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Infection Prevention, Control, and Regulations in
the Long-Term Care Facility
Spencer H. Durham, Pharm.D., BCPS (AQ-ID)Assistant Clinical Professor
Department of Pharmacy PracticeAuburn University Harrison School of Pharmacy
Disclosure
• I have no conflicts of interest to report related to this program
Objectives
• At the end of this presentation, the audience will be able to:
– 1. Identify legislation and regulatory considerations regarding antimicrobial stewardship in the long-term care setting
– 2. Describe techniques for providing antimicrobial stewardship based on national practice guidelines
– 3. Explain the pharmacist’s involvement in the provision of antimicrobial stewardship
– 4. Utilizing real-life case examples, work through the pharmacist’s approach to the provision of antimicrobial stewardship
Background
• “The thoughtless person playing with penicillin treatment is morally responsible for the death of the man who succumbs to infection with the penicillin-resistant organism. I hope this evil can be averted.”
- Sir Alexander Fleming
Antimicrobial Resistance
• Multidrug-resistant organisms (MDROs) are increasing at an alarming rate
• 2 million illnesses and 23,000 deaths associated with antibiotic-resistant bacteria annually
• In May 2016, colistin-resistant E.coli was first reported in the U.S.
• Misuse of antimicrobial agents is the major contributing factor to disseminated resistance
Antimicrobial Resistance
• Centers for Disease Control (CDC) report “Antibiotic Resistant Threats in the United States”
• Classifies 18 drug-resistant pathogens in one of three categories:
– Urgent
– Serious
– Concerning
Urgent Threats
• 3 different pathogens
– Potential to become widespread
– Associated with serious risks
– Require immediate public health attention
• Clostridium difficile
• Carbapenem-resistant Enterobacteriaceae
• Neisseria gonorrhoeae
Serious Threats
• 12 different pathogens
– Incidence of infection may be decreasing, or some therapeutic options may be available
– Close public health monitoring is required to prevent them becoming “urgent threats”
• MRSA
• VRE
• Drug-resistant Streptococcus pneumoniae
• Drug-resistant Tuberculosis
Serious Threats
• Drug-resistant Shigella
• Drug-resistant Salmonella (Typhi and non-typhoidal)
• Drug-resistant Campylobacter
• Multidrug-resistant Acinetobacter
• Multidrug-resistant Pseudomonas aeruginosa
• Extended-spectrum beta-lactamase (ESBL) producing organisms
• Fluconazole-resistant Candida
Concerning Threats
• 3 different pathogens
– Resistance is low and/or several treatment options available
– Can cause severe illness
• Vancomycin-resistant Staphylococcus aureus (VRSA)
• Erythromycin-resistant group A Streptococcus
• Clindamycin-resistant group B Streptococcus
Other Classifications
• World Health Organization (WHO) published alist of “Priority Pathogens” in 2017
• 12 antimicrobial resistant organisms considered the greatest threat to human health
• Classified into 3 categories according to the urgency of need for new antimicrobials:
– Critical
– High
– Medium
Critical Priority
• 3 pathogens
• Carbapenem-resistant Acinetobacterbaumannii
• Carbapenem-resistant Pseudomonas aeruginosa
• Carbapenem-resistant and ESBL-producing Enterobacteriaceae
High Priority
• 6 pathogens
• MRSA and VRSA
• Vancomycin-resistant Enterococcus faecium
• Clarithromycin-resistant Helicobacter pylori
• Fluoroquinolone-resistant Campylobacter
• Fluoroquinolone-resistant Salmonellae
• Cephalosporin and fluoroquinolone-resistant Neisseria gonorrhoeae
Medium Priority
• 3 pathogens
• Penicillin-non-susceptible Streptococcus pneumoniae
• Ampicillin-resistant Haemophilusinfluenza
• Fluoroquinolone-resistant Shigella
Antimicrobial Stewardship
• Although MDROs are occurring at a rapid rate, there has not been a corresponding increase in new drug development
– Little financial incentive for drug companies
• Appropriate antimicrobial stewardship is the best hope of combating MDROs
What is Antimicrobial Stewardship?
