2019 ANNUAL SCIENTIFIC SESSION Saturday General Session ...€¦ · 2019 ANNUAL SCIENTIFIC SESSION...

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2019 ANNUAL SCIENTIFIC SESSION Saturday General Session: Handouts February 22-23, 2019 Raleigh Marriott Crabtree Valley Hotel Raleigh, NC This continuing medical education activity is sponsored by the American College of Physicians

Transcript of 2019 ANNUAL SCIENTIFIC SESSION Saturday General Session ...€¦ · 2019 ANNUAL SCIENTIFIC SESSION...

Page 1: 2019 ANNUAL SCIENTIFIC SESSION Saturday General Session ...€¦ · 2019 ANNUAL SCIENTIFIC SESSION Saturday General Session: Handouts February 22-23, 2019 Raleigh Marriott Crabtree

2019 ANNUAL SCIENTIFIC SESSION Saturday General Session: Handouts

February 22-23, 2019 Raleigh Marriott Crabtree Valley Hotel • Raleigh, NC

This continuing medical education activity is sponsored by the American College of Physicians

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1

Ben Demarco, MD

Chapel Hill, NC

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David Zaas, MD, MBA 

Durham, NC

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Martha Adams, MD

Durham, NC

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Kavya Kannan, MD

Winston‐Salem, NC

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Harriet Burns, MD 

Burlington, NC

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Thank you for you support! Please Vote for your Favorite:

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Reflections of a Physician-Leader Battling Cancer

David Zaas, MD, MBAAssociate Professor of MedicineDuke University School of MedicinePresident Duke Raleigh Hospital

Building an Academic Career

2

Building a Family

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The Day My Life Changed

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Writing your own H&P

• Assessment– New diagnosis of AML

– Complex cytogenetics and leukemia cutis

– Intermediate to poor prognosis 5

• February 14, 2017

• History of present illness– 45 year old male diagnosed with

Acute Myeloid Leukemia

• Past medical history– None

• Social history– Wife and 2 boys, ages 11 and 13

– Works as physician leader at Duke since 2001

• Family history– No history of cancer

Thoughts as a Patient

• No longer a physician-scientist

• New role as a patient• Vulnerable, scared, worried about the future

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• Focus on your family• Not worried about myself, worried about how to

care for my wife and children

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Clinical Summary

• Enrolled in phase I clinical trial

• Spent over 2 months in hospital• Induction and consolidation

chemotherapy treatment

• Multiple complications

• Underwent haploidentical transplant • May 25, 2017

• 13 year old son Jake is the bone marrow donor

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On the Road to Recovery

• Cancer in remission

• Chemotherapy and bone marrow transplant successful

• Returned to work August 1, 2017

• Redefining what is normal for our family as we live life to the fullest

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Why me?

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WHY am I alive today?

• World Class Care

• Outstanding Physicians and Nurses

• Access to Clinical Research, Innovation, and Personalized Medicine

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WHY is research and innovation important?

• FLT3+ mutation associated with a poor prognosis in 1/3 AML patients

• Addition of the FLT3 inhibitor to standard induction & consolidation chemotherapy may improve survival

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“Never before in history has innovation offered promise of so much to so many in so short a time.”

Bill Gates

• “New personalized therapies for this subset of AML will likely lead to a change in standard of care for younger patients.”

• No longer the physician-scientist, I needed to have complete trust

WHY is trust so important?

• Trust in the care team was absolutely critical

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WHY need support?• Reliance on my co-workers, friends, and family was vital

• Everyone stepped up to help and support our family in a time of need

13Compassion is the critical element

WHY is Compassion so critical?

• Charles Darwin argued for “the greater strength of the social or maternal instincts than that of any other instinct or motive … Communities, which included the greatest number of the most sympathetic members, would flourish best, and rear the greatest number of offspring.”

• Compassion: complex construct, including elements of empathy, sympathy, sensitivity, non-judgment, a tolerance of distress, and a motivation to relieve suffering.

• Definition: “Recognizing, understanding, acknowledging and responding to ameliorate others’ concerns, distress, pain or suffering ”

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Compassion is critical at the bedside

• Compassion is foundation of patient-centered care

• Compassion emerges from a universal need for human connection

• Compassion correlates with important patient, staff, and organizational outcomes

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Care more for the individual patient than for the special features of the disease. . . . Put yourself in his place . . . The kindly word, the cheerful greeting, the sympathetic look - these the patient understands.

William Osler

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The importance of self-Compassion

• 3 Behaviors of people with high self-compassion– Kind rather than judgmental

about their failures– Recognize that failures are

shared human experience– Take a balanced approach

when they fall short

• Fostering self-compassion can be learned and enhanced

• Creates sense of self-worth and enables recovery after a setback– Triggers people to adopt a

growth mindset– Greater motivation to

improve themselves– Better able to arrive at

realistic self-appraisals

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Compassion is critical for leaders

• To lead, begin with warmth- the conduit of influence:

– Demonstrating you hear, understand, and can be trusted

• Trust increases:– information sharing, openness, fluidity,

cooperation and economic gains

• Best way to gain influence is to combine warmth and strength:

– When we feel confident and calm, we project authenticity and warmth.

