Anticoagulation Safety: A 2020 Update · Alan K. Jacobson, MD, FACC, is a staff cardiologist and...

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January 16, 2020 Webinar Month 134

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Anticoagulation Safety:

A 2020 Update

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Charles Denham, MD Chairman, TMIT TMIT High Performer Webinar January 16, 2020 Webinar Month 134

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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.

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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. None of the participants have any relationship medication or device companies discussed in their presentations.

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. He has been the medical director of the Cardiology Anticoagulation Clinic since 1990 and has overseen the initiation of both Point-of-Care testing and Patient self-testing for the monitoring of the prothrombin time. He has nothing to disclose. Robert Katzer, MD, MBA, FAEMS, FACEP, is a board-certified emergency medicine physician in Orange, California. He is affiliated with UC Irvine Medical Center and is an Instructor at University of California. He has nothing to disclose. Christopher R. Peabody, MD, MPH is a practicing Emergency Physician in California and Clinical Instructor at the University of California, San Francisco. He is also the Director of the UCSF Acute Care Innovation Center, an initiative of the UCSF Department of Emergency Medicine, which develops novel ways to deliver Emergency and Acute Care reliably and safely by developing new technology and validating best practices. He has a strong commitment to public service and healthcare delivery to vulnerable populations. Dr. Peabody completed his residency at one of the busiest safety-net hospitals in the country, Los Angeles County Hospital, and was the Chief Resident in Emergency Medicine at the University of Southern California. He has nothing to disclose. Gregory H. Botz, MD, FCCM, is a professor in the Department of Critical Care at the UT MD Anderson Cancer Center. He received his medical degree from George Washington University School of Medicine in Washington, DC. He completed an internship in internal medicine at Huntington Memorial Hospital and then completed a residency in anesthesiology and a fellowship in critical care medicine at Stanford University in California. He also completed a medical simulation fellowship at Stanford with Dr. David Gaba and the Laboratory for Human Performance in Healthcare. Dr. Botz is board-certified in anesthesiology and critical care medicine. He is a Fellow of the American College of Critical Care Medicine. He has nothing to disclose. 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. He does not currently work with any pharmaceutical or device company. His current area of research is in threat management to institutions including conflict of interest, healthcare fraud, and continuing professional education and consumer education including bystander care. Dr. Denham is a collaborator with Professor Christensen at Harvard Business School.

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Speakers and Reactors Dr. Alan Jacobson

Dr. Charles Denham Dr. Christopher Peabody

Dr. Robert Katzer Jennifer Dingman

Gregory Botz

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Voice of 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 TMIT High Performer Webinar January 16, 2020

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Charles Denham, MD Chairman, TMIT TMIT High Performer Webinar January 16, 2020 Webinar 134

In the News Update and December 2019 Webinar Recap

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In The News …

Recent Safety Scandals Suggest Healthcare Leaders Haven’t Learned Lessons

https://www.modernhealthcare.com/safety-quality/recent-safety-scandals-suggest-healthcare-leaders-havent-learned-lessons https://www.modernhealthcare.com/safety-quality/recent-safety-scandals-suggest-healthcare-leaders-havent-learned-lessons

November 09, 2019

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In The News …

https://www.modernhealthcare.com/safety-quality/hospitals-fall-short-patient-safety-goals-20-years-after-err-human

November 09, 2019

Hospitals Fall Short of Patient Safety Goals 20 Years after 'To Err Is Human'

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In The News …

Source: https://www.modernhealthcare.com/safety-quality/hospitals-fall-short-patient-safety-goals-20-years-after-err-human

November 09, 2019

Hospitals Fall Short of Patient Safety Goals 20 Years after 'To Err Is Human'

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In The News …

16

Patient Safety and COI Stories Being Followed

Nearly 200 investigations are underway at major academic centers. Critics fear that researchers of Chinese descent are being unfairly targeted. The N.I.H. and the F.B.I. have begun a vast effort to root out scientists who they say are stealing biomedical research for other countries from institutions across the United States. Almost all of the incidents they uncovered and that are under investigation involve scientists of Chinese descent, including naturalized American citizens, allegedly stealing for China. Seventy-one institutions, including many of the most prestigious medical schools in the United States, are now investigating 180 individual cases involving potential theft of intellectual property. The cases began after the N.I.H., prompted by information provided by the F.B.I., sent 18,000 letters last year urging administrators who oversee government grants to be vigilant.

