According to the World Health Organization, in the European region, the third-leading cause of unintentional death in children through age 14 is acute poisoning. WHO estimates that 3,000 children in that age group die each year, and that 90% of those poisonings take place in the home.
Those were the opening remarks by Olof Malmgren of Faubel & Co. at Pharmapack Feb. 16. Malmgren talked about child-resistant packaging and the role it can play on reducing the number of intoxications (poisoning by a drug or toxic substance) in children. In his presentation, Malmgren outlined the impact of poisonings, child-resistant package-testing methods in the U.S., and the lack of regulation for packaging in the E.U.
Youth poisonings are a very serious issue worldwide. In Germany alone (Malmgren's home), children are involved in 120,000 accidents per year that involve improper use of drugs, chemicals, and cleaning agents. And, in the U.S., approximately $3 billion is spent annually on the treatment of poisonings.
In the U.S., testing standards are outlined in ISO 8317/EN 14375, and dictate that child-resistant/senior-friendly package testing must be done by accredited companies. Malmgren mentioned two such companies--Perritt Laboratories and IVM Institute.
Tests in the U.S. must be conducted with 200 children aged 42 to 51 months and/or 100 people aged 50 to 70 years.
Senior citizens receive written test instructions detailing how to open and close the package prior to testing. Children aren't given any introduction to the packages. Both groups are given 5 minutes to open the packaging. Then, children are shown the opening procedures without instruction, and given 5 more minutes to open the packaging. Seniors are given an additional minute to prove the senior-friendliness.
In order for a package to be considered child-resistant, at least 85% of the 200 children must not be able to open the package within the first 5 minutes, and at least 80% must not be able to open the package during the testing. And, at least 90% of the adults must be able to open the packaging within 5 minutes in order for the packaging to be considered senior-friendly.
European directives 1999/45/EC and 1967/548/ECC lay out provisions regarding the classification, packaging, and labeling of drugs and other potentially dangerous substances, but there aren't any regulations in place that require child-resistant packaging.
It is up to individual countries to put laws in place to enforce these initiatives. In France, for example, child-resistant packaging laws don't exist at all. Malmgren showed a video of packaging analysis done by a pharmacist in Germany, who indicated that in that country, child-resistant packaging is still difficult to find. And, while Malmgren admits that the EU acknowledges that regulations are needed, he is unaware of any changes in the pipeline.
Although the U.S. has different requirements for child-resistant packaging, in Europe a generally accepted rule of thumb is as long as no more than eight pills are removed, regardless of their level of dangerousness, the packaging is considered to be child-resistant.