1. No category

Financial Disclosures
§  None to report
National Action Plan for Adverse Drug Event Prevention:
Key Public Health Issues in Anticoagulation Management
Nadine Shehab, PharmD, MPH
Division of Healthcare Quality Promotion, CDC
13th National Conference of the
Anticoagulation Forum
Thursday, April 23rd, 2015
Washington, DC
U.S. Department of Health & Human Services (HHS)
Centers for Disease Control and Prevention (CDC)
http://www.hhs.gov
http://www.cdc.gov
1
2
Objectives
§  Provide a brief overview of the national
epidemiology of anticoagulant adverse drug
events (ADEs)
Anticoagulant ADEs:
Opportunity for Impact
§  Introduce a new U.S. Department of Health and
Human Services (HHS) initiative targeted at
anticoagulant ADE prevention
§  Discuss key public health actions for advancing
anticoagulation safety identified in the HHS
National Action Plan for ADE Prevention
3
4
Inpatient ADEs
Inpatient ADEs:
Contribution of Anticoagulants
§  All ADEs
– 
– 
– 
– 
§  All ADEs
Affect ~1.9 million U.S. hospital stays annually (2008)
Drugs: most common causes of inpatient complications
Increase hospital LOS by ~ 1.7 to 4.6 days
~3.5 billion (2006 USD) hospital costs
– 
– 
– 
– 
Affect ~1.9 million U.S. hospital stays annually (2008)
Drugs: most common causes of inpatient complications
Increase hospital LOS by ~ 1.7 to 4.6 days
~3.5 billion (2006 USD) hospital costs
§  Anticoagulant ADEs (excessive
bleeding)
–  Most common ADE in a nationally
representative sample of hospitalized
Medicare beneficiaries (2008)
–  Contributed to 5 of 12 deaths due to
all adverse events (drug and non-drug
related)
Lucado J et al. HCUP Statistical Brief #109. April 2011. Agency for Healthcare Research and Quality, Rockville, MD.
Classen DC et al. Health Aff (Millwood) 2011;30:581–9.
Institute of Medicine. Preventing Medication Errors: Quality Chasm Series. Washington, DC: The National Academies Press, 2006.
HHS Office of Inspector General (OIG). Washington, DC. November 2010. Report No.: OEI-06-09-00090.
5
6
1 Long-term Care ADEs:
Contribution of Anticoagulants
Outpatient ADEs
§  All ADEs
– 
– 
– 
– 
Affect ~1.9 million U.S. hospital stays annually (2008)
Drugs: most common causes of inpatient complications
Increase hospital LOS by ~ 1.7 to 4.6 days
~3.5 billion (2006 USD) hospital costs
All ADEs
Hospital
Admissions
Emergency
Dept Visits
§  Anticoagulant ADEs (excessive
bleeding)
Physician
Office
Visits
–  Second most common ADE in a
nationally representative sample of
Medicare SNF residents (2011)
–  One-half of anticoagulant ADEs
judged to be preventable by
physician reviewers
HHS Office of Inspector General (OIG). Washington, DC. February 2014. Report No.: OEI-06-11-00370.
SNF Skilled Nursing Facility
~280,000
~1 million
~ 3.5 million
Annually
7
Bourgeois FT et al. Pharmacoepidemiol Drug Saf 2010;19:901–10.
CDC, unpublished data: Update to: Budnitz DS et al. JAMA 2006;296:1858–66.
8
Outpatient ADEs (ED Visits):
Contribution of Anticoagulants
All ADEs
Hospital
Admissions
Emergency
Dept Visits
Physician
Office
Visits
~68% ED visits: acute
hemorrhage (e.g., GI
hemorrhage, epistaxis)
~280,000
~1 million
~ 3.5 million
§  Warfarin second most
commonly implicated
drug in U.S. emergency
department (ED)visits for
ADEs (2004-2005)
Annually
~27% ED visits: laboratory
abnormalities (e.g.
elevated INR), fall/injury
while on warfarin
−  2006-2008: ~60,000 ED
visits for warfarin ADEs,
annually
−  2013: ~ >100,000 ED
visits for warfarin ADEs*
Budnitz DS et al. JAMA 2006;296:1858–66. Shehab N et al. Arch Int Med 2010;70:1926–33.
*CDC, unpublished data. Update to Budnitz DS et al. JAMA 2006;296:1858–66.
