No abstract available.
Pharmacoepidemiology*

Guidelines as Topic ; Pharmacoepidemiology ; Reference Standards

BACKGROUND: Apart from clinical outcomes, the "real-world" outcomes of intermittent short-course cyclosporine treatment remain poorly documented. OBJECTIVE: To evaluate various outcomes of short-course cyclosporine treatment for severe psoriasis; and to describe dermatologists' use of the Rule of Tens. METHODS: A 12-week pharmacoepidemiological study; 112 evaluable patients recruited by 43 dermatologists. RESULTS: The mean initial cyclosporine dose was 2.88+/-0.74 mg/kg/day. At 12 weeks, 64.3% of patients were continued beyond the study period at mean dose of 2.51+/-0.91 mg/kg/day. Percent body surface affected, Psoriasis Area Severity Index score, and patient and physician rating of psoriasis severity decreased significantly, while quality of life (QoL) improved significantly. Median patient satisfaction at 12 weeks was 85 (0~100 scale). Patient-reported non-adherence was 43.9% and 56.1%, respectively at both the time points (p=0.18). In modeling on logarithmized outcomes variables, living along was consistently the single most important (negative) determinant of therapeutic and patient outcomes. Safety and tolerance parameters were similar to the ones reported in the literature. Only 7.3% of physicians correctly identified the measures included in the Rule of Tens and the Rule's criterion for inferring severe psoriasis. CONCLUSION: With adequate monitoring and patient adherence, cyclosporine treatment reduces the severity of severe psoriasis, improves QoL, and is appropriately tolerated; leading to high patient satisfaction. Social support is a key determinant of therapeutic and patient outcomes and patients living along may require clinical attention. The relevance of the Rule of Tens was not evident.
Cyclosporine ; Humans ; Patient Compliance ; Patient Satisfaction ; Pharmacoepidemiology ; Psoriasis ; Quality of Life ; Transcutaneous Electric Nerve Stimulation ; Treatment Outcome

Post-marketing pharmacovigilance of drugs has become one of the most important activities for regulatory authorities. In China, pharmacovigilance is currently receiving the attention of government, pharmaceutical industries and the public. In order to support high quality pharmacoepidemiological studies and to stimulate innovation that benefits patients and the wider public, the European medicines agency (EMA) organized the European network of centres for pharmacoepidemiology and pharmacovigilance (ENCePP) to formulate and publish the Guide on Methodological Standards in Pharmacoepidemiology as a reference document for the methodological standards of pharmacovigilance activities in the European union (EU). It supplies methodological and scientific guidance, and advises on technical aspects of conducting parmacoepidemiological studies and undertaking parmacovigilance. As advice includes: legal and ethical requirements, general aspects of study protocols, research questions, approaches to data collection, study designs and methods, statistical and epidemiological analysis plans, quality control and quality assurance, reporting of adverse events to regulatory authorities, communication of findings, and so on. The translation and introduction of this guidance can provide a useful technical and methodological reference for us to carry out the pharmacovigilance (especially for parenterally administered Chinese medicine safety monitoring).
Guidelines as Topic ; Humans ; Pharmacoepidemiology ; methods ; standards ; Pharmacovigilance ; Reference Books, Medical ; Translating

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

Traditional Chinese medicine (TCM) safety assessment is an important content of post-marketing Chinese herbal medicine assessment and the primary question. It includes safety monitoring and safety evaluation. China has established the elementary system for the TCM safety monitoring, but did few things on safety evaluation. People have knew that the methods of pharmacoepidemiology have good practicability on drug safety assessment in recent years. This article analyzed three methods of pharmacoepidemiology used in post-marketing Chinese herbal medicine safety assessment. There are three examples that may give some suggestions to fellow doctors working for safety monitoring and evaluation of TCM.
Drug-Related Side Effects and Adverse Reactions ; Humans ; Medicine, Chinese Traditional ; adverse effects ; Pharmacoepidemiology ; methods ; Product Surveillance, Postmarketing ; methods ; Risk Assessment

