Enhanced labelling on alcoholic drinks: reviewing the evidence to guide alcohol policy.

Science.gov (United States)

Martin-Moreno, Jose M; Harris, Meggan E; Breda, Joao; Møller, Lars; Alfonso-Sanchez, Jose L; Gorgojo, Lydia

2013-12-01

Consumer and public health organizations have called for better labelling on alcoholic drinks. However, there is a lack of consensus about the best elements to include. This review summarizes alcohol labelling policy worldwide and examines available evidence to support enhanced labelling. A literature review was carried out in June-July 2012 on Scopus using the key word 'alcohol' combined with 'allergens', 'labels', 'nutrition information', 'ingredients', 'consumer information' and/or 'warning'. Articles discussing advertising and promotion of alcohol were excluded. A search through Google and the System for Grey Literature in Europe (SIGLE) identified additional sources on alcohol labelling policies, mainly from governmental and organizational websites. Five elements were identified as potentially useful to consumers: (i) a list of ingredients, (ii) nutritional information, (iii) serving size and servings per container, (iv) a definition of 'moderate' intake and (v) a health warning. Alcohol labelling policy with regard to these aspects is quite rudimentary in most countries, with few requiring a list of ingredients or health warnings, and none requiring basic nutritional information. Only one country (Australia) requires serving size and servings per container to be displayed. Our study suggests that there are both potential advantages and disadvantages to providing consumers with more information about alcohol products. Current evidence seems to support prompt inclusion of a list of ingredients, nutritional information (usually only kcal) and health warnings on labels. Standard drink and serving size is useful only when combined with other health education efforts. A definition of 'moderate intake' and recommended drinking guidelines are best suited to other contexts.

[Generic drugs: good or bad? Physician's knowledge of generic drugs and prescribing habits].

Science.gov (United States)

García, A J; Martos, F; Leiva, F; Sánchez de la Cuesta, F

2003-01-01

In this article we analyze the responses of 1220 Spanish physicians who participated in a survery about generic drugs. A previously validated questionnaire was sent to physicians through the Spanish Medical Councils of the different provinces. Four items were analyzed: what doctors know about generic drugs (knowledge); physicians' prescribing habits concerning these drugs (attitude and professional competence); how prescription of generic drugs effects pharmaceutical costs amd, finally, what doctors believe a generic drug should be. The influence of physician-related variables (age, type of contract, specialty, workload, etc.) on prescribing of generic drugs was also analyzed. In view of the results, we believe that to rationalize expenditure through and appropriate policy on generic drugs Spanish health authorities should offer more and better training and information (clear and independent) about what generic drugs are.

The short-term impact of Ontario's generic pricing reforms.

Directory of Open Access Journals (Sweden)

Michael R Law

Full Text Available Canadians pay amongst the highest generic drug prices in the world. In July 2010, the province of Ontario enacted a policy that halved reimbursement for generic drugs from the public drug plan, and substantially lowered prices for private purchases. We quantified the impact of this policy on overall generic drug expenditures in the province, and projected the impact in other provinces had they mimicked this pricing change.We used quarterly prescription generic drug dispensing data from the IMS-Brogan CompuScript Audit. We used the price per unit in both the pre- and post-policy period and two economics price indexes to estimate the expenditure reduction in Ontario. Further, we used the post-policy Ontario prices to estimate the potential reduction in other provinces.We estimate that total expenditure on generic drugs in Ontario during the second half of 2010 was between $181 and $194 million below what would be expected if prices had remained at pre-policy level. Over half of the reduction in spending was due to savings on just 10 generic ingredients. If other provinces had matched Ontario's prices, their expenditures over during the latter half of 2010 would have been $445 million lower.We found that if Ontario's pricing scheme were adopted nationally, overall spending on generic drugs in Canada would drop at least $1.28 billion annually--a 5% decrease in total prescription drug expenditure. Other provinces should seriously consider both changes to their generic drug prices and the use of more competitive bulk purchasing policies.

Generics Pricing: The Greek Paradox.

Science.gov (United States)

Karafyllis, Ioannis; Variti, Lamprini

2017-01-01

This paper explains and develops a methodological framework to help evaluate the performance of generic pharmaceutical policies and the correct evaluation of generics sales. Until today erroneous recording of generics does not help proper pricing and their penetration in the Greek market. This classifies Greece on the outliners in every study or comparison that is referred on papers or studies.

Quality of generic medicines in South Africa

DEFF Research Database (Denmark)

Patel, Aarti; Gauld, Robin; Norris, Pauline

2012-01-01

Generic Medicines are an important policy option allowing for access to affordable, essential medicines. Quality of generic medicines must be guaranteed through the activities of national medicines regulatory authorities. Existing negative perceptions surrounding the quality of generic medicines ...

Potential impact of policy regulation and generic competition on sales of cholesterol lowering medication, antidepressants and acid blocking agents in Belgium.

Science.gov (United States)

Fraeyman, J; Van Hal, G; De Loof, H; Remmen, R; De Meyer, G R Y; Beutels, P

2012-01-01

Pharmaceutical expenditures are increasing as a proportion of health expenditures in most rich countries. Antidepressants, acid blocking agents and cholesterol lowering medication are major contributors to medicine sales around the globe. We aimed to document the possible impact of policy regulations and generic market penetration on the evolution of sales volume and average cost per unit (Defined Daily Doses and packages) of antidepressants, acid blocking agents and cholesterol lowering medication. We extracted data from the IMS health database regarding the public price and sales volume of the antidepressants (selective serotonin reuptake inhibitors (SSRI's), monoamine oxidase inhibitors (MAOl's) and tricyclic and remaining antidepressants (TCA's)), acid blocking agents (proton pump inhibitors (PPl's) and H2 receptor antagonists) and cholesterol lowering medication (statins and fibrates) in Belgium between 1995 and 2009. We describe these sales data in relation to various national policy measures which were systematically searched in official records. Our analysis suggests that particular policy regulations have had immediate impact on sales figures and expenditures on pharmaceuticals in Belgium: changes in reimbursement conditions, a public tender and entry of generic competitors in a reference pricing system. However, possible sustainable effects seem to be counteracted by other mechanisms such as marketing strategies, prescribing behaviour, brand loyalty and the entry of pseudogenerics. It is likely that demand-side measures have a more sustainable impact on expenditure. Compared with other European countries, generic penetration in Belgium remains low. Alternative policy regulations aimed at enlarging the generic market and influencing pharmaceutical expenditures deserve consideration. This should include policies aiming to influence physicians' prescribing and a shared responsibility of pharmacists, physicians and patients towards expenditures.

Influencers of generic drug utilization: A systematic review.

Science.gov (United States)

Howard, Jennifer N; Harris, Ilene; Frank, Gavriella; Kiptanui, Zippora; Qian, Jingjing; Hansen, Richard

2017-08-04

With an increase in prescription drug spending and rising drug costs there is a need to encourage the use of generic prescription drugs. However, maximizing generic drug use is not possible without the public's positive perception and meeting their informational needs about generic drugs. Thus, improving the public's confidence in, and knowledge of generic drugs on the market is critical. The objective of this systematic review is to examine and evaluate the studies focusing on the nature and extent of key factors influencing generic drug use in the United States in order to help guide policy, education and practice interventions. Using multiple search engines and key word screening criteria, empirical studies published in English between January 1, 2005 and December 31, 2015 were identified. A qualitative synthesis of the evidence identified domains of key factors that influenced generic drug use across studies. Over 3000 citations met the key word screening criteria; 67 of these met inclusion criteria for the systematic review. Seven domains of factors that influence generic drug utilization were identified: 1) patient-related factors, 2) formulary management or cost containment, 3) healthcare policies, 4) promotional activities, 5) educational initiatives, 6) technology, and 7) physician-related factors. Patients, physicians, pharmacists, formulary managers, and policymakers play an important role in generic drug use. Understanding the factors influencing generic drug use can help guide future policy, education, and practice interventions to increase generic drug use. Copyright © 2017 Elsevier Inc. All rights reserved.

Generic medicines: solutions for a sustainable drug market?

Science.gov (United States)

Dylst, Pieter; Vulto, Arnold; Godman, Brian; Simoens, Steven

2013-10-01

Generic medicines offer equally high-quality treatment as originator medicines do at much lower prices. As such, they represent a considerable opportunity for authorities to obtain substantial savings. At the moment, the pharmaceutical landscape is changing and many pharmaceutical companies have altered their development and commercial strategies, combining both originator and generic divisions. In spite of this, the generic medicines industry is currently facing a number of challenges: delayed market access; the limited price differential with originator medicines; the continuous downwards pressure on prices; and the negative perception regarding generic medicines held by some key stakeholder groups. This could jeopardize the long-term sustainability of the generic manufacturing industry. Therefore, governments must focus on demand-side policies, alongside policies to accelerate market access, as the generic medicines industry will only be able to deliver competitive and sustainable prices if they are ensured a high volume. In the future, the generic medicines industry will increasingly look to biosimilars and generic versions of orphan drugs to expand their business.

Encouraging the use of generic medicines: implications for transition economies.

Science.gov (United States)

King, Derek R; Kanavos, Panos

2002-08-01

Generic drugs have a key role to play in the efficient allocation of financial resources for pharmaceutical medicines. Policies implemented in the countries with a high rate of generic drug use, such as Canada, Denmark, Germany, the Netherlands, the United Kingdom, and the United States, are reviewed, with consideration of the market structures that facilitate strong competition. Savings in these countries are realized through increases in the volume of generic drugs used and the frequently significant differences in the price between generic medicines and branded originator medicines. Their policy tools include the mix of supply-side measures and demand-side measures that are relevant for generic promotion and higher generic use. On the supply-side, key policy measures include generic drug marketing regulation that facilitates market entry soon after patent expiration, reference pricing, the pricing of branded originator products, and the degree of price competition in pharmaceutical markets. On the demand-side, measures typically encompass influencing prescribing and dispensing patterns as well as introducing a co-payment structure for consumers/patients that takes into consideration the difference in cost between branded and generic medicines. Quality of generic medicines is a pre-condition for all other measures discussed to take effect. The paper concludes by offering a list of policy options for decision-makers in Central and Eastern European economies in transition.

Brand vs generic adverse event reporting patterns: An authorized generic-controlled evaluation of cardiovascular medications.

Science.gov (United States)

Alatawi, Y; Rahman, Md M; Cheng, N; Qian, J; Peissig, P L; Berg, R L; Page, C D; Hansen, R A

2018-06-01

Some public scepticism exists about generics in terms of whether brand and generic drugs produce identical outcomes. This study explores whether adverse event (AE) reporting patterns are similar between brand and generic drugs, using authorized generics (AGs) as a control for possible generic drug perception biases. Events reported to the FDA Adverse Event Reporting System from the years 2004-2015 were analysed. Drugs were classified as brand, AG or generic based on drug and manufacturer names. Reports were included if amlodipine, losartan, metoprolol extended release (ER) or simvastatin were listed as primary or secondary suspect drugs. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting labelled AEs compared to reporting these AEs with all other drugs. The Breslow-Day test compared RORs across brand, AG and generic. Interrupted time series analysis evaluated the impact of generic entry on reporting trends. Generics accounted for significant percentages of total U.S. reports, but AGs accounted for smaller percentages of reports, including for amlodipine (14.26%), losartan (1.48%), metoprolol ER (0.35%) and simvastatin (0.70%). Whereas the RORs were significantly different for multiple brand vs generic comparisons, the AG vs generic comparisons yielded fewer statistically significant findings. Namely, only the ROR for AG differed from generic for amlodipine with peripheral oedema (P brand and generic compared with AG and generic. Use of AGs as a control for perception biases against generics is useful, but this approach can be limited by small AG report numbers. Requiring the manufacturer name to be printed on the prescription bottle or packaging could improve the accuracy of assignment for products being reported. © 2017 John Wiley & Sons Ltd.

Consumer opinion on social policy approaches to promoting positive body image: Airbrushed media images and disclaimer labels.

Science.gov (United States)

Paraskeva, Nicole; Lewis-Smith, Helena; Diedrichs, Phillippa C

2017-02-01

Disclaimer labels on airbrushed media images have generated political attention and advocacy as a social policy approach to promoting positive body image. Experimental research suggests that labelling is ineffective and consumers' viewpoints have been overlooked. A mixed-method study explored British consumers' ( N = 1555, aged 11-78 years) opinions on body image and social policy approaches. Thematic analysis indicated scepticism about the effectiveness of labelling images. Quantitatively, adults, although not adolescents, reported that labelling was unlikely to improve body image. Appearance diversity in media and reorienting social norms from appearance to function and health were perceived as effective strategies. Social policy and research implications are discussed.

Nutrition labelling is a trade policy issue: lessons from an analysis of specific trade concerns at the World Trade Organization.

Science.gov (United States)

Thow, Anne Marie; Jones, Alexandra; Hawkes, Corinna; Ali, Iqra; Labonté, Ronald

2017-01-12

Interpretive nutrition labels provide simplified nutrient-specific text and/or symbols on the front of pre-packaged foods, to encourage and enable consumers to make healthier choices. This type of labelling has been proposed as part of a comprehensive policy response to the global epidemic of non-communicable diseases. However, regulation of nutrition labelling falls under the remit of not just the health sector but also trade. Specific Trade Concerns have been raised at the World Trade Organization's Technical Barriers to Trade Committee regarding interpretive nutrition labelling initiatives in Thailand, Chile, Indonesia, Peru and Ecuador. This paper presents an analysis of the discussions of these concerns. Although nutrition labelling was identified as a legitimate policy objective, queries were raised regarding the justification of the specific labelling measures proposed, and the scientific evidence for effectiveness of such measures. Concerns were also raised regarding the consistency of the measures with international standards. Drawing on policy learning theory, we identified four lessons for public health policy makers, including: strategic framing of nutrition labelling policy objectives; pro-active policy engagement between trade and health to identify potential trade issues; identifying ways to minimize potential 'practical' trade concerns; and engagement with the Codex Alimentarius Commission to develop international guidance on interpretative labelling. This analysis indicates that while there is potential for trade sector concerns to stifle innovation in nutrition labelling policy, care in how interpretive nutrition labelling measures are crafted in light of trade commitments can minimize such a risk and help ensure that trade policy is coherent with nutrition action. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Coexistence of GMO production, labeling policies, and strategic firm interaction

NARCIS (Netherlands)

Venus, Thomas Johann

2017-01-01

This dissertation analyzes the market effects of the coexistence of genetically modified organism (GMO) and conventional production, labeling policies, and strategic firm interactions through vertical product differentiation. Although we focus on GMOs, the applied frameworks can be adopted and

Comparing Generic Drug Markets in Europe and the United States: Prices, Volumes, and Spending.

Science.gov (United States)

Wouters, Olivier J; Kanavos, Panos G; McKEE, Martin

2017-09-01

Policy Points: Our study indicates that there are opportunities for cost savings in generic drug markets in Europe and the United States. Regulators should make it easier for generic drugs to reach the market. Regulators and payers should apply measures to stimulate price competition among generic drugmakers and to increase generic drug use. To meaningfully evaluate policy options, it is important to analyze historical context and understand why similar initiatives failed previously. Rising drug prices are putting pressure on health care budgets. Policymakers are assessing how they can save money through generic drugs. We compared generic drug prices and market shares in 13 European countries, using data from 2013, to assess the amount of variation that exists between countries. To place these results in context, we reviewed evidence from recent studies on the prices and use of generics in Europe and the United States. We also surveyed peer-reviewed studies, gray literature, and books published since 2000 to (1) outline existing generic drug policies in European countries and the United States; (2) identify ways to increase generic drug use and to promote price competition among generic drug companies; and (3) explore barriers to implementing reform of generic drug policies, using a historical example from the United States as a case study. The prices and market shares of generics vary widely across Europe. For example, prices charged by manufacturers in Switzerland are, on average, more than 2.5 times those in Germany and more than 6 times those in the United Kingdom, based on the results of a commonly used price index. The proportion of prescriptions filled with generics ranges from 17% in Switzerland to 83% in the United Kingdom. By comparison, the United States has historically had low generic drug prices and high rates of generic drug use (84% in 2013), but has in recent years experienced sharp price increases for some off-patent products. There are policy

An audit of generic prescribing in a general surgical department.

LENUS (Irish Health Repository)

Gleeson, M

2013-01-17

BACKGROUND: The Health Service Executive introduced a generic prescription policy to reduce costs. Despite this, generic prescription rates remain low. AIM: To audit in-patient prescription practice in a single surgical department and identify potential savings which could be realised by adherence to the generic prescribing policy. METHODS: Surgical in-patient charts were obtained at the point of discharge and their drug prescription information was recorded. RESULTS: 51 % of prescriptions involved a trade-name prescription where an appropriate generic equivalent existed. The cost implications for hospital and community patients were found to be greatly affected by substitution policies that exist at hospital pharmacy level. CONCLUSION: There is a need to promote greater adherence to generic prescribing amongst hospital doctors in line with international best practice. It can have a positive impact in terms of safe prescribing and can have cost implications at both hospital and community level.

Rethinking generic skills

Directory of Open Access Journals (Sweden)

Roy Canning

2013-10-01

Full Text Available The paper provides a critical analysis of the notion of generic or transversal skillscontained with European Union policy discourses. The author presents a conceptualframework that challenges the idea that generic skills are universal, transferable andautonomous. An alternative analysis is put forward that argues the case forcontextualising skills and knowledge within particular understandings and cultures thatare more collective than individualistic in nature. The arguments are framed withinwider cross-disciplinary debates in linguistics, geosemiotics and social-cultural theoryand build upon an earlier paper exploring core skills in the UK (Canning, 2007.

Cigarette pack labelling in 12 countries at different levels of economic development.

Science.gov (United States)

Mir, Hassan; Buchanan, Daniel; Gilmore, Anna; McKee, Martin; Yusuf, Salim; Chow, Clara K

2011-05-01

With increasing restrictions on cigarette marketing, the cigarette pack itself has become a main means of marketing. We describe a method to examine cigarette labelling and use it to evaluate packs collected from 12 countries at different stages of economic development. Health warnings were present on all 115 packs of cigarettes examined, but were on the front and back panels of only 68 per cent. Promotional labels were widespread, found on packs from all countries and more numerous (although not necessarily larger) than health warning labels in 10 of the 12 countries. Deceptive terms such as 'light' and 'mild' were observed on 42 per cent of all packs examined. The simple method described here can be used to compare cigarette labelling and potentially evaluate and track the implementation of cigarette labelling policy. We found health warning legislation poorly enforced and cigarette packs widely used to promote smoking and deceive smokers about health risks. The findings underline the need for generic (plain) packaging.

Legal and policy foundations for global generic competition: Promoting affordable drug pricing in developing societies.

Science.gov (United States)

Zapatero Miguel, Pablo

2015-01-01

The so-called 'TRIPS flexibilities' restated in 2001 by the World Trade Organization's Doha Declaration on TRIPS and Public Health offer a variety of policy avenues for promoting global price-based competition for essential medicines, and thus for improving access to affordable medicines in the developing world. In recent years, developing countries and international organisations alike have begun to explore the potentialities of global generic markets and competition generally, and also of using compulsory licensing to remedy anti-competitive practices (e.g. excessive pricing) through TRIPS-compatible antitrust enforcement. These and other 'pro-competitive' TRIPS flexibilities currently available provide the critical leverage and policy space necessary to improve access to affordable medicines in the developing world.

Advocacy coalitions involved in California's menu labeling policy debate: Exploring coalition structure, policy beliefs, resources, and strategies.

Science.gov (United States)

Payán, Denise D; Lewis, LaVonna B; Cousineau, Michael R; Nichol, Michael B

2017-03-01

Advocacy coalitions often play an important role in the state health policymaking process, yet little is known about their structure, composition, and behavior. In 2008, California became the first state to enact a menu labeling law. Using the advocacy coalition framework, we examine different facets of the coalitions involved in California's menu labeling policy debate. We use a qualitative research approach to identify coalition members and explore their expressed beliefs and policy arguments, resources, and strategies by analyzing legislative documents (n = 87) and newspaper articles (n = 78) produced between 1999 and 2009. Between 2003 and 2008, six menu labeling bills were introduced in the state's legislature. We found the issue received increasing media attention during this period. We identified two advocacy coalitions involved in the debate-a public health (PH) coalition and an industry coalition. State organizations acted as coalition leaders and participated for a longer duration than elected officials. The structure and composition of each coalition varied. PH coalition leadership and membership notably increased compared to the industry coalition. The PH coalition, led by nonprofit PH and health organizations, promoted a clear and consistent message around informed decision making. The industry coalition, led by a state restaurant association, responded with cost and implementation arguments. Each coalition used various resources and strategies to advance desired outcomes. PH coalition leaders were particularly effective at using resources and employing advocacy strategies, which included engaging state legislators as coalition members, using public opinion polls and information, and leveraging media resources to garner support. Policy precedence and a local policy push emerged as important policymaking strategies. Areas for future research on the state health policymaking process are discussed. Copyright © 2017 Elsevier Ltd. All rights reserved.

78 FR 43974 - Energy and Water Use Labeling for Consumer Products Under the Energy Policy and Conservation Act...

Science.gov (United States)

2013-07-23

... FEDERAL TRADE COMMISSION 16 CFR Part 305 [3084-AB15] Energy and Water Use Labeling for Consumer Products Under the Energy Policy and Conservation Act (Energy Labeling Rule) AGENCY: Federal Trade...'') in 1979,\\1\\ pursuant to the Energy Policy and Conservation Act of 1975 (EPCA).\\2\\ The Rule requires...

Submissions to the Australian and New Zealand Review of Food Labelling Law and Policy support traffic light nutrition labelling.

Science.gov (United States)

White, John; Signal, Louise

2012-10-01

Food labels to support healthier choices are an important potential intervention for improving population health by reducing obesity and diet-related disease. This study examines the use of research evidence about traffic light nutrition labelling in submissions to the Review of Food Labelling Law and Policy conducted in Australia and New Zealand. Content analysis of final submissions to the Review and a literature review of documents reporting research evidence about traffic light labelling. Sixty-two submitters to the Review were categorised as 'supporters' of traffic light labelling and 29 as 'opponents'. Supporters focused on studies showing traffic light labels were better than other systems at helping consumers identify healthier food options. Opponents cited evidence that traffic light labels were no better than other systems in this respect and noted a lack of evidence that they led to changes in food consumption. A literature review demonstrated that, as a group, submitters had drawn attention to most of the relevant research evidence on traffic light labelling. Both supporters and opponents were, however, selective in their use of evidence. The weight of evidence suggested that traffic light labelling has strengths in helping consumers to identify healthier food options. Further research would be valuable in informing the development of an interpretive front-of-pack labelling system. The findings have significant implications for the development of front-of-pack nutrition labelling currently being considered in Australia and New Zealand. © 2012 The Authors. ANZJPH © 2012 Public Health Association of Australia.

Advocacy Coalitions involved in California’s Menu Labeling Policy Debate: Exploring Coalition Structure, Policy Beliefs, Resources, and Strategies

Science.gov (United States)

Payán, Denise D.; Lewis, LaVonna B.; Cousineau, Michael R.; Nichol, Michael B.

2017-01-01

Advocacy coalitions often play an important role in the state health policymaking process, yet little is known about their structure, composition, and behavior. In 2008, California became the first state to enact a menu labeling law. Using the advocacy coalition framework, we examine different facets of the coalitions involved in California’s menu labeling policy debate. We use a qualitative research approach to identify coalition members and explore their expressed beliefs and policy arguments, resources, and strategies by analyzing legislative documents (n=87) and newspaper articles (n=78) produced between 1999 and 2009. Between 2003 and 2008, six menu labeling bills were introduced in the state’s legislature. We found the issue received increasing media attention during this period. We identified two advocacy coalitions involved in the debate—a public health (PH) coalition and an industry coalition. State organizations acted as coalition leaders and participated for a longer duration than elected officials. The structure and composition of each coalition varied. PH coalition leadership and membership notably increased compared to the industry coalition. The PH coalition, led by nonprofit PH and health organizations, promoted a clear and consistent message around informed decision making. The industry coalition, led by a state restaurant association, responded with cost and implementation arguments. Each coalition used various resources and strategies to advance desired outcomes. PH coalition leaders were particularly effective at using resources and employing advocacy strategies, which included engaging state legislators as coalition members, using public opinion polls and information, and leveraging media resources to garner support. Policy precedence and a local policy push emerged as important policymaking strategies. Areas for future research on the state health policymaking process are discussed. PMID:28161674

Developing competitive and sustainable Polish generic medicines market.

Science.gov (United States)

Simoens, Steven

2009-10-01

To descriptively analyze the policy environment surrounding the Polish generic medicines retail market. The policy analysis was based on an international literature review. Also, a simulation exercise was carried out to compute potential savings from substituting generic for originator medicines in Poland using IMS Health pharmaceutical intelligence data. Poland has a mature, high-volume, low-value generic medicines market, primarily driven by the establishment of the reference price at the price of the cheapest medicine in combination with pricing regulation and the low level of medicine prices. The practice of discounting in the distribution chain implies that the National Health Fund and patients do not capture the potential savings from a generic medicines market where companies compete on price. This high-volume market has benefited in the past from the limited availability of originator medicines and a short data exclusivity period, even though there are no incentives for physicians to prescribe generic medicines and a financial disincentive for pharmacists to dispense generic medicines. Increased generic substitution would be expected to reduce public expenditure on originator medicines by 21%. To develop a competitive and sustainable market, Poland needs to consider moving away from competition by discount to competition by price. This could be achieved by replacing maximum distribution margins by fixed margins. Also, Poland may wish to raise reference prices as a temporary measure to boost market entry for medicine classes with few generic medicines.

Some drugs more equal than others: pseudo-generics and commercial practice.

Science.gov (United States)

Probyn, Andrew J

2004-11-08

This article analyses the impact of the Department of Health and Ageing's brand price premium policy for some products listed on the Pharmaceutical Benefits Scheme. The policy, introduced in 1990, allows pharmaceutical companies to charge patients an out-of-pocket expense for post-patent brands of pharmaceuticals. One of the policy's intended goals was to increase consumer awareness of price differentials between competing brands, with a view to encouraging greater use of cheaper generic products. More than fourteen years since its introduction, it is debatable whether the policy has achieved this aim. This article looks at how the brand price premium policy can be exploited by global pharmaceutical giants to entrench big-name brands in the Australian pharmaceutical market and, in some cases, prevent 'true' competition from generic pharmaceuticals. This is being done through the establishment of 'pseudo-generics' that are sourced from the same factory floor as the original product.

Language and Nutrition (Mis)Information: Food Labels, FDA Policies and Meaning

Science.gov (United States)

Taylor, Christy Marie

2013-01-01

In this dissertation, I address the ways in which food manufacturers can exploit the often vague and ambiguous nature of FDA policies concerning language and images used on food labels. Employing qualitative analysis methods (Strauss, 1987; Denzin and Lincoln, 2003; Mackey and Gass, 2005) that drew upon critical discourse analysis (Fairclough,…

Generic medicine and prescribing: A quick assessment

Directory of Open Access Journals (Sweden)

Mainul Haque

2017-01-01

Full Text Available Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts. The Food and Drug Administration (FDA describes that generic drugs are essential possibilities that allow better access to healthcare for all Americans. They are replicas of brand-name drugs and are the identical as those of brand-name drugs in dosage form, safety, strength, route of administration, quality, performance features, and anticipated to use. Healthcare authorities and users can be guaranteed that FDA-approved generic drug products have met the same stiff principles as the innovator drug. The company that made Bayer aspirin fought in court enthusiastically to keep generic versions off the shelves, in the 1920s. The company lost in court, and consumers suddenly had an array of choices in generic aspirin. The Supreme Court of India uttering ‘the Supreme Court's ruling will prevent companies from further seeking unwarranted patents on HIV and other essential medicines.’ Generic medicine cannot be sold at a price higher than the branded medicine, so it is regularly a low-priced option. Thereafter, both the end user and the government who pay for part of the price of the medicine under the Pharmaceutical Benefits Scheme in Australia are benefitted. The treatment of diseases using essential drugs, prescribed by their generic names, has been emphasised by the WHO and many national health policies. Although there are some improvements in generic medicine prescribing, it has been advised by the WHO that ‘countries should intensify efforts to measure and regularly monitor medicine prices and availability, and adopt policy measures to address the issues identified.’

Potential Cost Savings from Generic Medicines - Protecting the ...

African Journals Online (AJOL)

... a pro-generic policy since the introduction of the National Drug Policy in 1996. ... Medicines provided outside of hospitals accounted for 17% of medical aid ... in the chronic disease algorithms set out by the Council for Medical Schemes ...

Leveraging consumer's behaviour to promote generic drugs in Italy.

Science.gov (United States)

Zerbini, Cristina; Luceri, Beatrice; Vergura, Donata Tania

2017-04-01

The aim of this study was to fill the lack of knowledge regarding a more grounded exploration of the consumer's decision-making process in the context of generic drugs. In this perspective, a model, within the theoretical framework of the Theory of Planned Behaviour (TPB), for studying the consumers' purchase intention of generic drugs was developed. An online survey on 2,222 Italian people who bought drugs in the past was conducted. The proposed model was tested through structural equation modelling (SEM). Almost all the constructs considered in the model, except the perceived behavioural control, contribute to explain the consumer's purchase intention of generic drugs, after controlling for demographic variables (age, income, education). Specifically, attitude, subjective norm, past behaviour, self-identity and trust in the pharmacist have a positive influence on the intention to buy generic drugs. On the contrary, perceived risk towards products and brand sensitivity act negatively. The results of the present study could be useful to public policy makers in developing effective policies and educational campaigns aimed at promoting generic drugs. Specifically, marketing efforts should be directed to inform consumers about the generic drugs' characteristics to mitigate the perceived risk towards these products and to raise awareness during their decision-making process. Copyright © 2017 Elsevier B.V. All rights reserved.

The importance of being first: evidence from Canadian generic pharmaceuticals.

Science.gov (United States)

Hollis, Aidan

2002-12-01

This paper uses pooled cross-section data on Canadian ethical drug sales to examine the effect of entry timing on sales of generic drugs. The data is for all drugs for which the first generic competitor entered during the years 1994-1997. It is found that the first generic entrant has a lasting competitive advantage: being first into the market appears to lead to an increase of around 30% in market share (among generics) over a period of at least 4 years. This finding has considerable implications for the current policy of allowing brandname drug companies to issue pseudo-generic equivalents as a preemptive strike against true generic competitors. Copyright 2002 John Wiley & Sons, Ltd.

Label Review Training: Module 1: Label Basics, Page 25

Science.gov (United States)

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review: clarity, accuracy, consistency with EPA policy, and enforceability.

Consumers' Response to an On-Shelf Nutrition Labelling System in Supermarkets: Evidence to Inform Policy and Practice.

Science.gov (United States)

Hobin, Erin; Bollinger, Bryan; Sacco, Jocelyn; Liebman, Eli; Vanderlee, Lana; Zuo, Fei; Rosella, Laura; L'abbe, Mary; Manson, Heather; Hammond, David

2017-09-01

Policy Points: On-shelf nutrition labelling systems in supermarkets, such as the Guiding Stars system, are intended to provide consumers with simple, standardized nutrition information to support more informed and healthier food choices. Policies that support the provision of simplified nutrition labelling systems may encourage consumers to make positive shifts in food-purchasing behaviors. The shifts in consumer food-purchasing patterns observed in our study after the introduction of the Guiding Stars system in supermarkets translated into measurable nutritional benefits, including more items purchased with slightly less trans fat and sugar and more fiber and omega-3 fatty acids. This study is one of the first to report the positive impact of an on-shelf nutrition labelling system on supermarket sales and revenues-key information that was specifically requested by the US National Academies, as such labelling interventions may be more sustainable if they lead to higher revenues. Providing a nutrition rating system on the front of food packages or on retail shelf tags has been proposed as a policy strategy for supporting healthier food choices. Guiding Stars is an on-shelf nutrition labelling system that scores foods in a supermarket based on nutritional quality; scores are then translated into ratings of 0 to 3 stars. It is consistent with evidence-informed recommendations for well-designed labels, except for not labelling 0-star products. The largest supermarket retailer in Canada rolled out the Guiding Stars system in supermarkets across Ontario, Canada. The aim of our study was to examine the extent to which consumers respond to an on-shelf nutrition labelling system in supermarkets to inform current and future nutrition labelling policies and practices. Capitalizing on a natural experiment, we conducted a quasi-experimental study across 3 supermarket banners (or "chains") in Ontario, one of which implemented the Guiding Stars system in 2012. We used aggregated

Ready for policy? Stakeholder attitudes toward menu labelling in Toronto, Canada.

Science.gov (United States)

Mah, Catherine L; Vanderlinden, Loren; Mamatis, Dia; Ansara, Donna L; Levy, Jennifer; Swimmer, Lisa

2013-04-18

The purpose of this research was to assess key stakeholder attitudes regarding menu labelling in Toronto, the largest municipality in Canada. Menu labelling is a population health intervention where food-labelling principles are applied to the eating-out environment through disclosure of nutrient content of food items on restaurant menus at the point of sale. Menu-labelling legislation has been implemented in the United States, but has yet to be adopted in Canada. As provincial voluntary programs and federal analyses progress, municipal jurisdictions will need to assess the feasibility of moving forward with parallel interventions. Data were collected and analyzed in late 2011 to early 2012, including: a consumer eating-out module incorporated into a public health surveillance telephone survey (n=1,699); an online survey of independent restaurant operators (n=256); in-depth key informant interviews with executives and decision makers at chain restaurants (n=9); and a policy consultation with local restaurant associations. Toronto residents, particularly men, younger adults, and those with higher income or education, frequently eat out. A majority indicated that nutrition information is important to them; 69% note that they currently use it and 78% reported they would use it if it were readily available. Resistance to menu-labelling requirements at the municipal level was articulated by franchise/chain restaurant executives and industry associations. Despite overall low interest among independent restaurant operators, 57% reported feeling some responsibility to provide nutrition information and 50% believed it could be good for business. This research supports earlier literature that indicates strong public support for menu labelling alongside perceived barriers among the restaurant and foodservices sector. Leverage points for effective operator engagement for menu-labelling adoption were identified, nonetheless, highlighting the need for public health support.

Labelling fashion magazine advertisements: Effectiveness of different label formats on social comparison and body dissatisfaction.

Science.gov (United States)

Tiggemann, Marika; Brown, Zoe

2018-06-01

The experiment investigated the impact on women's body dissatisfaction of different forms of label added to fashion magazine advertisements. Participants were 340 female undergraduate students who viewed 15 fashion advertisements containing a thin and attractive model. They were randomly allocated to one of five label conditions: no label, generic disclaimer label (indicating image had been digitally altered), consequence label (indicating that viewing images might make women feel bad about themselves), informational label (indicating the model in the advertisement was underweight), or a graphic label (picture of a paint brush). Although exposure to the fashion advertisements resulted in increased body dissatisfaction, there was no significant effect of label type on body dissatisfaction; no form of label demonstrated any ameliorating effect. In addition, the consequence and informational labels resulted in increased perceived realism and state appearance comparison. Yet more extensive research is required before the effective implementation of any form of label. Copyright © 2018 Elsevier Ltd. All rights reserved.

Comparison of generic-to-brand switchback patterns for generic and authorized generic drugs

Science.gov (United States)

Hansen, Richard A.; Qian, Jingjing; Berg, Richard; Linneman, James; Seoane-Vazquez, Enrique; Dutcher, Sarah K.; Raofi, Saeid; Page, C. David; Peissig, Peggy

2018-01-01

Background While generic drugs are therapeutically equivalent to brand drugs, some patients and healthcare providers remain uncertain about whether they produce identical outcomes. Authorized generics, which are identical in formulation to corresponding brand drugs but marketed as a generic, provide a unique post-marketing opportunity to study whether utilization patterns are influenced by perceptions of generic drugs. Objectives To compare generic-to-brand switchback rates between generics and authorized generics. Methods A retrospective cohort study was conducted using claims and electronic health records data from a regional U.S. healthcare system. Ten drugs with authorized generics and generics marketed between 1999 and 2014 were evaluated. Eligible adult patients received a brand drug during the 6 months preceding generic entry, and then switched to a generic or authorized generic. Patients in this cohort were followed for up to 30 months from the index switch date to evaluate occurrence of generic-to-brand switchbacks. Switchback rates were compared between patients on authorized generics versus generics using Kaplan-Meier curves and Cox proportional hazards models, controlling for individual drug effects, age, sex, Charlson comorbidity score, pre-index drug use characteristics, and pre-index healthcare utilization. Results Among 5,542 unique patients that switched from brand-to-generic or brand-to-authorized generic, 264 (4.8%) switched back to the brand drug. Overall switchback rates were similar for authorized generics compared with generics (HR=0.86; 95% CI 0.65-1.15). The likelihood of switchback was higher for alendronate (HR=1.64; 95% CI 1.20-2.23) and simvastatin (HR=1.81; 95% CI 1.30-2.54) and lower for amlodipine (HR=0.27; 95% CI 0.17-0.42) compared with other drugs in the cohort. Conclusions Overall switchback rates were similar between authorized generic and generic drug users, indirectly supporting similar efficacy and tolerability profiles for

International experiences of promoting generics use and its implications to China.

Science.gov (United States)

Sun, Jing

2013-05-01

To summarize international experiences in promoting use of generics and to extract essence for China's reference. This is a commentary of two systematic reviews about policies to promote use of generics and its implications to China. Price, reimbursement, and generic substitution policies in European countries, and approaches in low and middle income countries in promoting market competition, appropriate intellectual property right protection strategy, and necessary demand side incentives, are all meaningful for China to contain soaring pharmaceutical expenditures, and to maintain the achievements and outcomes of the national health system reform. Effective promotion of generics use must be practice based on the real situation. Tailor-made and comprehensive measures are needed to address both demand and supply sides barriers before achieving tangible cost containment effect without unexpected side effects. © 2013 Wiley Publishing Asia Pty Ltd and Chinese Cochrane Center, West China Hospital of Sichuan University.

Methodological Considerations for Comparison of Brand Versus Generic Versus Authorized Generic Adverse Event Reports in the US Food and Drug Administration Adverse Event Reporting System (FAERS).

Science.gov (United States)

Rahman, Md Motiur; Alatawi, Yasser; Cheng, Ning; Qian, Jingjing; Peissig, Peggy L; Berg, Richard L; Page, David C; Hansen, Richard A

2017-12-01

The US Food and Drug Administration Adverse Event Reporting System (FAERS), a post-marketing safety database, can be used to differentiate brand versus generic safety signals. To explore the methods for identifying and analyzing brand versus generic adverse event (AE) reports. Public release FAERS data from January 2004 to March 2015 were analyzed using alendronate and carbamazepine as examples. Reports were classified as brand, generic, and authorized generic (AG). Disproportionality analyses compared reporting odds ratios (RORs) of selected known labeled serious adverse events stratifying by brand, generic, and AG. The homogeneity of these RORs was compared using the Breslow-Day test. The AG versus generic was the primary focus since the AG is identical to brand but marketed as a generic, therefore minimizing generic perception bias. Sensitivity analyses explored how methodological approach influenced results. Based on 17,521 US event reports involving alendronate and 3733 US event reports involving carbamazepine (immediate and extended release), no consistently significant differences were observed across RORs for the AGs versus generics. Similar results were obtained when comparing reporting patterns over all time and just after generic entry. The most restrictive approach for classifying AE reports yielded smaller report counts but similar results. Differentiation of FAERS reports as brand versus generic requires careful attention to risk of product misclassification, but the relative stability of findings across varying assumptions supports the utility of these approaches for potential signal detection.

Labelling and Self-Esteem: The Impact of Using Specific vs. Generic Labels

Science.gov (United States)

Taylor, Laura Marie; Hume, Ian Robert; Welsh, Nikki

2010-01-01

The aim of this study is to investigate the relationship between being labelled either as having dyslexia or as having general special educational needs (SEN) and a child's self-esteem. Seventy-five children aged between 8 and 15 years categorised as having dyslexia (N = 26), as having general SEN (N = 26) or as having no learning difficulties (N…

[Labeling of food containing genetically modified organisms: international policies and Brazilian legislation].

Science.gov (United States)

Costa, Thadeu Estevam Moreira Maramaldo; Marin, Victor Augustus

2011-08-01

The increase in surface area planted with genetically modified crops, with the subsequent transfer of such crops into the general environment for commercial trade, has raised questions about the safety of these products. The introduction of the Cartagena Protocol on Biosafety has led to the need to produce information and ensure training in this area for the implementation of policies on biosafety and for decision-making on the part of governments at the national, regional and international level. This article presents two main standpoints regarding the labeling of GM products (one adopted by the United States and the other by the European Union), as well as the position adopted by Brazil and its current legislation on labeling and commercial release of genetically modified (GM) products.

Comparison of Generic-to-Brand Switchback Rates Between Generic and Authorized Generic Drugs.

Science.gov (United States)

Hansen, Richard A; Qian, Jingjing; Berg, Richard; Linneman, James; Seoane-Vazquez, Enrique; Dutcher, Sarah K; Raofi, Saeid; Page, C David; Peissig, Peggy

2017-04-01

Generic drugs contain identical active ingredients as their corresponding brand drugs and are pharmaceutically equivalent and bioequivalent, whereas authorized generic drugs (AGs) contain both identical active and inactive ingredients as their corresponding brand drugs but are marketed as generics. This study compares generic-to-brand switchback rates between generic and AGs. Retrospective cohort study. Claims and electronic health record data from a regional U.S. health care system. The full cohort consisted of 5542 unique patients who received select branded drugs during the 6 months prior to their generic drug market availability (between 1999 and 2014) and then were switched to an AG or generic drug within 30 months of generic drug entry. For these patients, 5929 unique patient-drug combinations (867 with AGs and 5062 with generic drugs) were evaluated. Ten drugs with AGs and generics marketed between 1999 and 2014 were evaluated. The date of the first generic prescription was considered the index date for each drug, and it marked the beginning of follow-up to evaluate the occurrence of generic-to-brand switchback patterns over the subsequent 30 months. Switchback rates were compared between patients receiving AGs versus those receiving generics using multivariable Cox proportional hazards models, controlling for individual drug effects, age, sex, Charlson Comorbidity Score, pre-index drug use characteristics, and pre-index health care utilization. Among the 5542 unique patients who switched from brand to generic or brand to AG, 264 (4.8%) switched back to the brand drug. Overall switchback rates were similar for AGs compared with generics (hazard ratio [HR] 0.86, 95% confidence interval [CI] 0.65-1.15). The likelihood of switchback was higher for alendronate (HR 1.64, 95% CI 1.20-2.23) and simvastatin (HR 1.81, 95% CI 1.30-2.54) and lower for amlodipine (HR 0.27, 95% CI 0.17-0.42) compared with the other drugs evaluated. Overall switchback rates were similar

75 FR 80828 - Draft Compliance Policy Guide Sec. 510.800 Beverages-Serving Size Labeling; Availability

Science.gov (United States)

2010-12-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0575] Draft Compliance Policy Guide Sec. 510.800 Beverages--Serving Size Labeling; Availability AGENCY: Food... comments on the draft CPG to the Division of Dockets Management (HFA-305), Food and Drug Administration...

Packaging and labeling of pharmaceutical products obtained from the internet.

Science.gov (United States)

Veronin, Michael

2011-02-15

For patients, the prescription container label may be the only source of instructions on how to take their medicines. In the United States, the legal requirements for a prescription label are set by federal law and state statutes. The container should be comparable to that which manufacturers use to package drug products and should preserve a product's identity, strength, quality, and purity and prevent contamination. Safety features such as a child-resistant closure should be provided. Pharmaceutical products purchased from international online pharmacies are not approved by the Food and Drug Administration (FDA) and may not meet US guidelines for labeling and packaging. The study objective was to determine whether commonly purchased pharmaceutical products obtained from international online pharmacies are comparable to products dispensed in the United States with regard to labeling and packaging. During March 2006 through January 2007, 41 pharmaceutical oral dosage form samples were obtained from international Internet pharmacy websites for evaluation: 18 generic simvastatin samples, 18 generic amlodipine samples, and 5 generic sildenafil samples. Contents for each package were observed and recorded and comparison of the prescription labeling and packaging of these products was made with prescription labeling and packaging requirements in the United States. Of the 41 drug products obtained from online pharmacies from 12 different countries, only 1 product (from Canada) would meet both labeling and packaging guidelines for products dispensed in the United States. Of those not meeting the requirements, 7 were dispensed in paper envelopes with label affixed that was either handwritten or typed and contained missing information such as name and address of dispenser, name of prescriber, name of patient, and directions for use. Another 3 products did not have a label affixed to the drug product, but information was printed on a paper document enclosed in the shipping

Sustainability Labeling

NARCIS (Netherlands)

Dam, van Y.K.

2017-01-01

Sustainability labeling originated from a need to protect the identity of alternative systems of food production and to increase market transparency. From the 1980s onwards sustainability labeling has changed into a policy instrument replacing direct government regulation of the food market, and a

How Abbott’s Fenofibrate Franchise Avoided Generic Competition

Science.gov (United States)

Downing, Nicholas S.; Ross, Joseph S.; Jackevicius, Cynthia A.; Krumholz, Harlan M.

2013-01-01

The ongoing debate concerning the efficacy of fenofibrate has overshadowed an important aspect of the drug’s history: Abbott, the maker of branded fenofibrate, has produced several bioequivalent reformulations, which dominate the market even though generic fenofibrate has been available for almost a decade. This continued use of branded formulations, which cost twice as much as generic versions of fenofibrate, imposes an annual cost of approximately $700 million on our healthcare system. Abbott maintained its dominance of the fenofibrate market, in part, through a complex switching strategy involving the sequential launch of branded reformulations that had not been shown to be superior to the first generation product and patent litigation that delayed the approval of generic formulations. The small differences in dose of the newer branded formulations prevented substitution with generics of older generation products. As soon as direct generic competition seemed likely at the new dose level where substitution would be allowed, Abbott would launch another reformulation and the cycle would repeat. Our objective, using the fenofibrate example, is to describe how current policy can allow pharmaceutical companies to maintain market share using reformulations of branded medications without demonstrating the superiority of next generation products. PMID:22493409

Generic programming for deterministic neutron transport codes

International Nuclear Information System (INIS)

Plagne, L.; Poncot, A.

2005-01-01

This paper discusses the implementation of neutron transport codes via generic programming techniques. Two different Boltzmann equation approximations have been implemented, namely the Sn and SPn methods. This implementation experiment shows that generic programming allows us to improve maintainability and readability of source codes with no performance penalties compared to classical approaches. In the present implementation, matrices and vectors as well as linear algebra algorithms are treated separately from the rest of source code and gathered in a tool library called 'Generic Linear Algebra Solver System' (GLASS). Such a code architecture, based on a linear algebra library, allows us to separate the three different scientific fields involved in transport codes design: numerical analysis, reactor physics and computer science. Our library handles matrices with optional storage policies and thus applies both to Sn code, where the matrix elements are computed on the fly, and to SPn code where stored matrices are used. Thus, using GLASS allows us to share a large fraction of source code between Sn and SPn implementations. Moreover, the GLASS high level of abstraction allows the writing of numerical algorithms in a form which is very close to their textbook descriptions. Hence the GLASS algorithms collection, disconnected from computer science considerations (e.g. storage policy), is very easy to read, to maintain and to extend. (authors)

The Impact of Information on Doctors’ Attitudes Toward Generic Drugs

Directory of Open Access Journals (Sweden)

Aggeliki V. Tsaprantzi MD

2016-03-01

Full Text Available The objective of this study is to assess the impact of information on doctors’ attitudes and perceptions toward generics. A cross-sectional survey based on a specially designed 21-item questionnaire was conducted. The survey involved doctors of different specialties working in a public hospital in Greece. The analysis includes descriptive and inferential statistics, reliability and validity tests, as well as structural equation modeling to evaluate the causal model. Statistical analysis was accomplished by using SPSS 20 and Amos 20. A total of 134 questionnaires out of 162 were received, providing a response rate of 82.71%. A number of significant associations were found between information and perceptions about generic medicines with demographic characteristics. It seems that the provision of quality information on generic drugs influences doctors’ attitudes and prescription practices toward generic drugs. This is not a static process but a rather dynamic issue involving information provision policies for strengthening the proper doctors’ attitudes toward generic drugs.

Societal value of generic medicines beyond cost-saving through reduced prices.

Science.gov (United States)

Dylst, Pieter; Vulto, Arnold; Simoens, Steven

2015-01-01

This paper aims to provide an overview of the added societal value of generic medicines beyond their cost-saving potential through reduced prices. In addition, an observational case study will document the impact of generic entry on access to pharmacotherapy in The Netherlands and an illustrative exercise was carried out to highlight the budget impact of generic entry. A narrative literature review was carried out to explore the impact of generic medicines on access to pharmacotherapy, innovation and medication adherence. Data from the Medicines and Medical Devices Information Project database in The Netherlands were used for the case study in which the impact of generic medicine entrance on the budget and the number of users was calculated as an illustrative exercise. Generic medicines have an additional societal value beyond their cost-saving potential through reduced prices. Generic medicines increase access to pharmacotherapy, provide a stimulus for innovation by both originator companies and generic companies and, under the right circumstances, have a positive impact on medication adherence. Generic medicines offer more to society than just their cost-saving potential through reduced prices. As such, governments must not focus only on the prices of generic medicines as this will threaten their long-term sustainability. Governments must therefore act appropriately and implement a coherent set of policies to increase the use of generic medicines.

Public Preferences for the Use of Taxation and Labelling Policy Measures to Combat Obesity in Young Children in Australia.

Science.gov (United States)

Comans, Tracy; Moretto, Nicole; Byrnes, Joshua

2017-03-21

Objective : Childhood obesity is a serious concern for developed and developing countries. This study aimed to assess the level of support in Australia for regulation and to assess whether systematic differences occur between individuals who support increased regulation and individuals who oppose it. Methods : An online survey ( n = 563) was used to assess parental/caregiver preferences for taxation policy options and nutrition labelling designed to address the incidence of childhood obesity. Participants were parents or caregivers of young children (3 to 7 years) who were actively enrolled in an existing birth cohort study in South-East Queensland, Australia. Results : The majority of the parents (over 80%) strongly agreed or agreed with labelling food and drink with traffic light or teaspoon labelling. Support for taxation was more variable with around one third strongly supporting and a further 40% of participants equivocal about using taxation; however, a quarter strongly rejected this policy. Cluster analysis did not detect any socio-demographic differences between those who strongly supported taxation and those who did not. Conclusions : Better food labelling would be welcomed by parents to enhance food choices for their children. Taxation for health reasons would not be opposed by most parents. Implications for Public Health: Governments should consider taxation of unhealthy drinks and improved labelling to encourage healthy food purchasing.

Consumer choice between common generic and brand medicines in a country with a small generic market.

Science.gov (United States)

Fraeyman, Jessica; Peeters, Lies; Van Hal, Guido; Beutels, Philippe; De Meyer, Guido R Y; De Loof, Hans

2015-04-01

Generic medicines offer an opportunity for governments to contain pharmaceutical expenditures, since generics are generally 10%-80% lower in price than brand medicines. Belgium has a small generic market that takes up 15% of the total pharmaceutical market in packages sold. To determine the knowledge of consumers about the different available packages of a common over-the-counter medicine (acetaminophen) with regard to price advantage, quality, and effectiveness in a country with a small generic market. We conducted an online survey in the general Flemish population using a questionnaire with 25 statements. The questionnaire also contained 2 informative interventions. First, we showed the price per package and per tablet that the patient would pay in the pharmacy. Second, we provided the respondent with general information about generic medication (equivalence, effectiveness, price, and recognition). Before and after the interventions, we probed for preferences and knowledge about the different packages. Multivariate logistic models were used to examine the independent effects of consumer characteristics on responses to the survey statements. We obtained a sample of 1,636 respondents. The general attitude towards generic medication was positive-only 5% would rather not use a generic. Nevertheless, only 17% of the respondents were able to recognize a generic medicine. Older consumers (aged 60 years and above) were more often confused about the different packages (OR = 2.59, 95% CI = 1.76-3.80, P ≤ 0.001). Consumers without a higher education degree tended to be more doubtful about the difference in effectiveness and quality between the different brands (OR = 0.59, 95% CI = 0.44-0.79, P ≤ 0.001). Consumer recognition of the name of the active substance of acetaminophen was poor. When different brands were displayed, possible price advantage seemed to be an important motive to switch to a cheaper brand. Consumers generally found medicines

Health-related claims on food labels in Australia: understanding environmental health officers' roles and implications for policy.

