IHA’s Anticoagulant
ADE Webinar Series:
Pharmacist’s Role in
Anticoagulation
October 23, 2013
1
Webinar Agenda
• Overview & Introductions – Betsy Lee
• Pharmacist’s Role in Anticoagulation – Drs. John
Hertig & Zach Weber
– Outline benefits of a pharmacist run anticoagulation
program
– Identify strategies used to implement an
anticoagulation program
– Evaluate the potential cost savings to an institution
with a pharmacist run anticoagulation program
• Wrap-up – Betsy Lee
2
IHA’s Anticoagulant
ADE Webinar #3
Medication Reconciliation with Anticoagulation
(Oct. 29 from 10 - 11 a.m. ET)
– Identify key factors to consider when performing
medication reconciliation for a patient on
anticoagulation (i.e. drug interactions, social history,
etc.)
– Identify common barriers to medication reconciliation
– Define health literacy and identify strategies to
improve health literacy for those patients on
anticoagulation therapy
3
CE Information for the IHA Anticoagulation Bootcamp CE offerings
Anticoagulation Boot Camp – Pharmacist Role in Anticoagulation
Audience – This activity is designed for pharmacists.
Learning Objectives:
1. Outline benefits of a pharmacist run anticoagulation program
2. Identify strategies used to implement an anticoagulation program
3. Evaluate the potential cost savings to an institution with a pharmacist run anticoagulation program
Pharmacist Accreditation Statement - Purdue University College of Pharmacy is
accredited by the Accreditation Council for Pharmacy Education as a provider of continuing
pharmacy education. This is a knowledge based, continuing education activity of Purdue
University, an equal access/equal opportunity institution. Universal Activity Number (UAN):
0018-0000-13-143-L01-P, 1.0 contact hours (.1 CEU).
Release Date: 10/23/2013 Expiration Date: 10/24/2013
Required for Completion – To receive credit for this FREE, live, activity, you must attend and participate in the
CPE session. At the end of the session you will receive a URL to the evaluation and request for credit site. You
must complete the requested information. Your credits will be uploaded to CPE Monitor within 4 weeks.
Faculty Disclosure Statement – All faculty AND staff involved in the planning or presentation of continuing
education activities sponsored/provided by Purdue University College of Pharmacy are required to disclose to the
audience any real or apparent commercial financial affiliations related to the content of the presentation or
enduring material. Full disclosure of all commercial relationships must be made in writing to the audience prior to
the activity. All additional planning committee members and Purdue University College of Pharmacy staff have no
relationships to disclose.
Zach Weber, PharmD, BCPS, BCACP, CDE – Purdue University – has nothing to disclose
Any CPE questions should be directed to Dawn Sinclair at (765)494-5457 or sinclaid@purdue.edu
Anticoagulation ADE Boot Camp: Pharmacist’s Role in
Anticoagulation
Zach Weber, PharmD, BCPS, BCACP, CDE
Clinical Assistant Professor
Purdue University College of Pharmacy
Clinical Pharmacy Specialist, Ambulatory Care
Wishard/Eskenazi Health
Objectives
1. Outline benefits of a pharmacist run
anticoagulation program
2. Identify strategies used to implement an
anticoagulation program
3. Evaluate the potential cost savings to an
institution with a pharmacist run
anticoagulation program
Disclosure
• Nothing to disclose
First Things First
• What practice types do
you represent?
A) Pharmacist
B) Nurse
C) Physician
D) Safety or quality leader
E) Other
Expanding Pharmacy Practice
• Pharmaceutical Care/Collaborative Practice
Concept
– “Pharmaceutical care involves the process through
which a pharmacist cooperates with patients and
other professionals in designing, implementing,
and monitoring a therapeutic plan that will produce
specific therapeutic outcomes for the patient”
AJHP 1990;46:533-43
Expanding Pharmacy Practice
• Medication Therapy Management Services (MTMS)
– “A distinct service or group of services that optimize
therapeutic outcomes for individual patients. MTMS are
independent of, but can occur in conjunction with the
provision of a medication product”
• Clinical Pharmacy Services
– Discipline of clinical pharmacy – providing specialized,
optimized direct patient care
– Clinical pharmacist
– Roles of clinical pharmacists in health care – unique set of
knowledge and skills
http://www.pharmacist.com/mtm. Accessed September 20, 2013.
http://www.accp.com/docs/positions/commentaries/Clinpharmdef
nfinal.pdf. Accessed September 27, 2013.