• Before people decide what they think of the message, they decide what they think of you

• Judge leaders by how lovable and how fearsome

• “It may be answered that one should wish to be both, but because it is difficult to unite them in one person, it is much safer to be feared than loved.”

• Niccolò Machiavelli

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Impact of Compassionate leaders on teams

• To lead effectively– must be confident in

yourself– connected to others– committed to purpose– emotionally courageous

• To instill grit in your team– cultivating gratitude– compassion– pride

• Compassion and curiosity increase employee loyalty and trust

• Employee trust improves performance

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Compassion is overlooked in leadership training

• Taking on greater responsibilities and pressure causes us to stop caring about other people

• Proactive compassion counters the loss of empathy that results from holding power

• Asking how you can be of benefit to others in every interaction – Compassion is something we

create by applying it every day– Accountability matters-

demonstrate compassion by delivering on promises to your employees

• To nurture compassion:– Coach frequently– Put people first– Support volunteerism

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Life returning to normal!

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Reflections from a Cancer Survivor

• I was fortunate to beat leukemia:– access to care, clinical research, support from my employer, friends,

and family

• My team at work gained confidence and excelled

• My family grew even closer and my children matured

• I am a better physician, leader, husband, and father today because of my journey

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I am no longer invincible, but I am stronger, more COMPASSIONATE, and a better leader today!

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Questions?

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How to Pick the Right Antibiotic Course for Common Infections: A Case-Based Approach

Thomas L. Holland, MD

North Carolina ACP

February 23, 2019

• Consulting: Basilea Pharmaceutica (ceftobiprole), Genentech (investigational immunotherapeutic), Motif Bio (iclaprim), Theravance (telavancin)

• Scientific Advisory Board: Motif Bio

• Adjudication committee: Achaogen, Basilea, Karius

• Grant and salary support: NIH, FDA (via the Clinical Trials Transformation Initiative)

• Royalties: UpToDate

• Employment: Duke University

Disclosures

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Overview

• Background on the “antibiotic course”

• Get specific with some common bacterial syndromes– Pneumonia– Complicated UTI– Cellulitis – Bacteremia

• Recap the fundamental ideas:– Shorter is better (almost always)– “Complete the antibiotic course” is time-honored, deeply ingrained, and

fundamentally incorrect advice for most infections we treat

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WHO Top Ten Threats to Global Health in 2019

1) Air pollution and climate change

2) Noncommunicable diseases

3) Global influenza pandemic

4) Fragile and vulnerable settings

5) Antimicrobial resistance

6) Ebola and other high-threat pathogens

7) Weak primary health care

8) Vaccine hesitancy

9) Dengue

10) HIV

https://www.who.int/emergencies/ten‐threats‐to‐global‐health‐in‐2019, Accessed 1/29/19.

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WHO Top Ten Threats to Global Health in 2019

1) Air pollution and climate change

2) Noncommunicable diseases

3) Global influenza pandemic

4) Fragile and vulnerable settings

5) Antimicrobial resistance

6) Ebola and other high-threat pathogens

7) Weak primary health care

8) Vaccine hesitancy

9) Dengue

10) HIV

https://www.who.int/emergencies/ten‐threats‐to‐global‐health‐in‐2019, Accessed 1/29/19.

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There are lots of approaches to this issue

Reduce AMR

Diagnostics

Antibiotic Stewardship

NonantibioticapproachesNew Drugs

Prevention

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Most antibiotics are prescribed in primary care

Palms et al, JAMA Intern Med. 2018;178(9):1267‐9.7

Things the South loves: BBQ, football, and antibiotics

Hicks et al, Clin Infect Dis, 2015;60(9), 1308–16.

Antibiotic prescriptions per 1000 persons in 2011

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An emperor’s legacy: the 7-day course

Fernandez‐Lazaro et al, Clin Infect Dis, Jan 2019, ciy11309

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Definitions:

Early career = <11 yrsMid‐career = 11‐24 yrsLate career = >24 yrs

Prolonged Rx: >8 days

Late career physicians prescribe longer courses

Fernandez‐Lazaro et al, Clin Infect Dis, Jan 2019, ciy113010

The inconvenient truth

We don’t really know the optimal duration of antibiotics for most of the common infectious

syndromes we treat every day

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Optimal Duration: Our Knowledge

Rigorous analysis is rarely done– Duration typically established in pre-licensure studies

– Target duration often longer than necessary

– Subsequent trials utilize same duration to avoid non-inferiority

– Guidelines are built off these studies

Horsburgh et al, Trials 2013;14:88

Shortest duration to achieve clinical cure is not identified

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IDSA Guidance: Historical Perspective

Guideline Date Duration Authors Comments

SSTI: Cellulitis

2005 ?? No mention of duration

BacterialMeningitis

2004 7‐21 days based more on tradition than evidence

Intra‐AbdominalInfection

2003 ?? “continued until resolution of clinical signs of infection occurs including normalization of temperature and WBC count and return of GI function”

Diabetic Foot Infection

2006 1‐6 weeks

CAP 19982000

?? “We are not aware of any controlled trials that have specifically address the questions of how long pneumonia should be treated”

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Competing motivations

• Factors driving increased antibiotic use:– Mortality benefits of early appropriate therapy for septic patients

– Uncertain diagnoses

– Human psychology – better to overtreat unnecessarily than undertreat and be wrong?