Science.gov (United States)

Condon-Paoloni, Deanne; Yeatman, Heather R; Grigonis-Deane, Elizabeth

2015-01-01

Health and related claims on food labels can support consumer education initiatives that encourage purchase of healthier foods. A new food Standard on Nutrition, Health and Related Claims became law in January 2013. Implementation will need careful monitoring and enforcement to ensure that claims are truthful and have meaning. The current study explored factors that may impact on environmental health officers' food labelling policy enforcement practices. The study used a mixed-methods approach, using two previously validated quantitative questionnaire instruments that provided measures of the level of control that the officers exercised over their work, as well as qualitative, semi-structured, in-depth interviews. Local government; Australia. Thirty-seven officers in three Australian states participated in semi-structured in-depth interviews, as well as completing the quantitative questionnaires. Senior and junior officers, including field officers, participated in the study. The officers reported a high level of autonomy and control of their work, but also a heavy workload, dominated by concerns for public health and food safety, with limited time for monitoring food labels. Compliance of labels with proposed health claims regulations was not considered a priority. Lipsky's theory of street-level bureaucracy was used to enhance understanding of officers' work practices. Competing priorities affect environmental health officers' monitoring and enforcement of regulations. Understanding officers' work practices and their perceptions of enforcement is important to increase effectiveness of policy implementation and hence its capacity to augment education initiatives to optimize health benefits.

Theoretical vs. actual energy consumption of labelled dwellings in the Netherlands: Discrepancies and policy implications

International Nuclear Information System (INIS)

Majcen, D.; Itard, L.C.M.; Visscher, H.

2013-01-01

In Europe, the Energy Performance of Buildings Directive (EPBD) provides for compulsory energy performance certification (labelling) for all existing dwellings. In the Netherlands, a labelling scheme was introduced in 2008. Certificates contain the energy label of the dwelling and corresponding theoretical gas and electricity consumption, calculated based on the dwellings physical characteristics, its heating, ventilation and cooling systems and standard use characteristics. This paper reports on a large-scale study of around 200,000 dwellings comparing labels and theoretical energy use with data on actual energy use. The study shows that dwellings with a low energy label actually consume much less energy than predicted by the label, but on the other hand, energy-efficient dwellings consume more than predicted. In practice, policy targets are set according to the theoretical rather than the actual consumptions of the building stock. In line with identified discrepancies, the study shows that whereas most energy reduction targets can be met according to the theoretical energy consumption of the dwelling stock, the future actual energy reduction potential is much lower and fails to meet most of the current energy reduction targets. - Highlights: ► Actual gas consumption in Dutch dwellings is lower than the theoretical. ► In the dwellings with label A–B, theoretical gas consumption is lower than actual gas consumption. ► In less efficient dwellings, theoretical gas consumption is much higher than the actual. ► Most current energy reduction targets are unachievable if modelled with actual instead of theoretical energy consumption

Directing gaze: the effect of disclaimer labels on women's visual attention to fashion magazine advertisements.

Science.gov (United States)

Bury, Belinda; Tiggemann, Marika; Slater, Amy

2014-09-01

In an effort to combat the known negative effects of exposure to unrealistic thin ideal images, there is increasing worldwide pressure on fashion, media and advertising industries to disclose when images have been digitally altered. The current study used eye tracking technology to investigate experimentally how digital alteration disclaimer labels impact women's visual attention to fashion magazine advertisements. Participants were 60 female undergraduate students who viewed four thin ideal advertisements with either no disclaimer, a generic disclaimer, or a specific more detailed disclaimer. It was established that women did attend to the disclaimers. The nature of the disclaimer had no effect on time spent looking at particular body parts, but did affect the direction of gaze following reading of the disclaimer. This latter effect was found to be greater for women high on trait appearance comparison. Further research is paramount in guiding effective policy around the use of disclaimer labels. Copyright © 2014 Elsevier Ltd. All rights reserved.

7 CFR 361.3 - Declarations and labeling.

Science.gov (United States)

2010-01-01

... declaration must state the kind, variety, and origin of each lot of seed or screenings and the use for which... names used on the label shall be the commonly accepted coined, chemical (generic), or abbreviated... distinctly contrasting color. Mercurials and similarly toxic substances include the following: Aldrin...

Analysis of the Italian generic medicines retail market: recommendations to enhance long-term sustainability.

Science.gov (United States)

Dylst, Pieter; Vulto, Arnold; Simoens, Steven

2015-02-01

Italy is among the European countries with the lowest uptake of generic medicines. This paper provides a perspective on the Italian generic medicines retail market. Fast market entrance of generic medicines in Italy is hindered by several factors: the existence of Complementary Protection Certificates in the past, the large market for copies and multiple cases of patent linkage. Prices of generic medicines in Italy are low compared to other European countries. To contain pharmaceutical expenditure, pharmaceutical companies are currently forced to pay back in case of overspending, which disproportionally penalizes small and fast growing companies, to which most generic companies belong to. Current demand-side policies do not successfully stimulate the use of generic medicines. The current market environment surrounding the Italian generic medicines retail market (i.e., low prices, low volumes) threatens its long-term sustainability. Recommendations to enhance the long-term sustainability of the Italian generic medicines retail market round off this perspective paper.

Improving eco-labelling as an environmental policy instrument

DEFF Research Database (Denmark)

Daugbjerg, Carsten; Smed, Sinne; Andersen, Laura Mørch

2014-01-01

-labels as a reassurance that these attributes are actually delivered. We argue that the label will only have the desired effect if the consumers know the production standards underpinning it and have trust in the label. We test this argument using organic food as our example. The empirical results obtained on the basis...

Quality of generic medicines in South Africa: Perceptions versus Reality – A qualitative study

Directory of Open Access Journals (Sweden)

Patel Aarti

2012-09-01

Full Text Available Abstract Background Generic Medicines are an important policy option allowing for access to affordable, essential medicines. Quality of generic medicines must be guaranteed through the activities of national medicines regulatory authorities. Existing negative perceptions surrounding the quality of generic medicines must be addressed to ensure that people use them with confidence. Campaigns to increase the uptake of generic medicines by consumers and providers of healthcare need to be informed by local norms and practices. This study sought to compare South African consumers’ and healthcare providers’ perceptions of quality of generics to the actual quality of selected products. Methods The study was conducted at the local level in three cities of South Africa: Johannesburg, Durban and Cape Town. Purposive sampling was used to recruit consumer participants (n = 73 and random sampling used to recruit healthcare providers from public and private sectors (n = 15. Data were obtained through twelve focus group discussions with consumers and semi-structured interviews (n = 15 with healthcare providers in order to gain familiarity with perceptions of quality. One hundred and thirty five products comprising paracetamol tablets (n = 47, amoxicillin capsules (n = 45 and hydrochlorothiazide tablets (n = 43 were sourced from public and private sector healthcare providers. These products were subjected to in vitro dissolution, uniformity of weight and identity (Fourier Transformed Infrared Spectroscopy tests using prescribed methods from the British (2005 and United States Pharmacopeias (2006. Results Respondents described drug quality in relation to the effect on symptoms. Procurement and use behavior of healthcare providers was influenced by prior experience, manufacturers’ names and consumers’ ability to pay. All formulations passed the in vitro tests for quality. Conclusions This study showed clear differences between

Message framing in the context of the national menu-labelling policy: a comparison of public health and private industry interests.

Science.gov (United States)

Shelton, Rachel C; Colgrove, James; Lee, Grace; Truong, Michelle; Wingood, Gina M

2017-04-01

We conducted a content analysis of public comments to understand the key framing approaches used by private industry v. public health sector, with the goal of informing future public health messaging, framing and advocacy in the context of policy making. Comments to the proposed menu-labelling policy were extracted from Regulations.gov and analysed. A framing matrix was used to organize and code key devices and themes. Documents were analysed using content analysis with Dedoose software. Recent national nutrition-labelling regulations in the USA provide a timely opportunity to understand message framing in relation to obesity prevention and policy. We examined a total of ninety-seven documents submitted on behalf of organizations (private industry, n 64; public health, n 33). Public health focused on positive health consequences of the policy, used a social justice frame and supported its arguments with academic data. Industry was more critical of the policy; it used a market justice frame that emphasized minimal regulation, depicted its members as small, family-run businesses, and illustrated points with humanizing examples. Public health framing should counter and consider engaging directly with non-health-related arguments made by industry. Public health should include more powerful framing devices to convey their messages, including metaphors and humanizing examples.

Avoidance of generic competition by Abbott Laboratories' fenofibrate franchise.

Science.gov (United States)

Downing, Nicholas S; Ross, Joseph S; Jackevicius, Cynthia A; Krumholz, Harlan M

2012-05-14

The ongoing debate concerning the efficacy of fenofibrate has overshadowed an important aspect of the drug's history: Abbott Laboratories, the maker of branded fenofibrate, has produced several bioequivalent reformulations that dominate the market, although generic fenofibrate has been available for almost a decade. This continued use of branded formulations, which cost twice as much as generic versions of fenofibrate, imposes an annual cost of approximately $700 million on the US health care system. Abbott Laboratories maintained its dominance of the fenofibrate market in part through a complex switching strategy involving the sequential launch of branded reformulations that had not been shown to be superior to the first-generation product and patent litigation that delayed the approval of generic formulations. The small differences in dose of the newer branded formulations prevented their substitution with generics of older-generation products. As soon as direct generic competition seemed likely at the new dose level, where substitution would be allowed, Abbott would launch another reformulation, and the cycle would repeat. Based on the fenofibrate example, our objective is to describe how current policy can allow pharmaceutical companies to maintain market share using reformulations of branded medications, without demonstrating the superiority of next-generation products.

How to Read a Nutrition Facts Label

Medline Plus

Full Text Available ... Behavior School & Family Life First Aid & Safety Doctors & Hospitals Videos Recipes for Kids Kids site Sitio para ... nutricionales (video) Most packaged foods come with a Nutrition Facts label. These labels have a lot of important ... Policy Permissions Guidelines Privacy Policy & Terms of Use Notice ...

The impact on health outcomes and healthcare utilisation of switching to generic medicines consequent to reference pricing: the case of lamotrigine in New Zealand.

Science.gov (United States)

Lessing, Charon; Ashton, Toni; Davis, Peter

2014-10-01

Many countries have implemented generic reference pricing and substitution as methods of containing pharmaceutical expenditure. However, resistance to switching between medicines is apparent, especially in the case of anti-epileptic medicines. This study sought to exploit a nation-wide policy intervention on generic reference pricing in New Zealand to evaluate the health outcomes of patients switching from originator to generic lamotrigine, an anti-epileptic medicine. A retrospective study using the national health collections and prescription records was conducted comparing patients who switched from originator brand to generic lamotrigine with patients who remained on the originator brand. Primary outcome measures included switch behaviour, changes in utilisation of healthcare services at emergency departments, hospitalisations and use of specialist services, and mortality. Approximately one-quarter of all patients using the originator brand of lamotrigine switched to generic lamotrigine, half of whom made the switch within 60 days of the policy implementation. Multiple switches (three or more) between generic and brand products were evident for around 10% of switchers. Switch-back rates of 3% were apparent within 30 days post-switch. No difference in heath outcome measures was associated with switching from originator lamotrigine to a generic equivalent and hence no increased costs could be found for switchers. Switching from brand to generic lamotrigine is largely devoid of adverse health outcomes; however, creating an incentive to ensure a greater proportion of patients switch to generic lamotrigine is required to achieve maximal financial savings from a policy of generic reference pricing.

Restaurant Menu Labeling Policy: Review of Evidence and Controversies

Science.gov (United States)

VanEpps, Eric M.; Roberto, Christina A.; Park, Sara; Economos, Christina D.; Bleich, Sara N.

2016-01-01

In response to high rates of obesity in the USA, several American cities, counties, and states have passed laws requiring restaurant chains to post labels identifying the energy content of items on menus, and nationwide implementation of menu labeling is expected in late 2016. In this review, we identify and summarize the results of 16 studies that have assessed the impact of real-world numeric calorie posting. We also discuss several controversies surrounding the US Food and Drug Administration's implementation of federally mandated menu labeling. Overall, the evidence regarding menu labeling is mixed, showing that labels may reduce the energy content of food purchased in some contexts, but have little effect in other contexts. However, more data on a range of ong-term consumption habits and restaurant responses is needed to fully understand the impact menu labeling laws will have on the US population's diet. PMID:26877095

Effect of generic issues program on improving safety

International Nuclear Information System (INIS)

Fard, M. R.; Kauffman, J. V.

2010-01-01

The U.S. Nuclear Regulatory Commission (NRC) identifies (by its assessment of plant operation) certain issues involving public health and safety, the common defense and security, or the environment that could affect multiple entities under NRC jurisdiction. The Generic Issues Program (GIP) addresses the resolution of these Generic Issues (GIs). The resolution of these issues may involve new or revised rules, new or revised guidance, or revised interpretation of rules or guidance that affect nuclear power plant licensees, nuclear material certificate holders, or holders of other regulatory approvals. U.S. NRC provides information related to the past and ongoing GIP activities to the general public by the use of three main resources, namely NUREG-0933, 'Resolution of Generic Safety Issues, ' Generic Issues Management Control System (GIMCS), and GIP public web page. GIP information resources provide information such as historical information on resolved GIs, current status of the open GIs, policy documents, program procedures, GIP annual and quarterly reports and the process to contact GIP and propose a GI This paper provides an overview of the GIP and several examples of safety improvements resulting from the resolution of GIs. In addition, the paper provides a brief discussion of a few recent GIs to illustrate how the program functions to improve safety. (authors)

Food and Drug Labeling and the Adult Reader.

Science.gov (United States)

McKenna, Michael C.; Aker, Richard

1978-01-01

Full disclosure of ingredients on food, drugs, and cosmetic labels is really non-disclosure where the chemical formulation has no common name or where one generic name covers a variety of formations. The Food and Drug Administration offers suggestions for adult education programs in consumer awareness, understanding compound nomenclature, and…

Cigarette warning label policy alternatives and smoking-related health disparities.

Science.gov (United States)

Thrasher, James F; Carpenter, Matthew J; Andrews, Jeannette O; Gray, Kevin M; Alberg, Anthony J; Navarro, Ashley; Friedman, Daniela B; Cummings, K Michael

2012-12-01

Pictorial health warning labels on cigarette packaging have been proposed for the U.S., but their potential influences among populations that suffer tobacco-related health disparities are unknown. To evaluate pictorial health warning labels, including moderation of their influences by health literacy and race. From July 2011 to January 2012, field experiments were conducted with 981 adult smokers who were randomized to control (i.e., text-only labels, n=207) and experimental conditions (i.e., pictorial labels, n=774). The experimental condition systematically varied health warning label stimuli by health topic and image type. Linear mixed effects (LME) models estimated the influence of health warning label characteristics and participant characteristics on label ratings. Data were analyzed from January 2012 to April 2012. Compared to text-only warning labels, pictorial warning labels were rated as more personally relevant (5.7 vs 6.8, pinteractions indicated that labels with graphic imagery produced minimal differences in ratings across racial groups and levels of health literacy, whereas other imagery produced greater group differences. Pictorial health warning labels with graphic images have the most-pronounced short-term impacts on adult smokers, including smokers from groups that have in the past been hard to reach. Copyright © 2012 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Governments should implement energy-efficiency standards and labels--cautiously

International Nuclear Information System (INIS)

Wiel, Stephen; McMahon, James E.

2003-01-01

Energy-efficiency standards and labels can be the most effective long-term energy-efficiency policy any government can implement. This paper describes: (1) the benefits that can be obtained through this policy, (2) which countries are implementing standards and labels and for which products, (3) the processes they are using at each step along the way including the reasons why each step must be done carefully and thoroughly, and (4) the relationship of standard-setting and labeling to other energy-efficiency policies

The impact of price-cap regulations on market entry by generic pharmaceutical firms.

Science.gov (United States)

Zhang, Wei; Sun, Huiying; Guh, Daphne; Anis, Aslam H

2017-04-01

In 1998, the province of Ontario, Canada implemented price-cap '70/90' regulations: the first generic must be priced at ≤70% of the associated brand-name price and subsequent generics must be priced at ≤90% of the first generics' price. The price-cap was further lowered to 50% in 2006 and 25% in 2010 for all generic drugs regardless of the first or subsequent generic entrants. This study assessed the impact of such price-cap regulations on market entry by generic firms using the formulary database from 9 provinces (January 2004-March 2013). A logistic regression was estimated to compare the probability of entry during the three policy periods in Ontario ('70/90', '25', versus '50'). Since different price-caps were subsequently introduced in other provinces, Alberta, British Columbia, New Brunswick and Saskatchewan, difference-in-differences was used to compare market entry. In Ontario, compared with the period '50', generic firms were 76% and 63% less likely to enter markets in the periods '25' and '70/90', respectively. The difference-in-differences showed that the entry probability decreased the most in Ontario during the '25' period from the '50' period. Lowering the price-cap level to 25% leads to a significantly lower probability of market entry by generic firms.

Medicamentos genéricos no Brasil: impactos das políticas públicas sobre a indústria nacional Generic drugs in Brazil: impacts of public policies upon the national industry

Directory of Open Access Journals (Sweden)

Cristiane Quental

2008-04-01

Full Text Available O presente artigo faz eco a trabalhos recentes da Abrasco¹, Gadelha² e Guimarães³, que enfatizam a necessidade de uma maior integração entre as políticas voltadas para o desenvolvimento do sistema de saúde e aquelas voltadas para a promoção do desenvolvimento industrial e da inovação, como forma de garantir para o país os benefícios econômicos gerados pelos gastos em saúde, assegurando a continuidade da política social, num círculo virtuoso. Embora apresente o caso dos medicamentos genéricos como uma experiência de sucesso na integração das políticas sociais voltadas para um maior acesso da população a medicamentos com qualidade garantida, com as políticas econômicas voltadas para o desenvolvimento industrial, discute os impactos e as limitações da política dialogando com a análise da competitividade da indústria de medicamentos genéricos brasileira realizada por Abreu4.This paper echoes recent works of Abrasco¹, Gadelha² and Guimarães³ emphasizing the need for a better integration between health policies and industrial development and innovation policies as the only way to keep the economic benefits generated by health expenditures in the country instead of letting them escape through imports and threaten the continuity of the social policy by growing trade deficits. Although presenting the generic drug policy as a successful case in integrating social policies aimed at a better access to quality drugs for the population with economic policies aimed at industrial development, this paper discusses the impacts and limitations of the referred policy in a dialog with Abreu's analysis of industrial competitiveness in the Brazilian generics industry.

Physicians prefer greater detail in the biosimilar label (SmPC) - Results of a survey across seven European countries.

Science.gov (United States)

Hallersten, Anna; Fürst, Walter; Mezzasalma, Riccardo

2016-06-01

In the European Union, labels (Summaries of Product Characteristics, SmPCs) of biosimilars and their reference products are in many instances almost identical (following a generic approach) despite different data requirements for the authorization of biosimilars and generics. To understand physicians' preferences on type and detail of information in the biosimilar label and their use of information sources when prescribing biologics including biosimilars, EuropaBio surveyed 210 physicians across seven European countries. Among surveyed physicians, 90.5% use the label frequently or occasionally as an information source and 87.2% deemed a clear statement on the origin of data helpful or very helpful. When comparing excerpts from the label of an authorized biosimilar and modified texts with additional information, 78.1-82.9% preferred the samples with additional information. This survey shows that the label is an appropriate vehicle for providing physicians with information about biologics and that physicians prefer more product-specific information in the biosimilar label. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Consumers' views on generic medicines: a review of the literature.

Science.gov (United States)

Hassali, Mohamed A A; Shafie, Asrul A; Jamshed, Shazia; Ibrahim, Mohamed I M; Awaisu, Ahmed

2009-04-01

To review the literature on consumers' knowledge, attitudes and opinions of the use of generic medicines. A narrative review of studies conducted from 1970 to 2008 on consumers perceptions and views towards generic medicines was performed. An extensive literature search was undertaken using indexing services available at the authors' institution library. The following keywords were used for the search: brand, generic, multisource, medications, medicines, drugs, pharmaceuticals and consumers, customers, and patients. Electronic databases searched were Medline, Inside Web, ISI Web of Knowledge, Science Direct, Springer Link, JSTOR, Proquest, Ebsco Host and Google Scholar. These electronic databases were searched for full text papers published in English from 1970 to October 2008. Twenty studies were identified. Eleven were from the USA, four were from Europe, two were from Canada and one each was from Australia, Brazil and Malaysia. In general, consumers showed mixed reactions towards the use of generic medicines. This was evident from the divergence of views observed by country development level, consumers' socioeconomic characteristics, drug product characteristics, pharmaceutical reimbursement system, policy environment, contact with health care professionals, past experience with medications, and knowledge of the seriousness of a medical condition. Patient confidence and knowledge pertaining to generic medicines use have increased over the past four decades, especially in developed countries. Mass educational efforts, financial incentives, and greater communication among patients and health care professionals were seen as major drivers to the uptake of generic medicines among consumers.

Energy efficiency of office equipment - Proposal for a policy mix for Germany with an in-depth analysis of labelling strategies

International Nuclear Information System (INIS)

Duscha, Markus; Seebach, Dominik

2005-01-01

Research under contract with the German Federal Environmental Agency (UBA) identified a considerable energy saving potential fielding the area of office equipment. In this paper, a proposal for a policy mix is presented with the goal to increase energy efficiency by market-transformation in this sector. This was worked out by order of the UBA. Pending EU legislation like the Procurement Directive and the proposal for Eco-Design Directive have been considered. An in-depth analysis for labelling schemes for office equipment is provided with respect to the future of the Energy Star process, specifically the continuation of the Energy Star-cooperation between the U.S.EPA and the EU. Preliminary results gained after literature enquiry and interviews of experts were discussed during a workshop at the German Federal Environmental Ministry in September 2004. Our proposal for a policy mix includes: public procurement, efficiency labelling, training and education, energy management in public and private institutions, mandatory minimum standards, marketing. The demand for high efficient appliances should initially be boosted by green procurement to trigger market transformation. In the field of efficiency labelling, we first analyse the shortcomings of previous strategies. On this basis, we propose a two level-strategy for Germany: 1. The Energy Star process with improved structures shall act as a widely compliable labelling minimum standard. 2. An information programme about high efficient appliances ('quality-programme') should be established basing on existing structures (Energy Star, GEEA, TopTen) to minimise transaction costs

Research on consumer reactions to nutrition labelling (FLABEL)

DEFF Research Database (Denmark)

Grunert, Klaus G.

and the evaluation of existing ones difficult. Recent and ongoing research, including research in the European Union (EU)-funded FP7 project FLABEL (Food Labelling to Advance Better Education for Life), is accumulating evidence not only on consumer liking of labels and on self-reported use, but also on labels......Nutrition labels are potentially a major instrument for enabling consumers to make healthier food choices, but current insights into how nutrition labels are used by consumers in real-world shopping situations are limited, making the science-based formulation of new labelling policies......' attention-getting potential, on the way consumers draw inferences on product healthiness from them, and on how they actually affect choices. Based on the findings from this project, best practice guidelines will be developed for use of nutrition labelling in EU policy and the food industry, especially SMEs...

Was the media campaign that supported Australia's new pictorial cigarette warning labels and plain packaging policy associated with more attention to and talking about warning labels?

Science.gov (United States)

Nagelhout, Gera E; Osman, Amira; Yong, Hua-Hie; Huang, Li-Ling; Borland, Ron; Thrasher, James F

2015-10-01

Population-level interventions can possibly enhance each other's effects when they are implemented simultaneously. When the plain packaging policy was implemented in Australia, pictorial health warning labels (HWLs) on cigarette packages were also updated and a national mass media campaign was aired. This study examined whether smokers who recalled the media campaign reported more attention to and talking about HWLs. Longitudinal survey data was obtained among Australian adult smokers, aged 18 years and older, from an online consumer panel. One survey wave was conducted before (September 2012) and two waves were conducted after (January 2013 and May 2013) the interventions. The sample was replenished to maintain a sample size of 1000 participants at each wave. Generalized Estimating Equations analyses were performed. Compared to wave 1, attention to HWLs increased at wave 2 (b=0.32, SE=0.06, pCampaign recall was significantly associated with more attention to HWLs (b=0.29, SE=0.05, pcampaign was associated with more attention to and talking about HWLs. When adjusting for campaign recall, there was still an increasing trend in attention and talking. This suggests that the media campaign and the new packaging and labeling policies had independent and positive effects on attention to and talking about HWLs. Copyright © 2015 Elsevier Ltd. All rights reserved.

Bioequivalence of generic alendronate sodium tablets (70 mg to Fosamax® tablets (70 mg in fasting, healthy volunteers: a randomized, open-label, three-way, reference-replicated crossover study

Directory of Open Access Journals (Sweden)

Zhang Y

2017-07-01

Full Text Available Yifan Zhang,1 Xiaoyan Chen,1 Yunbiao Tang,2 Youming Lu,1 Lixia Guo,1 Dafang Zhong1 1State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, 2Department of Pharmacy, The General Hospital of Shenyang Military Region, Shenyang, People’s Republic of China Purpose: The aim of this study was to evaluate the bioequivalence of a generic product 70 mg alendronate sodium tablets with the reference product Fosamax® 70 mg tablet. Materials and methods: A single-center, open-label, randomized, three-period, three-sequence, reference-replicated crossover study was performed in 36 healthy Chinese male volunteers under fasting conditions. In each study period, the volunteers received a single oral dose of the generic or reference product (70 mg. Blood samples were collected at pre-dose and up to 8 h after administration. The bioequivalence of the generic product to the reference product was assessed using the US Food and Drug Administration (FDA and European Medicines Agency (EMA reference-scaled average bioequivalence (RSABE methods. Results: The average maximum concentrations (Cmax of alendronic acid were 64.78±43.76, 56.62±31.95, and 60.15±37.12 ng/mL after the single dose of the generic product and the first and second doses of the reference product, respectively. The areas under the plasma concentration–time curves from time 0 to the last timepoint (AUC0–t were 150.36±82.90, 148.15±85.97, and 167.11±110.87 h·ng/mL, respectively. Reference scaling was used because the within-subject standard deviations of the reference product (sWR for Cmax and AUC0–t were all higher than the cutoff value of 0.294. The 95% upper confidence bounds were -0.16 and -0.17 for Cmax and AUC0–t, respectively, and the point estimates for the generic/reference product ratio were 1.08 and 1.00, which satisfied the RSABE acceptance criteria of the FDA. The 90% CIs for Cmax and AUC0–t were 90.35%–129

The generic article

NARCIS (Netherlands)

Farkas, D.F.; Swart, Henriëtte de

2005-01-01

We take a fresh look at the connection between genericity and (in)definiteness by reconsidering a long-standing puzzle concerning the relation between definiteness and genericity. We contrast English on the one hand and Romance languages and Hungarian on the other, focusing on generic sentences

Label swapper device for spectral amplitude coded optical packet networks monolithically integrated on InP.

Science.gov (United States)

Muñoz, P; García-Olcina, R; Habib, C; Chen, L R; Leijtens, X J M; de Vries, T; Robbins, D; Capmany, J

2011-07-04

In this paper the design, fabrication and experimental characterization of an spectral amplitude coded (SAC) optical label swapper monolithically integrated on Indium Phosphide (InP) is presented. The device has a footprint of 4.8x1.5 mm2 and is able to perform label swapping operations required in SAC at a speed of 155 Mbps. The device was manufactured in InP using a multiple purpose generic integration scheme. Compared to previous SAC label swapper demonstrations, using discrete component assembly, this label swapper chip operates two order of magnitudes faster.

MilQuant: a free, generic software tool for isobaric tagging-based quantitation.

Science.gov (United States)

Zou, Xiao; Zhao, Minzhi; Shen, Hongyan; Zhao, Xuyang; Tong, Yuanpeng; Wang, Qingsong; Wei, Shicheng; Ji, Jianguo

2012-09-18

Isobaric tagging techniques such as iTRAQ and TMT are widely used in quantitative proteomics and especially useful for samples that demand in vitro labeling. Due to diversity in choices of MS acquisition approaches, identification algorithms, and relative abundance deduction strategies, researchers are faced with a plethora of possibilities when it comes to data analysis. However, the lack of generic and flexible software tool often makes it cumbersome for researchers to perform the analysis entirely as desired. In this paper, we present MilQuant, mzXML-based isobaric labeling quantitator, a pipeline of freely available programs that supports native acquisition files produced by all mass spectrometer types and collection approaches currently used in isobaric tagging based MS data collection. Moreover, aside from effective normalization and abundance ratio deduction algorithms, MilQuant exports various intermediate results along each step of the pipeline, making it easy for researchers to customize the analysis. The functionality of MilQuant was demonstrated by four distinct datasets from different laboratories. The compatibility and extendibility of MilQuant makes it a generic and flexible tool that can serve as a full solution to data analysis of isobaric tagging-based quantitation. Copyright © 2012 Elsevier B.V. All rights reserved.

Al18F-Labeling Of Heat-Sensitive Biomolecules for Positron Emission Tomography Imaging

Science.gov (United States)

Cleeren, Frederik; Lecina, Joan; Ahamed, Muneer; Raes, Geert; Devoogdt, Nick; Caveliers, Vicky; McQuade, Paul; Rubins, Daniel J; Li, Wenping; Verbruggen, Alfons; Xavier, Catarina; Bormans, Guy

2017-01-01

Positron emission tomography (PET) using radiolabeled biomolecules is a translational molecular imaging technology that is increasingly used in support of drug development. Current methods for radiolabeling biomolecules with fluorine-18 are laborious and require multistep procedures with moderate labeling yields. The Al18F-labeling strategy involves chelation in aqueous medium of aluminum mono[18F]fluoride ({Al18F}2+) by a suitable chelator conjugated to a biomolecule. However, the need for elevated temperatures (100-120 °C) required for the chelation reaction limits its widespread use. Therefore, we designed a new restrained complexing agent (RESCA) for application of the AlF strategy at room temperature. Methods. The new chelator RESCA was conjugated to three relevant biologicals and the constructs were labeled with {Al18F}2+ to evaluate the generic applicability of the one-step Al18F-RESCA-method. Results. We successfully labeled human serum albumin with excellent radiochemical yields in less than 30 minutes and confirmed in vivo stability of the Al18F-labeled protein in rats. In addition, we efficiently labeled nanobodies targeting the Kupffer cell marker CRIg, and performed µPET studies in healthy and CRIg deficient mice to demonstrate that the proposed radiolabeling method does not affect the functional integrity of the protein. Finally, an affibody targeting HER2 (PEP04314) was labeled site-specifically, and the distribution profile of (±)-[18F]AlF(RESCA)-PEP04314 in a rhesus monkey was compared with that of [18F]AlF(NOTA)-PEP04314 using whole-body PET/CT. Conclusion. This generic radiolabeling method has the potential to be a kit-based fluorine-18 labeling strategy, and could have a large impact on PET radiochemical space, potentially enabling the development of many new fluorine-18 labeled protein-based radiotracers. PMID:28824726

Al18F-Labeling Of Heat-Sensitive Biomolecules for Positron Emission Tomography Imaging.

Science.gov (United States)

Cleeren, Frederik; Lecina, Joan; Ahamed, Muneer; Raes, Geert; Devoogdt, Nick; Caveliers, Vicky; McQuade, Paul; Rubins, Daniel J; Li, Wenping; Verbruggen, Alfons; Xavier, Catarina; Bormans, Guy

2017-01-01

Positron emission tomography (PET) using radiolabeled biomolecules is a translational molecular imaging technology that is increasingly used in support of drug development. Current methods for radiolabeling biomolecules with fluorine-18 are laborious and require multistep procedures with moderate labeling yields. The Al 18 F-labeling strategy involves chelation in aqueous medium of aluminum mono[ 18 F]fluoride ({Al 18 F} 2+ ) by a suitable chelator conjugated to a biomolecule. However, the need for elevated temperatures (100-120 °C) required for the chelation reaction limits its widespread use. Therefore, we designed a new restrained complexing agent (RESCA) for application of the AlF strategy at room temperature. Methods. The new chelator RESCA was conjugated to three relevant biologicals and the constructs were labeled with {Al 18 F} 2+ to evaluate the generic applicability of the one-step Al 18 F-RESCA-method. Results. We successfully labeled human serum albumin with excellent radiochemical yields in less than 30 minutes and confirmed in vivo stability of the Al 18 F-labeled protein in rats. In addition, we efficiently labeled nanobodies targeting the Kupffer cell marker CRIg, and performed µPET studies in healthy and CRIg deficient mice to demonstrate that the proposed radiolabeling method does not affect the functional integrity of the protein. Finally, an affibody targeting HER2 (PEP04314) was labeled site-specifically, and the distribution profile of (±)-[ 18 F]AlF(RESCA)-PEP04314 in a rhesus monkey was compared with that of [ 18 F]AlF(NOTA)-PEP04314 using whole-body PET/CT. Conclusion. This generic radiolabeling method has the potential to be a kit-based fluorine-18 labeling strategy, and could have a large impact on PET radiochemical space, potentially enabling the development of many new fluorine-18 labeled protein-based radiotracers.

Comparison of brand versus generic antiepileptic drug adverse event reporting rates in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).

Science.gov (United States)

Rahman, Md Motiur; Alatawi, Yasser; Cheng, Ning; Qian, Jingjing; Plotkina, Annya V; Peissig, Peggy L; Berg, Richard L; Page, David; Hansen, Richard A

2017-09-01

Despite the cost saving role of generic anti-epileptic drugs (AEDs), debate exists as to whether generic substitution of branded AEDs may lead to therapeutic failure and increased toxicity. This study compared adverse event (AE) reporting rates for brand vs. authorized generic (AG) vs. generic AEDs. Since AGs are pharmaceutically identical to brand but perceived as generics, the generic vs. AG comparison minimized potential bias against generics. Events reported to the U.S. Food and Drug Administration Adverse Event Reporting System between January 2004 to March 2015 with lamotrigine, carbamazepine, and oxcarbazepine listed as primary or secondary suspect were classified as brand, generic, or AG based on the manufacturer. Disproportionality analyses using the reporting odds ratio (ROR) assessed the relative rate of reporting of labeled AEs compared to reporting these events with all other drugs. The Breslow-Day statistic compared RORs across brand, AG, and other generics using a Bonferroni-corrected Pbrand and generics for all three drugs of interest (Breslow-Day Pbrands and generics have similar reporting rates after accounting for generic perception biases. Disproportional suicide reporting was observed for generics compared with AGs and brand, although this finding needs further study. Copyright © 2017 Elsevier B.V. All rights reserved.

Performance implications of Porter's generic strategies in Slovak hospitals.

Science.gov (United States)

Hlavacka, S; Bacharova, L; Rusnakova, V; Wagner, R

2001-01-01

The aim of the study was to examine the use of Porter's generic strategies and their effect on performance in the context of the Slovak hospital industry. Using mail survey the study first identified the natural taxonomy of four strategic types of Slovak hospitals, based on their use of Porter's generic strategies in pure form and in combination. Next the study examined whether different strategic types were associated with different levels of organisational performance, while controlling for such variables as size and location, which have been argued to influence the hospital performance. The findings indicate that hospitals which follow a "stuck-in-the-middle" strategy, in general, have superior performance on all used performance measures, while hospitals that place only low emphasis on cost leadership, differentiation and focus, labelled "wait and see" in this study, perform the poorest. The study concludes that the research provided body of knowledge relevant for the Slovak hospital industry, that may be used by hospital managers in the strategy formulation process as well as by the researches in exploring the influence of different contingencies on hospitals' strategic orientation.

Potential Effect of Physical Activity Calorie Equivalent (PACE) Labeling on Adult Fast Food Ordering and Exercise

OpenAIRE

Antonelli, Ray; Viera, Anthony J.

2015-01-01

Introduction Numeric calorie content labels show limited efficacy in reducing the number of calories ordered from fast food meals. Physical activity calorie equivalent (PACE) labels are an alternative that may reduce the number of calories ordered in fast food meals while encouraging patrons to exercise. Methods A total of 1000 adults from 47 US states were randomly assigned via internet survey to one of four generic fast food menus: no label, calories only, calories + minutes, or calories + ...

Next Generation of Renewable Electricity Policy: How Rapid Change is Breaking Down Conventional Policy Categories

Energy Technology Data Exchange (ETDEWEB)

Couture, T. D. [E3 Analytics, Berlin (Germany); Jacobs, D. [International Energy Transition (IET), Boston, MA (United States); Rickerson, W. [Meister Consultants Group, Boston, MA (United States); Healey, V. [National Renewable Energy Lab. (NREL), Golden, CO (United States)

2015-02-01

A number of policies have been used historically in order to stimulate the growth of the renewable electricity sector. This paper examines four of these policy instruments: competitive tendering, sometimes called renewable electricity auctions, feed-in tariffs, net metering and net billing, and tradable renewable energy certificates. In recent years, however, a number of changes to both market circumstances and to policy priorities have resulted in numerous policy innovations, including the emergence of policy hybrids. With no common language for these evolving policy mechanisms, policymakers have generally continued to use the same traditional policy labels, occasionally generating confusion as many of these new policies no longer look, or act, like their traditional predecessors. In reviewing these changes, this paper makes two separate but related claims: first, policy labels themselves are breaking down and evolving. As a result, policy comparisons that rely on the conventional labels may no longer be appropriate, or advisable. Second, as policymakers continue to adapt, we are in effect witnessing the emergence of the next generation of renewable electricity policies, a change that could have significant impacts on investment, as well as on market growth in both developed and developing countries.

The Word Outside and the Pictures in Our Heads: Contingent Framing Effects of Labels on Health Policy Preferences by Political Ideology.

Science.gov (United States)

Roh, Sungjong; Niederdeppe, Jeff

2016-09-01

This study uses data from systematic Web image search results and two randomized survey experiments to analyze how frames commonly used in public debates about health issues, operationalized here as alternative word choices, influence public support for health policy reforms. In Study 1, analyses of Bing (N = 1,719), Google (N = 1,872), and Yahoo Images (N = 1,657) search results suggest that the images returned from the search query "sugar-sweetened beverage" are more likely to evoke health-related concepts than images returned from a search query about "soda." In contrast, "soda" search queries were more likely to incorporate brand-related concepts than "sugar-sweetened beverage" search queries. In Study 2, participants (N = 206) in a controlled Web experiment rated their support for policies to reduce consumption of these drinks. As expected, strong liberals had more support for policies designed to reduce the consumption of these drinks when the policies referenced "soda" compared to "sugar-sweetened beverage." To the contrary, items describing these drinks as "soda" produced lower policy support than items describing them as "sugar-sweetened beverage" among strong conservatives. In Study 3, participants (N = 1,000) in a national telephone survey experiment rated their support for a similar set of policies. Results conceptually replicated the previous Web-based experiment, such that strong liberals reported greater support for a penny-per-ounce taxation when labeled "soda" versus "sugar-sweetened beverages." In both Studies 2 and 3, more respondents referred to brand-related concepts in response to questions about "sugar-sweetened beverages" compared to "soda." We conclude with a discussion of theoretical and methodological implications for studying framing effects of labels.

Position paper: A generic approach for security policies composition

DEFF Research Database (Denmark)

Hernandez, Alejandro Mario; Nielson, Flemming

2012-01-01

When modelling access control in distributed systems, the problem of security policies composition arises. Much work has been done on different ways of combining policies, and using different logics to do this. In this paper, we propose a more general approach based on a 4-valued logic, that abst...

Exploring knowledge perceptions and attitudes about generic medicines among finalyear health science students

Directory of Open Access Journals (Sweden)

Varsha Bangalee

2016-05-01

Full Text Available Background. The use of generic medicines to reduce healthcare costs has become a mandated policy in South Africa. An increase in the use of generics can be achieved through improved knowledge, attitudes and perceptions of generic medicine among healthcare professionals. Objective. To explore knowledge, attitudes and perceptions among final-year health science students on generic medication. Methods. A cross-sectional survey was carried out among the final-year audiology, dental therapy, pharmacy, physiotherapy, occupational therapy, optometry, speech-language and sport science students enrolled at the University of KwaZulu-Natal. A questionnaire was used as the study tool, developed using information adapted from literature reviews. Data analysis was completed using Statistical Package for the Social Sciences (SPSS version 21, and computed using descriptive statistics. Results. Total number of participants was 211, as follows: audiology (n=14, dental therapy (n=15, pharmacy (n=81, physiotherapy (n=41, occupational therapy (n=6, optometry (n=25, speech-language (n=6 and sport science (n=23. A total of 90.0% of students had heard of generic medicines, with 20.9% of them agreeing that generic medicines are less effective than brand-name medicines. Concerning safety, 30.4% believed that brand-name medicines are required to meet higher safety standards than generic medicines. Regarding the need for information on issues pertaining to safety and efficacy of medicines, 53.3% of participants felt that this need was not being met. Conclusion. All groups had knowledge deficits about the safety, quality and efficacy of generic medicines. The dissemination of information about generic medicines may strengthen future knowledge, attitudes and perceptions.

Large-scale Labeled Datasets to Fuel Earth Science Deep Learning Applications

Science.gov (United States)

Maskey, M.; Ramachandran, R.; Miller, J.

2017-12-01

Deep learning has revolutionized computer vision and natural language processing with various algorithms scaled using high-performance computing. However, generic large-scale labeled datasets such as the ImageNet are the fuel that drives the impressive accuracy of deep learning results. Large-scale labeled datasets already exist in domains such as medical science, but creating them in the Earth science domain is a challenge. While there are ways to apply deep learning using limited labeled datasets, there is a need in the Earth sciences for creating large-scale labeled datasets for benchmarking and scaling deep learning applications. At the NASA Marshall Space Flight Center, we are using deep learning for a variety of Earth science applications where we have encountered the need for large-scale labeled datasets. We will discuss our approaches for creating such datasets and why these datasets are just as valuable as deep learning algorithms. We will also describe successful usage of these large-scale labeled datasets with our deep learning based applications.

Spine labeling in MRI via regularized distribution matching.

Science.gov (United States)

Hojjat, Seyed-Parsa; Ayed, Ismail; Garvin, Gregory J; Punithakumar, Kumaradevan

2017-11-01

This study investigates an efficient (nearly real-time) two-stage spine labeling algorithm that removes the need for an external training while being applicable to different types of MRI data and acquisition protocols. Based solely on the image being labeled (i.e., we do not use training data), the first stage aims at detecting potential vertebra candidates following the optimization of a functional containing two terms: (i) a distribution-matching term that encodes contextual information about the vertebrae via a density model learned from a very simple user input, which amounts to a point (mouse click) on a predefined vertebra; and (ii) a regularization constraint, which penalizes isolated candidates in the solution. The second stage removes false positives and identifies all vertebrae and discs by optimizing a geometric constraint, which embeds generic anatomical information on the interconnections between neighboring structures. Based on generic knowledge, our geometric constraint does not require external training. We performed quantitative evaluations of the algorithm over a data set of 90 mid-sagittal MRI images of the lumbar spine acquired from 45 different subjects. To assess the flexibility of the algorithm, we used both T1- and T2-weighted images for each subject. A total of 990 structures were automatically detected/labeled and compared to ground-truth annotations by an expert. On the T2-weighted data, we obtained an accuracy of 91.6% for the vertebrae and 89.2% for the discs. On the T1-weighted data, we obtained an accuracy of 90.7% for the vertebrae and 88.1% for the discs. Our algorithm removes the need for external training while being applicable to different types of MRI data and acquisition protocols. Based on the current testing data, a subject-specific model density and generic anatomical information, our method can achieve competitive performances when applied to T1- and T2-weighted MRI images.

Innovation policy for directing technical change in the power sector

International Nuclear Information System (INIS)

Aalbers, Rob; Shestalova, Victoria; Kocsis, Viktória

2013-01-01

This paper discusses policy instruments for redirecting technical change within the electricity sector to mitigate climate change. First, we unravel the mechanism behind directed technical change, explaining why markets may underprovide innovations in expensive renewable technologies in comparison to innovations in energy-efficient fossil-fuel generators. Subsequently, we characterize technical change in electricity generation technologies, stressing the heterogeneity of knowledge spillovers both within and between clean electricity generation technologies. We argue that there exists a rationale for a portfolio approach to innovation in the electricity sector, i.e., optimal innovation policies are neither fully generic nor fully specific; and they need to be adapted, in response to new information learned by the government. The existing innovation literature does not, however, provide a clear-cut answer for designing such a policy. We compare policy instruments and argue that public R and D support to clean technologies, either in the form of subsidies or prizes, seems to be the prime candidate for implementing non-generic innovation policy. - Highlights: • We analyze policies for spurring innovations in renewable electricity technologies. • The analysis unravels why research markets underprovide such innovations. • We conclude that non-generic R and D subsidies and prizes are the most suitable policies

Generic antibiotics in Japan.

Science.gov (United States)

Fujimura, Shigeru; Watanabe, Akira

2012-08-01

Generic drugs have been used extensively in many developed countries, although their use in Japan has been limited. Generic drugs reduce drug expenses and thereby national medical expenditure. Because generic drugs provide advantages for both public administration and consumers, it is expected that they will be more widely used in the future. However, the diffusion rate of generic drugs in Japan is quite low compared with that of other developed countries. An investigation on generic drugs conducted by the Ministry of Health, Labour and Welfare in Japan revealed that 17.2 % of doctors and 37.2 % of patients had not used generic drugs. The major reasons for this low use rate included distrust of off-patent products and lower drug price margin compared with the brand name drug. The generic drugs available in the market include external drugs such as wet packs, antihypertensive agents, analgesics, anticancer drugs, and antibiotics. Among them, antibiotics are frequently used in cases of acute infectious diseases. When the treatment of these infections is delayed, the infection might be aggravated rapidly. The pharmacokinetics-pharmacodynamics (PK-PD) theory has been adopted in recent chemotherapy, and in many cases, the most appropriate dosage and administration of antibiotics are determined for individual patients considering renal function; high-dosage antibiotics are used preferably for a short duration. Therefore, a highly detailed antimicrobial agent is necessary. However, some of the generic antibiotics have less antibacterial potency or solubility than the brand name products. We showed that the potency of the generic products of vancomycin and teicoplanin is lower than that of the branded drugs by 14.6 % and 17.3 %, respectively. Furthermore, we confirmed that a generic meropenem drug for injection required about 82 s to solubilize in saline, whereas the brand product required only about 21 s. It was thought that the cause may be the difference in size of bulk

Net private benefits of purchasing eco-labeled air conditioners and subsidization policies in China

International Nuclear Information System (INIS)

Sun, Junxiu; Yin, Haitao; Wang, Feng

2014-01-01

Built on a data set of 527 air conditioner models collected from an online retailer, this study investigates whether the savings that consumers realize on their private electricity bills from purchasing energy-efficient appliances compensate for the additional cost of the appliances on the market, and if not, the size of the gap between the savings and the cost. Our findings show that, except for the most energy-efficient category, the cost savings from using energy-efficient air conditioners does compensate for their higher price. Therefore, any government subsidy should be reserved for the most efficient products. For less energy-efficient appliances, the best policy may be to provide more effective information instead of a subsidy because the subsidy might attract consumers away from more energy-efficient air conditioners and result in an unwanted effect. - Highlights: • This paper analyses the net private benefits of purchasing eco-labeled air conditioners in China. • There is no need to subsidize less energy-efficient air conditioners. • The most recently proposed policy development in China is a reform headed in the right direction

Knowledge and perceptions of physicians from private medical centres towards generic medicines: a nationwide survey from Malaysia.

Science.gov (United States)

Kumar, Rohit; Hassali, Mohamed Azmi; Saleem, Fahad; Alrasheedy, Alian A; Kaur, Navneet; Wong, Zhi Yen; Kader, Muhamad Ali Sk Abdul

2015-01-01

medicines with regard to their bioequivalence, quality, efficacy and safety. Apart from the policy on generic substitution, it would also be recommended to have a national medicine pricing policy, which controls drug prices, in both the public and private sector. These efforts are worthwhile to reduce the drug expenditure and improve the medicine affordability in Malaysia.

Scripting XML with Generic Haskell

NARCIS (Netherlands)

Atanassow, F.; Clarke, D.; Jeuring, J.T.

2003-01-01

A generic program is written once and works on values of many data types. Generic Haskell is a recent extension of the functional programming language Haskell that supports generic programming. This paper discusses how Generic Haskell can be used to implement XML tools whose behaviour depends on

Scripting XML with Generic Haskell

NARCIS (Netherlands)

Atanassow, F.; Clarke, D.; Jeuring, J.T.

2007-01-01

A generic program is written once and works on values of many data types. Generic Haskell is a recent extension of the functional programming language Haskell that supports generic programming. This paper discusses how Generic Haskell can be used to implement XML tools whose behaviour depends on

A comparison of generic drug prices in seven European countries: a methodological analysis.

Science.gov (United States)

Wouters, Olivier J; Kanavos, Panos G

2017-03-31

Policymakers and researchers frequently compare the prices of medicines between countries. Such comparisons often serve as barometers of how pricing and reimbursement policies are performing. The aim of this study was to examine methodological challenges to comparing generic drug prices. We calculated all commonly used price indices based on 2013 IMS Health data on sales of 3156 generic drugs in seven European countries. There were large differences in generic drug prices between countries. However, the results varied depending on the choice of index, base country, unit of volume, method of currency conversion, and therapeutic category. The results also differed depending on whether one looked at the prices charged by manufacturers or those charged by pharmacists. Price indices are a useful statistical approach for comparing drug prices across countries, but researchers and policymakers should interpret price indices with caution given their limitations. Price-index results are highly sensitive to the choice of method and sample. More research is needed to determine the drivers of price differences between countries. The data suggest that some governments should aim to reduce distribution costs for generic drugs.

Impact of pharmaceutical policy interventions on utilization of antipsychotic medicines in Finland and Portugal in times of economic recession: interrupted time series analyses.

Science.gov (United States)

Leopold, Christine; Zhang, Fang; Mantel-Teeuwisse, Aukje K; Vogler, Sabine; Valkova, Silvia; Ross-Degnan, Dennis; Wagner, Anita K

2014-07-25

To analyze the impacts of pharmaceutical sector policies implemented to contain country spending during the economic recession--a reference price system in Finland and a mix of policies including changes in reimbursement rates, a generic promotion campaign and discounts granted to the public payer in Portugal - on utilization of, as a proxy for access to, antipsychotic medicines. We obtained monthly IMS Health sales data in standard units of antipsychotic medicines in Portugal and Finland for the period January 2007 to December 2011. We used an interrupted time series design to estimate changes in overall use and generic market shares by comparing pre-policy and post-policy levels and trends. Both countries' policy approaches were associated with slight, likely unintended, decreases in overall use of antipsychotic medicines and with increases in generic market shares of major antipsychotic products. In Finland, quetiapine and risperidone generic market shares increased substantially (estimates one year post-policy compared to before, quetiapine: 6.80% [3.92%, 9.68%]; risperidone: 11.13% [6.79%, 15.48%]. The policy interventions in Portugal resulted in a substantially increased generic market share for amisulpride (estimate one year post-policy compared to before: 22.95% [21.01%, 24.90%]; generic risperidone already dominated the market prior to the policy interventions. Different policy approaches to contain pharmaceutical expenditures in times of the economic recession in Finland and Portugal had intended--increased use of generics--and likely unintended--slightly decreased overall sales, possibly consistent with decreased access to needed medicines--impacts. These findings highlight the importance of monitoring and evaluating the effects of pharmaceutical policy interventions on use of medicines and health outcomes.

Generic Pharmaceutical Association (GPhA) - 2015 Annual Meeting (February 9-11, 2015 - Miami Beach, Florida, USA).

