INFORMATION ABOUT DRUGS IN FAMILY MAGAZINES

NARCIS (Netherlands)

VANTRIGT, AM; VANDENBERG, LTWD; PASMAN, M; HAAIJER-RUSKAMP, FM; WILLEMS, J; TROMP, TFJ

1995-01-01

Family magazines can play an important role in the diffusion of medical information and information regarding drugs to a 'lay audience'. We describe what kind of drugs are discussed in the family magazines and which information regarding these drugs is given. Furthermore, we look into the

Consumer views on safety of over-the-counter drugs, preferred retailers and information sources in Sweden: after re-regulation of the pharmacy market.

Science.gov (United States)

Westerlund, Tommy; Barzi, Sahra; Bernsten, Cecilia

2017-01-01

The availability of over-the-counter drugs (OTCs) has increased in Sweden since a re-regulation of the pharmacy market in 2009, through which non-pharmacy retailers became permitted to provide certain OTCs. To examine the adult general public's views on safety, purchasing and information channels, storage and disposal of OTCs in Sweden, three years after the re-regulation of the pharmacy market. A questionnaire study in 2012-13 in a stratified, random sample of all inhabitants in Sweden ≥ 18 years old. Totally 8,302 people (42%) answered the questionnaire. Seven percent found OTCs completely harmless regardless of how they are being used, 18% felt they should be used only on health professionals' recommendation. Differences in how OTCs are perceived were however found with regards to respondents' country of birth, family type, educational level and income. The pharmacy was still the preferred OTC drug retailer by 83% of the respondents and preferred information source by 80% Reasons for preferred retailers were primarily due to out of habit (45%), counseling provided (35%), the product range (34%) and the confidence in staff (27%). Analgesics are the most common OTCs to have at home (90%). The bathroom cabinet is the primary site for storage (42%) and 16% throw their OTC leftovers in the trash. The study population does not consider OTCs as harmless regardless of how they are used, but on the other hand feels they should not be taken on health professionals' recommendation only. The pharmacy is still the preferred retailer and information source, and there is room for further improvement in the storage and disposal of OTCs. A return of OTC drug leftovers to the pharmacy should be further encouraged. Due to several limitations, great caution should however be observed when generalizing the results to the adult population of Sweden.

Consumer views on safety of over-the-counter drugs, preferred retailers and information sources in Sweden: after re-regulation of the pharmacy market

Directory of Open Access Journals (Sweden)

Westerlund T

2017-03-01

Full Text Available Background: The availability of over-the-counter drugs (OTCs has increased in Sweden since a re-regulation of the pharmacy market in 2009, through which non-pharmacy retailers became permitted to provide certain OTCs. Objective: To examine the adult general public’s views on safety, purchasing and information channels, storage and disposal of OTCs in Sweden, three years after the re-regulation of the pharmacy market. Methods: A questionnaire study in 2012-13 in a stratified, random sample of all inhabitants in Sweden ≥ 18 years old. Results: Totally 8,302 people (42% answered the questionnaire. Seven percent found OTCs completely harmless regardless of how they are being used, 18% felt they should be used only on health professionals’ recommendation. Differences in how OTCs are perceived were however found with regards to respondents’ country of birth, family type, educational level and income. The pharmacy was still the preferred OTC drug retailer by 83% of the respondents and preferred information source by 80% Reasons for preferred retailers were primarily due to out of habit (45%, counseling provided (35%, the product range (34% and the confidence in staff (27%. Analgesics are the most common OTCs to have at home (90%. The bathroom cabinet is the primary site for storage (42% and 16% throw their OTC leftovers in the trash. Conclusions: The study population does not consider OTCs as harmless regardless of how they are used, but on the other hand feels they should not be taken on health professionals’ recommendation only. The pharmacy is still the preferred retailer and information source, and there is room for further improvement in the storage and disposal of OTCs. A return of OTC drug leftovers to the pharmacy should be further encouraged. Due to several limitations, great caution should however be observed when generalizing the results to the adult population of Sweden.

77 FR 69630 - Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug...

Science.gov (United States)

2012-11-20

... must be assembled and submitted. The application must include safety and effectiveness data, proposed labeling, product manufacturing information, and where necessary, complete information on food safety... Applications and Supporting Regulations, and Form FDA 356V AGENCY: Food and Drug Administration, HHS. ACTION...

Regulations And Control Of Food And Drugs

International Nuclear Information System (INIS)

Osuide, G.E.; Director General, National Agency For Food And Drugs Administration And Control, Federal Secretariat, Ikoyi, Lagos, Nigeria.

1996-01-01

Effective control of processed food and medicines is crucial for the maintenance of public health. Issues of wholesomeness, quality, efficacy and safety are of paramount concern to both consumers and regulatory agencies alike. Laws and regulatory are put in in place to ensure minimum standards of practice by the various operators in the food and pharmaceutical sub-sectors, such as will guarantee that the regulated products (food, drugs, cosmetics, medical devices, chemicals and bottled water) they deal in satisfy all the parameters of quality, wholesomeness, efficacy and safety. National Agency for Food and Drug Administration and Control (NAFDAC) was established to enforce all relevant laws and regulations on food and drugs among other-regulated products. NAFDAC has put in place appropriate administrative structures and procedures in its efforts to fulfill its mandate. Finally, the agency is in the process of extending its regulatory and control activities to cover irradiated food products in order to safeguard public health

Accuracy of drug advertisements in medical journals under new law regulating the marketing of pharmaceutical products in Switzerland.

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Santiago, Macarena Gonzalez; Bucher, Heiner C; Nordmann, Alain J

2008-12-31

New legal regulations for the marketing of pharmaceutical products were introduced in 2002 in Switzerland. We investigated whether claims in drug advertisements citing published scientific studies were justified by these studies after the introduction of these new regulations. In this cross-sectional study, two independent reviewers screened all issues of six major Swiss medical journals published in the year 2005 to identify all drug advertisements for analgesic, gastrointestinal and psychopharmacologic drugs and evaluated all drug advertisements referring to at least one publication. The pharmaceutical claim was rated as being supported, being based on a potentially biased study or not to be supported by the cited study according to pre-specified criteria. We also explored factors likely to be associated with supported advertisement claims. Of 2068 advertisements 577 (28%) promoted analgesic, psychopharmacologic or gastrointestinal drugs. Among them were 323 (56%) advertisements citing at least one reference. After excluding multiple publications of the same drug advertisement and advertisements with non-informative references, there remained 29 unique advertisements with at least one reference to a scientific study. These 29 advertisements contained 78 distinct pairs of claims of analgesic, gastrointestinal and psychopharmacologic drugs and referenced studies. Thirty-seven (47%) claims were supported, 16 (21%) claims were not supported by the corresponding reference, and 25 (32%) claims were based on potentially biased evidence, with no relevant differences between drug groups. Studies with conflict of interest and studies stating industry funding were more likely to support the corresponding claim (RR 1.52, 95% CI 1.07-2.17 and RR 1.50, 95% CI 0.98-2.28) than studies without identified conflict of interest and studies without information on type of funding. Following the introduction of new regulations for drug advertisement in Switzerland, 53% of all assessed

Effects of regulation on drug launch and pricing in interdependent markets.

Science.gov (United States)

Danzon, Patricia M; Epstein, Andrew J

2012-01-01

This study examines the effect of price regulation and competition on launch timing and pricing of new drugs. Our data cover launch experience in 15 countries from 1992 to 2003 for drugs in 12 major therapeutic classes. We estimate a two-equation model of launch hazard and launch price of new drugs. We find that launch timing and prices of new drugs are related to a country's average prices of established products in a class. Thus to the extent that price regulation reduces price levels, such regulation directly contributes to launch delay in the regulating country. Regulation by external referencing, whereby high-price countries reference low-price countries, also has indirect or spillover effects, contributing to launch delay and higher launch prices in low-price referenced countries. Referencing policies adopted in high-price countries indirectly impose welfare loss on low-price countries. These findings have implications for US proposals to constrain pharmaceutical prices through external referencing and drug importation.

Altered drug metabolism during pregnancy: hormonal regulation of drug-metabolizing enzymes.

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Jeong, Hyunyoung

2010-06-01

Medication use during pregnancy is prevalent, but pharmacokinetic information of most drugs used during pregnancy is lacking in spite of known effects of pregnancy on drug disposition. Accurate pharmacokinetic information is essential for optimal drug therapy in mother and fetus. Thus, understanding how pregnancy influences drug disposition is important for better prediction of pharmacokinetic changes of drugs in pregnant women. Pregnancy is known to affect hepatic drug metabolism, but the underlying mechanisms remain unknown. Physiological changes accompanying pregnancy are probably responsible for the reported alteration in drug metabolism during pregnancy. These include elevated concentrations of various hormones such as estrogen, progesterone, placental growth hormones and prolactin. This review covers how these hormones influence expression of drug-metabolizing enzymes (DMEs), thus potentially responsible for altered drug metabolism during pregnancy. The reader will gain a greater understanding of the altered drug metabolism in pregnant women and the regulatory effects of pregnancy hormones on expression of DMEs. In-depth studies in hormonal regulatory mechanisms as well as confirmatory studies in pregnant women are warranted for systematic understanding and prediction of the changes in hepatic drug metabolism during pregnancy.

Current knowledge of microRNA-mediated regulation of drug metabolism in humans.

Science.gov (United States)

Nakano, Masataka; Nakajima, Miki

2018-05-01

Understanding the factors causing inter- and intra-individual differences in drug metabolism potencies is required for the practice of personalized or precision medicine, as well as for the promotion of efficient drug development. The expression of drug-metabolizing enzymes is controlled by transcriptional regulation by nuclear receptors and transcriptional factors, epigenetic regulation, such as DNA methylation and histone acetylation, and post-translational modification. In addition to such regulation mechanisms, recent studies revealed that microRNAs (miRNAs), endogenous ~22-nucleotide non-coding RNAs that regulate gene expression through the translational repression and degradation of mRNAs, significantly contribute to post-transcriptional regulation of drug-metabolizing enzymes. Areas covered: This review summarizes the current knowledge regarding miRNAs-dependent regulation of drug-metabolizing enzymes and transcriptional factors and its physiological and clinical significance. We also describe recent advances in miRNA-dependent regulation research, showing that the presence of pseudogenes, single-nucleotide polymorphisms, and RNA editing affects miRNA targeting. Expert opinion: It is unwavering fact that miRNAs are critical factors causing inter- and intra-individual differences in the expression of drug-metabolizing enzymes. Consideration of miRNA-dependent regulation would be a helpful tool for optimizing personalized and precision medicine.

Risk-informed regulation

International Nuclear Information System (INIS)

Hoffman, D.R.

2003-01-01

In assessing safety for nuclear facilities, regulators have traditionally used a deterministic approach. New techniques for assessing nuclear or radiological risks make it possible for regulators to incorporate risk insights into their regulations. By 'risk-informing' the regulatory processes, independent bodies tasked with protecting the health and safety of the public can focus on those design and operational issues most important to safety. Such an approach is a move away from prescriptive regulations that were based on conservative engineering judgments toward regulations focused on issues that contribute significantly to safety. Despite the availability of probabilistic risk assessment (PRA) tools, organisations often struggle with how to best use this capability. Most international regulations are still based largely on deterministic analyses that were developed without the benefit of quantitative or measurable estimates of risk. PRA considers issues of risk in a more comprehensive manner by examining a wider spectrum of initiating events and their frequency, and considers the likelihood of events in a rigorous and comprehensive manner. In some countries, nuclear regulators are actively moving toward increasing the use of risk insights in a variety of strategic arenas, including risk-informed technical specifications (operating limits and conditions), in-service inspection and testing, programs, and assessment and enforcement actions. A risk-informed approach enhances the traditional deterministic approach by explicitly considering a broader range of safety challenges, focusing resources on the basis of risk significance, considering a broader range of counter measures to mitigate challenges, and explicitly identifying and quantifying uncertainties in analyses. (author)

76 FR 62630 - Information Security Regulations

Science.gov (United States)

2011-10-11

... CENTRAL INTELLIGENCE AGENCY 32 CFR Part 1902 Information Security Regulations AGENCY: Central... information security regulations which have become outdated. The Executive Order upon which the regulations... CFR Part 1902 Information security regulations. PART 1902 [REMOVED AND RESERVED] Sec. 1902.13 [Removed...

Protein Kinases C-Mediated Regulations of Drug Transporter Activity, Localization and Expression

Directory of Open Access Journals (Sweden)

Abdullah Mayati

2017-04-01

Full Text Available Drug transporters are now recognized as major actors in pharmacokinetics, involved notably in drug–drug interactions and drug adverse effects. Factors that govern their activity, localization and expression are therefore important to consider. In the present review, the implications of protein kinases C (PKCs in transporter regulations are summarized and discussed. Both solute carrier (SLC and ATP-binding cassette (ABC drug transporters can be regulated by PKCs-related signaling pathways. PKCs thus target activity, membrane localization and/or expression level of major influx and efflux drug transporters, in various normal and pathological types of cells and tissues, often in a PKC isoform-specific manner. PKCs are notably implicated in membrane insertion of bile acid transporters in liver and, in this way, are thought to contribute to cholestatic or choleretic effects of endogenous compounds or drugs. The exact clinical relevance of PKCs-related regulation of drug transporters in terms of drug resistance, pharmacokinetics, drug–drug interactions and drug toxicity remains however to be precisely determined. This issue is likely important to consider in the context of the development of new drugs targeting PKCs-mediated signaling pathways, for treating notably cancers, diabetes or psychiatric disorders.

Adequacy of pharmacological information provided in pharmaceutical drug advertisements in African medical journals.

Directory of Open Access Journals (Sweden)

Oshikoya KA

2009-06-01

manufacturer on both the container and pack of the drug} were mentioned in 65.6% and 50% adverts, respectively. The product and package descriptions were provided in 57 (72.2% Nigerian medical journals, which was significantly higher than in other African medical journals 39 (37.9% (P<0.001.Conclusions: None of the drug advertisements in the journals adequately provided the basic information required by the WHO for appropriate prescribing. More guidance and regulation is needed to ensure adequate information is provided.

Pharmacogenetics in drug regulation: promise, potential and pitfalls

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Shah, Rashmi R

2005-01-01

Pharmacogenetic factors operate at pharmacokinetic as well as pharmacodynamic levels—the two components of the dose–response curve of a drug. Polymorphisms in drug metabolizing enzymes, transporters and/or pharmacological targets of drugs may profoundly influence the dose–response relationship between individuals. For some drugs, although retrospective data from case studies suggests that these polymorphisms are frequently associated with adverse drug reactions or failure of efficacy, the clinical utility of such data remains unproven. There is, therefore, an urgent need for prospective data to determine whether pre-treatment genotyping can improve therapy. Various regulatory guidelines already recommend exploration of the role of genetic factors when investigating a drug for its pharmacokinetics, pharmacodynamics, dose–response relationship and drug interaction potential. Arising from the global heterogeneity in the frequency of variant alleles, regulatory guidelines also require the sponsors to provide additional information, usually pharmacogenetic bridging data, to determine whether data from one ethnic population can be extrapolated to another. At present, sponsors explore pharmacogenetic influences in early clinical pharmacokinetic studies but rarely do they carry the findings forward when designing dose–response studies or pivotal studies. When appropriate, regulatory authorities include genotype-specific recommendations in the prescribing information. Sometimes, this may include the need to adjust a dose in some genotypes under specific circumstances. Detailed references to pharmacogenetics in prescribing information and pharmacogenetically based prescribing in routine therapeutics will require robust prospective data from well-designed studies. With greater integration of pharmacogenetics in drug development, regulatory authorities expect to receive more detailed genetic data. This is likely to complicate the drug evaluation process as well as

Presenting efficacy information in direct-to-consumer prescription drug advertisements.

Science.gov (United States)

O'Donoghue, Amie C; Sullivan, Helen W; Aikin, Kathryn J; Chowdhury, Dhuly; Moultrie, Rebecca R; Rupert, Douglas J

2014-05-01

We evaluated whether presenting prescription drug efficacy information in direct-to-consumer (DTC) advertising helps individuals accurately report a drug's benefits and, if so, which numerical format is most helpful. We conducted a randomized, controlled study of individuals diagnosed with high cholesterol (n=2807) who viewed fictitious prescription drug print or television ads containing either no drug efficacy information or efficacy information in one of five numerical formats. We measured drug efficacy recall, drug perceptions and attitudes, behavioral intentions, and drug risk recall. Individuals who viewed absolute frequency and/or percentage information more accurately reported drug efficacy than participants who viewed no efficacy information. Participants who viewed relative frequency information generally reported drug efficacy less accurately than participants who viewed other numerical formats. Adding efficacy information to DTC ads-both in print and on television-may potentially increase an individual's knowledge of a drug's efficacy, which may improve patient-provider communication and promote more informed decisions. Providing quantitative efficacy information in a combination of formats (e.g., absolute frequency and percent) may help patients remember information and make decisions about prescription drugs. Published by Elsevier Ireland Ltd.

United States National Library of Medicine Drug Information Portal.

Science.gov (United States)

Hochstein, Colette; Goshorn, Jeanne; Chang, Florence

2009-01-01

The Drug Information Portal is a free Web resource from the National Library of Medicine (NLM) that provides a user-friendly gateway to current information for more than 15,000 drugs. The site guides users to related resources of NLM, the National Institutes of Health (NIH), and other government agencies. Current drug-related information regarding consumer health, clinical trials, AIDS, MeSH pharmacological actions, MEDLINE/PubMed biomedical literature, and physical properties and structure is easily retrieved by searching on a drug name. A varied selection of focused topics in medicine and drugs is also available from displayed subject headings. This column provides background information about the Drug Information Portal, as well as search basics.

A Development of Hybrid Drug Information System Using Image Recognition

Directory of Open Access Journals (Sweden)

HwaMin Lee

2015-04-01

Full Text Available In order to prevent drug abuse or misuse cases and avoid over-prescriptions, it is necessary for medicine taker to be provided with detailed information about the medicine. In this paper, we propose a drug information system and develop an application to provide information through drug image recognition using a smartphone. We designed a contents-based drug image search algorithm using the color, shape and imprint of drug. Our convenient application can provide users with detailed information about drugs and prevent drug misuse.

Adolescent neurocognitive development, self-regulation, and school-based drug use prevention.

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Pokhrel, Pallav; Herzog, Thaddeus A; Black, David S; Zaman, Adnin; Riggs, Nathaniel R; Sussman, Steve

2013-06-01

Adolescence is marked by several key development-related changes, including neurocognitive changes. Cognitive abilities associated with self-regulation are not fully developed until late adolescence or early adulthood whereas tendencies to take risks and seek thrilling and novel experience seem to increase significantly throughout this phase, resulting in a discrepancy between increased susceptibility to poor regulation and lower ability to exercise self-control. Increased vulnerability to drug use initiation, maintenance, and dependence during adolescence may be explained based on this imbalance in the self-regulation system. In this paper, we highlight the relevance of schools as a setting for delivering adolescent drug use prevention programs that are based on recent findings from neuroscience concerning adolescent brain development. We discuss evidence from school-based as well as laboratory research that suggests that suitable training may improve adolescents' executive brain functions that underlie self-regulation abilities and, as a result, help prevent drug use and abuse. We note that considerable further research is needed in order (1) to determine that self-regulation training has effects at the neurocognitive level and (2) to effectively incorporate self-regulation training based on neuropsychological models into school-based programming.

Information, Interests, and Environmental Regulation

DEFF Research Database (Denmark)

Winter, Søren; May, Peter J.

2002-01-01

This study contributes to the understanding of informational approaches to bringing about compliance with environmental regulations with particular attention to differences in the influence of information provided by different information sources. Based on theorizing from a combination of informa......This study contributes to the understanding of informational approaches to bringing about compliance with environmental regulations with particular attention to differences in the influence of information provided by different information sources. Based on theorizing from a combination...... of information processing and interest group literatures, we develop hypotheses about regulatees' reliance upon and the influence of different sources of information. We test these hypotheses for Danish farmers’ compliance with agro-environmental rules. Our findings show that information plays a role in bringing...

Direct-to-consumer prescription drug advertising: history, regulation, and issues.

Science.gov (United States)

Huh, Jisu; DeLorme, Denise E; Reid, Leonard N; An, Soontae

2010-03-01

Direct-to-consumer advertising has changed the way prescription drugs are marketed in the United States. This article traces the history of direct-to-consumer advertising of prescription and over-the-counter medications and describes how drug advertising is regulated and by whom. It also discusses the controversies that surround direct-to-consumer marketing of prescription drugs.

Changing effects of direct-to-consumer broadcast drug advertising information sources on prescription drug requests.

Science.gov (United States)

Lee, Annisa Lai

2009-06-01

This study tracks the changes of the effects of 4 information sources for direct-to-consumer drug advertising on patients' requests for prescription drugs from physicians since the inception of the "Guidance for Industry about Consumer-directed Broadcast Advertisements." The Guidance advises pharmaceuticals to use four information sources for consumers to seek further information to supplement broadcast drug advertisements: small-print information, the Internet, a toll-free number, and health-care providers (nurses, doctors, and pharmacists). Logistic models were created by using survey data collected by the Food and Drug Administration in 1999 and 2002. Results show that throughout the years, health-care providers remain the most used and strongest means associated with patients' direct requests for nonspecific and specific prescription drugs from doctors. The small-print information source gains power and changes from an indirect means associated with patients' discussing drugs with health-care providers to a direct means associated with patients' asking about nonspecific and specific drugs from their doctors. The Internet is not directly related to drug requests, but the effect of its association with patients seeking information from health-care providers grew 11-fold over the course of the study. The toll-free number lost its power altogether for both direct request for a prescription drug and further discussion with health-care providers. Patient demographics will be considered for specific policy implications.

Up-regulation of β-adrenoreceptors by drugs which cause depression

International Nuclear Information System (INIS)

Brand, L.; Van Rooyen, J.M.; Offermeier, J.

1988-01-01

A number of drugs associated with depressive episodes in man were investigated for their effects on rat cortical β-adrenoceptors, in view of the down-regulation of β-adrenoceptors caused by chronic administration of anti-depressant drugs. Scatchard analyses of [ 3 H]dihydro-alprenolol binding data provided B max and K D values for the cortical β-adrenoceptors. Up-regulation of the receptors occurred after daily injections of phenobarbitone for seven days (by 55%), pentobarbitone (by 143%), reserpine (by 82%) and propranolol (by 64%). β-adrenoceptors were not affected by daily injections of clonidine, chlorpromazine and flupenthixol for seven days. This work confirms the up-regulatory effect on β-adrenoceptors of certain drugs which produce depressions in man

Access to Orphan Drugs: A Comprehensive Review of Legislations, Regulations and Policies in 35 Countries.

Science.gov (United States)

Gammie, Todd; Lu, Christine Y; Babar, Zaheer Ud-Din

2015-01-01

To review existing regulations and policies utilised by countries to enable patient access to orphan drugs. A review of the literature (1998 to 2014) was performed to identify relevant, peer-reviewed articles. Using content analysis, we synthesised regulations and policies for access to orphan drugs by type and by country. Fifty seven articles and 35 countries were included in this review. Six broad categories of regulation and policy instruments were identified: national orphan drug policies, orphan drug designation, marketing authorization, incentives, marketing exclusivity, and pricing and reimbursement. The availability of orphan drugs depends on individual country's legislation and regulations including national orphan drug policies, orphan drug designation, marketing authorization, marketing exclusivity and incentives such as tax credits to ensure research, development and marketing. The majority of countries (27/35) had in place orphan drug legislation. Access to orphan drugs depends on individual country's pricing and reimbursement policies, which varied widely between countries. High prices and insufficient evidence often limit orphan drugs from meeting the traditional health technology assessment criteria, especially cost-effectiveness, which may influence access. Overall many countries have implemented a combination of legislations, regulations and policies for orphan drugs in the last two decades. While these may enable the availability and access to orphan drugs, there are critical differences between countries in terms of range and types of legislations, regulations and policies implemented. Importantly, China and India, two of the largest countries by population size, both lack national legislation for orphan medicines and rare diseases, which could have substantial negative impacts on their patient populations with rare diseases.

Access to Orphan Drugs: A Comprehensive Review of Legislations, Regulations and Policies in 35 Countries.

Directory of Open Access Journals (Sweden)

Todd Gammie

Full Text Available To review existing regulations and policies utilised by countries to enable patient access to orphan drugs.A review of the literature (1998 to 2014 was performed to identify relevant, peer-reviewed articles. Using content analysis, we synthesised regulations and policies for access to orphan drugs by type and by country.Fifty seven articles and 35 countries were included in this review. Six broad categories of regulation and policy instruments were identified: national orphan drug policies, orphan drug designation, marketing authorization, incentives, marketing exclusivity, and pricing and reimbursement. The availability of orphan drugs depends on individual country's legislation and regulations including national orphan drug policies, orphan drug designation, marketing authorization, marketing exclusivity and incentives such as tax credits to ensure research, development and marketing. The majority of countries (27/35 had in place orphan drug legislation. Access to orphan drugs depends on individual country's pricing and reimbursement policies, which varied widely between countries. High prices and insufficient evidence often limit orphan drugs from meeting the traditional health technology assessment criteria, especially cost-effectiveness, which may influence access.Overall many countries have implemented a combination of legislations, regulations and policies for orphan drugs in the last two decades. While these may enable the availability and access to orphan drugs, there are critical differences between countries in terms of range and types of legislations, regulations and policies implemented. Importantly, China and India, two of the largest countries by population size, both lack national legislation for orphan medicines and rare diseases, which could have substantial negative impacts on their patient populations with rare diseases.

Regulating khat--dilemmas and opportunities for the international drug control system.

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Klein, Axel; Beckerleg, Susan; Hailu, Degol

2009-11-01

The regulation of khat, one of the most recent psychoactive drugs to become a globally traded commodity, remains hotly contested within different producer and consumer countries. As regimes vary, it has been possible to compare khat policies in Africa, Europe and North America from different disciplinary perspectives. Field research was conducted in East Africa and Europe, using a combination of semistructured interviews, participant observation and the analysis of trade statistics. The research established the significance of khat for rural producers, regional economies, as a tax base and source of foreign exchange. At the same time, khat as a psychoactive substance is associated with health and public safety problems that in turn are met with often ill-informed legislative responses. Bans have in turn lead to the criminalisation of users and sellers and illegal drug markets. The empirical work from Africa provides a strong argument for promoting evidence-based approaches to khat regulation, harnessing the positive aspects of the khat economy to develop a control model that incorporates the voices and respects the needs of rural producers. Ultimately, the framework for khat may provide both a model and an opportunity for revising the international treaties governing the control of other plant psychoactive-based substances.

Pathological Gambling and Associated Drug and Alcohol Abuse, Emotion Regulation, and Anxious-Depressive Symptomatology.

Science.gov (United States)

Jauregui, Paula; Estévez, Ana; Urbiola, Irache

2016-06-01

Background and aims Pathological gambling is associated with comorbid disorders, such as anxiety, depression, and drug and alcohol abuse. Difficulties of emotion regulation may be one of the factors related to the presence of addictive disorders, along with comorbid symptomatology in pathological gamblers. Therefore, the aim of this study was to evaluate the difficulties of emotion regulation, drug and alcohol abuse, and anxious and depressive symptomatology in pathological gamblers, and the mediating role of difficulties of emotion regulation between anxiety and pathological gambling. Methods The study sample included 167 male pathological gamblers (mean age = 39.29 years) and 107 non-gamblers (mean age = 33.43 years). Pathological gambling (SOGS), difficulties of emotion regulation (DERS), drug and alcohol abuse (MUTICAGE CAD-4), and anxious and depressive symptomatology (SA-45) were measured. Student's t, Pearson's r, stepwise multiple linear regression and multiple mediation analyses were conducted. The study was approved by an Investigational Review Board. Results Relative to non-gamblers, pathological gamblers exhibited greater difficulties of emotion regulation, as well as more anxiety, depression, and drug abuse. Moreover, pathological gambling correlated with emotion regulation difficulties, anxiety, depression, and drug abuse. Besides, emotion regulation difficulties correlated with and predicted pathological gambling, drug and alcohol abuse, and anxious and depressive symptomatology. Finally, emotion regulation difficulties mediated the relationship between anxiety and pathological gambling controlling the effect of age, both when controlling and not controlling for the effect of other abuses. Discussion and conclusions These results suggest that difficulties of emotion regulation may provide new keys to understanding and treating pathological gambling and comorbid disorders.

Information needs for making clinical recommendations about potential drug-drug interactions: a synthesis of literature review and interviews.

Science.gov (United States)

Romagnoli, Katrina M; Nelson, Scott D; Hines, Lisa; Empey, Philip; Boyce, Richard D; Hochheiser, Harry

2017-02-22

Drug information compendia and drug-drug interaction information databases are critical resources for clinicians and pharmacists working to avoid adverse events due to exposure to potential drug-drug interactions (PDDIs). Our goal is to develop information models, annotated data, and search tools that will facilitate the interpretation of PDDI information. To better understand the information needs and work practices of specialists who search and synthesize PDDI evidence for drug information resources, we conducted an inquiry that combined a thematic analysis of published literature with unstructured interviews. Starting from an initial set of relevant articles, we developed search terms and conducted a literature search. Two reviewers conducted a thematic analysis of included articles. Unstructured interviews with drug information experts were conducted and similarly coded. Information needs, work processes, and indicators of potential strengths and weaknesses of information systems were identified. Review of 92 papers and 10 interviews identified 56 categories of information needs related to the interpretation of PDDI information including drug and interaction information; study design; evidence including clinical details, quality and content of reports, and consequences; and potential recommendations. We also identified strengths/weaknesses of PDDI information systems. We identified the kinds of information that might be most effective for summarizing PDDIs. The drug information experts we interviewed had differing goals, suggesting a need for detailed information models and flexible presentations. Several information needs not discussed in previous work were identified, including temporal overlaps in drug administration, biological plausibility of interactions, and assessment of the quality and content of reports. Richly structured depictions of PDDI information may help drug information experts more effectively interpret data and develop recommendations

Short history of regulations and approved indications of antimicrobial drugs for food animals in the USA.

Science.gov (United States)

Volkova, V V; DeMars, Z

2017-06-01

We review historical availability and regulation, and recent indications of antimicrobial drugs for food animals in the USA. We summarize the timeline of introduction of individual antimicrobial drug classes from the 1930s to present, history of regulation of antimicrobial drugs from the 1930s to present and indications of antimicrobial drugs in 1996-2014 for food animals in the USA. The history of antimicrobial drug regulation demonstrates a historical precedent for harmonized regulations of antimicrobials 'for human and other animals' in the USA. © 2016 John Wiley & Sons Ltd.

Study on the risk-informed regulation of NPP

International Nuclear Information System (INIS)

Wang Chaogui

2007-01-01

The risk-informed regulation is a modern type of NPP safety management mode using both deterministic and probabilistic approaches. It is necessary to entirely and systematically study the associated regulations, standards and practices in order to promote the developments of risk-informed regulations in China. This paper introduces the risk-informed regulation, gives out the basic principles, method and acceptance risk criteria of risk-informed decision,making, discusses the PSA requirements for risk-informed decision-making and makes some suggestions about the application of risk-informed regulations in Chinese NPP. (authors)

Drugs in sport

OpenAIRE

Robinson, D

2007-01-01

This new edition includes fresh information regarding drugs use and abuse in sport and the updated worldwide anti-doping laws, and changes to the prohibited and therapeutic use exemption lists. The objectives of the book are to review/discuss the latest information on drugs in sport by considering i) actions of drugs and hormones, ii) medication and nutritional supplements in sport, iii) the latest doping control regulations of the WADA, iv) the use of banned therapeutic drugs in sport, v) an...

Access to Orphan Drugs: A Comprehensive Review of Legislations, Regulations and Policies in 35 Countries

Science.gov (United States)

Gammie, Todd

2015-01-01

Objective To review existing regulations and policies utilised by countries to enable patient access to orphan drugs. Methods A review of the literature (1998 to 2014) was performed to identify relevant, peer-reviewed articles. Using content analysis, we synthesised regulations and policies for access to orphan drugs by type and by country. Results Fifty seven articles and 35 countries were included in this review. Six broad categories of regulation and policy instruments were identified: national orphan drug policies, orphan drug designation, marketing authorization, incentives, marketing exclusivity, and pricing and reimbursement. The availability of orphan drugs depends on individual country’s legislation and regulations including national orphan drug policies, orphan drug designation, marketing authorization, marketing exclusivity and incentives such as tax credits to ensure research, development and marketing. The majority of countries (27/35) had in place orphan drug legislation. Access to orphan drugs depends on individual country’s pricing and reimbursement policies, which varied widely between countries. High prices and insufficient evidence often limit orphan drugs from meeting the traditional health technology assessment criteria, especially cost-effectiveness, which may influence access. Conclusions Overall many countries have implemented a combination of legislations, regulations and policies for orphan drugs in the last two decades. While these may enable the availability and access to orphan drugs, there are critical differences between countries in terms of range and types of legislations, regulations and policies implemented. Importantly, China and India, two of the largest countries by population size, both lack national legislation for orphan medicines and rare diseases, which could have substantial negative impacts on their patient populations with rare diseases. PMID:26451948

The risks of risk aversion in drug regulation.

Science.gov (United States)

Eichler, Hans-Georg; Bloechl-Daum, Brigitte; Brasseur, Daniel; Breckenridge, Alasdair; Leufkens, Hubert; Raine, June; Salmonson, Tomas; Schneider, Christian K; Rasi, Guido

2013-12-01

Drugs are approved by regulatory agencies on the basis of their assessment of whether the available evidence indicates that the benefits of the drug outweigh its risks. In recent years, regulatory agencies have been criticized both for being overly tolerant of risks or being excessively risk-averse, which reflects the challenge in determining an appropriate balance between benefit and risk with the limited data that is typically available before drug approval. The negative consequences of regulatory tolerance in allowing drugs onto the market that turn out to be unsafe are obvious, but the potential for adverse effects on public health owing to the absence of new drugs because of regulatory risk-aversion is less apparent. Here, we discuss the consequences of regulatory risk-aversion for public health and suggest what might be done to best align acceptance of risk and uncertainty by regulators with the interests of public health.