Vast Dragnet Targets Theft of Biomedical Secrets for China

11-09-19

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In The News …

August 20, 2018

Unfortunately, threats to the integrity of U.S. biomedical research exist. NIH is aware that some foreign entities have mounted systematic programs to influence NIH researchers and peer reviewers and to take advantage of the long tradition of trust, fairness, and excellence of NIH supported research activities. This kind of inappropriate influence is not limited to biomedical research; it has been a significant issue for defense and energy research for some time. Three areas of concern have emerged: 1. Diversion of intellectual property (IP) in grant applications or produced by NIH supported

biomedical research to other entities, including other countries;

2. Sharing of confidential information on grant applications by NIH peer reviewers with others, including foreign entities, or otherwise attempting to influence funding decisions; and

3. Failure by some researchers working at NIH-funded institutions in the U.S. to disclose substantial resources from other organizations, including foreign governments, which threatens to distort decisions about the appropriate use of NIH funds.

“We recently reminded the community that applicants and awardees must disclose all forms of other support and financial interests, including support coming from foreign governments or- other foreign entities.” “We also expect and encourage your institution to notify us immediately upon identifying new information that affects your institution's applications or awards. Lastly, we encourage you to reach out to an FBI field office to schedule a briefing on this matter.”

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service National Institutes of Health Bethesda, Maryland 20892

LETTER TO THOSE ORGANIZATIONS RECEIVING FEDERAL GRANTS

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In The News …

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Tampa Bay Times Reports: • Deaths of children in 1 in 10

undergoing CV Surgery at JH All Children's

• Mutilation of children in burn unit in Maryland

• Cover up of harm • Retaliation against

whistleblower MD • Patient Safety Issues in all

Johns Hopkins hospitals • Whistle blower law suit • Multiple malpractice suits. • Regulatory problems • Oversight letting team of

doctors make unannounced visits

NYT & Propublica Reports: • Conflicts and large payments

to Chief Med Officer – resigns • CEO with conflicts, vote of

non-confidence – resigns • Board Members own equity in

start up with special deals. • Revision of conflict of interest

policies. • Top executives barred from

serving on corporate boards or investing in start-ups

Propublica & Houston Chronicle Reports:

• Cardiac Complications • Undeclared financial conflicts

of interest • Allegations of exaggerated

quality program to lure patients.

• Transplant program shut down based on reporting.

• Leadership restructuring • State and federal officials

enforcing safety standards. • 08-08-19 Feds Cease Greater

Oversight Of Baylor St. Luke’s Medical Center Initiated After Patient Death

New York Times & Washington Post Reports:

• Falsification of research in cardiac stem care.

• Scientific misconduct • 31 Articles Retracted • Many patients treated • Unknown impact of product

used in patients treated. • Hospital paid to settle

allegations. • Hospital pays $10M to settle

Tennessean & Beckers Hospital Review Reports:

• Nurse medication error during imaging with patient death

• Electronic medication dispensing cabinet safeguards overridden.

• Nurse indicted for reckless homicide for fatal error.

• State Health Officials decided no reason to discipline or take action against nurses license.

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In The News …

19

Medscape Reports: • Duke Settles Doctored Data

Lawsuit for $112.5 Million • Duke Whistleblower Gets

More Than $33 Million In Research Fraud Settlement

• William Foster, who ran the lab where the data were faked, studied the effects of pollutants on the lungs of mouse models.

• Thomas alleged that Duke had won some 50 grants from the NIH

The Washington Post Reports: • Baltimore Mayor Pugh involved in

self-dealing book scandal for hundreds of thousands of dollars.

• UMMS Board Chairman announced the board's unanimous decision March 21 to have CEO Robert Chrencik take a leave of absence.

• Resignations of three UMMS, including Baltimore Mayor Pugh.

• Hours before Mr. Burch notified the public of Mr. Chrencik's leave of absence, the Maryland House of Delegates unanimously fast-tracked bill to overhaul UMMS' 27-member board of directors.

• Kaiser Permanente paid Pugh more than $100,000 for 20,000 copies of her books during a period when the company was seeking a lucrative contract to provide health benefits to city employees.

Medscape Reports: • Between 2011 and 2019

William Roper, failed to disclose his seats on the boards of major corporations.

• At the same time, those corporations did business with the state, records show.

• Roper has served on the board of directors of DaVita, Inc.

• Roper also a member of the board of directors of three successor companies in the pharmacy benefits administration industry.

• None of his corporate board service was disclosed on state ethics forms.

