Background C. difficile is a contagious bacterium that can cause diarrhea, fever, colitis (an inflammation of the colon), toxic megacolon (a dilated colon that may be accompanied by septic shock), and, in some cases, death. The C. difficile bacterium colonizes in the large intestine. In infected patients, toxins produced by the organism cause CDI symptoms, primarily diarrhea and colitis. The most common risk factors for CDI are antimicrobial use, advanced age, hospitalization, and a weakened immune system . C. difficile is transmitted through the fecal-oral route and acquisition is most frequently attributed to the healthcare setting. Complications are common in patients age 65 and older and an estimated 1 in 11 patients 65 and older with healthcare-associated CDI dies within 30 days of CDI diagnosis. 44 Patients with a healthy immune response to the organism can be carriers of C. difficile (and contagious) but asymptomatic. These patients are considered “colonized” and are at higher risk of developing CDI. Research on CDI prevention practices has evolved and expanded over the last decade. The research summarized in this section reviews not only new knowledge, but also new technologies and policies now in widespread use. For example, electronic health records (EHRs) are valuable for antimicrobial stewardship efforts and CDI surveillance. Research on no-touch decontamination technology has grown in the last 10 years, as has understanding of CDI transmission pathways. Testing methods have also evolved, with Food and Drug Administration (FDA) approval of nucleic acid amplification tests (NAATs) in 2009. There are increased mandates for surveillance of CDI and the standard interim CDI case definitions that the CDC published in 2007 have been revised in recent years. Facilities have implemented new automated surveillance systems, and CDI data collection at the national level is now standardized, with the advent of the National Healthcare Safety Network’s (NHSN’s) LabID Event reporting in 2013. Potential for harm CDI is among the most common HAIs, representing roughly 12 percent of all HAIs. 45 Approximately half a million incident clinical infections occur (with more than 100,000 in U.S. nursing homes) per year in the United States, with around 30,000 deaths per year as a result of the pathogen. The financial cost of CDI is also high; in recent years, CDI has resulted in about $5 billion a year in healthcare costs. Costs attributable to primary and recurrent CDI are $24,205 and $10,580 per case, respectively. 46 CDI colonization is also a concern, and around 10 percent of admitted hospital patients were colonized with C. difficile. CDI incidence nearly tripled in the first decade of the 21 st century, and data from 2010 to 2016 showed CDI rates plateauing. However, after falling short of 2013 reduction goals, the Department of Health and Human Services set a target reduction of 30 percent in hospital-onset CDI from 2015 to 2020. Healthcare-associated CDI has been
decreasing slightly, while community-associated (CA) CDI is stable or increasing slightly; according to CDC estimates, in 2015, almost half of CDI cases were CA. The clinical severity of the infection has also evolved. Increasingly virulent strains were a concern roughly 10 years ago. However, a 10- year study of a sample of inpatient data found CDI-related mortality rates declined from 2005 to 2014. 47 Other CDI incidence outcomes, including rates of recurrent CDI, have increased. It is notable that healthcare-associated CDI incidence trends differ based on setting, with a greater decline seen in nursing homes versus hospitals and other healthcare facilities. Reimbursement policies have increasingly mandated and reinforced the reduction of CDI. CDI LabID Event reporting began in January 2013 for all acute care hospitals facility-wide using the NHSN. The Centers for Medicare & Medicaid Services (CMS) Inpatient Quality Reporting program’s CDI reporting requirements became mandatory as of January 1, 2013. Since 2017, CDI rates are among the hospital- acquired complications CMS uses to penalize the lowest performing hospitals. Many States also now mandate CDI data submission by hospitals to NHSN as part of State HAI public reporting programs. In the future, participation in surveillance reporting will increase and include a broader spectrum of settings. For example, data from a larger group of LTCFs will be used to establish national benchmarks and track achievement of prevention goals. Antimicrobial stewardship This section will briefly review the foundational elements of antimicrobial stewardship programs (ASPs) as recommended by the CDC and how antimicrobial stewardship is believed to work as a safety practice for preventing CDI. It will examine the evidence for the estimated effect of ASPs on CDI incidence rates and then provide a summary of common ASP components. ASPs are intended to limit and optimize antimicrobial prescribing, reduce the evolution of antibiotic-resistant bacteria, and improve patient outcomes. To meet these goals, the CDC provides a basic framework of recommendations for hospital settings, summarized here: 48 • 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 at least one recommended action, such as systemic evaluation of ongoing treatment needs after a set period of initial treatment (e.g., “antibiotic time out” after 48 hours).
• Tracking: Monitoring antibiotic prescribing and resistance patterns. • Reporting: Regularly reporting information on antibiotic use and resistance to doctors, nurses, and relevant staff. • Education: Educating clinicians about resistance and optimal prescribing. These elements are foundational and meant to complement additional ASP guidelines. The CDC notes that no template exists for an ASP, and ASPs can be effective in a variety of settings and under a diverseset of conditions. While the ASPs studied in the papers selected for this report included these foundational elements to varying degrees, they take many different forms based primarily on a particular facility’s resources and needs. Frequently, the ASPs are developed and executed by a multidisciplinary team with medical, pharmaceutical, and/or microbiological expertise. ASPs require tracking and reporting of data (at minimum quantifying antimicrobial use and CDI rates), as well as staff education and outreach. The “Action” element is operationalized through different strategies, the most common of which are patient case reviews, audits of antimicrobial use, restrictions on high-risk antimicrobials, and provider education. The Infectious Diseases Society of America and Society for Healthcare Epidemiology of America (IDSA/SHEA) guidelines recommend minimizing the frequency and duration of high- risk antimicrobials and using local epidemiology to determine which antimicrobials to address in an ASP. The guidelines further state that ASPs should consider reducing/restricting the use of drugs including fluoroquinolones, clindamycin, and cephalosporins. Antimicrobial stewardship as a PSP Antimicrobial exposure is widely considered one of the most significant and modifiable risk factors for CDI. In the last two decades, at the population level, increasing rates of CDI have been linked to increases in antimicrobial prescribing, particularly in older patients. 49 Patients receiving, or having recently received, antimicrobial therapy are more susceptible to colonization or infection with pathogenic bacteria such as C. difficile because antimicrobials alter gastrointestinal tract flora, destroying the bacteria that help to protect against C. difficile . The length and type of regimen also impacts CDI risk. Several broad-spectrum antimicrobials have been most strongly linked to CDI, and certain outbreaks appear to be associated with heavy prescribing of particular antimicrobials. Therefore, many CDI ASPs are designed to reduce the use of particular “high- risk” antimicrobials. The CDC found that people receiving high-risk antimicrobials had a three times higher risk of CDI than did people with low-risk or no antibiotic use. 50 There is increasing urgency about reducing overreliance on antimicrobials). The CDC estimates that between 30 and 50 percent of antimicrobial prescriptions are clinically inappropriate. 51
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