Outpatient Clinical Pharmacy Services
• Diseases managed
– Anticoagulation
– Lipid clinics
– Asthma
– Diabetes
– Osteoporosis
– Hypertension
– Immunizations
– Pharmacotherapy
– Infectious disease
• Service settings
– Hospital-based
outpatient clinics
– Physician clinics
– Community pharmacies
– Independent clinics
– Nursing homes
– Indian Health Service
– Self-insured employers
– Managed Care
Organizations
Anticoagulation Clinic Rationale
“Anticoagulation is a high risk treatment, which
commonly leads to adverse drug events due to
the complexity of dosing these medications,
monitoring their effects, and ensuring patient
compliance with outpatient therapy.”
Joint Commission National Patient Safety Goal Requirement 3E, 2008
N Engl J Med 2011;365:2002-12.
Anticoagulation Risks
N Engl J Med 2011;365:2002-12.
Anticoagulation Risks
N Engl J Med 2011;365:2002-12.
Anticoagulation Risks
Anticoagulation Considerations
• Warfarin challenges
– Narrow therapeutic window
– Considerable inter-subject variability
– Drug and diet interactions
– Labs difficult to standardize
– Good PK/PD understanding by both
patient/provider
– Availability of new oral anticoagulants
Cost Savings
• Reduced hospitalizations
• Reduced ED visits
• Increased medication safety/effectiveness
• Increased physician productivity
• Reduced adverse drug events
– Increased productivity/work days
– Increased quality of life
– Increased compliance
Primary cost
savings
http://www.hrsa.gov/publichealth/clinical/patientsafety/clinicalpharmacyservices.pdf
Question
What range below would be an appropriate
expectation for INR time within target range
(TTR) for warfarin therapy managed by
pharmacists?
http://www.hrsa.gov/publichealth/clinical/patientsafety/clinicalpharmacyservices.pdf
A. 30-40%
B. 40-50%
C. 50-60%
D. 60-70%
Question
What is the potential additional cost savings per
patient per year associated with reduced
hospital admissions when warfarin therapy is
managed by a pharmacist vs. a physician?
http://www.hrsa.gov/publichealth/clinical/patientsafety/clinicalpharmacyservices.pdf
A. $600-$1000
B. $1400-$1600
C. $2000-$2400
D. More than $2500
Parameter Pharmacist Care MD Care P-value
TTR* 63.5%
1
85.6%
2
67.2%
4
83.6%
5
55.2%
1
64.2%
2
54.6%
4
57.4%
5
< 0.001
1
N/A
2
< 0.0001
4
< 0.05
5
INR values/patient/year
13.8
4
7.5
4
< 0.0001
4
Hemorrhagic Events 8.2 fold increase
3
Adverse Events 5.1%
4
15.4%
4
Hospital Admissions 4%
2
1.7%
4
5.4/100 patient
-years
5
39%
2
8%
4
13.9/100 patient years
5
N/A
2
< 0.0001
4
< 0.01
5
Cost of complications
$180/person-year
3
$4,253/person-year
3
N/A
3
Total Cost/patient/year
$4,310
4
$8,461
4
N/A
4
Cost
Avoidance/patient/year
Hospital: $1,400
5
Hospital: $1,600
6
ED: $100
5
N/A
5,6
Anticoagulation Service Comparison
*TTR= INR time within target range
1. CHEST 2005;125:1515-1522
2. Am J Hosp Pharm 1985;42:304-308
3. Pharmacotherapy 1995;15:732-739
4. Pharmacotherapy 2011 31:686-694
5. Pharmacotherapy 2010;30:330-338
6. http://www.hrsa.gov/publichealth/clinical/patientsafety/clin
icalpharmacyservices.pdf
Setting Up a Clinic
• Conduct a needs assessment
– Identify treatment gaps or areas if high cost of
healthcare
• ICD-9-CM codes
• E codes: identify high-risk drugs for institutions
– E934.2 – anticoagulants
• Compliance with regional, state, or national compliance
measures
– HEDIS, The Joint Commission goals, etc.
Pharmacotherapy 2003;23:1153-1166
Setting Up a Clinic
• Outline goals for anticoagulation therapy
• Identify responsibilities of all involved parties
– Pharmacists
– Physicians
– Patient
– Support staff
– Learners
• Describe clinic workflow, documentation procedures,
and communication
• Review and/or update annually
Pharmacotherapy 2003;23:1153-1166
Setting Up a Clinic
• Building support for services
– Identify key personnel with responsibilities in an
institution
– Identify designated clinic space
• Must have own office and/or exam space
– Not ideal: waiting rooms, counters, front windows, etc.
