|  Abortion
is a commonly-performed clinical procedure. The current death
ratefrom abortion is 0.6 per 100,000 procedures versus death
rate fromchildbirth of 8 per 100,000 live births. Total 50
million conceptions take place every year, out of which 13
million get aborted. According to WHO, 80,000 women die annually
due to unsafe abortions. Almost one-fifth of worldwide abortions
take place in India. To solve this issue, there is a need
for over-the-counter availability of abortion pill. It has
been seen that 70 to 80% of unintended pregnancies occur between
15 and 19 years and more than 40%, above 40 years of age.
Table 1.4.3
Framwork for providing medical abortion |
 |
Abortion is a right all women must have. Abortion pill promotes
abortion as early as 8 days from LMP up to 7 to 9 weeks of
pregnancy. Easy access to abortion pill has its advantages
of privacy, safety and control over the process. It also improves
public awareness.US FDA approved RU-486 in September, 2000,
and it was given approval by Drug Controller of India in April,
2002 with formulation of guidelines in October 2002. "Mifepristone
is the result of the FDA’s careful evaluation of the
scientific evidence related to the safe and effective use
of this drug." (Dr. Jane Henney, Commissioner of Food
and Drugs).
Though sold over the counter in USA, UK, France, Sweden and
Canada, it has not increased the abortion rates. Abortion
rate is in a slight decline in the United States and France.
RU-486 advocates take example from France. It has been available
in France since 1988 and has accounted for one-third of all
abortions in France though the total number of abortions in
that country has not increased (Snell.) Not one woman has
died from the use of the drug according to Vicki Saporta of
the National Abortion Federation. Any pill over the counter
has its limitations, why debate only about abortion pill.
The people on pro-choice feel that RU-486 continues to expand
a woman’s right to choose issues regarding her reproductive
health. Misuse due to over the counter availability has not
been proven with sufficient data. Thus, abortion pill is the
option pill. With improved public awareness and education
in the coming years, this choice would help in improving the
reproductive health of women.
The Feminist Majority Foundation is in support of a woman’s
right to choose. Providing easy and earlier access to abortion
pill would increase privacy and decrease clinic violence.
Approval of the drug will also lead to much-needed research
on the use of mifepristone to treat ovarian cancer, endometriosis
and some types of breast cancers. |
Giving ‘over the
counter’ status to medical abortion pills implies allowing
them to be sold without a doctor’s prescription. There
can be some horrific sequelae of availability of these pills
over the counter. Patient may land up in shock with ruptured
ectopic pregnancy, may have hydropic foetus in the next pregnancy
if Rh negative, and did not receive anti-D, or there may be
continuation of pregnancy with a new-born baby suffering from
frank Mobius syndrome (congenital facial paralysis).
With more than 46 million abortions performed worldwide and
an estimated 6.5 to 7 million in India annually, the scope
of medical abortion is wide.
Before introduction of medical abortion pills into the market,
public should be aware of the risks and complications of the
procedure. The abortion process may not be 100% effective;
there may be potential risk of teratogenecity, it may require
days to weeks, the patient may have to come for frequent hospital
visits, there may be excessive cramping or bleeding per vaginum.
All such vital information can be disseminated only if she
first visits a health professional. The availability of ‘over
the counter’ pill may also dissatisfy people and have
negative implications on the long-term use and reputation
of the drug.
Screening is an important component of preabortion guidelines.
Essential criteria for screening include a baseline haemoglobin
and blood group estimation, pelvic examination to confirm
the period ofgestation and rule out ectopic pregnancy. This
also is the right forum to provide contraception counseling.
By these simple measures, complications of severe anaemia,
post-abortal sepsis, implications of missing an ectopic pregnancy
and occurrence of Rh isoimmunisation in future pregnancy can
be prevented.
It has also an additional advantage of preventing future
unwanted pregnancies. Checklist of eligibility criteria that
must be fulfilled by women seeking medical abortion include
informed decision, pregnancy within gestational limit, willing
to undergo surgical abortion in case of failure, return for
follow-up visits, easy access to medical facility in case
of emergency and no associated medical contraindication. For
successful implementation of medical abortion programmes,
screening is vital. ‘Over the counter’ availability
will deprive women of this important procedure.
The US FDA criteria of drug availability over the counter
are :
• there should be no need for medical screening
• no risk of teratogenecity
• no need of monitoring
• the drug should have a uniform dosage schedule.
Medical abortion pills do not fulfill these criteria. ‘Over
the counter’ availability of drugs to minors and adolescents
will affect the very moral fibre of our society.
It also hampers the documentation and recordkeeping of the
number of abortions. This drawback may have future implications
in formulating the National Population Policy plans. Thus,
medical abortion pills must not be sold over the counter and
be available only by doctor’s prescription. |