~40% ED visits for acute
hemorrhage resulted in
hospital admission
9
Outpatient ADEs
(Hospital Admissions)
10
Anticoagulation Underutilization and
Effectiveness Must be Addressed
Alongside Safety
§  ADEs responsible for ~100,000
emergent hospitalizations in
older Americans, annually*
§  Anticoagulants are underutilized in the U.S.
population
–  Less than one-half of AF patients eligible for warfarin
receiving it
–  Over 75% of patients with VTE may be non-adherent
with warfarin
−  ~ 67% resulting from just
four medication classes
(anticoagulants, insulin,
oral hypoglycemics,
antiplatelets)
§  Clinician & patient concerns around toxicity
(bleeding) contribute to underutilization
−  ~ 66% resulting from
unintentional overdoses or
supratherapeutic effects
Budnitz DS et al. N Engl J Med 2011;365:2002–12.
*Based on data from 2007-2009 in adults ≥65 years of age. Shehab N et al. Arch Int Med 2010;70:1926–33.
ED Emergency Department; GI Gastrointestinal; INR International Normalized Ratio
–  Our goal: to help advance the field of anticoagulation
safety to minimize these concerns
11
Beyth RJ et al. J Gen Intern Med 1996;11:721–8; Monette J et al. J Am Geriatr Soc 1997;45:1060–5; McCormick D et al. Arch Intern Med
2001;161:2458–63; Casciano JP et al. J Manag Care Pharm 2013;19:302–16; Chen SY et al. J Manag Care Pharm 2013;19:291–301.
12
AF Atrial fibrillation; VTE Venous thromboembolism
2 Federal Partners Represented
Office of the Assistant Secretary for Health
Administration for Community Living/
Administration on Aging
Agency for Healthcare Research and Quality
Assistant Secretary for Planning and Evaluation
Bureau of Prisons
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Department of Defense
Food and Drug Administration
Health Resources and Services Administration
Indian Health Service
National Institutes of Health
Office of Disease Prevention and Health Promotion
Office of the National Coordinator for Health IT
Veterans Health Administration
HHS Initiative on ADE
Prevention Launched
13
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What the ADE Action Plan
is About
The Charge
§  Form inter-Departmental, public, and
public-private partnerships
ü  Identify medication safety targets for Federal efforts
ü  Catalyze Federal agency efforts in medication safety
§  Initiate discussions that identify coordinated
Federal approaches to ADEs that are:
ü  Catalogue Federal agency best practices in
medication safety (e.g., IHS, VA)
–  Common
–  Clinically significant (complicate care, resourceconsuming)
–  Measurable (local, regional, or national)
–  Preventable
ü  Coordinate Federal agency activities in medication
safety
ü  Communicate among Federal agencies and with
public & private stakeholders
§  Incorporate approaches into a National
Action Plan for ADE Prevention IHS Indian Health Service; VA Veterans Administration
15
What the ADE Action Plan
is Not About
16
Past Success: HAI Action Plan
§  Creating clinical guidelines
§  Preventing all ADEs
–  Acknowledgment: subset of patients for
whom harms (bleeding) cannot be prevented §  “Penalizing” clinicians
–  Instead: helping to facilitate path for optimal
anticoagulation management
17
http://www.health.gov/hai/prevent_hai.asp
18
3 Using Data for Action:
Reductions in HAIs Achieved
The Targets (Phase 1)
§  Inpatient and outpatient harms resulting
from:
~20% reduc+on in SSIs from 2008 to 2012 1.  Anticoagulants
SIR 2.  Diabetes agents (oral agents, insulin)
3.  Opioids
~44% reduc+on in CLABSIs from 2008 to 2012 http://www.cdc.gov/hai/progress-report/index.html; HAIs Healthcare-associated infections; CLABSIs Central line-associated
bloodstream infections; SIR Standardized Infection Ratio; SSIs Surgical Site Infections
−  Acute pain
−  Non-malignant, chronic pain
19
20
Federal Interagency Workgroup for
Anticoagulant ADEs
Draft National Action Plan for ADE
Prevention Published Sep 4, 2013
Federal Interagency Steering CommiAee for Adverse Drug Events §  Convened from December 2012
to June 2013
Workgroup 1
ANTICOAGULANTS
Surveillance
Health IT
EvidenceBased
Prevention
Tools
Health IT
Incentives &
Oversight
Health IT
Research
(Unanswered
Questions)
Health IT
Public Comments received:
§  Cardiology/Hematology
–  Anticoagulation Forum
–  American Heart Association
–  American Society of Hematology
–  National Blood Clot Alliance
