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PACKAGING  OF MEDICINES AND CHILDREN SAFETY

Explore the impact of packaging on children's safety in pharmaceutical exposure based on data from Belgium's National Poison Centre in 2003. Highlights accident data analysis, key findings, and recommended precautions.

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PACKAGING  OF MEDICINES AND CHILDREN SAFETY

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  1. PACKAGING  OF MEDICINES AND CHILDREN SAFETY Accident data from Belgium Dr Martine MOSTIN

  2. NATIONAL POISON CENTRE • ~ 50.000 calls year • 75% calls from public • 80% accidental exposure • 50% children

  3. NATIONAL POISON CENTRE Calls reflect exposure rather than poisoning • Availability of product • Perceived risk (hypnotics, thyroid hormones, contraceptives …) • Need for information ( medical professionnals) : new drugs

  4. ACCIDENT DATA 2003 • Children exposure (0-14 y): 19.872 calls • Pharmaceutical exposure: 6.808 calls • Pharmaceutical exposure 1- 5 y: 4.836 calls

  5. ACCIDENT DATA 2003 • Child 1- 5 year • Pharmaceutical exposure Referred to hospital by PC OR Call received from hospital

  6. ACCIDENT DATA 2003 • 1385 significant exposure (28.5%) • 1247 single drug exposure • 1293 accidents • 67 therapeutic error • 19 adverse drug reactions • 6 circonstances n.sp

  7. ACCIDENT DATA 2003 • One death • 3 y old • Therapeutic error • Percutaneous administration of monochloroacetic acid

  8. HYPNOTICS and SEDATIVES Benzodiazepines • Liquid forms : 2% • < 8 tablets : 60% >8 tablets : 8% Unspecified : 30 %

  9. HYPNOTICS EN SEDATIVES Benzodiazepines Symptoms: 46 % ataxia, vertigo, drunkeness, vomiting, agitation, sedation, coma, hypotonia • Less than 8 tablets = significant exposure Life threatening intoxication unlikely with medical attention

  10. HYPNOTICS and SEDATIVES Zopiclone - Zolpidem • No therapeutic dosage for children • 1 tablet = usual hypnotic dose adult • Less 8 tablets = significant exposure • Life threatening intoxication unlikely with medical attention

  11. HYPNOTICS and SEDATIVES Clomethiazole • 192 mg tablets • Limited data on overdosage in children • 1 –2 tablets = significant exposure • Symptoms : • coma, risk cardiorespiratory arrest

  12. ANTIDEPRESSANTSTricyclic Antidepressants • All <8 tablets (19) or unknown (4) • Less 8 tablets = significant exposure • Cardiovascular toxicity, convulsions • Life threatening intoxication possible • medical attention mandatory !!

  13. ANTIDEPRESSANTS SSRI • Wider safety margin than T3AD • Symptoms : • Hyperthermia, agitation, hallucinations, convulsions • Less 8 tablets = significant exposure • Life threatening poisoning not expected

  14. ANTIDEPRESSANTS Trazodone • All <8 tablets (8) or unknown (7) • Limited data in children • Not recommended <6 y • 1-2 x 100mg, 19 month : somnolence, ataxia, hypotonia, bradypnea, bradycardia

  15. ANTIDEPRESSANTS Trazodone • Less 8 tablets = significant exposure • Life threatening poisoning not expected

  16. PHENOTHIAZINES • All <8 tablets or unknown • CNS depression, dysrythmia, hypotension • Medical attention almost needed

  17. RISPERIDONE • Liquid formulation (30 mg & 100 mg) • tablets 1-2-3 mg • Safety in children not established • Autism: 0,5 -3mg/ day • Limited data on overdosage • CNS depression/ cardiovascular symptoms /extrapyramidal effects

  18. OLANZAPINE • Symptoms reported with 10 mg • 5 -7,5 -10 mg tablets • CNS depression, tachycardia, hpotension, extrapyramidal syndrome

  19. DRUGS EXTERNAL USE • Ethanol based antiseptics • Hydrogen peroxide • Quaternary ammonium antiseptics • Keratolytic preparations • Pediculosis & scabies treatment • ….

  20. NARCOTIC ANALGESICS • Dextropropoxyphene : 150 mg tablet • toxic: 10mg /kg • lethal: 20mg/kg • Coma, respiratory depression, arrythmia, cardiac arrest

  21. NARCOTIC ANALGESICS • Methadone • Lethal ~10 mg child • Syrup • 50 -100 mg tablets • Underestimation danger by addicts

  22. MEDICAL ATTENTION • Narrow safety margin • (chloroquine, buflomedil, dextropropoxyphene…) • Life threatening symptoms reported in overdose • Safety in children not established • Limited data on overdosage

  23. CHILDREN ACCIDENTS • Dose taken often unknown • Ingestion < 8 units common • If > 8 units frequently reported, look at drug presentation • Therapeutic error : look at drug presentation

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