An Experimental Comparison of a Co-Design Visualizing Personal Drug Information and Patient Information Leaflets: Usability Aspects.

Science.gov (United States)

Khodambashi, Soudabeh; Haugland, Dagrun; Ellingsberg, Anette; Kottum, Hanne; Sund, Janne Kutschera; Nytrø, Øystein

2017-01-01

Providing patients with specific information about their own drugs can reduce unintentional misuse and improve compliance. Searching for information is time-consuming when information is not personalized and is written using medical vocabulary that is difficult for patients to understand. In this study we explored patient information needs regarding visualizing of drug information and interrelationships by conducting a total of four co-design workshops with patients, other users and pharmacists. We developed a prototype and drug ontology to support reasoning about drug interactions. We evaluated individual performance in finding information, understanding the drug interactions, and learning from the provided information in the prototype compared to using patient information leaflets (PILs). We concluded that interactive visualization of drug information helps individuals find information about drugs, their side effects and interactions more quickly and correctly compared to using PILs. Our study is limited to co-morbid patients with transient ischaemic attack with several chronic diseases.

Student-peer mentoring on a drug information response.

Science.gov (United States)

Rodis, Jennifer Lin; Backo, Jennifer; Schmidt, Brittany M; Pruchnicki, Maria C

2014-03-12

To implement a student peer-mentoring program with a drug information response assignment in an introductory pharmacy practice course. Second-year student pharmacists (P2 mentors) enrolled in an independent study course were randomly assigned first-year student pharmacists (P1 mentees) to mentor on a drug information assignment. The P2 mentors provided feedback to P1 mentees' assignment drafts. The P1 mentees had the opportunity to revise the draft prior to turning in the completed assignment to course faculty members for grading. Both P1 mentees and P2 mentors agreed the mentorship improved their ability to prepare a drug information response (76% and 100%, respectively). A majority of the student pharmacists would choose to be involved in the program again. The student peer-mentoring program was successful in improving student pharmacists' perceptions of ability to compose a drug information response.

Online drug information platform for the public in Hong Kong-Review of local drug information use and needs.

Science.gov (United States)

Cheng, F W T; So, S W K; Fung, B W T; Hung, W H; Lee, V W Y

2018-06-01

In view of the popularity of Internet usage in Hong Kong, an interactive web-based drug information platform entitled "Ask My Pharmacist - Online University Led drug Enquiry Platform" (AMPOULE) was launched in 2009 to better serve the needs of drug information in Hong Kong. This paper aimed to evaluate the utility of AMPOULE in improving drug-related knowledge among the public and to reassess the needs of the general public in Hong Kong. All enquiries sent via AMPOULE were reviewed. Demographic data, nature of questions and types of drug class covered were analyzed. The workload of pharmacists was examined with respect to the preparation time needed for the enquiry, the lag days to reply and also the timing of enquiry recipient. 2122 enquiries were received from 2009 to 2017. Most enquirers were from Hong Kong (56.6%) and female gender (49.2%). 13% of the concerned subjects were aged over 61-year-old. The most frequent types of questions and medications covered were "Drug Ingredients and Indications" (28.0%) and Adverse Drug Reactions (26.8%) and "Cardiovascular Medication" (21.9%) respectively but these varied in different age groups or enquirer groups. The median time for preparation was 40.0 min (IQR: 25-65 min) while the median time lag was found to be 2.5 days (IQR: 1.0-5.0 days). The number of enquiries received was evenly distributed throughout the day except during 1:00 am to 9:00 am and 7:00 pm to 8:00 pm. AMPOULE has demonstrated that an online platform providing patient-oriented drug information service through the Internet is promising and further promotion is warranted. Current data suggested that the need of different age groups and enquirer groups are different and should therefore be individualized. Copyright © 2018 Elsevier B.V. All rights reserved.

Regulating Direct-to-Consumer Advertising of Prescription Drugs in the Digital Age

Directory of Open Access Journals (Sweden)

Shannon Gibson

2014-07-01

Full Text Available The increasing prominence of new Internet and social media technologies and their growing importance as a source of health information are pushing the pharmaceutical industry towards digital channels. This paper explores the potential impacts of the pharmaceutical industry’s increasing interest in online marketing and considers how the existing regulatory framework in Canada translates into the social media sphere. Direct-to-consumer advertising (DTCA of prescription drugs is prohibited in Canada, as it is in most industrialized countries. Although Health Canada has reaffirmed that the existing DTCA regulations apply to new Internet and social media technologies, new dynamics such as user-generated content, consumer propagation, and targeted marketing make applying the existing regulations an uncertain process. Moreover, certain problems often associated with DTCA may be exacerbated in the social media context. Finally, there is skepticism around whether government regulators have the resources or political will to effectively monitor new digital media. As such, this paper considers not only the role of direct government regulation in monitoring and enforcing the regulation of DTCA, but also the role of third party oversight and industry self-regulation—both of which may play an important role in filling the gaps in the regulation of the Internet and social media.

Information to Improve Public Perceptions of the Food and Drug Administration (FDA’s Tobacco Regulatory Role

Directory of Open Access Journals (Sweden)

Amira Osman

2018-04-01

Full Text Available While the Food and Drug Administration (FDA has had regulatory authority over tobacco products since 2009, public awareness of this authority remains limited. This research examines several broad types of information about FDA tobacco regulatory mission that may improve the perceptions of FDA as a tobacco regulator. Using Amazon Mechanical Turk, 1766 adults, smokers and non-smokers, were randomly assigned to view a statement about FDA regulatory authority that varied three information types in a 2 × 2 × 2 between subjects experimental design: (1 FDA’s roles in regulating tobacco (yes/no; (2 The scientific basis of regulations (yes/no; and (3 A potential protective function of regulations (yes/no. Using factorial ANOVA, we estimated the main and interactive effects of all three types of information and of smoking status on the perceptions of FDA. Participants that were exposed to information on FDA roles reported higher FDA credibility and a greater perceived knowledge of FDA than those who did not. Exposure to information about the scientific basis of regulations led to more negative views of the tobacco industry. Participants who learned of the FDA’s commitment to protecting the public reported higher FDA credibility and more positive attitudes toward regulations than those who did not learn of this commitment. We observed no significant interaction effects. The findings suggest that providing information about the regulatory roles and protective characterization of the FDA’s tobacco regulatory mission positively influence public perceptions of FDA and tobacco regulations.

AGC kinases, mechanisms of regulation ‎and innovative drug development.

Science.gov (United States)

Leroux, Alejandro E; Schulze, Jörg O; Biondi, Ricardo M

2018-02-01

The group of AGC kinases consists of 63 evolutionarily related serine/threonine protein kinases comprising PDK1, PKB/Akt, SGK, PKC, PRK/PKN, MSK, RSK, S6K, PKA, PKG, DMPK, MRCK, ROCK, NDR, LATS, CRIK, MAST, GRK, Sgk494, and YANK, while two other families, Aurora and PLK, are the most closely related to the group. Eight of these families are physiologically activated downstream of growth factor signalling, while other AGC kinases are downstream effectors of a wide range of signals. The different AGC kinase families share aspects of their mechanisms of inhibition and activation. In the present review, we update the knowledge of the mechanisms of regulation of different AGC kinases. The conformation of the catalytic domain of many AGC kinases is regulated allosterically through the modulation of the conformation of a regulatory site on the small lobe of the kinase domain, the PIF-pocket. The PIF-pocket acts like an ON-OFF switch in AGC kinases with different modes of regulation, i.e. PDK1, PKB/Akt, LATS and Aurora kinases. In this review, we make emphasis on how the knowledge of the molecular mechanisms of regulation can guide the discovery and development of small allosteric modulators. Molecular probes stabilizing the PIF-pocket in the active conformation are activators, while compounds stabilizing the disrupted site are allosteric inhibitors. One challenge for the rational development of allosteric modulators is the lack of complete structural information of the inhibited forms of full-length AGC kinases. On the other hand, we suggest that the available information derived from molecular biology and biochemical studies can already guide screening strategies for the identification of innovative mode of action molecular probes and the development of selective allosteric drugs for the treatment of human diseases. Copyright © 2017 Elsevier Ltd. All rights reserved.

The influence of the European paediatric regulation on marketing authorisation of orphan drugs for children.

Science.gov (United States)

Kreeftmeijer-Vegter, Annemarie Rosan; de Boer, Anthonius; van der Vlugt-Meijer, Roselinda H; de Vries, Peter J

2014-08-05

Drug development for rare diseases is challenging, especially when these orphan drugs (OD) are intended for children. In 2007 the EU Paediatric Drug Regulation was enacted to improve the development of high quality and ethically researched medicines for children through the establishment of Paediatric Investigation Plans (PIPs). The effect of the EU Paediatric Drug Regulation on the marketing authorisation (MA) of drugs for children with rare diseases was studied. Data on all designated orphan drugs, their indication, MA, PIPs and indication group (adult or child) were obtained from the European Medicines Agency (EMA). The outcome and duration of the process from orphan drug designation (ODD) to MA, was compared, per indication, by age group. The effect of the Paediatric Drug Regulation, implemented in 2007, on the application process was assessed with survival analysis. Eighty-one orphan drugs obtained MA since 2000 and half are authorised for (a subgroup of) children; another 34 are currently undergoing further investigations in children through agreed PIPs. The Paediatric Drug Regulation did not significantly increase the number of ODDs with potential paediatric indications (58% before vs 64% after 2007 of ODDs, p = 0.1) and did not lead to more MAs for ODs with paediatric indications (60% vs 43%, p = 0.22). ODs authorised after 2007 had a longer time to MA than those authorised before 2007 (Hazard ratio (95% CI) 2.80 (1.84-4.28), p < 0.001); potential paediatric use did not influence the time to MA (Hazard ratio (95% CI) 1.14 (0.77-1.70), p = 0.52). The EU Paediatric Drug Regulation had a minor impact on development and availability of ODs for children, was associated with a longer time to MA, but ensured the further paediatric development of drugs still off-label to children. The impact of the Paediatric Drug Regulation on research quantity and quality in children through PIPs is not yet clear.

HIPPA privacy regulations: practical information for physicians.

Science.gov (United States)

McMahon, E B; Lee-Huber, T

2001-07-01

After much debate and controversy, the Bush administration announced on April 12, 2001, that it would implement the Health Insurance Portability and Accountability Act (HIPAA) privacy regulations issued by the Clinton administration in December of 2000. The privacy regulations became effective on April 14, 2001. Although the regulations are considered final, the Secretary of the Department of Health and Human Services has the power to modify the regulations at any time during the first year of implementation. These regulations affect how a patient's health information is used and disclosed, as well as how patients are informed of their privacy rights. As "covered entities," physicians have until April 14, 2003, to comply fully with the HIPAA privacy regulations, which are more than 1,500 pages in length. This article presents a basic overview of the new and complex regulations and highlights practical information about physicians' compliance with the regulations. However, this summary of the HIPAA privacy regulations should not be construed as legal advice or an opinion on specific situations. Please consult an attorney concerning your compliance with HIPAA and the regulations promulgated thereunder.

Progress toward risk informed regulation

International Nuclear Information System (INIS)

Rogers, K.C.

1997-01-01

For the last several years, the NRC, with encouragement from the industry, has been moving in the direction of risk informed regulation. This is consistent with the regulatory principle of efficiency, formally adopted by the Nuclear Regulatory Commission in 1991, which requires that regulatory activities be consistent with the degree of risk reduction they achieve. Probabilistic risk analysis has become the tool of choice for selecting the best of several alternatives. Closely related to risk informed regulation is the development of performance based rules. Such rules focus on the end result to be achieved. They do not specify the process, but instead establish the goals to be reached and how the achievement of those goals is to be judged. The inspection and enforcement activity is based on whether or not the goals have been met. The author goes on to offer comments on the history of the development of this process and its probable development in the future. He also addresses some issues which must be resolved or at least acknowledged. The success of risk informed regulation ultimately depends on having sufficiently reliable data to allow quantification of regulatory alternatives in terms of relative risk. Perhaps the area of human reliability and organizational performance has the greatest potential for improvement in reactor safety. The ability to model human performance is significantly less developed that the ability to model mechanical or electrical systems. The move toward risk informed, performance based regulation provides an unusual, perhaps unique, opportunity to establish a more rational, more effective basis for regulation

[Drug advertising--users want information. Report of telephone survey conducted by North-Rhine Westphalia Public Health Service on the topic of drug advertising and drug information for users].

Science.gov (United States)

Puteanus, U

2000-10-01

In Germany, drug advertising of non-prescription drugs is a controversial subject. On the one hand, consumer organisations plead for placing a ban on advertising or at least to offer a detailed description of medical risks in respect of protection. On the other hand, the pharmaceutical industry is keen on liberalizing the specific advertising law for drugs. A representative telephone survey among the population of North Rhine-Westphalia was conducted in April and May 1999. It showed consumer interest in advertising, the value of information on risks, the institution with maximum credibility in drug information for consumers, the importance of the now obligatory sentence after every advertisement: Regarding risks and side effects read the leaflet in the package and ask your physician or pharmacist, and to what extend the consumer would take advice from independent experts over the telephone about drugs. It was found that, in particular women, about 30% are occasionally interested in advertising, younger people are more open-minded about advertising than older people; and that doctors and pharmacists have the most credibility and are consulted for further information. It was also found that more than 80% of the population demanded precise information on the side effects of drugs. One-third of the consumers declared that the obligatory sentence (see above) led to greater demand for information from doctors or to read attentively the instruction leaflet. Nevertheless, there is a need for more information from more than half of the consumers, who would take advantage of an independent advice centre if this should exist.

Using cooperative learning for a drug information assignment.

Science.gov (United States)

Earl, Grace L

2009-11-12

To implement a cooperative learning activity to engage students in analyzing tertiary drug information resources in a literature evaluation course. The class was divided into 4 sections to form expert groups and each group researched a different set of references using the jigsaw technique. Each member of each expert group was reassigned to a jigsaw group so that each new group was composed of 4 students from 4 different expert groups. The jigsaw groups met to discuss search strategies and rate the usefulness of the references. In addition to group-based learning, teaching methods included students' writing an independent research paper to enhance their abilities to search and analyze drug information resources. The assignment and final course grades improved after implementation of the activity. Students agreed that class discussions were a useful learning experience and 75% (77/102) said they would use the drug information references for other courses. The jigsaw technique was successful in engaging students in cooperative learning to improve critical thinking skills regarding drug information.

Regulation of drug-metabolizing enzymes in infectious and inflammatory disease: implications for biologics-small molecule drug interactions.

Science.gov (United States)

Mallick, Pankajini; Taneja, Guncha; Moorthy, Bhagavatula; Ghose, Romi

2017-06-01

Drug-metabolizing enzymes (DMEs) are primarily down-regulated during infectious and inflammatory diseases, leading to disruption in the metabolism of small molecule drugs (smds), which are increasingly being prescribed therapeutically in combination with biologics for a number of chronic diseases. The biologics may exert pro- or anti-inflammatory effect, which may in turn affect the expression/activity of DMEs. Thus, patients with infectious/inflammatory diseases undergoing biologic/smd treatment can have complex changes in DMEs due to combined effects of the disease and treatment. Areas covered: We will discuss clinical biologics-SMD interaction and regulation of DMEs during infection and inflammatory diseases. Mechanistic studies will be discussed and consequences on biologic-small molecule combination therapy on disease outcome due to changes in drug metabolism will be highlighted. Expert opinion: The involvement of immunomodulatory mediators in biologic-SMDs is well known. Regulatory guidelines recommend appropriate in vitro or in vivo assessments for possible interactions. The role of cytokines in biologic-SMDs has been documented. However, the mechanisms of drug-drug interactions is much more complex, and is probably multi-factorial. Studies aimed at understanding the mechanism by which biologics effect the DMEs during inflammation/infection are clinically important.

Do no harm: the role of community pharmacists in regulating public access to prescription drugs in Saudi Arabia.

Science.gov (United States)

Bahnassi, Anas

2016-04-01

Pharmacists have a crucial role to ensure regulated public access to prescription drugs. The study aimed to investigate the views of community pharmacists practising in Saudi Arabia on their role in the unauthorised supply of prescription drugs, consider the possible contributory factors and report pharmacists' suggested strategies to regulate supply. One hundred community pharmacists were invited to participate in an interview-based survey, including questions on demographic characteristics, and the unauthorised supply of prescription drugs. Descriptive statistics were conducted, and associations between categorical responses tested; a P value of ≤0.05 was considered significant. Responses to open questions were analysed thematically. In Saudi Arabia, there is widespread unregulated supply of prescription drugs; pharmacists are under pressure from patients to provide prescription drugs for a wide range of clinical conditions. There are safety and appropriateness concerns when drugs are provided based on patient demand rather than clinical need. Pharmacists do not maintain patient records with information on drugs supplied and associated actions. While most pharmacists supply prescription drugs without the necessary prescriber authorisation, they also this may jeopardise patients safety. While we have many concerns about this practice its present form, we believe pharmacists should have certain prescribing privileges within their areas of competence. A legal framework is needed to guarantee proper pharmacists' training, support, mentorship and access to the tools required to provide safe pharmacy practice. © 2015 Royal Pharmaceutical Society.

Regulation of chromatin states by drugs of abuse.

Science.gov (United States)

Walker, Deena M; Cates, Hannah M; Heller, Elizabeth A; Nestler, Eric J

2015-02-01

Drug addiction involves long-term behavioral abnormalities and gene expression changes throughout the mesolimbic dopamine system. Epigenetic mechanisms establish/maintain alterations in gene expression in the brain, providing the impetus for investigations characterizing how epigenetic processes mediate the effects of drugs of abuse. This review focuses on evidence that epigenetic events, specifically histone modifications, regulate gene expression changes throughout the reward circuitry. Drugs of abuse induce changes in histone modifications throughout the reward circuitry by altering histone-modifying enzymes, manipulation of which reveals a role for histone modification in addiction-related behaviors. There is a complex interplay between these enzymes, resulting in a histone signature of the addicted phenotype. Insights gained from these studies are key to identifying novel targets for diagnosis and therapy. Copyright © 2014 Elsevier Ltd. All rights reserved.

DrugSig: A resource for computational drug repositioning utilizing gene expression signatures.

Directory of Open Access Journals (Sweden)

Hongyu Wu

Full Text Available Computational drug repositioning has been proved as an effective approach to develop new drug uses. However, currently existing strategies strongly rely on drug response gene signatures which scattered in separated or individual experimental data, and resulted in low efficient outputs. So, a fully drug response gene signatures database will be very helpful to these methods. We collected drug response microarray data and annotated related drug and targets information from public databases and scientific literature. By selecting top 500 up-regulated and down-regulated genes as drug signatures, we manually established the DrugSig database. Currently DrugSig contains more than 1300 drugs, 7000 microarray and 800 targets. Moreover, we developed the signature based and target based functions to aid drug repositioning. The constructed database can serve as a resource to quicken computational drug repositioning. Database URL: http://biotechlab.fudan.edu.cn/database/drugsig/.

Discussion about risk-informed regulations on the nuclear safety

International Nuclear Information System (INIS)

Gu Yeyi

2008-01-01

The article introduces the background and status quo of regulations on the nuclear safety in China, and points out the inadequacies existing with the current regulations. The author explains the risk-informed safety management concerning its development, status quo, and achievements made, in an attempt to make out the trend of improving regulations on the nuclear safety through risk-informed methods. Combining the U.S. development program of establishing risk-informed regulations on the nuclear safety, the author narrates principles and features of the new regulations system, and provides suggestions for the promotion of risk-informed safety management and establishment of risk-informed regulations on the nuclear safety. (author)

Drug-Target Interaction Prediction through Label Propagation with Linear Neighborhood Information.

Science.gov (United States)

Zhang, Wen; Chen, Yanlin; Li, Dingfang

2017-11-25

Interactions between drugs and target proteins provide important information for the drug discovery. Currently, experiments identified only a small number of drug-target interactions. Therefore, the development of computational methods for drug-target interaction prediction is an urgent task of theoretical interest and practical significance. In this paper, we propose a label propagation method with linear neighborhood information (LPLNI) for predicting unobserved drug-target interactions. Firstly, we calculate drug-drug linear neighborhood similarity in the feature spaces, by considering how to reconstruct data points from neighbors. Then, we take similarities as the manifold of drugs, and assume the manifold unchanged in the interaction space. At last, we predict unobserved interactions between known drugs and targets by using drug-drug linear neighborhood similarity and known drug-target interactions. The experiments show that LPLNI can utilize only known drug-target interactions to make high-accuracy predictions on four benchmark datasets. Furthermore, we consider incorporating chemical structures into LPLNI models. Experimental results demonstrate that the model with integrated information (LPLNI-II) can produce improved performances, better than other state-of-the-art methods. The known drug-target interactions are an important information source for computational predictions. The usefulness of the proposed method is demonstrated by cross validation and the case study.

Evaluation of Information Contained in Drug Advertisement and ...

African Journals Online (AJOL)

Evaluation of Information Contained in Drug Advertisement and Promotion Materials in Nigeria. ... Conclusion: This study reveals that advertising materials used in promoting drugs in Nigeria have incomplete ... AJOL African Journals Online.

Role of Information Anxiety and Information Load on Processing of Prescription Drug Information Leaflets.

Science.gov (United States)

Bapat, Shweta S; Patel, Harshali K; Sansgiry, Sujit S

2017-10-16

In this study, we evaluate the role of information anxiety and information load on the intention to read information from prescription drug information leaflets (PILs). These PILs were developed based on the principals of information load and consumer information processing. This was an experimental prospective repeated measures study conducted in the United States where 360 (62% response rate) university students (>18 years old) participated. Participants were presented with a scenario followed by exposure to the three drug product information sources used to operationalize information load. The three sources were: (i) current practice; (ii) pre-existing one-page text only; and (iii) interventional one-page prototype PILs designed for the study. Information anxiety was measured as anxiety experienced by the individual when encountering information. The outcome variable of intention to read PILs was defined as the likelihood that the patient will read the information provided in the leaflets. A survey questionnaire was used to capture the data and the objectives were analyzed by performing a repeated measures MANOVA using SAS version 9.3. When compared to current practice and one-page text only leaflets, one-page PILs had significantly lower scores on information anxiety ( p information load ( p Information anxiety and information load significantly impacted intention to read ( p < 0.001). Newly developed PILs increased patient's intention to read and can help in improving the counseling services provided by pharmacists.

Adherence to drug treatment in association with how the patient perceives care and information on drugs.

Science.gov (United States)

Ulfvarson, Johanna; Bardage, Carola; Wredling, Regina A-M; von Bahr, Christer; Adami, Johanna

2007-01-01

This study was to explore concordance with drugs prescribed and the patient's self-reported drug consumption, in relation to the older patient's perceived care and information given. Lack of adherence to prescriptions may lead to therapeutic failure with risks for relapse, unnecessary suffering and increased costs. A cross-sectional study with structured interviews of 200 patients who had recently been treated in a medical ward. Patients' medical records were studied to obtain information on their current use of drugs. The data were analyzed by logistic regression, adherence being the dependent response variable. The mean age of the study group was 79 years. The number of drugs reported in the medical chart ranged from one to 17 with a mean of 6.9. The patients reported a drug consumption ranging from 0 to 24 with a mean of 7.3. When comparing the interview results with the information in the medical charts, 30% of the patients showed adherence. An association was found between adherence and self-reported health status. Patients in the non-adherent group reported a higher consumption of drugs. Patients felt that the opportunity to ask questions of either the responsible physicians or of the nurses was influential in decreasing risk. In this study, the patient's total drug consumption was considered. The study showed a large discrepancy between the drugs stated in the medical chart and patient's self-reported drug consumption. The study failed to show that perceived information or educational level had an impact on the results but implicate that the quality of information influences adherence. It is of importance to recognize patients at risk for non-adherence. Decreased health status and many drugs are the main risk factors for patients being non-adherent, and should be recognized as such.

One and done: Reasons principal investigators conduct only one FDA-regulated drug trial

Directory of Open Access Journals (Sweden)

Amy Corneli, PhD, MPH

2017-06-01

Full Text Available Concerns have been raised over the high turnover rate for clinical investigators. Using the U.S. Food and Drug Administration's (FDA Bioresearch Monitoring Information System database, we conducted an online survey to identify factors that affect principal investigators' (PIs decisions to conduct only a single FDA-regulated drug trial. Of the 201 PIs who responded, 54.2% were classified as “one-and-done.” Among these investigators, 28.9% decided for personal reasons to not conduct another trial, and 44.4% were interested in conducting another trial, but no opportunities were available. Three categories of broad barriers were identified as generally burdensome or challenging by the majority of investigators: 1 workload balance (balancing trial implementation with other work obligations and opportunities (63.8%; 2 time requirements (time to initiate and implement trial; investigator and staff time (63.4%; and 3 data and safety reporting (56.5%. Additionally, 46.0% of investigators reported being generally unsatisfied with finance-related issues. These same top three barriers also affected investigators' decisions to no longer conduct FDA-regulated trials. Our findings illuminate three key aspects of investigator turnover. First, they confirm that investigator turnover occurs, as more than half of respondents were truly “one-and-done.” Second, because a large proportion of respondents wanted to conduct more FDA-regulated trials but lacked opportunities to do so, mechanisms that match interested investigators with research sponsors are needed. Third, by focusing on the barriers we identified that affected investigators' decisions to no longer conduct FDA-regulated trials, future efforts to reduce investigator turnover can target issues that matter the most to investigators.

Lipid Bilayer – mediated Regulation of Ion Channel Function by Amphiphilic Drugs

DEFF Research Database (Denmark)

Lundbæk, Jens August

2008-01-01

that are transforming it into a subject of quantitative science. It is described how the hydrophobic interactions between a membrane protein and the host lipid bilayer provide the basis for a mechanism, whereby protein function is regulated by the bilayer physical properties. The use of gramicidin channels as single-molecule......Drugs that at pico- to nanomolar concentration regulate ion channel function by high-affi nity binding to their cognate receptor often have a “ secondary pharmacology, ” in which the same molecule at low micromolar concentrations regulates a diversity of membrane proteins in an apparently...... nonspecifi c manner. It has long been suspected that this promiscuous regulation of membrane protein function could be due to changes in the physical properties of the host lipid bilayer, but the underlying mechanisms have been poorly understood. Given that pharmacological research often involves drug...

78 FR 6216 - Freedom of Information Act Regulations

Science.gov (United States)

2013-01-30

... DEPARTMENT OF THE INTERIOR Office of the Secretary 43 CFR Part 2 RIN 1093-AA15 Freedom of... regulation revises the Department's Freedom of Information Act regulations. DATES: Effective January 30, 2013... 31, 2012, revising the Department of the Interior Freedom of Information Act (FOIA) regulations. This...

34 CFR 86.1 - What is the purpose of the Drug and Alcohol Abuse Prevention regulations?

Science.gov (United States)

2010-07-01

... 34 Education 1 2010-07-01 2010-07-01 false What is the purpose of the Drug and Alcohol Abuse... ALCOHOL ABUSE PREVENTION General § 86.1 What is the purpose of the Drug and Alcohol Abuse Prevention regulations? The purpose of the Drug and Alcohol Abuse Prevention regulations is to implement section 22 of...

Prohibited or regulated? LSD psychotherapy and the United States Food and Drug Administration.

Science.gov (United States)

Oram, Matthew

2016-09-01

Over the 1950s and early 1960s, the use of the hallucinogenic drug lysergic acid diethylamide (LSD) to facilitate psychotherapy was a promising field of psychiatric research in the USA. However, during the 1960s, research began to decline, before coming to a complete halt in the mid-1970s. This has commonly been explained through the increase in prohibitive federal regulations during the 1960s that aimed to curb the growing recreational use of the drug. However, closely examining the Food and Drug Administration's regulation of LSD research in the 1960s will reveal that not only was LSD research never prohibited, but that the administration supported research to a greater degree than has been recognized. Instead, the decline in research reflected more complex changes in the regulation of pharmaceutical research and development. © The Author(s) 2016.

Outlook for risk assessment and risk-informed regulations

International Nuclear Information System (INIS)

Chakraborty, S.; Breutel, C.; Khatib-Rahbar, M.

2000-01-01

The Western nuclear regulatory process has evolved from the initial engineering judgment' framework of the 1960's, the prescriptive deterministic requirements of the 1970s, the transition years of the 1980s, to the present day movement toward risk-informed approaches. In this paper, a short overview of the historic development of safety regulation is provided. The critique of traditional regulatory practice will be summarized and the features of risk-informed regulation will be discussed. The implementation of risk-informed regulation is considered on the basis of general legal principles common to many member states of the NEA and IAEA. In a process to risk-inform regulation, principles such as equal treatment, proportionality of rules and predictability of administrative action are found to be important. (author)

Accuracy and completeness of drug information in Wikipedia medication monographs.

Science.gov (United States)

Reilly, Timothy; Jackson, William; Berger, Victoria; Candelario, Danielle

The primary objective of this study was to determine the accuracy and completeness of drug information on Wikipedia and Micromedex compared with U.S. Food and Drug Administration-approved U.S. product inserts. The top 10 brand and top 10 generic medications from the 2012 Institute for Health Informatics' list of top 200 drugs were selected for evaluation. Wikipedia medication information was evaluated and compared with Micromedex in 7 sections of drug information; the U.S. product inserts were used as the standard comparator. Wikipedia demonstrated significantly lower completeness and accuracy scores compared with Micromedex (mean composite scores 18.55 vs. 38.4, respectively; P <0.01). No difference was found between the mean composite scores for brand versus generic drugs in either reference (17.8 vs. 19.3, respectively [P = 0.62], for Wikipedia; 39.2 vs. 37.6, [P = 0.06] for Micromedex). Limitations to these results include the speed with which information is edited on Wikipedia, that there was no evaluation of off-label information, and the limited number of drugs that were evaluated. Wikipedia lacks the accuracy and completeness of standard clinical references and should not be a routine part of clinical decision making. More research should be conducted to evaluate the rationale for health care providers' use of Wikipedia. Copyright © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

21 CFR 1.406 - How will FDA handle classified information in an informal hearing?

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false How will FDA handle classified information in an informal hearing? 1.406 Section 1.406 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or...

78 FR 76059 - New Animal Drugs for Use in Animal Feeds; Bambermycins

Science.gov (United States)

2013-12-16

.... FDA-2012-N-0002] New Animal Drugs for Use in Animal Feeds; Bambermycins AGENCY: Food and Drug... amending the animal drug regulations to remove dairy replacement heifers from the pasture cattle class for....gov . SUPPLEMENTARY INFORMATION: FDA has noticed that the animal drug regulations for bambermycins...

Sources of drug information and their influence on the prescribing ...

African Journals Online (AJOL)

Sources of drug information and their influence on the prescribing behaviour of doctors in a teaching hospital in Ibadan, Nigeria. ... Drug information was sourced from colleagues (161, 98.8%), reference books (158, 96.9%), pharmaceutical sales representatives-PSRs (152, 93.2%), promotion materials (151, 92.6%), ...

New drug information resources for pharmacists at the National Library of Medicine.

Science.gov (United States)

Knoben, James E; Phillips, Steven J

2014-01-01

To provide an overview of selected drug information-related databases of the National Library of Medicine (NLM), with a focus on newer resources that support the professional information needs of pharmacists and other health care providers. NLM, which is the world's largest medical library, provides an array of bibliographic, factual, and evidence-based drug, herbal remedy, and dietary supplement information resources. Five of the more recently introduced online resources include areas of particular importance to pharmacists, including a repository of current product labeling/package inserts, with automated search links to associated information resources; a portal to drug information that allows pharmacists to search multiple databases simultaneously and link to related medication and health care information resources; authoritative information on the effects of medications, herbal remedies, and dietary supplements in nursing infants and their mothers; comprehensive information, including a case registry, on the potential for liver toxicity due to drugs, herbal remedies, and dietary supplements; and a pill identification system with two intuitive search methodologies. NLM provides several clinical-scientific drug information resources that are particularly useful in meeting the professional information needs of pharmacists.

Drug evaluation and the permissive principle: continuities and contradictions between standards and practices in antidepressant regulation.

Science.gov (United States)

Abraham, John; Davis, Courtney

2009-08-01

Pharmaceuticals are not permitted on to the market unless they are granted regulatory approval. The regulatory process is, therefore, crucial in whether or not a drug is widely prescribed. Regulatory agencies have developed standards of performance that pharmaceuticals are supposed to meet before entering the market. Regulation of technologies is often discussed by reference to the precautionary principle. In contrast, this paper develops the concept of the 'permissive principle' as a way of understanding the departure of regulators' practices from standards of drug efficacy to which regulatory agencies themselves subscribe. By taking a case study of antidepressant regulation in the UK and the USA, the mechanisms of permissive regulatory practices are examined. An STS methodology of both spatial (international) and temporal comparisons of regulatory practices with regulatory standards is employed to identify the nature and extent of the permissive regulation. It is found that the permissive principle was adopted by drug regulators in the UK and the USA, but more so by the former than the latter. Evidently, permissive regulation, which favours the commercial interests of the drug manufacturer, but is contrary to the interests of patients, may penetrate to the heart of regulatory science. On the other hand, permissive regulation of specific drugs should not be regarded as an inevitable result of marketing strategies and concomitant networks deployed by powerful pharmaceutical companies, because the extent of permissive regulation may vary according to the intra-institutional normative commitments of regulators to uphold their technical standards against the commercial interests of the manufacturer. Likely sociological factors that can account for such permissive regulatory practices are 'corporate bias', secrecy and excessive regulatory trust in the pharmaceutical industry in the UK, political expediency and ideological capture in the USA, combined in both countries

Protracted abstinence from distinct drugs of abuse shows regulation of a common gene network.