Tampa Bay Times Reports: • Johns Hopkins All Children’s

faces record state fines. • The planned $800,000 penalty is

the latest fallout from problems in the hospital’s heart surgery department.

• State regulators intend to hit Johns Hopkins All Children’s Hospital with some of the largest fines levied against a Florida hospital in recent memory,.

• The Times found that surgeons in the hospital’s Heart Institute made serious mistakes and their procedures went wrong in unusual ways. It also found that the hospital continued to perform heart surgeries for years after frontline workers raised safety concerns to their supervisions.

New York Times Reports: • Director of M.I.T.’s Media Lab

Resigns After Taking Money From Jeffrey Epstein.

• M.I.T. official, Joichi Ito, left the boards the MacArthur Foundation, the John S. and James L. Knight Foundation, and The New York Times.

• He “stepped down after the disclosure of his efforts to conceal his financial connections to Mr. Epstein, the disgraced financier who killed himself in a Manhattan jail cell last month while facing federal sex trafficking charges”. acknowledged last week that he had received $1.7 million from Mr. Epstein, including $1.2 million for his own outside investment funds.


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In The News …

20


Beth Israel COI & Theft: • Chinese cancer researcher,

confessed that he had planned to take the stolen samples to Sun Yat-sen Memorial Hospital, and publish the results under his own name.

• Customs officers officers found what they were looking for: 21 vials of brown liquid — cancer cells.

• The researcher admitted he had taken the samples to publish the work under his own name.

The arrest occurred at the Boston airport. Under questioning, court documents say, the researcher acknowledged that he had stolen eight of the samples and had replicated 11 more based on a colleague’s research. When he returned to China, he said, he would take the samples to Sun Yat-sen Memorial Hospital and turbocharge his career by publishing the results in China, under his own name. The researcher’s arrest on Dec. 10 signified an escalation in the F.B.I.’s efforts to root out scientists who, the authorities say, are stealing research from American laboratories. Federal prosecutors warn that he may be charged with transporting stolen goods or with the theft of trade secrets, a felony that brings a prison term of up to 10 years. “The researchers case is the first to unfold in the laboratories clustered around Harvard University, but it is not likely to be the last.”

Stolen Research: Chinese Scientist Is Accused of Smuggling Lab Samples

Source: New York Times

12-31-19

https://www.nytimes.com/2019/11/04/health/china-nih-scientists.html



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In The News …

21

1. Prohibit doctors from accepting anything at all from drug or device companies.

Conflict of Interest Code of Conduct

Source: Kaiser Conflict-of-Interest Policy, Forbes

2. Form an ethics committee to address any concerns doctors may have.

3. Direct all research funding, regardless of the source, to the institution and not to individuals.

4. Require all providers to disclose any past payments, prior to the policy’s implementation.

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A New Program

The Healthcare Innocence Project builds on the successful model of The Innocence Project. Where it used the new technology of DNA 25 years ago, we will use the new technology of electronic records and the digital DNA in the E.H.R. and administrative records to protect the medical identity of patients and the professional identity of caregivers. Both patients and caregivers may be unjustly treated through intentional or unintentional behaviors of insiders or outsiders of healthcare organizations. They include weaponization of HR, sham peer review, discrediting patients and families after healthcare accidents, or unjust harm through outsider cybersecurity issues.

The Healthcare Innocence Project

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www.HealthcareInnocenceProject.org

http://www.healthcareinnocenceproject.org/

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Healthcare Innocence Project

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From Mobsters to Managers. RICO (Racketeer Influenced and Corrupt Organizations Act)

Extends Beyond the Underworld

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Cardiac Arrest

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

Opioid Overdose

Common Accidents

Bullying

A Medical-Tactical Approach undertaken by clinical and non-clinical people can have enormous impact on los 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.