• “Stewardship” – the activity or job of protecting and being responsible for something
• Antimicrobial stewardship involves taking responsibility for the management of antimicrobials with the goal of using them most appropriately
What is Antimicrobial Stewardship?
• Per the Infectious Diseases Society of America (IDSA):– “Coordinated interventions designed to improve and
measure the appropriate use of antimicrobials by promoting the selection of the optimal antimicrobial drug regimen, dose, duration of therapy, and route of administration.”
– “Antimicrobial stewards seek to achieve optimal clinical outcomes related to antimicrobial use, minimize toxicity and other adverse events, reduce the costs of health care for infections, and limit the selection for antimicrobial resistant strains.”
What is Antimicrobial Stewardship?
• Antimicrobial stewardship encompasses numerous strategies:
– Limiting inappropriate use of all antibiotics
– Utilizing narrow-spectrum antibiotics
– IV to PO conversions
– Decreasing actual or potential adverse effects
– Renal dose adjustments
– Cost effectiveness
Benefits of Antimicrobial Stewardship
• Improved patient outcomes
• Decreased adverse events
– Reduced incidence of Clostridium difficileinfection (CDI)
• Improvement in the rates of antibiotic susceptibilities to targeted antibiotics
• Optimization of resource utilization across the continuum of care
Antimicrobial Stewardship
• Antimicrobial stewardship was traditionally developed and performed in the acute care setting
• However, the importance of stewardship in the outpatient and long-term care facility (LTCF) settings is becoming increasingly recognized
Barriers in the LTCF
• ~4 million patients live in or will be admitted to a LTCF each year
• Antibiotics are the most common medication prescribed in these facilities
– 7 out of 10 patients will receive at least one course of antibiotics
• 40-75% of antibiotic prescriptions are either unnecessary or written incorrectly
Barriers in the LTCF
• Older adults are at a naturally increased risk of infectious diseases due to immunosenescence
• Many antibiotics in the LTCF are prescribed for colonization as opposed to true infections
– Urinary tract
– Respiratory tract
Barriers in the LTCF
• Lack of infectious diseases providers
– Most LTCFs do not routinely have ID support
– Providers are generally family medicine, internal medicine, or mid-level providers
• Lack of ID pharmacist specialists
• Time and effort
– Other things seen as more of a priority
Barriers in the LTCF
• Lack of laboratory data
– Cultures may not be ordered as frequently in the LTC setting as in the acute care setting
– Labs may be send outs
• Practitioners may be less willing to accept pharmacist recommendations
Resistant Infections in the LTCF
• Many patients come from the acute care setting, where they may have acquired a MDRO
• Multiple treatment courses for similar conditions
– UTIs
– Pneumonias
– SSTIs
Resistant Infections in the LTCF
• Overuse of unnecessary broad-spectrum antimicrobials
– Fluoroquinolones
– Upper-generation cephalosporins
– Extended-spectrum penicillins
• Patient population
– Geriatric
– Weaker immune systems
– Multiple comorbidities
Regulatory Requirements
• Due to the importance of antimicrobial stewardship, various regulations are now in place to promote this practice
– State legislation
– Presidential directives
– Agency requirements
Regulations
• California is the first state to legislate antimicrobial stewardship
• Bill passed in 2008
– Requires all acute care hospitals to develop a process for monitoring appropriate use of antibiotics
– Must be monitored by a quality improvement committee
Regulatory Requirements
• California Senate Bill 1311 – Adopted September 2014
– Requires hospitals to implement stewardship programs in accordance with nationally established guidelines
– Create a physician-supervised multidisciplinary committee with at least one physician OR pharmacist with training in antimicrobial stewardship
Regulatory Requirements
• Missouri Senate Bill 579
• By August 28, 2017, all hospitals and ambulatory surgical centers will have a stewardship program in place
