CELEX: 51989PC0505
Language: en
Date: 1989-10-23
Title: DRAFT COUNCIL RESOLUTION ON IMPROVING THE PREVENTION AND TREATMENT OF ACUTE HUMAN POISONING

No C 294/10                            Official Journal of the European Communities                                   22. 11. 89
                                                               II
                                                       (Preparatory Acts)
                                                 COMMISSION
               Proposal for a Council resolution on improving the prevention and treatment of acute human
                                                           poisoning
                                                      COM(89) 505 final
                                     (Submitted by the Commission on 25 October 1989)
                                                        (89/C 294/08)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                           exchange of experience and information in the field of
                                                                   clinical toxicology;
Having regard to the Treaty establishing the European
Economic Community,                                                Whereas harmonized annual reports will also be of value
                                                                   in the context of the Council Decision of 22 April 1986
                                                                   (86/138/EEC) (2) concerning a demonstration project
Having regard to the draft resolution submitted by the             with a view to introducing a Community system of infor-
Commission,                                                        mation on accidents involving consumer products, which
                                                                   stipulates in Annex I (sub-section 2, paragraph 3) that
                                                                   additional information may be obtained from poison
Having regard       to   the  opinion   of   the  European         centres to supplement the basic information obtained
Parliament,                                                        from the casualty departments of hospitals;
Having regard to the opinion of the Economic and                   Whereas, in the context of the free movement of persons
Social Committee,                                                  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
Whereas, for a policy aimed at preventing the risks of             Member States;
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                Whereas this resolution should help to develop the use of
Community level;                                                   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, of
Whereas each poison centre in the Community, by virtue             workers exposed to dangerous substances liable to cause
of its informational, therapeutic and analytical functions,        acute poisoning:
is one of the bodies in the best position to collect clinical
toxicology data in its geographical area of activity and to
process this information;                                                                          I
                                                                   EXPRESSES THE POLITICAL WILL to take the necessary
Whereas     a harmonization of the procedures for                  steps to improve the prevention and treatment of acute
collecting  clinical toxicology data for all the poison            human poisoning;
centres in   the Community would facilitate the devel-
opment of    a policy for toxic risk prevention;
                                                                                                  II
Whereas, by fostering the integration of clinical and              INVITES THE MEMBER STATES:
analytical data, the Community wishes to achieve one of
the main objectives of its programme of action on toxi-            — to designate a competent authority so that it may
cology for health protection ('), namely to help ensure                take the necessary measures to ensure that the
the quality and comparability of data and encourage the                collection of call data and the annual reports on the
O OJ No C 184, 23. 7. 1986, p. 1.                                  O OJ No L 109, 26. 4. 1986, p. 23.
 ---pagebreak--- 22. 11. 89                             Official Journal of the European Communities                           No C 294/11
    work of the poison centres and the associated toxi-              This summary will deal in particular with records of
    cology services operating in the territory of the                poisoning, with a note on the measures taken or
    Member State concerned are based on the indications              planned by the competent authority to improve the
    set out in Annexes 1 and 2;                                      prevention of acute poisoning,, and shall be
                                                                     forwarded to the Commission before 31 March of
— to ensure that antidotes, i.e. the substances and prep-
                                                                     the following year, together with a list of the poison
    arations used specifically in cases of acute poisoning,
                                                                     centres operating on their territory showing the areas
    are available on the territory of the Member State
                                                                     which they cover, and the list of available antidotes.
    concerned;
                                                                     The Commission may, where necessary, arrange for
— to increase the practical scope for using antidotes on             all or part of the harmonized annual reports to be
   the territory of the Member State concerned by                    forwarded to it;
   requiring the competent authority to prepare and
   distribute a list, based on Annex 3, of available
   antidotes for treating acute poisoning cases and of                                       III
   sources of supply, so that the recipients have at their
                                                                 INVITES THE COMMISSION to arrange for regular
   disposal the information required to obtain these
                                                                 summary reports to be prepared for the Community indi-
   antidotes within the period during which they can be
                                                                 cating, in particular, the measures required at
   administered effectively;
                                                                 Community level for the prevention of acute poisoning,
   —to provide better emergency services in areas                and to expand on specific topics based on the infor-
   adjacent to other Member States by arranging for the          mation received from the Member States on the
   relevant competent authorities, in cooperation with           prevention and treatment of acute poisoning;
   the Commission, to set up between the poison centres
   a Community system of information and colla-
   boration concerning the availability of antidotes;                                       IV
— to arrange for the competent authority to produce a            AGREES to review the provisions of this Resolution
   summary of the harmonized annual reports of the               within a maximum period of five years following its
   poison centres and the associated toxicology services.        adoption, on the basis of a report from the Commission.
