Searching for Clues in Infectious Diseases

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1 Disclosure Searching for Clues in Infectious Diseases The speaker has no financial conflicts to disclose as relates to the content of this presentation John Esterly, PharmD, BCPS Northwestern Memorial Hospital Chicago State University College of Pharmacy Objectives List resources for accessing current consensus practice guidelines for the management of infectious diseases Describe an effective strategy for obtaining emerging, relevant information during interim periods between practice guideline updates Clinical Practice Guidelines "Clinical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. Field MJ, Lohr KN (Eds). Institute of Medicine, Considering Consensus ID Guidelines Point Formulated by expert panels and rigorously reviewed Based on best available medical evidence Widely applicable Updated regularly? Counterpoint Many authors have significant conflicts of interest Level of evidence may be minimal Unable to incorporate local considerations Woefully out of date? Sources for ID Guidelines Infectious Diseases Society of America (IDSA) Centers for Disease Control and Prevention (CDC) Department of Health lhand Human Services (DHHS) Society for Healthcare Epidemiology in America (SHEA) 1

2 Sources for ID Guidelines National Guideline Clearinghouse Relevant consensus expert panels in other practice areas Citi Critical lcare Mdii Medicine Oncology Cardiology Gastroenterology Pediatrics International Guideline Sources World Health Organization (WHO) European Society of Clinical Microbiology and Infectious Diseases (ESCMID) BitihS British Society for Antimicrobial i lchemotherapy (BSAC) International Antiretroviral Society (IAS USA) Which ID guideline resource do you most commonly use in practice? 1. CDC 2. IDSA 3. DHHS 4. SHEA 5. WHO IDSA Guidelines Infectious Diseases Society of America Consensus guidelines for most major types of clinically i ll encountered infections i Assembled by medical thought leaders Based on best available clinical data Very well referenced Many available for PDA, mobile devices, etc. IDSA Guidelines Every 12 to 18 months after publication, IDSA reviews it s guidelines to determine whether update is required. Updates constantly ongoing but many up to 10 years old before updates CDC Guidelines Centers for Disease Control and Prevention ID guidelines/information on communicable diseases impacting gpublic health Influenza, STDs, TB, hepatitis, travel health, immunizations Focused on prevention and treatment Updated frequently (some annually) A lot of other freely available resources Printable info, photos, podcasts, etc. 2

3 DHHS Guidelines (HIV/OIs) Federally approved HIV/AIDS adult, adolescent, and pediatric treatment guidelines Prevention and treatment of opportunistic infections Also consensus recommendations for testing, referral, exposure management International Antiretroviral Society Multiple online resources available free Guidelines Antiviral Treatment of Adult HIV Infection Resistance Testing in Adult HIV Metabolic Complications of Adult HIV Also has many educational webcasts/podcasts Pocket cards, Topics in Antiviral Medicine SHEA Guidelines Society of Healthcare Epidemiology of America (SHEA) online.org Focus is on epidemiology and infection control practices C. difficile management IC and abx proph in special populations such as hematology/oncology, etc. Antimicrobial stewardship WHO Guidelines World Health Organization Body for directing and coordinating health within the United nations system Creates overarching guidelines directed at public health issues including ID Most topics with direct guidelines are also represented by local (U.S. guidelines) ESCMID Guidelines European Society of Clinical Microbiology and Infectious Diseases Comprehensive set of clinical i l guidelines Many in conjunction with IDSA and other European expert panels Some guidelines more focused to European infection epidemiology Other Expert Panels Society of Critical Care Medicine ( Sepsis, IV catheter related BSI National Comprehensive Cancer Network ( Prevention and Treatment of Cancer related Infections American Medical Association ( assn.org) Summary/synthesis of recommendations from many specialty consensus guidelines 3

4 Consolidated in One Place? National Guideline Clearinghouse Public resource offering a database of evidence based clinicalpractice guidelines Searchable by topic or organization Includes expert commentaries Comparative analysis of multiple sources Current FDA news and announcements Summary of Guideline Resources Resource URL Comments IDSA Most comprehensive single source, Updated infrequently CDC Communicable diseases, public health measures, updated frequently DHHS Most comprehensive HIV and OI management IAS USA Comprehensive antiviral information SHEA Infection control, antimicrobial stewardship ESCMID Most comprehensive European source National Guideline Clearinghouse Single source database for evidence based guidelines Which infectious diseases journal has the highest impact factor? 1. AIDS 2. Clinical Infectious Diseases 3. Lancet Infectious Diseases 4. Infection and Immunology 5. Pharmacotherapy Best Sources for Emerging Evidence Primary literature Infectious diseases based society journals Other high impact infectious diseases journal sources High impact journals in other disciplines Most journals offer alerts of accepted manuscripts, TOC Journal indexing services Impact Factors for ID Journals Journal Impact Factor Comments (2009) The Lancet Infectious Diseases 15.6 Highest IF since inception Clinical Infectious Diseases 8.2 Journal of IDSA Emerging Infectious Diseases 6.8 CDC publication Journal of Infectious Diseases Highest historical IF AIDS 4.9 HIV focused Current Opinion Infectious Diseases 4.8 Broad based topics Journal of Antimicrobial Chemotherapy 4.4 Journal of BSAC Antiviral Therapy 4.3 Viral infections Journal of Acquired Immune Deficiency 4.2 HIV focus Syndromes Infection and Immunity 4.2 Clinical ID and immunology Other Select Journals to Consider*? Other high impact journals NEJM, JAMA, Annals/Archives of Internal Med Chest, Critical Care Med, Clinical Microbiology Review ID journals Antimicrobial Agents and Chemotherapy Infection Control and Hospital Epidemiology Pharmacy journals Pharmacotherapy, Annals of Pharm, AJHP *Not an all-inclusive list 4

