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O BJECTIVE

H ARMONIZATION OF C ATEGORIZATION S YSTEMS FOR A GENTS - F IRST D ATA FROM G ERMAN P OISONS C ENTRES XXVII I NTERNATIONAL C ONGRESS OF THE EAPCCT A THENS 2 M AY 2007 A. S TÜRER 1 , G . H ÜLLER 2 , HJ. R EINECKE 3 , C. S EIDEL 4 , U. S TEDTLER 5 , R. W AGNER 6 ,

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O BJECTIVE

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  1. HARMONIZATION OF CATEGORIZATION SYSTEMS FOR AGENTS -FIRST DATA FROM GERMAN POISONS CENTRES XXVII INTERNATIONAL CONGRESSOF THE EAPCCTATHENS 2 MAY 2007 A. STÜRER1,G. HÜLLER2, HJ.REINECKE3, C. SEIDEL4, U. STEDTLER5, R. WAGNER6, M. GANZERT7, D. WURM8, A. HAHN9, H. DESEL6, PCS: 1) ZURICH 2) ERFURT 3) MAINZ 4) BONN 5) FREIBURG 6) GÖTTINGEN 7) MUNICH 8) HOMBURG 9) BFR BERLIN

  2. OBJECTIVE • OBJECTIVE • METHODS • RESULTS • LIMITATIONS Categorization Systems for Agents => Central part in PC • CONCLUSION • FUTURE EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  3. ROLE OF THE CSA Cate- gorization System for Agents (CSA) • OBJECTIVE • METHODS • RESULTS Index (Names) of Agents • LIMITATIONS • CONCLUSION • FUTURE Recording of Agents (case collection) Identification of Agents (consulting) EAPCCT PRAGUE 20. APRIL 2006 - CATEGORIZATION SYSTEM FOR SUBSTANCES IN PC‘s - A. STÜRER

  4. OBJECTIVE: USE OF CSA categorization system 1st registration of agents processing of new product information • OBJECTIVE • METHODS „GROUP IT OR LOSE IT“ A. STÜRER - 2007 names of agents • RESULTS providing of substance / product info. recording ofcases • LIMITATIONS • CONCLUSION • FUTURE retrieval of cases for scientific evaluations annual reports EAPCCT PRAGUE 20. APRIL 2006 - CATEGORIZATION SYSTEM FOR SUBSTANCES IN PC‘s - A. STÜRER

  5. OBJECTIVE: CSA – ANNUAL REP. • OBJECTIVE • METHODS • RESULTS • LIMITATIONS • CONCLUSION • FUTURE EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  6. OBJECTIVE • OBJECTIVE • METHODS • RESULTS • LIMITATIONS Categorization Systems for Agents => central part in PC TDI Project (1999 – 2006) => Electronic product data exchange => Harmonization of CSA in Germany • CONCLUSION • TDI Project (2006) => Collection of harmonized data of Human Exposure 2005 in German PC • FUTURE EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  7. AIMS • OBJECTIVE • METHODS • RESULTS • LIMITATIONS Steps of the harmonization process Situation before using the TDI-CSA Current state of TDI-CSA integration Make TDI-CSA more familiar Presentation of the first common data collection grouped by TDI-CSA Future steps of CSA harmonization • CONCLUSION • FUTURE EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  8. METHODS • OBJECTIVE • METHODS • RESULTS • LIMITATIONS Evaluation of the preceding situation in German PC => Ques. • CONCLUSION • FUTURE EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  9. METHODS • OBJECTIVE • METHODS • RESULTS • LIMITATIONS Evaluation of the preceding situation in German PC => Ques. Developement of a harmon. CSA (1999 – 2006) => TDI-CSA • CONCLUSION • FUTURE EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  10. STRUCTURE OF TDI-CSA Cosmetics(COLIPA+EAPCCT) Plants • OBJECTIVE • METHODS • RESULTS LEVEL • LIMITATIONS Drugs (ATC-code) L-1 L-2 L-3 L-4 L-5 L-6 L-7 L-8 L-9 • CONCLUSION • FUTURE SECTOR Pesticides EAPCCT PRAGUE 20. APRIL 2006 - CATEGORIZATION SYSTEM FOR SUBSTANCES IN PC‘s - A. STÜRER