Science.gov (United States)

Le Merrer, Julie; Befort, Katia; Gardon, Olivier; Filliol, Dominique; Darcq, Emmanuel; Dembele, Doulaye; Becker, Jerome A J; Kieffer, Brigitte L

2012-01-01

Addiction is a chronic brain disorder. Prolonged abstinence from drugs of abuse involves dysphoria, high stress responsiveness and craving. The neurobiology of drug abstinence, however, is poorly understood. We previously identified a unique set of hundred mu-opioid receptor-dependent genes in the extended amygdala, a key site for hedonic and stress processing in the brain. Here we examined these candidate genes either immediately after chronic morphine, nicotine, Δ9-tetrahydrocannabinol or alcohol, or following 4 weeks of abstinence. Regulation patterns strongly differed among chronic groups. In contrast, gene regulations strikingly converged in the abstinent groups and revealed unforeseen common adaptations within a novel huntingtin-centered molecular network previously unreported in addiction research. This study demonstrates that, regardless the drug, a specific set of transcriptional regulations develops in the abstinent brain, which possibly contributes to the negative affect characterizing protracted abstinence. This transcriptional signature may represent a hallmark of drug abstinence and a unitary adaptive molecular mechanism in substance abuse disorders. © 2011 The Authors, Addiction Biology © 2011 Society for the Study of Addiction.

[Parenting Information: Drugs. Informacion Para los Padres: Sobre las Drojas.

Science.gov (United States)

Moreno, Steve

These two booklets provide basic information about drugs and drug abuse and are part of a series of 22 booklets, designed specifically to help parents understand their children and help them to learn. "Let's Talk about Drug Abuse," (booklet #18), reviews foreign substances or drugs young people are often exposed to (i.e., tobacco,…

The influence of the European paediatric regulation on marketing authorisation of orphan drugs for children

NARCIS (Netherlands)

Kreeftmeijer-Vegter, Annemarie Rosan; de Boer, Anthonius; van der Vlugt-Meijer, Roselinda H.; de Vries, Peter J.

2014-01-01

Background: Drug development for rare diseases is challenging, especially when these orphan drugs (OD) are intended for children. In 2007 the EU Paediatric Drug Regulation was enacted to improve the development of high quality and ethically researched medicines for children through the establishment

The influence of the European paediatric regulation on marketing authorisation of orphan drugs for children

NARCIS (Netherlands)

Kreeftmeijer-Vegter, Annemarie Rosan; de Boer, Anthonius; van der Vlugt-Meijer, Roselinda H; de Vries, Peter J

2014-01-01

BACKGROUND: Drug development for rare diseases is challenging, especially when these orphan drugs (OD) are intended for children. In 2007 the EU Paediatric Drug Regulation was enacted to improve the development of high quality and ethically researched medicines for children through the establishment

76 FR 58020 - Prescription Drug User Fee Act IV Information Technology Plan

Science.gov (United States)

2011-09-19

...] Prescription Drug User Fee Act IV Information Technology Plan AGENCY: Food and Drug Administration, HHS. ACTION... information technology (IT) plan entitled ``PDUFA IV Information Technology Plan'' (updated plan) to achieve... Information Technology Plan.'' This plan will meet one of the performance goals agreed to under the 2007...

A network integration approach for drug-target interaction prediction and computational drug repositioning from heterogeneous information.

Science.gov (United States)

Luo, Yunan; Zhao, Xinbin; Zhou, Jingtian; Yang, Jinglin; Zhang, Yanqing; Kuang, Wenhua; Peng, Jian; Chen, Ligong; Zeng, Jianyang

2017-09-18

The emergence of large-scale genomic, chemical and pharmacological data provides new opportunities for drug discovery and repositioning. In this work, we develop a computational pipeline, called DTINet, to predict novel drug-target interactions from a constructed heterogeneous network, which integrates diverse drug-related information. DTINet focuses on learning a low-dimensional vector representation of features, which accurately explains the topological properties of individual nodes in the heterogeneous network, and then makes prediction based on these representations via a vector space projection scheme. DTINet achieves substantial performance improvement over other state-of-the-art methods for drug-target interaction prediction. Moreover, we experimentally validate the novel interactions between three drugs and the cyclooxygenase proteins predicted by DTINet, and demonstrate the new potential applications of these identified cyclooxygenase inhibitors in preventing inflammatory diseases. These results indicate that DTINet can provide a practically useful tool for integrating heterogeneous information to predict new drug-target interactions and repurpose existing drugs.Network-based data integration for drug-target prediction is a promising avenue for drug repositioning, but performance is wanting. Here, the authors introduce DTINet, whose performance is enhanced in the face of noisy, incomplete and high-dimensional biological data by learning low-dimensional vector representations.

The usefulness and scientific accuracy of private sector Arabic language patient drug information leaflets.

Science.gov (United States)

Sukkari, Sana R; Al Humaidan, Abdullah S; Sasich, Larry D

2012-07-01

Inadequate access to useful scientifically accurate patient information is a major cause of the inappropriate use of drugs resulting in serious personal injury and related costs to the health care system. The definition of useful scientifically accurate patient information for prescription drugs was accepted by the US Secretary of the Department of Health and Human Services in 1996 as that derived from or consistent with the US FDA approved professional product label for a drug. Previous quality content studies found that English language patient drug information leaflets distributed by US pharmacies failed to meet minimum criteria defining useful and scientifically accurate information. Evaluation forms containing the explicit elements that define useful scientifically accurate information for three drugs with known serious adverse drug reactions were created based on the current US FDA approved professional product labels. The Arabic language patient drug information leaflets for celecoxib, paroxetine, and lamotrigine were obtained locally and evaluated using a methodology similar to that used in previous quality content patient drug information studies in the US. The Arabic leaflets failed to meet the definition of useful scientifically accurate information. The celecoxib leaflet contained 30% of the required information and the paroxetine and lamotrigine leaflets contained 24% and 20%, respectively. There are several limitations to this study. The Arabic leaflets from only one commercial North American vendor were evaluated and the evaluation included a limited number of drugs. A larger study is necessary to be able to generalize these results. The study results are consistent with those of previous quality content studies of commercially available English patient drug information leaflets. The results have important implications for patients as access to a reliable source of drug information may prevent harm or limit the suffering from serious adverse drug

Factors influencing GPs’ choice between drugs in a therapeutic drug group. A qualitative study

DEFF Research Database (Denmark)

Buusman, Allan; Andersen, Morten; Merrild, Camilla Hoffmann

2007-01-01

(GPs) were selected with reference to variation in organizational structure, age, and gender. Main outcome measures. GPs' description of drug choice in relation to specific patient encounters involving a prescription. Results. All informants appeared to consider drug price important...... as it was a recurring theme during all interviews. External factors outside the GP's control such as governmental regulation on prescribing and the pharmaceutical industry influenced most GPs. Internal factors related to the actual consultation included characteristics of the GP and the patient, drug characteristics......, and repeat prescriptions. These factors interact in a non-linear and unpredictable way similar to complex adaptive systems. Conclusion. GPs balance both internal and external factors when choosing between analogues. Drug choice is a regulated process in the realm of complex prescribing behaviour with drug...

77 FR 58021 - New Animal Drugs for Use in Animal Feeds; Monensin

Science.gov (United States)

2012-09-19

... [Docket No. FDA-2012-N-0002] New Animal Drugs for Use in Animal Feeds; Monensin AGENCY: Food and Drug... amending the animal drug regulations to remove a warning for growing cattle on pasture or in dry lot and to... . SUPPLEMENTARY INFORMATION: FDA has noticed that the animal drug regulations for certain monensin free-choice...

Design of a RESTful web information system for drug prescription and administration.

Science.gov (United States)

Bianchi, Lorenzo; Paganelli, Federica; Pettenati, Maria Chiara; Turchi, Stefano; Ciofi, Lucia; Iadanza, Ernesto; Giuli, Dino

2014-05-01

Drug prescription and administration processes strongly impact on the occurrence of risks in medical settings for they can be sources of adverse drug events (ADEs). A properly engineered use of information and communication technologies has proven to be a promising approach to reduce these risks. In this study, we propose PHARMA, a web information system which supports healthcare staff in the secure cooperative execution of drug prescription, transcription and registration tasks. PHARMA allows the easy sharing and management of documents containing drug-related information (i.e., drug prescriptions, medical reports, screening), which is often inconsistent and scattered across different information systems and heterogeneous organization domains (e.g., departments, other hospital facilities). PHARMA enables users to access such information in a consistent and secure way, through the adoption of REST and web-oriented design paradigms and protocols. We describe the implementation of the PHARMA prototype, and we discuss the results of the usability evaluation that we carried out with the staff of a hospital in Florence, Italy.

Self-regulation and selective exposure: the impact of depleted self-regulation resources on confirmatory information processing.

Science.gov (United States)

Fischer, Peter; Greitemeyer, Tobias; Frey, Dieter

2008-03-01

In the present research, the authors investigated the impact of self-regulation resources on confirmatory information processing, that is, the tendency of individuals to systematically prefer standpoint-consistent information to standpoint-inconsistent information in information evaluation and search. In 4 studies with political and economic decision-making scenarios, it was consistently found that individuals with depleted self-regulation resources exhibited a stronger tendency for confirmatory information processing than did individuals with nondepleted self-regulation resources. Alternative explanations based on processes of ego threat, cognitive load, and mood were ruled out. Mediational analyses suggested that individuals with depleted self-regulation resources experienced increased levels of commitment to their own standpoint, which resulted in increased confirmatory information processing. In sum, the impact of ego depletion on confirmatory information search seems to be more motivational than cognitive in nature.

Gemfibrozil and Fenofibrate, Food and Drug Administration-approved Lipid-lowering Drugs, Up-regulate Tripeptidyl-peptidase 1 in Brain Cells via Peroxisome Proliferator-activated Receptor α

Science.gov (United States)

Ghosh, Arunava; Corbett, Grant T.; Gonzalez, Frank J.; Pahan, Kalipada

2012-01-01

The classical late infantile neuronal ceroid lipofuscinosis (LINCLs) is an autosomal recessive disease, where the defective gene is Cln2, encoding tripeptidyl-peptidase I (TPP1). At the molecular level, LINCL is caused by accumulation of autofluorescent storage materials in neurons and other cell types. Currently, there is no established treatment for this fatal disease. This study reveals a novel use of gemfibrozil and fenofibrate, Food and Drug Administration-approved lipid-lowering drugs, in up-regulating TPP1 in brain cells. Both gemfibrozil and fenofibrate up-regulated mRNA, protein, and enzymatic activity of TPP1 in primary mouse neurons and astrocytes as well as human astrocytes and neuronal cells. Because gemfibrozil and fenofibrate are known to activate peroxisome proliferator-activated receptor-α (PPARα), the role of PPARα in gemfibrozil- and fenofibrate-mediated up-regulation of TPP1 was investigated revealing that both drugs up-regulated TPP1 mRNA, protein, and enzymatic activity both in vitro and in vivo in wild type (WT) and PPARβ−/−, but not PPARα−/−, mice. In an attempt to delineate the mechanism of TPP1 up-regulation, it was found that the effects of the fibrate drugs were abrogated in the absence of retinoid X receptor-α (RXRα), a molecule known to form a heterodimer with PPARα. Accordingly, all-trans-retinoic acid, alone or together with gemfibrozil, up-regulated TPP1. Co-immunoprecipitation and ChIP studies revealed the formation of a PPARα/RXRα heterodimer and binding of the heterodimer to an RXR-binding site on the Cln2 promoter. Together, this study demonstrates a unique mechanism for the up-regulation of TPP1 by fibrate drugs via PPARα/RXRα pathway. PMID:22989886

HSA-based multi-target combination therapy: regulating drugs' release from HSA and overcoming single drug resistance in a breast cancer model.

Science.gov (United States)

Gou, Yi; Zhang, Zhenlei; Li, Dongyang; Zhao, Lei; Cai, Meiling; Sun, Zhewen; Li, Yongping; Zhang, Yao; Khan, Hamid; Sun, Hongbing; Wang, Tao; Liang, Hong; Yang, Feng

2018-11-01

Multi-drug delivery systems, which may be promising solution to overcome obstacles, have limited the clinical success of multi-drug combination therapies to treat cancer. To this end, we used three different anticancer agents, Cu(BpT)Br, NAMI-A, and doxorubicin (DOX), to build human serum albumin (HSA)-based multi-drug delivery systems in a breast cancer model to investigate the therapeutic efficacy of overcoming single drug (DOX) resistance to cancer cells in vivo, and to regulate the drugs' release from HSA. The HSA complex structure revealed that NAMI-A and Cu(BpT)Br bind to the IB and IIA sub-domain of HSA by N-donor residue replacing a leaving group and coordinating to their metal centers, respectively. The MALDI-TOF mass spectra demonstrated that one DOX molecule is conjugated with lysine of HSA by a pH-sensitive linker. Furthermore, the release behavior of three agents form HSA can be regulated at different pH levels. Importantly, in vivo results revealed that the HSA-NAMI-A-Cu(BpT)Br-DOX complex not only increases the targeting ability compared with a combination of the three agents (the NAMI-A/Cu(BpT)Br/DOX mixture), but it also overcomes DOX resistance to drug-resistant breast cancer cell lines.

The evaluation of drug regulation - economic approaches into the valuation and evaluation of the drug regulatory framework

NARCIS (Netherlands)

Bouvy, J.C.

2013-01-01

The European pharmaceutical market is strictly regulated. Sufficient levels of quality, safety, and efficacy will have to be demonstrated before a pharmaceutical is allowed to enter the market. There is little evidence, however, that the current drug regulatory framework is achieving its goals of

A conceptual framework for the identification of candidate drugs and drug targets in acute promyelocytic leukemia

DEFF Research Database (Denmark)

Marstrand, T T; Borup, R; Willer, A

2010-01-01

regulation, and (ii) the identification of candidate drugs and drug targets for therapeutic interventions. Significantly, our study provides a conceptual framework that can be applied to any subtype of AML and cancer in general to uncover novel information from published microarray data sets at low cost...

A gene expression system offering multiple levels of regulation: the Dual Drug Control (DDC) system.

Science.gov (United States)

Sudomoina, Marina; Latypova, Ekaterina; Favorova, Olga O; Golemis, Erica A; Serebriiskii, Ilya G

2004-04-29

Whether for cell culture studies of protein function, construction of mouse models to enable in vivo analysis of disease epidemiology, or ultimately gene therapy of human diseases, a critical enabling step is the ability to achieve finely controlled regulation of gene expression. Previous efforts to achieve this goal have explored inducible drug regulation of gene expression, and construction of synthetic promoters based on two-hybrid paradigms, among others. In this report, we describe the combination of dimerizer-regulated two-hybrid and tetracycline regulatory elements in an ordered cascade, placing expression of endpoint reporters under the control of two distinct drugs. In this Dual Drug Control (DDC) system, a first plasmid expresses fusion proteins to DBD and AD, which interact only in the presence of a small molecule dimerizer; a second plasmid encodes a cassette transcriptionally responsive to the first DBD, directing expression of the Tet-OFF protein; and a third plasmid encodes a reporter gene transcriptionally responsive to binding by Tet-OFF. We evaluate the dynamic range and specificity of this system in comparison to other available systems. This study demonstrates the feasibility of combining two discrete drug-regulated expression systems in a temporally sequential cascade, without loss of dynamic range of signal induction. The efficient layering of control levels allowed by this combination of elements provides the potential for the generation of complex control circuitry that may advance ability to regulate gene expression in vivo.

A gene expression system offering multiple levels of regulation: the Dual Drug Control (DDC system

Directory of Open Access Journals (Sweden)

Golemis Erica A

2004-04-01

Full Text Available Abstract Background Whether for cell culture studies of protein function, construction of mouse models to enable in vivo analysis of disease epidemiology, or ultimately gene therapy of human diseases, a critical enabling step is the ability to achieve finely controlled regulation of gene expression. Previous efforts to achieve this goal have explored inducible drug regulation of gene expression, and construction of synthetic promoters based on two-hybrid paradigms, among others. Results In this report, we describe the combination of dimerizer-regulated two-hybrid and tetracycline regulatory elements in an ordered cascade, placing expression of endpoint reporters under the control of two distinct drugs. In this Dual Drug Control (DDC system, a first plasmid expresses fusion proteins to DBD and AD, which interact only in the presence of a small molecule dimerizer; a second plasmid encodes a cassette transcriptionally responsive to the first DBD, directing expression of the Tet-OFF protein; and a third plasmid encodes a reporter gene transcriptionally responsive to binding by Tet-OFF. We evaluate the dynamic range and specificity of this system in comparison to other available systems. Conclusion This study demonstrates the feasibility of combining two discrete drug-regulated expression systems in a temporally sequential cascade, without loss of dynamic range of signal induction. The efficient layering of control levels allowed by this combination of elements provides the potential for the generation of complex control circuitry that may advance ability to regulate gene expression in vivo.

Trust in online prescription drug information among internet users: the impact on information search behavior after exposure to direct-to-consumer advertising.

Science.gov (United States)

Menon, Ajit M; Deshpande, Aparna D; Perri, Matthew; Zinkhan, George M

2002-01-01

The proliferation of both manufacturer-controlled and independent medication-related websites has aroused concern among consumers and policy-makers concerning the trustworthiness of Web-based drug information. The authors examine consumers' trust in on-line prescription drug information and its influence on information search behavior. The study design involves a retrospective analysis of data from a 1998 national survey. The findings reveal that trust in drug information from traditional media sources such as television and newspapers transfers to the domain of the Internet. Furthermore, a greater trust in on-line prescription drug information stimulates utilization of the Internet for information search after exposure to prescription drug advertising.

75 FR 49946 - National Drug Intelligence Center: Agency Information Collection Activities: Proposed Extension...

Science.gov (United States)

2010-08-16

... DEPARTMENT OF JUSTICE [OMB Number 1105-0087] National Drug Intelligence Center: Agency Information...), National Drug Intelligence Center (NDIC), will be submitting the following information collection request... Kevin M. Walker, General Counsel, National Drug Intelligence Center, Fifth Floor, 319 Washington Street...

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.

Informational and symbolic content of over-the-counter drug advertising on television.

Science.gov (United States)

Tsao, J C

1997-01-01

The informational and symbolic content of 150 over-the-counter drug commercials on television are empirically analyzed in this study. Results on the informational content suggest that over-the-counter drug ads tend to focus on the concern of what the drug will do for the consumer, rather than on the reasons why the drug should be ingested. Accordingly, advertising strategy is centered on consumer awareness of the product as the primary goal. Educational commitment, however, did not seem to be blended into the promotional efforts for over-the-counter drugs. Findings on the symbolic content of over-the-counter drug ads reveal that drug images have been distorted. Performance of most drugs has been portrayed to be simple resolutions to relieve the symptom. Moreover, a casual attitude toward drug usage is encouraged in the commercials, while time lapse of drug effects is overlooked.

Assessing the quality of pharmacist answers to telephone drug information questions.

Science.gov (United States)

Woodward, C T; Stevenson, J G; Poremba, A

1990-04-01

A quality assurance (QA) program is described in which frontline pharmacists were asked test drug information questions via anonymous telephone calls. The program was instituted at a university hospital that began providing decentralized pharmaceutical services in 1985. Questions were developed on the basis of a pilot study conducted to determine the types and complexity of drug information questions received by frontline pharmacists at the hospital. Data on departmental clinical productivity were used to determine the number of questions that would be posed during each shift in the various service areas. The questions were posed during a 10-day period; the pharmacists were aware of the program, but the callers did not identify their affiliation with it. In response to 105 questions asked, 86 were judged to have been answered correctly, 13 answers were deemed incomplete, and 6 were judged incorrect. Pharmacists were more likely to respond incorrectly to complex questions and questions posed during the night shift. As a result of the audit, staff members with advanced clinical knowledge were asked to help less experienced pharmacists, the position of assistant director for drug information and staff development was created, and educational programs were instituted. The QA audit has been repeated twice. Posing test drug information questions via anonymous telephone calls is effective in assessing the quality of drug information provided by pharmacists in patient-care areas.

miR-133b down-regulates ABCC1 and enhances the sensitivity of CRC to anti-tumor drugs.

Science.gov (United States)

Chen, Miao; Li, Daojiang; Gong, Ni; Wu, Hao; Su, Chen; Xie, Canbin; Xiang, Hong; Lin, Changwei; Li, Xiaorong

2017-08-08

Multidrug resistance (MDR) is the main cause of failed chemotherapy treatments. Therefore, preventing MDR is pivotal in treating colorectal cancer (CRC). In a previous study miR-133b was shown to be a tumor suppressor. Additionally, in CRC cells transfected with miR-133b, ATP-binding cassette (ABC) subfamily C member 1(ABCC1) was shown to be significantly down regulated. Whether miR-133b also enhances the chemosensitivity of drugs used to treat CRC by targeting ABCC1 is still unclear. Here, we utilized flow cytometry and high-performance liquid chromatography (HPLC) analysis to identify the ability of miR-133b to reserve MDR in CRC. We then used a dual-luciferase reporter assay to validate that miR-133b targets ABCC1. Further in vivo experiments were designed to validate the method in which miR-133b reversed MDR in CRC cells. The results demonstrated that the level of miR-133b was down-regulated and the expression of ABCC1 was up-regulated in drug-resistant CRC cells compared to non-drug-resistant CRC cells. The restoration of miR-133b expression in CRC drug-resistant cells in vitro resulted in reduced IC50s to chemotherapeutic drugs, significantly induced G1 accumulation, inhibited growth and promoted necrosis in combination with either 5-fluorouracil (5-FU) or vincristine (VCR), and decreased the expression of ABCC1. The dual-luciferase assay demonstrated that miR-133b directly targets ABCC1. The combination of agomiRNA-133b with chemotherapeutic drugs in vivo inhibited tumor growth induced by CRC drug-resistant cells. A xenograft from the in vivo model resulted in up-regulated levels of miR-133b and down-regulated levels of ABCC1. Therefore, miR-133b enhances the chemosensitivity of CRC cells to anti-tumor drugs by directly down-regulating ABCC1. This discovery provides a therapeutic strategy in which miR-133b is used as a potential sensitizer for drug-resistant CRC.

21 CFR 207.25 - Information required in registration and drug listing.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Information required in registration and drug listing. 207.25 Section 207.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... manufactured by a registered blood bank, a copy of all current labeling (except that only one representative...

Physicians' Perception of Teratogenic Risk and Confidence in Prescribing Drugs in Pregnancy-Influence of Norwegian Drug Information Centers.

Science.gov (United States)

Bakkebø, Tina; Widnes, Sofia Frost; Aamlid, Synnøve Stubmo; Schjøtt, Jan

2016-05-01

Clinical decision support provided by drug information centers is an intervention that can ensure rational drug therapy for pregnant women. We have examined whether physicians' teratogenic risk perceptions and confidence in prescribing drugs to pregnant women is altered after advice from the Norwegian drug information centers, Regional Medicines and Pharmacovigilance Centres i Norway (RELIS). Physicians who consulted RELIS for advice on patient-specific drug use in pregnancy from November 2013 to April 2014 completed questionnaires before and after receiving the advice. A scale from 1 to 7 was used to rate confidence in prescribing and perception of teratogenic risk. The lower part of the scale represented a low perception of teratogenic risk and a high confidence in prescribing a drug in pregnancy. The data were analyzed using a mixed linear model. A total of 45 physicians participated in the study and they assessed 64 drugs or categories of drugs. Advice from RELIS increased confidence in prescribing, with a statistically significant mean change on the scale from 4.1 to 2.9. The assessment of teratogenic risk was reduced after advice from RELIS, with a mean change from 3.2 to 2.5, though this was not significant. A subgroup of 26 physicians completed questionnaires both before and after advice from RELIS and assessed a total of 32 drugs or categories of drugs. In 94% of these assessments, advice from RELIS altered the physician's confidence in prescribing. Perception of teratogenic risk was altered in 78% of the assessments. Our results show that physicians' perception of teratogenic risk and confidence in prescribing drugs to pregnant women is influenced by advice from Norwegian drug information centers. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

75 FR 12756 - Agency Information Collection Activities: Proposed Collection; Comment Request; Prescription Drug...

Science.gov (United States)

2010-03-17

... Advertisements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... drug advertisements. DATES: Submit written or electronic comments on the collection of information by... approval from the Office of Management and Budget (OMB) for each collection of information they conduct or...

Opinion On Drug Information Services Provided In A Multi- Specialty Teaching Hospital

Directory of Open Access Journals (Sweden)

Vijayakumar TM, Poovi G & Dhanaraju MD

2011-05-01

Full Text Available Objective: To evaluate the various drug information queriesreceived, and to access the drug information services providedby the pharmacy practice department.Method: Drug information queries received during wardrounds, direct communication, telephone or internet etc. weredocumented in the drug information request anddocumentation forms prepared by the department over theperiod of January 2010 to June 2010. Various parameters likestatus of enquirer, their specialty, mode of receipt of query,purpose of query, type of query etc. were consider forevaluation.Results: Out of 208 queries received, major 56 (26.9% frommale medical ward. Maximum [82 (39.4 %] queries were fromthe physicians. 73 (35.0 % of the queries were about therecent advances and the updating of the information, It wasfound that mostly the mode of request was during wardrounds 85 (40.9%. Most of the queries [126 (60.6%] wereanswered by written or printout format. Majority of thequeries [195 (93.8 %] were answered directly to theenquirers through direct access. Most of the queries wereanswered through books in the department [86 (41.3 %].Conclusion: Results of the external auditing revealed thatrequestors were generally satisfied with the service provided.The drug information services provided by clinical pharmacistsat the hospital were found to be useful and beneficial to thehealthcare professionals and patients.

78 FR 71558 - Insurance Cost Information Regulation

Science.gov (United States)

2013-11-29

.... FOR FURTHER INFORMATION CONTACT: Deborah Mazyck, Office of International Policy, Fuel Economy and... Transportation prescribe regulations requiring passenger motor vehicle dealers to distribute to prospective... vehicle dealers to distribute this information to prospective buyers. The House of Representatives...

Quality of drug label information on QT interval prolongation

DEFF Research Database (Denmark)

Warnier, Miriam J; Holtkamp, Frank A; Rutten, Frans H

2014-01-01

BACKGROUND: Information regarding QT-prolongation in the drug label may vary between products. This could lead to suboptimal risk minimization strategies. OBJECTIVE: To systematically assess the variation in the extent and content of information on QT prolongation in the summary of product......-prolongation'/'QT-prolongation') and the advice on cautionary measures pertaining to QT-prolongation in the label were examined, as well as their association. RESULTS: Of the 175 screened products, 44 contained information on QT in the SPC ('no QT-prolongation': 23%, 'unclear drug-QT association': 43%, 'possibly QT-prolongation': 16%, 'QT......-prolongation': 18%). 62% contained advices to act with caution in patients with additional risk factors for QT-prolongation. Products that more likely to have QT-prolonging properties according to the SPC provided more information on QT-prolongation in the SPC ('no prolongation': 10% and for the category 'QT...

76 FR 2807 - New Animal Drugs; Change of Sponsor

Science.gov (United States)

2011-01-18

.... FDA-2010-N-0002] New Animal Drugs; Change of Sponsor AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to...., Cambridge, MA 02141 has informed FDA that it has transferred ownership of, and all rights and interest in...

Protein redox chemistry: post-translational cysteine modifications that regulate signal transduction and drug pharmacology

Directory of Open Access Journals (Sweden)

Revati eWani

2014-10-01

Full Text Available The perception of reactive oxygen species (ROS has evolved over the past decade from agents of cellular damage to secondary messengers which modify signaling proteins in physiology and the disease state (e.g. cancer. New protein targets of specific oxidation are rapidly being identified. One emerging class of redox modification occurs to the thiol side chain of cysteine residues which can produce multiple chemically-distinct alterations to the protein (e.g. sulfenic/sulfinic/sulfonic acid, disulfides. These post-translational modifications (PTM are shown to affect the protein structure and function. Because redox-sensitive proteins can traffic between subcellular compartments that have different redox environments, cysteine oxidation enables a spatio-temporal control to signaling. Understanding ramifications of these oxidative modifications to the functions of signaling proteins is crucial for understanding cellular regulation as well as for informed-drug discovery process. The effects of EGFR oxidation of Cys797 on inhibitor pharmacology are presented to illustrate the principle. Taken together, cysteine redox PTM can impact both cell biology and drug pharmacology.

Pharmaceutical companies and their drugs on social media: a content analysis of drug information on popular social media sites.

Science.gov (United States)

Tyrawski, Jennifer; DeAndrea, David C

2015-06-01

Many concerns have been raised about pharmaceutical companies marketing their drugs directly to consumers on social media. This form of direct-to-consumer advertising (DTCA) can be interactive and, because it is largely unmonitored, the benefits of pharmaceutical treatment could easily be overemphasized compared to the risks. Additionally, nonexpert consumers can share their own drug product testimonials on social media and illegal online pharmacies can market their services on popular social media sites. There is great potential for the public to be exposed to misleading or dangerous information about pharmaceutical drugs on social media. Our central aim was to examine how pharmaceutical companies use social media to interact with the general public and market their drugs. We also sought to analyze the nature of information that appears in search results for widely used pharmaceutical drugs in the United States on Facebook, Twitter, and YouTube with a particular emphasis on the presence of illegal pharmacies. Content analyses were performed on (1) social media content on the Facebook, Twitter, and YouTube accounts of the top 15 pharmaceutical companies in the world and (2) the content that appears when searching on Facebook, Twitter, and YouTube for the top 20 pharmaceutical drugs purchased in the United States. Notably, for the company-specific analysis, we examined the presence of information similar to various forms of DTCA, the audience reach of company postings, and the quantity and quality of company-consumer interaction. For the drug-specific analysis, we documented the presence of illegal pharmacies, personal testimonials, and drug efficacy claims. From the company-specific analysis, we found information similar to help-seeking DTCA in 40.7% (301/740) of pharmaceutical companies' social media posts. Drug product claims were present in only 1.6% (12/740) of posts. Overall, there was a substantial amount of consumers who interacted with pharmaceutical

Pharmaceutical Companies and Their Drugs on Social Media: A Content Analysis of Drug Information on Popular Social Media Sites

Science.gov (United States)

2015-01-01

Background Many concerns have been raised about pharmaceutical companies marketing their drugs directly to consumers on social media. This form of direct-to-consumer advertising (DTCA) can be interactive and, because it is largely unmonitored, the benefits of pharmaceutical treatment could easily be overemphasized compared to the risks. Additionally, nonexpert consumers can share their own drug product testimonials on social media and illegal online pharmacies can market their services on popular social media sites. There is great potential for the public to be exposed to misleading or dangerous information about pharmaceutical drugs on social media. Objective Our central aim was to examine how pharmaceutical companies use social media to interact with the general public and market their drugs. We also sought to analyze the nature of information that appears in search results for widely used pharmaceutical drugs in the United States on Facebook, Twitter, and YouTube with a particular emphasis on the presence of illegal pharmacies. Methods Content analyses were performed on (1) social media content on the Facebook, Twitter, and YouTube accounts of the top 15 pharmaceutical companies in the world and (2) the content that appears when searching on Facebook, Twitter, and YouTube for the top 20 pharmaceutical drugs purchased in the United States. Notably, for the company-specific analysis, we examined the presence of information similar to various forms of DTCA, the audience reach of company postings, and the quantity and quality of company-consumer interaction. For the drug-specific analysis, we documented the presence of illegal pharmacies, personal testimonials, and drug efficacy claims. Results From the company-specific analysis, we found information similar to help-seeking DTCA in 40.7% (301/740) of pharmaceutical companies’ social media posts. Drug product claims were present in only 1.6% (12/740) of posts. Overall, there was a substantial amount of consumers

A proposal for a drug information database and text templates for generating package inserts

Directory of Open Access Journals (Sweden)

Okuya R

2013-07-01

Full Text Available Ryo Okuya,1 Masaomi Kimura,2 Michiko Ohkura,2 Fumito Tsuchiya3 1Graduate School of Engineering and Science, 2Faculty of Engineering, Shibaura Institute of Technology, Tokyo, 3School of Pharmacy, International University of Health and Welfare, Tokyo, Japan Abstract: To prevent prescription errors caused by information systems, a database to store complete and accurate drug information in a user-friendly format is needed. In previous studies, the primary method for obtaining data stored in a database is to extract drug information from package inserts by employing pattern matching or more sophisticated methods such as text mining. However, it is difficult to obtain a complete database because there is no strict rule concerning expressions used to describe drug information in package inserts. The authors' strategy was to first build a database and then automatically generate package inserts by embedding data in the database using templates. To create this database, the support of pharmaceutical companies to input accurate data is required. It is expected that this system will work, because these companies can earn merit for newly developed drugs to decrease the effort to create package inserts from scratch. This study designed the table schemata for the database and text templates to generate the package inserts. To handle the variety of drug-specific information in the package inserts, this information in drug composition descriptions was replaced with labels and the replacement descriptions utilizing cluster analysis were analyzed. To improve the method by which frequently repeated ingredient information and/or supplementary information are stored, the method was modified by introducing repeat tags in the templates to indicate repetition and improving the insertion of data into the database. The validity of this method was confirmed by inputting the drug information described in existing package inserts and checking that the method could

Drugs: Between Regulated Bodies and Deviant Morals. Argentina, 1880-1960

Directory of Open Access Journals (Sweden)

Victoria Sánchez Antelo

2018-01-01

Full Text Available The article examines the ways in which the “phenomenon of drugs” was discussed, defined, and addressed in Argentina between 1880 and 1960. It focuses on two central themes: the local political debates regarding the uses, regulation, and penalization of drugs, and the manner in which the practices, subjects, and social contexts related to drugs are conceptualized from the perspective of psychopathology and local criminology. Despite the fact that they were influenced by the guidelines of international entities and currents of thought, both of these processes feature a specific local dynamic that results in policies aimed at the control of bodies and populations, as well as in moral systems of classification of subjects and practices.

