Pharmacy and Pharmaceutical Sciences Commons^™

Comparison Of Post-Marketing Surveillance Approaches Regarding Infections Related To Tumor Necrosis Factor (Tnf) Inhibitors, Cheng Chen

Pharmaceutical Sciences ETDs

Objective: Both spontaneous (voluntary) reporting systems and observational approaches serve as important tools in post-marketing surveillance for adverse drug events, however, each has its own advantages. The primary purpose of this project was to compare and contrast the FDA Adverse Event Reporting System (FAERS) data and findings from observational studies in post-marketing surveillance through examining TNF inhibitors (etanercept, adalimumab, infliximab, certolizumab and golimumab) related infections, and secondarily, to examine the applicability of additional analyses in FAERS, such as multiple logistic regressions and time to onset of event analysis.

Methods: Using MedDRA^® preferred terms (PTs), infection and infestation cases in …

Pharmaceutical Federalism, Patricia J. Zettler

Faculty Publications By Year

There is growing interest in states regulating pharmaceuticals in ways that challenge the U.S. Food and Drug Administration’s (FDA) federal oversight. For example, in 2013 Maine enacted a law to permit the importation of unapproved drugs, reflecting concerns that federal requirements are too restrictive, while in 2014 Massachusetts banned an FDA-approved painkiller, reflecting concerns that federal requirements are too lax. This Article provides an account of this recent state interest in regulating drugs and considers its consequences. It argues that these state regulatory efforts, and the nascent litigation about them, demonstrate that the preemptive reach of the FDA’s authority extends …

Nsu Sharks Rx-Summer, 2017, Nova Southeastern University

NSU Sharks Rx

No abstract provided.

Analysis Of The Proposed Tpp-Related Patent Linkage System In Taiwan, Ping-Hsun Chen

Journal of Law and Health

The Trans-Pacific Partnership (TPP) Agreement mandates member states to implement a patent linkage system vested in Article 18.53. To successfully join the TPP Agreement, Taiwan has begun the legislation of a patent linkage system by proposing an amendment for the Pharmaceutical Affairs Act. Article 18.53 requires a member either to adopt a notification mechanism under Paragraph 1 or to stay the issuance of marketing approval under Paragraph 2. But, Taiwan’s proposal includes both measures. Taiwan’s patent linkage system allows a pioneer drug company to register patents claiming (a) a material, (b) a combination or formula, or (c) pharmaceutical use. The …

Determinan Harapan Peserta Jaminan Kesehatan Nasional Terhadap Layanan Di Klinik Pratama Kota Depok Periode Mei Tahun 2016, Baiq Qurrata Aini, Rita Damayanti

Jurnal Ekonomi Kesehatan Indonesia

The score of JKN member’s satisfaction in primary clinic in 2014 reached as high as 80%, which means that it achieved the target of Jaminan Kesehatan Nasional’s (JKN) Road Map. However, there were still many complaints coming from the BPJS customer as shown in YLKI report and in Kemenpan official website regarding unfulfillment of their expectations. This study aimed to obtain information about the determinant of member’s expectation to the service of primary clinic in Depok (May 2016). This study combined qualitative and quantitative study by sequential exploratory, which was started by qualitative study to explore the phenomena and then …

Analisis Pembiayaan Program Promotif Dan Preventif Pemberantasan Demam Berdarah Dengue (Dbd) Bersumber Pemerintah Di Kota Semarang Tahun 2013-2015, Nisa Kamila, Mardiati Nadjib

Jurnal Ekonomi Kesehatan Indonesia

In 2010–2014, Semarang was involved as the big three city with high incidence rate of dengue in Central Java province. This study aimed to analyze the financing by the local government for Dengue preventive program in 2013-2015, as well as the resources gap. The health account approach was used to analyze spending by source, function, and provider. Total local government spending for dengue in 2013 were IDR 4.018.927.020,- increased by 101% in 2014 and increased by 218% in 2015. The largest expenditure for Dengue Preventive program is epidemiological surveillance and infectious disease control. There was no gap between available resources …

