Welcome to Welcome · Training and Proficiency Support: Also part of Step 4 in ONC’s guide, EHR implementation involves the execution of a training plan that includes practice-specific

6/16/2016

1

1 © 2016 TMIT

Welcome to

For resource downloads go to:

www.safetyleaders.org

New Oral Anticoagulants:

New Patient Safety Challenges

2 © 2016 TMIT

Charles Denham, MD Chairman, TMIT

TMIT High Performer Webinar

June 16, 2016

Welcome

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If you wish to follow us on Twitter,

go to: http://twitter.com/TMIT1

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Also, go to:

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8 © 2016 TMIT

TMIT Purpose Statement

Our Purpose:

We will measure our success by how we protect and enrich the lives of families…patients AND caregivers.

Our Mission:

To accelerate performance solutions that save lives, save money, and create value in the communities we serve and ventures we undertake.

https://www.facebook.com/pages/SpeakerLink/130451070400768

https://www.facebook.com/CareMoms

https://www.facebook.com/ChasingZero

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9 © 2016 TMIT

Alan K. Jacobson, MD, FACC, is a staff cardiologist and the Associate Chief of Staff for Research at the Loma Linda VA Medical Center in Southern

California. A native of Canada, Dr. Jacobson has been at Loma Linda since heading south in 1977 for medical school. In addition to practicing general

cardiology, Dr. Jacobson has a special interest in antithrombotic therapy. His business relationships include Industry Relationships: Boehringer

Ingelheim BMS & Pfizer, Janssen & Bayer, Daiichi Sankyo, Sanofi Aventis, and POC INR device manufacturers.

Jennifer Dingman realized, after her mother's death in 1995 due to errors in medical diagnoses and treatment, that there is little to no help available for

patients and their families in similar situations. This life-changing experience left her feeling vulnerable, and she decided to dedicate her life to help

prevent medical tragedies from happening to others. She has nothing to disclose.

Charles Denham, MD, is the Chairman of TMIT; a former TMIT education grantee of CareFusion and AORN with co-production by Discovery Channel for

Chasing Zero documentary and Toolbox including models; and an education grantee of GE with co-production by Discovery Channel for Surfing the

Healthcare Tsunami documentary and Toolbox, including models. HCC is a former contractor for GE and CareFusion, and a former contractor with

Siemens and Nanosonics, which produces a sterilization device, Trophon. HCC is a former contractor with Senior Care Centers. HCC is a former

contractor for ByoPlanet, a producer of sanitation devices for multiple industries. Dr. Denham is a collaborator with Professor Christensen.

Disclosure Statement The following panelists certify:

that unless otherwise noted below, each presenter provided full disclosure information; does not intend to discuss

an unapproved/investigative use of a commercial product/device; and has no significant financial relationship(s) to

disclose. If unapproved uses of products are discussed, presenters are expected to disclose this to participants.

10 © 2016 TMIT

Speakers and Reactors

Alan Jacobson Jennifer Dingman Charles Denham

11 © 2016 TMIT

Voice of the Patient and Family

Jennifer Dingman

Founder, Persons United Limiting Substandards and

Errors in Healthcare (PULSE), Colorado Division

Co-founder, PULSE American Division

TMIT Patient Advocate Team Member

Pueblo, CO


June 16, 2016

12 © 2016 TMIT

Charles Denham, MD

Chairman, TMIT


June 16, 2016

In the News and Polling Highlights:

News Update and

May 2016 Webinar Polling

6/16/2016

4

© 2006 HCC, Inc. CD000000-0000XX 13 © 2016 TMIT

Six Major Health IT Challenges Identified by The ONC in May 2016

Source: Graber, ML, Bailey, R, Johnston, D, ONC. Goals and Priorities for Health Care Organizations to Improve Safety Using Health IT, Revised Report. Health

IT Safety Center Road Map, RTI: May 2016. Available at https://www.healthit.gov/sites/default/files/task_9_report.pdf

© 2006 HCC, Inc. CD000000-0000XX 14 © 2016 TMIT


Source: Graber, ML, Bailey, R, Johnston, D, ONC. Goals and Priorities for Health Care Organizations to Improve Safety Using Health IT,

Revised Report. Health IT Safety Center Road Map, RTI: May 2016.

