Antibiotic Stewardship in Nursing Homes – What is it, what are your roles and opportunities? JARRETT R. AMSDEN, PHARMD, BCPS ASSOCIATE PROFESSOR BUTLER UNIVERSITY COPHS & INFECTIOUS CLINICAL SPECIALIST COMMUNITY HEALTH NETWORK CO-CHAIR OF THE COMMUNITY HEALTH NETWORK ANTIMICROBIAL STEWARDSHIP PROGRAM Objectives Review and discuss antibiotic stewardship (ASP) and its application to nursing homes 2. Identify opportunities for ASP across a broad setting or an individual LTCF site 3. Discuss how to devise a process, identify each person’s role in the process and implement the process 4. Discuss methods of evaluating and revising the process during the pilot stages 1. Disclosure: I have no financial or commercial conflicts of interest Antimicrobial Stewardship “the optimal selection, dosage, and duration of antimicrobial treatment that results in the best clinical outcome for the treatment or prevention of infection, with minimal toxicity to the patient and minimal impact on subsequent resistance.” Missing is the appropriate diagnosis of the infection for which the antibiotic is prescribed Clin Infect Dis. 2007;44(2):159-177 Baseline Assessment Question The antibiotic choice Is there a best choice for a patient? Yes How would you characterize this choice? After allergies, the most narrow spectrum and most likely to promote adherence Is there a best dose for a patient and/or infection? Yes, it is in the drugs pharmacodynamics??? Is there an optimal duration for this infection Yes and No Yes there is, but in some circumstances it is less clear and/or hard to define Why is Antimicrobial Stewardship Important? 70% of LTCF residents receive an antimicrobial course annually 40-75% of these antimicrobial courses is inappropriate Overexposure to antibiotics leads to: Resistance Collateral infections – C. difficile Adverse events Drug interactions Multidrug-resistant organism colonization and transmission Clin Infect Dis. 2007;44(2):159-177; JAMA 2003;289: 1107–11; Infect Control Hosp Epidemiol 2000; 21:537–45 Why is Antimicrobial Stewardship Important? Prevention National Action Plan CMS CDC • National ASP implementation could prevent 619,000 infections over 5 years • Calls for developing ASP in LTCFs • Expanding, developing and monitoring programs • Will include infection control, ASP and antibiotic monitoring in their forthcoming LTCF requirements • Developed “Core Elements” for ASP in LTCFs JAMDA 2016;183.e1-183.e16 Approaches to ASP Antimicrobial Stewardship The “Front-end” The “Back-end” Process that occurs Process that occurs pre-prescription – (RESTRICTION) Employ tactics that limit what can be prescribed and by whom post-prescription – (Prospective audit and feedback) Provides recommendations on antibiotic selection, dose and duration Clin Infect Dis. 2007;44(2):159-177 Antimicrobial Stewardship The “Front-end” Methods The “Back-end” Methods Education and Education and Transparency Formulary restriction or approvals Order-sets or pathways Guidelines Dose optimization Decision support tools Transparency Guidelines De-escalation Duplication Duration Dose optimization IV to PO Clin Infect Dis. 2007;44(2):159-177 Antimicrobial Stewardship The “Front-end” Methods The “Back-end” Methods PROs Target antibiotic utilization issues Encourage formulary adherence Decrease costs Necessary during outbreaks CONs Questionable effect on resistance Compromises prescriber autonomy Variability in who staffs the process/resources Application across facilities is challenging Loopholes in the programs PROs Direct caregiver interactions Trained individuals making recs? Interventions can be tailored CONs Requires persistent monitoring and time Training and competency Personnel and resources Continuous feedback Clin Infect Dis. 2007;44(2):159-177 Antimicrobial Stewardship How to get it going Assess your current resources Identify and determine areas of need Get “top-down” buy-in Develop a plan or business plan pending resources Put it into action Measure and re-assess or re-adjust Barriers Resources and priorities Provider and personnel acceptance Direct causality of your efforts Keeping the fire lit Clin Infect Dis. 2007;44(2):159-177 Building a Multidisciplinary Team Admin Support ID Physician or Physician Champion Information Technology Antimicrobial Stewardship Micro Infection Prevention ID-trained Pharmacist Nursing Clin Infect Dis. 2007;44(2):159-177 Measuring Success Metrics Defined Daily Dose (DDD) – Antibiotic consumption