Volume - 01 September 2015-Monthly Issue Issue - 01
OF MEDICAL SCIENCES Linking Medical Fraternity with The Society......Again
- Informed Consent....Are Your Patients Properly Informed? - Shortfall of Health Care Service Provider
Free Circulation
~ Editorial ~ EDITORIAL BOARD Editor - In - Chief Dr. Jayesh Warade
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- Editor In Chief
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Opportunities to "consent" a patient
What is informed consent?
abound on the wards. The aim of this
Informed consent is the process by
article is to provide you with the tools
which the treating health care provider
required for the "basic minimum" as
discloses appropriate information to a
well
more
competent patient so that the patient
comprehensive picture of the informed
may make a voluntary choice to accept
consent process. You will find that the
or refuse treatment. (Appelbaum, 2007)
particular
the
It originates from the legal and ethical
patient's needs or the procedure) will
right the patient has to direct what
determine
or
happens to her body and from the
consent
ethical duty of the physician to involve
as
providing
a
circumstances
whether
comprehensive
a
informed
process is necessary.
(e.g.
basic
the patient in her health care.
What are the elements of full
signing a form. With this understanding,
informed consent?
the informed consent process should
The most important goal of informed
be seen as an invitation for the patient
consent is that the patient has an
to participate in health care decisions.
opportunity
The
to
be
an
informed
physician
is
also
generally
participant in her health care decisions.
obligated
It is generally accepted that informed
recommendation
consent includes a discussion of the
reasoning process with the patient.
following elements:
Comprehension on the part of the
The
nature
of
the
to
provide and
share
a his
patient is equally as important as the
decision/procedure
information provided. Consequently,
Reasonable alternatives to the
the discussion should be carried on in
proposed intervention
layperson's terms and the patient's
The relevant risks, benefits,
understanding should be assessed
and uncertainties related to each
along the way.
alternative Assessment
of
patient
understanding The
acceptance
of
the
intervention by the patient In order for the patient's consent to be valid,
she
must
be
considered
competent to make the decision at hand
and
her
consent
must
be
voluntary. It is easy for coercive situations to arise in medicine. Patients often feel powerless and vulnerable. the
Basic or simple consent entails letting
physician can make clear to the patient
the patient know what you would like to
that
a
do; giving basic information about the
decision-making process, not merely
procedure; and ensuring that the
To
encourage
she
is
voluntariness,
participating
in
patient assents or consents to the
because there is a high-level of
intervention.
refers
to
a
community
acceptance
of
a
treatment being offered is the only or
treatment, intervention, or clinical care.
best option and/or there is low risk
Basic consent is appropriate, for
involved in the treatment If a patient
example, when drawing blood in a
does not consent under the paradigm
patient
of basic consent, then a fuller informed
patient’s
Assent
willing
who
has
given
blood
consensus
that
before. Sometimes consent to the
consent discussion is warranted.
procedure
How
is
implied
(e.g.
the
much
information
the
is
patient came in to have blood
considered "adequate"?
drawn), but an explanation of the
How do you know when you have
elements of the procedure remain
provided enough information about a
necessary.
proposed intervention? Most of the
Decisions that merit this sort of basic
literature and law in this area suggest
informed consent process require a
one of three approaches:
low-level
of
patient
involvement
ďƒ˜ Reasonable
physician
standard:
what
would
a
decision? This standard is the
typical physician say about
most
this
incorporate
intervention?
This
challenging into
to
practice,
standard allows the physician
since
to determine what information
information to each patient.
it
requires
tailoring
is appropriate to disclose.
The best approach to the question
However, this standard is
of how much information is enough
often inadequate, since most
is
research
the
professional obligation to provide
typical physician tells the
the best care and respects the
patient
patient as a person, with the right to
shows
very
that
little.
This
one
that
meets
both
your
standard is also generally
a voice in health care decisions.
considered inconsistent with
What sorts of interventions require
the goals of informed consent,
informed consent?
as
the
All health care interventions require
physician rather than on what
some kind of consent by the patient,
the patient needs to know.
following a discussion of the procedure
the
focus
ďƒ˜ Reasonable
is
on
patient
with a health care provider. Patients fill
standard: what would the
out a general consent form when they
average patient need to know
are admitted or receive treatment from
in order to be an informed
a health care institution. Most health
participant in the decision?
care institutions have policies that
This standard focuses on
state
considering what a typical
require a signed consent form. For
patient would need to know in
example, surgery, anesthesia, and
order
other invasive procedures are usually
to
understand
the
decision at hand. ďƒ˜ Subjective standard: what
which
health
interventions
in this category. These signed forms are the culmination of a dialogue
would this particular patient
required
to
foster
the
patient's
need to know and understand
informed participation in the clinical
in order to make an informed
decision.