Information Security for Compliance with Select Agent Regulations

Science.gov (United States)

Lewis, Nick; Campbell, Mark J.

2015-01-01

The past decade has seen a significant rise in research on high-consequence human and animal pathogens, many now known as “select agents.” While physical security around these agents is tightly regulated, information security standards are still lagging. The understanding of the threats unique to the academic and research environment is still evolving, in part due to poor communication between the various stakeholders. Perhaps as a result, information security guidelines published by select agent regulators lack the critical details and directives needed to achieve even the lowest security level of the Federal Information Security Management Act (FISMA). While only government agencies are currently required to abide by the provisions of FISMA (unless specified as preconditions for obtaining government grants or contracts—still a relatively rare or narrowly scoped occurrence), the same strategies were recently recommended by executive order for others. We propose that information security guidelines for select agent research be updated to promulgate and detail FISMA standards and processes and that the latter be ultimately incorporated into select agent regulations. We also suggest that information security in academic and research institutions would greatly benefit from active efforts to improve communication among the biosecurity, security, and information technology communities, and from a secure venue for exchange of timely information on emerging threats and solutions in the research environment. PMID:26042864

Information security for compliance with select agent regulations.

Science.gov (United States)

Lewis, Nick; Campbell, Mark J; Baskin, Carole R

2015-01-01

The past decade has seen a significant rise in research on high-consequence human and animal pathogens, many now known as "select agents." While physical security around these agents is tightly regulated, information security standards are still lagging. The understanding of the threats unique to the academic and research environment is still evolving, in part due to poor communication between the various stakeholders. Perhaps as a result, information security guidelines published by select agent regulators lack the critical details and directives needed to achieve even the lowest security level of the Federal Information Security Management Act (FISMA). While only government agencies are currently required to abide by the provisions of FISMA (unless specified as preconditions for obtaining government grants or contracts--still a relatively rare or narrowly scoped occurrence), the same strategies were recently recommended by executive order for others. We propose that information security guidelines for select agent research be updated to promulgate and detail FISMA standards and processes and that the latter be ultimately incorporated into select agent regulations. We also suggest that information security in academic and research institutions would greatly benefit from active efforts to improve communication among the biosecurity, security, and information technology communities, and from a secure venue for exchange of timely information on emerging threats and solutions in the research environment.

77 FR 74827 - Working Group on Access to Information on Prescription Drug Container Labels

Science.gov (United States)

2012-12-18

... on Prescription Drug Container Labels AGENCY: Architectural and Transportation Barriers Compliance... information on prescription drug container labels accessible to people who are blind or visually impaired. The... stakeholder working group to develop best practices for making information on prescription drug container...

The Impact of Drug Trafficking on Informal Security Actors in Kenya

Directory of Open Access Journals (Sweden)

Moritz Schuberth

2014-01-01

Full Text Available The Kenyan state is currently under pressure from two sides: First, numerous non-state armed groups have taken over the provision of security in areas where the state is practically absent. Second, drug-trafficking organizations are gaining ground as the country is increasingly being used as a major transit hub for narcotics. This article investigates the relationship between drug trafficking and informal security provision in Kenya and draws analogies from comparable experiences in Latin America and West Africa. Field research in Kenya has demonstrated that profit-oriented, informal security actors in Mombasa work for drug lords, while their counterparts in Nairobi are more likely to be hired by politicians. Moreover, faith-based vigilante groups in both cities appear to be less susceptible to external manipulation by drug traffickers. The article concludes by considering the potential consequences of an expansion of the drug trade in Kenya.

Low literacy and written drug information: information-seeking, leaflet evaluation and preferences, and roles for images.

Science.gov (United States)

van Beusekom, Mara M; Grootens-Wiegers, Petronella; Bos, Mark J W; Guchelaar, Henk-Jan; van den Broek, Jos M

2016-12-01

Background Low-literate patients are at risk to misinterpret written drug information. For the (co-) design of targeted patient information, it is key to involve this group in determining their communication barriers and information needs. Objective To gain insight into how people with low literacy use and evaluate written drug information, and to identify ways in which they feel the patient leaflet can be improved, and in particular how images could be used. Setting Food banks and an education institution for Dutch language training in the Netherlands. Method Semi-structured focus groups and individual interviews were held with low-literate participants (n = 45). The thematic framework approach was used for analysis to identify themes in the data. Main outcome measure Low-literate people's experience with patient information leaflets, ideas for improvements, and perceptions on possible uses for visuals. Results Patient information leaflets were considered discouraging to use, and information difficult to find and understand. Many rely on alternative information sources. The leaflet should be shorter, and improved in terms of organisation, legibility and readability. Participants thought images could increase the leaflet's appeal, help ask questions, provide an overview, help understand textual information, aid recall, reassure, and even lead to increased confidence, empowerment and feeling of safety. Conclusion Already at the stages of paying attention to the leaflet and maintaining interest in the message, low-literate patients experience barriers in the communication process through written drug information. Short, structured, visual/textual explanations can lower the motivational threshold to use the leaflet, improve understanding, and empower the low-literate target group.

77 FR 18830 - Small Entity Compliance Guide: Further Amendments to General Regulations of the Food and Drug...

Science.gov (United States)

2012-03-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0121] Small Entity Compliance Guide: Further Amendments to General Regulations of the Food and Drug... Food and Drug Administration to Incorporate Tobacco Products--Small Entity Compliance Guide'' to the...

78 FR 71036 - Pipeline Safety: Random Drug Testing Rate; Contractor Management Information System Reporting...

Science.gov (United States)

2013-11-27

... PHMSA-2013-0248] Pipeline Safety: Random Drug Testing Rate; Contractor Management Information System Reporting; and Obtaining Drug and Alcohol Management Information System Sign-In Information AGENCY: Pipeline... Management Information System (MIS) Data; and New Method for Operators to Obtain User Name and Password for...

Study on institutionalization of risk-informed performance-based regulation

Energy Technology Data Exchange (ETDEWEB)

Kim, M. G.; Hong, S. Y.; Seo, M. R. [Korea Electric Power Research Institute, Taejon (Korea, Republic of)

2003-02-15

In this study, for the institutionalization of risk informed and performance based regulation in Korea, the latest technical movements of overseas countries are examined and reviewed. And the issues that was found when license change petition using risk information was submitted in Korean regulatory body are reviewed. Based on these review, the applicable areas to domestic situation will be found and proposed. This study can contribute to setting up the proper direction for the institutionalization of risk informed and performance based regulation.

Developing and promoting an intranet site for a drug information service.

Science.gov (United States)

Costerison, Emily C; Graham, Angie S

2008-04-01

The development and promotion of a drug information service (DIS) intranet site are described. Stanford Hospital and Clinics (SHC) is an acute and tertiary care facility with 613 licensed inpatient beds and 48 outpatient clinics. A DIS intranet site was developed to allow better accessibility to pharmacy forms and products (e.g., drug shortage list, reference guides) and to reduce repetitive requests to the DIS. The goal was to continue to provide information to SHC health care providers but allow the drug information specialist to focus on answering clinical questions. The intranet site was completed over a four-month period. The intranet site was divided into seven webpages: DIS overview, pharmacy and therapeutics, frequently asked questions, quick drug reference guide, ask the pharmacist, drug information resources, and referral center. The preparation for and implementation of the promotional phase took approximately two months. Promotional strategies included the creation and dissemination of brochures and stickers. The intranet site went live on January 1, 2007, and the advertising campaign began one month later. The utility of the site was measured for five months by tracking the number of visits to the site, the number of visits to each webpage, and the number of downloaded files. Request volume, caller affiliation, and question types received by the DIS call center were also recorded. Establishing a DIS intranet site required a considerable time investment and a willingness to work with existing infrastructures, such as the marketing and communications department and Web marketing staff.

The internet as a source of drug information: a profile of utilization by ...

African Journals Online (AJOL)

Open Access DOWNLOAD FULL TEXT ... Introduction: The internet is a useful tool which could provide quality drug information if well applied. Its utilization as a source of drug information by junior doctors in Nigeria is not well documented.

Science and scepticism: Drug information, young men and counterpublic health.

Science.gov (United States)

Farrugia, Adrian; Fraser, Suzanne

2017-11-01

It is perhaps no surprise that young people can be sceptical of the drug-related information they receive in school-based health education, health promotion and the media. Significant societal anxiety surrounds young people's drug consumption, so it is tempting to approach this scepticism as a problem to be solved. In this article, we look closely at a group of young Australian men (n = 25), all of whom hold deeply sceptical views about the drug information they received in schools, social marketing campaigns and public speech generally. We do not approach their scepticism as a problem to be solved in itself, however. Instead, we analyse its origins and how it relates to the way knowledge is constructed in drug education, health promotion and media accounts of drug use. To conceptualise this scepticism, we draw on Irwin and Michael's analysis of the changing relationship between science and society, Warner's theorisation of publics and counterpublics, and Race's related notion of 'counterpublic health'. The article organises the data into three key themes: scepticism about the accuracy of the claims made about drug risks and dangers, scepticism about representations of drug users, and scepticism about the motivations behind the health messages and drug policy in general. We then draw these different aspects of scepticism together to argue that the young men can be seen to constitute a health 'counterpublic', and we consider the implications of this approach, arguing for what has been described as a more diplomatic engagement between science and publics.

Advice on drug safety in pregnancy: are there differences between commonly used sources of information?

Science.gov (United States)

Frost Widnes, Sofia K; Schjøtt, Jan

2008-01-01

Safety regarding use in pregnancy is not established for many drugs. Inconsistencies between sources providing drug information can give rise to confusion with possible therapeutic consequences. Therefore, it is important to measure clinically important differences between drug information sources. The objective of this study was to compare two easily accessible Norwegian sources providing advice on drug safety in pregnancy - the product monographs in the Felleskatalog (FK), published by the pharmaceutical companies, and the five regional Drug Information Centres (DICs) in Norway - in addition to assessing the frequency of questions regarding drug safety in pregnancy made to the DICs according to the Anatomical Therapeutic Chemical (ATC) classification system. Advice on drug use in pregnancy provided by the DICs in 2003 and 2005 were compared with advice in the product monographs for the respective drugs in the FK. Comparison of advice was based on categorization to one of four categories: can be used, benefit-risk assessment, should not be used, or no available information. A total of 443 drug advice were categorized. Seven out of ten of drugs frequently enquired about, according to the ATC system, were drugs acting on the nervous system (group N). For 208 (47%) of the drugs, advice differed between the DICs and FK. Advice from the FK was significantly (p drugs that were newly introduced and those that had been on the market for a longer time, advice regarding use of drugs in the first trimester and advice regarding use of drugs in the second or third trimester, or between advice provided during 2003 and during 2005. The results of this study show considerable differences between two Norwegian sources providing advice on the use of drugs in pregnancy. Based on the knowledge that healthcare providers choose sources of information in a random manner, our results may be of clinical importance. We believe that the problem with heterogeneous drug information on this

Planning for management information systems in drug treatment organizations.

Science.gov (United States)

Zalkind, D; Zelon, H; Moore, M; Kaluzny, A

1979-02-01

An attempt to set up a management information system for individual drug abuse programs throughout a state is described. The principles upon which the system is based are discussed along with the problems encountered in its implementation. A series of guidelines for establishing management information systems in operating human services agencies is included.

Communicating efficacy information based on composite scores in direct-to-consumer prescription drug advertising.

Science.gov (United States)

Williams, Pamela A; O'Donoghue, Amie C; Sullivan, Helen W; Willoughby, Jessica Fitts; Squire, Claudia; Parvanta, Sarah; Betts, Kevin R

2016-04-01

Drug efficacy can be measured by composite scores, which consist of two or more symptoms or other clinical components of a disease. We evaluated how individuals interpret composite scores in direct-to-consumer (DTC) prescription drug advertising. We conducted an experimental study of seasonal allergy sufferers (n=1967) who viewed a fictitious print DTC ad that varied by the type of information featured (general indication, list of symptoms, or definition of composite scores) and the presence or absence of an educational intervention about composite scores. We measured composite score recognition and comprehension, and perceived drug efficacy and risk. Ads that featured either (1) the composite score definition alone or (2) the list of symptoms or general indication information along with the educational intervention improved composite score comprehension. Ads that included the composite score definition or the educational intervention led to lower confidence in the drug's benefits. The composite score definition improved composite score recognition and lowered drug risk perceptions. Adding composite score information to DTC print ads may improve individuals' comprehension of composite scores and affect their perceptions of the drug. Providing composite score information may lead to more informed patient-provider prescription drug decisions. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Bringing smart pills to market: FDA regulation of ingestible drug/device combination products.

Science.gov (United States)

Avery, Matthew; Liu, Dan

2011-01-01

Imagine a pill that, after you swallow it, can track its position in your body. Or imagine a pill that can transmit a message to a doctor to tell him that you have taken your bitter medicine. Pills like this already exist. These so-called smart pills are an emerging type of medical therapy. However, this nascent technology has yet to reach the market and developers of these novel therapies face significant regulatory challenges. This article predicts how the Food and Drug Administration will regulate smart pills and shows how the current regulatory regime is inadequate. The article then proposes modifying the current regulatory regime to encourage development of smart pills and other innovative combination products by: (1) regulating combination products based on their "novel mode of action" rather than their "primary mode of action," (2) creating a marketing approval pathway specifically for combination products, and (3) eliminating regulations that require sponsors to get marketing approval from multiple centers within FDA and providing regulatory guidance specifically for ingestible drug/device combination products.

78 FR 32595 - Revision of Freedom of Information Act Regulation

Science.gov (United States)

2013-05-31

... Revision of Freedom of Information Act Regulation AGENCY: Office of the Secretary, HUD. ACTION: Proposed rule. SUMMARY: This proposed rule would amend HUD's regulations implementing the Freedom of Information... with speech or hearing impairments may access this number via TTY by calling the toll-free Federal...

Drug safety in pregnancy: utopia or achievable prospect? Risk information, risk research and advocacy in Teratology Information Services.

Science.gov (United States)

Schaefer, Christof

2011-03-01

Even though from preclinical testing to drug risk labeling, the situation with drugs in pregnancy has improved substantially since the thalidomide scandal, there is still an increasing need to provide healthcare professionals and patients with updated individualized risk information for clinical decision making. For the majority of drugs, clinical experience is still insufficient with respect to their safety in pregnancy. There is often uncertainty in how to interpret the available scientific data. Based on 20 years of experience with Teratology Information Services (TIS) cooperating in the European Network of Teratology Information Services (ENTIS) methods of risk interpretation, follow-up of exposed pregnancies through the consultation process and their evaluation is discussed. Vitamin K antagonists, isotretinoin and angiotensin (AT) II-receptor-antagonists are presented as examples of misinterpretation of drug risks and subjects of research based on observational clinical data recorded in TIS. As many TIS are poorly funded, advocacy is necessary by establishing contacts with decision makers in health politics and administration, informing them of the high return in terms of health outcomes and cost savings provided by TIS as reference institutions in clinical teratology. © 2011 The Author. Congenital Anomalies © 2011 Japanese Teratology Society.

Light-Regulated Release of Entrapped Drugs from Photoresponsive Gold Nanoparticles

Directory of Open Access Journals (Sweden)

Kaniknun Sreejivungsa

2016-01-01

Full Text Available Release of a payload in a spatiotemporal fashion has a substantial impact on increasing therapeutic efficacy. In this work, a novel monolayer of gold nanoparticles (AuNPs featuring light-responsive ligands was investigated as a potential drug carrier whose drug release can be triggered by UV light. Hydrophobic molecules were noncovalently entrapped in the compartments of its monolayers. Once irradiated with UV light, the dinitrobenzyl linker was cleaved, leading to release of the entrapped agent. AuNPs were characterized using UV spectrophotometry, TEM, and a zetasizer. A naturally occurring compound extracted from Goniothalamus elegans Ast was chosen as a hydrophobic model drug. Entrapment and release of dye were monitored using fluorimetry. The percent encapsulation of dye was of 13.53%. Entrapped dye can be released upon UV irradiation and can be regulated by changing irradiation time. Up to 83.95±2.2% entrapped dye can be released after irradiation for 20 minutes. In the absence of UV light, dye release was only 19.75%. For comparison purposes, AuNPs having no dinitrobenzyl groups showed a minimal release of 12.23% and 11.69% with and without UV light, respectively. This demonstrated an alternative strategy to encapsulate drugs using a noncovalent approach followed by their controlled release upon UV irradiation.

Abbreviated New Drug Applications (ANDAS): Future trend in radiopharmaceuticals

International Nuclear Information System (INIS)

Kishore, R.

1990-01-01

The Drug Price Competition and Patent Term Restoration Act (commonly called Waxman Hatch Amendment) of 1984, to the Federal Food, Drug, and Cosmetic Act provided for abbreviated new drug applications (ANDAs) if the conditions specified in the Code of Federal Regulations (CFR) Title 21, subsection 312.55 are met. Under this subsection, reports of nonclinical laboratory studies and clinical investigations can be omitted. New drugs approved under these regulations are so called generic drugs as opposed to listed or pioneer (innovator) drugs. As the patents on more and more radiopharmaceuticals reach their expiration, the radiopharmaceutical industry is likely to produce more of these generic versions of innovator drugs. The ANDAs are required to contain information specified under subsections 314.50(a), (b), (d)(1) and (3), (e), and (g)

78 FR 11654 - Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About...

Science.gov (United States)

2013-02-19

...] Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About... Guidance for Industry and Food and Drug Administration Staff: Providing Information About Pediatric Uses of...ComplianceRegulatoryInformation/default.htm . To receive ``Draft Guidance for Industry and Food and Drug...

The Regulation of the Security of Electronic Information in Lithuania and Russia: the Comparative Aspects

Directory of Open Access Journals (Sweden)

Darius Štitilis

2013-02-01

Full Text Available Cybercrime has become a global phenomenon, which is causing more harm to individual citizens, organizations, society and the state. Most countries in the world compare cybercrime with such offences as terrorism and drug trafficking due to its risks and profitability. Therefore, the legal regulation of cybercrime is one of the most relevant problems in the world, including Lithuania and our neighbouring country, Russia. So far cybercrime analysis in scientific literature has been rather limited. We have not succeeded in finding a comparison between the regulatory practices of cybercrime in the Russian Federation and the Republic of Lithuania in any of the references. The main goal of the thesis paper is to analyse and to compare the electronic information security legal framework of the Russian Federation and the Republic of Lithuania. The article consists of two parts. The first part deals with the comparative aspect of strategic documents—the program governing electronic information protection in Lithuania and the Russian Federation. The second part of the article examines the comparative aspect of electronic information protection legislative, legal framework Republic of Lithuania and the Russian Federation. It was found that at the moment in both countries there is a strategic document which defines the planned state policy in this area, but the lack of a Lithuanian Law which can fully and consistently regulate social relations in relation to electronic information security. Several different approaches have been used in the research. The authors have used a comparative method to investigate the Lithuanian and Russian legal framework for the security of electronic information. Empirical analysis of legal documents was used to determine the legal regulation of the security of electronic information in Lithuania and Russia. Legal acts of the Republic of Lithuania and the Russian Federation have been analysed. Having analysed the official

The Regulation of the Security of Electronic Information in Lithuania and Russia: the Comparative Aspects

Directory of Open Access Journals (Sweden)

Darius Štitilis

2012-12-01

Full Text Available Cybercrime has become a global phenomenon, which is causing more harm to individual citizens, organizations, society and the state. Most countries in the world compare cybercrime with such offences as terrorism and drug trafficking due to its risks and profitability. Therefore, the legal regulation of cybercrime is one of the most relevant problems in the world, including Lithuania and our neighbouring country, Russia. So far cybercrime analysis in scientific literature has been rather limited. We have not succeeded in finding a comparison between the regulatory practices of cybercrime in the Russian Federation and the Republic of Lithuania in any of the references.The main goal of the thesis paper is to analyse and to compare the electronic information security legal framework of the Russian Federation and the Republic of Lithuania.The article consists of two parts. The first part deals with the comparative aspect of strategic documents—the program governing electronic information protection in Lithuania and the Russian Federation.The second part of the article examines the comparative aspect of electronic information protection legislative, legal framework Republic of Lithuania and the Russian Federation. It was found that at the moment in both countries there is a strategic document which defines the planned state policy in this area, but the lack of a Lithuanian Law which can fully and consistently regulate social relations in relation to electronic information security.Several different approaches have been used in the research. The authors have used a comparative method to investigate the Lithuanian and Russian legal framework for the security of electronic information. Empirical analysis of legal documents was used to determine the legal regulation of the security of electronic information in Lithuania and Russia. Legal acts of the Republic of Lithuania and the Russian Federation have been analysed. Having analysed the official

Print advertisements for Alzheimer's disease drugs: informational and transformational features.

Science.gov (United States)

Gooblar, Jonathan; Carpenter, Brian D

2013-06-01

We examined print advertisements for Alzheimer's disease drugs published in journals and magazines between January 2008 and February 2012, using an informational versus transformational theoretical framework to identify objective and persuasive features. In 29 unique advertisements, we used qualitative methods to code and interpret identifying information, charts, benefit and side effect language, and persuasive appeals embedded in graphics and narratives. Most elements contained a mixture of informational and transformational features. Charts were used infrequently, but when they did appear the accompanying text often exaggerated the data. Benefit statements covered an array of symptoms, drug properties, and caregiver issues. Side effect statements often used positive persuasive appeals. Graphics and narrative features emphasized positive emotions and outcomes. We found subtle and sophisticated attempts both to educate and to persuade readers. It is important for consumers and prescribing physicians to read print advertisements critically so that they can make informed treatment choices.

Techno-politics of genomic nationalism: tracing genomics and its use in drug regulation in Japan and Taiwan.

Science.gov (United States)

Kuo, Wen-Hua

2011-10-01

This paper compares the development of genomics as a form of state project in Japan and Taiwan. Broadening the concepts of genomic sovereignty and bionationalism, I argue that the establishment and use of genomic databases vary according to techno-political context. While both Japan and Taiwan hold population-based databases to be necessary for scientific advance and competitiveness, they differ in how they have attempted to transform the information produced by databases into regulatory schemes for drug approval. The effectiveness of Taiwan's biobank is severely limited by the IRB reviewing process. By contrast, while updating its regulations for drug approval, Japan, is using pharmacogenomics to deal with matters relating to ethnic identity. By analysing genomic initiatives in the political context that nurtures them, this paper seeks to capture how global science and local societies interact and offers insight into the assessment of state-sponsored science in East Asia as they become transnational. Copyright © 2011 Elsevier Ltd. All rights reserved.

Taxation and regulation of petroleum companies under asymmetric information; a monograph

Energy Technology Data Exchange (ETDEWEB)

Osmundsen, P

1994-12-01

The report relates to the taxation and regulation of petroleum companies. The main topics of this report are as follow: Taxation and regulation of petroleum companies under asymmetric information. A discussion of incentive problems and the principles for applying principal-agent analysis; taxation and regulation of petroleum companies under asymmetric information. A static adverse selection model; Petroleum Taxation with adverse selection. Interactions of dynamics in costs and information; Adverse selection and moral hazard in the petroleum industry, repeated auctions of incentive contracts; Petroleum taxation and regulation. Policy implications from principal-agent theory, and a comparison with the current Norwegian system. 54 refs., 7 figs.

Taxation and regulation of petroleum companies under asymmetric information; a monograph

International Nuclear Information System (INIS)

Osmundsen, P.

1994-12-01

The report relates to the taxation and regulation of petroleum companies. The main topics of this report are as follow: Taxation and regulation of petroleum companies under asymmetric information. A discussion of incentive problems and the principles for applying principal-agent analysis; taxation and regulation of petroleum companies under asymmetric information. A static adverse selection model; Petroleum Taxation with adverse selection. Interactions of dynamics in costs and information; Adverse selection and moral hazard in the petroleum industry, repeated auctions of incentive contracts; Petroleum taxation and regulation. Policy implications from principal-agent theory, and a comparison with the current Norwegian system. 54 refs., 7 figs

77 FR 55475 - Federal Acquisition Regulation; Information Collection; Permits, Authorities, or Franchises

Science.gov (United States)

2012-09-10

...; Information Collection; Permits, Authorities, or Franchises AGENCY: Department of Defense (DOD), General... approved information collection requirement concerning permits, authorities, or franchises for regulated..., Authorities, or Franchises, by any of the following methods: Regulations.gov : http://www.regulations.gov...

Predicted Impact of the Food and Drug Administration's Menu-Labeling Regulations on Restaurants in 4 New Jersey Cities.

Science.gov (United States)

Gruner, Jessie; DeWeese, Robin S; Lorts, Cori; Yedidia, Michael J; Ohri-Vachaspati, Punam

2018-02-01

To determine the proportion of restaurants that will be required to post calorie information under the Food and Drug Administration's menu-labeling regulations in 4 New Jersey cities. We classified geocoded 2014 data on 1753 restaurant outlets in accordance with the Food and Drug Administration's guidelines, which will require restaurants with 20 or more locations nationwide to post calorie information. We used multivariate logistic regression analyses to assess the association between menu-labeling requirements and census tract characteristics. Only 17.6% of restaurants will be affected by menu labeling; restaurants in higher-income tracts have higher odds than do restaurants in lower-income tracts (odds ratio [OR] = 1.55; P = .02). Restaurants in non-Hispanic Black (OR = 1.62; P = .02) and mixed race/ethnicity (OR = 1.44; P = .05) tracts have higher odds than do restaurants in non-Hispanic White tracts of being affected. Additional strategies are needed to help consumers make healthy choices at restaurants not affected by the menu-labeling law. These findings have implications for designing implementation strategies for the law and for evaluating its impact.

Schisandra chinensis regulates drug metabolizing enzymes and drug transporters via activation of Nrf2-mediated signaling pathway

Directory of Open Access Journals (Sweden)

He JL

2014-12-01

Full Text Available Jin-Lian He,1 Zhi-Wei Zhou,2,3 Juan-Juan Yin,2 Chang-Qiang He,1 Shu-Feng Zhou,2,3 Yang Yu1 1College of Chinese Medicine, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, People’s Republic of China; 2Department of Pharmaceutical Sciences, College of Pharmacy, University of South Florida, Tampa, FL, USA; 3Guizhou Provincial Key Laboratory for Regenerative Medicine, Stem Cell and Tissue Engineering Research Center and Sino-US Joint Laboratory for Medical Sciences, Guiyang Medical University, Guiyang, Guizhou, People’s Republic of China Abstract: Drug metabolizing enzymes (DMEs and drug transporters are regulated via epigenetic, transcriptional, posttranscriptional, and translational and posttranslational modifications. Phase I and II DMEs and drug transporters play an important role in the disposition and detoxification of a large number of endogenous and exogenous compounds. The nuclear factor (erythroid-derived 2-like 2 (Nrf2 is a critical regulator of a variety of important cytoprotective genes that are involved in disposition and detoxification of xenobiotics. Schisandra chinensis (SC is a commonly used traditional Chinese herbal medicine that has been primarily used to protect the liver because of its potent antioxidative and anti-inflammatory activities. SC can modulate some DMEs and drug transporters, but the underlying mechanisms are unclear. In this study, we aimed to explore the role of Nrf2 in the regulatory effect of SC extract (SCE on selected DMEs and drug transporters in human hepatocellular liver carcinoma cell line (HepG2 cells. The results showed that SCE, schisandrin A, and schisandrin B significantly increased the expression of NAD(PH: Nicotinamide Adenine Dinucleotide Phosphate-oxidase or:quinone oxidoreductase 1, heme oxygenase-1, glutamate–cysteine ligase, and glutathione S-transferase A4 at both transcriptional and posttranscriptional levels. Incubation of HepG2 cells with SCE resulted in a significant

THE SYNTHESIS AND ANALYSIS INFORMATION TECHNOLOGY OF INTERACTIVE REGULATIONS FUNCTIONAL MODELS

Directory of Open Access Journals (Sweden)

Владимир Александрович ТИМОФЕЕВ

2016-02-01

Full Text Available A person has no ability to capture entirely and to estimate correctly the logical coherence and consistency of Regulations in the Text Form. It leads to mistakes in a work of an Enterprise Staff and to the impossibility of mastering of the Regulations with considerable volume. Presented Information Technology allows the Regulations Executor to receive on-line proper information of the Optimum Actions in any possible Situation, which can arise in the course of the work. Leading Experts of any Enterprise may create the full-fledged Expert System by themselves with the help of Specialized Software. Such a System will contain the knowledge in the Functional Model of Regulations (the Optimum Business Process. Stages of realization of the represented Information Technology and the peculiarities of on-line data displaying for the Regulations Executor are illustrated by the Pharmacy Customer Service Regulations.

The Pathway Analysis of Micrornas Regulated Drug-Resistant Responses in HeLa Cells.

Science.gov (United States)

Yang, Yubo; Dai, Cuihong; Cai, Zhipeng; Hou, Aiju; Cheng, Dayou; Wu, Guanying; Li, Jing; Cui, Jie; Xu, Dechang

2016-03-01

Chemotherapy is the main strategy in the treatment of cancer; however, the development of drug-resistance is the obstacle in long-term treatment of cervical cancer. Cisplatin is one of the most common drugs used in cancer therapy. Recently, accumulating evidence suggests that miRNAs are involved in various bioactivities in oncogenesis. It is not unexpected that miRNAs play a key role in acquiring of drug-resistance in the progression of tumor. In this study, we induced and maintained four levels of cisplatin-resistant HeLa cell lines (HeLa/CR1, HeLa/CR2, HeLa/CR3, and HeLa/CR4). According to the previous studies and existing evidence, we selected five miRNAs (miR-183, miR-182, miR-30a, miR-15b, and miR-16) and their potential target mRNAs as our research targets. The real-time RT-PCR was adopted to detect the relative expression of miRNAs and their mRNAs. The results show that miR-182 and miR-15b were up-regulated in resistant cell lines, while miR-30a was significantly down-regulated. At the same time, their targets are related to drug resistance. Compared to their parent HeLa cell line, the expression of selected miRNAs in resistant cell lines altered. The alteration suggests that HeLa cell drug resistance is associated with distinct miRNAs, which indicates that miRNAs may be one of the therapy targets in the treatment of cervical cancer by sensitizing cell to chemotherapy. We suggested a possible network diagram based on the existing theory and the preliminary results of candidate miRNAs and their targets in HeLa cells during development of drug resistance.

Issues and future directions of 'introduction of Risk Informed Regulation'

International Nuclear Information System (INIS)

2008-01-01

In 2004, Nuclear Safety Commission of Japan (NSC) set up a taskforce for developing a scheme of Risk Informed Regulation (RIR) introduction, which had discussed various aspects of utilization of risk information in nuclear regulations. In the final report compiled in 2007, the taskforce identified the significance of RIR introduction from viewpoint of enhancement of rationality, consistency and transparency as well as appropriate allocation of regulatory resources in the nuclear safety regulation and major issues for the further promotion were as follows: NSC is to maintain the comprehensively promoting function of the RIR introduction with reviewing global trends and latest technological knowledge, regulatory bodies are to further enhance the RIR in inspection and operational area, utilities and industries are to utilize further risk information in their self-maintenance activities and to gather trouble information data, academic societies are to establish the standards for risk evaluation technology and RIR, and research institutes are to carry out safety research and risk training for risk-communicators. This article presented summary of the final report aiming at upgrading safety regulation with enhancement of RIR introduction. (T. Tanaka)

Antiviral Information Management System (AIMS): a prototype for operational innovation in drug development.

Science.gov (United States)

Jadhav, Pravin R; Neal, Lauren; Florian, Jeff; Chen, Ying; Naeger, Lisa; Robertson, Sarah; Soon, Guoxing; Birnkrant, Debra

2010-09-01

This article presents a prototype for an operational innovation in knowledge management (KM). These operational innovations are geared toward managing knowledge efficiently and accessing all available information by embracing advances in bioinformatics and allied fields. The specific components of the proposed KM system are (1) a database to archive hepatitis C virus (HCV) treatment data in a structured format and retrieve information in a query-capable manner and (2) an automated analysis tool to inform trial design elements for HCV drug development. The proposed framework is intended to benefit drug development by increasing efficiency of dose selection and improving the consistency of advice from US Food and Drug Administration (FDA). It is also hoped that the framework will encourage collaboration among FDA, industry, and academic scientists to guide the HCV drug development process using model-based quantitative analysis techniques.

