Pharmacy Administration, Policy and Regulation Commons^™

Monitoring Harm Perceptions Of Smokeless Tobacco Products Among U.S. Adults: Health Information National Trends Survey 2012, 2014, 2015, Shari P. Feirman, Elisabeth A. Donaldson, Mark Parascandola, Kimberly Snyder, Cindy Tworek

United States Food and Drug Administration: Publications

Introduction: Changes to the U.S. smokeless tobacco landscape in recent years include a change to health warnings on packages, the implementation of bans in some stadiums, and the launch of a federal youth pre- vention campaign. It is unclear whether such changes have impacted consumer beliefs about smokeless tobacco. This study examines relative harm perceptions of smokeless tobacco compared to cigarettes among adults and assesses changes in smokeless tobacco harm perceptions over time.

Methods: We analyzed data from three cycles (2012, 2014, 2015) of the Health Information National Trends Survey (HINTS). Using 2015 data, we assessed bivariate associations between smokeless …

Volumetry Of Low-Contrast Liver Lesions With Ct: Investigation Of Estimation Uncertainties In A Phantom Study, Qin Li, Yongguang Liang, Qiao Huang, Min Zong, Benjamin Berman, Marios A. Gavrielides, Lawrence H. Schwartz, Binsheng Zhao, Nicholas Petrick

United States Food and Drug Administration: Publications

Purpose: To evaluate the performance of lesion volumetry in hepatic CT as a function of various imaging acquisition parameters.

Methods: An anthropomorphic abdominal phantom with removable liver inserts was designed for this study. Two liver inserts, each containing 19 synthetic lesions with varying diameter (6–40 mm), shape, contrast (10–65 HU), and both homogenous and mixed-density were designed to have background and lesion CT values corresponding to arterial and portal-venous phase imaging, respectively. The two phantoms were scanned using two commercial CT scanners (GE 750 HD and Siemens Biograph mCT) across a set of imaging protocols (four slice thicknesses, …

Investigation Of Tattoo Pigments By Raman Spectroscopy, Betsy Jean Yakes, Tara Jade Michael, Marianita Perez-Gonzalez, Bhakti Petigara Harp

United States Food and Drug Administration: Publications

As a result of the increase in the practice of tattooing, the US Food and Drug Administration has identified a need for improved analytical methods to detect the pigments and potential impurities in the inks. Raman spectroscopy allows for nondestructive identification of compounds and is commonly used in art, archaeology, and forensics; however, the technique has only limitedly been applied to the identification of tattoo pigments. In this study, approximately 30 inorganic, organometallic, and organic pigmentswere evaluated with Raman spectroscopy by using 532, 633, and 780-nmlasers. Individual optimization of the instrumental parameters was performed for each pigment in order to …

Bacterial Endotoxin Detection In Hyaluronic Acid-Based Medical Devices, Larissa F. Baeva, Srilekha Sarkar Das, Victoria M. Hitchins

United States Food and Drug Administration: Publications

A simple and rapid method has been developed for testing bacterial endotoxin in hyaluronic acid (HA)-based medical devices. High-molecular-weight HA (HMW HA) in solution or HA-based medical devices was digested by the enzyme hyaluronidase to reduce solution viscosity by truncating the long chains of HA and to test for bacterial endotoxin. The bacterial endotoxin level was detected and measured by kinetic chromogenic Limulus Amebocyte Lysate (LAL) assay. The method was applied to two different ophthalmic viscosurgical devices (OVDs) and one dermal filler, and may easily be adapted to use with up to 3% HA solutions and other HA-based medical devices.

Pharmacokinetics And Distribution In Interstitial And Pulmonary Epithelial Lining Fluid Of Danofloxacin In Ruminant And Preruminant Calves, D. A. Mzyk, R. E. Baynes, K. M. Messenger, M. Martinez, G. W. Smith

United States Food and Drug Administration: Publications

The objective of this study was to compare active drug concentrations in the plasma vs. different effector compartments including interstitial fluid (ISF) and pulmonary epithelial lining fluid (PELF) of healthy preruminating (3-week-old) and ruminating (6-month-old) calves. Eight calves in each age group were given a single subcutaneous (s.c.) dose (8 mg/kg) of danofloxacin. Plasma, ISF, and bronchoalveolar lavage (BAL) fluid were collected over 96 h and analyzed by high-pressure liquid chromatography. PELF concentrations were calculated by a urea dilution assay of the BAL fluids. Plasma protein binding was measured using a microcentrifugation system. For most preruminant and ruminant calves, the …

