Establishing an Antimicrobial Stewardship Program

THE CENTERS FOR Disease Control and Prevention (CDC) estimates more than two million patients in the U.S. become infected and 23,000 die from drug-resistant infectious organisms each year.¹ The overuse and misuse of antimicrobials, a contributing factor to multidrug resistant organisms (MDROs), is one of the most pressing concerns challenging the healthcare industry today. As infectious organisms adapt to the very drugs designed to kill them, antibiotics and antimicrobials are rendered ineffective and a vulnerable population is at greater risk. Beyond the potential for serious side effects and adverse reactions that could occur with any drug, patients who become infected with MDROs require longer and more expensive hospital stays and risk long-term consequences and even death.

It is estimated between 20 percent to 50 percent of antibiotics prescribed in U.S. acute care hospitals are either unnecessary or used inappropriately.¹ Therefore, to gain a foothold on MDROs, numerous programs have been launched, including a partnership between the U.S. and European Union (EU) that outlines the urgency, need for collaboration and steps for antimicrobial oversight. The role of antimicrobial stewardship programs (ASPs) (coordinated programs that educate and improve prescription practices of antibiotics and antimicrobials to optimize clinical outcomes) affects the entire healthcare spectrum, from physicians to pharmacists, nursing staff and patients, and ASPs encompass specific and actionable steps to reduce risk and identify areas of improvement.

Since MDRO and antimicrobial misuse was first identified, multiple international stakeholders joined to combat the problem. In the 13 years since CDC published its 2006 guideline “Management of Multi-Drug Resistant Organisms in Healthcare Settings,” its resources have been enhanced by the National Strategy on Combating Antibiotic Resistant Bacteria through Executive Order 13676 signed in 2014 by President Obama and the March 2015 National Action Plan for Combating Antibiotic-Resistant Bacteria, as well as position papers and additional action plans by organizations such as the Association for Professionals in Infectious Control and Epidemiology (APIC), the American Pharmacy Association (APhA) and Pew Charitable Trust, not to mention the Transatlantic Task Force on Antimicrobial Resistance joint declaration formed between the EU and the U.S. This international collaboration highlights the global urgency since a 2014 report commissioned by the Wellcome Trust and United Kingdom Prime Minister suggested that, without intervention, 10 million lives could be lost by the year 2050.²

The ease and frequency of global mobility means easier transmission of newly emerging infectious diseases, including new drug-resistant bacteria, says Sarah M. Bishop, MSN, APRN, CCNS, CIC, director of infection prevention and control at the University of Louisville Hospital and a member of APIC’s Communications Committee: “A new disease can be transmitted from one side of the globe to your hospital doorstep in just one plane ride. The ever-present threat of global disease transmission translates into a need for healthcare facilities to be vigilant about screening and identification of newly emerging antibiotic-resistant bacteria based on travel history, exposure to healthcare in other countries and contact with others who may be in those risk categories. Healthcare facilities should collaborate with their infection preventionists (IPs) to design effective screening methods and develop communication tools to share information on current global disease threats.”

Closer to home, state, local and other federal agencies, as well as healthcare collaboratives, help in facilitating programs and tracking progress. Together, these resources demonstrate the immense challenge of gaining a foothold and how critical it is to do so.

The Challenge

While antibiotics have transformed healthcare, over time that transformation has come at a cost. Half of all hospital patients receive antibiotics that are most commonly prescribed for lung infections (22 percent), urinary tract infections (UTI) (14 percent) and suspected methicillin-resistant Staphylococcus aureus (MRSA) infections (17 percent). By one account, a third of antibiotics prescribed in hospitals for UTIs include a potential error. And, there are other concerns such as patients receiving powerful broad-range antibiotics are up to three times more likely to become infected with another even more drug-resistant germ. It is estimated a reduction in high-risk antibiotic prescriptions by 30 percent can lower deadly diarrheal infections by 26 percent.³ Clostridium difficile infections (CDIs), a potentially deadly outcome of antibiotic use, are a high priority since they affect more than 500,000 patients each year and cause more than 15,000 deaths in the U.S. alone.⁴

The danger is especially pronounced for patients who are immunocompromised because their reduced ability to fight infections makes them at even greater risk of complications and death associated with drug-resistant infections.

