‘Continuous drug mixing incidents threaten consumer health’

The recent mislabeling of medicines by Hyundai Pharm and other incidents of drug mix-ups are threatening consumers’ health, consumer groups said.

Issuing a statement Wednesday, the Citizens United for Consumer Sovereignty (CUCS), a consumer advocacy group, criticized Hyundai Pharm’s labeling errors, calling for self-reflection by the pharmaceutical industry.

“A drug product adulteration incident occurs when a product is packaged with another one or when another product is inside the medicine container,” the organization said, adding that the labeling error of Hyundai’s drug is a medical product adulteration accident.

The dementia drug and the hypertension drug involved in the product mix-up are both white, 6.5-mm in diameter, and circular tablets, not easily distinguishable, CUCS said. It is challenging to recognize the wrong product without looking closely. As a result, consumers are likely to take the medication without realizing it, it added.

“This is not just a case of mislabeling a container. It is a serious problem caused by a failure to comply with quality control standards,” the group pointed out.

This serious matter violates Article 48, Paragraph 1 of the Drug Safety Rules, which states that only products that have been thoroughly inspected and passed the quality inspection shall be released, CUCS said. It is subject to an administrative penalty of suspension of all manufacturing operations or a three-month suspension of manufacturing operations, it added.

The organization also criticized a series of drug mix-up incidents in recent years, claiming that consumer health is at great risk.

According to CUCS, seven drug adulteration incidents have occurred since 2019. They included Huons’ Perrison ST Tab, Janssen's Concerta OROS ER Tab, Pfizer’s Lyrica Cap, Samil’s Sudafed Tab, Hana Pharm’s Dyserin Cap, and Korea Korus’s Ana Tab.

“Adulteration of pharmaceutical products, like the one committed by Hyundai Pharm, is a problem that should not happen anymore. It is difficult to recover the damage caused by taking the wrong medicine. The pharmaceutical industry should take steps to thoroughly manage quality control to prevent such incidents from recurring,” the consumer group said.

The Ministry of Food and Drug Safety (MFDS) should also thoroughly investigate the cause of the accident, review the management and supervision manual to prevent the accident from recurring, and explore ways to strengthen responsibility and punishment in the event of an accident, he said, calling for positive steps.

Hyundai Pharm recently came under fire for distributing the dementia drug Tamirin ER Tab 8mg (galantamine hydrobromide) in the container of its severe hypertension drug Minoxidil Tab (minoxidil).

As a regulator, the ministry has asked medical and pharmaceutical professionals and consumers to take caution when dispensing and administering the two drugs, explaining their differences, including granule identification marks and surface conditions.