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

PURPOSE: The aim of this study was to identify usefulness of simple oral and gastric pH measurement using pH paper on detection of symptomatic gastroesophageal reflux in neonates. METHODS: This prospective study included a total of 66 neonates born at Konyang University Hospital from June 2004 to June 2005. Each neonate's oral and gastric pH levels measured with pH paper at 6 hourly intervals. Suspected gastroesophageal refluex neonates were studied 24-hr lower esophageal pH monitoring or upper GI series and confirmed. We compared oral and gastric pH between symptomatic gastroesophageal reflux (GER) group and asymptomatic (control) group. RESULTS: GER group consist of 12 neonates and control group consist of 54 neonates. Oral and gastric pH were 5.4+/-0.6, 2.9+/-0.5 in GER group, 6.0+/-0.3, 3.9+/-0.9 in control group, the differences between two groups were significant (P<0.05). All neonates of GER group were corfirmed gastroesophageal reflux by 24-hr lower esophageal pH monitoring or upper GI series studies. Our data indicate as a predictor for significantly symptomatic gastroesophageal reflux, at oral pH 5.75, has a sensitivity 92%, specificity 89%, positive predictive value of 65%, and negative predictive value of 98%. The difference between oral and gastric pH (oral pH-gastric pH) was not significant in each group. CONCLUSION: In neonates with symptomatic gastroesophageal reflux oral and gastric pH were significantly lower than asymptomatic neonates. Oral and gastric pH were related with clinically significant symptoms of gastroesophageal reflux. We suggest that pH measurement could be a possible simple screening test of symptomatic gastroesophageal reflux.
Esophageal pH Monitoring ; Gastroesophageal Reflux* ; Humans ; Hydrogen-Ion Concentration ; Infant, Newborn* ; Mass Screening ; Prospective Studies ; Sensitivity and Specificity

OBJECTIVE: The objective of this study was to compare laparoscopic surgery with laparotomy for surgical management of ovarian dermoid cysts. METHODS: One hundred and fifteen patients were managed with laparoscopy and eighty two patients were managed with laparotomy. Two groups were compaired for age, marrital status, parity, tumor size, operation type, previous surgery, operating time, blood loss, pre-, and postoperative hemoglobin change, hospital stay, complications and recurrences. RESULTS: Unilateral slapingo-oophorectomy was the most common type of operation in either group. Between twenty one and thirty was the most common age in either group and para 0 in laparoscopy and para 2 in laparotomy group was the most common. Unilateral ovarian cystectomy was significantly more common for para 0 in laparoscopy group (p=0.035). Number of singles were significantly higher in laparoscopy group (p=0.046). Tumor size was significantly larger in laparotomy group (6.1 vs 7.8 cm). Operating time was shorter for unilateral ovarian cystectomy in laparoscopy group. Blood loss, pre-, and postoperative hemoglobin change, hospital stay was significantly less in laparoscopy group. Febrile morbidity was higher in laparotomy group (p<0.001). However no major complications were noted in either group. CONCLUSION: We conclude that operative laparoscopy has many advantages in the management of ovarian dermoid cysts. However tumor size was a relative limitations for laparoscopy compaired with laparotomy.
Cystectomy ; Dermoid Cyst* ; Female ; Humans ; Laparoscopy* ; Laparotomy* ; Length of Stay ; Parity ; Recurrence

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

Drug utilization review (DUR) system has been defined as "structured, ongoing initiatives that interpret patterns of drug use in relation to predetermined criteria, and attempt to prevent or minimize inappropriate prescribing." This paper introduces the concept, purpose, and effective application of DUR in Korea. DUR can be classified as retrospective DUR, prospective DUR, and concurrent DUR based on the time direction of applying DUR. DUR can also be classified as quantitative DUR defined by retrospective DUR using databases including previously prescribed medicines, and qualitative DUR defined by DUR reflecting patient's clinical condition. We described the history of developing DUR in the United States and the Europe. Finally current status of DUR in Korea is described and the strategy of future settlement of DUR system in Korea is suggested.
Drug Utilization ; Drug Utilization Review ; Europe ; Korea ; United States

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