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CIDRAP Stewardship / Resistance Scan - VA outpatient prescribing; FDA to review new TB drug

Shiloh

Editor, Senior Moderator
Source: http://www.cidrap.umn.edu/news-perspective/2019/03/stewardship-resistance-scan-mar-11-2019



Stewardship / Resistance Scan for Mar 11, 2019
VA outpatient prescribing; FDA to review new TB drug

Filed Under:
Antimicrobial Stewardship; Tuberculosis

[h=3]VA study finds significant antibiotic over-prescribing in outpatients[/h] A new study by pharmacists with a Veterans Affairs (VA) hospital in upstate New York has found that 40% of the antibiotics prescribed for outpatients were inappropriate. The findings appeared in the American Journal of Infection Control.
The prospective observational cohort study, conducted at the VA Western New York Healthcare System, analyzed outpatient antibiotic prescriptions for 1,063 veterans over a 4-month period (June 2017 through September 2017). The researchers evaluated whether the antibiotic was appropriate for the indication, whether the selected antibiotic was first-line therapy or based on culture data, and whether the dose and duration of the antibiotic were appropriate. The primary objective was to identify the most commonly overused antibiotics and their associated syndromes.
The study found that 40% of the antibiotic prescriptions were unnecessary, the selected drug was inappropriate in 48% of cases, and the duration and dose were inappropriate in 25% and 19% of patients, respectively. The most common indications resulting in unnecessary antibiotics, based on the targeted included antibiotics, were urinary tract infections (21%), bronchitis (20%), skin and skin structure infections (17%), and sinusitis (10%). Azithromycin was the most commonly prescribed unnecessary antibiotic (37%) of the targeted agents, followed by ciprofloxacin (16%), amoxicillin/clavulanate (13%), and cephalexin (12%). Altogether, these drugs accounted for nearly 80% of unnecessary drug use.
The authors of the study suggest an outpatient stewardship program that focuses on these four drugs, including the use of alerts whenever the drugs are prescribed, could provide the most opportunities for intervention.
Mar 9 Am J Infect Control study

[h=3]FDA grants priority review for new TB drug[/h] The US Food and Drug Administration (FDA) has granted priority review to the new drug application for pretomanid, a novel tuberculosis (TB) drug candidate.
TB Alliance, which developed pretomanid, is seeking approval of the drug as part of a regimen for the treatment of multidrug-resistant (MDR), extensively drug-resistant (XDR), and treatment non-responsive MDR-TB. The regimen will also include bedaquiline and linezolid. In a phase 3 clinical trial of patients with XDR-TB and treatment non-responsive MDR-TB, interim results on the first 75 patients indicated 89% had a favorable outcome, with their clinical infection resolved and sputum cultures negative for TB after 6 months of treatment and 6 months of follow-up.
The World Health Organization estimates that roughly 558,000 cases of drug-resistant TB were diagnosed in 2017; 82% and 8.5% of these cases were MDR-TB and XDR-TB, respectively. The current success-rate for MDR-TB treatment is only 54%, compared with 82% for non-resistant TB.
TB Alliance says the FDA's decision is expected in third quarter 2019.
Mar 8 TB Alliance news release
 
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