Available at https://www.healthit.gov/sites/default/files/task_9_report.pdf

Safety issues have been identified at all phases

in the adoption and use of health IT. Because

this report is intended to help health care

organizations learn from other stakeholders and

set their own health IT safety goals and priorities,

in this section we organize findings across

sources’ reviews according to six areas related

to the safe use of health IT during adoption and

implementation. These six categories emerged

from the population of measures identified during

our research and proved useful for grouping the

identified goals, priorities, and recommendations

for further analysis.

6 Categories of Safety Issues

1. Leadership

2. Culture and Engagement

3. Planning and Readiness

4. Installation

5. Training and Proficiency

Support

6. Upgrades and Conversions

May, 2016

© 2006 HCC, Inc. CD000000-0000XX 15 © 2016 TMIT


Source: Graber, ML, Bailey, R, Johnston, D, ONC. Goals and Priorities for Health Care Organizations to Improve Safety Using Health IT, Revised Report. Health

IT Safety Center Road Map, RTI: May 2016. Available at https://www.healthit.gov/sites/default/files/task_9_report.pdf

1. Leadership: Leadership involves establishing a vision for an organization and sharing that vision so that others will follow willingly; providing the

information, knowledge and methods to realize that vision; and coordinating and balancing the conflicting interests of all members and stakeholders.

2. Culture and Engagement: High-reliability organizations maintain a commitment to safety at all levels, from frontline providers to managers and

executives. This commitment establishes a culture of safety that helps ensure engagement, creates blame-free environments, and encourages

collaboration to address patient safety problems.

3. Planning and Readiness: “Assess your practice readiness” and “plan your approach” are steps 1 and 2 of ONC’s step-by-step

guide to EHR implementation. The assessment phase is a foundation for all other EHR implementation steps, and involves determining

if the practice is ready to make the change from paper records to EHRs or to upgrade to a new version. The planning phase clarifies

and prioritizes implementation tasks and helps ensure clear communication about tasks to the entire team involved with the change

process.

4. Installation: Step 4 of ONC’s guide to EHR implementation is “conduct training and implement an EHR system.” EHR

implementation involves the installation of the EHR system and associated activities, such as mock “go-live” and pilot testing.

Configuration and pilot testing must involve clinicians familiar with the workflows in clinical practice. The EHR implementation plan and

schedule are executed during this phase.

5. Training and Proficiency Support: Also part of Step 4 in ONC’s guide, EHR implementation involves the execution of a training plan that includes

practice-specific goals and needs. Proficiency support acknowledges that transitioning from paper records to an EHR, or incorporating new or

different health IT products into the user’s workflow, is an ongoing learning process. Providing recurring and ongoing learning opportunities (sometimes called retraining) supports users in achieving true proficiency with the health IT so they can more fully and efficiently use the system and

resolve questions that arise after initial use of new systems.

6. Upgrades and Conversions: Upgrades and conversions often present specific challenges that require change control processes, testing, and

specific attention to users so that they are thoroughly trained and supported in achieving proficiency on the new system

May, 2016

Goals and Priorities for Health Care Organizations to

Improve Safety Using Health IT

© 2006 HCC, Inc. CD000000-0000XX 16 © 2016 TMIT


1: http://healthitanalytics.com/news/6-ehr-big-data-issues-impede-patient-safety-cut-quality

Source: Graber, ML, Bailey, R, Johnston, D, ONC. Goals and Priorities for Health Care Organizations to Improve Safety Using Health IT, Revised Report. Health IT Safety Center Road Map, RTI: May 2016. Available at https://www.healthit.gov/sites/default/files/task_9_report.pdf

May, 2016

Goals and Priorities for Health Care Organizations

to Improve Safety Using Health IT

This framework, proposed

by the Institute of

Medicine (IOM), can guide

stakeholder efforts to

identify health IT risks and

change usage patterns that

may put patients in harm’s

way. 1

6/16/2016

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© 2006 HCC, Inc. CD000000-0000XX 17 © 2016 TMIT

Meaningful Use is dead. Long live something better! High Impact Care Hazards to Patients, Students, and Employees

Choking

Anaphylaxis

Cardiac Arrest

Opioid Overdose

Active Shooter

Transportation Accidents

Non-trans Accidents

Bullying

A Medical-Tactical Approach

undertaken by clinical and non-

clinical people can have

enormous impact on loss of life

and harm from very common

hazards:

• High Impact Care Hazards

are frequent, severe,

preventable, and

measurable.

