scholarly journals 855. Impact of FDA Black Box Warning on Fluoroquinolone and Alternative Antibiotic Use in Southeastern US Hospitals

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S18-S18 ◽  
Author(s):  
Michael Yarrington ◽  
Deverick J Anderson ◽  
Elizabeth Dodds Ashley ◽  
Travis Jones ◽  
Melissa Johnson ◽  
...  
Keyword(s):  
Negative Binomial ◽  
Treatment Guidelines ◽  
Antibiotic Use ◽  
Black Box ◽  
Third Generation ◽  
Southeastern Us ◽  
Days Of Therapy ◽  
Alternative Antibiotic ◽  
Third Generation Cephalosporins ◽  
Community Onset

Abstract Background Many antimicrobial stewardship programs have set goals to reduce the use of fluoroquinolones because of risks of causing C. difficile and other adverse safety events. The US Food and Drug Administration issued a black box label warning for fluoroquinolones in June 2016 recommending avoidance of this class for treatment of uncomplicated infections. Methods We performed a retrospective cohort study of antimicrobial use (AU) data in 29 southeastern United States hospitals from 2013 to 2017. An interrupted time series approach with segmented negative binomial regression modeling was used to estimate the longitudinal trend and effect of the FDA safety announcement on AU rates. Fluoroquinolone and alternative antibiotic agent use rates were measured as days of therapy (DOT) per 1,000 patient days. Alternative antibiotics were analyzed individually or in groups (e.g., community-onset agent group included ceftriaxone, cefotaxime, and ertapenem). Results Hospital AU data for the 60-month period included a total of 6,685,950 patient days; 8 to 29 hospitals contributed AU data to estimates each month. FQ use rates declined at a consistent rate of approximately 1 DOT/1,000 patient days per month resulting in an overall 10% decrease prior to the FDA warning. A significant drop in FQ use rates occurred at the time of the announcement (P = 0.002), but there was no significant change in trend [rate ratio (RR) 0.89, 95% CI 0.79–1.01, P = 0.07, Figure 1]. Alternative antibiotic use significantly increased for the following antibiotic groups after the warning: community-onset agents (RR 1.24, 95% CI 1.11–1.38), atypical agents (RR 1.40, 95% CI 1.19–1.66), and third-generation cephalosporins (RR 1.54, 95% CI 1.19–1.65). Antipseudomonal β-lactam use remained stable (RR 0.96, 95% CI 0.88–1.05, P = 0.3). Conclusion Fluoroquinolone use was declining in our network prior to the FDA announcement and continued to decline after 2016. This is likely due to stewardship activities focusing on quinolone-sparing treatment guidelines. AU shifted away from FQ toward third-generation cephalosporins and atypical agents. Disclosures All authors: No reported disclosures.

scholarly journals Impact of FDA black box warning on fluoroquinolone and alternative antibiotic use in southeastern US hospitals

2019 ◽  
Vol 40 (11) ◽  
pp. 1297-1300 ◽  
Author(s):  
Michael E. Yarrington ◽  
Deverick J. Anderson ◽  
Elizabeth Dodds Ashley ◽  
Travis Jones ◽  
Angelina Davis ◽  
...  
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Antibiotic Use ◽  
Black Box ◽  
Serious Adverse Events ◽  
Southeastern Us ◽  
Before And After ◽  
Tract Infections ◽  
Psychiatric Side Effects ◽  
Alternative Antibiotic

