No abstract available.
Drug-Related Side Effects and Adverse Reactions* ; Humans ; Physicians, Family*

Despite extensive researches and pre-market clinical trials, only limited information on the adverse drug reactions (ADRs) of a drug can be collected at the time of market approval from regulatory agency. ADRs constitute a major public health problem. Post-marketing surveillance of drugs is important to detect signals for ADR. In Korea, one of the main methods for monitoring the safety of marketed drugs is spontaneous reporting system of suspected ADRs. Re-examination and re-evaluation system are in force for monitoring safety of new market approval drugs and currently under marketing drugs, respectively. Recently, regional pharmacovigilance centers were designated from Korean Food and Drug Administration for facilitating ADR surveillance. Over recent years, with the development of information technology, there has been an increased interest in establishing data mining system for detecting signals from Health Insurance Review Agency database. The purpose of this paper is to review the current status of Korean ADR surveillance system and suggest the possible solutions for developing active pharmacovigilance system in Korea.
Adverse Drug Reaction Reporting Systems/*organization & administration ; Humans ; Information Systems/organization & administration ; Korea/epidemiology ; Product Surveillance, Postmarketing ; Public Health Informatics/organization & administration

PURPOSE: To estimate the prevalence of co-prescribing contraindicated drugs for elderly patients in Busan. METHODS: We used the Health Insurance Review Agency (HIRA) claims database. Study population consisted of elderly patients who visited clinics or hospitals in Busan metropolitan city from January 1, 2000 to December 31, 2001. Contraindicated drugs were defined as 162 combinations of contraindicated drugs announced by the Korea Ministry of Health and Welfare in 2004. The co-prescription of contraindicated drugs was defined as prescribing two or more contraindicated drugs in combination in the same prescription. The prevalence of co-prescribing contraindicated drugswas estimated as proportion of co-prescribed patients out of the study patients. We estimated and age-adjusted prevalence and its 95% confidence interval of co-prescription of contraindicated drugs among the elderly patients in Korean population in 2001. RESULTS: The study elderly patients were 262,952 with 2,483,227 prescriptions. Among the study patients 1,208 (4.6%) were prescribed contraindicated drugs in combination. A total of 16,255 patients were estimated as the number of co-prescribed patients among the Korean elderly in 2001. Age-standardized prevalence of co-prescription to the Korean elderly was estimated to be 45 per 10,000 persons. The most frequently prescribed combinations were cisapride & amitriptyline, roxithromycin & ergoloid mesylate, and terfenadine & erythromycin, and the frequency were 325 (16.8%), 149 (7.7%), and 132 (6.8%),respectively. CONCLUSIONS: The contraindicated drugs were co-prescribed to the elderly patients in Korea. Many of these co-prescriptions should be avoided if unnecessary. The patients should be carefully monitored if they were inevitably prescribed the contraindicated drugs.
Aged ; Amitriptyline ; Cisapride ; Drug Combinations ; Drug Utilization Review ; Ergoloid Mesylates ; Erythromycin ; Humans ; Insurance, Health ; Korea ; Prescriptions ; Prevalence ; Roxithromycin ; Terfenadine

BACKGROUND: Ventilator associated pneumonia (VAP) is the most serious nosocomial infection of intensive care units. Several studies have investigated the relationship between the interval of ventilator circuit changes and the incidence of pneumonia in foreign countries, but there are no reports about it in Korea yet. So we performed this study to compare the clinical and cost impact between 3 days and 7 days interval in ventilator circuit changes. METHODS: Seoul National University Hospital is a 1,500-bed, university affiliated, tertiary and acute care hospital. All patients admitted to medical intensive care unit (MICU) and surgical intensive care unlt (SICU) between April 1, 1998 and October 31, 1998, requiring mechanical ventilation were included. Patients were divided into two groups of a-cay circuit changes and weekly changes. Daily surveillance was conducted using the criteria of VAP of the National Nosocomial Infection Surveillance System. Incidence of VAP and risk factors for VAP were evaluated. Standard microbiologic methods were used for the identification of clinical and environmental isolates. Statistical analysis was done by SAS Program (version 6.12), analysis of difference in variables was performed using chi-square test and t-test. Analysis of odds ratios was done with logistic regression analysis. RESULTS: VAP developed at a rate of 12.2 per 1,000 ventilator-days in the 3 days change group and 15.6 per 1,000 ventilator-days in the weekly change group (P=0.7240). The only statistically significant risk factor of VAP was duration of mechanical ventilation, The risk of VAP in patients with more than 7 days was 2.23 times higher than in patients with 7 days and below (OR; 2.2296). Estimated annual savings of nursing time by extending ventilator circuit change interval from 3 days to 7 days were 26,806 min 48 sec and estimated savings of cost by reduction of nursing times was calculated as 6,701,700 won. CONCLUSIONS: Weekly ventilator circuit changes in patients undergoing ventilation therapy in the ICU do not contribute to increased the rates of VAP and are cost-effective.
Cross Infection ; Humans ; Incidence ; Income ; Critical Care ; Intensive Care Units ; Korea ; Logistic Models ; Nursing ; Odds Ratio ; Pneumonia ; Pneumonia, Ventilator-Associated* ; Prospective Studies* ; Respiration, Artificial ; Risk Factors ; Seoul ; Ventilation ; Ventilators, Mechanical

