1. Integra(ng
PDMP
Data
into
the
Clinical
Workflow
Dr.
Jinhee
Lee
Public
Health
Advisor,
Division
of
Pharmacologic
Therapies
Center,
Center
for
Substance
Abuse
Treatment,
Substance
Abuse
and
Mental
Health
Services
Dr.
Michael
O’Neil
Drug
Diversion
and
Substance
Abuse
Consultant
South
College
School
of
Pharmacy
RxSummit
2014

2. Disclosure Statement
• Jinhee
Lee
has
no
financial
rela/onships
with
proprietary
en//es
that
produce
health
care
goods
and
services.
• Michael
O’Neil
has
no
financial
rela/onships
with
proprietary
en//es
that
produce
health
care
goods
and
services.

3. Objectives
• Define
current
tools
that
are
in
place
for
prescribers
and
dispensers
to
incorporate
PDMPs
through
electronic
health
informa/on
sources.
• Evaluate
effec/veness
of
current
PDMP
programs
to
op/mally
manage
pa/ents.
• Outline
opportuni/es
to
enhance
the
access
and
effec/veness
of
PDMP
programs.
3

4. Over
prescribing
for
various
reasons……..

5. Obj. 2 Evaluate effectiveness of current PDMP programs
to optimally manage patients……………………
in the clinical environment.
• basic
clinical
applica/ons
• limita/ons
• prescriber
/
pharmacist
vs.
law
enforcement
approaches
• example
cases

6. Clarification of Acronyms
• Controlled Substance Monitoring Database (CSMD)
• Controlled Substance Monitoring Program (CSMP)
• Controlled Substance Monitoring Program Database (CSMPD)
• Prescription Monitoring Program (PMP)
• Controlled Substance Database (CSD)
• Prescription Drug Monitoring Program (PDMP)
CSMD=CSMP = CSMPD = PMP = CSD = PDMP
6

7. Intent of PDMP
“Two intents depending on the origination of legislation and
the state of origination”
• Practitioner driven with specified allowances to law enforcement /
health professional boards
• Law enforcement driven with specified allowances for specific
healthcare professionals
• The differences are BIG!!!
7

8. Use of the PDMP
• The PDMP database is a tool and NOT definitive evidence of a
crime!
• The database should be used to pose further questions to the
patients, prescribers or law enforcement.
• “………then where does the crime come in?”
8

9. Two Major components of the PDMP
1.
pa/ent
tracking
of
records
2.
prescriber
tracking
of
records
3.
surveillance
/
monitoring
/
Research
•
review
for
today
is
on
pa/ent
data
9

10. Limitations
• pa/ent
names-­‐spellings
• addresses
• date
of
birth
• accurate
NDC
codes
• accurate
prescribers
/
accurate
pa/ents….legal
ramifica/ons
• lazy
pharmacists
/
techs
• reversing
errors
(reversing
transac/ons)
• current
state
interfaces………GeVng
beWer!
But…….
• diagnosis
unknown
• error
accountability?
• federal
data…..
VA
Medical
Centers?
• repor/ng
should
go
where?
• Internet
capabili/es
/
servers
10

11. Basic Observations of the PDMP Report
• early refills
• multiple pharmacies – (be cautious, many patients swap pharmacies due to
financial incentives for every prescription transferred)
• ?multiple doctors (sometimes hard to tell)
-cross cover prescribers
-prescription renewals
-is it the same address?
• persistent or continued randomness of similar medications including escalating-
deescalating doses, variation in products
• Combinations (Soma, Oxys, Xanax)
Example: e.g. oxycodone, morphine, hydromorphone, oxymorphone
(Indication?)
11

12. Sometimes more importantly…..
What’s
not
on
the
report!
12

13. What’s Not on the Report
• prescriber
verbal
changes
• is
the
DEA
Valid?
• fixed
errors
• controlled
substances
NOT
picked
up
• wrong
entries
• federal
prescrip/ons
(VA
Medical
centers),
data
waived
• methadone
/
buprenorphine
under
federal
programs
13

14. Optimizing PDMP Report Reviews:
Running the PDMP Report
• In
todays
busy
medical
offices
and
community
pharmacies…..
unless
you
get
more
help…rarely
do
new
processes
actually
facilitate
workflow!
• Individual
prescribers
and
pharmacist
should
have
their
“own”
access
codes.
• Most
states
allow
sharing
of
access
codes
up
to
2-­‐3
individuals
(nurse
manager,
pharmacy
technician,
medical
assistant,
etc.)
• As
pa/ent
records
are
pulled
by
assistants
for
appointments
or
technicians
for
filling
prescrip/ons.
“Flags”
should
be
part
of
the
assistants
/
techs
workflow
that
prompts
running
the
PDMP.

15. Strategies to consider
• The
most
important
factor…..train
your
staff
on
how
to
run
the
report.
If
you
don’t
know….
learn.
Designate
staff!
• Request
your
local/regional
professional
agencies
to
provide
CEs
as
part
of
PDMP
training.
• At
LEAST
login
to
the
PDMP
rou/nely.
-­‐forgoWen
or
expired
passwords
cost
significant
loss
of
/me
-­‐familiarity
with
PDMP
formaVng
helps!