DRUGS IN SPORT

Directory of Open Access Journals (Sweden)

David R. Mottram

2005-12-01

Full Text Available This new edition includes fresh information regarding drugs use and abuse in sport and the updated worldwide anti-doping laws, and changes to the prohibited and therapeutic use exemption lists. The objectives of the book are to review/discuss the latest information on drugs in sport by considering i actions of drugs and hormones, ii medication and nutritional supplements in sport, iii the latest doping control regulations of the WADA, iv the use of banned therapeutic drugs in sport, v an assessment of the prevalence of drug taking in sport. FEATURES A common, uniform strategy and evidence-based approach to organizing and interpreting the literature is used in all chapters. This textbook is composed of twelve parts with sub-sections in all of them. The topics of the parts are: i An introduction to drugs and their use in sport, ii Drug use and abuse in sport, iii Central nervous system stimulants, iv WADA regulations in relation to drugs used in the treatment of respiratory tract disorders, v Androgenic anabolic steroids, vi Peptide and glycoprotein hormones and sport, vii Blood boosting and sport, viii Drug treatment of inflammation in sports injuries, ix Alcohol, anti-anxiety drugs and sport, x Creatine, xi Doping control and sport, xii Prevalence of drug misuse in sport. Each specific chapter has been systematically developed from the data available in prospective, retrospective, case-control, and cross-sectional studies. The tables and figures are numerous, helpful and very useful. AUDIENCE The book provides a very useful resource for students on sports related courses, coaches and trainers, researchers, nutritionists, exercise physiologists, pharmacologists, healthcare professionals in the fields of sports medicine and those involved in the management and administration side of sport. The readers are going to discover that this is an excellent reference book. Extensively revised new edition of this book is also a first-rate resource for

Reforming the Regulation of Therapeutic Products in Canada: The Protecting of Canadians from Unsafe Drugs Act (Vanessa’s Law

Directory of Open Access Journals (Sweden)

Katherine Fierlbeck

2016-11-01

Full Text Available Enacted November 2014, Vanessa’s Law amends the Food and Drugs Act to give Health Canada greater powers to compel the disclosure of information, recall drugs and devices, impose fines and injunctions, and collect post-market safety information. The Act amends seriously outdated legislation that had been in place since 1954. While the explicit goals of the Act are to improve patient safety and provide transparency, it also establishes a regulatory framework that facilitates investment in the burgeoning field of biotechnology. While regulatory reform was already on the public agenda, public awareness of litigation against large pharmaceutical firms combined with the championing of the legislation by Conservative MP Terence Young, whose daughter Vanessa died from an adverse drug reaction, pushed the legislation through to implementation. Many key aspects of the Act depend upon the precise nature of supporting regulations that are still to be implemented. Despite the new powers conferred by the legislation on the Minister of Health, there is some concern that these discretionary powers may not be exercised, and that Health Canada may not have sufficient resources to take advantage of these new powers. Given experience to date since enactment, the new legislation, designed to provide greater transparency vis-à-vis therapeutic products, may actually have a chilling effect on independent scrutiny.

Enabling social listening for cardiac safety monitoring: Proceedings from a drug information association-cardiac safety research consortium cosponsored think tank.

Science.gov (United States)

Seifert, Harry A; Malik, Raleigh E; Bhattacharya, Mondira; Campbell, Kevin R; Okun, Sally; Pierce, Carrie; Terkowitz, Jeffrey; Turner, J Rick; Krucoff, Mitchell W; Powell, Gregory E

2017-12-01

This white paper provides a summary of the presentations and discussions from a think tank on "Enabling Social Listening for Cardiac Safety Monitoring" trials that was cosponsored by the Drug Information Association and the Cardiac Safety Research Consortium, and held at the White Oak headquarters of the US Food and Drug Administration on June 3, 2016. The meeting's goals were to explore current methods of collecting and evaluating social listening data and to consider their applicability to cardiac safety surveillance. Social listening is defined as the act of monitoring public postings on the Internet. It has several theoretical advantages for drug and device safety. First, these include the ability to detect adverse events that are "missed" by traditional sources and the ability to detect adverse events sooner than would be allowed by traditional sources, both by affording near-real-time access to data from culturally and geographically diverse sources. Social listening can also potentially introduce a novel patient voice into the conversation about drug safety, which could uniquely augment understanding of real-world medication use obtained from more traditional methodologies. Finally, it can allow for access to information about drug misuse and diversion. To date, the latter 2 of these have been realized. Although regulators from the Food and Drug Administration and the United Kingdom's Medicines and Healthcare Products Regulatory Agency participated in the think tank along with representatives from industry, academia, and patient groups, this article should not be construed to constitute regulatory guidance. Copyright © 2017 Elsevier Inc. All rights reserved.

RCC2 over-expression in tumor cells alters apoptosis and drug sensitivity by regulating Rac1 activation.

Science.gov (United States)

Wu, Nan; Ren, Dong; Li, Su; Ma, Wenli; Hu, Shaoyan; Jin, Yan; Xiao, Sheng

2018-01-10

Small GTP binding protein Rac1 is a component of NADPH oxidases and is essential for superoxide-induced cell death. Rac1 is activated by guanine nucleotide exchange factors (GEFs), and this activation can be blocked by regulator of chromosome condensation 2 (RCC2), which binds the switch regions of Rac1 to prevent access from GEFs. Three cancer cell lines with up- or down-regulation of RCC2 were used to evaluate cell proliferation, apoptosis, Rac1 signaling and sensitivity to a group of nine chemotherapeutic drugs. RCC2 expression in lung cancer and ovarian cancer were studied using immunochemistry stain of tumor tissue arrays. Forced RCC2 expression in tumor cells blocked spontaneous- or Staurosporine (STS)-induced apoptosis. In contrast, RCC2 knock down in these cells resulted in increased apoptosis to STS treatment. The protective activity of RCC2 on apoptosis was revoked by a constitutively activated Rac1, confirming a role of RCC2 in apoptosis by regulating Rac1. In an immunohistochemistry evaluation of tissue microarray, RCC2 was over-expressed in 88.3% of primary lung cancer and 65.2% of ovarian cancer as compared to non-neoplastic lung and ovarian tissues, respectively. Because chemotherapeutic drugs can kill tumor cells by activating Rac1/JNK pathway, we suspect that tumors with RCC2 overexpression would be more resistant to these drugs. Tumor cells with forced RCC2 expression indeed had significant difference in drug sensitivity compared to parental cells using a panel of common chemotherapeutic drugs. RCC2 regulates apoptosis by blocking Rac1 signaling. RCC2 expression in tumor can be a useful marker for predicting chemotherapeutic response.

Natural products, an important resource for discovery of multitarget drugs and functional food for regulation of hepatic glucose metabolism.

Science.gov (United States)

Li, Jian; Yu, Haiyang; Wang, Sijian; Wang, Wei; Chen, Qian; Ma, Yanmin; Zhang, Yi; Wang, Tao

2018-01-01

Imbalanced hepatic glucose homeostasis is one of the critical pathologic events in the development of metabolic syndromes (MSs). Therefore, regulation of imbalanced hepatic glucose homeostasis is important in drug development for MS treatment. In this review, we discuss the major targets that regulate hepatic glucose homeostasis in human physiologic and pathophysiologic processes, involving hepatic glucose uptake, glycolysis and glycogen synthesis, and summarize their changes in MSs. Recent literature suggests the necessity of multitarget drugs in the management of MS disorder for regulation of imbalanced glucose homeostasis in both experimental models and MS patients. Here, we highlight the potential bioactive compounds from natural products with medicinal or health care values, and focus on polypharmacologic and multitarget natural products with effects on various signaling pathways in hepatic glucose metabolism. This review shows the advantage and feasibility of discovering multicompound-multitarget drugs from natural products, and providing a new perspective of ways on drug and functional food development for MSs.

Default Drug Doses in Anesthesia Information Management Systems.

Science.gov (United States)

Rodriquez, Luis I; Smaka, Todd J; Mahla, Michael; Epstein, Richard H

2017-07-01

In the United States, anesthesia information management systems (AIMS) are well established, especially within academic practices. Many hospitals are replacing their stand-alone AIMS during migration to an enterprise-wide electronic health record. This presents an opportunity to review choices made during the original implementation, based on actual usage. One area amenable to this informatics approach is the configuration in the AIMS of quick buttons for typical drug doses. The use of such short cuts, as opposed to manual typing of doses, simplifies and may improve the accuracy of drug documentation within the AIMS. We analyzed administration data from 3 different institutions, 2 of which had empirically configured default doses, and one in which defaults had not been set up. Our first hypothesis was that most (ie, >50%) of drugs would need at least one change to the existing defaults. Our second hypothesis was that for most (>50%) drugs, the 4 most common doses at the site lacking defaults would be included among the most common doses at the 2 sites with defaults. If true, this would suggest that having default doses did not affect the typical administration behavior of providers. The frequency distribution of doses for all drugs was determined, and the 4 most common doses representing at least 5% of total administrations for each drug were identified. The appropriateness of the current defaults was determined by the number of changes (0-4) required to match actual usage at the 2 hospitals with defaults. At the institution without defaults, the most frequent doses for the 20 most commonly administered drugs were compared with the default doses at the other institutions. At the 2 institutions with defaults, 84.7% and 77.5% of drugs required at least 1 change in the default drug doses (P default drug doses, 100% of the 20 most commonly administered doses (representing ≥5% of use for that drug) were included in the most commonly administered doses at the other 2

EFFECTS OF PSYCHOTROPIC DRUGS AS BACTERIAL EFFLUX PUMP INHIBITORS ON QUORUM SENSING REGULATED BEHAVIORS

Directory of Open Access Journals (Sweden)

Aynur Aybey

2014-10-01

Full Text Available Psychotropic drugs are known to have antimicrobial activity against several groups of microorganisms. The antidepressant agents such as duloxetine, paroxetine, hydroxyzine and venlafaxine are shown to act as efflux pump inhibitors in bacterial cells. In order to the investigation of the effects of psychotropic drugs were determined for clinically significant pathogens by using standart broth microdillusion method. The anti-quorum sensing (anti-QS activity of psychotropic drugs was tested against four test pathogens using the agar well diffusion method. All drugs showed strong inhibitory effect on the growth of S. typhimurium. Additionally, quorum sensing-regulated behaviors of Pseudomonas aeruginosa, including swarming, swimming and twitching motility and alkaline protease production were investigated. Most effective drugs on swarming, swimming and twitching motility and alkaline protease production, respectively, were paroxetine and duloxetine; duloxetine; hydroxyzine and venlafaxine; paroxetine and venlafaxine; venlafaxine. Accordingly, psychotropic drugs were shown strongly anti-QS activity by acting as bacterial efflux pump inhibitors and effection on motility and alkaline protease production of P. aeruginosa.

77 FR 51496 - Federal Acquisition Regulation; Basic Safeguarding of Contractor Information Systems

Science.gov (United States)

2012-08-24

... Federal Acquisition Regulation; Basic Safeguarding of Contractor Information Systems AGENCY: Department of... Acquisition Regulation (FAR) to add a new subpart and contract clause for the basic safeguarding of contractor... information) that will be resident on or transiting through contractor information systems. DATES: Interested...

Information and interaction : influencing drug prescribing in Swedish primary care

OpenAIRE

Stålsby Lundborg, Cecilia

1999-01-01

Aim The studies concern drug information and continuing education on drug treatment, focusing on doctors' prescribing in primary care in Sweden. The long-term aim has been to develop educational models accepted by the doctors, and to develop and apply means of evaluating the education. Methods Data have been collected from the study populations mainly through questionnaires and dispensed prescriptions, i.e., quantitative data. In addition, qualitative interview data w...

Data-intensive drug development in the information age: applications of Systems Biology/Pharmacology/Toxicology.

Science.gov (United States)

Kiyosawa, Naoki; Manabe, Sunao

2016-01-01

Pharmaceutical companies continuously face challenges to deliver new drugs with true medical value. R&D productivity of drug development projects depends on 1) the value of the drug concept and 2) data and in-depth knowledge that are used rationally to evaluate the drug concept's validity. A model-based data-intensive drug development approach is a key competitive factor used by innovative pharmaceutical companies to reduce information bias and rationally demonstrate the value of drug concepts. Owing to the accumulation of publicly available biomedical information, our understanding of the pathophysiological mechanisms of diseases has developed considerably; it is the basis for identifying the right drug target and creating a drug concept with true medical value. Our understanding of the pathophysiological mechanisms of disease animal models can also be improved; it can thus support rational extrapolation of animal experiment results to clinical settings. The Systems Biology approach, which leverages publicly available transcriptome data, is useful for these purposes. Furthermore, applying Systems Pharmacology enables dynamic simulation of drug responses, from which key research questions to be addressed in the subsequent studies can be adequately informed. Application of Systems Biology/Pharmacology to toxicology research, namely Systems Toxicology, should considerably improve the predictability of drug-induced toxicities in clinical situations that are difficult to predict from conventional preclinical toxicology studies. Systems Biology/Pharmacology/Toxicology models can be continuously improved using iterative learn-confirm processes throughout preclinical and clinical drug discovery and development processes. Successful implementation of data-intensive drug development approaches requires cultivation of an adequate R&D culture to appreciate this approach.

Mindfulness meditation improves emotion regulation and reduces drug abuse.

Science.gov (United States)

Tang, Yi-Yuan; Tang, Rongxiang; Posner, Michael I

2016-06-01

The core clinical symptoms of addiction include an enhanced incentive for drug taking (craving), impaired self-control (impulsivity and compulsivity), emotional dysregulation (negative mood) and increased stress reactivity. Symptoms related to impaired self-control involve reduced activity in anterior cingulate cortex (ACC), adjacent prefrontal cortex (mPFC) and other brain areas. Behavioral training such as mindfulness meditation can increase the function of control networks including those leading to improved emotion regulation and thus may be a promising approach for the treatment of addiction. In a series of randomized controlled trials (RCTs), we tested whether increased ACC/mPFC activity is related to better self-control abilities in executive functions, emotion regulation and stress response in healthy and addicted populations. After a brief mindfulness training (Integrative Body-Mind Training, IBMT), we used the Positive and Negative Affect Schedule (PANAS) and Profile of Mood States (POMS) to measure emotion regulation, salivary cortisol for the stress response and fMRI for brain functional and DTI structural changes. Relaxation training was used to serve as an active control. In both smokers and nonsmokers, improved self-control abilities in emotion regulation and stress reduction were found after training and these changes were related to increased ACC/mPFC activity following training. Compared with nonsmokers, smokers showed reduced ACC/mPFC activity in the self-control network before training, and these deficits were ameliorated after training. These results indicate that promoting emotion regulation and improving ACC/mPFC brain activity can help for addiction prevention and treatment. Copyright © 2016 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Gemfibrozil and fenofibrate, Food and Drug Administration-approved lipid-lowering drugs, up-regulate tripeptidyl-peptidase 1 in brain cells via peroxisome proliferator-activated receptor α: implications for late infantile Batten disease therapy.

Science.gov (United States)

Ghosh, Arunava; Corbett, Grant T; Gonzalez, Frank J; Pahan, Kalipada

2012-11-09

The classical late infantile neuronal ceroid lipofuscinosis (LINCLs) is an autosomal recessive disease, where the defective gene is Cln2, encoding tripeptidyl-peptidase I (TPP1). At the molecular level, LINCL is caused by accumulation of autofluorescent storage materials in neurons and other cell types. Currently, there is no established treatment for this fatal disease. This study reveals a novel use of gemfibrozil and fenofibrate, Food and Drug Administration-approved lipid-lowering drugs, in up-regulating TPP1 in brain cells. Both gemfibrozil and fenofibrate up-regulated mRNA, protein, and enzymatic activity of TPP1 in primary mouse neurons and astrocytes as well as human astrocytes and neuronal cells. Because gemfibrozil and fenofibrate are known to activate peroxisome proliferator-activated receptor-α (PPARα), the role of PPARα in gemfibrozil- and fenofibrate-mediated up-regulation of TPP1 was investigated revealing that both drugs up-regulated TPP1 mRNA, protein, and enzymatic activity both in vitro and in vivo in wild type (WT) and PPARβ(-/-), but not PPARα(-/-), mice. In an attempt to delineate the mechanism of TPP1 up-regulation, it was found that the effects of the fibrate drugs were abrogated in the absence of retinoid X receptor-α (RXRα), a molecule known to form a heterodimer with PPARα. Accordingly, all-trans-retinoic acid, alone or together with gemfibrozil, up-regulated TPP1. Co-immunoprecipitation and ChIP studies revealed the formation of a PPARα/RXRα heterodimer and binding of the heterodimer to an RXR-binding site on the Cln2 promoter. Together, this study demonstrates a unique mechanism for the up-regulation of TPP1 by fibrate drugs via PPARα/RXRα pathway.

Hindered disulfide bonds to regulate release rate of model drug from mesoporous silica.

Science.gov (United States)

Nadrah, Peter; Maver, Uroš; Jemec, Anita; Tišler, Tatjana; Bele, Marjan; Dražić, Goran; Benčina, Mojca; Pintar, Albin; Planinšek, Odon; Gaberšček, Miran

2013-05-01

With the advancement of drug delivery systems based on mesoporous silica nanoparticles (MSNs), a simple and efficient method regulating the drug release kinetics is needed. We developed redox-responsive release systems with three levels of hindrance around the disulfide bond. A model drug (rhodamine B dye) was loaded into MSNs' mesoporous voids. The pore opening was capped with β-cyclodextrin in order to prevent leakage of drug. Indeed, in absence of a reducing agent the systems exhibited little leakage, while the addition of dithiothreitol cleaved the disulfide bonds and enabled the release of cargo. The release rate and the amount of released dye were tuned by the level of hindrance around disulfide bonds, with the increased hindrance causing a decrease in the release rate as well as in the amount of released drug. Thus, we demonstrated the ability of the present mesoporous systems to intrinsically control the release rate and the amount of the released cargo by only minor structural variations. Furthermore, an in vivo experiment on zebrafish confirmed that the present model delivery system is nonteratogenic.

Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: Teaching Drug Marketers How to Inform Better or Spin Better?

Science.gov (United States)

Doran, Evan

2016-01-01

Hyosun Kim’s report "Trouble Spots in Online Direct to Consumer Prescription Drug Promotion: A content Analysis of FDA Warning Letters" aims to teach marketers how to avoid breaching current Food and Drug Administration (FDA) guidelines in their online drug promotion. While Kim hopes to minimise the potential for online promotion to misinform consumers and the study is carefully conducted, teaching drug marketers how to avoid the common mistakes in online drug promotion is more likely to make marketers more adept at spinning information than appropriately balancing it PMID:27239884

76 FR 78933 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

Science.gov (United States)

2011-12-20

..., electronic record requirements, and investigator initiated research. Topics for discussion include the...] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical... Clinical Research Associates (SoCRA), is announcing a public workshop. The public workshop on FDA's...

Online drug databases: a new method to assess and compare inclusion of clinically relevant information.

Science.gov (United States)

Silva, Cristina; Fresco, Paula; Monteiro, Joaquim; Rama, Ana Cristina Ribeiro

2013-08-01

Evidence-Based Practice requires health care decisions to be based on the best available evidence. The model "Information Mastery" proposes that clinicians should use sources of information that have previously evaluated relevance and validity, provided at the point of care. Drug databases (DB) allow easy and fast access to information and have the benefit of more frequent content updates. Relevant information, in the context of drug therapy, is that which supports safe and effective use of medicines. Accordingly, the European Guideline on the Summary of Product Characteristics (EG-SmPC) was used as a standard to evaluate the inclusion of relevant information contents in DB. To develop and test a method to evaluate relevancy of DB contents, by assessing the inclusion of information items deemed relevant for effective and safe drug use. Hierarchical organisation and selection of the principles defined in the EGSmPC; definition of criteria to assess inclusion of selected information items; creation of a categorisation and quantification system that allows score calculation; calculation of relative differences (RD) of scores for comparison with an "ideal" database, defined as the one that achieves the best quantification possible for each of the information items; pilot test on a sample of 9 drug databases, using 10 drugs frequently associated in literature with morbidity-mortality and also being widely consumed in Portugal. Main outcome measure Calculate individual and global scores for clinically relevant information items of drug monographs in databases, using the categorisation and quantification system created. A--Method development: selection of sections, subsections, relevant information items and corresponding requisites; system to categorise and quantify their inclusion; score and RD calculation procedure. B--Pilot test: calculated scores for the 9 databases; globally, all databases evaluated significantly differed from the "ideal" database; some DB performed

75 FR 14448 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

Science.gov (United States)

2010-03-25

... requirements, and investigator initiated research. Topics for discussion include the following: (1) What FDA...] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical... Society of Clinical Research Associates, Inc. (SoCRA) is announcing a public workshop entitled ``FDA...

77 FR 8886 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

Science.gov (United States)

2012-02-15

..., electronic record requirements, and investigator initiated research. Topics for discussion include the...] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical... Research Associates (SoCRA) is announcing a public workshop. The public workshop on FDA's clinical trial...

Encouraging Maternal Sacrifice: How Regulations Governing the Consumption of Pharmaceuticals During Pregnancy Prioritize Fetal Safety over Maternal Health and Autonomy.

Science.gov (United States)

Donley, Greer

Pregnant women are routinely faced with the stressful decision of whether to consume needed medications during their pregnancies. Because the risks associated with pharmaceutical drug consumption during pregnancy are largely unknown, pregnant women both inadvertently consume dangerous medications and avoid needed drugs. Both outcomes are harmful to pregnant women and their fetuses. This unparalleled lack of drug safety information is a result of ill-conceived, paternalistic regulations in two areas of the law: regulations governing ethical research in human subjects and regulations that dictate the required labels on drugs. The former categorizes pregnant women as "vulnerable" and thus precludes them from most medical research. The result is that ninety-one percent of drugs lack any reliable safety information for pregnant consumers. The latter currently requires all drug labels to encourage drug avoidance during pregnancy, despite ample evidence that avoiding needed medications can harm pregnant women. On June 30, 2015, new pregnancy labeling regulations took effect. Though these regulations make important improvements, they continue to treat pregnant women unlike any population, including other unique subpopulations, such as children. As a result, the new regulations do not fix the problem of over-warning pregnant women about the risks of drug consumption. This article questions the legitimacy of both regulations and suggests three reforms for how to improve access to vital safety information: (1) amend the regulations governing ethical research in human subjects to reclassify pregnant women as non-vulnerable adults; (2) create incentives to generate safety data in pregnant women by granting a period of market exclusivity for drug companies that invest in this research; and (3) make the FDA pregnancy labeling regulations consistent with the routine FDA practice of requiring the display of balanced, human data on risk.

Development of Prescription Drug Information Leaflets: Impact of Cognitive Effort and Patient Involvement on Prescription Medication Information Processing.

Science.gov (United States)

Patel, Harshali K; Bapat, Shweta S; Bhansali, Archita H; Sansgiry, Sujit S

2018-01-01

The objective of this study was to develop a one-page (1-page) prescription drug information leaflet (PILs) and assess their impact on the information processing variables, across 2 levels of patient involvement. One-page PILs were developed using cognitive principles to lower mental effort and improve comprehension. An experimental, 3 × 2 repeated measures study was conducted to determine the impact of cognitive effort, manipulated using leaflet type on comprehension across 2 levels (high/low) of patient involvement. Adults (≥18 years) in a university setting in Houston were recruited for the study. Each participant was exposed to 3 different types of prescription drug information leaflet (the current practice, preexisting 1-page text-only, and 1-page PILs) for the 3 drugs (Celebrex, Ventolin HFA, Prezista) for a given involvement scenario. A prevalidated survey instrument was used to measure product knowledge, attitude toward leaflet, and intention to read. Multivariate analysis of variance indicated significant positive effect of cognitive effort, involvement, and their interaction effect across all measured variables. Mean scores for product knowledge, attitude toward leaflet, and intention to read were highest for PILs ( P information processing for consumers by reducing their cognitive effort.

Information on actual medication use and drug-related problems in older patients: questionnaire or interview?

Science.gov (United States)

Willeboordse, Floor; Grundeken, Lucienne H; van den Eijkel, Lisanne P; Schellevis, François G; Elders, Petra J M; Hugtenburg, Jacqueline G

2016-04-01

Information on medication use and drug-related problems is important in the preparation of clinical medication reviews. Critical information can only be provided by patients themselves, but interviewing patients is time-consuming. Alternatively, patient information could be obtained with a questionnaire. In this study the agreement between patient information on medication use and drug-related problems in older patients obtained with a questionnaire was compared with information obtained during an interview. General practice in The Netherlands. A questionnaire was developed to obtain information on actual medication use and drug-related problems. Two patient groups ≥65 years were selected based on general practitioner electronic medical records in nine practices; I. polypharmacy and II. ≥1 predefined general geriatric problems. Eligible patients were asked to complete the questionnaire and were interviewed afterwards. Agreement on information on medication use and drug-related problems collected with the questionnaire and interview was calculated. Ninety-seven patients participated. Of all medications used, 87.6 % (95 % CI 84.7-90.5) was reported identically in the questionnaire and interview. Agreement for the complete medication list was found for 45.4 % (95 % CI 35.8-55.3) of the patients. On drug-related problem level, agreement between questionnaire and interview was 75 %. Agreement tended to be lower in vulnerable patients characterized by ≥4 chronic diseases, ≥10 medications used and low health literacy. Information from a questionnaire showed reasonable agreement compared with interviewing. The patients reported more medications and drug-related problems in the interview than the questionnaire. Taking the limitations into account, a questionnaire seems a suitable tool for medication reviews that may replace an interview for most patients.

Curriculum and instructional methods for drug information, literature evaluation, and biostatistics: survey of US pharmacy schools.

Science.gov (United States)

Phillips, Jennifer A; Gabay, Michael P; Ficzere, Cathy; Ward, Kristina E

2012-06-01

The drug information curriculum in US colleges of pharmacy continues to evolve. The American College of Clinical Pharmacy (ACCP) Drug Information Practice and Research Network (DI PRN) published an opinion paper with specific recommendations regarding drug information education in 2009. Adoption of these recommendations has not been evaluated. To assess which recommendations made in the ACCP DI PRN opinion paper are included in US pharmacy school curricula and characterize faculty qualifications, educational methods, and recent changes in drug information education. An electronic survey was designed using the ACCP DI PRN opinion paper and the Accreditation Council for Pharmacy Education standards and guidelines for accreditation of PharmD programs in the US. Survey questions addressed curricular content within the following categories: drug information, literature evaluation, and biostatistics. A letter including the online survey link was sent via email to the dean of each US college/school of pharmacy (N = 128). Recipients were instructed to forward the email to the individual at their institution who was the most knowledgeable about the content and methodology used for didactic drug information education. Sixty-four responses were included in the final analysis. Of the 19 ACCP DI PRN minimum core concepts, 9 (47%) were included in curricula of all responding institutions; 14 of 19 (74%) were included in curricula for all but 1 institution. In contrast, 5 of 16 concepts (31%) were not formally taught by a number of institutions. Many respondents noted an increased focus on evidence-based medicine, medication safety, and informatics. Although a survey of drug information curricula documented substantial inclusion of the essential concepts presented in the ACCP DI PRN opinion paper, room for improvement remains in drug information curricula in US colleges of pharmacy.

77 FR 59156 - Antimicrobial Animal Drug Sales and Distribution Reporting; Extension of Comment Period

Science.gov (United States)

2012-09-26

.... FDA-2012-N-0447] Antimicrobial Animal Drug Sales and Distribution Reporting; Extension of Comment... its regulations relating to records and reports for approved antimicrobial new animal drugs. The... obtaining additional data and information about the extent of antimicrobial drug use in food-producing...

76 FR 51040 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

Science.gov (United States)

2011-08-17

... requirements, and investigator initiated research. Topics for discussion include the following: (1) What FDA...] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical... Clinical Research Associates (SoCRA) is announcing a public workshop. The public workshop on FDA's clinical...

Accuracy and Completeness of Drug Information in Wikipedia: A Comparison with Standard Textbooks of Pharmacology

Science.gov (United States)

Gutmann, Joanna; Muehlich, Susanne; Zolk, Oliver; Wojnowski, Leszek; Maas, Renke; Engelhardt, Stefan; Sarikas, Antonio

2014-01-01

The online resource Wikipedia is increasingly used by students for knowledge acquisition and learning. However, the lack of a formal editorial review and the heterogeneous expertise of contributors often results in skepticism by educators whether Wikipedia should be recommended to students as an information source. In this study we systematically analyzed the accuracy and completeness of drug information in the German and English language versions of Wikipedia in comparison to standard textbooks of pharmacology. In addition, references, revision history and readability were evaluated. Analysis of readability was performed using the Amstad readability index and the Erste Wiener Sachtextformel. The data on indication, mechanism of action, pharmacokinetics, adverse effects and contraindications for 100 curricular drugs were retrieved from standard German textbooks of general pharmacology and compared with the corresponding articles in the German language version of Wikipedia. Quantitative analysis revealed that accuracy of drug information in Wikipedia was 99.7%±0.2% when compared to the textbook data. The overall completeness of drug information in Wikipedia was 83.8±1.5% (ptextbook data overlap. Similar results were obtained for the English language version of Wikipedia. Of the drug information missing in Wikipedia, 62.5% was rated as didactically non-relevant in a qualitative re-evaluation study. Drug articles in Wikipedia had an average of 14.6±1.6 references and 262.8±37.4 edits performed by 142.7±17.6 editors. Both Wikipedia and textbooks samples had comparable, low readability. Our study suggests that Wikipedia is an accurate and comprehensive source of drug-related information for undergraduate medical education. PMID:25250889

76 FR 6798 - Agency Information Collection Activities; Proposed Collection; Comment Request; Presubmission...

Science.gov (United States)

2011-02-08

... submitted. The application must include safety and effectiveness data, proposed labeling, product manufacturing information, and where necessary, complete information on food safety (including microbial food..., New Animal Drug Applications and Supporting Regulations, and Food and Drug Administration Form 356V...

76 FR 2807 - New Animal Drugs; Change of Sponsor; Follicle Stimulating Hormone

Science.gov (United States)

2011-01-18

... [Docket No. FDA-2010-N-0002] New Animal Drugs; Change of Sponsor; Follicle Stimulating Hormone AGENCY...) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug....O. Box 324-12, Tyler, TX 75703 has informed FDA that it has transferred ownership of, and all rights...

Regulation of drug metabolism and toxicity by multiple factors of genetics, epigenetics, lncRNAs, gut microbiota, and diseases: a meeting report of the 21st International Symposium on Microsomes and Drug Oxidations (MDO

Directory of Open Access Journals (Sweden)

Ai-Ming Yu

2017-03-01

Full Text Available Variations in drug metabolism may alter drug efficacy and cause toxicity; better understanding of the mechanisms and risks shall help to practice precision medicine. At the 21st International Symposium on Microsomes and Drug Oxidations held in Davis, California, USA, in October 2–6, 2016, a number of speakers reported some new findings and ongoing studies on the regulation mechanisms behind variable drug metabolism and toxicity, and discussed potential implications to personalized medications. A considerably insightful overview was provided on genetic and epigenetic regulation of gene expression involved in drug absorption, distribution, metabolism, and excretion (ADME and drug response. Altered drug metabolism and disposition as well as molecular mechanisms among diseased and special populations were presented. In addition, the roles of gut microbiota in drug metabolism and toxicology as well as long non-coding RNAs in liver functions and diseases were discussed. These findings may offer new insights into improved understanding of ADME regulatory mechanisms and advance drug metabolism research.

Print Advertisements for Alzheimer’s Disease Drugs: Informational and Transformational Features

Science.gov (United States)

Gooblar, Jonathan; Carpenter, Brian D.

2014-01-01

Purpose We examined print advertisements for Alzheimer’s disease drugs published in journals and magazines between January 2008 and February 2012, using an informational versus transformational theoretical framework to identify objective and persuasive features. Methods In 29 unique advertisements, we used qualitative methods to code and interpret identifying information, charts, benefit and side effect language, and persuasive appeals embedded in graphics and narratives. Results Most elements contained a mixture of informational and transformational features. Charts were used infrequently, but when they did appear the accompanying text often exaggerated the data. Benefit statements covered an array of symptoms, drug properties, and caregiver issues. Side effect statements often used positive persuasive appeals. Graphics and narrative features emphasized positive emotions and outcomes. Implications We found subtle and sophisticated attempts both to educate and to persuade readers. It is important for consumers and prescribing physicians to read print advertisements critically so that they can make informed treatment choices. PMID:23687184

A perspective on risk informed regulation and the maintenance rule

International Nuclear Information System (INIS)

In, Young H.

2006-01-01

Establishing a new regulatory framework for the future can be a complex and difficult task where the current regulatory framework and the past regulatory history must be reconciled. The nuclear regulatory framework will evolve over time, and it is in our best interest to make the right changes, whether the change is incremental or innovative. Basically, the risk-informed regulation (RIR) is an innovative change that must be made incrementally. Therefore, it is important that the changes to the framework are carefully evaluated and studied before the actual implementation. Otherwise, we may see unnecessary patches along the way that can be damaging to the regulatory integrity and the public confidence in the regulation. Even though, the United States has led the risk-informed regulation implementation during last decade, there were some instances where the well intended changes were not well planned and coordinated, resulting in loss of valuable time and resources that led to confusions among involved parties. The risk-informed regulation is an emerging trend worldwide, and Korea is one of the few that are ahead of the pack in embracing this innovative change in the regulation. To better understand and plan for RIR, we need to study both the well-established regulatory framework and the emerging regulatory framework. In addition, the recent trends in other regulatory framework similar to its own should be carefully studied. The reasons for any stagnations or barriers in other regulatory frameworks should be carefully noted and see if we share similar problems so that we can formulate better solutions. Blindly following others regulatory changes is not recommended, since our regulatory environment is unique in itself. We should take their inputs and lessons learned, but adopt them specifically to our industry needs and regulatory environment. This paper will attempt to provide a perspective on the risk-informing process of a nuclear plant by a brief look into two key

78 FR 35117 - Orphan Drug Regulations

Science.gov (United States)

2013-06-12

..., ``This [framework] affects the plasma protein therapeutics industry significantly because various drugs... orphan designated.'' Because many plasma protein therapies lack orphan-drug designation, they are... change in delivery system from intravenous (IV) to oral may, in some cases and for some drugs, constitute...

28 CFR 16.82 - Exemption of the National Drug Intelligence Center Data Base-limited access.

Science.gov (United States)

2010-07-01

... (including those responsible for civil proceedings related to laws against drug trafficking); lead to the... laws and regulations regarding drug trafficking and charged with the acquisition of intelligence related to international aspects of drug trafficking. This consideration applies equally to information...

An Analysis of Televised Public Service Advertising. Drug Abuse Information Research Project.

Science.gov (United States)

Hanneman, Gerhard J.; And Others

Government regulations state that broadcasters are obligated to allot program time to matters of public interest, but neither law nor precedent have determined their commitment to present messages on social problems. To determine the amount of public service advertising (PSA) that is broadcast, particularly anti-drug appeals, a content analysis…

Obesity and Pediatric Drug Development.

