Sitagliptin and other ‘gliptins’ - why prescribe them?

Introduction In 2008, the Federal Drug Administration (FDA) required all new glucose-lowering therapies to show cardiovascular safety, and this applies to the dipeptidyl peptidase (DPP)-4 inhibitors (‘gliptins’). At present, there is contradictory evidence on whether the gliptins increase hospitalizations for heart failure. Areas covered This is an evaluation of the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) in high risk cardiovascular subjects with type 2 diabetes [1]. TECOS demonstrated non-inferiority for sitagliptin over placebo for the primary outcome, which was cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. There was no difference in the rate of hospitalization for heart failure between sitagliptin and placebo. Expert Opinion Despite the results of TECOS, debate over the effects of sitagliptin on the rates of hospitalizations for heart failure continues with some recent studies suggesting increased rates. Recently, empagliflozin (an inhibitor of sodium-glucose cotransporter 2) has been shown to reduce cardiovascular outcomes in subjects with type 2 diabetes, including the rates of hospitalization for heart failure. In our opinion, these positive findings with empagliflozin suggest that it should be prescribed in preference to the gliptins, including sitagliptin, unless any positive cardiovascular outcomes are reported for the gliptins.

Is there a role for microsampling in antibiotic pharmacokinetic studies?

- Introduction Clinical pharmacokinetic studies of antibiotics can establish evidence-based dosing regimens that improve the likelihood of eradicating the pathogen at the site of infection, reduce the potential for selection of resistant pathogens, and minimize harm to the patient. Innovations in small volume sampling (< 50 μL) or ‘microsampling’ may result in less-invasive sample collection, self-sampling and dried storage. Microsampling may open up opportunities in patient groups where sampling is challenging. - Areas Covered The challenges for implementation of microsampling to assure suitability of the results, include: acceptable study design, regulatory agency acceptance, and meeting bioanalytical validation requirements. This manuscript covers various microsampling methods, including dried blood/plasma spots, volumetric absorptive microsampling, capillary microsampling, plasma preparation technologies and solid-phase microextraction. - Expert Opinion The available analytical technology is being underutilized due to a lack of bridging studies and validated bioanalytical methods. These deficiencies represent major impediments to the application of microsampling to antibiotic pharmacokinetic studies. A conceptual framework for the assessment of the suitability of microsampling in clinical pharmacokinetic studies of antibiotics is provided. This model establishes a ‘contingency approach’ with consideration of the antibiotic and the type and location of the patient, as well as the more prescriptive bioanalytical validation protocols.

Simultaneous kinetic spectrophotometric determination of norfloxacin and rifampicin in pharmaceutical formulation and human urine samples by use of chemometrics approaches

A kinetic spectrophotometric method with aid of chemometrics is proposed for the simultaneous determination of norfloxacin and rifampicin in mixtures. The proposed method was applied for the simultaneous determination of these two compounds in pharmaceutical formulation and human urine samples, and the results obtained are similar to those obtained by high performance liquid chromatography.

Multicomponent kinetic spectrophotometric determination of pefloxacin and norfloxacin in pharmaceutical preparations and human plasma samples with the aid of chemometrics

A spectrophotometric method for the simultaneous determination of the important pharmaceuticals, pefloxacin and its structurally similar metabolite, norfloxacin, is described for the first time. The analysis is based on the monitoring of a kinetic spectrophotometric reaction of the two analytes with potassium permanganate as the oxidant. The measurement of the reaction process followed the absorbance decrease of potassium permanganate at 526 nm, and the accompanying increase of the product, potassium manganate, at 608 nm. It was essential to use multivariate calibrations to overcome severe spectral overlaps and similarities in reaction kinetics. Calibration curves for the individual analytes showed linear relationships over the concentration ranges of 1.0–11.5 mg L−1 at 526 and 608 nm for pefloxacin, and 0.15–1.8 mg L−1 at 526 and 608 nm for norfloxacin. Various multivariate calibration models were applied, at the two analytical wavelengths, for the simultaneous prediction of the two analytes including classical least squares (CLS), principal component regression (PCR), partial least squares (PLS), radial basis function-artificial neural network (RBF-ANN) and principal component-radial basis function-artificial neural network (PC-RBF-ANN). PLS and PC-RBF-ANN calibrations with the data collected at 526 nm, were the preferred methods—%RPET not, vert, similar 5, and LODs for pefloxacin and norfloxacin of 0.36 and 0.06 mg L−1, respectively. Then, the proposed method was applied successfully for the simultaneous determination of pefloxacin and norfloxacin present in pharmaceutical and human plasma samples. The results compared well with those from the alternative analysis by HPLC.