Analisis Perhitungan Kapitasi Pada Fasilitas Kesehatan Tingkat Pertama Yang Bekerja Sama Dengan Bpjs Kesehatan Kcu Kota Bogor Tahun 2015, Ayu Novia Kurnia, Atik Nurwahyuni

Jurnal Ekonomi Kesehatan Indonesia

Based on PMK No. 69 in 2013, capitation is set at the same tariff for all age groups and only distinguished for each primary health care. Capitation is not adjusted by individual risk. This study aimed to calculate the capitation by age, using cross sectional design. The result of this study was capitation by age groups at the primary health care level. It was indicated that there was different capitation between age groups, with higher capitation observed in the age group of 0-4 and ≥50 years old and declining in productive age.

Pemanfaatan Dana Kapitasi Oleh Puskesmas Di Kota Lubuklinggau Tahun 2014-2016, Muhammad Muhammad Yulianto Muhammad Yulianto, Mardiati Nadjib

Jurnal Ekonomi Kesehatan Indonesia

Since the implementationof National Health Insurance (JKN), Health Centers received the payment from Social Security Agency for Health (BPJS) using capitation. In Lubuklinggau City, there has been problem inutilizing capitation and financing surplus (SiLPA) for approximately 23% per year. This research aimed to analyze the utilization of capitationin Lubuklinggau City 2014-2016. This qualitative study was implemented in SimpangPeriuk Health Center, Taba, Citra Medika and Swasti Saba which werethe lowest and highest SiLPA absorption, and data were collected retrospectively. The study revealedthat the capitation funds have achieved the target (69,5%) while spending for operational was still under utilized (12,4%). The planning …

Analisis Faktor-Faktor Yang Berhubungan Dengan Tingginya Rujukan Kasus Non Spesialistik Pasien Jaminan Kesehatan Nasional Pada Puskesmas Di Kabupaten Sukabumi Tahun 2015, Masykur Alawi, Purnawan Junadi, Siti Nur Latifah

Jurnal Ekonomi Kesehatan Indonesia

Public Health Center is the frontline in the basic health services that include non-specialist cases to be solved in this primary health care level. However, a report from BPJS Kesehatan in 2015 showed that there were 11.487 referral of non-specialist cases in Primary Health Cares (PHCs) in Sukabumi. This study was to determine factors associated with high referral rate of National Health Insurance’s members with non-specialist cases by PHCs in Sukabumi in 2015. The study employed cross-sectional design in 58 PHCs along with a general practitioner in each centers using a whole sampling. The result showed that there were correlation …

Analisis Karakteristik Dan Persepsi Pengguna Pelayanan Terhadap Pemanfaatan Puskesmas Sebagai Gatekeeper Di Dua Puskesmas Kota Bekasi Tahun 2016, Fitria Kusumawati Wulandari, Anhari Achadi

Jurnal Ekonomi Kesehatan Indonesia

The concept of primary health care in the era of National Health Insurance (JKN) is developed by strengthening primary health care as a gatekeeper with the concept of managed care. In this concept of managed care, one og the success story of the gatekeeper system is assessed by the visit and referral rates to the Higher Level of Health Facilities (ALHF/Fasilitas Kesehatan Tingkat Lanjut). This study aimed to determine the characteristics and perception of service users towards utilization of public health centers (PHC/Puskesmas) as gatekeeper in two PHC in City of Bekasi. This study used cross-sectional design and data collection …

Efficient Synthesis Of Cn2097 Using In Situ Activation Of Sulfhydryl Group, Shaban Darwish, Keykavous Parang, John Marshall, Dennis J. Goebel, Rakesh Tiwari