• Antimicrobial use and resistance data must be reported and shared with the health department
– Does not have to be publically reported except under certain circumstances
Regulatory Requirements
• Presidential Executive Order “Combating Antibiotic-Resistant Bacteria,” was implemented in September 2014
– Requires federal agencies to review existing policies and propose new policies to require hospitals to implement stewardship programs
– Agencies will also help implement programs in the outpatient and long-term care facilities
Regulatory Requirements
• The Joint Commission (TJC)
– Medication Management Standard on Antimicrobial Stewardship (MM.09.01.01)
– Applies to acute care hospitals, critical access hospitals, and nursing care centers
– Became effective January 1st, 2017
Regulatory Requirements
• TJC
– Site must have an antimicrobial stewardship program in place based on current scientific literature
– Must educate practitioners and patients/family members on antimicrobials
– Pharmacist must be included as a team member
Regulatory Requirements
• TJC
– The stewardship program must include the CDC Core Elements of Antibiotic Stewardship Programs
– Utilizes policies and procedures approved by the organization
– Data on antimicrobial prescribing and resistance should be collected and analyzed
Regulatory Requirements
• Centers for Medicare & Medicaid Services (CMS)
– Conditions of Participation (CoP) related to antimicrobial stewardship in LTCFs was finalized in September 2016
– Utilized through a 2-phased approach
• Phase I – Implementation of infection prevention programs by 11/28/2016
• Phase II – Implementation of an antimicrobial stewardship program by 11/28/2017
Regulatory Requirements
• 3rd Phase
– Infection Preventionist must be identified for each LTCF, who will oversee the infection prevention program
– Must have specialized training in infection prevention and control
– Must be implemented by November 28, 2019
Regulatory Requirements
• CMS
– Infection control and prevention program must include the following:
• System for preventing, identifying, reporting, investigating, and controlling infectious diseases
• Program standards, policies, and procedures available in writing
• Antimicrobial protocols and a method for monitoring antimicrobial use must be included in the program
• Procedure for recording incidents and the subsequent corrective actions
Regulatory Requirements
• CMS
– Wide variety in LTCF in terms of number of patients treated, access to providers, patient level of severity, etc.
– Thus, specific ways in which the program will be implemented will vary from facility to facility
Stewardship Guidance
• CDC Core Elements of Antibiotic Stewardship for Nursing Homes
– 7 Core Elements of a successful program
• Leadership commitment
• Accountability
• Drug expertise
• Action
• Tracking
• Reporting
• Education
Stewardship Guidance
• CDC Core Elements
– Multidisciplinary team should have a single leader and pharmacy personnel, but should ideally include:
• Clinicians
• Infection prevention and epidemiologists
• Quality improvement personnel
• Laboratory personnel
• IT personnel
• Nurses
Stewardship Guidance
• CDC Core Elements
– Document dose, duration, and indication of antimicrobials
– Develop treatment protocols specific to the institution
– Antimicrobial Timeouts
• Useful for reassessing need for therapy
– Prior authorizations
– Dose optimization
Stewardship Guidance
• CDC Core Elements
– Provide targeted interventions for specific infections
• Urinary tract infections
• Skin and soft tissue infections
• MRSA infections
• Clostridium difficile associated diarrhea
• Community-acquired pneumonia
• Invasive infections
Stewardship Guidance
• The CDC encourages LTCFs to work in a step-wise fashion to implement stewardship programs
• Begin with implementing 1 or 2 activities, and gradually add others over time
– Any actions taken are thought to improve patient care
Guideline Recommendations
• Guidelines for developing and implementing antimicrobial stewardship programs
– Infectious Diseases Society of America (IDSA)
– Society for Healthcare Epidemiology of America (SHEA)
• Endorsed by numerous other organizations
Guideline Recommendations
• Stewardship team should include:
