In the surprisingly recent past, antimicrobial stewardship was not a primary concern among health care providers in the US. However, due to rising antimicrobial resistance, in the US and around the globe, it has become increasingly important to utilize antimicrobial therapy appropriately, while targeting patient-specific medication dosing based on infection type and site. According to the Centers for Disease Control and Prevention, approximately 20% to 50% of antibiotics prescribed in acute care hospitals nationwide are unnecessary or inappropriate.1 Antimicrobial stewardship programs (ASPs) aim to optimize patient outcomes while minimizing the unintended consequences of antimicrobial use, including toxicity and the emergence of pathogenic organisms (such as Clostridium difficile) and antimicrobial resistance.2
Florida’s Tampa General Hospital (TGH)—a tertiary care, academic medical center with 1,011 licensed beds—serves as the primary teaching site for the University of South Florida (USF) Morsani College of Medicine, while hosting community physicians across the Tampa Bay area. To properly manage antimicrobials within TGH, an ASP was initiated in the fall of 2010 with a focus on the following core antimicrobial stewardship principles:
As the program has expanded, additional focus now is extended to appropriate duration of antibiotic therapy, as well as quality initiatives, such as Surgical Care Improvement Project (SCIP) compliance, antibiotic desensitization, and antibiotic line-lock therapy. The ASP’s ongoing goal is to ensure appropriate prescribing, dosing, route, safety, and duration of antimicrobial therapy. To this end, TGH’s infectious disease (ID) pharmacists evaluate targeted antimicrobials on a daily basis and provide feedback to providers, manage antimicrobial formulary drug shortages, and assist in updating institutional policies involving antimicrobial agents.
Implementing the ASP
The ASP began in March 2010 with only one member, a well-respected ID physician champion, whose reputation has helped grow the ASP and garner support from medical providers. The first ID pharmacist joined the program in August 2010, at which time only one restricted antiinfective was on the hospital’s formulary.
TGH works with both community and academic providers, and this variability presents a challenge in terms of creating antimicrobial restrictions and criteria for use. For example, some community providers can be difficult to reach when stewardship-related interventions are required. Conversely, the teaching services, especially the medical residents and fellows, are readily available. Thus, customizing the ASP to meet the needs of all medical staff and the hospital’s culture was imperative.
Currently, the ASP team comprises one full-time ID physician, two full-time ID pharmacists, and one part-time USF faculty ID pharmacist; the ASP also collaborates closely with infection prevention, microbiology, and information technology (IT) representatives. The evolution and growth of this program has led to many providers reaching out to the ASP team for clinical recommendations, evidencing the program’s value.
The principal job responsibilities for the ID physician and ID pharmacists are as follows:
The ASP team meets with the pharmacy administration team once each month to ensure program goals are met and to discuss any new issues or trends. ID pharmacists provide clinical feedback on IT issues that relate to anti-infectives, examples of which include reviewing order sets involving surgical prophylaxis and HIV post-exposure prophylaxis, as well as optimizing ordering pathways in the electronic medical record (EMR). Recent efforts have focused on reducing medication errors in the HIV patient population. (See Table 1, which describes the year-to-year focus of the ASP in more detail.)
Transitioning to an EMR
In the second year of the program, TGH implemented a hospital-wide EMR. The pharmacy’s first actions were to update institutional order sets, align the formulary with the EMR system, and train staff members on how to interface with the EMR. It took time for staff to adjust to the electronic system, but the EMR has since aided dramatically in reducing adverse events caused by transcription errors or duplication.
Since the transition to an EMR system, we are able to take advantage of advanced functions within our clinical decision support software (CDSS) that benefit the ASP. Medication search lists can be created to identify patients receiving antiinfectives, thereby streamlining the process of identifying patients who require intervention. While the CDSS is utilized largely for clinical surveillance, pharmacy has worked to integrate many CDS alerts into the EMR system. Recently, the ASP team, in conjunction with IT, built EMR reports for both vancomycin levels obtained within the past 48 hours and positive blood cultures within the last 7 days. In addition, updates to blood culture samples (eg, preliminary result, final result) recorded in the CDSS are communicated to the ID pharmacists’ work phones via email, which facilitates rapid intervention for critical results. IT also has developed a customized drug-bug mismatch alert in the EMR to identify patients receiving antimicrobial therapy who have intermediate or resistant organism results.
Antiinfective allergy reports, now available in the EMR, identify patients with drug allergies. Furthermore, best practice alerts have been developed for certain high-risk medications, such as foscarnet, to ensure appropriate monitoring and follow-up and that auxiliary orders are entered to minimize toxicities. The ASP team utilizes pop-up alerts in the EMR that recommend alternate therapies to assist with medication shortages and institutional non-formulary agents. Additional CDS alerts identify patients with duplicate beta-lactam therapy and duplicate anaerobe coverage.