Pharmacy Faculty Articles and Research

CN2097 (R₇Cs-sCYK[KTE(β-Ala)]V) is a rationally designed peptidomimetic that shows effectiveness in preclinical models for the treatment of neurological disorders, such as Angelman syndrome, traumatic brain injury (TBI), and stroke. Because of its potential therapeutic activity for the treatment of human CNS disorders, there was an urgent need to develop an efficient strategy for large-scale synthesis of CN2097. The synthesis of CN2097 was accomplished using Fmoc/tBu solid phase chemistry in multiple steps. Two different peptide fragments (activated polyarginine peptide Npys-sCR₇ and CYK[KTE(β-Ala)]V) were synthesized, followed by solution phase coupling in water. Activation of the polyarginine (CR₇) …

A Microrna Signature Of Response To Erlotinib Is Descriptive Of Tgfβ Behaviour In Nsclc, Madeline J. Krentz Gober, James P. Collard, Katherine L. Thompson, Esther P. Black

Pharmaceutical Sciences Faculty Publications

Our previous work identified a 13-gene miRNA signature predictive of response to the epidermal growth factor receptor (EGFR) inhibitor, erlotinib, in Non-Small Cell Lung Cancer cell lines. Bioinformatic analysis of the signature showed a functional convergence on TGFβ canonical signalling. We hypothesized that TGFβ signalling controls expression of the miRNA genes comprising an erlotinib response signature in NSCLC. Western analysis revealed that TGFβ signalling via Smad2/3/4 occurred differently between erlotinib-resistant A549 and erlotinib- sensitive PC9 cells. We showed that TGFβ induced an interaction between Smad4 and putative Smad Binding Elements in PC9. However, qRT-PCR analysis showed that endogenous miR-140/141/200c expression …

Authority And Scope Of Vaccination: How States Differ, Sharon Xavioer, Jeff Goad

Pharmacy Faculty Articles and Research

"Despite all this, vaccine rates still fall short of desirable goals, such as those outlined in the Healthy People 2020 national initiative.⁷ Although the CDC and APhA promote the “immunization neighborhood” concept, meaning all appropriate professions should coordinate, communicate, and collaborate to increase immunization rates, challenges are still evident for pharmacies.⁸ One major factor is the variability in state laws and regulations that govern vaccine administration by pharmacists.⁵ Significant regulation differences limit which vaccines are permitted, which age groups of patients can be immunized, and which practice model pharmacists may operate under.⁹"

A Direct In Vivo Comparison Of The Melanocortin Monovalent Agonist Ac-His-Dphe-Arg-Trp-Nh2 Versus The Bivalent Agonist Ac-His-Dphe-Arg-Trp-Pedg20-His-Dphe-Arg-Trp-Nh2: A Bivalent Advantage, Cody J Lensing, Danielle N Adank, Stacey L Wilber, Katie T Freeman, Sathya M Schnell, Robert Charles Speth, Adam T Zarth, Carrie Haskell-Luevano

Faculty Articles

Bivalent ligands targeting putative melanocortin receptor dimers have been developed and characterized in vitro, however studies of their functional in vivo effects have been limited. The current report compares the effects of homobivalent ligand CJL-1-87, Ac-His-DPhe-Arg-Trp-PEDG20-His-DPhe-Arg-Trp-NH₂, to monovalent ligand CJL-1-14, Ac-His-DPhe-Arg-Trp-NH₂ on energy homeostasis in mice after central intracerebroventricular (ICV) administration into the lateral ventricle of the brain. Bivalent ligand CJL-1-87 had noteworthy advantages as an anti-obesity probe over CJL-1-14 in a fasting-refeeding in vivo paradigm. Treatment with CJL-1-87 significantly decreased food intake compared to CJL-1-14 or saline (50% less intake 2 to 8 hours after …

June 2017, Randy Curry, Cindy Brooks

RURAL ROCKS

Rural Rocks, the Rural Health Network newsletter by the SWOSU College of Pharmacy

Allosteric Modulatory Effects Of Sri-20041 And Sri-30827 On Cocaine And Hiv-1 Tat Protein Binding To Human Dopamine Transporter, Wei-Lun Sun, Pamela M. Quizon, Yaxia Yuan, Wei Zhang, Subramaniam Ananthan, Chang-Guo Zhan, Jun Zhu

