Update on Antimicrobial Stewardship Regulations and ... · data on its antimicrobial stewardship...

UPDATE ON ANTIMICROBIAL STEWARDSHIP REGULATIONS AND IMPLEMENTATION OF AN

AMS PROGRAM

Diane Rhee, Pharm.D.

Associate Professor of Pharmacy Practice

Roseman University of Health Sciences

Chair, Valley Health System Antimicrobial Stewardship Committee

OBJECTIVES

• Review Joint Commission Standards for Antimicrobial

Stewardship

• Evaluate CMS proposed rules for Antimicrobial Stewardship

• Assess CDC Antimicrobial Stewardship Criteria for

implementation

ANTIMICROBIAL STEWARDSHIP

• “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.” (IDSA)

https://www.idsociety.org/Stewardship_Policy/

JOINT COMMISSIONPREPUBLICATION STANDARDS: MEDICATION

MANAGEMENT STANDARD (MM.09.01.01)

• Issued June 22, 2016

• Hospitals and Critical Access Hospitals

• Separate for Skilled Nursing Facilities but same requirements

• Will go into effect January 1, 2017

• Standard: The [critical access] hospital has an antimicrobial

stewardship program based on current scientific literature.

• Elements 5-8: must show documentation

https://www.jointcommission.org/assets/1/6/HAP-CAH_Antimicrobial_Prepub.pdf

1. Leaders establish antimicrobial stewardship as an organizational

priority.

2. The [critical access] hospital educates staff and licensed independent

practitioners involved in antimicrobial ordering, dispensing, administration,

and monitoring about antimicrobial resistance and antimicrobial

stewardship practices. Education occurs upon hire or granting of initial

privileges and periodically thereafter, based on organizational need.

3. The [critical access] hospital educates patients, and their families as

needed, regarding the appropriate use of antimicrobial medications,

including antibiotics


4. The [critical access] hospital has an antimicrobial stewardship

multidisciplinary team that includes the following members, when

available in the setting:

• l Infectious disease physician

• l Infection preventionist(s)

• l Pharmacist(s)

• l Practitioner

• Note 1: Part-time or consultant staff are acceptable as members of the

antimicrobial stewardship multidisciplinary team.

• Note 2: Telehealth staff are acceptable as members of the antimicrobial

stewardship multidisciplinary team


• 5. The [critical access] hospital’s antimicrobial stewardship

program includes the following core elements:• Leadership commitment: Dedicating necessary human, financial, and information technology

resources.

• Accountability: Appointing a single leader responsible for program outcomes. Experience with

successful programs shows that a physician leader is effective.

• Drug expertise: Appointing a single pharmacist leader responsible for working to improve

antibiotic use.

• Action: Implementing recommended actions, such as systemic evaluation of ongoing treatment

need, after a set period of initial treatment (for example, “antibiotic time out” after 48 hours).

• Tracking: Monitoring the antimicrobial stewardship program, which may include information on

antibiotic prescribing and resistance patterns.

• Reporting: Regularly reporting information on the antimicrobial stewardship program, which

may include information on antibiotic use and resistance, to doctors, nurses, and relevant staff.

• Education: Educating practitioners, staff, and patients on the antimicrobial program, which may

include information about resistance and optimal prescribing.


6. The [critical access] hospital’s antimicrobial stewardship

program uses organization-approved multidisciplinary protocols

(for example, policies and procedures).

Note: Examples of protocols are as follows:

• Antibiotic Formulary Restrictions

• Assessment of Appropriateness of Antibiotics for Community-Acquired Pneumonia

• Assessment of Appropriateness of Antibiotics for Skin and Soft Tissue Infections

• Assessment of Appropriateness of Antibiotics for Urinary Tract Infections

• Care of the Patient with Clostridium difficile (c.-diff)

• Guidelines for Antimicrobial Use in Adults

• Guidelines for Antimicrobial Use in Pediatrics

• Plan for Parenteral to Oral Antibiotic Conversion

• Preauthorization Requirements for Specific Antimicrobials

• Use of Prophylactic Antibiotics


7. The [critical access] hospital collects, analyzes, and reports

data on its antimicrobial stewardship program.

Note: Examples of topics to collect and analyze data on may include

evaluation of the antimicrobial stewardship program, antimicrobial

prescribing patterns, and antimicrobial resistance patterns

8. The [critical access] hospital takes action on improvement

opportunities identified in its antimicrobial stewardship program.


