Predictable and Avoidable
Date of page: Tue 21 Aug 2001 at 9:25pmRecent Child Fatality 'Predictable and Avoidable' says the Child-Safe Packaging Group
The report of the inquest into the circumstances surrounding the death of three year old Yaqoob Lookman, published in most national newspapers on Thursday August 3rd, has been described by members of the Child-Safe Packaging Group as predictable, avoidable and the result of pure negligence.
Briefly, the child swallowed 44 ferrous sulphate tablets, which he extracted from two blister packs. The Child-Safe Packaging Group had declared this type of packaging to be dangerous since its own research was published in 1995.
Blister packs for pharmaceuticals are not tested for child resistance even though a standard has existed since 1997 and this situation is tolerated and accepted by the Medicines Control Agency.
Speaking on behalf of the group Dr James Robertson, a Staff Grade Paediatrician, said 'I qualified in 1989, since when I have treated hundreds of child ingestions. In our hospital we continue to treat several a week. The ferrous sulphate tablets, which killed the little boy in Yorkshire, are extremely toxic, even in small quantities.'
'It is a fact of life that medicines are not stored in locked cupboards by parents therefore child resistant packaging is a priority line of defence.' He continued 'I am appalled that there is a standard of testing for child resistance for blister packs but pharmaceuticals are excluded. Until child resistant packaging is used for substances that could be harmful to children I regret that I will see more ingestions and there will be more fatalities.'
'Blister packs are tested for child resistance in the United States, Canada and Germany and it utterly defeats me as to why they cannot be made and tested for child resistance here.'
ENDS
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Notes for Editors
1. The standard to which Dr Robertson was referring is BS EN 862, which sets out a protocol of child panel testing for blister packs but pharmaceuticals are deliberately and specifically excluded. -
2. Pharmaceuticals and other hazardous products are packaged in either rigid or flexible containers. Rigid packaging systems, bottle and child resistant closure, are subject to testing for child resistance and have been so since 1975. They have to comply with an international standard in its most recent manifestation; ISO 8317. -
3. The flexible packs like the blister, which failed to protect Yaqoob Lookman, are not subject to any standard of testing for child resistance in this country. There are standards in the United States, in Canada and indeed in Germany. There is no UK standard and no European one that covers pharmaceuticals.
4. Presently there is a draft CEN (Comit?? Europeen De Normalisation) Standard number CEN/TC 261/SC2/WG7 that covers testing of blister packs for pharmaceuticals for child resistance. This standard is 'bogged down' in discussion and unlikely to emerge until 2002.
5. At the same time the Medicines Control Agency is actively espousing the use of Patient Packs which invariably, for solid dose medicines, are packed in non child resistant blister packs and, because they are more costly, have, during 1999, occasioned losses to the National Health Service totalling ??202M.
6. The Child-Safe Packaging Group consists of the greater part of the supply industry for reclosable packaging systems for pharmaceutical or other hazardous products.
7. The Child-Safe Packaging Group commissioned research in 1995 that conclusively proved that blister packs in common use in the United Kingdom and other European countries were not child resistant. The results of this research were announced in the press then and have subsequently been referred to in papers published by the group and debates in the packaging and pharmaceutical industries.
8. The Child-Safe Packaging Group has undertaken further research indicating that there are more than 40,000 accidental ingestions by children under 51months every year in the UK. And based on this it is the group's view that another fatality is sadly almost inevitable.
9. In addition to the founder members listed above the other members of the group are ??? -
Pago, Colchester Sonoco
Capseals, Berkshire
RPC Containers Halstead,
Essex HSD Limited, South Wales
Owens Illinois,
USAUnique Mould Makers Limited, Canada- -
10. The Medicines Control Agency and the Department of Health are on record as saying that 'the primary duty is for parents to keep medicines out of the reach of children and child resistant packaging is only a last line of defence.' The Royal Pharmaceutical Society of Great Britain is on record as saying that 'blister packs are safe because children can only access one tablet at a time.' -
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