41990X1231(02)

RESOLUTION OF THE COUNCIL AND OF THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES, MEETING WITHIN THE COUNCIL of 3 December 1990 on improving the prevention and treatment of acute human poisoning (90/C 329/03)

THE COUNCIL OF THE EUROPEAN COMMUNITIES AND THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES OF THE EUROPEAN COMMUNITIES, MEETING WITHIN THE COUNCIL, Having regard to the Treaty establishing the European Economic Community, Having regard to the draft resolution submitted by the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas, for a policy aimed at preventing the risks of acute poisoning in the population and, in particular, among workers, it is desirable to have the maximum amount of comparable data on clinical toxicology at Community level; Whereas poison centres in the Community, by virtue of their informative therapeutic and analytical functions, are amongst those bodies in the best position to collect clinical toxicology data in their geographical areas of activity and to process this information; Whereas harmonization of the procedures for collecting clinical toxicology data for all the poison centres in the Community would facilitate the development of a policy for toxic risk prevention; Whereas, by fostering the integration of clinical and analytical data, the Community wishes to achieve one of the main objectives of its programme of action on toxicology for health protection (4), namely to help ensure the quality and comparability of data and encourage the exchange of experience and information in the field of clinical toxicology; Whereas harmonized annual reports would be of value in the context of the Ehlass project subject of Council Directive 86/138/EEC of 22 April 1986 concerning a demonstration project with a view to introducing a Community system of information on accidents involving consumer products (5); whereas Annex I (Section 2, third paragraph) of that Decision stipulates that additional information may be obtained from poison centres to supplement the basic information obtained from the casualty departments of hospitals; Whereas, with a view to the free movement of persons and goods, it is important to improve the availability of antidotes by facilitating exchanges of information on their availability, in particular in areas adjacent to other Member States; Whereas this resolution would help to develop the use of clinical toxicology data in overall assessments of the impact of chemical products and preparations on the health of the public in general and, more particularly, on the health of workers exposed to dangerous substances liable to cause acute poisoning; Whereas it is important to ensure access to information on the chemical composition of preparations in order to ensure the correct advice and treatment in connection with poisoning; Whereas this resolution should contribute to the development of health data with respect to the unlawful use of drugs with reference to the resolution of the Council of the Ministers for Health of the Member States, meeting within the Council of 16 May 1989, concerning a European network of health data on drug abuse (6); Whereas the information obtained in the event of poisoning by medicinal products may constitute a factor in the assessment of their safety in use; whereas it is desirable for the information collected in this connection by poison centres to be forwarded to the authorities responsible for medicinal products and drug monitoring; Whereas continued close cooperation with the various international agencies active in this area, in particular the World Health Organization (WHO), the United Nations Environment Programme (UNEP) and the International Labour Organization (ILO) through their joint International Programme on Chemical Safety (IPCS), and where appropriate the implementation of joint measures with those agencies, would be beneficial and is necessary to avoid duplication of effort, I EXPRESS THE WILL to take the necessary steps to improve the prevention and treatment of acute human poisoning. II INVITE THE MEMBER STATES: 1. to designate a competent authority to take the necessary measures to ensure that the collection of call data and the annual reports on the work of the poison centres or, where appropriate, other competent services operating in the territory of the Member State concerned are based essentially on the indications set out in Annexes I and II; 2.to ensure that antidotes i.e. the substances and preparations used specifically in cases of acute poisoning, are as widely available as possible in their respective territories; 3.to increase the practical scope for using antidotes in their respective territories. To that end, the competent authority will have drawn up and distributed to the poison centres and, where appropriate, to other competent services, information, based on the indicative list in Annex III, on the availability of antidotes for treating acute poisoning cases and on the sources of supply. That information should enable the recipients to obtain these antidotes within the requisite period for administering them effectively; 4.to provide better emergency services in areas adjacent to other Member States. To that end, the relevant competent authorities, in cooperation with the Commission, will set up between the poison centres or, where appropriate, other competent services a Community system of information and collaboration concerning the availability of antidotes; 5.to arrange for the competent authority to produce a summary of the harmonized annual reports of the poison centres and, where appropriate, of other competent services; This summary will deal in particular with records of acute poisoning, with a note on the measures taken or planned to improve the prevention of acute poisoning and will, if possible, also take account of available anonymous data on poisoning resulting from the taking of illegal drugs. The summary will be forwarded to the Commission before 15 May of the following year, together with a list of the poison centres or, where appropriate, other competent services operating in the territory of the Member State, showing the areas which they cover, and the list of available antidotes. The Commission may, where necessary, arrange for all or part of the harmonized annual reports referred to in Annex II to be forwarded to it. To help improve the safety of use of medicinal products, it would be desirable for the annual report on cases of poisoning involving them to be forwarded also to the authorities responsible for the safety of those products. The poison centres or, where appropriate, other competent services would be encouraged to give the drug-monitoring authorities every assistance possible and should in particular respond, on the basis of the legislation in force, to any specific request for informtion from those authorities. III INVITE THE COMMISSION TO: - prepare regular summary reports for the Community indicating, in particular, the measures required at Community level for the prevention of acute poisoning, -expand on specific topics based on the information received from the Member States on the prevention and treatment of acute poisoning. IV AGREE: -to review the provisions of this resolution within five years of their adoption on the basis of a Commission report. That review will take account of the need to step up prevention by means of the activities provided for in this resolution, -to invite the Commission to review the technical Annexes to this resolution at least every two years and, if necessary, update them regularly in the light of the experience acquired, -that in the preparation of the above report and in the updating of the Annexes the Commission will be assisted by a working party of experts appointed by the Member States.(1) OJ No C 294, 22. 11. 1989, p. 10.