– Concern for relapse

– Lack of data and knowledge

• Factors driving decreased antibiotic use:– Public health concerns – a very weak motivating force

– Growing recognition of harms of antibiotics

– Cost – also a weak driver, at least from the provider side

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15

Too short Too long

Resistance

Treatment failure

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CASES

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Case #1: Community-Acquired Pneumonia

• 70yo Vietnamese male p/w severe sepsis due to CAP, with hypoxic respiratory failure requiring intubation in the ED.

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Case, continued

• Initially given ceftriaxone/azithro but as he decompensated in the ED, broadened to vancomycin + pip/tazo*

• Blood and sputum cultures grow pan-sensitive S. pneumoniae, and therapy is narrowed to ceftriaxone

• He is extubated on HD #3 and transferred to gen med on HD #5, doing well

• What do you do with his antibiotics?

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Keefer et al500 patientsPCNDuration for cure: 2‐3 d

CAP Treatment Duration

Dawson & Hobby100 patientsPCNDuration for cure: 1.5‐2 d

Meads & Finland54 patientsPCNDuration for cure: 2‐3 days after fever resolution

El Moussaui et alRCT N=121 hospitalizedAmoxicillinDuration for cure: 3d

CAP Treatment in Practice10 – 14 Days

“Relapse” (N=3)1) Same pneumococcal species after     

receiving only 10 hours of treatment2/3) Different species 10 days – 1 month         

post tx

Conclusion: Relapses suggest tx even after fever and symptoms resolve is needed

Uranga et alRCT N= 312 hospitalizedFluoroquinolone (80%)Duration for cure: 5d

• Review of 1195 CAP and 544 HCAP cases• 13.6% received guideline-concordant therapy duration

– 6.9% with CAP (≤5d), 29% with HCAP (≤8d)– >97% were stable by day 4, but >50% remained on IV abx

• The average treatment course was 4 days IV, then 1 week PO, with more than half post-discharge

– 17.3% had antibiotic therapy stopped prior to discharge

• Therapy duration was not associated with readmission or mortality rate

Madaras‐Kelly et al, J Hosp Med 2016 Dec;11(12):832‐83920

Mount Ararat, Turkey21

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The untold story? Daptomycin vs Ceftriaxone for CAP

• Daptomycin worked fine for S. aureus pneumonia in a hamster model

• In 2000-2002, Cubist conducted 2 trials of daptomycin versus ceftriaxone among hospitalized adults with CAP– One of the exclusion criteria was >24h of potentially effective therapy

• Daptomycin did not meet noninferiority criteria

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The untold story? Daptomycin vs Ceftriaxone for CAP

• A single day of therapy was enough to influence outcomes

Pertel et al. CID 2008;46(8):1142‐51.23

RCT of Antibiotic Duration for CAP

• Hospitalized CAP patients in Spain (N=312)

• Usual care vs stop antibiotics at day 5 if clinically stable– Stable = afebrile, ≤1 of: SBP<90, HR>100, RR>24, SpO2<90%

– 70% of patients met stability criteria at day 5 in the intervention arm

• Antibiotic choice up to treating clinician– 80% fluoroquinolone

Take home message: duration can be based on clinical stability

JAMA Intern Med 2016;176(9):1257‐1265.24

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Case #2: Complicated UTI

• A 24yo female p/w sepsis due to pyelonephritis, and she has E. coli bacteremia. What is the appropriate antibiotic approach?

A) Vancomycin + pip/tazo

B) Intravenous ceftriaxone until culture results are available, then narrow to oral therapy

C) Prescribe one week of oral ciprofloxacin

D) Give one dose of oral fosfomycin

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Case #2: Complicated UTI

• A 24yo female p/w sepsis due to pyelonephritis, and she has E. coli bacteremia. What is the appropriate antibiotic approach?

