Ashley Marx, PharmD, BCPS

Recently released action plans detail procedures to combat antimicrobial resistance.

US health systems are taking stock of opportunities to adopt and enhance antimicrobial stewardship programs following a recent executive order from President Obama,

 from which came the 5-year National Action Plan for Combating Antibiotic-Resistant Bacteria.

 The order directed the secretary of Health and Human Services to propose regulations by the end of 2016 requiring US inpatient facilities to “implement robust antibiotic stewardship programs that adhere to best practices.” The President’s Council of Advisors on Science and Technology recommended that antimicrobial stewardship programs should be mandated as a Condition of Participation (CoP) for the Centers for Medicare & Medicaid Services (CMS) for inpatient and long-term care facilities by the end of 2017.

The release of the action plan in March 2015 coincided with the release of the World Health Organization’s draft global action plan on antimicrobial resistance.

 The aim of these actions is to preserve the activity of antimicrobial therapies for all people to ensure successful treatment and prevention of infectious diseases. Both policies cite a “one-health” approach, which is quickly becoming a new buzzword in public health circles and seeks to link human and veterinary medicine with bacteriology and the environment. The term “one-health” recognizes (1) that antibacterial therapy in an individual human or animal affects the community (locally and globally) due to the frequent transmission of resistance factors among bacterial species and (2) that negative consequences of antimicrobial resistance affect patients and their families, agriculture, pharmaceutical companies, and economies. Other key components of these action plans include increasing surveillance efforts to track and study antimicrobial usage and resistance, limiting the use of antimicrobials in agriculture, and promoting research and development of both new antimicrobials and rapid diagnostics for infectious diseases.

California is the only state that has mandated antimicrobial stewardship programs in acute-care hospitals. Its law previously required acute care facilities to evaluate the judicious use of antimicrobials. As of July 1, 2015, however, stewardship programs must also (1) follow professional and society guidelines, (2) establish a physician- led multidisciplinary committee or work group for antimicrobial stewardship, (3) have 1 physician or pharmacist on the committee who is knowledgeable about antimicrobial stewardship, and (4) report program activities to the hospital committee undertaking quality improvement activities.

 This additional legislation seeks to better define antimicrobial stewardship and elevate the quality and consistency of stewardship activities in acute care hospitals. It is too early to assess outcomes of the California Antimicrobial Stewardship Initiative, but collaboration among hospitals of all sizes, focused educational sessions, and creation of a statewide antibiogram will likely yield continuing benefits to the state.

What might a nationally mandated antimicrobial stewardship program look like? The best insight may be provided by results from this year’s version of the CMS infection control survey, which is performed to determine whether CoP standards are met. Several questions about antimicrobial stewardship practice at the facilities surveyed were added for information-gathering purposes only (with no resulting penalty or citation). The survey elements include hospital policies and procedures dedicated to improving antimicrobial use in the facility, a designated leader (physician or pharmacist) who is accountable for stewardship program outcomes, and programs to monitor antimicrobial use within the facility.

In addition, the survey aims to document progress on major tenets of the Centers for Disease Control and Prevention (CDC) Get Smart for Healthcare campaign; requires prescribers to specify the indication, dose, and duration of antibiotic orders; and provides a mechanism for an “antibiotic time-out,” whereby all providers can review the appropriateness of antimicrobial therapy after 48 hours of therapy.

 Based on the history of CMS informational survey elements later becoming requirements, it is likely that these will form the future process measures for antimicrobial stewardship in inpatient facilities. Bottom line: antimicrobial stewardship is coming to your health system, if it isn’t already there.

What can pharmacists and health systems do now to prepare for nationally mandated antimicrobial stewardship? For acute-care pharmacists, this is a clear call for leadership in antimicrobial stewardship efforts. Pharmacists can expect this to be a continuing area of job growth over the next decade, with more positions dedicated to developing and managing antimicrobial stewardship efforts and informatics, as well as greater emphasis placed on stewardship activities for all inpatient pharmacists. For those who are interested in participating in or leading antimicrobial stewardship efforts, 2 certificate training programs are available (see Sidebar), as are traditional postgraduate year 2 (PGY2) training programs in infectious diseases. American Society of Health- System Pharmacists—accredited PGY2 infectious diseases residents achieve specific goals related to antimicrobial stewardship.