Science.gov (United States)

Bowman, M

2015-02-01

The Generic Pharmaceutical Association (GPhA) chairman Craig Wheeler (Momenta Pharmaceuticals), welcomed attendees to the 2015 Annual Meeting by reflecting on the contributions of the generic industry over the past year and some of the challenges that lie ahead. In 2014, 86% of prescriptions dispensed in the U.S. were generic, contributing to the USD 1.4 trillion savings generated by the industry since its inception; however, there are still many challenges to face, including consolidation of customers, lag in Abbreviated New Drug Application (ANDA) approval timelines, restrictive Risk Evaluation and Mitigation Strategy (REMS) programs and labeling legislations. The continued drive into the branded business by many GPhA member companies has resulted in the association planning a structural division for companies involved in biologic and biosimilar products. During the 3-day meeting, attendees listened to expert panels discuss major business, regulatory and market trends developing in the generic industry, with insights from the U.S. Food and Drug Administration (FDA) and market analysts. The meeting also provided attendees with numerous opportunities to socialize and network with key decision makers in the industry. Copyright 2015 Prous Science, S.A.U. or its licensors. All rights reserved.

Consumer understanding of food labels: toward a generic tool for identifying the average consumer

DEFF Research Database (Denmark)

Sørensen, Henrik Selsøe; Holm, Lotte; Møgelvang-Hansen, Peter

2013-01-01

The ‘average consumer’ is referred to as a standard in regulatory contexts when attempts are made to benchmark how consumers are expected to reason while decoding food labels. An attempt is made to operationalize this hypothetical ‘average consumer’ by proposing a tool for measuring the level of ...... that independent future studies of consumer behavior and decision making in relation to food products in different contexts could benefit from this type of benchmarking tool.......The ‘average consumer’ is referred to as a standard in regulatory contexts when attempts are made to benchmark how consumers are expected to reason while decoding food labels. An attempt is made to operationalize this hypothetical ‘average consumer’ by proposing a tool for measuring the level...... of informedness of an individual consumer against the national median at any time. Informedness, i.e. the individual consumer's ability to interpret correctly the meaning of the words and signs on a food label is isolated as one essential dimension for dividing consumers into three groups: less-informed, informed...

LabelFlow Framework for Annotating Workflow Provenance

Directory of Open Access Journals (Sweden)

Pinar Alper

2018-02-01

Full Text Available Scientists routinely analyse and share data for others to use. Successful data (reuse relies on having metadata describing the context of analysis of data. In many disciplines the creation of contextual metadata is referred to as reporting. One method of implementing analyses is with workflows. A stand-out feature of workflows is their ability to record provenance from executions. Provenance is useful when analyses are executed with changing parameters (changing contexts and results need to be traced to respective parameters. In this paper we investigate whether provenance can be exploited to support reporting. Specifically; we outline a case-study based on a real-world workflow and set of reporting queries. We observe that provenance, as collected from workflow executions, is of limited use for reporting, as it supports queries partially. We identify that this is due to the generic nature of provenance, its lack of domain-specific contextual metadata. We observe that the required information is available in implicit form, embedded in data. We describe LabelFlow, a framework comprised of four Labelling Operators for decorating provenance with domain-specific Labels. LabelFlow can be instantiated for a domain by plugging it with domain-specific metadata extractors. We provide a tool that takes as input a workflow, and produces as output a Labelling Pipeline for that workflow, comprised of Labelling Operators. We revisit the case-study and show how Labels provide a more complete implementation of reporting queries.

The Politics and Policies of Regulating Generics in Latin America: A Survey of Seventeen States.

Science.gov (United States)

Sweet, Cassandra M

2017-06-01

When patents expire, are equivalent generic alternatives available to citizens? This article contributes to current discussion on access to medicine in the aftermath of the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The focus is on off-patent or "generic" medicines: their product definitions, quality standards and prescription procedures. Drawing from a survey conducted of seventeen countries across the Latin American region, this article examines the differences in definition of off-patent products and the paradox of their relatively lower consumption across multiple developing states. The findings point to pathways for improving standards, consumer information, and access in off-patent pharmaceutical markets. Copyright © 2017 by Duke University Press.

When health policy and empirical evidence collide: the case of cigarette package warning labels and economic consumer surplus.

Science.gov (United States)

Song, Anna V; Brown, Paul; Glantz, Stanton A

2014-02-01

In its graphic warning label regulations on cigarette packages, the Food and Drug Administration severely discounts the benefits of reduced smoking because of the lost "pleasure" smokers experience when they stop smoking; this is quantified as lost "consumer surplus." Consumer surplus is grounded in rational choice theory. However, empirical evidence from psychological cognitive science and behavioral economics demonstrates that the assumptions of rational choice are inconsistent with complex multidimensional decisions, particularly smoking. Rational choice does not account for the roles of emotions, misperceptions, optimistic bias, regret, and cognitive inefficiency that are germane to smoking, particularly because most smokers begin smoking in their youth. Continued application of a consumer surplus discount will undermine sensible policies to reduce tobacco use and other policies to promote public health.

Simulating the Impact of Sugar-Sweetened Beverage Warning Labels in Three Cities.

Science.gov (United States)

Lee, Bruce Y; Ferguson, Marie C; Hertenstein, Daniel L; Adam, Atif; Zenkov, Eli; Wang, Peggy I; Wong, Michelle S; Gittelsohn, Joel; Mui, Yeeli; Brown, Shawn T

2018-02-01

A number of locations have been considering sugar-sweetened beverage point-of-purchase warning label policies to help address rising adolescent overweight and obesity prevalence. To explore the impact of such policies, in 2016 detailed agent-based models of Baltimore, Philadelphia, and San Francisco were developed, representing their populations, school locations, and food sources, using data from various sources collected between 2005 and 2014. The model simulated, over a 7-year period, the mean change in BMI and obesity prevalence in each of the cities from sugar-sweetened beverage warning label policies. Data analysis conducted between 2016 and 2017 found that implementing sugar-sweetened beverage warning labels at all sugar-sweetened beverage retailers lowered obesity prevalence among adolescents in all three cities. Point-of-purchase labels with 8% efficacy (i.e., labels reducing probability of sugar-sweetened beverage consumption by 8%) resulted in the following percentage changes in obesity prevalence: Baltimore: -1.69% (95% CI= -2.75%, -0.97%, p<0.001); San Francisco: -4.08% (95% CI= -5.96%, -2.2%, p<0.001); Philadelphia: -2.17% (95% CI= -3.07%, -1.42%, p<0.001). Agent-based simulations showed how warning labels may decrease overweight and obesity prevalence in a variety of circumstances with label efficacy and literacy rate identified as potential drivers. Implementing a warning label policy may lead to a reduction in obesity prevalence. Focusing on warning label design and store compliance, especially at supermarkets, may further increase the health impact. Copyright © 2018 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

How large are the differences between originator and generic prices? Analysis of five molecules in 16 European countries

Directory of Open Access Journals (Sweden)

Sabine Vogler

2012-12-01

Full Text Available OBJECTIVE: To survey the price differences between originators and generics for a selected basket of molecules and to analyze similarities and differences with regard to the countries included and their generic policies. METHODS: Ex-factory prices as of November 2011 of five molecules provided from the Pharma Price Information (PPI service of the Austrian Health Institute were analyzed for 16 European countries (Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Portugal, Spain, Switzerland, Sweden, UK. The selected molecules were gemcitabine, mycophenolate mofetil, olanzapine, risperidone and sumatriptan. For a specific presentation (same pack size, dosage and pharmaceutical form of each molecule, the prices of the original product and the “most common generic” as defined by PPI were compared. RESULTS: Considerable variations among the extent of price differences between originator and generic were identified (gemicitabine: lowest price difference of 1.4% between originator and generic in Belgium and highest difference of 73.4% in Portugal; mycophenolate mofetil: 3.4% Norway – 71.7% Netherlands; olanzapine: 0.1% Spain – 97.1% Sweden; risperidone: 0.9% Netherlands – 97.3% UK; sumatriptan: 5.8% Greece – 95.0% Denmark. Further, no difference at all between originator and generic prices was found for some molecules in a few countries (Norway: for 4 of the 5 molecules analyzed; Spain: 3; Belgium: 2; in Austria, France and Greece for one molecule respectively. For the five molecules of the sample, Greece, Spain, Ireland and Norway consistently displayed lower price differences whereas Denmark, Finland and Sweden tended to show higher differences between originator and generic prices. CONCLUSION: Even if this research is illustrative and not representative due to the small sample size, results suggest confirming large differences across Europe. It appears that countries (e.g. Denmark

Exploring the opinions and experiences of patients with generic substitution: a representative study of Polish society.

Science.gov (United States)

Drozdowska, Aleksandra; Hermanowski, Tomasz

2015-02-01

Generics have the potential to contain drug therapy costs; successful implementation of generic substitution policy largely depends on consumers' willingness to choose generics. This study aims to analyse the opinions, experiences and preferences of Polish patients towards generic medicines. The study was performed in Poland. The survey was conducted in June 2013 by means of face-to-face interviews. Respondents were drawn from the general population according to a population structure. The study covered a representative sample of 1,000 Poles; the results can be generalized to apply to the Polish population at large. Fifty-two percent of respondents declared to be more often choosing generics, twenty-three percent did not have any specific preferences, and twenty-five percent were more willing to choose brand-name medicines. Past experience with cheaper generic medicines, secondary or lower education, low income and residence in specific regions of Poland were all significantly associated with an increased willingness to choose generics. Respondents' attitudes towards generics were mostly influenced by the opinions of doctors and pharmacists. According to respondents, attitudes towards generics among doctors, pharmacists, family and friends, and in the mass media were mostly positive. There was no relationship between the preference of respondents for generics and factors such as their age, life stage, gender, household size or urban/rural locality. As a result of substituting a brand-name drug with its generic equivalent, 72 % of respondents reported that they had not noticed any difference in drug effectiveness; 21 % had experienced a reduced effectiveness of treatment or increased side effects at least once; and 7 % claimed the generic worked better. The majority of respondents who used cheaper substitutes claimed that generics represented good or very good quality. The study demonstrates that, when choosing medicines, Poles rely mainly on the opinions of their

Calorie labeling and consumer estimation of calories purchased

OpenAIRE

Taksler, Glen B; Elbel, Brian

2014-01-01

Background Studies rarely find fewer calories purchased following calorie labeling implementation. However, few studies consider whether estimates of the number of calories purchased improved following calorie labeling legislation. Findings Researchers surveyed customers and collected purchase receipts at fast food restaurants in the United States cities of Philadelphia (which implemented calorie labeling policies) and Baltimore (a matched comparison city) in December 2009 (pre-implementation...

Optimizing Generic Functions

NARCIS (Netherlands)

Alimarine, A.; Smetsers, J.E.W.

2004-01-01

Generic functions are defined by induction on the structural representation of types. As a consequence, by defining just a single generic operation, one acquires this operation over any particular type. An instance on a specific type is generated by interpretation of the type's structure. A direct

Pharmaceutical expenditure forecast model to support health policy decision making.

Science.gov (United States)

Rémuzat, Cécile; Urbinati, Duccio; Kornfeld, Åsa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Mzoughi, Olfa; Toumi, Mondher

2014-01-01

With constant incentives for healthcare payers to contain their pharmaceutical budgets, modelling policy decision impact became critical. The objective of this project was to test the impact of various policy decisions on pharmaceutical budget (developed for the European Commission for the project 'European Union (EU) Pharmaceutical expenditure forecast' - http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). A model was built to assess policy scenarios' impact on the pharmaceutical budgets of seven member states of the EU, namely France, Germany, Greece, Hungary, Poland, Portugal, and the United Kingdom. The following scenarios were tested: expanding the UK policies to EU, changing time to market access, modifying generic price and penetration, shifting the distribution chain of biosimilars (retail/hospital). Applying the UK policy resulted in dramatic savings for Germany (10 times the base case forecast) and substantial additional savings for France and Portugal (2 and 4 times the base case forecast, respectively). Delaying time to market was found be to a very powerful tool to reduce pharmaceutical expenditure. Applying the EU transparency directive (6-month process for pricing and reimbursement) increased pharmaceutical expenditure for all countries (from 1.1 to 4 times the base case forecast), except in Germany (additional savings). Decreasing the price of generics and boosting the penetration rate, as well as shifting distribution of biosimilars through hospital chain were also key methods to reduce pharmaceutical expenditure. Change in the level of reimbursement rate to 100% in all countries led to an important increase in the pharmaceutical budget. Forecasting pharmaceutical expenditure is a critical exercise to inform policy decision makers. The most important leverages identified by the model on pharmaceutical budget were driven by generic and biosimilar prices, penetration rate, and distribution. Reducing, even slightly, the prices of

When Health Policy and Empirical Evidence Collide: The Case of Cigarette Package Warning Labels and Economic Consumer Surplus

Science.gov (United States)

Song, Anna V.; Brown, Paul

2014-01-01

In its graphic warning label regulations on cigarette packages, the Food and Drug Administration severely discounts the benefits of reduced smoking because of the lost “pleasure” smokers experience when they stop smoking; this is quantified as lost “consumer surplus.” Consumer surplus is grounded in rational choice theory. However, empirical evidence from psychological cognitive science and behavioral economics demonstrates that the assumptions of rational choice are inconsistent with complex multidimensional decisions, particularly smoking. Rational choice does not account for the roles of emotions, misperceptions, optimistic bias, regret, and cognitive inefficiency that are germane to smoking, particularly because most smokers begin smoking in their youth. Continued application of a consumer surplus discount will undermine sensible policies to reduce tobacco use and other policies to promote public health. PMID:24328661

Optimal Temporal Policies in Fluid Milk Advertising

OpenAIRE

Vande Kamp, Philip R.; Kaiser, Harry M.

1998-01-01

This study develops an approach to obtain optimal temporal advertising strategies when consumers' response to advertising is asymmetric. Using this approach, optimal strategies for generic fluid milk advertising in New York City are determined. Results indicate that pulsed advertising policies are significantly more effective in increasing demand than a uniform advertising policy. Sensitivity analyses show that the optimal advertising policies are insensitive to reasonable variations in inter...

Generic Example Proving Criteria for All

Science.gov (United States)

Yopp, David; Ely, Rob; Johnson­-Leung, Jennifer

2015-01-01

We review literature that discusses generic example proving and highlight ambiguities that pervade our research community's discourse about generic example arguments. We distinguish between pedagogical advice for choosing good examples that can serve as generic examples when teaching and advice for developing generic example arguments. We provide…

Generic and biosimilar medicines: quid?

Directory of Open Access Journals (Sweden)

Steven Simoens

2012-12-01

Full Text Available Once intellectual property protection, data and marketing exclusivity of reference medicines have expired, generic medicines and biosimilar medicines can enter the off-patent market. This market entry is conditional on the approval of marketing authorization, pricing and reimbursement. Given that there tends to be confusion surrounding generic and biosimilar medicines, this Editorial introduces basic concepts related to generic and biosimilar medicines and presents the different studies and articles included in this supplement dedicated to generic and biosimilar medicines.

Impact of price deregulation policy on the affordability of essential medicines for women's health: a panel data analysis.

Science.gov (United States)

Liu, Junjie; Wang, Liming; Liu, Chenxi; Zhang, Xinping

2017-12-01

A new policy which required deregulation on prices of off-patent medicines for women's health during procurement was introduced in China in September 2015. The current study examines this policy's impact on the affordability of essential medicines for women's health. Based on product-level panel data, a fixed effect regression model is employed by using procurement records from Hubei Centralist Tender for Drug Purchase platform. In the model, Affordability was measured with prices. The Competition consists of two parts: generic competition and therapeutic class competition which are measured with generic competitors and therapeutic substitutes. Instrument variable is used to deal with endogeneity. The policy helped control prices of essential medicines for women's health. Generic competition helped control prices, however, therapeutic class competition caused higher prices. The new policy helped enhance the affordability of essential medicines for women's health as expected, which provides empirical evidence on price deregulation. Besides, generic competition is important in price control despite strict regulatory system in China.

Do national drug policies influence antiretroviral drug prices? Evidence from the Southern African Development community.

Science.gov (United States)

Liu, Yao; Galárraga, Omar

2017-03-01

The efficacy of low- and middle-income countries’ (LMIC) national drug policies in managing antiretroviral (ARV) pharmaceutical prices is not well understood. Though ARV drug prices have been declining in LMIC over the past decade, little research has been done on the role of their national drug policies. This study aims to (i) analyse global ARV prices from 2004 to 2013 and (ii) examine the relationship of national drug policies to ARV prices. Analysis of ARV drug prices utilized data from the Global Price Reporting Mechanism from the World Health Organization (WHO). Ten of the most common ARV drugs (first-line and second-line) were selected. National drug policies were also assessed for 12 countries in the South African Development Community (SADC), which self-reported their policies through WHO surveys. The best predictor of ARV drug price was generic status—the generic versions of 8 out of 10 ARV drugs were priced lower than branded versions. However, other factors such as transaction volume, HIV prevalence, national drug policies and PEPFAR/CHAI involvement were either not associated with ARV drug price or were not consistent predictors of price across different ARV drugs. In the context of emerging international trade agreements, which aim to strengthen patent protections internationally and potentially delay the sale of generic drugs in LMIC, this study shines a spotlight on the importance of generic drugs in controlling ARV prices. Further research is needed to understand the impact of national drug policies on ARV prices.

Advertising and generic market entry.

Science.gov (United States)

Königbauer, Ingrid

2007-03-01

The effect of purely persuasive advertising on generic market entry and social welfare is analysed. An incumbent has the possibility to invest in advertising which affects the prescribing physician's perceived relative qualities of the brand-name and the generic version of the drug. Advertising creates product differentiation and can induce generic market entry which is deterred without differentiation due to strong Bertrand competition. However, over-investment in advertising can deter generic market entry under certain conditions and reduces welfare as compared to accommodated market entry.

Chain store management through private labels strategy

Directory of Open Access Journals (Sweden)

Martina Sopta

2007-07-01

Full Text Available The purpose of this paper is to examine the market shares of private labels in the European Union and on the global market, and to compare the results of the analysis with the level of presence of private labels on the Croatian market. Moreover, through the application of macro and microeconomic tools, the author tried to estimate the future trends of private labels in Croatia.For the purpose of the paper secondary and primary data was used in the research. Relevant scientific and professional literature of local and foreign authors was analyzed. In addition, a few recent research studies were analyzed and their results compared. Field research has been conducted by the survey method, with 225 respondents included in the intentional sample.The main hypothesis of the paper based on research is that, in total sales, private labels are gaining a growing share in all markets, regardless of the development level of those markets. Alongside the main hypothesis of the work, three supporting hypotheses were tested to see which private labels are a good alternative to other brands on the world market. Private labels are generally developed on generic products. The third supporting hypothesis starts from the assumption that the investments in the promotion of private labels are negligible, resulting in lower prices of thoseproducts. The results of research and analyses in the work indicate that the position of private labels will strengthen internationally, as part of the process of liberalization and globalization of trade flows. In the process of purchase of private labels the positioning of the point of sale and price have an increasing contribution. With the concentration of commerce in chain stores, the share of private labels grows, approaching a half of the total sales in some countries. Considering the Croatian market, according to the international product life cycle theory, the share of private labels in the total sales will grow in the future

From generic to biosimilar drugs: why take an innovative pace?

Directory of Open Access Journals (Sweden)

Fereshteh Barei

2012-12-01

Full Text Available BACKGROUND: The transition of the generic/biotechnology industry to innovation by investing in innovative R&D will enhance business expertise in biopharmaceutical development and manufacturing. The major impact of this evolution is on patient access to treatment and savings for the health care systems. OBJECTIVES: The aim of this paper is to investigate the innovative aspect of biosimilar and biobetter products, manufactured by some big generic companies. We will also try to explore the innovative business strategy, implementing this high risk product differentiation policy. METHODS: This qualitative research is conducted by a series of interviews with CEOs, physicians, and academics in different countries. The qualitative data obtained were analyzed by Nvivo9.2 software. A literature review has also contributed to our key findings. RESULTS: The results show that switching into biosimilars/biobetters is an innovative strategic choice, approved by some big generic pharmaceutical companies. The biosimilar/biobetter products can be considered innovative because of their value added quality. CONCLUSION: Expanding the product portfolio to biosimilars/biobetter can be considered as a long run strategy in the innovative business plans aiming to ensure the market access. Patients and their access to better treatments are major components of these innovative business models.

Encouraging generic use can yield significant savings.

Science.gov (United States)

Zimmerman, Christina

2012-11-01

Key findings. (1) Zero copayment for generic drugs is the greatest influencer of generic statin utilization. (2) Both higher copayments for generic drugs and lower copayments for competing brands are associated with a decreased probability of using generic statins. (3) Prior authorization and step therapy requirements for brand-name statins are associated with an increased use of generic drugs. (4) Greater use of generic statins should reduce costs for patients, plans, and Medicare.

A hedonic analysis of nutrition labels across product types and countries

DEFF Research Database (Denmark)

Edenbrandt, Anna Kristina; Smed, Sinne; Jansen, Leon

2018-01-01

show positive values attached to the label across countries and most product categories, suggesting that consumers do value the guidance that the nutrition labels provide. Policy implications from these results indicate that credible nutrition labels are relevant tools in the effort to combat diet...

PHARMACEUTICAL QUALITY OF GENERIC ATORVASTATIN PRODUCTS COMPARED WITH THE INNOVATOR PRODUCT: A NEED FOR REVISING PRICING POLICY IN PALESTINE.

Science.gov (United States)

Shawahna, Ramzi; Hroub, Abdel Kareem; Abed, Eliama; Jibali, Sondos; Al-Saghir, Ruba; Zaid, Abdel Naser

2016-01-01

Atorvastatin reduces morbidity and mortality due to cardiovascular events. This study was conducted to assess the prices and pharmaceutical quality of innovator atorvastatin 20 mg with its locally available generics in Palestine and to assess the suitability of their interchangeability. The prices of innovator and generic atorvastatin 20 mg were determined and compared. Innovator atorvastatin and four generic products were tested for their pharmaceutical quality. Tablets were tested for their drug contents, weight uniformity, hardness, disintegration and dissolution. Three out of four generics were less expensive than the innovator. Pharmaceutical quality assessments were satisfactory and within limits for all atorvastatin tested products. The average weight ranged from 206.6 ± 8.40 to 330 ± 3.92 mg and the %RSDs were within the permitted limits as per USP. Tablet hardness ranged from 102 ± 1.41 to 197.4 ± 6.88 kg and drug contents ranged from 92.2% to 105.3%. All products disintegrated within permitted time limits and showed very rapid dissolution. Products released more than 85% of their drug contents in less than 15 min. Our results showed that all tested innovator and generic atorvastatin products were of good pharmaceutical quality. Despite the lack of in vivo evaluation, our results indicate that these products are equivalent in vitro. Considering the in vitro release characteristics, these products might be used interchangeably. However, regulatory authorities permit the use of in vitro data in establishing similarity between immediate release oral dosage forms containing biopharmaceutical classification system class I and III drugs only.

76 FR 57767 - Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for...

Science.gov (United States)

2011-09-16

... NUCLEAR REGULATORY COMMISSION [NRC-2011-0204] Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for Operating Reactors AGENCY: Nuclear Regulatory Commission... FR 54507), that requested public comment on Draft NRC Generic Letter 2011- XX: Seismic Risk...

Has the increase in the availability of generic drugs lowered the price of cardiovascular drugs in South Africa?

Directory of Open Access Journals (Sweden)

Varsha Bangalee

2016-12-01

Conclusion: Increased generic competition is not a predictor of lower drug prices. The study also concludes that the current South African pharmaceutical policies have not yet achieved the lowest prices for drugs when compared internationally.

Why the Distilled Spirits Industry Council of Australia is not a credible partner for the Australian government in making alcohol policy.

Science.gov (United States)

Munro, Geoffrey

2012-06-01

In 2008 the Australian government increased the excise rate on ready-to-drink premixed spirits or 'alcopops' by 70% to reduce their attraction to young people. A campaign against the decision was led by the Distilled Spirits Industry Council of Australia, whose members include representatives of the world's largest spirits producers and which aspires to partner the government in making alcohol policy. Distilled Spirits Industry Council of Australia's central thesis appeared to lack substance and sincerity: first, it promoted industry data that were evidently premature and misleading; second, it claimed ready-to-drinks were a safer alternative to the consumption of full-strength spirits because spirits pose a threat to drinkers due to their higher alcoholic content. For spirits producers to concede that drinking spirits is generically hazardous may be unprecedented and contradicts the spirits industry's long-standing opposition to the introduction of health warnings on product labels. Although that admission did not survive the resolution of the case, the effect may be profound, as it might justify the demand for greater control of the labelling and marketing of spirits, and reduce the credibility of spirits producers, and the broader alcohol industry, on matters of policy. © 2011 Australasian Professional Society on Alcohol and other Drugs.

Pharmaceutical expenditure forecast model to support health policy decision making

Science.gov (United States)

Rémuzat, Cécile; Urbinati, Duccio; Kornfeld, Åsa; Vataire, Anne-Lise; Cetinsoy, Laurent; Aballéa, Samuel; Mzoughi, Olfa; Toumi, Mondher

2014-01-01

Background and objective With constant incentives for healthcare payers to contain their pharmaceutical budgets, modelling policy decision impact became critical. The objective of this project was to test the impact of various policy decisions on pharmaceutical budget (developed for the European Commission for the project ‘European Union (EU) Pharmaceutical expenditure forecast’ – http://ec.europa.eu/health/healthcare/key_documents/index_en.htm). Methods A model was built to assess policy scenarios’ impact on the pharmaceutical budgets of seven member states of the EU, namely France, Germany, Greece, Hungary, Poland, Portugal, and the United Kingdom. The following scenarios were tested: expanding the UK policies to EU, changing time to market access, modifying generic price and penetration, shifting the distribution chain of biosimilars (retail/hospital). Results Applying the UK policy resulted in dramatic savings for Germany (10 times the base case forecast) and substantial additional savings for France and Portugal (2 and 4 times the base case forecast, respectively). Delaying time to market was found be to a very powerful tool to reduce pharmaceutical expenditure. Applying the EU transparency directive (6-month process for pricing and reimbursement) increased pharmaceutical expenditure for all countries (from 1.1 to 4 times the base case forecast), except in Germany (additional savings). Decreasing the price of generics and boosting the penetration rate, as well as shifting distribution of biosimilars through hospital chain were also key methods to reduce pharmaceutical expenditure. Change in the level of reimbursement rate to 100% in all countries led to an important increase in the pharmaceutical budget. Conclusions Forecasting pharmaceutical expenditure is a critical exercise to inform policy decision makers. The most important leverages identified by the model on pharmaceutical budget were driven by generic and biosimilar prices, penetration rate

Toward a More Comprehensive Theory of Food Labels

OpenAIRE

Julie A. Caswell; Daniel I. Padberg

1992-01-01

Food labels play important third-party roles in the food marketing system through their impact on product design, advertising, consumer confidence in food quality, and consumer education on diet and health. However, current analysis focuses overwhelmingly on the label's direct use as a point-of-purchase shopping aid, even though such use is limited by consumers' information processing abilities and time. In rewriting label regulations, policy makers should consider the benefits and costs of t...

78 FR 8446 - Center for Drug Evaluation and Research; Prescription Drug Labeling Improvement and Enhancement...

Science.gov (United States)

2013-02-06

... utility of the prescription drug labeling as a communication tool and to discuss strategies for making it... the Web site after this document publishes in the Federal Register.) All holders of marketing... before June 30, 2001, and for generic drugs. The initiative is anticipated to take place over several...

Labeling of genetically modified food: closer to reality in the United States?

Science.gov (United States)

Wohlers, Anton E

2013-01-01

Within the broader context of several related biotech developments, including the proliferation of GM food in American grocery stories, the recent decision by Whole Foods Market, Inc. to require the labeling of all genetically modified (GM) organism products sold in its stores by 2018, and the development of GM animals for consumption, this essay asks whether the United States is inching towards a policy of mandatory GM food labeling. The analysis highlights aspects of the biotechnology policy debate in the United States and European Union, and traces public opinion as well as grassroots and legislative efforts aimed at GM food labeling. Findings show that activities at the federal level do not suggest any major regulatory changes regarding labeling in the near future; however, a growing number of individual states are considering GM food labeling legislation and political momentum in favor of labeling has picked up in recent years. Voluntary labeling by food companies may also become increasingly common.

NET 40 Generics Beginner's Guide

CERN Document Server

Mukherjee, Sudipta

2012-01-01

This is a concise, practical guide that will help you learn Generics in .NET, with lots of real world and fun-to-build examples and clear explanations. It is packed with screenshots to aid your understanding of the process. This book is aimed at beginners in Generics. It assumes some working knowledge of C# , but it isn't mandatory. The following would get the most use out of the book: Newbie C# developers struggling with Generics. Experienced C++ and Java Programmers who are migrating to C# and looking for an alternative to other generic frameworks like STL and JCF would find this book handy.

Should policy ethics come in two colours: green or white?

Science.gov (United States)

Oswald, Malcolm

2013-05-01

When writing about policy, do you think in green or white? If not, I recommend that you do. I suggest that writers and journal editors should explicitly label every policy ethics paper either 'green' or 'white'. A green paper is an unconstrained exploration of a policy question. The controversial 'After-birth abortion' paper is an example. Had it been labelled as 'green', readers could have understood what Giubilini and Minerva explained later: that it was a discussion of philosophical ideas, and not a policy proposal advocating infanticide. A serious policy proposal should be labelled by writer(s) and editor(s) as 'white'. Its purpose should be to influence policy. In order to influence policy, I suggest three essential, and two desirable, characteristics of any white paper. Most importantly, a white paper should be set in the context in which the policy is to be made and applied.

Brand-to-generic levetiracetam switch in patients with epilepsy in a routine clinical setting.

Science.gov (United States)

Markoula, Sofia; Chatzistefanidis, Dimitrios; Gatzonis, Stylianos; Siatouni, Anna; Siarava, Eleftheria; Verentzioti, Anastasia; Kyritsis, Athanassios P; Patsalos, Philip N

2017-05-01

The therapeutic equivalence of generic and brand antiepileptic drugs, based on studies performed on healthy volunteers, has been questioned. We compare, in a routine clinical setting, brand versus generic levetiracetam (LEV) bioequivalence in patients with epilepsy and also the clinical efficacy and tolerability of the substitution. A prospective, open-label, non-randomized, steady-state, multiple-dose, bioequivalence study was conducted in 12 patients with epilepsy (5 females), with a mean age of 38.4±16.2 years. Patients treated with the brand LEV (Keppra; UCB Pharma) were closely followed for a four-week period and subsequently switched to a generic LEV (Pharmaten) and followed for another four-week period. Blood samples were collected at the end of each 4-week period, during a dose interval for each formulation, for LEV concentration measurements by liquid chromatography mass spectrometry. Steady-state area under the curve (AUC) and peak plasma concentration (Cmax) data were subjected to conventional average bioequivalence analysis. Secondary clinical outcomes, including seizure frequency and adverse events, were recorded. Patients had epilepsy for a mean period of 14.1±10.6years and the mean daily LEV dose was 2583.3±763.7mg. The mean AUC±SD and Cmax±SD was 288.4±86.3(mg/L)h and 37.8±10.4mg/L respectively for brand LEV and 319.2±104.7(mg/L)h and 41.6±12.3mg/L respectively for the generic LEV. Statistic analysis showed no statistical significant difference in bioequivalence. Also, no change in seizures frequency and/or adverse events was recorded. In our clinical setting, generic LEV was determined to be bioequivalent to brand LEV. Furthermore, seizures frequency or/and adverse events were not affected upon switching from brand to generic LEV. Copyright © 2017 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

Development and validation of a tool to assess knowledge and attitudes towards generic medicines among students in Greece: The ATtitude TOwards GENerics (ATTOGEN questionnaire.

Directory of Open Access Journals (Sweden)

Philip J Domeyer

Full Text Available The use of generic medicines is a cost-effective policy, often dictated by fiscal restraints. To our knowledge, no fully validated tool exploring the students' knowledge and attitudes towards generic medicines exists. The aim of our study was to develop and validate a questionnaire exploring the knowledge and attitudes of M.Sc. in Health Care Management students and recent alumni's towards generic drugs in Greece.The development of the questionnaire was a result of literature review and pilot-testing of its preliminary versions to researchers and students. The final version of the questionnaire contains 18 items measuring the respondents' knowledge and attitude towards generic medicines on a 5-point Likert scale. Given the ordinal nature of the data, ordinal alpha and polychoric correlations were computed. The sample was randomly split into two halves. Exploratory factor analysis, performed in the first sample, was used for the creation of multi-item scales. Confirmatory factor analysis and Generalized Linear Latent and Mixed Model analysis (GLLAMM with the use of the rating scale model were used in the second sample to assess goodness of fit. An assessment of internal consistency reliability, test-retest reliability, and construct validity was also performed.Among 1402 persons contacted, 986 persons completed our questionnaire (response rate = 70.3%. Overall Cronbach's alpha was 0.871. The conjoint use of exploratory and confirmatory factor analysis resulted in a six-scale model, which seemed to fit the data well. Five of the six scales, namely trust, drug quality, state audit, fiscal impact and drug substitution were found to be valid and reliable, while the knowledge scale suffered only from low inter-scale correlations and a ceiling effect. However, the subsequent confirmatory factor and GLLAMM analyses indicated a good fit of the model to the data.The ATTOGEN instrument proved to be a reliable and valid tool, suitable for assessing students

Has the increase in the availability of generic drugs lowered the price of cardiovascular drugs in South Africa?

Directory of Open Access Journals (Sweden)

Varsha Bangalee

2016-10-01

Objective: To examine the relationship between originator drug prices and the number of generic brands within the cardiovascular class of drugs and to compare South African prices with international reference prices. Method: Data on private sector drug prices was sourced from the South African Medicine Price Registry. The relationship between the median proportional price and the number of brands in the therapeutic class was analysed using correlation analysis. International reference prices were obtained from the Management Sciences for Health International Drug Price Indicator Guide (2012 edition. Results: A weak correlation between originator and generic drug prices and the number of available brands was observed, the exception being diuretic drugs. The median prices per strength of the originator generic were still higher than the most expensive generic version manufactured by any other company, the exception being telmisartan. Comparison of price ratios between the originator drug, lowest priced generic and international reference price values revealed that the originator drug prices had a median price ratio of 20.99 (interquartile range 7.31—53.46 and the lowest priced generics had a median price ratio of 4.28 (interquartile range 2.10—8.47. Conclusion: Increased generic competition is not a predictor of lower drug prices. The study also concludes that the current South African pharmaceutical policies have not yet achieved the lowest prices for drugs when compared internationally.

Efficient Generic Functional Programming

NARCIS (Netherlands)

Alimarine, A.; Smetsers, J.E.W.

2005-01-01

Generic functions are defined by induction on the structural representation of types. As a consequence, by defining just a single generic operation, one acquires this operation over any particular data type. An instance on a specific type is generated by interpretation of the type's structure. A

Generic robot architecture

Science.gov (United States)

Bruemmer, David J [Idaho Falls, ID; Few, Douglas A [Idaho Falls, ID

2010-09-21

The present invention provides methods, computer readable media, and apparatuses for a generic robot architecture providing a framework that is easily portable to a variety of robot platforms and is configured to provide hardware abstractions, abstractions for generic robot attributes, environment abstractions, and robot behaviors. The generic robot architecture includes a hardware abstraction level and a robot abstraction level. The hardware abstraction level is configured for developing hardware abstractions that define, monitor, and control hardware modules available on a robot platform. The robot abstraction level is configured for defining robot attributes and provides a software framework for building robot behaviors from the robot attributes. Each of the robot attributes includes hardware information from at least one hardware abstraction. In addition, each robot attribute is configured to substantially isolate the robot behaviors from the at least one hardware abstraction.

A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries.

Science.gov (United States)

Waning, Brenda; Diedrichsen, Ellen; Moon, Suerie

2010-09-14

recommended ARVs will likely be hampered until Indian generic producers can provide the dramatic price reductions and improved formulations observed in the past. Rather than agreeing to inappropriate intellectual property obligations through free trade agreements, India and its trade partners--plus international organizations, donors, civil society and pharmaceutical manufacturers--should ensure that there is sufficient policy space for Indian pharmaceutical manufacturers to continue their central role in supplying developing countries with low-priced, quality-assured generic medicines.

Emotion Recognition in Children With Down Syndrome: Influence of Emotion Label and Expression Intensity.

Science.gov (United States)

Cebula, Katie R; Wishart, Jennifer G; Willis, Diane S; Pitcairn, Tom K

2017-03-01

Some children with Down syndrome may experience difficulties in recognizing facial emotions, particularly fear, but it is not clear why, nor how such skills can best be facilitated. Using a photo-matching task, emotion recognition was tested in children with Down syndrome, children with nonspecific intellectual disability and cognitively matched, typically developing children (all groups N = 21) under four conditions: veridical vs. exaggerated emotions and emotion-labelling vs. generic task instructions. In all groups, exaggerating emotions facilitated recognition accuracy and speed, with emotion labelling facilitating recognition accuracy. Overall accuracy and speed did not differ in the children with Down syndrome, although recognition of fear was poorer than in the typically developing children and unrelated to emotion label use. Implications for interventions are considered.

Multisource drug policies in Latin America: survey of 10 countries.

Science.gov (United States)

Homedes, Núria; Ugalde, Antonio

2005-01-01

Essential drug lists and generic drug policies have been promoted as strategies to improve access to pharmaceuticals and control their rapidly escalating costs. This article reports the results of a preliminary survey conducted in 10 Latin American countries. The study aimed to document the experiences of different countries in defining and implementing generic drug policies, determine the cost of registering different types of pharmaceutical products and the time needed to register them, and uncover the incentives governments have developed to promote the use of multisource drugs. The survey instrument was administered in person in Chile, Ecuador and Peru and by email in Argentina, Brazil, Bolivia, Colombia, Costa Rica, Nicaragua and Uruguay. There was a total of 22 respondents. Survey responses indicated that countries use the terms generic and bioequivalence differently. We suggest there is a need to harmonize definitions and technical concepts. PMID:15682251

Development and optimisation of generic decommissioning strategies for civil Magnox reactors

International Nuclear Information System (INIS)

Carpenter, G.; Hebditch, D.; Meek, N.; Patel, A.; Reeve, P.

2004-01-01

BNFL Environmental Services has formulated updated proposals for the use of decision analysis in the development of decommissioning strategy. The proposals are based on the Department of Transport, Local Government and the Regions manual for practitioners on multi-criteria analysis, specifically multi-criteria decision analysis, as suited to complex problems with a mixture of monetary and non-monetary objectives. They take account of up-to-date academic methodology, the newly issued BNFL decision analysis framework for environmental decisions and a wide variety of other engineering, optioneering and optimisation processes. The paper also summarises legislative and company policy areas of importance to decommissioning strategy development. Higher-level generic reactor and site remediation strategies already exist. At the lower level, various generic decommissioning reference processes and project options need development. For the past year, Environmental Services has held responsibility to respond to the Nuclear Installations Inspectorates' quinquennial review, develop and maintain up-to-date strategies, institute the review of a selected number of key strategies, and respond to changing circumstances including stakeholder views. Environmental Services is performing a range of generic studies for selection of strategies and end-points as used for a variety of waste management and site care and maintenance preparations. (author)

42 CFR 447.506 - Authorized generic drugs.

Science.gov (United States)

2010-10-01

... 42 Public Health 4 2010-10-01 2010-10-01 false Authorized generic drugs. 447.506 Section 447.506... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS PAYMENTS FOR SERVICES Payment for Drugs § 447.506 Authorized generic drugs. (a) Authorized generic drug defined. For the purposes of this subpart, an authorized generic drug...

Origin labelling; Cost analysis for producers and consumers

NARCIS (Netherlands)

Terluin, I.J.; Benninga, J.; Berkhout, P.; Immink, V.M.; Janssens, S.R.M.; Jongeneel, R.A.; Rau, M.L.; Tacken, G.M.L.

2012-01-01

By stating the origin of a foodstuff, producers can provide consumers with information about where the food comes from. Country of origin labelling is the subject of debate from two different policy areas. One debate takes place in the framework of EU quality policy for agricultural products, the

NRC policy on future reactor designs

International Nuclear Information System (INIS)

1985-07-01

On April 13, 1983, the US Nuclear Regulatory Commission issued for public comment a ''Proposed Commission Policy Statement on Severe Accidents and Related Views on Nuclear Reactor Regulation'' (48 FR 16014). This report presents and discusses the Commission's final version of that policy statement now entitled, ''Policy Statement on Severe Reactor Accidents Regarding Future Designs and Existing Plants.'' It provides an overview of comments received from the public and the Advisory Committee on Reactor Safeguards and the staff response to these. In addition to the Policy Statement, the report discusses how the policies of this statement relate to other NRC programs including the Severe Accident Research Program; the implementation of safety measures resulting from lessons learned in the accident at Three Mile Island; safety goal development; the resolution of Unresolved Safety Issues and other Generic Safety Issues; and possible revisions of rules or regulatory requirements resulting from the Severe Accident Source Term Program. Also discussed are the main features of a generic decision strategy for resolving Regulatory Questions and Technical Issues relating to severe accidents; the development and regulatory use of new safety information; the treatment of uncertainty in severe accident decision making; and the development and implementation of a Systems Reliability Program for both existing and future plants to ensure that the realized level of safety is commensurate with the safety analyses used in regulatory decisions

Generic phytosanitary irradiation treatments

International Nuclear Information System (INIS)

Hallman, Guy J.

2012-01-01

The history of the development of generic phytosanitary irradiation (PI) treatments is discussed beginning with its initial proposal in 1986. Generic PI treatments in use today are 150 Gy for all hosts of Tephritidae, 250 Gy for all arthropods on mango and papaya shipped from Australia to New Zealand, 300 Gy for all arthropods on mango shipped from Australia to Malaysia, 350 Gy for all arthropods on lychee shipped from Australia to New Zealand and 400 Gy for all hosts of insects other than pupae and adult Lepidoptera shipped to the United States. Efforts to develop additional generic PI treatments and reduce the dose for the 400 Gy treatment are ongoing with a broad based 5-year, 12-nation cooperative research project coordinated by the joint Food and Agricultural Organization/International Atomic Energy Agency Program on Nuclear Techniques in Food and Agriculture. Key groups identified for further development of generic PI treatments are Lepidoptera (eggs and larvae), mealybugs and scale insects. A dose of 250 Gy may suffice for these three groups plus others, such as thrips, weevils and whiteflies. - Highlights: ► The history of phytosanitary irradiation (PI) treatments is given. ► Generic PI treatments in use today are discussed. ► Suggestions for future research are presented. ► A dose of 250 Gy for most insects may suffice.

75 FR 21007 - Food Labeling; Public Workshop

Science.gov (United States)

2010-04-22

..., particularly small businesses, with firsthand working knowledge of FDA's requirements and compliance policies... Consumer Protection Act of 2004, (3) nutrition labeling requirements, (4) health and nutrition claims, and...

Determinants of generic drug substitution in Switzerland

Directory of Open Access Journals (Sweden)

Lufkin Thomas M

2011-01-01

Full Text Available Abstract Background Since generic drugs have the same therapeutic effect as the original formulation but at generally lower costs, their use should be more heavily promoted. However, a considerable number of barriers to their wider use have been observed in many countries. The present study examines the influence of patients, physicians and certain characteristics of the generics' market on generic substitution in Switzerland. Methods We used reimbursement claims' data submitted to a large health insurer by insured individuals living in one of Switzerland's three linguistic regions during 2003. All dispensed drugs studied here were substitutable. The outcome (use of a generic or not was modelled by logistic regression, adjusted for patients' characteristics (gender, age, treatment complexity, substitution groups and with several variables describing reimbursement incentives (deductible, co-payments and the generics' market (prices, packaging, co-branded original, number of available generics, etc.. Results The overall generics' substitution rate for 173,212 dispensed prescriptions was 31%, though this varied considerably across cantons. Poor health status (older patients, complex treatments was associated with lower generic use. Higher rates were associated with higher out-of-pocket costs, greater price differences between the original and the generic, and with the number of generics on the market, while reformulation and repackaging were associated with lower rates. The substitution rate was 13% lower among hospital physicians. The adoption of the prescribing practices of the canton with the highest substitution rate would increase substitution in other cantons to as much as 26%. Conclusions Patient health status explained a part of the reluctance to substitute an original formulation by a generic. Economic incentives were efficient, but with a moderate global effect. The huge interregional differences indicated that prescribing behaviours and

Comparative analysis of the labelling of nanotechnologies across four stakeholder groups

International Nuclear Information System (INIS)

Capon, Adam; Gillespie, James; Rolfe, Margaret; Smith, Wayne

2015-01-01

Societies are constantly challenged to develop policies around the introduction of new technologies, which by their very nature contain great uncertainty. This uncertainty gives prominence to varying viewpoints which are value laden and have the ability to drastically shift policy. The issue of nanotechnologies is a prime example. The labelling of products that contain new technologies has been one policy tool governments have used to address concerns around uncertainty. Our study develops evidence regarding opinions on the labelling of products made by nanotechnologies. We undertook a computer-assisted telephone (CATI) survey of the Australian public and those involved in nanotechnologies from the academic, business and government sectors using a standardised questionnaire. Analysis was undertaken using descriptive and logistic regression techniques. We explored reluctance to purchase as a result of labelling products which contained manufactured nanomaterials both generally and across five broad products (food, cosmetics/sunscreens, medicines, pesticides, tennis racquets/computers) which represent the broad categories of products regulated by differing government agencies in Australia. We examined the relationship between reluctance to purchase and risk perception, trust, and familiarity. We found irrespective of stakeholder, most supported the labelling of products which contained manufactured nanomaterials. Perception of risk was the main driver of reluctance to purchase, while trust and familiarity were likely to have an indirect effect through risk perception. Food is likely to be the greatest product impacted by labelling. Risk perception surrounding nanotechnologies and label ‘framing’ on the product are key issues to be addressed in the implementation of a labelling scheme

Comparative analysis of the labelling of nanotechnologies across four stakeholder groups

Science.gov (United States)

Capon, Adam; Gillespie, James; Rolfe, Margaret; Smith, Wayne

2015-08-01

Societies are constantly challenged to develop policies around the introduction of new technologies, which by their very nature contain great uncertainty. This uncertainty gives prominence to varying viewpoints which are value laden and have the ability to drastically shift policy. The issue of nanotechnologies is a prime example. The labelling of products that contain new technologies has been one policy tool governments have used to address concerns around uncertainty. Our study develops evidence regarding opinions on the labelling of products made by nanotechnologies. We undertook a computer-assisted telephone (CATI) survey of the Australian public and those involved in nanotechnologies from the academic, business and government sectors using a standardised questionnaire. Analysis was undertaken using descriptive and logistic regression techniques. We explored reluctance to purchase as a result of labelling products which contained manufactured nanomaterials both generally and across five broad products (food, cosmetics/sunscreens, medicines, pesticides, tennis racquets/computers) which represent the broad categories of products regulated by differing government agencies in Australia. We examined the relationship between reluctance to purchase and risk perception, trust, and familiarity. We found irrespective of stakeholder, most supported the labelling of products which contained manufactured nanomaterials. Perception of risk was the main driver of reluctance to purchase, while trust and familiarity were likely to have an indirect effect through risk perception. Food is likely to be the greatest product impacted by labelling. Risk perception surrounding nanotechnologies and label `framing' on the product are key issues to be addressed in the implementation of a labelling scheme.

Comparative analysis of the labelling of nanotechnologies across four stakeholder groups

Energy Technology Data Exchange (ETDEWEB)

Capon, Adam, E-mail: acap1921@uni.sydney.edu.au; Gillespie, James, E-mail: james.gillespie@sydney.edu.au [University of Sydney, Menzies Centre for Health Policy, School of Public Health (Australia); Rolfe, Margaret, E-mail: margaret.rolfe@sydney.edu.au [University of Sydney, University Centre for Rural Health, School of Public Health (Australia); Smith, Wayne, E-mail: wayne.smith@doh.health.nsw.gov.au [Health Protection NSW, Environmental Health Branch (Australia)

2015-08-15

Societies are constantly challenged to develop policies around the introduction of new technologies, which by their very nature contain great uncertainty. This uncertainty gives prominence to varying viewpoints which are value laden and have the ability to drastically shift policy. The issue of nanotechnologies is a prime example. The labelling of products that contain new technologies has been one policy tool governments have used to address concerns around uncertainty. Our study develops evidence regarding opinions on the labelling of products made by nanotechnologies. We undertook a computer-assisted telephone (CATI) survey of the Australian public and those involved in nanotechnologies from the academic, business and government sectors using a standardised questionnaire. Analysis was undertaken using descriptive and logistic regression techniques. We explored reluctance to purchase as a result of labelling products which contained manufactured nanomaterials both generally and across five broad products (food, cosmetics/sunscreens, medicines, pesticides, tennis racquets/computers) which represent the broad categories of products regulated by differing government agencies in Australia. We examined the relationship between reluctance to purchase and risk perception, trust, and familiarity. We found irrespective of stakeholder, most supported the labelling of products which contained manufactured nanomaterials. Perception of risk was the main driver of reluctance to purchase, while trust and familiarity were likely to have an indirect effect through risk perception. Food is likely to be the greatest product impacted by labelling. Risk perception surrounding nanotechnologies and label ‘framing’ on the product are key issues to be addressed in the implementation of a labelling scheme.

Switching from originator brand medicines to generic equivalents in selected developing countries: how much could be saved?

Science.gov (United States)

Cameron, Alexandra; Mantel-Teeuwisse, Aukje K; Leufkens, Hubert G M; Laing, Richard Ogilvie

2012-01-01

In low- and middle-income countries, patients and reimbursement agencies that purchase medicines in the private sector pay more for originator brands when generic equivalents exist. We estimated the savings that could be obtained from a hypothetical switch in medicine consumption from originator brands to lowest-priced generic equivalents for a selection of medicines in 17 countries. In this cost minimization analysis, the prices of originator brands and their lowest-priced generic equivalents were obtained from facility-based surveys conducted by using a standard methodology. Fourteen medicines most commonly included in the surveys, plus three statins, were included in the analysis. For each medicine, the volume of private sector consumption of the originator brand product was obtained from IMS Health, Inc. Volumes were applied to the median unit prices for both originator brands and their lowest-priced generics to estimate cost savings. Prices were adjusted to 2008 by using consumer price index data and were adjusted for purchasing power parity. For the medicines studied, an average of 9% to 89% could be saved by an individual country from a switch in private sector purchases from originator brands to lowest-priced generics. In public hospitals in China, US $ 370 million could be saved from switching only four medicines, saving an average of 65%. Across individual medicines, average potential savings ranged from 11% for beclometasone inhaler to 73% for ceftriaxone injection. Substantial savings could be achieved by switching private sector purchases from originator brand medicines to lowest-priced generic equivalents. Strategies to promote generic uptake, such as generic substitution by pharmacists and increasing confidence in generics by professionals and the public, should be included in national medicines policies. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Generic clearance values

International Nuclear Information System (INIS)

Bossio, M.C.; Muniz, C.C.

2009-01-01

This paper analyzes the Generic Clearance Values established for natural and artificial radionuclides with the objective of evaluating their degree of conservatism in views of adopting them into the regulatory body. Generic clearance values for natural radionuclides have been chosen by experts judgments as the optimum boundary between, on one hand, the ubiquitous unmodified soil concentrations and, on the other hand, activity concentrations in ores, mineral sands, industrial residues and wastes. For artificial radionuclides the clearance levels have been derived from the scenarios postulated in the document 'Safety Reports Series Nr 44' of the IAEA considering quantitative exemption criteria. A set of 8 scenarios were postulated covering external, ingestion and inhalation exposure pathways. For each radionuclide, the generic clearance level was derived as the more restrictive value obtained from the scenarios, that is the lowest ratio between the applicable individual dose and the dose per unit activity concentration (Bq/g). The individual dose was calculated by a formula depending on each scenario and pathway, with different parameters, such as exposure time, dosimetric factors, dilution factor, density of the material, geometric factors, etc. It was concluded that the basis and parameters used for the derivation of the generic clearance levels are quite conservative and therefore its the adoption in Argentina has been recommended. It is expected that their implementation will contribute to optimize the regulatory management system. (author)

Generic Clearance Values

International Nuclear Information System (INIS)

Bossio, M.C.; Muniz, C.C.