Day of Therapy (DOT) – Clinical antibiotic use The DDD is calculated as the total number of grams of antimicrobial agent used divided by the number of grams in an average daily dose DOTs are expressed as the administration of a single agent on a given day regardless of the number of doses administered or dosage strength Resistance rates via the antibiogram or infection control Incidence of resistant or problematic organisms Number/percentage of successful interventions or prescriptions considered appropriate Clin Infect Dis. 2007;44(2):159-177 Antibiotic Stewardship APPLICATIONS TO LONG-TERM CARE FACILITIES Optimal Care in LTCF – an upward climb LTCFs house 50-200 residents per facility Average staffing per 100 resident beds Indiana Staffing Minimums 7 RNs 13 LPNs 35 CNAs < 20% have fulltime physician providers Statutes for staffing vary by state Guidelines for staffing ratios CNAs to residents > 1:12 RNs + LPNs to residents > 1:30 RNs to residents > 1:120 Nursing 1DON RN full-time included in 1 RN 8 consecutive hours/7days/wk and 1 LPN Charge Nurse each shift For 1-60 resident: DON may be Charge Nurse included in: RN/LPN RATIO 0.5 LPN hour per resident day to resident ratio (averaged over 1 week, excluding DON) Physician – in person Must see a resident at least once every 30 days for the first 90 days Then at least every (60) days thereafter Alternating visits by PA, NP, etc. are acceptable Infections in elderly – the challenges Higher incidence of infection Lower barriers to infection (skin, immune deficits, etc.) More indwelling devices Comorbid conditions Elderly patients tend to: Have poor localization of or atypical “text book” symptoms Inability to demonstrate physical declines Inability to communicate physical or mental changes Changes are often slow or too subtle to be detected Detecting an overall functional decline is the key Suspecting infections in LTCF patients Defining a declining functional status New onset or increase in: Confusion Incontinence Falling Decreasing mobility Decreasing food intake Failure to cooperate with staff High KP, et al. Clin Infect Dis 2009;48:149-171 Suspecting infections in LTCF patients Fever Elderly have lower basal body temperatures Defining fever as 100°F (37.8°C) had a sensitivity of 70% and specificity of 90% for detecting infection Accepted criteria for defining fever in LTCFs Single temperature of 100°F (37.8°C) Repeated temperatures of > 99°F (37.2°C) orally or > 99.5°F (37.5°C) rectally 2°F (1.1°C) increase in temperature above baseline High KP, et al. Clin Infect Dis 2009;48:149-171 The Patient Assessment 1st Layer CNAs measuring the resident vital signs and clinical symptoms Must convey the possibility of a fever and symptoms to LPN/RN 2nd Layer LPN/RN should corroborate these findings and conduct a complete resident examination and document the critical findings This examination and documentation is vital to communication to the physician or physician extender 3rd Layer LPN/RN to call physician or physician extender with COMPLETE list of findings Ideally the provider should facilitate the evaluation over the phone and order directed tests/labs as able and necessary to make appropriate clinical decisions Conduct their own patient assessment/evaluation at the next time point High KP, et al. Clin Infect Dis 2009;48:149-171 Laboratory Testing for Infection CBC with differential within 24 hours WBC > 14,000 cells/mm3 (LR 3.7), > 90% neutrophils (LR 7.5), bands > 6% (LR 4.7) are potential indicators of infection If normal, this may limit further testing needs BMP While not needed for infectious sources it may be useful for establishing or ruling out metabolic causes May aid with optimal drug dosing High KP, et al. Clin Infect Dis 2009;48:149-171 Laboratory Testing for Infection UTIs Incidence 0.1-2.4 cases/1000 resident days Patients with indwelling catheters will almost always have WBCs and bacteriuria, but this is rarely indicative of a UTI Urinalysis +/- Culture MUST have symptoms to support testing 10-50% of institutionalized patients will have asymptomatic bacteriuria Must define symptoms for those catheterized vs non-catheterized Absence of WBC in the urine or negative leukocyte esterase and nitrite in a dipstick test can be used to rule-out bacteriuria If a patient has a chronic indwelling catheter this should be changed before culturing High KP, et al. Clin Infect Dis 2009;48:149-171 Laboratory Testing for Infection Bacteremia Bacteremia