AbstractWe analyzed antibiotic use data from 29 southeastern US hospitals over a 5-year period to determine changes in antibiotic use after the fluoroquinolone US Food and Drug Administration (FDA) advisory update in 2016. Fluoroquinolone use declined both before and after the FDA announcement, and the use of select, alternative antibiotics increased after the announcement.Fluoroquinolones are among the 4 most commonly prescribed antibiotic classes.1,2 Postmarketing reports of serious adverse events linked to fluoroquinolones include tendonitis, neuropathy, hypoglycemia, psychiatric side effects, and possible aortic vessel rupture, leading to safety label changes in July 2008 and August 2013.3 In July 2016, the US Food and Drug Administration (FDA) strengthened the “black box” warning following an initial safety announcement in May 2016, recommending avoidance of fluoroquinolones for uncomplicated infections such as acute exacerbation of chronic bronchitis, uncomplicated urinary tract infections, and acute bacterial sinusitis.4 Concerns over safety and the association with Clostridiodes difficile infection have led inpatient antimicrobial stewardship programs (ASPs) to develop initiatives to promote avoidance of quinolones. The objective of this study was to quantify the effect of the 2016 FDA “black box” update on inpatient antibiotic use among a cohort of southeastern US hospitals.

scholarly journals Effect of educational intervention on the appropriate use of oral antimicrobials in oral and maxillofacial surgery: a retrospective secondary data analysis

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Junya Kusumoto ◽  
Atsushi Uda ◽  
Takeshi Kimura ◽  
Shungo Furudoi ◽  
Ryosuke Yoshii ◽  
...  
Keyword(s):  
Educational Intervention ◽  
Oral Surgery ◽  
Maxillofacial Surgery ◽  
Antibiotic Use ◽  
Oral And Maxillofacial Surgery ◽  
Third Generation ◽  
Oral Antibiotics ◽  
Appropriate Use ◽  
Before And After ◽  
Third Generation Cephalosporins

Abstract Background In Japan, oral third-generation cephalosporins with broad-spectrum activity are commonly prescribed in the practices of dentistry and oral surgery. However, there are few reports on the appropriate use of antibiotics in the field of oral surgery. This study aimed to evaluate the appropriateness of antibiotic use before and after an educational intervention in the Department of Oral and Maxillofacial Surgery, Kobe University Hospital. Methods The use of oral antibiotics was investigated among inpatients and outpatients before and after an educational intervention conducted by the antimicrobial stewardship team. Additionally, the frequency of surgical site infection after the surgical removal of an impacted third mandibular molar under general anesthesia and the prevalence of adverse effects of the prescribed antibiotics were comparatively evaluated between 2013 and 2018. Results After the educational intervention, a remarkable reduction was noted in the prescription of oral third-generation cephalosporins, but increased use of penicillins was noted among outpatients. There was reduced use of macrolides and quinolones in outpatients. Although a similar trend was seen for inpatients, the use of quinolones increased in this population. Despite the change in the pattern of antibiotic prescription, inpatients who underwent mandibular third molar extraction between 2013 and 2018 did not show a significant increase in the prevalence of surgical site infections (6.2% vs. 1.8%, p = .336) and adverse effects of drugs (2.1% vs. 0%, p = .466). Conclusions This study suggests that the judicious use of oral antibiotics is possible through conscious and habitual practice of appropriate antibiotic use. However, further investigation is required to develop measures for appropriate use of oral antibiotics.

Impact of simplified therapeutic guidelines on antibiotic prescriptions: a prospective multicentre comparative study

2019 ◽  
Vol 75 (3) ◽  
pp. 747-755
Author(s):  
Pierre-Marie Roger ◽  
Ingrid Peyraud ◽  
Michel Vitris ◽  
Valérie Romain ◽  
Laura Bestman ◽  
...  
Keyword(s):  
Clavulanic Acid ◽  
Odds Ratio ◽  
Adjusted Odds Ratio ◽  
Antibiotic Use ◽  
Antibiotic Consumption ◽  
Third Generation ◽  
Therapeutic Guidelines ◽  
Amoxicillin Clavulanic Acid ◽  
The Impact ◽  
Third Generation Cephalosporins

