SEDATION: WHAT’S NEW?universe-syllabi.gi.org/acg2012_46_slides.pdfGIGI P < M/Md P < M/Md UmerUmer 100 100 ColonoscopyColonoscopy P bolus vsP bolus vs F/Md RNRN P < F/Md P < F/Md

ACG Postgraduate Course Copyright 2012 ACG

October 2012 1

SEDATION:SEDATION:WHAT’S NEW?

John J. Vargo, MD, MPH, FACGAssociate Professor of MedicineCleveland Clinic Lerner College of MedicineChairman, Department of Gastroenterology and HepatologyVice Chairman, Digestive Disease InstituteCleveland Clinic

COI

Boston Scientific: Consultant Cook Medical: Consultant Olympus America, Inc.: Consultant Ethicon EndoSurgery: Consultant gEye Cue Ltd.: Advisory Board


October 2012 2

Outline Drug shortages Propofolp Pharmacoeconomics Capnography Obstructive sleep apnea


October 2012 3

Why is it important to get this right?

Author Colonoscopycohort

Incident CRC Control CRC P value

Singh et al. 39,375 47% 28% P < 0.001

Lakoff et al. 110,402 42% 31% nr

Zauber AG et al. N Engl J Med 2012;366:687-96.Kaminski et al. N Engl J Med 2010;362:1795-1803. Singh et al. JAMA 2006;295:236623-75.Lakoff et al. Clin Gastroneterol Hepatol 2008;6:1117–1121.

Pay for Performance (P4P): AHRQ Resources

Drug Shortages Number of shortages up 300% since 2005

(FDA) 80% globally are generic 40% practices affected on a daily basis Smaller outpatient > Health system Use of “gray marketers” Cost fluctuations Potency Quality

http://www.forbes.com/sites/dougschoen/2012/02/13/the-drug-shortage-crisis-in-america/Accessed 9/30/12


October 2012 4

Anatomy of Drug ShortageCritical Dependence:

Small number of ShortageGeneric Manufacturers

Regulatory intervention Decreased output

Shortage

(FDA)Factory Upgrades

ConsolidationChange in Business Model

Lack of Resources

Limited InventoryNo lead time

Drug Shortages as of 9/30/12

Sedation

Other GI Medications

Atropine

Alfentanil

Diazepam

Fentanyl

Midazolam

Propofol

Epinephrine Esomeprazole Erythromycin Lidocaine Metoclopramide NaloxonePropofol Ondansetron Secretin Tetracycline

http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314743.htmAccessed 9/30/12


October 2012 5

Drug Shortages: Implications

Alternative medication Alternative sedation targeting Cancellation / postponement Service shift to alternative setting Adverse outcomes?

Beware the Substitute!

Fresenius Propoven 1% temporarily reintroducedreintroduced

Utilizes MCT in addition to LCT No antibacterial retardant (EDTA): STRICT

ASEPTIC TECHNIQUE Must pass through a sterile filter to remove p g

particulate matter including glass European barcoding may not be recognized

http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM310360.pdfAccessed 9/30/12


October 2012 6

What is being done?

Executive order 13588 Signed 10/13/11 FDA: Expedite regulatory reviews FDA: Increased staffing, Drug Shortage Program

Public Law 122-144 Part of Prescription Drug User Fee Act reauthorization Signed July 2012Signed July 2012 Manufacturer must notify gov’t of interruption /

discontinuance Strategic plan to prevent drug shortages Hospital repackaging

Drug Shortage Prevention Act of 2012 (H.R. 3839)

Establishment of a Critical Drug List

Introduced Jan 31, 2012

Referred toJ

g Secretary of Health and

Human Resources Coordination Communication Expedite critical shortage

l

Referred to Committee

Jan 31, 2012

Reported by Committee

(not yet occurred)

Passed House(not yet occurred)

Passed Senate(not yet

applications Attorney General Controlled substance quota

Passed Senateoccurred)

Signed by the President

(not yet occurred)

http://www.govtrack.us/congress/bills/112/hr3839. Accessed 9/30/12


October 2012 7

Drug Shortage Prevention Act of 2012 (H.R. 3839)

Establishment of a Critical Drug List

Introduced Jan 31, 2012

Referred toJ

g Secretary of Health and

Human Resources Coordination Communication Expedite critical shortage

l

Referred to Committee

Jan 31, 2012

Reported by Committee

(not yet occurred)

Passed House(not yet occurred)

Passed Senate(not yet

Probability of passage: 2%Probability of passage: 2%

applications Attorney General Controlled substance quota

Passed Senateoccurred)

Signed by the President

(not yet occurred)

http://www.govtrack.us/congress/bills/112/hr3839. Accessed 9/30/12

Drug Shortages

www.fda.gov/Drugs/DrugSafety//default.htm www.ashp.org/shortages


October 2012 8

Multisociety Sedation Curriculum

Sedation pharmacology

Informed consentInformed consent

Levels of sedation

Administration of sedation

Airway / rescue

Anesthesiologist Indications

MonitoringMonitoring

Postprocedure assessment

Pregnancy

Assessment of competency

EDP-Directed Propofol for Screening Colonoscopy in U.S.