• Lifeline Behaviors

undertaken by anyone can

save lives.

© 2006 HCC, Inc. CD000000-0000XX 18 © 2016 TMIT

In the News

Source: CNN website http://www.cnn.com/2016/06/12/us/orlando-nightclub-shooting/

June 13, 2016

© 2006 HCC, Inc. CD000000-0000XX 19 © 2016 TMIT

CNO claims hospital forced her out after she raised concerns about EMR

Source: Becker’s Hospital Review website

http://www.beckershospitalreview.com/legal-regulatory-issues/cno-claims-hospital-forced-her-out-after-she-raised-concerns-about-emr.html

June 14, 2016

The lawsuit alleges the EMR system mixes

patients' records, so information in one

patient's chart moves to another patient's

chart. It also alleges the EMR has issues

tracking and updating patient medications

and does not display patient code status

information, which informs providers of

patients' desired medical interventions,

according to the report.

© 2006 HCC, Inc. CD000000-0000XX 20 © 2016 TMIT

AHRQ: Hospitals that mess up are urged to fess up

Source: Becker’s Hospital Review website

http://www.beckershospitalreview.com/legal-regulatory-issues/ahrq-hospitals-that-mess-up-are-urged-to-fess-up.html

June 13, 2016

Recently, the AHRQ published guidelines for hospitals to adopt that promote

honesty regarding mistakes. The idea behind the guidelines is that being open

and honest about mistakes and taking accountability can reduce hospital

liability and improve safety. The guidelines, called "Communication and

Optimal Resolution," or "Candor," aims to save hospitals from expensive

malpractice litigation fees while encouraging higher scrutiny of medical errors.

It is also designed to support patients, families and clinicians after a medical

error occurs, which can be traumatic for all parties. Candor was developed

with a $23 million federal research grant and was tested at 14 hospitals in

three health systems, according to the report.

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© 2006 HCC, Inc. CD000000-0000XX 21 © 2016 TMIT

Making It Possible for Hospitals to Be Honest About Medical Errors

Source: Insurance Journal website

http://www.insurancejournal.com/news/national/2016/06/10/416553.htm

June 10, 2016

The biggest barrier to hospitals being more transparent is their legal departments,

[Helen Haskell] said. “These are people who are very vested in this process,” she said.

“When [Candor is] implemented well, hospitals save tons of money and what they’re

saving on is defense.”

Haskell said ending hospital secrecy is a prerequisite to making them safer for patients.

“Without disclosure, without accountability it never gets fixed,” she said.

Candor has its roots in that idea. Kraman was newly appointed chief of staff at the

Lexington VA when an internal review indicated that a patient’s death weeks before had

been caused by a medication error. The family had no idea. “We decided that we could

put it together in a dossier and hide it, and hope they never come back. We didn’t feel

comfortable doing that,” he said.

© 2006 HCC, Inc. CD000000-0000XX 22 © 2016 TMIT

Source: KGVO website

http://newstalkkgvo.com/ex-va-manager-claims-retaliation-for-making-safety-report/

June 11, 2016

Dianne Scotten was the VA’s associate chief of inpatient care from March to

December 2014. Soon after her arrival, she reported to the VA’s Quality

Management Program that there was a dispute over whether a surgical towel

count had been completed during an operation.

Scotten’s attorney, Jill Gerdrum (JER-drum), says Associate Director for

Patient Care Services Norlynn Nelson then reprimanded Scotten, reassigned

her, cut off communications and effectively coerced her resignation.

© 2006 HCC, Inc. CD000000-0000XX 23 © 2016 TMIT

Family Caregivers Become More Crucial as Elderly Population Grows

Source: The Wall Street Journal website

http://www.wsj.com/articles/family-caregivers-become-more-crucial-as-elderly-population-grows-1464946204

June 3, 2016

“Families have always been the backbone of our system for caring for people,”

said Kathy Greenlee, the assistant secretary for aging at the U.S. Department

of Health and Human Services. “Really, if we didn’t have them, we couldn’t

afford as a country to monetize their care and we couldn’t replace,

frankly, the love they provide to family members.”