A) Vancomycin + pip/tazo

B) Intravenous ceftriaxone until culture results are available, then narrow to oral therapy

C) Prescribe one week of oral ciprofloxacin

D) Give one dose of oral fosfomycin

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Pyelonephritis: Cipro 7 vs 14 days

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• Multicenter (21), prospective non‐inferiority RCT

• Open label (D1‐7), double blind placebo controlled (D8‐14)

• Cipro 500mg PO BID; Option for first dose 400mg IV

Study                          Design

• Non‐pregnant women ≥ 18yrs with acute pyelonephritisPatients

• Primary objective: clinical and bacteriological efficacy 10‐14d after treatment with cipro

• Secondary outcome: Long term (42‐63d) cumulative efficacyEndpoint

Lancet 2012; 380: 484–90

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28Lancet 2012; 380: 484–90

29Lancet 2012; 380: 484–90

Results Cipro 7d Cipro 14d Difference(90% CI)

NI p value

Short‐term efficacy N=73 N=83

Cure 71 (97%) 80 (96%) ‐0.9% (‐6.5 to 4.8)

0.004

Clinical failure 2 (3%) 3 (4%)

Cumulative efficacy N=73 N=84

Cure 68 (93%) 78 (93%) ‐0.3%              (‐7.4 to 7.2)

0.015

Clinical failure 5 (7%) 6 (7%)

Adverse effects N=86 N=93

Mucosal Candida 0 5 (5%) 0.036

Total 4 (5%) 6 (6%)

• Open-label RCT of 538 women with lower UTI in Switzerland, Poland, and Israel

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Study design

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Conclusion: single dose fosfomycin is inferior to nitrofurantoin for uncomplicated UTI in women

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Case #3: Cellulitis

• 53yo male with obesity and onychomycosis p/w LLE cellulitis, no abscess. What is the appropriate approach?

A) Vancomycin + pip/tazo

B) First-generation cephalosporin

C) Collect blood cultures and start TMP/SMX

D) Plain films to look for gas

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Case #3: Cellulitis

• 53yo male with obesity and onychomycosis p/w LLE cellulitis, no abscess. What is the appropriate approach?

A) Vancomycin + pip/tazo

B) First-generation cephalosporin

C) Collect blood cultures and start TMP/SMX

D) Plain films to look for gas

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Nonpurulent cellulitis

• RCT of 153 patients with uncomplicated cellulitis (no abscesses)

• Cephalexin + (TMP/SMX or placebo) x 7-14 days– Patients provided 14d rx, told to stop abx 3 days after they believed themselves cured

(min 7d, max 14d)

• 85% vs 82% cure rate (NS)

• Results similar in subsequent larger RCT (N=500)

Pallin et al, Clin Infect Dis 2013Moran et al, JAMA 2017

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What if there’s an abscess?

• RCT (N=786) of adults and kids with skin abscess <5cm who received I&D

• Clindamycin vs TMP/SMX vs placebo

• Same cure rate with either antibiotic (~82%), better than placebo (69%) – Though at the cost of adverse events

• Clinda 22%, TMP/SMX 11%, placebo 12%

Daum et al, NEJM 2017; 376:2545‐2555 36

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Case #4: Bacteremia

• 63yo female hospitalized for Crohn’s flare develops fever and superficial thrombophlebitis at a PIV site. She is started on vancomycin and the IV is removed. Blood cultures from the line and a peripheral stick grow S. epidermidis. What do you do with her antibiotics?

A) Get follow-up blood cultures and if negative, complete 5 days of vancomycin

B) Convert to oral antibiotics to complete 10-14 daysC) Stop antibiotics, coag-neg staph is a contaminantD) Convert to oral antibiotics to complete ~7 days total

antibiotic course

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Case #4: Bacteremia

• 63yo female hospitalized for Crohn’s flare develops fever and superficial thrombophlebitis at a PIV site. She is started on vancomycin and the IV is removed. Blood cultures from the line and a peripheral stick grow S. epidermidis. What do you do with her antibiotics?

A) Get follow-up blood cultures and if negative, complete 5 days of vancomycin

B) Convert to oral antibiotics to complete 10-14 daysC) Stop antibiotics, coag-neg staph is a contaminantD) Convert to oral antibiotics to complete ~7 days total

antibiotic course

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Staph BSI

Algorithm (255)

Usual care (254)Known complicated ifxn excluded

Success• Alive• No persistence• No relapse• No post-rx complications• No ΔRx/nonresponder

SAE

Adjudication

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Duration of Antibiotic Therapy

At the discretion of the treating clinicianSOC

ABT

0 7 14 21 28 35 42

Complicated

Uncomplicated

Complicated

Uncomplicated

Simple

Days

14

5

0–3CoNS

S. aureus 28–42

7–28

Success According to Clinical Category

Absolute Difference

% (95% CI): 46.9 (22.1–71.6)

87.9%92.3%

73.3% 75.6%

35.7%

84.6% 87.2% 89.5%

70.6%

82.6%

0%

20%

40%

60%

80%

100%

SimpleCoNS

UncomplicatedCoNS

ComplicatedCoNS

UncomplicatedS. aureus

ComplicatedS. aureus

Ov

era

ll S

uc

ce

ss

in I

TT

SOC ABT

S. aureus S. aureus

-1.9 days95% CI -3.1 to -0.6

-3.1 days95% CI -4.9 to -1.3

Prespecified Secondary Endpoint: Duration of Therapy

6.2

1.8

8.4

15.9

4.4

1.8

5.3

15.3

0 7 14 21

Duration of therapy

Simple CoNS

Uncomplicated CoNS

Uncomplicated S. aureus

Mean Days

SOC

ABT

Uncomplicated S. aureus

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Gram-negative bacteremia

• Two important recent trials:1) 7 days of antibiotics for uncomplicated GNR

bacteremia was non-inferior to 14 days• Uncomp = source control, no fever, stable

