Dr. Karel Kostev - Dr. Gabriele Haas (Hrsg.)

Abstract
Pharmacoepidemiological databases are a very useful tool, without which well-directed quality improvements and targeted risk management of adverse drug effects would not be possible. Data from such retrospective databases allow investigations into specific subpopulations - e.g., groups with specific diagnoses - thanks to their size and duration of observation. Regarding the quality of such data, it has been proven that carefully planned observational studies can produce results comparable to those of randomized controlled trials. This book presents eight epidemiological and health-economic studies based on two large epidemiological databases: IMS Disease Analyzer database and IMS LRx.. The IMS® Disease Analyzer patient database is one of the most comprehensive pharmacoepidemiological databases in Europe. It has been the basis of a number of studies and peer-reviewed scientific publications in the fields of pharmacoepidemiology, health economics, pharmacovigilance, compliance/persistence, pharmaceutical guidelines, prescribing behavior, and drug application. Using these databases, a great number of studies have been conducted to analyze the duration, adverse effects, success, costs, and courses of and compliance with therapies and therapy changes. The studies also play an important part in drug safety and risk prevention. The IMS® LRx database accesses nationwide pharmacy data centers processing prescription data of all German patients with statutory health insurance for reimbursement purposes. It contains roughly 95 % of all prescriptions issued nationwide since 2008. The compilation of studies in this book illustrates the benefits of secondary data in the form of retrospective databases for everyday healthcare.


Authors

Dr. Karel Kostev is the senior research consultant and the leader of epidemiology team at IMS Health GmbH in Frankfurt. He studied in sociology and statistics from the University of Freiburg and earned a doctor's degree in medical statistics at the University of Leipzig. He has extensive experience in pharmacoepidemiology and health economic research,the analysis of persistence/compliance, and drug safety using observational data. He is author or co-author of many medical and health economic publications.

Dr. Gabriele Haas works as a product manager for medical and patient data at IMS Health in Frankfurt. She studied pharmaceutics in Frankfurt am Main and graduated with a Ph.D. in natural sciences, in the special field of pharmaceutics, oncology and immunology. Her professional career was in the pharmaceutical industry until she began working for one of the largest statutory health insurance companies in Germany, in the area of medication cost management and managed care. During this time she completed her studies to become a health economist.

Wioletta Kotowa, M.D. is an engagement manager in health economics and outcomes research at IMS Consulting Group in Germany. Her main focus is on health economic evaluations, health technology assessments, and value dossiers. Her background includes four years of clinical experience in internal medicine, roles as a researcher and lecturer at the Medical University, and positions in the pharmaceutical industry in Germany. She co-authored a number of health economic publications and is a member of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), the German Society for Health Economy (DGGÖ) and the German Network of Evidence-based Medicine (DNEbM).

Detlef Schröder-Bernhardi is the senior product specialist and consultant for IMS Frankfurt. He holds a degree in biomedical statistics from the University of Giessen and has over thirty years of experience in the development, design, and implementation of research projects utilizing longitudinal patient data.

Silvia Kruppert is the senior business analyst for the CES LifeLink team at IMS Health in Frankfurt. She holds a degree in medical documentation. Over the last ten years, Silvia has gained expert knowledge of performing studies based on patient data that cover local and international market research studies and cost-effectiveness analysis.

Dr. med. Sabine Fuchs, MPH worked as a consultant for IMS HEOR in Nuremberg from 2009 until 2011. She is a medical doctor with a postgraduate specialization in public health and was focused on planning and conducting health economic studies and value dossiers in addition to writing medical scientific publications. Currently she is head of health promotion and planning at the public health department of the city of Nuremberg.

Claudia Nitzschmann is the proprietor of clawitter-translations. com. She holds two bachelor's and one master's degree from the International University Bremen (now Jacobs University Bremen). She has translated numerous scientific publications in the areas of medical research and epidemiology for IMS Health.

Jörg Mathes, MPharm is a senior consultant for health economics and outcomes research at IMS Consulting Group in Germany. He joined IMS in 2005. His main focus is on health technology assessment, value dossiers, IQWiG appraisals, reference pricing, and retrospective database analyses. He possesses a degree of MPharm from the University of Regensburg.

Keywords
Medical Care, Epidemiology, Health Economics, IMS Patient Databases, corticosteroid nasal sprays, Basal insulin therapy, type 2 diabetes, Insulin glargine, Insulin, intensified conventional therapy, ICT, insulin detemir, NPH insulin, type 1 diabetes, granulocyte colony-stimulating factors, G-CSF, erythropoiesis-stimulating agents, renal anemia, healthcare system, reflux disease, Medication, drug,



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