The Korean Society of Epidemiology publishes a scholarly journal titled 'Korean Journal of Epidemiology', which announces and discusses the results of epidemiological studies from the past 30 yr. Since its first publication in 1979, the journal has contributed to the advancement of epidemiology as well as the prevention and control of disease, and the promotion of health in Korea. In 2009, the editorial board has decided to publish the journal in English to contribute internationally, and change the journal's name. The new name of the journal is 'Epidemiology and Health'. The abstract and full text of articles will be published as an open access online journal, which will be posted onto the homepage (http://www.e-epih.org/) in real time for anyone in the world to access free of charge. Our editorial policy is that 'Epidemiology and Health' is open to every researcher in fields related to epidemiology, regardless of membership, his or her major and nationality. Editorials, lectures, review papers, original articles, epidemic and case investigations, brief communications and letters will be published to generate active discussion through the journal along with the publication of the papers. 'Epidemiology and Health' welcomes articles from various fields of epidemiology, such as 1) infectious diseases epidemiology, 2) chronic diseases epidemiology, 3) nutritional epidemiology, 4) clinical epidemiology, 5) pharmacoepidemiology, 6) genetic or molecular epidemiology, 7) social epidemiology, 8) environmental or occupational epidemiology, 9) epidemiological methods and biostatistics, 10) disease prevention and control, 11) health promotion and, 12) all other fields related to epidemiology.
Biostatistics ; Chronic Disease ; Communicable Diseases ; Editorial Policies ; Epidemiologic Methods ; Epidemiologic Studies ; Fees and Charges ; Health Promotion ; Lectures ; Molecular Epidemiology ; Pharmacoepidemiology ; Publications

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

It has become apparent that infants and children are not small adults. Usually, they suffer from a different array of infectious diseases. The disposition of antimicrobial agents in their bodies is different and is often their response to drug therapy. And, there are substantial differences in these variables even among pediatric age groups. The intelligent use of antimicrobial agents in children requires more than simple extrapolation of observations made in adults. So, we need a very intensive research effort into the pharmacodynamic and kinetic and response to antimicrobial drugs in the pediatric patients. Also, the frequent empirical antibiotic use has led to increased resistance to certain antimicrobial groups. Appropriate prescription of antibiotics in primary care is influenced by several factors in the antibiotic use by general practitioners. An empirical prescription guideline based on the pharmacoepidemiology of resistance, recommending the use of potent and effective antibiotics that are less influenced by resistance to the marker, may help counter the spread of resistance in the community.
Adult ; Anti-Bacterial Agents ; Anti-Infective Agents ; Child ; Communicable Diseases ; Drug Resistance, Microbial ; Drug Therapy ; General Practitioners ; Humans ; Infant ; Pharmacoepidemiology ; Prescriptions ; Primary Health Care*

BACKGROUND: Abacavir is a widely-used nucleoside reverse transcriptase inhibitor for the treatment of human immunodeficiency virus (HIV) infection. Mandatory postmarketing surveillance was conducted in Korea to monitor the safety and evaluate the effectiveness of Ziagen® (abacavir sulfate 300 mg; ViiV Healthcare, Middlesex, UK). MATERIALS AND METHODS: An open-label, multi-center, non-interventional postmarketing surveillance study was conducted from June 2010 to June 2016 to monitor the safety and effectiveness of Ziagen across 12 hospitals in Korea. Subjects older than 18 years taking Ziagen according to prescribing information were enrolled. The primary outcome was defined as the occurrence of any adverse events after Ziagen administration. Secondary outcomes included the occurrence of adverse drug reactions, occurrence of serious adverse events, and effectiveness of Ziagen administration. RESULTS: A total of 669 patients were enrolled in this study, with a total observation period of 1047.8 person-years. Of these, 90.7% of patients were male. The mean age of patients was 45.8±11.9 years. One-hundred ninety-six (29.3%) patients reported 315 adverse events, and four patients reported seven serious adverse events, without any fatal events. There was one potential case of an abacavir hypersensitivity reaction. Among the 97 adverse drug reactions that were reported from 75 patients, the most frequent adverse drug reactions included diarrhea (12 events), dyspepsia (10 events), and rash (9 events). No ischemic heart disease was observed. In the effectiveness analysis, 91% of patients achieved HIV-1 RNA under 50 copies/mL after 24 months of observation with abacavir administration. CONCLUSION: Our data showed the safety and effectiveness of Ziagen in a real-world setting. During the study period, Ziagen was well-tolerated, with one incident of a clinically suspected abacavir hypersensitivity reaction. The postmarketing surveillance of Ziagen did not highlight any new safety information. These data may be helpful in understanding abacavir and the HIV treatment practices in Korea.
Delivery of Health Care ; Diarrhea ; Drug-Related Side Effects and Adverse Reactions ; Dyspepsia ; Exanthema ; HIV ; HIV-1 ; Humans ; Hypersensitivity ; Korea ; Male ; Myocardial Ischemia ; Pharmacoepidemiology ; RNA ; RNA-Directed DNA Polymerase