For a wide range of decisions, explicit
without harming the patient,
written consent is neither required nor
such
needed,
emergency where the patient is
but
some
meaningful
discussion is always needed. For instance, a man contemplating having a prostate-specific antigen screen for prostate cancer should know the
as
a
life-threatening
not conscious. ďƒ˜ When the patient has waived consent. ďƒ˜ When
a
competent
patient
relevant arguments for and against this
designates a trusted loved-one
screening test, discussed in lay terms.
to make treatment decisions for him or her. In some cultures, family
members
make
treatment decisions on behalf of their loved-ones. Provided the patient
consents
to
this
arrangement and is assured that any questions about his/her medical care will be answered, the physician may seek consent from a family member in lieu of Is it ever acceptable to not have a
the patient.
full informed consent? Exceptions to full informed consent
When is it appropriate to question a
are:
patient's ability to participate in
If
the
patient
does
not
have
decision making?
decision-making capacity, such as a
In most cases, it is clear whether or not
person with dementia, in which case a
patients have capacity to make their
proxy, or surrogate decision-maker,
own decisions. Occasionally, it is not
must be found.
so clear. Patients
ďƒ˜ A
lack
of
decision-making
unusual
amount
of
are under stress
an
during
capacity with inadequate time to
illness and can experience anxiety,
find
fear, and depression. The stress
an
appropriate
proxy
associated with illness should not
What
necessarily
preclude
one
from
decision making capacity varies
participating
in
own
care.
from day to day?
one's
about
the
patient
whose
However, precautions should be taken
A patient’s decision-making capacity is
to ensure the patient does have the
variable
capacity to make good decisions.
underlying disease processes ebb and
There are several different standards
flow. You should do what you can to
of decision-making capacity. Generally
catch a patient in a lucid state - even
you should assess the patient's ability
lightening up on the medications if
to:
necessary and safe - in order to Understand
his
or
her
situation, the
risks
their
medications
or
include her in the decision making process.
Understand
as
waxing
Delirious and
patients
waning
have
abilities
to
associated with the decision at
understand information. However, if a
hand, and
careful assessment is done and
Communicate
a
decision
based on that understanding.
documented at each contact, and during lucid periods the patient
When this is unclear, a psychiatric
consistently and persistently makes
consultation can be helpful. Of course,
the same decision over time, this
just because a patient refuses a
may constitute adequate decisional
treatment does not in itself mean the
capacity for the question at hand.
patient is incompetent. Competent patients have the right to refuse
What should occur if the patient
treatment, even those treatments that
cannot give informed consent?
may be life-saving. Treatment refusal
If the patient is determined to be
may, however, be an indication that it
incapacitated/incompetent
is necessary to pause to discuss
health care decisions, a surrogate
further
and
decision maker must speak for her.
understanding about the decision, as
There is a specific hierarchy of
well as your own.
appropriate
the
patient's
beliefs
decision
to
make
makers
as
defined. If no appropriate surrogate
decision
maker
is
available,
the
reproductive health, mental health,
physicians are expected to act in the
and substance abuse.
best interest of the patient until a
The
surrogate is found or appointed. In
physician is the well-being of the child.
rare
no
Therefore, if the parental decision
a
places the child at risk of harm then
guardian ad litem may have to be
further action may be indicated. When
appointed by the court. Confer with
there
social work and risk management if
between the parents and physicians
you have trouble finding a legal
that
surrogate for the patient.
consultation may be pursued, and
circumstances,
surrogate
can
be
when identified,
primary
are
responsibility
differences
cannot
be
in
of
the
opinion
resolved
ethics
legal avenues may be pursued when How does informed consent apply
all other means have failed. Children
to children?
should be included in decision-making
Children
do
not
have
the
at a developmentally appropriate level
decision-making capacity to provide
and assent should be sought when
informed consent. Since consent, by
possible.
definition, is given for an intervention
Is
for oneself, parents cannot provide
presumed/implied consent?
informed consent on behalf of their
The patient's consent should only be
children. Instead they can provide
"presumed," rather than obtained, in
informed permission for treatment. For
emergency situations when the patient
older children and adolescents, assent
is unconscious or incompetent and no
should always be sought in addition to
surrogate decision maker is available,
the
legal
and the emergency interventions will
surrogates. Adolescents and mature
prevent death or disability. In general,
minors are legally and ethically
the
authorized
informed
hospital ward, ICU or clinic does not
consent if they are emancipated,
represent implied consent to all
they
treatment
authorization
may
matters
to
of
provide
provide
regarding
consent sexual
for and
there
such
patient's
and
a
thing
presence
in
procedures.
