PRACTICE REPORTS Antimicrobial stewardship program
Implementation and first-year results of an antimicrobial stewardship program at a community hospital James M. Bartlett and Patricia L. Siola
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An audio interview that supplements the information in this article is available on AJHP’s website at www.ajhp.org/ site/misc/podcasts.xhtml.
ntimicrobial stewardship programs (ASPs) have been advocated within acute care facilities to decrease antimicrobial expenditures and to lessen selective pressure that could contribute to the development of resistance.1,2 Published reports about ASPs often pertain to programs at large university centers and teaching hospitals.3-5 However, the burden of resistant bacteria is not limited to these settings. A published analysis of data from the National Nosocomial Infection Surveillance System reported on rates of Staphylococcus aureus bloodstream infections due to methicillinresistant S. aureus, pneumonia due to
Purpose. The implementation of an antimicrobial stewardship program (ASP) at a small community hospital affiliated with an accountable care organization (ACO) is described, including a report on first-year program outcomes. Summary. With no infectious diseases (ID)–trained pharmacists on staff, a 155bed hospital formed an ASP by restructuring its clinical pharmacy services. One full-time pharmacist led the program; nine full- or part-time pharmacists—none of whom had residency training—shared ASP responsibilities on a weekly rotation. Under a contract with a private medical group, an ID physician reviewed cases with ASP pharmacists for up to two hours each weekday. ASP interventions and tracking and reporting of outcomes were done primarily by pharmacists. Monitoring of pharmacy purchases in the first year of the program indicated an annualized 26% decrease in overall antimicrobial
ceftazidime-resistant Pseudomonas aeruginosa, and urinary tract infec-
James M. Bartlett, Pharm.D., is Clinical Pharmacist, Kenmore Mercy Hospital, Kenmore, NY; at the time of writing, he was a clinical pharmacy consultant for Trinity Medical of Western New York, Buffalo. Patricia L. Siola, B.S.Pharm., M.B.A., Ph.D., FASHP, FACHE, is Director of Pharmacy, Catholic Health System–Northtowns, Buffalo. Address correspondence to Dr. Bartlett ([email protected]). Jeffrey Frost, M.D., Jeffrey Martinez, M.D., James Swiencicki, Jr., M.D., and Matthew Antalek, D.O., of Internal Medicine ID Associates, LLC, are acknowledged for their guidance and work with the antimicrobial stewardship program. Frank Heinrich, B.S.Pharm., Kristen Kelsey, B.S.Pharm., Kevin Brandon, B.S.Pharm., Debby Morris-Allen, Pharm.D., Jeff Olek, B.S.Pharm., Annette Bobsein, B.S.Pharm., Brenda Queeno, Pharm.D., Nicole Janiszewski, Pharm.D.,
expenditures from prior-year spending, with a nearly 18% decrease in defined daily doses per 1000 patient-days. Total first-year direct cost savings attributed to the ASP were estimated at $145,353. Pharmacist-initiated conversions of patients from i.v. to oral antimicrobial therapy increased by 688% (p < 0.0001). Overall, the rate of ID physician acceptance of ASP-recommended interventions (mainly streamlining of therapy, limiting the duration of therapy to a specific stop date, and discontinuation of nonindicated drugs) was 74%. Conclusion. An ASP was implemented at a small ACO-affiliated community hospital by a team of pharmacists without specialized ID training. During the first year of the program, antimicrobial expenditures were reduced and there was a significant increase in pharmacist-initiated i.v.-to-oral conversions. Am J Health-Syst Pharm. 2014; 71:943-9
tions due to ciprofloxacin-resistant Escherichia coli, by hospital size.6
Brian Wetzel, Pharm.D., and Courtney LaDuca, Pharm.D., are acknowledged for their dedication to the success of the program. Dr. Bartlett formerly served as a clinical pharmacy consultant for Trinity Medical of Western New York, providing care transition medication reviews for patients of Catholic Medical Partners (CMP), the independent practice association that provided funding for antimicrobial stewardship program physician support. He currently serves as a per-diem clinical pharmacy consultant with CMP. Dr. Siola has declared no potential conflicts of interest. Copyright © 2014, American Society of Health-System Pharmacists, Inc. All rights reserved. 1079-2082/14/0601-0943$06.00. DOI 10.2146/ajhp130602
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This report showed that during the period 2000–04, the rates of all three of these bacterial illnesses were relatively high in hospitals with less than 200 beds. Additionally, the most recent published data from the National Healthcare Safety Network on device-associated infection events suggest that 65% of hospitals reporting data to the network have less than 200 beds and 54% are not teaching institutions.7 In a 2009 survey of infectious diseases (ID) physicians in the Infectious Diseases Society of America (IDSA) Emerging Infections Network regarding the prevalence and characteristics of ASPs throughout the country, it was noted that respondents who did not have an ASP at their institution were significantly more likely to practice at a community hospital with less than 200 beds.8 This report went on to say that “small community hospitals still represent the frontier for new stewardship programs.” The editors of the journal Clinical Infectious Diseases (CID) echoed this sentiment by soliciting articles for a supplement in 2011 titled “Antimicrobial Stewardship for the Community Hospital: Practical Tools & Techniques for Implementation.”9-12 Our literature search found that the first published report of an ASP in a community hospital with less than 200 beds appeared in 2003.13 We identified three relevant reports published since then, all in 2012; these reports described ASPs at a 141-bed rural hospital, a 100-bed community hospital, and a 60-bed long-term acute care hospital, with the latter two programs being implemented with involvement by the same ID physician group.14-16 The joint IDSA and Society for Healthcare Epidemiology of America guidelines for antimicrobial stewardship state that core members of an antimicrobial stewardship team should be an ID physician and an ID-trained pharmacist, with 944