– Infectious diseases physician
– Clinical pharmacist with infectious diseases training
– Microbiologist
– IT specialist
– Infection prevention and hospital epidemiologist
Guideline Recommendations
• Recommended proactive strategies:– Utilize preauthorization and/or prospective
audit in addition to feedback• Patient specific review of prescribed pharmacotherapy
• Can be done by clinicians who are not members of the stewardship team
– Utilize facility-specific treatment algorithms to standardize and improve antibiotic prescribing based on local bacterial susceptibility
• Clinical pathways, guidelines, and order sets
• Can target specific infectious diseases
Guideline Recommendations
• Reduce the use of antibiotics associated with Clostridium difficile infection
• Encourage individual prescribers to perform routine review of antibiotic regimens
– Antibiotic time-outs, stop orders
• Pharmacokinetic monitoring for aminoglycosides and vancomycin
• Use alternative dosing strategies for beta-lactam antimicrobials
Guideline Recommendations
• Utilize oral antibiotics as initial therapy when appropriate and transition IV antimicrobials to oral in a timely fashion
• Utilize allergy assessments and penicillin skin testing for patients with beta-lactam allergies
• Antimicrobial therapy should generally be used for the shortest effective duration
• Stratified antibiograms should be used when possible
Guideline Recommendations
• Selective or cascade reporting of antimicrobial susceptibility should be utilized instead of reporting all antibiotics tested
• Utilize rapid viral testing for respiratory pathogens
• Both rapid diagnostic and conventional cultures should be performed on blood specimens
Guideline Recommendations
• The following should NOT generally be utilized:
– Didactic education as the only measure to decrease inappropriate antibiotic use
• Can be used to augment other activities
– Antibiotic cycling
Antibiogram
• Antibiogram – periodic summary (usually one year) of antimicrobial susceptibilities from local isolates (usually those of a specific hospital or health system)
• Used for:
– Selection of empiric antimicrobial therapy
– Monitor for trends in resistance
AntibiogramEscherichia coli
Klebsiella
pneumoniae
Proteus
mirabilis
Pseudomonas
aeruginosa
Amikacin 99 100 100 96
Ampicillin/sulbactam 63 88 89 -
Ampicillin 42 - 84 -
Aztreonam 95 96 98 76
Cefazolin 89 93 89 -
Cefepime 96 96 98 82
Ceftazidime 94 95 97 79
Ceftriaxone 96 96 97 -
Doripenem 99 100 100 92
Gentamicin 94 97 83 84
Ciprofloxacin 70 85 72 58
Levofloxacin 72 95 69 57
Piperacillin/tazobactam 98 96 99 85
Trimeth/sulfa 74 86 73 -
(-) = Not Applicable or Not Tested
Antibiogram
MRSAStaphylococcus
Aureus (MSSA)
Enterococcus
faecalisVRE
Cefazolin - 100 - -
Clindamycin 71 73 - -
Erythromycin 10 54 10 -
Gentamicin 99 95 - -
Levofloxacin 43 82 52 -
Linezolid 100 100 100 100
Penicillin - - 86 -
Rifampin 99 100 - -
Tetracycline 91 93 26 26
Tigecycline 100 100 100 -
Trimeth/Sulfa 99 98 - -
Vancomycin 100 100 91 0
(-) = Not Applicable or Not Tested
Culture and SensitivityUrine Culture: >100,000 CFUs Escherichia coli
SUSC INTPAmpicillin………………………….... >=8 RAmpicillin/sulbactam………………. >=8 RCefazolin……………………………. 16 RCefepime……………………………. <=1 SCeftriaxone………………………...... <=1 SCiprofloxacin………………………... <=2 SImipenem……………………………. <=2 SGentamicin ………………………….. <=2 SNitrofurantoin……………………….. >=256 RPiperacillin/tazobactam……………… <=4 STrimethoprim/sufamethoxazole…….. <10 S
MIC Interpretation
• Minimum inhibitory concentration (MIC)
– MIC = Mixture with the lowest concentration of antibiotic where there is no visible growth
– ***Remember, just because an antibiotic has the lowest MIC for a pathogen, does not mean it is the best choice***
• The number associated with the MIC is variable by drug, so the lower the number does not necessarily mean a bacteria is more sensitive to the drug
Antimicrobial Stewardship
• The perfect recipe for a pathogen to develop resistance to an antibiotic is to give a low concentration of the antibiotic over a prolonged period of time– In general, use upper end of dosing range– Do not prolong therapy longer than
needed, but MUST counsel patients to finish their course of antibiotics!
