Antimicrobial Stewardship in Hospitals to Become National Requirement
The Centers for Medicare and Medicaid Services (CMS) and the Joint Commission recently took actions to push the nation's hospitals into being stewards—not just users—of the antimicrobial armamentarium.
On June 16, CMS proposed requiring hospitals and critical access hospitals to have "antibiotic stewardship" programs with certain features.
Five days later, the Joint Commission issued a prepublication version of the accreditation organization's new antimicrobial stewardship standard and announced it goes into effect on January 1.
Proposed Condition of Participation
CMS stated that its goal in adding antimicrobial stewardship programs (ASPs) to the regulation on infection control is for hospitals, including critical access hospitals, to improve their antimicrobial prescribing practices and "curb" patients' risk of possibly deadly antimicrobial-resistant infections.
The agency has been expected for nearly two years to propose making ASPs a condition of participation in the Medicare and Medicaid programs.
In September 2014, President Obama issued an executive order instructing the Department of Health and Human Services, which oversees CMS, to propose a requirement for "robust" ASPs by the end of calendar year 2016.
The CMS proposal would require every hospital to appoint one qualified person, on the basis of recommendations by pharmacy and medical staff leaderships, to lead the facility's ASP.
The leader would be responsible for
- Development and implementation of the hospitalwide ASP, based on nationally recognized guidelines, to monitor and improve the use of antimicrobials,
- Documentation of the program's activities,
- Communication and collaboration on antimicrobial-use issues, and
- Competency-based training and education on the practical applications of antimicrobial stewardship guidelines, policies, and procedures.
Further, the program must
- Show coordination among all the hospital's staffs, services, and programs responsible for antimicrobial use and resistance,
- Document the evidence-based use of antimicrobials throughout the hospital,
- Demonstrate improvements in proper antimicrobial use by all departments and services of the hospital,
- Adhere to nationally recognized guidelines and best practices for improving antimicrobial use, and
- Reflect the scope and complexity of the hospital's services.
To establish and maintain an ASP with these attributes, CMS estimated, an "average-size" hospital of about 124 beds would need the services of 0.25 pharmacist full-time equivalent (FTE), 0.1 physician FTE, and 0.05 network data analyst FTE.
Results of ASHP surveys of hospital pharmacy directors in 2015 and 2013 indicate that pharmacists' primary role in ASPs continues to be leadership and accountability; in hospitals with fewer than 50 staffed beds, however, pharmacists' primary role is clinical support as of the 2015 survey.
The CMS proposal is available online (www.gpo.gov/fdsys/pkg/FR-2016-06-16/pdf/2016-13925.pdf). Comments are due to the agency by August 15.
Medication Management (MM) Standard
MM.09.01.01, the Joint Commission's antimicrobial stewardship standard for hospitals, critical access hospitals, and nursing care centers, was officially published in the July issue of The Joint Commission Perspectives newsletter.
This standard has eight elements of performance. One element requires accredited healthcare organizations to have an "antimicrobial stewardship multidisciplinary team" and, when available in the healthcare setting, at least one pharmacist on that team.
Margaret VanAmringe, executive vice president of the Joint Commission's public policy and government relations unit, said the new standard was created to ensure that healthcare organizations have an "identifiable" ASP.
The effort started in 2012, she said, with the work of the National Summit on Overuse, organized by the Joint Commission and the American Medical Association–convened Physician Consortium for Performance Improvement. Physicians' prescribing of antibiotics for viral upper respiratory tract infections (URIs) in pediatric patients had been identified as one of the concerns to address at the summit. The work group, which included ASHP representative Marc Scheetz, an infectious diseases pharmacist at Northwestern Memorial Hospital in Chicago, issued the following recommendation: "Start an antibiotic stewardship program to provide a structured mechanism for organizations to address antibiotic prescribing for URIs."
Over time, the issue of antimicrobial resistance gained attention and urgency, VanAmringe said. So the Joint Commission decided to create a standard that would prompt healthcare organizations to consider the appropriate use of antibiotics and other antimicrobials.
The fact that Joint Commission–accredited organizations already have to meet 15 standards that "relate to" an ASP "doesn't mean you have identified accountability, resources, [and] the right competencies for stewardship," she said. "That's different."
In addition to having a multidisciplinary antimicrobial stewardship team with certain professionals as members, the new standard requires accredited organizations to
- Show leadership commitment to the ASP,
- Educate staff members and licensed independent practitioners,
- Educate patients and, as needed, their families,
- Ensure that the program includes the Centers for Disease Control and Prevention's (CDC's) seven core elements of ASPs—leadership commitment, accountability, drug expertise, action, tracking, reporting, and education—in hospitals or nursing homes,
- Use organization-approved multidisciplinary protocols in the program,
- Collect, analyze, and report data on the program, and
- Act on the opportunities for improvement identified through the program.
VanAmringe said the Joint Commission discussed its plan for an antimicrobial stewardship standard with CMS to ensure that the accreditation organization headed in a direction compatible with the agency's path.
The new standard, said Bona Benjamin, ASHP director of medication-use quality improvement, reinforces the "ASHP Statement on the Pharmacist's Role in Antimicrobial Stewardship and Infection Prevention and Control," approved in 2009.
A recently published commentary, "The Essential Role of Pharmacists in Antimicrobial Stewardship," emphasizes the need for ASPs to have pharmacists with training in that type of work. The article was written on behalf of ASHP and the Society of Infectious Diseases Pharmacists and published in the July issue of the journal Infection Control and Hospital Epidemiology. Deborah Pasko, ASHP director of medication safety and quality, said the article describes the training and competencies that pharmacists need to provide antimicrobial stewardship and the alternatives to residency training in infectious diseases.
CDC, when it issued the core elements of ASPs in 2014, recognized pharmacists' essential role, Benjamin said.
One of the core elements is drug expertise. To have that expertise in a hospital-run program, according to CDC, the hospital must identify "a single pharmacy leader who will co-lead the program."
CMS stated that it wants to give hospitals flexibility in how they implement their ASPs.
The agency named several sources, including the Antimicrobial Stewardship Resources section of ASHP's website, for guidance on best practices for implementing ASPs.
A recent addition to the resource center is the guidance document Antibiotic Stewardship in Acute Care: A Practical Playbook.
The Playbook is a product of the National Quality Forum's National Quality Partners Antibiotic Stewardship Action Team, on which Pasko served.
The publication provides a brief rationale and overview of each of CDC's core elements of ASPs, examples for implementation, potential barriers, suggested solutions, and suggested tools and resources.
Members of ASHP's Antimicrobial Resistance Task Force provided some of the information that appears in the Playbook document, Pasko said.
Pasko said recordings of webinars featuring ASHP members discussing their ASPs will be added to the resource center.
ASHP is also developing standardized metrics for pharmacy ASPs, she said.
Such metrics are needed to demonstrate compliance and progress to surveyors from the Joint Commission and the state health agencies visiting on CMS's behalf, Pasko said. "It’s not just a matter of them coming in your hospital anymore and then [saying] 'Thank you; well, show us information that you have around antimicrobial stewardship.'"
She said the surveyors want to see data on the ASP and evidence that it is improving antimicrobial use in the hospital.
Although the Joint Commission's standard seems to emphasize education—it's the subject of two of the eight elements of performance—Benjamin cautioned against pursuing education of healthcare providers, patients, and families to the detriment of continuous drug expertise.
She said studies have shown that education alone does not lead to an increase in appropriate antimicrobial use in hospitals.
[This news story appears in the Aug. 1, 2016, issue of AJHP.]