• Mostly urinary source, mostly Enterobacteriaceae

Yahav et al, Clin Inf Dis, December 2018, ciy1054 43

From: Association of 30-Day Mortality With Oral Step-Down vs Continued Intravenous Therapy in Patients Hospitalized With Enterobacteriaceae Bacteremia

JAMA Intern Med. Published online January 22, 2019. doi:10.1001/jamainternmed.2018.6226

Tamma et al, JAMA Intern Med. Published online January 2019

• Retrospective cohort, N=1478• Clinical response by day 5• Total treatment duration 7‐16 

days

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IDSA Guidance: UpdatedGuideline Date Duration Authors Comments

SSTI: Cellulitis

2005 ?? No mention of duration

2014 5 days

BacterialMeningitis

2004 7‐21 days based more on tradition than evidence

IAI

2003 ?? “continued until resolution of clinical signs of infection  occurs including normalization of temperature and WBC count and return of GI function”

2010 4‐7 days “unless it is difficult to achieve source control”

Diabetic Foot Infection

2006 1‐6 weeks

2012 “can usually be discontinued once the clinical signs andsymptoms of infection have resolved”

CAP2000 ??

2007 5 days

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Copyright © 2016 American Medical Association. All rights reserved.

From: The New Antibiotic Mantra—“Shorter Is Better”

JAMA Intern Med. 2016;176(9):1254-1255. doi:10.1001/jamainternmed.2016.3646

Infections for Which Short-Course Therapy Has Been Shown to Be Equivalent in Efficacy to Longer Therapy

Table Title:

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A cautionary tale 

• 520 kids with AOM received 10 days amox/clav vs 5 days (with additional 5 days of placebo)

• In children 6 to 23 months of age with otitis media, 5 days of antibiotic therapy was associated with less-favorable outcomes than standard 10-day treatment.

• The shorter course did not result in a lower rate of adverse events or of emergence of antimicrobial resistance.

N Engl J Med 2016; 375:2446‐2456

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Conclusions

• We know less than we would like to regarding optimal duration of antibiotic therapy, even for common bacterial infections

• In general, shorter durations of antibiotic therapy are as effective as longer ones

• Once your patient is doing better, it may be time to stop

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• 528 patients with left-sided uncomplicated acute diverticulitis at 22 sites in the Netherlands

• Could have up to 5cm abscess

• Randomized to antibiotics (amox/clav) vs observation

• Primary endpoint was time to recovery

Daniels, L., et al (2017), Br J Surg, 104: 52–61. doi:10.1002/bjs.10309

50

Randomized clinical trial of observational versus antibiotic treatment for a first episode of CT‐proven uncomplicated acute diverticulitis

British Journal of SurgeryVolume 104, Issue 1, pages 52-61, 30 SEP 2016 DOI: 10.1002/bjs.10309http://onlinelibrary.wiley.com/doi/10.1002/bjs.10309/full#bjs10309-fig-0002 51

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Randomized clinical trial of observational versus antibiotic treatment for a first episode of CT‐proven uncomplicated acute diverticulitis

British Journal of SurgeryVolume 104, Issue 1, pages 52‐61, 30 SEP 2016 DOI: 10.1002/bjs.10309http://onlinelibrary.wiley.com/doi/10.1002/bjs.10309/full#bjs10309‐fig‐0003

52

One last word on resistance

• Target selection:– Treat infection select for resistance mutations resistant

pathogens spread

– Examples: TB, HIV, gonococcus

• Collateral selection:– Commensal organisms exposed to antibiotics select for

resistance spread to asymptomatic carriers promiscuous bacteria share resistance genes

– Examples: E. coli, klebsiella, enterococcus, S. aureus

BMJ 2017;358:j3418 53

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Safe Opioid Prescribing 2019Meeting Current Standards of Care

Lawrence Greenblatt, MD, FACPProfessor of Medicine and

Community and Family MedicineCo-Chair Opioid Safety Committee

Duke Health1

Learning Objectives

After today’s session participants will be able to…

• Describe the extent of the opioid epidemic in our state and nationally.

• List the adverse outcomes seen more commonly in geriatric patients.

• Compare ED and OD death data for seniors vs middle aged persons.

• Know where to find and utilize the CDC Opioid Guidelines.

• Recognize tools including the PEG Score and Opioid Risk Tool.

• Act on indications for naloxone co-prescribing.

• Articulate current and future North Carolina laws around opioid safety.

2

Disclosures

None

3

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Yikes!Fentanyl

Heroin

Cocaine

Meth

PrescriptionOpioids

4

Heroin overdose deaths have leveled off and and are reported decreasing a bit in 2017.