 ---pagebreak--- N o C 294/12                             Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                22. 11. 89
                                                                   ANNEX     1
                                                  Harmonized case data record sheet
             1. Centre code:
            2. Call registration number:
                                                                                                                Recall: ( )
            3. 3.1. Date (mmdd):
                3.2. Time (hhmm):
            4. 4.1. Enquirer:
                     Name: ....
                     Address:
                     Tel. number:
                4.2. Type of enquirer:
                     4.2.1. Hospital:
                            Accident and Emergency (Casualty) (         )
                            General Medical ( )
                            Intensive Care ( )
                            Paediatric ( )
                            Other ( )
                            Unknown ( )
                            Other Poisons Centres ( )
                     4.2.2. Outside hospital:
                            Physicians ( )
                            Nurses ( )
                            Pharmacists ( )
                            Veterinary surgeons ( )
                            Occupational health services (       )
                            Industry/manufacturers ( )
                            Emergency Services ( )
                            General Public ( )
                            Mass Media ( )
                            Authorities ( )
                            Others ( )
                            Unknown ( )
            5. Type of enquiry:
                Call related to a case (  )      Information only (      )       Other (    )       Unknown ( )
            6. Patient:
                6.1. Multiple cases: Yes; Number:
 ---pagebreak--- 22. 11. 89                            Official J o u r n a l of the E u r o p e a n Communities                                N o C 294/13
              6.2. Human: Name:
                   6.2.1. Age (yymmdd):                                                                      ; if estimated (  )
                          Unknown Child (      )       Unknown Adult (         )     Unknown (    )
                   6.2.2. Sex: Male (    )     Female (      )
                   6.2.3. Weight (kg):                                                                      , if estimated (   )
                   6.2.4. Pregnant: Duration (weeks):
                   6.2.5. Lactating: yes (  )
              6.3. Animal species:
           7. Agents:                                                                     Classification of product
                                                                                  Annual Report         Poisons Centre
              7.1. Name (given by caller):
                   Composition of product:
                   Manufacturer (if relevant):
                   Quantity:
                   — No:                       Vol.:                        Wt.:                           , if estimated (    )
                   — Unknown (       )
                   Exposure:
                   — Acute (     )      Chronic (   )
                   Frequency:
                   — Single (    )      Repeated (     )
              7.2. Name (given by caller):
                   Composition of product:
                   Manufacturer (if relevant):
                   Quantity:
                   — No:                       Vol.:                        Wt.:                            , if estimated (   )
                   — Unknown (       )
                   Exposure:
                   — Acute (     )      Chronic (    )
                   Frequency:
                   — Single (     )     Repeated (     )
              7.3. Name (given by caller):
                   Composition of product:
                   Manufacturer (if relevant):
                   Quantity:
                   — No:                        Vol.:                        Wt.:                             , if estimated (  )
                   — Unknown (        )
                    Exposure:
                   — Acute (      )     Chronic (    )
                    Frequency:
                   — Single (      )     Repeated (     )
 ---pagebreak--- N o C 294/14                              Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s                          22. 1 1 . 89
                                                                                                Classification of product
                                                                                      Annual Report           Poisons Centre
                7.4. Name (given by caller):
                     Composition of product:
                     Manufacturer (if relevant):
                     Quantity:
                     — No:                        Vol.:                         Wt.:                              , if estimated (   )
                     — Unknown (        )
                     Exposure:
                     — Acute (    )       Chronic (     )
                     Frequency:
                     — Single (   )        Repeated (      )
                7.5. Name (given by caller):
                     Composition of product:
                     Manufacturer (if relevant): '.