both compensated for their time.2 However, in the CID supplement on antimicrobial stewardship in community hospitals, it was noted that ID-trained pharmacists are not always available and that program design and intervention techniques need to be individualized in smaller institutions, where resources may be limited.9,10 The American Society of Health-System Pharmacists published a statement on the pharmacist’s role in antimicrobial stewardship and similarly recommended that because of limited training opportunities, pharmacists without advanced training in infectious diseases may have to assume some ASP responsibilities.17 To that end, in this article we describe the development and first-year results of a comprehensive ASP utilizing prospective audit and feedback at a 155-bed accountable care organization (ACO)–affiliated community hospital without ID- or residency-trained pharmacists. Background An ASP was developed at a community hospital licensed to operate 148 general medical–surgical beds, 16 medical–surgical intensive care unit beds, and 20 medical rehabilitation beds. During the study period, there were 14 intensive care and 121 medical–surgical beds in operation, for a total of 135 acute care beds in addition to the 20 medical rehabilitation beds. The hospital is one of three in a nonprofit health care system (a total of 1083 acute care beds) that has partnered with an independent practice association (IPA) of over 900 physicians. In April 2012, the system was named as one of the first 27 organizations nationwide chosen for the federal Medicare Shared Savings Program, which rewards ACOs for improving the delivery of health care services to Medicare beneficiaries.18 At the time of the study described here, the hospital operated an average of 155 beds daily each year; patient volume statistics
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for 2011 and 2012 are shown in Table 1. The pharmacy department is open from 0630 to 2300 on weekdays and from 0700 to 2300 on weekends, with overnight coverage provided by an offsite hospital within the same health system. During the study period, the pharmacy department was staffed by eight full-time pharmacists and one part-time pharmacist, with a full-time lead pharmacist. Additional staff coverage was provided by perdiem pharmacists when needed, but they did not rotate through the position of antimicrobial stewardship pharmacist. At the time of writing, there were no pharmacists with postgraduate year 2 ID residency training or postgraduate year 1 training. All full- and part-time pharmacists rotate through dispensing and clinical duties. Before initiation of the formalized ASP in 2012, there were already measures in place to control antimicrobial use; these measures were continued through the study period. There was a systemwide antimicrobial formulary, with restrictions for linezolid, daptomycin, tigecycline, ertapenem, and the echinocandins. For restricted agents, ordering physicians were required to request an ID consultation within 48 hours. All antimicrobial orders were assigned a seven-day automatic stop order. There were also policies in place for automatic pharmacist dosage adjustments of most antimicrobials, i.v.to-oral conversions, and automatic discontinuation of most postoperative prophylactic antimicrobials within 24 hours in accordance with recent guidelines.19 Most i.v. aminoglycoside and i.v. vancomycin orders were written as “pharmacy to dose” in 2011; in February 2012, a systemwide policy extending this designation to all orders for i.v. vancomycin and aminoglycosides (unless specified otherwise) was approved. An extendedinfusion piperacillin–tazobactam dosage adjustment protocol was also in place, as described by Lodise et
PRACTICE REPORTS Antimicrobial stewardship program
al.20 In 2011, the method of detecting Clostridium difficile infection among the hospital’s patients was an enzyme immunoassay (EIA) for toxins A and B; in June 2012, this was changed to a process using an EIA for glutamate dehydrogenase and toxins A and B, with DNA amplification for investigation of inconclusive results, likely increasing testing sensitivity and the number of cases detected.21 Program development and implementation The ASP was developed to be a payroll-neutral initiative for the hospital. One pharmacist full-time equivalent (FTE) was dedicated to the program, but this was done through restructuring of the clinical services. At the time of development, five FTEs were dedicated to staffing the central pharmacy from 0630 to 2300 on weekdays, with three FTEs assigned to clinical services. Clinical pharmacists monitored the drug therapy of all admitted patients, including all antimicrobial agents. They performed automatic dosage adjustments, vancomycin and aminoglycoside pharmacokinetic dosing, and i.v.-to-oral antimicrobial conversions. They also monitored culture and sensitivity results to assess the appropriateness of current therapy and opportunities for streamlining. When the position of antimicrobial stewardship pharmacist was created, all functions related to antimicrobial therapy were shifted to this individual, allowing the other two clinical pharmacists to monitor a greater number of patients. No clinical pharmacy services were discontinued; services were actually expanded during this time period. Hospital executives and pharmacy management were in support of the development of an ASP. The IPA that was working with the health care system to gain ACO status viewed it as an opportunity to help provide high-quality services across the continuum of care while reducing
health care costs. The IPA contracted to fund the ID group for two hours of antimicrobial stewardship time daily, Monday through Friday. The program was funded before the determination of specific goals. Prior to initiation of the program, it was decided that its goal would be to decrease antimicrobial expenditures by $200,000 from the 2011 total of $569,786, with a target intervention acceptance rate of 75%. During the first three months of the program, the pharmacist charged with developing the role of the antimicrobial stewardship pharmacist served in that capacity, preparing cases for review with the ID physician and performing interventions. During this time, the entire staff of full- and part-time pharmacists was trained in the program and began rotating through the ASP-dedicated position on a weekly basis. There were four physicians involved in the program, with three following a two-week rotation schedule and the fourth filling in as necessary. Based on the hospital’s size and the personnel resources available, it was decided to monitor all patients
on antimicrobials. A daily report of all patients receiving i.v. or oral antimicrobials was developed, and information on all patients was gathered on a handwritten tracking form. The antimicrobial stewardship pharmacist made all necessary adjustments to therapy, as allowed per policy, and reviewed cases with the ID physician daily. The cases reviewed were those identified by the pharmacist as presenting opportunities for intervention and those in which ASP review was requested by the ID physician. Interventions were made primarily by the ASP pharmacist and tracked for acceptance. Depending on the urgency of the recommendation, either a progress note was written as a permanent part of the medical record or the ordering physician was called. Recommendations were considered accepted if they were enacted by the end of the next day. All interventions were logged in the pharmacy information system. For easier tracking, all interventions were also logged in a shared spreadsheet (Excel 2003, Microsoft Corporation, Redmond, WA); this allowed for the tracking and filtering of interven-
Table 1.
