Research and Publication Highlights

Bibliography of completed research and book chapter

Modeling with Medicinal Chemistry: Practical Innovative Technology-based Activity to Enhance Student’s Learning Through Inter-Departmental Collaboration: PART I

Background: Concepts of formulary management and its applications in clinical practice is a challenge faced by many first professional year pharmacy students. This challenge may be attributed to a lack of foundational knowledge and practical skills at this level. Preparing students for lifelong learning mandates early exposure to practical application of concepts. This warrants the need for students to integrate knowledge, skills, abilities, and attitudes in clinical practice. As a result, a state-of-the-art one stop shopping structure of the day (SOD) activity was created for P1 pharmacy students to enable the authors to assess their skill sets. Objective: The objective of the study was to assess the impact of this technique on students’ ability to integrate science into practice. Methods: An institutionally structured curriculum permits concurrent administration of standalone but related courses through inter-departmental collaboration. Connecting the dots in drug information, medicinal chemistry, pharmacology, and pharmacokinetics was identified as a creative means to accomplish this goal. A comprehensive literature search to identify existing models was conducted in PubMed, International Pharmaceutical Abstract (IPA), Embase, Cumulative Index in Allied Health Literature (CINAHL), and alternate resources from inception to 2013 without success. A Pre-class interactive technology-based “Structure of the Day” activity was created utilizing the Moodle course platform, Accelrys®, and SoftChalk® software. Students identified functional groups on new molecular entities, determined the relationships to pharmacological properties, pharmacokinetic profiles, and their applications to drug formulary management. Application activities via in-class discussions and debate were implemented to assess knowledge, attitude and ability to integrate the basic sciences into a skill-building activity. Results:The expected outcome was captured through the sequential activities facilitated by an audience response system. The overall results of the study were promising and positive. The assessment on knowledge, ability, skills and attitude ranged from 72% to 95%. Conclusion: The investigators plan to implement this technique in the curriculum

Welcome to the Excerpts in Pharmacy Research Journal

The editorial board at Cedarville University School of Pharmacy welcomes you to the inaugural issue of the Excerpts in Pharmacy Research Journal (ISSN 2374-4693)

Emergency Contraceptive (EC) Use in Indigent Populations

The indigent population in America is defined as persons who do not have the financial means to support themselves and are below the federal/state poverty line. According to the 2010 United States Census, 13.8% of Americans are living below the poverty line. Indigent populations often rely on the help of others to provide for their basic needs, whether the help of family and friends or government support. Indigent women are disproportionately affected by unwanted, unplanned pregnancies. It is a continuous cycle that plagues families, often causing poverty and an increased dependence on the welfare system. In Medicaid-eligible populations, many women have reported inconsistency in taking their normal birth control after having their first child which may result in another unplanned and/or unwanted pregnancy. This has led to a push for contraceptive education, both routine and emergency, to be integrated in as many places as possible, including schools, doctors’ offices, women’s clinics, and pharmacies

Factors Influencing Emergency Contraception Use in Indigent Populations

Introduction: Indigent women are disproportionately affected by unwanted, unplanned pregnancies. Studies previously identified lack of knowledge about emergency contraception (EC) as a major deterrent from use. This study was performed to address three potential barriers to the use of EC in indigent populations: culture and religion, patient education, and cost. For the entirety of this study, EC refers to levonorgestrel (LNG). Objectives: To determine the impact of culture and religion, patient education, and cost on EC use in the indigent population. Methods: This study was a cross-sectional observational study to explore and investigate relationships between indigent populations and the use of EC. To be included in the study, participants had to be: at least 14 years old, female, and have an annual household income below the federal poverty line (FPL). Those excluded were less than 14 years old, male, and reported an annual household income above the FPL. A questionnaire consisting of 31 survey questions were utilized to assess the endpoints of the study. The study utilized both paper and electronic forms of the survey. Participants signed informed consent to enable them participate in the study. Out of 319 participants, 59 met all inclusion criteria and were used in statistical analyses. Results:Based on Kruskal-Wallis results, religious groups’ acceptance of EC influenced indigent women’s decision to use it (p=0.016). Level of education also influenced women’s understanding of EC as an abortifacient and knowledge of when LNG is effective. Spearman rho revealed correlations between participants’ willingness to pay for EC or routine birth control and knowing that EC was an option (coefficient 0.391; p-value 0.005). There was also a correlation between the cost of EC and ultimate use (coefficient -0.603; p-value Conclusion: Our research found that religious groups’ acceptance of EC use and knowledge about how LNG works does affect the decision to use EC. Neither cultural identification nor cost of EC appears to have a significant impact on the final decision to use