About 40 million U.S. family caregivers provided unpaid care, valued at $470

billion, to an adult with limitations in daily activities in 2013, according to AARP.

© 2006 HCC, Inc. CD000000-0000XX 24 © 2016 TMIT

Improving Safety for Hospitalized Patients Much Progress but Many Challenges Remain

Source: The Journal of the American Medical Association website

http://jama.jamanetwork.com/article.aspx?articleid=2528945

June 13, 2016

Improving safety has focused on hospitalized patients, but it is equally

important in other settings, particularly long-term care and ambulatory care.

The recent National Academy of Medicine report on diagnostic errors

found that the average US patient can expect to be harmed by a

diagnostic error at some point in his or her lifetime. To parallel the effort

that has been made to date on hospital safety, substantial effort is needed to

determine how to measure and reduce diagnostic errors and ensure that this

information is integrated into practice where it will translate into meaningful

benefits for patients.

Improving Safety for Hospitalized Patients

Much Progress but Many Challenges Remain

6/16/2016

7

Anonymous Polling Questions

I would like a Medical Tactical Certificate Course covering Anaphylaxis, Sudden

Cardiac Death, Choking, Opioid OD, and Injury Care for Active Shooter Events.

100%

90%

80%

70%

60%

50%

40%

30%

20%

10% 6%

18%

12%

Source: TMIT High Performer Webinar Series; High Impact Care Hazards: Opioid OD, Anaphylaxis, Cardiac Arrest, Choking, and On-site Transportation Accidents – May 19, 2016

Very

Strongly

Agree

10

Strongly

Agree

9

Agree

8

Agree

7

Very

Strongly

Disagree

1

Disagree

3

Strongly

Disagree

2

Neutral

6

Neutral

5

Negative to

Neutral

4

83% Agreed and 59% Strongly or Very Strongly Agreed,

and 47% Very Strongly Agreed

47%

12%

6%

6/16/2016

8


I would like a webinar on Patient and Caregiver Safety

that could be offered to Non-clinical staff.

100%

90%

80%

70%

60%

50%

40%

30%

20%

10% 5%

16%

11%

Source: TMIT High Performer Webinar Series; High Impact Care Hazards: Opioid OD, Anaphylaxis, Cardiac Arrest, Choking, and On-site Transportation Accidents – May 19, 2016

Very

Strongly

Agree

10

Strongly

Agree

9

Agree

8

Agree

7

Very

Strongly

Disagree

1

Disagree

3

Strongly

Disagree

2

Neutral

6

Neutral

5

Negative to

Neutral

4

90% Agreed and 69% Strongly or Very Strongly Agreed,

and 58% Very Strongly Agreed

58%

11%

30 © 2016

Opioid Addiction 2016 Facts and Figures

Centers for Disease Control.

Available at http://www.cdc.gov/vitalsigns/heroin/infographic.html#responding.

© 2015 TMIT 31

HHS National Action Plan

for ADEs

August 2014

Source: [No authors listed.] National Action Plan for Adverse Drug Event Prevention. Office of Disease Prevention and Health Promotion. Office of the Assistant

Secretary for Health, Office of the Secretary. Washington, DC: U.S. Department of Health and Human Services; 2014 Aug. Available at

http://www.health.gov/hai/pdfs/ADE-Action-Plan-508c.pdf. Last accessed January 21, 2015.

© 2015 TMIT 32

Impact of ADEs

Classen DC, Resar R, Griffin F, et al. 'Global trigger tool' shows that adverse events in hospitals may be ten times greater than previously measured. Health Aff (Millwood) 2011 Apr;30(4):581-9. Available at

http://content.healthaffairs.org/content/30/4/581.full.pdf. Last accessed January 21, 2015.

Weiss AJ, Elixhauser A, Bae J, et al. Origin of Adverse Drug Events in U.S. Hospitals, 2011: Statistical Brief #158. Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Health Care Policy and Research (US); 2013 Jul. Available at http://www.hcup-us.ahrq.gov/reports/statbriefs/sb158.jsp. Last accessed January 21, 2015.

