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As Contraceptive Drugs' Accessibility Should Increase But Remains Insufficient

Problems will arise at the conversion of oral contraceptives to prescription-only


By Park Heejung
Published: June 14, 2012
Translated by Marilyn Hook

A heated debated has been started by the Korea Food and Drug Administration’s June 7th announcement of a drug reclassification that includes the conversion of emergency (post-coital) contraception into “ordinary” medication, and oral contraception (taken regularly) into “specialty” medication. If the classification is enforced, it will be possible to obtain emergency contraception without a prescription at an ordinary pharmacy, but all of the oral contraceptives currently on the market will begin to require a prescription from a doctor.

The Korean Pharmaceutical Association and the Korean Medical Association, whose interests are at stake, quickly released official statements and began an all-out war.  The KPA insists that pre- and post-coital contraceptives should both be over-the-counter, and the KMA insists that both should require a prescription.

The stance of women’s groups has been to welcome the conversion of emergency contraception that allows it to be purchased over-the-counter.
 
However, they oppose the reclassification of regular oral contraceptives as prescription-only, calling it “a policy that can only worsen women’s health, right of access to medical care, and quality of life.”

Used worldwide for 50 years, birth control pill quite safe

Image of women who have used the pill with few problems during the 50 years that it has been sold over-the-counter opposing the KFDA’s announcement that it will become prescription-only. © Ilda

The KFDA cited the points that “long-term use” of the pill “affects female hormone levels, and side effects such as thrombosis” can occur, and that, “The restrictions and cautions regarding use are extensive, so consultation with a physician prior to use and regular examinations are advised,” as reasons for the conversion.

It explained that the fact that “among the USA, Japan, the UK, France, Germany, Italy, Switzerland, and Canada, eight medically-advanced countries, all of them classify it as prescription-only” was another basis for the decision.

However, oral contraceptives have been classified and used as over-the-counter drugs for over 50 years in this country. As they have been using them not just for birth control but as treatment for irregular menstrual cycles and acne, the majority of women’s opinion is that the KFDA’s conversion measure is “incomprehensible.”

Dr. Chu Hye-in of the Department of Family Medicine at Sallim (“giving life”) Medical Cooperative pointed out, “There is a lack of grounds for the KFDA’s exaggeration of the side effects of oral contraceptives, after all this time.” The KFDA’s stated reason hardly warrants the conversion of oral contraceptives, which have been over-the-counter drugs for 50 years, into prescription-only.

The Korean Pharmaceutical Association emphasized that the pill is “a product whose safety and effectiveness has been proved worldwide over the last 50 years.” They argue that because today’s oral contraceptives are low-dose drugs whose female hormone (synthetic estrogen) content is only 20-30 micrograms per pill, they have become even safer.
 
Furthermore, in the USA and other medically-advanced countries that the KFDA used as examples, the argument for the need to convert these kinds of low-dose drugs and also oral contraceptives into over-the-counter medications is gaining steam.

“The accessibility of oral contraceptives must not decrease”

Above all, women’s organizations fear that the conversion of oral contraceptives into prescription-only medication will decrease their accessibility.

The Network for Women’s Right of Determination of Pregnancy and Birth called attention to the “very important problem” that the accessibility of birth control poses “especially to women who, for social or economic reasons, cannot easily visit a doctor.”

Due to the estimation that, along with the burden of consultation fees, the prices of existing oral contraceptives will increase threefold if this reclassification goes through, hoarding is occurring. The burden of a consultation fee, especially, could become the main factor that raises the threshold for acquiring the pill for students and those with low income.

Above all, women complain of the difficulty caused by having to go to the obstetrician-gynecologist’s office and get a prescription every time. On Internet communities centered around women, like the ones whose main theme is raising children or beauty, it is easy to find posts opposing the conversion. The reasons include discomfort experienced at the ob-gyn’s, extra fees for unnecessary exams, and mistrust of the doctors.

The difficulty is even greater for unmarried women, due to society’s negative perception of women having sex outside of marriage.

The Network for Women’s Right of Determination of Pregnancy and Birth voiced concern that “if, because of the problems of cost and accessibility, countless women begin to depend on emergency contraception instead of regular oral contraceptives, it will have serious effects on their health and lives.”

Only 2.5% of Korean women use the pill. Compared to the so-called “medically-advanced countries,” in which the rates are 20-40% despite the drugs’ prescription-only status, this is an absurdly low level.

The rate of condom usage is also very low; at 20-30%, it is the lowest among OECD (Organization for Economic Cooperation and Development) member countries. This is because Korean culture is reluctant to discuss birth control or even sex itself. There are many people who, ignorant about birth control, leave it to chance by using methods that have a high failure rate, like the “pull-out” method or the rhythm method, and this in turn leads to a high rate of terminated pregnancies.

The women who are taking issue with the KFDA’s announcement are the same 2.5% who use existing birth control drugs. They worry that, though birth control should be more accessible, the conversion will make it less accessible than it is today.

The Korean Food and Drug Administration will hold a public hearing about the birth control pill controversy on June 15th at 2p.m. at the Fire Insurance Association’s assembly hall in Yeoui-do. It plans to gather up the opinions collected at the public hearing and others received by July 6th, and make its decision on the conversion at the end of July after consultation with bodies such as the Central Pharmaceutical Affairs Council.

2 comments:

  1. the point of emergency oral contraceptive (EOC) is to use it asap. the earlier it is used, the more effective it will be. setting an appointment with a doctor to get a prescription for EOC is likely to increase the time frame between unprotected sexual activity and EOC use, thereby decreasing its efficacy. it makes sense to make EOC available without a prescription. regular oral contraceptives are not 100% safe and have health risks associated with them. some types can increase the risk of clots (esp in women who smoke). in addition, some prescription drugs can cause regular oral contraceptives to become less effective. if regular oral contraceptives are made prescription only, the dispensing pharmacist can warn the patient and advise the patient to use backup protection. regulation is there to protect the patients. there seems to be a greater problem at large, and switching birth control from OTC to prescription is probably not going to affect accessibility much.

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  2. Yeah, those health concerns are the FDA's reason and I see their point. I'm curious why you think that needing a prescription is probably not going to affect accessibility, though - I think the article's point that visiting a doctor poses a problem with cost and time for low-income women seems valid.

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