  11. STRUCTURE OF TDI-CSA • OBJECTIVE retrieval (daily work) • METHODS • RESULTS hierachcal structure (tree) • LIMITATIONS technical link (non-ambiguous) • CONCLUSION • FUTURE EAPCCT PRAGUE 20. APRIL 2006 - CATEGORIZATION SYSTEM FOR SUBSTANCES IN PC‘s - A. STÜRER

  12. STRUCTURE OF TDI-CSA – „TREE“ = products • OBJECTIVE = remedies = human drugs = cardiovascular system • METHODS ATC-Code 2007 (n = 5410) (Vet-ATC; n=5900) WHO Collaborating Centre for Drug Statistics Methodology, Oslo • RESULTS • LIMITATIONS hum. Drugs Metoprolol • CONCLUSION • FUTURE EAPCCT PRAGUE 20. APRIL 2006 - CATEGORIZATION SYSTEM FOR SUBSTANCES IN PC‘s - A. STÜRER

  13. STRUCTURE OF TDI-CSA – „TREE“ = natural environment • OBJECTIVE = plants >>> taxonomical classification >>> • METHODS Taxonomical classification according to: Zander, ed.: Dictionary of plant names, Kater pupl. 2000, 16th edition (n = 2‘700) • RESULTS • LIMITATIONS Plants Golden Chain Tree • CONCLUSION • FUTURE EAPCCT PRAGUE 20. APRIL 2006 - CATEGORIZATION SYSTEM FOR SUBSTANCES IN PC‘s - A. STÜRER

  14. STRUCTURE OF TDI-CSA – „TREE“ = products • OBJECTIVE =products of daily demand = cosmetics = cosmetics for nails • METHODS = nail polish and -remover Cosmetic Frame Formulations EAPCCT & COLIPA, 2000 completed by some own categories (n = 180) = nail polish • RESULTS = nail polish remover • LIMITATIONS Cosmetics Nail Polish • CONCLUSION • FUTURE EAPCCT PRAGUE 20. APRIL 2006 - CATEGORIZATION SYSTEM FOR SUBSTANCES IN PC‘s - A. STÜRER

