First Do No Harm: Support Legislative Efforts to Combat the Adverse Drug Event Epidemic  – MedCity News

If
four
full
737s
were
crashing
daily
resulting
in
total
loss
of
life,
there
would
be
a
public
outcry
and
immediate
governmental
intervention.
Yet,
we
lose
an
equivalent
number
of
people
daily
—

275,000
American
lives
annually
—
to
adverse
drug
events
(ADEs).
This
public
health
crisis
largely
goes
unnoticed
because
it
happens
to
one
mother,
one
son,
one
sister,
and
one
friend
at
a
time
in
homes,
clinics,
emergency
rooms,
nursing
homes,
and
hospitals.
Outdated
surveillance
and
reporting
systems
mean
many
more

ADEs
go
unrecorded.
Most
ADEs
occur
when
medications
are
administered
and
taken
correctly,
contrary
to
the
popular
belief
that
this
is
most
frequently
due
to
non-adherence.
The
impact
is
worse
for
women,
who
are
twice
as
likely
to
experience
ADEs,
and
for
non-White
patients.
This
is
because
clinical
trials
for
the
generic
drugs
we
primarily
prescribe
were
conducted
years
ago
and
mostly
included
only
White
males
of
European
ancestry.

While
some
medication
harm
may
be
unavoidable,
studies
indicate
that

half
or
more
can
be
prevented
by
prioritizing
education,
equitable
healthcare
access,
and
technology,
which
will
require
legislative
action.

The
growing
public
health
crisis  

In
2016,
the
last
time
it
was
measured,
we
spent

$528
billion
on
non-optimized
medication,
a
staggering
figure
that
exceeds
the
cost
of
the
drugs
themselves
or
any
major
chronic
disease.
The
more
medications
a
patient
takes,
the
higher
the
risk
of
ADEs.
Currently,

over
40
million
patients
take
five
or
more
medications
daily.
With
the
“silver
tsunami”
of
baby
boomers
aging
into
Medicare,
this
number
is
expected
to
double
by
2040.
The
time
to
act
is
now. 
  
Despite
investment
in
precision
medicine,

pharmacogenomics
(PGx)
testing
is
still
underutilized
as
a
tool
for
reducing
avoidable
medication
harm.
PGx
testing
helps
determine
which
drugs
and
doses
are
likely
to
be
safe
and/or
effective
based
on
each
patient’s
genetic
makeup.
It
is
precision
medicine
for
medications.
Unlike
other
genetic
variations
that
are
usually
uncommon,

PGx
variations
occur
in
over
99%
of
patients.
A
single,
comprehensive,
multi-gene
test
can
help
maximize
the
safety
and
efficacy
of
many
commonly
prescribed
medications
used
in
mental
health,
pain
management,
cardiovascular
care,
cancer
care,
and
more.
Drug-gene
interactions
are
very
similar
to
drug-drug
interactions
–
in
fact,
the
FDA
has
stated
in

drug
development
guidance
that
they
are
similar
in
scope
and
should
therefore
receive
similar
attention.
The
key
differentiator
is
unlike
drugs,
genetics
cannot
be
altered.
 
Consider
the

1,300
patients
that
die
each
year,
not
from
cancer,
but
from
the
fluorouracil
or
capecitabine
treatment
itself.
For

5-7%
of
patients
with
DPYD
PGx
variants,
standard
doses
of
these
medications
can
be
toxic
with
a

25.6
times
increased
risk
of
treatment
related
death.
Or,
consider
the
8%
of
patients
with
certain
PGx
variations
impacting
citalopram
and
escitalopram
metabolism
that
are

34.3%
more
likely
to
become
suicide
victims
because
the
drugs
are
processed
out
too
quickly
to
provide
treatment
benefit
or
so
slowly
that
they
increase
adverse
effects
leading
to
treatment
discontinuation.
Perhaps
also
consider
the
patients
who
continue
to
receive
clopidogrel
without
PGx
testing
despite
an

FDA
black
box,
first
added
in
2010,
warning
that
patients
with
certain
PGx
variants
are
more
likely
to
have
another
heart
attack
or
stroke.
 
 

The
promise
of
PGx
testing 
 
Biomarker
testing,
including
PGx
testing,
can
help
turn
this
tide.
Numerous
studies
have
confirmed
that
optimizing
prescribing
with
PGx
testing
reduces

emergency
room
visits,

hospitalizations,
and

healthcare
costs.
A

large
trial
in
several
European
countries
across
various
specialties
and
care
settings
showed
a
30%
reduction
in
clinically
significant
adverse
drug
events
in
just
12
weeks.
A

recent
meta-analysis
in
adult
cancer
patients
showed
a
53%
reduction
in
significant
adverse
events
with
use
of
PGx
testing.
And
despite
the
lack
of
widespread
adoption,

medical
liability
risks
are
increasing
when
evidence-based
PGx
testing
is
not
discussed
with
and
offered
to
patients.
So
why
isn’t
it
standard
of
care? 
Numerous
hurdles
stand
in
the
way
of
PGx
testing
becoming
the
standard
of
care,
including:

