Pharmacy Administration, Policy and Regulation Commons^™

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 …

The Role Of Community Pharmacy-Based Vaccination In The Usa: Current Practice And Future Directions, Albert Bach, Jeffery A. Goad

Pharmacy Faculty Articles and Research

Community pharmacy-based provision of immunizations in the USA has become commonplace in the last few decades, with success in increasing rates of immunizations. Community pharmacy-based vaccination services are provided by pharmacists educated in the practice of immunization delivery and provide a convenient and accessible option for receiving immunizations. The pharmacist's role in immunization practice has been described as serving in the roles of educator, facilitator, and immunizer. With a majority of pharmacist-provided vaccinations occurring in the community pharmacy setting, there are many examples of community pharmacists serving in these immunization roles with successful outcomes. Different community pharmacies employ a number …

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 …

Compliance To The Consort Statement On Participant Flow Diagrams In Infectious Disease Randomized Clinical Trials, Onyeka P. Godwin, Brandon Dyson, Paul S. Lee, Soon Park, Euni Lee

Pharmacy Faculty Articles and Research

Background: The Consolidated Standard of Reporting Trials (CONSORT) Guidelines were developed to support adequate reporting of randomized controlled trials (RCTs).

Method: A systematic review was conducted including RCTs of infectious diseases published in the top general medical and infectious disease journals in 2010. The level of compliance to flow diagram and its association with the CONSORT endorsement by the journals were evaluated.

Results: A total of 67 studies were included in the analysis and a half of the studies were HIV/AIDS RCTs. About 78% of the studies included the flow diagram and 66% of the studies described …

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 …

Einstein's Medication Reach Program Enhances Patient Care, Deborah Hauser Rph, Mha

Population Health Matters (Formerly Health Policy Newsletter)

No abstract provided.

Implementation Of A Pharmacy-Based Adult Vaccine Benefit: Recommendations For A Commercial Health Plan Benefit, Jeffery A. Goad, Kelly J. Ko, Rolin L. Wade, Hsing-Ting Yu, Ross M. Miller, Bruce Sherman

Pharmacy Faculty Articles and Research

BACKGROUND: Although vaccination rates in children exceed 90% in the United States, adults are vaccinated at far lower rates. In order to address this issue, additional community immunizers are needed, and pharmacists are in an ideal position to fill this void.

OBJECTIVES: To explore issues and barriers related to implementation of a pharmacy-based adult vaccine benefit and develop recommendations supporting a pathway for benefit expansion.

METHODS: A literature review on the current environment surrounding pharmacy-based adult vaccinations and structured interviews were conducted to inform an expert panel meeting using a modified Delphi process (pre/post survey). The goal …

Pharmaceutical Policy Process: Lessons From The Newly Independent States, Irina Ghazaryan

Muskie School Capstones and Dissertations

Although the pharmaceutical sector in Armenia is currently mainly established, some challenges still cause a big concern. Such facts as a lack of important policies on pharmaceuticals, an outdated legislation and a lack of regulation suggest that the pharmaceutical policy process in Armenia is not effective enough and its insufficient effectiveness is one of the most important barriers for successful implementation of pharmaceutical reforms in the country. The goal of this capstone was to analyze pharmaceutical policy process in Armenia and other Newly Independent States and to develop recommendations for Armenia. Data and information were obtained from publication searches and …

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 …

Influence Of Oncotype Dx® On Chemotherapy Prescribing In Early Stage Breast Cancer Patients: A Claims-Based Evaluation Of Utilization In The Real World, Kenneth Neil Kennedy

Theses and Dissertations--Pharmacy

The decision for adjuvant therapy in women with early stage breast cancer (ESBC) has historically been guided by the presence or absence of specific biological markers (hormone and HER2 receptors), age, and extent of nodal involvement. Oncotype DX® is a validated assay that quantifies protein expression that can predict the risk of cancer recurrence. This study evaluates if the use of Oncotype DX® impacts chemotherapy prescribing in ESBC. This retrospective, cohort study identified patients with ESBC from a large commercially insured population from January 2007 through June 2009. Patients were identified as having ESBC by utilizing procedure and diagnosis codes …