as
the
The
patient's wishes and values may be
quite different from the values of the
While the principle of respect for
physician.
person obligates you to do your best to include the patient in the health care decisions that affect her life and body, the principle of beneficence may require you to act on the patient's behalf when her life is at stake.
health centre (PHC). But actually,
Recently released government data on
there are 34,750 doctors sanctioned.
the rural health infrastructure and
25 states have surplus doctors in
personnel confirms that Samarin Bai's
position compared to required, the
problem of not finding doctors nearby
total surplus working out to 5,115. On
is not a rare example from some
the other hand, the remaining states
inaccessible forest. At the country level,
have a combined shortfall of 3,002
there is a staggering shortfall of 81% of
doctors.
specialist doctors, 12% of percent
The surpluses shown in healthcare
general physicians, 21% nurses and
personnel in many states are not real -
5% of auxiliary nurse cum midwives.
they arise because goal posts are
Among
staff,
shifted by lowering requirements. In
shortfalls range from 29% percent for
reality the shortages are all round. This
pharmacists
for
would apply to ANMs too which are
63%
'surplus' in 25 states/UTs amounting to
percent for radiographers. But what is
a whopping 42,548 for India. This is
more shocking is that since a decade
because the earlier standard of two
ago, many of these shortfalls have
ANMs per sub-centre has been diluted
increased except for nurses and ANM.
to one. Despite this several states
A bizarre aspect of this data put out
don't even have that sole ANM in
annually by the ministry of health is
many sub-centres.
that in many categories of health
In
personnel, some states have surplus
sub-centre for every 5000 persons (or
appointments
3000 persons in tribal and hilly areas)
laboratory
technical
to
support
45%
technicians
while
percent and
others
have
fact,
the
norm
of
having
a
shortfalls. For example, at the country
is
level, 25,308 doctors are required
national average is over 5400, with
going by the Indian Public Health
some states like UP having an above
Standards (IPHS), which says that one
7000 average. Similarly, the national
doctor is needed for every primary
average of population per PHC is
crumbling
fast.
Currently,
the
nearly 33,000 against the norm of 30,000 and the average for community health centres (CHC) is running at 1.5 lakh compared to the prescribed norm of one lakh per CHC
Lp-PLA2 Test to Gauge Heart Attack
Recently FDA Approved Drug
Risk
Repatha (evolocumab) ; Amgen; For
The test is designed for people with no
the treatment of high cholesterol,
history of heart disease, and it appears
Approved August 2015
to be especially useful for women A cardiac test that helps better predict
Addyi
future coronary heart disease risk in
Pharmaceuticals; For the treatment
women, and especially black women,
of
may help health care professionals
generalized hypoactive sexual desire
identify these patients before they
disorder, Approved August 2015
(flibanserin);
premenopausal
Sprout
women
with
experience a serious [heart disease] event, like a heart attack
Varubi (rolapitant); Tesaro; For the
The test tracks the activity of a specific
prevention of delayed nausea and
biological
vomiting
signal
inflammation, Vascular associated
of
vascular
called
inflammation with
artery-clogging
the plaques
Lp-PLA2. is
strongly
buildup in
associated
with
chemotherapay, Approved September 2015
of
blood
Synjardy
(empagliflozin
and
vessels, the FDA explained. As plaque
metformin
accumulates, arteries narrow and the
Boehringer
chances of a serious cardiovascular
treatment of type II diabetes, Approved
event increase.
August 2015
"Patients with test results that show Lp-PLA2 activity greater than the level of 225 nanomoles per minute per milliliter are at increased risk for a [heart disease] event"
hydrochloride) Ingelheim;
For
; the
server and can be accessed by any
The purpose of National Transplant
registered member of ISOT. The
Registry is to collect transplant related
information submitted will be treated
data from various centres in the
as highly confidential. So the members
country and to be able to collate the
will be able to see the data of their
data from time to time to derive the
hospital. Only collated data will be
following information
available for viewing. The site is to be
The number of transplants done in the country. Essential data
of
phase data related to kidney and liver
demographic Indian
Patients
undergoing transplants. The
developed in phases and in the first
transplants will be captured. If you are doing transplants in India (kidney, heart, liver, pancreas, lungs), you may
immunosuppressive
register on the website with your
regimes used by various
essential information and a username
centres.
and password will be sent to you within
Short term and long term
24 to 48 hours. The Registry would
results of the allograft.
help in doing a national audit to
Complications
during
understand
short
and
long
term
management in short term
outcomes in the complicated field of
and long term.
transplants.
Patient
survival
after
transplants. The HLA profile of Indian Patients. Number
of
Living
and
cadaver transplants. Relationship in case of related transplants. Profile of Donors The data will be stored in a secure