• Include computers, printers, point-of-care devices, work
space
• Include room for learners, if needed
Pharmacotherapy 2003;23:1153-1166
Setting Up a Clinic
• Collaborative Practice Agreement
– Example: “The Pharmacy Practice Act allows
pharmacists to practice under a Collaborative Practice
Agreement with individual physicians. Pharmacist
may participate in the practice of managing and
modifying drug therapy according to a written protocol
between the specific pharmacist and the individual
physician(s) who is/are responsible for the patients
care and authorized to prescribe drugs. By signing this
document, the named physicians agree that the named
pharmacists may enter into a Collaborative Practice for
their patients.”
Pharmacotherapy 2003;23:1153-1166
Setting Up a Clinic
• Referral process
– Identify patients to be managed by the pharmacist
– Communicate relevant anticoagulation-related
information
• PMH
• Anticoagulant indication
• Special considerations
– Goal: referral is completed for all patients prior to
initial visit
Pharmacotherapy 2003;23:1153-1166
Setting Up a Clinic: Referral Process
Which providers
can refer
If patients can
self-refer
How the referral
will be made
• Electronically entered by
provider
• Handwritten/faxed order in
progress note completed by
support staff
• Handwritten/faxed form
completed by the provider
Who schedules
the patient
Referral Example
Pharmacotherapy 2003;23:1153-1166
Building Support for Services
• Physicians
– Need physician support
• Can have oversight by NPs or PAs
– Educate unaware physicians on abilities of
pharmacists as drug therapy experts
– Enlist a few key physicians with knowledge of, or
experience with, pharmacy services to garner support
from others within the practice
– Communicate ongoing treatment plans to boost
acceptance and understanding of pharmacy services
Pharmacotherapy 2003;23:1153-1166
Building Support for Services
• Nursing staff
– Nurses assisting physicians
• Identify patients who may be candidates for pharmacy-
managed services
• Provide information to patients about pharmacy-
managed services
– Nursing support
• Obtain vital signs, make telephone calls, triage patients,
place patients in exam rooms, complete laboratory tests,
etc.
Pharmacotherapy 2003;23:1153-1166
Building Support for Services
• Laboratory support
– Level of support varies
• Possible increase in number of tests and/or urgent tests due to
new pharmacy services (i.e. more acute INR results, etc.)
– POC devices
• Will number of tests and/or revenue reduce for lab services?
• Agreement with lab services
– Obtain POC test
– Maintain POC device
– Order supplies
– Run control tests
– Keep logs/records, etc.
Pharmacotherapy 2003;23:1153-1166
Building Support for Services
• Obligation to communicate to patients
– Role of the clinic team members
– Role of anticoagulation therapy
– Their responsibilities in anticoagulation
management
• Patient contract
– Terms for dismissal from the clinic
• Complete contract at initial clinic visit
Pharmacotherapy 2003;23:1153-1166
Patient
Contract
http://hfhs-formslibrary.org/forms/HFHS-03-0265MR-1009%20anticoagulation%20Pt%20Agreement.pdf
Patient Education
• Choosing patient education materials and devices
– Can be time consuming: ask clerical staff or students
– Patients can ‘check out’ videos or books
– Consider offering multiple languages
• Electronic files, if able, by disease state, literacy
level, and language
• Teaching devices: training syringes, dietary aids,
medical alert bracelets, etc.
Building Support for Services
• Billing/reimbursement
– Specific method depends on the:
• Payer
– Medicare, Medicaid, Third Party Payers, First Party Payers (self
pay)
• Setting
– Hospital-based clinics, Physician clinics, Community pharmacies,
Managed Health Care, Other
• Professional
– Pharmacists
• Other methods
– CLIA waived testing
Pharmacotherapy 2003;23:1153-1166
Ancillary Support
• Developing clinic schedule
• Developing documentation templates
– Provide summary of clinic visit
– Complete in EMR to share results with physicians
• Scheduling/rescheduling appointments
• Calling patients/appointment reminders
• Collecting insurance payments
• Processing consultations
• Ordering laboratory tests
Pharmacotherapy 2003;23:1153-1166
Building Your Books
• What days in clinic?
• What times available?
