Since 1983, 47 children under 6 years old have died in the United States after accidentally ingesting drugs packaged in bottles.
By comparison, no child has died from an overdose of drugs packaged in blister packs - the name for the thin strip of plastic film and foil packaging that seals each tablet individually.
For Peter Mayberry, who is executive director of the Healthcare Compliance Packaging Council, a blister pack industry group, that's a strong reason for the federal government to reconsider its rules on drug packaging.
The HCPC, in Falls Church, Va., wants the Consumer Product Safety Commission to develop new rules to test when a package is child-resistant because, it contends, the current rules favor traditional bottles and discourage drug companies from using blister packaging, also called unit dose packaging.
Mayberry's group is mounting an aggressive effort: it sent a letter Oct. 22 to CPSC Chairman Harold Stratton outlining its concerns, and met with agency officials last month. At this point, discussions are informal but Mayberry said HCPC might file a formal petition.
The crux of HCPC's argument rests on CPSC data on childhood deaths from 1983 to 2002 that the group obtained through the Freedom of Information Act. According to HCPC, 85 percent of cases where young children have accidentally ingested drugs involved bottles, compared with 7 percent for unit dose packaging.
The group said that children also typically swallow fewer pills when they breach unit dose packaging - five pills at most in the blister pack cases, compared with 30 or more in some cases involving bottles, according to the HCPC analysis of CPSC data.
``The weakest unit dose packaging is better than the most effective cap and vial closure for the simple reason that children have to remove one dose at a time from the unit dose format,'' Mayberry said.
The HCPC wants the CPSC to drop ``subjective'' provisions from its testing protocol that require pharmaceutical manufacturers to determine on their own if a blister pack has failed the test. That subjectivity makes drug companies reluctant to use the packaging, he said.
Instead, an objective standard should be set, similar to a protocol the Europeans are developing for determining when a blister pack is child resistant, Mayberry said.
Mayberry said HCPC's effort is targeting the prescription drug market, where only about 20 percent of medicine, mainly birth control, is available in blisters. About 80 percent of over the counter medicine is available in blisters, even if the same medicine is also available in bottle packaging.
Mayberry also said that some child-resistant blister packaging is not popular with consumers.
``We have consistently been told by manufacturers that a primary reason they have not adopted unit dose formats ... for their prescription products is because the child-resistant protocol requires them to fortify the packages to the point that older consumers have difficulty using them properly,'' he said.
CPSC officials said they were still examining the HCPC request and had no comment, but an agency spokesman defended its ongoing campaign against childhood poisonings.
In the 1960s, up to 450 young children a year died from poisonings from drugs and other products, like cleaners. But that number has fallen to about 30 deaths a year because of the agency's child-resistant packaging requirements, the development of poison control centers and public awareness, said CPSC spokesman Ken Giles.
Open to changes
Mayberry, however, thinks there are signs that the CPSC is open to changes.
A CPSC economist, Gregory Rodgers, published an article in a medical journal in September that examined the impact of child-resistant packaging on reducing deaths of accidental aspirin overdoses.
The article said child-resistant packaging has reduced aspirin deaths by 34 percent, but because its ``effectiveness is only partial, further poison prevention strategies should be developed.'' The article, which did not mention blister packs, was a ``major reason'' why the HCPC sent its letter now, Mayberry said.
HCPC also pointed to the impact of a 1997 Food and Drug Administration rule that required blister packaging for iron supplements.
Since the rule went into effect, one child has died from iron poisonings. Before the rule, deaths were at least five times more frequent, HCPC said.
The Closure Manufacturers Association, a Kilmarnock, Va., trade group representing the makers of bottle caps and closures, said it was still studying HCPC's submissions and declined to comment.