  15. METHODS • OBJECTIVE • METHODS • RESULTS • LIMITATIONS Evaluation of the preceding situation in German PC => Ques. Developement of a harmon. CSA (1999 – 2006) => TDI-CSA Test period in 2 PC (Erfurt+Mainz) (2001 – 2005), completion • CONCLUSION • FUTURE EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  16. METHODS • OBJECTIVE • METHODS • RESULTS • LIMITATIONS Evaluation of the preceding situation in German PC => Ques. Developement of a harmon. CSA (1999 – 2006) => TDI-CSA Test period in 2 PC (Erfurt+Mainz) (2001 – 2005), completion • CONCLUSION • FUTURE Distribution 1st version TDI-CSA (Sept. 2006) to German PC (n = 15‘029) EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  17. METHODS • OBJECTIVE • METHODS • RESULTS • LIMITATIONS Data Collection (2006) Inclusion criteria: Exposure of humans in 2005 Grouping criteria: First 3 levels of TDI-CSA Age groups(Children <18y=< Adult; unknown) Course(Poisoning severity score; most serious known situation of the course; +/- follow up) => FORM • CONCLUSION • FUTURE EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  18. METHODS • OBJECTIVE • METHODS • RESULTS • LIMITATIONS • CONCLUSION • FUTURE 40 Sectors x 3 Age Groups x 6 Severity Grading = 720 fields per PC x 7 PC = 5‘040 primary data EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  19. METHODS • OBJECTIVE • METHODS • RESULTS • LIMITATIONS Data collection and pooling in independent PC (9-11/2006) Returning complete data set to participating PC (11/2006) Common evaluation and quality control (since 11/2006) Questionnaire: „Depth of use“ (Jan. 2007) • CONCLUSION • FUTURE EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  20. QUESTIONNAIRE-1: BEFORETDI-CSA • OBJECTIVE • METHODS • RESULTS • LIMITATIONS 7/10 participating PC 4 different CSA, regional extensions Existing CSA used since 6 – 27 y 6/7 maintain CSA, mostly infrequent 7/7 categorization of new agents 4/7 immediately with case recording, mostly 2nd pass before annual report Maintenance of CSA: 1-5 person (1.5) Categorization of Agents: 1-20 p. (1.0) • CONCLUSION • FUTURE EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  21. IMPLEMENTATION OF TDI-CSA • OBJECTIVE • METHODS • RESULTS • LIMITATIONS 7 of 10 PC integrated TDI-CSA at least up to first 3 levels, 2 month Parallel use of regional CSA and TDI-CSA First 3 levels cover 40 categories („Sectors“: hum. drugs, cosmetics, …) 4/7 integrated complete TDI-CSA 2/7 complete categorization of the regional index of agents (cases) • CONCLUSION • FUTURE EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  22. DATA COLL.: HUM. EXPO. 2005 • OBJECTIVE • METHODS • RESULTS • LIMITATIONS 7/10 PCs 137‘689 cases1‘270-27‘952 (Median 23‘220) cases/PC 78% of all Exposures in German PC • CONCLUSION • FUTURE EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  23. HUMAN EXPOSURE 2005 • OBJECTIVE • METHODS • RESULTS • LIMITATIONS • CONCLUSION • FUTURE EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  24. HUMAN EXPOSURE 2005 • OBJECTIVE DATA • METHODS • RESULTS • LIMITATIONS • CONCLUSION • FUTURE EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  25. LEVEL 1CATEGORIES • OBJECTIVE • METHODS • RESULTS • LIMITATIONS • CONCLUSION • FUTURE EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  26. SECTOR: SECTOR: SECTOR: SECTOR: LEVEL 2-3CATEGORIES • OBJECTIVE • METHODS • RESULTS • LIMITATIONS • CONCLUSION • FUTURE EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  27. TOP 10CATEGORIES • OBJECTIVE • METHODS • RESULTS • LIMITATIONS • CONCLUSION • FUTURE EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  28. GER = USA ? • OBJECTIVE • METHODS • RESULTS • LIMITATIONS • CONCLUSION • FUTURE EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  29. HIGH RISC CATEGORIES • OBJECTIVE • METHODS • RESULTS • LIMITATIONS • CONCLUSION • FUTURE EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  30. HIGH RISC CATEGORIES • OBJECTIVE • METHODS • RESULTS • LIMITATIONS • CONCLUSION • FUTURE EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  31. LIMITATIONS • OBJECTIVE • METHODS • RESULTS • LIMITATIONS In about 5-10% of the cases data attribution to the TDI-CSA is not completely reliable (incompatibility) Currently categorization of cases down to the deepest level is only in 2 PC obtainable There is probably a bias towards lower severity grades (follow up is performed in only 8%) • CONCLUSION • FUTURE EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  32. CONCLUSION • OBJECTIVE • METHODS • RESULTS • LIMITATIONS In 7/10 German PC the first step to a harmonized CSA was successful. The procedure for a multi-centre maintenance and update is running. A dataset of over 130‘000 cases is ready to be subjected to internal quality control measurements and benchmarking between PC. • CONCLUSION • FUTURE EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  33. CONCLUSION • OBJECTIVE • METHODS • RESULTS • LIMITATIONS For the first time within the 40-year history of the German PC common data of human exposure and poisonings in Germany are available for preliminary risk assessment and epidemiological analysis. • CONCLUSION • FUTURE EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  34. FUTURE • OBJECTIVE • METHODS • RESULTS • LIMITATIONS A complete integration of the TDI-CSA in all German PC will take about another 5 years. A new working group within the Society of Clinical Toxicology of German speaking PC (7/11) ensure the maintenance of the TDI-CSA=> www.klinitox.de -> WG V – “categories” (next meeting Sept. 2007) • CONCLUSION • FUTURE EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  35. FUTURE • OBJECTIVE • METHODS • RESULTS • LIMITATIONS A first federal institute (BVL) will use one sector of the TDI-CSA (cosmetics) and will share the System with the cosmetic industry. The experience of harmonisation as well as the TDI-CSA may serve as a basis for further harmonization on a European level. • CONCLUSION • FUTURE EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  36. THANKS TDI-Team PC Erfurt: G. Hüller Mainz: HJ. Reinecke,I. Weilemann, H. Zeimentz Bonn: C. Seidel Freiburg: U. Stedtler Göttingen: R. Wagner, H. Desel Homburg: S. Meier, D. Wurm Munich: M. Ganzert BfR K. Begemann, A. Hahn, G. Heinemeyer PC Zurich Team H. Kupferschmidt, C. Rauber-Lüthy EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

  37. THE END FURTHER INFORMATION: www.klinitox.de/129.0.html > TKS EAPCCT ATHENS 2 MAY 2007 - HARMONIZATIONOF CSA – FIRST DATA FROM PCS - A. STÜRER

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