Forster AJ, Murff HJ, Peterson JF, et al. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med 2003 Feb 4;138(3):161-7. Bourgeois FT, Shannon MW, Valim C, et al. Adverse drug events in the outpatient setting: an 11-year national analysis. Pharmacoepidemiol Drug Saf 2010 Sep;19(9):901-10. Available at

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2932855/pdf/nihms224997.pdf. Last accessed January 21, 2015.

Budnitz DS, Pollock DA, Weidenbach KN, et al. National surveillance of emergency department visits for outpatient adverse drug events. JAMA 2006 Oct 18;296(15):1858-66. Available at http://jama.jamanetwork.com/data/Journals/JAMA/5045/JOC60142.pdf. Last accessed January 21, 2015.

6/16/2016

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© 2015 TMIT 33

Complex System

Source: [No authors listed.] National Action Plan for Adverse Drug Event Prevention. Office of Disease Prevention and Health Promotion. Office of the Assistant

Secretary for Health, Office of the Secretary. Washington, DC: U.S. Department of Health and Human Services; 2014 Aug. Available at

http://www.health.gov/hai/pdfs/ADE-Action-Plan-508c.pdf. Last accessed January 21, 2015.

© 2015 TMIT 34

Target High-Impact Preventable ADEs

Source: Office of Disease Prevention and Health Promotion. ADE Prevention: 201 Action Plan Conference.

Office of the Assistant Secretary for Health, Office of the Secretary. Washington, DC: U.S. Department of Health and Human Services; 2014 Oct 30.

Available at http://www.health.gov/hai/pdfs/2014-ADE-Action-Plan-Conference-Slides.pdf. Last accessed January 19, 2015.

© 2015 TMIT 35

Triple Threat

Implicated in 67% of all

Emergency Hospitalizations

Source: Budnitz DS, Lovegrove MC, Shehab N, et al. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med 2011 Nov

24;365(21):2002-12. Available at http://www.nejm.org/doi/pdf/10.1056/NEJMsa1103053. Last accessed January 21, 2015.

ADE Prevention Federal Advisory Group

6/16/2016

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© 2015 TMIT 37

Anticoagulation ADEs Common

…Yet Anticoagulants Still Underused © 2015 TMIT 38

Anticoagulation ADEs

Source: Budnitz DS, Pollock DA, Weidenbach KN, et al. National surveillance of emergency department visits for outpatient adverse drug events. JAMA

2006 Oct 18;296(15):1858-66. Available at http://jama.jamanetwork.com/data/Journals/JAMA/5045/JOC60142.pdf. Last accessed January 21, 2015.

© 2015 TMIT 39

Outpatient Anticoagulation Management

40 © 2015 TMIT

Alan K. Jacobson, MD, FACC Assistant Professor of Medicine

Loma Linda University School of Medicine

Director, Anticoagulation Services

Veterans Affairs Medical Center

Prior Anti-coag Presentations: • Feb 19, 2015

• April 21, 2015

6/16/2016

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I am interested in a DEEP DIVE on Anticoagulation Best Practices &

Protocols

Very

Strongly

Agree

10

Strongly

Agree

9

Agree

8

Agree

7

Very

Strongly

Disagree

1

Disagree

3

Strongly

Disagree

2

Neutral

6

Neutral

5

Negative to

Neutral

4

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

55%

12%

5%

41 © 2015 TMIT

18%

4% 3%

Source: TMIT High Performer Webinar Series; An Old Problem: A New Focus – February 19, 2015