2010-01-01

This paper analyzes the Generic Clearance Values established for natural and artificial radionuclides with the objective of evaluating their degree of conservatism in views of adopting them into the regulatory body. Generic clearance values for natural radionuclides have been chosen by experts judgments as the optimum boundary between, on the one hand, the ubiquitous unmodified soil concentrations and, on the other hand, activity concentrations in ores, mineral sands, industrial residues and wastes. For artificial radionuclides the clearance levels have been derived from the scenarios postulated in the document Safety Reports Series 44 of the IAEA considering quantitative exemption criteria. A set of 8 scenarios were postulated covering external, ingestion and inhalation exposure pathways. For each radionuclide, the generic clearance level was derived as the more restrictive value obtained from the scenarios, that is the lowest ratio between the applicable individual dose and the dose per unit activity concentration (Bq/g). The individual dose was calculated by a formula depending on each scenario and pathway, with different parameters, such as exposure time, dosimetric factors, dilution factor, density of the material, geometric factors, etc. It was concluded that the basis and parameters used for the derivation of the generic clearance levels are quite conservative and therefore its the adoption in Argentina has been recommended. It is expected that their implementation will contribute to optimize the regulatory management system. (authors) [es

A systematic review of calorie labeling and modified calorie labeling interventions: Impact on consumer and restaurant behavior

Science.gov (United States)

Bleich, Sara N.; Economos, Christina D.; Spiker, Marie L.; Vercammen, Kelsey; VanEpps, Eric M.; Block, Jason P.; Elbel, Brian; Story, Mary; Roberto, Christina A.

2017-01-01

Background Evidence on the effects of restaurant calorie labeling on consumer and restaurant behavior is mixed. This paper examined: 1) consumer responses to calorie information alone or compared to modified calorie information, and 2) changes in restaurant offerings following or in advance of menu labeling implementation. Methods We searched PubMed, Web of Science, Policy File and PAIS International to identify restaurant calorie labeling studies through October 1, 2016, that measured calories ordered, consumed, or available for purchase on restaurant menus. We also searched reference lists of calorie labeling articles. Results Fifty-three studies were included: 18 in real-world restaurants, 9 in cafeterias, and 21 in laboratory or simulation settings. Five examined restaurant offerings. Conclusion Due to a lack of well-powered studies with strong designs, the degree to which menu labeling encourages lower calorie purchases and whether that translates to a healthier population is unclear. Although there is limited evidence that menu labeling affects calories purchased at fast-food restaurants, some evidence demonstrates that it lowers calories purchased at certain types of restaurants and in cafeteria settings. The limited data on modified calorie labels find that such labels can encourage lower-calorie purchases, but may not differ in effects relative to calorie labels alone. PMID:29045080

A Systematic Review of Calorie Labeling and Modified Calorie Labeling Interventions: Impact on Consumer and Restaurant Behavior.

Science.gov (United States)

Bleich, Sara N; Economos, Christina D; Spiker, Marie L; Vercammen, Kelsey A; VanEpps, Eric M; Block, Jason P; Elbel, Brian; Story, Mary; Roberto, Christina A

2017-12-01

Evidence on the effects of restaurant calorie labeling on consumer and restaurant behavior is mixed. This paper examined: (1) consumer responses to calorie information alone or compared to modified calorie information and (2) changes in restaurant offerings following or in advance of menu labeling implementation. Searches were conducted in PubMed, Web of Science, Policy File, and PAIS International to identify restaurant calorie labeling studies through October 1, 2016, that measured calories ordered, consumed, or available for purchase on restaurant menus. The reference lists of calorie labeling articles were also searched. Fifty-three studies were included: 18 in real-world restaurants, 9 in cafeterias, and 21 in laboratory or simulation settings. Five examined restaurant offerings. Because of a lack of well-powered studies with strong designs, the degree to which menu labeling encourages lower-calorie purchases and whether that translates to a healthier population are unclear. Although there is limited evidence that menu labeling affects calories purchased at fast-food restaurants, some evidence demonstrates that it lowers calories purchased at certain types of restaurants and in cafeteria settings. The limited data on modified calorie labels find that such labels can encourage lower-calorie purchases but may not differ in effects relative to calorie labels alone. © 2017 The Obesity Society.

The impact of menu energy labelling across socioeconomic groups: A systematic review.

Science.gov (United States)

Sarink, Danja; Peeters, Anna; Freak-Poli, Rosanne; Beauchamp, Alison; Woods, Julie; Ball, Kylie; Backholer, Kathryn

2016-04-01

Menu energy labelling at point of purchase is gaining traction worldwide, yet the potential impact for different socioeconomic groups is unclear. We aimed to summarise evidence on the effectiveness of menu energy labelling by socioeconomic position (SEP). A systematic search for papers published to September 2015 was conducted using terms for labelling, food outlets, and SEP. Quality of studies was assessed. Results were summarised across stages of an intervention logic pathway. Eighteen papers were identified. Of twelve studies reporting the effect of menu energy labelling in low SEP populations, six reported on purchase outcomes. All but one of these reported no positive effect of the policy for this population. Two of the five studies that compared purchase outcomes of menu labelling across SEP groups reported that the policy was effective overall. These two studies reported either a significant decline in fast food calories purchased from consumers in high (but not low) SEP neighbourhoods or a significantly greater decline in calories purchased among consumers visiting stores in higher SEP neighbourhoods post policy implementation. None of the included papers reached the highest quality score. The current evidence describing the impact of menu energy labelling within or across SEP is limited in quantity and quality. Of the two studies that reported a positive benefit of menu energy labelling overall, both identified a greater effect on fast food purchases among consumers visiting stores in high compared to low SEP neighbourhoods. It is difficult to know whether the absence of effectiveness reported in low SEP populations represents a true lack of effectiveness or is a result of a more general lack of policy effectiveness or the limited quality of the reviewed studies. Copyright © 2016 Elsevier Ltd. All rights reserved.

Generic phytosanitary irradiation treatments

Energy Technology Data Exchange (ETDEWEB)

Hallman, Guy J [United States Department of Agriculture, Agricultural Research Service, Weslaco, TX (United States)

2013-01-15

The history of the development of generic phytosanitary irradiation (PI) treatments is discussed beginning with its initial proposal in 1986. Generic PI treatments in use today are 150 Gy for all hosts of Tephritidae, 250 Gy for all arthropods on mango and papaya shipped from Australia to New Zealand, 300 Gy for all arthropods on mango shipped from Australia to Malaysia, 350 Gy for all arthropods on lychee shipped from Australia to New Zealand and 400 Gy for all hosts of insects other than pupae and adult Lepidoptera shipped to the United States. Efforts to develop additional generic PI treatments and reduce the dose for the 400 Gy treatment are ongoing with a broad based 5-year, 12-nation cooperative research project coordinated by the joint Food and Agricultural Organization/International Atomic Energy Agency Program on Nuclear Techniques in Food and Agriculture. Key groups identified for further development of generic PI treatments are Lepidoptera (eggs and larvae), mealybugs and scale insects. A dose of 250 Gy may suffice for these three groups plus others, such as thrips, weevils and whiteflies. (author)

Generic phytosanitary irradiation treatments

Science.gov (United States)

Hallman, Guy J.

2012-07-01

The history of the development of generic phytosanitary irradiation (PI) treatments is discussed beginning with its initial proposal in 1986. Generic PI treatments in use today are 150 Gy for all hosts of Tephritidae, 250 Gy for all arthropods on mango and papaya shipped from Australia to New Zealand, 300 Gy for all arthropods on mango shipped from Australia to Malaysia, 350 Gy for all arthropods on lychee shipped from Australia to New Zealand and 400 Gy for all hosts of insects other than pupae and adult Lepidoptera shipped to the United States. Efforts to develop additional generic PI treatments and reduce the dose for the 400 Gy treatment are ongoing with a broad based 5-year, 12-nation cooperative research project coordinated by the joint Food and Agricultural Organization/International Atomic Energy Agency Program on Nuclear Techniques in Food and Agriculture. Key groups identified for further development of generic PI treatments are Lepidoptera (eggs and larvae), mealybugs and scale insects. A dose of 250 Gy may suffice for these three groups plus others, such as thrips, weevils and whiteflies.

Global Potential of Energy Efficiency Standards and Labeling Programs

Energy Technology Data Exchange (ETDEWEB)

McNeil, Michael A; McNeil, Michael A.; Letschert, Virginie; de la Rue du Can, Stephane

2008-06-15

This report estimates the global potential reductions in greenhouse gas emissions by 2030 for energy efficiency improvements associated with equipment (appliances, lighting, and HVAC) in buildings by means of energy efficiency standards and labels (EES&L). A consensus has emerged among the world's scientists and many corporate and political leaders regarding the need to address the threat of climate change through emissions mitigation and adaptation. A further consensus has emerged that a central component of these strategies must be focused around energy, which is the primary generator of greenhouse gas emissions. Two important questions result from this consensus: 'what kinds of policies encourage the appropriate transformation to energy efficiency' and 'how much impact can these policies have'? This report aims to contribute to the dialogue surrounding these issues by considering the potential impacts of a single policy type, applied on a global scale. The policy addressed in this report is Energy Efficient Standards and Labeling (EES&L) for energy-consuming equipment, which has now been implemented in over 60 countries. Mandatory energy performance standards are important because they contribute positively to a nation's economy and provide relative certainty about the outcome (both timing and magnitudes). Labels also contribute positively to a nation's economy and importantly increase the awareness of the energy-consuming public. Other policies not analyzed here (utility incentives, tax credits) are complimentary to standards and labels and also contribute in significant ways to reducing greenhouse gas emissions. We believe the analysis reported here to be the first systematic attempt to evaluate the potential of savings from EES&L for all countries and for such a large set of products. The goal of the analysis is to provide an assessment that is sufficiently well-quantified and accurate to allow comparison and integration

Generic Advantages

Indian Academy of Sciences (India)

First page Back Continue Last page Overview Graphics. Generic Advantages. Scalability an incremental coverage. Standardization. Business Plan Flexibility. Lifecycle Flexibility. Reliability. Service Interoperability. Changed Industry dynamics.

Phytosanitary irradiation of fresh tropical commodities in Hawaii: Generic treatments, commercial adoption, and current issues

International Nuclear Information System (INIS)

Follett, Peter A.; Weinert, Eric D.

2012-01-01

Hawaii is a pioneer in the use of phytosanitary irradiation. The commercial X-ray irradiation facility, Hawaii Pride LLC, has been shipping papaya and other tropical fruits and vegetables to the United States mainland using irradiation for 11 years. Irradiation is an approved treatment to control quarantine pests in 17 fruits and 7 vegetables for export from Hawaii to the US mainland. Hawaiian purple sweet potato is the highest volume product with annual exports of more than 12 million lbs (5500 t). The advent of generic radiation treatments for tephritid fruit flies (150 Gy) and other insects (400 Gy) will accelerate commodity export approvals and facilitate worldwide adoption. Lowering doses for specific pests and commodities can lower treatment costs and increase capacity owing to shorter treatment times, and will minimize any quality problems. Current impediments to wider adoption include the 1 kGy limit for fresh horticultural products, the labeling requirement, and non-acceptance of phytosanitary irradiation in Japan, the European Union, and elsewhere. Irradiation has potential as a treatment for unregulated imports to prevent new pest incursions. - Highlights: ► Irradiation is used to control quarantine insects in exported fresh commodities. ► Hawaii exported 5.7 t of tropical produce using irradiation in 2010. ► Generic radiation treatments will accelerate commodity export approvals. ► Lowering the dose for specific commodities will reduce costs/maintain quality. ► Current issues include the 1 kGy dose limit and labeling requirements.

Developing a policy game intervention to enhance collaboration in public health policymaking in three European countries

DEFF Research Database (Denmark)

Spitters, H P E M; van Oers, J A M; Sandu, P

2017-01-01

the design and development of the generic frame of the In2Action game focusing on enhancing collaboration in local public health policymaking networks. By keeping the game generic, it became suitable for each of the three country cases with only minor changes. The generic frame of the game is expected......BACKGROUND: One of the key elements to enhance the uptake of evidence in public health policies is stimulating cross-sector collaboration. An intervention stimulating collaboration is a policy game. The aim of this study was to describe the design and methods of the development process......: In2Action was developed as a role-play game of one day, with main focus to develop in collaboration a cross-sector implementation plan based on the approved strategic local public health policy. CONCLUSIONS: This study introduced an innovative intervention for public health policymaking. It described...

Disclaimer labels on fashion magazine advertisements: effects on social comparison and body dissatisfaction.

Science.gov (United States)

Tiggemann, Marika; Slater, Amy; Bury, Belinda; Hawkins, Kimberley; Firth, Bonny

2013-01-01

Recent proposals across a number of Western countries have suggested that idealised media images should carry some sort of disclaimer informing readers when these images have been digitally enhanced. The present studies aimed to experimentally investigate the impact on women's body dissatisfaction of the addition of such warning labels to fashion magazine advertisements. Participants were 120 and 114 female undergraduate students in Experiment 1 and Experiment 2 respectively. In both experiments, participants viewed fashion magazine advertisements with either no warning label, a generic warning label, or a specific more detailed warning label. In neither experiment was there a significant effect of type of label. However, state appearance comparison was found to predict change in body dissatisfaction irrespective of condition. Unexpectedly, trait appearance comparison moderated the effect of label on body dissatisfaction, such that for women high on trait appearance comparison, exposure to specific warning labels actually resulted in increased body dissatisfaction. In sum, the present results showed no benefit of warning labels in ameliorating the known negative effect of viewing thin-ideal media images, and even suggested that one form of warning (specific) might be harmful for some individuals. Accordingly, it was concluded that more extensive research is required to guide the most effective use of disclaimer labels. Copyright © 2012 Elsevier Ltd. All rights reserved.

Generic penetration in the retail antidepressant market.

Science.gov (United States)

Ventimiglia, Jeffrey; Kalali, Amir H

2010-06-01

In this article, we explore the accelerated penetration of generic antidepressants in the United States market following the availability of generic citalopram and sertraline. Analysis suggests that overall, generic penetration into the antidepressant market has grown from approximately 41 percent in January 2004 to over 73 percent in January 2010. Similar trends are uncovered when branded and generic prescriptions are analyzed by specialty.

Operational policy for disposal of land-derived wastewater to the ...

African Journals Online (AJOL)

Basic Principles, providing the broad reference framework or direction of the policy • Ground Rules, providing more specific rules, derived within the broader context of the Basic Principles • Management Framework, providing a generic, structured approach within which to implement the policy. This paper is to provide an ...

Eco label and integrated product policies. Supporting companies by networking

International Nuclear Information System (INIS)

Frey, M.; Iraldo, F.

1999-01-01

In 1998 IEFE Bocconi University (Italy) carried out a project for the diffusion of the European Commission Eco label, the certification of the environmental quality of products. What clearly emerges from this experience is that some Italian SMEs, among the most innovative and market-oriented, are prone and ready to grasp the opportunities connected with the Eco label adoption. The more these enterprises are capable of starting up a network of socio-institutional actors eager to support them in promoting the environmental quality of their products, the more they succeed in exploiting the above mentioned opportunities [it

Merger mania: mergers and acquisitions in the generic drug sector from 1995 to 2016.

Science.gov (United States)

Gagnon, Marc-André; Volesky, Karena D

2017-08-22

Drug shortages and increasing generic drug prices are associated with low levels of competition. Mergers and acquisitions impact the level of competition. Record merger and acquisition activity was reported for the pharmaceutical sector in 2014/15, yet information on mergers and acquisitions in the generic drug sector are absent from the literature. This information is necessary to understand if and how such mergers and acquisitions can be a factor in drug shortages and increasing prices. Data on completed merger and acquisition deals that had a generic drug company being taken over (i.e. 'target') were extracted from Bloomberg Finance L.P. The number and announced value of deals are presented globally, for the United States, and globally excluding the United States annually from 1995 to 2016 in United States dollars. Generic drug companies comprised 9.3% of the value of all deals with pharmaceutical targets occurring from 1995 to 2016. Globally, in 1995 there were no deals, in 2014 there were 22 deals worth $1.86 billion, in 2015 there were 34 deals totalling $33.56 billion, and in 2016 there were 42 deals worth in excess of $44 billion. This substantial increase was partially attributed to Teva's 2016 acquisition of Allergan's generic drug business. The surge in mergers and acquisitions for 2015/16 was driven by deals in the United States, where they represented 89.7% of the dollar value of deals in those years. The recent blitz in mergers and acquisitions signals that the generic drug industry is undergoing a transformation, especially in the United States. This restructuring can negatively affect the level of competition that might impact prices and shortages for some products, emphasizing the importance of updating regulations and procurement policies.

Potential Effect of Physical Activity Calorie Equivalent (PACE) Labeling on Adult Fast Food Ordering and Exercise.

Science.gov (United States)

Antonelli, Ray; Viera, Anthony J

2015-01-01

Numeric calorie content labels show limited efficacy in reducing the number of calories ordered from fast food meals. Physical activity calorie equivalent (PACE) labels are an alternative that may reduce the number of calories ordered in fast food meals while encouraging patrons to exercise. A total of 1000 adults from 47 US states were randomly assigned via internet survey to one of four generic fast food menus: no label, calories only, calories + minutes, or calories + miles necessary to walk to burn off the calories. After completing hypothetical orders participants were asked to rate the likelihood of calorie-only and PACE labels to influence (1) food choice and (2) physical activity. Respondents (n = 823) ordered a median of 1580 calories from the no-label menu, 1200 from the calories-only menu, 1140 from the calories + minutes menu, and 1210 from the calories + miles menu (p = 0.0001). 40% of respondents reported that PACE labels were "very likely" to influence food item choice vs. 28% for calorie-only labels (pcalorie-only labels (pcalories ordered in fast food meals and may have the added benefit of encouraging exercise.

Developing a policy game intervention to enhance collaboration in public health policymaking in three European countries.

Science.gov (United States)

Spitters, H P E M; van Oers, J A M; Sandu, P; Lau, C J; Quanjel, M; Dulf, D; Chereches, R; van de Goor, L A M

2017-12-19

One of the key elements to enhance the uptake of evidence in public health policies is stimulating cross-sector collaboration. An intervention stimulating collaboration is a policy game. The aim of this study was to describe the design and methods of the development process of the policy game ‘In2Action’ within a real-life setting of public health policymaking networks in the Netherlands, Denmark and Romania. The development of the policy game intervention consisted of three phases, pre intervention, designing the game intervention and tailoring the intervention. In2Action was developed as a role-play game of one day, with main focus to develop in collaboration a cross-sector implementation plan based on the approved strategic local public health policy. This study introduced an innovative intervention for public health policymaking. It described the design and development of the generic frame of the In2Action game focusing on enhancing collaboration in local public health policymaking networks. By keeping the game generic, it became suitable for each of the three country cases with only minor changes. The generic frame of the game is expected to be generalizable for other European countries to stimulate interaction and collaboration in the policy process.

9 CFR 317.17 - Interpretation and statement of labeling policy for cured products; special labeling requirements...

Science.gov (United States)

2010-01-01

... AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION AND VOLUNTARY... with another substance to cure a product must be identified in the ingredients statement on the label...

Exploring knowledge, perceptions and attitudes about generic ...

African Journals Online (AJOL)

Exploring knowledge, perceptions and attitudes about generic medicines among final-year health science students. ... had knowledge deficits about the safety, quality and efficacy of generic medicines. The dissemination of information about generic medicines may strengthen future knowledge, attitudes and perceptions.

Generic medicines: Perceptions of Physicians in Basrah, Iraq

Directory of Open Access Journals (Sweden)

Adheed Khalid Sharrad

2009-08-01

Full Text Available BackgroundThe use of cheaper generic medicines is a strategy promotedin many countries to reduce rising health care costs. The aimof this study was to explore factors affecting generic medicineprescribing by physicians in Basrah, Iraq.MethodologyA purposive sample of ten physicians practicing in Basrahwas interviewed using a semi-structured interview guide.ResultsAnalysis of the interviews identified seven major themes:medicine prescribing practice, knowledge of therapeuticequivalency of generic medicine, patients’ acceptance ofgeneric medicine, counterfeit medicine, drug informationsource and effect of drug advertising on medicines choice,brand substitution practice by community pharmacists, and,finally strategies to improve generic medicine usefulness.Participants identified helpful strategies to increase genericprescribing including; physician and patient education ongeneric medicine; persuading physicians about the safety andefficacy of generic medicines; and finally educating seniormedical students on generic prescribing.ConclusionThe data suggest that participants were enthusiasticabout prescribing generic medicines. However physiciansinsist that pharmacists should not be allowed tosubstitute generic drugs without prior approval ofdoctors.

Comparing approaches to generic programming in Haskell

NARCIS (Netherlands)

Hinze, R.; Jeuring, J.T.; Löh, A.

2006-01-01

The last decade has seen a number of approaches to generic programming: PolyP, Functorial ML, `Scrap Your Boilerplate', Generic Haskell, `Generics for the Masses', etc. The approaches vary in sophistication and target audience: some propose full-blown pro- gramming languages, some suggest

Immunoliposome-PCR: a generic ultrasensitive quantitative antigen detection system

Directory of Open Access Journals (Sweden)

He Junkun

2012-06-01

encapsulate multiple reporters per liposome also helps overcome the effect of polymerase inhibitors present in biological specimens. Finally, the biotin-labeled liposome detection reagent can be coupled through a NeutrAvidin bridge to a multitude of biotin-labeled probes, making ILPCR a highly generic assay system.

Generic Switching and Non-Persistence among Medicine Users

DEFF Research Database (Denmark)

Østergaard Rathe, Jette; Andersen, Morten; Jarbøl, Dorte Ejg

2015-01-01

BACKGROUND: Generic substitution means that one medicinal product is replaced by another product containing the same active substance. It is strictly regulated with respect to its bioequivalence, and all products must have undergone appropriate studies. Although generic substitution is widely...... implemented, it still remains to be answered how generic switch influences persistence to long-term treatment, and if it is modified by patients' concerns about medicine and views on generic medicine. This study focuses on users of antidepressants and antiepileptics, and their experience of generic switching....... METHODS: The study was an observational cohort study. By use of a prescription database, we identified patients who had redeemed prescriptions on generically substitutable drugs, and a questionnaire was mailed to them. We analyzed predictors of discontinuation in relation to generic switch and patients...

Outstanding Questions In First Amendment Law Related To Food Labeling Disclosure Requirements For Health.

Science.gov (United States)

Pomeranz, Jennifer L

2015-11-01

The federal and state governments are increasingly focusing on food labeling as a method to support good health. Many such laws are opposed by the food industry and may be challenged in court, raising the question of what is legally feasible. This article analyzes outstanding questions in First Amendment law related to commercial disclosure requirements and conducts legal analysis and policy evaluation for three current policies. These include the Food and Drug Administration's draft regulation requiring an added sugar disclosure on the Nutrition Facts panel, California's proposed sugar-sweetened beverage safety warning label bill, and Vermont's law requiring labels of genetically engineered food to disclose this information. I recommend several methods for policy makers to enact food labeling laws within First Amendment parameters, including imposing factual commercial disclosure requirements, disclosing the government entity issuing a warning, collecting evidence, and identifying legitimate governmental interests. Project HOPE—The People-to-People Health Foundation, Inc.

Article choice in plural generics

NARCIS (Netherlands)

Farkas, D.F.; Swart, Henriëtte de

2007-01-01

We discuss two groups of languages where article use contrasts in generic plural sentences but is otherwise essentially similar. The languages in the first group (English and Dutch) use bare plurals in the expression of kind reference (‘Dinosaurs are extinct’) and in generic

40 CFR 721.9973 - Zirconium dichlorides (generic).

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Zirconium dichlorides (generic). 721... Substances § 721.9973 Zirconium dichlorides (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as zirconium dichlorides (PMNs P...

Comparing approaches to generic programming in Haskell

NARCIS (Netherlands)

Hinze, R.; Jeuring, J.T.; Löh, A.

2006-01-01

The last decade has seen a number of approaches to data- type-generic programming: PolyP, Functorial ML, `Scrap Your Boiler- plate', Generic Haskell, `Generics for the Masses', etc. The approaches vary in sophistication and target audience: some propose full-blown pro- gramming languages, some

Patient knowledge, perceptions, and acceptance of generic medicines: a comprehensive review of the current literature

Directory of Open Access Journals (Sweden)

Alrasheedy AA

2014-04-01

such misconceptions varied from one country to another. However, in many countries, there was a meaningful percentage of patients who had negative perceptions and misconceptions about generic medicines. Moreover, such misconceptions and negative perceptions were reported as major obstacles to the use and acceptance of generic medicines among patients. Further, studies that focused on specific populations (eg, patients with epilepsy, psychosis, or renal disease reported a more negative perception and more resistance to the use of generic medicines. The type of medical condition and its level of seriousness or severity, recommendations by health care professionals, price difference (ie, cost saving, previous experience of generic medicines, and knowledge/information about generic medicines were considered to be important factors that affect a patient’s decision to use a generic medicine or a brand medicine. Conclusion: The results from this literature search show that patients and medicine consumers tend to prefer original brand medicines over generic medicines. Further, in many countries, there is still a considerable proportion of patients and consumers who lack adequate knowledge or have insufficient information about generic medicines. Thus, there is a need for educational interventions and activities to educate patients about generic medicines. It is also evident in the literature that health care professionals (physicians and pharmacists play a key role in the promotion of generic medicines and in patients’ acceptance of generic medicines and generic substitution. Hence, health care professionals need to play a more active role by educating patients and recommending generic medicines to their patients. Keywords: patients, generic substitution, perceptions, policy

40 CFR 721.9959 - Polyurethane polymer (generic).

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Polyurethane polymer (generic). 721... Substances § 721.9959 Polyurethane polymer (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a polyurethane polymer (PMN P-01...

Proceedings Workshop on Generic Programming (WGP2000)

NARCIS (Netherlands)

Jeuring, J.T.

2000-01-01

This report contains the papers selected for presentation at the 2nd Workshop on Generic Programming (WGP2000), which was held on July 6, 2000 in Ponte de Lima, Portugal. Generic programming is about making programs more adaptable by making them more general. Generic programs often embody

Skin rash during treatment with generic itraconazole.

Science.gov (United States)

De Vuono, Antonio; Palleria, Caterina; Scicchitano, Francesca; Squillace, Aida; De Sarro, Giovambattista; Gallelli, Luca

2014-04-01

Generic drugs have the same active substance, the same pharmaceutical form, the same therapeutic indications and a similar bioequivalence with the reference medicinal product (branded). Although a similar efficacy is postulated, some cases of clinical inefficacy during treatment with generic formulations have been reported. In this case, we describe a woman with onychomycosis that developed a skin rash during treatment with a generic formulation of itraconazole. Drug administration and its re-challenge confirmed the association between itraconazole and skin rash. Both Naranjo probability scale and World Health Organization causality assessment scale documented a probable association between generic-itraconazole and skin rash. The switch from generic formulation to brand one induced an improvement of symptoms. Since we are unable to evaluate the role of each excipient in the development of skin rash, we cannot rule out their involvement. However, more data are necessary to better define the similarities or differences between branded and generic formulations.

Is bioavailability altered in generic versus brand anticonvulsants?

Science.gov (United States)

Jankovic, Slobodan M; Ignjatovic Ristic, Dragana

2015-03-01

Therapeutic window of anticonvulsants is not a wide one, with phenytoin being one extreme, which can be classified as a narrow therapeutic index drug, since its ratio between the least toxic and the least effective concentration is less than twofold. In order to obtain marketing authorization, a generic anticonvulsant should demonstrate relative bioequivalence with its brand-name counterpart. However, although bioequivalent, generic anticonvulsants still do not have the same bioavailability as brand-name drugs, which may lead to larger fluctuations of steady-state plasma concentrations, and sometimes to loss of seizure control if a patient is switched from brand-name to generic or from generic to generic anticonvulsant. Generic anticonvulsants are effective, safe and affordable drugs for treatment of epilepsy, and patients could be successfully treated with them from the very beginning. It is switching from brand-name to generic anticonvulsant or from one generic anticonvulsant to another that should be avoided in clinical practice, since subtle differences in bioavailability may disturb optimal degree of seizure control to which the patient was previously successfully titrated.

Improving the energy labelling scheme

DEFF Research Database (Denmark)

Gram-Hanssen, Kirsten; Christensen, Toke Haunstrup

This report summarises the main results of an EU project on consumer response to energy labels in buildings. This report is mainly directed at Danish policy makers. The main focus is therefore on results that are relevant from a Danish point of view and on how they can be used to further strengthen...

A survey exploring knowledge and perceptions of general practitioners towards the use of generic medicines in the northern state of Malaysia.

Science.gov (United States)

Chua, Gin Nie; Hassali, Mohamed Azmi; Shafie, Asrul Akmal; Awaisu, Ahmed

2010-05-01

The objective of this study was to evaluate the general practitioners' (GPs') knowledge and perceptions towards generic medicines in a northern state of Malaysia. A postal cross-sectional survey involving registered GPs in Penang, Malaysia was undertaken. A 23-item questionnaire was developed, validated and administered on the GPs. Eighty-seven GPs responded to the survey (response rate 26.8%). The majority of the respondents (85.1%) claimed that they actively prescribed generic medicines in their practice. On the other hand, only 4.6% of the respondents correctly identified the Malaysia's National Pharmaceutical Control Bureau's bioequivalence standard for generic products. There were misconceptions among the respondents about the concepts of "bioequivalence", "efficacy", "safety", and "manufacturing standards" of generic medicines. GPs in this survey believed that a standard guideline on brand substitution process, collaboration with pharmacists, patient education and information on safety and efficacy of generic medicines were necessary to ensure quality use of generics. Furthermore, advertisements and product bonuses offered by pharmaceutical companies, patient's socio-economic factors as well as credibility of manufacturers were factors reported to influence their choice of medicine. Although it appeared that GPs have largely accepted the use of generic medicines, they still have concerns regarding the reliability and quality of such products. GPs need to be educated and reassured about generic products approval system in Malaysia concerning bioequivalence, quality, and safety. The current findings have important implications in establishing generic medicines policy in Malaysia. Copyright (c) 2009 Elsevier Ireland Ltd. All rights reserved.

A multicenter experience with generic tacrolimus conversion.

Science.gov (United States)

McDevitt-Potter, Lisa M; Sadaka, Basma; Tichy, Eric M; Rogers, Christin C; Gabardi, Steven

2011-09-27

The first generic tacrolimus product gained Food and Drug Administration approval in August 2009. This prospective, observational trial sought to determine the need for dose titrations and measure drug cost savings on conversion to generic tacrolimus. Transplant recipients on stable tacrolimus doses were converted from brand to generic tacrolimus on a mg:mg basis. Data were collected at the time of generic conversion (study arm) and at a time point exactly 6 months before conversion (control arm) for all subjects. Seventy conversions from four centers are reported. Subjects were a mean of 70 months after kidney (n=37), liver (n=28), or multiorgan (n=5) transplant. In the study arm, mean tacrolimus doses were 4.4 and 4.5 mg/d and mean tacrolimus trough concentrations were 5.8 and 5.9 ng/mL before and after conversion, respectively. In the control arm, mean tacrolimus doses were 4.6 and 4.6 mg/d and mean tacrolimus trough concentrations were 6.1 and 5.9 ng/mL before and after the control time point, respectively. Dose titrations occurred in five patients (7%) in the control arm and 15 patients (21%) in the study arm (P=0.028). Mean monthly drug costs were $645 for brand, $593 for generic, and $595 for generic after dose titrations. Mean monthly patient copays were $38 for brand and $15 for generic. These cumulative data show that dose requirements and trough levels are similar between brand and generic tacrolimus and that generic substitution allows for savings. However, postconversion monitoring is prudent as patients may require dose titration.

Brand loyalty, patients and limited generic medicines uptake.

Science.gov (United States)

Costa-Font, Joan; Rudisill, Caroline; Tan, Stefanie

2014-06-01

The sluggish development of European generic drug markets depends heavily on demand side factors, and more specifically, patients' and doctors' loyalty to branded products. Loyalty to originator drugs, to the point where originator prices rise upon generic entry has been described as the 'generics paradox'. Originator loyalty can emerge for a plethora of reasons; including costs, perceptions about quality and physician advice. We know very little about the behavioural underpinnings of brand loyalty from the consumer or patient standpoint. This paper attempts to test the extent to which patients are brand loyal by drawing upon Spain's 2002 Health Barometer survey as it includes questions about consumer acceptance of generics in a country with exceptionally low generic uptake and substitution at the time of the study. Our findings suggest that at least 13% of the population would not accept generics as substitutes to the originator. These results confirm evidence of brand loyalty for a minority. Alongside high levels of awareness of generics, we find that low cost-sharing levels explain consumer brand loyalty but their impact on acceptance of generic substitution is very small. Higher cost-sharing and exempting fewer patients from cost-sharing have the potential to encourage generic acceptance. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Generic domain models in software engineering

Science.gov (United States)

Maiden, Neil

1992-01-01

This paper outlines three research directions related to domain-specific software development: (1) reuse of generic models for domain-specific software development; (2) empirical evidence to determine these generic models, namely elicitation of mental knowledge schema possessed by expert software developers; and (3) exploitation of generic domain models to assist modelling of specific applications. It focuses on knowledge acquisition for domain-specific software development, with emphasis on tool support for the most important phases of software development.

76 FR 54507 - Proposed Generic Communication; Draft NRC Generic Letter 2011-XX: Seismic Risk Evaluations for...

Science.gov (United States)

2011-09-01

... NUCLEAR REGULATORY COMMISSION [NRC-2011-0204] Proposed Generic Communication; Draft NRC Generic... functions. SSCs in operating nuclear power plants are designed either in accordance with, or have been... nuclear reactors. The background information relevant to this GL includes the individual plant...

Practicing the Generic (City)

DEFF Research Database (Denmark)

Hansen, Lone Koefoed

2010-01-01

Flanagan proposes that most locative media artworks neglect the particularities of spaces, their historical and political layers. Koolhaas, on the other hand, states that all urban areas are alike, that we are facing a global Generic City. The paper analyses digital media artist Esther Polak......’s NomadicMILK project in light of the generic and particular properties of space as laid out by Flanagan and Koolhaas in order to discuss the possible reconfiguring practices of locative media....

Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study

Science.gov (United States)

Sarpatwari, Ameet; Dejene, Sara; Khan, Nazleen F; Lii, Joyce; Rogers, James R; Dutcher, Sarah K; Raofi, Saeid; Bohn, Justin; Connolly, John; Fischer, Michael A; Kesselheim, Aaron S; Gagne, Joshua J

2018-01-01

Abstract Objectives To compare rates of switchbacks to branded drug products for patients switched from branded to authorized generic drug products, which have the same active ingredients, appearance, and excipients as the branded product, with patients switched from branded to generic drug products, which have the same active ingredients as the branded product but may differ in appearance and excipients. Design Observational cohort study. Setting Private (a large commercial health plan) and public (Medicaid) insurance programs in the US. Participants Beneficiaries of a large US commercial health insurer between 2004 and 2013 (primary cohort) and Medicaid beneficiaries between 2000 and 2010 (replication cohort). Main outcome measures Patients taking branded products for one of the study drugs (alendronate tablets, amlodipine tablets, amlodipine-benazepril capsules, calcitonin salmon nasal spray, escitalopram tablets, glipizide extended release tablets, quinapril tablets, and sertraline tablets) were identified when they switched to an authorized generic or a generic drug product after the date of market entry of generic drug products. These patients were followed for switchbacks to the branded drug product in the year after their switch to an authorized generic or a generic drug product. Cox proportional hazard models were used to estimate hazard ratios and 95% confidence intervals after adjusting for demographics, including age, sex, and calendar year. Inverse variance meta-analysis was used to pool adjusted hazard ratios across all drug products. Results A total of 94 909 patients switched from branded to authorized generic drug products and 116 017 patients switched from branded to generic drug products and contributed to the switchback analysis. Unadjusted incidence rates of switchback varied across drug products, ranging from a low of 3.8 per 100 person years (for alendronate tablets) to a high of 17.8 per 100 person years (for amlodipine

Brand and generic medications: Are they interchangeable

International Nuclear Information System (INIS)

Al-Jazairi, Abdulrazak S.; Blhareth, S.; Eqtefan, Iyad S.; Al-Suwayeh, Saleh A.

2008-01-01

Generic substitution has become a common practice since the late 1970s in the United States. At that time, many of these generics caused bioavailability problems, which fueled suspicions about their efficacy and safety and the Food and Drug Administration (FDA) standards for bioequivalence. In Saudi Arabia, the increasing number of local products raised several concerns with regard to switching from brands to generics. Our objective was to review and examine the basis of the controversy surrounding brand and generic interchangeability and to explore a practical approach in pursuing a switch. Articles indexed initially under terms such as generic medications, generic substitution, bioequivalence and bioinequivalence were identified. These terms were used to search the indexing service, MEDLINE (1966-2006). References from the extracted articles and additional data sources, including the Code of Federal Regulations and Regulatory Guidelines from the FDA Center for Drug Evaluation and research were also reviewed. Foe most drugs, bioequivalence testing generally should enable clinicians to routinely substitute generic for innovator products. However, for narrow therapeutic, critical dose drugs, or for highly variable drugs, safe switching between products can not be assured. These drugs need special precautions and blood level monitoring upon switching. FDA firmly believes that approved generic and brand drugs can be dispensed with the full expectation that the consumer will receive the same clinical benefit. Performing the switch process is an advisable practice to reduce health care costs in countries with strong post-marketing surveillance program, but caution is to be exercised when narrow therapeutic index drugs or highly variable drugs are prescribed. (author)

The Market Dynamics of Generic Medicines in the Private Sector of 19 Low and Middle Income Countries between 2001 and 2011: A Descriptive Time Series Analysis

Science.gov (United States)

Kaplan, Warren A.; Wirtz, Veronika J.; Stephens, Peter

2013-01-01

This observational study investigates the private sector, retail pharmaceutical market of 19 low and middle income countries (LMICs) in Latin America, Asia and the Middle East/South Africa analyzing the relationships between volume market share of generic and originator medicines over a time series from 2001 to 2011. Over 5000 individual pharmaceutical substances were divided into generic (unbranded generic, branded generic medicines) and originator categories for each country, including the United States as a comparator. In 9 selected LMICs, the market share of those originator substances with the largest decrease over time was compared to the market share of their counterpart generic versions. Generic medicines (branded generic plus unbranded generic) represent between 70 and 80% of market share in the private sector of these LMICs which exceeds that of most European countries. Branded generic medicine market share is higher than that of unbranded generics in all three regions and this is in contrast to the U.S. Although switching from an originator to its generic counterpart can save money, this narrative in reality is complex at the level of individual medicines. In some countries, the market behavior of some originator medicines that showed the most temporal decrease, showed switching to their generic counterpart. In other countries such as in the Middle East/South Africa and Asia, the loss of these originators was not accompanied by any change at all in market share of the equivalent generic version. For those countries with a significant increase in generic medicines market share and/or with evidence of comprehensive “switching” to generic versions, notably in Latin America, it would be worthwhile to establish cause-effect relationships between pharmaceutical policies and uptake of generic medicines. The absence of change in the generic medicines market share in other countries suggests that, at a minimum, generic medicines have not been strongly

The market dynamics of generic medicines in the private sector of 19 low and middle income countries between 2001 and 2011: a descriptive time series analysis.

Science.gov (United States)

Kaplan, Warren A; Wirtz, Veronika J; Stephens, Peter

2013-01-01

This observational study investigates the private sector, retail pharmaceutical market of 19 low and middle income countries (LMICs) in Latin America, Asia and the Middle East/South Africa analyzing the relationships between volume market share of generic and originator medicines over a time series from 2001 to 2011. Over 5000 individual pharmaceutical substances were divided into generic (unbranded generic, branded generic medicines) and originator categories for each country, including the United States as a comparator. In 9 selected LMICs, the market share of those originator substances with the largest decrease over time was compared to the market share of their counterpart generic versions. Generic medicines (branded generic plus unbranded generic) represent between 70 and 80% of market share in the private sector of these LMICs which exceeds that of most European countries. Branded generic medicine market share is higher than that of unbranded generics in all three regions and this is in contrast to the U.S. Although switching from an originator to its generic counterpart can save money, this narrative in reality is complex at the level of individual medicines. In some countries, the market behavior of some originator medicines that showed the most temporal decrease, showed switching to their generic counterpart. In other countries such as in the Middle East/South Africa and Asia, the loss of these originators was not accompanied by any change at all in market share of the equivalent generic version. For those countries with a significant increase in generic medicines market share and/or with evidence of comprehensive "switching" to generic versions, notably in Latin America, it would be worthwhile to establish cause-effect relationships between pharmaceutical policies and uptake of generic medicines. The absence of change in the generic medicines market share in other countries suggests that, at a minimum, generic medicines have not been strongly promoted.

The market dynamics of generic medicines in the private sector of 19 low and middle income countries between 2001 and 2011: a descriptive time series analysis.

Directory of Open Access Journals (Sweden)

Warren A Kaplan

Full Text Available This observational study investigates the private sector, retail pharmaceutical market of 19 low and middle income countries (LMICs in Latin America, Asia and the Middle East/South Africa analyzing the relationships between volume market share of generic and originator medicines over a time series from 2001 to 2011. Over 5000 individual pharmaceutical substances were divided into generic (unbranded generic, branded generic medicines and originator categories for each country, including the United States as a comparator. In 9 selected LMICs, the market share of those originator substances with the largest decrease over time was compared to the market share of their counterpart generic versions. Generic medicines (branded generic plus unbranded generic represent between 70 and 80% of market share in the private sector of these LMICs which exceeds that of most European countries. Branded generic medicine market share is higher than that of unbranded generics in all three regions and this is in contrast to the U.S. Although switching from an originator to its generic counterpart can save money, this narrative in reality is complex at the level of individual medicines. In some countries, the market behavior of some originator medicines that showed the most temporal decrease, showed switching to their generic counterpart. In other countries such as in the Middle East/South Africa and Asia, the loss of these originators was not accompanied by any change at all in market share of the equivalent generic version. For those countries with a significant increase in generic medicines market share and/or with evidence of comprehensive "switching" to generic versions, notably in Latin America, it would be worthwhile to establish cause-effect relationships between pharmaceutical policies and uptake of generic medicines. The absence of change in the generic medicines market share in other countries suggests that, at a minimum, generic medicines have not been

Food labels promote healthy choices by a decision bias in the amygdala.

Science.gov (United States)

Grabenhorst, Fabian; Schulte, Frank P; Maderwald, Stefan; Brand, Matthias

2013-07-01

Food labeling is the major health policy strategy to counter rising obesity rates. Based on traditional economic theory, such strategies assume that detailed nutritional information will necessarily help individuals make better, healthier choices. However, in contrast to the well-known utility of labels in food marketing, evidence for the efficacy of nutritional labeling is mixed. Psychological and behavioral economic theories suggest that successful marketing strategies activate automatic decision biases and emotions, which involve implicit emotional brain systems. Accordingly, simple, intuitive food labels that engage these neural systems could represent a promising approach for promoting healthier choices. Here we used functional MRI to investigate this possibility. Healthy, mildly hungry subjects performed a food evaluation task and a food choice task. The main experimental manipulation was to pair identical foods with simple labels that emphasized either taste benefits or health-related food properties. We found that such labels biased food evaluations in the amygdala, a core emotional brain system. When labels biased the amygdala's evaluations towards health-related food properties, the strength of this bias predicted behavioral shifts towards healthier choices. At the time of decision-making, amygdala activity encoded key decision variables, potentially reflecting active amygdala participation in food choice. Our findings underscore the potential utility of food labeling in health policy and indicate a principal role for emotional brain systems when labels guide food choices. Copyright © 2013 Elsevier Inc. All rights reserved.

Contact Geometry of Hyperbolic Equations of Generic Type

Directory of Open Access Journals (Sweden)

Dennis The

2008-08-01

Full Text Available We study the contact geometry of scalar second order hyperbolic equations in the plane of generic type. Following a derivation of parametrized contact-invariants to distinguish Monge-Ampère (class 6-6, Goursat (class 6-7 and generic (class 7-7 hyperbolic equations, we use Cartan's equivalence method to study the generic case. An intriguing feature of this class of equations is that every generic hyperbolic equation admits at most a nine-dimensional contact symmetry algebra. The nine-dimensional bound is sharp: normal forms for the contact-equivalence classes of these maximally symmetric generic hyperbolic equations are derived and explicit symmetry algebras are presented. Moreover, these maximally symmetric equations are Darboux integrable. An enumeration of several submaximally symmetric (eight and seven-dimensional generic hyperbolic structures is also given.

Best Practice in Policy Package Design

DEFF Research Database (Denmark)

Kessler, Florian; Vesela, Jirina; Vencl, Vaclav

2010-01-01

This deliverable focuses on the identification and analysis of best practice examples of policy package design. For this purpose a methodology is developed that allows the systematic analysis of both national and EU policy packages. Eight packages were selected and analysed, highlighting...... the factors which supported the design and implementation process in each case. The results of the analysis show which factors led to these cases to be considered best practice. In addition, factors are identified which are not yet part of the generic policy packaging framework presented in earlier OPTIC...... Deliverables. The consideration of these factors will help to further improve the framework in the subsequent work packages....

Generic penetration in the retail atypical antipsychotic market.

Science.gov (United States)

Lenderts, Susan; Kalali, Amir H; Buckley, Peter

2010-03-01

In this article, we explore the penetration of generic atypical antipsychotics in the United States market before and after the availability of generic risperidone in July 2008. Analysis suggests that, overall, generic penetration into the atypical antipsychotic market has grown from approximately three percent in January 2008 to more than 25 percent in December 2009. Similar trends are uncovered when branded and generic prescriptions are analyzed by specialty.

Relative bioavailability of generic and branded acetylcysteine effervescent tablets: A single-dose, open-label, randomized-sequence, two-period crossover study in fasting healthy Chinese male volunteers.

Science.gov (United States)

Liu, Yan-Mei; Liu, Yun; Lu, Chuan; Jia, Jing-Ying; Liu, Gang-Yi; Weng, Li-Ping; Wang, Jia-Yan; Li, Guo-Xiu; Wang, Wei; Li, Shui-Jun; Yu, Chen

2010-11-01

Acetylcysteine may be used as a muco- lytic agent for the treatment of chronic bronchitis, chronic obstructive pulmonary disease, and other pulmonary diseases complicated by the production of viscous mucus. However, little is known of its pharmacokinetic properties when given orally in healthy volunteers, particularly in a Chinese Han population. This study was conducted to provide support for the marketing of a generic product in China. The purpose of this study was to compare the pharmacokinetics and relative bioavailability of a generic test formulation and a branded reference formulation of acetylcysteine in fasting healthy Chinese male volunteers. A single-dose, open-label, randomized-sequence, 2-period crossover design with a 7-day washout period between doses was used in this study. Healthy Chinese male nonsmokers aged 18 to 40 years with a body mass index (BMI) of 19 to 25 kg/m(2) were selected. Eligible volunteers were randomly assigned to receive acetylcysteine 600 mg PO as either the test formulation (3 tablets of 200 mg each) or reference formulation (1 tablet of 600 mg) under fasting conditions. A total of 15 serial blood samples were collected over a 24-hour interval, and total plasma acetylcysteine concentrations were analyzed by a validated liquid chromatography-isotopic dilution mass spectrometry method. Pharmacokinetic parameters (C(max), T(max), t(½) AUC(0-t), and AUC(0-∞) were calculated and analyzed statistically. The 2 formulations were considered bioequivalent if the 90% CIs of the log-transformed ratios (test/reference) of C(max) and AUC were within the predetermined bioequivalence ranges (70%-143% for C(max); 80%-125% for AUC), as established by the State Food and Drug Administration of China. Tolerability was determined by vital signs, clinical laboratory tests, 12-lead ECGs, physical examinations, and interviews with the subjects about adverse events (AEs). A total of 24 healthy Chinese Han male volunteers were enrolled in and

Reagan outlines nonproliferation policy

International Nuclear Information System (INIS)

Walsh, J.

1981-01-01

The Reagan Administration wants to shift from efforts to impose direct control over the fuel cycle and nuclear technology to a framework based on cooperation and initiatives for greater political stability. A nuclear-free zone for the Middle East is one area to explore. Congress responded to this announced plan with a counter move to tighten non-proliferation strategies. Reagan's policy will be to restore the US as an aggressive, but reliable nuclear trading partner operating under adequate safeguards. Critics find this approach dangerous and contradictory. The policy is still too general to answer specific questions about bilateral arrangements, generic permits, plutonium recycling, and other matters

The impact of South Korea's new drug-pricing policy on market competition among off-patent drugs.

Science.gov (United States)

Kwon, Hye-Young; Kim, Hyungmin; Godman, Brian; Reich, Michael R

2015-01-01

A new pricing policy was introduced in Korea in April 2012 with the aim of strengthening competition among off-patent drugs by eliminating price gaps between originators and generics. Examine the effect of newly implemented pricing policy. Retrospectively examining the effects through extracting from the National Health Insurance claims data a 30-month panel dataset (January 2011-June 2013) containing consumption data in four major therapeutic classes (antihypertensives, lipid-lowering drugs, antiulcerants and antidepressants). Proxies for market competition were examined before and after the policy. The new pricing policy did not enhance competition among off-patent drugs. In fact, price dispersion significantly decreased as opposed to the expected change. Originator-to-generic utilization increased 6.12 times (p = 0.000) after the new policy. The new pricing policy made no impact on competition among off-patent drugs. Competition in the off-patent market cannot be enhanced unless both supply and demand side measures are coordinated.

40 CFR 721.2083 - Polysubstituted carbomonocyclic hydroxylamine (generic).

Science.gov (United States)

2010-07-01

... hydroxylamine (generic). 721.2083 Section 721.2083 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Specific Chemical Substances § 721.2083 Polysubstituted carbomonocyclic hydroxylamine (generic). (a... generically as a polysubstituted carbomonocyclic hydroxylamine (PMN P-97-878) is subject to reporting under...

Sharing, samples, and generics: an antitrust framework.

Science.gov (United States)

Carrier, Michael A

Rising drug prices are in the news. By increasing price, drug companies have placed vital, even life-saving, medicines out of the reach of consumers. In a recent development, brand firms have prevented generics even from entering the market. The ruse for this strategy involves risk-management programs known as Risk Evaluation and Mitigation Strategies ("REMS"). Pursuant to legislation enacted in 2007, the FDA requires REMS when a drug's risks (such as death or injury) outweigh its rewards. Brands have used this regime, intended to bring drugs to the market, to block generic competition. Regulations such as the federal Hatch-Waxman Act and state substitution laws foster widespread generic competition. But these regimes can only be effectuated through generic entry. And that entry can take place only if a generic can use a brand's sample to show that its product is equivalent. More than 100 generic firms have complained that they have not been able to access needed samples. One study of 40 drugs subject to restricted access programs found that generics' inability to enter cost more than $5 billion a year. Brand firms have contended that antitrust law does not compel them to deal with their competitors and have highlighted concerns related to safety and product liability in justifying their refusals. This Article rebuts these claims. It highlights the importance of samples in the regulatory regime and the FDA's inability to address the issue. It shows how a sharing requirement in this setting is consistent with Supreme Court caselaw. And it demonstrates that the brands' behavior fails the defendant-friendly "no economic sense" test because the conduct literally makes no sense other than by harming generics. Brands' denial of samples offers a textbook case of monopolization. In the universe of pharmaceutical antitrust behavior, other conduct--such as "pay for delay" settlements between brands and generics and "product hopping" from one drug to a slightly modified

Standards for labelling and storage of anaesthetic medications--an audit.

