ADE and Harm Collaborative: Reducing ADEs and harm associated with opioids - Safer post-operative pain management

March 21, 2013

2 PROPRIETARY & CONFIDENTIAL – © 2012 PREMIER INC.

Agenda, March 21, 2013

• Welcome • Collaborative education overview • Post-operative Pain Management: Challenges and New

Directions • T.J. Gan, M.D., MHS, F.R.C.A FFARCS(I) • Professor and Vice Chair for Clinical Research,

Department of Anesthesiology, Duke University Medical Center

• Q & A • Monthly Progress Reports • Next Steps

3 PROPRIETARY & CONFIDENTIAL – © 2012 PREMIER INC.

Collaborative Objectives

• Safer post-operative pain management that reduces both ADEs and Harm

• Address three focus areas: • Identification (screening patients for risk)

»Webinar 1 and 2 • Standardization of monitoring post-operative

patients on opioids (tools/technology/processes) »Webinar 3 and 4

• Education and communication (at transitions of care and discharge)

»Webinar 5 and 6

4 PROPRIETARY & CONFIDENTIAL – © 2012 PREMIER INC.

What do we want to accomplish?

Goal:

To reduce ADEs and Harm associated with opioids use among surgical inpatients by implementing evidence-based strategies and processes to make pain management safer • By the end of 2013, reduce opioid related ADEs and Harm

by 40% compared to 2010

• For pilot population, by 6.30.2013: 100% elective surgery patients screened preoperatively

for OSA and opioid tolerance

100% elective surgery patients’ pain assessed using a standardized tool

100% elective surgery patients discharged to home on an opioid will have documentation of written/verbal discharge instructions to include: the name, purpose, action, side effects, monitoring and “what to do if this happens” for the opioid discharge medication.

5 PROPRIETARY & CONFIDENTIAL – © 2012 PREMIER INC.

Focus 2: Safe communication and monitoring during the perioperative period

• A standardized hand-off/transition communication process is in place for all patients receiving opioids, which includes, at minimum: 1) history of snoring, obesity or OSA and 2) drug and dose history for previous shift;

• Standardization of pain assessment tools for patients on opioids post-operatively house-wide;

• Continuous oximetry is used in all post-operative patients receiving IV narcotics/ opioids; and,

• Continuous capnography is used on all post-operative patients receiving supplemental oxygen and receiving IV narcotics/opioids, epidural, or PCA (patient controlled analgesia)

Post-operative Pain Management. Challenges

and New Directions T. J. Gan, M.D., MHS, F.R.C.A. FFARCS(I)

Professor and Vice Chair for Clinical Research Department of Anesthesiology Duke University Medical Center

Incidence and Severity of Postoperative Pain

1. Apfelbaum, Gan et al. Anesth Analg. 2003 2. Warfield, et al. Anesthesiology 1993 3. Gan TJ. ASRA 2012 abstract.

Readmissions from Same-day Surgeries: Pain Is Most Common Reason (US)

Mean charges for patients readmitted due to pain were $1,869 ± $4,553 per visit

38% of patients readmitted for pain had undergone orthopedic procedures

Inadequate Acute Pain Management Has Consequences

Delayed ambulation1 Increased CV and pulmonary pathophysiology Shortened or missed rehabilitation sessions1 Decreased quality of life2 Increased cost of care3 Potential for progression from acute to

chronic pain4

1. Morrison et al. Pain. 2003;103:303-311; 2. Wu et al. Anesth Analg. 2003;97:1078-1085; 3. Coley et al. J Clin Anesth. 2002;14:349-353; 4. Pluijms et al. Acta Anaesthesiol Scand. 2006;50:804-808.

Long-Term Consequences of Acute Pain: Potential for Progression to Chronic Pain

Woolf. Ann Intern Med. 2004;140:441; Petersen-Felix. Swiss Med Weekly. 2002;132:273-278; Woolf. Nature.1983;306:686-688; Woolf et al. Nature. 1992;355:75-8.

Acute Postoperative Pain Has Been Associated With Chronic Pain After Common Procedures

Incidence of Chronic Post-Surgical Pain

US Surgical Volumes (1000s)1

Amputation 57-62%2 159

Breast surgery 27-48%3,4 479

Thoracotomy 52-61%5,6 110

Inguinal hernia repair 19-40%7,8 609

Coronary artery bypass 23-39%9-11 598

Caesarean section 12%12 220

Factors correlated with the development of post-surgical chronic pain1:

