packaging of medicines and children safety accident data from belgium dr martine mostin
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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
Availability of product
Perceived risk (hypnotics, thyroid hormones, contraceptives …)
Need for information ( medical professionnals) : new drugs
Calls reflect exposure rather than poisoning
CHILDRENAGE GROUPS
1- 4 y68% <1y
9%
?12%
5-9 y11%
CHILDRENAGENT TYPES
Pesticides4%
Cosmetics8%
Animals1%
Misc4%
Plants/mush,10%
Pharmaceutic.38%
Food3%
Household32%
ACCIDENT DATA 2003
Children exposure (0-14 y): 19.872 calls Pharmaceutical exposure: 6.808 calls Pharmaceutical exposure 1- 5 y: 4.836
calls
DRUG CATEGORIES Children 1- 5 y
ANALGESICS14%
RESP.DIS. 18%
CNS AGENTS15%
EXTERN.USE 17%
FOOD SUPPL.3%
OTHER1%
UNCLASSIF 1%
VITAMINS,MIN.2%
HORMONES10%
CARDIOVASC.5%
GASTRO-INTEST.6%
ANTIINFECT.2%
GENITO-URINARY<1%
ACCIDENT DATA 2003
• Child 1- 5 year
• Pharmaceutical exposure
Referred to hospital by PCOR
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
DRUG CATEGORIESCHILD 1- 5 HOSPITAL
ANALGESICS11%
RESP.DIS. 18%
CNS AGENTS24%
EXTERN.USE 17%
FOOD SUPPL.1%
OTHER2%
UNCLASSIF%
VITAMINS,MIN.2%
HORMONES5%
CARDIOVASC.8%
GASTRO-INTEST.8%
ANTIINFECT.2%
GENITO-URINARY1%
CNS AGENTS
Neuroleptics12% Anticholinest
1%
Antimigraine 1%
Stim,anorex3%
Anticonvuls;7%
Antiparkin.3%
Antihistamin. 10%
Antidepres,18%
Hypnot, Sedatives
45%
HYPNOTICS and SEDATIVES
Zopiclone, Zolpidem
4%
Other3%
Benzodiaz93%
HYPNOTICS
SEDATIVES
Total(1-5 y)
Hosp H/T
Benzodiaz. 274 136 50%
Zopiclone, Zolpidem
34 13 38%
Barbiturates 3 2 67%
Hydroxyzine 3 1 33%
Clomethiazole 2 2 100%
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
Trazodone18%
Other 11%
Lithium 3%
Tricyclic and related34%
SSRI34%
ANTIDEPRESSANTS Total(1-5 y)
Hosp H/T
SSRI 55 25 45%
Tricyclics 27 23 85%
Trazodone 20 15 75%
Venlafaxine 5 3 60%
Lithium 4 2 50%
Mirtazapine 4 3 75%
Reboxetine 3 2 67%
ANTIDEPRESSANTSTricyclic Antidepressants
All <8 tablets (19) or unknown (4)
Less 8 tablets = significant exposureCardiovascular 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 y1-2 x 100mg, 19 month : somnolence,
ataxia, hypotonia, bradypnea, bradycardia
ANTIDEPRESSANTS Trazodone
Less 8 tablets = significant exposure
Life threatening poisoning not expected
NEUROLEPTICS
Olanzapine9%
Butyrophen,14%
Other11%
Phenothiazine43%
Risperidone24%
NEUROLEPTICS Total(1-5 y)
Hosp H/T
Phenothiazines 20 19 95%
Risperidone 14 12 86%
Buyrophenone 12 6 50%
Olanzapine 5 4 80%
Other 10 6 60%
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 overdosageCNS depression/ cardiovascular
symptoms /extrapyramidal effects
OLANZAPINE
Symptoms reported with 10 mg
5 -7,5 -10 mg tablets
CNS depression, tachycardia, hpotension, extrapyramidal syndrome
DRUG CATEGORIESCHILD 1- 5 HOSPITAL
ANALGESICS11%
RESP.DIS. 18%
CNS AGENTS24%
EXTERN.USE 17%
FOOD SUPPL.1%
OTHER2%
UNCLASSIF%
VITAMINS,MIN.2%
HORMONES5%
CARDIOVASC.8%
GASTRO-INTEST.8%
ANTIINFECT.2%
GENITO-URINARY1%
DRUGS EXTERNAL USE
Ethanol based antiseptics
Hydrogen peroxide
Quaternary ammonium antiseptics
Keratolytic preparations
Pediculosis & scabies treatment
….
DRUG CATEGORIESCHILD 1- 5 HOSPITAL
ANALGESICS11%
RESP.DIS. 18%
CNS AGENTS24%
EXTERN.USE 17%
FOOD SUPPL.1%
OTHER2%
UNCLASSIF%
VITAMINS,MIN.2%
HORMONES5%
CARDIOVASC.8%
GASTRO-INTEST.8%
ANTIINFECT.2%
GENITO-URINARY1%
ANALGESICS
ANTIPYRETICSANTIINFLAMMATORY
Total(1-5 y)
Hosp H/T
NSAID 375 65 17%
PARACETAMOL 173 47 27%
ASSOCIATIONS 45 7 16%
SALICYLATES 43 14 33%
NARCOTIC ANALG. 40 33 83%
DRUG USED GOUT 8 4 50%
PYRAZOLON 7 4 57%
MISCELLANEOUS 4 2 50%
NARCOTIC ANALGESICS
Dextropropoxyphene : 150 mg tablettoxic: 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
DRUG CATEGORIESCHILD 1- 5 HOSPITAL
ANALGESICS11%
RESP.DIS. 18%
CNS AGENTS24%
EXTERN.USE 17%
FOOD SUPPL.1%
OTHER2%
UNCLASSIF%
VITAMINS,MIN.2%
HORMONES5%
CARDIOVASC.8%
GASTRO-INTEST.8%
ANTIINFECT.2%
GENITO-URINARY1%
DRUGS RESPIR. DISEASE
Total(1-5 y)
Hosp H/T
Antitussives 423 136 32%
Drug used in bronchospasm
223 54 24%
Drugs rhinitis, sinusitis 237 82 35%
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