Science.gov (United States)

Imran, Muhammad; Khan, Fauzia Anis; Abbasi, Shemila

2009-12-01

To check compliance of anaesthetist to current policies set for the use of medication within operation room and for induction room floor stock. The initial audit was conducted from 1st October to 31st November 2006 and reaudit after dissemination and sharing of results within the department repeated in July-August 2007. In each audit four operating rooms were visited twice a week. Syringes were checked for standard drug labelling for narcotic and non narcotic preparations. Drug trolley was checked for any expired drugs and whether the trolley was locked in case of operating room (OR) where list was ended or was on hold. Any unattended drug was noted and Induction room was checked twice weekly for accurate drug inventory and for standard drug storage recommendations. Labels were according to standard in non narcotic drugs on 25% syringes in first audit and 63% in second audit, likewise, narcotics labels were according to standards in 41% in first and 57% in second audit. Unattended drugs were present once in first and twice in second audit. There was 100% compliance in other drug storage policy parameters in both audits. Poor compliance of drug labelling standards for both narcotic and non narcotic drugs was present. However, second audit revealed improvement in all areas of drug handling. Dissemination of policies and reminders are important for continuing improvement in use of medication within operation room and within induction room floor stock.

Associations between generic substitution and patients' attitudes, beliefs and experience

DEFF Research Database (Denmark)

Østergaard Rathe, Jette; Larsen, Pia Veldt; Andersen, Morten

2013-01-01

Abstract Background Generic substitution has been implemented in many countries, but knowledge about patients’ attitudes, beliefs and experiences is still sparse. Aim To assess associations between generic switching and patients’ attitudes, beliefs and experiences with previous generic switching...... on generic medicine and confidence in the healthcare system. Only prescriptions issued by the general practitioners were included. For each patient we focused on one purchase of a generically substitutable drug (index drug). Patients were identified by means of a dispensing database. Results Earlier generic...... switches within the index ATC code were statistically significantly associated with experience of a generic switch (adjusted OR 5.93 95% CI 4.70; 7.49). Having had more than 5 earlier switches within other ATC codes and having negative views on generic medicines reduced the odds of experiencing a generic...

Supporting Healthier Food Policies in Southeast Asia | CRDI ...

International Development Research Centre (IDRC) Digital Library (Canada)

INFORMAS has developed research modules to investigate food environments, including aspects such as food composition, labelling, diets, and policies. Researchers will adapt two research modules on public and private sector policies to understand how policies can influence change. They will review public and private ...

Generics, Supergenerics and Patent Strategies--SMi's 13th Annual Meeting.

Science.gov (United States)

Edwards, Catherine

2010-07-01

SMi's 13th Annual Meeting on Generics, Supergenerics and Patent Strategies, held in London, included topics covering new trends in the generics field, the difficulties faced by companies in entering the generics market and recent developments in IP. This conference report highlights selected presentations on generics in India, protecting pharmaceutical products in China, changes in generics law and litigation in the US and Europe, challenges for market selection and entry for generics companies, the influence of changes in the healthcare market on the generics industry, supergenerics, and biosimilars.

PROBLEM OF GENERIC REPLACEMENT: ADVANTAGES AND DISADVANTAGES

Directory of Open Access Journals (Sweden)

S. N. Tolpygina

2009-01-01

Full Text Available The main differences between original and generic drugs as well as registration criteria for generics are described. Possible reasons of discrepancy in bioequivalence and therapeutic equivalence of original and generic drugs are reviewed. The examples of such a discrepancy as a result of comparative clinical trails (enalapril maleate are discussed. Approaches to planning of comparative trails on drug therapeutic equivalence are presented. 

A generic approach to integrate biodiversity considerations in screening and scoping for EIA

International Nuclear Information System (INIS)

Slootweg, Roel; Kolhoff, Arend

2003-01-01

The Convention on Biological Diversity (CBD) requires parties to apply environmental impact assessment (EIA) to projects that potentially negatively impact on biodiversity. As members of the International Association of Impact Assessment, the authors have developed a conceptual framework to integrate biodiversity considerations in EIA. By defining biodiversity in terms of composition, structure, and key processes, and by describing the way in which human activities affect these so-called components of biodiversity, it is possible to assess the potential impacts of human activities on biodiversity. Furthermore, the authors have translated this conceptual framework in generic guidelines for screening and scoping in impact assessment. Countries can use these generic guidelines to further operationalise the framework within the existing national procedures for impact assessment. This paper is fully coherent and partly overlapping with the guidelines recently adopted by the CBD, but differs in the sense that it provides more scientific background and is less policy-oriented

A generic coordinate system and a set of generic variables for MFE database

International Nuclear Information System (INIS)

Miner, W.H. Jr.; Ross, D.W.; Solano, E.R.; Valanju, P.M.; Wiley, J.C.

1993-01-01

Over the last several years, profile data from nine different tokamaks have been stored in the magnetic fusion energy database (MFEDB). These data sets have come from a variety of sources and most are given in different coordinate systems. In order to attempt any intermachine analysis, it is convenient to transform these data sets into one generic coordinate system and to choose a uniform set of variable names. The authors describe the data sets from each tokamak indicating the source of the data and the coordinate system in which it is given. Next, they discuss the generic coordinate that has been adopted and show how it is implemented for each tokamak. Finally, the generic naming convention that has been adopted is discussed. It follows closely that which was used by Christiansen et al. for the ITER Global Energy Confinement H-Mode Database. For further clarification, they discuss the characteristics of the magnetic geometry given a Fourier representation of the magnetic equilibria

Generic Software Architecture for Launchers

Science.gov (United States)

Carre, Emilien; Gast, Philippe; Hiron, Emmanuel; Leblanc, Alain; Lesens, David; Mescam, Emmanuelle; Moro, Pierre

2015-09-01

The definition and reuse of generic software architecture for launchers is not so usual for several reasons: the number of European launcher families is very small (Ariane 5 and Vega for these last decades); the real time constraints (reactivity and determinism needs) are very hard; low levels of versatility are required (implying often an ad hoc development of the launcher mission). In comparison, satellites are often built on a generic platform made up of reusable hardware building blocks (processors, star-trackers, gyroscopes, etc.) and reusable software building blocks (middleware, TM/TC, On Board Control Procedure, etc.). If some of these reasons are still valid (e.g. the limited number of development), the increase of the available CPU power makes today an approach based on a generic time triggered middleware (ensuring the full determinism of the system) and a centralised mission and vehicle management (offering more flexibility in the design and facilitating the long term maintenance) achievable. This paper presents an example of generic software architecture which could be envisaged for future launchers, based on the previously described principles and supported by model driven engineering and automatic code generation.

40 CFR 721.324 - Alkoxylated acrylate polymer (generic).

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Alkoxylated acrylate polymer (generic... Substances § 721.324 Alkoxylated acrylate polymer (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkoxylated acrylate polymer...

Generic maintenance immunosuppression in solid organ transplant recipients.

Science.gov (United States)

Ensor, Christopher R; Trofe-Clark, Jennifer; Gabardi, Steven; McDevitt-Potter, Lisa M; Shullo, Michael A

2011-11-01

Survival after solid organ transplantation has increased in the era of tacrolimus and mycophenolate. This increased survival could be due in part to the broad clinical use of these potent and specific agents for maintenance immunosuppression. These drugs have enhanced specificity and potency for T and B lymphocytes compared with their predecessors, cyclosporine and azathioprine. Between 2008 and 2010, the United States Food and Drug Administration approved several generic formulations of both tacrolimus and mycophenolate mofetil. Deciding whether generic products can be safely substituted for the innovator product is a clinical dilemma similar to that which occurred when generic formulations of cyclosporine became available. We describe the concerns regarding generic immunosuppression use, summarize expert opinion and consensus statements in transplantation, analyze the potential impact of generic substitution, and provide estimates of populations affected based on generic drug market penetration. Formulary considerations such as cost, availability, and potential drug ordering and drug selection errors are described, and transplant coordinator and patient perspectives are reviewed. Finally, general recommendations about the use of generic maintenance immunosuppression in solid organ transplant recipients are provided. Although more research is needed to confirm clinical and therapeutic equivalence and pharmacoeconomic benefit, generic immunosuppressants can be safely substituted for innovator products as long as patients consistently receive the same product, patients and clinicians are aware of when substitutions occur, and enhanced therapeutic drug monitoring is provided during the transition.

Sodium ferric gluconate (SFG) in complex with sucrose for IV infusion: bioequivalence of a new generic product with the branded product in healthy volunteers.

Science.gov (United States)

Baribeault, David

2011-08-01

Parenteral sodium ferric gluconate in complex (Ferrlecit [branded SFG]) is used to treat patients with iron deficiency anemia undergoing chronic hemodialysis and receiving supplemental epoetin. This comparative pharmacokinetic study (GeneraMedix, Inc., Study 17909) evaluates whether the recently approved generic product Nulecit (generic SFG) and the branded product Ferrlecit (branded SFG) are bioequivalent. In this open-label study, 240 healthy volunteers in a fasting state were assigned randomly to a single 10-min intravenous (IV) infusion of 125 mg of generic or branded SFG. Total and transferrin-bound iron concentrations were determined for the 36-h period after infusion and corrected for pretreatment levels. Maximum concentration (Cmax) and area under the concentration-time curve of 0 to 36 h (AUC[0-36]) were compared between the two products. Demonstration of bioequivalence required that the 90% confidence intervals of each parameter evaluated for generic SFG were within 80% to 125% of the corresponding values for branded SFG. Uncorrected and baseline-corrected mean serum concentrations of total serum iron during the 36-h assessment period were similar for generic and branded SFG. For total serum iron, the geometric mean ratios of corrected Cmax and AUC[0-36] were 100%. For transferrin-bound iron, the geometric mean ratios were 87% for corrected Cmax and 92% for corrected AUC[0-36]. All associated 90% confidence intervals were within the range of 80% to 125%. A new generic SFG in complex for IV infusion is bioequivalent to the branded SFG in complex for IV infusion. The generic SFG is AB rated by the FDA and considered therapeutically equivalent to the branded product.

Relative bioavailability of generic and branded 250-mg and 500-mg oral chlorphenesin carbamate tablets in healthy Korean volunteers: a single-dose, randomized-sequence, open-label, two-period crossover trial.

Science.gov (United States)

Yu, Ji-young; Song, Hyun Ho; Kim, Bo Gyeom; Park, Hyeon Ju; Choi, Kwang Sik; Kwon, Young Ee

2009-11-01

Chlorphenesin carbamate is a skeletal muscle relaxant approved in Korea for use in the treatment of pain and discomfort related to skeletal muscle trauma and inflammation. The aim of this study was to assess the bioequivalence of a generic formulation of chlorphenesin carbamate at doses of 250 and 500 mg and 2 branded formulations of the same doses in healthy Korean adults. This single-dose, randomized-sequence, open-label, 2-period crossover study was conducted in healthy Korean male and female volunteers. Subjects were assigned to receive, in a randomized sequence, a single dose of the generic (test) and branded (reference) formulations of chlorphenesin carbamate at a dose of 250 or 500 mg. Blood samples were drawn at 0, 0.33, 0.67, 1, 1.5, 2, 3, 4, 6, 9, 12, and 15 hours after administration. Pharmacokinetic properties (C(max), T(max), AUC(0-t) AUC(0-infinity), t(1/2), and ke) were determined using HPLC. The formulations were to be considered bioequivalent if the 90% CIs of the treatment ratios of the geometric means of C(max) and AUC(0-t) were within a predetermined range of log 0.80 to log 1.25 based on regulatory criteria. Tolerability was assessed by monitoring for adverse events (AEs) on physical examination and/or e-mail and personal interview at the beginning and end of each study period. Twenty-eight subjects (22 men, 6 women) received chlorphenesin carbamate at the 250-mg dose, and 24 male subjects received the 500-mg dose. The mean (SD) ages of the subjects were 24.0 (2.6) and 24.0 (1.9) years in the 250- and 500-mg groups, respectively. No significant differences were found between the test and reference formulations (90% CIs: C(max), 1.0048-1.1153 with the 250-mg dose and 0.9630-1.1189 with the 500-mg dose; AUC(0-t), 0.9882-1.0546 and 0.9842-1.0578, respectively). No clinically significant AEs (upper gastric pain, abdominal bloating, pyrexia, edema, nausea, heartburn, constipation, headache, dizziness, drowsiness, or fatigue) were reported throughout

Skin rash during treatment with generic itraconazole

OpenAIRE

De Vuono, Antonio; Palleria, Caterina; Scicchitano, Francesca; Squillace, Aida; De Sarro, Giovambattista; Gallelli, Luca

2014-01-01

Generic drugs have the same active substance, the same pharmaceutical form, the same therapeutic indications and a similar bioequivalence with the reference medicinal product (branded). Although a similar efficacy is postulated, some cases of clinical inefficacy during treatment with generic formulations have been reported. In this case, we describe a woman with onychomycosis that developed a skin rash during treatment with a generic formulation of itraconazole. Drug administration and its re...

40 CFR 721.5350 - Substituted nitrile (generic name).

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Substituted nitrile (generic name... Substances § 721.5350 Substituted nitrile (generic name). (a) Chemical substances and significant new uses subject to reporting. (1) The chemical substance identified generically as a substituted nitrile (PMN P-83...

Australian Consumers' Concerns and Preferences for Food Policy Alternatives

OpenAIRE

Umberger, Wendy J.; Scott, Emily M.; Stringer, Randy

2008-01-01

Results from a 2007 Australian consumer survey conducted at a large farmers market are used to explore the hypothesis that consumers who are more concerned about certain types of food labeling information, particularly information related to food production attributes, are more likely to support policies which help develop farmers markets and support mandatory labeling policies. Product information and attributes such as Country-of-Origin, No Growth Hormones Used, Free Range and Animals Treat...

Generic Penetration of the SSRI Market.

Science.gov (United States)

Cascade, Elisa F; Kalali, Amir H

2008-04-01

In this article, we investigate the penetration of generic selective serotonin reuptake inhibitors (SSRIs) in the US market and the implications for patient out-of-pocket expense. The data suggest that generic penetration into the SSRI market has grown from approximately nine percent in 2000, the year that the patent for Prozac((R)) expired, to 72 percent in 2007. For December, 2007, the difference in patient out-of-pocket expense for branded vs. generic agents was, on average, $55.42 for patients paying by cash (i.e., they had no prescription drug insurance) and $22.39 for patients with insurance coverage.

Energy-efficiency labels and standards: A guidebook for appliances, equipment and lighting

Energy Technology Data Exchange (ETDEWEB)

McMahon, James E.; Wiel, Stephen

2001-02-16

Energy-performance improvements in consumer products are an essential element in any government's portfolio of energy-efficiency and climate change mitigation programs. Governments need to develop balanced programs, both voluntary and regulatory, that remove cost-ineffective, energy-wasting products from the marketplace and stimulate the development of cost-effective, energy-efficient technology. Energy-efficiency labels and standards for appliances, equipment, and lighting products deserve to be among the first policy tools considered by a country's energy policy makers. The U.S. Agency for International Development (USAID) and the United Nations Foundation (UNF) recognize the need to support policy makers in their efforts to implement energy-efficiency standards and labeling programs and have developed this guidebook, together with the Collaborative Labeling and Appliance Standards Program (CLASP), as a primary reference. This guidebook was prepared over the course of the past year with significant contribution from the authors and reviewers mentioned previously. Their diligent participation has made this the international guidance tool it was intended to be. The lead authors would also like to thank the following individuals for their support in the development, production, and distribution of the guidebook: Marcy Beck, Elisa Derby, Diana Dhunke, Ted Gartner, and Julie Osborn of Lawrence Berkeley National Laboratory as well as Anthony Ma of Bevilacqua-Knight, Inc. This guidebook is designed as a manual for government officials and others around the world responsible for developing, implementing, enforcing, monitoring, and maintaining labeling and standards-setting programs. It discusses the pros and cons of adopting energy-efficiency labels and standards and describes the data, facilities, and institutional and human resources needed for these programs. It provides guidance on the design, development, implementation, maintenance, and evaluation of the

40 CFR 721.555 - Alkyl amino nitriles (generic).

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Alkyl amino nitriles (generic). 721... Substances § 721.555 Alkyl amino nitriles (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified generically as alkyl amino nitriles (PMNs P-96...

40 CFR Appendix III to Part 600 - Sample Fuel Economy Label Calculation

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 29 2010-07-01 2010-07-01 false Sample Fuel Economy Label Calculation...) ENERGY POLICY FUEL ECONOMY AND CARBON-RELATED EXHAUST EMISSIONS OF MOTOR VEHICLES Pt. 600, App. III Appendix III to Part 600—Sample Fuel Economy Label Calculation Suppose that a manufacturer called Mizer...

A Generic Approach to Parameter Control

NARCIS (Netherlands)

Karafotias, G.; Smit, S.K.; Eiben, A.E.

2012-01-01

On-line control of EA parameters is an approach to parameter setting that offers the advantage of values changing during the run. In this paper, we investigate parameter control from a generic and parameter-independent perspective. We propose a generic control mechanism that is targeted to

The use of generic drugs in prevention of chronic disease is far more cost-effective than thought, and may save money.

Science.gov (United States)

Shrank, William H; Choudhry, Niteesh K; Liberman, Joshua N; Brennan, Troyen A

2011-07-01

In this article we highlight the important role that medication therapy can play in preventing disease and controlling costs. Focusing on coronary artery disease, we demonstrate that prevention, with the appropriate use of generic medications, appears far more cost-effective than previously documented, and it may even save on costs. For example, an earlier study estimated that reducing blood pressure to widely established clinical guidelines in nondiabetic patients cost an estimated $52,983 per quality-adjusted life-year if a brand-name drug was used. However, we estimate that the cost is just $7,753 per quality-adjusted life-year at generic medication prices. As the nation attempts to find strategies to improve population health without adding to the unsustainably high cost of care, policy makers should focus on ensuring that patients have access to essential generic medications.

Danish Energy Efficiency Policy

DEFF Research Database (Denmark)

Togeby, Mikael; Larsen, Anders; Dyhr-Mikkelsen, Kirsten

2009-01-01

Ten groups of policy instruments for promoting energy efficiency are actively used in Denmark. Among these are the EU instruments such as the CO2 emissions trading scheme and labelling of appliances, labelling of all buildings, combined with national instruments such as high taxes especially...... of the entire Danish energy efficiency policy portfolio must be carried out before end 2008 and put forward for discussion among governing parties no later than February 2009. A consortium comprising Ea Energy Analyses, Niras, the Department of Society and Globalisation (Roskilde University) and 4-Fact...... on households and the public sector, obligations for energy companies (electricity, natural gas, district heating, and oil) to deliver documented savings, strict building codes, special instructions for the public sector, and an Electricity Saving Trust. A political agreement from 2005 states that an evaluation...

The Generic Data Capture Facility

Science.gov (United States)

Connell, Edward B.; Barnes, William P.; Stallings, William H.

1987-01-01

The Generic Data Capture Facility, which can provide data capture support for a variety of different types of spacecraft while enabling operations costs to be carefully controlled, is discussed. The data capture functions, data protection, isolation of users from data acquisition problems, data reconstruction, and quality and accounting are addressed. The TDM and packet data formats utilized by the system are described, and the development of generic facilities is considered.

Does educational intervention improve doctors’ knowledge and perceptions of generic medicines and their generic prescribing rate? A study from Malaysia

Science.gov (United States)

Wong, Zhi Yen; Alrasheedy, Alian A.; Saleem, Fahad; Mohamad Yahaya, Abdul Haniff; Aljadhey, Hisham

2014-01-01

Objectives: To investigate the impact of an educational intervention on doctors’ knowledge and perceptions towards generic medicines and their generic (international non-proprietary name) prescribing practice. Methods: This is a single-cohort pre-/post-intervention pilot study. The study was conducted in a tertiary care hospital in Perak, Malaysia. All doctors from the internal medicine department were invited to participate in the educational intervention. The intervention consisted of an interactive lecture, an educational booklet and a drug list. Doctors’ knowledge and perceptions were assessed by using a validated questionnaire, while the international non-proprietary name prescribing practice was assessed by screening the prescription before and after the intervention. Results: The intervention was effective in improving doctors’ knowledge towards bioequivalence, similarity of generic medicines and safety standards required for generic medicine registration (p = 0.034, p = 0.034 and p = 0.022, respectively). In terms of perceptions towards generic medicines, no significant changes were noted (p > 0.05). Similarly, no impact on international non-proprietary name prescribing practice was observed after the intervention (p > 0.05). Conclusion: Doctors had inadequate knowledge and misconceptions about generic medicines before the intervention. Moreover, international non-proprietary name prescribing was not a common practice. However, the educational intervention was only effective in improving doctors’ knowledge of generic medicines. PMID:26770747

Environmental science-policy interactions

DEFF Research Database (Denmark)

Kamelarczyk, Kewin Bach Friis

+ (Reduced Emissions from Deforestation and forest Degradation and enhancement of forest carbon stocks) process and the phenomenon of deforestation in Zambia as research examples. The research was carried out from mid 2008 and to mid 2013 and applies a mixed methods research design. Fieldwork was carried out...... to science? This PhD thesis contributes to answering this questions; however it does this by questioning the conceptions of science that contribute to political decision-making and by exploring the relationship between scientific knowledge, other types of knowledge and policy. This PhD study employs the REDD...... in future REDD+ design and implementation. To curtail potential negative consequences of the identified mode of science-policy interaction in Zambia, the study concludes by making a number of proposals. The proposals are generic in nature and may be found relevant in environmental policy processes outside...

A developmental analysis of generic nouns in Southern Peruvian Quechua.

Science.gov (United States)

Mannheim, Bruce; Gelman, Susan A; Escalante, Carmen; Huayhua, Margarita; Puma, Rosalía

2010-01-01

Generic noun phrases (e.g., "Cats like to drink milk") are a primary means by which adults express generalizations to children, yet they pose a challenging induction puzzle for learners. Although prior research has established that English speakers understand and produce generic noun phrases by preschool age, little is known regarding the cross-cultural generality of generic acquisition. Southern Peruvian Quechua provides a valuable comparison because, unlike English, it is a highly inflected language in which generics are marked by the absence rather than the presence of any linguistic markers. Moreover, Quechua is spoken in a cultural context that differs markedly from the highly educated, middle-class contexts within which earlier research on generics was conducted. We presented participants from 5 age groups (3-6, 7-9, 10-12, 14-35, and 36-90 years of age) with two tasks that examined the ability to distinguish generic from non-generic utterances. In Study 1, even the youngest children understood generics as applying broadly to a category (like "all") and distinct from indefinite reference ("some"). However, there was a developmental lag before children understood that generics, unlike "all", can include exceptions. Study 2 revealed that generic interpretations are more frequent for utterances that (a) lack specifying markers and (b) are animate. Altogether, generic interpretations are found among the youngest participants, and may be a default mode of quantification. These data demonstrate the cross-cultural importance of generic information in linguistic expression.

Innovation and inter-firm linkages : new implications for policy

NARCIS (Netherlands)

Nooteboom, B

This article discusses the implications for competition, innovation and learning of different forms of inter-firm linkage, ways to govern them, different 'generic systems' of innovation, and government policy. It employs a transformed theory of transactions that can deal with innovation and

Associations between generic substitution and patient-related factors

DEFF Research Database (Denmark)

Østergaard Rathe, Jette

Associations between generic substitution and patient-related factors Jette Østergaard Rathe1, Pia V. Larsen1, Morten Andersen2, Janus L. Thomsen3, Maja S. Paulsen1, Jens Søndergaard1 1. Research Unit of General Practice, Institute of Public Health, University of Southern Denmark 2. Centre...... for Pharmacoepidemiology, Karolinska Institutet, Department of Medicine Solna, Stockholm, Sweden 3. Danish Quality Unit of General Practice, Odense, Denmark Background Generic substitution means that chemically equivalent but less expensive drugs are dispensed in place of a brand name product. Although generic medicines...... by definition are bioequivalent to their brand name counterparts there are concerns about whether generic substitution is always accompanied by clinical equivalence in terms of effectiveness and that it may cause concerns and thereby causing some skepticism towards generic substitution. There is, however...

Family Genericity

DEFF Research Database (Denmark)

Ernst, Erik

2006-01-01

Type abstraction in object-oriented languages embody two techniques, each with its own strenghts and weaknesses. The first technique is extension, yielding abstraction mechanisms with good support for gradual specification. The prime example is inheritance. The second technique is functional abst...... the result as family genericity. The presented language design has been implemented....

Hanford Generic Interim Safety Basis

International Nuclear Information System (INIS)

Lavender, J.C.

1994-01-01

The purpose of this document is to identify WHC programs and requirements that are an integral part of the authorization basis for nuclear facilities that are generic to all WHC-managed facilities. The purpose of these programs is to implement the DOE Orders, as WHC becomes contractually obligated to implement them. The Hanford Generic ISB focuses on the institutional controls and safety requirements identified in DOE Order 5480.23, Nuclear Safety Analysis Reports

Hanford Generic Interim Safety Basis

Energy Technology Data Exchange (ETDEWEB)

Lavender, J.C.

1994-09-09

The purpose of this document is to identify WHC programs and requirements that are an integral part of the authorization basis for nuclear facilities that are generic to all WHC-managed facilities. The purpose of these programs is to implement the DOE Orders, as WHC becomes contractually obligated to implement them. The Hanford Generic ISB focuses on the institutional controls and safety requirements identified in DOE Order 5480.23, Nuclear Safety Analysis Reports.

40 CFR Appendix Viii to Part 600 - Fuel Economy Label Formats

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 29 2010-07-01 2010-07-01 false Fuel Economy Label Formats VIII... POLICY FUEL ECONOMY AND CARBON-RELATED EXHAUST EMISSIONS OF MOTOR VEHICLES Pt. 600, App. VIII Appendix VIII to Part 600—Fuel Economy Label Formats EC01MY92.117 EC01MY92.118 EC01MY92.119 EC01MY92.120...

Advances on generic exemption levels and generic clearance levels in the argentinean regulatory field

International Nuclear Information System (INIS)

Muñiz, C.C.; Bossio, M.C.

2011-01-01

With the aim of optimizing the regulatory effort in Argentina, the Nuclear Regulatory Authority (ARN) evaluated two worldwide concepts used in the radioactive waste management field: “Generic Exemption Levels” and “Generic Clearance Levels”. The objective of this paper is to present the progress made in the past two years in relation to these topics and to present the results of the specific requests received from users of radioactive material. Since the approval of both Generic Levels, the ARN received two exemption requests. The first one, regarding the practice of dismantling lighting rods with 241 Am. The other case regards the international trade, distribution, usage and final disposal of lighting products with radioactive material ( 85 Kr and 232 Th). Concerning clearance, there has not been any request yet. However, in the future the ARN expects to receive this kind of requests from nuclear power plants and other facilities related to the nuclear fuel cycle. (authors) [es

Generic medications for you, but brand-name medications for me.

Science.gov (United States)

Keenum, Amy J; Devoe, Jennifer E; Chisolm, Deena J; Wallace, Lorraine S

2012-01-01

Because generic medications are less expensive than brand-name medications, government and private insurers have encouraged and/or mandated the use of generics. This study aimed at evaluating perceptions about generic medications among English-speaking women of childbearing age currently enrolled in U.S. TennCare (Medicaid). We recruited a convenience sample of patients from the waiting room of a primary care/gynecology health clinic, with 80% recruitment rate among those approached. We orally administered a 25-item questionnaire to gather sociodemographic information and to assess beliefs regarding the efficacy, safety, cost, and preferences for personal use of generic medications. The average age of the women (n=172) was 28.8 ± 6.4 years, and most were white (82.0%) and currently married (58.1%). Nearly one-fifth (19.2%) had not completed high school. Most women believed that generic medications were less expensive (97.6%) and better value (60.5%) than brand-name medications, but only 45.3% preferred to take generics themselves. About a quarter (23.3%) believed that brand-name medications were more effective than generics, whereas 13.4% believed that generics caused more side effects. Few women reported that their doctor (29.7%) and/or pharmacist (35.5%) had ever talked to them about taking generics. Awareness of the benefits of generics did not equal preferences for personal use of generics among this sample of women enrolled in U.S. TennCare. Furthermore, women reported that providers-both physicians and pharmacists-infrequently discussed generic substitution with them. Copyright © 2012 Elsevier Inc. All rights reserved.

Towards Using a Generic Robot as Training Partner

DEFF Research Database (Denmark)

Sørensen, Anders Stengaard; Savarimuthu, Thiusius Rajeeth; Nielsen, Jacob

2014-01-01

In this paper, we demonstrate how a generic industrial robot can be used as a training partner, for upper limb training. The motion path and human/robot interaction of a non-generic upper-arm training robot is transferred to a generic industrial robot arm, and we demonstrate that the robot arm can...... implement the same type of interaction, but can expand the training regime to include both upper arm and shoulder training. We compare the generic robot to two affordable but custom-built training robots, and outline interesting directions for future work based on these training robots....

The effect of digital alteration disclaimer labels on social comparison and body image: Instructions and individual differences

OpenAIRE

Bury, B.; Tiggemann, M.; Slater, A.

2016-01-01

The current study aimed to investigate the effect of digital alteration disclaimer labels appended to fashion magazine advertisements, as well as instructional condition, on women’s social comparison and body dissatisfaction. Participants were 378 female undergraduate students who viewed 11 thin ideal advertisements with either no disclaimer, a generic disclaimer, or a more detailed specific disclaimer. There were three instructional conditions: neutral, distractor, and social comparison. Dis...

Innovation strategies for generic drug companies: moving into supergenerics.

Science.gov (United States)

Ross, Malcolm S F

2010-04-01

Pharmaceutical companies that market generic products generally are not regarded as innovators, but rather as companies that produce copies of originator products to be launched at patent expiration. However, many generics companies have developed excellent scientific innovative skills in an effort to circumvent the defense patents of originator companies. More patents per product, in terms of both drug substances (process patents and polymorph patents) and formulations, are issued to generics companies than to companies that are traditionally considered to be 'innovators'. This quantity of issued patents highlights the technical knowledge and skill sets that are available in generics companies. In order to adopt a completely innovative model (ie, the development of NCEs), a generics company would require a completely new set of skills in several fields, including a sufficient knowledge base, project and risk management experience, and capability for clinical data evaluation. However, with relatively little investment, generics companies should be able to progress into the so-called 'supergeneric' drug space - an area of innovation that reflects the existing competencies of both innovative and generics companies.

Calorie labeling, fast food purchasing and restaurant visits.

Science.gov (United States)

Elbel, Brian; Mijanovich, Tod; Dixon, L Beth; Abrams, Courtney; Weitzman, Beth; Kersh, Rogan; Auchincloss, Amy H; Ogedegbe, Gbenga

2013-11-01

Obesity is a pressing public health problem without proven population-wide solutions. Researchers sought to determine whether a city-mandated policy requiring calorie labeling at fast food restaurants was associated with consumer awareness of labels, calories purchased and fast food restaurant visits. Difference-in-differences design, with data collected from consumers outside fast food restaurants and via a random digit dial telephone survey, before (December 2009) and after (June 2010) labeling in Philadelphia (which implemented mandatory labeling) and Baltimore (matched comparison city). Measures included: self-reported use of calorie information, calories purchased determined via fast food receipts, and self-reported weekly fast-food visits. The consumer sample was predominantly Black (71%), and high school educated (62%). Postlabeling, 38% of Philadelphia consumers noticed the calorie labels for a 33% point (P < 0.001) increase relative to Baltimore. Calories purchased and number of fast food visits did not change in either city over time. While some consumers report noticing and using calorie information, no population level changes were noted in calories purchased or fast food visits. Other controlled studies are needed to examine the longer term impact of labeling as it becomes national law. Copyright © 2013 The Obesity Society.

78 FR 22553 - Generic Drug Facilities, Sites, and Organizations

Science.gov (United States)

2013-04-16

...] Generic Drug Facilities, Sites, and Organizations AGENCY: Food and Drug Administration, HHS. ACTION.... Generic drug facilities, certain sites, and organizations identified in a generic drug submission are... active pharmaceutical ingredients and certain other sites and organizations that support the manufacture...

Health care models guiding mental health policy in Kenya 1965 - 1997

Directory of Open Access Journals (Sweden)

Jenkins Rachel

2010-04-01

Full Text Available Abstract Background Mental health policy is needed to set the strategy and direction for the provision of mental health services in a country. Policy formulation does not occur in a vacuum, however, but is influenced by local and international factors in the health sector and other sectors. Methods This study was carried out in 1997 to examine the evolution of mental health policy in Kenya between 1965 and 1997 in the context of changing international concepts of health and development. Qualitative content analysis of policy documents was combined with interviews of key policy makers. Results The study showed that during the period 1965-1997 the generic health policy in Kenya changed from one based on the Medical Model in the 1960s and 1970s to one based on the Primary Health Care Model in the late 1970s and the 1980s and finally to one based on the Market Model of health care in the 1990s. The mental health policy, on the other hand, evolved from one based on the Medical Model in the 1960s to one based on the Primary Health Care Model in the 1990s, but did not embrace the Market Model of health care. This resulted in a situation in the 1990s where the mental health policy was rooted in a different conceptual model from that of the generic health policy under which it was supposed to be implemented. This "Model Muddlement" may have impeded the implementation of the mental health policy in Kenya. Conclusions Integration of the national mental health policy with the general health policy and other sector policies would be appropriate and is now underway.

Synthesis and labelling of epidepride

International Nuclear Information System (INIS)

Yang Min; Pei Zhuguo; Hu Mingyang; Wang Bocheng; Zhou Xingqin

2001-01-01

S-(-)-N-[(1-ethyl-2-pyrrolidinyl) methyl]-5-iodo-2,3-dimethoxybenzamide (proposed generic name, epidepride) is a very potent dopamine D2 antagonist. It was synthesized by five steps from 3-methoxysalicylic acid. [ 131 I]epidepride was obtained in 97.3% radiochemical yields from the corresponding 5-(tributyltin) derivative using hydrogen peroxide as the oxidant. The aryltin precursor was prepared from non-labelled epidepride by palladium-catalyzed stannylene using bis (tri-n-butyltin) in triethylamine. [ 131 I] epidepride was stable under 4 degree C, and partition coefficient was 72.3 at pH 7.40. The biodistribution study in rats exhibited high localization in the striatum of the brain with the striatum/cerebellum ratio reaching 237/1 at 320 min postinjection. All these results suggest that [ 131 I] epidepride may be used widely as a useful dopamine D2 receptor imaging agent for SPECT

Consumer Acceptance of Eco-Labeled Fish: A Mexican Case Study

Directory of Open Access Journals (Sweden)

Mónica Pérez-Ramírez

2015-04-01

Full Text Available Fish eco-labeling is a market-based incentive program for sustainable fisheries. This paper examines consumers’ acceptance of eco-labeled fish by using data from a pilot study conducted in a coastal area of northwestern Mexico. An ordered probit model was applied, using 364 observations. The results show that most respondents favor the idea of eco-labeled fish as a sustainable option and know that this is a costlier option. Income level, consumers’ occupation and frequency of fish consumption are factors taken into account in the buying decision. Price was not a statistically significant factor affecting purchase decision. The study suggests that employed consumers with knowledge of labels may prioritize their demand for eco-labeled fish. Thus, providing a clear definition of sustainability that increases consumer awareness might be a promising strategy in developing the market for eco-labeled fish. The results and their implications could be employed as an element for future development of consumer policies related to fish sustainability.

Integration of generic issues

International Nuclear Information System (INIS)

Thatcher, D.

1989-01-01

The NRC has recognized the need to integrate generic issues (GIs). The GI process includes a number of phases, all of which should recognize the potential for overlap and conflict among related issues. In addition to the issues themselves, other related NRC and industry programs and activities need to be factored into the GI process. Integration has taken place, or is taking place, for a number of GIs. Each case of integration involves a specific set of circumstances and, as a result, the way in which integration proceeds can vary. This paper discusses the integration of issues in the generic issue process and provides a number of examples

Socio-Economic Disparities in Attitude and Preference for Menu Labels among Vietnamese Restaurant Customers.

Science.gov (United States)

Nguyen, Long Hoang; Tran, Bach Xuan; Thi Nguyen, Huong Lan; Le, Huong Thi; Do, Hoa Thi; Kim Dang, Anh; Nguyen, Cuong Tat; Latkin, Carl A; Zhang, Melvyn W B; Ho, Roger C M

2018-03-06

Calories and nutrition labeling on restaurant menus are powerful policy interventions to reduce the burden of obesity epidemic. However, the success of this policy requires an assurance of equal benefits among customers with different characteristics, especially people at a higher risk of poor health outcomes and eating habits. This study examined the sociodemographic disparities in the attitude and preference for calories and nutrition labeling on menus among customers in various food facilities. A cross-sectional study was conducted with 1746 customers of food facilities in Hanoi, Vietnam, who were recruited by using a multistage sampling method. Socio-economic characteristics, attitudes regarding the necessity and preferences for calories, and nutrition labeling on menus were analyzed. Multivariate logistic regression was employed to determine the associated factors with attitudes and preferences. Results show that most of the sample understood the necessity to have calories and nutrition labeling (59.8%), and 71.8% preferred to have calories and nutrition labeling. People who often visited food facilities (Odd Ratio (OR) = 1.36; 95% confident interval (CI) = 1.06-1.74) and had higher education and were more likely to understand the necessity of calories and nutrition labeling. Factors such as being homemakers, often going to dine-in restaurants, and perceiving that labeling was unnecessary were negatively associated with preferences for calories and nutrition labeling. The results of this study encourage policymakers to implement calories and nutrition labeling in the future. Health education interventions to improve knowledge and attitude as regards calories and nutrition labeling on menus are important, particularly for males, less-educated individuals, and high-income people.

Exploring the Knowledge and Perception of Generic Medicines among Final Year Undergraduate Medical, Pharmacy, and Nursing Students in Sierra Leone: A Comparative Cross-Sectional Approach

Directory of Open Access Journals (Sweden)

Peter Bai James

2018-01-01

Full Text Available Most low-income nations have national medicine policy that emphasized the use of generic medicines in the public health sector. However, the use of generics is often debatable as there are concerns over its efficacy, quality, and safety compared to their branded counterparts. This study was conducted to compare the knowledge and perception of generic medicines among final year undergraduate medical, pharmacy, and nursing students in Sierra Leone. We conducted a questionnaire-based cross-sectional study among these students at the College of Medicine and Allied Health Sciences University of Sierra Leone. Out of the 62 students, only two (2/62, 3.2% knew about the acceptable bioequivalence limit. At least half of respondents in all three groups agreed that all generics are therapeutically equivalent to their innovator brand. At least half of the medicine (21/42, 50% and nursing (6/9, 66.6% students, compared to pharmacy students (5/11, 45.5%, believed that higher safety standards are required for proprietary medicines than for generic medicines. Most of them agreed that they need more information on the safety, quality, and efficacy aspects of generics (59/62, 95.2%. All three groups of healthcare students, despite variations in their responses, demonstrated a deficiency in knowledge and misconception regarding generic medicines. Training on issues surrounding generic drugs in healthcare training institutions is highly needed among future healthcare providers in Sierra Leone.

Nutrition labelling: a review of research on consumer and industry response in the global South

Directory of Open Access Journals (Sweden)

Jessie Mandle

2015-01-01

Full Text Available Background: To identify peer-reviewed research on consumers’ usage and attitudes towards the nutrition label and the food industry's response to labelling regulations outside Europe, North America, and Australia and to determine knowledge gaps for future research. Design: Narrative review. Results: This review identified nutrition labelling research from 20 countries in Asia, Africa, the Middle East, and Latin America. Consumers prefer that pre-packaged food include nutrition information, although there is a disparity between rates of use and comprehension. Consumer preference is for front-of-pack labelling and for information that shows per serving or portion as a reference unit, and label formats with graphics or symbols. Research on the food and beverage industry's response is more limited but shows that industry plays an active role in influencing legislation and regulation. Conclusions: Consumers around the world share preferences with consumers in higher income countries with respect to labelling. However, this may reflect the research study populations, who are often better educated than the general population. Investigation is required into how nutrition labels are received in emerging economies especially among the urban and rural poor, in order to assess the effectiveness of labelling policies. Further research into the outlook of the food and beverage industry, and also on expanded labelling regulations is a priority. Sharing context-specific research regarding labelling between countries in the global South could be mutually beneficial in evaluating obesity prevention policies and strategies.

Nutrition labelling: a review of research on consumer and industry response in the global South.

Science.gov (United States)

Mandle, Jessie; Tugendhaft, Aviva; Michalow, Julia; Hofman, Karen

2015-01-01

To identify peer-reviewed research on consumers' usage and attitudes towards the nutrition label and the food industry's response to labelling regulations outside Europe, North America, and Australia and to determine knowledge gaps for future research. Narrative review. This review identified nutrition labelling research from 20 countries in Asia, Africa, the Middle East, and Latin America. Consumers prefer that pre-packaged food include nutrition information, although there is a disparity between rates of use and comprehension. Consumer preference is for front-of-pack labelling and for information that shows per serving or portion as a reference unit, and label formats with graphics or symbols. Research on the food and beverage industry's response is more limited but shows that industry plays an active role in influencing legislation and regulation. Consumers around the world share preferences with consumers in higher income countries with respect to labelling. However, this may reflect the research study populations, who are often better educated than the general population. Investigation is required into how nutrition labels are received in emerging economies especially among the urban and rural poor, in order to assess the effectiveness of labelling policies. Further research into the outlook of the food and beverage industry, and also on expanded labelling regulations is a priority. Sharing context-specific research regarding labelling between countries in the global South could be mutually beneficial in evaluating obesity prevention policies and strategies.

Nutrition labelling: a review of research on consumer and industry response in the global South

Science.gov (United States)

Mandle, Jessie; Tugendhaft, Aviva; Michalow, Julia; Hofman, Karen

2015-01-01

Background To identify peer-reviewed research on consumers’ usage and attitudes towards the nutrition label and the food industry's response to labelling regulations outside Europe, North America, and Australia and to determine knowledge gaps for future research. Design Narrative review. Results This review identified nutrition labelling research from 20 countries in Asia, Africa, the Middle East, and Latin America. Consumers prefer that pre-packaged food include nutrition information, although there is a disparity between rates of use and comprehension. Consumer preference is for front-of-pack labelling and for information that shows per serving or portion as a reference unit, and label formats with graphics or symbols. Research on the food and beverage industry's response is more limited but shows that industry plays an active role in influencing legislation and regulation. Conclusions Consumers around the world share preferences with consumers in higher income countries with respect to labelling. However, this may reflect the research study populations, who are often better educated than the general population. Investigation is required into how nutrition labels are received in emerging economies especially among the urban and rural poor, in order to assess the effectiveness of labelling policies. Further research into the outlook of the food and beverage industry, and also on expanded labelling regulations is a priority. Sharing context-specific research regarding labelling between countries in the global South could be mutually beneficial in evaluating obesity prevention policies and strategies. PMID:25623608

Comparison of selective arterial spin labeling using 1D and 2D tagging RF pulses

Energy Technology Data Exchange (ETDEWEB)

Konstandin, Simon; Heiler, Patrick M.; Schad, Lothar R. [Heidelberg Univ., Mannheim (Germany). Computer Assisted Clinical Medicine; Scharf, Johann [Heidelberg Univ., Mannheim (Germany). Dept. of Neuroradiology

2011-07-01

Generic arterial spin labeling (ASL) techniques label all brain feeding arteries. In this work, we used two different selective ASL (SASL) methods to show the perfusion of one single artery. A slice selective inversion of an area including the desired vessel was compared to a multidimensional RF pulse with Gaussian profile to label only the artery of interest. Perfusion images with a resolution of 2 x 2 x 5 mm{sup 3} are shown that were acquired after tagging only the internal carotid artery of healthy volunteers. In addition, both techniques were applied to a patient with an extra-intracranial bypass to illustrate its perfusion territory. These perfusion images are consistent with a standard angiography. SASL imaging with a resolution of 2 x 2 x 5 mm{sup 3} is possible in a total scan time of 5 min. The presented MR techniques may in part replace the assessment of revascularization success by conventional angiography. (orig.)

Comparison of selective arterial spin labeling using 1D and 2D tagging RF pulses

International Nuclear Information System (INIS)

Konstandin, Simon; Heiler, Patrick M.; Schad, Lothar R.; Scharf, Johann

2011-01-01

Generic arterial spin labeling (ASL) techniques label all brain feeding arteries. In this work, we used two different selective ASL (SASL) methods to show the perfusion of one single artery. A slice selective inversion of an area including the desired vessel was compared to a multidimensional RF pulse with Gaussian profile to label only the artery of interest. Perfusion images with a resolution of 2 x 2 x 5 mm 3 are shown that were acquired after tagging only the internal carotid artery of healthy volunteers. In addition, both techniques were applied to a patient with an extra-intracranial bypass to illustrate its perfusion territory. These perfusion images are consistent with a standard angiography. SASL imaging with a resolution of 2 x 2 x 5 mm 3 is possible in a total scan time of 5 min. The presented MR techniques may in part replace the assessment of revascularization success by conventional angiography. (orig.)

Disclaimer labels on fashion magazine advertisements: Impact on visual attention and relationship with body dissatisfaction.

Science.gov (United States)

Bury, Belinda; Tiggemann, Marika; Slater, Amy

2016-03-01

Globally there is increasing advocacy for the implementation of laws requiring disclaimer labels to be attached to media images that have been digitally altered, with the goal of reducing the known negative effects of exposure to unrealistic thin ideal imagery for women. The current study used eye tracking technology to establish how digital alteration disclaimer labels affect women's visual attention to fashion magazine advertisements, and the interrelationship with body dissatisfaction and state appearance comparison. Participants were 120 female undergraduate students who viewed four thin ideal advertisements with either no disclaimer, a generic disclaimer, or a more detailed specific disclaimer. It was found that women did attend to the disclaimers. Specifically worded disclaimers directed visual attention towards target body areas, which resulted in increased body dissatisfaction, while state appearance comparison predicted increased body dissatisfaction. Further research is imperative to provide guidance on the most effective use of disclaimer labels. Copyright © 2015 Elsevier Ltd. All rights reserved.

CVD Prevention Through Policy: a Review of Mass Media, Food/Menu Labeling, Taxation/Subsidies, Built Environment, School Procurement, Worksite Wellness, and Marketing Standards to Improve Diet.

Science.gov (United States)

Afshin, Ashkan; Penalvo, Jose; Del Gobbo, Liana; Kashaf, Michael; Micha, Renata; Morrish, Kurtis; Pearson-Stuttard, Jonathan; Rehm, Colin; Shangguan, Siyi; Smith, Jessica D; Mozaffarian, Dariush

2015-11-01

Poor diet is the leading cause of cardiovascular disease in the USA and globally. Evidence-based policies are crucial to improve diet and population health. We reviewed the effectiveness for a range of policy levers to alter diet and diet-related risk factors. We identified evidence to support benefits of focused mass media campaigns (especially for fruits, vegetables, salt), food pricing strategies (both subsidies and taxation, with stronger effects at lower income levels), school procurement policies (for increasing healthful or reducing unhealthful choices), and worksite wellness programs (especially when comprehensive and multicomponent). Evidence was inconclusive for food and menu labeling (for consumer or industry behavior) and changes in local built environment (e.g., availability or accessibility of supermarkets, fast food outlets). We found little empiric evidence evaluating marketing restrictions, although broad principles and large resources spent on marketing suggest utility. Widespread implementation and evaluation of evidence-based policy strategies, with further research on other strategies with mixed/limited evidence, are essential "population medicine" to reduce health and economic burdens and inequities of diet-related illness worldwide.

Privacy Impact Assessment for the PC Label System

Science.gov (United States)

The PC Label System collects contact information for individuals with an interest in EPA's Region 1. Learn how this data will be collected in the system, how it will be used, access to the data, the purpose of data collection, and record retention policies

South African patient's acceptance of generic drugs

African Journals Online (AJOL)

mechanism in this regard for final consumers, insurance providers, and ... facilities are viewed as inferior, treated with sus- picion and ... to choose a generic drug if the decision was supported by their doctor ... The effect of brand to generic and ...

Association Between Changes in CMS Reimbursement Policy and Drug Labels for Erythrocyte-Stimulating Agents With Outcomes for Older Patients Undergoing Hemodialysis Covered by Fee-for-Service Medicare.

Science.gov (United States)

Wang, Cunlin; Kane, Robert; Levenson, Mark; Kelman, Jeffrey; Wernecke, Michael; Lee, Joo-Yeon; Kozlowski, Steven; Dekmezian, Carmen; Zhang, Zhiwei; Thompson, Aliza; Smith, Kimberly; Wu, Yu-Te; Wei, Yuqin; Chillarige, Yoganand; Ryan, Qin; Worrall, Chris; MaCurdy, Thomas E; Graham, David J

2016-12-01

In 2011, the US Centers for Medicare & Medicaid Services (CMS) changed its reimbursement policy for hemodialysis to a bundled comprehensive payment system that included the cost of erythrocyte-stimulating agents (ESAs). Also in 2011, the US Food and Drug Administration revised the drug label for ESAs, recommending more conservative dosing in patients with chronic kidney disease. In response to concerns that these measures could have adverse effects on patient care and outcomes, the CMS and the FDA initiated a collaboration to assess the effect. To assess the effects of the changes in reimbursement policy and the ESA drug label on patients who underwent incident hemodialysis. For this retrospective cohort study, patients 66 years or older who had undergone incident hemodialysis, and were enrolled in Medicare parts A, B, or D for at least 12 months prior to hemodialysis initiation between January 1, 2008, and December 31, 2013, were recruited from hemodialysis centers across the United States. Patients were divided into 2 cohorts based on their date of hemodialysis initiation and followed: January 1, 2008, to December 31, 2009, for the prepolicy cohort and July 1, 2011, to June 30, 2013, for the postpolicy cohort, with the exclusion of January 1, 2010, to June 30, 2011, as a transition period. Changes in CMS reimbursement policy for dialysis and the FDA label for ESAs. Major adverse cardiovascular events (MACEs), including acute myocardial infarction (AMI), stroke, and all-cause mortality; hospitalized congestive heart failure (H-CHF); venous thromboembolism; and red blood cell transfusions. Secondary outcomes included evaluating effects on black and other patient subgroups. Baseline characteristics of the 69 718 incident hemodialysis patients were similar between cohorts. Compared with the prepolicy period, the risk of MACE, death, H-CHF, and venous thromboembolism were similar in the postpolicy period, and the risk of stroke decreased (hazard ratio [HR], 0.77; 95

Impact of generic substitution decision support on electronic prescribing behavior.

Science.gov (United States)

Stenner, Shane P; Chen, Qingxia; Johnson, Kevin B

2010-01-01

To evaluate the impact of generic substitution decision support on electronic (e-) prescribing of generic medications. The authors analyzed retrospective outpatient e-prescribing data from an academic medical center and affiliated network for July 1, 2005-September 30, 2008 using an interrupted time-series design to assess the rate of generic prescribing before and after implementing generic substitution decision support. To assess background secular trends, e-prescribing was compared with a concurrent random sample of hand-generated prescriptions. Proportion of generic medications prescribed before and after the intervention, evaluated over time, and compared with a sample of prescriptions generated without e-prescribing. The proportion of generic medication prescriptions increased from 32.1% to 54.2% after the intervention (22.1% increase, 95% CI 21.9% to 22.3%), with no diminution in magnitude of improvement post-intervention. In the concurrent control group, increases in proportion of generic prescriptions (29.3% to 31.4% to 37.4% in the pre-intervention, post-intervention, and end-of-study periods, respectively) were not commensurate with the intervention. There was a larger change in generic prescribing rates among authorized prescribers (24.6%) than nurses (18.5%; adjusted OR 1.38, 95% CI 1.17 to 1.63). Two years after the intervention, the proportion of generic prescribing remained significantly higher for e-prescriptions (58.1%; 95% CI 57.5% to 58.7%) than for hand-generated prescriptions ordered at the same time (37.4%; 95% CI 34.9% to 39.9%) (p<0.0001). Generic prescribing increased significantly in every specialty. Implementation of generic substitution decision support was associated with dramatic and sustained improvements in the rate of outpatient generic e-prescribing across all specialties.

Generic Graph Grammar: A Simple Grammar for Generic Procedural Modelling

DEFF Research Database (Denmark)

Christiansen, Asger Nyman; Bærentzen, Jakob Andreas

2012-01-01

in a directed cyclic graph. Furthermore, the basic productions are chosen such that Generic Graph Grammar seamlessly combines the capabilities of L-systems to imitate biological growth (to model trees, animals, etc.) and those of split grammars to design structured objects (chairs, houses, etc.). This results...