16. Facilita(ng
Work
Flow
with
the
PDMP
Tool;
When
to
Run
the
Report
• State
mandated
reports
(chronic
opioids
or
benzodiazepines),
opioids
>
than
3
months
• Annually
with
chronic
controlled
substances?
• The
report
does
not
need
to
be
run
for
every
pa/ent!
(unless
otherwise
mandated
by
the
state)
• Flags:
new
pa/ents,
unknown
pa/ents,
pa/ents
that
travel
long
distances,
unusual
cocktail
prescrip/ons.
• Recommended
to
go
back
At
LEAST
6months….1
year
is
usually
op/mal.

18. Case Points:
Prescribers
/
pharmacists
should
not
spend
lots
of
/me
interpre/ng
“gray
areas”.
• Rarely
is
this
ever
about
1
or
2
prescrip/ons
• Occasionally
“extra
scripts”
• Den/sts,
ER
visits
• Frequently
there
are
“clinically
relevant”
jus/fica/ons.
Clinical
judgment
is
frequently
warranted
and
reports
should
be
confirmed
via
phone
calls,
emails,
etc.
• Prescribers
and
pharmacists
are
not
looking
for
subtle/es
Everyone
is
looking
at
trends
or
paYerns
18

19. Evaluating the Printout
• Pick
drug
• Note
QTY
• Note
Dates
• Note
Prescribers
• Note
addresses
19

20. State XXX= BOARD OF PHARMACY – PATIENT PROFILE
Date 4/15/2012 Date of Birth 12-10-1966 Beginning Date: 04-01-11 =nbsp Ending Date: 04-15-12
First Name: MIKE Last Name: =OWEN
First
Name
Address
Zip
Fill
date
Rx
no.
Product
Name
Strength
Qty
Doctor
Name
Doctor
Dea
Pharm
Name
Pharm
Dea
Ph
Zip
MIKE
319
LOWER
25526
4/2/2011
11222
APAP/HYDRO
500MG-­‐10
MG
180
SMITH
JOE
DH0267890
TOM’S
PHARM
GF1234567
25526
MIKE
319
LOWER
25526
5/3/2011
19976
APAP/HYDRO
500MG-­‐10
MG
180
SMITH
JOE
DH0267890
TOM’S
PHARM
GF1234567
25526
MIKE
319
LOWER
25526
5/27/2011
23466
APAP/HYDRO
500MG-­‐10
MG
180
SMITH
JOE
DH0267890
TOM’S
PHARM
GF1234567
25526
MIKE
319
LOWER
25526
6/4/2011
31111
APAP/HYDRO
500MG-­‐10
MG
180
SMITH
JOE
DH0267890
TOM’S
PHARM
GF1234567
25526
Case
1
1. Early
Refill?
2. How
many
days
of
medica/on?
3. Change
of
prescriber?
20

21. Findings
• Early
Refillers
(professional
judgment
vs.
negligence)
• Dr.
Shoppers
• Pa/ent
cocktails
• Mul/ple
medica/ons
(polypharmacy)
• Mul/ple
prescribers
• Aberrant
paWerns
of
prescribing
medica/ons
• Escala/on
of
doses
/
de-­‐escala/on
of
doses
• Changes
in
medica/ons
• Acute
medica/ons
and
Chronic
medica/ons
• Disease
state
knowledge
Frequently
requires
clinical
judgment……..
21

22. Clarification, Verification and Documentation of
the Prescription or Whether to Even Prescribe
• Calling the prescriber(s)
- validating patient
- validating prescription
- quantity
- validating indication
• Questioning the patient
- previous prescriptions
- other practitioners
- indication
• Documentation of the query / discussion / intervention
22

23. Findings and anomalies should lead to further questions by
the prescriber, pharmacist (not technician), or investigator
• When
was
last
refill
for
drug
X
• Have
you
had
any
other
scripts
for
drug
X?
• Indica/ons
for
drug
X
/
Hx?
• Do
the
other
Drs
Know?
• Distance
Travelled?
• What
other
medica/ons
do
you
take…….where
are
they
filled?
• OK
to
call
prescriber?
23

24. Key Considerations:
Prescribers
and
pharmacists
are
making
on
the
spot
real
/me
“clinical
decisions”
with
the
PDMP.
Law
enforcement
is
not.
Law
Enforcement
is
usually
accessing
the
PDMP
AFTER
some
report,
probable
cause
or
inves/ga/on
of
diversion,
etc.
has
been
reported.
Poor
PROFESSIONAL
judgment
by
a
prescriber
is
NOT
CRIMINAL!
So
prosecu/ons
are
very
difficult,
labor
intensive,
last
forever
and
costs
big
bucks…..open
have
minimum
outcome.
State
professional
boards
MUST
step
up
enforcement
for
professional
“misbehaviors”,
poor
prac/ces
and
errors.
24

