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Medical Sciences	47%
Business, Economics, Finance and Accounting	29%

Selected Abstracts

Off label and unlicensed prescribing in a specialist oncology center in Australia

ASIA-PACIFIC JOURNAL OF CLINICAL ONCOLOGY, Issue 4 2009
James D MELLOR
Abstract Aim: Oncology is an area with a high prevalence of off-label and unlicensed prescribing. A previous audit conducted in 2001 at the Peter MacCallum Cancer Centre, a specialist oncology hospital, showed that 22% of all prescriptions were either off-label or unlicensed. This study aimed to determine if the rates of off-label and unlicensed prescribing in oncology had changed between 2001 and 2008. Methods: All prescriptions at the Peter MacCallum Cancer Centre were reviewed on a single day in March 2008. Each prescription was classified as licensed, off-label or unlicensed by comparing to the Approved Product Information (API). Results: The medications of 132 patients were assessed. Among the 1094 prescriptions, 382 (35%) were off-label and 44 (4%) were unlicensed. 112 (85%) patients received at least one off-label or unlicensed drug. Conclusion: The results of the audit suggest that the level of off-label prescribing increased by 17% since 2001. This study confirmed the extensive off-label and unlicensed drug usage as suggested by the literature and demonstrated a higher rate of off-label prescribing than the previous audit in 2001. The results demonstrate that 85% of all cancer patients in the study were prescribed at least one drug that had not been fully tested by the regulatory approval process. [source]

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PRESCRIBER, Issue 4 2008
Article first published online: 20 MAR 200
Suicide warning for all antidepressants All antidepressants are to include a warning of the risk of suicide in their product information, the MHRA says. The requirement formerly applied only to SSRIs but, following a US review of safety data, the Agency says the risk is similar for all classes of antidepressants. Patients at increased risk include young people with psychiatric morbidity and those with a history of suicidal ideation. Patients are at increased risk of suicide until remission occurs, and clinical experience shows that the risk is increased during the early stages of recovery. Confusion over type 2 diabetes management Contradictory findings have been reported from two studies of intensive management of type 2 diabetes. The STENO-2 study (N Engl J Med 2008;358:580-91) found that tight control of blood glucose, blood pressure and lipids plus low-dose aspirin in 160 patients with type 2 diabetes and microalbuminuria significantly reduced all-cause mortality, cardiovascular events, cardiovascular death and microvascular complications by 40-60 per cent. The US National Heart, Blood and Lung Institute has announced the end of the intensive treatment arm of the ACCORD study (unpublished). This study was comparing intensive lowering of blood glucose below currently recommended levels (target HbA1C <6 per cent) with conventional management in adults with type 2 diabetes at especially high risk for heart attack and stroke. Although mortality was reduced in both arms compared with other populations, intensive treatment was associated with increased mortality equivalent to three deaths per 1000 patients per year over four years. Another antibiotics campaign The Government has launched another campaign to promote public awareness that antibiotics are not appropriate for viral infections causing coughs, colds and sore throats. Get Well Soon , Without Antibiotics is supported by a national advertising campaign and leaflets and posters encouraging the public to ask advice rather than demand a prescription. Details are available at www.dh.gov.uk. Episenta: once-daily sodium valproate Following a launch to specialists last year, a new once-daily modified-release formulation of sodium valproate is being promoted more widely to GPs. Episenta is licensed for the treatment of all forms of epilepsy and is formulated as modified-release capsules of 150mg and 300mg and sachets of modified-release granules of 500mg and 1000mg. The dose may be administered once or twice daily. Patients may be switched from enteric-coated tablets of valproate to the same dose given as Episenta. Episenta costs £5.70 or £10.90 for 100 × 150mg or 300mg capsules, and £18 or £35.50 for 100 × 500mg or 1000mg sachets. Latest NICE agenda The Department of Health has referred a new batch of topics for appraisal by NICE. Six of seven technology appraisals are for cancer drugs; the last is for dabigatran etexilate for venous thromboembolism. There will be four new clinical guidelines: autism spectrum disorders, hypertension in pregnancy, bed-wetting in children and severe mental illness with substance abuse. Two combined public health and clinical guidelines will address alcohol misuse. Varenicline vs NRT Varenicline (Champix) offers slightly greater smoking cessation rates than nicotine replacement therapy (NRT) in the long term and better symptom improvement, an international study has shown (Thorax 2008; published online:10.1136/ thx.2007.090647). A total of 746 smokers were randomised to treatment with varenicline 1mg twice daily for 12 weeks or transdermal NRT (21mg reducing to 7mg per day) for 10 weeks. Continuous abstinence rates for the last four weeks of treatment were 56 vs 43 per cent. The corresponding rates for one year were 26 and 20 per cent. Varenicline was associated with greater reductions in cravings, withdrawal symptoms and smoking satisfaction, but more nausea (37 vs 10 per cent). Adverse reactions class effect of statins The MHRA has identified several adverse effects that it says are class effects of the statins (Drug Safety Update 2008;1:Issue 7). Following a review of clinical trials and spontaneous reports, it is now apparent that any statin may be associated with sleep disturbance, depression, memory loss and sexual dysfunction; interstitial lung disease has been reported rarely. Product information is being updated to include the new information. Depression, including suicidal ideation, has also been associated with varenicline (Champix), the MHRA says; affected patients should stop treatment immediately. The combination of transdermal nicotine replacement therapy (NRT) and varenicline appears to be associated with a higher incidence of nausea, headache, vomiting, dizziness, dyspepsia and fatigue than NRT alone. The MHRA has also announced that, following the suspension of marketing authorisation for carisoprodol (Carisoma), it is considering a phased withdrawal of the closely-related meprobamate , the main active metabolite of carisoprodol. Following a successful pilot study, the public are being encouraged to report adverse reactions on yellow cards; the MHRA notes that health professionals provide more complete reports but patients include more information about quality of life. The scheme will be promoted via community pharmacies throughout the UK from February 2008. Cochrane: evidence on back pain interventions The latest release of Cochrane reviews includes three meta-analyses assessing interventions for back pain. Overall, NSAIDs were found to be effective as short-term treatment for acute or chronic back pain but the effect size was small. They were comparable with paracetamol but associated with more adverse effects; COX-2 selective NSAIDs were similarly effective, with slightly fewer adverse effects. There was no evidence that antidepressants reduced back pain but intensive individual patient education (lasting 2.5 hours) was effective for acute and subacute back pain and comparable with manipulation and physiotherapy; its effects on chronic pain were unclear. Copyright © 2008 Wiley Interface Ltd [source]