Knowledge mobilisation in healthcare: a critical review of health sector and generic management literature.

Science.gov (United States)

Ferlie, Ewan; Crilly, Tessa; Jashapara, Ashok; Peckham, Anna

2012-04-01

The health policy domain has displayed increasing interest in questions of knowledge management and knowledge mobilisation within healthcare organisations. We analyse here the findings of a critical review of generic management and health-related literatures, covering the period 2000-2008. Using 29 pre-selected journals, supplemented by a search of selected electronic databases, we map twelve substantive domains classified into four broad groups: taxonomic and philosophical (e.g. different types of knowledge); theoretical discourse (e.g. critical organisational studies); disciplinary fields (e.g. organisational learning and Information Systems/Information Technology); and organisational processes and structures (e.g. organisational form). We explore cross-overs and gaps between these traditionally separate literature streams. We found that health sector literature has absorbed some generic concepts, notably Communities of Practice, but has not yet deployed the performance-oriented perspective of the Resource Based View (RBV) of the Firm. The generic literature uses healthcare sites to develop critical analyses of power and control in knowledge management, rooted in neo-Marxist/labour process and Foucauldian approaches. The review generates three theoretically grounded statements to inform future enquiry, by: (a) importing the RBV stream; (b) developing the critical organisational studies perspective further; and (c) exploring the theoretical argument that networks and other alternative organisational forms facilitate knowledge sharing. Copyright © 2012 Elsevier Ltd. All rights reserved.

Clinical review: impact of statin substitution policies on patient outcomes

DEFF Research Database (Denmark)

Atar, Dan; Carmena, Rafael; Clemmensen, Peter

2009-01-01

BACKGROUND: The increasing awareness of cost issues in health care has led to the increasing use of policy-driven substitution of branded for generic medications, particularly relative to statin treatment for cardiovascular diseases. While there are potential short-term health care savings...

Cost-Effectiveness of Single- Versus Generic Multiple-Tablet Regimens for Treatment of HIV-1 Infection in the United States.

Directory of Open Access Journals (Sweden)

Donna E Sweet

Full Text Available The possibility of incorporating generics into combination antiretroviral therapy and breaking apart once-daily single-tablet regimens (STRs, may result in less efficacious medications and/or more complex regimens with the expectation of marked monetary savings. A modeling approach that assesses the merits of such policies in terms of lifelong costs and health outcomes using adherence and effectiveness data from real-world U.S. settings.A comprehensive computer-based microsimulation model was developed to assess the lifetime health (life expectancy and quality adjusted life-years--QALYs and economic outcomes in HIV-1 infected patients initiating STRs compared with multiple-table regimens including generic medications where possible (gMTRs. The STRs considered included tenofovir disoproxil fumarate/emtricitabine and efavirenz or rilpivirine or elvitegravir/cobicistat. gMTRs substitutions included each counterpart to STRs, including generic lamivudine for emtricitabine and generic versus branded efavirenz.Life expectancy is estimated to be 1.301 years higher (discounted 0.619 QALY gain in HIV-1 patients initiating a single-tablet regimen in comparison to a generic-based multiple-table regimen. STRs were associated with an average increment of $26,547.43 per patient in medication and $1,824.09 in other medical costs due to longer survival which were partially offset by higher inpatients costs ($12,035.61 with gMTRs treatment. Overall, STRs presented incremental lifetime costs of $16,335.91 compared with gMTRs, resulting in an incremental cost-effectiveness ratio of $26,383.82 per QALY gained.STRs continue to represent good value for money under contemporary cost-effectiveness thresholds despite substantial price reductions of generic medications in the U. S.

Desired and Undesired Effects of Energy Labels--An Eye-Tracking Study.

Science.gov (United States)

Waechter, Signe; Sütterlin, Bernadette; Siegrist, Michael

2015-01-01

Saving energy is an important pillar for the mitigation of climate change. Electric devices (e.g., freezer and television) are an important player in the residential sector in the final demand for energy. Consumers' purchase decisions are therefore crucial to successfully reach the energy-efficiency goals. Putting energy labels on products is often considered an adequate way of empowering consumers to make informed purchase decisions. Consequently, this approach should contribute to reducing overall energy consumption. The effectiveness of its measurement depends on consumers' use and interpretation of the information provided. Despite advances in energy efficiency and a mandatory labeling policy, final energy consumption per capita is in many countries still increasing. This paper provides a systematic analysis of consumers' reactions to one of the most widely used eco-labels, the European Union (EU) energy label, by using eye-tracking methodology as an objective measurement. The study's results partially support the EU's mandatory policy, showing that the energy label triggers attention toward energy information in general. However, the energy label's effect on consumers' actual product choices seems to be rather low. The study's results show that the currently used presentation format on the label is insufficient. The findings suggest that it does not facilitate the integration of energy-related information. Furthermore, the current format can attract consumers to focus more on energy-efficiency information, leading them to disregard information about actual energy consumption. As a result, the final energy consumption may increase because excellent ratings on energy efficiency (e.g., A++) do not automatically imply little consumption. Finally, implications for policymakers and suggestions for further research are discussed.

Generic substitution of antiretrovirals: patients' and health care providers' opinions.

Science.gov (United States)

Kieran, Jennifer A; O'Reilly, Eimear; O'Dea, Siobhan; Bergin, Colm; O'Leary, Aisling

2017-10-01

There is interest in introducing generic antiretroviral drugs (ARVs) into high-income countries in order to maximise efficiency in health care budgets. Studies examining patients' and providers' knowledge and attitudes to generic substitution in HIV are few. This was a cross-sectional, observational study with a convenience sample of adult HIV-infected patients and health care providers (HCPs). Data on demographics, knowledge of generic medicine and facilitators of generic substitution were collected. Descriptive and univariate analysis was performed using SPSS V.23™. Questionnaires were completed by 66 patients. Seventy-one per cent would have no concerns with the introduction of generic ARVs. An increase in frequency of administration (61%) or pill burden (53%) would make patients less likely to accept generic ARVs. There were 30 respondents to the HCP survey. Concerns included the supply chain of generics, loss of fixed dose combinations, adherence and use of older medications. An increase in dosing frequency (76%) or an increase in pill burden (50%) would make HCPs less likely to prescribe a generic ARV. The main perceived advantage was financial. Generic substitution of ARVs would be acceptable to the majority of patients and HCPs. Reinvesting savings back into HIV services would facilitate the success of such a programme.

Benefits of Digital Equipment Generic Qualification Activities

International Nuclear Information System (INIS)

Thomas, James E.; Steiman, Samuel C.

2002-01-01

As a result of nuclear power plant instrumentation and control obsolescence issues, there have been numerous activities during recent years relating to the qualification of digital equipment. Some of these activities have been 'generic' in nature in that the qualification was not limited to plant specific applications, but was intended to cover a broad base of potential applications of the digital equipment. These generic qualifications have been funded by equipment manufacturers and by utility groups and organizations. The generic activities sponsored by the Electric Power Research Institute (EPRI) have been pilot projects for an overall generic qualification approach. The primary benefit resulting from the generic qualification work to date is that a number of digital platforms and digital devices are now available for use in various nuclear safety-related applications. Many of the tests and evaluations necessary to support plant specific applications have been completed. The amount of data and documentation that each utility must develop on a case by case basis has been significantly reduced. There are also a number of additional benefits resulting from these industry efforts. The challenges and difficulties in qualifying digital equipment for safety-related applications are now more clearly understood. EPRI has published a lessons learned document (EPRI Report 1001452, Generic Qualification of Commercial Grade Digital Devices: Lessons Learned from Initial Pilots, which covers several different qualification areas, including device selection, project planning, vendor surveys and design reviews, and electromagnetic compatibility (EMC) qualification. Application of the experience and lessons learned from the EPRI pilot activities should help reduce the effort and cost required for future qualification work. Most generic qualification activities for commercial equipment have been conducted using the approach of EPRI TR-106439, Guideline on Evaluation and Acceptance

Consumer reactions to the use of EU quality labels on food products

DEFF Research Database (Denmark)

Grunert, Klaus G; Aachmann, Kristina

2015-01-01

The EU promotes three types of food quality labels, PDO, PGI and TSG in order to protect producers of food with special qualities and to aid consumers in their decision-making. This papers reviews published research on how these labels affect consumers. 35 studies were identified and are reviewed...... based on a hierarchy of effects framework. While results are conflicting, some overall themes emerge, suggesting that the role of these quality labels in consumer decision-making at present is still relatively low. Suggestions for research are made that would provide a better basis for evidence......-based policy formulation with regard to food quality labels....

Bioequivalence study of a generic Risperidone (Iperdal® in healthy Thai male volunteers

Directory of Open Access Journals (Sweden)

Werawath Mahatthanatrakul

2008-05-01

Full Text Available The objective of this study was to compare the rate and extent of absorption of a generic risperidone (Iperdal® with a reference formulation (Risperdal® when given orally. The study was an open label, randomized, two-period, two-sequence,single dose cross-over design with a 2 weeks washout period in 16 healthy Thai male volunteers. Single oral dose of two 2-mg tablets of risperidone were administered and serial blood samples were collected from the antecubital vein before and at0.17, 0.33, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 24 and 48 hours post dose. Risperidone plasma concentrations were assayed using a validated High Performance Liquid Chromatographic (HPLC-UV method modified from Avenosoet al. (2000. Pharamcokinetic parameters i.e. Cmax, AUC0à48 and Tmax were analyzed by noncompartment analysis. Variations of the data were analyzed by “Two Way Analysis of Variance” (ANOVA. Statistics were tested as stated in USP 28 guidelinefor bioequivalence study. The maximum concentration (Cmax, ng/ml of risperidone for the innovator and the generic product were 31.11±17.24 (range 5.64-56.78 and 32.58±19.77 (range 5.29-84.56 ng/ml, respectively. The area under theplasma concentration-time curve (AUC0®48 of the innovator and the generic product were 160.64±152.89 (range 18.57- 550.32 and 144.03±127.37 (range 16.27-456.0 ng.hr/ml, respectively. The time to maximum concentration (Tmax of theinnovator and the generic product were 0.97±0.41(range 0.5-2 and 1.02±0.32 (range 0.5-1.5 hr, respectively. The 90% confidence interval of the ratio of the ln-transformed of Cmax and AUC0à48 of both preparations were 89.39-112.99% and80.02-107.28% respectively which were within the acceptance range of 80.00-125.00%. Therefore, it can be concluded that both preparations used in this study are bioequivalent in terms of both the rate and extent of absorption.

Non-commutative Chern numbers for generic aperiodic discrete systems

Science.gov (United States)

Bourne, Chris; Prodan, Emil

2018-06-01

The search for strong topological phases in generic aperiodic materials and meta-materials is now vigorously pursued by the condensed matter physics community. In this work, we first introduce the concept of patterned resonators as a unifying theoretical framework for topological electronic, photonic, phononic etc (aperiodic) systems. We then discuss, in physical terms, the philosophy behind an operator theoretic analysis used to systematize such systems. A model calculation of the Hall conductance of a 2-dimensional amorphous lattice is given, where we present numerical evidence of its quantization in the mobility gap regime. Motivated by such facts, we then present the main result of our work, which is the extension of the Chern number formulas to Hamiltonians associated to lattices without a canonical labeling of the sites, together with index theorems that assure the quantization and stability of these Chern numbers in the mobility gap regime. Our results cover a broad range of applications, in particular, those involving quasi-crystalline, amorphous as well as synthetic (i.e. algorithmically generated) lattices.

Clinical review: impact of statin substitution policies on patient outcomes

NARCIS (Netherlands)

Atar, Dan; Carmena, Rafael; Clemmensen, Peter; K-Laflamme, Annik; Wassmann, Sven; Lansberg, Peter; Hobbs, Richard

2009-01-01

The increasing awareness of cost issues in health care has led to the increasing use of policy-driven substitution of branded for generic medications, particularly relative to statin treatment for cardiovascular diseases. While there are potential short-term health care savings, the consequences for

HTGR generic technology program plan (FY 80)

International Nuclear Information System (INIS)

1980-01-01

Purpose of the program is to develop base technology and to perform design and development common to the HTGR Steam Cycle, Gas Turbine, and Process Heat Plants. The generic technology program breaks into the base technology, generic component, pebble-bed study, technology transfer, and fresh fuel programs

Socio-Economic Disparities in Attitude and Preference for Menu Labels among Vietnamese Restaurant Customers

Science.gov (United States)

Nguyen, Long Hoang; Thi Nguyen, Huong Lan; Le, Huong Thi; Do, Hoa Thi; Kim Dang, Anh; Nguyen, Cuong Tat; Latkin, Carl A.; Zhang, Melvyn W. B.; Ho, Roger C. M.

2018-01-01

Calories and nutrition labeling on restaurant menus are powerful policy interventions to reduce the burden of obesity epidemic. However, the success of this policy requires an assurance of equal benefits among customers with different characteristics, especially people at a higher risk of poor health outcomes and eating habits. This study examined the sociodemographic disparities in the attitude and preference for calories and nutrition labeling on menus among customers in various food facilities. A cross-sectional study was conducted with 1746 customers of food facilities in Hanoi, Vietnam, who were recruited by using a multistage sampling method. Socio-economic characteristics, attitudes regarding the necessity and preferences for calories, and nutrition labeling on menus were analyzed. Multivariate logistic regression was employed to determine the associated factors with attitudes and preferences. Results show that most of the sample understood the necessity to have calories and nutrition labeling (59.8%), and 71.8% preferred to have calories and nutrition labeling. People who often visited food facilities (Odd Ratio (OR) = 1.36; 95% confident interval (CI) = 1.06–1.74) and had higher education and were more likely to understand the necessity of calories and nutrition labeling. Factors such as being homemakers, often going to dine-in restaurants, and perceiving that labeling was unnecessary were negatively associated with preferences for calories and nutrition labeling. The results of this study encourage policymakers to implement calories and nutrition labeling in the future. Health education interventions to improve knowledge and attitude as regards calories and nutrition labeling on menus are important, particularly for males, less-educated individuals, and high-income people. PMID:29509723

Socio-Economic Disparities in Attitude and Preference for Menu Labels among Vietnamese Restaurant Customers

Directory of Open Access Journals (Sweden)

Long Hoang Nguyen

2018-03-01

Full Text Available Calories and nutrition labeling on restaurant menus are powerful policy interventions to reduce the burden of obesity epidemic. However, the success of this policy requires an assurance of equal benefits among customers with different characteristics, especially people at a higher risk of poor health outcomes and eating habits. This study examined the sociodemographic disparities in the attitude and preference for calories and nutrition labeling on menus among customers in various food facilities. A cross-sectional study was conducted with 1746 customers of food facilities in Hanoi, Vietnam, who were recruited by using a multistage sampling method. Socio-economic characteristics, attitudes regarding the necessity and preferences for calories, and nutrition labeling on menus were analyzed. Multivariate logistic regression was employed to determine the associated factors with attitudes and preferences. Results show that most of the sample understood the necessity to have calories and nutrition labeling (59.8%, and 71.8% preferred to have calories and nutrition labeling. People who often visited food facilities (Odd Ratio (OR = 1.36; 95% confident interval (CI = 1.06–1.74 and had higher education and were more likely to understand the necessity of calories and nutrition labeling. Factors such as being homemakers, often going to dine-in restaurants, and perceiving that labeling was unnecessary were negatively associated with preferences for calories and nutrition labeling. The results of this study encourage policymakers to implement calories and nutrition labeling in the future. Health education interventions to improve knowledge and attitude as regards calories and nutrition labeling on menus are important, particularly for males, less-educated individuals, and high-income people.

Generic switching of warfarin and risk of excessive anticoagulation

DEFF Research Database (Denmark)

Hellfritzsch, Maja; Rathe, Jette; Stage, Tore Bjerregaard

2016-01-01

PURPOSE: Generic switching of warfarin was recently repealed in Denmark, as adverse drug reaction (ADR) reports suggested risk of excessive anticoagulation following switches from branded to generic warfarin. We investigated this putative association in a formalized pharmacoepidemiological analysis....... METHODS: We conducted a nationwide cohort study based on Danish healthcare registries, including data from the introduction of generic warfarin until the repeal (January 2011-April 2015). We followed Danish warfarin users over time and compared the rate of incident hospitalizations due to excessive...... anticoagulation (i.e. increased INR or any bleeding requiring hospitalization) in periods following a recent switch to generic warfarin to the rate in periods without a recent switch. RESULTS: We included 105,751 warfarin users, filling a total of 1,539,640 prescriptions for warfarin (2.5% for generic warfarin...

Generic communications index. Listings of communications 1971-1989

Energy Technology Data Exchange (ETDEWEB)

Hagemeyer, D; Towle, H

1991-05-01

As part of its program to feed back information on operating experience to industry, the U.S. Nuclear Regulatory Commission (NRC) issues generic communications called bulletins (about 5/yr), circulars (now discontinued), generic letters (about 20/yr), and information notices (about 100/yr). The report presents an updated Generic Communications Index (GCI; previously published in NUREG/CR-4690, Vol. 1, December 1987) of all such communications from 1971, when such documentation started, to 1989. The GCI consists of records, one for each communication, containing fields for identification number, title, NRC technical contact, general system or topic, specific component or topic, cause or defect, potential effect, remarks, and vendors involved. To facilitate information retrieval, the report also contains topical listings of generic communications numbers. (author)

Rooting out institutional corruption to manage inappropriate off-label drug use.

Science.gov (United States)

Rodwin, Marc A

2013-01-01

Prescribing drugs for uses that the FDA has not approved - off-label drug use - can sometimes be justified but is typically not supported by substantial evidence of effectiveness. At the root of inappropriate off-label drug use lie perverse incentives for pharmaceutical firms and flawed oversight of prescribing physicians. Typical reform proposals such as increased sanctions for manufacturers might reduce the incidence of unjustified off-label use, but they do not remove the source of the problem. Public policy should address the cause and control the practice. To manage inappropriate off-label drug use, off-label prescriptions must be tracked in order to monitor the risks and benefits and the manufacturers' conduct. Even more important, reimbursement rules should be changed so that manufacturers cannot profit from off-label sales. When off-label sales pass a critical threshold, manufacturers should also be required to pay for independent testing of the safety and effectiveness of off-label drug uses and for the FDA to review the evidence. Manufacturers should also finance, under FDA supervision, programs designed to warn physicians and the public about the risks of off-label drug use. © 2013 American Society of Law, Medicine & Ethics, Inc.

Kebijakan Labeling terhadap Impor Wine di Pasar Uni Eropa Tahun 2010-2012 (Studi Kasus: Wine Australia)

OpenAIRE

", Afrizal; Ulfa, Putri Nabillah

2016-01-01

This research describes about how the impact of wine labeling policy reform by the European Union to Australian wine imports in the EU market in 2010 until 2012. This is done by European Union because Australian wine import in 2004, 2005 and 2006 increase in EU Market. Besides that, European Union wants to protect their wine by the reformation. In this research writer finds out that wine labeling policy reforms by European Union has influence to protect their domestic products from the Austra...

Do nations still need national energy policies

Energy Technology Data Exchange (ETDEWEB)

Schlesinger, James [Lehman Brothers, Washington, DC (United States); Odell, P [Erasmus Univ., Rotterdam (Netherlands). Dept. of International Energy Studies; Jones, D

1993-02-01

Once again the issue has arisen whether a national energy policy is necessary or even desirable. No doubt renewed debate has been stimulated by recent developments - the collapse of the Soviet threat, an altered perception of the power of OPEC, or a jaundiced view regarding the effectiveness of governments in this arena. Yet, beneath the surface lie longer-standing issues regarding interests and ideology. This article attempts to deal with the issue, first, as a generic level, then in terms of the transformed energy market, and, finally, in relation to the content of energy policy. (author)

17 CFR 230.135a - Generic advertising.

Science.gov (United States)

2010-04-01

... 17 Commodity and Securities Exchanges 2 2010-04-01 2010-04-01 false Generic advertising. 230.135a Section 230.135a Commodity and Securities Exchanges SECURITIES AND EXCHANGE COMMISSION GENERAL RULES AND REGULATIONS, SECURITIES ACT OF 1933 General § 230.135a Generic advertising. (a) For the purposes only of...

78 FR 59911 - Generic Information Collection for Land Management Planning

Science.gov (United States)

2013-09-30

... DEPARTMENT OF AGRICULTURE Forest Service Generic Information Collection for Land Management... organizations on the proposed information collection, Generic Information Collection for Land Management... related to forest management. The intent of this generic information collection request (ICR) is to...

Advancing STEM Education: A 2020 Vision

Science.gov (United States)

Bybee, Rodger W.

2010-01-01

STEM (an acronym for science, technology, engineering and mathematics) had its origins in the 1990s at the National Science Foundation (NSF) and has been used as a generic label for any event, policy, program, or practice that involves one or several of the STEM disciplines. However, a recent survey on the "perception of STEM" found that most…

Generic substitution: micro evidence from register data in Norway.

Science.gov (United States)

Dalen, Dag Morten; Furu, Kari; Locatelli, Marilena; Strøm, Steinar

2011-02-01

The importance of prices, doctor and patient characteristics, and market institutions for the likelihood of choosing generic drugs instead of the more expensive original brand-name version are examined. Using an extensive dataset extracted from The Norwegian Prescription Database containing all prescriptions dispensed to individuals in February 2004 and 2006 on 23 different drugs (chemical substances) in Norway, we find strong evidence for the importance of both doctor and patient characteristics for the choice probabilities. The price difference between brand and generic versions and insurance coverage both affect generic substitution. Moreover, controlling for the retail chain affiliation of the dispensing pharmacy, we find that pharmacies play an important role in promoting generic substitution. In markets with more recent entry of generic drugs, brand-name loyalty proves to be much stronger, giving less explanatory power to our demand model.

Fuel consumption rates of passenger cars in China: Labels versus real-world

International Nuclear Information System (INIS)

Huo Hong; Yao Zhiliang; He Kebin; Yu Xin

2011-01-01

Recently, China has implemented many policy measures to control the oil demand of on-road vehicles. In 2010, China started to report the fuel consumption rates of light-duty vehicles tested in laboratory and to require new vehicles to show the rates on window labels. In this study, we examined the differences between the test and real-world fuel consumption of Chinese passenger cars by using the data reported by real-world drivers on the internet voluntarily. The sales-weighted average fuel consumption of new cars in China in 2009 was 7.80 L/100 km in laboratory and 9.02 L/100 km in real-world, representing a difference of 15.5%. For the 153 individual car models examined, the real-world fuel consumption rates were -8 to 60% different from the test values. The simulation results of the International Vehicle Emission model show that the real-world driving cycles in 22 selected Chinese cities could result in -8 to 34% of changes in fuel consumption compared to the laboratory driving cycle. Further government effort on fuel consumption estimates adjustment, local driving cycle development, and real-world data accumulation through communication with the public is needed to improve the accuracy of the labeling policy. - Research highlights: → China requires new cars sold to show the test fuel use levels on window labels. → Real-world fuel consumption rates of cars are 15.5% higher than the label values. → Discrepancy between the test cycle and real conditions is a major cause for the gap. → China should adjust the estimates, collect fuel use data, and develop driving cycles. → More official and academic efforts are needed to improve the labeling policy.

Corporate Strategies for Generic Medicines in Brazil: A Study with the Sector’s Ten Largest CompaniesHttp://Dx.Doi.Org/10.5585/Riae.V10i1.1710

Directory of Open Access Journals (Sweden)

Silvia Antonio Sfair

2011-06-01

Full Text Available In Brazil, generic drugs are considered safe and effective and substantially cheaper than the so-called reference medicinal products. Due to this, generic drugs have become an important sector within the pharmaceutical market. However, topical studies are scarce and researchers focus on health professionals and direct sales. This article looks to expand on the understanding concerning the subject investigating the vision of those responsible for production, its relationship with physicians, government policies and delivery chain management in serving the consumer. To present this objective, in-depth interviews were conducted with ten executives occupying strategic positions in the pharmaceutical industry in general. The sample represents approximately 84% of generic drug sales in Brazil. The results have demonstrated that government performance plays an important role in the marketing of generic drugs to the population, while the drugstore and distributors were identified in this market as growth barriers, due to the practices used at point of sale. Doctors are considered the prime agent in popularizing the use of generic drugs in Brazil.

Toward Technology-Sensitive Catching-Up Policies: Insights from Renewable Energy in China

DEFF Research Database (Denmark)

Binz, Christian; Gosens, Jorrit; Hansen, Teis

2017-01-01

, but were of limited importance in the early solar PV industry, and resulted only in a limited period of rapid growth in the biomass power plant industry. The relative progress achieved in these three industries is not related to top-down policy guidance alone, but also to private sector initiative......, international interdependencies, and flexibility in adapting policy mixes to each industry's technological characteristics. These results suggest that policy makers in newly industrializing countries (NICs) should avoid drafting generic sector plans, but should tailor plans to individual industries, and respond...... to changing policy support needs as technological capacities and global competitiveness develop....

Do higher-priced generic medicines enjoy a competitive advantage under reference pricing?

Science.gov (United States)

Puig-Junoy, Jaume

2012-11-01

In many countries with generic reference pricing, generic producers and distributors compete by means of undisclosed discounts offered to pharmacies in order to reduce acquisition costs and to induce them to dispense their generic to patients in preference over others. The objective of this article is to test the hypothesis that under prevailing reference pricing systems for generic medicines, those medicines sold at a higher consumer price may enjoy a competitive advantage. Real transaction prices for 179 generic medicines acquired by pharmacies in Spain have been used to calculate the discount rate on acquisition versus reimbursed costs to pharmacies. Two empirical hypotheses are tested: the discount rate at which pharmacies acquire generic medicines is higher for those pharmaceutical presentations for which there are more generic competitors; and, the discount rate at which pharmacies acquire generic medicines is higher for those pharmaceutical forms for which the consumer price has declined less in relation to the consumer price of the brand drug before generic entry (higher-priced generic medicines). An average discount rate of 39.3% on acquisition versus reimbursed costs to pharmacies has been observed. The magnitude of the discount positively depends on the number of competitors in the market. The higher the ratio of the consumer price of the generic to that of the brand drug prior to generic entry (i.e. the smaller the price reduction of the generic in relation to the brand drug), the larger the discount rate. Under reference pricing there is intense price competition among generic firms in the form of unusually high discounts to pharmacies on official ex-factory prices reimbursed to pharmacies. However, this effect is highly distorting because it favours those medicines with a higher relative price in relation to the brand price before generic entry.

Comparative effectiveness of generic versus brand-name antiepileptic medications.

Science.gov (United States)

Gagne, Joshua J; Kesselheim, Aaron S; Choudhry, Niteesh K; Polinski, Jennifer M; Hutchins, David; Matlin, Olga S; Brennan, Troyen A; Avorn, Jerry; Shrank, William H

2015-11-01

The objective of this study was to compare treatment persistence and rates of seizure-related events in patients who initiate antiepileptic drug (AED) therapy with a generic versus a brand-name product. We used linked electronic medical and pharmacy claims data to identify Medicare beneficiaries who initiated one of five AEDs (clonazepam, gabapentin, oxcarbazepine, phenytoin, zonisamide). We matched initiators of generic versus brand-name versions of these drugs using a propensity score that accounted for demographic, clinical, and health service utilization variables. We used a Cox proportional hazards model to compare rates of seizure-related emergency room (ER) visit or hospitalization (primary outcome) and ER visit for bone fracture or head injury (secondary outcome) between the matched generic and brand-name initiators. We also compared treatment persistence, measured as time to first 14-day treatment gap, between generic and brand-name initiators. We identified 19,760 AED initiators who met study eligibility criteria; 18,306 (93%) initiated a generic AED. In the matched cohort, we observed 47 seizure-related hospitalizations and ER visits among brand-name initiators and 31 events among generic initiators, corresponding to a hazard ratio of 0.53 (95% confidence interval, 0.30 to 0.96). Similar results were observed for the secondary clinical endpoint and across sensitivity analyses. Mean time to first treatment gap was 124.2 days (standard deviation [sd], 125.8) for brand-name initiators and 137.9 (sd, 148.6) for generic initiators. Patients who initiated generic AEDs had fewer adverse seizure-related clinical outcomes and longer continuous treatment periods before experiencing a gap than those who initiated brand-name versions. Copyright © 2015 Elsevier Inc. All rights reserved.

Generic drugs: Review and experiences from South India

Directory of Open Access Journals (Sweden)

Philip Mathew

2015-01-01

Full Text Available The cost of pharmaceuticals, as a percentage of total healthcare spending, has been rising worldwide. This has resulted in strained national budgets and a high proportion of people without access to essential medications. Though India has become a global hub of generic drug manufacturing, the expected benefits of cheaper drugs are not translating into savings for ordinary people. This is in part due to the rise of branded generics, which are marketed at a price point close to the innovator brands. Unbranded generic medicines are not finding their way into prescriptions due to issues of confidence and perception, though they are proven to be much cheaper and comparable in efficacy to branded medicines. The drug inventory of unbranded generic manufacturers fares reasonably when reviewed using the World Health Organization-Health Action International (WHO-HAI tool for analysing drug availability. Also, unbranded generic medicines are much cheaper when compared to the most selling brands and they can bring down the treatment costs in primary care and family practice. We share our experience in running a community pharmacy for an urban health center in the Pathanamthitta district of Kerala State, which is run solely on generic medicines. The drug availability at the community pharmacy was 73.3% when analyzed using WHO-HAI tool and the savings for the final consumers were up to 93.1%, when compared with most-selling brand of the same formulation.

What do people really think of generic medicines? A systematic review and critical appraisal of literature on stakeholder perceptions of generic drugs.

LENUS (Irish Health Repository)

Dunne, Suzanne S

2015-07-01

Considerable emphasis is presently being placed on usage of generic medicines by governments focussed on the potential economic benefits associated with their use. Concurrently, there is increasing discussion in the lay media of perceived doubts regarding the quality and equivalence of generic medicines. The objective of this paper is to report the outcomes of a systematic search for peer-reviewed, published studies that focus on physician, pharmacist and patient\\/consumer perspectives of generic medicines.

Energy-Efficiency Labels and Standards: A Guidebook forAppliances, Equipment, and Lighting - 2nd Edition

Energy Technology Data Exchange (ETDEWEB)

Wiel, Stephen; McMahon, James E.

2005-04-28

Energy-performance improvements in consumer products are an essential element in any government's portfolio of energy-efficiency and climate change mitigation programs. Governments need to develop balanced programs, both voluntary and regulatory, that remove cost-ineffective, energy-wasting products from the marketplace and stimulate the development of cost-effective, energy-efficient technology. Energy-efficiency labels and standards for appliances, equipment, and lighting products deserve to be among the first policy tools considered by a country's energy policy makers. The U.S. Agency for International Development (USAID) and several other organizations identified on the cover of this guidebook recognize the need to support policy makers in their efforts to implement energy-efficiency standards and labeling programs and have developed this guidebook, together with the Collaborative Labeling and Appliance Standards Program (CLASP), as a primary reference. This second edition of the guidebook was prepared over the course of the past year, four years after the preparation of the first edition, with a significant contribution from the authors and reviewers mentioned previously. Their diligent participation helps maintain this book as the international guidance tool it has become. The lead authors would like to thank the members of the Communications Office of the Environmental Energy Technologies Division, Lawrence Berkeley National Laboratory for their support in the development, production, and distribution of the guidebook. This guidebook is designed as a manual for government officials and others around the world responsible for developing, implementing, enforcing, monitoring, and maintaining labeling and standards setting programs. It discusses the pros and cons of adopting energy-efficiency labels and standards and describes the data, facilities, and institutional and human resources needed for these programs. It provides guidance on the design

The effect of digital alteration disclaimer labels on social comparison and body image: Instructions and individual differences.

Science.gov (United States)

Bury, Belinda; Tiggemann, Marika; Slater, Amy

2016-06-01

The current study aimed to investigate the effect of digital alteration disclaimer labels appended to fashion magazine advertisements, as well as instructional condition, on women's social comparison and body dissatisfaction. Participants were 378 female undergraduate students who viewed 11 thin ideal advertisements with either no disclaimer, a generic disclaimer, or a more detailed specific disclaimer. There were three instructional conditions: neutral, distractor, and social comparison. Disclaimer labels did not affect appearance comparison or body dissatisfaction, but instructional condition did, with the social comparison instructions producing the highest appearance comparison and body dissatisfaction. In addition, there was a three-way interaction with trait appearance comparison, such that women high on trait appearance comparison who saw specifically worded disclaimers in the distractor instructional condition experienced increased body dissatisfaction, whereas women low on this trait experienced decreased body dissatisfaction. It seems that both instructions and individual differences may influence responses to disclaimer labels. Copyright © 2016 Elsevier Ltd. All rights reserved.

Once more the generic name Passerina Vieillot

NARCIS (Netherlands)

Oort, van E.D.

1910-01-01

The note on the generic name of the Snow-bunting by Dr. E. Hartert in this part of our periodical gives me cause to revert to the subject of my note on the generic name Passerina Vieillot and to state here, that I stand to what I have said about the rejection of this name in Zoology (Notes Leyden

Generic Reed Solomon Encorder

Directory of Open Access Journals (Sweden)

Petrus Mursanto

2006-11-01

Full Text Available Reed Solomon (RS codes is a mechanism to detect and correct burst of errors in data transmission and storage systems. It provides a solid introduction to foundation mathematical concept of Galois Field algebra and its application. With the development of digital hardware technology, the RS concepts were brought into reality, i.e. the implementation of RS codec chips. This paper presents the development steps of a generic RS encoder using VHDL. The encoder is able to handle generic width of data, variable length of information, number of error as well as variable form of primitive polynomial and generator polynomial used in the system. The design has been implemented for FPGA chip Xilinx XC3S200-5FT256 and has a better performance than commercially available equivalent encoder.

[Generic drugs and the consumption trends of antihypertensives in Morocco].

Science.gov (United States)

Berrada El Azizi, Ghizlane; Ahid, Samir; Ghanname, Imane; Ghannam, Imane; Belaiche, Abdelmajid; Hassar, Mohammed; Cherrah, Yahia

2013-01-01

To evaluate the evolution of consumption of antihypertensive drugs generic among 1991-2010, to assess the impacts after the institution of Mandatory Health Insurance and the marketing of generic drugs. We used sales data from the Moroccan subsidiary of IMS Health Intercontinental Marketing Service. Consumption of generic antihypertensive drugs increased from 0.08 to 10.65 DDD/1 000 inhabitants/day between 1991 and 2010. In 2010, generic of the calcium channel blockers (CCBs) represented 4.08 DDD/1 000 inhabitants/day (82.09%), followed by angiotensin converting enzyme inhibitors (ACEI) by 2.40 DDD/1 000 inhabitants/day (48.29%). The generics market of CCBs is the most dominant and represented in 2010, 79.21% in volume and 62.58% in value. In developing countries like Morocco, the generic drug is a key element for access to treatment especially for the poor population. © 2013 Société Française de Pharmacologie et de Thérapeutique.

[Analysis of generic drug supply in France].

Science.gov (United States)

Taboulet, F; Haramburu, F; Latry, Ph

2003-09-01

The list of generic medicines (LGM), published since 1997 by the Agence Française de Sécurité Sanitaire des Produits de Santé (AFFSSaPS), the French Medicine Agency, concerns a special part of the medicines reimbursed by the National Health Insurance (Social Security). The objectives of the present study were: i) to describe the components of this list, based on pharmaceutical, economical and therapeutic characteristics, ii) to study differences between generic and reference products (formulations, excipients, prices, etc.), iii) to analyze information on excipients provided to health care professionals. The 21st version of the LGM (April 2001) was used. Therapeutic value was retrieved from the 2001 AFSSaPS report on the therapeutic value of 4490 reimbursed medicines. Information on excipients in the LGM and the Vidal dictionary (reference prescription book in France) was compared. The products included in the LGM represent 20% of all reimbursed medicines. The mean price differences between generics and their reference products vary between 30 and 50% for more than two thirds of the generic groups. The therapeutic value of the products of the LGM was judged important in 71% of cases (vs 63% for the 4409 assessed medicines) and insufficient in 13% of cases (vs 19%). Information on excipients is often missing and sometimes erroneous. Although the LGM is regularly revised and thus the generic market in perpetual change, the 2001 cross description of this pharmaceutical market provides much informations and raises some concern.

Evaluation of generic and branded herbicides : technical report.

Science.gov (United States)

2015-03-01

As with other generic brand products in the marketplace, generic herbicides often have a lower initial product cost than : their brand-name counterparts. While the purchase price of herbicides is important to TxDOT, it is essential to look at : more ...

Automated analysis in generic groups

Science.gov (United States)

Fagerholm, Edvard

This thesis studies automated methods for analyzing hardness assumptions in generic group models, following ideas of symbolic cryptography. We define a broad class of generic and symbolic group models for different settings---symmetric or asymmetric (leveled) k-linear groups --- and prove ''computational soundness'' theorems for the symbolic models. Based on this result, we formulate a master theorem that relates the hardness of an assumption to solving problems in polynomial algebra. We systematically analyze these problems identifying different classes of assumptions and obtain decidability and undecidability results. Then, we develop automated procedures for verifying the conditions of our master theorems, and thus the validity of hardness assumptions in generic group models. The concrete outcome is an automated tool, the Generic Group Analyzer, which takes as input the statement of an assumption, and outputs either a proof of its generic hardness or shows an algebraic attack against the assumption. Structure-preserving signatures are signature schemes defined over bilinear groups in which messages, public keys and signatures are group elements, and the verification algorithm consists of evaluating ''pairing-product equations''. Recent work on structure-preserving signatures studies optimality of these schemes in terms of the number of group elements needed in the verification key and the signature, and the number of pairing-product equations in the verification algorithm. While the size of keys and signatures is crucial for many applications, another aspect of performance is the time it takes to verify a signature. The most expensive operation during verification is the computation of pairings. However, the concrete number of pairings is not captured by the number of pairing-product equations considered in earlier work. We consider the question of what is the minimal number of pairing computations needed to verify structure-preserving signatures. We build an

Impact of alternative interventions on changes in generic dispensing rates.

Science.gov (United States)

O'Malley, A James; Frank, Richard G; Kaddis, Atheer; Rothenberg, Barbara M; McNeil, Barbara J

2006-10-01

To evaluate the effectiveness of four alternative interventions (member mailings, advertising campaigns, free generic drug samples to physicians, and physician financial incentives) used by a major health insurer to encourage its members to switch to generic drugs. Using claim-level data from Blue Cross Blue Shield of Michigan, we evaluated the success of four interventions implemented during 2000-2003 designed to increase the use of generic drugs among its members. Around 13 million claims involving seven important classes of drugs were used to assess the effectiveness of the interventions. For each intervention a control group was developed that most closely resembled the corresponding intervention group. Logistic regression models with interaction effects between the treatment group (intervention versus control) and the status of the intervention (active versus not active) were used to evaluate if the interventions had an effect on the generic dispensing rate (GDR). Because the mail order pharmacy was considered more aggressive at converting prescriptions to generics, separate generic purchasing models were fitted to retail and mail order claims. In secondary analyses separate models were also fitted to claims involving a new condition and claims refilled for preexisting conditions. The interventions did not appear to increase the market penetration of generic drugs for either retail or mail order claims, or for claims involving new or preexisting conditions. In addition, we found that the ratio of copayments for brand name to generic drugs had a large positive effect on the GDR. The interventions did not appear to directly influence the GDR. Financial incentives expressed to consumers through benefit designs have a large influence on their switching to generic drugs and on the less-costly mail-order mode of purchase.

Pharmaceutical policies: effects of reference pricing, other pricing, and purchasing policies.

Science.gov (United States)

Acosta, Angela; Ciapponi, Agustín; Aaserud, Morten; Vietto, Valeria; Austvoll-Dahlgren, Astrid; Kösters, Jan Peter; Vacca, Claudia; Machado, Manuel; Diaz Ayala, Diana Hazbeydy; Oxman, Andrew D

2014-10-16

, healthcare utilisation and health outcomes or costs (expenditures); the study had to be a randomised trial, non-randomised trial, interrupted time series (ITS), repeated measures (RM) study or a controlled before-after study of a pharmaceutical pricing or purchasing policy for a large jurisdiction or system of care. Two review authors independently extracted data and assessed the risk of bias. Results were summarised in tables. There were too few comparisons with similar outcomes across studies to allow for meta-analysis or meaningful exploration of heterogeneity. We included 18 studies (seven identified in the update): 17 of reference pricing, one of which also assessed maximum prices, and one of index pricing. None of the studies were trials. All included studies used ITS or RM analyses. The quality of the evidence was low or very low for all outcomes. Three reference pricing studies reported cumulative drug expenditures at one year after the transition period. Two studies reported the median relative insurer's cumulative expenditures, on both reference drugs and cost share drugs, of -18%, ranging from -36% to 3%. The third study reported relative insurer's cumulative expenditures on total market of -1.5%. Four reference pricing studies reported median relative insurer's expenditures on both reference drugs and cost share drugs of -10%, ranging from -53% to 4% at one year after the transition period. Four reference pricing studies reported a median relative change of 15% in reference drugs prescriptions at one year (range -14% to 166%). Three reference pricing studies reported a median relative change of -39% in cost share drugs prescriptions at one year (range -87% to -17%). One study of index pricing reported a relative change of 55% (95% CI 11% to 98%) in the use of generic drugs and -43% relative change (95% CI -67% to -18%) in brand drugs at six months after the transition period. The same study reported a price change of -5.3% and -1.1% for generic and brand drugs

Radiation dose estimates for carbon-11-labelled PET tracers

International Nuclear Information System (INIS)

Aart, Jasper van der; Hallett, William A.; Rabiner, Eugenii A.; Passchier, Jan; Comley, Robert A.

2012-01-01

Introduction: Carbon-11-labelled positron emission tomography (PET) tracers commonly used in biomedical research expose subjects to ionising radiation. Dosimetry is the measurement of radiation dose, but also commonly refers to the estimation of health risk associated with ionising radiation. This review describes radiation dosimetry of carbon-11-labelled molecules in the context of current PET research and the most widely used regulatory guidelines. Methods: A MEDLINE literature search returned 42 articles; 32 of these were based on human PET data dealing with radiation dosimetry of carbon-11 molecules. Radiation burden expressed as effective dose and maximum absorbed organ dose was compared between tracers. Results: All but one of the carbon-11-labelled PET tracers have an effective dose under 9 μSv/MBq, with a mean of 5.9 μSv/MBq. Data show that serial PET scans in a single subject are feasible for the majority of radiotracers. Conclusion: Although differing in approach, the two most widely used regulatory frameworks (those in the USA and the EU) do not differ substantially with regard to the maximum allowable injected activity per PET study. The predictive validity of animal dosimetry models is critically discussed in relation to human dosimetry. Finally, empirical PET data are related to human dose estimates based on homogenous distribution, generic models and maximum cumulated activities. Despite the contribution of these models to general risk estimation, human dosimetry studies are recommended where continued use of a new PET tracer is foreseen.

Predictors of generic substitution: The role of psychological, sociodemographic, and contextual factors.

Science.gov (United States)

Drozdowska, Aleksandra; Hermanowski, Tomasz

2016-01-01

Escalating pharmaceutical costs have become a global challenge for both governments and patients. Generic substitution is one way of decreasing these costs. The aim of this study was to investigate factors associated with patients' choice between generic drugs and innovator drugs. The survey was conducted in June 2013, 1000 people from across Poland were chosen as a representative population sample. The outcome (a preference for generics/a preference for innovator pharmaceuticals/no preference) was modeled by multinomial logistic regression, adjusted for several variables describing patients' sensitivity to selected generic features (price, brand, and country of origin), to third-party opinions about generics (information on generics in the mass media, opinions of health professionals (i.e. physicians, pharmacists), relatives/friends), as well as patients' personal experiences and income per household. The results supported the predictive capacity of most independent variables (except for patient sensitivity to the country of origin and to the information on generics in the mass media), denoting patients' preferences toward generic substitution. Patient sensitivity to recommendations by physicians, generic brand, and household income were the strongest predictors of the choice between generic and innovator pharmaceuticals (P brand or their physician's opinion, as well as in respondents who were sensitive to recommendations by pharmacists or attached a greater value to a past experience with generics (their own experience or that of relatives/friends). In consideration of the foregoing, awareness-raising campaigns may be recommended, supported by a variety of systemic solutions and tools to encourage generic substitution. Copyright © 2016 Elsevier Inc. All rights reserved.

The effects of restaurant menu calorie labeling on hypothetical meal choices of females with disordered eating.

Science.gov (United States)

Haynos, Ann F; Roberto, Christina A

2017-03-01

Concerns have been raised that obesity public policy measures may have harmful effects on individuals with eating disorders. However, little research has investigated this topic. We examined the impact of a popular obesity public policy, menu calorie labeling, on hypothetical food choices of women with disordered eating. Seven hundred sixteen adult females completed an online survey in which they were randomly assigned to receive a restaurant menu with or without calorie information listed. Participants selected foods representative of a meal they would choose to consume and answered questions on restaurant ordering and menu labeling. Participants completed the Eating Disorder Examination Questionnaire (Fairburn & Beglin, ) to assess global eating pathology. Diagnoses of anorexia nervosa (AN), bulimia nervosa (BN), and binge-eating disorder (BED) were also derived from this measure. Generalized linear modeling examined the impact of menu label condition, disordered eating, and the menu label by disordered eating interaction on hypothetical food selection and related variables. When disordered eating was examined continuously, menu labeling did not differentially affect food selections of those with elevated disordered eating (p = .45). However, when examined by eating disorder diagnosis, participants with AN or BN ordered significantly fewer (p < .001) and participants with BED ordered significantly more (p = .001) calories in the menu label versus no label condition. Menu labeling may decrease the calories ordered among individuals with AN or BN and increase calories ordered among individuals with BED. © 2017 Wiley Periodicals, Inc.

Generic nuclear power plant component failure data bank

International Nuclear Information System (INIS)

Araujo Goes, A.G. de; Gibelli, S.M.O.

1988-11-01

This report consist in the development of a generic nuclear power plant component failure data bank. This data bank was implemented in a PC-XT microcomputer, IBM compatible, using the Open Access II program. Generic failure data tables for Westinghouse nuclear power plants and for general PWR power plants are presented. They are the final product of a research which included a preselection and a selection of data collected from the available sources in the library of CNEN (National Nuclear Energy Commission) and from the CIN/CNEN (Neclear Information Center). Futhermore, a proposal of evaluating models of average failure rates of pumps and valves are also presented. Through the electronic data bank one can easily have a generic view of failure rate ranges as well as failure models foe a certain component. It is very importante to develop procedures to collect and store generic failure data that can be quickly accessed, in order to update the Probabilistic Safety Study of Angra-1 and to used in studies which may have component failures of nuclear power plant safety systems. In the future, data specialization can be achieved by means of statistical calculations involving specific data collected from the operational experience of Angra-1 nuclear power plant and the generic data bank. (author) [pt

Addition of generic medication vouchers to a pharmacist academic detailing program: effects on the generic dispensing ratio in a physician-hospital organization.

Science.gov (United States)

Bhargava, Vinay; Greg, Mark E; Shields, Mark C

2010-01-01

Generic dispensing ratio (GDR) is an important measure of efficiency in pharmacy benefit management. A few studies have examined the effects of academic detailing or generic drug samples on GDR. On July 1, 2007, a physician-hospital organization (PHO) with a pay-for-performance incentive for generic utilization initiated a pilot generic medication voucher program that augmented its existing pharmacist-led academic detailing efforts. No published studies have examined the role of generic medication vouchers in promoting generic drug utilization. To determine if supplementing an existing academic detailing initiative in a PHO with a generic medication voucher program would be more effective in increasing the GDR compared with academic detailing alone. The intervention took place over the 9-month period from July 1, 2007, through March 31, 2008. Vouchers provided patients with the first fill of a 30-day supply of a generic drug at no cost to the patient for 8 specific generic medications obtained through a national community pharmacy chain. The study was conducted in a PHO composed of 7 hospitals and approximately 2,900 physicians (900 primary care providers [PCPs] and 2,000 specialists). Of the approximately 300 PCP practices, 21 practices with at least 2 physicians each were selected on the basis of high prescription volume (more than 500 pharmacy claims for the practice over a 12-month pre-baseline period) and low GDR (practice GDR less than 55% in the 12-month pre-baseline period). These 21 practices were then randomized to a control group of academic detailing alone or the intervention group that received academic detailing plus generic medication vouchers. One of 10 intervention groups declined to participate, and 2 of 11 control groups dropped out of the PHO. GDR was calculated monthly for all pharmacy claims including the 8 voucher medications. GDR was defined as the ratio of the total number of paid generic pharmacy claims divided by the total number of paid

Calorie labeling and consumer estimation of calories purchased.

Science.gov (United States)

Taksler, Glen B; Elbel, Brian

2014-07-12

Studies rarely find fewer calories purchased following calorie labeling implementation. However, few studies consider whether estimates of the number of calories purchased improved following calorie labeling legislation. Researchers surveyed customers and collected purchase receipts at fast food restaurants in the United States cities of Philadelphia (which implemented calorie labeling policies) and Baltimore (a matched comparison city) in December 2009 (pre-implementation) and June 2010 (post-implementation). A difference-in-difference design was used to examine the difference between estimated and actual calories purchased, and the odds of underestimating calories.Participants in both cities, both pre- and post-calorie labeling, tended to underestimate calories purchased, by an average 216-409 calories. Adjusted difference-in-differences in estimated-actual calories were significant for individuals who ordered small meals and those with some college education (accuracy in Philadelphia improved by 78 and 231 calories, respectively, relative to Baltimore, p = 0.03-0.04). However, categorical accuracy was similar; the adjusted odds ratio [AOR] for underestimation by >100 calories was 0.90 (p = 0.48) in difference-in-difference models. Accuracy was most improved for subjects with a BA or higher education (AOR = 0.25, p calories varied by subgroup, suggesting that at some level, consumers may incorporate labeling information.

Using Service Oriented Architecture in a Generic Virtual Power Plant

DEFF Research Database (Denmark)

Andersen, Peter Bach; Poulsen, Bjarne; Træholt, Chresten

2009-01-01

The purpose of this paper is to find and describe a suitable software framework that can be used to help implement the concept of a Generic Virtual Power Plant in the future power system. The Generic Virtual Power Plant concept, along with the utilization of distributed energy resources, has many...... the Generic Virtual Power Plant, an array of different software design principles, patterns and architectures must be applied. Especially Service Oriented Architecture (SOA) can aid in implementing the Generic Virtual Power Plant.......The purpose of this paper is to find and describe a suitable software framework that can be used to help implement the concept of a Generic Virtual Power Plant in the future power system. The Generic Virtual Power Plant concept, along with the utilization of distributed energy resources, has many...... interesting properties that can influence the future shape of power markets. The concept holds many promises including cheaper power to the consumer, a more flexible and responsive power production and the support of a more environment-friendly development. In order to realize a software solution supporting...

Generic tacrolimus in solid organ transplantation

DEFF Research Database (Denmark)

Taube, D; Jones, G; O'Beirne, J

2014-01-01

The availability of a wide range of immunosuppressive therapies has revolutionized the management of patients who have undergone solid organ transplantation (SOT). However, the cost of immunosuppressive drugs remains high. This situation has led to the development of generic equivalents, which...... innovator tacrolimus drug (Prograf) in both healthy volunteers and kidney transplant patients. Clinical experience with this generic tacrolimus formulation has also been established in both de novo and conversion patients who have undergone kidney and liver transplantation, as well as in conversion of other...

A Note on the impact on sales from introducing healthy labeled meals on the lunch menu

DEFF Research Database (Denmark)

Thunström, Linda; Nordström, Leif Jonas

Menu labeling of prepared meals away from home is a policy designed to help consumers make healthier food choices. In this paper, we use a field experiment to analyze if a restaurant benefits from introducing a healthy labeled meal on its menu by experiencing an overall increase in sales. We cann...... reject the hypothesis that sales are the same before and after the introduction of a healthy labeled meal on the menu, i.e., our data does not support the idea that restaurants increase their sales from supplying a healthy labeled meal....

Generic immunosuppression in transplantation: current evidence and controversial issues.

