Trending Topics in Health-System Pharmacy
Shortening treatment for TB
Results from an international randomized controlled clinical trial were presented on October 21 at the 51st Union World Conference on Lung Health. They showed that a 4-month daily treatment regimen containing high-dose rifapentine with moxifloxacin is as safe and effective as the existing standard 6-month daily regimen in curing drug-susceptible tuberculosis (TB).
According to CDC, this regimen is the first successful short-course treatment for drug-susceptible TB disease in almost 40 years. Although the United States has made substantial progress in reducing TB, more than 9,000 patients are diagnosed with TB each year.
CDC’s Tuberculosis Trials Consortium led the Phase III, open-label trial (31/A5349) in collaboration with the AIDS Clinical Trials Group funded by the National Institute of Allergy and Infectious Diseases. More than 2,500 participants ages 12 years and older, including 214 people with HIV, enrolled at 34 clinical sites in 13 countries.
The study examined the efficacy and safety of two 4-month regimens of high-dose rifapentine with or without moxifloxacin. These were compared with the existing 6-month regimen (2RHZE/4RH), which includes 8 weeks of daily treatment with rifampin, isoniazid, pyrazinamide, and ethambutol and 18 weeks of daily treatment with rifampin and isoniazid.
One of the 4-month regimens—2PHZM/2PHM—included 8 weeks of daily treatment with high-dose, or “optimized,” rifapentine, isoniazid,
pyrazinamide, and moxifloxacin and 9 weeks of daily treatment with rifapentine, isoniazid, and moxifloxacin. This regimen met noninferiority criteria for efficacy in all of the several planned analyses and was safe and well tolerated.
The second new treatment regimen—2PHZE/2PH—included 8 weeks of daily treatment with the same dose of rifapentine, isoniazid, pyrazinamide, and ethambutol and 9 weeks of daily treatment with rifapentine and isoniazid. This regimen did not meet noninferiority criteria when compared with the existing standard regimen.
Guidelines for automated insulin delivery
New guidelines for the use of continuous glucose monitors (CGMs) and automated insulin dosing (AID) systems in hospitals, developed by a consensus panel organized by the Diabetes Technology Society and published on September 28 in the Journal of Diabetes Science and Technology, consist of 77 recommendations for management of hospitalized patients with diabetes.
The panel, which consisted of 24 international experts in the use of CGMs and AID systems, reviewed the medical literature pertaining to continuation of home CGMs after hospitalization; initiation of CGMs in the hospital; continuation of AID systems in the hospital; logistics and hands-on care of hospitalized patients using CGMs and AID systems; and data management of CGMs and AID systems in the hospital.
The panelists then developed three types of recommendations for each topic, including clinical practice, research, and hospital policies for each of the five topics.
They include strong and mild recommendations for using the technology optimally, strong and mild recommendations for researchers and manufacturers working to improve the safety and effectiveness of the technology, and strong and mild recommendations for hospitals to build an environment for facilitating use of these devices. The authors noted the need for additional research on device accuracy, practices for deployment, data management, and achievable outcomes for CGMs and AID systems in the hospital setting.
Preventing falls (or not) in older adults
Falls, particularly in older patients, can cause fractures, overuse health resources, and adversely affect patients’ quality of life. A study published in the New England Journal of Medicine on November 5 showed that community screening—advice by mail, screening for fall risk, and a targeted exercise or multifactorial intervention to prevent falls—did not result in fewer fractures than advice by mail alone.
The study, a pragmatic, three-group, cluster-randomized controlled trial, was performed by investigators in the Prevention of Fall Injury Trial Study Group.
The researchers estimated the effect of advice sent by mail, risk screening for falls, and targeted interventions (multifactorial fall prevention or exercise for people at increased risk for falls) compared with advice by mail only. The primary outcome was the rate of fractures per 100 person-years over 18 months. Secondary outcomes were falls, health-related quality of life, frailty, and a parallel economic evaluation.
More than 9,800 people aged 70 years or older were selected from 63 general practices across England. Of these, 3,223 were assigned to advice by mail alone, 3,279 to falls-risk screening and targeted exercise in addition to advice by mail, and 3,301 to falls-risk screening and targeted multifactorial fall prevention in addition to advice by mail.
A falls-risk screening questionnaire was sent to those assigned to the exercise and multifactorial fall-prevention groups. Of the 5,779 participants from these groups who returned questionnaires, 2,153 (37%) were considered at increased risk for falls and were invited to receive the intervention. Fracture data were available for 9,802 of the 9803 participants.
The study results showed that screening and targeted intervention did not result in lower fracture rates, while the exercise strategy was associated with small gains in health-related quality of life and the lowest overall costs. Three adverse events occurred during the trial period: one episode of angina, one fall during a multifactorial fall-prevention assessment, and one hip fracture.
β-lactamase UTIs increase among hospitalized ED patients
A study from researchers at hospitals across the United States and led by David A. Talan, MD, from the University of Southern California Medical Center, shows that among adults hospitalized for urinary tract infection (UTI) in many U.S. locations, ESBL-producing Enterobacteriaceae have emerged as a common cause of infection that is often not initially treated with an in vitro–active antibiotic. The study was published on October 31 in the Annals of Emergency Medicine.
Although Enterobacteriaceae resistant to ceftriaxone, mediated through extended-spectrum β-lactamases (ESBLs), commonly cause urinary tract infections worldwide, they have been less prevalent in North America.
The researchers prospectively enrolled adults hospitalized for UTI from 11 geographically diverse university-affiliated hospital emergency departments (EDs) during 2018 and 2019. Among participants with culture-confirmed infection, they evaluated prevalence of antimicrobial resistance, including that caused by ESBL-producing Enterobacteriaceae, resistance risk factors, and time to treatment with in vitro–active antibiotics.
Of 527 total participants, overall prevalence of ESBL-producing Enterobacteriaceae infection was 17.2%. Infection risk from ESBL-producing Enterobacteriaceae infection included hospital, long-term care, or antibiotic exposure within 90 days, and a fluoroquinolone- or ceftriaxone-resistant isolate within 1 year. Enterobacteriaceae resistance rates for other antimicrobials were fluoroquinolone 32.3%, gentamicin 13.7%, amikacin 1.3%, and meropenem 0.3%. Ceftriaxone was the most common empirical antibiotic.
The researchers found that in vitro–active antibiotics were not administered within 12 hours of presentation to 48 participants (53.9%) with ESBL-producing Enterobacteriaceae infection, including 17 (58.6%) with sepsis. Compared with other Enterobacteriaceae infections, ESBL infections were associated with longer time to in vitro–active treatment (17.3 h vs. 3.5 h).