Quality of poisoning management advice in the Monthly Index of Medical Specialties Annual

EMERGENCY MEDICINE AUSTRALASIA, Issue 5-6 2005
James Mallows
Abstract Background:, The Monthly Index of Medical Specialties (MIMS) contains Therapeutic Goods Administration-approved product information supplied by manufacturers. It is widely used by health-care professionals but is not specifically designed as a toxicology reference. Objectives:, To determine how widespread the use of MIMS is as a toxicology reference. To evaluate the quality of poisoning management advice it contains. Methods:, First, a survey of 500 consecutive calls to the NSW Poison Information Centre (PIC) was undertaken asking health-care workers which toxicology references were consulted prior to calling and which references they would use if the PIC were not available. Second, a consensus opinion for poisoning management was obtained, for 25 medications which are either commonly involved in poisoning or potentially life-threatening in overdose, by review of 5 current toxicology references for contraindicated treatments, ineffective treatments and specific recommended treatments and antidotes. MIMS poisoning management advice was then compared with this toxicology consensus opinion. Results:, In total, 276 doctors and 222 nurses were surveyed. Prior to calling the PIC 22.8% of doctors and 6.8% of nurses consulted MIMS. In total, 25.7% of doctors and 39.6% nurses stated they would use the MIMS for poisoning management advice if the PIC were not available. For the 25 drugs assessed, 14 contained inaccurate poisoning management: 1 recommended ineffective treatments and 14 omitted specific treatments or antidotes. Conclusion:, The MIMS is often used as a toxicology reference by physicians prior to calling the PIC. It contains a number of significant inaccuracies pertaining to management of poisonings and should not be used as a primary reference for poisoning advice. [source]

