O BJECTIVE

HHARMONIZATION OF ARMONIZATION OF CCATEGORIZATION ATEGORIZATION SSYSTEMS YSTEMS

FOR FOR AAGENTS GENTS --

FFIRST IRST DDATA FROM ATA FROM GGERMAN ERMAN PPOISONS OISONS CCENTRESENTRES

XXVII INTERNATIONAL CONGRESS OF 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

OBJECTIVE

Categorization Systems for Agents => Central part in PC

EAPCCT ATHENS 2 MAY 2007 - HARMONIZATION OF CSA – FIRST DATA FROM PCS - A. STÜRER

OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS

Cate-gorization System for

Agents (CSA)

ROLE OF THE CSA

Identification of Agents (consulting)

Recording of Agents(case collection)

Index (Names) of Agents

EAPCCT PRAGUE 20. APRIL 2006 - CATEGORIZATION SYSTEM FOR SUBSTANCES IN PC‘s - A. STÜRER

OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS

processing ofnew product information

OBJECTIVE: USE OF CSA

categorization

system

names of

agents

recording ofcases

providing of substance / product info.

retrieval of cases for scientific

evaluations

1st registration of agents

annual reports


„GROUP IT O

R LOSE IT

“A. STÜRER - 2

007

OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS

OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS

OBJECTIVE: CSA – ANNUAL

REP.


OBJECTIVE

Categorization Systems for Agents => central part in PC TDI Project (1999 – 2006) => Electronic product data exchange => Harmonization of CSA in Germany TDI Project (2006) => Collection of harmonized data

of Human Exposure 2005 in German PC


OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS

AIMS

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


OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS

METHODS

1. Evaluation of the preceding situation in German PC => Ques.


OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS

METHODS


2. Developement of a harmon. CSA (1999 – 2006) => TDI-CSA


OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS

STRUCTURE OF TDI-CSA

L-1 L-2 L-3 L-4 L-5 L-6 L-7 L-8 L-9

Plants

Cosmetics(COLIPA+EAPCCT)

Drugs (ATC-code)

Pesticides

SECTOR

LEVEL


OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS

STRUCTURE OF TDI-CSA

technical link (non-ambiguous)

retrieval (daily work)

hierachcal structure (tree)


OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS

STRUCTURE OF TDI-CSA – „TREE“

= products= remedies

= human drugs= cardiovascular system

hum. Drugs Metoprolol

ATC-Code 2007

(n = 5410)

(Vet-ATC; n=5900)WHO Collaborating Centre for Drug Statistics Methodology, Oslo


OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS


= natural environment= plants

>>> taxonomical classification >>>

Plants Golden Chain Tree

Taxonomical classification according to:

Zander, ed.: Dictionary of plant names,

Kater pupl. 2000, 16th edition

(n = 2‘700)


OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS


= products=products of daily demand

= cosmetics= cosmetics for nails

Cosmetics Nail Polish

= nail polish and -remover= nail polish= nail polish removerCosmetic Frame

FormulationsEAPCCT & COLIPA, 2000

completed by some own categories

(n = 180)


OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS

METHODS



3. Test period in 2 PC (Erfurt+Mainz) (2001 – 2005), completion


OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS

METHODS



3. Test period in 2 PC (Erfurt+Mainz) (2001 – 2005), completion

4. Distribution 1st version TDI-CSA (Sept. 2006) to German PC (n = 15‘029)


OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS

METHODS

5. 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)

=> FORMEAPCCT ATHENS 2 MAY 2007 - HARMONIZATION OF CSA – FIRST DATA FROM PCS - A. STÜRER

OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS

METHODS

40 Sectors x 3 Age Groups x 6 Severity Grading

= 720 fields per PC

x 7 PC = 5‘040 primary dataEAPCCT ATHENS 2 MAY 2007 - HARMONIZATION OF CSA – FIRST DATA FROM PCS - A. STÜRER

OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS

METHODS

6. Data collection and pooling in independent PC (9-11/2006)

7. Returning complete data set to participating PC (11/2006)

8. Common evaluation and quality control (since 11/2006)

9. Questionnaire: „Depth of use“ (Jan. 2007)


OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS

QUESTIONNAIRE-1: BEFORE TDI-CSA 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)


OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS

IMPLEMENTATION OF TDI-CSA 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)


OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS

DATA COLL.: HUM. EXPO. 2005 7/10 PCs 137‘689 cases 1‘270-27‘952 (Median 23‘220) cases/PC

78% of all Exposures in German PCHuman Exposures 2005 in Germany (n=177'367)

(*2004, GfKT WG-II, Data collection Pharmacovigilance May 2006)

GOE16%

FRE10%

ERF10%

MAI13%

BON13%

HOM1%

MUE15%

PC-819%

PC-10*1%

PC-9*2%


OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS

HUMAN EXPOSURE 2005

GOE FRE ERF MAI BON HOM MUE

unkn.AdultChild

0

2'000

4'000

6'000

8'000

10'000

12'000

14'000

16'000

Age Groups


Adult Children unknown

Cases 60'386 71'361 5'941

% 44% 52% 4%

Range 40 - 68% 24 - 59% 1 - 13%

OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS

HUMAN EXPOSURE 2005

DATA


OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS

LEVEL 1 CATEGORIES Level 1 Categories - Total

(n = 131'688)

Products82%

Zivilisation Remnants /

Waste2%

Natural Environment

16%

Level 1 Categories - Adult (n = 59'181)

Natural Environment

7%

Products90%

Zivilisation Remnants /

Waste2%

Level 1 Categories - Children (n = 68'878)