Research Proposal: Emrs Changing Patient Medication Errors, Kerry Moore

Applied Research Projects

In 2009 the federal government initiated the American Recovery and Reinvestment Act (ARRA) in efforts to improve timely and quality health care. This new initiative promised to provide great incentives to health care providers who took advantage of the program by implementing electronic medical records (EMRs) within their facilities, clinics, and practices. Coupled with tight deadlines and the incentive of reimbursement, the health care world has been witness to an influx of EMRs being developed by vendors and implemented at health care facilities. The rate at which these EMRs have been implemented has been astounding. So fast, the health care …

Awareness And Utilization Of The Ohio Automated Rx Reporting System By Physician Assistants, Julia Cathleen Rose

All Theses And Dissertations

Chronic pain has become a public health epidemic. As pain complaints increase, so does the potential for drug abuse/misuse. Prescription drug monitoring programs (PDMPs) are active in 49 of the 50 states to assist providers in recognizing drug abuse/misuse. There is no clear standardization of who utilizes the PDMP and how. Little is still known about the ways PDMP results are incorporated into clinical decision making, what barriers exist, and how providers may or may not alter their prescribing plans based on the results. Laws surrounding prescribing practices and use of the Ohio Automated Rx Reporting System (OARRS) are constantly …

Bridging The Location Gap: Physician Perspectives Of Physician-Pharmacist Collaboration In Patient Care (Bridge Phase Ii), Keri D. Hager, Donald Uden, Daniel M. Tomaszewski

Pharmacy Faculty Articles and Research

Background: To optimize patient outcomes, the patient-centred medical home model emphasizes comprehensive team-based care. Pharmacists are qualified to enhance appropriate medication use and help improve patient outcomes through provision of medication therapy management (MTM) services. To optimally provide MTM, pharmacists must effectively collaborate with physicians. This study explored factors that influence pharmacist-physician collaboration.

Methods and Findings: A convenience sample of five physicians participated in semi-structured interviews and the resulting data were analyzed using qualitative methods. Transcripts of the interviews were independently coded for themes by two researchers. Five themes emerged: trustworthiness, role specification, relationship initiation, effects on practice, …

Applying The Pharmacists’ Patient Care Process To Immunization Services: A Resource Guide For Pharmacists, Albert Bach, Jeff Goad, Mitchel Rothholz, Brian Wall, Anne Burns, Liza Chapman, Jean-Venable “Kelly” R. Goode, Sheila Seed, Rebecca Snead

Pharmacy Faculty Articles and Research

"This guidance document has been written and formatted to align comprehensive components of a pharmacy-based immunization patient encounter Collect Assess Plan Implement Follow-Up 6 American Pharmacists Association and recommendations from the National Vaccine Advisory Committee (NVAC) the Standards for Adult Immunization Practice with the original framework of the PPCP.5 The colored columns to the right throughout this document are the PPCP steps as they have been published by JCPP, and the main document text describes how to integrate each PPCP step into immunization services."

Scientific And Regulatory Policy Committee (Srpc) Review*: Interpretation And Use Of Cell Proliferation Data In Cancer Risk Assessment, Charles E. Wood, Renee R. Hukkanen, Radhakrisha Sura, David Jacobson-Kram, Thomas Nolte, Marielle Odin, Samuel M. Cohen

United States Food and Drug Administration: Publications

Increased cell proliferation is a central key event in the mode of action for many non-genotoxic carcinogens, and quantitative cell proliferation data play an important role in the cancer risk assessment of many pharmaceutical and environmental compounds. Currently, there is limited unified information on assay standards, reference values, targeted applications, study design issues, and quality control considerations for proliferation data. Here, we review issues in measuring cell proliferation indices, considerations for targeted studies, and applications within current risk assessment frameworks. As the regulatory environment moves toward more prospective evaluations based on quantitative pathway-based models, standardiza- tion of proliferation assays will …

Characterization Of Pasteurella Multocida Strains Isolated From Geese, Zsuzsanna Varga, Dmitriy V. Volokhov, Laszlo Stipkovits, Akos Thuma, Boglarka Sellyei, Tibor Magyar

United States Food and Drug Administration: Publications

Phenotypic and genotypic diversity of forty-two Pasteurella multocida isolates from geese were characterized by analysis of their capsular type, Heddleston serotype, biotype, fimbrial gene allele type, comparative outer membrane protein (OMP) electrophoresis patterns, and were analyzed using PCR for the presence of virulence-associated genes (toxA, tbpA, pfhA, hgbA, hgbB, nanH, nanB, fimA, hsf-1, and pmHAS). A sequence comparison of the thdF and rpoB housekeeping genes of twenty representative P. multocida strains from three different OMP groups demonstrated that seventeen strains were closely related phylogenetically to previously published strains of P. multocida subsp. multocida and P. multocida subsp. gallicida, and only …

Retirees And Pharmaceutical Costs: Is There Really A Crisis?, Justine Maiello

Seton Hall University Dissertations and Theses (ETDs)

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The Chemistry Of Pesticides, Walter R. Benson

United States Food and Drug Administration: Publications

Introduction

This review is limited to the structures and a few reactions of the pesticides mainly insecticides-that affect mammalian systems and that are the subject of papers by other authors in this monograph. There is no attempt to give a complete review of the chemistry of pesticides. It is intended only to show the breadth and depth of pesticide chemistry through the use of examples. With proper use of the references, and of the papers by Crosby, Freed and Montgomery, and Owens in this monograph, the reader will be able to find information for other chemicals.

