Regulatory sciences and translational pharmacogenetics: amitriptyline as a case in point

Regulatory developments and clinical implementation, or the lack thereof, are primary clinchers, in the enduring endeavors to realize the translational quality of pharmacogenetics. Here, we present the case of amitriptyline, an established drug with pharmacogenetic implications. The integration of pharmacogenetic information in the official product literature and throughout the evaluation of safety concerns is considered. In our opinion, apart from emboldening genomic research in drug development and the valid pursuit towards global harmonization in the field, it is rational to look into the applicability of the data we have today.

The Importance of Architecture in Food and Drink Experiences Within a Tourism Context

This article explores the relationship between spatial settings and food and drink experiences in tourism and hospitality. Food and drink providers often appear unaware or deliberately neglectful of the effects of the environment on food and drink experiences. However, certain tourism and hospitality providers successfully make use of architecture and design, and/or integrated multisensory experiences to enhance customer perceptions and satisfaction. Based on a scoping review and architectural precedents, this article provides unique examples of architecture and design, and discusses their influence on the total tourism and/or hospitality product. Literature from the fields of food sciences, psychology, design, and architecture is used to explain these influences. Taken together, this article highlights how the careful and targeted use of architecture and architectural design can substantially contribute to meaningful and memorable dining experiences in tourism. Specifically, this article illustrates how architecture can help provide multisensory dining experiences. Considerations for future research are provided and include: investigating the differences between permanent and temporary food and drink installations and framing future empirical research with pertinent theoretical frameworks.

Off-label use of antibiotics in hospitalised children in a tertiary care teaching hospital

Background: Children constitute one-third of the population and they suffer from a variety of infectious diseases and are commonly prescribed antibiotics. Most of the antibiotics lack sufficient information on safety and efficacy in children and are thus prescribed off-label. This study was envisaged to assess the off-label use of antibiotics in hospitalized children.Methods: Total 120 patients were included in the study. Off-label use was determined on the basis of product literature and National Formulary of India. Descriptive statistics was used to present the data i.e. percentage; proportions, frequency, mean and standard deviation using Microsoft excel worksheet.Results: A total of 791 drugs from different classes were prescribed to 120 patients with a mean of 6.6±2.68 drugs described per patient during their stay in the hospital. 100 out of 120 (83%) patients were prescribed at least one antibiotic during their stay in the hospital. Out of the 204 antibiotics prescribed, 43(21%) were prescribed off-label. Antibiotic dose was the most common reason followed by age (1month-1 year more than 2-6 years of age) and frequency in off-label use.Conclusions: Antibiotics are commonly prescribed to children with substantial off-label use. The same must be seriously addressed by the policy makers and stakeholders in order to promote their rational use.

Guidance for Selecting Health Care Products Using Human Factors Techniques

In health care, a wide variety of professionals use a wide variety of products when providing care to a wide variety of patients. In addition, safety reports support the idea that medical products vary in terms of usability, compatibility, and functionality. All this variability may contribute to purchasers failing to fully understand and define the needs for and risks of these products. Some purchasing decisions in the Veterans Health Administration (VHA) utilize well-defined procedures such as investigation by Integrated Product Teams (IPTs), which includes a hands-on evaluation of multiple options prior to crafting a national contract. Ideally, all products would go through rigorous functionality and usability testing under a variety of conditions prior to purchase, but such an approval process does not currently exist. The Purchasing Checklist aids purchasers in investigating patient safety concerns related to usability when planning a purchase when extensive hands-on evaluation is not possible. The checklist includes steps such as assembling a team that includes key representatives, considering the purchase needs and options, performing heuristic evaluation of the product literature and other available information, and documenting trade-offs to identify the best option.

Hip and knee arthroplasty implants contraindicated in obesity

IntroductionHigh patient weight is a risk factor for mechanical implant failure and some manufacturers list obesity as a contraindication for implant use. We reviewed data from the 2012–2013 UK National Joint Registry to determine whether surgical practice reflects these manufacturer recommendations.MethodsThe product literature for the most commonly used hip and knee implants was reviewed for recommendations against use in obese patients (body mass index [BMI] ≥ 30kg/m2). The total number of obese patients undergoing hip and knee arthroplasty was calculated, as was the proportion receiving implants against manufacturer recommendations.ResultsOut of 200,054 patient records, 147,691 (74%) had a recorded BMI. The mean BMI for patients undergoing primary total hip arthroplasty was 29kg/m2, compared with 31kg/m2for total knee arthroplasty. Of the 25 components reviewed, 5 listed obesity as a contraindication or recommended against implant use in obese patients. A total of 10,745 patients (16% of all obese patients) received implants against manufacturer recommendations.ConclusionsA high proportion of patients are receiving implants against manufacturer recommendations. However, there are limitations to using BMI for stratifying risk of implant fatigue failure and manufacturers should therefore provide more detailed guidelines on size specific implant load limits to facilitate surgical decisions.

Which mesh for hernia repair?

INTRODUCTION The concept of using a mesh to repair hernias was introduced over 50 years ago. Mesh repair is now standard in most countries and widely accepted as superior to primary suture repair. As a result, there has been a rapid growth in the variety of meshes available and choosing the appropriate one can be difficult. This article outlines the general properties of meshes and factors to be considered when selecting one. MATERIALS AND METHODS We performed a search of the medical literature from 1950 to 1 May 2009, as indexed by Medline, using the PubMed search engine (< http://www.pubmed.gov >). To capture all potentially relevant articles with the highest degree of sensitivity, the search terms were intentionally broad. We used the following terms: ‘mesh, pore size, strength, recurrence, complications, lightweight, properties’. We also hand-searched the bibliographies of relevant articles and product literature to identify additional pertinent reports. RESULTS AND CONCLUSIONS The most important properties of meshes were found to be the type of filament, tensile strength and porosity. These determine the weight of the mesh and its biocompatibility. The tensile strength required is much less than originally presumed and light-weight meshes are thought to be superior due to their increased flexibility and reduction in discomfort. Large pores are also associated with a reduced risk of infection and shrinkage. For meshes placed in the peritoneal cavity, consideration should also be given to the risk of adhesion formation. A variety of composite meshes have been promoted to address this, but none appears superior to the others. Finally, biomaterials such as acellular dermis have a place for use in infected fields but have yet to prove their worth in routine hernia repair.