Photo/IllutrationMaki Yokomaku stands beside pictures of her late son Kohei, who struggled to take split pills for adults, on Jan. 7. (Naoyuki Himeno)

Children who have long suffered in being unable to take adult-size medicines may soon get more of a helping hand than just a spoonful of sugar.

Pharmaceutical companies will be encouraged by the government to improve adult medicines for children, who often find the pills too big and too bitter to swallow.

The Liberal Democratic Party's Health, Labor and Welfare Division gave preliminary approval on March 7 to a health ministry draft of a revised law on pharmaceuticals and medical devices. The ministry is scheduled to submit the draft in the current Diet session.

For many medicines in Japan there is no recommended dosage or administration methods for children listed on the drug packaging insert.

Therefore, doctors have no choice but to prescribe splitting adult-size pills by referring to how each medicine is taken overseas.

However, taking pills that have been split into a smaller dosage has drawbacks in medical treatments for children because of the bitter taste and a sharp edge that could be painfully caught in a child's throat.

“I knew that the medicines were necessary (for my son). But I got angry at them,” said Maki Yokomaku, 46, of Ogaki, Gifu Prefecture, looking back on her son Kohei's fight against acute myelocytic leukemia.

Kohei, who died of the disease at age 5 in 2003, would be administered anticancer agents with an infusion as well as take up to six kinds of oral drugs to protect him against infectious diseases.

Yokomaku was told by a pharmacist, “The medicine tastes bitter because it is for adults and has been split.”

She struggled to somehow have Kohei ingest the medicines by mixing them with jam or jelly. But he would readily vomit partly due to the anticancer agents and need to retake them if he threw them up within 30 minutes after taking them.

“We took all day to take the medicines,” Yokomaku recalled.

She sometimes vented her anger on a pharmacist saying, “Undergoing medical treatments are already afflicting my son. Why does he further need to be subjected to difficult oral drugs?”

Hidefumi Nakamura, director for clinical research and development at the National Center for Child Health and Development, said in European countries and the United States, the governments mandate that pharmaceutical companies develop a child’s portion in conjunction with an adults’ medicine. That leads to an increased number of medicines that are usable for children.

In Japan, pharmaceutical companies are not obligated to do so.

“In Japan, there are many medicines of which a children’s size does not exist, and cut-up pills of adults are used for children. We need to move forward in development of children’s drugs,” said Nakamura.

The draft of the revised law says that the government should designate highly necessary medicines, financially support pharmaceutical companies and shorten the approval period of a new drug application.

Masao Nakagawa, director of Kyoto Kizugawa hospital and former head of the department of drug development promotion at the Japan Pediatric Society, reported that 277 drugs could be adapted for children's use, accounting for 25 percent of all 1,125 items that had been approved between fiscal 2001 and 2014.

The Pharmaceuticals and Medical Devices Agency (PMDA) said that 11 items, or 6 percent of the 185 adult anti-cancer drugs that had been approved from fiscal 2010 to 2017, are useful for children.

Michiyo Sakiyama, senior assessor at the office of vaccine and blood products of oncology at PMDA as well as a pediatrician, said it is difficult to develop children’s drugs.

“It is necessary for children’s drugs to be prepared in their dosage size and shapes (for a wide variety of ages),” she said.

The government will establish the “pharmaceutical products for specific usage” framework. Based on the policy, it will designate medicines whose dosage and administration methods for children are needed to be set up or whose shape should be redesigned.

The government will subsidize companies that will work on the development of such medicines so they can conduct clinical investigations to determine the drug's efficacy and safety. It intends to prioritize the inspection of such medicines to grant them approvals so that the period between an application and its launch will be shortened, as well as give them preferential treatment concerning taxes.

Detailed requirements of subsidized medicines are expected to be determined after the bill's passage.