The global public health issue of pharmaceutical waste : what role for pharmacists?

Purpose Pharmaceuticals have played an important role in improving the quality of life of the human population in modern times. However, it must also be acknowledged that both the production and use of pharmaceuticals have a significant, negative impact on the environment and consequently, a negative impact on the health of humans and wildlife. This negative impact is due to the embedded carbon in pharmaceuticals' manufacture and distribution and the waste generated in their manufacture, consumption and disposal. Pharmaceutical waste is comprised of contaminated waste (unwanted pharmaceuticals and their original containers) and non-contaminated waste (non-hazardous packaging waste). The paper aims to discuss these issues. Design/methodology/approach The article is a literature review. Findings The article identified a gap in the literature around pharmacist attitudes and behaviour toward the environmentally responsible handling of pharmaceutical waste. Originality/value Pharmacists, with their professional commitment to the quality use of medicines and their active participation in the medicines management pathway, already play an important role in the more sustainable use of pharmaceuticals. Even so, they have the potential to play an even greater role with the environmentally responsible disposal of pharmaceutical waste (including packaging waste) and the education of other health professionals and the general public on this topic.

Development of a cognitive framework for pharmaceutical care

Pharmaceutical Care is defined as “the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient’s quality of life”. One of the fundamental concepts in understanding needs for pharmaceutical care are Drug-Related Problems (DRPs). As the complexity of medication treatment increases, identification of drug-related problems (DRPs) by healthcare professionals remains vital to patient safety and Quality Use of Medicines(QUM). DRPs have been used by many researchers to evaluate the QUM in different settings. DRPs present, however, a list of potential problems not a strategic framework for assessing a medication regimen.

BioPatML : pattern sharing for the genomic sciences

Computational biology increasingly demands the sharing of sophisticated data and annotations between research groups. Web 2.0 style sharing and publication requires that biological systems be described in well-defined, yet flexible and extensible formats which enhance exchange and re-use. In contrast to many of the standards for exchange in the genomic sciences, descriptions of biological sequences show a great diversity in format and function, impeding the definition and exchange of sequence patterns. In this presentation, we introduce BioPatML, an XML-based pattern description language that supports a wide range of patterns and allows the construction of complex, hierarchically structured patterns and pattern libraries. BioPatML unifies the diversity of current pattern description languages and fills a gap in the set of XML-based description languages for biological systems. We discuss the structure and elements of the language, and demonstrate its advantages on a series of applications, showing lightweight integration between the BioPatML parser and search engine, and the SilverGene genome browser. We conclude by describing our site to enable large scale pattern sharing, and our efforts to seed this repository.

A learning community approach to doctoral education in the social sciences

The paper reports on the findings of a community learning approach to doctoral education involving scholarly writing groups (SWGs) which was developed and implemented in the context of a higher degree research programme within the social sciences in an Australian university. The research evaluated the impact of the teaching intervention on students' perceptions of the community learning experience, their knowledge of scholarly writing and their attitudes towards writing. The findings are suggestive of the advantages of community approaches to learning in higher degree research education as a supplement to independent supervision. The SWGs were associated with improvements in both participants' knowledge of scholarly writing and their attitudes towards writing. However, a variety of characteristics of doctoral education are potential impediments to the creation of ongoing and regular interactions in learning communities such as SWGs. The paper concludes that a flexible approach to the recognition and enhancement of community approaches to learning is required to acknowledge the complex and diverse context of contemporary doctoral education.

Crossing boundaries: Implications of advances in basic sciences for the management of addiction.

This set of papers in this issue of "Addictive Behaviors" was presented at the 2004 'Addictions' conference, which, for the first time, was held in the Southern Hemisphere, on the Sunshine Coast of Queensland, Australia. The theme of the conference, Crossing Boundaries: Implications of Advances in Basic Sciences for the Management of Addiction, speaks for itself. The papers derive from a wide range of empirical paradigms and cover issues with relevance to the development of addiction, to the maintenance of problematic use, and to assessment, treatment, and relapse. Research from Europe and the United States is represented, as well as work from Australia. An international perspective is strongly emphasized from the initial paper by Obot, Poznyak, and Moneiro, (see record 2004-19599-015) which describes the WHO Report on the Neuroscience of Psychoactive Substance Use and Dependence, and summarises some of the report's implications for policy and practice. Hall, Carter, and Morley (see record 2004-19599-014) close the issue with a paper on the wide-ranging ethical implications of advances in neuroscience research, including issues arising from the identification of high risk for addiction, the potential for coercive pharmacotherapy, use of medications to enhance function, and risks to privacy.

