October 18, 2016
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New regulatory requirements for implementation of antimicrobial stewardship — barrier or opportunity?

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Kimberly D. Boeser

Antimicrobial agents are a precious resource that need to be protected and used wisely to conserve their effectiveness. The overuse and misuse of antimicrobial agents have created the current antibiotic resistance crisis and could lead to what many experts suggest will be a post-antibiotic era. Antimicrobial stewardship has become the cornerstone for oversight of appropriate antimicrobial use.

Antimicrobial stewardship programs (ASPs) have been present in the acute care hospital setting for more than a decade. The first guidelines were published in January 2007, and since then, strong evidence has validated that ASPs optimize the treatment of infections and reduce adverse events associated with antibiotic use. They contribute to improved quality of care, patient safety, and can provide cost-saving opportunities. ASPs can be effectively implemented in various hospitals, including critical access hospitals, community-based hospitals and large, academic medical centers. However, implementation and sustainability of ASPs do have barriers.

The most significant obstacles include the allocation of resources such as training, knowledge and education of antibiotic stewardship principles and gaps in information technology (IT) systems that do not allow for easy tracking and monitoring of antibiotic use, resistance trends and outcomes. Now, the impending regulatory requirements from CMS and The Joint Commission emphasize the need to overcome these barriers. These requirements can be perceived as an obstacle to many organizations but could also be viewed as an opportunity to evaluate their needs and justify expansion of current ASPs or the development of new ones.

In 2014, the CDC conducted a survey of more than 4,000 U.S. hospitals through the National Healthcare Safety Network (NHSN). Results indicated that only 39.2% met all seven of the CDC’s core elements for antimicrobial stewardship, which include leadership commitment, accountability, drug expertise, action, tracking, reporting, and education. The Joint Commission followed suit, releasing new antimicrobial stewardship standards under Medication Management (MM.09.01.01), effective Jan. 1, 2017. These requirements are a direct reflection of the core elements and include eight standards that must be met by hospitals and critical access hospitals. Additionally, CMS includes antimicrobial stewardship in its infection control survey (Section 1.C). The President’s Council of Advisors on Science and Technology recommends these requirements be in place by the end of 2017. The goal is for 100% compliance from all hospitals and critical access hospitals by 2020.

A multidisciplinary approach that includes an ASP champion (co-leadership with a physician and pharmacist), infection prevention, informatics and microbiology is the ideal state for an ASP. This structure has proven difficult for many organizations lacking the resources to cover all of these specialties. A policy statement in 2012 suggested “antimicrobial stewardship must be a fiduciary responsibility for all health care institutions across the continuum of care.”

Core elements 1, 2 and 3 support the need for these designated resources. Core element 1 specifies that a letter of commitment be signed by executive leadership designating human, financial and IT resources. Core element 3 specifies a team structure comprising pharmacists, ID physicians, infection preventionists and a clinical microbiologist. To meet this condition, health professionals should be trained in antimicrobial stewardship. The Joint Commission standards 4, 5 and 6 echo these CDC core elements. Training pharmacists through postgraduate year 2 (PGY2) ID residencies is one mechanism to meet the aforementioned need. Eighty PGY2 ID pharmacy residency programs are accredited through the American Society of Health-System Pharmacists; however, the majority of these programs only have one position available annually. This will not be sufficient to meet the need for more pharmacy experts to lead or practice antimicrobial stewardship. This problem also creates a barrier for many smaller hospitals and critical access hospitals that do not have ID physicians on site or pharmacists who are trained in ID or stewardship. A review by Rohde and colleagues describes that hospitalists are a good resource, and given their combined “focus on quality improvement and patient safety,” they have the potential to fill essential roles in ASPs. The Society of Infectious Diseases Pharmacists offers an opportunity for those pharmacists not formally trained in ID to complete an “intensive practice-based activity ... in the area of appropriate use of antimicrobial agents.”

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Awareness of, collaboration for and commitment to antimicrobial stewardship principles by the health care industry has often slowed or halted forward momentum of ASPs. Education and raising awareness of antibiotic resistance and antimicrobial stewardship in the community setting and health care are essential to the success of ASPs. However, Ackerman and colleagues wrote that education alone cannot significantly impact change. They summarized that education of patients and physicians targeting the misuse of antibiotic prescribing for acute viral respiratory tract infections, including acute bronchitis, demonstrated limited improvement “on average, to less than 20% absolute reduction across the study populations of physicians.” Nevertheless, they suggested that with more training in effective communication skills, point-of-care testing and more rapid diagnostic testing, the multilevel approach of education is beneficial. Core element 7 focuses on the component of education. The Joint Commission standard 2 requires education of staff and independent practitioners involved in antimicrobial ordering, dispensing, administration, and monitoring of antimicrobial resistance and antimicrobial stewardship practices. This education should be conducted upon initial hiring and periodically thereafter. The Joint Commission standard 3 focuses on educating patients and their families as needed regarding the appropriate use of antimicrobial medications, including antibiotics. In should also be recognized that the CDC’s core element 3 — drug expertise — would require mechanisms and opportunities to advance the education and training of ID pharmacists and physicians.

The most significant barrier to the success of an ASP is the ability to collect and analyze data on the outcomes of a program, to track and report antibiotic use and antibiotic resistance trends, and benchmark with other organizations. IT infrastructure and available resources are limited, and can be cost-prohibitive for organizations. One of the national goals is antibiotic use and antibiotic resistance reporting through the NHSN Antibiotic Use and Resistance (AUR) Module. The goal of this module, according to the CDC, is to provide “a mechanism for facilities to report and analyze antimicrobial use and/or resistance as part of local or regional efforts to reduce antimicrobial-resistant infections through antimicrobial stewardship efforts or interruption of transmission of resistant pathogens at their facility.” The national goal is to have 95% of eligible hospitals reporting antibiotic use data to NHSN AUR by 2020. This is an aggressive goal and organizations will need to ensure that their IT infrastructure has this capability of reporting. Core elements 4 (action), 5 (tracking) and 6 (reporting) encompass this objective. The tracking and reporting of antibiotic use and resistance can further be broken down into internal/organizational reporting to the executive teams and doctors, nurses and relevant staff, but also national reporting.

The question to consider when evaluating if the new, impending regulatory requirements represent a barrier or opportunity is, “Are you a glass half-full or half-empty person?” The glass half-full individual would see this as an opportunity to move antimicrobial stewardship principles and practice forward. Now would be the time to build a case for the expansion or implementation of an ASP. The glass half-empty perception may make one continue to feel overwhelmed with the work ahead, and progress could be stalled. Many of us who have worked our whole careers building and sustaining stewardship programs feel we have a somewhat daunting task ahead of us. However, the recognition and call for stewardship at the national and even international level is a tremendous advancement. We need to seize the opportunity to overcome these barriers and turn them into steppingstones. Ultimately, the ones who will benefit the most are our patients and our communities.

Disclosure: Boeser reports no relevant financial disclosures.