Choking & Drowning

Anaphylaxis

Major Trauma

Transportation Accidents

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Med Tac Story Article

Active Shooter Healthcare Article

AED & Bleeding Control Gear Article

Rapid Response Teams Article

Battling Failure to Rescue

Automated External Defibrillator

& Bleeding Control Gear Placement

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

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Published November 11, 2019 https://www.campussafetymagazine.com/news/inadequate-

placement-of-aed-and-bleeding-control-gear-could-cost-you/

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Meaningful Use is dead. Long live something better! YouTube Patient Safety Briefings

Active Shooter Events in Healthcare https://www.youtube.com/watch?v=qSsWAs5JJBw&feature=youtu.be

Med Tac Bystander Care Training https://www.youtube.com/watch?v=2lM0jh4qCQU&feature=youtu.be

Opioid Overdose Crisis 2019 Update https://www.youtube.com/watch?v=vyCxQWxaEqE

YouTube TMIT Patient Safety Briefings

Sudden Cardiac Arrest https://www.youtube.com/watch?v=qdXW5WxDDY8&feature=youtu.be

Med Tac Lifeguard-Surf Program https://www.youtube.com/watch?v=G1V8s7LWL6M&feature=youtu.be

Rapid Response Teams https://www.youtube.com/channel/UCCcoR25LxSltmrdRqyCQ7fA/

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Casey Clements, MD, PhD Emergency Medicine Physician Mayo Clinic Rochester, MN TMIT High Performer Webinar December 19, 2019

Violence in Healthcare and Keeping Everyone Safe

28 © 2020 TMIT Source: C. Denham, TMIT

The #1 Concern to healthcare leaders is brand damage of the institution and the individual brands of those who serve. Their brand is what they are known for by the public. Our Emerging Threats Community of Practice is addressing the inside, outside, and inside-outside threats to patients, caregivers, and institutions.

© C Denham 2019

© C Denham 2019

29 © 2020 TMIT

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93% Agreed and 79% Strongly or Very Strongly Agreed, and 65% Very Strongly Agreed

Anonymous Survey Questions

Source: TMIT High Performer Webinar Series; Violence in Healthcare and Keeping Everyone Safe – December 19, 2019

I would like another webinar on WORKPLACE VIOLENCE

30 © 2020 TMIT

• Actual case studies with outcomes and best practices. • Ambulatory clinics -tips to de-escalate including a rual areas some are

very small and only have 3 staff members present daily. • Behavioral health practices; • BERT team set up and implementation • Bringing together groups working on various pieces of workplace

violence within an organization. Definitions of WPV. Recognized categories of WPV.

• Consolidation of staff reporting to make it easier to report and thereby collect data

• Coworker workplace bullying and violence • Data collection • De-escalation techniques • De-escalation techniques; adherent behavior identification • Domestic violence spill over and the effects on institution or employees. • Early recognition and preadmit preparation for patients either known to

be violent or with a history of being violent. • Educating staff and notifying public violence is not tolerated • Facility accountability

• How a patient to staff assault should be reported to the authorities/police.

• How long did implementation take? • How to avoid VIWP • How to identify hazards and mitigate them, • How to initiate a safety program • How to manage behavioral health patients, those with active addiction

needing our care, family member violence • How to recognize before event occurs • I would like to see what a huddle would look like/sound like • Identifying the patient so all workers know they have a history of

violence • Interaction with HR secondary to staff dismissal. • Legal complications with the use of physical restraints. • Long-term stay patients, other interventions besides separate unit • Mobbing in the workplace and employee's stalking another employees • More about varieties of improvement efforts


The topics I wish to have covered in a webinar on WORKPLACE VIOLENCE

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• More on CIU and new area topics • more on how to keep staff and patients safe • Nursing impact and how to keep our nurses safe. Great presentation

from Dr. Clements. I think a complementary webinar from the nurse's perspective would be nice.

• Operationalizing "flagging' process for violence and overcoming reluctance to labeling patients as violent

• OSHA response to amount of incidents reported • Patient contracts, clinical and legal. • Patient Safety Integration • pediatrics • Physician on employee (not just RNs) • Post violence event debriefing with focus on staff support • prevention • Processes for immediate response, ED best practices • Prosecution of Behavioral Health patients that are boarded in the ED • psychiatric • reporting structures and overcoming :this is expected in healthcare" • risk assessment tools, EHR tools banners, community coalition,

Environmental risk assessment • Senior Leadership Buy in • specific training on dealing with unexpected violence • strategies for managing behavioral health pts that preserve dignity of PT

and safety of staff • Strategies for smaller, rural hospitals (may not have Security staff) • Strategies on how to manage behaviors. • TDO and ECO patients • Tolerance: Acceptance. The decision about clinical must keep vs

behavior unacceptable/unsafe for caretakers • verbal abuse • Violence between patient's and their family's and how to help facilitate

through the problem. • Violence prevention from patient family members and visitors • Virginia laws • what forms are being used in other violence review committees • what happens if a Staff who was assaulted retaliates?


