1. Antibiotic Stewardship The Increased Scrutiny of Antibiotic Use Jennifer L. Hardesty, PharmD, FASCP Chief Clinical Officer Corporate Compliance Officer Remedi SeniorCare William Vaughan RN, BSN Vice President, Education and Clinical Affairs Remedi SeniorCare

2. Disclosure / Contact Jennifer Hardesty is a shareholder at Remedi SeniorCare William Vaughan is a shareholder at Remedi SeniorCare, a contractor to CMS (QAPI) and a member of the Institute for Safe Medication Practices clinical advisory board (Long-Term Care Advise ERR) Contact : – jennifer.hardesty@remedirx.com – william.vaughan@remedirx.com

3. Objectives Discuss current and proposed federal regulations which impact the use of antibiotics in nursing homes. Identify three clinical practices which maximize the benefits and minimize the risks associated with the use of antibiotics in long term care residents. Describe the concept of antibiotic stewardship and identify four core elements of an antibiotic stewardship program.

4. Regulatory “Priorities”

5. Antibiotics

6. “However, with the recent emergence of resistant organisms, pediatric organizations have strongly recommended initial antibiotics only for certain children” - Merck Manual

7. “Ninety–98% of rhinosinusitis cases are viral, and antibiotics are not guaranteed to help even if the causative agent is bacterial.” - CDC

8. “Although warranted in some cases, antibiotics are greatly overused.” - American Academy of Family Physicians

11. Nursing Homes ~ 4 million admissions / year ABT use common (up to 70% / year) Inappropriate prescribing (up to 75%) – Unnecessary – Wrong drug, dose or duration Colonization common Source: CDC (http://www.cdc.gov/media/releases/2015/p0915-nursing-home-antibiotics.html )

12. In the Crosshairs: Urinary Tract “Infections” Generalized change in condition (falls, mental status, etc.) – Adverse drug reaction ("Any symptom in an elderly patient should be considered a drug side effect until proven otherwise.”– Gurwitz et al) – Fluid / electrolyte imbalance – Infection + urine culture  Antibiotics  colonization

13. In the Crosshairs: Urinary Tract “Infections” “Don’t obtain a urine culture unless there are clear signs and symptoms that localize to the urinary tract.” – AMDA “Don’t use antimicrobials to treat bacteriuria in older adults unless specific urinary tract symptoms are present.” – AGS

14. In the Crosshairs: Urinary Tract “Infections” A patient with advanced dementia may be unable to report urinary symptoms … In this situation, it is reasonable to obtain a urine culture if there are signs of systemic infection such as fever … leukocytosis, or a left shift or chills in the absence of additional symptoms (e.g., new cough) to suggest an alternative source of infection. – AMDA

15. Other High Risk Areas

16. Current Regulations F 281 (Profession standards of quality) – “Standards published by professional organizations” F 329 (Unnecessary Drugs) – Indication – Dose – Duration – Monitoring – Adverse consequences (c. diff)

17. No Absolutes Rationale for Care Based on: Evidence Thoughtful risk / benefit analysis Resident / surrogate involvement  Document especially in high risk situations

18. Actions to Consider Engage Medical Directors / Consultant Pharmacists Educate – Prescribers – Nursing staff – Residents / surrogates /families Discuss / document goals of care

19. Actions to Consider Don’t succumb to perceived regulatory pressure to “do something” – Watchful waiting – Antibiotic “time out” Quality assurance – Consistency of prescribing practices – Type of antibiotic (broad spectrum) – Duration of therapy Choosing Wisely (www.choosingwisely.org)

20. Proposed Regulations Infection and Prevention Control Officer Infection Prevention and Control Program – Antibiotic stewardship Quality Assurance Performance Improvement

23. Antibiotics- Some Facts Each Year in the US: ~2 million people become infected with resistant bacteria At least 23,000 people die each year as a direct result of these infections 250,000 patients (hospitalization) get Clostridium difficile each year, C. difficile kills at least 14,000 people each year

24. Resistance Develops….Survival of the Fittest

25. Antibiotic Resistance Spreads…..

26. Fast-paced resistance Resistance develops quickly: Methicillin: o developed in 1960 o resistance by 1962 Linezolid o developed in 2000 o resistance by 2001

27. Adverse Drug Reactions: Antibiotic Overuse Adverse Drug Events  N/V/D  Myalgias  Blood dyscrasias  Candidiasis  C. Difficile

28. Additional Problems: Clostridium Difficile

29. Clostridium Difficile

30. C.Difficile - Treatment Drug Treatment: Metronidazole $ Vancomycin $$-$$$ Fidaxomicin (Dificid) $$$$ Recurrence -can occur in up to 25% of patients (another episode of C. difficile within 8 weeks) Relapse of the initial infection Re-infection with a new strain Recurrence Treatment: First recurrence- the same medication Second recurrence, a tapered or pulsed oral vancomycin Third recurrence fecal transplant should be considered Long-term care facility residents are particularly at risk for C. Difficile complications

31. CDC: What Can the Health Care Community Do?

33. Antimicrobial Stewardship Patients receive the right antibiotic, at the right dose, at the right time, and for the right duration Coordinated interventions designed to improve and measure the appropriate use of antimicrobial agents by promoting the selection of the optimal antimicrobial drug regimen

