OBJECTIVES. Our goal was to describe the prevalence of any, occasional, and regular breast milk expression, mothers' reasons for expressing their milk, and sociodemographic factors associated with breast milk expression. PARTICIPANTS AND METHODS. Breastfeeding mothers participating in the 2005–2007 Infant Feeding Practices Study II formed the cohort for these analyses, which were conducted among those with infants in 3 age groups: 1.5 to 4.5 months (n = 1564); >4.5 to 6.5 months (n = 1128); and >6.5 to 9.5 months (n = 914). For the analyses we used frequency and stepwise multiple logistic regression procedures. RESULTS. Eighty-five percent of breastfeeding mothers of infants in the youngest age group had successfully expressed milk at some time since their infant was born. When asked only about the previous 2-week period, 68% of the breastfeeding mothers of infants in this youngest age group had expressed milk, with 43% having done so occasionally and 25% on a regular schedule. Approximately one quarter of breastfeeding mothers of infants in the 2 older infant age groups also expressed milk on a regular schedule. The percentage of mothers expressing milk decreased with increasing infant age. Mothers expressed milk for various reasons. The most frequently cited reason was to get breast milk for someone else to feed their infant. In all 3 age groups, reporting any breast milk expression, compared with none, was positively associated with maternal employment, higher income, lack of previous breastfeeding experience, and living in the Midwest versus the West. In all 3 age groups, expressing milk on a regular schedule, compared with occasionally, was positively associated with maternal employment and the use of an electric versus manual breast pump. CONCLUSIONS. Breast milk expression is a very common practice. It is associated most strongly with maternal employment, a recognized barrier to breastfeeding.

Among patients in the US Medicare nondialysis population with first exposure to IV iron, the risk of anaphylaxis was highest for iron dextran and lowest for iron sucrose.

Following the release of the framework for the Real-World Evidence (RWE) Program, the US Food and Drug Administration (FDA) is actively evaluating and exploring ways to optimize the utility of real-world data (RWD) and RWE to support regulatory decision making. For rare conditions, conducting traditional randomized clinical trials may not always be feasible, and RWD and RWE have played and will continue to play an important role. We use three case examples-cerliponase alfa, asfotase alfa, and uridine triacetate-to illustrate how RWD from disease registries, medical records with chart review, and literature, respectively, have been used to generate RWE to support regulatory decisions for selected rare diseases. These

HIV infection was associated with a higher risk of overdose mortality. Drug use behavior, systematic disease and liver damage associated with HIV infection appeared to account for a substantial portion of this association. The data suggest a group to target with interventions to reduce overdose mortality rates.

Survival of HIV-seropositive participants receiving HAART approximated that of HIV-seronegative participants only when therapy was given at CD4 cell counts > 350 cells/microL. These data, restricted to IDUs, suggest initiating or switching to HAART at higher CD4 cell levels than are currently recommended.

IMPORTANCE In 2011, the US Centers for Medicare & Medicaid Services (CMS) changed its reimbursement policy for hemodialysis to a bundled comprehensive payment system that included the cost of erythrocyte-stimulating agents (ESAs). Also in 2011, the US Food and Drug Administration revised the drug label for ESAs, recommending more conservative dosing in patients with chronic kidney disease. In response to concerns that these measures could have adverse effects on patient care and outcomes, the CMS and the FDA initiated a collaboration to assess the effect. OBJECTIVE To assess the effects of the changes in reimbursement policy and the ESA drug label on patients who underwent incident hemodialysis. DESIGN, SETTING, AND PARTICIPANTS For this retrospective cohort study, patients 66 years or older who had undergone incident hemodialysis, and were enrolled in Medicare parts A, B, or D for at least 12 months prior to hemodialysis initiation between January 1, 2008, and December 31, 2013, were recruited from hemodialysis centers across the United States. Patients were divided into 2 cohorts based on their date of hemodialysis initiation and followed:

To quantify the risk of death among recent-onset (< 5 years) injection drug users, we enrolled 2089 injection drug users (IDUs) age

Purpose-The goal of this study is to summarize trends in rates of adverse events attributable to acetaminophen use, including hepatotoxicity and mortality.Methods-A comprehensive analysis of data from three national surveillance systems estimated rates of acetaminophen-related events identified in different settings, including calls to poison centers (2008-2012), emergency department visits (2004-2012), and inpatient hospitalizations (1998)(1999)(2000)(2001)(2002)(2003)(2004)(2005)(2006)(2007)(2008)(2009)(2010)(2011). Rates of acetaminophen-related events were calculated per setting, census population, and distributed drug units. Conclusions-Acetaminophen-related adverse events continue to be a public health burden. Future studies with additional time points are necessary to confirm trends and determine whether recent risk mitigation efforts had a beneficial impact on acetaminophen-related adverse events. Results-Rates