Science.gov (United States)

El Hajj, Sandra; Kim, Miae; Phillips, Karen; Gabardi, Steven

2015-05-01

The overall success of organ transplantation in the 21st century has been predicated, in part, on the use of newer, more potent, and selective immunosuppressive agents. However, the high cost of lifelong immunosuppression represents a financial burden for many patients. In the past 15 years, regulatory agencies in Europe and America have approved several generic immunosuppressants. One concern is whether the conversion between innovator and generic immunosuppressants will prove to be problematic. This manuscript aims to compare and contrast the bioequivalence requirements among regulatory authorities in the USA, Europe, and Canada, evaluate published studies of generic immunosuppressants in transplant recipients, summarize consensus statements made by transplant organizations and discuss how to engage patients in discussion regarding the choice between innovator and generic immunosuppressants.

The Hazard Analysis and Critical Control Points (HACCP) generic model for the production of Thai fermented pork sausage (Nham).

Science.gov (United States)

Paukatong, K V; Kunawasen, S

2001-01-01

Nham is a traditional Thai fermented pork sausage. The major ingredients of Nham are ground pork meat and shredded pork rind. Nham has been reported to be contaminated with Salmonella spp., Staphylococcus aureus, and Listeria monocytogenes. Therefore, it is a potential cause of foodborne diseases for consumers. A Hazard Analysis and Critical Control Points (HACCP) generic model has been developed for the Nham process. Nham processing plants were observed and a generic flow diagram of Nham processes was constructed. Hazard analysis was then conducted. Other than microbial hazards, the pathogens previously found in Nham, sodium nitrite and metal were identified as chemical and physical hazards in this product, respectively. Four steps in the Nham process have been identified as critical control points. These steps are the weighing of the nitrite compound, stuffing, fermentation, and labeling. The chemical hazard of nitrite must be controlled during the weighing step. The critical limit of nitrite levels in the Nham mixture has been set at 100-200 ppm. This level is high enough to control Clostridium botulinum but does not cause chemical hazards to the consumer. The physical hazard from metal clips could be prevented by visual inspection of every Nham product during stuffing. The microbiological hazard in Nham could be reduced in the fermentation process. The critical limit of the pH of Nham was set at lower than 4.6. Since this product is not cooked during processing, finally, educating the consumer, by providing information on the label such as "safe if cooked before consumption", could be an alternative way to prevent the microbiological hazards of this product.

Monitoring the health-related labelling of foods and non-alcoholic beverages in retail settings.

Science.gov (United States)

Rayner, M; Wood, A; Lawrence, M; Mhurchu, C N; Albert, J; Barquera, S; Friel, S; Hawkes, C; Kelly, B; Kumanyika, S; L'abbé, M; Lee, A; Lobstein, T; Ma, J; Macmullan, J; Mohan, S; Monteiro, C; Neal, B; Sacks, G; Sanders, D; Snowdon, W; Swinburn, B; Vandevijvere, S; Walker, C

2013-10-01

Food labelling on food packaging has the potential to have both positive and negative effects on diets. Monitoring different aspects of food labelling would help to identify priority policy options to help people make healthier food choices. A taxonomy of the elements of health-related food labelling is proposed. A systematic review of studies that assessed the nature and extent of health-related food labelling has been conducted to identify approaches to monitoring food labelling. A step-wise approach has been developed for independently assessing the nature and extent of health-related food labelling in different countries and over time. Procedures for sampling the food supply, and collecting and analysing data are proposed, as well as quantifiable measurement indicators and benchmarks for health-related food labelling. © 2013 The Authors. Obesity Reviews published by John Wiley & Sons Ltd on behalf of the International Association for the Study of Obesity.

Lawsuits allege price fixing by generic drug makers

Directory of Open Access Journals (Sweden)

Robbins RA

2016-12-01

Full Text Available No abstract available. Article truncated at 150 words. Two years after high generic drug prices became a public controversy, Reuters is reporting that 20 states filed a lawsuit Thursday against Mylan, Teva Pharmaceuticals and four other generic drug makers (1. The suit alleges the companies conspired to fix prices or allocated markets to prop up prices. The civil lawsuit, led by antitrust investigators in Connecticut, comes one day after the U.S. Department of Justice filed criminal charges against two former executives of the generic drug maker, Heritage. The states attorneys general asked the court to order the companies to disgorge ill-gotten gains, which were not defined, pay attorneys' fees and stop collusion. Of the states in the Southwest only Nevada is participating in the lawsuit. The cases are part of a broader generic drug pricing probe that remains under way at the state and federal level, as well as in the U.S. Congress. In 2014, media reports of …

Mixed WTO ruling on generic drug development.

Science.gov (United States)

Elliott, R

2000-01-01

On 17 March 2000, the World Trade Organization upheld the provision in Canada's patent laws that allows generic drug manufacturers to develop (but not sell) their cheaper versions of patented medicines before the 20-year patients expire. The decision prevents pharmaceutical companies from enjoying market monopolies beyond their patent terms, avoiding what would otherwise be even lengthier delays in the sale of cheaper, generic drugs in Canada. This decision is of significance not only to Canada, but also to other WTO member countries and to all individuals who use pharmaceutical products. However, the decision is not all positive: the WTO also ruled that Canada is violating international agreements by letting generic manufacturers stockpile their versions of patented drugs before patents expire. This article explains the issues, the arguments, and the decision.

40 CFR 600.307-08 - Fuel economy label format requirements.

Science.gov (United States)

2010-07-01

... to battery electric vehicles, fuel cell vehicles, plug-in hybrid electric vehicles and vehicles... 40 Protection of Environment 29 2010-07-01 2010-07-01 false Fuel economy label format requirements...) ENERGY POLICY FUEL ECONOMY AND CARBON-RELATED EXHAUST EMISSIONS OF MOTOR VEHICLES Fuel Economy...

40 CFR 721.10036 - Acetaldehyde based polymer (generic).

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Acetaldehyde based polymer (generic... Specific Chemical Substances § 721.10036 Acetaldehyde based polymer (generic). (a) Chemical substance and... based polymer (PMN P-02-406) is subject to reporting under this section for the significant new uses...

Enhancing Safety through Generic Competencies

Directory of Open Access Journals (Sweden)

S. Mockel

2014-03-01

Full Text Available This article provides insights into proactive safety management and mitigation. An analysis of accident reports reveals categories of supervening causes of accidents which can be directly linked to the concept of generic competencies (information management, communication and coordination, problem solving, and effect control. These findings strongly suggest adding the human element as another safety-constituting pillar to the concept of ship safety next to technology and regulation. We argue that the human element has unique abilities in dealing with critical and highly dynamic situations which can contribute to the system's recovery from non-routine or critical situations. By educating seafarers in generic competencies we claim to enable the people onboard to successfully deal with critical situations.

Generic magnetic fusion reactor cost assessment

International Nuclear Information System (INIS)

Sheffield, J.

1985-01-01

The Fusion Energy Division of the Oak Ridge National Laboratory discusses ''generic'' magnetic fusion reactors. The author comments on DT burning magnetic fusion reactor models being possibly operational in the 21st century. Representative parameters from D-T reactor studies are given, as well as a shematic diagram of a generic fusion reactor. Values are given for winding pack current density for existing and future superconducting coils. Topics included are the variation of the cost of electricity (COE), the dependence of the COE on the net electric power of the reactor, and COE formula definitions

Applying policy network theory to policy-making in China: the case of urban health insurance reform.

Science.gov (United States)

Zheng, Haitao; de Jong, Martin; Koppenjan, Joop

2010-01-01

In this article, we explore whether policy network theory can be applied in the People's Republic of China (PRC). We carried out a literature review of how this approach has already been dealt with in the Chinese policy sciences thus far. We then present the key concepts and research approach in policy networks theory in the Western literature and try these on a Chinese case to see the fit. We follow this with a description and analysis of the policy-making process regarding the health insurance reform in China from 1998 until the present. Based on this case study, we argue that this body of theory is useful to describe and explain policy-making processes in the Chinese context. However, limitations in the generic model appear in capturing the fundamentally different political and administrative systems, crucially different cultural values in the applicability of some research methods common in Western countries. Finally, we address which political and cultural aspects turn out to be different in the PRC and how they affect methodological and practical problems that PRC researchers will encounter when studying decision-making processes.

Generic radiation safety design for SSRL synchrotron radiation beamlines

Energy Technology Data Exchange (ETDEWEB)

Liu, James C. [Radiation Protection Department, Stanford Linear Accelerator Center (SLAC), MS 48, P.O. Box 20450, Stanford, CA 94309 (United States)]. E-mail: james@slac.stanford.edu; Fasso, Alberto [Radiation Protection Department, Stanford Linear Accelerator Center (SLAC), MS 48, P.O. Box 20450, Stanford, CA 94309 (United States); Khater, Hesham [Radiation Protection Department, Stanford Linear Accelerator Center (SLAC), MS 48, P.O. Box 20450, Stanford, CA 94309 (United States); Prinz, Alyssa [Radiation Protection Department, Stanford Linear Accelerator Center (SLAC), MS 48, P.O. Box 20450, Stanford, CA 94309 (United States); Rokni, Sayed [Radiation Protection Department, Stanford Linear Accelerator Center (SLAC), MS 48, P.O. Box 20450, Stanford, CA 94309 (United States)

2006-12-15

To allow for a conservative, simple, uniform, consistent, efficient radiation safety design for all SSRL beamlines, a generic approach has been developed, considering both synchrotron radiation (SR) and gas bremsstrahlung (GB) hazards. To develop the methodology and rules needed for generic beamline design, analytic models, the STAC8 code, and the FLUKA Monte Carlo code were used to pre-calculate sets of curves and tables that can be looked up for each beamline safety design. Conservative beam parameters and standard targets and geometries were used in the calculations. This paper presents the SPEAR3 beamline parameters that were considered in the design, the safety design considerations, and the main pre-calculated results that are needed for generic shielding design. In the end, the rules and practices for generic SSRL beamline design are summarized.

A Policy Language for Modelling Recommendations

Science.gov (United States)

Abou El Kalam, Anas; Balbiani, Philippe

While current and emergent applications become more and more complex, most of existing security policies and models only consider a yes/no response to the access requests. Consequently, modelling, formalizing and implementing permissions, obligations and prohibitions do not cover the richness of all the possible scenarios. In fact, several applications have access rules with the recommendation access modality. In this paper we focus on the problem of formalizing security policies with recommendation needs. The aim is to provide a generic domain-independent formal system for modelling not only permissions, prohibitions and obligations, but also recommendations. In this respect, we present our logic-based language, the semantics, the truth conditions, our axiomatic as well as inference rules. We also give a representative use case with our specification of recommendation requirements. Finally, we explain how our logical framework could be used to query the security policy and to check its consistency.

The generic strategy trap.

Science.gov (United States)

Miller, D

1992-01-01

Management experts claim that for a company to thrive, it must concentrate on a single generic strategy--on one thing it does better than its rivals. But specialization also has its disadvantages. The author suggests that a broader, mixed approach may be preferable.

Exploring technology diffusion in emerging markets – the role of public policy for wind energy

International Nuclear Information System (INIS)

Friebe, Christian A.; Flotow, Paschen von; Täube, Florian A.

2014-01-01

This study challenges the implicit assumption of homogeneity in national institutional contexts made in past studies of (renewable) energy policy. We propose that institutional differences matter by focusing on several technology-specific and generic policy factors that can foster technology diffusion through private sector activity. More specifically, we explore perceptions of early adopters in emerging economy contexts using wind park project developers as an example. By applying a parsimonious method for our questionnaire as well as qualitative data we make several contributions: Methodologically, we introduce Maximum Difference Scaling to the energy policy domain. Empirically, we identify several public influences on private investment, and assess their relative importance. This leads to new insights challenging findings from industrialized economies; we identified additional institutional barriers to diffusion, hence, the requirement of a combination of technology-specific and generic policy measures. - Highlights: • Explorative qualitative and quantitative study of project developers in emerging markets. • Identifies influencing factors for technology diffusion regarding wind farms. • Predictable public authorities and well-implemented public processes attract intern. project developers. • Feed-in-Tariffs and grid access guarantees are particularly appealing

Acceptability and confidence in antiretroviral generics of physicians and HIV-infected patients in France.

Science.gov (United States)

Allavena, Clotilde; Jacomet, Christine; Pereira, Bruno; Morand-Joubert, Laurence; Bagheri, Haleh; Cotte, Laurent; Garaffo, Rodolphe; Gerbaud, Laurent; Dellamonica, Pierre

2014-01-01

Switching brand name medications to generics is recommended in France in the interest of cost effectiveness but patients and physicians are sometimes not convinced that switching is appropriate. Some antiretroviral (ARV) generics (ZDV, 3TC, NVP) have been marketed in France since 2013. A multicentric cross-sectional survey was performed in September 2013 to evaluate the perception of generics overall and ARV generics in physicians and HIV-infected patients and factors associated to their acceptability. Adult HIV outpatients were asked to complete a self-questionnaire on their perception of generics. Physicians completed a questionnaire on the acceptability of generics and ARV generics. Socio-demographic data, medical history and HIV history were collected. 116 physicians in 33 clinics (68% in University Hospital) included 556 patients (France-native 77%, active employment 59%, covered by social Insurance 100%, homosexual/bisexual contamination 47%, median HIV duration 13 years, hepatitis coinfection 16%, on ARV therapy 95%). Overall, patients accepted and had confidence in generics in 76% and 55% of the cases, respectively. Switching ARVs for generics was accepted by 44% of the patients but only by 17% if the pill burden was going to increase. 75% of the physicians would prescribe generics, but this decreased to only 26% if the combo had to be broken. The main reasons for non-prescription of generics were previous brand name ARV-induced side effects (35%), refusal of generics overall (37%), lack of understanding of generics (26%), risk of non-observance of treatment (44%), anxiety (47%) and depressive symptoms (25%). In multivariate analysis, factors associated with the acceptability of ARV generics in patients were the use of generics overall (p<0.001) and in physicians, the absence of concern regarding the drug efficacy (p<0.001) and being aware that the patient would accept generics overall (p=0.03) and ARV generics (p=0.04). No factors related to

Introduction of developing a list of MSO generic scenarios for PHWR

Energy Technology Data Exchange (ETDEWEB)

Park, Jae Wan; Park, Jun Hyun; Bae, Hui Soo [STANDARD Testing and Engineering Ing. Ltd, Daejeon (Korea, Republic of)

2016-10-15

Multiple Spurious Operation(MSO) scenarios should contain scenarios threatening Post-fire safe shutdown function by MSO of Safe Shutdown Equipments(SSEs) as well as Non-SSEs. The list of MSO generic scenarios(NEI 00-01, Appendix G) was developed by industrial survey. Although not all scenarios of the list of MSO generic scenarios(NEI 00-01, Appendix G) are considered applicable to every reactor type, this list provides an input about MSO identification and treatment process. If NEI 00-01 is applied to other reactor type, analyst should review applicability of the list of generic scenarios(NEI 00-01, Appendix G) and consider potential MSO scenarios undescribed in the list of MSO generic scenarios(NEI 00-01, Appendix G). Especially, in PHWR case, there is no list of MSO generic scenarios in Canada or internationally. There are substantial physical variations between NPPs. So some generic scenarios(NEI 00-01, Appendix G) would need validation. Nevertheless, industrial stakeholder have not did any MSO work until now. In this paper, results of first stage research that develop the list of MSO generic scenarios for pressurized heavy water reactor(PHWR) is introduced. According to the review results, specific review of the list of MSO generic scenarios(NEI 00-01, Appendix G) is required such as how it applies to PHWR. And criteria was established for review of availability of the list of generic scenarios(NEI 00-01, Appendix G). However there are still many tasks such as potential scenario review, risk model review and expert panel review.

The influence of calorie and physical activity labelling on snack and beverage choices.

Science.gov (United States)

Masic, U; Christiansen, P; Boyland, E J

2017-05-01

Much research suggests nutrition labelling does not influence lower energy food choice. This study aimed to assess the impact of physical activity based and kilocalorie (Kcal) based labels on the energy content of snack food and beverage choices made. An independent-groups design, utilizing an online questionnaire platform tested 458 UK adults (87 men), aged 18-64 years (mean: 30 years) whose BMI ranged from 16 to 41 kg/m 2 (mean: 24 kg/m 2 ). Participants were randomized to one of four label information conditions (no label, Kcal label, physical activity label [duration of walking required to burn the Kcal in the product], Kcal and physical activity label) and were asked to choose from higher and lower energy options for a series of items. Label condition significantly affected low vs. high-energy product selection of snack foods (p snack and beverage choices than the Kcal label condition (p snack food and beverage items, when compared with no information or Kcal information. These findings could inform the debate around potential legislative policies to facilitate healthier nutritional choices at a population level. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

Frequency and Informativeness of Gestural Cues Accompanying Generic and Particular Reference

Science.gov (United States)

Meyer, Meredith; Gelman, Susan A.; Stilwell, Sarah M.

2015-01-01

Generic noun phrases, or generics, refer to abstract categories ("Dogs" bark) rather than particular individuals ("Those dogs" bark). Study 1 investigated how parents use gestures in association with generic versus particular reference during naturalistic interactions with their 2- and 3-year-old children. Parents provided…

Distribution and trends in outpatient utilization of generic versus brand name psychopharmaceuticals during a ten-year period in Croatia.

Science.gov (United States)

Polić-ViŽintin, Marina; Stimac, Danijela; Sostar, Zvonimir; Tripković, Ingrid

2014-08-15

Drug costs increasingly pose a burden upon the otherwise inadequate health care resources and rational drug utilization is an important segment of every national health policy. Optimal patient care should be the goal of rational pharmacotherapy, whereby the economic burden of treatment is just one of the elements to be considered on choosing appropriate therapy.The aim of this study was to determine distribution and trends in the outpatient utilization of generic versus brand name psychopharmaceuticals and to evaluate the rationality of prescribing psychopharmaceuticals during a ten-year period. Using the World Health Organization Anatomical-Therapeutic-Chemical classification/Defined Daily Doses (ATC/DDD) methodology, the number of DDD was calculated from data collected from pharmacies on the number and size of drug packages. The ratio of generic and brand name drug costs served as an indicator on assessing the rationality of drug utilization. Total cost for psychopharmaceuticals increased by 20.1%, more for brand name than for generic agents (32.7% vs. 7.4%). The highest share of generic psychopharmaceuticals as compared with brand name drugs according to DDD per 1000 inhabitants per day (DDD/1000/day) was in the group of psycholeptics (83.6% in 2001 vs. 82.2% in 2010), most in hypnotics and sedatives, and least in antipsychotics. The share of generic psychopharmaceuticals in total drug utilization according to financial indicators decreased by 9.6% and according to DDD/1000/day by 12%. The greatest decrease was in antidepressants, i.e. by 33.8% according to financial indicators and by 46% according to DDD/1000/day; and in antipsychotics by 30.9% according to DDD/1000/day, while showing an increase by 8.5% according to financial indicators. In the therapeutic subgroup of mood stabilizers, the share of generic drugs in total drug utilization declined by 32% according to DDD/1000/day, but increased by 25.1% according to financial indicators. The lack of uniform

Exploring community pharmacists' views on generic medicines: a nationwide study from Malaysia.

Science.gov (United States)

Chong, Chee Ping; Hassali, Mohamed Azmi; Bahari, Mohd Baidi; Shafie, Asrul Akmal

2011-02-01

To evaluate the Malaysian community pharmacists' views on generic medicines. A sample of 1419 Malaysian community pharmacies with resident pharmacists. A cross-sectional nationwide survey using a self-completed mailing questionnaire. Pharmacists' views on generic medicines including issues surrounding efficacy, safety, quality and bioequivalence. Responses were received from 219 pharmacies (response rate 15.4%). Only 50.2% of the surveyed pharmacists agreed that all products that are approved as generic equivalents can be considered therapeutically equivalent with the innovator medicines. Around 76% of respondents indicated that generic substitution of narrow therapeutic index medicines is inappropriate. The majority of the pharmacists understood that a generic medicine must contain the same amount of active ingredient (84.5%) and must be in the same dosage form as the innovator brand (71.7%). About 21% of respondents though that generic medicines are of inferior quality compared to innovator medicines. Most of the pharmacists (61.6%) disagreed that generic medicines produce more side-effects than innovator brand. Pharmacists graduated from Malaysian universities, twinning program and overseas universities were not differed significantly in their views on generic medicines. Additionally, the respondents appeared to have difficulty in ascertaining the bioequivalent status of the marketed generic products in Malaysia. The Malaysian pharmacists' have lack of information and/or trust in the generic manufacturing and/or approval system in Malaysia. This issue should be addressed by pharmacy educators and relevant government agencies.

Harmonization of malaria rapid diagnostic tests: best practices in labelling including instructions for use.

Science.gov (United States)

Jacobs, Jan; Barbé, Barbara; Gillet, Philippe; Aidoo, Michael; Serra-Casas, Elisa; Van Erps, Jan; Daviaud, Joelle; Incardona, Sandra; Cunningham, Jane; Visser, Theodoor

2014-12-17

Rapid diagnostic tests (RDTs) largely account for the scale-up of malaria diagnosis in endemic settings. However, diversity in labelling including the instructions for use (IFU) limits their interchangeability and user-friendliness. Uniform, easy to follow and consistent labelling, aligned with international standards and appropriate for the level of the end user's education and training, is crucial but a consolidated resource of information regarding best practices for IFU and labelling of RDT devices, packaging and accessories is not available. The Roll Back Malaria Partnership (RBM) commissioned the compilation of international standards and regulatory documents and published literature containing specifications and/or recommendations for RDT design, packaging and labelling of in vitro diagnostics (IVD) (which includes RDTs), complemented with a questionnaire based survey of RDT manufacturers and implementers. A summary of desirable RDT labelling characteristics was compiled, which was reviewed and discussed during a RBM Stakeholder consultation meeting and subsequently amended and refined by a dedicated task force consisting of country programme implementers, experts in RDT implementation, IVD regulatory experts and manufacturers. This process led to the development of consensus documents with a list of suggested terms and abbreviations as well as specifications for labelling of box, device packaging, cassettes, buffer bottle and accessories (lancets, alcohol swabs, transfer devices, desiccants). Emphasis was placed on durability (permanent printing or water-resistant labels), legibility (font size, letter type), comprehension (use of symbols) and ease of reference (e.g. place of labelling on the box or cassette packaging allowing quick oversight). A generic IFU template was developed, comprising background information, a template for procedure and reading/interpretation, a selection of appropriate references and a symbol key of internationally recognized

Adoption and Design of Emerging Dietary Policies to Improve Cardiometabolic Health in the US.

Science.gov (United States)

Huang, Yue; Pomeranz, Jennifer; Wilde, Parke; Capewell, Simon; Gaziano, Tom; O'Flaherty, Martin; Kersh, Rogan; Whitsel, Laurie; Mozaffarian, Dariush; Micha, Renata

2018-04-14

Suboptimal diet is a leading cause of cardiometabolic disease and economic burdens. Evidence-based dietary policies within 5 domains-food prices, reformulation, marketing, labeling, and government food assistance programs-appear promising at improving cardiometabolic health. Yet, the extent of new dietary policy adoption in the US and key elements crucial to define in designing such policies are not well established. We created an inventory of recent US dietary policy cases aiming to improve cardiometabolic health and assessed the extent of their proposal and adoption at federal, state, local, and tribal levels; and categorized and characterized the key elements in their policy design. Recent federal dietary policies adopted to improve cardiometabolic health include reformulation (trans-fat elimination), marketing (mass-media campaigns to increase fruits and vegetables), labeling (Nutrition Facts Panel updates, menu calorie labeling), and food assistance programs (financial incentives for fruits and vegetables in the Supplemental Nutrition Assistance Program (SNAP) and Women, Infant and Children (WIC) program). Federal voluntary guidelines have been proposed for sodium reformulation and food marketing to children. Recent state proposals included sugar-sweetened beverage (SSB) taxes, marketing restrictions, and SNAP restrictions, but few were enacted. Local efforts varied significantly, with certain localities consistently leading in the proposal or adoption of relevant policies. Across all jurisdictions, most commonly selected dietary targets included fruits and vegetables, SSBs, trans-fat, added sugar, sodium, and calories; other healthy (e.g., nuts) or unhealthy (e.g., processed meats) factors were largely not addressed. Key policy elements to define in designing these policies included those common across domains (e.g., level of government, target population, dietary target, dietary definition, implementation mechanism), and domain-specific (e.g., media channels

A generic coding approach for the examination of meal patterns.

Science.gov (United States)

Woolhead, Clara; Gibney, Michael J; Walsh, Marianne C; Brennan, Lorraine; Gibney, Eileen R

2015-08-01

Meal pattern analysis can be complex because of the large variability in meal consumption. The use of aggregated, generic meal data may address some of these issues. The objective was to develop a meal coding system and use it to explore meal patterns. Dietary data were used from the National Adult Nutrition Survey (2008-2010), which collected 4-d food diary information from 1500 healthy adults. Self-recorded meal types were listed for each food item. Common food group combinations were identified to generate a number of generic meals for each meal type: breakfast, light meals, main meals, snacks, and beverages. Mean nutritional compositions of the generic meals were determined and substituted into the data set to produce a generic meal data set. Statistical comparisons were performed against the original National Adult Nutrition Survey data. Principal component analysis was carried out by using these generic meals to identify meal patterns. A total of 21,948 individual meals were reduced to 63 generic meals. Good agreement was seen for nutritional comparisons (original compared with generic data sets mean ± SD), such as fat (75.7 ± 29.4 and 71.7 ± 12.9 g, respectively, P = 0.243) and protein (83.3 ± 26.9 and 80.1 ± 13.4 g, respectively, P = 0.525). Similarly, Bland-Altman plots demonstrated good agreement (<5% outside limits of agreement) for many nutrients, including protein, saturated fat, and polyunsaturated fat. Twelve meal types were identified from the principal component analysis ranging in meal-type inclusion/exclusion, varying in energy-dense meals, and differing in the constituents of the meals. A novel meal coding system was developed; dietary intake data were recoded by using generic meal consumption data. Analysis revealed that the generic meal coding system may be appropriate when examining nutrient intakes in the population. Furthermore, such a coding system was shown to be suitable for use in determining meal-based dietary patterns. © 2015

Conflicts about water: a case study about conflict and contest in Dutch rural policy

NARCIS (Netherlands)

Boonstra, W.J.; Frouws, J.

2005-01-01

The Dutch countryside forms the scene for pressing problems of management and allocation of land and water. These problems underscore the need for comprehensive rural policies. For that purpose, area-based rural policy has been initiated. This new policy is part of a larger policy shift, labelled in

Pointing As a Socio-Pragmatic Cue to Particular vs.Generic Reference

Science.gov (United States)

Meyer, Meredith; Baldwin, Dare A.

2013-01-01

Generic noun phrases, or generics, refer to abstract kind categories ("Dogs" bark) rather than particular individuals ("Those dogs" bark). How do children distinguish these distinct kinds of reference? We examined the role of one socio-pragmatic cue, namely pointing, in producing and comprehending generic versus particular…

[Users sceptical about generic drugs: an anthropological approach].

Science.gov (United States)

Sarradon-Eck, A; Blanc, M-A; Faure, M

2007-06-01

Since the enactment of the 2002 legislative measures favoring the prescription of generic drugs, various quantitative studies have shown that approval by prescribers and users has risen in France. Nevertheless, scepticism remains as well as distrust towards these drugs focusing on their effectiveness compared with brand-name drugs, on potential dangers, and on the interruption they cause in prescription and consumption habits. Using a comprehensive approach, this article analyzes the social and cultural logic behind the negative image of generic drugs. The materials issued from an ethnographic study on the prescription of drugs for high blood pressure. Sixty-eight interviews were undertaken between April 2002 and October 2004 with people (39 women and 29 men, between the age of 40 and 95, 52 over the age of 60) treated for over a year for high blood pressure in rural areas in the Southeast of France. Thirteen people provided unsolicited opinions about generic drugs. Analysis of the information collected shows that users have various representations of generic drugs, including the idea of counterfeited and foreign drugs. These representations interfere with the adjustment process and the development of consumer loyalty. They are part of a set of social representations about drugs which form and express the user's reality. In these representations, the drug is an ambivalent object, carrier of both biological effectiveness and toxicity; it is also the metonymical extension of the prescriber, bestowing upon the prescription a symbolic value. By placing the generic drug in its network of symbolic and social meaning, this study highlights the coherence of the scepticism towards generic drugs by consumers (and prescribers) with a system of common opinion in which drugs are everyday things, personalized and compatible with users, symbolic exchange carriers in the physician-patient relationship, and in which confidence in the drug is also that given to the health care

Method for developing cost estimates for generic regulatory requirements

International Nuclear Information System (INIS)

1985-01-01

The NRC has established a practice of performing regulatory analyses, reflecting costs as well as benefits, of proposed new or revised generic requirements. A method had been developed to assist the NRC in preparing the types of cost estimates required for this purpose and for assigning priorities in the resolution of generic safety issues. The cost of a generic requirement is defined as the net present value of total lifetime cost incurred by the public, industry, and government in implementing the requirement for all affected plants. The method described here is for commercial light-water-reactor power plants. Estimating the cost for a generic requirement involves several steps: (1) identifying the activities that must be carried out to fully implement the requirement, (2) defining the work packages associated with the major activities, (3) identifying the individual elements of cost for each work package, (4) estimating the magnitude of each cost element, (5) aggregating individual plant costs over the plant lifetime, and (6) aggregating all plant costs and generic costs to produce a total, national, present value of lifetime cost for the requirement. The method developed addresses all six steps. In this paper, we discuss on the first three

An evaluation of consumers' knowledge, perceptions and attitudes regarding generic medicines in Auckland.

Science.gov (United States)

Babar, Zaheer-Ud-Din; Stewart, Joanna; Reddy, Shiwangni; Alzaher, Woroud; Vareed, Prateeka; Yacoub, Nineweh; Dhroptee, Bandhana; Rew, Anne

2010-08-01

The aim of this project was to evaluate the perceptions, knowledge and attitudes regarding generic medicines. A cross-sectional study, with self administered questionnaires, was conducted to survey consumers visiting pharmacies in four regions of Auckland (North Shore, Waitakere, Central Auckland and South Auckland). Through stratified random sampling, approximately 10% of pharmacies from each region were selected, which turn out to be 30 pharmacies. Every alternate customer coming to the pharmacy, who was eligible to participate in the study, was asked by the researchers to complete the questionnaire. A total of 441 questionnaires were included in the analysis. Different response rates were obtained in different regions of Auckland. Of all respondents, 51.6% had previous knowledge of generic medicines. Pharmacists were the main source of information regarding generic medicines followed by doctors and media. A higher level of education had a direct relationship with having correct knowledge of generics (P = .002). Attitude of participants toward the use of generic medicines was determined by their knowledge of generics, whether it was recommended by a pharmacist and their type of illness. Participants were more prepared to change to a generic for a minor illness (79%) than for a major illness (58.7%). Those who had better knowledge were more likely than those with poor knowledge to say they would to use a generic in major illness (P = .001) as well as minor illness (P < .0001). Previous positive experiences with generics also determined consumers' willingness to use generics. Many consumers have misconceptions regarding generic medicines. Having knowledge about generics and the advice by doctors and pharmacists are key indicators to improve the quality use of generic medicines.

Patients' concern about their medicine after a generic switch

DEFF Research Database (Denmark)

Østergaard Rathe, Jette; Søndergaard, Jens; Jarbøl, Dorte E

2014-01-01

PURPOSE: This study aims to investigate the possible association between patients' concerns about their medicine and generic switch. METHODS: Cross-sectional survey was carried out comprising responses from 2217 randomly selected persons aged 20 years or older and living in the Region of Southern...... Denmark, who had redeemed generically substitutable drugs in September 2008. For each patient, we focused on the purchase of one generically substitutable drug (index drug). We applied the specific concerns subscale from the Beliefs about Medicine Questionnaire (BMQ) to analyse lack of confidence....... RESULTS: No statistically significant associations were found between concerns about the index medicine and the generic switch (-0.02 95% CI: -0.10; 0.05). Viewing medicines as harmful in general was associated with increased concerns (BMQ general harm: 0.39 95% CI: 0.30; 0.47 and BMQ general overuse: 0...

Generic Drugs: Questions and Answers

Science.gov (United States)

... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Drugs Home Drugs Resources for You Information for Consumers (Drugs) Questions & Answers Generic Drugs: Questions & Answers Share Tweet Linkedin Pin it More ...

A Domain-Specific Language for Generic Interlocking Models and Their Properties

DEFF Research Database (Denmark)

Vu, Linh Hong; Haxthausen, Anne Elisabeth; Peleska, Jan

2017-01-01

of this work is to provide a domain-specific language for generic models and an instantiator tool taking not only configuration data but also a generic model as input instead of using a hard-coded generator for instantiating only one fixed generic model and its properties with configuration data....

Bioequivalence and in vitro antimicrobial activity between generic and brand-name levofloxacin.

Science.gov (United States)

Sun, Hsin-Yun; Liao, Hsiao-Wei; Sheng, Meng-Huei; Tai, Hui-Min; Kuo, Ching-Hua; Sheng, Wang-Huei

2016-07-01

Generic agents play a crucial role in reducing the cost of medical care in many countries. However, the therapeutic equivalence remains a great concern. Our study aims to assess the in vitro antimicrobial activity and bioequivalence between generic and brand-name levofloxacin. Enantiomeric purity test, dissolution test, and in vitro antimicrobial susceptibility against seven clinically important pathogens by the agar dilution method were employed to assess the similarity between four generic products and brand-name levofloxacin (Daiichi Sankyo). All the generic and brand-name levofloxacin passed enantiomeric purity test. The results of dissolution tests were not similar among the generic products and the brand-name levofloxacin. Compared with the generic products, the brand-name levofloxacin had the smallest mean variations (-25% to 13%) with reference standard (United States Pharmacopeia levofloxacin Reference Standards). Variations were observed particularly in dissolution profiles and in vitro activity between generic products and brand-name levofloxacin. Copyright © 2016 Elsevier Inc. All rights reserved.

Increased Topical Generic Prices by Manufacturers: An Isolated Trend or Worrisome Future?

Science.gov (United States)

Bhatt, Mehul D; Bhatt, Birju D; Dorrian, James T; McLellan, Beth N

2018-03-12

There is limited data regarding generic medication prices. Recent studies have shown price changes at the retail level, but much is not known about the pharmaceutical supply chain or price changes at the manufacturer level. We sought to examine the extent of price changes for topical generic medications. A comprehensive review of average wholesale prices (AWP) and manufacturers of topical generics and available corresponding branded medications was conducted for 2005 and 2016. A total of 51 topical chemical entities were examined. Between 2005 and 2016, the AWP of topical generics increased by 273% and the AWP of topical branded increased by 379%. The topical generic with the most price change increased by 2529%. Eight of the top twenty topical generics with the highest increase in AWP also had an increase in the number of manufacturers. These findings are not generalizable to medications used in other areas of medicine CONCLUSIONS: Topical generic prices are rapidly increasing at the manufacturer level. Copyright © 2018. Published by Elsevier Inc.

Front of Pack Labels Enhance Attention to Nutrition Information in Novel & Commercial Brands.

Science.gov (United States)

Becker, Mark W; Bello, Nora M; Sundar, Raghav P; Peltier, Chad; Bix, Laura

2015-10-01

1) To assess whether Front-of-Pack (FOP) nutrition labels garner attention more readily than more complete, mandated nutrition information (the Nutrition Facts Panel (NFP), required in the US), and 2) To determine whether label design characteristics, specifically, color coding and/or coding with facial icons, increase attention to the FOP label. In two experiments, we tracked the allocation of attention while participants (n=125) viewed novel and commercial packages with varied FOP designs using a change detection methodology. We found empirical evidence that FOP labels are attended more often, and earlier, than the currently mandated NFP, and that this benefit is due both to its placement on the front of the package and to the design characteristics of the FOP. Specifically, the use of color in FOPs increased attention to the label, but there was no evidence that coding information via facial icons impacted attention. Our work supports a growing body of evidence supporting the use of FOP labels to attract attention to nutritional information. Findings may be relevant to inform policy decisions on labeling standards.

Pharmaceutical policies in European countries.

Science.gov (United States)

Barros, Pedro Pita

2010-01-01

Pharmaceutical expenditures have an important role in Europe. The attempts to control expenditure have used a wide range of policy measures. We reviewed the main measures adopted by the European Union countries, especially in countries where governments are the largest third-party payers. To complement a literature review on the topic, data was gathered from national reviews of health systems and direct inquiries to several government bodies. Almost all countries regulate prices of pharmaceutical products. Popular policy measures include international referencing to set prices (using as benchmark countries that have set lower prices), internal reference pricing systems to promote price competition in domestic markets, and positive lists for reimbursement to promote consumption of generics (including in some cases substitution by pharmacists of drugs prescribed by physicians). Despite the wide range of policy measures, it is not possible to identify a "silver bullet" to control pharmaceutical expenditures. We also identified two main policy challenges: policy coordination among countries within the European Union to maintain incentives for R&D at the global level, and the development of new relationships with the pharmaceutical industry; namely, the so-called risk-sharing agreements between the pharmaceutical industry and governments/regulators (or large third-party payers).

Feather segmentation to discriminate between different enrofloxacin treatments in order to monitor off-label use in the poultry sector.

Science.gov (United States)

Jansen, Larissa J M; Bolck, Yvette J C; Berendsen, Bjorn J A

2016-01-01

Antibiotics are commonly used in the poultry industry to treat bacterial infections. In the combat against bacterial resistance, policies require, besides a reduction of antibiotic usage in humans and animals, an up-to-date farmer registration mentioning all treatments. For enforcement of such policies, tests are needed to antedate administration and to determine the type of treatment so as to prevent off-label use and the supervacaneous use of last-resort antibiotics like cephalosporins and fluoroquinolones. After poultry treatment, high amounts of enrofloxacin and its metabolite ciprofloxacin are deposited in chicken feathers. A method is presented to discriminate different treatments based on differentiating extractable and non-extractable enrofloxacin and ciprofloxacin in chicken feathers. With this approach, we show it is possible to distinguish between a registered therapeutic oral treatment, an off-label spray treatment and an illegal prolonged sub-therapeutic treatment with enrofloxacin. This approach is a new and strong tool in the enforcement of new policies in the fight against off-label and supervacaneous antibiotic use.

Guide for generic application of Reliability Centered Maintenance (RCM) recommendations

International Nuclear Information System (INIS)

Schwan, C.A.; Toomey, G.E.; Morgan, T.A.; Darling, S.S.

1991-02-01

Previously completed reliability centered maintenance (RCM) studies form the basis for developing or refining a preventive maintenance program. This report describes a generic methodology that will help utilities optimize nuclear plant maintenance programs using RCM techniques. This guide addresses the following areas: history of the generic methodology development process, and use of the generic methodology for conducting system-to-system and component-to-component evaluations. 2 refs., 2 figs., 5 tabs

When Does an Argument Use a Generic Example?

Science.gov (United States)

Yopp, David A.; Ely, Rob

2016-01-01

We offer criteria that an observer can use to determine whether an argument that uses an example to argue for a general claim appeals to that example generically. We review existing literature on generic example and note the strengths of each contribution, as well as inconsistencies among uses of the term. We offer several examples from the…

The generics in transplantation and the rules on their use.

Science.gov (United States)

Masri, Marwan

2003-06-01

By definition a product identified by its official chemical name rather than an advertised brand name is called a generic. If a drug exert its pharmacological effects at the same site, have the same potency, same dosage form and same bioavailability as a brand name, reference listed drug (RLD), is considered as a generic. However inactive ingredients can differ between brand name and generic. It is through the regulations of the FDA that the generics gained many ground in the drug market, they currently account to more than 42% of the total prescription in the USA. These regulations include the abbreviated new drug application (ANDA) for the registration process and drug substitution at the pharmacy level without patient or physician consent. This coupled with a keen interest of third party payers and the health authorities to reduce the high transplant health budget (over 2 Billion US $) made it a necessity to introduce the generics into the field of transplantation. Using the above mentioned definition we can theoretically say that all anti-lymphocytes, produced in the same animal species, are generic of each. Moreover, monoclonal antibodies that are directed against the same target and have the same bioavailability are also consider generics to each other. Of all the immunosuppressive drugs that have been introduced into the field of transplantation none has been as dominant as Cyclosporine. Cyclosporine became and still is the backbone for any immunosuppressive protocol. In the year 1992, Consupren, the first, non-FDA approved, generic to Sandimmun was introduced. Although Consupren was not bioequivalent to Neoral, however, long-term results in kidney transplantation have been similar for both drugs. The introduction of Consupren resulted in a near 40% reduction in the total cost of immunosuppressive therapy. Interestingly the cost of the brand name drug Neoral was also reduced by 20%. The cost reduction allowed the introduction of the new immunosuppressive

The SENSEI Generic In Situ Interface

Energy Technology Data Exchange (ETDEWEB)

Ayachit, Utkarsh [Kitware, Inc., Clifton Park, NY (United States); Whitlock, Brad [Intelligent Light, Rutherford, NJ (United States); Wolf, Matthew [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Loring, Burlen [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Geveci, Berk [Kitware, Inc., Clifton Park, NY (United States); Lonie, David [Kitware, Inc., Clifton Park, NY (United States); Bethel, E. Wes [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States)

2017-04-11

The SENSEI generic in situ interface is an API that promotes code portability and reusability. From the simulation view, a developer can instrument their code with the SENSEI API and then make make use of any number of in situ infrastructures. From the method view, a developer can write an in situ method using the SENSEI API, then expect it to run in any number of in situ infrastructures, or be invoked directly from a simulation code, with little or no modification. This paper presents the design principles underlying the SENSEI generic interface, along with some simplified coding examples.

Comparison of Outcomes Following a Switch From a Brand to an Authorized Versus Independent Generic Drug.

Science.gov (United States)

Hansen, R A; Qian, J; Berg, R L; Linneman, J G; Seoane-Vazquez, E; Dutcher, S; Raofi, S; Page, C D; Peissig, P L

2018-02-01

Authorized generics are identical in formulation to brand drugs, manufactured by the brand company but marketed as a generic. Generics, marketed by generic manufacturers, are required to demonstrate pharmaceutical and bioequivalence to the brand drug, but repetition of clinical trials is not required. This retrospective cohort study compared outcomes for generics and authorized generics, which serves as a generic vs. brand proxy that minimizes bias against generics. For the seven drugs studied between 1999 and 2014, 5,234 unique patients were on brand drugs prior to generic entry and 4,900 (93.6%) switched to a generic. During the 12 months following the brand-to-generic switch, patients using generics vs. authorized generics were similar in terms of outpatient visits, urgent care visits, hospitalizations, and medication discontinuation. The likelihood of emergency department (ED) visits was slightly higher for authorized generics compared with generics. These data suggest that generics were clinically no worse than their proxy brand comparators. © 2017 American Society for Clinical Pharmacology and Therapeutics.

40 CFR 721.10146 - Partially fluorinated condensation polymer (generic).

Science.gov (United States)

2010-07-01

... polymer (generic). 721.10146 Section 721.10146 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Specific Chemical Substances § 721.10146 Partially fluorinated condensation polymer (generic). (a) Chemical... as partially fluorinated condensation polymer (PMN P-07-87) is subject to reporting under this...

Calorie estimation accuracy and menu labeling perceptions among individuals with and without binge eating and/or purging disorders.

Science.gov (United States)

Roberto, Christina A; Haynos, Ann F; Schwartz, Marlene B; Brownell, Kelly D; White, Marney A

2013-09-01

Menu labeling is a public health policy that requires chain restaurants in the USA to post kilocalorie information on their menus to help consumers make informed choices. However, there is concern that such a policy might promote disordered eating. This web-based study compared individuals with self-reported binge eating disorder (N = 52), bulimia nervosa (N = 25), and purging disorder (N = 17) and those without eating disorders (No ED) (N = 277) on restaurant calorie information knowledge and perceptions of menu labeling legislation. On average, people answered 1.46 ± 1.08 questions correctly (out of 6) (25%) on a calorie information quiz and 92% of the sample was in favor of menu labeling. The findings did not differ based on eating disorder, dieting, or weight status, or race/ethnicity. The results indicated that people have difficulty estimating the calories in restaurant meals and individuals with and without eating disorders are largely in favor of menu labeling laws.

Label, nudge or tax? A review of health policies for risky behaviours.

Science.gov (United States)

Galizzi, Matteo M

2012-02-17

This work proposes a critical, non systematic, review of the three main lines of health policy interventions to deal with risky behaviours, such as over-eating, smoking, sedentary lives, and excess alcohol drinking, namely: i) the release of information on health risks and consequences; ii) the use of incentives; and iii) direct policy intervention in markets, through regulation and taxation. First, the health and economic impact of the risky behaviours epidemics are briefly described. Then a critical review follows on the evidence existing on the effectiveness of each type of intervention. The review will also highlight the public health approach staying beyond each type of policy on risky behaviours and critically consider them within the context of more general health and social policy interventions.

40 CFR 721.10151 - Modified styrene, divinylbenzene polymer (generic).

Science.gov (United States)

2010-07-01

... polymer (generic). 721.10151 Section 721.10151 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Specific Chemical Substances § 721.10151 Modified styrene, divinylbenzene polymer (generic). (a) Chemical... as modified styrene, divinylbenzene polymer (PMN P-07-642) is subject to reporting under this section...

Model of a Generic Natural Uranium Conversion Plant ? Suggested Measures to Strengthen International Safeguards

Energy Technology Data Exchange (ETDEWEB)

Raffo-Caiado, Ana Claudia [ORNL; Begovich, John M [ORNL; Ferrada, Juan J [ORNL

2009-11-01

This is the final report that closed a joint collaboration effort between DOE and the National Nuclear Energy Commission of Brazil (CNEN). In 2005, DOE and CNEN started a collaborative effort to evaluate measures that can strengthen the effectiveness of international safeguards at a natural uranium conversion plant (NUCP). The work was performed by DOE s Oak Ridge National Laboratory and CNEN. A generic model of a NUCP was developed and typical processing steps were defined. Advanced instrumentation and techniques for verification purposes were identified and investigated. The scope of the work was triggered by the International Atomic Energy Agency s 2003 revised policy concerning the starting point of safeguards at uranium conversion facilities. Prior to this policy only the final products of the uranium conversion plant were considered to be of composition and purity suitable for use in the nuclear fuel cycle and therefore, subject to the IAEA safeguards control. DOE and CNEN have explored options for implementing the IAEA policy, although Brazil understands that the new policy established by the IAEA is beyond the framework of the Quadripartite Agreement of which it is one of the parties, together with Argentina, the Brazilian-Argentine Agency for Accounting and Control of Nuclear Materials (ABACC) and the IAEA. Two technical papers on this subject were published at the 2005 and 2008 INMM Annual Meetings.

Developing a generic environmental safety case

International Nuclear Information System (INIS)

Bailey, Lucy

2014-01-01

The Nuclear Decommissioning Authority (NDA) has been charged with implementing the United Kingdom government's policy for the long-term management of higher activity radioactive waste by planning, building and operating a geological disposal facility (GDF). Within the NDA, we - the Radioactive Waste Management Directorate (RWMD) - are tasked with the development of a GDF. The UK government has also decided that a process of voluntarism and partnership will be followed to identify a suitable site for the GDF. To date there is no volunteer community and the site selection process to find a volunteer host community is under review. RWMD has an ongoing role to provide advice to UK radioactive waste producers on the conditioning and packaging of wastes and to undertake disposability assessments of waste packaging proposals to determine their suitability for eventual disposal in a GDF. We also need to demonstrate our confidence that a GDF would be safe. Therefore RWMD has published a generic Environmental Safety Case (ESC) (NDA, 2010) to demonstrate that we are confident that a GDF could be developed to meet the guidelines set down by the environmental regulators (EA/NIEA, 2009) in a range of geological settings. The ESC includes reference case calculations that are used as a benchmark for disposability assessments. (author)

Generic task problem descriptions: Category B, C, and D tasks

International Nuclear Information System (INIS)

1978-06-01

This document contains information relating to Category B, C, and D generic technical activities. The specific information provided for each task includes the reactor type to which the generic issue applies, the NRC division with lead responsibility and a description of the problem to be addressed by the task. Also provided in this document is a listing of Category A generic technical activities and definitions of Priority Categories A, B, C, and D

Impact of pharmaceutical policy interventions on utilization of antipsychotic medicines in Finland and Portugal in times of economic recession : interrupted time series analyses

NARCIS (Netherlands)

Leopold, Christine; Zhang, Fang; Mantel-Teeuwisse, Aukje K|info:eu-repo/dai/nl/266775098; Vogler, Sabine; Valkova, Silvia; Ross-Degnan, Dennis; Wagner, Anita K

2014-01-01

OBJECTIVES: To analyze the impacts of pharmaceutical sector policies implemented to contain country spending during the economic recession--a reference price system in Finland and a mix of policies including changes in reimbursement rates, a generic promotion campaign and discounts granted to the

Mandating nutrient menu labeling in restaurants: potential public health benefits.

Science.gov (United States)

Stran, Kimberly A; Turner, Lori W; Knol, Linda

2013-03-01

Many Americans have replaced home-cooked meals with fast food and restaurants meals. This contributes to increased incidences of overweight and obesity. Implementing policies that require restaurants to disclose nutrition information has the potential to improve nutrition knowledge and food behaviors. The purpose of this paper was to examine the potential health benefits of nutrient menu labeling in restaurants, the progress of this legislation and to provide results regarding the implementation of these policies. Data sources were obtained from a search of multiple databases including PubMed, Science Direct, Academic Search Premier, and Google Scholar. Study inclusion criteria were publication in the past ten years, obesity prevention, and utilization of nutrition labeling on menus in restaurants. The initial policies to provide consumers with nutrition information in restaurant settings began at the state levels in 2006. These laws demonstrated success, other states followed, and a national law was passed and is being implemented. Mandating nutrient menu disclosure has the potential to influence a large number of people; this legislation has the opportunity to impact Americans who dine at a fast food or chain restaurant. Given the growing obesity epidemic, continued research is necessary to gauge the effectiveness of this new law and its effects on the health status of the American people.

Factors influencing the preference for purchasing generic drugs in a Southern Brazilian city.

Science.gov (United States)

Guttier, Marília Cruz; Silveira, Marysabel Pinto Telis; Luiza, Vera Lucia; Bertoldi, Andréa Dâmaso

2017-06-26

The objective of this study is to identify factors associated with the preference for purchasing generic drugs in a medium-sized municipality in Southern Brazil. We have analyzed data from a population-based cross-sectional study conducted in 2012 with a sample of 2,856 adults (≥ 20 years old). The preference for purchasing generic drugs was the main outcome. The explanatory variables were the demographic and socioeconomic variables. Statistical analyses included Poisson regressions. The preference for purchasing generic drugs was 63.2% (95%CI 61.4-64.9). The variables correlated with this preference in the fully adjusted models were: male (prevalence ratio [PR] = 1.08; 95%CI 1.03-1.14), age of 20-39 years (PR = 1.10; 95%CI 1.02-1.20), low socioeconomic status (PR = 1.15; 95%CI 1.03-1.28), and good knowledge about generic drugs (PR= 4.66; 95%CI 2.89-7.52). Among those who preferred to purchase generic drugs, 55.1% have reported accepting to replace the prescribed drug (if not a generic) with the equivalent generic drug. Another correlate of the preference for purchasing generic drugs was because individuals consider their quality equivalent to reference medicines (PR = 2.15; 95%CI 1.93-2.41). Knowledge about generic drugs was the main correlate of the preference for purchasing generic drugs. The greater the knowledge or positive perception about generic drugs, the greater is the preference to purchase them. Therefore, educational campaigns for healthcare professionals and consumers appear to be the best strategy for expanding the use of generic drugs in Brazil.