The topics I wish to have covered in a webinar on WORKPLACE VIOLENCE

32 © 2020 TMIT

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I would like a webinar on HOSPITAL ACQUIRED CONDTIONS Known as the HACs

33 © 2020 TMIT

• Alcohol withdrawal • All aspects • All topics and how to get staff on board • Best practices with PSI 90 especially when volumes are low • C. Difficile infections • CDIFF, MRSA • CLABSI • Clarity re: definitions. • Closterium difficile • Communicable Dr • Device infection risks • Drug-resistant • DVT nosocomial infections • Fall with injury • Falls • Falls with injury, pressure ulcers, surgical lacerations

• Hospital acquired infections • Influenza • Latest prevention protocols; updated exceptions to events • Pressure injuries • Pressure injury and surgical site infection • Progress- and how to maintain zero and momentum • Reduction of surgical site infections (are vendors a part of the

problem?) • SSI, CLABSI, CAUTI • Staff injury due to workplace violence • Strategies for reducing MDROS • UTI, falls, aspiration pneumonia, SSI • Violence and misbehavior by patients • What to do daily to try to avoid any HAC's and some of the best

trends to follow.


The topics I wish to have covered in a webinar on HOSPITAL ACQUIRED CONDTIONS (HACs) include:

34 © 2020 TMIT

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I would like a webinar on ADVERSE DRUG EVENTS

35 © 2020 TMIT

• Anti COAG ok • Anti-coagulation & DOACS • Antipsychotic use especially w/dementia • Avoiding wrong dose treatment of wrong dose • Best practice for admin of anti-coagulation meds in hospital • Definition of adverse drug events & what is counted in monitoring in

numerator/denominator; calculating error rates; benchmarks • Drug diversion • Drug interactions • Geriatric patients with multiple medications • Herbals & their interaction with prescription medications • High risk MEDSM on DC • How med rec can reduce the incident of adverse med events and tips on

getting providers to complete med recs on hospital admission. • How to educate staff on common drugs and their adverse events. We

have an educational opportunity for nurses being familiar with s/s of hypoxia caused by narcotics/sedatives.

• I would like to see how drug events differ by people being admitted to the emergency room versus those who are patients and have adverse reactions caused by healthcare workers.

• Insulin, seizure medications, and pain relievers. • Most common • Most common and mitigating strategies • Not sure what topics I would want to see, • Opioids • Pediatric errors • Poly pharmacy on admission and prior to d/c • Potential drug adverse events from drug substitutions due to shortages • Prevention • Reporting, investigations, information-sharing, leadership engagement,

education and interventions, • Sedative • Sentinel events / serious harms from adverse drug • Use of coumadin in the elderly • Using trigger drugs for event analysis • Whatever you have


The topics I wish to have covered in a webinar on ADVERSE DRUG EVENTS INCLUDING ANTI-COAGULATION

36 © 2020 TMIT

Alan K. Jacobson, MD, FACC Assistant Professor of Medicine Loma Linda University School of Medicine Director, Anticoagulation Services Veterans Affairs Medical Center Loma Linda, CA TMIT High Performer Webinar January 16, 2020

New Oral Anticoagulants: New Patient Safety Challenges

37 © 2020 TMIT

Robert Katzer, MD, MBA, FAEMS, FACEP

Associate Clinical Professor Associate Base Hospital Director Department of Emergency Medicine UC Irvine Medical Director, City of Anaheim Fire and Rescue Air Medic, San Bernardino County Sheriff Orange, CA TMIT High Performer Webinar January 16, 2020

Pre-presentation Questions & Comments

38 © 2020 TMIT

Christopher R. Peabody, MD, MPH Emergency Physician Director, UCSF Acute Care Innovation Center, University of California San Francisco

Clinical Instructor, University of California San Francisco San Francisco, CA TMIT High Performer Webinar January 16, 2020

Pre-presentation Questions & Comments

Anticoagulation Safety A 2020 Update

Alan K. Jacobson, MD Cardiology Section

Loma Linda VA Medical Center Loma Linda University School of Medicine

16 January 2020

Disclosures

Department of Veteran Affairs

Industry Relationships Astra Zeneca Boehringer Ingelheim Bristol-Myers Squibb / Pfizer Daiichi Sankyo Janssen Pharmaceuticals Portola Pharmaceuticals

Outline

Update on DVT Prevention Update on Joint Commission and Anticoagulation The future of optimizing Safety and Efficacy of

Anticoagulation Management (Anticoagulation Stewardship)

Hemostasis

Vessel Graphic

Slow Flow

Fibrin Platelets RBCs

Coagulation Thrombus

High Flow

Fibrin Platelets RBCs

White Thrombus

Venous Thromboembolic Disease

Venous ThromboEmbolism (VTE) Are DVT and PE manifestations of the same disease …, or not?