–  New York State Anticoagulation Coalition
§  Geriatrics (American Geriatrics Society)
§  Hospital associations/affiliates (e.g., Intermountain Healthcare, The Joint
Commission)
§  Individual physicians, nurses, pharmacists
§  Industry
§  Patient safety / Healthcare quality (e.g., American Health Quality Association,
National Patient Safety Foundation, Pharmacy Quality Alliance)
§  Pharmacy (e.g., Academy of Managed Care Pharmacy, American Society
of Consultant Pharmacists, American Society of Health-System Pharmacists)
§  Participation by ~11 Federal
agencies
§  Lead non-Federal SME
consultant: Scott Kaatz, DO §  Input from >15 SMEs/organizations
(academia, hospital care,
ambulatory care, long-term care,
home care, state QIOs)
IT Information Technology; SME Subject Matter Expert; QIO Quality Improvement Organization
21
22
Key Action Plan
Recommendations
§  To minimize population harms from anticoagulants, Federal
partners will need to:
Anticoagulant ADEs:
Key Action Plan
Recommendations
Surveillance
1.  Support advancement of surveillance strategies that better
identify real-world burden and scope of anticoagulant ADEs
EvidenceBased
Prevention
Tools
2.  Support development, dissemination, and uptake of optimal
AC management strategies, especially in critical, underaddressed settings such care transitions and long-term care
(e.g., nursing homes)
Incentives &
Oversight
3.  Support policies (e.g., quality measures, EHR standards) that
incentivize optimal AC management and that minimize
payment/coverage barriers to such management
Research
(Unanswered
Questions)
4.  Support research of real-world management of newer oral
anticoagulants (e.g., drug selection, transitions among
agents, adherence, laboratory testing, reversal strategies)
AC Anticoagulation; EHR Electronic Health Record
23
24
4 Key Action Plan
Recommendations
Q: How can federal resources facilitate
better surveillance of anticoagulant ADEs at
the local level? Lessons learned from HAIs
§  To minimize population harms from anticoagulants, Federal
partners will need to:
Surveillance
1.  Support advancement of surveillance strategies that better
identify real-world burden and scope of anticoagulant ADEs
EvidenceBased
Prevention
Tools
2.  Support development, dissemination, and uptake of optimal
AC management strategies, especially in critical, underaddressed settings such care transitions and long-term care
(e.g., nursing homes)
Incentives &
Oversight
3.  Support policies (e.g., quality measures, EHR standards) that
incentivize optimal AC management and that minimize
payment/coverage barriers to such management
Research
(Unanswered
Questions)
Training Protocols Forms Support Materials §  Analysis Resources (Data & Reports) §  FAQs § 
§ 
§ 
§ 
4.  Support research of real-world management of newer oral
anticoagulants (e.g., drug selection, transitions among
agents, adherence, laboratory testing, reversal strategies)
AC Anticoagulation; EHR Electronic Health Record
25
HAIs Healthcare associated infections
http://www.cdc.gov/nhsn/
Key Action Plan
Recommendations
Advancing the Concept of
Anticoagulation Stewardship
§  To minimize population harms from anticoagulants, Federal
partners will need to:
Surveillance
1.  Support advancement of surveillance strategies that better
identify real-world burden and scope of anticoagulant ADEs
EvidenceBased
Prevention
Tools
2.  Support development, dissemination, and uptake of optimal
AC management strategies, especially in critical, underaddressed settings such care transitions and long-term care
(e.g., nursing homes)
Incentives &
Oversight
3.  Support policies (e.g., quality measures, EHR standards) that
incentivize optimal AC management and that minimize
payment/coverage barriers to such management
Research
(Unanswered
Questions)
26
Antibiotic Stewardship
As an Example
4.  Support research of real-world management of newer oral
anticoagulants (e.g., drug selection, transitions among
agents, adherence, laboratory testing, reversal strategies)
AC Anticoagulation; EHR Electronic Health Record
27
March 4, 2014:
“CDC recommends that all
hospitals implement antibiotic
stewardship programs that
include, at a minimum, seven
core elements”
1.  Leadership
2.  Accountability
3.  Drug expertise
4.  Tracking
5.  Reporting
6.  Education
7.  Action
Fridkin S et al. MMWR Morb Mortal Wkly Rep 2014;63:1–7 (Early Release).