                     Quantity:
                     — No:                        Vol.:                         Wt.:                              , if estimated (   )
                     — Unknown (        )
                     Exposure:
                     — Acute (    )       Chronic (     )
                     Frequency:
                     — Single (    )       Repeated (      )
                7.6. Time since exposure:                                                                                   (ddhhmm)
             8. Location:
                8.1. Home and surroundings (         )
                8.2. Workplace:
                     — Factory/workshop (         )       Laboratory (    )        Agriculture/horticulture (     )
                     — Other (    )
                8.3. Community:
                         Nursery or        primary school ( )             Other school,          university,    educational     estab-
                         lishment ( )         Hospital, clinic, nursing home ( )
                     — Institution: prison, military, etc. (        )   Other (        )
                8.4. Enclosed public spaces (      )
                8.5. Open places (    )
                8.6. Other (   )
                8.7. Unknown (      )
 ---pagebreak--- 22. 11. 89                                    Official Journal of the European Communities No C 294/15
            9. Circumstances:
               9.1. Accidental/Unintentional
                    — General ( )
                    — Occupational ( )
                    — Environmental ( )
                    — Transport Accident ( )
                    — Fire ( )
                    — Therapeutic error ( )
                    — Misuse ( )
                    — Other ( )
                    — Unknown ( )
               9.2. Intentional
                    — Suicide ( )
                    — Misuse ( )
                    — Abuse ( )
                    — Malicious/criminal (            )
                    — Other ( )
                    — Unknown ( )
               9.3. Adverse reaction:
                    — Drug ( )
                    — Food ( )
                    — Other ( )
               9.4. Unknown (          )
           10. Route of exposure:
               10.1.   Ingestion (       )
               10.2.   Inhalation (        )
               10.3.   Cutaneous (          )
               10.4.   Eye contact (          )
               10.5.   Bite (    )
               10.6.   Sting (     )
               10.7.    Injection:
                       —    Subcutaneous ( )
                       —    Intramuscular ( )
                       —    Intravenous ( )
                       —    Intra-arterial ( )
               10.8.   Mucosal:
                       — Buccal ( )
                       — Nasal ( )
                       — Rectal ( )
                       — Vaginal ( )
               10.9.   Placental (       )
                10.10. Other (       )
                10.11. Unknown (           )
 ---pagebreak--- N o C 294/16                           Official J o u r n a l of the E u r o p e a n Communities                   22. 11. 89
           11. Signs and symptoms:
               11.1. Signs and symptoms present
               11.2. Signs and symptoms not present
               11.3. Unknown
               Poisons Centre free text:
               Poisons Centre local symptom code: ...
           12. Toxicological analysis:
               yes (   )
           13. Other investigations:
               yes (  )
           14. Treatment:                                                          Treatment carried     Treatment
                                                                                  out before enquiry   recommended
                                                                                                          by PC
               14.1. None                                                                ( )               ( )
                     Prevention of absorption:
                     — Gastric emptying                                                  (  )              (   )
                     — Emesis                                                            (  )              (   )
                     — Lavage                                                            (  )              (   )
                     — Activated charcoal                                                (  )              (   )
                     Symptomatic treatment                                               (  )              (   )
                     Elimination                                                         (  )              (   )
                     Life support procedures                                             (  )              (   )
                     Antidote therapy                                                    (  )              (   )
                     Other                                                               (  )              (   )
               14.2. Place of treatment:
                     — Treatment at home or at place of incident, not by physician (             )
                     — Treatment outside hospital by a physician (           )
                     — Treatment in hospital (      )         Other (  )
           15. Estimated risk: non-toxic (    )
               — Probably non-toxic (low toxicity/minimal exposure) (               )
               — Poisoning not excluded (       )      Predictable risk (      )
               — Symptoms unrelated to exposure (            )
           16. Outcome:
               Complete recovery (     )     sequelae (        )   death (     )      unknown (      )
           Signature:
 ---pagebreak--- 22. 11. 89                             Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s            N o C 294/17
                                                                ANNEX      2
                                  LAYOUT OF T H E HARMONIZED ANNUAL REPORTS
           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 request, 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
                       —    1-4
                       —    5-9
                       —    10-14
                       —    15-19
                       —    20-69
                       —    > 70
                       —    unknown
                   — Aetiological agents:
                       — non-pharmaceutical chemical substances (simple or compound, natural or synthetic):
                           — industrial
                           — pesticides
                           — household products
                           — 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 hallucinogenic or poisonous mushrooms)
                       — others (including toxins of bacterial origin, e.g. botulism)
                       — not identified
                    — Location:
                       — home and immediate surroundings
                       — workplace:
                           — industry
                           — agriculture/horticulture
                            — other
 ---pagebreak--- N o C 294/18                            Official J o u r n a l of the E u r o p e a n C o m m u n i t i e s          22. 11. 89
                        — public establishments (e.g. schools or training centres, government offices, post offices,
                           libraries, public transport — trains, buses, underground railways, etc.)
                        — enclosed public places (e.g. bars, discotheques, restaurants, shopping centres, department
                           stores, etc.)
