ADE and Harm Collaborative: Reducing ADEs and harm associated with opioids - Safer post-operative pain management. March 21, 2013

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1 ADE and Harm Collaborative: Reducing ADEs and harm associated with opioids - Safer post-operative pain management March 21, 2013

2 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 2 PROPRIETARY & CONFIDENTIAL 2012 PREMIER INC.

3 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 3 PROPRIETARY & CONFIDENTIAL 2012 PREMIER INC.

4 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 : 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. 4 PROPRIETARY & CONFIDENTIAL 2012 PREMIER INC.

5 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) 5 PROPRIETARY & CONFIDENTIAL 2012 PREMIER INC.

6 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

7 Incidence and Severity of Postoperative Pain 1. Apfelbaum, Gan et al. Anesth Analg Warfield, et al. Anesthesiology Gan TJ. ASRA 2012 abstract.

8 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

9 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: ; 2. Wu et al. Anesth Analg. 2003;97: ; 3. Coley et al. J Clin Anesth. 2002;14: ; 4. Pluijms et al. Acta Anaesthesiol Scand. 2006;50:

10 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: ; Woolf. Nature.1983;306: ; Woolf et al. Nature. 1992;355:75-8.

11 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% 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% Caesarean section 12% Factors correlated with the development of post-surgical chronic pain 1 : 1.Nerve injury 2.Inflammation 3.Intense acute postoperative pain 1. Kehlet et al. Lancet. 2006;367: ; 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: ; 5. Katz et al. Clin J Pain. 1996;12:50-55; 6. Perttunen et al. Acta Anaesthesiol Scand. 1999;43: ; 7.Massaron et al. Hernia. 2007;11: ; 8. O Dwyer et al. Br J Surg. 2005;92: ; 9. Steegers et al. J Pain. 2007;8: ; 10. Taillefer et al. J Thorac Cardiovasc Surg. 2006;131: ; 11. Bruce et al. Pain. 2003;104: ; 12. Nikolajsen et al. Acta Anaesthesiol Scand. 2004;48:

12 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 postthoracotomy pain syndrome were: Those who experienced severe acute pain: 67% vs 38% (P = ) 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:

13 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

14 HCAHPS in Pain Management : July 2009 June 2010 Hospital Consumer Assessment of Health Plans Survey

15 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

16 Side Effects Postsurgery Up to Two Weeks

17 Opioid Analgesic Monotherapy

18 Respiratory Depression and Cardiac Arrest With Morphine is Often Unpredictable

19 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:

20 Trade-offs in Pain Management: Patients Have Concerns That May Hinder Treatment Gan et al. Brit J Anaesthesia. 2004;92:681-68

21 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

22 Outcomes: Cost and Length of Stay (LOS) Regional ADE=adverse drug event. Oderda, Gan et al. J Pain & Palliative Care Pharmacotherapy 2012

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

24 What are we trying to achieve? Effective and consistent analgesia Minimal adverse events Patient satisfaction

25 Balancing the imperatives

26 Multimodal or balanced analgesia doses of each analgesic Improved antinociception due to synergistic/ additive effects May severity of side effects of each drug Kehlet H, et al. Anesth Analg 1993;77: Playford RJ, et al. Digestion 1991;49:

27 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,

28 A Multimodal Approach Addresses the Complex Nature of Pain Transmission

29 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

30 Adjunctive Analgesics NSAIDs and COX-2 selective inhibitors (coxibs) Acetaminophen Local anesthetics Ketamine Gabapentin / pregabalin Clonidine / dexmedetomidine Magnesium, neostigmine, adenosine, naloxone Non pharmacological techniques

31 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

32 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: Person B, Wexner S. Curr Probl Surg. 2006;43:6-65.

33 Miller and Gan et al. Anesthesiology ASA abstract 2011 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)* < LOS open (days) 11.8 ± 9.9; 7 (6-14)* 7.1 ± 3.9; 6 ( )* LOS laparoscopic (days) 6.5 ± 3.8; 6 (4.25-7)* 4.9 ± 3.7; 4(3-5.5)* Urinary Tract Infection (UTI) 26.5% 13.4% 0.03 Mean ± SD; Median (IQR)

34 Pain Score and Morphine Consumption Traditional Care vs. ERAS Miller and Gan et al. Anesthesiology Abstract 2011

35 Ketamine in Opioid Dependent Patients Undergoing Spine Surgery Ketamine Placebo P Value % PACU Morphine (mg) 18 ± ± PACU VAS 4.1 ± ± h Morphine (mg) 142 ± ± h Morphine (mg) 203 ± ± VAS 5.4 ± ± week Morphine mg/hr equivalents 0.8 ± ± week VAS 3.1 ± ± Hospital Discharge (min) 4, hour Loftus R, et al. Anesthesiology 2010;113:639-46

36 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 shortand long-term pain management Moving from opioid based to opioid sparing regimen

37 Questions?

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 38 PROPRIETARY & CONFIDENTIAL 2012 PREMIER INC.

39 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 39 PROPRIETARY & CONFIDENTIAL 2012 PREMIER INC.

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