Pharmacists who currently work in facilities with active antimicrobial stewardship programs should seek opportunities to enhance their education on infectious diseases and antimicrobials in collaboration with stewardship program personnel. Pharmacists can also increase the effectiveness of the stewardship program by coordinating multidisciplinary education efforts in their service areas. This helps the pharmacist become more confident and skillful in teaching about antimicrobials.

Pharmacists who are working in acute care environments without active antimicrobial stewardship programs should educate themselves about the benefits of antimicrobial stewardship and start a dialogue with their leadership to promote creation of a multidiscipline committee. Excellent resources and toolkits are available from the CDC; these include slide sets, sample business plans, and recommendations for discussing stewardship activities with hospital executives.

The most successful initial antimicrobial stewardship activities will use data that are readily available at the site (eg, medication administration records and lists of patients on target drugs), have measurable outcomes (and include a period of baseline data), and target “low-hanging fruit” (easy to achieve, less controversial interventions, such as intravenous to oral interchange or intervention on combinations of antibiotics with redundant spectra of activity). In contrast, choosing to review the most frequently used empirical combinations of drugs as a first initiative will likely take considerable time and may not be well received by clinicians who are not familiar with the personnel and/or intent of the stewardship program.

Pharmacists who are currently active in antimicrobial stewardship should take stock of their programs and highlight opportunities in multidisciplinary quality committees and with hospital administration to expand and enhance activities related to anticipated performance measures. As we transition to a time when all pharmacists may be called upon to participate in stewardship activities in some capacity, it becomes imperative to delineate activities and roles that can be incorporated into pharmacists’ regular work flow; if the work is to be successful, it cannot be relegated to random days when there is time left at the end of a shift. In addition, efforts to make antimicrobial stewardship a core component of professional education and clerkships must be redoubled.

Health systems should begin positioning themselves for success by cultivating necessary pharmacist and information technology resources. Now is the time for strategic investment in personnel with specific stewardship training and experience in informatics that can bring pertinent data to the point of patient care to empower rational antimicrobial use.

As most health systems have converted or are in the process of converting to electronic medical record systems, the next logical step is to build informatics solutions to antimicrobial prescribing problems, such as screens that prompt clinicians to note the indication of therapy and duration when issuing a prescription. Prompting a meaningful evaluation of ongoing treatment, or “antimicrobial time-out,” at 48 hours of therapy, however, will require special care and attention. To appropriately evaluate the need for ongoing antimicrobial therapy, the clinician needs to review the originally prescribed regimen and indication for therapy, relevant laboratory and microbiology data, and clinical status of the patient. Without a thoughtful approach, it is unlikely that the antimicrobial time-out would be successful because it would simply be bypassed by the vast majority of providers.

Global consensus is that antimicrobial resistance is a threat that no sector can ignore or manage on its own. Pharmacists, in collaboration with other health systems professionals, stand to gain tremendously from the advance of antimicrobial stewardship programs in the United States and around the world.

Ashley Marx, PharmD, BCPS, is a clinical pharmacy specialist in infectious diseases at UNC Medical Center and assistant professor of clinical education at UNC Eshelman School of Pharmacy.

		The White House, Office of the Press Secretary. Executive order—combating antibiotic-resistant bacteria. Exec. Order No. 13676, 3 CFR. www.whitehouse.gov/the-press-office/2014/09/18/executive-order-combating-antibiotic-resistant-bacteria. Effective September 18, 2014.

		National action plan for combating antibiotic-resistant bacteria. The White House website. www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf. Published March 2015.

		President’s Council of Advisors on Science and Technology. Report to the President on combating antibiotic resistance. The White House website. http://1.usa.gov/1qhDgF6. Published September 2014.

		Antimicrobial resistance: draft global action plan on antimicrobial resistance. World Health Organization website. http://apps.who.int/gb/ebwha/pdf_files/WHA68/A68_20-en.pdf?ua=1. Published March 27, 2015.

		Cal SB 1311 (2014) (codified at Cal Health and Safety Code 1288.85).

		Hospital infection control worksheet. Centers for Medicare & Medicaid Services website. http://go.cms.gov/1B6NCSV. Published November 26, 2014.

Ashley Marx, PharmD, BCPS

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