occurs in 5-40/100,000 resident days Secondary bacteremia occurs in 6% of patients ~50% from urinary tract ~10% from respiratory tract and skin or soft tissue ~5% from abdominal source ~3% from IV catheters ~20% unidentified sources Blood cultures Generally low yield in elderly patients Symptoms of bacteremia are less obvious the elderly and are frequently associated with other organ system issues Necessary in patients where bacteremia or urosepsis is suspected High KP, et al. Clin Infect Dis 2009;48:149-171 Laboratory Testing for Infection Pneumonia Common source of infection with high mortality in LTCF patients Monitoring and imaging RR > 25 breaths/min and SAO2 < 90% are strong predictors of potential respiratory failure SAO2 < 94% had 80% sensitivity, specificity 91% and PPV 95% for diagnosing pneumonia CXR can be helpful to determine origin of hypoxemia Sputum specimens can be o potential value, but are low yielding – mixed flora in >35% of cases Urine antigen testing for S. pneumoniae or L. pneumophila are limited by sensitivity, but potentially useful for early detection Rapid influenza testing may identify the index case and reduce outbreaks Multiplex panels can detect other viruses including RSV – treatment is limited High KP, et al. Clin Infect Dis 2009;48:149-171 Laboratory Testing for Infection Skin and Skin structure infections (SSTIs) 3rd most common infectious etiology – 1-9% (0.9-2.1 cases/1000 resident days Most common infections Cellulitis Pressure ulcers Scabies Obtaining culture specimens Do not perform superficial swab cultures Areas of discrete abscess or deep tissue specimens in select circumstances can be used to direct therapy High KP, et al. Clin Infect Dis 2009;48:149-171 Laboratory Testing for Infection Gastrointestinal 1/3 of LTCF residents will have an episode of diarrhea annually 1/3 of deaths attributed to diarrheal causes are in LTCF residents > 74 years 3 or more unformed, loose stools for > 48 hours C. difficile Most common identifiable cause of diarrhea in LTCF 3 or more loose, watery (often explosive) stools in 24 hours Rates of asymptomatic carriage range from 10-30% When using PCR testing, this is often combined with clinical criterion Carriers can transmit disease Highly susceptible to antibiotic flora disruptions New diagnostic tests and/or algorithms with older tests have improved sensitivity and specificity Use of PCR tests may increase rate of false positive tests due to detecting carriers High KP, et al. Clin Infect Dis 2009;48:149-171 Laboratory Testing for Infection Gastrointestinal Illnesses of the small bowel can be watched for 7 days with volume assessment provided that Not in an outbreak setting Clinically stable Symptoms do not persist past 7 days Persistent symptoms, but clinically stable should have the stool checked for O&P Colitis is associated with fever, abdominal cramps, diarrhea w/ or w/o blood, and/or WBCs in the stool Patients exposed to antibiotics in the past 30 days C. difficile Patients not exposed to antibiotics or with a negative C. difficile test Enteric pathogens – Salmonella, Shigella, Ecoli O157:h7 High KP, et al. Clin Infect Dis 2009;48:149-171 The McGreer Criteria STONE ND, ET AL. SURVEILLANCE DEFINITIONS OF INFECTIONS IN LONG-TERM CARE FACILITIES: REVISITING THE MCGREER CRITERIA. INFECT CONTROL HOSP EPIDEMIOL 2012;33(10):965-977 The McGreer Criteria Criteria developed to help define infections in LTCFs that are likely to be true infections These definitions may not be adequate for real-time case finding, diagnosis, clinical decision making - antibiotic selection Definitions are aligned with the IDSA criteria for evaluating fever in LTCF residents Criteria for using these definitions All symptoms must be new or acutely worse Consider and evaluate non-infectious etiologies before calling this an infection Identification of infection MUST be based upon multiple pieces of data Stone ND, et al. Infect Control Hosp Epidemiol 2012;33(10):965-977 The McGreer Criteria Elements of the McGreer Criteria may provide a more complete definition for assessment criteria Definitions for acute changes in mental and/or functional status Uses a more objective ADL scale for functional declines Common cold/pharyngitis signs and symptoms Elements may be to stringent at the clinical decision point UTIs must have microbiological confirmation GI illness definitions of diarrhea are uniform for C. difficile vs non-C. difficile infections Stone ND, et al. Infect