•34.8% non-EDP •2007 Medicare claims

•Anesthetist Medicare: $95•Anesthetist non-Medicare: $450•Assuming stable model: $3.2 B over 10 yr

$1.5 million / life year savedHow can ADP become cost

effective?31 fold increase in EDP mortality

17 fold decrease in ADP cost

Hassan C et al. Endoscopy 2012:456-64.

over 10 yr


October 2012 9

Growth of Anesthesia Professional Delivered Sedation

billion dollars5 billion dollars

Inadomi J et al. Gastrointest Endosc 2010;72:580-6.

CPT Code 00810$155/case CMS$437/case private

Growth of Anesthesia Professional Delivered Sedation

billion dollars5 billion dollarsChange in Business

Model:Independent Consultant

Model Employee Model

Inadomi J et al. Gastrointest Endosc 2010;72:580-6.

CPT Code 00810$155/case CMS$437/case private


October 2012 10

Pharmaco-economics

5 billion dollarsNortheast: the epicenter of growthAnesthesiologist employee modelAssociated with increased anesthesia rates:

CPT Code 00810$155/case CMS

Associated with increased anesthesia rates:Age > 45Higher incomesLower unemploymentMore populated marketsHigher concentration GisEthnicity

Inadomi J et al. Gastrointest Endosc 2010;72:580-6.Liu et al. JAMA 2012; 307:1178-84.Khiani et al Clin Gastroenterol Hepatol 2012;10:58-64.

$155/case CMS$437/case private

EthnicityMedicare (2x) and Commercial (4x) payorgrowth

OIG Advisory Opinion No. 12-06 Arrangement 1: “company model”

Ph i i (PE) ld bli h Physician-owner (PE) would establish an anesthesiologist company and pay anesthesiologist as an independent contractor a negotiated rate.

OIG: PE receives part of A’s compensation in return for referral to A

A i d t t i t t t A is under pressure to enter into agreement to stem loss of business

“Safe harbors” would not protect distribution of profits to PE


October 2012 11

OIG Advisory Opinion No. 12-06 Arrangement 2: “management fee model” A

would pay center per-patient fee for “management services” for AEC space and use of AEC personnel to PE.

Excludes federal health care programs ( FHCP)( )

Risk that A’s payment of “management service fee” would induce AEC’s referral of all patients including FHCP

OIG Advisory Opinion No. 12-06 Proposed arrangements could generate

prohibited remuneration the anti-kickback statute


October 2012 12

Propofol and Recovery: RCTs

AuthorAuthor Subject #Subject # ProcedureProcedure SedationSedation PropofolPropofolAdministrationAdministration

PatientPatientRecoveryRecovery

TimeTime

SipeSipe 8080 ColonoscopyColonoscopy P bolus vsP bolus vsM/MdM/Md

RNRN P < M/MdP < M/Md

VargoVargo 7575 ERCP / EUSERCP / EUS P bolus vsP bolus vsM/MdM/Md

GIGI P < M/MdP < M/Md

UmerUmer 100100 ColonoscopyColonoscopy P bolus vsP bolus vsF/MdF/Md

RNRN P < F/MdP < F/Md

WestonWeston 2020 EGDEGD P bolus vsP bolus vs RNRN P < M/MdP < M/Md

Psychomotoric Recovery

What to measure?Driving simulatorPM testsWestonWeston 2020 EGDEGD P bolus vsP bolus vs

M/MdM/MdRNRN P < M/MdP < M/Md

WehrmannWehrmann 198198 ERCPERCP P bolus vsP bolus vsMd/PzMd/Pz

“Assisting“AssistingPhysician”Physician”

P < Md/PzP < Md/Pz

PM tests

Is MAC Assisted Colonoscopy Safe? Patient unable to provide feedback Perforation? Splenic injury