25. Complications and Barriers……
• Corporate
policies
and
procedures
• Lack
of
training
is
big
across
the
board!
• Who
to
report
is
some/mes
confusing,
frustra/ng,
difficult
• Manpower
• $$$$$
• …and
we
haven’t
even
seen
the
lawyers
yet…..
25

26. Repor(ng
Clinical
Findings
• Law
Enforcement
• Prescribers
• Colleagues

27. Case
2
First
Name
Address
Zip
Fill
date
Rx
no.
Product
Name
Strength
Qty
Doctor
Name
Doctor
Dea
Pharm
Name
Pharm
Dea
Ph
Zip
MIKE
319
LOWER
25526
4/2/2011
11222
APAP/HYDRO
500MG-­‐10MG
180
SMITHJOE
0267890
TOM’S
PHARM
FT1234567
25526
MIKE
319
LOWER
25526
4/9/11
19986
Oxymorphone
ER
20MG
60
SMITH
JOE
CS0267890
TOM’S
PHARM
FT1234567
25526
MIKE
319
LOWER
25526
4/27/2011
23466
APAP/HYDRO
500MG-­‐10MG
180
SMITH
JOE
CS0267890
TOM’S
PHARM
FT1234567
25526
MIKE
319
LOWER
25526
5/4/2011
31111
Oxycodone
ER
40
MG
45
SMITH
JOE
CS0267890
TOM’S
PHARM
FT1234567
25526
MIKE
319
LOWER
25526
5/12/2011
44445
hydromorphone
4mg
80
JONES
BILL
CJ9839432
TOM’S
PHARM
FT1234567
25526
MIKE
319
LOWER
25526
5/9/11
59986
Oxymorphone
ER
20MG
60
SMITH
JOE
CS0267890
TOM’S
PHARM
FT1234567
25526
MIKE
319
LOWER
25526
5/23/2011
69976
APAP/HYDRO
500MG-­‐10MG
180
SMITH
JOE
CS0267890
TOM’S
PHARM
FT1234567
25526
MIKE
319
LOWER
25526
5/27/2011
23466
Morphine
sulf
liq
10mg/5ml
100
SMITHJOE
CS0267890
TOM’S
PHARM
FT1234567
25526
MIKE
319
LOWER
25526
5/4/2011
31111
Oxycodone
ER
40
MG
45
SMITH
JOE
CS0267890
TOM’S
PHARM
FT1234567
25526
27

28. Summary
• PDMP
is
an
amazing
and
evolving
tool!
• The
PDMP
is
NOT
evidence
of
a
crime!
• Usually
involves
blatant,
repe//ve,
and
illegal
behaviors.
• Flags
and
strategies
can
be
ini/ated
that
help
minimize
interrup/on
of
clinician’s
work
flow.
• Enforcement
of
the
PDMP
is
also
s/ll
evolving
28

29. Integra/ng
PDMP
Data
Into
the
Clinical
Workflow
Jinhee
Lee,
PharmD
Division
of
Pharmacologic
Therapies
Center
for
Substance
Abuse
Treatment
Substance
Abuse
and
Mental
Health
Services
Administra/on

30. Status of State
Prescription Drug Monitoring Programs (PDMPs)
AK
AL
AR
CA
CO
ID
IL IN
IA
MN
MO
MT
NE1
NV
ND
OH
OK
OR
TN
UT
WA
AZ
SD
NM
VA
WY
MI
GA
KS
HI
TX
ME
MS
WI
NY
PA
LA
KY
NC
SC
FL
NH
MA
RI
CT
NJ
DE
MD
VT
WV
1
The
opera/on
of
Nebraska’s
Prescrip/on
Monitoring
Program
is
currently
being
facilitated
through
the
state’s
Health
Informa/on
Ini/a/ve.
Par/cipa/on
by
pa/ents,
physicians,
and
other
health
care
providers
is
voluntary.
2
The
Mayor
of
D.C.
has
approved
the
legisla/on
but
it
is
pending
a
30-­‐day
review
process
by
Congress.
States with operational PDMPs
States with enacted PDMP legislation,
but program not yet operational
States with legislation pending
© 2014 The National Alliance for Model State Drug Laws (NAMSDL). Headquarters Office: 215 Lincoln Ave. Suite 201, Santa Fe, NM. 87501. This
information was compiled using legal databases, state agency websites and direct communications with state PDMP representatives.
D.C.2
30

31. The
Story
So
Far
Stakeholders
Organizations
White
House
Roundtable
on
Health
IT
&
Prescrip(on
Drug
Abuse
June
3,
2011
Federal & State Partners
State Participants
Action Plan
Slide
31

32. PDMP
Workflow
Today
and
in
the
Future
• PDMPs
today
– primarily
standalone
systems
– Separated
from
rest
of
health
IT
ecosystem
– accessed
via
web
portals
– Human-­‐centric
process
• PDMPs
tomorrow
– Integrated
with
other
health
IT
in
the
pa/ent
workflow
– Machine-­‐centric
process
Page
32