Control Hosp Epidemiol 2012;33(10):965-977 Loeb vs. McGreer Evaluation of Fever (Loeb) Surveillance of Infections (McGreer) Similar infections and basic definitions Screening criteria Less detailed criteria to allow decision to order tests or prescribe therapies Intended to help guide antibiotic prescribing (prospective) Documenting criteria More detailed criteria to enhance infection identification Intended to define if an infection is present and could be used to determine antibiotic appropriateness (quasi-prospective , mostly retrospective) High KP, et al. Clin Infect Dis 2009;48:149-171 Stone ND, et al. Infect Control Hosp Epidemiol 2012;33(10):965-977 AMDA and CDC Antimicrobial Stewardship Core Elements AMDA PRESS RELEASE WITH HYPERLINKS TO CDC: HTTP://WWW.AMDA.COM/NEWS/RELEASES/2015/CD C%20RELEASES%20CORE%20ELEMENTS%20FOR%20N HS.PDF PRIMARY CDC SITE: HTTP://WWW.CDC.GOV/LONGTERMCARE/PREVENTIO N/ANTIBIOTIC-STEWARDSHIP.HTML MORRILL HJ, ET AL. JAMDA 17 (2016);183.E1-183.E16 AMDA and CDC Process Leadership Commitment • Support and commit to appropriate antibiotic use Accountability • Identify physician, nursing and pharmacy “leads” in and across facilities Drug expertise • Access to antibiotic stewardship experts within facilities Action Tracking • Implement at least one policy or practice to improve antibiotic use • Monitor process measure of antibiotic use and outcome Reporting • Provide feedback to providers, nursing staff and stakeholders Education • Provide resources to staff, residents and families Antimicrobial Stewardship in LTCFs There are only 14 published works on ASP interventions in LTCFs Noted needs for ASP High rates of unnecessary antibiotic use Increased risk or prevalence of MDR organisms Increased risk for C. difficile Noted barriers to ASP Lack of proven ASP strategies Lack of funding, resources and infrastructure at LTCF sites Diagnostic dilemmas and appropriate prescribing Lack of ID-trained physicians or pharmacists Resident and family expectations Morrill HJ, et al. JAMDA 17 (2016);183.e1-183.e16 Selected Studies to Discuss Antimicrobial Stewardship in LTCFs 33 month prospective study in a 190 bed VA LTCF in proximity to an acute care hospital 3 months of monitoring practice habits followed by 30 months of data collection following an educational intervention Results Outcome 3mo preintervention 6mo postintervention 7-30mo postintervention Ur cx sent /1000 pt days 3.7 (2.8-4.9) 1.5 (1.1-2.1)* 1.3 (1.1-1.5) Inappropriate Ur cx /1000 pt 2.6 (1.8-3.6) days 0.9 (0.6-1.4)* 0.6 (0.5-0.8)* ASB treated /1000 pt days 1.7 (1.1-2.6) 0.6 (0.4-1.0)* 0.3 (0.2-0.4) Abx days /1000 pt days 167.7 117.4* 109* Ur= urine; cx=culture; pt=patient; ASB=asymptomatic bacteriuria; Abx=antibiotics; * indicates p<0.05 compared to pre-intervention period Zabarsky et al. Am J Infect Control. 2008;36:476-480 Antimicrobial Stewardship in LTCFs Retrospective cohort study of LTCF patients who received antibiotic therapy for suspected UTI Data from a 6 month period across 4 LTCF sites Dependent variable: signs/symptoms of a UTI using the Loeb et al. criteria Independent variables: resident characteristics, site, etc. Indwelling catheter patients were excluded from the primary analysis (n=16, #23 antibiotic Rx’s) Results 56% were > 85 years, mean ADLH 2.0 (1.2), mean CPS 2.0 (0.6) 204 antibiotic courses for 151 residents (26% with multiple courses) 71-97% had urine studies and 64-85% of prescribers had the result prior to their antibiotic order Mean duration of antibiotic therapy was 7.6 days vs 8.1 days for asymptomatic vs symptomatic patients, respectively (p=NS) Multivariate analysis demonstrated that only the LTCF site impacted the likelihood of an antibiotic prescription for an asymptomatic UTI Phillips CD, et al. BMC Geriatrics 2012;12:73 Antimicrobial Stewardship in LTCFs Prospective cluster randomized controlled study across 30 LTCFs evaluating the use of an ASP tool to direct antibiotic prescribing 15 NHs were stratified to the intervention tool and 15 as controls Primary outcome measure is mean number of antibiotic prescriptions/100 residents (prevalence) and DDD/1000 residents (consumption) Results Mean number of prescriptions was not significantly different between groups in either period DDD/1000 residents was significantly decreased using the intervention tool 4.9% (95%CI 1-8.6%, p=0.02) compared to a 5.1% increase (95% CI 0.2-10.2%, p-0.04) 100% compliance to the interventional tool was only 