CMS PROPOSED RULE CHANGES TO CONDITIONS OF PARTICIPATION

• Released June 13, 2016, 60 day comment period

• “We believe that a closer, more streamlined connection between infection prevention and

control and antibiotic stewardship programs with hospitals' QAPI programs will translate

to better quality and healthier patients.”

• Enhance the accountability of hospital leadership for the infection prevention and control

and antibiotic stewardship programs as well as delineate the responsibilities for the

leaders of the infection prevention and control program and the AS program respectively.

• Develop and manage an infection prevention and control program and antimicrobial

stewardship program that “reflects the scope and complexity of the hospital services

provided.”

https://www.federalregister.gov/articles/2016/06/16/2016-13925/medicare-and-medicaid-programs-hospital-and-critical-access-hospital-cah-changes-to-promote#p-98

DESIGNATED LEADER OF ANTIMICROBIAL STEWARDSHIP PROGRAM RESPONSIBILITIES

• Development and implementation of facility-wide program based on nationally-

recognized guidelines

• Monitor and improve the use of antibiotics

• Responsible for all documentation, written or electronic, of stewardship activities

• Communicating and collaborating with medical and nursing staff, pharmacy

leadership, infection control, and QAPI programs on antibiotic use issues

• Competency-based training and education of hospital personnel and staff,

including medical staff, and, as applicable, personnel providing contracted services

at the hospital, on the practical applications of antibiotic stewardship guidelines,

policies and procedures


INFECTION PREVENTIONIST/INFECTION CONTROL PROFESSIONAL RESPONSIBILITIES

• Responsible for development and implementation of hospital-wide infection surveillance,

prevention, and control policies and procedures that adhere to nationally recognized guidelines

• Responsible for all documentation, written or electronic, of prevention and control program,

and its surveillance, prevention, and control activities

• Communicate with QAPI program on all infection prevention and control issues

• Direct role in competency-based training and education of hospital personnel and staff,

including medical staff, and, as applicable, personnel providing contracted services at the

hospital, on the practical applications of infection prevention and control guidelines, policies,

and procedures

• Responsible for preventing and controlling HAIs, including auditing of adherence to infection

prevention and control policies and procedures by hospital personnel

• Communicate and collaborate with antibiotic stewardship program


HOSPITALS HAVE TO:

• Demonstrate coordination among all components of the hospital

responsible for antibiotic use and factors that lead to antimicrobial

resistance, including, but not limited to, the infection prevention and

control program, the QAPI program, the medical staff, nursing services,

and pharmacy services

• Document the evidence-based use of antibiotics in all departments and

services of the hospital

• Demonstrate improvements, including sustained improvements, in

proper antibiotic use, such as through reductions in CDI and antibiotic

resistance in all departments and services of the hospital.


Leadership Support Established at

Facility

Does your facility have a formal or written statement of support from

leadership that supports efforts to improve antibiotic use (antibiotic

stewardship) Yes No

Does your facility receive any budgeted financial support for antibiotic

stewardship activities (i.e. support for salary, training, or IT support) Yes No

Accountability

Is there a physician leader responsible for program outcomes of stewardship

activities at your facility Yes No

Drug Expertise

Is there a pharmacist leader responsible for working to improve antibiotic use

at your facility? Yes No

CDC CORE ELEMENTS TO ANTIMICROBIAL STEWARDSHIP

https://www.cdc.gov/getsmart/healthcare/pdfs/checklist.pdf

Key Support for the Antibiotic Stewardship Program

Does any of the below work with the stewardship leaders to

improve antibiotic use?

Established at

Facility

Clinicians Yes No

Infection Prevention and Healthcare Epidemiology Yes No

Quality Improvement Yes No

Microbiology (Laboratory) Yes No

Information Technology (IT) Yes No

Nursing Yes No



Actions to Support Optimal Antibiotic Use

POLICIES Policy Established

Does your facility have a policy that requires prescribers to document in the

medical record or during order entry a dose, duration, and indication for all

antibiotic prescriptions Yes No

Does your facility have facility-specific treatment recommendations, based on

national guidelines and local susceptibility, to assist with antibiotic selection

for common conditions? Yes No



Specific Interventions to Improve Antibiotic UseAre the following actions to improve antibiotic prescribing conducted in your facility?

