• Health Policy and Management
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• v.34 no.2
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• pp.106-119
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• 2024

Drug shortage is a persistent phenomenon that poses a public health risk worldwide and occurs due to a range of causes. The purpose of this study is to review key policies to prepare for and respond to drug shortages in selected countries, such as the United States, Canada, and some European countries in order to draw implications. This study reviewed the reports and articles derived from search engines and Google Scholar by using keywords such as drug shortage and stock-out. Over the last decade or so, the United States have strengthened requirements on advance notification for disruption and interruption of drug manufacturing, established the Inter-agency Drug Shortages Task Force to promote the communication and coordination of responses, and expedited drug regulatory processes. Similarly, Canada established the Multi-Stakeholder Steering Committee on drug shortages by involving representatives from central and local governments and private sectors. Canada also adopted a tiered approach to the communication of drug shortages based on the assessment of the severity of the shortage problem and released a detailed information guide on communication. In 2019, the joint task force between the European Medicines Agency and the Heads of Medicines Agencies issued guidelines on drug shortage communication in the European Economic Area. The countries reviewed in this paper focus on communication across different stakeholders for the monitoring of and timely response to drug shortages. The efforts to protect public health from the negative impact of the drug shortage crisis would require multi-sectorial and multi-governmental coordination and development of guidelines.

• Clinical and Experimental Pediatrics
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• v.48 no.1
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• pp.63-67
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• 2005

Purpose : Henoch-$Sch{\ddot{o}}nlein$ purpura(HSP) is a systemic vasculitis, characterized by cutaneous palpable purpura, gastrointestinal(GI) symptoms, arthritis and renal involvement. In general, the prognosis is determined by GI complication as well as the severity of nephritis. In this study, we analyzed the statistical relationship between the GI symptom and other clinical findings for assessing the prognosis, and evaluated abdominal ultrasonographic findings for early diagnosis of this disease with atypical clinical presentation and early detection of serious GI complications. Methods : One hundred seventy seven patients with HSP in the Department of Pediatrics, Wonkwang University Hospital from January 1994 to June 2004, were enrolled. We retrospectively analyzed charts about clinical and abdominal ultrasonographic findings, and classified our patients into two groups(GI-Sx(-), GI-Sx(+)) for statistical analysis. Results : The ratio of female to male is 1.5 : 1. The peak age incidence was five to eight years in 95 cases(53%). The GI symptoms appeared in 117 cases(66%), which include abdominal pain 115 (98 %), tenderness 45(38%), nausea and vomiting 35(30%), bloody stool 10(8.5%), diarrhea four(3.4%), rebound tenderness four(3.4%), and also intussusception and appendicitis were complicated in five and two cases respectively. GI-Sx(+) group had an increased risk of renal involvement and relapse than the GI-Sx(-) group. But there were no relationships about sex and age incidence, or other clinical and laboratory findings between two groups. Ultrasonographic findings in 98 patients with GI symptoms included small bowel thickening in 70 cases(71%) in which duodenum, jejunum and ileum were involved in 71%, 45.7%, 40% respectively, small bowel dilatation in 41 cases(42%), lymph node swelling in 46 cases(47%), and ascites in 25 cases(25.5%). Conclusion : GI symptoms in patients with HSP suggested increased risk of renal involvement and relapse. Abdominal ultrasonography could be helpful in the early diagnosis on atypical clinical presentation and early detection of serious GI complication in these patients.

• Clinical and Experimental Pediatrics
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• v.48 no.9
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• pp.998-1003
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• 2005