5 Case study of Post guideline Emerging Data "Vancomycin Therapeutic Monitoring: Review and Recommendations from the ASHP, IDSA and SIDP Task Force Consensus guideline suggesting more aggressive dosing strategies needed to meet pharmacodynamic goals in setting of increasing vancomycin MICs Level of clinical evidence relatively low Vancomycin TDM Guidelines Recommendations include goal troughs of for complicated infections Consider loading doses of 25 30mg/kg TBW in seriously ill patients to achieve rapid target trough concentrations Also recommends stringent monitoring based on limited safety data for aggressive dosing Rybak, et al. Am J Health-Syst Pharm;2009;66:82-98 Rybak, et al. Am J Health-Syst Pharm;2009;66:82-98 Level of Evidence for Vancomycin TDM Association between aggressive vancomycin dosing and nephrotoxicity? TABLE 4. Final logistic regression model for the occurrence of nephrotoxicity (n=246). Parameter Adjusted odds ratio 95% Confidence P value interval Vancomycin at 4 g per day Wt of kg CrCl level of ml/min ICU residence Rybak, et al. Am J Health-Syst Pharm;2009;66:82-98 Lodise TP et al. Antimicrob. Agents Chemother. 2008;52: Other Studies after Widespread Guideline Implementation? Prospective, Multicenter Study of Vancomycin Trough and Nephrotoxicity Table 1. Bivariate analysis of the relationship between the vancomycin exposure profile and nephrotoxicity. Table 3. Logistic regression model for the occurrence of nephrotoxicity. Table 3. Results of multivariate analysis (n=288) Variable OR for nephrotoxicity 95% CI Trough conc. >15 mg/liter LOT* with vancomycin Race (black) Heart failure Metastatic solid tumor *LOT=length of therapy Lodise TP et al. Clin Infect Dis. 2009;49: Bosso JA. Antimicrob Agents Chemother Dec;55(12):

Validation of Target Troughs? Vancomycin vs. Linezolid Pneumonia? Table 2. Vancomycin Trough Concentrations and Poor Outcomes. Characteristic N = 308 Trough <10 mg/l (n=70) Trough 10 14.

682 52 (57.8%) 0.016 13/76 (17.1%).476 34 (39.5%) REF 10/77 (13.0%) REF 31 (50.0%) 0.206 17/62 (27.4%).032 Kullar R, et al. Clin Infect Dis. 2011;52:975-981. Walkey AJ et al. Chest 2011;139:1148-1155.

6 Validation of Target Troughs? Vancomycin vs. Linezolid Pneumonia? Table 2. Vancomycin Trough Concentrations and Poor Outcomes. Characteristic N = 308 Trough <10 mg/l (n=70) Trough mg/l (n=90) Trough mg/l (n=86) Trough >20 mg/l (n=62) Vancomycin failure n (%) P (vs reference category) Nephrotoxicity n(%) P (vs reference category) 46 (65.7%) /65 (15.4%) (57.8%) /76 (17.1%) (39.5%) REF 10/77 (13.0%) REF 31 (50.0%) /62 (27.4%).032 Kullar R, et al. Clin Infect Dis. 2011;52: Walkey AJ et al. Chest 2011;139: Meta analysis Summary Randomized controlled trials do not support superiority of linezolid over glycopeptide antibiotics for the treatment of nosocomial pneumonia. We recommendthat decisions between linezolid or glycopeptide antibiotics for empirical or MRSAdirected therapy of nosocomial pneumonia depend on local availability, antibiotic resistance patterns, preferred routes of delivery, and cost, rather than presumed differences in efficacy. Vancomycin vs. Linezolid Pneumonia? Figure1. Clinical response rates in per-protocol (PP) and modified intent-to-treat (mitt) patients at end-of-study (EOS) and end of therapy (EOT). Walkey AJ et al. Chest 2011;139: Wunderink RG et al. Clin Infect Dis. 2012;54: Other Sources Early data presented in abstract form at professional meetings Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) IDSA Annual Meeting Conference on Retroviruses and Opportunistic Infections (CROI) Making a Difference in Infectious Diseases (MAD ID) Pharmacy professional meetings Last But Not Least Professional organizations offering listserve access for opinion of specialty practitioners Society of Infectious Diseases Pharmacists ACCP Infectious Diseases Research & Practice Network (ID PRN) ASHP Section of Clinical Specialists & Scientists Networking (locally) with fellow practitioners and previous Mentors 6

7 Which of the following guideline resources would be most beneficial for up to date recommendations on treating influenza? a) Centers for Disease Control b) Infectious Diseases Society of America c) Society for Healthcare Epidemiology of America d) Society of Critical Care Medicine Which would be the most valuable source for obtaining relevant emerging clinical data between guideline updates? a) Networking with other practitioners b) Professional Meetings c) Primary literature c) Primary literature d) Organization listserves 7

D DAVID PUBLISHING. 1. Introduction. Kathryn Koliha 1, Julie Falk 1, Rachana Patel 1 and Karen Kier 2

D DAVID PUBLISHING. 1. Introduction. Kathryn Koliha 1, Julie Falk 1, Rachana Patel 1 and Karen Kier 2 Journal of Pharmacy and Pharmacology 5 (2017) 607-615 doi: 10.17265/2328-2150/2017.09.001 D DAVID PUBLISHING Comparative Evaluation of Pharmacist-Managed Vancomycin Dosing in a Community Hospital Following