Although early natural menopause has been postulated to increase stroke risk, studies have not produced convincing results. We examined the associations between stroke risks and age at natural menopause or time since natural menopause. 5,731 naturally postmenopausal women more than 65 yr of age were followed from 1993 to 1998. Information on age at menopause and risk factors were obtained using mailed questionnaires. 186 cases of stroke occurred over a total 27,936 person years. After adjusting for age, hypertension, and physical activity, age at menopause was not found to be significantly associated with stroke or cerebral infarction. However, adjusted relative risks (aRRs) showed a significant increasing tendency of hemorrhagic stroke versus age at menopause (aRRs, 0.66, 0.48, 1.00 and 2.33 for the following age groups at menopause; 40-44, 45-49, 50-54 [reference group], and > or =55 yr). Time since menopause (11-20, 21-30, and > or =31 yr) was not found to be significantly associated with cerebral infarction, or hemorrhagic stroke. Late menopause (menopause age > or =55 yr) showed a tendency of a lower risk of cerebral infarction (aRR, 0.79) and a higher risk of hemorrhagic stroke (aRR, 2.33). Further study is warranted to determine stroke risk in women during the decade following menopause.
Adult ; Age Factors ; Aged ; Aged, 80 and over ; Cerebral Hemorrhage/etiology ; Cerebral Infarction/etiology ; Cerebrovascular Accident/*etiology ; Cohort Studies ; Female ; Humans ; Korea ; *Menopause ; Middle Aged ; Prospective Studies ; Questionnaires ; Research Support, Non-U.S. Gov't ; Time Factors

This study was conducted to estimate the prevalence rates and to explore associated factors of sarcopenic obesity (SO) in 2,221 Koreans over 60 yr-of age from the Fourth Korea National Health and Nutrition Examination Survey (2009). Participants were assessed by dual energy X-ray absorptiometry. Appendicular skeletal muscle mass divided by body weight was used to define sarcopenia and waist circumference was used to define obesity. We estimated the prevalence rates of SO according to age-groups, sex and region. In addition, each group was compared by demographic characteristics, metabolic status, nutrition, and physical activity. The prevalence rates of SO were 6.1% (95% confidential interval [CI] = 6.1-6.2) for men and 7.3% (95% CI = 7.3-7.3) for women, respectively. SO was positively associated with no current working and the number of combined medical conditions. High serum insulin level was positively associated with SO, whereas vitamin D was negatively associated with SO in both men and women. In conclusion, the prevalence rates of SO are 6.1% in men and 7.3% in women. SO is associated with insulin resistance, inappropriate nutrition, and low physical activity.
Age Factors ; Aged ; Aged, 80 and over ; Databases, Factual ; Demography ; Female ; Humans ; Insulin/blood ; Male ; Middle Aged ; Nutritional Status ; Obesity/*epidemiology/etiology ; Odds Ratio ; Prevalence ; Republic of Korea/epidemiology ; Risk Factors ; Sarcopenia/*complications ; Sex Factors ; Vitamin D/blood ; Waist Circumference

The development of information technologies has led to the era of big data; such enormous collections of information on drugs and adverse drug reactions are stored in either a structured, a semistructured, or an unstructured form. Because of the nature of the emerging issue of drug safety, it is common for policy makers and healthcare professionals to make decisions without sufficient evidence. Big data may be used as an efficient pharmacovigilance tool, which enables us to recognize adverse drug reactions that may not have been identified in pre-marketing clinical trials, in order to capture the patterns of drug utilization and adverse events, and to predict the occurrence of adverse drug reactions. National surveillance systems using electronic health databases have been established successfully in the US and Europe. The Korea Institute of Drug Safety and Risk Management (KIDS) plans to establish a big data platform for pharmacovigilance in Korea. The big data may be effectively used for evidence-based regulatory and clinical decision making in the field of drug safety and risk management.
Administrative Personnel ; Decision Making* ; Delivery of Health Care ; Drug Utilization ; Drug-Related Side Effects and Adverse Reactions ; Europe ; Humans ; Korea ; Pharmacoepidemiology ; Pharmacovigilance ; Risk Management

OBJECTIVES: The relationship between substance dependence and poor decision making has received much attention in recent years. This study aimed to test the hypothesis that alcohol dependent subjects would demonstrate a more perseverative decision-making pattern, during ambiguous situations. METHODS: 15 alcohol dependent patients and 15 healthy normal controls performed a novel computerized decision-making task, which presented figures of coins. The subjects were instructed to guess whether the total number of coins was 'odd' or 'even'. Besides these two response, one could select a third alternative - 'pass' - in case the chances were assumed to be low. RESULTS: There was significant difference in performance between the two groups (F=4.339, p=0.008). The control group gained 15.4+/-14.4 points, whereas the alcohol dependent group lost 0.6+/-5.3 points. The normal control group demonstrated a tendency to make more pass responses as the trials were repeated. In contrast, the alcohol dependent group didn't make use of the alternative, but kept challenging between 'odd' and 'even', although they sensed that the chances were low. CONCLUSION: The alcohol dependent patients demonstrated a more rigid and perseverative response pattern and showed deficits in making use of compromise alternatives.
Alcoholism ; Decision Making ; Humans ; Numismatics ; Substance-Related Disorders