33. Ac(on
Plan
Implementa(on
• SAMHSA
provided
funding
for
implementa/on
of
the
Ac/on
Plan
through
the
“Enhancing
Access
to
PDMPs
through
Health
IT
Project”.
– SAMHSA
partnered
with
ONC,
ONDCP,
&
the
CDC.
– ONC
has
management
oversight
of
the
effort.
Slide
33

34. • Goal:
Increase
/mely
access
to
PDMP
data
in
an
effort
to
reduce
prescrip/on
drug
misuse
and
overdoses.
– Explore
ways
to
use
HIT
to
link
prescribers
and
dispensers
with
the
valuable
data
in
PDMPs.
– Main
issue:
How
to
make
this
informa/on
more
available
to
three
key
groups
of
clinical
decision
makers:
Enhancing
Access
to
PDMPs
through
Health
IT
Project

35. Improve
clinician
workflow
by
connec(ng
PDMPs
to
health
IT
Support
(mely
decision-­‐making
at
the
point
of
care
Establish
standards
for
facilita/ng
informa/on
exchange
Provide
recommenda/ons
and
pilot
input
Test
the
feasibility
of
using
health
IT
to
enhance
PDMP
access
Reduce
prescrip+on
drug
misuse
and
overdose
in
the
United
States
Enhancing
Access
to
PDMPs
through
Health
IT
Project

36. Phase
1
Pilots:
Overview
36

37. Phase 2 Pilots - Overview
State
End
User
Pilot
Summary
Illinois
Emergency
Department
• Automated
query
via
intermediary
and
interstate
hub
to
PDMP
upon
pa/ent
admission
to
ED
• PDMP
data
integrated
into
EHR
as
a
PDF
via
a
Direct
message
Indiana
Emergency
Department
• Automated
query
via
HIE
to
mul/ple
states’
PDMPs
upon
pa/ent
admission
to
ED
• Pa/ent
risk
score
and
PDMP
data
integrated
into
EHR
Kansas
Providers
• Unsolicited
report
of
at-­‐risk
pa/ents
sent
via
Direct
to
EHR-­‐integrated
mailboxes
Michigan
Providers
• Automated
query
via
e-­‐Prescribing
sopware
to
mul/ple
states’
PDMPs
and
result
integrated
in
pa/ent’s
medica/on
history
Nebraska
Emergency
Department
• Automated
query
via
HIE
to
PDMP
upon
pa/ent
admission
to
ED
• Easy
access
to
PDMP
with
SSO
• PDMP
data
integrated
into
EHR
Oklahoma
Emergency
Department
• Established
PDMP
access
directly
though
an
HIE
• Developed
a
SSO
from
the
EHR
through
the
HIE
to
the
PDMP
• Alert
flag
represen/ng
the
PDMP
data
Tennessee
Pharmacy
• Real-­‐/me
repor/ng
of
dispensing
controlled
substance
data
to
the
PDMP
using
an
exis/ng
network
Slide
37

38. • Enhancing
Access”
Pilot
White
Papers:
Eight
papers
detailing
each
pilot’s
design,
technical
configura/on,
outcomes,
and
plans
for
expansion.
The
white
papers
also
highlight
various
personal
anecdotes
from
the
par/cipants
who
wrote
about
how
they
integrated
PDMP
data
into
their
clinical
workflow
and
the
success
it
had
on
their
prac/ce.
• The
Road
to
Connec+vity:
A
roadmap
for
connec/ng
to
PDMPs
through
health
IT.
• Work
Group
Recommenda+ons–Final
Report:
Stakeholders
iden/fied
challenges
and
recommended
solu/ons
to
increase
/mely
use
of
PDMP
data
by
clinicians.
More
than
94
people
across
53
organiza/ons
formed
work
groups
to
define
barriers
and
rapidly
finalize
recommenda/ons
to
address
the
problem.
• Videos:
Pilot
par/cipants
detail
their
individual
baWles
against
prescrip/on
drug
abuse,
recalling
the
advantages
of
their
state’s
PDMP
including
real-­‐/me
repor/ng
and
how
they
used
health
IT
to
connect
clinicians
to
this
important
database.
• PDMPConnect:
A
website
providing
a
forum
for
connec/ng
members
of
the
PDMP
community
to
share
valuable
experience,
informa/on,
and
resources
wherever
they
are.
**All
resources
available
at:
www.healthit.gov/pdmp
Enhancing
Access
to
PDMP
using
Health
IT
Phases
1&2:
Resources

39. SAMHSA
-­‐
PDMP
EHR
Coopera(ve
Agreements
• FY
12
–
Provided
2
year
funding
for
9
states:
FL,
IN,
IL,
KS,
ME,
OH,
TX,
WA,
WV
• FY
13
–
Provides
2
year
funding
for
7
states:
KY,
MA,
ND,
NY,
RI,
SC,
WI
– Purpose:
1)
Improve
real-­‐/me
access
to
PDMP
data
by
integra/ng
PDMPs
into
exis/ng
technologies
like
EHRs
(FY12,13)
2)
Strengthen
currently
opera/onal
state
PDMPs
by
increasing
interoperability
between
states
(FY12)
3)
Evaluate
whether
these
enhancements
have
an
impact
on
prescrip/on
drug
abuse
(FY12)
Slide
39