Abstract Objectives We studied the impact of simplified therapeutic guidelines (STGs) associated with accompanied self-antibiotic reassessment (ASAR) on antibiotic use. Methods Prospective antibiotic audits and feedback took place at 15 hospitals for 12 months, allowing STGs with ≤15 drugs to be devised. STGs were explained to prescribers through sessions referred to as ASAR. Optimal therapy was defined by the conjunction of a diagnosis and the drug specified in the STGs. Analysis of consumption focused on critical drugs: amoxicillin/clavulanic acid, third-generation cephalosporins and fluoroquinolones. Results We compared prescriptions in five hospitals before (n = 179) and after (n = 168) the implementation of STGs + ASAR. These tools were associated with optimal therapies and amoxicillin/clavulanic acid prescriptions [adjusted odds ratio (AOR) 3.28, 95% CI 1.82–5.92 and 2.18, 95% CI 1.38–3.44, respectively] and fewer prescriptions for urine colonization [AOR 0.20 (95% CI 0.06–0.61)]. Comparison of prescriptions (n = 1221) from 10 departments of three clinics with STGs + ASAR for the first quarters of 2018 and 2019 revealed that the prescriptions by 23 ASAR participants more often complied with STGs than those by 28 other doctors (71% versus 60%, P = 0.003). STGs alone were adopted by 10 clinics; comparing the prescriptions (n = 311) with the 5 clinics with both tools, we observed fewer unnecessary therapies in the latter [AOR 0.52 (95% CI 0.34–0.80)]. The variation in critical antibiotic consumption between 2017 and 2018 was −16% for the 5 clinics with both tools and +20% for the other 10 (P = 0.020). Conclusions STGs + ASAR promote optimal antibiotic therapy and reduce antibiotic use.

scholarly journals Health and economic impact of the pneumococcal conjugate vaccine in hindering antimicrobial resistance in China

2021 ◽  
Vol 118 (13) ◽  
pp. e2004933118
Author(s):  
Ember (Yiwei) Lu ◽  
Hui-Han Chen ◽  
Hongqing Zhao ◽  
Sachiko Ozawa
Keyword(s):  
Antimicrobial Resistance ◽  
Conjugate Vaccine ◽  
Pneumococcal Conjugate Vaccine ◽  
Antibiotic Use ◽  
Status Quo ◽  
Third Generation ◽  
Dynamic Representation ◽  
The Status ◽  
Third Generation Cephalosporins ◽  
Coverage Increase

Antimicrobial resistance (AMR) poses a serious threat to global public health. However, vaccinations have been largely undervalued as a method to hinder AMR progression. This study examined the AMR impact of increasing pneumococcal conjugate vaccine (PCV) coverage in China. China has one of the world’s highest rates of antibiotic use and low PCV coverage. We developed an agent-based DREAMR (Dynamic Representation of the Economics of AMR) model to examine the health and economic benefits of slowing AMR against commonly used antibiotics. We simulated PCV coverage, pneumococcal infections, antibiotic use, and AMR accumulation. Four antibiotics to treat pneumococcal diseases (penicillin, amoxicillin, third-generation cephalosporins, and meropenem) were modeled with antibiotic utilization, pharmacokinetics, and pharmacodynamics factored into predicting AMR accumulation. Three PCV coverage scenarios were simulated over 5 y: 1) status quo with no change in coverage, 2) scaled coverage increase to 99% in 5 y, and 3) accelerated coverage increase to 85% over 2 y followed by 3 y to reach 99% coverage. Compared to the status quo, we found that AMR against penicillin, amoxicillin, and third-generation cephalosporins was significantly reduced by 6.6%, 10.9%, and 9.8% in the scaled scenario and by 10.5%, 17.0%, and 15.4% in the accelerated scenario. Cumulative costs due to AMR, including direct and indirect costs to patients and caretakers, were reduced by $371 million in the scaled and $586 million in the accelerated scenarios compared to the status quo. AMR-reducing benefits of vaccines are essential to quantify in order to drive appropriate investment.

scholarly journals Antimicrobial point prevalence surveys in two Ghanaian hospitals: opportunities for antimicrobial stewardship