Development of a Novel Aspirin Suppository Formulation and Evaluation of the Acetylation of COX-1 Via a HT-29/Caco-2 Cell Absorption Assay Used to Detect the Absorption of Aspirin Formulated With Various Bases and Excipients

As the baby-boomer population ages, hospitalization rates will rise, increasing the number of patients who are NPO. Research indicates that aspirin use also increases with advanced age. With the increased prevalence of this demographic, there continues to be a growing need for alternative dosage forms for aspirin administration. A common and limited-risk alternative is rectally administered aspirin. However, there appears to be only one commercially available aspirin suppository and it has yielded erratic results as shown in previous research. Aspirin is considered a pro-drug; once it is inside the body, the acidic environment cleaves the aspirin molecule down to salicylic acid, its active form. Rectal cells may not provide an acidic environment needed to cleave the aspirin molecule into salicylic acid, thereby inhibiting the absorption and rate of onset of the drug. With this thought in mind and with the erratic results from the literature, the aim of this study, to be completed by summer of 2015, is to create a novel aspirin suppository. The study will be a prospective preclinical in-vitro design conducted in the Cedarville University Pharmaceutical Sciences lab. The samples will include two colonic adenocarcinoma cell lines, Caco-2 and HT-29. A standard curve will be developed as a baseline by using a 12(S)-HETE ELISA Assay using purified 12(S)-HETE. The two cell lines will be cultured, then incubated. Aspirin will be added to the samples and incubated again for 30 minutes. After incubation, medium samples will be taken and the same ELISA Assay will be performed on the results. The cell line that yields the most consistent results will be selected. The various aspirin formulations will be tested on this cell line in the same fashion. The ELISA assay will be performed and the concentration of 12(S)-HETE will be determined, plotted, and compared to the standard curve. A repeated-measures ANOVA will then be performed to analyze statistical significance

Indicators of sustainable capacity building for health research: analysis of four African case studies

<p>Abstract</p> <p>Background</p> <p>Despite substantial investment in health capacity building in developing countries, evaluations of capacity building effectiveness are scarce. By analysing projects in Africa that had successfully built sustainable capacity, we aimed to identify evidence that could indicate that capacity building was likely to be sustainable.</p> <p>Methods</p> <p>Four projects were selected as case studies using pre-determined criteria, including the achievement of sustainable capacity. By mapping the capacity building activities in each case study onto a framework previously used for evaluating health research capacity in Ghana, we were able to identify activities that were common to all projects. We used these activities to derive indicators which could be used in other projects to monitor progress towards building sustainable research capacity.</p> <p>Results</p> <p>Indicators of sustainable capacity building increased in complexity as projects matured and included</p> <p>- early engagement of stakeholders; explicit plans for scale up; strategies for influencing policies; quality assessments (<it>awareness and experiential stages)</it></p> <p>- improved resources; institutionalisation of activities; innovation <it>(expansion stage)</it></p> <p>- funding for core activities secured; management and decision-making led by southern partners <it>(consolidation stage)</it>.</p> <p>Projects became sustainable after a median of 66 months. The main challenges to achieving sustainability were high turnover of staff and stakeholders, and difficulties in embedding new activities into existing systems, securing funding and influencing policy development.</p> <p>Conclusions</p> <p>Our indicators of sustainable capacity building need to be tested prospectively in a variety of projects to assess their usefulness. For each project the evidence required to show that indicators have been achieved should evolve with the project and they should be determined prospectively in collaboration with stakeholders.</p

Management and outcomes of gastrointestinal congenital anomalies in low, middle and high income countries: Protocol for a multicentre, international, prospective cohort study

Introduction Congenital anomalies are the fifth leading cause of death in children <5 years of age globally, contributing an estimated half a million deaths per year. Very limited literature exists from low and middle income countries (LMICs) where most of these deaths occur. The Global PaedSurg Research Collaboration aims to undertake the first multicentre, international, prospective cohort study of a selection of common congenital anomalies comparing management and outcomes between low, middle and high income countries (HICs) globally. Methods and analysis The Global PaedSurg Research Collaboration consists of surgeons, paediatricians, anaesthetists and allied healthcare professionals involved in the surgical care of children globally. Collaborators will prospectively collect observational data on consecutive patients presenting for the first time, with one of seven common congenital anomalies (oesophageal atresia, congenital diaphragmatic hernia, intestinal atresia, gastroschisis, exomphalos, anorectal malformation and Hirschsprung''s disease). Patient recruitment will be for a minimum of 1 month from October 2018 to April 2019 with a 30-day post-primary intervention follow-up period. Anonymous data will be collected on patient demographics, clinical status, interventions and outcomes using REDCap. Collaborators will complete a survey regarding the resources and facilities for neonatal and paediatric surgery at their centre. The primary outcome is all-cause in-hospital mortality. Secondary outcomes include the occurrence of postoperative complications. Chi-squared analysis will be used to compare mortality between LMICs and HICs. Multilevel, multivariate logistic regression analysis will be undertaken to identify patient-level and hospital-level factors affecting outcomes with adjustment for confounding factors. Ethics and dissemination At the host centre, this study is classified as an audit not requiring ethical approval. All participating collaborators have gained local approval in accordance with their institutional ethical regulations. Collaborators will be encouraged to present the results locally, nationally and internationally. The results will be submitted for open access publication in a peer reviewed journal

