Infection Prevention, Control, and Regulations in the Long ... · Antibiotic-Resistant acteria,”...

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???