2020 ◽  
Vol 2 (1) ◽  
Author(s):  
Daniel Kwame Afriyie ◽  
Israel A Sefah ◽  
Jacqueline Sneddon ◽  
William Malcolm ◽  
Rachel McKinney ◽  
...  
Keyword(s):  
Antibiotic Use ◽  
Point Prevalence ◽  
Antimicrobial Use ◽  
Third Generation ◽  
Surgical Prophylaxis ◽  
Duration Of Treatment ◽  
Prevalence Studies ◽  
Guideline Compliance ◽  
Almost All ◽  
Third Generation Cephalosporins

Abstract Background Improved knowledge regarding antimicrobial use in Ghana is needed to reduce antimicrobial resistance (AMR). This includes point prevalence studies (PPSs) in hospitals. Objectives were to: (i) provide baseline data in two hospitals [Keta Municipal Hospital (KMH) and Ghana Police Hospital (GPH)] and identify priorities for improvement; (ii) assess the feasibility of conducting PPSs; and (iii) compare results with other studies. Methods Standard PPS design using the Global PPS paper forms, subsequently transferred to their template. Training undertaken by the Scottish team. Quality indicators included: rationale for use; stop/review dates; and guideline compliance. Results Prevalence of antibiotic use was 65.0% in GPH and 82.0% in KMH. Penicillins and other β-lactam antibiotics were the most frequently prescribed in both hospitals, with third-generation cephalosporins mainly used in GPH. Antibiotic treatment was mainly empirical and commonly administered intravenously, duration was generally short with timely oral switching and infections were mainly community acquired. Encouragingly, there was good documentation of the indications for antibiotic use in both hospitals and 50.0%–66.7% guideline compliance (although for many indications no guideline existed). In addition, almost all prescribed antibiotics had stop dates and there were no missed doses. The duration of use for surgical prophylaxis was generally more than 1 day (69.0% in GPH and 77.0% in KMH). Conclusions These two hospitals were the first in Ghana to use the Global PPS system. We found the PPS was feasible, relatively rapid and achieved with limited training. Targets for improvement identified included reduction of broad-spectrum antibiotics and duration of treatment.

scholarly journals 2089. Effect of the Duke Antimicrobial Stewardship Outreach Network (DASON): A Multi-Center Time Series Analysis

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S705-S706
Author(s):  
Michael E Yarrington ◽  
Elizabeth Dodds Ashley ◽  
Melissa D Johnson ◽  
Angelina Davis ◽  
April Dyer ◽  
...  
Keyword(s):  
Broad Spectrum ◽  
Negative Binomial ◽  
Statistical Significance ◽  
Cohort Analysis ◽  
Negative Binomial Regression ◽  
Antibiotic Use ◽  
First Year ◽  
Hospital Data ◽  
Hospital Size ◽  
Days Of Therapy

Abstract Background DASON is a 30-member, community hospital network in the southeastern United States that supports the development and growth of local antibiotic stewardship programs (ASPs). Collaborative activities include on-site visits from liaison clinical pharmacists, data sharing for routine feedback and benchmarking, and educational programs. Methods We performed a retrospective cohort analysis of antibiotic use (AU) in 17 hospitals that participated in DASON for a minimum of 42 months during 2013–2018. Segmented negative binomial regression models were used to estimate the change in facility-wide AU after an initial 1-year assessment, planning, and ASP intervention initiation period. Baseline AU trend (1 to 12 months) was compared against AU following the first year (13 to 42 months). Monthly AU rates were measured in days of therapy (DOT) per 1,000 patient-days (pd). Models assessed overall AU and specific antibiotic groups, as defined by the National Healthcare Safety Network AU option. The models controlled for hospital size, presence of a pre-existing formal ASP upon network entry, and year of network entry. Results Hospital data included a total of 2,988,930 pd over 5 years. Facility-wide AU was increasing during the first year of network entry and then began decreasing by 0.2% per month (P = 0.01, figure). Fluoroquinolone use was stagnant in year one and then decreased by 1.5% per month (P ≤ 0.001, figure). Antifungal agents were decreasing in year one and continued to decrease 0.7% per month thereafter (P = 0.03, figure). Agents predominantly used for resistant Gram-positive infections and broad-spectrum agents used for hospital-onset infections were increasing during year one and then attenuated afterward, though the slope change did not reach statistical significance. The presence of a pre-existing formal ASP was not a significant covariate in any model, while bed size and year of network entry significantly contributed to models of some antibiotic groups. Conclusion Participation in DASON was associated with a decline in total AU and fluoroquinolone use, and a trend toward attenuated use of other broad-spectrum agents in community hospitals. Collaborative network experiences can help local ASPs achieve reductions in AU. Disclosures All authors: No reported disclosures.