Recently, the pharmacy department developed patient scoring—an option available in the 2014 EMR upgrade package—that enables identification of high-risk patients who require medication reconciliation (eg, patients with HIV), patients who may qualify for IV to PO therapy conversion for targeted agents, and patients receiving vancomycin without recent lab test results. In addition, the ASP uses an EMR tool to communicate with pharmacists and assist with decisions regarding deescalation and duration of antimicrobial therapy.
While the EMR has become quite valuable at our institution, it should be noted that time and resources are required to appropriately build and customize EMR functionalities that can assist ASPs. Opportunities remain for further optimization and modifications to improve the user experience and enhance patient safety.
Essential Elements for Success
Effective communication, both within and outside the pharmacy department, is critical to ASP success. TGH utilizes three primary communication strategies: EMR chart notes, physician sticky notes, and discussing the patient’s clinical course and treatment regimen directly with providers.
The ASP team records notes in the EMR and also communicates directly with providers about patient care. Phone calls are necessary, for example, when the provider notes do not specify the full clinical thought process surrounding prescribing. Direct communication through phone conversations also ensures pharmacists and providers have all the information necessary to make clinical decisions, while averting any antagonism.
Appropriate Training and Feedback
Providing positive feedback to pharmacists who make appropriate, meaningful ASP interventions is essential, as it increases confidence and encourages staff to intervene again when necessary. It is not uncommon for pharmacists’ knowledge of antiinfectives to vary. Therefore, encourage clinical questions from pharmacy team members. In addition, seek feedback to ensure antiinfectives are appropriately managed and clinical questions are resolved. TGH maintains an ASP intranet site, where staff can access various resources that provide answers to common antiinfective questions.
Collaboration with IT
In 2007, the Infectious Diseases Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) published guidelines on the development of institutional ASPs.2 These guidelines recommend that an IT specialist be included as an integral member of the ASP team.
Most EMRs offer functionalities and capabilities that can assist with ASP activities, so having an IT resource dedicated to the ASP is extremely useful in order to understand the EMR’s capabilities and to build reports, alerts, and other content in a timely manner. In addition, a dedicated IT staff member can ensure that ASP tasks are not delayed because they compete with other tasks charged to the IT department.
Developing ASP Policies and Procedures
The ASP team developed a dose optimization policy for the pharmacy department that allows pharmacists to dose-adjust select antimicrobial agents based on creatinine clearance. (Select patient populations [ie, solid organ transplant, cystic fibrosis, patients who weigh less than 40 kg] are excluded from this policy, and direct conversation with the provider must take place for all dose optimization interventions.) This policy has significantly minimized phone calls to providers.
TGH also recently developed a protocol for fecal microbiota transplantation (FMT) for patients with difficult-to-treat Clostridium difficile infection (see SIDEBAR). The FMT protocol requires ID involvement and approval.
Challenges to Optimizing the ASP
The development of a robust ASP can take quite awhile, especially if an organization has not been involved in stewardship interventions previously. In addition, gaining staff buy-in for the ASP can be challenging. For example, at TGH we experienced some resistance from providers when making interventions related to antibiotic choice and duration. Such resistance may stem from clinical disagreement or from providers’ fear of losing autonomy. This challenge can be overcome with time and increasing familiarity with the ASP, although this varies from institution to institution. We have been able to obtain buy-in from many clinicians through direct communication (both in-person and telephone calls). This communication focuses on discussing the current state of the patient and devising a plan centered on the antiinfective agents. Often, we take a step-wise approach, tailoring antibiotics individually over time. Moreover, we provide clinicians with evidence-based medicine recommendations and journal articles to support ASP recommendations.
The culture of the hospital has slowly adjusted to the concepts of antimicrobial stewardship. Making it clear that the intent of the ASP is not focused solely on financial goals, but rather on ensuring appropriate patient care, has improved acceptance. Opportunities also have been created through rounding activities to expose medical students and residents to the ID pharmacist’s role on the interdisciplinary team.
We encountered some additional challenges due to the variety of provider types that practice at our hospital. As mentioned, there are multiple specialty groups at TGH, including academic providers and private providers in the community. Some community providers practice at multiple institutions and are not based at TGH. Because they spend little time at our hospital, contacting these providers can be difficult. The main method of communication is via an outside pager system, but this system is not always reliable, resulting in large expenditures of time and effort for only a few interventions. While it is ideal to have in-person conversations with providers, the size and complexity of our institution does not always allow for this. We have worked closely with our unit-based pharmacists to empower them in their role with antiinfectives to positively impact patient care.
Results and Conclusion
TGH has realized significant benefits from the implementation of a robust ASP. Utilization of broad-spectrum antiinfectives (ie, carbapenems, echinocandins) has decreased (based on tracked data through the University Health Consortium database,3 which allow participating academic institutions to compare their performance [ie, antimicrobial utilization] to other institutions across the country). In addition, the institution has realized significant financial savings, surpassing the initial expectations of both pharmacy and hospital administration.