Analysis of Knowledge Level and Perception on Singkawang City Community towards Generic Medicines

Directory of Open Access Journals (Sweden)

Forid Morison

2015-03-01

Full Text Available Survey data show that the use of generic medicines in Indonesia is relatively very small, which only amounted 7%. This is due to lack of knowledge and poor perceptions towards generic medicines. Knowledge level and perceptions towards generic medicines are inflenced by community characteristics and information resource regarding generic medicines. The aim of this study was to determine the association between community characteristic and information resources with knowledge level and perception towards generic medicines. This study was an analytical survey with cross-sectional descriptive approach on 142 selected respondents who were fulfi inclusion and exclusion criteria. This study was conducted in June 2014 at several randomly selected locations on Singkawang City. The study show that 76 respondents (53.5% had inadequate knowledge and 123 respondents (86.6% had a good perception towards generic medicines. There is signifiant relationship between ethnicity (p=0.000 and information resources (p=0.009 with knowledge level regarding generic medicines at signifiance level of p<0.05. Although good perceptions were noted among the respondents, widespread dissemination of information regarding generic medicines should be continued to increase generic medicines used.

77 FR 60125 - Generic Drug Facilities, Sites and Organizations

Science.gov (United States)

2012-10-02

...] Generic Drug Facilities, Sites and Organizations AGENCY: Food and Drug Administration, HHS. ACTION: Notice..., and certain sites and organizations identified in a generic drug submission, that they must provide... and Innovation Act (FDASIA). This notice is intended to help organizations ascertain if they need to...

Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada.

Science.gov (United States)

Kuribayashi, Ryosuke; Appleton, Scott

2017-09-01

Generic drugs are assuming an increasingly important role in sustaining modern healthcare systems, as the cost of healthcare, including drug usage, is gradually expanding around the world. To date, published articles comparing generic drug reviews between different countries are scarce. The objective of this study was to examine generic drug reviews in Japan and Canada. We surveyed generic drug reviews from Japan and Canada and compared the following points: general matter (application types, type of partial change or Supplement to an Abbreviated New Drug Submission, application and approval numbers, review period, application format, review report, responsibility for review), bioequivalence studies for solid oral dosage forms, and bioequivalence guidelines, guidance, or basic principles regarding various dosage forms. This survey described the many similarities and differences in generic drug reviews between the two countries and points that should be improved to promote better generic drug reviews. In particular, regulations for the definition of the same or different active pharmaceutical ingredients (APIs) are similar for both authorities. The results clarified the future challenges of generic drug reviews, and the differences highlighted by this survey will be important considerations for the future. This is the first article to present and discuss the details of generic drug reviews between Japan and Canada.

Label, nudge or tax? A review of health policies for risky behaviours

Directory of Open Access Journals (Sweden)

Matteo M. Galizzi

2012-02-01

Full Text Available This work proposes a critical, non systematic, review of the three main lines of health policy interventions to deal with risky behaviours, such as over-eating, smoking, sedentary lives, and excess alcohol drinking, namely: i the release of information on health risks and consequences; ii the use of financial incentives; and iii direct policy intervention in markets, through regulation and taxation. First, the health and economic impact of the risky behaviours epidemics are briefly described. Then a critical review follows on the evidence existing on the effectiveness of each type of intervention. The review will also highlight the public health approach staying beyond each type of policy on risky behaviours and critically consider them within the context of more general health and social policy interventions.

An economic evaluation of salt reduction policies to reduce coronary heart disease in England: a policy modeling study.

Science.gov (United States)

Collins, Marissa; Mason, Helen; O'Flaherty, Martin; Guzman-Castillo, Maria; Critchley, Julia; Capewell, Simon

2014-07-01

Dietary salt intake has been causally linked to high blood pressure and increased risk of cardiovascular events. Cardiovascular disease causes approximately 35% of total UK deaths, at an estimated annual cost of £30 billion. The World Health Organization and the National Institute for Health and Care Excellence have recommended a reduction in the intake of salt in people's diets. This study evaluated the cost-effectiveness of four population health policies to reduce dietary salt intake on an English population to prevent coronary heart disease (CHD). The validated IMPACT CHD model was used to quantify and compare four policies: 1) Change4Life health promotion campaign, 2) front-of-pack traffic light labeling to display salt content, 3) Food Standards Agency working with the food industry to reduce salt (voluntary), and 4) mandatory reformulation to reduce salt in processed foods. The effectiveness of these policies in reducing salt intake, and hence blood pressure, was determined by systematic literature review. The model calculated the reduction in mortality associated with each policy, quantified as life-years gained over 10 years. Policy costs were calculated using evidence from published sources. Health care costs for specific CHD patient groups were estimated. Costs were compared against a "do nothing" baseline. All policies resulted in a life-year gain over the baseline. Change4life and labeling each gained approximately 1960 life-years, voluntary reformulation 14,560 life-years, and mandatory reformulation 19,320 life-years. Each policy appeared cost saving, with mandatory reformulation offering the largest cost saving, more than £660 million. All policies to reduce dietary salt intake could gain life-years and reduce health care expenditure on coronary heart disease. Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Restructuring energy systems for sustainability? Energy transition policy in the Netherlands

International Nuclear Information System (INIS)

Kern, Florian; Smith, Adrian

2008-01-01

Increasingly, researchers and policy makers are confronting the challenge of restructuring energy systems into more sustainable forms. A 'transition management' model, and its adoption in the Netherlands, is attracting attention. Starting from the socio-technical multi-level theory that informs 'transition management', we analyse the 'energy transition' project carried out by the Dutch Ministry of Economic Affairs. Despite considerable achievements, their approach risks capture by the incumbent energy regime, thereby undermining original policy ambitions for structural innovation of the energy system. This experience presents generic dilemmas for transitions approaches

Generic legislation of new psychoactive drugs.

Science.gov (United States)

van Amsterdam, Jan; Nutt, David; van den Brink, Wim

2013-03-01

New psychoactive drugs (NPDs, new psychoactive substances) enter the market all the time. However, it takes several months to ban these NPDs and immediate action is generally not possible. Several European countries and drug enforcement officers insist on a faster procedure to ban NPDs. Introduction of generic legislation, in which clusters of psychotropic drugs are banned in advance, has been mentioned as a possible solution. Here we discuss the pros and cons of such an approach. First, generic legislation could unintentionally increase the expenditures of enforcement, black market practices, administrative burden and health risks for users. Second, it may have a negative impact on research and the development of new treatments. Third, due to the complexity of generic legislation, problems in the enforcement are anticipated due to lack of knowledge about the chemical nomenclature. Finally, various legal options are already available to ban the use, sale and trade of NPDs. We therefore conclude that the currently used scientific benefit-risk evaluation should be continued to limit the adverse health effects of NPDs. Only in emergency cases, where fatal incidents (may) occur, should this approach be overruled.

The attractions of medicine: the generic motivations of medical school applicants in relation to demography, personality and achievement

Directory of Open Access Journals (Sweden)

Katona Cornelius

2006-02-01

Full Text Available Abstract Background The motivational and other factors used by medical students in making their career choices for specific medical specialities have been looked at in a number of studies in the literature. There are however few studies that assess the generic factors which make medicine itself of interest to medical students and to potential medical students. This study describes a novel questionnaire that assesses the interests and attractions of different aspects of medical practice in a varied range of medical scenarios, and relates them to demographic, academic, personality and learning style measures in a large group of individuals considering applying to medical school. Methods A questionnaire study was conducted among those attending Medlink, a two-day conference for individuals considering applying to medical school for a career in medicine. The main outcome measure was the Medical Situations Questionnaire, in which individuals ranked the attraction of three different aspects of medical practise in each of nine detailed, realistic medical scenarios in a wide range of medical specialities. As well as requiring clear choices, the questionnaire was also designed so that all of the possible answers were attractive and positive, thereby helping to eliminate social demand characteristics. Factor analysis of the responses found four generic motivational dimensions, which we labelled Indispensability, Helping People, Respect and Science. Background factors assessed included sex, ethnicity, class, medical parents, GCSE academic achievement, the 'Big Five' personality factors, empathy, learning styles, and a social desirability scale. Results 2867 individuals, broadly representative of applicants to medical schools, completed the questionnaire. The four generic motivational factors correlated with a range of background factors. These correlations were explored by multiple regression, and by path analysis, using LISREL to assess direct and

The attractions of medicine: the generic motivations of medical school applicants in relation to demography, personality and achievement.

Science.gov (United States)

McManus, I C; Livingston, G; Katona, Cornelius

2006-02-21

The motivational and other factors used by medical students in making their career choices for specific medical specialities have been looked at in a number of studies in the literature. There are however few studies that assess the generic factors which make medicine itself of interest to medical students and to potential medical students. This study describes a novel questionnaire that assesses the interests and attractions of different aspects of medical practice in a varied range of medical scenarios, and relates them to demographic, academic, personality and learning style measures in a large group of individuals considering applying to medical school. A questionnaire study was conducted among those attending Medlink, a two-day conference for individuals considering applying to medical school for a career in medicine. The main outcome measure was the Medical Situations Questionnaire, in which individuals ranked the attraction of three different aspects of medical practise in each of nine detailed, realistic medical scenarios in a wide range of medical specialities. As well as requiring clear choices, the questionnaire was also designed so that all of the possible answers were attractive and positive, thereby helping to eliminate social demand characteristics. Factor analysis of the responses found four generic motivational dimensions, which we labelled Indispensability, Helping People, Respect and Science. Background factors assessed included sex, ethnicity, class, medical parents, GCSE academic achievement, the 'Big Five' personality factors, empathy, learning styles, and a social desirability scale. 2867 individuals, broadly representative of applicants to medical schools, completed the questionnaire. The four generic motivational factors correlated with a range of background factors. These correlations were explored by multiple regression, and by path analysis, using LISREL to assess direct and indirect effects upon the factors. Helping People was

Nutrition labelling and the choices logo in Israel: positions and perceptions of leading health policy makers.

Science.gov (United States)

Gesser-Edelsburg, A; Endevelt, R; Tirosh-Kamienchick, Y

2014-02-01

Based on the Social Marketing approach and Diffusion of Innovations Theory that indicates the importance of opinion leaders with respect to the spreading of new ideas, concepts or practices within a community, the present study aimed to examine positions and perceptions of Israeli leading dietitians and health officials regarding nutrition labelling and the Choices logo, before it was launched in Israel in February 2011, as well as how they would communicate it to the public as agents of influence. The study involved in-depth face-to-face and telephone interviews with 15 senior dietitians and Health Ministry officials using semi-structured protocols including questions about nutrition labelling and the Choices logo. The respondents considered that the nutrition facts panels usually found on the backs of packages are too complicated for the average consumer. Simiularly, fronts of packages are cluttered with advertisements and health claims, causing confusion. The study participants would like to see an integrative label on the front of the package to facilitate consumers' decisions. However, the Choices logo raises ethical and social questions about the conflict between corporate interests and public health: (i) the label's relativity versus objectivity; (ii) the consumer's responsibility to create a balanced diet; (iii) the label's credibility; and (iv) bias against companies, products and audiences. The results of the present study highlight the importance of a need for an integrated programme of nutrition promotion, including the use of social marketing based on a cooperative effort between the food industry, regulators and professionals, to recommend changes and adjustments in nutritional front of package labelling with the aim of promoting healthier nutrition consumption. © 2013 The Authors Journal of Human Nutrition and Dietetics © 2013 The British Dietetic Association Ltd.

A Generic Danish Distribution Grid Model for Smart Grid Technology Testing

DEFF Research Database (Denmark)

Cha, Seung-Tae; Wu, Qiuwei; Østergaard, Jacob

2012-01-01

This paper describes the development of a generic Danish distribution grid model for smart grid technology testing based on the Bornholm power system. The frequency dependent network equivalent (FDNE) method has been used in order to accurately preserve the desired properties and characteristics...... as a generic Smart Grid benchmark model for testing purposes....... by comparing the transient response of the original Bornholm power system model and the developed generic model under significant fault conditions. The results clearly show that the equivalent generic distribution grid model retains the dynamic characteristics of the original system, and can be used...

Endogenous versus exogenous generic reference pricing for pharmaceuticals.

Science.gov (United States)

Antoñanzas, F; Juárez-Castelló, C A; Rodríguez-Ibeas, R

2017-12-01

In this paper we carry out a vertical differentiation duopoly model applied to pharmaceutical markets to analyze how endogenous and exogenous generic reference pricing influence competition between generic and branded drugs producers. Unlike the literature, we characterize for the exogenous case the equilibrium prices for all feasible relevant reference prices. Competition is enhanced after the introduction of a reference pricing system. We also compare both reference pricing systems on welfare grounds, assuming two different objective functions for health authorities: (i) standard social welfare and (ii) gross consumer surplus net of total pharmaceutical expenditures. We show that regardless of the objective function, health authorities will never choose endogenous reference pricing. When health authorities are paternalistic, the exogenous reference price that maximizes standard social welfare is such that the price of the generic drug is the reference price while the price of the branded drug is higher than the reference price. When health authorities are not paternalistic, the optimal exogenous reference price is such that the price of the branded drug is the reference price while the price of the generic drug is lower than the reference price.

Development of a generic virus behavioural detector: a preview ...

African Journals Online (AJOL)

The Generic Virus Behavioral Detector (GVBD) is a system (program) that monitors various system activities; reading and writing block of disks and memory and the use of Interrupts. A technique for its realisation is presented. Key Words: Computer virus, interrupts, handlers, GVBD (Generic Virus Behavioral Detector).

The Role of Quality Labels in Market-Driven Animal Welfare

DEFF Research Database (Denmark)

Heerwagen, L. R.; Mørkbak, M. R.; Denver, S.

2015-01-01

In policy-making the consumption of specially labelled products, and its role in improving the welfare of livestock, has attracted considerable attention. There is in many countries a diverse market for animal welfare-friendly products which is potentially confusing and may lack transparency. We...... ask whether special quality labels that involve medium levels of animal welfare, as compared with labels promoting premium levels of animal welfare, have a role to play in promoting improvements in animal welfare. The Danish pork market is our reference case, but we also widen the context by comparing...... the markets for pork in three other European countries. Our findings suggest that in order to improve animal welfare through demand for welfare-friendly products it is important to maintain separate the market for products with strong animal welfare profiles from markets for products with medium levels...

Co-Labeling for Multi-View Weakly Labeled Learning.

Science.gov (United States)

Xu, Xinxing; Li, Wen; Xu, Dong; Tsang, Ivor W

2016-06-01

It is often expensive and time consuming to collect labeled training samples in many real-world applications. To reduce human effort on annotating training samples, many machine learning techniques (e.g., semi-supervised learning (SSL), multi-instance learning (MIL), etc.) have been studied to exploit weakly labeled training samples. Meanwhile, when the training data is represented with multiple types of features, many multi-view learning methods have shown that classifiers trained on different views can help each other to better utilize the unlabeled training samples for the SSL task. In this paper, we study a new learning problem called multi-view weakly labeled learning, in which we aim to develop a unified approach to learn robust classifiers by effectively utilizing different types of weakly labeled multi-view data from a broad range of tasks including SSL, MIL and relative outlier detection (ROD). We propose an effective approach called co-labeling to solve the multi-view weakly labeled learning problem. Specifically, we model the learning problem on each view as a weakly labeled learning problem, which aims to learn an optimal classifier from a set of pseudo-label vectors generated by using the classifiers trained from other views. Unlike traditional co-training approaches using a single pseudo-label vector for training each classifier, our co-labeling approach explores different strategies to utilize the predictions from different views, biases and iterations for generating the pseudo-label vectors, making our approach more robust for real-world applications. Moreover, to further improve the weakly labeled learning on each view, we also exploit the inherent group structure in the pseudo-label vectors generated from different strategies, which leads to a new multi-layer multiple kernel learning problem. Promising results for text-based image retrieval on the NUS-WIDE dataset as well as news classification and text categorization on several real-world multi

Placebo Responses to Original vs. Generic ASA Brands During Exposure to Noxious Heat: A Pilot fMRI Study of Neurofunctional Correlates.

Science.gov (United States)

Fehse, Kai; Maikowski, Lea; Simmank, Fabian; Gutyrchik, Evgeny; Meissner, Karin

2015-10-01

We studied the expectation effects associated with brands by labeling placebo interventions (original and generic analgesic) and investigating the potential differences in efficacy between the two placebos in dealing with noxious heat pain, as well as exploring the neurometabolic correlates of the placebo response. We applied a two by two design with two identical placebo interventions that differed only in their labeling. One group was told that they received 500 mg of "Aspirin" (original brand) while the other group was told that they received a popular ASA generic (1A Pharma). After establishing the individual pain level of each subject, we measured pain intensities behaviorally before and after the intervention and looked for corresponding brain areas with increased hemodynamic response using functional magnetic resonance imaging. At the behavioral level, we found decreases in pain intensity from baseline to the intervention condition with the original brand only. At the neuronal level, we specifically observed activations of the anterior insulae under the baseline conditions, complemented by activations of the dorsomedial prefrontal cortex after the interventions. A direct comparison of the two placebo conditions revealed higher values of activation for the bilateral dorsolateral (as well as dorsomedial) prefrontal cortex for the original brand. Our data indicate a behavioral placebo response for the original brand only. Expectations by subjects appear to be triggered not only by the placebo treatment itself but also by the trusted brand, which thus serves as an enhanced placebo. Both processes appear to be based on fronto-cortical neural networks, as these areas showed significantly stronger activations with the original brand. Wiley Periodicals, Inc.

Factors influencing the preference for purchasing generic drugs in a Southern Brazilian city

Directory of Open Access Journals (Sweden)

Marília Cruz Guttier

Full Text Available ABSTRACT OBJECTIVE The objective of this study is to identify factors associated with the preference for purchasing generic drugs in a medium-sized municipality in Southern Brazil. METHODS We have analyzed data from a population-based cross-sectional study conducted in 2012 with a sample of 2,856 adults (≥ 20 years old. The preference for purchasing generic drugs was the main outcome. The explanatory variables were the demographic and socioeconomic variables. Statistical analyses included Poisson regressions. RESULTS The preference for purchasing generic drugs was 63.2% (95%CI 61.4–64.9. The variables correlated with this preference in the fully adjusted models were: male (prevalence ratio [PR] = 1.08; 95%CI 1.03–1.14, age of 20–39 years (PR = 1.10; 95%CI 1.02–1.20, low socioeconomic status (PR = 1.15; 95%CI 1.03–1.28, and good knowledge about generic drugs (PR= 4.66; 95%CI 2.89–7.52. Among those who preferred to purchase generic drugs, 55.1% have reported accepting to replace the prescribed drug (if not a generic with the equivalent generic drug. Another correlate of the preference for purchasing generic drugs was because individuals consider their quality equivalent to reference medicines (PR = 2.15; 95%CI 1.93–2.41. CONCLUSIONS Knowledge about generic drugs was the main correlate of the preference for purchasing generic drugs. The greater the knowledge or positive perception about generic drugs, the greater is the preference to purchase them. Therefore, educational campaigns for healthcare professionals and consumers appear to be the best strategy for expanding the use of generic drugs in Brazil.

75 FR 45130 - Draft Compliance Policy Guide Sec. 690.800 Salmonella

Science.gov (United States)

2010-08-02

... humans, such as pet food and pet treats, contaminated with Salmonella and also on regulatory policy... Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send two self-addressed adhesive labels to assist that office in processing your...

40 CFR 721.10017 - Amine terminated bisphenol A diglycidyl ether polymer (generic).

Science.gov (United States)

2010-07-01

... diglycidyl ether polymer (generic). 721.10017 Section 721.10017 Protection of Environment ENVIRONMENTAL... ether polymer (generic). (a) Chemical substances and significant new uses subject to reporting. (1) The chemical substances identified generically as amine terminated bisphenol A diglycidyl ether polymer (PMNs P...

GENERIC DRUG IN GLOBAL MARKET AND REGULATORY ENVIRONMENT

OpenAIRE

Pankaj Kumar*, Bharti Mangla2, Satbir Singh, Arapna Rana

2017-01-01

Different regulatory authorities regulate the drug development in various countries of the world. Various Regulatory authority for generic drug application Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceutical and Medical Devices Agency (PMDA), Health Product and Food Branch (HPFB) Central Drug Standard of Organization (CDSO). Generic manufacturers may file an abbreviated New Drug Application (ANDA) that incorporates the safety/effectiveness data submitted by ori...

Generic information can retrieve known biological associations: implications for biomedical knowledge discovery.

Directory of Open Access Journals (Sweden)

Herman H H B M van Haagen

Full Text Available MOTIVATION: Weighted semantic networks built from text-mined literature can be used to retrieve known protein-protein or gene-disease associations, and have been shown to anticipate associations years before they are explicitly stated in the literature. Our text-mining system recognizes over 640,000 biomedical concepts: some are specific (i.e., names of genes or proteins others generic (e.g., 'Homo sapiens'. Generic concepts may play important roles in automated information retrieval, extraction, and inference but may also result in concept overload and confound retrieval and reasoning with low-relevance or even spurious links. Here, we attempted to optimize the retrieval performance for protein-protein interactions (PPI by filtering generic concepts (node filtering or links to generic concepts (edge filtering from a weighted semantic network. First, we defined metrics based on network properties that quantify the specificity of concepts. Then using these metrics, we systematically filtered generic information from the network while monitoring retrieval performance of known protein-protein interactions. We also systematically filtered specific information from the network (inverse filtering, and assessed the retrieval performance of networks composed of generic information alone. RESULTS: Filtering generic or specific information induced a two-phase response in retrieval performance: initially the effects of filtering were minimal but beyond a critical threshold network performance suddenly drops. Contrary to expectations, networks composed exclusively of generic information demonstrated retrieval performance comparable to unfiltered networks that also contain specific concepts. Furthermore, an analysis using individual generic concepts demonstrated that they can effectively support the retrieval of known protein-protein interactions. For instance the concept "binding" is indicative for PPI retrieval and the concept "mutation abnormality" is

Potential cost savings from generic medicines – protecting the ...

African Journals Online (AJOL)

the difference between brand and generic medicines listed for that algorithm, and also as the median of differences between generic medicines for the same condition. Results: Three of the algorithms .... Protecting the PMBs, as a key element of the new community-rated medical schemes environment, is therefore vital.

Does the market share of generic medicines influence the price level?: a European analysis.

Science.gov (United States)

Dylst, Pieter; Simoens, Steven

2011-10-01

After the expiry of patents for originator medicines, generic medicines can enter the market, and price competition may occur. This process generates savings to the healthcare payer and to patients, but knowledge about the factors affecting price competition in the pharmaceutical market following patent expiry is still limited. This study aimed to investigate the relationship between the market share of generic medicines and the change of the medicine price level in European off-patent markets. Data on medicine volumes and values for 35 active substances were purchased from IMS Health. Ex-manufacturer prices were used, and the analysis was limited to medicines in immediate-release, oral, solid dosage forms. Countries included were Austria, Belgium, Denmark, Germany, France, Italy, the Netherlands, Spain, Sweden and the UK, which constitute a mix of countries with low and high generic medicines market shares. Data were available from June 2002 until March 2007. Market volume has risen in both high and low generic market share countries (+29.27% and +27.40%, respectively), but the cause of the rise is different for the two markets. In low generic market share countries, the rise was caused by the increased use of generic medicines, while in high market share countries, the rise was driven by the increased use of generic medicines and a shift of use from originator to generic medicines. Market value was substantially decreased in high generic market share countries (-26.6%), while the decrease in low generic market share countries was limited (-0.06%). In high generic market share countries, medicine prices dropped by -43.18% versus -21.56% in low market share countries. The extent to which price competition from generic medicines leads to price reductions appears to vary according to the market share of generic medicines. High generic market share countries have seen a larger decrease in medicine prices than low market share countries.

Pharmaceutical quality of docetaxel generics versus originator drug product: a comparative analysis.

Science.gov (United States)

Vial, Jérôme; Cohen, Mélanie; Sassiat, Patrick; Thiébaut, Didier

2008-07-01

The aim of this study was to evaluate the quality of 31 commercially available generic formulations of docetaxel purchased in 14 countries by comparing their docetaxel content, impurity levels and pH versus those of the proprietary product Taxotere (Tx). Generic formulations were purchased in 14 countries in Asia, Africa, the Middle East and Latin America. Levels of docetaxel and impurities (chromatographic peaks above 0.05%) were obtained for each sample using reverse-phase liquid chromatography with ultraviolet detection. The pH of aqueous solutions of generic docetaxel formulations and Tx was also measured. A global evaluation of quality was conducted on each product using a multicriteria desirability analysis based on standards defined by the International Conference on Harmonisation guidelines and the US Pharmacopeia paclitaxel injection monograph. Most generic formulations contained a lower than expected amount of docetaxel and/or a high level of impurities: 21 generic docetaxel formulations had an average mass of docetaxel that was generic docetaxel formulations had a total impurity content of >3.0%, almost twice the level of impurities in Tx 20 mg. In total, 33 impurities not present in Tx were detected in the generic samples. Desirability analysis demonstrated that none of the generic docetaxel formulations had composition characteristics similar to those of Tx. This study demonstrated that from an analytical point of view, 90% of the generic docetaxel formulations evaluated contained insufficient active drug, high levels of impurities or both. This has the potential to affect both efficacy and safety of the drug.

Cisplatin-induced hyponatremia in malignancy: comparison between brand-name and generic formulation.

Science.gov (United States)

Ochi, Nobuaki; Yamane, Hiromichi; Hotta, Katsuyuki; Fujii, Hiromi; Isozaki, Hideko; Honda, Yoshihiro; Yamagishi, Tomoko; Kubo, Toshio; Tanimoto, Mitsune; Kiura, Katsuyuki; Takigawa, Nagio

2014-01-01

Widespread use of generic drugs is considered to be indispensable if reductions in total health care costs are to be achieved, but the market share of such drugs remains low. In general, generic drugs have the same active ingredients as brand-name drugs, but this is not always the case. Thus, toxicity profiles may vary when brand-name and generic drugs are compared. We retrospectively investigated the incidence of hyponatremia in patients receiving brand-name cisplatin (CDDP) and a generic counterpart thereof. We reviewed the medical records of patients treated with brand-name CDDP (n=53) and a generic formulation (n=26), and compared the incidences of hyponatremia and renal toxicity. Toxicities were graded using the Common Terminology Criteria for Adverse Events, version 4.0. Differences between groups were evaluated using the Student's t-test, and the odds ratio for hyponatremia was estimated via logistic regression analysis. Serum creatinine levels after chemotherapy increased significantly in both the brand-name and generic CDDP groups; no significant difference was evident between the two groups. Hyponatremia of grade 3 or above developed in 30.7% of the generic CDDP group compared to 15.1% of the brand-name CDDP group (P=0.011). Multivariate analysis showed that the use of generic CDDP increased the incidence of hyponatremia (odds ratio =5.661, 95% confidence interval =1.403-22.839; P=0.015). Oncologists should be aware that use of a generic CDDP might be associated with more hyponatremia than would use of brand-name CDDP.

Development of the generic drug industry in the US after the Hatch-Waxman Act of 1984

Directory of Open Access Journals (Sweden)

Garth Boehm

2013-09-01

Full Text Available The key events in the development of the US generic drug industry after the Hatch-Waxman Act of 1984 are systematically reviewed, including the process of approval for generic drugs, bioequivalence issues including “switchability”, bioequivalence for complicated dosage forms, patent extension, generic drug safety, generic substitution and low-cost generics. The backlog in generic review, generic drug user fees, and “quality by design” for generic drugs is also discussed. The evolution of the US generic drug industry after the Hatch-Waxman Act in 1984 has afforded several lessons of great benefit to other countries wishing to establish or re-establish a domestic generic drug industry.

Consumers’ Awareness and Attitudinal Determinants of European Union Quality Label Use on Traditional Foods

Directory of Open Access Journals (Sweden)

Wim Verbeke

2012-11-01

Full Text Available This study analyses European consumers’ awareness and determinants of use of PDO, PGI and TSG labels in six European countries (Italy, Spain, France, Bel- gium, Norway and Poland using data from a cross-sectional survey with 4,828 participants. The study confirms a higher awareness of PDO (68.1% as compared to PGI (36.4% and TSG (25.2%. Awareness is higher among men and people aged above 50 years. Consumers’ use of a PDO, PGI or TSG label is triggered by the belief that the label signals better product quality. Quality beliefs are shaped by an interest in getting information about product quality through the quality label. Interest in the origin of foods is a stronger direct and indirect driver of label use than interest in support for the local economy, but both motivations are not directly related to TSG-label use. Differences in the role of determinants are small between the three labelling schemes and between countries with versus without a strong tradition of quality labels in their agri- cultural and food quality policies. Apart from building general awareness and favourable quality perceptions of the quality schemes and their respective labels, efforts to stimulate consumers’ interest in origin and getting information about product quality through EU quality labels are recommended.

Factors influencing anti-asthmatic generic drug consumption in Morocco: 1999-2010.

Science.gov (United States)

Ghanname, Imane; Ahid, Samir; Berrada, Ghizlane; Belaiche, Abdelmjid; Hassar, Mohammed; Cherrah, Yahia

2014-01-01

The increasing availability of generic drugs (GD) resulted in a remarkable reduction in treatment costs that allowed a better access to health care.The aim of this study is to evaluate the share of anti-asthmatic generic drugs during the period 1999-2010 in Morocco and to look at the factors influencing generic development. In this study, we used Moroccan sales data from IMS Health (Intercontinental Marketing Services). The consumption of the drugs was expressed in DDD/1000 inhabitants/day according to the WHO ATC/DDD methodology. Between 1999 and 2010, anti-asthmatic consumption increased from 3.91 to 14.43 DDD/1000 inhabitants/day. The market of anti-asthmatic generic drugs progressed from 1.83 (47%) to 2.18 (23%) DDD/1000 inhabitants/day from 1999 to 2010. In 2010, inhaled glucocorticosteroids ranked first (0.83 DDD/1000 inhabitants/day), followed by inhaled short acting beta agonists (0.73 DDD/1000 inhabitants/day). The number of brands went from 27 in 1999 to 34 in 2010, with a generic share increasing from 55.55% to 70.59%. The number of anti-asthmatic pharmaceutical preparations increased from 57 to 64 during the same period, of which 31 and 42 were generic preparations. In 2010, the total cost of anti-asthmatic dugs was about 22 million euro, the generics representing 14 million euro. Despite the introduction of a compulsory insurance scheme called "AMO", that allows a refund for 69.5% of anti-asthmatic specialties marketed in Morocco, anti-asthmatic generic drug consumption remains limited. The Moroccan market is still largely dominated by the originator drugs with still valid patents.

Off-label drugs for weight management

Directory of Open Access Journals (Sweden)

Hendricks EJ

2017-06-01

Full Text Available Ed J Hendricks Center for Weight Management, Roseville and Sacramento, CA, USA Abstract: The global pandemic of obesity and overweight now affects between 2.8 and 3.5 ­billion of the world population and shows no signs of abatement. Treatment for what is now recognized as a chronic disease includes pharmacotherapy, considered an essential component of comprehensive therapy. New drug discovery is robust, but the pace of the US Food and Drug Administration approval for obesity drugs has been glacial, and only a handful of approved drugs are available for treating obesity. In the last 20 years, the US Food and Drug Administration has approved 208 drugs for cancer, 118 for cardiovascular diseases, 168 for neurological diseases, and 223 endocrinologic drugs, but only 6 for obesity, 2 of which have been taken off market. Currently, there are only 9 drugs approved by the FDA for obesity treatment. US physicians have turned to off-label drug use in their effort to care for increasing numbers of patients with excess adiposity. Phentermine is the most commonly used drug for treating obesity. Although approved only for short-term use, US physicians have used it successfully for long-term since its initial approval in 1959. This drug, used off-label for long-term, has proven to be safe and effective, far safer than the disease it is used to treat. Phentermine and diethylpropion, an equally safe but somewhat less effective drug, are both generic and therefore inexpensive. These drugs have been maligned inappropriately because their two-dimensional structure diagrams resemble amphetamine and also because of unproven presumptions about their potential adverse effects. In the face of an increasing epidemic, worldwide obese and overweight patients deserve effective treatment that prescribing these drugs could provide, if rehabilitated and used more frequently. US physicians will likely continue to use any drug proven useful off-label for this illness until

Generic ICT Skills Profiles: Future Skills for Tomorrow's World.

Science.gov (United States)

International Co-operation Europe Ltd. (ICEL), Brussels, Belgium.

This document describes generic skills profiles relevant to key jobs in information and communications technology (ICT). The profiles cover the main job areas for which the ICT industry is experiencing skills shortages. These types of information are provided for 18 generic job profiles: job description (vision, role, lifestyle); examples of job…

Implications of Graphic Cigarette Warning Labels on Smoking Behavior: An International Perspective

OpenAIRE

Jung, Minsoo

2016-01-01

Graphic warning labels (GWLs) have been developed as a representative non-price policy to block such marketing. This study investigated the current state and effect of the global introduction of GWLs and examines the future tasks related to GWLs. We systematically reviewed literatures on GWL and a tobacco control strategy in the past fifteen years. The policy of enforcing GWLs has spread globally based on the Framework Convention on Tobacco Control. GWLs are more effective than text warnings ...

Preliminary statement on general policy for rulemaking to improve nuclear power plant licensing

International Nuclear Information System (INIS)

1978-11-01

In June 1977 an NRC study group seeking to identify ways to improve the effectiveness of NRC nuclear power plant licensing procedures, recommended (among other measures) that rulemaking should be considered for the generic resolution of certain major issues that are presently litigated in individual licensing proceedings (NUREG--0292). In response to a Commission directive, the staff prepared an interim statement of general policy and plans for rulemaking, which the Commission approved for publication n the Federal Register at Affirmation Session 78-7 held on October 26, 1978. This interim policy statement fully supports Executive Order 12044 of March 23, 1978, requesting improvement of existing and future government regulations so as to be as simple and clear as possible and avoid imposing unnecessary burdens on the economy, on individuals, on public and private organizations, or on State and local governments. This NUREG publication includes the full text of the Federal Register notice published concurrently. Also provided are Enclosures A and B which contain more complete information than is presented in the FR notice regarding the selection and discussion of issues proposed by the staff for generic rulemaking. However, the discussion of issues avoids being overly specific about the likely outcome of rulemaking in order to stimulate creative public and industry comments as desirable inputs to shaping the ultimate form of generic rules

Interchangeability and comparative effectiveness between generic and brand montelukast immediate release tablets after a single oral administration in healthy volunteers.

Science.gov (United States)

Zaid, Abdel Naser; Mousa, Ayman; Ghazal, Nadia; Bustami, Rana

2015-01-01

Montelukast is a leukotriene receptor antagonist. The release of leukotrienes causes narrowing and constricting in the respiratory airways. Blocking the action of these leukotrienes, montelukast can be used for the prophylaxis and treatment of chronic asthma. The aim of this study was to evaluate the interchangeability and comparative effectiveness between a generic and a brand montelukast 10 mg immediate release tablets (Broncast(®) and Singulair(®), respectively) after a single oral dose among Arab Mediterranean volunteers. An open-label, randomized two-period crossover bioequivalence design was conducted in 31 healthy male volunteers with a 1 week washout between each study period and under fasting conditions. The plasma drug concentration was assessed by using a previously validated LC MS/MS method. The ratio between the generic and brand of geometric least squares means was reported for both generic and brand products. Moreover, an in vitro dissolution study was conducted on generic and brand tablets using three different pH media, and similarity and non-similarity factors (f2 and f1) were calculated. The used bioanalytical method was found to be linear within the range 6.098-365.855 ng/mL. The correlation coefficient was close to 0.999 during the course of the study validation. Statistical comparison of the main pharmacokinetic parameters showed the inexistence of any significant difference between generic and the brand. The point estimates (ratios of geometric means) were 111.939, 111.711, and 112.169 % for AUC0-24, AUC0-∞, and Cmax, respectively. The 90 % confidence intervals (CIs) were within the pre-defined limits of 80.00-125.00 % as specified by the FDA and EMA for bioequivalence studies. F2 and f1 were higher than 50 and lower than 15, respectively in all selected pH media. Broncast(®) immediate release film coated tablets (10 mg/tablet) are bioequivalent to Singulair(®) immediate release film coated tablets (10 mg/tablet), with a

U.S. NRC's generic issues program

International Nuclear Information System (INIS)

Kauffman, J.V.; Foster, J.W.

2008-01-01

The United States Nuclear Regulatory Commission (NRC) has a Generic Issues Program (GIP) to address Generic Issues (GI). A GI is defined as 'a regulatory matter involving the design, construction, operation, or decommissioning of several, or a class of, NRC licensees or certificate holders that is not sufficiently addressed by existing rules, guidance, or programs'. This rather legalistic definition has several practical corollaries: First, a GI must involve safety. Second, the issue must involve at least two plants, or it would be a plant-specific issue rather than a GI. Third, the potential safety question must not be covered by existing regulations and guidance (compliance). Thus, the effect of a GI is to potentially change the body of regulations and associated guidance (e.g., regulatory guides). The GIP was started in 1976, thus it is a relatively mature program. Approximately 850 issues have been processed by the program to date. More importantly, even after 30 years, new GIs continue to be proposed. The entire set of Generic Issues (GIs) is updated annually in NUREG-0933, 'A Prioritization of Generic Safety Issues'. GIs normally involve complex questions of safety and regulation. Efficient and effective means of addressing these issues are very important for regulatory effectiveness. If an issue proves to pose a genuine, significant safety question, then swift, effective, enforceable, and cost-effective action needs to be taken. Conversely, if an issue is of little safety significance, the issue should be dismissed in an expeditious manner, avoiding unnecessary expenditure of resources and regulatory burden or uncertainty. This paper provides a summary of the 5-stage program, from identification through the regulatory assessment stage. The paper also includes a discussion of the program's seven criteria, sources of proposed GIs, recent improvements, publicly available information, historical performance, and status of current GIs. (authors)

When zero is greater than one: consumer misinterpretations of nutrition labels.

Science.gov (United States)

Graham, Dan J; Mohr, Gina S

2014-12-01

Front-of-package (FOP) nutrition labels are increasingly used by food manufacturers. A call to regulate the content and format of these labels resulted in recommendations by the Institute of Medicine (IOM) for standardized FOP labels that clearly communicate packaged foods' healthfulness. It is currently unclear how consumers would interpret and use these proposed labels. This research addresses psychological factors affecting the efficacy of FOP label use. It was hypothesized that IOM's proposed 0- to 3-point rating scale would produce the zero-comparison effect, leading to more favorable evaluations than are warranted for the least healthful products (i.e., those earning zero nutritional points). In two studies (Study 1, n = 68; Study 2, n = 101), participants evaluated products containing FOP labels on the basis of IOM recommendations. Primary outcomes were perceived product healthfulness and purchase intentions. Study 1 demonstrated that less-healthful products were rated by study participants to be equally healthful as more-healthful products. The relationship between FOP rating and purchase intentions was mediated by perceived healthfulness. Biases in product healthfulness ratings were exacerbated for consumers with higher (vs. lower) health concern. Study 2 demonstrated that by changing the rating scale from 0-3 to 1-4, consumers avoid the zero-comparison effect and accurately evaluate products' healthfulness. This research has implications for theory and policy in the domains of nutrition labeling and consumer health. Specifically, FOP labels can help consumers identify healthful options, but products receiving zero nutritional points may be misidentified as healthful; a simple label modification can prevent this confusion.

Label Review Training: Module 1: Label Basics, Page 21

Science.gov (United States)

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. Learn about types of labels.

Toward Cultural Policy Studies on Mobility: Reflections on a Study of the Hong Kong Working Holiday Scheme

Directory of Open Access Journals (Sweden)

Louis Ho

2017-05-01

Full Text Available Cultural policy is predominantly, and practically, considered the sum of a government’s activities with respect to the arts, humanities and heritage. Thus, cultural policy encompasses a much broader range of activities than was traditionally associated with an arts policy. Critical cultural policy studies, then, sees a distinction between ‘explicit’ cultural policies that are manifestly labelled as ‘cultural’, and ‘implicit’ cultural policies that are not labelled as such, but that work to shape cultural experiences. This article considers this explicit/implicit cultural policy distinction through John Urry’s idea of ‘social as mobility’, suggesting that some public policies regarding mobility (such as immigration, international trade and labour policy have led to specific cultural consequences and therefore qualify as implicit cultural policy. Using Hong Kong’s working holiday scheme as a case study, this article explores how an economic policy on temporary immigrant labour involves a deliberate cultural agenda as well as ‘unintentional’ cultural consequences and problematises the fact that cultural policy studies are largely framed by the idea of ‘social as society’.

IAEA's experience in compiling a generic component reliability data base

International Nuclear Information System (INIS)

Tomic, B.; Lederman, L.

1988-01-01

Reliability data are an essential part of probabilistic safety assessment. The quality of data can determine the quality of the study as a whole. It is obvious that component failure data originated from the plant being analyzed would be most appropriate. However, in few cases complete reliance on plant experience is possible, mainly because of the rather limited operating experience. Nuclear plants, although of different design, often use fairly similar components, so some of the experience could be combined and transferred from one plant to another. In addition information about component failures is available also from experts with knowledge on component design, manufacturing and operation. That bring us to the importance of assessing generic data. (Generic is meant to be everything that is not plant specific regarding the plant being analyzed). The generic data available in the open literature, can be divided in three broad categories. The first one includes data base used in previous analysis. These can be plant specific or updated from generic with plant specific information (latter case deserve special attention). The second one is based on compilation of plants' operating experience usually based on some kind of event reporting system. The third category includes data sources based on expert opinions (single or aggregate) or combination of expert opinions and other nuclear and non-nuclear experience. This paper reflects insights gained in compiling data from generic data sources and highlights advantages and pitfalls of using generic component reliability data in PSAs

[Two cases of pulmonary aspergilosis, which deteriorated with generic itraconazole].

Science.gov (United States)

Saito, Wakana; Shishikura, Yutaka; Nishimaki, Katsushi; Kikuchi, Tadashi; Sasamori, Kan; Kikuchi, Yoshihiro; Miki, Hiroshi

2014-07-01

We experienced two cases of pulmonary aspergillosis, which deteriorated during treatment with generic itraconazole (ITCZ) because of low plasma concentration. One case was chronic pulmonary aspergillosis and the other was allergic bronchopulmonary aspergillosis (ABPA). Treatment of both cases was started with a brand-name-ITCZ, and changed to a generic ITCZ. Deterioration of pulmonary aspergillosis occurred after 8 months and 9 months from change to generic ITCZ respectively. In the first case, the ITCZ-plasma concentration was 46.9 ng/mL and of OH-ITCZ 96.5 ng/mL with generic ITCZ at the dose of 300 mg/day, but increased to 1,559.7 ng/mL and to 2,485.0 ng/mL with the brand-name-ITCZ 300 mg/day, respectively. In the second case, the ITCZ-plasma concentration was 27.2 ng/mL and of OH-ITCZ 20.1 ng/mL with 150 mg/day for generic ITCZ, but reached 857.3 ng/mL and to 1,144.2 ng/ml with the brand-name-ITCZ 300 mg/day, respectively. After treatment failure, the first case was changed to voriconazole, then brand-name-ITCZ 300 mg/day, and the second case to the brand-name-ITCZ 300 mg/day, with successful clinical course. Plasma concentrations of ITCZ can differ significantly depending on the patient or type of ITCZ. The ITCZ-plasma concentration should be controlled after changing from a brand-name-ITCZ to a generic ITCZ.

Label Review Training: Module 1: Label Basics, Page 22

Science.gov (United States)

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. Learn about what labels require review.

Label Review Training: Module 1: Label Basics, Page 19

Science.gov (United States)

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. This section covers supplemental distributor labeling.

Label Review Training: Module 1: Label Basics, Page 15

Science.gov (United States)

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. Learn about the consequences of improper labeling.

Label Review Training: Module 1: Label Basics, Page 14

Science.gov (United States)

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. Learn about positive effects from proper labeling.

Label Review Training: Module 1: Label Basics, Page 18

Science.gov (United States)

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. This section discusses the types of labels.

Label Review Training: Module 1: Label Basics, Page 26

Science.gov (United States)

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. Learn about mandatory and advisory label statements.

DYNAMO-HIA--a Dynamic Modeling tool for generic Health Impact Assessments.

Directory of Open Access Journals (Sweden)

Stefan K Lhachimi

Full Text Available BACKGROUND: Currently, no standard tool is publicly available that allows researchers or policy-makers to quantify the impact of policies using epidemiological evidence within the causal framework of Health Impact Assessment (HIA. A standard tool should comply with three technical criteria (real-life population, dynamic projection, explicit risk-factor states and three usability criteria (modest data requirements, rich model output, generally accessible to be useful in the applied setting of HIA. With DYNAMO-HIA (Dynamic Modeling for Health Impact Assessment, we introduce such a generic software tool specifically designed to facilitate quantification in the assessment of the health impacts of policies. METHODS AND RESULTS: DYNAMO-HIA quantifies the impact of user-specified risk-factor changes on multiple diseases and in turn on overall population health, comparing one reference scenario with one or more intervention scenarios. The Markov-based modeling approach allows for explicit risk-factor states and simulation of a real-life population. A built-in parameter estimation module ensures that only standard population-level epidemiological evidence is required, i.e. data on incidence, prevalence, relative risks, and mortality. DYNAMO-HIA provides a rich output of summary measures--e.g. life expectancy and disease-free life expectancy--and detailed data--e.g. prevalences and mortality/survival rates--by age, sex, and risk-factor status over time. DYNAMO-HIA is controlled via a graphical user interface and is publicly available from the internet, ensuring general accessibility. We illustrate the use of DYNAMO-HIA with two example applications: a policy causing an overall increase in alcohol consumption and quantifying the disease-burden of smoking. CONCLUSION: By combining modest data needs with general accessibility and user friendliness within the causal framework of HIA, DYNAMO-HIA is a potential standard tool for health impact assessment based

Label Review Training: Module 1: Label Basics, Page 24

Science.gov (United States)

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. This page is about which labels require review.

Label Review Training: Module 1: Label Basics, Page 27

Science.gov (United States)

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. See examples of mandatory and advisory label statements.

Label Review Training: Module 1: Label Basics, Page 17

Science.gov (United States)

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. See an overview of the importance of labels.

Do All Ducks Lay Eggs? The Generic Overgeneralization Effect

Science.gov (United States)

Leslie, Sarah-Jane; Khemlani, Sangeet; Glucksberg, Sam

2011-01-01

Generics are statements such as "tigers are striped" and "ducks lay eggs". They express general, though not universal or exceptionless, claims about kinds (Carlson & Pelletier, 1995). For example, the generic "ducks lay eggs" seems true even though many ducks (e.g. the males) do not lay eggs. The universally quantified version of the statement…

Label Review Training: Module 1: Label Basics, Page 23

Science.gov (United States)

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. Lists types of labels that do not require review.

Climate policies for road transport revisited (II): Closing the policy gap with cap-and-trade

International Nuclear Information System (INIS)

Flachsland, Christian; Brunner, Steffen; Edenhofer, Ottmar; Creutzig, Felix

2011-01-01

Current policies in the road transport sector fail to deliver consistent and efficient incentives for greenhouse gas abatement (see companion article by ). Market-based instruments such as cap-and-trade systems close this policy gap and complement traditional policies that are required where specific market failures arise. Even in presence of strong existing non-market policies, cap-and-trade delivers additional abatement and efficiency by incentivizing demand side abatement options. This paper analyzes generic design options and economic impacts of including the European road transport sector into the EU ETS. Suitable points of regulation are up- and midstream in the fuel chain to ensure effectiveness (cover all emissions and avoid double-counting), efficiency (incentivize all abatement options) and low transaction costs. Based on year 2020 marginal abatement cost curves from different models and current EU climate policy objectives we show that in contrast to conventional wisdom, road transport inclusion would not change the EU ETS allowance price. Hence, industrial carbon leakage induced by adding road transport to the EU ETS may be less important than previously estimated. - Research highlights: → We analyze the rationale, design and economic impacts of including road transportation into GHG cap-and-trade systems. → Suitable points of regulation are up- and mid-stream. → Including European road transport into the EU ETS by 2020 would not change the EU allowance price.

Development of a generic data base for failure rate

International Nuclear Information System (INIS)

Mosleh, A.; Apostolakis, G.

1985-01-01

The data analysis task in a probabilistic risk assessment (PRA) involves the assessment of data needs, the collection of information, and, finally, the analysis of the data to generate estimates for various parameters. This paper describes a framework for developing a data base for component failure rates and presents mathematical methods for the analysis of various types of information. The discussion is focused on the development of generic data bases used in PRAs. For plants without an operating history, the generic distributions are used directly to calculate component unavailability. In the case of plants that have operated for some time, the generic distributions can be used as priors in Bayesian analysis and, thus, specialized by plant-specific experience

Dual-process theory and consumer response to front-of-package nutrition label formats.

Science.gov (United States)

Sanjari, S Setareh; Jahn, Steffen; Boztug, Yasemin

2017-11-01

Nutrition labeling literature yields fragmented results about the effect of front-of-package (FOP) nutrition label formats on healthy food choice. Specifically, it is unclear which type of nutrition label format is effective across different shopping situations. To address this gap, the present review investigates the available nutrition labeling literature through the prism of dual-process theory, which posits that decisions are made either quickly and automatically (system 1) or slowly and deliberately (system 2). A systematically performed review of nutrition labeling literature returned 59 papers that provide findings that can be explained according to dual-process theory. The findings of these studies suggest that the effectiveness of nutrition label formats is influenced by the consumer's dominant processing system, which is a function of specific contexts and personal variables (eg, motivation, nutrition knowledge, time pressure, and depletion). Examination of reported findings through a situational processing perspective reveals that consumers might prefer different FOP nutrition label formats in different situations and can exhibit varying responses to the same label format across situations. This review offers several suggestions for policy makers and researchers to help improve current FOP nutrition label formats. © The Author(s) 2017. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Fuel Economy Label and CAFE Data Inventory

Science.gov (United States)

The Fuel Economy Label and CAFE Data asset contains measured summary fuel economy estimates and test data for light-duty vehicle manufacturers by model for certification as required under the Energy Policy and Conservation Act of 1975 (EPCA) and The Energy Independent Security Act of 2007 (EISA) to collect vehicle fuel economy estimates for the creation of Economy Labels and for the calculation of Corporate Average Fuel Economy (CAFE). Manufacturers submit data on an annual basis, or as needed to document vehicle model changes.The EPA performs targeted fuel economy confirmatory tests on approximately 15% of vehicles submitted for validation. Confirmatory data on vehicles is associated with its corresponding submission data to verify the accuracy of manufacturer submissions beyond standard business rules. Submitted data comes in XML format or as documents, with the majority of submissions being sent in XML, and includes descriptive information on the vehicle itself, fuel economy information, and the manufacturer's testing approach. This data may contain proprietary information (CBI) such as information on estimated sales or other data elements indicated by the submitter as confidential. CBI data is not publically available; however, within the EPA data can accessed under the restrictions of the Office of Transportation and Air Quality (OTAQ) CBI policy [RCS Link]. Datasets are segmented by vehicle model/manufacturer and/or year with corresponding fuel economy, te

Label Review Training: Module 1: Label Basics, Page 16

Science.gov (United States)

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. Learn about the importance of labels and the role in enforcement.

'Genericism' in Danish welfare professions

DEFF Research Database (Denmark)

Larsen, Verner

and skills in the basic disciplines of the professions also termed as disciplinary and procedural knowledge '. Thus the main research question for this paper is: What consequences do recent reform actions in Danish welfare education concerning generic competence have on developing professional knowledge...

Efficient Multi-Label Feature Selection Using Entropy-Based Label Selection

Directory of Open Access Journals (Sweden)

Jaesung Lee

2016-11-01

Full Text Available Multi-label feature selection is designed to select a subset of features according to their importance to multiple labels. This task can be achieved by ranking the dependencies of features and selecting the features with the highest rankings. In a multi-label feature selection problem, the algorithm may be faced with a dataset containing a large number of labels. Because the computational cost of multi-label feature selection increases according to the number of labels, the algorithm may suffer from a degradation in performance when processing very large datasets. In this study, we propose an efficient multi-label feature selection method based on an information-theoretic label selection strategy. By identifying a subset of labels that significantly influence the importance of features, the proposed method efficiently outputs a feature subset. Experimental results demonstrate that the proposed method can identify a feature subset much faster than conventional multi-label feature selection methods for large multi-label datasets.

Obesity prevention and personal responsibility: the case of front-of-pack food labelling in Australia.