Nomenclature

Pesticides or economic …

Quantitative Calculation Of Gas Chromatographic Peaks In Pesticide Residue Analyses, Jean A. Gaul

United States Food and Drug Administration: Publications

Comparison of five methods for calculating gas chromatographic peaks (disc integration, triangulation, peak height X width at half height, R_t X peak height, and peak height) shows no significant difference in the calculated results when aldrin, heptachlor epoxide, and dieldrin are injected into a gas chromatograph equipped with electron capture detector.

Problems are associated with the calculation of toxaphene, chlordane, DDT, and BHC. The author makes suggestions for calculating these four residues when present individually and in combinations with other pesticides. Use of the last four toxaphene peaks compares favorably with results obtained by using the entire toxaphene curve. …

Analysis Of Pesticide Residues By Polarography, Raymond J. Gajan

United States Food and Drug Administration: Publications

Polarography is a rapid, sensitive, and relatively specific technique that can be applied to pesticide residue analysis. The technique should also prove a valuable tool in overall pesticide research, such as monitoring new columns, studying kinetics, identifying and determining metabolites, assaying primary pesticide standards, and conducting stability studies.

Diphenylamine-Zinc Chloride As A Chromogenic Agent For The Detection Of A Mixture Of Ddt, Chlordane, And Toxaphene On Thin Layer Chromatograms, Lewis J. Faucheux Jr.

United States Food and Drug Administration: Publications

Diphenylamine-ZnCI, has been evaluated as a chromogenic agent for detection of toxaphene, DDT, and chlordane on Al₂O₃ a thin layer plates. Characteristic colors were obtained for these pesticides; a lower level of about 5 μg was detectable. Color reactions of 34 pesticides at the 20 μg level are presented.

Pesticide Residues, J. William Cook, Sidney Williams

United States Food and Drug Administration: Publications

METHODOLOGY for residue analysis has advanced rapidly during the current review period, from November 1962 through October 1964. Notable progress has been made in the development and refinement of methods of analysis by which any or all of a large number of pesticide residue chemicals can be detected and measured in one general operation. This is of particular significance because great interest has developed-outside the scientific community as well as within - in the possible presence of pesticide chemicals in all parts of our environment, including man himself. Only by the use of improved methodology will it be possible to …

Exposure To Parathion Effect On General Population And Asthmatics, Robert S. Ganelin, Cipriano Cueto Jr., G. Allen Mail

United States Food and Drug Administration: Publications

There has been much lay and medical concern regarding toxic effects of insecticides on the general population. In addition to direct toxic effects, it is suspected that insecticidal application has deleterious physical effects on persons with respiratory diseases. To evaluate some of these problems, the authors have attempted to quantitate actual absorption, symptoms, and laboratory evidence of intoxication in persons with varying degrees of exposure to parathion. By means of controlled observations, the respiratory effect of application of this compound on persons with bronchial asthma was also measured. The results suggest that the effect of this chemical on the general …

Application Of Oscillographic Polarography To Determination Of Organic Phosphorus Pesticide Residues, Raymond J. Gajan

United States Food and Drug Administration: Publications

Some organic phosphorus pesticides have been determined successfully by polarography (1-7). However, in most cases the methods were used to determine the pesticide in commercial formulations. Little has been reported on the polarographic determination of microgram amounts of these pesticides such as those encountered in pesticide residue analysis.

Many of the methods used for the determination of these pesticides are nonspecific. They are based on cholinesterase assay (8- 12), radioactive tracer analysis (13, 14), total phosphorus (15-17), and paper chromatography (18-24).

In this paper we will discuss the polarography of Systox, Di-Syston, and· Thimet and some of their oxidation products, …

Swine Brucellosis And Human Health, Us Public Health Service

United States Food and Drug Administration: Publications

Swine brucellosis is caused by Brucella suis, a strain of bacteria which also cau ses human brucellosis, or undulant fever. T his disease is an imp 0 r tan t public health problem which affects thousands of farmers, livestock handlers, meat processors, and butchers .. The U. S. Department of Agriculture estimates that 6.15 percent of the 1.8 million swine herds in the Nation are infected with brucellosis. This represents about 131,000 in f e c ted herds on farms, where some 579,000 farm people come into daily c ontact with these herds. The infection rate among these rural persons …