Focus on Alternative and Complementary Therapies
www.pharmpress.com/fact
Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2005; 10: 42
Although there is substantial evidence that herbal medicines can cause serious adverse reactions (ADRs), there is still a lack of knowledge on the occurrence of ADRs in CAM in general practice and hence there is a need for a better reporting of adverse events for CAM. Our aim was to develop a physician-led electronic system for reporting prescribing patterns and ADRs specially designed for products of anthroposophical medicine (EVAMED).
Based on the web-oriented postgreSQL-database system, QuaDoSta EvaMed can easily be connected to the data of common practice software of physicians. Both documentation and classification of ADRs are based on the WHO standards of adverse reaction terminology (WHO-ART) and grading of severity (from 1 = light to 4 = severe).
Since September 2004, the data of 31 German anthroposophically oriented physicians have been collected. Over this period, a total of 63 239 prescriptions of 129 640 (39% allopathic, 46% anthroposophical, 8% homoeopathic, 7% herbal) remedies from 32 607 patients (57% female, 54% children) were documented. ADRs were reported in 68 cases (WHO-grade I 26, WHO-grade II 32, WHO-grade III 10). Thirty-one of them were related to the prescription of anthroposophical remedies.
There is an urgent need for the documentation of ADRs, especially considering the background of harmonising the registration of herbal medicines in the European Union. The EvaMed project is a substantial effort to fulfil this need.
The EvaMed project is sponsored with a grant from the SAG-Foundation and financially supported by WALA and WELEDA.