6% increase in opioid overdose deaths in 2017

5

We Are Not Winning…

6

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Opioids State and Local Perspective

Thanks to Mary Beth Cox, MPH and Scott Proescholdbell, MPHN.C. State Center for Health Statistics, Vital Statistics‐Deaths, 1999‐2016  Medication or drug overdose: X40‐X44, X60‐X64, Y10‐Y14, X85. Analysis by Injury Epidemiology and Surveillance Unit

Medication or Drug Overdose Deaths by IntentNC Residents, 1999 ‐ 2016 1851

1624

186

400

200

400

600

800

1,000

1,200

1,400

1,600

1,800

2,000

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

Number of deaths

All intents

Unintentional

Self‐inflicted

Undetermined

Assault

410% increase in deaths since 19991,000+ deaths per yearUnintentional overdoses are driving this increase

The News and Observer, January 2019

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Source: Deaths‐N.C. State Center for Health Statistics, Vital Statistics, 2012‐2016, Unintentional medication or drug overdose: X40‐X44/ /Population‐National Center for Health Statistics, 2012‐2016/Economic impact‐CDC WISQARS, Cost of Injury Reports, National Center for Injury Prevention and Control, CDC for all medication and drug deaths (any intent), Base year (2010) costs indexed to state 2015 prices. Analysis by Injury Epidemiology and Surveillance Unit

Unintentional Medication & Drug Deaths by County North Carolina Residents, 2012‐2016

total combined costsfor 2016 alone

$2.1 BILLION 

Source: N.C. State Center for Health Statistics, Vital Statistics‐Deaths, 1999‐2016Analysis by Injury Epidemiology and Surveillance Unit

Substances* Contributing to Unintentional Medication or Drug Overdose Deaths, North Carolina Residents, 1999‐2015

592

538

510

462

0

100

200

300

400

500

600

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

Number of Deaths

Commonly Prescribed Opioid Medications

Other Synthetic Narcotics

Heroin

Cocaine

*These counts are not mutually exclusive. If the death involved multiple drugs it can be counted on multiple lines. 

Rates of Unintentional/Undetermined Prescription Opioid Overdose Deaths & Outpatient Opioid Analgesic Prescriptions Dispensed

North Carolina Residents, 2011‐2015

Source: Deaths‐ N.C. State Center for Health Statistics, Vital Statistics, 2011‐2015, Overdose: (X40‐X44 & Y10‐Y14) and commonly prescribed opioid T‐codes (T40.2 and T40.3)/Population‐National Center for Health Statistics, 2011‐2015/Opioid Dispensing‐ Controlled Substance Reporting System, NC Division of Mental Health, 2011‐2015Analysis: Injury and Epidemiology Surveillance Unit 

Average mortality rate: 6.4 per 100,000 persons

Average dispensing rate: 82.9 Rx per 100 persons

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114

174197

306

396

526

157134 126

181

245

425

0 0 0 938

195

0

100

200

300

400

500

600

2011 2012 2013 2014 2015 2016*

Cases Positive

Heroin

Fentanyl

Fentanyl Analogues**

Heroin, Fentanyl, and Fentanyl Analogues Detected in Toxicology Testing, Office of Chief Medical Examiner Investigated Deaths

Source: N.C. Office of the Chief Medical Examiner (OCME) and the OCME Toxicology Laboratory.*Data for 2016 is considered provisional and is current as of Feb. 2017.**Fentanyl analogues include: Acetyl fentanyl, Butrylfentanyl, Furanylfentanyl, Fluorofentanyl, Acrylfentanyl, Fluoroisobutrylfentanyl, Beta‐Hydroxythiofentanyl, Carfentanil. The presence of a drug does not necessarily indicate that it was attributed to the cause of death

2016 – Fentanyl & Fentanyl Analogues detected in a larger proportion of death investigations by the OCME

14

Epidemic of Endocarditis

Trends in Drug Use–Associated Infective Endocarditis and Heart Valve Surgery, 2007 to 2017:A Study of Statewide Discharge Data. Schranz et al.  Annals of Internal Med. January 1, 2019

15 fold increase!

15

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0

2

4

6

8

10

12

14

2010 2011 2012 2013 2014 2015

X‐fold increase in incidence rate relative to 2010 

Endocarditis & Sepsis Among Likely Drug Users, North Carolina, 2010–2015 

Endocarditis Sepsis

Sepsis (bloodstream infections)

increased 4 times

Heart valve infections associated with injection drug

use increased 13.5 times

Source: NC Division of Public Health, Epidemiology Section, NC EDSS, 2010‐2015

Source: Deaths‐N.C. State Center for Health Statistics, Vital Statistics, 2014/ Hospitalizations‐N.C. State Center for Health Statistics, Vital Statistics, 2014/ED‐NC DETECT, 2014/ Misuse‐NSDUH 2013‐2014/Prescriptions‐CSRS, 2014.  Analysis by Injury Epidemiology and Surveillance Unit

913

Deaths

2,698 Hospitalizations

3,515 Emergency Department Visits

349,000 NC Residents reported misusing prescription pain relievers

7,717,711 Prescriptions for opioids dispensed

1.0

2.9

3.8

382

8,453

In 2014, for every 1 opioid overdose death, there were just under 3 hospitalizations and nearly 4 ED visits due to medication or drug overdose.