Thrombus in one of the deep veins

Embolus

Perfusion defect

Virchow’s Triad Medically Ill Hospitalized Patients

Rudolf Virchow 1821–1902

Hypercoagulable State

To heart

Muscle relaxed

To heart

Valve cusp closed

Contracted muscle

Vein

Valve cusp open

Venous Clot

Venous Ultrasound

Clot Embolizes

Pulmonary Embolus

Spiral CT Scan

Prevention of VTE Medically Ill Adults

MEDENOX Trial A Comparison of Enoxaparin with Placebo for the

Prevention of Venous Thromboembolism in Acutely Ill Medical Patients N Engl J Med 1999; 341:793-800

“We chose a duration of prophylaxis of 6 to 14 days in order to match the usual duration of hospitalization among medical patients. We cannot rule out the possibility that treatment was too short in the case of some patients and that it was discontinued while they were still at risk for venous thromboembolism.”

So what has happened since 1999?

Shorter hospital stays Documentation that majority of events occur post

discharge Failure of multiple trials of NOACs due to excess

bleeding

When after admission does VTE occur?

Amin AN, et al. J Hosp Med. 2012;7(3):231-238.

Amin et al

11,139 patients 366 symptomatic events in first 180 days Mean length of Stay 5.3 days 56.6% of events occurred following discharge 97 events days 0-9 82 events days 10-19

Trials of NOACs 2010 EXCLAIM – enox (Lovenox) vs. enox

VTE 2.5% vs. 4.0% Bleeding 0.8% vs. 0.3% 2011 ADOPT – apixaban (Eliquis) vs. enox

VTE 2.7% vs. 3.1% Bleeding 0.5% vs. 0.2% 2013 MAGELLAN rivaroxaban (Xarelto) vs. enox

VTE 4.4% vs. 5.7% Bleeding 1.1% vs. 0.4% 2018 MARINER rivaroxaban (Xarelto) vs. placebo

VTE 0.83% vs. 1.1% Bleeding 0.28% vs. 0.15%) 1. Hull RD, et al. Ann Intern Med. 2010;153(1):8-18 2. Goldhaber SZ, et al. N Engl J Med. 2011;365(23):2167-2177. 3. Cohen AT, et al. N Engl J Med. 2013;368(6):513-523. 4. Raskob GE, et al. N Engl J Med. 2018; 379:1118-1127

ASH Guidelines VTE Prevention Medically Ill Adults

In medical inpatients, when medication is used to prevent VTE, low-molecular-weight heparin is preferred over unfractionated heparin because it is only administered once a day and has fewer complications.

In medical inpatients, when a medication is used to prevent VTE, low-molecular-weight heparin during the hospital stay is preferred over a direct oral anticoagulant administered in hospital or after discharge.

Blood Advances. 2018; 2:3198-3225

October 2019

Parts of Mariner plus parts of Magellan in post hoc analysis results in FDA approval:

Rivaroxaban 10 mg. q day through hospitalization and through day 31-39 post admit.

For medically ill hospitalized NOT at high risk of bleeding: ulcer within 3 months, any bleeding in 3 months, active cancer, severe bronchiectasis, dual antiplatelet therapy https://www.abstractsonline.com/pp8/#!/4682/presentation/44984

What does this mean?

Potential for shifting standards of care Potential for changes to order sets Resulting potential for challenges in evaluating quality

of care

A second drug approved prior to rivaroxaban, betrixaban (Bevyxxa)

Update on Joint Commission and Anticoagulation

Revised National Patient Safety Goals Sentinel Event Alert #61

Joint Commission & Anticoagulation

Effective July 1, 2019, eight new elements of performance will be applicable to all Joint Commission-accredited hospitals, critical access hospitals, nursing care centers, and medical centers (accredited under the ambulatory health care program). These new requirements are at NPSG.03.05.01 in the National Patient Safety Goals® chapter.

For years, this NPSG has played an important role in improving the safety of patients receiving anticoagulation therapy. However, there has been a rise in adverse drug events associated with direct oral anticoagulants (DOACs), and The Joint Commission believes that relevant updates to this NPSG to address DOACs may help reverse that trend.

