Safety management in routine medical practice is one of the important issues that must be addressed by medical staffs, even it is hard to deal with various happenings and problems encountered in medical facilities.Here we present some arrangements in a reporting system of incidents and accidents to motivate each staffer to notice the significance of safely, and quantify the urgency and severity of reports using the originally developed management score at the Toride Kyodo General Hospital.The reports from all sections of the hospital were previously evaluated by five risk managers. This practice was effective in analyzing reports rapidly and appropriately, but was insufficient to motivate all of staffs to give much more heed to safety in routine medical practice. Instead, these reports are now discussed and analyzed by a group of people consiting of representatives of all sections and the departments in the hospital. This innovation evoked more interest and concerns about the safety management among the whole medical staff.We also utilized the management level, which was stratified into three grades from the point of urgency and severity of cases. The first level means the occurrence without urgency or need to change any systems, procedures and organizations. The second level requires some change in systems, but no urgent action. The accident at the third level should be dealt with as soon as possible by any of feasible ways. The total score, obtained by summing up a lisk level multiplied by a management level in each report, decreased between May and August in 2004, despite increases in the total numbers of monthly reports.In conclusion, the incident/accident reporting system became more familiar to medical staffs through the use of group-working. The management score and the derived total score may be available for comparing outcomes of safety management activities among different observation periods or facilities.
Reporting ; Safety ; Accidents ; Analysis ; Management

Event reporting can provide data to study the failure points of an organization's work process. As part of the ongoing efforts to improve transfusion safety, a Medical Event Reporting System Transfusion Medicine, (MERS - TM) as designed by Kaplan et al was implemented in the Transfusion Medicine Unit of the University Malaya Medical Centre to provide a standardized means of organized data collection and analysis of transfusion errors, adverse events and near misses. An event reporting form was designed to detect, identify, classify and study the frequency and pattern of events occurring in the unit. Events detected were classified according to Eihdhoven Classification model (ECM) adopted for MERS - TM. Since our system reported all events, we called it Event Reporting System - Transfusion Medicine (ERS-TM). Data was collected and analyzed from the reporting forms for a period of five months from January 15th to June 15th 2002. The initial half of the period was a process of evaluation during which 118 events were reported, coded, analyzed and corrective measures adopted to prevent the recurrence of the same event. The latter half saw the reporting of 122 events following the adoption of corrective measures. There was a reduction in the occurrence of some events and an increase in others, which were mainly beyond the organization's control. A longer period of evaluation is necessary to identify the underlying contributory causes that can be useful to develop plans for corrective and preventive action and thereby reduce the rate of recurrence of errors through proper training and adoption of just culture.
Reporting ; Transfusion, NOS ; Medicine ; experience ; seconds

Introduction: In the 2016 National TB Prevalence Survey, the prevalence-to-notification ratio for smear-positive pulmonary tuberculosis was 3.1. In the TB registry, 94% of cases were reported by public providers, suggesting insufficient reporting from private physicians. This study describes the feasibility and acceptability of an electronic mobile device application for possible use among private physicians for reporting their TB cases. Methods: This interventional, pre-, and post-test study uses an electronic mobile device application to report TB cases. Using the application, physicians collected and uploaded specific information for reporting cases. The participants were duly-licensed physicians and board certified in any of the following: Internal Medicine, Adult Infectious Diseases, Adult Pulmonology, Pediatrics, Pediatric Infectious Diseases, or Pediatric Pulmonology. The participants used an electronic mobile device application for reporting TB cases. Feasibility and acceptability were assessed using a questionnaire and through a focus group discussion. Data were summarized with mean and standard deviation for continuous variables and proportions for categorical variables. Results: The study was conducted at the Research Institute for Tropical Medicine, a government hospital with a Tuberculosis Directly Observed Treatment Short-Course (TB DOTS) facility. Of the 30 physicians invited to participate, 24 provided consent, but only 15 downloaded the application (age range 34-61, mean 39 years, 11 females). Eleven of 15 physicians (73%) assessed the mobile application as easy to navigate and felt that information encoded was relevant to patient care. However, the internet connection affected the speed of the application. The physicians said they had no time, were too busy, or simply forgot to encode patient data. Conclusion The use of the application is acceptable but not feasible for use by private physicians. Modification to the application may be done to improve uptake by private physicians.
tuberculosis ; case reporting ; digital mobile device

The Japan Society for Oriental Medicine (JSOM) began its second Special Committee for EBM (evidence- based medicine) project in 2005. Evidence Report Task Force (ER-TF) of the furthered the project on Evidence Reporting in Kampo Treatment initiated by the previous committee in 2001. The second Committee once again collected randomized control trial (RCT) literature only, to produce structured abstracts (SA). ors were then asked to make comments in these SA, as would be found in international EBM medical journals. There was concern, however, that their comments were reviewed negatively by authors of original article. Therefore a workshop entitled “How to Write Appropriate Comments” was held at the 58th Annual Meeting of JSOM in Hiroshima, on June 17, 2007. This workshop proved educational, and demonstrated ways to write more positive comments, including the so-called “sandwich technique” of writing first positive, then negative, then positive comments (PNP).
Medicine, Kampo ; seconds ; Educational workshop ; Special C ; Reporting

