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

NATIONAL POISON CENTRE ~ calls year 75% calls from public 80% accidental exposure 50% children

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

ACCIDENT DATA 2003 Children exposure (0-14 y): calls Pharmaceutical exposure: calls Pharmaceutical exposure 1- 5 y: calls

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

ACCIDENT DATA 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 SEDATIVES Total (1-5 y) HospH/T Benzodiaz % Zopiclone, Zolpidem % Barbiturates3267% Hydroxyzine3133% Clomethiazole22100%

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

ANTIDEPRESSANTS Total (1-5 y) HospH/T SSRI552545% Tricyclics272385% Trazodone201575% Venlafaxine5360% Lithium4250% Mirtazapine4375% Reboxetine3267%

ANTIDEPRESSANTS Tricyclic 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

NEUROLEPTICSTotal (1-5 y) HospH/T Phenothiazines201995% Risperidone141286% Buyrophenone12650% Olanzapine5480% Other10660%

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

RISPERIDONE Liquid formulation (30 mg & 100 mg) tablets 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 ….

ANALGESICS ANTIPYRETICS ANTIINFLAMMATORY Total (1-5 y) HospH/T NSAID % PARACETAMOL % ASSOCIATIONS45716% SALICYLATES431433% NARCOTIC ANALG % DRUG USED GOUT8450% PYRAZOLON7457% MISCELLANEOUS4250%

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 mg tablets Underestimation danger by addicts

DRUGS RESPIR. DISEASE Total (1-5 y) HospH/T Antitussives % Drug used in bronchospasm % Drugs rhinitis, sinusitis %

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