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.
|