Web Link for NPSG.03.05.01

https://www.jointcommission.org/standards/r3-report/r3-report-issue-19-national-patient-safety-goal-for-anticoagulant-therapy/

Eight standards, last two only have new numbers The other six have been expanded to include

relevance for the NOACs / DOACs




Standards

New or Amended Elements of Performance:* EP-1: Initiation and maintenance of anticoagulants EP-2: Reversal and bleeding events EP-3: Perioperative management EP-4: Laboratory monitoring to monitor and adjust EP-5: Identify, respond to, and report ADEs EP-6: Patient and family education * Including DOACs

Joint Commission Sentinel Event #61

https://www.jointcommission.org/en/resources/patient-safety-topics/sentinel-event/sentinel-event-alert-newsletters/sentinel-event-alert-61-managing-the-risks-of-direct-oral-anticoagulants/

Accompanying infographic





Anticoagulation Stewardship

Federal partners should lead efforts to promote the concept of “anticoagulation stewardship” to reduce anticoagulant ADE burden. Page 66

FDA issued RFP

Anticoagulation Forum and CDC

Leadership

Scott Kaatz, DO Jack Ansell, MD Allison Burnett, PharmD Steve Deitelzweig, MD Dan Witt, PharmD

David Garcia, MD Tracy Minichiello, MD Liz Goldstein, MBA Darren Triller, PharmD ACF Board of Directors

Technical Expert Panel Victoria Agramonte, Brooklyn Hospital Andrew Bland, The Joint Commission Brittany Bogan, Michigan Health & Hospital Assoc. Debra Feinberg, University of Binghamton Randy Fenninger, National Blood Clot Alliance Helen Larios, The Joint Commission Steven Meisel, Fairview Health Services Anne Myrka, IPRO Jessie Roach, Centers for Medicare & Medicaid Services Shelly Sahu, National Institutes of Health Nadine Shehab, Centers for Disease Control Barbara Zarowitz, University of Maryland

Anticoagulation Stewardship Defined

Coordinated, efficient, and sustainable system-level initiatives designed to achieve optimal anticoagulant-related health outcomes and minimize avoidable adverse drug events through the: Application of optimal evidence-based care Appropriate prescribing, dispensing, and administration of anticoagulants and related agents Provision of appropriate patient monitoring and clinical responsiveness”

Anticoagulation Stewardship Programs NEW REPORT RELEASE

Summary of Core Elements of Anticoagulation Stewardship Programs

1. Secure Administrative Leadership Commitment 2. Establish Professional Accountability and Expertise 3. Engage Multidisciplinary Support 4. Perform Data Collection, Tracking, and Analysis

5. Implement Systematic Care

6. Facilitate Transitions of Care

7. Advance Education, Comprehension, and Competency


Secure Administrative Leadership Commitment: Dedicating necessary human, financial, and technology resources

Administrative leadership support may take a number of forms, for example: • Endorsement within institutional statements and/or strategic plans • Provision of budgeted resources • AC related quality improvement and safety strategies, metrics, and

goals


Establish Professional Accountability and Expertise: Appointing a single leader responsible for program outcomes, supported by at least one clinician with expertise in anticoagulation management

Key duties of the leader include: • Develop stewardship goals and implement strategy • Identify and petition for resources • Evaluate and report on program performance • Represent and advocate for stewardship program at

administrative meetings


Engage Multidisciplinary Support: Involving key specialists and disciplines to obtain perspective from all domains of the care delivery system

Multidisciplinary Perspectives Important to Anticoagulation Stewardship Efforts

Blood Bank Finance Nursing

Case Management Home Care Nutrition

Clinical Providers Imaging Pharmacy

Discharge Planning Information Technology Quality Improvement

Education Laboratory Rehabilitation

Emergency Medicine Long-Term Care Risk Management


Perform Data Collection, Tracking, and Analysis: Defining the population, objectively evaluating performance, guiding decision-making

• Under/over-utilization • Inappropriate prescribing • Inappropriate laboratory/diagnostics • Suboptimal management of ADEs • Suboptimal care transitions • Excessive event rates (bleeding, thrombosis)

Common Anticoagulation-Related System Deficiencies


Examples of Possible Metrics

• % care transitions with appropriate documentation and communication

• Proportion of patients receiving formal education • Incidence of anticoagulated related ADEs • Adherence rate to management protocols


Implement Systematic Care: Implementing sustainable, efficient, evidence-based action(s) at the system level to assure the safety and quality of anticoagulation management

