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Introduction


1.1 Definition

Emergency Contraception is a method of contraception "that can be used to prevent pregnancy after an unprotected act of sexual intercourse". There are both hormonal and non-hormonal methods for emergency contraception. These methods have also been called as ‘morning after pill’, or ‘post-coital contraception’; but the term `emergency contraception’ is most suitable as these methods are to be used by women within a few hours to a few days of unprotected intercourse and not just the next morning. Besides, emergency contraception also conveys that the method is for one-time use for a contraceptive accident, and not as an ongoing method, following every act of sexual intercourse.

1.2 History

Dr Ary Haspels, a Dutch family planning pioneer, in mid 1960s, first administered high doses of estrogen to a 13 year old rape victim. This became the first standard regimen for emergency use of steroidal hormones to prevent pregnancy 1. Research on other regimens soon followed. In mid 1970s, Canadian physician Albert Yuzpe used high dose of combined oral contraceptive pills which soon became the preferred regimen for emergency contraception2.This combination regimen containing 100µg ethinylestradiol and 0.5 mg levonorgestrel taken twice at 12 hour interval within 72 hours of exposure is commonly known as Yuzpe regimen.

In 1970, investigators in a number of countries initiated studies of levonorgestrel (LNG) in varying doses for use in routine post-coital contraception. Results revealed that a single dose of 0.75 mg of LNG within 72 hours of unprotected intercourse was effective in preventing pregnancy but resulted in higher incidence of menstrual disturbances. These earlier studies, however, suggested that levonorgestrel might prove useful in emergency post-coital contraception 3. During this period post coital insertion of intra-uterine device was also shown to be effective in preventing pregnancy4 .

The first WHO-sponsored comparative study of 834 women in Hong Kong suggested that levonorgestrel alone, used within 48 hours of unprotected intercourse was as effective as the Yuzpe regimen and caused fewer side effects5. The subsequent multicentre study conducted by WHO at 21 centers in 14 countries and involving 1998 women confirmed these results. This study in which India also participated, revealed that levonorgestrel regimen (0.75 mg dose repeated 12 hours later) was more effective than Yuzpe regimen upto 72 hours and was much better tolerated. WHO study also found that the sooner the drug is taken after unprotected sex, more effective it is6. The WHO task force has also evaluated the efficacy of mifepristone in its varying doses as an emergenccy contraceptive 7.

At present, levonorgestrel-only regimen has become the first progestin-only tablet specifically developed for post-coital contraception approved by the United States Food and Drug Administration (FDA) and Drug Controller of India (DCI).

 

Table 1 : History of EC methods

Mid 1960s : High dose estrogen
Early 1970s : Combined estrogen-progestinpill (Yuzpe regimen) 

Late 1970s :

Copper-T IUD
Mid 1990s : Levonorgestrel only pills

Mid 1990s :

Anti progestin mifepristone

1.3 Global Status of EC

Emergency contraception has been available for more than 30 years to prevent unplanned pregnancies. The increase in the number of induced abortions globally has intensified the role of emergency contraception to prevent unintended pregnancies. In 1995, the Rockefeller Foundation convened a meeting in Bellagio, Italy to discuss emergency contraception and expand its access and use in developing countries. A group of seven organizations working in the field of family planning formed the Consortium for Emergency Contraception, which later grew to a 20-member organization. The Consortium worked collectively with local government, policy-makers and family planning programmers in different countries. It dealt with the concerns among providers about the mechanism of action, safety, side-effects and several other legal and ethical issues. Due to the Consortium’s effort, ECP formulation of combined estrogen-progestin regimen was added to the WHO Model List of Essential Drugs in 1995 and the levonorgestrel-only regimen was added in 1997.

The Consortium identified a stepwise strategic approach for introduction of EC in four countries – Indonesia, Kenya, Mexico and Sri Lanka. The other countries where EC is approved and registered are Bangladesh, Brazil, Canada, China, Czech Republic, Egypt, Ghana, Jamaica, Mexico, Nigeria, South Africa, Venezuela, Vietnam, Yemen, USA, UK, France and most European countries.

Efforts are continuing to expand EC introduction in other developing countries and improve its availability, accessibility and affordability to even the poorest women. By October, 2002 a registered EC pill is available in more than 90 countries.

1.4 Need for EC in India

Despite a National Family Welfare Programme and wide-spread efforts by the Government, India has crossed a population of one billion. It is estimated that 78% of the conceptions each year are unplanned and 25% are definitely unwanted8.

In the nineties, India had nearly twice as many abortions as had been estimated in seventies. While a small fraction was due to increase in extra-marital sex, the overwhelming majority was due to unwanted and mis-timed pregnancies within marriage9.

The number of abortions in India is estimated to be over 11 million in a year, of which 6.7 million are induced and 4 million are spontaneous. In spite of abortions being legalized since 1971, there are still 10-11 illegal abortions for each legal abortion. This accounts for 15,000 to 20,000 abortion-related deaths annually and a high associated morbidity, almost all of which is preventable9.

This emphasizes the need for strengthening the already existing framework in order to increase the acceptability and use of various contraceptive methods along with an additional ‘back-up’ method whenever the regular method fails. The ‘back-up’ method is specifically indicated for couples using condoms, contraceptive pills and traditional methods in case of failure, incorrect use or an occasional non-use. As per National Family Health Survey II report10 , acceptance of IUD and COC is 2% each amongst eligible couples, 3% for condoms and 4% for traditional methods. This shows that the number of couples requiring ‘back-up’ method is substantially large as compared to IUD users and further stresses the need for a safe and effective ‘back-up’ method.

The demographic surveys have revealed a large “unmet need” of contraception in India. This issue has been specifically addressed in National Population Policy (2000). Offering emergency contraception is an important service delivery intervention for reducing the unmet need of contraception.

EC methods are going to occupy a unique position in range of contraceptive choices currently available to Indian women as these are the only methods couples can use to prevent pregnancy after a contraceptive accident or
unprotected sexual exposure. Easy accessibility to EC will make a huge difference in preventing unwanted pregnancies and deaths due to unsafe abortions.

1.5 EC pills in India

Levonorgestrel only regimen has been approved by the Drug Controller of India to be used as a "dedicated product" for emergency contraception. The pharmaceutical companies have been given permission to manufacture and market levonorgestrel (LNG) as a specially packaged two-pill pack, each pill containing 0.75 mg levonorgestrel. Currently this is
available at a reasonable cost on medical prescription. Government of India has made the EC pill available free of cost throught its network of family welfare clinics.

1.6 Indications for EC

Unprotected sexual exposure may occur in the following circumstances necessitating the use of emergency contraception :

+ Failure to use a contraceptive

sexual activity was unplanned and accidental

miscalculation of safe period

failed coitus interruptus

+ There is a contraceptive accident or misuse :

condom break, dislodgement or improper withdrawal resulting in semen leakage

diaphragm or cervical cap slips out of place

contraceptive pills are forgotten on two or more consecutive days or there is delay in starting a pack by more than 2 days

intra-uterine device is expelled or misplaced

more than 2 weeks late for progestin only contraceptive injection and more than 3 days late for combined estrogen progestin injection

failure of spermicidal tablet (today) to melt before intercourse

+ Unprotected exposure

sexual assault, rape or sexual coercion.


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