2% 1%


I am interested in joining a community of practice on Anticoagulation

Mgmt

Very

Strongly

Agree

10

Strongly

Agree

9

Agree

8

Agree

7

Very

Strongly

Disagree

1

Disagree

3

Strongly

Disagree

2

Neutral

6

Neutral

5

Negative to

Neutral

4

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

27%

16% 14%

42 © 2015 TMIT

10% 11% 11%


2% 3% 1%

5%


I need help developing ROI Business Case for Anticoag Programs

Very

Strongly

Agree

10

Strongly

Agree

9

Agree

8

Agree

7

Very

Strongly

Disagree

1

Disagree

3

Strongly

Disagree

2

Neutral

6

Neutral

5

Negative to

Neutral

4

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

24%

12% 9%

43 © 2015 TMIT

11% 9%

16%


3% 3% 6% 6%


My organization has Anticoagulation Expertise to share with others

Very

Strongly

Agree

10

Strongly

Agree

9

Agree

8

Agree

7

Very

Strongly

Disagree

1

Disagree

3

Strongly

Disagree

2

Neutral

6

Neutral

5

Negative to

Neutral

4

100%

90%

80%

70%

60%

50%

40%

30%

20%

10% 11%

4%

10%

44 © 2015 TMIT

5%

12% 17%


16%

6% 7%

12%

6/16/2016

12


I am interested collaborating/connecting with my Community

Pharmacists

Very

Strongly

Agree

10

Strongly

Agree

9

Agree

8

Agree

7

Very

Strongly

Disagree

1

Disagree

3

Strongly

Disagree

2

Neutral

6

Neutral

5

Negative to

Neutral

4

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

26%

9% 12%

45 © 2015 TMIT

6%

12% 13%


7% 5%

3% 7%

46 © 2015 TMIT

Alan K. Jacobson, MD, FACC Assistant Professor of Medicine

Loma Linda University School of Medicine


Veterans Affairs Medical Center


June 16, 2016



Anticoagulation ADEs –

An Old Problem: A New Focus



Alan K. Jacobson, MD FACC Loma Linda University School of Medicine


Cardiology Section

Loma Linda VA Medical Center

Loma Linda, CA

Disclosures

• Department of Veterans Affairs The information contained in this presentation does not represent any official

endorsement nor recommendation by the Department of Veterans Affairs but

represent the professional opinion of the presenter.

• Industry Relationships: • Boehringer Ingelheim

• BMS & Pfizer

• Janssen & Bayer

• Daiichi Sankyo

• Sanofi Aventis

• POC INR device manufacturers

6/16/2016

13

Outline

Background: Anticoagulation for AF Stroke Risk Reduction

HHS ADE Initiative

Are the “new” TSOACs the answer or simply a new challenge

Frequency of Major Bleeding

Case Fatality of Major Bleeding

Management of Novel Anticoagulant associated bleeds

Role of reversal agents

The future

Disturbed Flow

(left atrium)

Stroke Risk

Blood Flow in Atrial Fibrillation

4 mm. clot - occlude cerebral artery

1.9 2.3 2.1

0.9

Warfarin in Prospective AF Trials Intention-to-treat analysis

Control

Warfarin

AFASAK SPAF BAATAF CAFA SPINAF 825 504 922 490 896 p=0.03 p=0.01 p=0.002 p>0.2 p=0.001

8

6

4

2

0

Str

oke

Rat

e (%

/yea

r)

Adapted from Atwood, Albers, Herz 1993;18:27-38

4.6

3.0 3.6

4.3

person-years

p value

7.0

0.4

Severity of Stroke With AF

• 1061 patients admitted with acute ischemic stroke

• 20.3% had AF

• Bedridden state

• With AF 41.2%

• Without AF 23.7%

• Odds ratio for bedridden state following stroke due to AF 2.23 (95% CI, 1.87-2.59; P<.0005)

• Bleeding into brain has even higher disability.

P<.0005

Dulli et al. Neuroepidemiology. 2003;22:118-123. AHA data, Framingham data

6/16/2016

14

0

20

40

60

80

100

INR

Incid

ence p

er

100 P

atient-

Years

Figure 3. INR-Specific Incidence of All Adverse Events (All Episodes of

Thromboembolism, All Major Bleeding Episodes, and Unclassified Stroke).

The dotted lines indicate the 95 percent confidence interval. Cannegeiter et al

National Action Plan for

Adverse Drug Event

Prevention

http://www.health.gov/hai/pdfs/ADE-Action-Plan-508c.pdf

6/16/2016

15

National Action Plan for

Adverse Drug Event Prevention

The three initial targets of the ADE Action Plan are:

Anticoagulants (primary ADE of concern:

bleeding)

Diabetes agents (primary ADE of concern:

hypoglycemia)

Opioids (primary ADE of concern: accidental

overdoses/oversedation /respiratory depression)

Limitations of Warfarin

Despite improved outcomes and fewer hemorrhagic events with better

INR control, warfarin still has several limitations:

• Narrow therapeutic index.

