Child poisoning study Project Team

1. Toxicological criteria for child-resistant packaging for pharmaceuticals Part 1Accident Case DataDr Glyn Volans

2. Guy’s & St Thomas’ NHS Foundation Trust, London, UK Medical Toxicology Unit Bara V, Bates N, Edwards N, Volans G,Wiseman H. Pharmacy Tomlin S Child poisoning study Project Team

3. European Standard For unit, strip or blister packages limits access to no more than 8 dose units does not take toxicity into account Non-reclosable child-resistant packaging for pharmaceuticals

4. To use accident data to identify selected pharmaceuticals that are particularly hazardous to children To review quality and quantity of toxicity data in case reports from publications surveillance systems Child poisoning studyAims

5. To assess the hazard to children from maximum 8 dose units To suggest how to use toxicity data as criterion for deciding appropriate child-resistant packaging for drugs Child poisoning studyAims

6. For 13 drugs Accidental ingestions Age: 0-5 years Dose, clinical effects, outcome Not multiple ingestions or liquids or drugs given by someone else Sources Literature Poisons centre case reports London AAPCC 1983-2000 Child poisoning studyMethods (1)

7. For each case we graded toxicity using the Poisons Severity Score (Persson et al. 1998, Clin Toxicol, 36,205-213 ) For each drug we reviewed doses associated with each grade of severity Child poisoning studyMethods (2)

8. Facilitates comparison of cases Lists symptoms and signs associated with each grade Grades of severity of poisoning 0 No signs of poisoning 1 minor symptoms, resolving spontaneously 2. Moderate, pronounced prolonged symptoms 3. Severe, life threatening symptoms 4. Death Persson et al 1966 Poisoning Severity Score(EAPCC / IPCS / EC)

9. Child poisoning studyDrugs reviewed

10. Few cases fulfilled the case criteria Severe or fatal cases: Only 10-20 were found for each of impramine, dothiepin, Lomotil, quinine Less than 10 each for the other drugs a wide dose range for each grade of poisoning Child poisoning study Results

11. Child poisoning studyDrugs reviewed

12. Toxic doses in childrennumbers of highest dose units

13. Child poisoning studySevere toxicity from doses equivalent to < 8 units

14. Case reports dose estimates often missing or unreliable child age and weight often missing or unreliable toxic dose data few serious cases few cases for children of same age and weight Child poisoning studyConclusions

15. From a survey of case reports of poisoning with selected drugs : Estimating toxic dose is difficult Nevertheless evidence shows: Pharmaceuticals may cause severe toxicity to children in doses equivalent to less than 8 units Child poisoning studyPart 1Conclusions

16. Packaging allowing access to 8 dose units will not always protect children from severe poisoning. Child poisoning study Conclusions

17. Need to compare case data with evidence from clinical trials and therapeutic data Steve Tomlin’s presentation Can more be done to improve the quality of childhood accident data for pharmaceuticals? Child poisoning study Discussion

18. Collect targeted case data new molecules non prescription switches generics paediatric formulations all severe toxic exposures Improve/standardise European data Report centrally as for ADR’s to WHO Uppsala Improve staff training, audit and research Proposals for improvements & developments

19. This study was commissioned by ANEC European Association for Coordination of Consumer Representation in Standardisation ANEC Project Advisor Dr Franz Fiala Acknowledgement