February 01, 2007
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New guidelines assist with antimicrobial stewardship efforts

Providing appropriate antibiotic therapy should be considered a key component of patient safety initiatives.

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In January, the Infectious Diseases Society of America, together with the Society for Healthcare Epidemiology of America, released guidelines on developing institutional programs to enhance antimicrobial stewardship. These new guidelines provide a more established foundation for clinicians who often struggle to justify these efforts to institutional leadership.

Stewardship, defined as “appropriate selection, dosing, route and duration of antimicrobial therapy” is also frequently referred to as antibiotic management. The new guidelines specifically addressed patients in the acute hospital setting, and clearly point out that providing appropriate antibiotic therapy should be considered a component of patient safety initiatives within these institutions.

In the guidelines, there were 11 elements suggested for consideration for inclusion in any antimicrobial stewardship program. The first five elements address the appropriate configuration for the team charged with overseeing stewardship and associated support from necessary hospital personnel. Key members include an infectious diseases physician as well as an infectious disease-trained clinical pharmacist. Collaboration or inclusion of representatives from infection control, microbiology and information systems and hospital epidemiology should also be considered.

Elizabeth Dodds Ashley, PharmD, BCPS
Elizabeth Dodds Ashley

In addition to identifying key members, it highlighted that several collaborations within the medical center are required in order for a program to be successful. These include working closely with infection control and pharmacy leadership. Hospital administration is charged with providing support for the stewardship team, not only through direct salary support of the team leadership, but also through provision of appropriate computer-based support and associated infrastructure.

Focus

When it comes to the focus of antimicrobial stewardship activities, two different strategies are proposed. These are prospective audit with intervention and feedback, and formulary restriction programs with preauthorization requirements for specific agents. The first strategy received the highest ranking for a recommendation in the clinical guidelines, A-I. This represents good evidence to support a recommendation for use with evidence from at least one properly randomized, controlled trial. In contrast, although pre-authorization is also recommended either as a sole method, or in combination with the prospective audit approach, this approach received a slightly lower recommendation grade of B-II (moderate evidence of support with data from at least one well-designed trial) for controlling resistance, and a grade of A-II for affecting cost and antimicrobial use. Realizing the resources at many institutions are limited, creative solutions to provide these services are also discussed. Some options included prospective monitoring programs conducted only a few times a week based on availability of personnel, or targeting select units where known use problems had been identified.

In addition to the two core components of a stewardship program, eight supplement activities are offered as possible additional activities based on localized needs. These interventions received varying recommendation grades from having good evidence such as with educational programs, development of guidelines, streamlining or de-escalation of therapy, dose optimization and systematic parental to oral therapy conversions. Moderate evidence was present to support the implementations of antimicrobial order forms. Although included as possible interventions, poor evidence was available to support antimicrobial cycling and routine use of combination therapy regarding the ability of these interventions to prevent antimicrobial resistance.

Technology

  Antimicrobial Stewardship

Technology is also another useful tool in designing prospective surveillance programs. Computerized physician order entry systems theoretically provide an ideal setting for decision support during the antibiotic ordering process. There are limited institutions, however in which such technology is being routinely employed. Experimental programs that assist with drug selection, interaction identification and dose calculation individualized for a patient’s organ function have been piloted with success, and will hopefully be used more widely in the future.

Currently, there are several commercially available software programs that can be used to assist in surveillance efforts, without the prospective decision support functionality. Many of these were developed to assist infection control departments and do not always include a pharmacy component. Therefore, members of the stewardship committee should be involved in the selection of appropriate software to meet the needs of the core team members.

The guidelines also identify a close collaboration with the microbiology laboratory as an essential component of any stewardship program. To intervene effectively, the team requires access to patient-specific culture information. These efforts can also assist with infection control efforts and facilitate more specific resistance reporting by developing unit- or service-specific antibiograms.

Documenting the impact

Key to the continued support of any program within an institution is a method to document the effect of such a service. The new guidelines prescribe a comprehensive approach to tracking program effect. These goals should be assessed by prospectively defined markers of success. Some of the most common targets for a program involve tracking process measures, such as quantity of drug used or overall drug costs, at defined intervals. Although these data are often easy to obtain, it is important to remember that the success of a program should also be measured in terms of desired outcome of a program. These clinical markers of success, including reduction in resistance pattern and improved patient outcomes may at times result in higher direct drug costs, but overall lower costs for the institution.

Finally, the guidelines identify 14 specific areas that should be targeted for future research efforts. These include assessment of the efficacy of many program components that could not be strongly recommended such as antimicrobial cycling and formulary restriction or preauthorization requirements; specific analysis of targeted patient groups within the acute care setting and the efficacy of various permutations of the program components that were suggested. Also, more thorough investigations are proposed for areas where theoretical advantages exist such as decreased resistance from varied antimicrobial use and the ability of antimicrobials to cause collateral damage.

Research into the process of antimicrobial stewardship is another area of interest including development of automated surveillance strategies, decision support systems, and educational impact for infectious diseases fellows. Research collaborations with other services such as the effect of stewardship programs beyond what is provided by infection control, and exploring the utility of more rapid diagnostic approaches with the microbiology laboratory should also be explored. New and improved anti-infective agents and a better understanding of the epidemiology of resistance within an institution remain areas where further research is warranted as is the effect of pharmaceutical industry interventions on prescribing patterns in various clinical setting.

The publication of these new guidelines will hopefully provide existing stewardship efforts with additional justification with which to request support. Hopefully, these guidelines will also stimulate the development of stewardship programs at institutions where resources for these efforts were previously lacking.

For more information:
  • Elizabeth Dodds Ashley, PharmD, MHS, BCPS, is a Clinical Associate in the Department of Medicine, Division of Infectious Diseases at Duke University Medical Center in Durham, N.C.
  • Dellit TH, Owens RC, McGowan JE Jr, et al. Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America Guidelines for Developing an Institutional Program to Enhance Antimicrobial Stewardship. Clin Infect Dis. 2007;44:159-77.