scholarly journals 132. Standardized Antimicrobial Administration Ratios to Guide Antimicrobial Stewardship in the Neonatal Intensive Care Unit: a Single Center Experience

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S178-S179
Author(s):  
Steven Smoke ◽  
Uzma Hasan ◽  
Eileen Steffen ◽  
Kamtorn Vangvanichyakorn
Keyword(s):  
Neonatal Intensive Care ◽  
Antibacterial Agents ◽  
Panel Member ◽  
Antibiotic Use ◽  
Third Generation ◽  
Review Panel ◽  
Implementation Period ◽  
Third Generation Cephalosporins ◽  
Neonatal Population ◽  
Antimicrobial Administration

Abstract Background Antimicrobial stewardship (AMS) is particularly challenging in the neonatal population. Both under- and overuse can negatively impact outcomes. There are limited reports of strategies to improve AMS in the neonatal population. Standardized Antimicrobial Administration Ratios (SAARs) are novel metrics of antimicrobial use, recently introduced for neonatal populations by the National Healthcare Safety Network (NHSN). We describe our experience using SAARs to guide AMS in the neonatal intensive care unit (NICU). Methods This was a retrospective study conducted from January 2020 to April 2021. A team consisting of AMS and NICU department staff identified and implemented AMS strategies. Based on a review of NICU SAAR data, a goal was set to reduce third generation cephalosporin use by encouraging aminoglycoside use when appropriate. The pre-implementation period was January 2020 to May 2020 and the post-implementation period was July 2020 to April 2021. Antibiotic use was measured as SAARs and compared between study periods. The primary outcome was the neonatal SAAR for third generation cephalosporins. Secondary outcomes included SAARs for aminoglycosides and all neonatal antibacterial agents. SAARs were compared using the NHSN Statistics Calculator. Results For third generation cephalosporins, there were 385 observed antimicrobial days (OAD) and 115 expected antimicrobial days (EAD) in the pre-implementation period compared to 597 OAD and 228 EAD in the post implementation period. This resulted in a SAAR of 3.34 and 2.62, respectively; a reduction of 22% (p < 0.001). For aminoglycosides, there were 713 OAD and 584 EAD compared to 1617 OAD and 1155 EAD. This resulted in a SAAR of 1.22 and 1.4; an increase of 15% (p = 0.002). For all neonatal antibacterial agents, there were 2716 OAD and 1739 EAD compared to 5321 OAD and 3438 EAD. This resulted in a SAAR of 1.56 and 1.55; indicating no change in use (p = 0.70). See Table 1 for results. Table 1. Antibiotic Use Conclusion While this initiative resulted in decreased use of third generation cephalosporins, this was not associated with a decrease in antibiotic use overall. Use of SAARs in the NICU may be helpful in both identifying opportunities to improve antibiotic use and monitoring antibiotic use over time. Disclosures Steven Smoke, PharmD, Karius (Advisor or Review Panel member) Shionogi (Scientific Research Study Investigator, Advisor or Review Panel member)

Cefuroxime Treatment Failure and Haemophilus influenzae Meningitis: Case Report and Review of Literature

