Blister-packed drugs targeted by new guidelines


April 15, 2002

National guidelines on blister-packed drugs have been launched by BSI to improve child safety.

BS 8404 has been fast-tracked at the request of the UK Government following the recent death of a child in West Yorkshire.

In the near future the UK Medicines Control Agency will be consulting on a change to the law which could require the pharmaceutical industry to comply with BS 8404.

Pharmaceutical products are involved in over half the cases of accidental poisoning in the home among under fives, who form over 80% of cases.

Each year there are around 6,000 visits to hospital casualty departments involving pills or tablets and there has been one fatality within the last two years.

Safety warnings were added to labelling of iron-containing medicines in 2001 because of the risks of overdoses in the under fives. About 600 are admitted to hospital each year as a result of accidents involving iron tablets.

In the UK, the law requires that aspirin and paracetamol sold in reclosable containers like bottles must be tested to BS EN 28317 for child resistance.

But no test is specified for non-reclosable packaging like blister packs and strip packs, which are becoming increasingly popular ways of packaging drugs. Here, the law only requires them to be "selected with a view to their resistance to opening by children".

The new standard, BS 8404, sets performance requirements for the child-resistance of blister-packs. The requirements reflect the principle that they must be difficult for children to open, while still being accessible to adults, including senior citizens.

The standard requires that blister-packed drugs are independently tested using children. They are allowed five minutes to try to open the pack, then given a silent demonstration and allowed another five-minute attempt. The pack is deemed child-resistant if less than 15% of the children can open it before the demonstration, and less than 20% afterwards. 

David Lazenby CBE, Director of British Standards, said: "We have fast-tracked this British Standard to ensure that improved blister-packs reach the market. It enables brand owners and packaging firms to prove that they're the best - and only the best is good enough for Britain's children.

"Drug companies across Europe also want to operate to these high standards, and a European standard will follow. The whole supply chain - brand owners, packaging firms, wholesalers and retailers - will want to show excellence by making sure that the standard has been followed. This will also be a strong way to show due diligence in a court case," David Lazenby added.

The new British Standard has support from the UK Medicines Control Agency, and the UK Department of Trade and Industry's Consumer Safety Unit. A spokesman for the UK Department of Health said: "We welcome this standard and will be consulting on amendments to the Medicines (Child Safety) Regulations in due course."