Opioid Deaths, Hospitalizations, ED Visits, Misuse & Dispensing, NC Residents, 2014

What proportion of Medicare patients filled an opioid prescriptions over a 3 month interval?

What was the average daily dose in morphine milligram equivalents?

18

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Medicare Advantage –short vs long term?

Percentage of total fill prescribed to long term users?

Medicare for >65–short vs long term?

Percentage of total fill prescribed to long term users?

19

Opioids in the Older Adult

• Altered thinking/delirium

• Bowel and/or bladder dysfunction

• Dry mouth

• Pruritus

• Suppressed respiration, increased CO2

• ?others-UTI, pneumonia, falls, MVA’s

20

Risky Prescribing

• Higher MME

• # days prescribed

• Multiple prescribers

• Opioid plus benzo (especially early in the course)

Jena AB et al Opioid prescribing by multiple providers in medicare…BMJ 2014Kuo YF et al, Trends in opioid prescriptions among part D medicare recipients…American Journal of Medicine 2016

21

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Duke Data (Raman et al.)

• Medicare Part D Claims study, 5% sample

• 144K got a new opioid Rx– 6.5% became long term

– 40% from multiple prescribers

– 18% multiple pharmacies

– 22% had peak MME 50-89

• 6% had peak MME >90– 18.5% became long term

– 13% had >3 pharmacies

– 40% had >3 prescribers

22

23

24

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CDC Guideline for Prescribing Opioids for Chronic Pain• Importance: Primary care clinicians (who doesn’t?) find

managing chronic pain challenging. Proof of long-term efficacy is lacking. Misuse, abuse, and dependence are common. Training has been limited for most clinicians.

• Objective: To provide recommendations about opioids prescribing for primary care clinicians treating adult patients with chronic pain outside of active cancer treatment, palliative care, and end-of-life care.

• FYI: Our Medical Board has made these the standard exempting cancer patients, palliative care, and EOL care.

http://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htmPublished March 15, 2016 25

CDC Guideline for Prescribing Opioids for Chronic Pain

• Based largely on limited data.

• All major recommendations are based on limited RCT’s, observations, or expert opinion

• Generally reasonable

• The best we have and the expectation is clear

http://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm26

Determining When to Initiate or Continue Opioids for Chronic Pain

Recommendation 1:• Non-pharmacologic therapy and non-opioid pharmacologic

therapy are preferred for chronic pain.

• Patients often underestimate the risks.

• Clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient.

• If opioids are used, they should be combined with non-pharmacologic therapy and non-opioid pharmacologic therapy, as appropriate.

http://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm 27

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There are good alternatives…

28

Data Sources (NSAID’s vs. Opioids)‐Derry, C., & Derry, S. (2009). Single dose oral naproxen and naproxen sodium for acute postoperative pain in adults. … Cochrane Database Syst Rev, (11). ‐Derry, C., Derry, S., & Moore, R. (2013). Single dose oral ibuprofen plus paracetamol ( acetaminophen ) for acute postoperative pain ( Review ). Cochrane Database of Systemic Reviews‐Gaskell, H., Derry, S., Moore, R., & McQuay, H. (2009). Single dose oral oxycodone and oxycodone plus paracetamol ( acetaminophen ) for acute postoperative pain in adults. Cochrane Database of Systematic Reviews‐Holdgate, A., & Pollock, T. (2004). Nonsteroidal anti‐inflammatory drugs ( NSAIDs ) versus opioids for acute renal colic. Cochrane Database of Systemic Reviews, (1), ‐Moore, P. A. (2013). Combining ibuprofen and acetaminophen for acute pain management after third‐molar extractions. Journal of the American Dental Association, 144(8), 898–908.

29

Here is the latest!

• JAMA 3/6/18 Erin Krebs et al.– Veterans with LBP or Hip/Knee OA

– Moderate or worse pain

– Opioid-based approach vs. Non-opioid

– 12 month follow up

– Function was primary outcome: no difference

– Pain intensity better controlled with non-opioids

– Side effects better with non-opioids

– Anxiety better with opioidsJAMA March 6, 2018Effect of Opioid vs Nonopioid Medications on Pain‐Related Function in Patients with Chronic Back Pain or Hip or Knee Osteoarthritis Pain.  Erin E. Krebs , et al. 30

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Determining When to Initiate or Continue Opioids for Chronic PainRecommendation 2:

• Before starting opioid therapy for chronic pain, clinicians should establish treatment goals with all patients, including realistic goals for pain and function, and should consider how therapy will be discontinued if benefits do not outweigh risks. Clinicians should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety.

http://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm 31

Krebs, E.E., Lorenz, K.A., Blair, M.J., et al. (2009). Development and initial validation of the PEG, a three‐item scale assessing pain intensity and interference.  Journal of General Internal Medicine, 24: 733‐738.

