Understanding Drug Development: A Primer on the Food and Drug Administration.

Over the past year, the Severe Acute Respiratory Syndrome Coronavirus 2 pandemic has led to rapid advancement regarding therapeutics, vaccines, and testing. In the United States, the Food and Drug Administration (FDA) is the agency ensuring standardization, reproducibility, and meeting benchmarks of safety and efficacy for these products. Among medical professionals and the public, there are often questions about the role of regulation, product development and approval, and terminology often used in regard to the FDA. This manuscript will serve as an introduction to the FDA, clarify the steps of drug development and approval, review terms related to product use, and discuss the role of the medical community and industry. The FDA serves as a regulatory agency ensuring safety, efficacy, and quality are met in the approval of drugs, vaccines, biologics, and testing products. Understanding the terms of development can help providers with many new products being developed.

Integration of a Lean Daily Management System into an Antimicrobial Stewardship Program.

Growing demands and limited guidance on efficient use of resources to advance stewardship initiatives challenge antimicrobial stewardship programs (ASP). METHODS: The primary aim was to incorporate a Lean Readiness and Metrics Board (RMB) into ASP and assess team member accountability and satisfaction with weekly 15-minute huddle participation within 1 year of implementation. ASP team survey data were analyzed for comments regarding Lean integration, team communication, and productivity. The second aim was to develop 5 shared metrics associated with quality, people, delivery, safety, and stewardship and evaluate ASP team productivity by assessing the impact of projects targeted at each specific metric. Pharmacist-physician ASP scheduling conflicts were addressed through identified rounding times under the "People" metric. The "Quality" metric assessed ASP intervention disagreement rate and collaborations that occurred to reduce disagreement. ASP tracked the number of individuals educated by ASP monthly through the "Delivery" metric. RESULTS: Since August 2018, ASP replaced hour-long monthly meetings with weekly huddles at the RMB. On average, 14 members (88%) of the ASP participate weekly. Team members report improvement in communication and satisfaction with Lean integration. Metric utilization enhanced productivity. For the metrics under "People," "Quality," and "Delivery," reduced scheduling conflicts occurred, the ASP intervention disagreement rate decreased (37.0%-25.6%; P < 0.001), and the ASP educated an average of 79 learners per month. CONCLUSIONS: Weekly huddles at the RMB enhanced communication and team accountability while visually displaying program needs, progress, and achievements. The RMB helps to ensure ongoing institutional commitment, and Lean methods show promise for evaluating and improving ASP productivity.

Novel outpatient antibiotic prescribing report of respiratory infections in a pediatric health system's emergency departments and urgent care clinics.

We developed a report of overall antibiotic use for respiratory infections in pediatric emergency departments and urgent care clinics. Antibiotics were used in 5.3% of diagnoses where antibiotics are not recommended, and first-line guideline-concordant antibiotics were used in 87% of diagnoses where antibiotics are recommended. Outpatient antibiotic stewardship efforts need to target site and diagnosis-specific challenges.

More Than Dysuria: Corynebacterial Encrusted Cystitis.

Corynebacterium species, typically considered contaminants in urine culture, can cause encrusted cystitis (EC), a form of chronic urinary tract infection causing pain, bladder necrosis, renal failure, and death. Delayed diagnosis is common due to its rarity and the fastidious nature of Corynebacterium urealyticum. Reported mostly in elderly and immunocompromised patients, EC is rare in pediatric patients. A female adolescent on high dose steroids developed persistent dysuria after urinary catheterization. Abnormal bladder ultrasound and characteristic cystoscopy led to the diagnosis of EC. Appropriate treatment instituted 4 months from onset of dysuria led to an excellent response.

Supraphysiological testosterone enanthate administration prevents bone loss and augments bone strength in gonadectomized male and female rats.

High-dose testosterone enanthate (TE) may prevent hypogonadism-induced osteopenia. For this study, 3-mo-old male and female Fisher SAS rats underwent sham surgery, gonadectomy (GX), or GX plus 28 days TE administration (7.0 mg/wk). GX reduced serum sex hormones (i.e., testosterone, dihydrotestosterone, and estradiol) (P < 0.05) in both sexes and bone concentrations of testosterone (males only), and estradiol (females only). GX also elevated urine deoxypyridinoline/creatinine in both sexes and serum osteocalcin (females only), findings that are consistent with high-turnover osteopenia. GX reduced cancellous bone volume (CBV) and increased osteoid surfaces in tibia of both sexes. GX males also experienced reduced trabecular number and width and increased trabecular separation, whereas GX females experienced increased osteoblast and osteoid surfaces. Bone biomechanical characteristics remained unaffected by GX, except that femoral stiffness was reduced in females. In contrast, TE administration to GX rats elevated serum and bone androgens to supraphysiological concentrations in both sexes but altered neither serum nor bone estradiol in males. Additionally, TE did not prevent GX-induced reductions in serum or bone estradiol in females. TE also reduced markers of high-turnover osteopenia in both sexes. In males, TE prevented GX-induced changes in trabecular number and separation, CBV, and osteoid surfaces while diminishing osteoblast and osteoclast surfaces; however, these changes were not fully prevented in females. In both sexes, TE increased femoral length and femoral maximal strength to above that of Sham and GX animals while preventing the loss of femoral stiffness in females. In conclusion, TE administration appears protective of cancellous bone in male rats and augments cortical bone strength in both sexes.