1. Joyce S. Willens, PhD, RN, BC Villanova University

2. History of EBG Existed in clinical practice for decades Called Practice Guidelines Practice Policies Clinical Policies Clinical Algorithms Position Statements

3. History Movement began in US in the mid 1980s National Institute of Health came under pressure from policy makers to provide formal system of assessing new medical developments Evolved into NIH Consensus Development

4. Experience with EB Guidelines AHCPR- 1992 Reviewed pain literature All neuraxial opioid studies

5. Experience with EB Guidelines APS - 1994 Reviewed ALL literature for these guidelines

6. Sickle Cell Pain Guidelines Computer data bases used to search literature beginning in 1965 Key words pain and sickle cell anemia Inclusion criteria were: Research articles including assessment and measurement Pain guidelines and management articles

7. Presented “State of the Art” Cardiology conference 2000 Tel Aviv, Israel

8. Presentation given in Tel Aviv Israel in 1990

9. Clinical Practice Guidelines  Systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical conditions (Institute of Medicine).

10. Process Developed levels of scientific evidence Developed strength and consistency of evidence A- type 1 or consistent findings from multiple study types B – evidence of types II, III, or IV but findings are inconsistent

11. Currently -Identify the Problem Began with noticing > use of naloxone Tracking by nurses and pharmacists Commonality IV PCA Incidence of sudden onset life-threatening respiratory event with IV opioid analgesia is 3.6 per 10,000 adults

12. Comprehensive Literature Review There were no universally accepted guidelines to direct effective and safe assessment and monitoring practices. Research has not firmly established that measuring SpO2 and capnography (ETCO2) prevents mortality

13. ASPMN Expert Consensus Panel Led by Donna Jarzyna, MS, RN-BC, CNS-BC Carla R. Jungquist, PhD, RN-C, FNP Chris Pasero, MD, RN-BC, FAAN Allison Nisbet, MSN, RN, CPHON, AOCNS, CNS-BC Linda Oakes, MSN, RN-BC, CCNS Susan J. Dempsey, MN,RN-BC, CNS Diane Santangelo, MS, RN, ANP-C Rosemary C. Polomano, PhD, RN, FAAN Convened in April 2008

14. Monitoring Defined – practice of using the nurse observations of sedation and respiration including but not limited to the use of sedation assessment scales and technologies to collect serial measurement to anticipate and recognize unintended advancing sedation or respiratory depression.

15. Step 1 Panel members independently searched electronic databases Medline PubMed Cumulative Index to Nursing and Allied Health Literature (CINAHL) Cochrane Library

16. Relevant Publications Data based articles Case reports Clinical Reviews commentaries and editorials Terms – opioid induced sedation and respiratory depression > 50 citations were on black board for review Tele conferences were held to discuss the readings

17. Step 2 17 articles of varying quality were selected Each panel member independently rated at least 3 articles Scope of content Overall quality Adequacy of references Evidence of research synthesis Confirmation of existing evidence and research Relevance to practice

18. Cohen’s Kappa Statistic Calculated percent agreement 0.72- 1.00 High degree of concordance among raters

19. Consensus on categories for evidence Individual Patient Risks Iatrogenic Risks Pharmacology Monitoring

20. Literature Included Meta-analysis Systematic reviews Randomized controlled trials (RCT) Clinical Trials Prospective observational studies Retrospective reviews Secondary analyses

21. Opinion Based Data Survey members to conduct practice analysis Use of monitoring when pt receiving opioids On-line survey January 2009-end of February These results have been published in 2011 Conducted the survey again in 2013 Published in September issue 2014

22. ASA Grading System Originally used by an ASA taskforce for their report on operating room fires Class I – Normally healthy Class II- Patient with mild systemic disease Class III- Patient with severe systemic disease Class IV- Patient with severe systemic disease that is a threat to life Class V- Morbid patient who is not expected to survive without the surgery Class VI- A declared brain- dead patient for organ removal

23. Strength of Evidence and Benefit Risk Ratio ACC/AHA Taskforce on Practice Guidelines (2010) Class I. Evidence and/or general agreement that a given treatment is useful and effective Benefit>>> Risk Class II. Conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of treatment