Hospital Census Statistics for Study Site Variable
2011
2012
Change (%)
Discharges by category Medical 4,386 4,938 Surgical 2,683 2,738 Physical/medical rehabilitation 319 340 Total 7,388 8,016 Mean daily census 104 107 Total patient-days 37,218 38,253 Case mix index Medicare 1.60 1.52 Non-Medicare 1.62 1.91 Other discharge data Medicare 1,994 2,436 Non-Medicare 5,080 5,252 Hospitalist attending (%)a 48 53 Emergency department visitsb 21,872 23,870 Outpatient ambulatory surgery visits 9,930 10,843
11.2 2.0 6.2 8.5 2.7 2.7 –5.3 15.2 18.1 3.3 9.4 8.4 8.4
Discharges by authority of hospitalist attending physician. Excludes emergency department admissions.
a
b
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tions to determine the types of drug therapy recommendations being made, by whom and to whom they were made, and whether or not they were being accepted. Interventions were classified by type (Table 2) and were further classified based on the location or type of infection. After the first two months of the program, a student completing an advanced practice pharmacy experience began working with the antimicrobial stewardship pharmacist to gather patient data and prepare for the daily meetings. Methods This was a quasiexperimental study designed to assess the impact of the ASP on economic outcomes by comparison of data collected during the year before and the year after program implementation. The ASP began at the start of 2012. Economic outcomes. The measures of antimicrobial use that could be monitored were acquisition cost
and defined daily doses (DDDs) purchased. For each evaluated medication, acquisition cost was normalized per patient-day and per discharge, and consumption was reported in terms of DDDs per 1000 patientdays. Prices were not adjusted for inflation because it was desired to see the actual cost difference in antimicrobial purchases attainable during the intervention period compared with the prior year. DDDs were calculated by querying the distributor (McKesson, San Francisco, CA) about all purchases for antiinfectives, excluding ophthalmologic, otic, and topical products. Rifaximin, demeclocycline, and antiretrovirals were excluded from the calculations because they were used over the study period almost exclusively for the treatment of hepatic encephalopathy, the syndrome of inappropriate antidiuretic hormone, and postexposure prophylaxis, respectively. A savings to the i.v. general ledger was reported due to a change in prod-
Table 2.
ASP Intervention Classifications and Recommendations During Study Perioda Classification
No. Interventions
Perform i.v.-to-oral conversion 29 Narrow empiric therapy 57 Broaden empiric therapy 30 Streamline to definitive therapy based on positive cultures 102 Streamline based on negative cultures 45 Change therapy due to culture–treatment mismatch 22 Change to less expensive regimen with similar spectrum 10 Change antimicrobial class to lessen selective pressure 5 Change due to actual or high risk of adverse event 6 Discontinue antimicrobial(s) not indicated 167 Discontinue duplicate therapy 22 Clarify indication 39 Limit duration to specific stop date 159 Clarify intended duration 11 Reorder antimicrobial stopped by ASO 23 Order laboratory monitoring 12 Recommend infectious diseases consult 4 Recommend dose or frequency changeb 29 Other 25 Total 797 b
ASP = antimicrobial stewardship program, ASO = automatic stop order. Not covered by automatic pharmacist medication conversion policies.
a
b
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uct in June 2012, at which time the health system changed from vials and Mini-Bag Plus containers (Baxter Healthcare Corporation, Deerfield, IL) to Duplex bags (Duplex Drug Delivery System, B. Braun Medical Inc., Bethlehem, PA) for multiple antibiotics. With the Duplex system, the i.v. solution was included in the cost of the antimicrobial. To obtain cost data for purposes of the study, the price per i.v. solution at the time of the change was multiplied by the number of Duplex units purchased. The number of serum drug level measurements required for monitoring vancomycin therapy was also determined, and the difference in laboratory expenditures during the preimplementation and postimplementation periods was reported. Process measure outcomes. The number of recommendations made and the percentage accepted were determined. Data were also gathered on the quantity of automatic dosage adjustments and i.v.-to-oral conversions. Because all pharmacists were familiar with the policies and experienced in the ASP, some of these perpolicy changes were done at the time of order entry, by other pharmacists performing clinical functions, or by interns on the weekends; only those changes done by the antimicrobial stewardship pharmacist were tabulated. Of these per-policy changes, only i.v.-to-oral conversion data from 2011 could be extracted for comparison. Clinical outcomes. This study was designed not to evaluate clinical outcomes but rather to determine the feasibility and economic impact of starting and running the ASP. The study was not designed to determine the program’s impact on resistance rates or hospital length of stay. Prior to initiation, there was not a hospital antibiogram available; one has since been developed, but a historical comparison was not possible. Statistical analysis. Acquisition costs and DDDs are reported as an-
PRACTICE REPORTS Antimicrobial stewardship program
nualized figures for 2011 and 2012, and, thus, no statistical analysis was performed. The number of i.v.-tooral conversions per policy was collected monthly and is reported here as an annual total and percentage increase. The number of measured serum vancomycin levels was collected monthly and reported here as an annual total, with associated cost savings. Monthly data on i.v.-to-oral conversions and serum vancomycin measurements were analyzed using the Mann–Whitney U test for continuous nonparametric data. The a priori level of significance was set at 0.05 for a two-tailed test. Statistical calculations were performed using Minitab (version 16.2.2, Minitab Inc., State College, PA). Results In total, antimicrobial acquisition costs decreased by 25.5%, from $569,786 in 2011 to $424,433 in 2012—a direct cost savings of $145,353—while the total number of discharges increased by 8.5% and total patient-days increased by 2.7%. The antimicrobial cost per discharge dropped by 31%, from $75.51 to $52.13, and the cost per inpatientday decreased by 28.4%, from $15.01 to $10.74. The calculated savings to the i.v. general ledger totaled $6,207. There were 174 fewer serum vancomycin measurements; given the associated cost of $32.71 each, this reduction yielded a total laboratory savings of $5,692. The mean number of serum vancomycin levels tested monthly decreased from 113.3 to 98.8, but this was not statistically significant (p = 0.07). Total savings for 2012 compared with 2011 were $157,252. Antimicrobial DDDs decreased from 1,627 to 1,338 per 1,000 patient-days from 2011 to 2012, a decrease of 17.8%. The rate of acceptance for ASP recommendations made was 73.9% (Table 3). There were a total of 797 recommendations made in 2012, but only 716 were included in the accep-