40. PDMP
EHR
Coopera(ve
Agreement
State
Updates
• Illinois*
– Currently
connected
to
Anderson
Hospital.
• Over
700
requests
per
week
to
IL
PMP
• Requests
triggered
upon
pa/ent
presenta/on
or
admission
to
ER.
• PMP
report
returned
and
presented
on
select
worksta/ons
in
the
ER
and
immediate
care
loca/ons
– Plans
to
integrate
with
a
EMR
sopware
company
that
is
used
by
many
opioid
treatment
programs.
• Tes/ng
to
begin
within
the
next
30
days
– Plans
to
bring
another
hospital
online
within
the
quarter
– Within
the
next
6
months,
three
hospitals
fully
implemented
and
five
hospitals
in
the
tes/ng
stage
• West
Virginia
– Planning
with
a
clinic,
hospital
and
the
West
Virginia
Health
Informa/on
Network
con/nues.
Slide
40
*Murzynski,
Stanley.
“Illinois
PMP
SAMHSA
Grantee
Mee/ng
on
Data
Integra/on.”
PowerPoint
presenta/on.
SAMHSA,
Rockville,
MD.
19
Feb
2014.

41. PDMP
EHR
Coopera(ve
Agreement
State
Updates
(cont)
• Kansas*
– Integra/on
at
Via
Chris/
Hospital
fully
func/onal
• K-­‐TRACS
is
integrated
into
the
physician’s
workflow
• VC
currently
has
267
users
+
– Integra/on
with
LACIE
(Lewis
And
Clark
Informa/on
Exchange)
• Tes/ng
successfully
completed
• Hospital
pilot
an/cipated
by
end
of
this
month
• An/cipate
3-­‐4K
users
in
the
KC
metro
– Integra/on
with
major
pharmacy
chain
• Ohio**
– Currently
integrated
into
the
EMR
of
22
hospitals
and
6
primary
care
prac/ces
– Plans
to
expand
and
integrate
into
over
200
community
pharmacies,
addi/onal
hospitals,
and
15
ambulatory
clinics
Slide
41
*Singleton,
Marty.
“Kansas
PDMP
Status
Update.”
PowerPoint
presenta/on.
SAMHSA,
Rockville,
MD.
19
Feb
2014.
**Garner,
Chad.
“Bringing
Ohio’s
PMP
Into
the
Clinician
Workflow.”
PowerPoint
presenta/on.
CADCA,
Na/onal
Harbor,
MD.
4
Feb
2014.

42. Now
and
Then
Enhancing
Access
to
PDMPs
using
Health
IT
project
–
Phases
1
&
2
• September
2011
-­‐
March
2013
• Pilots
demonstrated
proof
of
concept.
• Various
non-­‐standard
approaches
were
also
used
that
need
to
be
refined
or
harmonized
with
the
exis/ng
porzolio
of
standards
and
implementa/on
specifica/ons.
• Abbreviated
S&I
Ini/a/ve
(Jan
–
March
2013)
 Did
not
iden/fy,
evaluate
and
harmonize
standards
for
the
exchange
of
informa/on
from
PDMP
to
EHRs
or
HIEs.
 Valuable
feedback
from
stakeholders
but
only
iden/fied
where
standards
were
needed
and
the
poten/al
standards
that
could
be
used.
PDMP
&
Health
IT
Integra>on
Ini>a>ve
–
Phase
3
• November
2013
–
TBD
• Full
S&I
Framework
Ini/a/ve
• Assess
the
current
PDMP
infrastructure
and
available
standards
that
could
be
harmonized
to
allow
interoperable
communica/ons
between
PDMPs
and
health
IT
systems.

43. PDMP
Ecosystem
Pharmacy
PMPi /
RxCheck PDMP
Other
State
PDMPs
NCPDP
Script
PDMP
Portal
Switches
NCPDP
Telecom
ASAP
Pharmacy
Benefits Mgmt
Provider
EHR System
NIEM-­‐PMP
NIEM-­‐PMP
Provider
EHR System
Provider
EHR System
Data
Out
Needs
for
standards
(data
format
and
content;
transport
and
security
protocols)

44. PDMP
Interoperability
Challenges
• One
of
the
current
technical
barriers
to
interoperability
is
the
lack
of
standard
methods
to
exchange
and
integrate
the
prescrip/on
drug
data
available
in
PDMPs
into
health
IT
systems.
– Lack
of
common
technical
standards
and
vocabularies
to
enable
PDMPs
to
share
computable
informa/on
with
the
EHR
that
providers
can
use
to
support
clinical
decision-­‐
making.
• To
achieve
interoperability,
consistent
and
standardized
electronic
methods
need
to
be
established
to
enable
seamless
data
transmission
between
PDMPs
and
health
IT
systems.

