The conversion of emergency pills into OTC triggers controversies over side effects
By Park Heejung
Published: June 14, 2012
Translated by Hwang Yu-jin
Since the Korea Food and Drug Administration (KFDA)
announced its decision to list emergency contraceptives as over-the-counter
(OTC) drugs, there has been a fierce debate for and against the plan.
Women’s groups welcome the news that emergency pills to
avoid unwanted pregnancy can be bought at a pharmacy without a visit to a
doctor. However, along with the Korean Medical Association (KMA) whose
interests depend on the issue, some religious and pro-life groups are against
the idea mentioning reasons such as “practical abortions” and “promiscuity.”
“Birth control
failure” is the worst side effect
About the reasons behind the decision, the KFDA said it took
into consideration that “the pills are taken only once” and “hardly any side
effects have been reported compared to conventional birth control pills which
have side effects such as thrombosis.” The organization added it also
considered that “morning-after pills are sold as OTC drugs in the U.S., the
U.K., France, Switzerland, and Canada.”
The KFDA dismissed the claim that emergency pills are an
abortive remedy by saying, “It’s not an abortive drug according to the medical
and legal judgment submitted by an expert in medicine and law in 2001 when
emergency pills were authorized.”
The KMA expressed its concern over the abuse of emergency
pills once the pills are reclassified as OTC. The association has been emphasizing
side effects, including complacency regarding birth control and the possibility
for women to experience undesired pregnancy by mistaking atypical bleeding for
periods, resulting in the higher abortion rate.
According to the KFDA’s clinical tests, profuse menstruation
experienced by 30.9% of users, accounts for the highest proportion of the pills’ side
effects at, followed by nausea/vomiting, stomachache, and fatigue.
Proponents of the decision to reclassify the pills as OTC are
highlighting that the largest side effect of emergency pills is “birth control
failure.”
Morning-after pills inhibit fertilized eggs from implanting on
the uterus walls by using high concentration hormone. The pills should be taken
within 72 hours of sexual intercourse, and can only be taken once in one
menstruation cycle. If a woman fails to follow these rules, the medicinal effect
will drop significantly. It is recommended that the pills be taken within 12
hours after unprotected intercourse to increase the success rate.
Therefore, taking the pill in time is the key. For this
reason, proponents claim that it is the right decision to reclassify emergency
contraceptives as OTC so that people have easier access to them.
Abuse and side
effects should be solved by safety measures
The Korean Pharmaceutical Association doesn’t agree that
morning-after pills should require a doctor’s prescription because even doctors
are not certain whether a woman has conceived within a short period of time. The
association also thinks problems are not likely to occur since side effects
such as digestive problems (including nausea and vomiting), headache,
dizziness, and abnormal vaginal bleeding usually disappear within 48 hours.
Chu Hye-in, a doctor at the Department of Family Medicine,
Sallim (“giving life”) Health Cooperative, said, “As for ordinary women who
don’t suffer from reduced liver or kidney function, the conversion of emergency
pills into OTC is not a problem if they receive a proper education on drug
usage.”
In addition, completely preventing abuse of the drug is
impossible. Chu pointed out, “Emergency contraceptives are not covered by
insurance, so even if someone gets a prescription several times from different
doctors, there’s no way to tally up the numbers.”
According to a report by the Korean Pharmaceutical
Association, some resort to expedient means. For example, men get a
prescription, even though only women are allowed to get a doctor’s prescription
for emergency pills under the current system, or some doctors prescribe the
drug under incorrect social security numbers.
Many foreign countries don’t require a prescription for
morning-after pills. Other than a few exceptions, emergency pills are
classified as OTC in most European and North American OECD nations.
These nations offer information on emergency pills and have
safety measures to prevent abuse of the pills. In some countries, it is
obligatory for pharmacists to put morning-after pills out of arm’s reach of
customers so that they can buy the drug only after a consultation. In several
provinces of Canada, pharmacists are required to receive a filled-out survey on
morning-after pills from a customer who visits to buy it.
As for teenagers who lack relevant information, some
countries have institutional policies
that require those under sixteen or eighteen to get parental consent or a
doctor’s prescription. This procedure is devised to provide sex education for
minors during a doctor’s consultation.
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