title: [Quality and safety of Chinese medicine drugs in Germany - an update].
abstract: BACKGROUND
  In the past, traditional Chinese medicine (TCM) drugs (TCD) had in part severe shortcomings regarding quality and safety. The current state of knowledge in this field was evaluated.
  
  
  METHODS
  Expert interviews by using standardized questionnaires, systematic literature research of studies from Germany published in 1998–2013, systematic inquiries to surveillance authorities and information centers for intoxications as well as investigation of certificates of analysis of the TCM granulate ‘Tianwang buxin dan’ from 8 available sources in Germany and analyses of its content of lead, cadmium, and mercury.
  
  
  RESULTS
  Current quality and safety risks comprise self-medication, TCM-unexperienced pharmacies, Internet sale and granulates. 11 studies published between 1998 and 2008 evaluated the quality and safety of TCD in Germany. Also in newer studies, the values found for heavy metals, pesticides, and microbiological contaminants of TCD in part exceeded the maximum permissible values. 28 reports of adverse events were made to the Center for Therapy Safety in Chinese Drug Therapy (CTCA) within the years 2004–2012. A definite causality was determined in 2 cases (allergic reaction, reaction of the circulatory system); 7 of the 28 reports had a likely causality. 61 of 104 (59%) certificates of ‘Tianwang buxin dan’ from 8 different sources could be obtained. 45 of 61 certificates (74%) complied with the requirements according to the pharmacy work rules. Shortcomings were, amongst others, lacking analyses (identity, aflatoxines, microbiology, pesticides). Critical values were exceeded neither in the certificates nor in the analyses arranged by us.
  
  
  CONCLUSIONS
  Shortcomings in quality and safety risks of TCD still remain, but must be further distinguished. Reports of adverse events are very rare.
authors.affiliation: Uni-Zentrum Naturheilkunde, Institut für Umweltmedizin und Krankenhaushygiene, Universitätsklinikum Freiburg, Freiburg, Deutschland.
authors.forename: Nadja
authors.initials: N
authors.lastname: Hempen
authors.forename: Roman
authors.initials: R
authors.lastname: Huber
mesh_terms: D003257:Consumer Product Safety / Q000592:standards; D004340:Drug Contamination; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000592:standards*; D005858:Germany; D006801:Humans
chemical_list: D004365:Drugs, Chinese Herbal