1.Nerve injury 2.Inflammation 3.Intense acute postoperative pain

1. Kehlet et al. Lancet. 2006;367:1618-1625; 2. Hanley et al. J Pain. 2007;8:102-10; 3. Carpenter et al. Cancer Prac. 1999;7:66-70; 4. Poleschuk et al. J Pain. 2006;7:626-634; 5. Katz et al. Clin J Pain. 1996;12:50-55; 6. Perttunen et al. Acta Anaesthesiol Scand. 1999;43:563-567; 7.Massaron et al. Hernia. 2007;11:517-525; 8. O’Dwyer et al. Br J Surg. 2005;92:166-170; 9. Steegers et al. J Pain. 2007;8:667-673; 10. Taillefer et al. J Thorac Cardiovasc Surg. 2006;131:1274-1280; 11. Bruce et al. Pain. 2003;104:265-273; 12. Nikolajsen et al. Acta Anaesthesiol Scand. 2004;48:111-116.

The Severity of Post-Operative Pain is Associated With Development of Chronic Pain In a long term evaluation of thoracotomy patients

(N=149), Those who developed chronic post-thoracotomy pain syndrome were: – Those who experienced severe acute pain: 67% vs

38% (P = 0.0001) – Those who experienced a prolonged duration

(1month) of severe acute pain (P = 0.02)

*Chronic pain assessed 6 months to 3.5 years post-surgery Pluijms et al. Acta Anaesthesiol Scand. 2006;50:804-808.

Patient’s Perspectives on Hospital Pain Management

The Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey is the first national, standardized, publicly reported survey measuring and comparing patients’ perceptions of their hospital experiences – In two 1-year, nationwide HCAHPS surveys of 3765

reporting hospitals conducted in 2008 and 2009, pain management received an average score of 68 (out of a possible 100), revealing room for improvement in pain management

Results of the HCAHPS will soon be one of the measures used to calculate institutional incentive payments

HCAHPS in Pain Management : July 2009 – June 2010

Hospital Consumer Assessment of Health Plans Survey

Opioids – Main Strong Analgesic

Bind to opioid receptors in spinal cord, brainstem and limbic cortex

Good Efficacy: dose dependent pain relief with no ceiling effect

Good Safety Profile: No cardiovascular, hepatic or renal effects

Multiple agents: Morphine, hydromorphone, fentanyl, sufentanil, oxycodone, oxymorphone

Multiple delivery systems: oral, parenteral, transdermal, epidural, spinal

Side Effects Postsurgery Up to Two Weeks

Opioid Analgesic Monotherapy

Respiratory Depression and Cardiac Arrest With Morphine is Often Unpredictable

Morphine or Incision Length Correlation With Bowel Function Return?

Colectomy patients (40) ● Primarily left colon and

rectal procedures

Return of bowel function? ● Correlation between

morphine PCA dose and first bowel sounds (P = 0.001), flatus (P = 0.003), and first bowel movement (shown; P = 0.002)

● No correlation between incision length and morphine dose

PCA = patient-controlled analgesia.

Adapted with permission from Cali RL, et al. Dis Colon Rectum. 2000;43:163-168.

“Trade-offs” in Pain Management: Patients Have Concerns That May Hinder Treatment

Gan et al. Brit J Anaesthesia. 2004;92:681-68

Recent Joint Commission Sentinel Event Alert Reinforces the Severity of the Opioid Problem

• Opioid analgesics rank among the drugs most frequently associated with adverse drug events

• A number of safety measures, including education and monitoring, may reduce the risks of opioid-related adverse events

• Key patients warrant multimodal opioid sparing approaches; including non-opioid pain medications

Patients at the Highest Risk for Oversedation and Respiratory Depression Sleep apnea or sleep disorder Morbid obesity Snoring Older age No recent opioid use Post-surgery, especially after upper

abdominal or thoracic surgery Increased opioid dose requirement Longer time receiving general

anesthesia during surgery Concomitant use of other sedating

drugs Smoker

Outcomes: Cost and Length of Stay (LOS) Regional

ADE=adverse drug event.

Oderda, Gan et al. J Pain & Palliative Care Pharmacotherapy 2012

Effect of Opioid-Related Adverse Events on Outcomes in Selected Surgical Patients

What are we trying to achieve?

Effective and consistent analgesia

Minimal adverse events

Patient satisfaction

Balancing the imperatives

Multimodal or balanced analgesia

⇓ doses of each analgesic

Improved anti-nociception due to synergistic/ additive effects

May ⇓ severity of side effects of each drug

Kehlet H, et al. Anesth Analg 1993;77:1048–56 Playford RJ, et al. Digestion 1991;49:198–203

Monotherapy vs Multimodal Analgesia

Give More

Opioids!