Purpose : We evaluated the occurrence of renal scarring in children with unilateral vesicoureteral reflux(VUR), and the relationships between renal scar formation and risk factors such as VUR, duration of fever, acute-phase reactant, age, and sex. Methods : We retrospectively analyzed the data of 35 children newly diagnosed with unilateral vesicoureteral reflux after urinary tract infection(UTI) in Wallace Memorial Baptist Hospital between January 1996 and December 2004. Ultrasonography, Erythrocyte sedimentation rate(ESR), and C-reactive protein(CRP) were performed initially. Voiding cystourethrography(VCUG) was performed 1 to 3 weeks after treatment with UTI. $^{99m}Tc$-dimercaptosuccinic acid(DMSA) scan was performed 4 to 6 months after treatment. Results : Scintigraphic renal damage was present in 29 percent of the refluxing and in 3 percent of the nonrefluxing kidneys(P<0.05). The severity of VUR was significantly correlated with renal scar formation(P<0.05). The duration of fever before treatmen($5.0{\pm}1.3$ vs $2.6{\pm}1.3$) and prolonged fever of over 5 days were significantly different between renal scar group and non-renal scar group(P<0.05). ESR($56.3{\pm}23.8$ vs $27.9{\pm}18.1mm/hr$, P<0.05) and CRP($12.8{\pm}7.3$ vs $3.9{\pm}3.8mg/dL$, P<0.05) at the diagnosis of UTI in the renal scar group were higher, compared to those of the non-renal scar group. There were no significant differences in age and sex between the two groups. Conclusion : The presence and grade of VUR, the duration of fever before treatment, prolonged fever over 5 days, ESR, and CRP were risk factors for renal scarring, irrespective of age and sex. Diagnosis and management of VUR, in children with UTI, is important to prevent renal scars.

• Korean Journal of Psychosomatic Medicine
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• v.21 no.1
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• pp.44-54
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• 2013

Objectives : To investigate the frequency and clinical characteristics of premenstrual syndrome(PMS)/premenstrual dysphoric disorder(PMDD) in high school students, and determine the correlates of PMS/PMDD in association with comorbid depression and anxiety. Methods : A total of 1688 students were recruited from 5 high schools in Seoul, Korea. Subjects completed the questionnaire composed of scales to measure premenstrual symptoms, depression, and anxiety, as well as sociodemographic and reproductive variables. Subjects were categorized into 3 groups by using the Premenstrual Symptom Screening Tool(PSST) to determine the frequency and clinical characteristics of PMS/PMDD. Multivariate logistic regression was used to identify the correlates of PMS/PMDD. Results : The frequency of moderate to severe PMS and PMDD was 20.1% and 6.4%, respectively. Irritability(78.8%), fatigue(76.4%), and emotional sensitivity(69.8%) were common premenstrual symptoms, and functional impairment in academic performance(67.1%) was dominant. Dysmenorrhea[odd ratio(OR)=3.68, 95% confidence interval(CI) 2.45-5.55], family history of PMS(OR=1.91, 95% CI 1.35-2.71), and use of oral contraceptive (OR=1.85, 95% CI 1.16-2.94) were associated with the increased risk of PMS/PMDD after adjustment for depression and anxiety. Negative attitude to menses(OR=15.60, 95% CI 3.61-67.42) was associated with the increased risk of PMS/PMDD, particularly in subjects without depression and anxiety. Conclusions : PMS was common, as the frequency of PMS more than moderate severity including PMDD exceeded 25%, and disrupted daily functioning in adolescents. PMS is associated with various sociodemographic and menstrual characteristics, and these associations are affected by comorbid depression and anxiety.

• Journal of Distribution Research
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• v.17 no.5
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• pp.39-57
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• 2012