• Policies, procedures, protocols • Standardized order sets • Electronic clinical decision support features • Clinical pharmacy programs • Educational programs and material • Many others…


Facilitate Transitions of Care: Creating systems to optimize communication and ensure safe transitions between care settings

• Facilities • “Inbound” patients • “Outbound” patients

• Invasive Procedures (all types, all settings) • Elective • Emergent

• Outpatient environment: “Shared” patients: • Concurrent outpatient prescribers (e.g. PCP, cardiology) • Pharmacies (e.g. multiple pharmacies, OTC use) • Insurance changes, gaps


Advance Education, Comprehension, and Competency: Assuring that clinicians, patients, and others have the knowledge and skills necessary to optimize outcomes • Clinician education, competence • Patient and family education, comprehension


Checklist for Core Elements of Anticoagulation Stewardship Programs


Anticoagulation Stewardship Resources excellence.acforum.org

Summary

Prevention of VTE in the Medically Ill Joint Commission revisions to NPSG to include DOAC

anticoagulants Publication of Standards for Anticoagulation

Stewardship programs, modeled on Antibiotic Stewardship programs.

Anticoagulation Safety in 2020:

Optimizing Systems to find the sweet spot between maximal effectiveness and

maximal safety

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National Survey Questions I would like another webinar on

ANTICOAGULATION MANAGEMENT

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

The topics I wish to have covered in a webinar on ANTICOAGULATION MANAGEMENT

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National Survey Questions I would like a webinar on

EMERGENCY DEPARTMENT PATIENT SAFETY

Very Strongly

Agree

10 Strongly

Agree

9 Agree

8 Agree

7 Very

Strongly Disagree

1

Disagree

3 Strongly Disagree

2 Neutral

6 Neutral


4

The topics I wish to have covered in a webinar on EMERGENCY DEPARTMENT PATIENT SAFETY

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National Survey Questions I would like a webinar on

EMERGING THREATS IN PATIENT SAFETY

Very Strongly

Agree

10 Strongly

Agree

9 Agree

8 Agree

7 Very

Strongly Disagree

1

Disagree

3 Strongly Disagree

2 Neutral

6 Neutral


4

The topics I wish to have covered in a webinar on EMERGING THREATS IN PATIENT SAFETY

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Speakers and Reactors Dr. Alan Jacobson

Dr. Charles Denham Dr. Christopher Peabody

Dr. Robert Katzer Jennifer Dingman

Gregory Botz

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Gregory H. Botz, MD, FCCM Professor, Department of Critical Care Division of Anesthesiology and Critical Care The University of Texas MD Anderson Cancer Center Houston, TX Adjunct Clinical Associate Professor, Department Anesthesiology Stanford University Medical School TMIT High Performer Webinar January 16, 2020

Reaction to Presentation

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Voice of 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 TMIT High Performer Webinar January 16, 2020

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In The News …

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Dec 10, 2018

These were big stories with no small implications. If these scandals were the work of only a few selfish individuals, most HR departments could resolve them. Unfortunately, the problems are endemic and deeply embedded in medical culture. When it comes to the questionable ethics of accepting money and perks from drug and device companies, doctors and hospital administrators routinely look the other way.

Source: Forbes https://www.forbes.com/sites/robertpearl/2018/12/10/shame-scandal/#785cc45c6807

Shame, Scandal Plague Healthcare Providers In 2018

In 2005, Dr. Sharon Levine designed and orchestrated the industry’s strictest conflict-of-interest policy, a program that defied the doomsday predictions of many doctors. Only two of the 5,000 physicians working in the medical group at the time left as a result of the new policy. (Kaiser conflict of interest policy)

https://www.forbes.com/sites/robertpearl/2018/12/10/shame-scandal/#785cc45c6807

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Healthcare Innocence Project

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Doctors, Defamation, and Damages: Medical Practitioners Fighting Back.

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Meaningful Use is dead. Long live something better! In the News: Med Tac Updates

Source: Campus Safety Nov/Dec Issue - https://www.campussafetymagazine.com/public/med-tac-training-bystanders/

Nov/Dec 2018 Issue

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Meaningful Use is dead. Long live something better! Med Tac Slides and Articles in RESOURCES SECTION

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Med Tac Articles: Campus Safety Magazine

Anticoagulation Safety: A 2020 Update · Alan K. Jacobson, MD, FACC, is a staff cardiologist and...

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