• Need for therapeutic monitoring.

• Dietary and drug interactions necessitate more frequent monitoring.

• High rate of adverse events, particularly in non-structured setting.

Almost half of the patients who would benefit, and

have no contraindications, DO NOT receive therapy.

Ongoing Patient Education

Ongoing QI

Direct Active Management

by Qualified Health Care Provider

Patient Scheduling

and Tracking

Accessible, Accurate, and

Frequent PT/INR

Testing

Patient-specific

Decision Support

and Interaction

Systematic Anticoagulation Management

“Enabling Technologies”

Ongoing Patient Education

Ongoing QI

Direct Active Management

by Qualified Health Care Provider

Patient Scheduling

and Tracking

Evaluation of kidney and

liver function

Drug reconciliation

Patient-specific

Decision Support

and Interaction

Systematic Anticoagulation Management

– Novel Anticoagulants

6/16/2016

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Are the “new” TSOACs the Answer?

“Novel” Anticoagulants – 5 years old

• NOAC

• Novel Oral AntiCoagulant

• Non-vitamin K antagonist Oral AntiCoagulant

• DOAC

• Direct acting Oral AntiCoagulant

• TSOAC

• Target Specific Oral AntiCoagulant

Four Novel Agents

• Dabigatran / Pradaxa

• Rivaroxaban / Xarelto

• Apixaban / Eliquis

• Edoxaban / Savaysa

• All with generally comparable safety and

efficacy BUT each has multiple unique

characteristics and considerations

TSOAC Effectiveness

• Stroke Prevention in AF

• 19% reduction in stroke / systemic emboli

Ruff et al Lancet 2013 Hirschi and Kundi Vasa. 2014

6/16/2016

17

TSOAC Effectiveness



• 51% reduction in hemorrhagic stroke


TSOAC Effectiveness




• 52% reduction in intracranial bleeding


TSOAC Effectiveness





• 10% reduction in all-cause mortality


TSOAC Effectiveness





• 10% reduction in all-cause mortality

• VTE

• Comparable efficacy

• 40% reduction in major bleeding


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Major Bleeding TSOAC vs. Warfarin

Incidence of major bleeds

• NOAC

• 43,050 patients

• 2,158 major bleeds (5.01%)

• VKA

• 29,911 patients

• 1,826 major bleeds (6.10%)

• 18% reduction in major bleeds

Caldeira et al Heart 2015; 101:1204-1211


Incidence of fatal bleeds

• NOAC

• 43,050 patients

• 121 fatal bleeds (0.28%)

• VKA

• 29,911 patients


• NOACs associated with a 47% odds reduction in the

risk of fatal bleeding OR 0.53 95% CI 0.42-0.68



Case Fatality

• NOAC

• 2,158 major bleeds


• VKA

• 1,826 major bleeds


• NOACs associated with a 32% odds reduction in the

case fatality rate OR 0.68, 95% CI 0.48-0.96


Major Bleeding Case Fatality

• Meta-analysis of 12 studies

• Case-fatality rate for major bleeding:

• DOAC 7.57% (30% reduction)

• VKA (warfarin) 11.05%

• Fatal bleeding per 100 patient years:

• DOAC 0.16%

• VKA (warfarin) 0.32%

Crowther et al Thromb Haemost 2015; 13: 2012-20

Mortality Outcome in patients receiving direct oral anticoagulants …

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Bottom Line

• Major bleeding events are more frequent

with warfarin than with TSOACs

• A patient who has a major bleeding event

while on warfarin is more likely to die

from it than a patient on a TSOAC

• Even in the absence of a reversal agent

for the TSOAC !

Approach to TSOAC Associated Bleeding


• Find and fix the leak!


• Find and fix the leak!

Everything else is ancillary.

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Managing Bleeding Complications in

Patients Treated with DOACs

• Initial Assessment

• Hemodynamic stability

• Source of bleeding

• Time since last dose of anticoagulant

• Which anticoagulant?

