Utilization, Spending, and Price Trends for Quinolones in the US Medicaid Programs: 25 Years’ Experience 1991–2015

Almalki, Ziyad S.; Yue, Xiaomeng; Xia, Ying; Wigle, Patricia R.; Guo, Jeff J.

doi:10.1007/s41669-016-0007-y

Cited by 27 publications

(21 citation statements)

References 50 publications

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“…The Centers for Disease Control and Prevention (CDC) reported a rise in outpatient fluoroquinolone use between 1991 and 2010 that plateaued between 2011 and 2015. 6 A Veterans' Health Administration study showed a non-statistically significant decline in inpatient fluoroquinolone use as a percentage of all antimicrobials between 2007 and 2015. 7 A review of a drug database that included inpatient antimicrobial use data from >300 US hospitals found a nearly 20% decrease in fluoroquinolone use between 2006 and 2012.…”

Section: Discussionmentioning

confidence: 99%

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

Yarrington

Anderson

Ashley

et al. 2019

Infect. Control Hosp. Epidemiol.

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We 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 , 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.

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Section: Discussionmentioning

confidence: 99%

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

Yarrington

Anderson

Ashley

et al. 2019

Infect. Control Hosp. Epidemiol.

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“…Consequently, FQs are one of the most commonly prescribed classes of antibiotics, with ϳ30 million oral prescriptions for FQs being dispensed in the United States in 2014 (7). Use of FQs has increased dramatically over time, with a reported 245.5% increase in Medicaid payments for quinolone agents between 1991 and 2015 (7,8).…”

mentioning

confidence: 99%

Don't Get Wound Up: Revised Fluoroquinolone Breakpoints for Enterobacteriaceae and Pseudomonas aeruginosa

et al. 2019

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Fluoroquinolones remain some of the more commonly prescribed antimicrobial agents in the United States, despite the wide array of reported side effects that are associated with their use. In 2019, the Clinical and Laboratory Standards Institute revised the fluoroquinolone antimicrobial susceptibility testing breakpoints for both Enterobacteriaceae and Pseudomonas aeruginosa. This breakpoint revision was deemed necessary on the basis of pharmacokinetic and pharmacodynamic analyses suggesting that the previous breakpoints were too high, in addition to the inability of the previous breakpoints to detect low-level resistance to this antibiotic class. In this minireview, we review the published data in support of this revision, as well as the potential challenges that these breakpoint revisions are likely to pose for clinical laboratories.A ntimicrobial susceptibility testing (AST) is one of the most important functions of a clinical microbiology laboratory. In the United States, as well as in many other countries, Clinical and Laboratory Standards Institute (CLSI) M100 performance standards (1) are widely used for the interpretation of AST results. Regardless of whether testing is performed by disk diffusion (i.e., Kirby-Bauer method) or MIC-based methods, results are compared with established criteria that enable the laboratory to categorize the result as susceptible, intermediate, or resistant to a given antibiotic.The setting of AST breakpoints is a complex and dynamic process that integrates microbiological, pharmacokinetic (PK)/pharmacodynamic (PD), and clinical outcome data (2, 3). In 2019, the 29th edition of the CLSI M100 supplement features several breakpoint revisions for a number of bacteria (4); however, revision of the fluoroquinolone (FQ) breakpoints for Enterobacteriaceae and Pseudomonas aeruginosa will arguably affect the largest number of isolates tested in clinical laboratories. A comparison of the previous and revised CLSI FQ breakpoints, as well as the European Committee on Antimicrobial Susceptibility Testing (EUCAST) breakpoints (5), is shown in Table 1. In 2017, EUCAST lowered the FQ breakpoints for several organisms (including Grampositive bacteria). It is important to note that the revision of the CLSI FQ breakpoints was limited solely to Enterobacteriaceae and P. aeruginosa and other bacteria were not included in this change. In addition, there are currently no CLSI-approved breakpoints for moxifloxacin for either Enterobacteriaceae or P. aeruginosa. In this minireview, we review the evidence for the necessity of this FQ breakpoint revision, as well as the issues this is likely to pose for clinical microbiology laboratories. REVIEW OF FLUOROQUINOLONESFQs are a class of broad-spectrum antibiotics that inhibit bacterial DNA synthesis by interfering with the enzymes DNA gyrase and topoisomerase IV. Although the individ-Citation Van TT, Minejima E, Chiu CA, Butler-Wu SM. 2019. Don't get wound up: revised fluoroquinolone breakpoints for Enterobacteriaceae and Pseudomonas aeruginosa. J Clin Microb...

