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

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