http://www.cdc.gov/getsmart/healthcare/pdfs/core-elements.pdf
28
Key Action Plan
Recommendations
Advancing the Concept of
Anticoagulation Stewardship
March 4, 2014:
Can the same be achieved
“CDC recommends that all
for Anticoagulation?
hospitals implement antibiotic
stewardship programs that
include, at a minimum, seven
core elements”
1.  Leadership
2.  Accountability
3.  Drug expertise
4.  Tracking
5.  Reporting
8. Evaluate an+coagula+on safety prac+ces, take ac+on 6.  Education
to improve prac+ces, and measure the effec+veness of those ac+ons… 7.  Action
http://www.jointcommission.org/assets/1/6/HAP_NPSG_Chapter_2014.pdf
§  To minimize population harms from anticoagulants, Federal
partners will need to:
Surveillance
1.  Support advancement of surveillance strategies that better
identify real-world burden and scope of anticoagulant ADEs
EvidenceBased
Prevention
Tools
2.  Support development, dissemination, and uptake of optimal
AC management strategies, especially in critical, underaddressed settings such care transitions and long-term care
(e.g., nursing homes)
Incentives &
Oversight
3.  Support policies (e.g., quality measures, EHR standards) that
incentivize optimal AC management and that minimize
payment/coverage barriers to such management
Research
(Unanswered
Questions)
4.  Support research of real-world management of newer oral
anticoagulants (e.g., drug selection, transitions among
agents, adherence, laboratory testing, reversal strategies)
AC Anticoagulation; EHR Electronic Health Record
29
30
5 Q: What actions can potentially advance healthcare
Q: What actions can potentially advance healthcare
policy strategies for preventing anticoagulant ADEs?
Area Key Issues (Examples) Recommenda+ons policy strategies for preventing anticoagulant ADEs?
Area Payment/Coverage Key Issues (Examples) Recommenda+ons Payment/Coverage AnDcoagulaDon Clinics §  Payments to non-­‐physician providers §  Physician billing for anDcoagulaDon management services Warfarin PST/
PSM §  Reimbursement/enrollment challenges LTC, home care §  PracDce delivery model challenges §  Explore and minimize potenDal barriers to improved and consistent use of evidence-­‐
based anDcoagulaDon management pracDces AnDcoagulaDon Clinics §  Payments to non-­‐physician providers §  Physician billing for anDcoagulaDon management services Warfarin PST/
PSM §  Reimbursement/enrollment challenges LTC, home care §  PracDce delivery model challenges §  Explore and minimize potenDal barriers to improved and consistent use of evidence-­‐
based anDcoagulaDon management pracDces Healthcare Quality Measures §  Current focus: are anDcoagulants are being used when §  IdenDfy possible measures that address: indicated (e.g., SCIP, VTE, and stroke measures); less –  Safety consideraDons focused on whether anDcoagulants are being used –  Newer oral agents safely –  High-­‐risk populaDons/
se[ngs (e.g., elderly, LTC) –  Clinical outcomes vs. surrogate indicators LTC Long-term care; PSM Patient self-management; PST Patient self-testing; SCIP Surgical Care Improvement Project; VTE Venous
thromboembolism
31
Key Action Plan
Recommendations
1.  Support advancement of surveillance strategies that better
identify real-world burden and scope of anticoagulant ADEs
EvidenceBased
Prevention
Tools
2.  Support development, dissemination, and uptake of optimal
AC management strategies, especially in critical, underaddressed settings such care transitions and long-term care
(e.g., nursing homes)
Incentives &
Oversight
3.  Support policies (e.g., quality measures, EHR standards) that
incentivize optimal AC management and that minimize
payment/coverage barriers to such management
Research
(Unanswered
Questions)
32
Support Advancements in
Real-world Management of
Newer Oral Anticoagulants
§  To minimize population harms from anticoagulants, Federal
partners will need to:
Surveillance
LTC Long-term care; PSM Patient self-management; PST Patient self-testing; SCIP Surgical Care Improvement Project; VTE Venous
thromboembolism
§  Agent selection (patient-centered,
individualized approaches)
Potentially
§  Transitions among agents
important role
remains for
§  Peri-procedural management
anticoagulation