45. 45
• A
collabora/ve
community
of
par/cipants
from
the
public
and
private
sectors
who
are
focused
on
providing
the
tools,
services
and
guidance
to
facilitate
the
func/onal
exchange
of
health
informa/on.
• Creates
a
open
and
transparent
process
where
healthcare
stakeholders
can
focus
on
solving
real-­‐world
interoperability
challenges.
• Is
a
consensus-­‐driven,
coordinated,
incremental
standards
process.
Each
S&I
Ini/a/ve
focuses
on
narrowly-­‐defined,
broadly
applicable
challenge,
tackled
through
a
rigorous
development
cycle,
and
provides
input
to
Federal
Advisory
CommiWees
for
considera/on.
The Standards &
Interoperability (S&I) Framework:

46. ONC Standards and Interoperability
(S&I) Framework Lifecycle
Our Missions
» Promote a sustainable ecosystem that drives increasing interoperability and standards adoption.
» Create a collaborative, coordinated, incremental standards process that is led by the industry in solving
real world problems.
» Leverage “government as a platform” – provide tools, coordination, and harmonization that will support
interested parties as they develop solutions to interoperability and standards adoption.
46
Tools and Services
Use Case
Development
and Functional
Requirements
Standards Development
Support
Certification
and Testing
Harmonization of
Core Concepts
Implementation
Specifications
Pilot Demonstration
Projects
Reference
Implementation
Architecture Refinement and Management

47. PDMP
&
Health
IT
Integra(on
Ini(a(ve
Purpose
&
Goals
• The
purpose
of
this
ini/a/ve
is
to
bring
together
the
PDMP
and
health
IT
communi/es
to
standardize
the
data
format,
and
transport
and
security
protocols
to
exchange
pa/ent
informa/on
between
PDMPs
and
health
IT
systems
(e.g.,
EHRs
pharmacy
systems).
• The
specific
goals
are:
– Iden/fy
exis/ng
connec/ons
that
consume
PDMP.
– Iden/fy,
evaluate,
and
harmonize
the
data
format(s)
sent
from
PDMPs
to
EHRs.
– Evaluate
and
select
transport
protocol(s)
systems
support.
– Evaluate
and
select
security
protocol(s)
systems
support.
– Map
selected
health
IT
standards
to
standards
already
in
use
for
PDMP-­‐to-­‐PDMP
interstate
exchange.
• The
results
of
this
work
would
enable
health
care
providers
to
make
more
informed
clinical
decisions
though
/mely
and
convenient
access
to
PDMP
data
in
an
effort
to
reduce
prescrip/on
drug
misuse
and
overdose
in
the
United
States.
47

48. PDMP
&
Health
IT
Integra(on
Ini(a(ve
Stakeholder
Community
10%
15%
6%
13%
11%
45%
HIT/EHR,
Vendors/PHR
and
Associa/ons
Provider/Provider
Organiza/ons
SDOs/Analy/cs/Research
Federal/State/Local
Agencies
Other
State
PDMP/PMP/Or
Affiliate
48
• This
is
an
open
government
ini/a/ve.
To
succeed,
the
S&I
Framework
works
with
a
set
of
mo/vated
organiza/ons
and
individuals
who
share
the
mission
and
goals
of
care
delivery
transforma/on
through
improved
interoperability.
Stakeholder
Par(cipa(on
by
Industry
(n=190)

49. Phase
Planned
Ac(vi(es
Pre-­‐Discovery
• Development
of
Ini/a/ve
Background
• Development
of
Ini/a/ve
Charter
• Defini/on
of
Goals
&
Ini/a/ve
Outcomes
Discovery
• Crea/on/Valida/on
of
Use
Cases,
User
Stories
&
Func/onal
Requirements
• Iden/fica/on
of
interoperability
gaps,
barriers,
obstacles
and
costs
• Review
of
Vocabulary
Implementa(on
• Crea/on
of
aligned
specifica/on
• Documenta/on
of
relevant
specifica/ons
and
reference
implementa/ons
such
as
guides,
design
documents,
etc.
• Valida/on
of
Vocabulary
• Development
of
tes/ng
tools
and
reference
implementa/on
tools
Pilot
• Valida/on
of
aligned
specifica/ons,
tes/ng
tools,
and
reference
implementa/on
tools
• Revision
of
documenta/on
and
tools
Evalua(on
• Measurement
of
ini/a/ve
success
against
goals
and
outcomes
• Iden/fica/on
of
best
prac/ces
and
lessons
learned
from
pilots
for
wider
scale
deployment
• Iden/fica/on
of
hard
and
sop
policy
tools
that
could
be
considered
for
wider
scale
deployments
S&I
Framework
Phases
&
PDMP
&
Health
IT
Integra/on
Ac/vi/es
49
We are Here