tance rate calculation. It was decided not to include recommendations if the patient involved was discharged the day after the recommendation and insufficient information was available in the discharge summary to determine if the recommendation was enacted; also, recommendations were not included if the patient was discharged the same day the recommendation was made because it was not possible to determine if the recommendation was seen prior to dictation of the discharge plan. Automatic i.v.-to-oral conversions increased from 39 in 2011 to 288 in 2012 (p < 0.001), with no changes in the applicable policies during that time frame. Discussion This article describes the design and first-year results of an ASP at a nonteaching community hospital operating 155 beds. The program was implemented through the collaboration of the hospital administration and pharmacy management, with the financial support of an IPA in contracting for ID physician services. To our knowledge, the ASP
is unique in that it was developed within an ACO with funding from a stakeholder outside of the acute care facility. The program was recently expanded to a 290-bed community teaching facility and a 123-bed satellite campus within the organization. As mentioned, all full- or parttime pharmacists in the department served in the position of antimicrobial stewardship pharmacist on a weekly rotation. None of these pharmacists had specialized ID training. This is a much different model than that in place at most larger institutions, where the ASP is the responsibility of specific individuals, and allowed for a very robust program that could continue in the absence of any particular individual. Feedback from the clinical pharmacists about the ASP has been generally positive, including reports of increased job satisfaction and opportunities for education. Anecdotally, as a result of the ASP-fostered increased knowledge of and comfort level with antimicrobial therapy throughout the pharmacy department, there was a pharmacist-perceived increase in antimicrobial interventions made by
Table 3.
Monthly ASP Interventions and Acceptance Rate During Study Perioda
Mo Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Total
No. Interventions
No. Evaluable Interventionsb
No. (%) Accepted Interventionsc
72 74 81 64 65 74 50 52 69 66 55 75 797
69 66 71 58 58 71 43 50 58 59 51 62 716
58 (84.1) 47 (71.2) 58 (81.7) 44 (75.9) 39 (67.2) 56 (78.9) 28 (65.1) 38 (76.0) 43 (74.1) 44 (74.6) 33 (64.7) 40 (65.6) 529 (73.9)
ASP = antimicrobial stewardship program. Interventions whose acceptance could be evaluated. c Recommendations enacted by the end of the following day. a
b
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pharmacists while performing other job functions that was not captured in the totals reported in Tables 2 and 3; physician confidence in pharmacy recommendations also seemed to increase, as suggested by a perceived increase in antimicrobial-related questions from prescribers. While antimicrobial stewardship can be defined as the process of promoting rational use of antimicrobials by ensuring the correct drug, dose, route, and duration of therapy,1 most ASPs must choose to focus on a select few antimicrobials, with the majority reporting that selection is made based on cost, while some more-established programs are able to focus on specific infections. Given the small size of the institution involved in the ASP described here, it was decided to monitor all patients on antimicrobials because at any given time there may not be many patients on high-cost agents appropriate for intervention. In the course of the year, the ASP monitored almost 11,500 patient-days of antimicrobial therapy, an average of 45 patients daily. One limitation of our study was its quasiexperimental design; consequently, our results can only suggest an association between ASP activities and the reported results. We feel that this design was appropriate, as randomization would not have been possible given the hospitalwide nature of the program and the involvement of every pharmacist. A major limitation of the reported data pertains to the lack of information on actual doses administered to patients (all reported usage data were derived from purchase records). Another notable study limitation was the inability of the ASP to track patterns of antimicrobial resistance relative to a true baseline, as no antibiogram data for the year before ASP implementation were available. There was also a change in June 2012 in the hospital’s method of testing for C. difficile infection; this likely increased the 948
number of cases detected during the postimplementation period, but to what extent this occurred is currently unknown. The total savings of $157,252 and the direct cost savings of $145,353 attributable to the ASP did not reach the goal of $200,000; however, these figures represent an overall 25.5% decrease in direct costs that was achieved while the number of discharges increased by 8.5% and total patient-days increased by 2.7%. This cost reduction resulted in the continuation of the program and expansion to other sites within the health system. The intervention acceptance rate of 73.9% also did not reach the goal of 75%. Periodic review of ASP interventions not accepted is being used to provide targeted education. The more than sixfold increase in i.v.-tooral conversions was accomplished without any changes to the conversion policy. The increase in conversions was most likely attributable to giving an ASP-dedicated pharmacist responsibility for tracking antimicrobials for the entire week; prior to ASP implementation, multiple pharmacists with many other pharmacotherapy problems to focus on were often responsible for a given patient care area throughout the week. Conclusion An ASP was implemented at a small ACO-affiliated community hospital by a team of pharmacists without specialized ID training. During the first year of the program, antimicrobial expenditures were reduced and there was a significant increase in pharmacist-initiated i.v.to-oral conversions.