The unabated influx of micro businesses has turned the Korean retailing market to a rat race, which causes severe financial distress for micro business owners due to heavy competition. The woes of these micro business owner's are exacerbated by the presence of large scale distributors such as Super Supermarket(SSM) and large discount stores. In summary, the Korean retail market is overburdened an uneconomically viable. Retailing has low barriers to entry which attracts unskilled labor or those with little capital. These start-ups have low opportunity costs since they would make low wages elsewhere in the economy. Thus, these owners are content with relatively low returns on their investment. These 'subsistence ventures' are maintained for economical viability rather than economic growth. These 'subsistence ventures' intensifies competition among small-scale businesses. The presence of large retail corporations also aggravates the situation. The recent stagnation of the economy has worsened the retail market in Korea. The overwhelming competition solidifies the coarse structural system and the prolonged economic sluggishness has increased the risk of insolvency for micro business owners. As the economy continues to stagnate, the imminent risk in retailing market will rise up to surface threatening economic stability. More systematic inflows and outflows of retailers are required in order to redress this structural problem. It has been empirically shown that the self-employment rate is high in Korea compared to other OECD countries. To draw the comparison of self-employment rate by industry, Korea shows high rates among transportation, whole sale, retail, education, lodging, and restaurants. In the case of the transportation and education service sectors, this high rate can be explained by the idiosyncratic nature of Korean culture. In the transportation sector, political policies favor private cap service and private freight carriers. In the education service sector, Koreans put particular emphasis on education that leads to many private institutions that outnumber other OECD countries. For these singular reasons, Korea maintains high micro business, self-employed rates particularly in retailing. A comparable nation is Japan, with its similar social, economic, cultural environment among OECD countries. Unlike Korea, Japan has much lower rates of micro business which continues to decrease. Also Korean retailers are much more destitute than Japanese. The fundamental problem of Korean retailing is the involuntary exit of these 'subsistence ventures,' micro businesses with low margins, in which a small drop in demand can lead to financial difficulties for the owner. This problem will be exacerbated when Korean babyboomers retire and join the micro business ventures. The first priority in order to cope with the severity of oversupply in retailing is to provide better opportunities for the potential self-employers. There should be viable alternatives to subsistent ventures. Strengthening the retirement program, scrutiny of exit process, reconfiguration of policy funds are the recommendations.

• The Journal of the Korean life insurance medical association
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• v.4 no.1
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• pp.110-132
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• 1987

A study on hepatomegaly detected by abdominal palpation, and facial telangiectasia in a total of 3,418 insured persons medically examined at the Honam Medical Room of Dong Bang Life Insurance Company Ltd. from February, 1984 to August, 1985 was undertaken. The results were as follows: 1) Hepatomegaly was found in 383 cases(27.5%) among the 1,395 insureds of male and in 163 cases(8.1%) among the 2,023 insureds of female. The difference of incidence of hepatomegaly between all males and females showed statistical significance(p<0.001). In each age group, the incidence of hepatomegaly in :nale was higher than that in female. The incidence of hepatomegaly in each age group in male increased cnosiderably with age; it showed 11.6%,16.2%, 42.6% and 52.9% from second to sixth decade in order, thereafter in seventh decade it decreased to 26.7%, While the incidence of hepatomegaly in female increased slightly in each age group. 2) Facial telangiectasia was found in 318 cases(22.8%) among all males and in 157 cases(7.8%) among all females. The difference of incidence of telangiectasia between all males and females showed statistical significance(p<0.001). In each age group, the incidence of telangiectasia in male was higher than that in female, except of second decade. The incidence of facial telangiectasia in each age group in male increased considerably with age; while it increased slightly in female. 3) Facial telangiectasia accompanied by hepatomegaly was found in 235 cases(61.4%) among 383 cases of hepatomegaly in male and in 69 cases(42.3%) among 163 cases of hepatomegaly in female. The difference of incidence of telangiectasia between males and females show ed statistical significance(p<0.001). 4) Facial telangiectasia without spider angiomata accompanied by hepatomegaly was found in 201 cases(52.5%) among 383 cases of hepatomegaly in all males and in 67 casgs(41.4%) among 163 cases of hepatomegaly in all females; facial spider angiomata accompanied by hepatomegaly was found in 34 cases(8.9%) among 383 cases of hepatomegaly in all males and in 2 cases(1.2%) among 163 cases of hepatomegaly in all females. 5) Abnormal SGOT activity was found in 19 cases(7.9%) among 242 cases of hepatomegaly in all males and in one case(1.5%) among 67 cases of hepatomegaly in all females. The difference of incidence of abnormal SGOT activity showed statistical significance(p<0.001). The incidence of abnormal SGOT activity by the size of hepatomegaly, that is, palpated <1 finger's breadth, <2 fingers' breadth and ${\geqq}2$ fingers' breadth, revealed 2.2%, 6.0% and 60.0% respectively in all males, while abnormal SGOT activity was found only one case in fifth decade among 67 cases of hepatomegaly in all females. 6) In ordinary medical examination(the insured amount is low) abnormal SGOT activity was found in 7 cases(4.8%) among 146 cases of hepatomegaly palpated $1\frac{1}{2}$ fingers' breadth and under, while it was not found in 37 cases of the same sized hepatomegaly in all females. Above mentioned 7 cases are thought to be very significant because 7 cases occupy 35% in 20 cases of abnormal SGOT activity with hepatomegaly. 7) Abnormal SGOT activity was found in 12 cases(4.4%) among 273 cases of hepatomegaly of "not firm" consistency, while it was found in 8 cases(22.2%) among 36 cases of hepatomegaly of "firm" consistency. The difference of incidence of abnormal SGOT activity showed statistical significance(p<0.05). 8) Abnormal SGOT activity was found in 5 cases(17.9%) among 28 cases of spider angiomata with hepatomegaly, while it was found in 10 cases(7.3%) among 166 cases of telangiectasia without spider angiomata with hepatomegaly. Owing to a small number of cases, statistical significance was not recognized, but the incidence of abnormal SGOT activity in spider angiomata cases with hepatomegaly is apt to be higher than that in telangiectasia cases without spider angiomata with hepatomegaly. 9) The incidence of abnormal SGOT activity is apt to be higher with age in male group; abnormal SGOT activity was not found among 4 cases of hepatomegaly in second decade and it was 3.8% in third decade, 4.5% in fourth decade, 9.3% in fifth decade, 17.5% in sixth decade and 33.3% in seventh decade, while the incidence of it was only one case among 67 cases in all females. 10) It is believed that the performance of liver function test to the subjects with hepatomegaly even in ordinary medical examination(the insured amount is low) will give considerable contribution for medical selection of hepatomegaly risk. 11) Age of the insured(young or old), presence of facial telangiectasia or spider angiomata especially and their severity, and consistency of enlarged liver(firm or not) should be considered to increase accuracy in evaluating hepatomegaly risk.