34. Antibiotic Stewardship Programs are a “win‐win” for all involved! Antibiotic Stewardship will: –Decrease antibiotic resistance –Decrease C. difficile infections –Decrease costs –Increase good patient outcomes Antibiotic Stewardship will: –Decrease antibiotic resistance –Decrease C. difficile infections –Decrease costs –Increase good patient outcomes http://www.cdc.gov/getsmart/healthcare/factsheets/antibiotic-use.html

35. LTC Core Elements for Antibiotic Stewardship http://www.cdc.gov/longtermcare/prevention/antibi otic-stewardship.html

36. Leadership Commitment Write statements in support of improving antibiotic use to be shared with staff, residents and families Include stewardship-related duties in position descriptions: o Medical Director o Clinical nurse leads, DON o Consultant pharmacist Communicate with nursing staff,prescribing clinicians o Expectations about use of antibiotics o Monitoring and enforcement of stewardship policies Create a culture which promotes antibiotic stewardship o Messaging o Education o Celebrating improvement

37. Accountability Medical Director: set standards for antibiotic prescribing practices for all clinical providers Director of Nursing: set the practice standards for assessing, monitoring and communicating changes in a resident’s condition by front-line nursing staff. Infection prevention program coordinator: o Track antibiotic starts o Monitor adherence to evidence-based published criteria o Review antibiotic resistance patterns in the facility Consultant pharmacist : support antibiotic stewardship oversight through quality assurance activities Laboratory Services: o Alerting facility if certain antibiotic-resistant organisms are identified, o Educate staff on the differences in diagnostic tests available o Antibiogram

38. Drug Expertise Partner with antibiotic stewardship program leads at the hospitals within your referral network Infectious Disease practitioners and consultants in your community Consultant Pharmacists

39. Action Through Policy/Practice Change Policies that support optimal antibiotic use o Require dose, duration, indication for every order o Viewing culture data Broad interventions to improve antibiotic use o Improving the evaluation and communication of clinical signs/symptoms o “Communication Tool” o INTERACT Tools o “Antibiotic time-out” o Developing antibiotic monitoring and infection management guidance Infection and syndrome specific interventions to improve antibiotic use o Asymp tomatic bacteriuria (ASB) o Urinary tract infection prophylaxis o Lower Respiratory Tract Infections (Viral vs Bacterial)

40. Tools and Protocols: INTERACT Programs https://interact2.net/tools_v4.html

41. Process Measures: o Completeness of clinical assessment documentation at the time of the antibiotic prescription o Completeness of antibiotic prescribing documentation o Antibiotic selection is consistent with recommended agents for specific indications o Point prevalence of antibiotic use o Antibiotic days of therapy (DOT) o Post-prescription review of appropriateness Outcome Measures: o Track C. difficile and resistant organisms o Track adverse drug events related to antibiotic use o Antibiotic resistance o Track costs related to antibiotic use Tracking/Reporting: Use and Outcomes

42. Tools and Protocols: Antibiotic Appropriateness Assessment - G+ Infections

43. Tools and Protocols: Antibiotic Appropriateness Assessment- UTI http://www.remedirx.com/site/wp-content/uploads/2016/02/2016-02-M.R.-UTI-Assess-Tool.pdf

44. Education Provide antibiotic stewardship education to clinicians, nursing staff, residents and families Linking education with feedback on physician prescribing practices Interactive academic detailing (e.g., face-to-face interactive workshops) has the strongest evidence for improving medication prescribing practices Providing feedback on individual physician prescribing practices and adherence to the guidelines over 12 months

45. Tools and Protocols: Appropriate Antibiotic Use Summary http://www.cdc.gov/getsmart/community/materials-references/print-materials/hcp/adult-approp-summary.pdf

46. The First Steps: Ensure all orders have dose, duration, and indications Get cultures before starting antibiotics Take an “antibiotic timeout,” reassessing antibiotics after 48–72 hours Implement policies that encourage best practices o Es tablishment of minimum criteria for prescribing antibiotics o Review of antibiotic appropriateness/resistance patterns o Nursing protocols for monitoring patients’ status for an evolving condition if there is no specific indication for antibiotics

47. Small, Sustainable Changes Facility should not attempt to implement all of the interventions at once. Interventions to implement should be tailored to the areas that most need improvement at your facility Essential to monitor and measure o Measurement Framework- various measures of antibiotic use to assess effectiveness of improvements

48. Antibiotic Stewardship: Measurement Framework http://www.cdc.gov/getsmart/healthcare/pdfs/Antibiotic_Stewardship_Measurement_Framework.pdf

49. http://www.remedirx.com/news-events/news/

50. Changing Prescribing Behaviors Effect of Behavioral Interventions on Inappropriate Antibiotic Prescribing Among Prescribers; Leeker et al. JAMA. 2016;315(6):562-570. doi:10.1001/jama.2016.0275

51. Antibiotic Stewardship: Are You Ready?

52. LTC Antibiotic Stewardship Tool Core Elements Checklist

57. Thank You Questions?