The complexity of healthcare decisions, particularly if starting antibiotic treatment prior to diagnostic testing, can be a daunting life-or-death situation. Providers may feel pressure to prescribe antibiotics from patients who do not understand the requirements of their care or the implications of inappropriate antibiotic use. Providers themselves may use outdated practices or misunderstood information about antibacterial recommendations. Even staffing shortfalls may put undue pressure on facilities of all sizes to meet a growing demand for patient care.

However, there is evidence ASPs work. Antimicrobial expenditures, which were on the increase by 14.4 percent annually in the years preceding the development of ASPs, decreased by 9.75 percent the year after implementation, and they remain stable, with an overall cost savings of $1.7 million.⁵

Meta-analysis shows ASPs reduce infections and colonization with multidrug-resistant gram-negative bacteria and extendedspectrum β-lactamase-producing gram-negative bacteria, as well as MRSA and CDI infection rates. Patient outcomes are improved, adverse events are lessened and antibiotic-resistant organisms are reduced. Equally important, ASPs used in conjunction with other infection prevention control methods such as hand hygiene are even more effective than ASPs alone.²

“Everything plays together,” says Michael Klepser, PharmD, FCCP, at the Ferris State University College of Pharmacy and APhA spokesperson. “Stewardship is not just about cost-containment. It really does optimize therapy and patient outcomes.”

Changing prescribing practices and the culture of care can be hard, but both are critical to reducing dependence on antimicrobials, the emergence of new MDROs, as well as ensuring patients are best cared for in the immediate and long-term by preventing infections.

The Core Elements of an ASP

With multiple stakeholders invested, there are numerous resources to complement the CDC’s Core Elements of Hospital Antibiotic Stewardship Program for hospitals, long-term care and outpatient facilities. Core elements include:

• With key buy-in and proactive leadership, IPs, physicians, nurses, pharmacy leaders, laboratory staff and all parties with roles to play in infection prevention and control will be well-equipped to understand, promote and implement ASP best practices. An ideal team, says Klepser, would see both a pharmacist and physician trained in IP in leadership roles with coordination of laboratories, infection control, etc.

• Leadership will create an air of accountability to ensure each party has support necessary to perform critical ASP duties and hold them to a standard of care.

• A commitment to ensuring drug expertise, whether through an in-house pharmacist trained in ASP or outsourced pharmacist via telemedicine, hospital collaboratives or by other methods, is critical to patient care and program success. In support of this effort, documentation of dose, duration and indication for all antibiotics must be captured.

• All parties must take action for ASP to be a success. Nurses are a fantastic frontline resource working with IPs and physicians in initiating pre-antibiotic cultures, antimicrobial reviews and antibiotic reconciliation between care transitions.

• Surveillance tracking of antibiotic use and infection trends either by the CDC National Healthcare Safety Network (NHSN) Antimicrobial Use and Resistance module or some other means will help to ensure efforts are applied consistently, as well as to identify any prescribing trends and to assess the effectiveness of ASP implementation. “There are different things you can look at,” says Klepser. “Depending on the institution, you may look at CDI infections, decreased length of hospital stays or antibiotic reduction.” No matter which parameter or combination is chosen, says Klepser, “it is all about improving patient outcomes.”

• The reporting of timely, nonpunitive data and trends to providers, facilities and board of directors provides important information on antibiotic use, rates of CDI infections and, in the event of MDRO identification, how it is contained.

• Finally, ensuring education about ASPs is continual, frequent and specific to each job function concerning how the overall program ties together is imperative to foster a supportive team environment. “There are certificate programs,” says Klepser. Widely known for pharmacists is the Society of Infectious Disease Pharmacists antimicrobial stewardship certificates for both longterm and acute care.