• Neonatal Medicine
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• v.17 no.2
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• pp.201-206
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• 2010

Purpose: Recently, after patent ductus arteriosus (PDA) ligation in preterm infants, unexplained hemodynamic instabilities are reported. To determine the incidence, risk factors and clinical manifestations of hemodynamic instability after PDA ligation in very low birth weight (VLBW) infants. Methods: This retrospective multicenter study enrolled 18 VLBW infants who underwent PDA ligation from January 2002 to February 2008. Hemodynamic instability defined as unexplained cardiopulmonary dysfunction with increased dependency on mechanical ventilation and decreased blood pressure. Results: The mean gestational age and birth weight (BW) of all infants were $27^{+6}{\pm}1^{+6}$ weeks and 951${\pm}$245 g. Hemodynamic instability group (HI) included seven infants (39%) and hemodynamic stability group (HS) included 11 infants (61%). Compared to HS, HI had lower BW (1,033${\pm}$285 g vs. 821${\pm}$126 g, P=0.048) and weight on operation day (1,195${\pm}$404 g vs. 893${\pm}$151 g, P=0.042), longer hospital days (105${\pm}$29 vs. 141${\pm}$39, P=0.038), more severe bronchopulmonary dysplasia (BPD), (no/mild/moderate/severe, 2/5/2/2 vs. 0/1/2/4, P=0.038) and higher preoperative $FiO_2$ (0.29${\pm}$0.06 vs. 0.38${\pm}$0.09, P=0.02). One case of mortality due to sepsis, which was not associated with ligation, was observed among HS. Conclusion: The incidence of hemodynamic instability after PDA ligation in VLBW infants was 39%. Low BW, low weight on operation day and preoperative high $FiO_2$ might be risk factors of hemodynamic instability after PDA ligation in VLBW infants. The hemodynamic instability could increase the severity of BPD and hospital days.

• Sleep Medicine and Psychophysiology
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• v.18 no.2
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• pp.82-86
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• 2011

