Child Safety in Europe and the United States

Are changes needed for child-resistant packaging?

Poisoning is the third leading cause for injury in the WHO European region, and more than $3 billion is spent annually in the United States on poisoning treatment, shared Olof Malmgren, business development manager for Faubel, at Pharmapack Europe. Malmgren spoke before the audience in Paris on February 16.

While Malmgren mainly discussed blister packaging marketed in Europe, his observations may also urge U.S. drug manufacturers to look at their solutions for child resistance. Malmgren indicated that quite a few suppliers offer packaging and labeling concepts intended to create a safer environment for children.

During his presentation, Malmgren expressed concern that a number of blister packages used in Europe may not offer child resistance. He shared a short video of children opening blister packages with ease and another of a pharmacist who identified three marketed blisters he felt were not child resistant.

“If regulations in Europe were to change, 70 to 80% of blisters will need to be redesigned,” Malmgren told the audience.

Those regulations may be Regulation (EC) No. 1901/2006 of the European Parliament and of the Council of December 2006 on Medicinal Products for Paediatric Use, which does not call for extensive testing with children, fellow Pharmapack Europe speaker Anne Gaynot later explained. Gaynot serves as head of laboratory of pharmacotechny, Lille 2 Pharmaceutical Sciences University, France. While several EU member countries do offer some guidance on child-resistant drug packaging, there are no EU mandates, she explained.

ISO 8317:2003 “Child-Resistant Packaging—Requirements and Testing Procedures for Reclosable Packages” is available, but she said that “child resistance tests are not sufficient.”

Both Malmgren and Gaynot pointed somewhat favorably to U.S. package testing protocols under the Consumer Product Safety Commission (CPSC) as well as 16 CFR § 1700.20 “Testing Procedure for Special Packaging” based on toxicity. The latter states that “in the case of unit packaging . . . a test failure shall be any child who opens or gains access to the number of individual units which constitute the amount that may produce serious personal injury or serious illness, or a child who opens or gains access to more than 8 individual units, whichever number is lower. . . .”

However, according to Safe Kids Worldwide, child poisoning deaths still occur at alarming rates. Its new research found that while the death rate among children from poisoning has been cut in half since the late 1970s, the percentage of all child poisoning deaths due to medications has nearly doubled, from 36% to 64%.

The 50th anniversary of National Poison Prevention Week was March 18–24, 2012, and to mark it, organizations like the Academy of Pediatrics offered several tips on poison control. In terms of packaging, these tips urge users to “Store medicine, cleaners, paints/varnishes, and pesticides in their original packaging in locked cabinets or containers” and “Purchase and keep all medicines in containers with safety caps.”

In the United States, however, drug manufacturer’s original packaging may not be readily available to consumers, as many prescriptions are repackaged into pharmacy vials with child-resistant caps.

Malmgren urges drug manufacturers to “question current packaging concepts in terms of child resistance and determine whether better alternatives are available.”

Faubel Pharma Services Corp. will be exhibiting at Pharmapack North America May 22–23 in Stand F935. Please visit

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