Evaluating Consumer Preferences For Medicare Part D Using Conjoint Analysis, La'marcus Wingate

Theses and Dissertations (ETD)

The establishment of an outpatient prescription drug benefit in Medicare, Medicare Part D, was one of the more significant events in United States healthcare reform history. Many seniors have chosen to enroll in the plan as the program has an enrollment of over 27 million. One central premise of Medicare Part D was that the plan would be administered entirely through private insurance plans. Because many plans would be competing against one another for potential beneficiaries, it was expected that companies would offer seniors plans with high quality benefits at lower costs that would presumably be attractive to seniors. However, …

The Incidence Of Hip Fracture Associated With Proton Pump Inhibitor (Ppi) And/Or H2 Receptor Antagonist (H2ra) Use In The Kentucky Medicaid Population, Timothy C. Umeh

MPA/MPP/MPFM Capstone Projects

No executive summary.

Incentives For Orphan Drug Research And Development In The United States, Enrique Seoane-Vazquez, Rosa Rodriguez-Monguio, Sheryl L. Szeinbach, Jay Visaria

Pharmacy Faculty Articles and Research

Background: The Orphan Drug Act (1983) established several incentives to encourage the development of orphan drugs (ODs) to treat rare diseases and conditions. This study analyzed the characteristics of OD designations, approvals, sponsors, and evaluated the effective patent and market exclusivity life of orphan new molecular entities (NMEs) approved in the US between 1983 and 2007.

Methods: Primary data sources were the FDA Orange Book, the FDA Office of Orphan Drugs Development, and the US Patent and Trademark Office. Data included all orphan designations and approvals listed by the FDA and all NMEs approved by the FDA during …

Why Pharmacists Choose To Seek Or Not Seek Board Certification In Pharmacy Practice: A Comparison Of Motivation And Motivating Factors, Mark Tankersley

Theses and Dissertations (ETD)

The stated mission of the Board of Pharmaceutical Specialties (BPS) with regard to specialization is, via board certification, to recognize specialty areas, define skill standards for those specialty areas, and evaluate the knowledge and skills of individual Pharmacy specialists. The perceived or real benefits to the pharmacist of pursuing board certification are unknown. These benefits can be evaluated by separating into values (valences) and instrumentalities, the latter of which is the perceived or known probability that a performance will lead to an outcome. The primary purpose of this study was to determine the differences in values and instrumentalities perceived by …

Drug Selection And Adverse Drug Reactions: Balancing Outcomes And Costs, Enrique Seoane-Vazquez

Pharmacy Faculty Articles and Research

"Regulatory agencies approve drugs for marketing when the ratio of risk to benefit of the drugs is positive, i.e. the potential benefit of using the drug justifies the risk of drug related adverse reactions (ADR). At the point of approval of a drug there is not adequate information about all possible negative outcomes arising from its use in clinical practice. The information is even more limited for patient subgroups, diseases and treatment combinations that were not evaluated in the clinical trials required for approval. Therefore, performing post-marketing pharmacoepidemiological studies is necessary for a better understanding of drug use in usual …

Purchasing Pharmaceuticals (Health, Nutrition And Population (Hnp) Discussion Paper), Ulrika Enemark, Anita Alban, Enrique Seoane-Vazquez

Pharmacy Faculty Books and Book Chapters

This paper discusses the purchasing of pharmaceuticals as a key component of costeffective and equitable healthcare delivery. Pharmaceuticals account for a high, sometimes the dominant share of health expenditures in developing countries, but the desired health outcomes can only be achieved if the adequate medicines reach the right people and are used in the correct way. This requires purchasing arrangements that take into account the information asymmetry between patients and providers, ensure selection of effective, safe and affordable medicines and set economic incentives in a way that encourages rational drug use. The organizational and institutional frameworks define the roles of …

Price Of Pharmaceuticals, Value, R&D, And Intergenerational Equity, Enrique Seoane-Vazquez

Pharmacy Faculty Articles and Research

"A few issues are more debated today than the price of pharmaceuticals. The debate is prompted by the lack of drug access for the world's population, the high expenditures of pharmaceutical companies in marketing and profits, and the need for research and development of new drugs."

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 …