Applying domain knowledge and social information to product analysis and recommendations: an agent-based decision support system

EXPERT SYSTEMS, Issue 3 2004
Wei-Po LeeArticle first published online: 24 JUN 200
Abstract: The advance of Internet and Web technologies has boosted the development of electronic commerce. More and more people have changed their traditional trading behaviors and started to conduct Internet shopping. However, the exponentially increasing product information provided by Internet enterprises causes the problem of information overload, and this inevitably reduces the customer's satisfaction and loyalty. To overcome this problem, in this paper we propose a multi-agent system that is capable of eliciting expert knowledge and of recommending optimal products for individual consumers. The recommendations are based on both product knowledge from domain experts and the customer's preferences from system,consumer interactions. In addition, the system also uses behavior patterns collected from previous consumers to predict what the current consumer may expect. Experiments have been conducted and the results show that our system can give sensible recommendations, and it is able to adapt to the most up-to-date preferences for the customers. [source]

Ease of reading of mandatory information on Canadian food product labels

INTERNATIONAL JOURNAL OF CONSUMER STUDIES, Issue 4 2009
Mary Alton Mackey
Abstract Food product labels present individual product information, safety, nutrition, electronic inventory, container and environmental information, in various formats, languages and images. Some information is mandatory; much is promotional. The food label is an essential tool for regulators of safe food handling, nutrition policy and fair competition. Mandatory information on food labels in Canada is required to be presented in both English and French, readily discernable, prominently displayed and legible. This study examines the ease of finding and reading of mandatory label components on selected Canadian food products. A validated typographical scoring system assessed the lists of ingredients on a purposive sample of 100 food labels representing foods in all groups in Canada's Food Guide. Seven percent of the ingredient lists were easy to read; 26% were difficult to read and 67% were very difficult to read. Well-educated resourceful readers in consumer focus groups examined food labels for key elements that influence ease of finding and reading information. Focus groups and typographical scoring identified: colour contrast, case, print style, print size, space between the lines, reverse print, organization, justification, type of surface, hyphenation and print reproduction as factors that affect ease of reading. Print that curves around a container, lack of paragraphing or point form organization make reading difficult; text blocks at right angles to each other make comparisons difficult; separation of the nutrition facts table from the list of ingredients makes decision making tedious. Inadequate spacing between lines of print creates problems for readers of English and exacerbates problems for readers of French. Words placed over illustrations, busy backgrounds or watermarks increase reading difficulty. Hazard statements, instructions and storage information imbedded in other information without added space or appropriate heading is difficult to find and read. Canadian consumers echo consumers in 28 European countries who find label information difficult to find and to read and want clear guidelines/regulations on the placement and the typography of mandatory food label components [source]

Website evaluation criteria among US college student consumers with different shopping orientations and Internet channel usage

INTERNATIONAL JOURNAL OF CONSUMER STUDIES, Issue 3 2007
Yoo-Kyoung Seock
Abstract The purpose of this study was to compare the website evaluation criteria among college student consumers in the US with different shopping orientations and Internet channel usage (i.e. online information searchers, online purchasers). The sample for this research was 414 college students, non-married and aged 18,22 who have experience in visiting websites selling apparel products. Five apparel website evaluation criteria were identified by factor analysis (i.e. product information, customer service, privacy/security, navigation, auditory experience/comparison shopping). Based on shopping orientation factors, cluster analysis revealed three shopping orientation clusters (i.e. Hesitant In-home Shoppers, Practical Clothing Shoppers, Involved Clothing Shoppers). Factorial manova showed that website evaluation criteria were significantly different among college student consumers with different shopping orientations and between online information searchers and online purchasers. Implications and limitations of the study are discussed. [source]

A survey of herbal and alternative medication use among participants with eating disorder symptoms