• Try to use the most narrow-spectrum agent possible as quickly as possible
Antimicrobial Stewardship
• SNAP approach to antimicrobial stewardship
• Safety, Need, Appropriate, Prudent
• Step-by-step process to assess antimicrobial therapy when antibiotics have already been prescribed
• If initially recommending an antibiotic, change to the NAPS approach
Antimicrobial Stewardship
• “S” – Safety
• Ask “is it safe for this patient to be receiving this drug?”
• Assessment of allergies
• Assess for likelihood of potential adverse drug reactions
Antimicrobial Stewardship
• “N” – Need
• Ask “Does this patient need antimicrobial therapy?– Does the patient actually have an
infection?
– Is the infection likely to be:• Bacterial?
• Viral?
• Fungal?
Antimicrobial Stewardship
• “A” – Appropriate
• Ask “Is the drug that has been prescribed treating, or likely to treat, the infection?”– Is the drug a guideline recommended
therapy?
– Does the drug provide appropriate coverage against the pathogens most likely causing the infection?
– Will the drug reach the site of infection?
Antimicrobial Stewardship
• “P” – Prudent
• Ask “Is this the most prudent drug to use for this infection?”
– Is this the “best” choice?
– Is the drug the most-narrow spectrum agent that will adequately treat this infection?
• This often cannot be fully assessed unless culture and susceptibility results are available
Case 1
• HPI: D.B. is a 67-year-old WM, permanent resident of a LTCF, who is evaluated for a 3-day history of fever and productive cough
• Allergies: NKDA• PMH: DM, HTN, dyslipidemia• Meds: Metformin, glypizide,
atorvastatin, lisinopril, HCTZ• PE: BP 130/82; HR 80; RR 26; Temp
101.5
Case 1
• Chest x-ray: bilateral infiltrates
• The attending physician initiates therapy with ceftriaxone 1 gram IV daily
Case 1
• Which of the following is the most appropriate recommendation for D.B. at this time?A) Continue the currently prescribed therapy
B) Change to ceftriaxone 2 grams IV daily
C) Discontinue antibiotics; infection is likely viral
D) Change to levofloxacin 750 mg
Case 2
• J.S. is a 76-year-old female who is evaluated by the attending physician of her LTCF for a large, pus-filled boil on her back.
• Allergies: Sulfonamides (rash)
• PMH: depression, DM2, hyperlipidemia
• Meds: insulin glargine, sertraline, atorvastatin
• PE: BP 118/76; HR 70; RR 18; Temp 99
Case 2
• She is prescribed Bactrim DS, 1 tablet PO BID for 14 days
Case 2
• Do you agree with the initial choice of antimicrobial therapy?
• What is the most likely bacterial etiology
• Are there any non-pharmacological therapies that should be recommended at this time?
