Japan's Consumer Safety Investigation Commission advised the Ministry of Health, Labor and Welfare in a Dec. 18 report to introduce child-resistant packaging for medicines to stop children mistakenly ingesting them.
The report points out that as children grow, they tend to put all nearby objects into their mouths, copying others' actions as they become more interested in their surroundings and retrieving objects of interest. It calls for the introduction of packaging that children cannot open even if medicines fall into their hands -- while at the same time calling for packaging standards that ensure medicines can still be opened by others including the elderly.
Examples it gave for child-resistant packaging were packages that required an increased level of strength to open, such as sheet-style wrappers that must be strongly pressed to remove the pills; those requiring complex procedures to open, such as bottles whose caps must be simultaneously pressed down upon and turned; and sheets of pills with stickers that must be peeled off before removing the medicine.
The commission, a branch of the government's Consumer Affairs Agency, investigated medicine packaging-related consumer accidents through experiments. In one trial, children aged 3 to 4 and adults aged 50 to 85 were given medicines whose packaging had sheet-style wrappers requiring differing levels of strength to open.
According to the report, it was determined via the experiment that it is possible to come up with packaging that is difficult for children to open, but which adults can still manage to open without difficulty. The report also pointed out the possibility of machines that could determine the level of strength required to open packaging, which would help cut costs and development time.
The Japan Poison Information Center, a public interest incorporated foundation, notes that the number of reported cases in which children under age 5 mistakenly ingest medicines has been increasing since 2006 -- reaching 8,433 in 2014. Among these, 849 children subsequently experienced symptoms such as sleepiness and vomiting.
While child-resistant medicine containers are being proactively introduced in Western countries, the matter is left up to the discretion of individual pharmaceutical companies in Japan -- and the problem remains largely unaddressed.
Major pharmaceutical company GlaxoSmithKline K.K. (GSK) has childproofed 11 of its medicinal products to prevent accidental ingestion by youngsters. These have included sheets of pills with special additional sheets underneath to provide a second layer of thickness, as well as others where stickers are first peeled off before removing medicines, and bottles with twist-off caps that must be simultaneously pressed down.
"In order to meet the standards of Western countries, we conducted numerous tests at inspection agencies in the United States," a GSK representative said.
Because the implementation of child-resistant packaging requires both time and funds, companies are recoiling at the requirements. "There is going to be no way around a cost increase of at least 10 percent," commented a representative of one pharmaceutical company that does not yet have plans to implement the measures. "And because the government decides the price of medicines in Japan, we are going to be the ones shouldering these costs. For all but the major corporations, it will be impossible."
Akinori Komatsubara, a professor of human life engineering at Waseda University, joins the consumer accidents study commission in calling for measures that aim to prevent accidental ingestion of medicines in line with growing children's behavioral traits.
"Two-year-olds look at their parents taking medicine, and the danger exists that they will mimic the action as a game of make-believe -- while 3-year-olds may try to bring medicines to their parents in an effort to be helpful," notes Komatsubara, "The risks must be evaluated differently depending upon children's ages."
The Japan Pharmaceutical Association, meanwhile, points out that accidents involving medicines do not involve only children, with cases also occurring whereby elderly persons have ingested the drugs along with the hard packaging in which they are encased -- causing damage to the throat and esophagus, as well as the stomach and other organs.
Morimoto, a pharmaceutical company based in Osaka, has developed film-based packaging that is both flexible and resistant to heat and acids. The packaging may be easily expelled from the body even when falsely ingested, and the manufacturing cost is lower than that of standard packaging.