Kolon Pharmaceutical’s prescription flu treatment Comiflu (oseltamivir phosphate) was distributed to a daycare center via a donation group without a doctor’s prescription, and the regulator belatedly began investigating the matter . Comiflu is a generic copy of Tamiflu.
A day care center in Jecheon, North Chungcheong Province, recently distributed free Comiflu to children, sources from the Korea Pharmaceutical Association (KPA) and pharmaceutical industry said on Wednesday. As a result, the parents and guardians filed a complaint with the day care center and the Jecheon Public Health Center, and the distribution of medicine was suspended.
According to KPA, Comiflu was delivered by Korea Love Sharing Community, a donation group, to the Jecheon Welfare Center, Daycare Directors Council and Kindergarten.
Comiflu at the daycare came from those donated by Kolon Pharmaceutical to Korea Love Sharing Community in April.
The most serious problem is that Comiflu, a prescription drug, has been distributed to children without a doctor’s prescription.
Tamiflu, the original drug, has reported neuropsychiatric adverse effects such as seizures and delirium in children and adolescents.
In 2018, the Ministry of Food and Drug Safety (MFDS) distributed a safety letter urging children and adolescents not to be left alone for two days after taking the drug after a teenager who took the drugs died of a fall due to suspected side effects.
Kim Woo-joo, a professor of infectious diseases at Korea University’s Guro Hospital, said people must have been negligent in administering flu treatment.
“Although the causal relationship is unclear, the treatment could cause delirium or a neurological disorder in adolescents,” he said. “It became a problem in Japan once, and the Korean regulator took action to warn people about the use.”
Seeing the problem, the MFDS began to investigate whether Kolon Pharmaceutical’s drug donation was legal. The ministry also signaled that it may take legal action against Korea Love Sharing Community.
KPA, the group of pharmacists, also criticized Kolon’s act.
Although the company says it intended to give the flu treatment to children in other countries, the company must have known that the drug could be used in Korea, given that the drug’s expiration date was less than four months, KPA said.
Overseas drug donations are only possible when the expiration is more than four months.
KPA said it would find facts about Kolon, the donation group, and the daycare and prosecute them if it uncovers illegal acts.
“We need to improve the drug donation and administration system, so that doctors and pharmacists manage donated drugs,” KPA said.
Also, pharmaceutical companies should stop giving out drugs that are approaching their expiry date.
Kolon Pharmaceutical said it found it unfair to accuse the company.
“The company is also investigating the case. We delivered Comiflu to Korea Love Sharing Community under the drug donation procedure, and it was legally possible,” an official from Kolon Pharmaceutical said.
The official added that the medicine was distributed in the wrong place by the donation group, not the company.
“We have not received a response from the Korea Love Sharing Community on why Comiflu went to daycare and where he gave the medicine, how much he gave and how much he recovered,” he said. declared.
While many Korean drugmakers donate to Korea Love Sharing Community, he added that Kolon would hold the group accountable.