• New/return patients per day
• New patients: 20-30 minutes
• Return patients: 10-15 minutes
• Visit length for new vs. return patient
• New warfarin education
• New hospital discharge
• Peri-procedural anticoagulation
Pharmacotherapy 2003;23:1153-1166
Considerations: Clinic Scheduling
Clinic
Schedule
Integration
Overall
workload
Nursing,
medical
assistant, or
technician
requirements
Patient no-
shows
Electronic or print
review process
J Am Med Inform Assoc 2009;16(6):826-836
J Am Pharm Assoc 2003;49(1):78-85
Fam Med 2001;33(7):533-538
Ancillary Support
• Patient flow through clinic
– How does a patient enter the clinic and ultimately
get to a room to see the pharmacist?
• What are all the steps in between?
– Mirror established processes as much as possible
• Advantages: higher revenue potential, more efficient
use of time, integrated into current practice
• Disadvantages: less control over scheduling/process,
may not view/look up patients ahead of time, potential
of overbooking, potential of loss to follow up
Pharmacotherapy 2003;23:1153-1166
J Am Med Inform Assoc 2009;16(6):826-836
J Am Pharm Assoc 2003;49(1):78-85
Fam Med 2001;33(7):533-538
Patient
checks
in and
placed in
room
POC INR
performed
PharmD
reviews
INR
results
PharmD –
patient
interview
and data
processing
Patient
checkout
with follow
up
appointment
PharmD complete
note and send to
collaborating
provider for co-
signature
Established Patient
Patient
checks
in and
placed in
room
POC INR
performed
PharmD
reviews
INR
results
PharmD –
patient
interview
and data
processing
Patient
checkout
with follow
up
appointment
PharmD complete
note and send to
collaborating
provider for co-
signature
New Patient
Initial
Education
Additional Services
• Peri-procedural anticoagulation
– Dosing instructions for warfarin and enoxaparin
for procedures
Patient Care Considerations
• Urgent patient care issues
– Patient requires physician evaluation immediately,
later the same day, or next day
– Establish protocol…include office mangers,
clerical, and nursing staff in process
• Pharmacist-initiated referrals
– Who coordinates referrals made by you and
ensures appointments are made?
Documentation
• Requirements vary by state +/- additional rules
from state board of pharmacy
– Type of document (referral, order forms, etc.)
– Acceptable storage (hard copy or electronic)
– Duration of storage (i.e. 5 years)
• If no specific state rules, implement standard
of practice in neighboring states
Hard Copy Documentation
• Referral binder: provider referrals, orders, and
consultations
– Referral form: patient name, MRN, date, provider
signature, and ICD-9 code
– If billing, choose the same ICD-9 code as referring
provider
• Helpful for regulatory audits (especially if
EMR is down at time of audit)
http://www.hhs.gov/ocr/privacy/hipaa/understanding/srsummary.html. Accessed October 14, 2011
Hard Copy Documentation
• Shadow chart
– Good for portability
– Limited access to EMRs/EHRs
– Written medical chart difficult
to locate
– Quick access for learners to
review prior information
• Can contain any type of
information
• NOT a legal document
http://www.hhs.gov/ocr/privacy/hipaa/understanding/srsummary.html. Accessed October 14, 2011
Your Progress Note
Other Progress Notes
Procedure Results
Lab Values
Dosing History
(i.e warfarin)
Training and Credentialing
• Hospital-based outpatient clinic: credentialing
may be required for clinical privileges from
hospital credentialing board
– Required for all recognized providers
• Physician-based or community pharmacy:
credentials verified and documented by
administrators
Possible Additional Training
• EMR and/or POC devices
• Basic life support
• Clinical Laboratory Improvement
Amendments (CLIA) waivers
– Who will perform quality assurance tests?
• Specific payer (Medicaid), state board of
pharmacy, or physician practice group
– Diabetes, smoking cessation, immunizations, and
anticoagulation
http://wwwn.cdc.gov/clia/regs/toc.aspx. Accessed October 14, 2011.
Other Considerations
• Obtaining an identification badge
• Getting office keys made
• Ordering a pager and lab coat
• Photocopier pass code
• Business and appointment cards
• Phone, fax, and voice mail
• Ordering a copier, fax, and scanner
Tips for Success
• Preparation before starting clinic
– Ensure processes and flow of service…practice runs
• Outstanding record keeping
– Medical/legal liability
– Documentation of benefit
– Open communication between pharmacist and other
support personal
– Helping patients understand clinic benefit and
structure
• Focus on clinical responsibilities
Anticoagulation ADE Boot Camp: Pharmacists Role in
Anticoagulation
Zach Weber, PharmD, BCPS, BCACP, CDE
Clinical Assistant Professor
Purdue University College of Pharmacy
Clinical Pharmacy Specialist, Ambulatory Care
Wishard/Eskenazi Health
Thank you
54
