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.