Overview of the continuously expanding EU acquis in the area of criminal law, part 2: approximation of criminal law, 'operational' powers for Europol, Eurojust and 'mutual recognition'

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The impact of European integration on the German system of pharmaceutical product authorization

The European Union has evolved since 1965 into an influential political player in the regulation of pharmaceutical safety standards. The objective of establishing a single European market for pharmaceuticals makes it necessary for member-states to adopt uniform safety standards and marketing authorization procedures. This article investigates the impact of the European integration process on the German marketing authorization system for pharmaceuticals. The analysis shows that the main focal points and objectives of European regulation of pharmaceutical safety have shifted since 1965. The initial phase saw the introduction of uniform European safety standards as a result of which Germany was obliged to undertake “catch-up” modernization. From the mid-1970s, these standards were extended and specified in greater detail. Since the mid-1990s, a process of reorientation has been under way. The formation of the European Agency for the Evaluation of Medicinal Products (EMEA) and the growing importance of the European authorization procedure, combined with intensified global competition on pharmaceutical markets, are exerting indirect pressure for EU member-states to adjust their medicines policies. Consequently, over the past few years Germany has been engaged in a competition-oriented reorganization of its pharmaceutical product authorization system the outcome of which will be to give higher priority to economic interests.Die Europäische Gemeinschaft ist in der Regulierung der Arzneimittelsicherheit seit 1965 zu einem einflussreichen politischen Akteur geworden. Das Ziel eines einheitlichen europäischen Marktes für Arzneimittel erfordert eine Vereinheitlichung der Sicherheitsstandards und Zulassungsverfahren in den Mitgliedstaaten. Im folgenden Beitrag wird der Frage nachgegangen, welche Auswirkungen der Prozess der Europäischen Integration auf das System der Arzneimittelzulassung in Deutschland hat. Es wird deutlich, dass sich die Schwerpunkte und Zielsetzungen der europäischen Regulierung der Arzneimittelsicherheit seit 1965 verschoben haben. Nach einer ersten Phase der Etablierung einheitlicher europäischer Sicherheitsstandards, die in Deutschland eine nachholende Modernisierung erforderlich machten, wurden diese Standards seit Mitte der 1970er Jahre ausgebaut und präzisiert. Seit Mitte der 1990er Jahre kommt es zu einer Neuausrichtung. Die Errichtung der europäischen Arzneimittelagentur EMEA und der Bedeutungsgewinn der europäischen Zulassungsverfahren erzeugen in Verbindung mit dem verschärften globalen Wettbewerb auf den Arzneimittelmärkten einen mittelbaren Anpassungsdruck auf die nationalen Arzneimittelpolitiken. In der Konsequenz wird in Deutschland seit einigen Jahren eine wettbewerbsorientierte Umgestaltung der Arzneimittelzulassung betrieben, die zu einer Aufwertung ökonomischer Interessen im Zulassungssystem führt

Adverse drug reactions in older people : detection and prevention

Adverse drug reactions (ADRs) in older adults are an important healthcare problem since they are frequently a cause of hospitalization, occur commonly during admission, and are an important cause of morbidity and mortality. Older adults are particularly susceptible to ADRs because they are usually on multiple drug regimens and because age is associated with changes in pharmacokinetics and pharmacodynamics. The presentation of an ADR in older adults is often atypical, which further complicates its recognition. One potential strategy for improving recognition of ADRs is to identify those patients who are at risk of an ADR. The recently developed GerontoNet ADR Risk Score is a practical tool for identification of older patients who are at increased risk for an ADR and who may represent a target for interventions aimed at reducing ADRs. Provision of adequate education in the domain of clinical geriatric pharmacology can improve recognition of ADRs. Besides formal surveillance systems, built-in computer programs with electronic prescribing databases and clinical pharmacist involvement in patient care within multidisciplinary geriatric teams might help to minimize the occurrence of ADRs. In addition, a number of actions can be taken in hospitals to stimulate appropriate prescribing and to assure adequate communication between primary and hospital care. In older adults with complex medical problems and needs, a global evaluation obtained through a comprehensive geriatric assessment may be helpful in simplifying drug prescription and prioritizing pharmacological and healthcare needs, resulting in an improvement in quality of prescribing

A review of interventions used to improve adherence with medication in older

Background: Medication mismanagement is a continuous problem particularly in older people. Numerous interventions have been developed and tested in an attempt to improve adherence with medication in this client group. Objectives: This review aimed to examine the simple to complex interventions that have been used to assess and improve adherence with medication in older people. Design: An extensive review of the literature was performed and 20 relevant research papers and one report were chosen. Findings: Research papers were evaluated according to design, RCTs were analysed using the JADAD scoring system, systematic reviews and reviews of the literature were reviewed using the Critical Appraisal Skills Programme and subjected to a narrative analysis. This process assisted the development to emerging themes. Four themes were developed: patient barriers, health professional involvement, and health related outcomes and formation giving. Conclusions: The salient findings of the review infer that there is no clear definition of non–adherent behavior. Quantitative interventions fail to assess patient choice in relation to medication taking. Pharmacist-driven interventions are resource intensive. Health care outcomes and clinical effectiveness are seldom addressed in interventions. Among the many difficulties encountered when attempting to use interventions to promote adherence with medication in older people is their perceptions and beliefs, the appropriateness of the medicines prescribed as well as the impact of lifestyle patterns; smoking, alcohol and diet. Many intervention studies are of poor quality and do not include a theoretical framework to underpin the interventions being used. More focused research is needed to improve understanding of the theoretical knowledge that underpins the complexities of adherence with medication in older people. In-depth qualitative studies can be used to develop such theory. In addition, the quality of intervention research can be improved by the inclusion of a research framework such as the Medical Research Council model