Mortality from gastrointestinal congenital anomalies at 264 hospitals in 74 low-income, middle-income, and high-income countries: a multicentre, international, prospective cohort study

Background: Congenital anomalies are the fifth leading cause of mortality in children younger than 5 years globally. Many gastrointestinal congenital anomalies are fatal without timely access to neonatal surgical care, but few studies have been done on these conditions in low-income and middle-income countries (LMICs). We compared outcomes of the seven most common gastrointestinal congenital anomalies in low-income, middle-income, and high-income countries globally, and identified factors associated with mortality. // Methods: We did a multicentre, international prospective cohort study of patients younger than 16 years, presenting to hospital for the first time with oesophageal atresia, congenital diaphragmatic hernia, intestinal atresia, gastroschisis, exomphalos, anorectal malformation, and Hirschsprung's disease. Recruitment was of consecutive patients for a minimum of 1 month between October, 2018, and April, 2019. We collected data on patient demographics, clinical status, interventions, and outcomes using the REDCap platform. Patients were followed up for 30 days after primary intervention, or 30 days after admission if they did not receive an intervention. The primary outcome was all-cause, in-hospital mortality for all conditions combined and each condition individually, stratified by country income status. We did a complete case analysis. // Findings: We included 3849 patients with 3975 study conditions (560 with oesophageal atresia, 448 with congenital diaphragmatic hernia, 681 with intestinal atresia, 453 with gastroschisis, 325 with exomphalos, 991 with anorectal malformation, and 517 with Hirschsprung's disease) from 264 hospitals (89 in high-income countries, 166 in middle-income countries, and nine in low-income countries) in 74 countries. Of the 3849 patients, 2231 (58·0%) were male. Median gestational age at birth was 38 weeks (IQR 36–39) and median bodyweight at presentation was 2·8 kg (2·3–3·3). Mortality among all patients was 37 (39·8%) of 93 in low-income countries, 583 (20·4%) of 2860 in middle-income countries, and 50 (5·6%) of 896 in high-income countries (p<0·0001 between all country income groups). Gastroschisis had the greatest difference in mortality between country income strata (nine [90·0%] of ten in low-income countries, 97 [31·9%] of 304 in middle-income countries, and two [1·4%] of 139 in high-income countries; p≤0·0001 between all country income groups). Factors significantly associated with higher mortality for all patients combined included country income status (low-income vs high-income countries, risk ratio 2·78 [95% CI 1·88–4·11], p<0·0001; middle-income vs high-income countries, 2·11 [1·59–2·79], p<0·0001), sepsis at presentation (1·20 [1·04–1·40], p=0·016), higher American Society of Anesthesiologists (ASA) score at primary intervention (ASA 4–5 vs ASA 1–2, 1·82 [1·40–2·35], p<0·0001; ASA 3 vs ASA 1–2, 1·58, [1·30–1·92], p<0·0001]), surgical safety checklist not used (1·39 [1·02–1·90], p=0·035), and ventilation or parenteral nutrition unavailable when needed (ventilation 1·96, [1·41–2·71], p=0·0001; parenteral nutrition 1·35, [1·05–1·74], p=0·018). Administration of parenteral nutrition (0·61, [0·47–0·79], p=0·0002) and use of a peripherally inserted central catheter (0·65 [0·50–0·86], p=0·0024) or percutaneous central line (0·69 [0·48–1·00], p=0·049) were associated with lower mortality. // Interpretation: Unacceptable differences in mortality exist for gastrointestinal congenital anomalies between low-income, middle-income, and high-income countries. Improving access to quality neonatal surgical care in LMICs will be vital to achieve Sustainable Development Goal 3.2 of ending preventable deaths in neonates and children younger than 5 years by 2030