Potent Opioids

Weak Opioids

Breakthrough Pain

Moderate to Severe Pain

Mild to Moderate

Pain

Weak Opioids,

Tapentadol

Neural Blockade, Ketamine

Acetaminophen, NSAIDs, Coxibs, Gabapentanoids,

A Multimodal Approach Addresses the Complex Nature of Pain Transmission

Anesthesiology

“Whenever possible, anesthesiologists should employ multimodal pain management therapy.

Unless contraindicated, all patients should receive an around-the-clock regimen of NSAIDs,

coxibs, or acetaminophen.”

ASA Task Force on Acute Pain Management. Anesthesiology. 2012;116:248–73

Adjunctive Analgesics NSAIDs and COX-2 selective inhibitors (coxibs)

Acetaminophen

Local anesthetics

Ketamine

Gabapentin / pregabalin

Clonidine / dexmedetomidine

Magnesium, neostigmine, adenosine, naloxone

Non pharmacological techniques

New Analgesics and Novel Delivery Systems

New Analgesics – Cannabinoids: Dronabinol, Ajulemic acid – TRP-V1 receptor agonist: Capsaicin,

Resiniferatoxin – Anti-nerve growth factor- NGF Antibodies – LOX Inhibitors- Powerful anti-inflamatories that

have less side effects Novel Delivery System

– Depobupivacaine – Fentanyl iontopheresis – Sufentanil Nanotap

Enhanced Recovery After Surgery (ERAS)

“An interdisciplinary multimodal concept to accelerate postoperative convalescence and reduce general morbidity (including POI) by simultaneously applying several interventions”

What are the appropriate choices in constructing ERAS, multimodal protocols?

Mattei P. World J Surg. 2006;30:1382-1391. Person B, Wexner S. Curr Probl Surg. 2006;43:6-65.

Reduction in length of stay and complications

Traditional ERAS p-value

LOS – all procedures (days) 9.6 ± 8.4; 7 (5.5-10)* 5.8 ± 3.9; 5 (3-7)* < 0.0001

LOS – open (days) 11.8 ± 9.9; 7 (6-14)* 7.1 ± 3.9; 6 (4.5-8.5)* 0.004

LOS – laparoscopic (days) 6.5 ± 3.8; 6 (4.25-7)* 4.9 ± 3.7; 4(3-5.5)* 0.005

Urinary Tract Infection (UTI) 26.5% 13.4% 0.03

Mean ± SD; Median (IQR)

Miller and Gan et al. Anesthesiology ASA abstract 2011

Pain Score and Morphine Consumption Traditional Care vs. ERAS

Miller and Gan et al. Anesthesiology Abstract 2011

Ketamine in Opioid Dependent Patients Undergoing Spine Surgery

Ketamine Placebo P Value %

PACU Morphine (mg) 18 ± 14 22 ± 20 0.21 ↓ 18.0

PACU VAS 4.1 ± 3.1 5.6 ± 3.0 0.03 ↓ 26.7

24 h Morphine (mg) 142 ± 82 202 ± 176 0.03 ↓ 30

48 h Morphine (mg) 203 ± 109 323 ± 347 0.04 ↓ 37

48 VAS 5.4 ± 2.1 5.3 ± 2.2 0.83 ↑ 1.0

6 week Morphine mg/hr equivalents

0.8 ± 1.1 2.8 ± 6.9 0.04 ↓ 71

6 week VAS 3.1 ± 2.4 4.2 ± 2.4 0.02 ↓ 26.2

Hospital Discharge (min) 4,364 4571 0.73 ↓ 3.45 hour

Loftus R, et al. Anesthesiology 2010;113:639-46

Conclusions Pain is still poorly managed

Acute pain can lead to long-term chronic pain

Opioid analgesics, while effective, can result in significant side effects

Multimodal analgesic regimen improves both short- and long-term pain management

Moving from opioid based to opioid sparing regimen

Questions?

PROPRIETARY & CONFIDENTIAL – © 2012 PREMIER INC. 38

Q&A

T.J. Gan, M.D., MHS, F.R.C.A. FFARC S (I) Professor and Vice Chair for Clinical

Research Department of Anesthesiology

Duke University Medical Center

Leslie Schultz, RN, PhD, CPHQ Clinical Consultant

Premier Safety Institute

Jeff Vawter, MHA Director, Partnership for Patients

Collaborative Education & Delivery

Cristina Wilhelm, RN, BSN Manager, QUEST

Collaborative Education & Delivery

39 PROPRIETARY & CONFIDENTIAL – © 2012 PREMIER INC.

Thank you for participating in today’s Webinar!

Questions after today’s presentation? Please contact us:

Cristina Wilhelm, Manager, QUEST Collaborative Education & Delivery cristina_wilhelm@premierinc.com

Jeff Vawter, Director, PFP Collaborative Education & Delivery jeff_vawter@premierinc.com