50. 50
• 1.0
Preface
and
Introduc(on
• 2.0
Ini(a(ve
Overview
– 2.1
Ini/a/ve
Challenge
Statement**
• 3.0
Use
Case
Scope
– 3.1
Background**
– 3.2
In
Scope
– 3.2
Out
of
Scope
– 3.3
Communi/es
of
Interest
(Stakeholders)
**
• 4.0
Value
Statement**
• 5.0
Use
Case
Assump(ons
• 6.0
Pre-­‐Condi(ons
• 7.0
Post
Condi(ons
• 8.0
Actors
and
Roles
• 9.0
Use
Case
Diagram
PDMP
&
Health
IT
Integra(on
Ini(a(ve
Use
Case
Outline
• 10.0 Scenario: Workflow
– 10.1 User Story 1, 2, x, …
– 10.2 Activity Diagram
o 10.2.1 Base Flow
o 10.2.2 Alternate Flow (if needed)
– 10.3 Functional Requirements
o 10.3.1 Information Interchange
Requirements
o 10.3.2 System Requirements
– 10.4 Sequence Diagram
• 11.0 Dataset Requirements
• 12.0 Risks, Issues and Obstacles
• Appendices
– Privacy and Security Considerations
– Related Use Cases
– Previous Work Efforts
– References
** Leverage content from Charter

51. While it is understood that there are various workflows that can take place when a
Healthcare Professional queries a PDMP (see full context diagram), for the purposes of
this use case, we will be focusing on the transactions originating from the HIT to the next
end point, which would be the PDMP, a Hub, or HIE/Pharmacy Intermediary
• Scenario
#1
–
HIT
to
In-­‐State
PDMP
• Scenario
#2
–
HIT
to
Hub
• Scenario
#3
–
HIT
to
HIE/Pharmacy
Intermediary
EHR
or
Pharmacy
System
EHR
or
Pharmacy
System
Hub
EHR
or
Pharmacy
System
HIE/
Pharmacy
Intermediary
51
PDMP
&
Health
IT
Integra(on
Ini(a(ve
Use
Case
Scenarios
-­‐
examples

52. SDO
Ballo(ng,
RI
&
Pilots*
Standards
&
Harmoniza(on
Process
The
Harmoniza/on
Process
provides
detailed
analysis
of
candidate
standards
to
determine
“fitness
for
use”
in
support
of
Ini/a/ve
func/onal
requirements.
The
resul/ng
technical
design,
gap
analysis
and
harmoniza/on
ac/vi/es
lead
to
the
evalua/on
and
selec/on
of
drap
standards.
These
standards
are
then
used
to
develop
the
real
world
implementa/on
guidance
via
an
Implementa/on
Guide
or
Technical
Specifica/on
which
are
then
validated
through
Reference
Implementa/on
(RI)
and
Pilots.
The
documented
gap
mi/ga/on
and
lessons
learned
from
the
RI
and
Pilot
efforts
are
then
incorporated
into
an
SDO-­‐balloted
ar/fact
to
be
proposed
as
implementa/on
guidance
for
Recommenda/on.
*Depending
on
the
ini>a>ve
the
SDO
Ballo>ng,
RI
&
Pilot
ac>vi>es
may
occur
prior
to
the
recommending
a
harmonized
standard,
this
also
means
that
ongoing
pilots
can
provide
feedback
to
draK
standards
or
specifica>ons;
May
not
be
applicable
to
the
PDMP
&
HIT
Integra>on
Ini>a>ve
Leveraged
from
previous
S&I
Ini+a+ves
52
Implementa(on
Guidance
for
Real-­‐World
Implementers
Drar
Harmonized
Profile/
Standard
Evalua/on
and
Selec/on
of
Standards
Valida/on
of
Standard
Harmonized
Profile/Standard
for
Recommenda(on
Use
Case
Requirements
Candidate
Standards
Technical
Design
Standards
&
Technical
Gap
Analysis

53. Standardiza(on
Development
&
Harmoniza(on:
Workflow
Outputs
1. Validate
candidate
standards
list
2. Map
UCR
to
candidate
standards
3. Analyze
mapped
standards
per
HITSC
criteria
to
narrow
down
any
conflic(ng
standards
resul/ng
from
the
UCR-­‐
Standards
mapping
4. Perform
technical
feasibility
of
analysis
5. Review
with
community
Use
Case
Requirements
Crosswalk
1. Develop
gap
mi/ga/on
plan
2. Drap
Solu/on
diagram
3. Validate
solu/on
plan
2. Confirm
data
model
approach
4. Modify/harmonize
exis/ng
standard(s)
to
produce
final
standards
5. Achieve
community
consensus
or
agreement
Final
standards
1. Using
final
standards,
develop
Implementa/on
Guide
document
2. Document
IG
Conformance
Statements
in
RTM
3. Develop
Examples
to
inform
implementers
4. Validate
examples
5. Achieve
community
consensus
or
agreement
Implementa(on
Guide
1. Survey
SDO
or
standards
organiza/on
op/ons
2. Select
ballo/ng
approach
3. Align
/meline
with
ballot
cycles
4. Submit
documents
informing
SDO
of
intent
to
ballot
5. Submit
content
to
SDO
6. Conduct
ballo/ng
cycle
&
reconcilia/on
per
SDO
guidelines
Balloted
standards
Evaluate
Standards
Plan
for
Solu(on
and
Final
standards
Develop
Implementa(on
Guide
*SDO
Ballo(ng
53