Molecular Modeling and Biopharmaceutical Center Faculty Publications

Dopamine transporter (DAT) is the target of cocaine and HIV-1 transactivator of transcription (Tat) protein. Identifying allosteric modulatory molecules with potential attenuation of cocaine and Tat binding to DAT are of great scientific and clinical interest. We demonstrated that tyrosine 470 and 88 act as functional recognition residues in human DAT (hDAT) for Tat-induced inhibition of DA transport and transporter conformational transitions. Here we investigated the allosteric modulatory effects of two allosteric ligands, SRI-20041 and SRI-30827 on cocaine binding on wild type (WT) hDAT, Y470 H and Y88 F mutants. Effect of SRI-30827 on Tat-induced inhibition of [³H]WIN35,428 …

Compartmentalized Camp Responses To Prostaglandin Ep2 Receptor Activation In Human Airway Smooth Muscle Cells, Shailesh R. Agarwal, Kathryn Miyashiro, Htun Latt, Rennolds S. Ostrom, Robert D. Harvey

Pharmacy Faculty Articles and Research

Background and Purpose

Previous studies indicate that prostaglandin EP2 receptors (EP2Rs) selectively couple to adenylyl cyclase type 2 (AC2) in non-lipid raft domains of airway smooth muscle (ASM) cells, where they regulate specific cAMP-dependent responses. The goal of the present study was to identify the cellular microdomains where EP2Rs stimulate cAMP production.

Experimental Approach

FRET-based cAMP biosensors were targeted to different subcellular locations of primary human ASM cells. The Epac2-camps biosensor, which expresses throughout the cell, was used to measure bulk cytoplasmic responses. Epac2-MyrPalm and Epac2-CAAX were used to measure responses associated with lipid raft and non-raft regions of the …

Data-Driven Design Of An Ebola Therapeutic, Robert A. Lodder

Pharmaceutical Sciences Faculty Publications

Formulation is very important in drug delivery. The wrong formulation can render a drug product useless. The amount of preclinical (animal and in vitro) work that must be done before a new drug candidate can be tested in humans can be a problem. The cost of these cGxP studies is typically $3-$5 million. If the wrong drug product formulation is tested, new iterations of the formulation must be tested with additional costs.

Data-driven computational science can help reduce this cost. In the absence of existing human exposure, a battery of preclinical tests must be performed in at least two species …

Towards A Better Understanding Of On And Off Target Effects Of The Lymphocyte-Specific Kinase Lck For The Development Of Novel And Safer Pharmaceuticals, Xiaofei Zhang, Amir Kucharski, Wibe A. De Jong, Sally R. Ellingson

Markey Cancer Center Faculty Publications

In this work we have developed a multi-tiered computational platform to study protein-drug interactions. At the beginning of the workflow more efficient and less accurate methods are used to enable large libraries of proteins in many conformations and massive chemical libraries to be screened. At each subsequent step in the workflow a subset of input data is investigated with increased accuracy and more computationally expensive methods. We demonstrate the developed workflow with the investigation of the lymphocyte-specific kinase LCK, which is implicated as a drug target in many cancers and also known to have toxic effects when unintentionally targeted. Several …

Synthesis And Evaluation Of Antimicrobial Activity Of [R4w4k]-Levofloxacin And [R4w4k]-Levofloxacin-Q Conjugates, Neda Riahifard, Kathy Tavakoli, Jason Yamaki, Keykavous Parang, Rakesh Tiwari