Antimicrobial stewardship is critical for health care facilities of all scopes and sizes. Choosing the most appropriate antimicrobial agent, as well as the correct dosing and duration of therapy, is a necessary step to providing effective patient care. Identifying the type of program that best suits the needs of your organization and then customizing it to meet specific goals is the driving concept. Maintaining open communication and working to ensure staff and administration buy into the program are the defining elements of success.
Developing an Institutional Protocol for Fecal Microbiota Transplantation (FMT)
One of the most common infections afflicting patients in health care and community settings involves Clostridium difficile. A C. diff infection (CDI) can cause a spectrum of illness, including symptomless carriage, mild to moderate diarrhea, or fulminant and occasionally fatal pseudomembranous colitis.1 Signs and symptoms of disease include fever, abdominal cramping and discomfort, and increased white blood cell count. One of the main risk factors for CDI is antimicrobial exposure.
While ASPs work to limit unnecessary antimicrobial exposure and minimize the risk of CDI, some patients will develop this infection regardless. The two main antibiotics used to treat CDI are metronidazole and oral vancomycin. Fidaxomicin is a newer agent used for CDI; however, it is not included in the 2010 IDSA/SHEA guidelines for CDI.1,2 Recurrence of disease is a significant burden on the patient, and that burden increases with each episode of infection. For a first recurrence of CDI, the effectiveness of antibiotic treatment is about 60%.2
Fecal microbiota transplantation (FMT) is a treatment modality that is becoming more common, especially for patients having undergone multiple treatment courses for recurrent disease. FMT is a process for restoring a patient’s bowel flora utilizing healthy flora from a stool donor (usually a close relative). Beyond this, companies are beginning to produce ready-to-use, healthy-stool products that are pre-screened for infectious agents by a source company. Research has shown a success rate higher than 90% when treating CDI with FMT.2
Our institution first initiated FMT in May 2014, when caring for a patient with severe CDI, refractory to medical management in the first 48 hours. Clinical options were determined to be surgery or FMT, so a decision was made to initiate FMT using a source company provider. Following a successful experience with this patient—ie, no readmission to date and no known recurrence of CDI—we sought to develop an institutional protocol for FMT.
After reviewing protocols from various institutions that were already performing FMT, we created a protocol that appropriately addressed the use of FMT at our hospital. Our institution’s pharmacy and therapeutics committee recently approved this protocol for use in adult patients (>18 years of age) with recurrent CDI (3 or more recurrences) or severe CDI not responding to standard therapy after 48 hours. All patients receiving FMT are required to sign a consent form created by IDSA (available at www.idsociety.org/uploadedFiles/IDSA/Guidelines-Patient_Care/Emerging_Clinical_Issues/FMT/FMT%20Consent%20Form.pdf). Patients being considered for FMT must have an ID consult to evaluate the appropriateness of this therapeutic option. FMT is not utilized by other services in the institution (eg, gastroenterology, surgery). Patients who are deemed candidates for FMT are given a bowel preparation the night before the procedure (if they are clinically stable to receive the preparation). In addition, patients receive a proton pump inhibitor the night before and morning of FMT, which is consistent with protocols at other centers. Finally, patients receive a one-time dose of loperamide approximately 1 hour prior to FMT, to aid in retention of the product. The FMT product is instilled via a naso-duodenal tube and administered over approximately 1 hour.
To date, our results have been successful: 12 patients have received FMT at TGH without complications. We are encouraged by this promising treatment modality for patients with CDI. Recently, we launched an order set in the EMR to facilitate the ordering pathway for ID providers. This order set is limited only to ID providers to ensure it is utilized in appropriate clinical cases that follow our protocol.
Ripal Jariwala Joshi, PharmD, AAHIVP, is cochair of the TGH antimicrobial subcommittee. Her current practice includes supporting stewardship services throughout the hospital, collaborating with ID and non-ID services, and providing education related to ID and ASP. Ripal received her doctor of pharmacy degree from the University of Tennessee in 2008. Her postgraduate training included a pharmacy practice residency at the VA Sierra Nevada Health Care System (Reno, NV) and a specialty residency in infectious diseases at the Bay Pines VA Health Care System (Bay Pines, FL). Ripal’s professional interests include multidrug resistant organisms, stewardship-related activities, and antifungal pharmacotherapy.
Kristen Zeitler, BS, PharmD, BCPS, cochair of the TGH antimicrobial subcommittee, received a BS in chemistry from Fairfield University in Connecticut in 2007, followed by a doctor of pharmacy from the University at Buffalo in 2011. She completed a pharmacy practice residency and an infectious diseases specialty residency at the hospital of the University of Pennsylvania in Philadelphia. Kristen joined TGH in 2013 to further develop and grow the antimicrobial stewardship program. Her practice interests include antimicrobial dosing and pharmacokinetics, antimicrobial stewardship, and fungal infections.