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pharmacist’s role in antimicrobial stewardship and infection prevention and control. Am J Health-Syst Pharm. 2010; 67:575-7. Centers for Medicare and Medicaid Services. First accountable care organizations under the Medicare Shared Savings Program. www.cms.gov/Newsroom/ MediaReleaseDatabase/Fact-Sheets/ 2012-Fact-Sheets-Items/2012-04-10.html (accessed 2013 Jun 2). Bratzler DW, Dellinger EP, Olsen KM et al. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health-Syst Pharm. 2013; 70:195-283. Lodise TP, Lomaestro BM, Drusano GL, for the Society of Infectious Diseases Pharmacists. Application of antimicrobial pharmacodynamic concepts into clinical practice: focus on beta-lactam antibiotics: insights from the Society of Infectious Diseases Pharmacists. Pharmacotherapy. 2006; 26:1320-32. Cohen Stuart HM, Gerding Dale NM, Stuart Johnson MD et al. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). Infect Control Hosp Epidemiol. 2010; 31:431-55.
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Implementation and first-year results of an antimicrobial stewardship program at a community hospital James M. Bartlett and Patricia L. Siola
Scan to access AJHP Voices
A
An audio interview that supplements the information in this article is available on AJHP’s website at www.ajhp.org/ site/misc/podcasts.xhtml.
ntimicrobial stewardship programs (ASPs) have been advocated within acute care facilities to decrease antimicrobial expenditures and to lessen selective pressure that could contribute to the development of resistance.1,2 Published reports about ASPs often pertain to programs at large university centers and teaching hospitals.3-5 However, the burden of resistant bacteria is not limited to these settings. A published analysis of data from the National Nosocomial Infection Surveillance System reported on rates of Staphylococcus aureus bloodstream infections due to methicillinresistant S. aureus, pneumonia due to
Purpose. The implementation of an antimicrobial stewardship program (ASP) at a small community hospital affiliated with an accountable care organization (ACO) is described, including a report on first-year program outcomes. Summary. With no infectious diseases (ID)–trained pharmacists on staff, a 155bed hospital formed an ASP by restructuring its clinical pharmacy services. One full-time pharmacist led the program; nine full- or part-time pharmacists—none of whom had residency training—shared ASP responsibilities on a weekly rotation. Under a contract with a private medical group, an ID physician reviewed cases with ASP pharmacists for up to two hours each weekday. ASP interventions and tracking and reporting of outcomes were done primarily by pharmacists. Monitoring of pharmacy purchases in the first year of the program indicated an annualized 26% decrease in overall antimicrobial
ceftazidime-resistant Pseudomonas aeruginosa, and urinary tract infec-
James M. Bartlett, Pharm.D., is Clinical Pharmacist, Kenmore Mercy Hospital, Kenmore, NY; at the time of writing, he was a clinical pharmacy consultant for Trinity Medical of Western New York, Buffalo. Patricia L. Siola, B.S.Pharm., M.B.A., Ph.D., FASHP, FACHE, is Director of Pharmacy, Catholic Health System–Northtowns, Buffalo. Address correspondence to Dr. Bartlett ([email protected]). Jeffrey Frost, M.D., Jeffrey Martinez, M.D., James Swiencicki, Jr., M.D., and Matthew Antalek, D.O., of Internal Medicine ID Associates, LLC, are acknowledged for their guidance and work with the antimicrobial stewardship program. Frank Heinrich, B.S.Pharm., Kristen Kelsey, B.S.Pharm., Kevin Brandon, B.S.Pharm., Debby Morris-Allen, Pharm.D., Jeff Olek, B.S.Pharm., Annette Bobsein, B.S.Pharm., Brenda Queeno, Pharm.D., Nicole Janiszewski, Pharm.D.,
expenditures from prior-year spending, with a nearly 18% decrease in defined daily doses per 1000 patient-days. Total first-year direct cost savings attributed to the ASP were estimated at $145,353. Pharmacist-initiated conversions of patients from i.v. to oral antimicrobial therapy increased by 688% (p < 0.0001). Overall, the rate of ID physician acceptance of ASP-recommended interventions (mainly streamlining of therapy, limiting the duration of therapy to a specific stop date, and discontinuation of nonindicated drugs) was 74%. Conclusion. An ASP was implemented at a small ACO-affiliated community hospital by a team of pharmacists without specialized ID training. During the first year of the program, antimicrobial expenditures were reduced and there was a significant increase in pharmacist-initiated i.v.-to-oral conversions. Am J Health-Syst Pharm. 2014; 71:943-9
tions due to ciprofloxacin-resistant Escherichia coli, by hospital size.6
Brian Wetzel, Pharm.D., and Courtney LaDuca, Pharm.D., are acknowledged for their dedication to the success of the program. Dr. Bartlett formerly served as a clinical pharmacy consultant for Trinity Medical of Western New York, providing care transition medication reviews for patients of Catholic Medical Partners (CMP), the independent practice association that provided funding for antimicrobial stewardship program physician support. He currently serves as a per-diem clinical pharmacy consultant with CMP. Dr. Siola has declared no potential conflicts of interest. Copyright © 2014, American Society of Health-System Pharmacists, Inc. All rights reserved. 1079-2082/14/0601-0943$06.00. DOI 10.2146/ajhp130602
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This report showed that during the period 2000–04, the rates of all three of these bacterial illnesses were relatively high in hospitals with less than 200 beds. Additionally, the most recent published data from the National Healthcare Safety Network on device-associated infection events suggest that 65% of hospitals reporting data to the network have less than 200 beds and 54% are not teaching institutions.7 In a 2009 survey of infectious diseases (ID) physicians in the Infectious Diseases Society of America (IDSA) Emerging Infections Network regarding the prevalence and characteristics of ASPs throughout the country, it was noted that respondents who did not have an ASP at their institution were significantly more likely to practice at a community hospital with less than 200 beds.8 This report went on to say that “small community hospitals still represent the frontier for new stewardship programs.” The editors of the journal Clinical Infectious Diseases (CID) echoed this sentiment by soliciting articles for a supplement in 2011 titled “Antimicrobial Stewardship for the Community Hospital: Practical Tools & Techniques for Implementation.”9-12 Our literature search found that the first published report of an ASP in a community hospital with less than 200 beds appeared in 2003.13 We identified three relevant reports published since then, all in 2012; these reports described ASPs at a 141-bed rural hospital, a 100-bed community hospital, and a 60-bed long-term acute care hospital, with the latter two programs being implemented with involvement by the same ID physician group.14-16 The joint IDSA and Society for Healthcare Epidemiology of America guidelines for antimicrobial stewardship state that core members of an antimicrobial stewardship team should be an ID physician and an ID-trained pharmacist, with 944