PEDIATRICS ◽  
1989 ◽  
Vol 84 (1) ◽  
pp. 132-135
Author(s):  
MOSHE ARDITI ◽  
BETSY C. HEROLD ◽  
RAM YOGEV
Keyword(s):  
Case Report ◽  
Bacterial Meningitis ◽  
Haemophilus Influenzae ◽  
Subdural Effusion ◽  
Third Generation ◽  
Review Of Literature ◽  
Single Drug ◽  
Days Of Therapy ◽  
Meningitis In Children ◽  
Third Generation Cephalosporins

Bacterial meningitis continues to be a major cause of morbidity and mortality in children despite effective antimicrobial therapy. Ampicillin and chloramphenicol have been the treatments of choice for bacterial meningitis in children older than 3 months of age, but recommendations also include cefuroxime and third-generation cephalosporins as possible single-drug alternatives. Although cefuroxime has been reported to be as effective as conventional therapy and some have recommended it for treatment of bacterial meningitis in children, there have been recent concerns about its efficacy. The purpose of this report is to describe an infant who had a relapse of Haemophilus influenzae meningitis 1 day after completing 30 days of therapy with iv cefuroxime for H influenzae meningitis complicated by sterile subdural effusion and possible osteomyelitis.

scholarly journals 1986. Impact of Two-Step Testing on the Diagnosis and Management of Clostridium difficile in a Multi-Hospital Healthcare System

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S665-S666
Author(s):  
Angelina Davis ◽  
Todd Parker ◽  
Julia Coluccio ◽  
Kimberly Mann ◽  
Elizabeth Dodds Ashley ◽  
...  
Keyword(s):  
Health System ◽  
Community Health ◽  
Negative Binomial ◽  
Cohort Analysis ◽  
Antibiotic Use ◽  
Baseline Period ◽  
Post Intervention ◽  
Care Community ◽  
Days Of Therapy ◽  
The Impact

Abstract Background Distinguishing active C. difficile infection (CDI) from asymptomatic colonization remains a significant challenge. A multi-step testing algorithm can improve the diagnostic accuracy of CDI and associated antibacterial prescribing. This study evaluated the impact of two-step testing on CDI rates and management in a multi-hospital community health system. Methods Two-step C. difficile testing (PCR for initial screening followed by EIA for toxin detection) was implemented in 6 acute care community hospitals in April 2018. EIA testing was automatically performed on all stool samples with a positive C. difficile PCR result. Prior to implementation, PCR alone was used to identify CDI. Messaging attached to the PCR laboratory report alerted prescribers of discrepant results (PCR +/EIA -). Anti-C. difficile therapy was at the discretion of the prescriber. We performed a retrospective cohort analysis over a 2-year period to evaluate the effect of two-step testing on system-wide hospital-onset CDI (HO-CDI) per 10,000 patient-days (PD) and anti-CDI antimicrobial use (AU) in days of therapy (DOT) per 1,000 PD. Segmented negative binomial regression with hospital clustering was used to estimate predicted HO-CDI rate for the baseline period between April 1, 2017 through March 31, 2018 and the post-intervention between May 1, 2018 through March 31, 2019. The implementation date at all sites in April 2018 was unknown; therefore, this month was removed from the analysis. Anti-CDI agents included fidaxomicin, metronidazole, and oral vancomycin, but may have included non-CDI indications for metronidazole. Results A total of 115 HO-CDI cases were identified; 91 (79%) before and 24 (21%) after. Prior to implementation of two-step testing, CDI rates declined at 4% per month (P = NS). The rate immediately dropped by 36% (P = 0.004) after two-step testing was implemented, but the trend did not significantly change (P = 0.52, Figure 1). Community-onset CDI rates also decreased during this time period. Combined facility-wide anti-CDI agent use was 824.87 before and 838.21 DOT/1,000 PD after and did not significantly change. Conclusion Use of a two-step approach for CDI testing reduced HO-CDI rates, but did not have a significant impact on anti-CDI antibiotic use in a multi-hospital community health system. Disclosures All authors: No reported disclosures.

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