This paper reviewed structure and current status of laws related to patient safety using patient safety law matrix to promote systematic approach in legal system of patient safety. Laws related to patient safety can be divided into three areas: laws for preventing; laws for knowing about; and laws for responding. In the case of Korea, gaps are especially prominent in the areas of laws for knowing about and responding. Patient safety law which will be enacted in July 2016 will fill the gap in the area of laws for knowing about. This law will be comprehensive law, covering the full spectrum of laws related to patient safety. However, after reviewing current patient safety law in Korea, the following drawbacks were identified: absence of code for grasping the current patient safety level; absence of code for mandatory reporting in patient safety reporting system; and absence of code for privilege about patient safety work product. Furthermore we need wider discussions about covering issues of open disclosure, apology law, coroners system, and complaint management system in patient safety law.
Coroners and Medical Examiners ; Disclosure ; Hand Strength ; Humans ; Jurisprudence ; Korea* ; Mandatory Reporting ; Patient Safety* ; Risk Management

OBJECTIVETo discuss the modes for smooth progress of ADR monitoring under the new Measures for the Administration of Adverse Drug Reaction Report and Monitoring.

METHODWork modes for ADR monitoring in drug manufacturers were explored by explaining the new Measures and analyzing current state and constrains.

RESULT AND CONCLUSIONAs there is a larger gap between the requirements of new Measures and current status, it is difficult for drug manufacturers to meet all the requirements in short-term. Therefore, drug manufacturers are suggested to gradually complete ADR monitoring under the mode of one platform and four expansions, and thereby finally meeting the requirements of new Measures and fulfilling their duties and missions.

Evidence body is defined as an evidence complex incorporating the evidence obtained from various research methods and various resources. As one of common parenterally administered Chinese medicines, Shuxuetong's safety drew high concern from doctors. However, we only have grasped several but less systematic evidence on the safety of Shuxuetong. To build a safety evidence body of Shuxuetong injection. Review and evaluate the evidence related to the safety of Shuxuetong injection after accumulating, searching and classfying related literature. Accoeding to levels of evidence from high to low, the evidence related to the safety of Shuxuetong injection was classified as following: the evidence from a long-term, prospective, large-sample-size and intensive hospital monitoring study was the strongest; the evidence of hospital information system (HIS) data analysis; the evidence of spontaneous reporting system (SRS) data analysis; the evidence of adverse drugreactions (ADRs)/adverse drug events (ADEs) reported in systematic evaluation, ADRs case report, toxicological tests, pharmacological tests were weakest. Based on the evidence body, Shuxuetong Injection was proved to be safe, and its ADRs were mainly allergic reactions, and more often happened among the old patients.
Adverse Drug Reaction Reporting Systems ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Female ; Humans ; Prospective Studies

OBJECTIVEThis paper is aimed to explore the adverse reaction condition of Shuanghuangli an injection with three common used signal detecting methods based on SRS database of Jiangsu province, and to evaluate the performance of three methods.

METHODThree methods would be used to detect the signals based on the SRS database of Jiangsu province. Consistency of the results of these three methods with that proved in descriptions was evaluated by Kappa test. The trend graph of the confidence intervals of several time points was used to demonstrate the trend of the signal.

RESULTThe PRR method was consistent with ROR method in high degree in any situation. The results of BCPNN method was close to PRR and ROR method only when the related report count was larger. PRR and ROR methods had higher false positive rate than BCPNN method.

CONCLUSIONPRR or ROR method is proposed for signal detecting when the report count is large. BCPNN method is proposed for trend demonstration of signal with graph.

PURPOSE: This study aimed to describe Korean nurses' willingness to report suspected elder abuse and examine its related factors. METHODS: A descriptive correlational design was used. A convenience sample of 365 nurses from a hospital completed our questionnaires. Stepwise logistic regression analysis was performed to examine predictors of willingness to report. RESULTS: Sixty-eight nurses (18.6%) were not willing to report suspected elder abuse. In the stepwise logistic regression analysis, fewer years in clinical work, a higher level of knowledge on elder abuse law, and the perception of more severe abuse were found to be significant predictors of willingness to report elder abuse. CONCLUSION: As the Welfare of the Aged Act included a clause on mandated reporters, nurses' role in intervening in elder abuse cases has become more critical. In order to increase nurses' reporting, education on elder abuse should be provided to all nurses, and support programs should be designed for nurses to effectively involve them in reporting elder abuse.
Aged ; Elder Abuse ; Humans ; Jurisprudence ; Logistic Models ; Mandatory Reporting ; Surveys and Questionnaires

Safety assessment in clinical trials is dependent on an in-depth analysis of the adverse events to a great extent. However, there are difficulties in summary classification, data management and statistical analysis of the adverse events because of the different expressions on the same adverse events caused by regional, linguistic, ethnic, cultural and other differences. In order to ensure the normative expressions, it's necessary to standardize the terms in recording the adverse events. MedDRA (medical dictionary for regulatory activities) has been widely recommended and applied in the world as a powerful support for the adverse events reporting in clinical trials. In this paper, the development history, applicable scope, hierarchy structure, encoding term selection and standardized query strategies of the MedDRA is introduced. Furthermore, the practical process of adverse events encoding with MedDRA is proposed. Finally, the framework of statistical analysis about adverse events is discussed.
Adverse Drug Reaction Reporting Systems ; standards ; statistics & numerical data ; Databases, Pharmaceutical ; standards ; Humans