Government’s plan to reclassify birth-control pills gets pushed back
By Chung Hee-hyung
The government is considering reclassifying non-emergency oral contraceptive pills as prescription drugs, requiring doctors’ written instructions before they are taken prior to sexual intercourse. Conversely, emergency contraceptives – taken after unprotected sex - will be sold as over-the-counter (OTC) drugs and would no longer need prescriptions for purchase.
The Korean Food and Drug Administration’s (KFDA) proposed change is part of the agency’s move to reclassify all medications sold in the country. All drugs are subject to reclassification review, but the sensitivity of pregnancy and birth control has drawn disproportionate attention on contraceptive pills. Physicians, pharmacists and civil advocate groups are all voicing different opinions, forcing the government to postpone finalizing the reclassification plan.
“The government will make a careful decision after weighing all options available, and we are open to any proposals,” said Rim Che-min, the minister of Health and Welfare on July 31. “The government will make its final announcement on reclassification by the end of next month.”
Initially, the government planned to make contraceptives available from early August, when the demand for birth control-pills surges during vacation season.
Contraception pills prevent pregnancy by interfering with a body’s hormone activity. Non-emergency pills are usually taken for three weeks from the date of menstruation, with seven days of intervals in between. It is designed to correspond with women’s menstrual cycle and suppress the release of an ovum, or egg, for fertilization by a sperm.
Emergency pills are taken after an egg has already been fertilized, preventing a fertilized egg from attaching to the walls of the uterus. More often known as morning-after pills, the term is somewhat misleading, because it is effective up to 72 hours after sex. Doctors refer to them as “post coital contraception” to stress their after-fertilization effects.
A lot of interests are at stake, since whether drugs require doctors’ prescriptions or are available for over-the-counter purchase determines who gets the most money out of selling them. Of the two types of contraceptives, the real crux of the matter lies in emergency pills, which saw a 60 percent increase in sales from 2004 to 2010, according to KFDA’s report. The sale of non-emergency contraceptives dropped 13 percent during the same period.
Not surprisingly, pharmacists support the government’s decision to classify emergency contraceptives as OTC drugs, as most consumers would buy the medicines at drugstores. In response, physicians argue that all contraceptives purchases should need prescription before purchase, be it emergency or non-emergency ones. They are particularly critical of the government’s move to drop the prescription requirement for the former.
“No drugs are more vulnerable to abuse than emergency contraceptives,” said Shin Jung-ho, Secretary-General of Korean Society of Obstetrics and Gynecology. “Taking a single emergency pill after sex looks much easier than taking regular dosages of non-emergency contraceptives at fixed intervals. Females may think they no longer have to take precautions, and this could prompt irresponsible sex.”
Shin said that such convenience could be a curse in disguise, because emergency pills contain 10 to 15 times more hormones than non-emergency types, causing much damage to regular hormone activities. It may lead to such side effects as nausea, headaches and vaginal bleeding.
Shin said that the last is particularly worrisome, because females might mistake them for normal menstruation and fail to notice that the emergency pill may not have worked. In fact, emergency contraceptives have an alarmingly high failure rate, which ranges from 15 to 40 percent.
Doctors even suspect that something more than public-health concern is behind the scene. Korean Medical Association said in its statement in June that “some interest groups” could be involved in the government’s reclassification process. “Reclassifying emergency pills as OTC drugs would lead to an increase in pharmacists’ sales revenue,” the statement said.
The government, on its part, defended its rationale for making the drugs available for ready purchase despite their potential side effects.
“They may contain unusually large amount of hormones, but emergency pills are taken only after unprotected intercourse, and taking them is essentially a one-off event,” the KFDA said in its statement released in June. “There is less need to worry about their side effects.”
For females, it is imperative to take emergency pills as early as possible, because the longer the delay the less effective it becomes. If taken immediately after intercourse, their effectiveness (the rate at which emergency pills successfully prevents pregnancy) can be as high as 95 percent.
But the number drops to 60 percent if the pills are administered after 72 hours, although the World Health Organization reported that emergency contraceptives could block pregnancy as late as 120 hours after intercourse. This gave the government another reason for getting rid of prescription requirements for post coital contraceptives.
“Unless emergency contraceptives are readily available, they would be much less effective than they otherwise could be,” the KFDA said in its statement. The agency cited the United States, U.K and Canada as countries that classified emergency pills as OTC drugs. Civil rights groups agree.
“It is really important to protect women from unwanted sex and let them make their own decisions on pregnancy and birth control,” said Nam Eun-kyung of Citizens’ Coalition of Economic Justice. “Guaranteeing easy access to contraceptives is one such step in that direction.” She refuted the argument that non-prescription emergency pills would encourage careless and irresponsible sex.
“Whatever problem such sex may have should be addressed through sexuality education in schools and government policies encouraging open discussion of birth control,” said Nam. “It is a problem that calls for an all-out effort by every interested party. Females should not bear disproportionately heavy burden for that, and unfortunately requiring doctors’ prescription for contraceptives has just such an effect.”