Natural Environment

22%

Zivilisa-tion Remnents /

Waste1%

Products73%


OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS

LEVEL 2-3 CATEGORIES


OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS

-40000 -30000 -20000 -10000 0 10000 20000

Remedies

Human Drugs

Homöopathic drugs

Human Drugs - unclassified

Medical Products

Veterinary Drugs

Remedies - unclassified

Remedies

Adult Children

SECTOR:

-6000 -4000 -2000 0 2000 4000 6000 8000 10000 12000

Products of daily DemandObjects of daily Demand (except Cleaning and Room Air

Conditioning Agents)Cosmetics

Foods and Food-Additives

Tobacco Products

Products of daily Demand – unclassified

Products of daily Demand

Adult Children

SECTOR:

-10000 -5000 0 5000 10000 15000 20000

Chemical / Physicochemical Products

Construction Materials, Sealants and Adhesives

Paints, Varnish and Dyers

Illuminant Fuels, Inflammable Matters, Scents,

Cleaning Agents, Detergents and Care Products

Chemicals for Technical Tools, Processes and

Products for Plants and Animals

Chemical / Physicochemical Articles -

Drugs of Abuse

Chemical / Physicochemical Products / Drugs of Abuse

Adult Children

SECTOR:

-6000 -4000 -2000 0 2000 4000 6000 8000 10000 12000 14000 16000

Natural Environment

Fungi

Microbes

Plants

Animals

Natural Environment - miscellaneous / unclassified

Natural Environment

Adult Children

SECTOR:

TOP 10 CATEGORIES


OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS

TOP 10 CATEGORIES (ADULT) %

Human Drugs 57.9

Cleaning Agents, Detergents and Care Products 7.3

Foods and Food-Additives 6.0

Products - unclassified 3.7

Plants 3.3

Chemicals for Technical Tools, Processes and Products 2.9

Basic Materials 2.9

Drugs of Abuse 2.6

Pesticides and Exterminator 2.2

Civilisation Remnants, Inherited Waste 1.8

TOP 10 CATEGORIES (CHILDREN) %

Human Drugs 25.3

Plants 20.3

Cleaning Agents, Detergents and Care Products 14.4

Cosmetics 7.2

Chemicals for Technical Tools, Processes and Products 4.4

Foods and Food-Additives 3.6

Products - unclassified 3.0

Illuminant Fuels, Inflammable Matters, Scents, Decorations and similar Agents 2.5

Paints, Varnish and Dyers 2.4

Objects of daily Demand (except Cleaning and Room Air Conditioning Agents) 2.1

GER = USA ?


OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS

N° MOST FREQUENT CATEGORIES (ADULT >= 18y))GER [%]

Comparability ComparisonUSA [%]

MOST FREQUENT CAT. (ADULT > 19y)

1 Human Drugs 57.9 = = 59.8 several Groups of drugs

2 Cleaning Agents, Detergents and Care Products 7.3 = < 9.1 Cleaning substances (household)

3 Foods and Food-Additives 6.0 (=) > 4.2 Food products/food poisoning

4 Products - unclassified 3.7 <> - -

5 Plants 3.3 ? - ?

6 Chemicals for Technical Tools, Processes and Products 2.9 ? - ?

7 Basic Materials 2.9 (=) = 3.3 Chemicals

8 Drugs of Abuse 2.6 (=) = 2.7 Stimulants and street drugs

9 Pesticides and Exterminator 2.2 = < 5.0 Pesticides

10 Civilisation Remnants, Inherited Waste 1.8 ? < 3.1 Fumes/gases/vapors

11 Animals 1.7 (=) << 6.8 Bites and envenomations

12 Fungi 1.7 ? - ?

13 Cosmetics 1.4 = << 4.5 Cosmetics/personal care products

14 Paints, Varnish and Dyers 1.2 ? - ?

15 Chemical / Physicochemical Articles - unclassified 0.9 <> - -

different groups <> - 3.3 Hydrocarbons

within Food <> - 5.2 Alcohols

SUM 97.6 107.0 SUM

HIGH RISC CATEGORIES


OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS

CHILDREN / PSS asympt minor moder. severe fatal unkn.

Drugs of Abuse (n=293) 15.0 47.4 19.5 3.8 0.0 14.3

Human Drugs (n=18'051) 71.1 21.6 2.1 0.4 0.1 4.8

Foods and -Additives (n=2541) 70.5 21.3 2.8 0.4 0.0 5.0

TOTAL (68'878) 76.3 18.2 1.3 0.2 0.0 4.0

0% 20% 40% 60% 80% 100%

Drugs of Abuse (n=293)

Human Drugs (n=18'051)

Foods and -Additives (n=2541)

TOTAL (68'878)

Severity Grading - CHILDREN

asympt. minor moderate severe fatal unknown

HIGH RISC CATEGORIES


OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

LIMITATIONS

ADULT / PSS asympt minor moder. severe fatal unkn.

Drugs of Abuse (n=1'594) 9.1 57.5 18.6 6.8 0.1 7.8

Human Drugs (n=34'989) 23.0 52.0 12.7 4.6 0.2 7.5

Pesticides (n=1'347) 26.7 48.7 6.3 4.0 0.8 13.4

TOTAL (68'878) 27.8 49.5 10.5 3.6 0.2 8.4

0% 20% 40% 60% 80% 100%

Drugs of Abuse (n=1'594)

Human Drugs (n=34'989)

Pesticides (n=1'347)

TOTAL (68'878)

Severity Grading - ADULT

asympt. minor moderate severe fatal unknown

LIMITATIONS


OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

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


OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

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


OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

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.

FUTURE


OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

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)

FUTURE


OBJECTIVE

METHODS

RESULTS

CONCLUSION

FUTURE

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.

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


THE END


FURTHER INFORMATION:

www.klinitox.de/129.0.html> TKS

O BJECTIVE

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