PhRMA report highlights challenges to antibiotic development
A new report from the pharmaceutical industry shows there are nearly 90 drugs in clinical development against drug-resistant infections—not nearly enough to meet the growing challenge of antimicrobial resistance (AMR).
The report from the Pharmaceutical Research and Manufacturers of America (PhRMA) profiles the 89 drugs from US-based companies that are in clinical trials or awaiting review by the US Food and Drug Administration, along with the bacterial pathogens they target. The list includes antibiotics and non-traditional antibacterial products, including bacteriophages, live therapeutic products, and monoclonal antibodies.
But like a recent report from the World Health Organization (WHO), the PhRMA report notes the lack of innovative antibacterial drugs in the pipeline and highlights the scientific and financial challenges that hinder antibiotic research and development and have led many companies to abandon the antibiotic market.
“Unfortunately, the treatments we need to combat this growing threat are dwindling and the current pipeline is insufficient to deal with the growing threat of AMR [antimicrobial resistance] as many biopharmaceutical companies have abandoned research into new infectious disease treatments,” the report states. “The findings here confirm what has been warned about by others: there are too few antimicrobial medicines in development targeting priority pathogens identified by the CDC [Centers for Disease Control and Prevention] and WHO as posing the greatest risk to public health to meet current and anticipated needs.”
The report concludes that without policy interventions, the broken market for new antibiotics will persist at the expense of patients and global health.
Apr 29 PhRMA Medicines in Development for AMR 2021 report
Review finds delayed antibiotics effective for respiratory infections
A systematic review and meta-analysis of individual patient data from 13 studies found that delayed antibiotic prescribing for respiratory infections appears to be a safe and effective strategy for most patients, including those in higher-risk subgroups, an international team of researchers reported this week in the BMJ.
The researchers looked at data from nine randomized controlled trials and four observational studies involving 55,682 patients who belonged to a delayed antibiotic prescription group and an immediate or no-antibiotic prescription group. The primary outcome analyzed was the average symptom severity 2 to 4 days after the initial consultation, measured on a seven-item scale (ranging from normal  to as bad as could be ). The secondary outcomes were duration of illness after initial consultation, complications resulting in admission to a hospital or death, reconsultation with the same or worsening illness, and patient satisfaction.
No difference was found in symptom severity for delayed versus immediate antibiotics (adjusted mean difference, -0.003; 95% confidence interval [CI], -0.12 to 0.11) or delayed versus no antibiotics (0.02; 95% CI, -0.11 to 0.15). Symptom duration was slightly longer in those given delayed versus immediate antibiotics (11.4 vs 10.9 days) but was similar for delayed versus no antibiotics.
Complications resulting in hospital admission or death were lower with delayed antibiotics than with no antibiotics (odds ratio [OR], 0.62; 95% CI, 0.30 to 1.27) and with delayed versus immediate antibiotics (OR, 0.78; 95% CI, 0.53 to 1.13). A significant reduction in reconsultation rates (OR, 0.72; 95% CI, 0.60 to 0.87) and an increase in patient satisfaction (adjusted mean difference, 0.09; 95% CI, 0.06 to 0.11) were observed in delayed versus no antibiotics.
Subgroup analysis showed that children younger than 5 years had a slightly higher follow-up symptom severity with delayed antibiotics than with immediate antibiotics (adjusted mean difference, 0.10; 95% CI, 0.03 to 0.18), but no increased severity was found in older age groups.
The study authors say that while delayed antibiotic prescribing and no antibiotic prescribing were equally effective for clinical outcomes, the increased patient satisfaction and lower reconsultation rate suggests it could be a stewardship strategy that works for both patients and providers.
“Delayed prescribing could be used as a standalone interventional approach, but it might also be a way of resolving mismatched expectations between clinician and patient,” they wrote.
Apr 28 BMJ study
Outpatient UTI stewardship tied to more guideline-concordant prescribing
An outpatient stewardship program implemented at a primary care clinic and an urgent care clinic in North Carolina was associated with an increase in guideline-concordant antibiotic prescribing for urinary tract infection (UTI), researchers reported this week in Open Forum Infectious Diseases.
The quasi-experimental study conducted by researchers at Duke University looked at the effect of a two-phase intervention implemented at the clinics from August 2017 through July 2019. Phase 1 included the development of clinic-specific antibiograms and UTI diagnosis and treatment guidelines, which were presented during educational sessions with clinic providers. Phase 2 consisted of clinic- and provider-specific feedback emails showing trends in UTI diagnoses, guideline concordance, and antibiotic prescribing.
The primary outcome of the study was the percent of encounters with first- or second-line antibiotics prescribed according to clinic-specific guidelines from August 2016 through July 2019.
The researchers collected data on 4,724 patients and 6,381 UTI encounters. Immediately after phase 1, a 21.8% increase in the percentage of prescriptions for guideline-concordant prescriptions was observed (95% CI, 11.5% to 32%), followed by a 0.5% decline for each 2-week period afterward. Guideline concordance stabilized after implementation of phase 2, and further decline was not seen (-0.6%; 95% CI, -1.6% to 0.4%).
Overall, the mean percent of guideline concordance at the primary care clinic increased from 65% at baseline to 72.6% in phase 1 and 75% in phase 2; at the urgent care clinic, it rose from 35.8% to 57.3% to 61%. The shift in prescribing resulted in a 52% decline in fluoroquinolone use at both clinics. The mean number of UTI diagnoses per 2-week period also declined at both clinics.
“The present study suggests that the provision of clinic-specific urinary antibiograms along with treatment guidelines, clinician education, and data feedback to clinicians was successful at increasing guideline concordance, including a robust shift away from fluoroquinolones towards other agents with narrower spectrum and lower collateral damage, and reducing UTI diagnoses,” the study authors wrote.
Apr 28 Open Forum Infect Dis abstract