Case 3
• N.P. is an 85-year-old AAF, permanent resident of the LTCF, who undergoing an evaluation by the NP because the nurses have noted that she is experiencing increased confusion from her baseline
• Allergies: Penicillin (rash)
• PMH: Dementia, dyslipidemia, COPD, CHF
• Meds: Numerous
• PE: BP 132/76, P 80, RR 22, T 99.6°F
Case 3
• A variety of tests were ordered, with the urinalysis showing multiple abnormalities
– Leukocyte esterase, nitrite +
• A urine culture is ordered and sent to the lab
• She is prescribed levofloxacin 500 mg IV daily
• Do you agree with this choice of empiric therapy?
Case 3
• Urine culture results:
Case 3
• Which of the following is the best recommendation for this patient?A) Continue the current therapy
B) Change to cephalexin
C) Change to Bactrim
D) Change to IM ceftriaxone
Case 4
• J.R. is a 62-year-old WM, recent admit to your LTCF s/p stroke. He complains today of a dry cough x 3 days, rhinorrhea, and sore throat.
• Allergies: NKDA
• PMH: Stroke, HTN, DM
• Meds: Numerous
• PE: BP 140/86, P 74, RR 22, T 97.5°F
Case 4
• Chest x-ray: negative
• Rapid strep: negative
• The attending physician orders cefdinir 300 mg PO BID for 7 days, plus azithromycin 500 mg PO on day 1, then 250 mg PO on days 2-5
Case 4
• What is the best recommendation for J.R. at this time?A) Continue the current therapy
B) Change to levofloxacin
C) Change to Bactrim
D) Discontinue antibiotics
Antimicrobial Stewardship
• Additional Resources:
• www.idsociety.org
– IDSA clinical practice guidelines
– Antimicrobial Stewardship guidelines
• www.cdc.org
• www.cms.org
• www.jointcommission.org
References
• Barlam TF, Cosgrove SE, Abbo LM, et al. Implementing an antibiotic stewardship program: guidelines by the infectious diseases society of America and the society for healthcare epidemiology of America. Clin Infect Dis. 2016;62(10):1197-202.
• Centers for Disease Control and Prevention. Discovery of first mcr-1 gene in E. coli bacteria found in a human in United States. Available from: http://www.cdc.gov/media/releases/2016/s0531-mcr-1.html. Accessed June 12, 2016.
• Centers for Disease Control and Prevention. Core Elements of Hospital Antibiotic Stewardship Programs. Available from: http://www.cdc.gov/getsmart/healthcare/implementation/core-elements.html. Accessed July 16, 2016.
• California Department of Public Health. The California Antimicrobial Stewardship Program Initiative. Available from: http://www.cdph.ca.gov/programs/hai/Pages/antimicrobialStewardshipProgramInitiative.aspx. Accessed June 12, 2016.
• The White House. National Action Plan for Combating Antibiotic-Resistant Bacteria. Available from: https://www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antiboticresistant_bacteria.pdf. Accessed July 16, 2016.
References
• Centers for Medicare and Medicaid Services. CMS Issues Proposed Rule that Prohibits Discrimination, Reduces Hospital-Acquired Conditions, and Promotes Antibiotic Stewardship in Hospitals. Available from: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2016-Fact-sheets-items/2016-06-13.html. Accessed July 8, 2016.
• Lowy FD. Antimicrobial resistance: the example of Staphylococcus aureus. J ClinInvest. 2003;111(9):1265-1273.
• Infectious Diseases Society of America. Faces of antimicrobial resistance. Available from: http://www.idsociety.org/uploadedFiles/IDSA/FOAR/FOAR%20Report%201-up%20final.pdf. Accessed May 9, 2017.
• Centers for Disease Control and Prevention. Antibiotic resistant threats in the United States, 2013. Available from: https://www.cdc.gov/drugresistance/threat-report-2013/. Accessed May 9, 2017.
• World Health Organization. Global priority list of antibiotic-resistant bacteria to guide research, discovery, and development of new antibiotics. Available from: http://www.who.int/medicines/publications/WHO-PPL-Short_Summary_25Feb-ET_NM_WHO.pdf. Accessed May 9, 2017
QUESTIONS???