Science.gov (United States)

Vaughns, Janelle D; Conklin, Laurie S; Long, Ying; Zheng, Panli; Faruque, Fahim; Green, Dionna J; van den Anker, John N; Burckart, Gilbert J

2018-05-01

There is a lack of dosing guidelines for use in obese children. Moreover, the impact of obesity on drug safety and clinical outcomes is poorly defined. The paucity of information needed for the safe and effective use of drugs in obese patients remains a problem, even after drug approval. To assess the current incorporation of obesity as a covariate in pediatric drug development, the pediatric medical and clinical pharmacology reviews under the Food and Drug Administration (FDA) Amendments Act of 2007 and the FDA Safety and Innovation Act (FDASIA) of 2012 were reviewed for obesity studies. FDA labels were also reviewed for statements addressing obesity in pediatric patients. Forty-five drugs studied in pediatric patients under the FDA Amendments Act were found to have statements and key words in the medical and clinical pharmacology reviews and labels related to obesity. Forty-four products were identified similarly with pediatric studies under FDASIA. Of the 89 product labels identified, none provided dosing information related to obesity. The effect of body mass index on drug pharmacokinetics was mentioned in only 4 labels. We conclude that there is little information presently available to provide guidance related to dosing in obese pediatric patients. Moving forward, regulators, clinicians, and the pharmaceutical industry should consider situations in drug development in which the inclusion of obese patients in pediatric trials is necessary to facilitate the safe and effective use of new drug products in the obese pediatric population. © 2018, The American College of Clinical Pharmacology.

Drug-target interaction prediction from PSSM based evolutionary information.

Science.gov (United States)

Mousavian, Zaynab; Khakabimamaghani, Sahand; Kavousi, Kaveh; Masoudi-Nejad, Ali

2016-01-01

The labor-intensive and expensive experimental process of drug-target interaction prediction has motivated many researchers to focus on in silico prediction, which leads to the helpful information in supporting the experimental interaction data. Therefore, they have proposed several computational approaches for discovering new drug-target interactions. Several learning-based methods have been increasingly developed which can be categorized into two main groups: similarity-based and feature-based. In this paper, we firstly use the bi-gram features extracted from the Position Specific Scoring Matrix (PSSM) of proteins in predicting drug-target interactions. Our results demonstrate the high-confidence prediction ability of the Bigram-PSSM model in terms of several performance indicators specifically for enzymes and ion channels. Moreover, we investigate the impact of negative selection strategy on the performance of the prediction, which is not widely taken into account in the other relevant studies. This is important, as the number of non-interacting drug-target pairs are usually extremely large in comparison with the number of interacting ones in existing drug-target interaction data. An interesting observation is that different levels of performance reduction have been attained for four datasets when we change the sampling method from the random sampling to the balanced sampling. Copyright © 2015 Elsevier Inc. All rights reserved.

OPPIDUM surveillance program: 20 years of information on drug abuse in France.

Science.gov (United States)

Frauger, Elisabeth; Moracchini, Christophe; Le Boisselier, Reynald; Braunstein, David; Thirion, Xavier; Micallef, Joëlle

2013-12-01

It is important to assess drug abuse liability in 'real life' using different surveillance systems. Some are based on specific population surveys, such as individuals with drug abuse or dependence, or under opiate maintenance treatment, because this population is very familiar with drugs and is more likely to divert or abuse them. In France, an original surveillance system based on this specific population and called 'Observation of illegal drugs and misuse of psychotropic medications (OPPIDUM) survey' was set up in 1990 as the first of its kind. The aim of this article is to describe this precursor of French drug abuse surveillance using different examples, to demonstrate its ability to effectively give health authorities and physicians interesting data on drug abuse. OPPIDUM is an annual, cross-sectional survey that anonymously collects information on abuse and dependence observed in patients recruited in specialized care centers dedicated to drug dependence. From 1990 to 2010, a total of 50,734 patients were included with descriptions of 102,631 psychoactive substance consumptions. These data have outlined emergent behaviors such as the misuse of buprenorphine by intravenous or nasal administration. It has contributed to assess abuse liability of emergent drugs such as clonazepam or methylphenidate. This surveillance system was also able to detect the decrease of flunitrazepam abuse following implementation of regulatory measures. OPPIDUM's twenty years of experience clearly demonstrate that collection of valid and useful data on drug abuse is possible and can provide helpful information for physicians and health authorities. © 2013 The Authors Fundamental and Clinical Pharmacology © 2013 Société Française de Pharmacologie et de Thérapeutique.

Personality and self-regulation: trait and information-processing perspectives.

Science.gov (United States)

Hoyle, Rick H

2006-12-01

This article introduces the special issue of Journal of Personality on personality and self-regulation. The goal of the issue is to illustrate and inspire research that integrates personality and process-oriented accounts of self-regulation. The article begins by discussing the trait perspective on self-regulation--distinguishing between temperament and personality accounts--and the information-processing perspective. Three approaches to integrating these perspectives are then presented. These range from methodological approaches, in which constructs representing the two perspectives are examined in integrated statistical models, to conceptual approaches, in which the two perspectives are unified in a holistic theoretical model of self-regulation. The article concludes with an overview of the special issue contributions, which are organized in four sections: broad, integrative models of personality and self-regulation; models that examine the developmental origins of self-regulation and self-regulatory styles; focused programs of research that concern specific aspects or applications of self-regulation; and strategies for increasing the efficiency and effectiveness of self-regulation.

Accuracy and completeness of drug information in Wikipedia: a comparison with standard textbooks of pharmacology.

Directory of Open Access Journals (Sweden)

Jona Kräenbring

Full Text Available The online resource Wikipedia is increasingly used by students for knowledge acquisition and learning. However, the lack of a formal editorial review and the heterogeneous expertise of contributors often results in skepticism by educators whether Wikipedia should be recommended to students as an information source. In this study we systematically analyzed the accuracy and completeness of drug information in the German and English language versions of Wikipedia in comparison to standard textbooks of pharmacology. In addition, references, revision history and readability were evaluated. Analysis of readability was performed using the Amstad readability index and the Erste Wiener Sachtextformel. The data on indication, mechanism of action, pharmacokinetics, adverse effects and contraindications for 100 curricular drugs were retrieved from standard German textbooks of general pharmacology and compared with the corresponding articles in the German language version of Wikipedia. Quantitative analysis revealed that accuracy of drug information in Wikipedia was 99.7% ± 0.2% when compared to the textbook data. The overall completeness of drug information in Wikipedia was 83.8 ± 1.5% (p < 0.001. Completeness varied in-between categories, and was lowest in the category "pharmacokinetics" (68.0% ± 4.2%; p < 0.001 and highest in the category "indication" (91.3% ± 2.0% when compared to the textbook data overlap. Similar results were obtained for the English language version of Wikipedia. Of the drug information missing in Wikipedia, 62.5% was rated as didactically non-relevant in a qualitative re-evaluation study. Drug articles in Wikipedia had an average of 14.6 ± 1.6 references and 262.8 ± 37.4 edits performed by 142.7 ± 17.6 editors. Both Wikipedia and textbooks samples had comparable, low readability. Our study suggests that Wikipedia is an accurate and comprehensive source of drug-related information for undergraduate medical education.

Accuracy and completeness of drug information in Wikipedia: a comparison with standard textbooks of pharmacology.

Science.gov (United States)

Kräenbring, Jona; Monzon Penza, Tika; Gutmann, Joanna; Muehlich, Susanne; Zolk, Oliver; Wojnowski, Leszek; Maas, Renke; Engelhardt, Stefan; Sarikas, Antonio

2014-01-01

The online resource Wikipedia is increasingly used by students for knowledge acquisition and learning. However, the lack of a formal editorial review and the heterogeneous expertise of contributors often results in skepticism by educators whether Wikipedia should be recommended to students as an information source. In this study we systematically analyzed the accuracy and completeness of drug information in the German and English language versions of Wikipedia in comparison to standard textbooks of pharmacology. In addition, references, revision history and readability were evaluated. Analysis of readability was performed using the Amstad readability index and the Erste Wiener Sachtextformel. The data on indication, mechanism of action, pharmacokinetics, adverse effects and contraindications for 100 curricular drugs were retrieved from standard German textbooks of general pharmacology and compared with the corresponding articles in the German language version of Wikipedia. Quantitative analysis revealed that accuracy of drug information in Wikipedia was 99.7% ± 0.2% when compared to the textbook data. The overall completeness of drug information in Wikipedia was 83.8 ± 1.5% (p < 0.001). Completeness varied in-between categories, and was lowest in the category "pharmacokinetics" (68.0% ± 4.2%; p < 0.001) and highest in the category "indication" (91.3% ± 2.0%) when compared to the textbook data overlap. Similar results were obtained for the English language version of Wikipedia. Of the drug information missing in Wikipedia, 62.5% was rated as didactically non-relevant in a qualitative re-evaluation study. Drug articles in Wikipedia had an average of 14.6 ± 1.6 references and 262.8 ± 37.4 edits performed by 142.7 ± 17.6 editors. Both Wikipedia and textbooks samples had comparable, low readability. Our study suggests that Wikipedia is an accurate and comprehensive source of drug-related information for undergraduate medical education.

78 FR 37542 - Agency Information Collection Activities: Proposed Collection; Comment Request

Science.gov (United States)

2013-06-21

... techniques or other forms of information technology to minimize the information collection burden. DATES... Collection and Supporting Regulations. CMS-379 Financial Statement of Debtor and Supporting Regulations. CMS... Drug Event Data from Contracted Part D Providers for Payment. CMS-10261 Part C Medicare Advantage...

76 FR 34086 - Mandatory Guidelines for Federal Workplace Drug Testing Programs; Request for Information...

Science.gov (United States)

2011-06-10

... Mandatory Guidelines for Federal Workplace Drug Testing Programs; Request for Information Regarding Specific Issues Related to the Use of the Oral Fluid Specimen for Drug Testing AGENCY: Substance Abuse and Mental... may be applied to the Mandatory Guidelines for Federal Workplace Drug Testing Programs (oral fluid...

The problem of the information in the environmental regulation

Directory of Open Access Journals (Sweden)

Nohra León R.

2002-01-01

Full Text Available There are two outstanding elements for the recent studies of environmental regulation: Firsdy the importance of recognizing the rationality agents that participate in the process to be regulated and in the other hand the asymmetric information problem. So, this context shows a mechanism regulation theory to price a natural resource, just like water, under moral hazard and adverse selection. These are issues concerned by every social scientist; therefore geographers must take these tools trying to develop harder works that engage some academic subjects.

77 FR 67366 - Federal Acquisition Regulation; Information Collection; Travel Costs

Science.gov (United States)

2012-11-09

...; Information Collection; Travel Costs AGENCY: Department of Defense (DOD), General Services Administration (GSA... requirement concerning Travel Costs. Public comments are particularly invited on: Whether this collection of...- 0088, Travel Costs by any of the following methods: Regulations.gov : http://www.regulations.gov...

Use of anonymous Web communities and websites by medical consumers in Japan to research drug information.

Science.gov (United States)

Kishimoto, Keiko; Fukushima, Noriko

2011-01-01

In this study, we investigated the status of researching drug information online, and the type of Internet user who uses anonymous Web communities and websites. A Web-based cross-sectional survey of 10875 male and female Internet users aged 16 and over was conducted in March 2010. Of 10282 analyzed respondents, excluding medical professionals, about 47% reported that they had previously searched the Internet for drug information and had used online resources ranging from drug information search engines and pharmaceutical industry websites to social networking sites and Twitter. Respondents who had researched drug information online (n=4861) were analyzed by two multivariable logistic regressions. In Model 1, the use of anonymous websites associated with age (OR, 0.778; 95% CI, 0.742-0.816), referring to the reputation and the narrative of other Internet users on shopping (OR, 1.640; 95% CI, 1.450-1.855), taking a prescription drug (OR, 0.806; 95% CI, 0.705-0.922), and frequent consulting with non-professionals about medical care and health (OR, 1.613; 95% CI, 1.396-1.865). In Model 2, use of only anonymous websites was associated with age (OR, 0.753; 95% CI, 0.705-0.805), using the Internet daily (OR, 0.611; 95% CI, 0.462-0.808), taking a prescription drug (OR, 0.614; 95% CI, 0.505-0.747), and experience a side effect (OR, 0.526; 95% CI, 0.421-0.658). The analysis revealed the profiles of Internet users who researched drug information on social media sites where the information providers are anonymous and do not necessarily have adequate knowledge of medicine and online information literacy.

[Prescription, dispensing, and regulation of psychoactive anorexigenic drugs in Belo Horizonte, Minas Gerais, Brazil].

Science.gov (United States)

Carneiro, Mônica de Fátima Gontijo; Guerra, Augusto Afonso; Acurcio, Francisco de Assis

2008-08-01

This retrospective study in Belo Horizonte, Minas Gerais, Brazil, aimed to provide indicators on the sale and consumption of anorexigenic substances. During the first stage, 2,906 of 168,237 prescriptions received by pharmacies in 2003 were analyzed, showing low quality of prescriptions. Projected consumption in defined daily doses was 19.75 DDD/1,000 inhabitants/day in 2003. Fenproporex (59.8%) was the most widely consumed drug. One pharmacy was responsible for 39.8% of the pharmaceutical sales. During the second stage, 14,554 sales records from this "blockbuster" pharmacy were analyzed, from April to August 2005; 9.2% of sales were for anorexigenic products, 91.8% of which prescribed in association with another substance. The data suggest irrational use of anorexigenic drugs by these consumers and highlight the need for proper regulation of these products. It is important to understand both the role of pharmacies in this regulation and that of physicians in the rational use of these substances.

Toward introduction of risk informed safety regulation. Nuclear Safety Commission taskforce's interim report

International Nuclear Information System (INIS)

2006-01-01

Nuclear Safety Commission's taskforce on 'Introduction of Safety Regulation Utilizing Risk Information' completed the interim report on its future subjects and directions in December 2005. Although current safety regulatory activities have been based on deterministic approach, this report shows the risk informed approach is expected to be very useful for making nuclear safety regulation and assurance activities reasonable and also for appropriate allocation of regulatory resources. For introduction of risk informed regulation, it also recommends pileups of experiences with gradual introduction and trial of the risk informed approach, improvement of plant maintenance rules and regulatory requirements utilizing risk information, and establishment of framework to assure quality of risk evaluation. (T. Tanaka)

Information about adverse drug reactions reported in children

DEFF Research Database (Denmark)

Aagaard, Lise; Christensen, Arne; Hansen, Ebba Holme

2010-01-01

AIM: To review the literature on adverse drug reactions (ADRs) in children with respect to occurrence, seriousness, type, therapeutic group, age and gender of the child and category of reporter. METHODS: Medline and Embase databases were searched from origin and updated until February 2010. We...... included empirically based articles on ADRs in populations aged 0 to 17 years. Studies monitoring ADRs in patients with particular conditions or drug exposure were excluded. We extracted information about types and seriousness of ADRs, therapeutic groups, age and gender of the child and category...... of reporter. ADR occurrence was calculated as incidence rate and prevalence. RESULTS: We included 33 studies monitoring ADRs in general paediatric populations. The highest numbers of ADRs were reported in national ADR databases where data were collected over a longer period than in studies monitoring...

Comparison of the safety information on drug labels in three developed countries: The USA, UK and Canada

Directory of Open Access Journals (Sweden)

Thamir M. Alshammari

2017-12-01

Full Text Available The safety information on drug labels of a company marketing the same drugs in different countries is sometimes different. The aim of the present study is to understand the differences in the volume and content of safety information on the drug labels from the same manufacturers in three developed countries: the United States of America (USA, the United Kingdom (UK and Canada. This study involved the calculation of the proportion of total safety information (PSI and of contraindications (PCI in comparison to all information on the label and the percentage of boxed warnings (PBW among the 100 labels studied from each country. The PSI on the labels of different countries is different with USA labels bearing lesser value PSI and UK labels bearing higher value PSI. The qualitative information provided on these drug labels from each country in ‘contraindications’ sections, ‘boxed/serious warnings’ and ‘overdosage’ sections presented differences in the information provided on most of the labels. We have found distinct differences between the safety information available on drug labels in terms of volume and content. We conclude that the safety information for the same products should be standardised across all countries.

Possible drug–drug interaction in dogs and cats resulted from alteration in drug metabolism: A mini review

Directory of Open Access Journals (Sweden)

Kazuaki Sasaki

2015-05-01

Full Text Available Pharmacokinetic drug–drug interactions (in particular at metabolism may result in fatal adverse effects in some cases. This basic information, therefore, is needed for drug therapy even in veterinary medicine, as multidrug therapy is not rare in canines and felines. The aim of this review was focused on possible drug–drug interactions in dogs and cats. The interaction includes enzyme induction by phenobarbital, enzyme inhibition by ketoconazole and fluoroquinolones, and down-regulation of enzymes by dexamethasone. A final conclusion based upon the available literatures and author’s experience is given at the end of the review.

Norwegian elderly patients' need for drug information and attitudes towards medication use reviews in community pharmacies.

Science.gov (United States)

Mamen, Anette Vik; Håkonsen, Helle; Kjome, Reidun L S; Gustavsen-Krabbesund, Bjørn; Toverud, Else-Lydia

2015-12-01

Medication use review (MUR) is a community pharmacy service in several countries. Knowledge about what patients want from such a service is limited. The aim of this study was therefore to investigate Norwegian elderly patients' need for drug information and their attitudes towards MURs. In Norway's two largest cities, 162 patients (72% women; mean age: 78.9 years) who used at least one prescription drug were recruited from 18 senior centres. They were interviewed personally with a structured questionnaire (29 closed and 4 open-ended questions). The average number of prescription drugs used was 4.4. Seventy per cent also used over-the-counter drugs. The main source of drug information was the general practitioner (GP) followed by package inserts and pharmacy staff. For drug-related problems, 62% would contact the GP compared with 24% who preferred the pharmacist. Fifty per cent remembered no information when collecting prescriptions. However, 56% wanted to know more about their medication and 55% were interested in a MUR. The main topics they wished to address were effect/side effects and interactions. Lack of privacy was reported to be a major obstacle in the current situation. This study shows that community pharmacies in Norway play a minor role regarding drug information to elderly polypharmacy patients. The GP is both their main information source and whom they contact for drug-related problems. However, half of the patients would like to know more about their medication. More than half were positive towards taking part in a MUR. © 2015 Royal Pharmaceutical Society.

Expression and Regulation of Drug Transporters and Metabolizing Enzymes in the Human Gastrointestinal Tract.

Science.gov (United States)

Drozdzik, M; Oswald, S

2016-01-01

Orally administered drugs must pass through the intestinal wall and then through the liver before reaching systemic circulation. During this process drugs are subjected to different processes that may determine the therapeutic value. The intestinal barrier with active drug metabolizing enzymes and drug transporters in enterocytes plays an important role in the determination of drug bioavailability. Accumulating information demonstrates variable distribution of drug metabolizing enzymes and transporters along the human gastrointestinal tract (GI), that creates specific barrier characteristics in different segments of the GI. In this review, expression of drug metabolizing enzymes and transporters in the healthy and diseased human GI as well as their regulatory aspects: genetic, miRNA, DNA methylation are outlined. The knowledge of unique interplay between drug metabolizing enzymes and transporters in specific segments of the GI tract allows more precise definition of drug release sites within the GI in order to assure more complete bioavailability and prediction of drug interactions.

75 FR 38422 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs

Science.gov (United States)

2010-07-02

... 2105-AD84 Procedures for Transportation Workplace Drug and Alcohol Testing Programs AGENCY: Office of..., 2011. DATES: This rule is effective July 2, 2010. FOR FURTHER INFORMATION CONTACT: For program issues... Federal Regulations, as follows: PART 40--PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING...

21 CFR 200.200 - Prescription drugs; reminder advertisements and reminder labeling to provide price information to...

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Prescription drugs; reminder advertisements and reminder labeling to provide price information to consumers. 200.200 Section 200.200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL GENERAL Prescription Drug Consumer Price Listing §...

Passive flow regulators for drug delivery and hydrocephalus treatment

Science.gov (United States)

Chappel, E.; Dumont-Fillon, D.; Mefti, S.

2014-03-01

Passive flow regulators are usually intended to deliver or drain a fluid at a constant rate independently from pressure variations. New designs of passive flow regulators made of a stack of a silicon membrane anodically bonded to a Pyrex substrate are proposed. A first design has been built for the derivation of cerebrospinal fluid (CSF) towards peritoneum for hydrocephalus treatment. The device allows draining CSF at the patient production rate independently from postural changes. The flow rate is regulated at 20 ml/h in the range 10 to 40 mbar. Specific features to adjust in vivo the nominal flow rate are shown. A second design including high pressure shut-off feature has been made. The intended use is drug delivery with pressurized reservoir of typically 100 to 300 mbar. In both cases, the membrane comprises several holes facing pillars in the Pyrex substrate. These pillars are machined in a cavity which ensures a gap between the membrane and the pillars at rest. The fluid in the pressurized reservoir is directly in contact with the top surface of the membrane, inducing its deflection towards Pyrex substrate and closing progressively the fluidic pathway through each hole of the membrane. Since the membrane deflection is highly non-linear, FEM simulations have been performed to determine both radial position and diameter of the membrane holes that ensure a constant flow rate for a given range of pressure.

A study on the relevance and influence of the existing regulation and risk informed/performance based regulation

Energy Technology Data Exchange (ETDEWEB)

Cheong, B. J.; Kang, J. M.; Kim, H. S.; Koh, S. H.; Kang, D. H.; Park, C. H. [Cheju Univ., Jeju (Korea, Republic of)

2003-02-15

The goal of this study is to estimate the relevance and Influence of the Existing Regulation and the RI-PBR to the institutionalization of the regulatory system. This study reviews the current regulatory system and the status of the RI-PBR implementation of the US NRC and Korea based upon SECY Papers, Risk Informed Regulation Implementation Plan (RIRIP) of the US NRC and other domestic studies. In order to investigate the perceptions, knowledge level, ground for the regulatory change, a survey was performed to Korean nuclear utilities, researchers and regulators on the perception on the RIR. The questionnaire was composed of 50 questions regarding personal details on work experience, level of education and specific field of work ; level of knowledge on the risk informed performance based regulation (RI-PBR); the perception of the current regulation, the effectiveness, level of procedure, flexibility, dependency on the regulator and personal view, and the perception of the RI-PBR such as flexibility of regulation, introduction time and the effect of RI-PBR, safety improvement, public perception, parts of the existing regulatory system that should be changed, etc. 515 answered from all sectors of the nuclear field; utilities, engineering companies, research institutes, and regulatory bodies.

Effectiveness of Gross Model-Based Emotion Regulation Strategies Training on Anger Reduction in Drug-Dependent Individuals and its Sustainability in Follow-up.

Science.gov (United States)

Massah, Omid; Sohrabi, Faramarz; A'azami, Yousef; Doostian, Younes; Farhoudian, Ali; Daneshmand, Reza

2016-03-01

Emotion plays an important role in adapting to life changes and stressful events. Difficulty regulating emotions is one of the problems drug abusers often face, and teaching these individuals to express and manage their emotions can be effective on improving their difficult circumstances. The present study aimed to determine the effectiveness of the Gross model-based emotion regulation strategies training on anger reduction in drug-dependent individuals. The present study had a quasi-experimental design wherein pretest-posttest evaluations were applied using a control group. The population under study included addicts attending Marivan's methadone maintenance therapy centers in 2012 - 2013. Convenience sampling was used to select 30 substance-dependent individuals undergoing maintenance treatment who were then randomly assigned to the experiment and control groups. The experiment group received its training in eight two-hour sessions. Data were analyzed using analysis of co-variance and paired t-test. There was significant reduction in anger symptoms of drug-dependent individuals after gross model based emotion regulation training (ERT) (P emotion regulation strategies training. Based on the results of this study, we may conclude that the gross model based emotion regulation strategies training can be applied alongside other therapies to treat drug abusers undergoing rehabilitation.

Associations of gender and age groups on the knowledge and use of drug information resources by American pharmacists.

Science.gov (United States)

Carvajal, Manuel J; Clauson, Kevin A; Gershman, Jennifer; Polen, Hyla H

2013-04-01

To explore knowledge and use of drug information resources by pharmacists and identify patterns influenced by gender and age-group classification. A survey questionnaire was mailed nationwide to 1,000 practitioners working in community (n = 500) and hospital (n = 500) settings who answer drug information questions as part of their expected job responsibilities. Responses pertaining to drug information resource use and knowledge of different types of drug-related queries, resource media preferences, and perceived adequacy of resources maintained in the pharmacy were analyzed by gender and age group. The t statistic was used to test for significant differences of means and percentages between genders and between age groups. Descriptive statistics were used to characterize other findings. Gender and age group classification influenced patterns of knowledge and use of drug information resources by pharmacists. They also affected pharmacists' perceptions of the most common types of questions prompting them to consult a drug information reference, as well as the resources consulted. Micromedex, exclusively available in electronic format, was the most commonly consulted resource overall by pharmacists. Lexi-Comp Online was the leading choice by women, preferred over Micromedex, but was not one of the top two resources selected by men. This study successfully identified the influence of gender and age-group classification in assessing drug information resource knowledge and use of general and specific types of drug-related queries.

Turkish Final Year Medical Students' Exposure to and Attitudes Concerning Drug Company Interactions: A Perspective from a Minimally Regulated Environment for Medical Students.

Science.gov (United States)

Beyhun, Nazim Ercument; Kolayli, Cevriye Ceyda; Can, Gamze; Topbas, Murat

2016-01-01

Interactions between drug companies and medical students may affect evidence-based medical practice and patient safety. The aim of this study was to assess drug company-medical student interactions in a medical faculty where limited specific national or institutional regulations apply between drug companies and medical students. The objectives of the study were to determine the exposure and attitudes of final year medical students in terms of drug company-medical student and physician interactions, to identify factors affecting those attitudes and to provide data for policymakers working on the regulation of interactions between drug companies and medical students. This anonymous questionnaire-based study of 154 medical final year medical students at the Karadeniz Technical University Medical Faculty, Trabzon, Turkey, in April and May 2015 attracted a response rate of 92.2% (n/N, 154/164). Exposure to interaction with a pharmaceutical representative was reported by 90.3% (139/154) of students, and 68.8% (106/154) reported experiencing such interaction alongside a resident. In addition, 83.7% (128/153) of students reported an interaction during internship. Furthermore, 69.9% (107/153) of students agreed that interactions influence physicians' prescription preferences, while 33.1% (51/154) thought that a medical student should never accept a gift from a drug company and 24.7% (38/154) agreed with the proposition that "drug companies should not hold activities in medical faculties". Students with rational prescription training expressed greater agreement with the statement "I am skeptical concerning the information provided by drug companies during interactions" than those who had not received such training, and this finding was supported by logistic regression [O.R.(C.I), p -3.7(1.2-11.5), p = 0.022]. Acceptance of advertisement brochures was found to significantly reduce the level of agreement with the proposition that "A physician should not accept any gift from a

Turkish Final Year Medical Students' Exposure to and Attitudes Concerning Drug Company Interactions: A Perspective from a Minimally Regulated Environment for Medical Students.

Directory of Open Access Journals (Sweden)

Nazim Ercument Beyhun

Full Text Available Interactions between drug companies and medical students may affect evidence-based medical practice and patient safety. The aim of this study was to assess drug company-medical student interactions in a medical faculty where limited specific national or institutional regulations apply between drug companies and medical students. The objectives of the study were to determine the exposure and attitudes of final year medical students in terms of drug company-medical student and physician interactions, to identify factors affecting those attitudes and to provide data for policymakers working on the regulation of interactions between drug companies and medical students. This anonymous questionnaire-based study of 154 medical final year medical students at the Karadeniz Technical University Medical Faculty, Trabzon, Turkey, in April and May 2015 attracted a response rate of 92.2% (n/N, 154/164. Exposure to interaction with a pharmaceutical representative was reported by 90.3% (139/154 of students, and 68.8% (106/154 reported experiencing such interaction alongside a resident. In addition, 83.7% (128/153 of students reported an interaction during internship. Furthermore, 69.9% (107/153 of students agreed that interactions influence physicians' prescription preferences, while 33.1% (51/154 thought that a medical student should never accept a gift from a drug company and 24.7% (38/154 agreed with the proposition that "drug companies should not hold activities in medical faculties". Students with rational prescription training expressed greater agreement with the statement "I am skeptical concerning the information provided by drug companies during interactions" than those who had not received such training, and this finding was supported by logistic regression [O.R.(C.I, p -3.7(1.2-11.5, p = 0.022]. Acceptance of advertisement brochures was found to significantly reduce the level of agreement with the proposition that "A physician should not accept any

Turkish Final Year Medical Students’ Exposure to and Attitudes Concerning Drug Company Interactions: A Perspective from a Minimally Regulated Environment for Medical Students

Science.gov (United States)

Beyhun, Nazim Ercument; Kolayli, Cevriye Ceyda; Can, Gamze; Topbas, Murat

2016-01-01

Interactions between drug companies and medical students may affect evidence-based medical practice and patient safety. The aim of this study was to assess drug company–medical student interactions in a medical faculty where limited specific national or institutional regulations apply between drug companies and medical students. The objectives of the study were to determine the exposure and attitudes of final year medical students in terms of drug company–medical student and physician interactions, to identify factors affecting those attitudes and to provide data for policymakers working on the regulation of interactions between drug companies and medical students. This anonymous questionnaire-based study of 154 medical final year medical students at the Karadeniz Technical University Medical Faculty, Trabzon, Turkey, in April and May 2015 attracted a response rate of 92.2% (n/N, 154/164). Exposure to interaction with a pharmaceutical representative was reported by 90.3% (139/154) of students, and 68.8% (106/154) reported experiencing such interaction alongside a resident. In addition, 83.7% (128/153) of students reported an interaction during internship. Furthermore, 69.9% (107/153) of students agreed that interactions influence physicians’ prescription preferences, while 33.1% (51/154) thought that a medical student should never accept a gift from a drug company and 24.7% (38/154) agreed with the proposition that “drug companies should not hold activities in medical faculties”. Students with rational prescription training expressed greater agreement with the statement “I am skeptical concerning the information provided by drug companies during interactions” than those who had not received such training, and this finding was supported by logistic regression [O.R.(C.I), p -3.7(1.2–11.5), p = 0.022]. Acceptance of advertisement brochures was found to significantly reduce the level of agreement with the proposition that “A physician should not

77 FR 63805 - Federal Acquisition Regulation; Information Collection; Service Contracting

Science.gov (United States)

2012-10-17

... use of appropriate technological collection techniques or other forms of information technology. DATES... all correspondence related to this collection. All comments received will be posted without change to http://www.regulations.gov , including any personal and/or business confidential information provided...

Testimonials and Informational Videos on Branded Prescription Drug Websites: Experimental Study to Assess Influence on Consumer Knowledge and Perceptions.

Science.gov (United States)

Sullivan, Helen W; O'Donoghue, Amie C; Gard Read, Jennifer; Amoozegar, Jacqueline B; Aikin, Kathryn J; Rupert, Douglas J

2018-01-23

Direct-to-consumer (DTC) promotion of prescription drugs can affect consumer behaviors and health outcomes, and Internet drug promotion is growing rapidly. Branded drug websites often capitalize on the multimedia capabilities of the Internet by using videos to emphasize drug benefits and characteristics. However, it is unknown how such videos affect consumer processing of drug information. This study aimed to examine how videos on prescription drug websites, and the inclusion of risk information in those videos, influence consumer knowledge and perceptions. We conducted an experimental study in which online panel participants with acid reflux (n=1070) or high blood pressure (n=1055) were randomly assigned to view 1 of the 10 fictitious prescription drug websites and complete a short questionnaire. On each website, we manipulated the type of video (patient testimonial, mechanism of action animation, or none) and whether the video mentioned drug risks. Participants who viewed any video were less likely to recognize drug risks presented only in the website text (P≤.01). Including risk information in videos increased participants' recognition of the risks presented in the videos (P≤.01). However, in some cases, including risk information in videos decreased participants' recognition of the risks not presented in the videos (ie, risks presented in text only; P≤.04). Participants who viewed a video without drug risk information thought that the website placed more emphasis on benefits, compared with participants who viewed the video with drug risk information (P≤.01). Compared with participants who viewed a video without drug risk information, participants who viewed a video with drug risk information thought that the drug was less effective in the high blood pressure sample (P=.03) and thought that risks were more serious in the acid reflux sample (P=.01). There were no significant differences between risk and nonrisk video conditions on other perception

A survey on the factors influencing the pattern of medicine's use: Concerns on irrational use of drugs.

Science.gov (United States)

Soleymani, Fatemeh; Ahmadizar, Fariba; Meysamie, Alipasha; Abdollahi, Mohammad

2013-04-01

Pharmacists have a remarkable role in rational use of drugs by dissemination of drug information to guide patients, physicians, and policy makers. The present study was undertaken to evaluate the pharmacists' view point about the main factors affecting current drug use pattern regarding rational drug use and the most effective strategies for improving and promoting rational drug use among pharmacists. In a cross-sectional survey, pre-designed questionnaires were filled in convenient sampling by pharmacists who had attended the congress of rational drug use in Tehran, Iran. A total of 144 pharmacists with the average age of 40.78 years old were enrolled to the study. Data indicated that the most priorities in irrational use of drugs from pharmacists' view point were lack of appropriate cooperation and communication between physicians and pharmacists (39%), pharmacists' low tariff and economic issues (34%), lack of public knowledge about drug usage (45%), and lack of supervisory regulations on pharmacy practice (15.8%). In this study, lack of public knowledge and awareness about appropriate use of medicines was the most important element from pharmacists' viewpoint in occurrence of irrational drug use. Dissemination of information and compiling of diverse strategies in education, management, regulation, and finance can be very efficient due to a strong relationship between drug policies and performance of regulations and supervisions as well as drug services.