• Renal function

• Interacting medications

• Risk Stratify

Adapted from McMaster and Boehringer Canada



• Minor Bleeding

• Local hemostatic measures

• Consider anticoagulant withdrawal based on

balancing bleeding and thrombotic risks




• Moderate Bleeding

• General measures

• Anticoagulant withdrawal

• Mechanical compression

• Monitor hemodynamic status

• Volume replacement

• Definitive interventions

• Blood Product Transfusions

• RBC if anemic

• FFP or platelets




• Life-Threatening Bleeding

• Everything that is being done for moderate

• Intensive care setting, hemodynamic support

• Nonspecific antidotes

• 4 factor PCC

• Activated PCC

• Specific reversal

• Idarucizumab, andexanet

• Adjunctive Therapie

• Desmopressin, antifibrinolytics, charcoal


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What to consider before reversal?

• Is a DOAC present?

• WHEN WAS THE LAST DOSE?

• Does it need to be reversed?

• If so, with specific or nonspecific reversal?

Limitations of Reversal Agents

• Reversal agents can only eliminate the

anticoagulant contribution to the bleeding

problem. They rarely stop the bleeding

because they do not fix the problem.

• Most deaths from major bleeding occur in

patients NOT on anticoagulants or other

“blood thinners”.

Do we really need reversal agents?

• Annual rate of major bleeding remains at

2-3% in the AF population.

• Even with NOACS, annual rate of

intracranial hemorrhage is 0.1-0.5% in the

AF population

• Some patients may require reversal

because of trauma or need for urgent

surgery.

The Future of Reversal

• The coming years will be exciting as we

continue to refine our management of

these TSOACs (new indications, lab

measurement) and explore the boundaries

of reversal.

• And, there are already “novel” classes of

anticoagulants on the horizon.

• (anti FXII or FXI)

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TMIT = ACTION

• What actions do we need to consider for

managing TSOAC associated bleeding?

• Educate patients

• Facilitate local policies and expertise to

provide predictable systematic evaluation

and management of these events

Even with the new TSOACs,

Safe and Effective Anticoagulation

STILL

Requires Competent Management

INCLUDING Education

Casual use of any anticoagulant will yield suboptimal

clinical outcomes.

THESE ARE NOT CASUAL USE DRUGS!!!

Questions?

© 2006 HCC, Inc. CD000000-0000XX 88 © 2015 TMIT

Polling Questions

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9

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8

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7

Very

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1

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3

Strongly

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2

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6

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5

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Neutral

4

I am interested in joining a community of practice on Anticoagulation Mgmt

I am interested in a DEEP DIVE on Anticoagulation Best Practices & Protocols

including the NEW Medications

Very

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10

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9

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8

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6/16/2016

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© 2006 HCC, Inc. CD000000-0000XX 89 © 2015 TMIT

Polling Questions

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9

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7

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3

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Negative to

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4

My organization has Anticoagulation Expertise to share with others

I need help developing ROI Business Case for Anticoag Programs

Very

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10

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9

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8

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7

Very

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1

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3

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2

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6

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4

© 2006 HCC, Inc. CD000000-0000XX 90 © 2015 TMIT

Polling Questions

Free Text Entry

The topics in Anticoagulation Management I need help with are:

I am interested collaborating/connecting with my Community Pharmacists

Very

Strongly

Agree

10

Strongly

Agree

9

Agree

8

Agree

7

Very

Strongly

Disagree

1

Disagree

3

Strongly

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Neutral

6

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Negative to

Neutral

4

© 2006 HCC, Inc. CD000000-0000XX 91 © 2015 TMIT

Polling Questions

Free Text Entry

New topics of any area I need help with are:

92 © 2016 TMIT

Speakers and Reactors

Alan Jacobson Jennifer Dingman Charles Denham

6/16/2016

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93 © 2016 TMIT

Voice of the Patient and Family

Jennifer Dingman

Founder, Persons United Limiting Substandards and

Errors in Healthcare (PULSE), Colorado Division

Co-founder, PULSE American Division

TMIT Patient Advocate Team Member

Pueblo, CO


June 16, 2016

Documents

Welcome to Welcome · Training and Proficiency Support: Also part of Step 4 in ONC’s guide, EHR implementation involves the execution of a training plan that includes practice-specific