Supplemental Support

Beyond the CDC’s core elements, APIC, the Society for Healthcare Epidemiology of America and the Society of Infectious Disease Pharmacists recommend additional elements of a timely diagnosis by a microbiological laboratory that can provide clear-cut information as to whether the patient is infected, what the pathogen is and the susceptibility of the organism, and that can translate the results into day-to-day infection management.

In many cases, the source of the outbreak can be tracked in just a few days. And, because diagnostics are improving rapidly and infections can morph quickly, it is important results are interpreted by a clinical microbiologist who can further advise what they mean.²

It is common practice for patients to be started on antibiotics while the results of diagnostic tests are pending. However, what should also be common practice is revisiting the use of that antibiotic once results are in, which does not always happen. Within 48 hours of initiating antibiotics, physicians should consider whether diagnostic tests confirm the patient has an infection that can be treated with antibiotics and, if so, whether the antibiotic currently prescribed is the right one administered by the safest route.

Without question, smaller and more rural health clinics may find staffing challenges complicate their ability to create an ASP. However, these facilities are not alone, and they are encouraged to reach out to their state hospital associations, state and local health agencies and even telemedicine options to identify already existing ASPs with which they can collaborate.

Tracking Progress

Comparative data is a critical component to assess the execution and success of an ASP. Although it is difficult to attribute specific individual modifications to multifactorial antibiotic-resistant infections, an accounting of how antibiotics are used and the rate of which and where MDROs are identified can help facilities and the larger community understand progression and progress. “It is important to have measurable goals, accurate performance data and an effective method to provide feedback to frontline clinicians on how their prescribing practices align with overall stewardship goals,” says Bishop.²

Facilities should track both their compliance with set ASP protocols, as well as evidence of their effects. Laboratory reports are key to this effort, and those facilities that use offsite services are encouraged to include stewardship efforts in their contracts. Once data is collected, IPs and hospital epidemiologists can audit and analyze data.

Whether using a facility-specific tracker or one linked to a larger metadata registry, it is important the data collected and analyzed are of value to the facility and its staff. Days of therapy (DOT), rather than antibiotic expenditures, is considered to be most valuable for stewardship efforts. It should be noted antibiotic expenditures are an ineffective way of tracking stewardship efforts since they do not always correlate to antibiotic use. The CDC’s NHSN includes an antibiotic use option whereby systems can be configured to include electronic medication administration records, and barcoding medication records can be reported using an HL7-standardized clinical document architecture. NHSN will automatically collect and report monthly DOT data, which can be analyzed in aggregate or by specific agents and facility locations. As more facilities come online, CDC will begin providing risk-adjusted facility benchmarks for antibiotic use.¹

Once data is collected and analyzed, the collective healthcare team can begin to see trends in treatment recommendations, administration information, diagnostics and patient progress. The distilling of data is where the team approach of stewardship can be most telling. For example, are antibiotics being commonly prescribed and/or misprescribed for certain conditions? Once diagnostic test results are in, is the treatment reevaluated? Should antibiotic time-outs be implemented, and if they are, are they adhered to? How often are unnecessary and duplicate therapies being prescribed? How can inpatient facilities work with outpatient facilities to coordinate patient care?

Compliance

As healthcare organizations and governments hone their focus on the challenge of antibiotic resistance and implementation of ASPs, compliance requirement considerations are already in development. For example, since 2016, the Centers for Medicare and Medicaid Services (CMS) has required long-term care facilities to update their infection prevention programs, including the appointment of a designated person in charge of them. Requirements have since been expanded to include ASP protocols and monitoring of antibiotic use. CMS has also proposed an infection control conditions-of-participation rule that requires ASPs in all acute care and critical access hospitals, approval of which is pending. And, in 2017, the Joint Commission Antimicrobial Stewardship Standard began requiring hospitals, critical access hospitals and nursing facilities to implement ASPs and form multidisciplinary teams, which include IPs, to oversee them.

The success of ASP will ultimately depend on leadership commitment, its trickle-down effect and the execution of sound collaboration and the distillation of data at the patient level.