(2) Opinion delivered on 23 November 1990 (not yet published in the Official Journal).

(3) OJ No C 124, 21. 5. 1990, p. 1.

(4) OJ No C 184, 23. 7. 1986, p. 1.

(5) OJ No L 109, 26. 4. 1986, p. 23.

(6) OJ No C 185, 22. 7. 1989, p. 1.

ANNEX I

HARMONIZED CASE DATA RECORD SHEET (to be completed in so far as the data are available, at the time of consultation or at a later stage, provided this is compatible with national laws and policies) (1)

>TABLE>

>TABLE>

14.2. Place of treatment Treatment at home or at place of poisoning, not by physician O Treatment outside hospital by a physician O Treatment in hospital O Other O 15.Estimated risk: Non-toxic O Probably non-toxic (low toxicity/minimal exposure) O Poisoning possible O Confirmed poisoning O Symptoms unrelated to exposure O 16.Outcome: Hospitalization O - If yes, number of days: Complete recovery O Sequelae O Death O Unknown O Signature: .................................................... (1) The headings of particular relevance for the purpose of prevention are marked by a double asterisk.

(2) yymmdd = abbreviation corresponding to year/month/day.

(3) hhmm = abbreviation corresponding to hour/minute.

ANNEX II

LAYOUT OF THE HARMONIZED ANNUAL REPORTS (1)

1. Identification of the body drafting the report Name; full address (indicating country); telephone, telex and fax numbers (if any); name of person in charge of centre. 2.Year The year covered by the annual report in question. 3.Administrative information on the centre Description of staff at centre (medical and administrative personnel); a brief description of the centre's work; the size of the population served. ** 4.Calls to the centre The total number of calls, their monthly variation, their distribution according to the person making the enquiry, the way in which the call is made (telephone, letter, etc.), the reasons (actual or presumed poisoning, simple request for information, etc.). ** 5.Poisoning cases - the number of cases and the frequency should be indicated for each category or sub-category, -if the centre has the necessary resources, it would be desirable to break down the data in terms of the classes of aetiological agents listed below. 5.1. Cases involving human beings - males, females (including pregnant women, nursing mothers), unspecified -age groups (in years): < 1 >TABLE>

- Aetiological agents: - non-pharmaceutical chemical substances (simple or compound, natural or synthetic): - industrial -pesticides -household products -cosmetics and personal hygiene products -drugs which may lead to dependence -others -pharmaceutical substances (human or veterinary) -animals as such (whether by their venom or through consumption of poisonous meat - e.g. ichthyosarcotoxism - where chemical products, bacteria or putrefaction are not the cause) -plants as such (including poisonous mushrooms and plants which may lead to dependence) -others (including toxins of bacterial origin, e.g. botulism) -not identified - Location: Home and surroundings O Workplace: Factory/workshop O Laboratory O Agriculture/horticulture O Other O Community: Nursery or primary school O Other school, university, educational establishment O Hospital, clinic, nursing home O Institution: prison, military, etc. O Other O Enclosed public places (e.g.: bars, discotheques, restaurants, shopping centres, department stores, etc.) Open places (e.g.: sports grounds, children's playgrounds, etc.) Other Unknown - Circumstances: >TABLE>

** 5. 5.1. - (d) Unknown O - Estimated risk: Non-toxic O Probably non-toxic (low toxicity/minimal exposure) O Poisoning possible O Confirmed poisoning O Symptoms unrelated to exposure O -Treatment: -none -symptomatic only -specific (antidote therapy) -elimination of the toxic substance -Outcome -complete recovery -hospitalization (number of days) -sequelae -death -unknown 5.2.Animals ** 6.Record of poisoning cases Draw up a list of the 15 most frequent causes of poisoning in decreasing order of frequency (indicating the number of calls) with a breakdown by age group, if the centre has the necessary resources. 7.Record of requests for information Draw up a list of the 15 reasons for which most requests for information are received. 8.Record of toxicological analyses Draw up a list of the 15 toxicological analyses which are most frequently requested by the centre. 9.Comments in free text On all treatment given and information provided; on particularly interesting cases which may have been encountered, on other activities (teaching, research, etc.) and on any other aspect not included elsewhere. 10.Conclusions These are to deal mainly with the impact of the centre's activities on prevention. (1) The headings of particular relevance for the purpose of prevention are marked by a double asterisk.

ANNEX III

INDICATIVE LIST OF ANTIDOTES

A. SPECIFIC ANTIDOTES >TABLE>

B. AGENTS TO PREVENT ABSORPTION OF TOXIC SUBSTANCES IN THE GASTROINTESTINAL TRACT>TABLE>

C. AGENTS TO PREVENT ABSORPTION AND/OR DAMAGE ON THE SKIN>TABLE>

D. EMETICS >TABLE POSITION>

E. CATHARTICS AND SOLUTIONS USED FOR WHOLE GUT LAVAGE >TABLE>

F. AGENTS TO MODIFY URINARY pH >TABLE>