INTERNATIONAL JOURNAL OF EATING DISORDERS, Issue 8 2006
Kristine J. Steffen PharmD
Abstract Objective: The purpose of this survey was to collect data on herbal use in participants with eating disorder symptoms. Method: A survey was administered to 100 participants who had either sought treatment at the Eating Disorder Institute (EDI) or had been enrolled in previous research as the result of eating disorder symptoms. Results: Of the 100 participants, 64% used an herbal product for weight loss. The mean monthly expenditure on herbs over the past year was $33.88 ± $41.10, with a range of $2,$200. Dexatrim (Chattem, Chattanooga, TN; N = 27) and St. John's Wort (N = 19) had the highest reported use. Magazines were the most common source of product information (38.3%), with health care professionals being reported less frequently as the source of information. Knowledge of ephedra-related adverse effects was variable, and depended on a previous history of use. The majority (62.3%) of herb users reported an adverse effect. Conclusion: Herbal use is frequent among those with eating disorder symptoms, often resulting in substantial financial cost. Health professionals are rarely the source of herbal information. Therefore, there is ample room for educational interventions, which may result in the safer use of herbal products. © 2006 by Wiley Periodicals, Inc. Int J Eat Disord 2006; 39:741,746 [source]

Phenotypic and genotypic characterization of competitive exclusion products for use in poultry

JOURNAL OF APPLIED MICROBIOLOGY, Issue 6 2003
R.D. Wagner
Abstract Aims: Phenotypic and genotypic bacteria identification methods were compared for their efficacy in determining the composition of competitive exclusion (CE) products. Methods and Results: Phenotypic methods used for bacterial identification were fatty acid methyl ester profiles, biochemical assays and carbohydrate utilization profiles. Genotypic methods were MicroSeq16S rRNA sequence analysis and BLAST searches of the GenBank sequence database. Agreement between phenotypic and genotypic methods for identification of bacteria isolated from the Preempt CE product was 20%. A defined test mixture of bacteria was identified to the species level 100% by BLAST analysis, 64% by MicroSeq and 36% by phenotypic techniques. Conclusions: The wide range of facultative and obligate anaerobic bacteria present in a CE product are more accurately identified with 16S rRNA sequence analyses than with phenotypic identification techniques. Significance and Impact of the Study: These results will provide guidelines for manufacturers of CE products to submit more reliable product information for market approval by regulatory agencies. [source]

Consumer knowledge and use of country-of-origin information at the point of purchase

JOURNAL OF CONSUMER BEHAVIOUR, Issue 2 2004
John P. Liefeld
Abstract This paper reports an investigation of American and Canadian consumer acquisition and/or knowledge of the country of origin of products at the time of purchase. Consumer knowledge of the country of origin of purchased products was tested as purchasers left the cash register. If the purchaser knew the country of origin of the product just purchased, they were further questioned to discover the role such knowledge might have played in their choice between alternatives. More than 93 per cent of 1,248 purchasers intercepted at the cash register had not acquired while shopping, or did not know from prior experience, the country of origin of a product they had just purchased. Of the 91 (6.5 per cent) who had acquired or knew the country of origin of a product they had just purchased, only 27 (2.2 per cent of the total) indicated that their knowledge of the product's country of origin possibly might have played a role in their product choice. These findings reveal that the country of origin of products is not an important attribute in the choice processes of the great majority of North American consumers. Confirmation of these findings by replication with less obtrusive and more externally valid measures of consumer acquisition and use of product information prior to purchase is needed. Copyright © 2004 Henry Stewart Publications. [source]

Measurement of the setting expansion of phosphate-bonded investment materials: Part II , An evaluation of the Casting-Ring Test at 10 laboratories

