BusinessDay 04 Mar 2018

C002D5556 Sunday 04 March 2018
46BDSUNDAY
Health&Science
Life and Death: Why maintaining Oxytocin quality
standards can save women’s lives during childbirth
Every millennium has had
unique challenges, and
some challenges have
carried on from one millennia
to another. One
of such challenges is maternal
mortality. For centuries, death has
been feared as one of the possible
dangers to a woman while giving
birth. Although the annual maternal
mortality rate has reduced
by about 43% from 1990 to 2015
worldwide, this has hardly reflected
on the maternal mortality
rates in Nigeria. Everyday in 2015,
approximately 830 women died
from preventable causes related
to pregnancy and childbirth. 19%
of maternal deaths worldwide in
2015 were in Nigeria.
Maternal mortality is caused
by many factors; from eclampsia
to prolonged labour to infections.
However, Post-Partum Haemorrhage
(PPH), defined as loss of
more than 500ml of blood from
the vagina immediately after
labour or within 24 hours after
delivery, is arguably the leading
cause of maternal mortality in developing
countries. Post-partum
haemorrhage is caused by excessive
bleeding as a result of the
uterus being unable to contract
efficiently, from vaginal or cervical
tears. According to the World
Health Organisation (WHO),
PPH accounts for one quarter of
all maternal deaths worldwide.
Providing solutions to PPH, could
lead to a reduction of about 30%
in maternal deaths, quite a significant
figure.
Post-partum haemorrhage
is both preventable and treatable.
In its 2012 Guideline for
the Prevention and Treatment of
Post-Partum Haemorrhage, WHO
recommended that all women giving
birth should be given “uterotonics”
which are medicines used
to induce or increase the contraction
of the uterus during delivery.
Uterotonics include oxytocin,
misoprostol and ergometrine.
However, because of its proven
efficacy and safety, it is recommended
that oxytocin be given
as the first line drug against postpartum
haemorrhage. Oxytocin
needs a stable cold chain from
point of manufacture to point of
use.
These medications which easily
prevent PPH are readily available
and fairly affordable. Still,
the frequency and fatality of postpartum
haemorrhage in Nigeria
is quite high. To investigate why
deaths from PPH remain high in
Nigeria, the US Pharmacopeial
Convention (USP) in collaboration
with the National Agency for
Food and Drug Administration and
Control (NAFDAC) carried out a
survey in 2016 to determine the
quality of oxytocin and related
PPH drugs in various hospitals and
clinics across the six geo-political
zones of Nigeria. The survey found
that about 74.2% of oxytocin
samples in the country failed lab
quality evaluations, and 33.7% of
misoprostol tablets were found
to be of sub-standard quality.
This means that 3 out 4 oxytocin
ampoules in Nigerian hospitals
are of sub-standard quality. In
other words, the likelihood that
only about a quarter of oxytocin
doses administered in Nigeria will
have met the required quality standards.
Alongside other prevailing
factors, this could help explain why
Nigeria still has an unreasonably
high rate of maternal deaths due
to complications from pregnancy
and childbirth.
Reducing the circulation and
use of sub-standard uterotonics,
especially oxytocin injections,
may contribute significantly to
the reduction of maternal deaths
in Nigeria. But before that step, we
must first understand why there is
such a high failure rate of such an
otherwise potent drug in Nigeria,
and few questions needed to be
addressed. Are oxytocin injections
not manufactured properly by the
pharmaceutical companies? Is the
active ingredient added to the drug
not the right amount? Are there
problems with the importation
and transport systems? Are there
issues with the storage systems for
oxytocin? Are oxytocin injections
administered at the recommended
dose by healthcare providers?
In a follow up to the survey, the
United States Agency for International
Development (USAID)
– funded “Promoting the Quality of
Medicine (PQM)” project, implemented
by the U.S Pharmacopeial
(USP) Convention, commissioned
a team of researchers, led by Dr.
Chioma Ejekam of the Department
of Community Health, Lagos University
Teaching Hospital (LUTH)
to examine clinical experiences
with regards to the use of oxytocin
injections by healthcare providers
in Lagos State.
The results of this research
were presented in Lagos at a
roundtable discussion with the
theme “Dissemination of the Clinical
Experiences of Oxytocin Quality
used by Healthcare Providers
in Lagos State” on 20th February,
2018 . The commissioned
research revealed the following:
Firstly, 41% of healthcare providers
in Lagos State have used an
oxytocin dose that was higher
than the World Health Organisation
(WHO) recommendation.
Secondly, just over 64% admitted
that they had no way of reporting
the perceived ineffectiveness of
the drug and thirdly, about 13% of
the 705 healthcare providers from
public and private health facilities
who were interviewed, have at
one time or another come across
an ineffective brand of oxytocin.
The most striking of the findings
however, was that only 52% of
the respondents knew the proper
storage procedures for oxytocin,
which is supposed to be stored
between 2 –8°Celcius. Ejekam
pointed out during an interview
with Nigeria Health Watch that, “If
these skilled health workers do not
know the proper storage of oxytocin,
imagine what the knowledge
of the lower cadre health workers
would be.”
Renowned Professor of Obstetrics
and Gynaecology, Frank
Giwa-Osagie,a professor, stressed
the need for regulatory agencies
to increase their post-marketing
surveillance of medications across
the country and the enforcement
of standard regulatory procedures
for the storage of medications in
hospitals and pharmacies. The fact
that 52% of healthcare workers interviewed
did not know the proper
storage conditions for oxytocin and
41% have administered oxytocin
at a dose higher than WHO recommended
guidelines is a serious
cause for concern.
While efforts are made to improve
the overall supply chain
system, storage procedures and
administration of oxytocin injections,
it could be helpful to also pay
more attention to misoprostol, an
alternative drug recommended
by the WHO and International
Federation of Gynecology and
Obstetrics (FIGO) for the management
of PPH. Because misoprostol
is administered orally, it does not
require administration by a skilled
healthcare professional, and it can
be stored at room temperature
without losing its efficacy. These
factors mean that misoprostol has
less of a failure rate than oxytocin in
Nigeria. As Akinola, a professor and
current President of the Society of
Gynaecology & Obstetrics of Nigeria
(SOGON) mentioned during
the Lagos USP meeting, there are a
number of potential product options
for the prevention and treatment of
PPH, however they’re only useful if
they’re good quality products.
Chimezie Anyakora of U.S Pharmacopeia
Convention mentioned
that they plan to expand the Clinical
Experience of the use of Oxytocin
Survey to cover more states across
the length and breadth of Nigeria,
to unearth more significant findings
that will help in reducing post-partum
haemorrhage when oxytocin
is administered in Nigeria.
It could also be useful for the
US Pharmacopeia Convention to
include other uterotonics such as
ergometrine and misoprostol in
the Nationwide Clinical Experience
Survey they intend to conduct on
oxytocin. By understanding the
experience of different healthcare
providers from all regions of the
Federation, we will have a more
flexible and robust approach towards
the use of specific medications
for the prevention and management
of PPH.
These findings, though only from
Lagos State, reveal the task ahead
for Nigeria if it is to reduce maternal
mortality through the proper use
of oxytocin. All participants at the
dissemination discussion agreed
that there is an urgent need to revolutionize
the Drug Supply Chain
System in Nigeria. From challenges
of standard procurement practices,
to the arrival of the medications at
the ports, to the vehicles conveying
them to different locations across
the country, to the pharmacies
and hospitals where these drugs
are stored before use, care must
be taken to ensure that the right
storage conditions are maintained
for this vital drug to ultimately save
Nigerian women from dying from
complications after childbirth.
- Nigeria HealthWatch