Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Jul 2005
[Electronic health professional cards as indispensable elements of the upcoming health telematics infrastructure. Interactions with electronic patient data cards].
The German law for the modernization of statutory health care defines a functional framework for the upcoming telematics infrastructure in health care based on electronic health professional cards, electronic patient data cards and the necessary information, communication and security infrastructure. The currently ongoing discussion for the implementation is strongly influenced by diverse particulate interests often hindering systematic development. ⋯ The interdependence of the components is illustrated using the example of the ATG concept for an electronic patient record. These facts call for a stepwise implementation of telematic infrastructure based on the presented mechanisms.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · May 2005
Comparative Study[Important aspects of geriatric pharmacotherapy].
Drug prescription for geriatric patients is one of the most prevalent yet also one of the most difficult interventions in geriatrics. Although this article focuses solely on specific important aspects of geriatric pharmacotherapy, medication in clinical practice is only one type of geriatric intervention that needs to be embedded in a well-coordinated bundle of multidimensional interventions addressing functional and psychosocial aspects alike. Not every older patient is per se a geriatric patient, nor is each geriatric patient per se of very old age. ⋯ In order to improve quality and safety of geriatric pharmacotherapy, a group of experts in the field developed a set of explicit age-adjusted criteria for potentially inappropriate drugs in 1991. These criteria have been regularly updated thereafter until 2003 and focus on age-related aspects of specific drugs and dosages as well as on co-morbid states and co-medications. As long as geriatric patients are rarely included in clinical trials on drug effectiveness and drug safety, these criteria should be applied and used in clinical practice at least to identify any demand for a detailed explicit justification of a therapeutic decision not in line with the explicit criteria in order to enhance safety of drug treatment in geriatric patients.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Apr 2005
[Ethical and regulatory requirements for conducting clinical trials: patient information and patient informed consent].
Written informed consent must be obtained from legally competent subjects, after having been duly informed verbally and in writing, before participation in a clinical trial with pharmaceutical products or medical devices. For persons or minors incapable of giving their informed legal consent, the written consent of the subject's legal representative is mandatory. The subject's presumed or expressed wish must be considered.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Apr 2005
[Clinical trials in Germany and in the EU in the new legislative environment. An analysis from the industry's point of view].
The European Union's (EU) Directive 2001/20/EC and its accompanying directives and guidance aim at approximating laws, regulations and administrative provisions relating to the implementation of Good Clinical Practice and Good Manufacturing Practice in the conduct of clinical trials on investigational medicinal products for human use in the EU member states. In addition, the establishment of two European databases for collecting information on clinical trials and suspected unexpected serious adverse events, respectively, should increase the transparency of clinical trials in the EU and thus improve patient safety. ⋯ There is the hope that patient safety will be improved by these measures. The future task of all involved stakeholders will be to work on a harmonisation of the different requirements in order to achieve the original goals intended by the Directive 2001/20/EC.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Feb 2005
Practice Guideline Guideline[Reorganization of the procedures and the tasks of the responsible ethics committees after the 12th AMG amendment. Concepts of the permanent working group of the medical ethics committees in Germany].
Since 12(th) of August 2004 the EU Directive 2001/20/EG has been implemented into the national law. The 12th AMG amendment of 30 July 2004 and the good clinical practice decree on the conduct of clinical trials on drugs for human use of 9 August 2004 have been authorized and must be considered for new clinical trials with investigational medical products (drugs). The scope of the changes are to increase the quality of clinical trials and to continue the process of harmonization within the European Community. ⋯ Thus, the role of the ethics committees has been changed; the committees are considered as an institution comparable to an authority to protect the rights and safety of human subjects involved in clinical trials. The permanent working group of the medical ethics committees in Germany has established a procedure to meet these requirements, particularly in the case of multicentre clinical trials, where only a single opinion shall be given for each member state. This article describes this procedure (application, process of ethical consideration among the leading and local ethics committees in multicentre trials, responsibilities during the trial).