JOURNAL OF ORAL REHABILITATION, Issue 7 2004
C. H. Lloyd
summary, The Casting-Ring Test has the potential to fulfil the requirement for a reliable ,Standard' test to measure the setting expansion of phosphate-bonded investment materials. The purpose of this study was to investigate the reproducibility of the measurements and the value that is produced at 10 test sites. The Casting-Ring Test apparatus, three phosphate-bonded investment products and one ring liner product were sent to the 10 participants, together with a detailed test protocol. Participants were asked to use their normal vacuum mixers. Reproducibility at individual sites was good. However, there were significant differences between test sites for the mean setting expansions, attributed to the range of vacuum mixers employed. From these results, the Casting-Ring Test appears to satisfy the requirements for adoption as an ISO standard test. The effect produced by different vacuum-mixer models would be manifest in any test. Not only does this have implications when determining the value of setting expansion for product information, but such a range of setting expansions will also be reproduced during production of moulds in commercial dental laboratory practice. However, for any specific product and vacuum-mixer combination, the setting expansion will be consistent and will not vary from mould to mould. [source]

EVALUATION OF REPLICATED PROJECTIVE MAPPING OF GRANOLA BARS

JOURNAL OF SENSORY STUDIES, Issue 5 2010
JESSICA KENNEDY
ABSTRACT The application of projective mapping to quickly gather information on overall product differences provides a unique way to probe consumer perceptions and gather product information. A group of 15 consumers performed a projective mapping exercise three times on a set of eight "berry flavored" granola bars, including descriptors of the products. The projective mapping task was performed in replicates to evaluate the consistency of results obtained via this technique. Analysis of the replications by multifactor analysis indicated for the majority of consumers, that the three individual maps did not show a high degree of similarity (80% of RV coefficients < 0.5). However, consensus maps from the three replications indicated a similar group perception of the products over the replications, as depicted by hierarchical multifactor analysis. Terms collected from the maps were summarized and regressed into the product space for interpretation, both in terms of consumer criteria used to differentiate among products and identification of key product attributes. PRACTICAL APPLICATIONS The findings from this study add to the growing knowledge on projective mapping. The results presented here aimed to substantiate the value and reliability of projective mapping when used with consumers. Although projective mapping is not a replacement for quantitative descriptive analysis, it is an efficient tool for consumer research; as well as product or category exploration which can be utilized early in the product development process. The addition of descriptors directly onto the maps by panelists makes it possible to use projective mapping as a stand-alone method by increasing the amount and interpretability of data provided by panelists. When used with consumers, projective mapping links the consumer perception of the product space with a consumer-driven lexicon. [source]

Early communication of drug safety concerns: a feasibility study on enhancing interaction between the pharmaceutical industry and regulators

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 3 2010
Elizabeth Swain BPharm, MRPharmS
Abstract Purpose The responsibility for monitoring the safety of marketed medicines is shared between regulatory authorities and the pharmaceutical industry and is underpinned by legal obligations on both sides. Both marketing authorisation holders (MAHs) and regulators initially evaluate and investigate potential safety concerns, and then work together on further review as appropriate. We wanted to test the feasibility of enhanced interaction between MAH and regulator via a regular monthly, two-way communication of potential safety concerns between the MAHs and the Medicines and Healthcare Products Regulatory Agency (MHRA). It was envisaged that such a process would aid prioritisation and planning by both parties, avoid duplication of effort and support a collaborative approach for decision making. Methods Four MAHs took part in the pilot, which was conducted between July 2007 and June 2008. Potential safety concerns were exchanged on a monthly basis. The MAH/MHRA proposed a timeline for evaluation of each potential safety concern. The pilot did not include serious public health issues which are immediately reported to regulatory authorities. Results During the pilot, 136 potential safety concerns were exchanged. Thirteen per cent of these resulted in a change to product information for health professionals and patients. There was concurrence between the MAHs and MHRA on timelines proposed for evaluation. Conclusions The pilot proved feasible for the companies involved and indicated potential benefits of a system for avoiding duplication of effort and supporting a collaborative approach to planning and prioritisation of investigation of potential safety concerns between pharmaceutical industry and regulatory authorities. Copyright © 2009 John Wiley & Sons, Ltd. This article was published online on December 27, 2009. An error was subsequently identified. This notice is included in the online and print versions to indicate that both have been corrected (08/01/10). [source]

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Sensory enabling technology acceptance model (SE-TAM): A multiple-group structural model comparison