Pharmacy Faculty Articles and Research

The development of a new class of antibiotics to fight bacterial resistance is a time-consuming effort associated with high-cost and commercial risks. Thus, modification, conjugation or combination of existing antibiotics to enhance their efficacy is a suitable strategy. We have previously reported that the amphiphilic cyclic peptide [R4W4] had antibacterial activity with a minimum inhibitory concentration (MIC) of 2.97 g/mL against Methicillin-resistant Staphylococcus aureus (MRSA). Herein, we hypothesized that conjugation or combination of the amphiphilic cyclic peptide [R4W4] with levofloxacin or levofloxacin-Q could improve the antibacterial activity of levofloxacin and levofloxacin-Q. Fmoc/tBu solid-phase chemistry was employed to synthesize conjugates of …

Pharmacological Approaches For The Management Of Patients With Moderately Elevated Triglycerides (150-499 Mg/Dl), Michael S. Kelly, Craig Beavers, John D. Bucheit, Evan M. Sisson, Dave L. Dixon

Pharmacy Faculty Articles and Research

Hypertriglyceridemia, defined as serum triglyceride (TG) levels > 150 mg/dL, now affects over one-quarter of the U.S. adult population and is associated with an increased risk of atherosclerotic cardiovascular disease. Available guidelines for managing hypertriglyceridemia vary with respect to triglyceride thresholds and severity of disease. Lifestyle modifications and management of secondary causes (e.g., diabetes) remain the first step in managing hypertriglyceridemia, with pharmacotherapy reserved to reduce the risk of pancreatitis and/or further reduce TG levels. Several classes of lipid-lowering agents are available with variable TG-lowering efficacy. While there is no consensus regarding the choice of initial TG-lowering pharmacotherapy, there is general …

Effects Of Phosphodiesterase 3a Modulation On Murine Cerebral Microhemorrhages, Rachita K. Sumbria, Vitaly Vasilevko, Mher Mahoney Grigoryan, Annlia Paganini-Hill, Ronald Kim, David H. Cribbs, Mark J. Fisher

Pharmacy Faculty Articles and Research

Background: Cerebral microbleeds (CMB) are MRI-demonstrable cerebral microhemorrhages (CMH) which commonly coexist with ischemic stroke. This creates a challenging therapeutic milieu, and a strategy that simultaneously protects the vessel wall and provides anti-thrombotic activity is an attractive potential approach. Phosphodiesterase 3A (PDE3A) inhibition is known to provide cerebral vessel wall protection combined with anti-thrombotic effects. As an initial step in the development of a therapy that simultaneously treats CMB and ischemic stroke, we hypothesized that inhibition of the PDE3A pathway is protective against CMH development.

Methods: The effect of PDE3A pathway inhibition was studied in the inflammation-induced and …

Prevalence And Predictors Of Herbal Medicine Use Among Adults In The United States, Mohamed Rashrash, Jon C. Schommer, Lawrence M. Brown

Pharmacy Faculty Articles and Research

Objective: To describe the prevalence of herbal medicine use among US adults and to assess factors associated with and predictors of herbal use. Design: The data for herbal products use were collected from the 2015 National Consumer Survey on the Medication Experience and Pharmacists’ Roles. Chi-square test was used to analyz factors associated with herbal use, and predictors of herbal use were assessed with logistic regression analysis. Results: Factors associated with herbal supplement use include age older than 70, having a higher than high school education, using prescription medications or over-thecounter (OTC) medications, and using a mail-order …

Commencement Program 2017, Loma Linda University

Commencement Programs

CONTENTS

1 | Message from the President

3 | 2017 Events of Commencement

5 | The Academic Procession

7 | Significance of Academic Regalia

9 | The Good Samaritan

10 | University History Highlights

12 | Loma Linda University Song - "Healing Love"

13 | The University Honorees

26 | The Programs, The School Honorees, and The Speakers

• School of Medicine, 27
• School of Pharmacy, 52
• School of Dentistry, 64
• School of Allied Health Professions - Allied Health Studies, Cardiopulmonary Sciences, Clinical Laboratory Science, Communication Sciences and Disorders, Health Informatics and Information Management, Nutrition and Dietetics, Physician Assistant Sciences, Radiation …