§  Tools to promote adherence
clinics
§  Development and interpretation of
potential laboratory assays
§  Real-world management of bleeding
events, development of reversal protocols
4.  Support research of real-world management of newer oral
anticoagulants (e.g., drug selection, transitions among
agents, adherence, laboratory testing, reversal strategies)
AC Anticoagulation; EHR Electronic Health Record
33
So there’s an Action Plan,
Now (and So) What: Federal Partners
§  Progress collaboratively
–  Continue communication and coordination across
Federal agencies
–  Initiate collaboration with and seek input from public
& private sector stakeholders
34
So there’s an Action Plan,
Now (and So) What:
Hospitals, Clinics, Providers, Professional Organizations…
§  Identify and close gaps in key quality improvement
areas (e.g., new agents)
§  Improve dissemination and sharing of successful AC
management strategies across institutions/providers
§  Engage in national policies impacting medication
management
§  Generate momentum
–  Implementation and uptake of evidence-based
policies, practices, and guidelines at national and
local (hospital or clinic) levels
–  Nationally recognized quality measures (e.g., NQF, TJC)
–  Quality reporting, financial incentive and certification
programs (e.g., Star Ratings, EHR Incentive Program,
Conditions of Participation)
§  Evaluate impact
§  Leverage new federal funding opportunities for AC
management research and quality improvement
–  Biggest challenge?
AC Anticoagulation; EHR Electronic Health Record; NQF National Quality Forum; TJC The Joint Commission
35
36
6 Federal Funding Opportunities:
Anticoagulant Management/Safety
Acknowledgments
–  Centers on how medications move through the health care
system and how this systemic process can be improved so that
patients are not harmed, while health care delivery is improved –  Specific areas of interest: Medication management approaches
for patients with multiple chronic diseases, particularly those who
use anti-coagulants…
§ 
§ 
§ 
§ 
§ 
Don Wright, MD, MPH
Rebekah Rasooly, PhD
Mishale Mistry, PharmD, MPH
Christine Lee, PharmD, PhD
Andrew York, PharmD
§ 
§ 
§ 
§ 
CAPT Dan Budnitz, MD, MPH
LCDR Andrew Geller, MD
Mary George, MD, MSPH, FACS, FAHA
Scott Grosse, PhD
Federal Steering Committee
for ADEs
and Federal Interagency
Workgroup
for Anticoagulant ADEs
and
Scott Kaatz, DO
§  FDA: Novel Interventions and Collaborations to
Improving the Safe Use of Medications (U01)
−  Develop innovative methods to better understand and reduce the
occurrence of adverse events in post market use of drugs
−  Examples include…serious bleeding in patients on anticoagulants
−  Approaches could include the use of innovative messaging
strategies, electronic health records, mobile technologies…
http://grants.nih.gov/grants/guide/pa-files/PA-14-002.html
http://www.fda.gov/Drugs/DrugSafety/SafeUseInitiative/ucm277720.htm
Centers for Disease Control
and Prevention
HHS Office of Disease Prevention
and Health Promotion
§  AHRQ: Advancing Patient Safety Implementation through
Safe Medication Use Research (R18)
The findings and conclusions in this report are those of the authors and do not necessarily represent the
official position of the Centers for Disease Control and Prevention or
the Department of Health and Human Services.
37
38
Thank You
National Action Plan for ADE Prevention: http://
www.health.gov/hai/ade.asp
Surveillance
EvidenceBased
Prevention
Tools
Incentives &
Oversight
Research
(Unanswered
Questions)
1.  Support advancement of surveillance strategies that better
identify real-world burden and scope of anticoagulant ADEs
2.  Support development, dissemination, and uptake of optimal
AC management strategies, especially in under-addressed
settings such care transitions and long-term care (e.g., nursing
homes)
3.  Support policies (e.g., quality measures, EHR standards) that
incentivize optimal AC management and that minimize
payment/coverage barriers to such management
4.  Support research of real-world management of newer oral
anticoagulants (e.g., drug selection, transitions among agents,
adherence, laboratory testing, reversal strategies)
AC Anticoagulation; EHR Electronic Health Record
39
7