Regulation and information in the US uranium industry

International Nuclear Information System (INIS)

Mason, C.F.

1983-01-01

This thesis investigates the government control of the uranium industry, to see if any social inefficiencies induced by socially suboptimal exploration levels were reduced. The investigation develops a model of firm behavior where exploration yields discoveries of ore, and also produces information that may be used to predict future successes. Based on this model, it is shown that socially inefficient levels of exploration may result. A method for controlling such an industry is suggested: regulating future prices. A natural characterization of successful regulation is provided, to allow the testing of the question posed above. A statistical learning model is developed to characterize the incorporation of new information in agents' formations of their beliefs. Exploration and production cost functions are estimated from available data: together the model of industry behavior, and the statistical learning model, these estimates allow the testing of the main question of the thesis. The results of the test suggest that the government's actions did not induce firms to choose socially optimal levels of exploration. Firms tended to explore more than society would have liked, suggesting that firms were attempting to use exploration information to speculate on future markets

Drug advertisements in two dermatology journals: a critical comparison of IJDVL and JAAD.

Science.gov (United States)

Gahalaut, Pratik; Chauhan, Sandhya; Mishra, Nitin; Rastogi, Madhurkant; Thakur, Richa

2014-01-01

Though drug promotion regulations exist worldwide, low quality of journal drug advertising is a global issue. Medical journals are regarded as a leading source of information for new drugs. They may also modulate prescribing behavior of physicians without their knowledge. A comparative analysis of advertisements from different countries may provide insights regarding strengths and weaknesses of different regulating systems. Prescription drug advertisements from the Indian Journal of Dermatology, Venereology, and Leprology (IJDVL) and Journal of American Academy of Dermatology (JAAD) were compared to check their compliance with criteria of World Health Organization (WHO) and International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). All the prescription drug advertisements of at least one page length appearing in all the issues of IJDVL and JAAD from January 2012 till December 2012 were included in this study. The contents of both advertisements were compared for compliance regarding different criteria of ethical codes for drug advertising of WHO and IFPMA. Statistical analysis was done using Fisher's exact test. Compared to IJDVL, more advertisements in JAAD complied with WHO and IFPMA codes. On the whole, advertisements in IJDVL had significantly less information regarding the approved usage, dosage, abbreviated prescribing information (API), summary of scientific information, safety information regarding the drug, and references to the scientific literature to support various claims. However, JAAD had more advertisements with multiple claims than IJDVL, and many advertisements interspersed between scientific articles while IJDVL had none. The complex issue of ethical drug advertising in dermatology journals requires constant review and discussion. Dermatologists should be cautious in assessing any advertisement or claim even if it seems evidence-based. The results from our study highlight the need for a global, proactive and effective

Drug advertisements in two dermatology journals: A critical comparison of IJDVL and JAAD

Directory of Open Access Journals (Sweden)

Pratik Gahalaut

2014-01-01

Full Text Available Background: Though drug promotion regulations exist worldwide, low quality of journal drug advertising is a global issue. Medical journals are regarded as a leading source of information for new drugs. They may also modulate prescribing behavior of physicians without their knowledge. A comparative analysis of advertisements from different countries may provide insights regarding strengths and weaknesses of different regulating systems. Aims: Prescription drug advertisements from the Indian Journal of Dermatology, Venereology, and Leprology (IJDVL and Journal of American Academy of Dermatology (JAAD were compared to check their compliance with criteria of World Health Organization (WHO and International Federation of Pharmaceutical Manufacturers and Associations (IFPMA. Methods: All the prescription drug advertisements of at least one page length appearing in all the issues of IJDVL and JAAD from January 2012 till December 2012 were included in this study. The contents of both advertisements were compared for compliance regarding different criteria of ethical codes for drug advertising of WHO and IFPMA. Statistical analysis was done using Fisher′s exact test. Results: Compared to IJDVL, more advertisements in JAAD complied with WHO and IFPMA codes. On the whole, advertisements in IJDVL had significantly less information regarding the approved usage, dosage, abbreviated prescribing information (API, summary of scientific information, safety information regarding the drug, and references to the scientific literature to support various claims. However, JAAD had more advertisements with multiple claims than IJDVL, and many advertisements interspersed between scientific articles while IJDVL had none. Conclusion: The complex issue of ethical drug advertising in dermatology journals requires constant review and discussion. Dermatologists should be cautious in assessing any advertisement or claim even if it seems evidence-based. The results from our

The Predictive Role of Difficulties in Emotion Regulation and Self-Control with Susceptibility to Addiction in Drug-Dependent Individuals

Directory of Open Access Journals (Sweden)

Mahmoud Shirazi

2015-06-01

Full Text Available Objective: The present study aimed to examine the predictive role of difficulties in emotion regulation and self-control in potential for addiction among drug-dependent individuals. Method: This was a correlational study which falls within the category of descriptive studies. The statistical population of the current study included all patients under treatment in outpatient health centers in Bam, among whom 315 individuals were selected through cluster sampling method as the participants of the study. Difficulties in Emotion Regulation Scale, Self-Control Scale, and Addiction Susceptibility Questionnaire were used for data collection purposes. Results: The results indicated that difficulties engaging in goal directed behavior, impulse control difficulties, lack of emotional awareness, and lack of emotional clarity (dimensions of difficulties in emotion regulation had a significant positive correlation with potential for addiction. In addition, there was a negative significant relationship between self-control and potential for addiction among drug-dependent individuals. Conclusion: In addition to common methods of abstinence from drug dependence, teaching self-control and emotional control techniques to addicted patients can help them reduce their dependence.

The Use of Economic Evidence to Inform Drug Pricing Decisions in Jordan.

Science.gov (United States)

Hammad, Eman A

2016-01-01

Drug pricing is an example of a priority setting in a developing country with official requirements for the use of cost-effectiveness (CE) evidence. To describe the role of economic evidence in drug pricing decisions in Jordan. A prospective review of all applications submitted between November 2013 and May 2015 to the Jordan Food and Drug Association's drug pricing committee was carried out. All applications that involved requests for CE evidence were reviewed. Details on the type of study, the extent, and whether the evidence submitted was part of the formal deliberations were extracted and summarized. The committee reviewed a total of 1608 drug pricing applications over the period of the study. CE evidence was requested in only 11 applications. The submitted evidence was of limited use to the committee due to concerns about quality, relevance of studies, and lack of pharmacoeconomic expertise. There were also no clear rules describing how CE would inform pricing decisions. Limited local data and health economic experience were the main barriers to the use of economic evidence in drug pricing decisions in Jordan. In addition, there are no official rules describing the elements and process by which the CE evidence would inform drug pricing decisions. This study summarized accumulated observations for the current use of economic evaluations and evidence-based decision making in Jordan. Recommendations have been proposed to applicants and key decision makers to enhance the role of economic evidence in influencing health policies and evidence-based decision making across priority settings. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Associations of gender and age groups on the knowledge and use of drug information resources by American pharmacists

Directory of Open Access Journals (Sweden)

Carvajal MJ

2013-06-01

Full Text Available Objectives: To explore knowledge and use of drug information resources by pharmacists and identify patterns influenced by gender and age-group classification. Methods: A survey questionnaire was mailed nationwide to 1,000 practitioners working in community (n = 500 and hospital (n = 500 settings who answer drug information questions as part of their expected job responsibilities. Responses pertaining to drug information resource use and knowledge of different types of drug-related queries, resource media preferences, and perceived adequacy of resources maintained in the pharmacy were analyzed by gender and age group. The t statistic was used to test for significant differences of means and percentages between genders and between age groups. Descriptive statistics were used to characterize other findings.Results: Gender and age group classification influenced patterns of knowledge and use of drug information resources by pharmacists. They also affected pharmacists’ perceptions of the most common types of questions prompting them to consult a drug information reference, as well as the resources consulted. Micromedex, exclusively available in electronic format, was the most commonly consulted resource overall by pharmacists. Lexi-Comp Online was the leading choice by women, preferred over Micromedex, but was not one of the top two resources selected by men. Conclusion: This study successfully identified the influence of gender and age-group classification in assessing drug information resource knowledge and use of general and specific types of drug-related queries.

78 FR 5873 - Regulations Relating to Information Reporting by Foreign Financial Institutions and Withholding...

Science.gov (United States)

2013-01-28

... Service 26 CFR Parts 1 and 301 Regulations Relating to Information Reporting by Foreign Financial... 9610] RIN 1545-BK68 Regulations Relating to Information Reporting by Foreign Financial Institutions and... (Code) regarding information reporting by foreign financial institutions (FFIs) with respect to U.S...

77 FR 69626 - Federal Acquisition Regulation; Information Collection; Subcontracting Plans/Individual...

Science.gov (United States)

2012-11-20

... collection of information on those who are to respond, through the use of appropriate technological... this collection. All comments received will be posted without change to http://www.regulations.gov , including any personal and/or business confidential information provided. FOR FURTHER INFORMATION CONTACT...

Assessment of prescribing information for generic drugs manufactured in the Middle East and marketed in Saudi Arabia

International Nuclear Information System (INIS)

Gebran, N.; Al-Haldari, K.

2006-01-01

Little research has assessed the quality of manufacturer provided prescribing information or documented difference in key aspects of drug information among different marketed generic products of the same drug particularly in Middle East and Arabian Gulf. We assessed the quality of written prescribing information for selected generic drugs marketed in Saudi Arabia and manufactured in various countries of Middle East. We assessed the correctness and completeness of information pertaining to indications, dosage cautions/contraindications, side effects and drug interactions in 37 packages inserts for generic products registered in Saudi Arabia and manufactured in the Middle East, including atenolol (6 inserts), fluoxetine (4 inserts), ciprofloxacin (11 inserts), melformin (7 inserts) and omeprazole (9 inserts). We also described deficiencies in quality and quantity of manufacturers provided information that could be misleading to patients and prescribes. We found substantial disagreement in information between generic packages inserts versus the British National Formulary and the package insert of the brand product marketed in Saudi Arabia. A cumulative average of 63.16% of drug information indicators were in agreement with these standard references. Section headings with the least conformity with study references were those related to dosage (57, 28%) and side effects (54+-30%). Our results indicate that national authorities should implement appropriate measures aimed at removing misleading and incorrect information in generic package inserts and incorporating crucial prescribing information that is missing. National authorities in the Middle East and Arabian Gulf should strengthen collaboration and information interchange among each other and with international agencies to maintain common quality standards for delivering information through package inserts. (author)

Drug information, misinformation, and disinformation on social media: a content analysis study.

Science.gov (United States)

Al Khaja, Khalid A J; AlKhaja, Alwaleed K; Sequeira, Reginald P

2018-05-24

Dissemination of misleading drug information through social media can be detrimental to the health of the public. This study, carried out in Bahrain, evaluated the truthfulness of 22 social media claims about drugs (72.7%), dietary supplements (22.7%), and toxic bisphenol-A (4.5%). They circulated on WhatsApp platform, as case studies. We categorized claims as objectively true, false, or potentially misleading. The content analysis revealed that "potentially misleading" claims were the most frequent messages (59.1%). They tend to exaggerate the efficacy or safety without sufficient evidence to substantiate claims. False claims (27.3%) were likely due to unfair competition or deception. Overall, 13.6% of the messages were objectively true claims that could withstand regulatory scrutiny. Majority of the drug-related messages on social media were potentially misleading or false claims that lacked credible evidence to support them. In the public interest, regulatory authorities should monitor such information disseminated via social media platforms.

Service quality and asymmetric information in the regulation of monopolies: The Chilean electricity distribution industry

Science.gov (United States)

Melo, Oscar Alfredo

This study is an enquiry about the role that service quality, asymmetric information, scope of regulation and regulator's preferences play in the regulation of monopolies, with an application to the case of the Chilean electricity distribution industry. In Chapter 1, I present the problem of regulating a monopolist and introduce the special conditions that the electricity sector has. Later I discuss the main characteristics of the electricity system that operates in Chile. The literature on regulation is reviewed in Chapter 2. A special emphasis is given to the problems of quality and information, and the lack of its proper joint treatment. In Chapter 3, I develop four theoretical models of regulation that explicitly consider the regulation of price and quality versus price-only regulation, and a symmetric versus asymmetric information structure where only the regulator knows its true costs. In these models, I also consider the effect of a regulator that may have a preference between consumers and the regulated monopolistic firms. I conclude that with symmetric information and independent of the scope of regulation, having a regulator that prefers consumers or producers does not affect the efficiency of the outcome. I also show that the regulator's inability to set quality, thus regulating only price, leads to an inefficient outcome, away from the first best solution that can be achieved by regulating both price and quality, even with asymmetric information, as long as the regulator does not have a "biased" preference for consumers or the monopolistic producers. If the regulator has a "bias," then the equilibrium will be inefficient with asymmetric information. But the effect on equilibrium price and quality depends on the direction of the effect of quality on the marginal effect of price in demand. More importantly, no closed-form solution can be derived unless drastic simplifications are made. To further investigate the outcome of the models, I use numerical

77 FR 69442 - Federal Acquisition Regulation; Information Collection; Economic Price Adjustment

Science.gov (United States)

2012-11-19

...; Information Collection; Economic Price Adjustment AGENCIES: Department of Defense (DOD), General Services... economic price adjustment. Public comments are particularly invited on: Whether this collection of..., Economic Price Adjustment by any of the following methods: Regulations.gov : http://www.regulations.gov...

76 FR 35218 - Federal Acquisition Regulation; Information Collection; Cost or Pricing Data Requirements and...

Science.gov (United States)

2011-06-16

... Pricing Data, by any of the following methods: Regulations.gov : http://www.regulations.gov . Submit...; Information Collection; Cost or Pricing Data Requirements and Information Other Than Cost or Pricing Data... concerning cost or pricing data requirements and information other than cost or pricing data. Public comments...

77 FR 43076 - Federal Acquisition Regulation; Information Collection; Value Engineering Requirements

Science.gov (United States)

2012-07-23

... respond, through the use of appropriate technological collection techniques or other forms of information... collection. All comments received will be posted without change to http://www.regulations.gov , including any personal and/or business confidential information provided. FOR FURTHER INFORMATION CONTACT: Mr. Curtis E...

Accuracy of manual entry of drug administration data into an anesthesia information management system.

Science.gov (United States)

Avidan, Alexander; Dotan, Koren; Weissman, Charles; Cohen, Matan J; Levin, Phillip D

2014-11-01

Data on drug administration are entered manually into anesthesia information management systems (AIMS). This study examined whether these data are accurate regarding drug name, dose administered, and time of administration, and whether the stage of anesthesia influences data accuracy. Real-time observational data on drug administration during elective operations were compared with computerized information on drug administration entered by anesthesiologists. A trained observer (K.D.) performed the observations. Data were collected during 57 operations which included 596 separate occasions of drug administration by 22 anesthesiologists. No AIMS records were found for 90 (15.1%) occasions of drug administration (omissions), while there were 11 (1.8%) AIMS records where drug administration was not observed. The AIMS and observer data matched for drug name on 495 of 596 (83.1%) occasions, for dose on 439 of 495 (92.5%) occasions, and for time on 476 of 495 (96.2%) occasions. Amongst the 90 omitted records, 34 (37.8%) were for vasoactive drugs with 24 (27.7%) for small doses of hypnotics. Omissions occurred mostly during maintenance: 50 of 153 (24.6%), followed by induction: 30 of 325 (9.2%) and emergence: 10 of 57 (17.5%) (P < 0.001). Time and dose inaccuracies occurred mainly during induction, followed by maintenance and emergence; time inaccuracies were 7/325 (8.3%), 10/203 (4.9%), and 0/57 (0%), respectively (P = 0.07), and dose inaccuracies were 15/325 (4.6%), 3/203 (1.5%), and 1/57 (1.7%), respectively (P = 0.11). The range of accuracy varies when anesthesiologists manually enter drug administration data into an AIMS. Charting omissions represent the largest cause of inaccuracy, principally by omissions of records for vasopressors and small doses of hypnotic drugs. Manually entered drug administration data are not without errors. Accuracy of entering drug administration data remains the responsibility of the anesthesiologist.

Analysis of the data on pregnancy and lactation provided by patient information leaflets of anti-rheumatic drugs in Argentina.

Science.gov (United States)

Sabando, Miguel Ormaza; Saavedra, Maira Arias; Sequeira, Gabriel; Kerzberg, Eduardo

2018-04-01

To analyse the level of consistency and updating of the information on pregnancy and lactation provided by patient information leaflets (PILs) of the antirheumatic drugs approved in Argentina. Inconsistencies between the 2016 EULAR Task Force recommendations on the use of anti-rheumatic drugs during pregnancy and lactation and the information provided by PILs of the same drugs approved in Argentina were analysed along with inconsistencies within the PILs of different registered trademarks of these drugs. Eighty-eight PILs of 32 drugs were analysed. Out of the 88 PILs, 50% presented information inconsistencies as to pregnancy. Medications comprised in this group were: hydroxychloroquine, sulfasalazine, azathioprine, tacrolimus, cyclosporine, NSAIDs (during the first two trimesters), celecoxib, some glucocorticoids, colchicine, and some anti-TNF drugs (etanercept, adalimumab and infliximab) during part of the pregnancy. As for lactation, 56% had information inconsistencies. Medications encompassed in this group were: hydroxychloroquine, chloroquine, sulfasalazine, azathioprine, tacrolimus, cyclosporine, NSAIDs, celecoxib, meprednisone, prednisone, colchicine, and anti-TNF drugs. Out of 17 drugs that had more than one registered trademark, information inconsistencies on pregnancy were found in the PILs of sulfasalazine, diclofenac, ibuprofen and methylprednisolone. Concerning lactation, inconsistencies were present in the PILs of hydroxychloroquine, sulfasalazine, diclofenac, ibuprofen, meprednisone, and colchicine. At least half of the PILs of anti-rheumatic drugs analysed in this study had information inconsistencies on pregnancy and lactation. This is a serious state of affairs because the consensual decision-making process between patient and professional may be compromised, which, in turn, may give rise to medical-legal issues.

21 CFR 1.403 - What requirements apply to an informal hearing?

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false What requirements apply to an informal hearing? 1.403 Section 1.403 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Administrative Detention of Food for Human or Animal Consumption...

The nuclear industry's transition to risk-informed regulation and operation in the United States

International Nuclear Information System (INIS)

Kadak, Andrew C.; Matsuo, Toshihiro

2007-01-01

This paper summarizes a study of the transition of the United States nuclear industry from a prescriptive regulatory structure to a more risk informed approach to operations and regulations. The transition occurred over a 20 yr period in which gradual changes were made in the fundamental regulations and to the approach to nuclear safety and operations. While the number of actual regulatory changes were few, they are continuing. The utilities that embraced risk informed operations made dramatic changes in the way they approached operations and outage management. Those utilities that used risk in operations showed dramatic improvement in safety based on Institute of Nuclear Power Operations (INPO) performance indicators. It was also shown that the use of risk did not negatively affect safety performance of the plants compared to standard prescriptive approaches. This was despite having greater flexibility in compliance to regulatory standards and the use of the newly instituted risk-informed reactor oversight process. Key factors affecting the successful transition to a more risk-informed approach to regulations and operations are: strong top management support and leadership both at the regulator and the utility; education and training in risk principles and probabilistic risk Assessment tools for engineers, operators and maintenance staff; a slow and steady introduction of risk initiatives in areas that can show value to both the regulator and the industry; a transparent regulatory foundation built around a safety goal policy and the development of a strong safety culture at the utility to allow for more independence in safety compliance and risk management. The experience of the United States shows positive results in both safety and economics. The INPO and NRC metrics presented show that the use of risk information in operations and regulation is marginally better with no degradation in safety when plants that have embraced risk-informed approaches are compared

Prescription drug brand Web sites: Guidance where none exists

Directory of Open Access Journals (Sweden)

Lewis Glinert, Ph.D

2010-01-01

Full Text Available This paper applies insights from linguistics and discourse analysis to prescription drug brand Web sites, with special reference to the 100 top-selling drugs. Such sites give the outward appearance of being a place to go for straightforward information about a specific brand. In reality, they present a confused mix of brand information, health information and hype, muddled organization, and poor indication of authority, creating an imbalance between benefit and risk content. In so doing, they breach the letter and spirit of the regulations governing direct-to-consumer advertising, which the FDA has by default applied to such Web sites but which were not designed for this special type of discourse. The many communicative difficulties proven to be caused by Web sites in general, in particular for the elderly and less literate, also pose ethical problems. A rethinking of the verbal and visual design of these drug sites is needed -- and new regulatory guidance, for which this paper offers recommendations. At stake is not just the quality of health information at brand drug sites but also their credibility.

National Clearinghouse for Drug Abuse Information Selected Reference Series, Series 4, No. 1.

Science.gov (United States)

National Inst. on Drug Abuse (DHEW/PHS), Rockville, MD. National Clearinghouse for Drug Abuse Information.

This bibliography, which attempts to gather the significant research on the reproductive effects of the drugs of abuse, is one in a series prepared by the National Clearinghouse for Drug Abuse Information on subjects of topical interest. Selection of literature is based on its currency, its significance in the field, and its availability in local…

A workshop series using peer-grading to build drug information, writing, critical-thinking, and constructive feedback skills.

Science.gov (United States)

Davis, Lindsay E

2014-12-15

To utilize a skills-based workshop series to develop pharmacy students' drug information, writing, critical-thinking, and evaluation skills during the final didactic year of training. A workshop series was implemented to focus on written (researched) responses to drug information questions. These workshops used blinded peer-grading to facilitate timely feedback and strengthen assessment skills. Each workshop was aligned to the didactic coursework content to complement and extend learning, while bridging and advancing research, writing, and critical thinking skills. Attainment of knowledge and skills was assessed by rubric-facilitated peer grades, faculty member grading, peer critique, and faculty member-guided discussion of drug information responses. Annual instructor and course evaluations consistently revealed favorable student feedback regarding workshop value. A drug information workshop series using peer-grading as the primary assessment tool was successfully implemented and was well received by pharmacy students.

Characterization of Complementary and Alternative Medicine-Related Consultations in an Academic Drug Information Service.

Science.gov (United States)

Gregory, Philip J; Jalloh, Mohamed A; Abe, Andrew M; Hu, James; Hein, Darren J

2016-12-01

To characterize requests received through an academic drug information consultation service related to complementary and alternative medicines. A retrospective review and descriptive analysis of drug information consultations was conducted. A total of 195 consultations related to complementary and alternative medicine were evaluated. All consultation requests involved questions about dietary supplements. The most common request types were related to safety and tolerability (39%), effectiveness (38%), and therapeutic use (34%). Sixty-eight percent of the requests were from pharmacists. The most frequent consultation requests from pharmacists were questions related to drug interactions (37%), therapeutic use (37%), or stability/compatibility/storage (34%). Nearly 60% of complementary and alternative medicine-related consultation requests were able to be completely addressed using available resources. Among review sources, Natural Medicines Comprehensive Database, Clinical Pharmacology, Micromedex, and Pharmacist's Letter were the most common resources used to address consultations. Utilization of a drug information service may be a viable option for health care professionals to help answer a complementary and alternative medicine-related question. Additionally, pharmacists and other health care professionals may consider acquiring resources identified to consistently answering these questions. © The Author(s) 2015.

EU Criminal Law and the Regulation of Information and Communication Technology

Directory of Open Access Journals (Sweden)

Sarah Summers

2015-07-01

Full Text Available The opportunities afforded by the global information space give rise to the potential for the commission of new crimes –crimes such as hacking or denial of service attacks– and for existing crimes, such as speech offences or fraud, to be committed in new ways and with potentially larger consequences. One of the biggest challenges for the regulation of information and communications technology is that the global information space does not respect national boundaries. In order to be successful, any regulatory approach will call for some degree of cooperation between countries. This poses an obvious problem for those seeking to develop a regulatory structure. This challenge is particularly relevant in the criminal law context, as the criminal law has traditionally been considered to be the product and responsibility of national law. This article considers the EU’s regulatory approach in this area. The aim here is not to offer a critique of the EU’s regulatory structure in the context of cybercrime, but rather to use the situation in the EU to illustrate various issues arising in the context of the criminal law regulation of information and communications technology. This article examines some of the issues which have arisen in the context of the regulation of cyber activity at the EU level as a result of this tension between national sovereignty and broader overarching EU regulation and assesses the relevance of these issues in the context of criminal law regulation more broadly. Consideration of the processes of criminalisation and harmonisation provides the basis for an analysis of the manner in which the EU seeks to justify its involvement in criminal law in this field.

Information Processing in Auto-regulated Systems

Directory of Open Access Journals (Sweden)

Karl Javorszky

2003-06-01

Full Text Available Abstract: We present a model of information processing which is based on two concurrent ways of describing the world, where a description in one of the languages limits the possibilities for realisations in the other language. The two describing dimensions appear in our common sense as dichotomies of perspectives: subjective - objective; diversity - similarity; individual - collective. We abstract from the subjective connotations and treat the test theoretical case of an interval on which several concurrent categories can be introduced. We investigate multidimensional partitions as potential carriers of information and compare their efficiency to that of sequenced carriers. We regard the same assembly once as a contemporary collection, once as a longitudinal sequence and find promising inroads towards understanding information processing by auto-regulated systems. Information is understood to point out that what is the case from among alternatives, which could be the case. We have translated these ideas into logical operations on the set of natural numbers and have found two equivalence points on N where matches between sequential and commutative ways of presenting a state of the world can agree in a stable fashion: a flip-flop mechanism is envisioned. By following this new approach, a mathematical treatment of some poignant biomathematical problems is allowed. Also, the concepts presented in this treatise may well have relevance and applications within the information processing and the theory of language fields.

Guidelines to PET measurements of the target occupancy in the brain for drug development

Energy Technology Data Exchange (ETDEWEB)

Takano, Akihiro; Varrone, Andrea; Gulyas, Balazs; Halldin, Christer [Karolinska Institutet, Department of Clinical Neuroscience, Centre for Psychiatric Research, Stockholm (Sweden); Salvadori, Piero [CNR Istituto di Fisiologia Clinica, Pisa (Italy); Gee, Antony [Kings College London, Department of Chemistry and Biology, Division of Imaging Sciences and Biomedical Engineering, London (United Kingdom); Windhorst, Albert; Lammertsma, Adriaan A. [VU University Medical Center, Department of Radiology and Nuclear Medicine, Amsterdam (Netherlands); Vercouillie, Johnny [Universite Francois Rabelais de Tours, UMR Inserm U930, Tours (France); Bormans, Guy [KU Leuven, Nuclear Medicine and Molecular Imaging, Department of Imaging and Pathology, Leuven (Belgium)

2016-11-15

This guideline summarizes the current view of the European Association of Nuclear Medicine Drug Development Committee. The purpose of this guideline is to guarantee a high standard of PET studies that are aimed at measuring target occupancy in the brain within the framework of development programs of drugs that act within the central nervous system (CNS drugs). This guideline is intended to present information specifically adapted to European practice. The information provided should be applied within the context of local conditions and regulations. (orig.)

Czech Teratology Information Service: comparison of treatments by psychotropic and antiepileptic drugs.

Science.gov (United States)

Manáková, Eva; Hubicková-Heringová, Lucie; Jelínek, Richard

2006-12-01

Care, treatment and follow-up in psychiatric and epileptic pregnant women were compared with women inquiring Czech Teratology Information Service (CZTIS) due to other exposure to drugs during pregnancy. Data were collected by CZTIS, member of European Network of Teratology Information Services from 1996. Exposed groups were compared with pregnant women exposed to drugs which were not classified as major teratogens or hyperthermia. Groups do not vary in age, reproductive history and other parameters. We observed higher frequency of miscarriage and voluntary termination of pregnancy in the group of psychiatric patients. The number of malformation in prospective follow-up cases was lower than in control group. Chronic diseases as epilepsy or psychiatric disorders have to be treated during pregnancy. Women should obtain accurate information about possible risk before pregnancy. Co-operation is needed in these cases. Physicians should keep in mind that appropriate information is to be given to the patient according to her disease, education and comprehension of the problem. If there is any doubt they should organize help for their patients.

Regulatory environment of transitioning to risk-informed regulations in U.S.A

International Nuclear Information System (INIS)

Choi, C. H.; Kim, C. H.

1999-01-01

With the publication of the PRA Policy Statement and recent regulatory guides, the U.S.NRC makes a continuous approach towards risk-informed regulations with the goal of establishing an overall framework for risk-informed decisions in all regulatory activities as well as plant specific licensing issues. Faced with the changing environment of deregulation of the electricity generation market, the licensee's effort to reduce design margins to enhance flexibility and to relieve unnecessary regulatory burdens have been focused on the control and reduction of plant operating costs. The risk-informed approach provides a structured, systematic, and defensible method that can be applied not only to rulemaking, but also to licensing, inspection, enforcement, and performance assessment, as well as provides basis for prioritization in the establishment of programs and the allocation of resources. This report describes the current regulatory environment of transitioning to risk-informed regulations with an emphasis on its background, concepts, regulatory guides, proposed options for modifying the 10CFR50, and risk-informed applications in U.S.A. Review of the risk informed applications utilizing the information provided by the PRAs and their insights in the U.S.NRC and nuclear industry will provide the insights of predicting the expected regulation changes in Korea. Also it could provide the applicable methods or guides for the implementation of the risk-informed applications in plant design and operations. (author)

Improvement of infrastructure for risk-informed regulation

International Nuclear Information System (INIS)

Muta, Hitoshi; Tanji, Junichi; Kondo, Keisuke; Uchida, Tsuyoshi; Ito, Tomomichi

2011-01-01

Improvement of the infrastructure of probabilistic safety assessment (PSA) is essential to the risk-informed regulation for nuclear power plants. JNES conducted update of initiating event frequency and improvement of method for uncertainty analysis to enhance the technology bases of PSA in 2010. Furthermore, JNES improved human reliability assessment method and reliability assessment method for digital reactor protection systems. JNES estimated initiating event frequencies both for power and shutdown operation based on the recent operating experiences in NPPs of Japan using hierarchical Bayesian method. As for improvement of uncertainty analysis method, JNES conducted trial analysis using SOKC (State-Of-Knowledge Correlation) for representative PWR and BWR of Japan. The study on the advanced HRA method with operator cognitive action model was conducted. The study on reliability analysis method for digital reactor protection systems using Bayesian Network Method was conducted. In order to ensure the quality of PSA, JNES studied requirements and methods for PSA peer review via the preparation of peer review for PSA of a representative Japanese BWR plant conducted by JNES. As an effort to develop the procedures of internal fire PSA and internal flooding PSA, trial analyses were conducted to grasp the risk level cause by fire and flooding in nuclear power plants. JNES participated in OECD/NEA PRISME and FIRE project to obtain the latest information and data to validate and improve the fire propagation analysis codes and the parameters for fire PSA. Furthermore, JNES studies schemes for endorsement and application in risk-informed regulation of PSA standards established by Atomic Energy Society of Japan. (author)

76 FR 34886 - General Services Administration Acquisition Regulation; Implementation of Information Technology...

Science.gov (United States)

2011-06-15

... Acquisition Regulation; Implementation of Information Technology Security Provision AGENCY: Office of... information technology (IT) supplies, services and systems with security requirements. DATES: Effective Date... effective date that include information technology (IT) supplies, services and systems with security...

77 FR 749 - General Services Administration Acquisition Regulation; Implementation of Information Technology...

Science.gov (United States)

2012-01-06

... Acquisition Regulation; Implementation of Information Technology Security Provision AGENCY: Office of... orders that include information technology (IT) supplies, services and systems. DATES: Effective Date... 6, 2012 that include information technology (IT) supplies, services and systems with security...

49 CFR 40.321 - What is the general confidentiality rule for drug and alcohol test information?

Science.gov (United States)

2010-10-01

... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Confidentiality and Release of Information § 40.321 What is the general confidentiality rule for drug and alcohol test... DOT drug or alcohol testing process, you are prohibited from releasing individual test results or...

Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.

Science.gov (United States)

2010-09-29

The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health.

Multifaceted determinants of online non-prescription drug information seeking and the impact on consumers' use of purchase channels.

Science.gov (United States)

Holtgräfe, Catherine; Zentes, Joachim

2012-06-01

The growing importance of the Internet as an information and purchasing channel is drawing widespread attention from marketing decision makers. Nevertheless, the relevance of the Internet to the so-called self-medication market in Germany has been paid barely enough attention. Our study aims to contribute insights concerning the penetration of the Internet in this market, as well as to give an overview of the critical determinants of Internet use for non-prescription drug information seeking, such as the accessibility of professional information, trust in health professionals' opinion and the ability to search online, as well as the perceived usefulness and credibility of online non-prescription drug information. Furthermore, we demonstrate that the preferred use of the Internet as a non-prescription drug information source positively influences the choice of unconventional purchase channels for non-prescription drugs and negatively affects the use of stationary pharmacies.

Direct-to-consumer advertising (DTCA) for prescription drugs: consumers' attitudes and preferences concerning its regulation in South Korea.