Loss Of Resistance To Angiotensin Ii-Induced Hypertension In The Jackson Laboratory Recombination-Activating Gene Null Mouse On The C57bl/6j Background, Hong Ji, Amrita V Pai, Crystal A West, Xie Wu, Robert Charles Speth, Kathryn Sandberg

Faculty Articles

Resistance to angiotensin II (Ang II)–induced hypertension in T-cell–deficient male mice with a targeted mutation in the recombination-activating gene-1 (Rag1) on the C57BL/6J background (B6.Rag1^−/−-M), which was reported by 5 independent laboratories including ours before 2015, has been lost. In mice purchased from Jackson Laboratory in 2015 and 2016, the time course and magnitude increase in mean arterial pressure induced by 2 weeks of Ang II infusion at 490 ng/kg per minute was identical between B6.Rag1^−/−-M and male wild-type littermates. Moreover, there were no differences in the time course or magnitude increase …

Immune Checkpoint Inhibition And The Prevalence Of Autoimmune Disorders Among Patients With Lung And Renal Cancer, Sherif M. El-Refai

Pharmaceutical Sciences Faculty Publications

PURPOSE: Immune checkpoint inhibition reactivates the immune response against cancer cells in multiple tissue types and has been shown to induce durable responses. However, for patients with autoimmune disorders, their conditions can worsen with this reactivation. We sought to identify, among patients with lung and renal cancer, how many harbor a comorbid autoimmune condition and may be at risk of worsening their condition while on immune checkpoint inhibitors such as nivolumab and pembrolizumab.

METHODS: An administrative health care claims database, Truven MarketScan, was used to identify patients diagnosed with lung and renal cancer from 2010 to 2013. We assessed patients …

Identification Of A Nucleoside Analog Active Against Adenosine Kinase-Expressing Plasma Cell Malignancies, Utthara Nayar, Jouliana Sadek, Jonathan Reichel, Denise Hernandez-Hopkins, Gunkut Akar, Peter J. Barelli, Michelle A. Sahai, Hufeng Zhou, Jennifer Totonchy, David Jayabalan, Ruben Niesvizky, Ilaria Guasparri, Duane Hassane, Yifang Liu, Shizuko Sei, Robert H. Shoemaker, J. David Warren, Olivier Elemento, Kenneth M. Kaye, Ethel Cesarman

Pharmacy Faculty Articles and Research

Primary effusion lymphoma (PEL) is a largely incurable malignancy of B cell origin with plasmacytic differentiation. Here, we report the identification of a highly effective inhibitor of PEL. This compound, 6-ethylthioinosine (6-ETI), is a nucleoside analog with toxicity to PEL in vitro and in vivo, but not to other lymphoma cell lines tested. We developed and performed resistome analysis, an unbiased approach based on RNA sequencing of resistant subclones, to discover the molecular mechanisms of sensitivity. We found different adenosine kinase–inactivating (ADK-inactivating) alterations in all resistant clones and determined that ADK is required to phosphorylate and activate 6-ETI. Further, we …

Power Dissipation And Power Correlations For A Retreatblade Impeller Under Different Baffling Conditions, Chadakarn Sirasitthichoke

Theses

Glass-lined stirred reactors and tanks are commonly used in the pharmaceutical industry because of their corrosion resistance, ease of cleanliness and minimization of product contamination. Most industrial glass-lined tank reactors are provided with a torispherical tank bottom and a retreat curve impeller with low impeller clearance from the vessel bottom. The power, P, dissipated by the impeller is a critical process parameter to mixing processes to achieve the desired mixing effect, especially since the power per unit volume, P/V, directly controls mass transfer processes and other mixing phenomena. However, little information has been published about the power dissipation and the …

Introduction To Systematic Reviews And Meta Analysis Php ###, Joanna Burkhardt

Library Impact Statements

No abstract provided.

May 2017, Randy Curry, Cindy Brooks

RURAL ROCKS

Rural Rocks, the Rural Health Network newsletter by the SWOSU College of Pharmacy