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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 Accident data from Belgium Dr Martine MOSTIN
NATIONAL POISON CENTRE • ~ 50.000 calls year • 75% calls from public • 80% accidental exposure • 50% children
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
ACCIDENT DATA 2003 • Children exposure (0-14 y): 19.872 calls • Pharmaceutical exposure: 6.808 calls • Pharmaceutical exposure 1- 5 y: 4.836 calls
ACCIDENT DATA 2003 • Child 1- 5 year • Pharmaceutical exposure Referred to hospital by PC OR Call received from hospital
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
ACCIDENT DATA 2003 • One death • 3 y old • Therapeutic error • Percutaneous administration of monochloroacetic acid
HYPNOTICS and SEDATIVES Benzodiazepines • Liquid forms : 2% • < 8 tablets : 60% >8 tablets : 8% Unspecified : 30 %
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
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
HYPNOTICS and SEDATIVES Clomethiazole • 192 mg tablets • Limited data on overdosage in children • 1 –2 tablets = significant exposure • Symptoms : • coma, risk cardiorespiratory arrest
ANTIDEPRESSANTSTricyclic Antidepressants • All <8 tablets (19) or unknown (4) • Less 8 tablets = significant exposure • Cardiovascular toxicity, convulsions • Life threatening intoxication possible • medical attention mandatory !!
ANTIDEPRESSANTS SSRI • Wider safety margin than T3AD • Symptoms : • Hyperthermia, agitation, hallucinations, convulsions • Less 8 tablets = significant exposure • Life threatening poisoning not expected
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
ANTIDEPRESSANTS Trazodone • Less 8 tablets = significant exposure • Life threatening poisoning not expected
PHENOTHIAZINES • All <8 tablets or unknown • CNS depression, dysrythmia, hypotension • Medical attention almost needed
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
OLANZAPINE • Symptoms reported with 10 mg • 5 -7,5 -10 mg tablets • CNS depression, tachycardia, hpotension, extrapyramidal syndrome
DRUGS EXTERNAL USE • Ethanol based antiseptics • Hydrogen peroxide • Quaternary ammonium antiseptics • Keratolytic preparations • Pediculosis & scabies treatment • ….
NARCOTIC ANALGESICS • Dextropropoxyphene : 150 mg tablet • toxic: 10mg /kg • lethal: 20mg/kg • Coma, respiratory depression, arrythmia, cardiac arrest
NARCOTIC ANALGESICS • Methadone • Lethal ~10 mg child • Syrup • 50 -100 mg tablets • Underestimation danger by addicts
MEDICAL ATTENTION • Narrow safety margin • (chloroquine, buflomedil, dextropropoxyphene…) • Life threatening symptoms reported in overdose • Safety in children not established • Limited data on overdosage
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