Objectives: The Berlin Questionnaire (BQ) has been used to help identify patients at high risk of having sleep apnea in primary care. But it has not been validated in a sleep clinic for Korean patients. The aim of this study is to evaluate the usefulness of the BQ as a screening tool for obstructive sleep apnea (OSA) for Korean patients in a sleep clinic. Methods: The BQ was prospectively applied to 121 subjects with OSA suspicion who visited to our sleep clinic. All subjects performed overnight polysomnography. OSA was defined as an apnea-hypopnea index (AHI) ${\geq}5$. We investigated the sensitivity, specificity, positive and negative predictive values of the BQ according to severity by AHI. Results: In 121 subjects, 73.6% were males, with a mean age of $48.8{\pm}13.0$ years. Twenty-five (20.6%) patients did not have OSA (AHI<5), 30 (25%) patients had mild OSA ($AHI{\geq}5$ and <15), 26 (21.4%) had moderate ($AHI{\geq}15$ and <30), and 40 (33%) had severe OSA ($AHI{\geq}30$). The BQ identified 69.4% of the patients as being at high risk for having OSA. The sensitivity and specificity of the BQ were 71.9% and 40%, for $AHI{\geq}5$, 75.8% and 38.2% for $AHI{\geq}15$, 77.5% and 34.6% for $AHI{\geq}30$, respectively. The positive and negative predictive values of the BQ were 82.1% and 27.0% for $AHI{\geq}5$, respectively. Positive and negative likelihood ratios were 1.2 and 0.7, and the overall diagnostic accuracy of the BQ was 65.3%, using an AHI cut-off of 5. Conclusion: Due to modest sensitivity and low specificity, the BQ does not seem to be an appropriate tool for identifying patients with obstructive sleep apnea in a sleep clinic population.

• Clinical and Experimental Pediatrics
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• v.53 no.3
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• pp.380-391
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• 2010

Purpose : Respiratory syncytial virus (RSV) is one of the main pathogens causing lower respiratory infections (LRI) in young children, usually of limited severity. However, in congenital heart disease (CHD) patients, one of the high-risk groups for RSV infection, RSV can cause serious illnesses and fatal results. To elucidate the effects of RSV infection in CHD patients, we observed RSV infection cases among CHD patients and non-CHD patients. Methods : On admission of 343 LRI patients over 3 years, 77 cases of RSV infection were detected by the RSV antigen rapid test of nasopharyngeal secretion. We compared RSV infection cases among groups of CHD and non-CHD patients. Results : During the winter season, RSV caused 20-0% of LRI admissions in children. In patients with completely repaired simple left to right (L-R) shunt diseases such as ventricular septal defect, atrial septal defect, and patent ductus arteriosus, RSV infections required short admission days similar to non-CHD patients. In patients with repaired CHD other than simple L-R shunt CHD, for whom some significant hemodynamic problems remained, RSV infection required long admission days with severe clinical course. In children with unrepaired CHD, RSV infection mostly occurred in early infant age, with long admission days. RSV infections within a month after cardiac surgery also required long admission days and severe clinical course. Conclusion : To avoid the tragedic outcome of severe RSV infection in the CHD patients, efforts to find the subgroups of CHD patients at high risk to RSV infection are needed, and effective preventive treatment should be applied.

• Journal of agricultural medicine and community health
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• v.36 no.2
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• pp.87-100
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• 2011

Objectives: This study aimed to identify factors associated with smoking relapse. Methods: The study sample was recruited among subjects who were enrolled in the smoking cessation clinic of a public health center and had succeeded in quitting smoking for at least six months. A total of 159 male subjects were followed via mail survey one year later. The independent variables in the analyses were socio-demographic characteristics, smoking history and behavior, receipt of smoking cessation aids, health behaviors and components of the health belief model (HBM). The dependent variable was smoking relapse assessed one year after quitting. Ordered logit regressions were used to identify factors associated with smoking relapse. Results: The relapse rate of the ex-smokers in our sample was 25.8%, and the occasional smoking rate was 17.0%. Univariate analyses revealed that only factors related to the HBM, such as perceived susceptibility to diseases (p<0.01), perceived severity of diseases (p<0.01), perceived health benefits of not smoking (p<0.01), perceived barriers to quitting smoking due to increasing stress and difficulty in social life (p<0.01), and self-efficacy (p<0.01) were associated with the likelihood of relapse for ex-smokers. Ordered logit analyses yielded two significant factors affecting the likelihood of relapse, the perceived barriers to quitting smoking and self-efficacy. Conclusions: Our results indicate that higher levels of barriers to quitting smoking and lower levels of self-efficacy were significantly related to risk of smoking relapse. These findings may be useful for identifying those at highest risk for relapse and choosing the optimal strategies for prevention of relapse for ex-smokers.