• 
  Inconsistent
  insurance
  coverage:
  A
  significant
  barrier
  to
  equitable
  access
  and
  adoption
  of
  biomarker
  testing,
  including
  PGx
  testing,
  is
  
  inconsistent
  insurance
  coverage
  that
  has
  not
  kept
  pace
  with
  professional
  guidelines
  and
  advances
  in
  the
  evidence.
  This
  has
  led
  to
  further
  socioeconomic,
  racial,
  and
  ethnic
  disparities
  in
  accessing
  quality
  care. 
• 
  Lack
  of
  education
  and
  clinical
  decision
  support:
  Both
  
  provider
  and
  patient
  education
  and
  prioritization
  of
  integrated
  clinical
  decision
  support
  are
  necessary
  to
  realize
  the
  benefits
  of
  genomic
  medicine,
  including
  PGx-guided
  medication
  management. 
• 
  Pharmacists’
  lack
  of
  recognition
  as
  healthcare
  providers:
  Although
  many
  states
  recognize
  pharmacists
  as
  healthcare
  providers,
  they
  are
  not
  yet
  acknowledged
  as
  providers
  at
  the
  federal
  level.
  This
  lack
  of
  federal
  recognition
  hinders
  reimbursement
  for
  pharmacists,
  despite
  their
  provision
  of
  numerous
  and
  essential
  direct-care
  patient
  services
  that
  align
  with
  their
  training,
  including
  PGx-guided
  medication
  management. 
   

Support
biomarker
legislation
and
prioritize
PGx
education

To
address
insurance
coverage
barriers,

biomarker
legislation
has
been
enacted
in
sixteen
states
including
Arizona,
California,
Georgia,
Illinois,
Maryland,
Texas,
and
New
York,
and
introduced
in
eleven
others.
The
National
College
of
Insurance
Legislators
(NCOIL)
endorsed
model
biomarker
legislation
in
the
summer
of
2023,
setting
the
stage
for
expected
nationwide
adoption.
Typically,
this
legislation
requires
state
insurance
providers,
including
Medicaid
and
commercial
payers,
to
cover
tests
that
guide
treatment
decisions
based
on
medical
and
scientific
evidence
including
testing
covered
by
CMS
NCDs,
Medicare
Administrative
Contractor
LCDS,
or
nationally
recognized
clinical
practice
guidelines
and
consensus
statements.

Medicare
LCDs
have
covered
certain
evidence-based
PGx
testing
since
2020.

Clinicians
must
prioritize
educating
themselves
about
PGx
testing
and
incorporate
it
into
their
practice
to
improve
patient
safety
and
care.
Free
resources
can
be
found

at NIH
Inter-Society
Coordinating
Committee
for
Practitioner
Education
in
Genomics
(ISCC-PEG).
Healthcare
professionals
in
states
that
have
not
enacted
biomarker
legislation
can
learn
how
to
support
state
efforts
at

ACS
CAN. 

Other
legislative
actions
and
advocacy efforts
to
improve
drug
safety
and
reduce
ADEs
are
also
in
the
works.
They
include: 

• 
  Right
  Drug
  Dose
  Now
  Act
  of
  2024
  –
  
  You
  can
  urge
  your
  congressional
  representatives
  to
  support
  this
  act
  –
  learn
  more
  and
  sign
  support
  at
  
  Fourth
  Cause.
  Reintroduced
  by
  Swalwell
  and
  Crenshaw
  at
  the
  end
  of
  March,
  this
  bipartisan
  
  act
  would:
  • 
    Require
    an
    assessment
    and
    update
    of
    the
    National
    Action
    Plan
    for
    Adverse
    Drug
    Event
    Prevention; 
  • 
    Create
    a
    healthcare
    provider
    educational
    campaign
    on
    preventing
    adverse
    drug
    events,
    in
    part
    by
    using
    evidence-based
    PGx
    information. 
  • 
    Incentivize
    updates
    to
    electronic
    health
    record
    systems
    to
    ensure
    that
    healthcare
    providers
    are
    alerted
    to
    interactions
    between
    medications
    and
    genes
    when
    making
    prescribing
    decisions; 
  • 
    Enhance
    reporting
    systems
    that
    would
    assist
    with
    the
    reporting
    of
    PGx-associated
    adverse
    drug
    events 
  • A
    second
    associated
    bill
    
    authorizes
    sustained
    funding
    for
    PGx
    implementation
    research
    and
    guideline
    development. 
• 
  Pharmacy
  and
  Medically
  Underserved
  Areas
  Enhancement
  Act  –
  The
  bill
  would
  enable
  pharmacists
  to
  deliver
  Medicare
  Part
  B
  services
  that
  are
  already
  authorized
  by
  their
  respective
  state
  laws. Learn
  more
  at
  
  ASHP. 

The
Hippocratic
oath
of
“first
do
no
harm”
can’t
stop
with
direct
patient
care;
the
healthcare
industry
and
its
key
stakeholders
must
address
persistent
public
health
problems
systematically. We
have
the
tools
to
reduce
medication
harm
by
half
or
more;
it
is
long
past
time
to
make
this
a
public
health
priority.
Common-sense
legislation
needs
to
be
passed
to
ensure
we
move
beyond
an
outdated
system
for
medication
management
and
safety
that
is
no
longer
serving
providers
or
the
patients
they
care
for.
  

Editor’s
note:
The
author
on
the
PGx
committee
of
the
NIH
Inter-Society
Coordinating
Committee
for
Practitioner
Education
in
Genomics
(ISCC-PEG),
a
member
of
the
PGx
workgroup
for
the
American
Cancer
Society
Cancer
Action
Network
(ACS
CAN)
and
serves
on
the
steering
committee
for
STRIPE,
the
FDA
collaborative
community
for
PGx.

Photo:
z_wei,
Getty
Images

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