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“…Indeed, levofloxacin and ciprofloxacin appear both on the list of the most used antibiotics (data related to prescriptions reimbursed by the Italian Health System in 2018) in Italy together with amoxicillin and clavulanic acid, ceftriaxone, cefixime, and fluconazole (Italian Medicine Agency, 2017). The well-established use of levofloxacin and ciprofloxacin is not a prerogative of the Italian pharmaceutical market rather it is extended to other countries, including the US where both drugs dominated the antibiotic pharmaceutical market for almost 20 years (Almalki et al, 2017). From the same observation, it is possible to deduce that the lower number of ICSRs related to first-generation quinolones could be related to their lower use in the clinical practice.…”

Section: Discussion Icsrs Involving Quinolones In the Italian Spontanmentioning

confidence: 99%

“…According to Belliveau PP et al, almost 46% of levofloxacin prescriptions were replaceable by other conventional antimicrobial therapies (Belliveau et al, 2000). Literature data suggest that two main reasons may underline the higher prescription of quinolones, including the fact that prescribers intend to use a broader-spectrum agent than necessary and, second, since patients expect to be prescribed medication at the end of the visit, clinicians tend to increase their antibacterial-prescribing habit to ensure the patients are satisfied with their care (Almalki et al, 2017).…”

Section: Agementioning

confidence: 99%

Quinolones-Induced Musculoskeletal, Neurological, and Psychiatric ADRs: A Pharmacovigilance Study Based on Data From the Italian Spontaneous Reporting System

et al. 2020

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Background: The use of quinolones has been associated with the development of serious and persistent adverse drug reaction (ADR) mainly affecting muscles, joints and the nervous system. This risk has led the European Medicines Agency (EMA) to endorse some restrictions on the use of this class of antibiotic. Therefore, we performed a study to primary estimate the reporting probability of musculoskeletal, neurological, and psychiatric ADRs among quinolone generations using national data. Methods: We retrieved Individual Case Safety Reports (ICSRs) with a quinolone as suspected drug among those reported through the Campania spontaneous reporting system from January 1 st , 2001 to April 30 th 2019. Moreover, we retrieved national aggregated safety data from the online public report system (RAM system) for the period from January 1 st , 2002 to March 31 st , 2019. Risk factors were classified as "age greater than 60 years," "therapeutic indication," "renal failure," "organ transplantation," "use of corticosteroid," and "history of side effects". Reporting odds ratio (ROR) was computed to evaluate the reporting probability of musculoskeletal, neurological, or psychiatric events among quinolones generations. Results: A total of 87 ICSRs with a quinolone as suspected drug that reported at least one musculoskeletal, neurological, and psychiatric adverse event were identified in the Campania spontaneous reporting system. Forty-nine (56.3%) ICSRs reported risk factors (total risk factors 59). The most reported risk factor was "age greater than 60 years" (69.5%), followed by "therapeutic indication" (16.9%), "renal failure" (5.1%), "organ transplantation" (3.4%), "use of corticosteroid" (3.4%), and "history of side effects" (1.7%). Second-generation quinolones were associated with a lower reporting probability of musculoskeletal (ROR 0.70; 95% CI 0.63-0.79), neurological (ROR 0.81;

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Utilization, Spending, and Price Trends for Quinolones in the US Medicaid Programs: 25 Years’ Experience 1991–2015

Cited by 27 publications

References 50 publications

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

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

Don't Get Wound Up: Revised Fluoroquinolone Breakpoints for Enterobacteriaceae and Pseudomonas aeruginosa

Quinolones-Induced Musculoskeletal, Neurological, and Psychiatric ADRs: A Pharmacovigilance Study Based on Data From the Italian Spontaneous Reporting System

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