54. Harmoniza/on
Timeline
Week
Target
Date
(2014)
All
Hands
WG
Mee(ng
Tasks
Review
&
Comments
from
Community
via
Wiki
page
due
following
Monday
@
12
noon
1
3/25
Harmoniza(on
Kick-­‐Off
&
Process
Overview
Introduce:
Overview
of
UCR-­‐Standards
Mapping
Review:
N/A
2
4/1
Introduce:
Candidate
Standards
List
&
UCR-­‐Standards
Mapping
Review:
Candidate
Standards
List
3
4/8
Finalize:
Candidate
Standards
List
Review:
UCR-­‐Standards
Mapping
Review:
UCR-­‐Standards
Mapping
4
4/15
Review:
UCR-­‐Standards
Mapping
Review:
UCR-­‐Standards
Mapping
5
4/22
Finalize:
Outcome
of
UCR-­‐Standards
Mapping
Introduce:
Gap
Mi(ga(on
Plan
Review:
Gap
Mi(ga(on
Plan
6
4/29
Finalize:
Gap
Mi(ga(on
Plan
Introduce:
HITSC
Evalua(on
Review:
HITSC
Evalua(on
7
5/6
Review:
HITSC
Evalua(on
Review:
HITSC
Evalua(on
8
5/13
Finalize:
Full
Review
of
HITSC
Evalua(on,
Total
Ra(ngs,
List
of
Final
Standards
for
Solu(on
Plan
Introduce:
Solu(on
Plan
Review:
Solu(on
Plan
9
5/20
Review:
Solu(on
Plan
Review:
Solu(on
Plan
10
5/27
Finalize:
Solu(on
Plan
Introduce:
Implementa(on
Guide
(IG)
Template
Review:
Implementa(on
Guide
Template
11-­‐15
6/3
–
7/1
Review:
Implementa(on
Guide
Review:
Implementa(on
Guide
16-­‐17
7/8
–
7/15
End-­‐to-­‐End
Community
Review
of
Implementa(on
Guide
End-­‐to-­‐End
Review
of
Implementa(on
Guide
18
7/22
Consensus
Vote

55. PDMP Project Timeline
Kick-­‐off
(11/14)
Pre-­‐Discovery,
Call
for
Par/cipa/on
Jan
14
June
14
Discovery
Ini(a(ve
End
55
Nov
13
July
14
Mar
14
Implementation Pilot
User
Stories,
Use
Cases,
Func/onal
Requirements
Standards
Gap
Analysis
Harmonized
Specifica/ons
Technology
Evalua/ons
Reference
Model
Implementa/on
&
Valida/on
Use
Case
Kick
Off
Use
Case
Consensus
Standards
and
Harmoniza(on
Kick
Off
Pilot
Kick
Off

56. Join
us!
• The PDMP & Health IT Integration Initiative is open for anyone
to join
• This community meets each week on Tuesday from
12:00-1:30 pm ET by webinar and teleconference.
• We use Wiki pages to facilitate discussion. Information on
how to join the Community can be found on the PDMP &
Health IT Integration Initiative:
• http://wiki.siframework.org/PDMP+%26+Health+IT+Integration
+Homepage
• In order to ensure the success of our initiative and the
subsequent pilots, we encourage broad and diverse
participation from the community.
• This is your chance to have an impact on the creation and implementation of pilots that will use
selected standards in transactions between PDMPs and Health IT systems.
56

57. PDMP
&
Health
IT
Integra(on
Ini(a(ve
Resources
57
• Initiative Wiki Homepage
– http://wiki.siframework.org/PDMP+%26+Health+IT+Integration
+Homepage
• Become a Community Member
– http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Join
+the+Initiative
• Project Charter
– http://wiki.siframework.org/PDMP+%26+Health+IT+Integration
+Charter+and+Members
• Standards and Interoperability(S&I) Framework
– http://wiki.siframework.org/Introduction+and+Overview
• S & I Calendar of Events
– http://wiki.siframework.org/Calendar

58. PDMP
&
Health
IT
Integra(on
Ini(a(ve
Support
Leads
• For questions, please feel free to contact our support team:
– Initiative Coordinators:
• Johnathon Coleman jc@securityrs.com
• Sherry Green sgreen@namsdl.org
– ONC Leads:
• Jennifer Frazier Jennifer.Frazier@hhs.gov
• Helen Caton-Peters Helen.Caton-Peters@hhs.gov
– SAMHSA Leads:
• Jinhee Lee Jinhee.Lee@samhsa.hhs.gov
• Kate Tipping Kate.Tipping@samhsa.hhs.gov
– Support Team:
• Project Management:
– Jamie Parker jamie.parker@esacinc.com
– Ali Khan Ali.Khan@esacinc.com (Support)
• Use Case Development:
– Presha Patel presha.patel@accenture.com
– Ahsin Azim Ahsin.Azim@accenture.com (Support)
• Vocabulary and Terminology Subject Matter Expert:
– Mark Roche mrochemd@gmail.com
58

59. Thank
you!
Jinhee
Lee,
PharmD
jinhee.lee@samhsa.hhs.gov
The findings and conclusions in this report are those of the author and do not necessarily
represent the views of the Substance Abuse and Mental Health Services Administration.
Slide
59