both compensated for their time.2 However, in the CID supplement on antimicrobial stewardship in community hospitals, it was noted that ID-trained pharmacists are not always available and that program design and intervention techniques need to be individualized in smaller institutions, where resources may be limited.9,10 The American Society of Health-System Pharmacists published a statement on the pharmacist’s role in antimicrobial stewardship and similarly recommended that because of limited training opportunities, pharmacists without advanced training in infectious diseases may have to assume some ASP responsibilities.17 To that end, in this article we describe the development and first-year results of a comprehensive ASP utilizing prospective audit and feedback at a 155-bed accountable care organization (ACO)–affiliated community hospital without ID- or residency-trained pharmacists. Background An ASP was developed at a community hospital licensed to operate 148 general medical–surgical beds, 16 medical–surgical intensive care unit beds, and 20 medical rehabilitation beds. During the study period, there were 14 intensive care and 121 medical–surgical beds in operation, for a total of 135 acute care beds in addition to the 20 medical rehabilitation beds. The hospital is one of three in a nonprofit health care system (a total of 1083 acute care beds) that has partnered with an independent practice association (IPA) of over 900 physicians. In April 2012, the system was named as one of the first 27 organizations nationwide chosen for the federal Medicare Shared Savings Program, which rewards ACOs for improving the delivery of health care services to Medicare beneficiaries.18 At the time of the study described here, the hospital operated an average of 155 beds daily each year; patient volume statistics
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for 2011 and 2012 are shown in Table 1. The pharmacy department is open from 0630 to 2300 on weekdays and from 0700 to 2300 on weekends, with overnight coverage provided by an offsite hospital within the same health system. During the study period, the pharmacy department was staffed by eight full-time pharmacists and one part-time pharmacist, with a full-time lead pharmacist. Additional staff coverage was provided by perdiem pharmacists when needed, but they did not rotate through the position of antimicrobial stewardship pharmacist. At the time of writing, there were no pharmacists with postgraduate year 2 ID residency training or postgraduate year 1 training. All full- and part-time pharmacists rotate through dispensing and clinical duties. Before initiation of the formalized ASP in 2012, there were already measures in place to control antimicrobial use; these measures were continued through the study period. There was a systemwide antimicrobial formulary, with restrictions for linezolid, daptomycin, tigecycline, ertapenem, and the echinocandins. For restricted agents, ordering physicians were required to request an ID consultation within 48 hours. All antimicrobial orders were assigned a seven-day automatic stop order. There were also policies in place for automatic pharmacist dosage adjustments of most antimicrobials, i.v.to-oral conversions, and automatic discontinuation of most postoperative prophylactic antimicrobials within 24 hours in accordance with recent guidelines.19 Most i.v. aminoglycoside and i.v. vancomycin orders were written as “pharmacy to dose” in 2011; in February 2012, a systemwide policy extending this designation to all orders for i.v. vancomycin and aminoglycosides (unless specified otherwise) was approved. An extendedinfusion piperacillin–tazobactam dosage adjustment protocol was also in place, as described by Lodise et
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al.20 In 2011, the method of detecting Clostridium difficile infection among the hospital’s patients was an enzyme immunoassay (EIA) for toxins A and B; in June 2012, this was changed to a process using an EIA for glutamate dehydrogenase and toxins A and B, with DNA amplification for investigation of inconclusive results, likely increasing testing sensitivity and the number of cases detected.21 Program development and implementation The ASP was developed to be a payroll-neutral initiative for the hospital. One pharmacist full-time equivalent (FTE) was dedicated to the program, but this was done through restructuring of the clinical services. At the time of development, five FTEs were dedicated to staffing the central pharmacy from 0630 to 2300 on weekdays, with three FTEs assigned to clinical services. Clinical pharmacists monitored the drug therapy of all admitted patients, including all antimicrobial agents. They performed automatic dosage adjustments, vancomycin and aminoglycoside pharmacokinetic dosing, and i.v.-to-oral antimicrobial conversions. They also monitored culture and sensitivity results to assess the appropriateness of current therapy and opportunities for streamlining. When the position of antimicrobial stewardship pharmacist was created, all functions related to antimicrobial therapy were shifted to this individual, allowing the other two clinical pharmacists to monitor a greater number of patients. No clinical pharmacy services were discontinued; services were actually expanded during this time period. Hospital executives and pharmacy management were in support of the development of an ASP. The IPA that was working with the health care system to gain ACO status viewed it as an opportunity to help provide high-quality services across the continuum of care while reducing
health care costs. The IPA contracted to fund the ID group for two hours of antimicrobial stewardship time daily, Monday through Friday. The program was funded before the determination of specific goals. Prior to initiation of the program, it was decided that its goal would be to decrease antimicrobial expenditures by $200,000 from the 2011 total of $569,786, with a target intervention acceptance rate of 75%. During the first three months of the program, the pharmacist charged with developing the role of the antimicrobial stewardship pharmacist served in that capacity, preparing cases for review with the ID physician and performing interventions. During this time, the entire staff of full- and part-time pharmacists was trained in the program and began rotating through the ASP-dedicated position on a weekly basis. There were four physicians involved in the program, with three following a two-week rotation schedule and the fourth filling in as necessary. Based on the hospital’s size and the personnel resources available, it was decided to monitor all patients
on antimicrobials. A daily report of all patients receiving i.v. or oral antimicrobials was developed, and information on all patients was gathered on a handwritten tracking form. The antimicrobial stewardship pharmacist made all necessary adjustments to therapy, as allowed per policy, and reviewed cases with the ID physician daily. The cases reviewed were those identified by the pharmacist as presenting opportunities for intervention and those in which ASP review was requested by the ID physician. Interventions were made primarily by the ASP pharmacist and tracked for acceptance. Depending on the urgency of the recommendation, either a progress note was written as a permanent part of the medical record or the ordering physician was called. Recommendations were considered accepted if they were enacted by the end of the next day. All interventions were logged in the pharmacy information system. For easier tracking, all interventions were also logged in a shared spreadsheet (Excel 2003, Microsoft Corporation, Redmond, WA); this allowed for the tracking and filtering of interven-
Table 1.
