Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Feb 2005
Practice Guideline Guideline[Decree on the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use].
In Germany, Directive 2001/20/EC is implemented by articles 40 to 42a of the Federal Drug Act and by the Decree on Good Clinical Practice. Pivotal provisions have been included into the Federal Drug Act, such as those aiming at the clinical trial subject's protection and defining responsibilities for the evaluation of applications as well as for pharmacovigilance and surveillance. The Decree comprises: relevant definitions; requirements for manufacturing, importation and labelling of investigational medicinal products; the procedures to obtain the ethics committee's opinion and the authorization from the competent authority on the trial application and on amendments thereof; documentation and information tasks of the investigator, sponsor and competent authority; rules for inspection to verify compliance with good clinical and manufacturing practice. Finally, the decree lists infringements within the meaning of article 97, paragraph 2, no. 31 of the Federal Drug Act, and lays down the necessary provisions for a transitional period and the entering into force of the new provisions.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Feb 2005
[Clinical guidelines. What do doctors and patients get from them].
Now more than ever physicians need effective management of the constantly increasing flood of medical information. The authors discuss possibilities for developing clinical guidelines as a core element of this information management and the requirements of these possibilities. The development of clinical guidelines is a process also suitable for involving patient and consumer expertise in health care. Models of involving patients are described and how these processes can build an important base for shared decision making of physicians and patients.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Dec 2004
Review[Thiomersal and immunisations].
Thiomersal was used in the 1930s for the first time for the preservation of vaccines to prevent bacterial and fungal contamination. Thiomersal is an organic compound containing 49% mercury (Hg) by weight. It is generally well known that mercury and its compounds, including thiomersal, ethylmercury, and methylmercury, act as nephro- and neurotoxicants, however, at much higher doses than used in vaccines. ⋯ Today a child in Germany can be immunised in accordance with the official recommendations (STIKO) almost without the administration of thiomerosal (residual amounts). Results of new pharmacokinetic and epidemiological studies are discussed. The evidence available to date does not support the hypothesis of a potential relationship between neurodevelopmental disorders and thiomersal-containing vaccines.
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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz · Nov 2004
Clinical Trial[Self-medication with over-the-counter (OTC) preparations in Germany].
Self-medication with OTC drugs is attracting attention in developed countries. This study examines prevalence and determinants of OTC drug use in a representative sample of German adults aged 18-79 years. A total of 7099 participants of the Drug Utilisation Survey were interviewed regarding drug use including OTC use within the last 7 days prior to the interview. ⋯ The most commonly reported indication for self-medication with OTC drugs is "prevention". Beside prescribed medication, self-medication with OTC drugs is an important part of drug usage for men and women in Germany. Health consciousness appears to be a significant factor to explain the prevalence OTC drug use.