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Biomedical subjects

Brian Edwards

Publications and source records attributed to Brian Edwards.

5 recordsLinked to original sources

Defining the competencies of those conducting pharmacovigilance.

PURPOSE: The absence of agreed competencies in pharmacovigilance and patient risk management is a key factor hindering the development of training and a curriculum in these interrelated disciplines. If competencies were to be developed, they could be tailored to the different roles and responsibilities of the various staff involved. PROPOSAL: We describe a simple theoretical model of functional and behavioural competencies that is based on an organisation with three levels of staff: evidence collectors and gatherers, evidence processors and distillers, and decision makers. CONCLUSIONS: To stimulate discussion about how to enhance the progress already being made in pharmacovigilance and patient risk management, we have proposed functional and behavioural competencies for pharmacovigilance as a way of identifying and measuring scientific and personal skills pertinent to pharmacovigilance. Competencies should, we believe, be agreed and adopted by all those seeking to improve pharmacovigilance. We invite discussion of these proposals.

Communication↗

Dermatologic emergencies.

Primary care physicians are the gatekeepers of the medical community. They are the physicians to whom patients first present, and they are often the physicians with whom patients have the longest lasting relationships. Primary care physicians, as a result of these long-term relationships, have been endowed with a unique responsibility to the health of their patients. By the very nature of their practice, primary care physicians do not have the resources to treat emergent life-threatening conditions. They must, however, be able to diagnose these potentially life-threatening conditions and be able to stabilize and appropriately refer a patient for urgent evaluation by specialists or emergency physicians. There are many types of emergencies encountered in the outpatient setting, ranging from cardiac to toxicologic. As important as recognizing signs and symptoms of cardiac ischemia is the ability to recognize potentially life-threatening dermatologic disorders or dermatologic manifestations of life-threatening systemic diseases.

Emergencies↗

Synchronous electrorotation of nanowires in fluid.

We demonstrate electrorotation of metal nanowires phase-locked to a driving alternating current electric field. Field rotation was accomplished by a low-frequency signal that modulates the amplitude of the high-frequency field. Steady, synchronous rotation of the nanowires was observed for frequencies up to a maximum rotational frequency, which depends on the magnitude of the applied electric field. A locally two-dimensional nanowire fluid flow model was developed to calculate the viscous fluid drag torque, including drag contributions due to the proximity of the floor. Synchronicity and phase-lock angle predicted by equating the calculated fluid drag and electrical driving torques is in good agreement with experimentally determined values, which provides support for the model. Synchronous electrorotation allows for precise control of nanowire rotational speed and orientation for frequencies as low as a fraction of 1 Hz. Potential applications include reconfigurable polarization filters, microfluidic valves, and stirring devices.

Computer Simulation↗

Managing the interface with marketing to improve delivery of pharmacovigilance within the pharmaceutical industry.

The pharmaceutical industry is under pressure to improve the scientific quality of its decisions concerning the benefit and risks of its products while ensuring compliance with acceptable standards of marketing. All those in a pharmaceutical company who currently work within pharmacovigilance should be encouraged to lead from the front to examine ongoing marketing activities to see how they can be adapted more towards pharmacovigilance and risk management. The current irony is that the personnel who have the greatest influence on benefit-risk decisions of a product are not necessarily those who acknowledge that they are performing pharmacovigilance. Indeed, for all concerned, whether their orientation is scientific and commercial, effective communication with prescribers and consumers usually underpins product success. Also, a substantial 'marketing' budget is culturally acceptable for the pharmaceutical industry so it is logical to assume that resource for postmarketing activity is often made available. Given these realities, I suggest we should strive for an integrated marketing and risk-management plan based on the best available evidence and that being fully aware and in control of the safety issues for your products is the best way to commercialise them successfully. This approach can still be consistent with other corporate responsibilities such as trying to reduce the financial burden of product development. If this article stimulates further debate about how the pharmaceutical industry can more effectively organise resources and operations to support pharmacovigilance, risk management, and marketing, then it will have achieved its purpose.

Drug Industry↗

Effect of choice of surgical gloves on dough time measurements of acrylic bone cement.

In this study we investigated the effect of the brand of surgical gloves on the dough time determination for acrylic bone cements. Four different brands of powder-free latex surgical gloves were tested. Two commercial bone cements, Surgical Simplex P and Palacos R, were used for dough time measurement following standard test methods for acrylic bone cements (ASTM F-451 and ISO 5833). The results show that the measured dough time depended largely on the brand of gloves used, and could vary by nearly 250%. The surface morphological structures of gloves, determined by SEM, probably contribute to the differences in the measured dough time. This study provides experimental evidence that supports the need to describe the type of gloves used, in detail, when dough time is reported. It also illustrates the importance of the glove brand, when bone cement is to be handled as a dough in the clinical setting.

Biocompatible Materials↗