Adverse drug reactions constitute a major public health problem. In recent years, serious safety issues arose with marketed drugs, and public outcry demanded better safety surveillance. Now regulatory focus is shifting to the active post-marketing safety surveillance. This paper provides an overview of the recent international initiatives of drug safety management especially focused on the US and Europe. The US Food and Drug Administration's (FDA) Sentinel Initiative is a long-term program designed to build and implement a national electronic system for monitoring the safety of FDA-approved drugs and other medical products. The Sentinel System will enable FDA to monitor the safety of medical products with the assistance of a wide array of collaborating institutions throughout the nation. The European Network of Centers for Pharmacoepidemiology and Pharmacovigilance is a collaborative scientific network coordinated by the European Medicines Agency and developed in collaboration with European experts in the fields of pharmacoepidemiology and pharmacovigilance. Its goal is to further strengthen the post-marketing monitoring of medicinal products in Europe by facilitating the conduct of multi-center, independent, post-authorization studies focusing on safety and on benefit-risk. Medicine is a global enterprise that demands worldwide standards for good drug safety practices. In the near future, we have to establish a Korean Sentinel System for active post-marketing safety surveillance to ensure the safety and effectiveness of drugs used in medical practice.
Cooperative Behavior ; Dietary Sucrose ; Drug Toxicity ; Electronics ; Electrons ; Europe ; Nitriles ; Organothiophosphorus Compounds ; Pharmacoepidemiology ; Pharmacovigilance ; Public Health ; Pyrethrins ; Safety Management

PURPOSE: Biofeedback is a major treatment method for constipated patients with non-relaxing puborectalis syndrome. However a significant percent of patients still showed poor outcome, and little has been known about the predictors associated with outcome of biofeedback. The aim of this study was to determine the outcome and identify predictors associated with poor outcome of biofeedback therapy for constipated patients with non- relaxing puborectalis syndrome. METHODS: Fifty-two constipated patients with non-relaxing puborectalis syndrome (median age, 47 years) who had more than one biofeedback session after defecography were evaluated by standardized questionnaire, before, immediately after treatment, and at follow-up. Clinical bowel symptoms and anorectal physiological studies were analyzed. Any differences in demographics, clinical symptoms, and parameters of anorectal physiological study were evaluated between success group (patients felt improvement in symptoms at follow-up) and failure group (patients felt no improvement). RESULTS: Follow up (mean follow-up; 17 months) results were evaluated by an independent observer in 45 patients. At post-biofeedback, 42 (81 percents) patients felt improvement in symptoms, including 7 (13 percents) with complete symptom relief. At follow-up, 25 (56 percents) patients felt improvement in symptoms, including 1 (2 percents) with complete symptom relief. There was a significant reduction in difficult defecation (from 81 to 44, 53 percent, from pre-biofeedback to post-biofeedback, and at follow up respectively; P<0.005, P<0.01), sensation of incomplete defecation (from 90 to 50, 40 percent; P< 0.00001, P<0.000005), laxative use (from 25 to 10, 11 percent; P<0.05), and enema use (from 13 to 0, 2 percent; P<0.01, P<0.05). Normal spontaneous bowel movement was increased from 42 percent pre-biofeedback to 81 percent post-biofeedback (P<0.0001), 80 percent at follow up (P<0.0005). Pre-biofeedback presence of symptoms of bowel habit change predict poor outcome (15 vs. 0 percent; failure vs. success, P<0.05). High pressure zone in prebiofeedback manometry was longer in failure group than in success group (2.80 vs 2.01 cm, P<0.05). In the success group, 11 (44 percent) had a rectocele, 1 (4 percent) had a rectal intussussception, 18 (72 percent) had a descending perineal syndrome, and 3 (12 percent) had a sigmoidocele. In the failure group, 4 (20 percent) had a rectocele, and 1 (5 percent) had a rectal intussusception, 14 (70 percent) had a descending perineal syndrome, and a sigmoidocele was not accompanied (P<0.05). Accompanied rectocele, rectal intussusception, descending perineal syndrome, and sigmoidocele did not influence outcome. CONCLUSIONS: Biofeedback is an effective option and should be considered as the first line therapy. Bowel habit change and long high pressure zone in pre-biofeedback manometry were predictors associated with poor outcome of biofeedback therapy for constipated patients with non-relaxing puborectalis syndrome.
Biofeedback, Psychology* ; Defecation ; Defecography ; Demography ; Enema ; Follow-Up Studies ; Humans ; Intussusception ; Manometry ; Surveys and Questionnaires ; Rectocele ; Sensation