Broad Interventions Action Performed

Is there a formal procedure for all clinicians to review appropriateness of all

antibiotics at 48 hours after the initial order (i.e. antibiotic time out)?

Yes No

Do specific antibiotic agents need to be approved by a physician or pharmacist

prior to dispensing (i.e. preauthorization) at your facility?

Yes No

Does a physician or pharmacist review course of therapy for specified

antibiotic agents (i.e. prospective audit with feedback) at your facility?

Yes No



Pharmacist-Driven Interventions Are the following actions implemented at your facility?

Action Performed

Automatic changes from intravenous to oral antibiotic therapy in appropriate

situations?

Yes No

Dose adjustments in cases of organ dysfunction Yes No

Dose optimization (pharmacokinetics/pharmacodynamics) to optimize the

treatment of organisms with reduced susceptibility

Yes No

Automatic alerts in situations where therapy might be unnecessarily

duplicative

Yes No

Time-sensitive automatic stop orders for specified antibiotic prescriptions Yes No



Diagnosis and Infections Specific Interventions Does your facility have specific interventions in place to ensure optimal

use of antibiotics to treat the following common infections?

Action

Performed

Community-acquired pneumonia Yes No

Urinary tract infections Yes No

Skin and soft tissue infections Yes No

Surgical prophylaxis Yes No

Empiric treatment of Methicillin-resistant Staphylococcus aureus (MRSA) Yes No

Non-C. difficile infection (CDI) antibiotics in new cases of CDI Yes No

Culture-proven invasive (i.e. bloodstream) infections Yes No



COMMUNITY-ACQUIRED PNEUMONIA

Jun-16 %

% Followed Algorithm 51

% PCN Allergy 21

Therapy if not CTX + Azith

% Levofloxacin 13

% Moxifloxacin 20

% Doxycycline 6

% Minocycline 8

% Ceftaroline 1

% Other 0

% Prolonged QTc 42

% Alternate Therapy Appropriate 40

% Followed by ID 49

May-16 %

% Followed Algorithm 55

% PCN Allergy 16

Therapy if not CTX + Azith

% Levofloxacin 17

% Moxifloxacin 17

% Doxycycline 2

% Minocycline 6

% Ceftaroline 2

% Other 0

% Prolonged QTc 12

% Alternate Therapy Appropriate 29

% Followed by ID 51

Tracking: Monitoring Antibiotic Prescribing, Use, and Resistance

Process Measures Measure Performed

Does your stewardship program monitor adherence to a documentation

policy (dose, duration, and indication)?

Yes No

Does your stewardship program monitor adherence to facility-specific

treatment recommendations?

Yes No

Does your stewardship program monitor compliance with one or more of

the specific interventions in place?

Yes No



Total # Interventions % Interventions Denied

Tracking: Monitoring Antibiotic Prescribing, Use, and Resistance

Antibiotic Use and Outcome Measures Measure Performed

Does your facility track rates of C. difficile infection? Yes No

Does your facility produce an antibiogram (cumulative antibiotic

susceptibility report)?

Yes No

Does your facility monitor antibiotic use (consumption) at the unit and/or facility-wide level by one of the

following metrics:

By counts of antibiotics administered to patients per day (Days of therapy) Yes No

By number of grams of antibiotic used (Define Daily Dose) Yes No

By direct expenditure for antibiotics (purchasing costs) Yes No



Reporting Information to Staff on Improving Antibiotic Use and Resistance

Does your stewardship program share facility-specific reports on antibiotic use

with prescribers

Yes No

Has a current antibiogram been distributed to prescribers at your facility Yes No

Do prescribers ever receive direct, personalized communication about how they

can improve their antibiotic prescribing?

Yes No

Education

Does your stewardship program provide education to clinicians and other

relevant staff on improving antibiotic prescribing?

Yes No



UPDATE ON ANTIMICROBIAL STEWARDSHIP REGULATIONS AND IMPLEMENTATION OF AN

AMS PROGRAM

Diane Rhee, Pharm.D.

Associate Professor of Pharmacy Practice

Roseman University of Health Sciences

Chair, Valley Health System Antimicrobial Stewardship Committee

Update on Antimicrobial Stewardship Regulations and ... · data on its antimicrobial stewardship...

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