Patient unable to change position ?Risk of aspiration

A th i id i bilit Anesthesia provider variability


October 2012 13

• Patient monitoring– Oximetry

SEDASYSTM

– Capnography– EKG– NIBP– Patient Responsiveness

• Oxygen deliveryA d f l d li• And propofol delivery– Computer controlled

infusion pump Investigational CAPS device, limited by U.S. law to investigational use only

Multicenter Controlled Trial of CAPS Versus Standard of Care: Primary Outcome

O2

<90%

(% �

sec)

*

n = 363

n = 141

AU

C of

SpO

PambiancoPambianco DJ ,et al. DJ ,et al. GastrointestGastrointest EndoscEndosc 20102010

n = 358

n = 138

n 141


October 2012 14

FDA and Sedasys®

4/20/10: Company sent “Not Approvable” letter during the first quarterletter during the first quarter

FDA options offered, not disclosed Appeal process approved 11/10 Approved in Canada for colonoscopy C mark in Europe for colonoscopy / upperC mark in Europe for colonoscopy / upper

endoscopy

http://google.com/hostednews/ap/articleAccessed 9/30/12

FDA and Sedasys®

Still no word Labeling: Sedasys ® + propofol Training: Anesthesia-directed hands on Post-marketing studies: ASA III

ld l Elderly BMI > 35


October 2012 15

OSA and Sedation-related Hypoxemia

Low risk: n= 143High risk: n=90

Relative Risk Hypoxemia Berlin(+):1 48: 95%:0 58 3 80

Khiani et al. Gastrointest Endosc 2009;70:1116-20

1.48: 95%:0.58-3.80

What Is Capnography? A non-invasive, continuous measurement of

exhaled carbon dioxide concentration

Expired CO2 is sampled via a specialized nasal cannulae

M til ti NOT ti Measures ventilation, NOT oxygenation


October 2012 16

D

Normal Waveform

A-B: Baseline = no CO2 in breath

B-C: Rapid rise in CO2

C-D: Alveolar plateau

D-E: Inhalation

C-D: Alveolar plateau

D: End expiration (EtCO2)

Capnography and Hypoxemia

ProcedureProcedure SedationSedation NN Hypoxemia Hypoxemia ddReductionReduction

QadeerQadeer et al.et al.(2002)(2002)

ERCP / EUSERCP / EUS Opioid / Opioid / BenzoBenzo

293293 YesYes

LightdaleLightdale et et al. (2006)al. (2006)

EGD/colonEGD/colon Opioid / Opioid / BenzoBenzo

163163 YesYes

Beitz et al.Beitz et al. ColonoscopyColonoscopy PropofolPropofol 760760 YesYesBeitz et al. Beitz et al. (2012)(2012)

ColonoscopyColonoscopy PropofolPropofol 760760 YesYes


October 2012 17

Capnography Caveats

Adult EGD: moderate sedation Adult Colonoscopy: moderate sedation Predictive outcomes Training Cost

Capnography and the ASA

“During moderate and deep sedation the adequacy of ventilation shall be monitored by continual observation of qualitative clinical signs and monitoring for the presence of exhaled carbon dioxide…”

Standards for Basic Anesthetic Monitoring, g,Standard II, Section 3.2.4

www.asahq.org/For-Memebers/Standards-Guidelines-and-Statments.aspxAccessed 9/30/12


October 2012 18

MAC Endoscopic Outcomes Colonoscopy No difference in ADR, Metwally et al. 25% increase in the detection of “advanced

neoplasia” (OR 1.25, 95% CI: 1.1o-1.43). Wang et al., W J Gastroenterol

ERCP Increased deep biliary cannulation Patel et al DDS 2010Patel et al., DDS 2010

EUS Increased yield FNA solid pancreatic lesions Ootaki et al , Anesthesiology

Telaprevir (Incivek, Vertex) and Bocepravir (Victrelis, S h i )

New Medications, New Challenges

Schering) Antiviral agents for Hepatitis C NS3/4A Protease inhibitors Interaction with benzodiazepines ? Propofol


October 2012 19

Summary Endoscopist-directed propofol to be

dominant strategy for elective EGD / colonoscopycolonoscopy

Emerging efficacy data for anesthesiologist directed sedation for advanced procedures

Policy changes may alter anesthesiologist employee model

Sedation curriculum: standardized approach Room for research Sleep apnea Capnography

Documents

SEDATION: WHAT’S NEW?universe-syllabi.gi.org/acg2012_46_slides.pdfGIGI P < M/Md P < M/Md UmerUmer 100 100 ColonoscopyColonoscopy P bolus vsP bolus vs F/Md RNRN P < F/Md P < F/Md