pediatric emergency department of Asan Medical Center between March 2008 and February 2009. We made a frequency analysis on parameters such as activities just before the accident, the presence of any obstacles or lubricant materials, specific home place in the home where the injuries occurred, flooring materials on which the slip-down happened, additional objects hit after slip down, the site and kind of injury, the duration of therapy, and the disposition. Results: Walking was the most common activity just before the injury. Because rooms and bathrooms were most common places in the home for slip down injuries, laminated papers/ vinyl floor coverings and tiles were the most common flooring materials used in the places where the injuries occured. Most commonly, no obstacles caused the children to slip down, but the furniture, stairs, doorsills, wetness, or soapy fluid followed after that. Over half of the children who slipped (58%) also collided with other than the floor itself after the slip-down, most common objects hit were the edges of the furniture, and doorsills, followed by stairways. The head and neck were the most commonly injured sites, and a laceration was the most common kind of injury. Most children needed less than 1 week of therapy, only 4 children (1.53%) admitted. There were no mortalities. Conclusion: The environmental factors contributing to slip-down injuries were the bathroom, laminated papers/vinyl floors, the furniture, stairs, doorsills, and wetness or soapy fluid. Especially, the furniture, stairs, and doorsills can be both primary obstacles and secondary collision objects. For the safety of our children, we must consider these factors on housing, when decorating or remodeling our house.

• Clinical and Experimental Pediatrics
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• v.45 no.9
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• pp.1134-1140
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• 2002

Purpose : Childhood accidents have been increasing recently. Accidents rank as the leading cause of childhood mortality and morbidity. We performed this study to evaluate the causes of childhood accidents. Methods : The authors analysed retrospectively the medical records of 6,410 cases of childhood accidental injuries who visited the emergency room of Asan Medical Center from January 1990 to December 1999. Results : The most common type of accidents was trauma which accounted for 5,038 cases of the total accidents, followed by falls, burns, foreign body aspiration, and poisoning. The most common age of foreign body aspiration was under two years old and the male to female ratio was 2 to 1. The most common site of foreign body aspiration was the esophagus and the stomach, followed by the respiratory tract. In airways, the right and left main bronchus were the most common site for foreign body aspiration and were accompanied by the highest mortality. The most common foreign body in the gastrointestinal tract and respiratory tract were coins and peanuts, respectively. Conclusion : The most common cause of accidents was trauma, followed by falls, burns, foreign body aspiration, and poisoning. The incidence of foreign body aspiration and poisoning is increasing in infants. In cases of foreign bodies in airways, proper management is needed because of the high mortality rate.

• Journal of Preventive Medicine and Public Health
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• v.21 no.2 s.24
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• pp.224-237
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• 1988

To determine the causes of and related factors to childhood injuries, the emergency room records and inpatient medical records were reviewed for 4,849 injured children out of 15,790 pediatric patients(<15 years old) who visited the emergency rooms of 3 university hospitals and 2 general hospitals in Taegu from 1 January to 31 December 1987. Out of total injured children, 54.675 were 3-8 years old and the male to female ratio of the total injured children was about 2:1. The leading causes of injury were falls and slips (29.1%) and traffic accident(28.2%). The frequency of injury was higher in May-October than the rest of months and 51.6% of the injuries occurred between 15 and 20 o'clock. Falls and slips took place most frequently at the stairway(25.7%). The most common interpersonal violence was inflicted injuries(85.6%) and there were 11 child rapes. Dog bites accounted for 67.6% of all biting injuries and it occured 2.9 times more in male than in female. CO intoxication was the most common cause of poisoning (45.3%) and scalding accounted for 85.2% of all burns. Common places of drownings were river (32.2%), swimming pool (22.6%) and construction site(19.3%). To prevent childhood injuries, it is recommended to eliminate the hazardous environmental factors, to provide safe playgrounds, to educate the children for safety from kindergarten and the general public through mass communication, to establish a strict safety standard for houses, public buildings and facilities, and playgrounds.

• Journal of Korean Neurosurgical Society
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• v.51 no.4
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• pp.215-218
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• 2012

Objective: Traumatic epidural hematomas (EDHs) in children are a relatively unusual occurrence. The cause and outcome vary depending on period and reg ion of study. The aims of this analysis were to review the cause and outcome of pediatric EDHs nowadays and to discuss outcome-related variables in a large consecutive series of surgically treated EDH in children. Methods: This is a retrospective review of 29 patients with surgically treated EDHs between Jan 2000 and February 2010. Patients' medical records, computed tomographic (Cl) scans, and, if performed, magnetic resonance imaging (MRI) were reviewed to define variables associated with outcome. Variables included in the analysis were age, associated severe intracranial injury, abnormal pupillary response, hematoma thickness, severity of head injury (Glasgow Coma Scale score), parenchymal brain injury, and diffuse axonal injury. Results: The mean (SO) age of the patients was 109 months (0-185 months). Most of the injuries with EDHs occurred in traffic accident (14 cases, 48.2%) and followed by slip down in 6 cases and falls in 6 cases. There were one birth injury and one unknown cause. EDHs in traffic accidents occurred in pedestrians hit by a motor vehicle, 9 cases; motorbike and car accidents, 5 cases and bicycle accidents, 1 case. The locations of hematoma were almost same in both sides (left side in 15 cases). Temporal lobe is the most common site of hematomas (13 cases, 44%). The mean size of the EDHs was 18 mm (range, 5-40 mm). Heterogeneous hematomas in CT scans were 20 cases (67%). Two patients were referred with unilateral or bilateral dilated pupil(s). There was enlargement of EDH in 5 patients (17%). All of them were heterogeneous hematomas in CT scans. Except for 4 patients, all EDHs were associated with skull fracture(s) (87%). There was no case of patient with major organ injury. CT or MRI revealed brain contusion in 5 patients, and diffuse axonal injury in one patient The mortality was zero, and the outcomes were excellent in 26 and good in 2 patients. None of the tested variables were found to have a prognostic relevance. Conclusion: Regardless of the EDH size, the clinical status of the patients, the abnormal pupillary findings, or the cause of injury, the outcome and prognosis of the patients with EDH were excellent.