Major reclassification switches 212 prescription drugs to OTC items


The government has decided to allow emergency contraception pills, known as morning-after pills, to be sold at pharmacies without a doctor’s prescription.

Instead the authorities decided to tighten management on ordinary oral contraceptive pills, designating them as prescription drugs. Currently, day-after pills are classified as prescription pills while ordinary pills are sold without doctors’ orders.

The Korea Food and Drug Administration on Thursday announced that a guideline for the reclassification of all 39,254 drugs sold in the country has been set and the authorities have commenced with the discrimination procedure. They have decided to switch a total of 273 over-the-counter drugs to prescription drugs and 212 prescription items to OTC. After consulting with social leaders, the drug agency will finalize the lineup in July, and it will come into effect no later than the beginning of next year.

The most controversial issue is the redesignation of oral contraceptives.

According to the plan, women will be given much wider access to the morning-after pill, which has been recommended to be used under very limited terms such as rape.

“According to our panel of experts, the main mechanism behind the emergency pills is the interference of hormonal action, linked to interference of implantation. It is not an abortion,” Cho Ki-ho, a KFDA official, said, trying to dispel the opposition’s claims that the wider access is allowing easier abortion.

The authorities also noted that many of the more serious side effects of the drug have not been detected in Korea.

“The most commonly reported side effects of the drug including irregular menstruation, headache, nausea and vomiting are reported to cease within 48 hours. Thromboembolism and other serious adverse effects have not yet been reported in Korea,” Cho said.

The government explained that in order to prevent abuse of the drug by minors, a prescription is still required for teenagers. Currently, morning-after pills are sold as OTC drugs in the U.S., U.K., France, Switzerland and Canada. The U.S. and U.K. also require a prescription for teenagers.

“Although the pills have been proven safe, we will continue to consult with representatives from religious and other fields because we understand that the issue is related to public antipathy,” Cho said,

The plan was made after groups of consumers and women’s rights activists demanded the revision to respect women’s right to choose what they need for their body a couple years ago.

The authorities expect the regulation change will cut down on the country’s staggering 300,000 abortions believed to be performed every year.

“We are hoping that the wider access to the morning-after pill will prevent unwanted pregnancies. Because the drug is effective within 12 hours from sexual intercourse and at utmost 72 hours, time and access to the drug is very important. The pill is not an ordinary contraceptive. It is for very limited, urgent and frightening situations only,” Lee said.

On Thursday, a group of gynecologists protested the plan.

“In Sweden, the morning-after pills was reclassified as an OTC drug from 2001 but by 2007, the abortion rate increased by 17 percent. The more important thing is that the failure rate of the pill is more than 15 percent, which shows that the drug is not a cure to irresponsible sex,” Park No-jun, the head of gynecologists in Seoul, said.

“Women’s bodies are very sophisticated. If people take the pills for granted instead of taking regular contraceptive methods, they will not only abuse the drugs but also their health,” Shin Jung-ho, secretary general of the Korean Society of Obstetrics and Gynecology, warned.

Alongside day-after pills, hyaluronic acid sodium drops to soften dry eye syndrome and lactulose-based drugs for constipation will be sold without prescriptions under the new rule. Ursa, the best-selling hepatic function medicine by Daewoong and a children’s carsickness patch will be moved to the prescription drug zone for their side effects.

By Bae Ji-sook (baejisook@heraldcorp.com)