Hospital Census Statistics for Study Site Variable
2011
2012
Change (%)
Discharges by category Medical 4,386 4,938 Surgical 2,683 2,738 Physical/medical rehabilitation 319 340 Total 7,388 8,016 Mean daily census 104 107 Total patient-days 37,218 38,253 Case mix index Medicare 1.60 1.52 Non-Medicare 1.62 1.91 Other discharge data Medicare 1,994 2,436 Non-Medicare 5,080 5,252 Hospitalist attending (%)a 48 53 Emergency department visitsb 21,872 23,870 Outpatient ambulatory surgery visits 9,930 10,843
11.2 2.0 6.2 8.5 2.7 2.7 –5.3 15.2 18.1 3.3 9.4 8.4 8.4
Discharges by authority of hospitalist attending physician. Excludes emergency department admissions.
a
b
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tions to determine the types of drug therapy recommendations being made, by whom and to whom they were made, and whether or not they were being accepted. Interventions were classified by type (Table 2) and were further classified based on the location or type of infection. After the first two months of the program, a student completing an advanced practice pharmacy experience began working with the antimicrobial stewardship pharmacist to gather patient data and prepare for the daily meetings. Methods This was a quasiexperimental study designed to assess the impact of the ASP on economic outcomes by comparison of data collected during the year before and the year after program implementation. The ASP began at the start of 2012. Economic outcomes. The measures of antimicrobial use that could be monitored were acquisition cost
and defined daily doses (DDDs) purchased. For each evaluated medication, acquisition cost was normalized per patient-day and per discharge, and consumption was reported in terms of DDDs per 1000 patientdays. Prices were not adjusted for inflation because it was desired to see the actual cost difference in antimicrobial purchases attainable during the intervention period compared with the prior year. DDDs were calculated by querying the distributor (McKesson, San Francisco, CA) about all purchases for antiinfectives, excluding ophthalmologic, otic, and topical products. Rifaximin, demeclocycline, and antiretrovirals were excluded from the calculations because they were used over the study period almost exclusively for the treatment of hepatic encephalopathy, the syndrome of inappropriate antidiuretic hormone, and postexposure prophylaxis, respectively. A savings to the i.v. general ledger was reported due to a change in prod-
Table 2.
ASP Intervention Classifications and Recommendations During Study Perioda Classification
No. Interventions
Perform i.v.-to-oral conversion 29 Narrow empiric therapy 57 Broaden empiric therapy 30 Streamline to definitive therapy based on positive cultures 102 Streamline based on negative cultures 45 Change therapy due to culture–treatment mismatch 22 Change to less expensive regimen with similar spectrum 10 Change antimicrobial class to lessen selective pressure 5 Change due to actual or high risk of adverse event 6 Discontinue antimicrobial(s) not indicated 167 Discontinue duplicate therapy 22 Clarify indication 39 Limit duration to specific stop date 159 Clarify intended duration 11 Reorder antimicrobial stopped by ASO 23 Order laboratory monitoring 12 Recommend infectious diseases consult 4 Recommend dose or frequency changeb 29 Other 25 Total 797 b
ASP = antimicrobial stewardship program, ASO = automatic stop order. Not covered by automatic pharmacist medication conversion policies.
a
b
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uct in June 2012, at which time the health system changed from vials and Mini-Bag Plus containers (Baxter Healthcare Corporation, Deerfield, IL) to Duplex bags (Duplex Drug Delivery System, B. Braun Medical Inc., Bethlehem, PA) for multiple antibiotics. With the Duplex system, the i.v. solution was included in the cost of the antimicrobial. To obtain cost data for purposes of the study, the price per i.v. solution at the time of the change was multiplied by the number of Duplex units purchased. The number of serum drug level measurements required for monitoring vancomycin therapy was also determined, and the difference in laboratory expenditures during the preimplementation and postimplementation periods was reported. Process measure outcomes. The number of recommendations made and the percentage accepted were determined. Data were also gathered on the quantity of automatic dosage adjustments and i.v.-to-oral conversions. Because all pharmacists were familiar with the policies and experienced in the ASP, some of these perpolicy changes were done at the time of order entry, by other pharmacists performing clinical functions, or by interns on the weekends; only those changes done by the antimicrobial stewardship pharmacist were tabulated. Of these per-policy changes, only i.v.-to-oral conversion data from 2011 could be extracted for comparison. Clinical outcomes. This study was designed not to evaluate clinical outcomes but rather to determine the feasibility and economic impact of starting and running the ASP. The study was not designed to determine the program’s impact on resistance rates or hospital length of stay. Prior to initiation, there was not a hospital antibiogram available; one has since been developed, but a historical comparison was not possible. Statistical analysis. Acquisition costs and DDDs are reported as an-
PRACTICE REPORTS Antimicrobial stewardship program
nualized figures for 2011 and 2012, and, thus, no statistical analysis was performed. The number of i.v.-tooral conversions per policy was collected monthly and is reported here as an annual total and percentage increase. The number of measured serum vancomycin levels was collected monthly and reported here as an annual total, with associated cost savings. Monthly data on i.v.-to-oral conversions and serum vancomycin measurements were analyzed using the Mann–Whitney U test for continuous nonparametric data. The a priori level of significance was set at 0.05 for a two-tailed test. Statistical calculations were performed using Minitab (version 16.2.2, Minitab Inc., State College, PA). Results In total, antimicrobial acquisition costs decreased by 25.5%, from $569,786 in 2011 to $424,433 in 2012—a direct cost savings of $145,353—while the total number of discharges increased by 8.5% and total patient-days increased by 2.7%. The antimicrobial cost per discharge dropped by 31%, from $75.51 to $52.13, and the cost per inpatientday decreased by 28.4%, from $15.01 to $10.74. The calculated savings to the i.v. general ledger totaled $6,207. There were 174 fewer serum vancomycin measurements; given the associated cost of $32.71 each, this reduction yielded a total laboratory savings of $5,692. The mean number of serum vancomycin levels tested monthly decreased from 113.3 to 98.8, but this was not statistically significant (p = 0.07). Total savings for 2012 compared with 2011 were $157,252. Antimicrobial DDDs decreased from 1,627 to 1,338 per 1,000 patient-days from 2011 to 2012, a decrease of 17.8%. The rate of acceptance for ASP recommendations made was 73.9% (Table 3). There were a total of 797 recommendations made in 2012, but only 716 were included in the accep-