24. Strength of Evidence and Benefit Risk Ratio Class II. Conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of treatment Class IIa-. Weight of evidence/opinion is in favor of usefulness Benefit >>Risk Class IIb. Usefulness/efficacy is less well established by the evidence Benefit > Risk

25. Strength of Evidence and Benefit Risk Ratio Class III. Conditions for which there is evidence and/or general agreement that the treatment is not useful and in some cases may be harmful Risk > Benefit ACCF/AHA Taskforce on Practice Guidelines. Methodology Manual for ACCF/AHA Guideline Writing Committees http://my.americanherat.org.idc/groups/ahamahpubli c/@wcm/@sop/documents/downloadable//ic,_319826 /pdf

26. Statement of Conditions Aligned with ASPMN mission and goals Serves as a guide for developing and implementing safe and effective plans of care Facilitates systems-level changes Applies scientifically derived and consensus based among panel members No pharmaceutical involvement

27. Individual Risks Factors that predispose a person to unintended opioid- induced advancing sedation and respiratory depression Not limited to Age Anatomic anomalies Physical characteristics Primary and comorbid medical condition Psychologic states Functional status

28. Patient Risk Factors Two categories Sleep disordered breathing – B-1 evidence Postoperative pulmonary complications B-1 evidence

29. Sleep disordered Breathing Factors that predispose a person to unintended opioid- induced advancing sedation and respiratory depression.

30. Sleep Disordered Breathing Keywords: sleep apnea- 7,647 citations Risk factors- 436,675 citations Combined with the word and 1639 citations 91 were deemed relevant

31. Postoperative Pulmonary Complications Postoperative complications 11,861 citations Risks 180,339 citations Combined using and- 521 citations 68 were deemed relevant

32. Other Categories Iatrogenic Risks with Pain Treatment Modalities Supplemental Opioids with Peripheral Local Anesthetic Agents Parenteral, Subcutaneous, and Patient Controlled Analgesia Coadministration of Antihistamines Coadministration of Benzodiazepines

33. Other Categories Timing as a Predictor for Opioid-Induced Sedation and Respiratory Depression Categories B-1 and B-2 Evidence Communication Not much in literature Support for SBAR

34. Categories Pharmacology- pharmacologic agents that are administered for the treatment of pain in the acute care setting Comparison of Opioid Analgesics – Category C-2 NS difference in respiratory depression between opioids Acetaminophen- Category A-1 Evidence NSAIDs – Category A-1 Evidence

35. Categories Anticonvulsants – Category A-1 Evidence for Sedation Antidepressants- Category D- Insufficient Evidence Clonidine- Category C-2 Evidence Ketamine-Category C-2 Evidence Dexmedetomidine- Category C-2 Evidence

36. Categories Patient Monitoring Practices Opioid –Induced Sedation Sedation Scales Opioid-induced Respiratory Depression Technology Supported Monitoring Use of pulse oximetry Use of capnography

37. After Each Category Recommendation Statements for each category Statements for each category Should, is recommended, is indicated, is useful/effective/beneficial Unknown/unclear/uncertain/not well established Recommendations for Education Implementation Strategies

38. Finished Document Sent out for external review by 10 experts Pain Management Nurses Pharm D Anesthesiologists

39. Presentations Jungquist, C.R. & Willens, J.S. Preventing adverse events secondary to opioid-induced advancing sedation and respiratory depression in adult hospitalized patients: Evidence to bedside- American Pain Society-Honolulu, HI May 2012

40. Presentations Jungquist, C.R. & Willens, J.S. Preventing adverse events secondary to opioid-induced advancing sedation and respiratory depression in adult hospitalized patients: Evidence to bedside- American Society for Pain Management Nursing- Baltimore, MD September 2012

41. Monitoring for Opioid Induced Sedation and Respiratory Depression- 2 nd survey 2013 Asked whether their hospital was practicing 4 safety procedures Written guidelines for assessment after opioid initiation or titration Double- check of PCA when initiating, titrating or inserting new PCA Two person check of epidural drug/programing as above Bar code medication administration

