Child-safety standards probed by CPSC

The US Consumer Product Safety Commission has started a review of
its criteria to determine whether drug packages meet its
child-resistance standards.

The US Consumer Product Safety Commission has started a review of its criteria to determine whether a drug package meets its child-resistance standards, which have not been updated since the early 1970s.

The move follows a petition from the Healthcare Compliance Packaging Council​ - a trade organisation representing the packaging industry - which maintains that the current standards are a disincentive to the use of push-through packaging in which each dose is housed in a separate cavity.

In the USA, most pharmaceuticals are shipped in glass bottles and then re-packed into smaller bottles at the pharmacy where a prescription is presented. The situation is very different in Europe and Asia, where manufacturers have been quicker to adopt unit-dose packaging. "One reason often cited by manufacturers for packaging drugs differently in the US is concern over complying with CPSC's child resistance testing requirements​," according to the petition.

This disincentive is significant because CPSC data have revealed that single-dose packaging is far more effective than cap-and-vial closure systems at protecting small children from accidental poisonings.

Central to the HCPC's petition is a revision to a specific provision of CPSC's test protocol that applies an objective pass/fail standard to most types of drug packaging, but in particular applies a subjective, qualitative standard to unit dose formats. This 10-minute test involves asking a child to open a pack and remove pills. If it manages to take out eight, the packaging fails the criteria, and the failure threshold gets lower if a drug can cause "serious injury or illness" with fewer pills.

While push-through formats can be strengthened to pass the current standard, this can make it difficult for adults to use the package properly and creates a disincentive for pharmaceutical manufacturers to adopt single dose formats for their products.

The HCPC's petition is asking for a practical definition of what constitutes a serious injury or illness, and has asked the CPSC to maintain the "eight-pill" rule as the sole criteria to show child resistance.

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