PSYCHOLOGY & MARKETING, Issue 9 2008
Jiyeon Kim
Sensory enabling technology (SET) can deliver product information that is similar to the information obtained from direct product examination, thus reducing product risk. In addition, the interactivity and customer involvement created by sensory enabling technologies can enhance the entertainment value of the online shopping experience. The proposed model examined this dual role of sensory experience enablers in the online soft goods shopping process for three types of sensory enabling technologies that are widely applied in online retail sites. The results provided empirical support for perceived usefulness and perceived entertainment value as strong predictors of consumers' attitudes toward using all three of the sensory enabling technologies tested in this study. The impact of perceived ease of use differed by technology. Attitudes toward using sensory enabling technologies had a significant impact on the actual use of all three SETs; however, the impact of technology anxiety and innovativeness on the use of SET also appeared to differ by technology. Virtual try-on played a strong hedonic role, increasing the entertainment value of the online shopping process, whereas 2D views (larger view and alternate views) showed a strong functional role. The 3D rotation view served both functional and hedonic roles. The results indicate that each sensory enabling technology makes a unique contribution to online shopping,either by reducing product risk perceptions or by increasing perceived entertainment value. © 2008 Wiley Periodicals, Inc. [source]

"So that's what that is": Examining the impact of analogy on consumers' knowledge development for really new products

PSYCHOLOGY & MARKETING, Issue 6 2002
Jennifer Gregan-Paxton
The ever-accelerating pace of technological change has heralded an increasing number of new product introductions involving products that defy classification within existing categories. With the advent of these so-called "really new products," new questions about the influence of prior knowledge on consumer learning emerge. Chief among these is whether and to what extent prior knowledge plays a role in the comprehension of such products. Applying analogical learning theory to address this question, this investigation presents evidence indicating that analogy provides an effective link to the structural knowledge needed for consumers to learn about truly novel innovations. Reflecting this, subjects who engaged in analogical processing of new product information were more focused in their processing than subjects who processed the same information in the absence of analogy. Moreover, there was evidence to suggest that analogical processing itself results in the generation of positive affect. © 2002 Wiley Periodicals, Inc. [source]

Obstetric implications of current Australian product information for thyroid-related medications

AUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 1 2009
Jim R. STOCKIGT
No abstract is available for this article. [source]

A study of natural rubber latex allergens in gloves used by healthcare workers in Singapore

BRITISH JOURNAL OF DERMATOLOGY, Issue 5 2005
D. Koh
Summary Background, Allergy to natural rubber latex (NRL) proteins is a well-recognized health problem among subjects using protective gloves and products made of NRL. There is currently no information on NRL allergen levels in gloves used in Singapore. Objectives, This study aims to quantify the amount of specific allergens (Hev b 1, Hev b 3, Hev b 5 and Hev b 6.02) found in rubber gloves used in Singapore. It also aims to determine if these levels are above thresholds that may cause NRL allergy. It also compares the levels of these specific allergens in gloves used for different purposes, namely gloves used for examination purposes or for surgical procedures. Methods, Forty-nine rubber gloves were obtained from major hospitals and healthcare departments in Singapore and were analysed for their NRL allergen levels. FITkitTM, based on the enzyme immunometric assay technique, was used to determine the specific allergen levels of Hev b 1, Hev b 3, Hev b 5 and Hev b 6.02 in the gloves. Results, Examination gloves had higher NRL allergen content compared with surgical gloves, and powdered gloves had higher allergen content compared with nonpowdered gloves. Among the various allergens, Hev b 5 and Hev b 6.02 were present in larger quantities than Hev b 1 and Hev b 3. Only two of 19 (11%) surgical gloves had the sum of the four allergens (Hev b 1, Hev b 3, Hev b 5, Hev b 6.02) in excess of 1 µg g,1, which is believed to be a clinically relevant threshold. Among the examination gloves, 25 of 30 (83%) exceeded this level. Conclusions, This study shows that NRL allergen levels are present in the majority of examination gloves used by healthcare workers in Singapore at levels high enough to cause NRL allergy among sensitized persons. The information can serve as evidence for a possible requirement for manufacturers to produce gloves with low NRL allergen levels and to state the allergen level in gloves in the product information. [source]