                        — open places (e.g. sports grounds, children's playgrounds, etc.)
                        — other or unknown
                    — Circumstances:
                        — accidental acute poisoning
                        — deliberate acute poisoning
                        — side effect of drugs
                        — accidental chronic poisoning
                        — deliberate chronic poisoning
                        — other or unknown
                    — Initial evaluation:
                        — non-toxic
                        — probably non-toxic
                        — poisoning not excluded
                        — predictable risk
                        — established poisoning
                        — symptoms unrelated to the exposure
                    — Treatment:
                        — none
                        — symptomatic only
                        — specific (antidote therapy)
                    — Outcome:
                        — complete recovery
                        — hospitalization (number of days)
                        — sequelae
                        — death
                        — unknown
               5.2. Animals
            6. Record of poisoning cases
               Drawn up a list of the 15 most frequent causes of poisoning in decreasing order of frequency (indi-
               cating the number of calls), with a breakdown by age group.
            7. Record of requests for information
               Draw up a list of the 15 products 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.
 ---pagebreak--- 22. 11. 89                             Official Journal of the European Communities                          No C 294/19
                                                               ANNEX 3
                                               INDICATIVE LIST OF ANTIDOTES
           I. Specific antidotes
                                                                                       Availability in terms
                             Antidote                                 Main indications of urgency of use in
                                                                                             treatment
              Acetylcysteine                           Paracetamol                               B
                                                       Chloroform                                B
                                                       Carbon tetrachloride                      B
                                                       Acrylonitrile                             B
              Amyl nitrite                              Cyanide                                  A
              Antivenins and                                                                    A-C
              antoxins
              Atropine                                  Cholinergic syndrome                     A
              Benzylpenicillin                          Amatoxins                                 B
              Calcium gluconate                         Hydrofluoric acid                        A
                                                        Fluorides                                A
                                                        Oxalates                                 A
              Calcium sodium edetate                    Lead                                      B
              (EDTA)
              Dantrolene                                Malignant Hyperthermia                    A
                                                        Malignant Neuroleptic Syndrome           A
              Deferoxamine                              Iron                                      B
                                                        Aluminium                                 B
              Diazepam                                  Seizures                                  A
                                                        Chloroquine                               A
              Dicobalt Edetate                          Cyanide                                   A
              Digoxin specific antibody                 Digoxin                                   B
              fragments                                 Digitoxin                                 B
              (FAB)                                     Digitalis Glucosides                      B
              Dimercaprol (BAL)                         Arsenic                                   B
                                                        Gold, inorganic mercury                   B
                                                        Lead encephalopathy                       B
              4-Dimethylaminophenol                     Cyanide                                   A
               (4-DMAP)
               Diphenhydramine                          Drug-induced dystonias                    A
               Ethanol                                   Methanol                                 A
                                                         Ethylene glycol                          A
               A: required to be immediately available (within 30 minutes);
               B: required to be available within two hours;
               C: required to be available within six hours.
 ---pagebreak--- No C 294/20                           Official Journal of the European Communities                           22. 11. 89
                                                                                       Availability in terms
                           Antidote                                 Main indications   of urgency of use in
                                                                                             treatment
            Etybenzatropine                          Drug-induced dystonias                      A
            Flumazenil                               Benzodiazepines                             B
            Folinic Acid                             Folic Acid Antagonists                      A
            Glucagon                                 -blockers                                   A
            Hydroxocobalamin                         Cyanide                                     A
            (Vit. B 12 a)
            Methionine                               Paracetamol                                 B
            4-Methylpyrazole                         Ethylene glycol                             A
                                                     Methanol                                    A
            Methylthioninium chloride                Methaemoglobinaemia                         A
            (Methylene blue)
            N-Acetyl penicillamine                   Mercury (organic and                        C
                                                               metallic)
            Naloxone                                 Opiates                                     A
            Neostigmine                              Neuromuscular block (curare type)           A
                                                     Peripheral anticholinergic
                                                     poisoning                                   A
            Oximes                                   Organophosphates                            B
            Oxygen                                   Carbon monoxide                             A
                                                     Cyanide                                     A
                                                     Hydrogen sulphide                           A
            Oxygen hyperbaric                        Carbon monoxide                             C
                                                     Cyanide                                     C
                                                     Hydrogen sulphide                           c
                                                     Carbon tetrachloride                        c
            D-Penicillamine                          Copper                                      c
                                                     Gold, Lead, Mercury                         c
                                                     (elemental) Zinc                            c
            Pentetic Acid (DTPA)                     Plutonium, actinides                        A
            (Diethylenetriamine pentaacetic
            acid)
            Phentolamine                             Alpha-adrenergic poisoning                  A
            A: required to be immediately available (within 30 minutes);
            B: required to be available within two hours;
            C: required to be available within six hours.