46% and 31% for parts A and B, respectively Fleet E, et al. J Antimicrob Chemother 2014;69:2265-2273 A case to ponder JAMA 2014;312(16):1687-1688 UTI Case PMH: 80-year-old female with 2-year history of 8 UTIs and 6 treated with antibiotics (no catheter) History of falls, cognitive impairment and incontinence Primary problem: Increased confusion, urinary frequency, cloudy urine, lethargy, hallucinations and falls HPI Family reports that she “doesn’t look right,” but the nursing staff states she is not confused. The patient reports no dysuria or abdominal pain but does chronically complain of voiding frequently. She is afebrile with no abdominal, suprapubic, or flank tenderness, but her urine has a foul odor. Newly inserted catheterized urine was collected JAMA 2014;312(16):1687-1688 UTI Case Result Reference Range Color Yellow, hazy Yellow Specific gravity 1.005 1.005-1.030 pH 7.5 5-7.5 Blood 1+ Negative Protein Negative Negative Nitrite 1+ Negative Leukocyte esterase 3+ Negative Bacteria 3+ None-few/hpf White blood cells 40-100/hpf 0-5/hpf Red blood cells 2/hpf 0-5/hpf Epithelial cells 0-5/lpf None-few/lpf Culture: > 100,000 cfu/mL Ecoli – Only resistant to Ampicillin JAMA 2014;312(16):1687-1688 UTI Case How do you interpret these test results in the context of this patient case? A. B. C. D. The patient has asymptomatic pyuria and bacteriuria. The patient has a UTI due chronic incontinence and a positive urine culture. A positive urinalysis and urine culture are always a UTI. Since the patient has a history of recurrent UTIs, current urine test results are also indicative of an UTI. JAMA 2014;312(16):1687-1688 Discussion Points In adults >= 65 years or older, positive dipstick ((+ ) leukocyte esterase, nitrite,or both) for a urine culture with more than 100 000 CFU/mL Sensitivity: 65% - 100% Specificity:20% - 77% Positive predictive value(PPV): 31% - 45% Negative predictive value(NPV),90% - 100% Positive likelihood ratio (LR+): 1.25 - 2.8 Negative likelihood ratio (LR−): 0 - 0.46. Take home points PPV is too low to use to determine UTI NPV is high enough to make the diagnosis of a UTI unlikely JAMA 2014;312(16):1687-1688 Discussion Points Urinalysis - > 10 WBCs/hpf is an accepted threshold for pyuria required for a UTI diagnosis > 10 WBCs/hpf in relation to a culture with > 100,000 CFU/mL Sensitivity: 78% Specificity: 63% PPV: 64% NPV: 74% LR+: 2.11 LR−: 0.35. Pyuria should only be used to confirm a clinical diagnosis of UTI (guided by signs and symptoms). JAMA 2014;312(16):1687-1688 Does this patient have a UTI? How do you interpret these test results? A. B. C. D. The patient has asymptomatic pyuria and bacteriuria. The patient has a UTI due chronic incontinence and a positive urine culture. A positive urinalysis and urine culture are always a UTI. Since the patient has a history of recurrent UTIs, current urine test results are also indicative of an UTI. JAMA 2014;312(16):1687-1688 Does the patient have a UTI The clinical criteria for symptomatic UTI in older women (no catheter) include 2 or more: Fever Worsened urinary urgency or frequency Acute dysuria Suprapubic tenderness Costovertebral angle pain or tenderness Patient did not have these symptoms, so she was diagnosed with Asymptomatic pyuria and bacteruria JAMA 2014;312(16):1687-1688 Opportunities and Roles in Antimicrobial Stewardship Opportunities The opportunities are limitless Any intervention directed at a perceived or actual problem will likely result in a benefit In time, these opportunities will soon be expectations so now is the time to start thinking about these items Roles It will vary by your role in the facility or process, but be pro-active The AMDA and CDC core elements should offer you guidance on how and where you CAN or NEED to fit into this process This needs to be multi-disciplinary, so tap your colleagues or anyone interested Conclusions Antibiotic stewardship is clearly needed in LTCFs The opportunities are vast and can be either self-identified or identified by data gathering ASP processes are multi-disciplinary and interventions should be multi-faceted Getting involved and using the CDC core elements is a start Education needs to be directed to both nursing and prescribers Evaluating the process needs to be based on the data that is accessible and applicable Revising the process with feedback from the nursing staff and providers is essential Transparency of the process to residents, family and all caregivers is a must