PEG ScoreThree –Item Scale Assessing Pain Intensity and Interference

32

Determining When to Initiate or Continue Opioids for Chronic Pain

Recommendation 3:• Before starting and

periodically during opioid therapy, clinicians should discuss with patients known risks and realistic benefits of opioid therapy and patient and clinician responsibilities for managing therapy.

http://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm 33

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Opioid Selection, Dosage, Duration, Follow-up, and Discontinuation

Recommendation 4:

When starting opioid therapy for chronic pain, clinicians should

prescribe immediate-release opioids instead of extended-

release/long-acting (ER/LA) opioids.

http://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm34

Opioid Selection, Dosage, Duration, Follow-up, and Discontinuation

Recommendation 5:

When opioids are started, clinicians should prescribe the lowest

effective dosage. Clinicians should use caution when prescribing

opioids at any dosage, should carefully reassess evidence of

individual benefits and risks when increasing dosage to 50

morphine milligram equivalents (MME) or more per day, and should

avoid increasing dosage to 90 MME or more per day or carefully

justify a decision to titrate dosage to 90 MME or more per day.

http://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm35

Opioid Selection, Dosage, Duration, Follow-up, and Discontinuation

Recommendation 6:

Long-term opioid use often begins with treatment of acute pain.

When opioids are used for acute pain, clinicians should prescribe

the lowest effective dose of immediate-release opioids and should

prescribe no greater quantity than needed for the expected

duration of pain severe enough to require opioids. Three days or

less will often be sufficient; more than 7 days will rarely be

needed.

http://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm 36

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Measuring The Quality Of New Opioid Prescriptions: New Performance Measures Are Needed. McKethan et al. Health Affairs Blog Nov 26, 2018

How do our new starts look?

37

Where pain relievers were obtained mostRecent Nonmedical Use among Past Year Users Aged 12 or Older: 2010

71%from friend/relative(free + bought/stolen)

73%of all meds/nonmedical are from 1 MD  

4%Of all nonmedical are from Drug dealer/stranger

4%of all nonmedical are from more than 1 MD  

38

Opioid Selection, Dosage, Duration, Follow-up, and DiscontinuationRecommendation 7:

• Clinicians should evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy for chronic pain or of dose escalation. Clinicians should evaluate benefits and harms of continued therapy with patients every 3 months or more frequently. If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids.

http://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm 39

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Assessing Risk and Addressing Harms of Opioid Use

Recommendation 8:

• Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms. Clinicians should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, higher opioid dosages (>50 MME/d), or concurrent benzodiazepine use are present.

http://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm 40

Opioid Risk Tool

MARK EACH BOX THAT APPLIES FEMALE MALE

1. Family history of substance abuse

Alcohol 1 3

Illicit drugs 2 3

Prescription drugs 4 4

2.  Personal history of substance abuse

Alcohol 3 3

Illicit drugs 4 4

Prescription drugs 5 5

3. Age between 16 and 45 years 1 1

4. History of preadolescent sexual abuse 3 0

5. Psychological distress

ADD, OCD, bipolar, schizophrenia 2 2

Depression 1 1

Scoring Totals:

ADMINISTER

On initial visit

Prior to opioid therapy

SCORING (risk)

0‐3: low

4‐7: moderate

>8: high

41

Naloxone‐Like a safety belt

Mucosal Atomization Device (MAD) Luer‐lock syringe

Prefilled ampule of naloxone

42

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Assessing Risk and Addressing Harms of Opioid Use

Recommendation 9:• Clinicians should review the patient’s history of controlled

substance prescriptions using state prescription drug monitoring program (Still called CSRS and now branded PMP AWARxE) data to determine whether the patient is receiving opioid dosages or dangerous combinations that put him or her at high risk for overdose. Clinicians should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months.

http://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm 43

Interesting new features!

44

Visual Representation of Controlled Substance Rx’s

45

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Recommendation 10

– Prior to starting opioids for chronic pain and periodically during therapy,

UDS can assess for prescribed opioids as well as other controlled

substances and illicit drugs that increase risk for overdose when

combined with opioids (including non-prescribed opioids,

benzodiazepines and heroin).

– A relatively inexpensive immunoassay panel can be used for commonly

prescribed opioids and illicit drugs.

Assessing Risk and Addressing Harms of Opioid Use

46

Assessing Risk and Addressing Harms of Opioid Use

http://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm

Recommendation 11:• Clinicians should avoid

prescribing opioid pain medication and benzodiazepines concurrently whenever possible

47

Assessing Risk and Addressing Harms of Opioid Use

Recommendation 12:• Clinicians should offer or arrange evidence-based treatment

(usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder.

http://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm 48

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You practice in North Carolina

• STOP ACT– APP’s in Pain Clinics need quarterly review– 5 day for acute pain, 7 days for post-op pain

1/1/18– Will be required to sign up for and use PMP

AWARxE when the system is ready and HIE connected.

– Electronic prescribing requirement 2020• NC Medical Board

– 3 hour CME every 3 years– Auditing for high risk prescriber behaviors

49

Documentation Tools

• www.communitycarenc.org(search for “Opioid Safety”)

50

Free CME (www.communitycarenc.org/project-echo)

51

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52