tance rate calculation. It was decided not to include recommendations if the patient involved was discharged the day after the recommendation and insufficient information was available in the discharge summary to determine if the recommendation was enacted; also, recommendations were not included if the patient was discharged the same day the recommendation was made because it was not possible to determine if the recommendation was seen prior to dictation of the discharge plan. Automatic i.v.-to-oral conversions increased from 39 in 2011 to 288 in 2012 (p < 0.001), with no changes in the applicable policies during that time frame. Discussion This article describes the design and first-year results of an ASP at a nonteaching community hospital operating 155 beds. The program was implemented through the collaboration of the hospital administration and pharmacy management, with the financial support of an IPA in contracting for ID physician services. To our knowledge, the ASP
is unique in that it was developed within an ACO with funding from a stakeholder outside of the acute care facility. The program was recently expanded to a 290-bed community teaching facility and a 123-bed satellite campus within the organization. As mentioned, all full- or parttime pharmacists in the department served in the position of antimicrobial stewardship pharmacist on a weekly rotation. None of these pharmacists had specialized ID training. This is a much different model than that in place at most larger institutions, where the ASP is the responsibility of specific individuals, and allowed for a very robust program that could continue in the absence of any particular individual. Feedback from the clinical pharmacists about the ASP has been generally positive, including reports of increased job satisfaction and opportunities for education. Anecdotally, as a result of the ASP-fostered increased knowledge of and comfort level with antimicrobial therapy throughout the pharmacy department, there was a pharmacist-perceived increase in antimicrobial interventions made by
Table 3.
Monthly ASP Interventions and Acceptance Rate During Study Perioda
Mo Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Total
No. Interventions
No. Evaluable Interventionsb
No. (%) Accepted Interventionsc
72 74 81 64 65 74 50 52 69 66 55 75 797
69 66 71 58 58 71 43 50 58 59 51 62 716
58 (84.1) 47 (71.2) 58 (81.7) 44 (75.9) 39 (67.2) 56 (78.9) 28 (65.1) 38 (76.0) 43 (74.1) 44 (74.6) 33 (64.7) 40 (65.6) 529 (73.9)
ASP = antimicrobial stewardship program. Interventions whose acceptance could be evaluated. c Recommendations enacted by the end of the following day. a
b
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pharmacists while performing other job functions that was not captured in the totals reported in Tables 2 and 3; physician confidence in pharmacy recommendations also seemed to increase, as suggested by a perceived increase in antimicrobial-related questions from prescribers. While antimicrobial stewardship can be defined as the process of promoting rational use of antimicrobials by ensuring the correct drug, dose, route, and duration of therapy,1 most ASPs must choose to focus on a select few antimicrobials, with the majority reporting that selection is made based on cost, while some more-established programs are able to focus on specific infections. Given the small size of the institution involved in the ASP described here, it was decided to monitor all patients on antimicrobials because at any given time there may not be many patients on high-cost agents appropriate for intervention. In the course of the year, the ASP monitored almost 11,500 patient-days of antimicrobial therapy, an average of 45 patients daily. One limitation of our study was its quasiexperimental design; consequently, our results can only suggest an association between ASP activities and the reported results. We feel that this design was appropriate, as randomization would not have been possible given the hospitalwide nature of the program and the involvement of every pharmacist. A major limitation of the reported data pertains to the lack of information on actual doses administered to patients (all reported usage data were derived from purchase records). Another notable study limitation was the inability of the ASP to track patterns of antimicrobial resistance relative to a true baseline, as no antibiogram data for the year before ASP implementation were available. There was also a change in June 2012 in the hospital’s method of testing for C. difficile infection; this likely increased the 948
number of cases detected during the postimplementation period, but to what extent this occurred is currently unknown. The total savings of $157,252 and the direct cost savings of $145,353 attributable to the ASP did not reach the goal of $200,000; however, these figures represent an overall 25.5% decrease in direct costs that was achieved while the number of discharges increased by 8.5% and total patient-days increased by 2.7%. This cost reduction resulted in the continuation of the program and expansion to other sites within the health system. The intervention acceptance rate of 73.9% also did not reach the goal of 75%. Periodic review of ASP interventions not accepted is being used to provide targeted education. The more than sixfold increase in i.v.-tooral conversions was accomplished without any changes to the conversion policy. The increase in conversions was most likely attributable to giving an ASP-dedicated pharmacist responsibility for tracking antimicrobials for the entire week; prior to ASP implementation, multiple pharmacists with many other pharmacotherapy problems to focus on were often responsible for a given patient care area throughout the week. Conclusion An ASP was implemented at a small ACO-affiliated community hospital by a team of pharmacists without specialized ID training. During the first year of the program, antimicrobial expenditures were reduced and there was a significant increase in pharmacist-initiated i.v.to-oral conversions.
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