42. Monitoring for Opioid Induced Sedation and Respiratory Depression- 2 nd survey 2013 ASPMN members invited via email June 2013 noted 102 hospitals responded Practice changes over time Written guidelines for assessment after opioid initiation/titration 86% 2013 vs. 90% in 2009 Double check of PCA program, initiation, titrating or hanging new bag 96% vs 96% 2 person check of epidural drugs/programming 80% vs. 86% Bar code med administration 65% vs 30%

43. Pulse Oximetry Monitoring 28% of institutions represented in this survey use continuous pulse oximetry 2% reported they did not know their institution’s practices or do not use electronic monitoring at all Over the last 4 years the use of pulse ox has increased The use of end tidal CO2 monitoring has increased from 2% to 11%

44. Sedation Scales All institutions reported using some type of sedation scale 90% of nurses endorsed assigning numbers to a level of sedation Results of the survey indicate that changes in practice are occurring Frequency of screening for high risk-OSA Authorized agent controlled analgesia Criteria for defining respiratory depression Hired or trained a “expert pain nurse” Initiated or refined order sets for PCA Changed from intermittent to continuous pulse ox monitoring Implemented use of sedation scale

45. Pasero Opioid-Induced Sedation Scale with Interventions S= Sleep; easy to arouseNo action necessary 1. Awake and alertNo action necessary may > opioid 2. Slightly drowsy, easily arouse No action necessary may > 3. Frequently drowsy, arousable, drifts off to sleep during conversation- Unacceptable- monitor resp and sedation levels < opioid dose 25 -50% Consider administration of opioid-sparing nonopioid 4. Somnolent, minimal or no response to verbal or physical stim Unacceptable; stop opioid; consider administering naloxone

46. Respiratory Assessment More than measuring rate for 30 -60 seconds Depth and regularity of respirations Notice trends Listen to sound of patient’s respiration Snoring indicates airway obstruction Decrease dose 25%- 50% Consider continuous ETCO2 monitoring

47. Clinical Signs of OSA Frequent, loud snoring Neck circumference > 17” man- 16” woman BMI of 35 kg/m2 or more

49. Physical Exam Awake, alert, oriented Appears quite ill and uncomfortable One episode of emesis VS 98.2, 85, 18, 148/88 Pain intensity rating 10 on a 0 to 10 scale

50. Chronology of Treatment Admitted to ER at 5:37 PM 5:50 PM given hydromorphone 1 mg IV 6:19 PM same 6:40 PM evaluated by MD 6:50 PM hydromorphone 1 mg IV 7:21 PM fentanyl 100 mcg IV 7:25 PM fentanyl 100 mcg IV 7:30 PM fentanyl 50 mcg IV- Pain 10/10 7:40 PM fentanyl 25 mcg IV

51. Chronology of Treatment 10:00 PM promethazine 12.5 mg IV and MSO4 5mg IV 10:25 PM Respiratory therapist called for BIPAP PMH of multiple apneic episodes after analgesia 10:30 PM placed on BIPAP 11:15 PM promethazine 12.5 plus MSO4 5mg IV Next day 00:15 AM Desaturation noted BIPAP reapplied

52. Medical Floor 2:10 AM PCA is begun 9:50 AM emesis- zophran given - pain 10/10 11:17 AM MD consult- awake, alert & oriented Pain consultation –NP PCA changed to 2 mg MSO4 per dose every 15 minutes with no dose limit 4:00 PM alert and oriented Pt chart for SPO2 left blank 5:45-9:37 PM – multiple blanks on pt record

53. 9:37 lorazepam 1 mg IV given for agitation and anxiety Removing BIPAP mask, climbing out of bed NOTE THE MD WAS NOT CALLED PRIOR TO ADMINISTRATION OF LORAZEPAM 10:33 PM Code Blue called 10:54 Narcan 0.8 mg IV Pulseless electrical activity Revived but never regained consciousness Died a year later

54. Did not have ETCO2 monitoring on the floor NEVER did an arterial blood gas analysis Settled out of court