Wednesday, January 27, 2021

Japanese drugmaker reports major product contamination issue in December

 Via FiercePharma in December: 

A "grave" manufacturing error in Japan tainted antifungal tablets with high doses of a sleep medication, leading to the death of one woman in her 70s and side effects in hundreds more people. 

Kobayashi Kako, the drugmaker behind the mix-up, said employees may have failed to follow company procedure when removing and mixing ingredients for the two highly divergent drugs, Osaka newspaper Asahi Shimbun reported.

The woman passed away Dec. 10 at a Tokyo-area hospital after taking Kobayashi's antifungal drug Itraconazole 50 Meek, the newspaper said.

The company's own investigation revealed 5 milligrams of a sleep med—identified by The Mainichi Shimbun as rilmazafone hydrochloride hydrate—had been added to each problematic tablet of Itraconazole 50 Meek. That amount is two-and-a-half times what's typically included in a single rilmazafone pill...

...To prevent these sorts of mistakes, Kobayashi said it keeps its drug ingredients in clearly differentiated containers. Components for its athlete's foot med go in a pulp-based, drum can-shaped container a little less than 3 feet tall, while its sleep med is stored in a flat box that clearly bears the drug's name. The company also requires two employees to work as a team when drug ingredients are removed and mixed.

Thing is, it didn't always work out this way. There was a period when a single staffer performed that task, Kobayashi Kako admitted to Asahi Shimbun. It suspects the mix-up may have happened then. 

This is a reminder of how simple errors can have profound negative consequences, and seemingly clear distinctions can apparently be missed. 

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