Ideal Vial Size for Infliximab in the Treatment of Inflammatory Bowel Disease: An Analysis of Pharmaceutical Waste and Physician Opinions.

Background: Infliximab is a weight-based prescription for multiple autoimmune diseases and is dispensed only in single-use, 100mg vials. We aim to compute the quantity of infliximab waste at our site and in an ideal world where weight-based prescribing practices are followed. We estimate hypothetical waste reduction and cost-savings if a smaller vial is dispensed. We also surveyed gastroenterologists to study prescription rounding practices for infliximab. Methods: A pre-existing registry of 426 inflammatory bowel disease patients identified 112 individuals who had received a total of 1003 infliximab administrations from December 2013 to May 2019. We calculated infliximab wastage per administration for the real world and an ideal (weight-based) world. Analysis of potential waste reduction and cost-savings was computed with the hypothetical creation of 50 and 25mg vials. Infliximab-prescribing gastroenterologists completed an online survey, determining reasons for rounding of weight-based prescription, rounding practices, and biosimilar use. Results: At our site, the total value of infliximab wasted was between $112738.08 and $243209.50. Utilizing 50 and 25mg vials would reduce this waste by 92.2% and 99.4%, respectively. If prescriber guidelines were followed precisely, the total value of waste was between $132781.08 and $286448.19. Utilizing 50 and 25mg vials would reduce waste by 50.39% and 75.34%, respectively. The physician survey revealed that 68.1% rounded doses while only 31.9% prescribed exact weight-based doses. Conclusions: Infliximab-prescribing gastroenterologists considered reducing drug waste as a common reason in their rounding practices. Our analysis demonstrates significant waste reduction and cost-savings are possible with the introduction of 50 and 25mg vials.

Author Correction: Differences in the fecal microbiota of neonates born at home or in the hospital.

A correction to this article has been published and is linked from the HTML and PDF versions of this paper. The error has been fixed in the paper.

Differences in the fecal microbiota of neonates born at home or in the hospital.

Research on the neonatal microbiome has been performed mostly on hospital-born infants, who often undergo multiple birth-related interventions. Both the hospital environment and interventions around the time of birth may affect the neonate microbiome. In this study, we determine the structure of the microbiota in feces from babies born in the hospital or at home, and from vaginal samples of their mothers. We included 35 vaginally-born, breast-fed neonates, 14 of whom delivered at home (4 in water), and 21 who delivered in the hospital. Feces from babies and mothers and maternal vaginal swab samples were collected at enrollment, the day of birth, followed by days 1, 2, 7, 14, 21, and 28. At the time of birth, the diversity of the vaginal microbiota of mothers delivering in the hospital was higher than in mothers delivering at home, and showed higher proportion of Lactobacillus. Among 20 infants not exposed to perinatal maternal antibiotics or water birth, fecal beta diversity differed significantly by birth site, with hospital-born infants having lower Bacteroides, Bifidobacterium, Streptococcus, and Lactobacillus, and higher Clostridium and Enterobacteriaceae family (LDA > 3.0), than babies born at home. At 1 month of age, feces from infants born in the hospital also induced greater pro-inflammatory gene expression (TLR4, IL-8, occludin and TGFß) in human colon epithelial HT-29 cells. The results of this work suggest that hospitalization (perinatal interventions or the hospital environment) may affect the microbiota of the vaginal source and the initial colonization during labor and birth, with effects that could persist in the intestinal microbiota of infants 1 month after birth. More research is needed to determine specific factors that alter bacterial transmission between mother and baby and the long-term health implications of these differences for the developing infant.

Increased weight gain by C-section: Functional significance of the primordial microbiome.

Epidemiological evidence supports a direct association between early microbiota impact-including C-section-and obesity. We performed antibiotic-free, fostered C-sections and determined the impact on the early microbiota and body weight during development. Mice in the C-section group gained more body mass after weaning, with a stronger phenotype in females. C-section-born mice lacked the dynamic developmental gut microbiota changes observed in control mice. The results demonstrate a causal relationship between C-section and increased body weight, supporting the involvement of maternal vaginal bacteria in normal metabolic development.