THE WATCHMEN

1 Volume - 01 September 2015-Monthly Issue Issue - 01

OF MEDICAL SCIENCES Bridging The Gap‌..!!!

- Informed Consent....Are Your Patients Properly Informed?

- Shortfall of Health Care Service Provider Free Circulation

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~ Editorial ~ EDITORIAL BOARD Editor - In - Chief Dr. Jayesh Warade

We are happy to present you the first issue of "THE WATCHMEN". This magazine is dedicated to social responsibility of medical fraternity, the obligation on the part of society toward medical fraternity, development of science, limitations of the science, issues regarding medical practice and all other aspects of this profession to create awareness among medical professionals as well as society.

All of you are requested to extend your support, provide feedback and suggestions for the success of this venture

- Editor In Chief

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6

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

7 informed consent?

With this understanding, the informed

The most important goal of informed

consent process should be seen as an

consent is that the patient has an

invitation for the patient to participate

opportunity

informed

in health care decisions. The physician

participant in her health care decisions.

is also generally obligated to provide a

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

to

 The

be

an

nature

of

the

and

share

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 encourage

Basic or simple consent entails letting

voluntariness, the physician can make

the patient know what you would like

clear to the patient that she is

to do; giving basic information about

participating

decision-making

the procedure; and ensuring that the

process, not merely signing a form.

patient assents or consents to the

vulnerable.

To

in

a

8 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

for

involved in the treatment If a patient

example, when drawing blood in a

does not consent under the paradigm

patient who has given blood before.

of basic consent, then a fuller informed

Sometimes

patient’s

Assent

willing

consent

procedure

is

appropriate,

consent is

implied

consensus

that

to

the

consent discussion is warranted.

(e.g.

the

How

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

because there is a high-level of

ďƒ˜ Reasonable standard:

physician what

would

a

9 typical physician say about

most

this

incorporate

intervention?

This

challenging it

into

requires

to

practice,

standard allows the physician

since

tailoring

to determine what information

information to each patient.

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

one

that

meets

both

your

shows

that

the

professional obligation to provide

typical physician

tells

the

the best care and respects the

This

patient as a person, with the right to

patient

very

little.

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.

decision? This standard is the

For a wide range of decisions, explicit

10 written consent is neither required nor

without harming the patient,

needed,

such

but

some

meaningful

as

a

life-threatening

discussion is always needed. For

emergency where the patient is

instance, a man contemplating having

not conscious.

a prostate-specific antigen screen for

ďƒ˜ When the patient has waived

prostate cancer should know the

consent.

relevant arguments for and against

ďƒ˜ When

a

competent

patient

this screening test, discussed in lay

designates a trusted loved-one

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

ďƒ˜ A

lack

of

decision-making

clear. Patients

unusual

amount

of

are

under an

stress

during

capacity with inadequate time to

illness and can experience anxiety,

find

fear,

an

appropriate

proxy

and

depression. The

stress

11 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,

as

the

risks

medications

or

include her in the decision making process.

 Understand

their

waxing

Delirious and

patients

waning

have

abilities

to

associated with the decision at hand,

understand information. However, if a

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

decision maker must speak for her.

the

patient's

beliefs

and

understanding about the decision, as

There

is

well as your own.

appropriate

a

specific decision

to

make

hierarchy

of

makers

as

defined. If no appropriate surrogate

12 decision

maker

is

available,

the

mental

physicians are expected to act in the

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,

health,

primary

are

and

substance

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

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 authorization of legal surrogates.

and the emergency interventions will

Adolescents and mature minors are

prevent death or disability. In general,

legally and ethically authorized to

the

provide informed consent if they

hospital ward, ICU or clinic does not

are emancipated, they may provide

represent implied consent to all

consent

treatment

sexual

do

for and

not

matters

have

regarding

reproductive

health,

there

such

patient's

and

a

thing

presence

in

procedures.

as

the

The

patient's wishes and values may be

13 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.

14

15

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%

doctors.

of 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 many

annually by the ministry of health is

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

crumbling

norm

fast.

of

having

Currently,

a

shortfalls. For example, at the country

is

the

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

16 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

17 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

(flibanserin);

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

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

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)

and

Ingelheim;

For

; the

18

With Best Complement From...

19 server and can be accessed by any The purpose of National Transplant

registered

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

Patients

undergoing transplants.  The

of

ISOT. The

developed in phases and in the first phase data related to kidney and liver

demographic Indian

member

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 results of the allograft.  Complications

24 to 48 hours. The Registry would help in doing a national audit to

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

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