 ---pagebreak--- 22. 11. 89                          Official Journal of the European Communities                                  No C 294/21
                                                                                            Availability in terms
                          Antidote                                Main indications          of urgency of use in
                                                                                                  treatment
           Physostigmine                            Central anticholinergic syndrome from
                                                    — atropine and derivatives                        A
                                                    — other drugs                                     A
           Phytomenadione (Vit. Ki)                 Coumarin and indanedione anticoagulants           B
           Potassium ferric hexacya-                Thallium                                          B
           noferrate (Prussian Blue)
           Prenalterol                              -blockers                                         A
           Protamine sulphate                       Heparin                                           A
           Pyridoxine (Vit. B6)                     Isoniazid                                         A
                                                    Crimidine                                         B
                                                    Ethylene glycol                                   B
                                                    Gyromitrin                                        B
                                                    Hydrazines                                        B
           Silibinin                                Amatoxins                                         B
           Sodium nitrite                           Cyanide                                           A
           Sodium thiosulphate                      Cyanide                                           A
           Succimer (DMSA) (2,3 Dimer-              Lead                                               B
           caprol succinic acid                     Mercury (inorganic and organic)                    B
                                                    Arsenic                                            B
           Tolonium Chloride                        Methaemoglobinaemia                               A
           (Toluidine blue)
           Trientine                                Copper                                             B
           (Triethylene tetramine)
           Unitiol (DMPS)                           Mercury (methyl- and inorganic)                    B
           (2,3-Dimercapto-1 -propane-
           sulphonic acid)                          Lead                                               B
           A: required to be immediately available (within 30 minutes);
           B: required to be available within two hours;
           C: required to be available within six hours.
 ---pagebreak--- N o C 294/22                              Official Journal of the European Communities                                22. 11. 89
            II. Agents to prevent absorption of toxic substances in the gastro-intestinal tract
                                                                                                Availability in terms
                               Antidote                                 Main indications        of urgency of use in
                                                                                                      treatment
                Activated charcoal                       (for most poisonings)                            A
                Cholestyramine                           Digitalis, Coumarin, Chlordecone                 B
                Fullers Earth                            Paraquat, Diquat                                 A
                Potassium ferrocyanide                   Copper                                           A
                Sodium bicarbonate                       Iron                                             A
                                                         Organophosphates                                 A
                Sodium sulphate                          Barium                                           A
                Starch                                   Iodine                                           A
           III. Agents to prevent absorption and/or damage on the skin
                                                                                                Availability in terms
                               Antidote                                Main indications         of urgency of use in
                                                                                                      treatment
                Calcium gluconate gel                    Hydrofluoric acid                                A
                Macrogol 400 (PEG)                       Phenol                                           A
                Copper sulphate, sodium bicar-           White Phosphorus                                 A
                bonate, hydroxyethylcellulose
           IV. Emetics
                                                                                                Availability in terms
                               Antidote                                Main indications         of urgency of use in
                                                                                                      treatment
                Apomorphine                                                                               A
                Ipecacuanha                                                                               A
                A: required to be immediately available (within 30 minutes);
                B: required to be available within two hours;
                C: required to be available within six hours.
 ---pagebreak--- 22. 11. 89                               Official Journal of the European Communities                        N o C 294/23
           V. Cathartics and solutions used for whole gut lavage
                                                                                       Availability in terms
                              Antidote                                Main indications of urgency of use in
                                                                                             treatment
               Magnesium citrate                                                                 B
               Magnesium sulphate                                                                B
               Mannitol                                                                          B
               Sodium sulphate                                                                   B
               Sorbitol                                                                          B
               Whole gut lavage fluids                                                           B
               (Polyethylene glycol electrolyte
               lavage solution)
           VI. Agents to modify urinary pH
                                                                                       Availability in terms
                               Antidote                               Main indications of urgency of use in
                                                                                             treatment
               Ammonium chloride                                                                  B
               Arginine hydrochloride                                                             B
               Hydrochloric acid (0.1 N)                                                          B
               Sodium bicarbonate                                                                 A
               A: required to be immediately available (within 30 minutes);
                B: required to be available within two hours;
                C: required to be available within six hours.