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Challenges in drug utilization research The Contergan (thalidomide) catastrophe required an explanation free from the specific interests of the pharmaceutical industry and demanded methodically reliable and scientifically independent studies into medication risks, in particular after admission to the market. As the Contergan experience showed, there are severe risks that then become obvious only when the drug is used in outpatient care. These considerations motivated the constitution of the Drug Utilisation Research Group (DURG) at the European WHO Office (1964). The founding members came from those countries whose health system is organized nation wide. In these countries, which include Great Britain, Germany and its Nordic neighbors, the well-being of the citizens has priority to commercial interests. These countries have data for their health systems at their disposal which form a suitable basis for drug utilization research. The first drug utilization studies that became models for this kind of research were published in the Nordic countries [Baksaas 1980, Gross and Inman 1977]. Germany was represented in the DURG (WHO) by Karl Kimbel and Hans Friebel. In 1996 the EURO DURG was established as an independent society in Balaton, Hungary and as the umbrella organization for all the national societies. The "Gesellschaft für Arzneimittelanwendungsforschung (GAA)" (Society for Drug Utilization Research) was one of the co-founders. Already in 1992 Karl Kimbel had taken the initiative in founding the GAA. In its constitution the Society defined the following aims and tasks: It supports scientific research into the utilization of drugs; in particular, it is concerned with the influences on drug use and prescribing behavior and the study of benefits and risks of drug therapy. It is engaged in the distribution of research results. It supports international co-operation in these fields. In setting these aims the GAA adopts an important position - as a Public Health Discipline - in relation to pharmacoepidemiology whose focal point lies in research into the effects and side-effects of drugs, primarily in clinical studies. Karl Kimbel thought the following questions should guide the research activities of the EURO DURG:
In his opinion, the results of such studies, should form the basis for research in the following context:
Likewise he was involved in the demand for the unrestricted publication of the Drug Prescribing Report 1997 (Arznei-Verordnungs-Report 1997) against legal objections of the pharmaceutical industry. Kimbel's aim was to provide a neutral ground for uncensored drug reports. Karl Kimbel regarded close co-operation of national and European research as important. Joint projects which must be borne in mind are: the Mapping Europe project - an international comparison of drug use in Europe. Kimbel made an effort to establish an internationally defined daily dose (DDD) and ATC (WHO drug coding system), used commonly in all participating countries, as a technical prerequisite for international drug utilization research. With respect to quality assurance and optimization of drug therapy Kimbel was convinced that it is hard to determine the deviding lines between necessary and unnecessary use which are not clear, above all, to the general practitioner. Therefore, he regarded the definition of "necessary" and "unnecessary use" as the most crucial problem for research, since the GP urgently needs this information for everyday prescribing. All of us who work in the field of drug utilization research are very thankful to Karl Kimbel for having laid the most important milestone for our research. We can best show our appreciation by putting his ideas into practice. PD
Dr. med. L. von Ferber
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The
data base used to examine these questions should be, according to
Kimbel, the implementation of documents from statuatory health insurance
or state-financed health care, as is the case in the Nordic countries,
Great Britain, Canada and Italy. In Germany the statutory health insurance
(GKV) data is most suitable. Such data are a reliable basis for epidemiological
statistics concerning mortality, morbidity and care, if they can be
made widely available and be analyzed both on a population and on
an individual level. These data are then particularly suitable for
drug utilization research. Just last year Karl Kimbel intensified
his efforts in public statements to resume research on a random sample
of insured persons in the GKV. He engaged in the campaign promoting
patient-related research within the limits set by the data protection
laws.