Will they know enough? Pre-service primary teachers' knowledge base for teaching intergrated social sciences

A significant issue in primary teacher education is developing a knowledge base which prepares teachers to teach in a range of subject areas. In Australia, the problem in primary social science education is compounded by the integrated nature of the key learning area of Studies of Society and Environment (SOSE). Recent debates on teaching integrated social sciences omit discussions on the knowledge base for teaching. In this paper, a case study approach is used to investigate primary pre-service teachers’ approaches to developing a knowledge base in designing a SOSE curriculum unit. Data from five teacher-educators who taught primary SOSE curriculum indicates that novice teachers’ subject content knowledge, as revealed through their curriculum planning, lacked a disciplinary basis. However, understanding of inquiry learning, which is fundamental to social science education, was much stronger. This paper identifies a gap in the scholarship on teaching integrated social science and illustrates the need to support and develop primary teachers’ disciplinary knowledge in teacher education.

Southern theory : the global dynamics of knowledge in the social sciences

Up front I am impelled to acknowledge an intellectual debt to Raewyn Connell as one of my PhD supervisors about 20 years ago and as having a lasting influence on my own sociological approach to research. One of key themes of this book is that southern theorists are rarely read in the northern hemisphere. This is not the case for Connell, however, one of Australia’s most internationally renowned scholars. The tome reads as the creative outpouring of her lifelong thirst for social science. Its main claim is that southern theory ‘has as much intellectual power as metropolitan social thought, and more political relevance’ (p. xii). A big but compelling claim, as I will explain.

Best practices in prediction for decision-making : lessons from the atmospheric and earth sciences

Predictions that result from scientific research hold great appeal for decision-makers who are grappling with complex and controversial environmental issues, by promising to enhance their ability to determine a need for and outcomes of alternative decisions. A problem exists in that decision-makers and scientists in the public and private sectors solicit, produce, and use such predictions with little understanding of their accuracy or utility, and often without systematic evaluation or mechanisms of accountability. In order to contribute to a more effective role for ecological science in support of decision-making, this paper discusses three ``best practices'' for quantitative ecosystem modeling and prediction gleaned from research on modeling, prediction, and decision-making in the atmospheric and earth sciences. The lessons are distilled from a series of case studies and placed into the specific context of examples from ecological science.

Values, wellness and the social sciences curriculum

Recent initiatives in values education in Australia emphasise the importance of the process of valuing and general methodologies that foster this in the classroom. Although a range of strategies are available, this chapter argues that inquiry-based approaches in the Social Sciences play a significant role in linking valuing processes with decision making skills. Collectively, these approaches prompt the development of reasoning and self awareness which also impact on student wellness. This chapter proposes some curriculum approaches to foreground values education in the Australian Social Sciences classroom. It argues that valuing is an important life skill that can be cultivated in the classroom through specific valuing strategies. It contends that the development of the capacity to make informed value choices is a critical factor in promoting wellness and resilience in students and in preparing them for the decision making skills required for effective participation in society.

Embedding values through global education in social sciences pre-service teacher education : linking the head and heart

This chapter aims to situate values education as a core component of social science pre-service teacher education. In particular, it reflects on an experiment in embedding a values laden Global Education perspective in a fourth year social science curriculum method unit. This unit was designed and taught by the researcher on the assumption that beginning social science teachers need to be empowered with pedagogical skills and new dispositions to deal with value laden emerging global and regional concerns in their secondary school classrooms. Moreover, it was assumed that when pre-service teachers engage in dynamic and interactive learning experiences in their curriculum unit, they commence the process of ‘capacity building’ those skills which prepare them for their own lifelong professional learning. This approach to values education also aimed at providing pre-service teachers with opportunities to ‘create deep understandings of teaching and learning’ (Barnes, 1989, p. 17) by reflecting on the ways in which ‘pedagogy can be transformative’ (Lovat and Toomey, 2011 add page no from Chapter One). It was assumed that this tertiary experience would foster the sine qua non of teaching – a commitment to students and their learning. Central to fostering new ‘dispositions’ through this approach, was the belief in the power of pedagogy to make the difference in enhancing student participation and learning. In this sense, this experiment in values education in secondary social science pre-service teacher education aligns with the Troika metaphor for a paradigm change, articulated by Lovat and Toomey (2009) in Chapter One.