Science.gov (United States)

Suh, Hae Sun; Lee, Donghyun; Kim, Sang Yong; Chee, Dong Hyun; Kang, Hye-Young

2011-08-01

To examine consumers' attitudes toward direct-to-consumer advertising (DTCA) for prescription drugs in Korea. We conducted a survey of 350 patients visiting community pharmacies to fill their prescriptions. Consumers' attitudes toward DTCA were assessed in terms of whether they felt DTCA was necessary, their trust in the information provided by DTCA, and their intention to use the information provided by DTCA. We examined consumers' preferences regarding the regulation of DTCA and their expectations of the effects of DTCA. About 60% of the respondents responded that DTCA is necessary and that they intended to use the information from DTCA. Less than half of the respondents reported that they would trust DTCA information. About 70% of the participants expressed the need for prior vetting of the DTCA content. Respondents had the highest expectation on the effect of DTCA as an information source for patients. Positive consumer expectations regarding the effects of DTCA were significantly associated with positive consumer attitudes toward DTCA (odds ratio=4.70, 95% confidence interval: 2.25-9.82). This study provides evidence that consumers in South Korea generally have positive attitudes toward DTCA. However, most of the respondents wanted a prior examination system of DTCA content to ensure that the information conveyed to them via DTCA was trustworthy. Policy-makers should be cautious and well-prepared if they decide to introduce DTCA in Korea. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Prescription painkillers and controlled substances: an appraisal of drug information provided by six US pharmacies

Directory of Open Access Journals (Sweden)

Gill PS

2013-02-01

Full Text Available Preetinder S GillCollege of Technology, Eastern Michigan University, Ypsilanti, MI, USABackground: Health literacy impacts health outcomes. Health literacy is a measure of a person's competence to find, access, contextualize, and understand the information needed to make health decisions. Low levels of health literacy have been associated with poor health status. Health literacy can be enhanced by improving the readability of health literature. Misuse and abuse of prescription medicines and controlled substances is rising. It could be argued that improving the readability of the drug-information documents associated with these medicines could serve to alleviate this situation in a small, albeit incremental, manner. This paper provides a readability assessment of 71 such documents.Methods: The readability of drug-information documents associated with 12 commonly misused and abused painkiller medicines and controlled substances published by the top six US pharmacies was assessed. The Flesch-Kincaid Grade Level, Flesch Reading Ease, and Simple Measure of Gobbledygook (SMOG indices were used to assess the readability of these drug-information documents. One-way analysis of variance (ANOVA was used to compare the readability of the documents.Results: The average Flesch-Kincaid Grade Level index score was found to be 11.16. The average Flesch Reading Ease index score was found to be 45.94. The average SMOG index score was found to be 13.60. Pharmacies C and E had the best average readability scores, whereas pharmacies A and B had the worst average readability scores.Conclusion: Access, contents, and formatting of the documents were qualitatively analyzed to make recommendations to improve readability. Pharmacies C and E were used as benchmarks to identify the seven best practices. Good drug-information documents should have: (1 clear purpose, (2 limited scope, (3 summary/brief review, (4 well-placed graphics, (5 informative illustrations, (6 clean

Association of Risk Perception and Information Provided on the Labels of Over-the-Counter Drugs: Role of Race, Education, Age and Income

Directory of Open Access Journals (Sweden)

Sunil Mathur

2014-01-01

Full Text Available Background: The use of over-the-counter (OTC drugs has increased tremendously, however, information on risk perception regarding the use of OTC drugs and their potential toxicity is scarce. Hence, the purpose of this study was to investigate the perception of OTC drug safety and efficacy based on reading product packaging and the effect of race, education, age and income. Methods: We used the HINTS 2012 data set with total sample size of 2,554. Results: OTC drug users having some high school education had a lower chance of frequently reading information included in the product labeling with the OTC medication. OTC drug users less than 50 years of age were always likely to read drug information on the OTC drug labeling. Also, Non-Hispanic blacks were more likely to read OTC drug labeling than Non-Hispanic whites.  OTC drug users less than 50 years of age consider OTC drugs safer than prescription drugs.  Conversely, OTC drug users with a high school, some college or bachelor’s degree consider OTC drugs less safe than prescription drugs.  Non-Hispanic blacks, non-Hispanic whites, and subjects of lower income were less likely to consider OTC drugs safer than prescription drugs.  OTC drug users with a high school education and some college perceive OTC drugs to be less effective than prescription drugs.Conclusion: To conclude, age, education, race, and income affect risk perception on OTC drugs.  Consumer information programs need to be designed so that meaningful results can be incorporated into public policy. Providing information on the labeling of OTC drugs and likelihood of patients reading this information require further study.

Information Sources on U. S. Radio Regulations in the Law Library.

Science.gov (United States)

Lockwood, James D.

An annotated bibliography gives the radio regulations in the U.S., using sources available in the University of Michigan Law Library as well as the University of Michigan Libraries. Information is applicable to other law, university and public libraries. Relevant material on television regulations is included. Listings cover federal agencies, card…

Developing the support business-processes information system for self-regulation institute

Directory of Open Access Journals (Sweden)

Kravchenko Anatoly Vasilevich

2011-11-01

Full Text Available Studying the methods of sructurization, optimization and the automation for modern self-regulation institute business-processes are considered in the article. The aim of the text is to show the strategy of modeling self-regulation information system and the strategy of the membership dues accounting and agency compensation.

Implications of the Food, Drug, and Cosmetic Act on the quality assurance of radiopharmaceuticals used in the United States

International Nuclear Information System (INIS)

Kishore, R.; Sheinin, E.B.

1990-01-01

The drug sections of the Federal Food, Drug, and Cosmetic Act (Title 21 U.S.C.) are intended to assure the consumer that drugs are safe and effective for their intended use. The Act requires that new drugs be approved by the FDA before they go on the market. The regulations for the new drug review process, are contained in the Code of Federal Regulations (CFR) Title 21, sections 312 for Investigational New Drugs (INDs), 314 for New Drug Applications (NDAs). Section 361 deals with radioactive drugs for certain research (RDR) uses. The regulations require that sufficient information be provided on the acceptable limits and the analytical methods used for the assurance of the identity, strength, quality, purity and the stability of the new drug as well as the raw materials used in the preparation of the new drug. The impact of the Act on the control of radiopharmaceutical products will be discussed

Under the Influence: The Interplay among Industry, Publishing, and Drug Regulation.

Science.gov (United States)

Cosgrove, Lisa; Vannoy, Steven; Mintzes, Barbara; Shaughnessy, Allen F

2016-01-01

The relationships among academe, publishing, and industry can facilitate commercial bias in how drug efficacy and safety data are obtained, interpreted, and presented to regulatory bodies and prescribers. Through a critique of published and unpublished trials submitted to the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for approval of a new antidepressant, vortioxetine, we present a case study of the "ghost management" of the information delivery process. We argue that currently accepted practices undermine regulatory safeguards aimed at protecting the public from unsafe or ineffective medicines. The economies of influence that may intentionally and unintentionally produce evidence-biased-rather than evidence-based-medicine are identified. This is not a simple story of author financial conflicts of interest, but rather a complex tale of ghost management of the entire process of bringing a drug to market. This case study shows how weak regulatory policies allow for design choices and reporting strategies that can make marginal products look novel, more effective, and safer than they are, and how the selective and imbalanced reporting of clinical trial data in medical journals results in the marketing of expensive "me-too" drugs with questionable risk/benefit profiles. We offer solutions for neutralizing these economies of influence.

Risk informed regulation of nuclear facilities: Overview of the current status

International Nuclear Information System (INIS)

2005-02-01

This report provides guidance on the use of risk information by regulatory bodies as part of an integrated decision making process. This addresses the way in which risk information is being used in decisions about safety issues at nuclear plants, sometimes referred to as risk informed decision making, and how risk information is being used by regulatory bodies as an input into the activities that they carry out, sometimes referred to as risk informed regulation

IMPROVING ACCESS TO DRUGS

Directory of Open Access Journals (Sweden)

Max Joseph Herman

2012-11-01

Full Text Available Although essentially not all therapies need drug intervention, drugs is still an important components in health sector, either in preventive, curative, rehabilitative or promotion efforts. Hence the access to drugs is a main problem, either in international or national scale even to the smallest unit. The problem on access to drugs is very complicated and cannot be separated especially from pharmacy management problems; moreover in general from the overall lack of policy development and effective of health policy, and also the implementation process. With the policy development and effective health policy, rational drug uses, sufficient health service budget so a country can overcome the health problems. Besides infrastructures, regulations, distribution and cultural influences; the main obstacles for drug access is drugs affordability if the price of drugs is an important part and determined by many factors, especially the drug status whether is still patent orgenerics that significantly decrease cost of health cares and enhance the drugs affordability. The determination of essential drug prices in developing countries should based on equity principal so that poor people pay cheaper and could afford the essential drugs. WHO predicts two third of world population can not afford the essential drugs in which in developing countries, some are because of in efficient budget allocation in consequence of drug distribution management, including incorrect selection and allocation and also irrational uses. In part these could be overcome by enhancing performances on the allocation pharmacy needs, including the management of information system, inventory management, stock management and the distribution. Key words: access, drugs, essential drugs, generic drugs

78 FR 70025 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement...

Science.gov (United States)

2013-11-22

... and Procedures AGENCY: Defense Acquisition Regulations System, Department of Defense (DoD). ACTION... proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information..., withhold, or withdraw purchasing system approval at the conclusion of a purchasing system review...

Study on default setting for risk-informed regulation

International Nuclear Information System (INIS)

Jang, S.C.; Ha, J.J.; Jung, W.D.; Jeong, K.S.; Han, S.H.

1998-12-01

Both performing and validating a detailed risk analysis of a complex system are costly and time-consuming undertakings. With the increased use of probabilistic safety analysis (PSA) in regulatory decision making, both regulated parties and regulators have generally favored the use of defaults, because they can greatly facilitate the process of performing a PSA in the first place as well as the process of reviewing and verifying the PSA. The use of defaults may also ensure more uniform standards of PSA quality. However, regulatory agencies differ in their approaches to the use of default values, and the implications of these differences are not yet well understood. Moreover, large heterogeneity among licensees makes it difficult to set suitable defaults. This study focus on the development of model for setting defaults in order to achieve more applicability of risk-informed regulation. In particular, explored are the effects of different levels of conservatism in setting defaults, and their implications for the crafting of regularity incentives. (author). 17 refs., 1 tab

49 CFR Appendix F to Part 40 - Drug and Alcohol Testing Information that C/TPAs May Transmit to Employers

Science.gov (United States)

2010-10-01

... 49 Transportation 1 2010-10-01 2010-10-01 false Drug and Alcohol Testing Information that C/TPAs... Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Pt. 40, App. F Appendix F to Part 40—Drug and Alcohol Testing Information that C/TPAs May Transmit to Employers 1. If you...

78 FR 55202 - Regulations Relating to Information Reporting by Foreign Financial Institutions and Withholding...

Science.gov (United States)

2013-09-10

... Regulations Relating to Information Reporting by Foreign Financial Institutions and Withholding on Certain... (78 FR 5874). The regulations related to information reporting by foreign financial institutions (FFIs... foreign branch of a U.S. financial institution that is a reporting Model 1 FFI must withhold in accordance...

77 FR 9021 - Regulations Relating to Information Reporting by Foreign Financial Institutions and Withholding...

Science.gov (United States)

2012-02-15

... Service 26 CFR Parts 1 and 301 Regulations Relating to Information Reporting by Foreign Financial...-121647-10] RIN 1545-BK68 Regulations Relating to Information Reporting by Foreign Financial Institutions... respect to withholding and reporting under chapter 4. If a territory financial institution is a flow...

Prescription drug brand Web sites: Guidance where none exists

Directory of Open Access Journals (Sweden)

Lewis Glinert

2010-06-01

Full Text Available This paper applies insights from linguistics and discourse analysis to prescription drug brand Web sites, with special reference to the 100 top-selling drugs. Such sites give the outward appearance of being a place to go for straightforward information about a specific brand. In reality, they present a confused mix of brand information, health information and hype, muddled organization, and poor indication of authority, creating an imbalance between benefit and risk content. In so doing, they breach the letter and spirit of the regulations governing direct-to-consumer advertising, which the FDA has by default applied to such Web sites but which were not designed for this special type of discourse. The many communicative difficulties proven to be caused by Web sites in general, in particular for the elderly and less literate, also pose ethical problems. A rethinking of the verbal and visual design of these drug sites is needed -- and new regulatory guidance, for which this paper offers recommendations. At stake is not just the quality of health information at brand drug sites but also their credibility. Type: Original Research

Improvement of infrastructure for risk-informed regulation

International Nuclear Information System (INIS)

2012-01-01

Improvement of the infrastructure of probabilistic safety assessment (PSA) is essential to the risk-informed regulation for nuclear power plants. JNES conducted update of initiating event frequencies and improvement of the method for uncertainty analysis to enhance the technology bases of PSA in 2011. Furthermore, JNES improved the human reliability analysis method and the reliability analysis method for digital reactor protection systems. JNES estimated initiating event frequencies both for power and shutdown operation based on the recent operating experiences in Nuclear Power Plants (NPPs) of Japan using the hierarchical Bayesian method. As for improvement of the uncertainty analysis method, JNES conducted trial analyses using SOKC (State-Of-Knowledge Correlation) for the representative PWR plant and BWR plant of Japan. The study on the advanced HRA method with operator cognitive action model was conducted to improve a quality of HRA. The study on analyses of 'defense in depth' and 'diversity' for introducing digital instrumentation and control (I and C) systems was conducted. In order to ensure the quality of PSA, JNES conducted a peer review of a representative Japanese BWR plant PSA by the professional PSA engineers from the U.S. in order to extract to improve quality of PSA, and made an effort to develop the procedures of internal fire PSA. JNES participated in OECD/NEA PRISME and FIRE project to obtain the latest information and data to validate and improve the fire propagation analysis codes and the parameters for fire PSA as well. Furthermore, JNES studied schemes for the endorsement and application in the risk-informed regulation of PSA standards established by Atomic Energy Society of Japan. (author)

The sources and popularity of online drug information: an analysis of top search engine results and web page views.

Science.gov (United States)

Law, Michael R; Mintzes, Barbara; Morgan, Steven G

2011-03-01

The Internet has become a popular source of health information. However, there is little information on what drug information and which Web sites are being searched. To investigate the sources of online information about prescription drugs by assessing the most common Web sites returned in online drug searches and to assess the comparative popularity of Web pages for particular drugs. This was a cross-sectional study of search results for the most commonly dispensed drugs in the US (n=278 active ingredients) on 4 popular search engines: Bing, Google (both US and Canada), and Yahoo. We determined the number of times a Web site appeared as the first result. A linked retrospective analysis counted Wikipedia page hits for each of these drugs in 2008 and 2009. About three quarters of the first result on Google USA for both brand and generic names linked to the National Library of Medicine. In contrast, Wikipedia was the first result for approximately 80% of generic name searches on the other 3 sites. On these other sites, over two thirds of brand name searches led to industry-sponsored sites. The Wikipedia pages with the highest number of hits were mainly for opiates, benzodiazepines, antibiotics, and antidepressants. Wikipedia and the National Library of Medicine rank highly in online drug searches. Further, our results suggest that patients most often seek information on drugs with the potential for dependence, for stigmatized conditions, that have received media attention, and for episodic treatments. Quality improvement efforts should focus on these drugs.

75 FR 54017 - New Animal Drugs; Change of Sponsor; Penicillin G Benzathine and Penicillin G Procaine Suspension...

Science.gov (United States)

2010-09-03

... [Docket No. FDA-2010-N-0002] New Animal Drugs; Change of Sponsor; Penicillin G Benzathine and Penicillin G... animal drug regulations to reflect a change of sponsor for two new animal drug applications (NADAs) from..., Syracuse, NY 13201, has informed FDA that it has transferred ownership of, and all rights and interest in...

77 FR 21565 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Science.gov (United States)

2012-04-10

... ``Food and Drug Administration Recall Regulations'' has been approved by the Office of Management and..., Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0439...

MedlinePlus: Drug Information

Science.gov (United States)

... supplements and herbal remedies to learn about their effectiveness, usual dosage, and drug interactions. All herbs and ... Alternative Therapies Cancer Chemotherapy Cold and Cough Medicines Complementary ...

Agreement of label information of cardiovascular drugs in pregnancy among Korea, the USA, the UK, and Japan.

Science.gov (United States)

Lee, Shin Haeng; Shin, Ju-Young; Park, Mi-Ju; Park, Byung-Joo

2014-04-01

Drug label is a common source of information; however, the content varies widely. This study aims to evaluate label information on cardiovascular drugs regarding pregnancy for their similarities in Korea, USA, UK, and Japan. Study drugs were selected as following (1) cardiovascular drugs according to the WHO ATC code (C01-C09) and (2) drugs currently marketed in all four countries were included. Evidence level was classified into five categories ('Definite', 'Probable', 'Possible', 'Unlikely', and 'Unclassified') and recommendation level was classified into four categories ('Contraindicated', 'Cautious', 'Compatible', and 'Unclassified'). Frequency and proportion were presented. Percent agreement and kappa coefficient with 95% confidence interval (CI) were calculated using SAS ver. 9.3. Total of 50 cardiovascular drugs were included. 'Unclassified' was represented the most in Korea, followed by Japan and UK (58%, 54%, and 46%, pdrugs in all four countries were classified as 'contraindicated' or 'cautious'. Japanese labels had the largest proportion of 'contraindicated' level (62%), and Korea and UK followed (58%, 44%, pdrugs were 'compatible' whereas, there were none in Korea, UK, and Japan (pdrugs in pregnancy differed widely. Reliable safety information in pregnancy should be provided through regular updates. Copyright © 2014 Elsevier Inc. All rights reserved.

[Cooperation with the electronic medical record and accounting system of an actual dose of drug given by a radiology information system].

Science.gov (United States)

Yamamoto, Hideo; Yoneda, Tarou; Satou, Shuji; Ishikawa, Toru; Hara, Misako

2009-12-20

By input of the actual dose of a drug given into a radiology information system, the system converting with an accounting system into a cost of the drug from the actual dose in the electronic medical record was built. In the drug master, the first unit was set as the cost of the drug, and we set the second unit as the actual dose. The second unit in the radiology information system was received by the accounting system through electronic medical record. In the accounting system, the actual dose was changed into the cost of the drug using the dose of conversion to the first unit. The actual dose was recorded on a radiology information system and electronic medical record. The actual dose was indicated on the accounting system, and the cost for the drug was calculated. About the actual dose of drug, cooperation of the information in a radiology information system and electronic medical record were completed. It was possible to decide the volume of drug from the correct dose of drug at the previous inspection. If it is necessary for the patient to have another treatment of medicine, it is important to know the actual dose of drug given. Moreover, authenticity of electronic medical record based on a statute has also improved.

Seniors' perceptions of prescription drug advertisements: a pilot study of the potential impact on informed decision making.

Science.gov (United States)

Grenard, Jerry L; Uy, Visith; Pagán, José A; Frosch, Dominick L

2011-10-01

To conduct a pilot study exploring seniors' perceptions of direct-to-consumer advertising (DTCA) of prescription drugs and how the advertisements might prepare them for making informed decisions with their physicians. We interviewed 15 seniors (ages 63-82) individually after they each watched nine prescription drug advertisements recorded from broadcast television. Grounded Theory methods were used to identify core themes related to the research questions. Four themes emerged from the interviews about DTCA: (1) awareness of medications was increased, (2) information was missing or misleading and drugs were often perceived as more effective than clinical evidence would suggest, (3) most seniors were more strongly influenced by personal or vicarious experience with a drug - and by their physician - than by DTCA, and (4) most seniors were circumspect about the information in commercial DTCA. DTCA may have some limited benefit for informed decision making by seniors, but the advertisements do not provide enough detailed information and some information is misinterpreted. Physicians should be aware that many patients may misunderstand DTCA, and that a certain amount of time may be required during consultations to correct these misconceptions until better advertising methods are employed by the pharmaceutical industry. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Information technology-based approaches to reducing repeat drug exposure in patients with known drug allergies.

Science.gov (United States)

Cresswell, Kathrin M; Sheikh, Aziz

2008-05-01

There is increasing interest internationally in ways of reducing the high disease burden resulting from errors in medicine management. Repeat exposure to drugs to which patients have a known allergy has been a repeatedly identified error, often with disastrous consequences. Drug allergies are immunologically mediated reactions that are characterized by specificity and recurrence on reexposure. These repeat reactions should therefore be preventable. We argue that there is insufficient attention being paid to studying and implementing system-based approaches to reducing the risk of such accidental reexposure. Drawing on recent and ongoing research, we discuss a number of information technology-based interventions that can be used to reduce the risk of recurrent exposure. Proven to be effective in this respect are interventions that provide real-time clinical decision support; also promising are interventions aiming to enhance patient recognition, such as bar coding, radiofrequency identification, and biometric technologies.

77 FR 9659 - General Services Administration Acquisition Regulation; Information Collection; GSA Mentor...

Science.gov (United States)

2012-02-17

... Services Administration Acquisition Regulation; Information Collection; GSA Mentor-Prot[eacute]g[eacute... collection concerning the GSA Mentor-Prot[eacute]g[eacute] Program, General Service Administration...- 0286, GSA Mentor-Prot[eacute]g[eacute] Program by any of the following methods: Regulations.gov : http...

The synthesis and application involving regulation of the insoluble drug release from mesoporous silica nanotubes

International Nuclear Information System (INIS)

Li, Jia; Wang, Yan; Zheng, Xin; Zhang, Ying; Sun, Changshan; Gao, Yikun; Jiang, Tongying; Wang, Siling

2015-01-01

Highlights: • Mesoporous silica nanotubes (SNT) were synthesized by using CNT as hard template, and the formation of the SNT shows that CTAB played a significant effect on the coating process. • The tube mesoporous silica materials which were seldom reported were applied in the drug delivery system to improve the loading amount and the drug dissolution. • The release rate could be controlled by the gelatin layer on the silica surface and the mechanism was illustrated. - Abstract: Mesoporous silica nanotubes (SNT) were synthesized using hard template carbon nanotubes (CNT) with the aid of cetyltrimethyl ammonium bromide (CTAB) in a method, which was simple and inexpensive. Scanning electron microscopy, transmission electron microscopy and specific surface area analysis were employed to characterize the morphology and structure of SNT, and the formation mechanism of SNT was also examined by Fourier transform infrared spectroscopy. There are few published reports of the mesoporous SNT with large specific surface area applied in the drug delivery systems to improve the amount of drug loading. In addition, the structure of SNT allows investigators to control the drug particle size in the pore channels and significantly increase the drug dissolution rate. The insoluble drug, cilostazol, was chosen as a model drug to be loaded into SNT and we developed a simple and efficient method for regulating the drug release by using a gelatin coating with different thicknesses around the SNT. The release rate was adjusted by the amount of gelatin surrounding the SNT, with an increased barrier leading to a reduction in the release rate. A model developed on the basis of the Weibull modulus was established to fit the release results

Prescription drug coupons: evolution and need for regulation in direct-to-consumer advertising.

Science.gov (United States)

Mackey, Tim K; Yagi, Nozomi; Liang, Bryan A

2014-01-01

Pharmaceutical marketing in the United States had undergone a shift from largely exclusively targeting physicians to considerable efforts in targeting patients through various forms of direct-to-consumer advertising ("DTCA"). This includes the use of DTCA in prescription drug coupons ("PDCs"), a new form of DTCA that offers discounts and rebates directly to consumers to lower costs of drug purchasing. Our examination of PDCs reveals that the use and types of PDC programs is expanding and includes promotion of the vast majority of top grossing pharmaceuticals. However, controversy regarding this emerging form of DTCA has given rise to health policy concerns about their overall impact on prescription drug expenditures for consumers, payers, and the health care system, and whether they lead to optimal long-term utilization of pharmaceuticals. In response to these concerns and the growing popularity of PDCs, what we propose here are clearer regulation and regulatory guidance for PDC DTCA use. This would include review for appropriate disclosure of marketing claims, increased transparency in PDC use for pharmaceutical pricing, and leveraging potential positive benefits of PDC use for vulnerable or underserved patient populations. Copyright © 2014 Elsevier Inc. All rights reserved.

77 FR 27461 - Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X...

Science.gov (United States)

2012-05-10

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0384] Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X-Ray Imaging Device Premarket Notifications; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

48 CFR 223.570 - Drug-free work force.

Science.gov (United States)

2010-10-01

... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Drug-free work force. 223.570 Section 223.570 Federal Acquisition Regulations System DEFENSE ACQUISITION REGULATIONS SYSTEM... TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Drug-Free Workplace 223.570 Drug-free work force. ...

Information needs: an sociocognitive analysis in academic management in the context of regulation

Directory of Open Access Journals (Sweden)

Nadi Helena Presser

2012-12-01

Full Text Available It presents a sociocognitive analysis of information needs investigation that arises from the different tasks that the coordinators of the graduate studies take in their activity. The context of regulation, research subject, constitutes in the social environment under which information are produced and used. The study of the document of Applied Social Sciences I area composed the empirical basis of research. It was found that the information needs, which arise from the set of tasks which are in the center of regulation, are formed in the academic communities. At the same time they produce complex results, many tasks can be decomposed into understandable elements and identified information needs.

An Agile Enterprise Regulation Architecture for Health Information Security Management

Science.gov (United States)

Chen, Ying-Pei; Hsieh, Sung-Huai; Chien, Tsan-Nan; Chen, Heng-Shuen; Luh, Jer-Junn; Lai, Jin-Shin; Lai, Feipei; Chen, Sao-Jie

2010-01-01

Abstract Information security management for healthcare enterprises is complex as well as mission critical. Information technology requests from clinical users are of such urgency that the information office should do its best to achieve as many user requests as possible at a high service level using swift security policies. This research proposes the Agile Enterprise Regulation Architecture (AERA) of information security management for healthcare enterprises to implement as part of the electronic health record process. Survey outcomes and evidential experiences from a sample of medical center users proved that AERA encourages the information officials and enterprise administrators to overcome the challenges faced within an electronically equipped hospital. PMID:20815748

An agile enterprise regulation architecture for health information security management.

Science.gov (United States)

Chen, Ying-Pei; Hsieh, Sung-Huai; Cheng, Po-Hsun; Chien, Tsan-Nan; Chen, Heng-Shuen; Luh, Jer-Junn; Lai, Jin-Shin; Lai, Feipei; Chen, Sao-Jie

2010-09-01

Information security management for healthcare enterprises is complex as well as mission critical. Information technology requests from clinical users are of such urgency that the information office should do its best to achieve as many user requests as possible at a high service level using swift security policies. This research proposes the Agile Enterprise Regulation Architecture (AERA) of information security management for healthcare enterprises to implement as part of the electronic health record process. Survey outcomes and evidential experiences from a sample of medical center users proved that AERA encourages the information officials and enterprise administrators to overcome the challenges faced within an electronically equipped hospital.

Herb-drug interactions: challenges and opportunities for improved predictions.

Science.gov (United States)

Brantley, Scott J; Argikar, Aneesh A; Lin, Yvonne S; Nagar, Swati; Paine, Mary F

2014-03-01

Supported by a usage history that predates written records and the perception that "natural" ensures safety, herbal products have increasingly been incorporated into Western health care. Consumers often self-administer these products concomitantly with conventional medications without informing their health care provider(s). Such herb-drug combinations can produce untoward effects when the herbal product perturbs the activity of drug metabolizing enzymes and/or transporters. Despite increasing recognition of these types of herb-drug interactions, a standard system for interaction prediction and evaluation is nonexistent. Consequently, the mechanisms underlying herb-drug interactions remain an understudied area of pharmacotherapy. Evaluation of herbal product interaction liability is challenging due to variability in herbal product composition, uncertainty of the causative constituents, and often scant knowledge of causative constituent pharmacokinetics. These limitations are confounded further by the varying perspectives concerning herbal product regulation. Systematic evaluation of herbal product drug interaction liability, as is routine for new drugs under development, necessitates identifying individual constituents from herbal products and characterizing the interaction potential of such constituents. Integration of this information into in silico models that estimate the pharmacokinetics of individual constituents should facilitate prospective identification of herb-drug interactions. These concepts are highlighted with the exemplar herbal products milk thistle and resveratrol. Implementation of this methodology should help provide definitive information to both consumers and clinicians about the risk of adding herbal products to conventional pharmacotherapeutic regimens.

49 CFR 40.323 - May program participants release drug or alcohol test information in connection with legal...

Science.gov (United States)

2010-10-01

... 49 Transportation 1 2010-10-01 2010-10-01 false May program participants release drug or alcohol... the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING... information pertaining to an employee's drug or alcohol test without the employee's consent in certain legal...

Direct-to-Consumer Promotion of Prescription Drugs on Mobile Devices: Content Analysis.

Science.gov (United States)

Aikin, Kathryn J; Sullivan, Helen W; Dolina, Suzanne; Lynch, Molly; Squiers, Linda B

2017-07-04

US Food and Drug Administration (FDA) regulations state that any prescription drug promotion that presents drug benefits to consumers must also disclose certain information about the drug's risks in a similar manner. Nearly three-quarters of all US mobile phone subscribers use a smartphone, and over half report receiving mobile advertisements on their device. The objective of this project was to investigate how prescription drugs are being promoted to consumers using mobile technologies. We were particularly interested in the presentation of drug benefits and risks, with regard to presence, placement, and prominence. We analyzed a sample of 51 mobile promotional communications and their associated linked landing pages. We assessed the content and format of the mobile communications and landing pages with regard to presentation of drug benefits and risks. Of the 51 mobile communications we coded, 41% (21/51) were product claim communications (includes the drug name, benefits, and risks), 22% (11/51) were reminder communications (includes drug name only), and 37% (19/51) were help-seeking communications (includes information about the medical condition but not the drug name). Some of the product claim communications (5/21, 24%) required scrolling to see all the benefit information; in contrast, 95% (20/21) required scrolling to see all the risk information. Of the 19 product claim communications that presented both benefits and risks, 95% (18/19) presented benefits before risks and 47% (9/19) used a bigger font for benefits than for risks. Most mobile communications (35/51, 69%) linked to branded drug websites with both benefits and risks, 25% (13/51) linked to a landing page with benefits but no visible risks, and 6% (3/51) linked to a landing page with risks but no visible benefits. Few landing pages (4/51, 8%) required scrolling to see all the benefit information; in contrast, 51% (26/51) required scrolling to see all the risk information. Of the 35 landing pages

Prescription Drug Promotion from 2001-2014: Data from the U.S. Food and Drug Administration.

Directory of Open Access Journals (Sweden)

Helen W Sullivan

Full Text Available The volume of prescription drug promotion over time is often measured by assessing changes in ad spending. However, this method obscures the fact that some types of advertising are more expensive than others. Another way to measure the changes in prescription drug promotion over time is to assess the number of promotional pieces submitted to the U.S. Food and Drug Administration (FDA. Form FDA 2253 collects information such as the date submitted and the type of material submitted. We analyzed data from Forms FDA 2253 received from 2001-2014. We examined the frequency of submissions by audience (consumer and healthcare professional and type of promotional material. There was a noted increase in prescription drug promotion submissions across all media in the early 2000s. Although non-Internet promotion submissions have since plateaued, Internet promotion continued to increase. These results can help public health advocates and regulators focus attention and resources.

Characterizing, Classifying, and Understanding Information Security Laws and Regulations: Considerations for Policymakers and Organizations Protecting Sensitive Information Assets

Science.gov (United States)

Thaw, David Bernard

2011-01-01

Current scholarly understanding of information security regulation in the United States is limited. Several competing mechanisms exist, many of which are untested in the courts and before state regulators, and new mechanisms are being proposed on a regular basis. Perhaps of even greater concern, the pace at which technology and threats change far…

Thoughtflow: Standards and Tools for Provenance Capture and Workflow Definition to Support Model-Informed Drug Discovery and Development.

Science.gov (United States)

Wilkins, J J; Chan, Pls; Chard, J; Smith, G; Smith, M K; Beer, M; Dunn, A; Flandorfer, C; Franklin, C; Gomeni, R; Harnisch, L; Kaye, R; Moodie, S; Sardu, M L; Wang, E; Watson, E; Wolstencroft, K; Cheung, Sya

2017-05-01

Pharmacometric analyses are complex and multifactorial. It is essential to check, track, and document the vast amounts of data and metadata that are generated during these analyses (and the relationships between them) in order to comply with regulations, support quality control, auditing, and reporting. It is, however, challenging, tedious, error-prone, and time-consuming, and diverts pharmacometricians from the more useful business of doing science. Automating this process would save time, reduce transcriptional errors, support the retention and transfer of knowledge, encourage good practice, and help ensure that pharmacometric analyses appropriately impact decisions. The ability to document, communicate, and reconstruct a complete pharmacometric analysis using an open standard would have considerable benefits. In this article, the Innovative Medicines Initiative (IMI) Drug Disease Model Resources (DDMoRe) consortium proposes a set of standards to facilitate the capture, storage, and reporting of knowledge (including assumptions and decisions) in the context of model-informed drug discovery and development (MID3), as well as to support reproducibility: "Thoughtflow." A prototype software implementation is provided. © 2017 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

Mechanistic and Structural Insights Into the Unique TetR-Dependent Regulation of a Drug Efflux Pump in Mycobacterium abscessus.

Science.gov (United States)

Richard, Matthias; Gutiérrez, Ana Victoria; Viljoen, Albertus J; Ghigo, Eric; Blaise, Mickael; Kremer, Laurent

2018-01-01

Mycobacterium abscessus is an emerging human pathogen causing severe pulmonary infections and is refractory to standard antibiotherapy, yet few drug resistance mechanisms have been reported in this organism. Recently, mutations in MAB_4384 leading to up-regulation of the MmpS5/MmpL5 efflux pump were linked to increased resistance to thiacetazone derivatives. Herein, the DNA-binding activity of MAB_4384 was investigated by electrophoretic mobility shift assays using the palindromic sequence IR S5/L5 located upstream of mmpS5/mmpL5 . Introduction of point mutations within IR S5/L5 identified the sequence requirements for optimal binding of the regulator. Moreover, formation of the protein/IR S5/L5 complex was severely impaired for MAB_4384 harboring D14N or F57L substitutions. IR S5/L5 /lacZ reporter fusions in M. abscessus demonstrated increased β-galactosidase activity either in strains lacking a functional MAB_4384 or in cultures treated with the TAC analogs. In addition, X-ray crystallography confirmed a typical TetR homodimeric structure of MAB_4384 and unraveled a putative ligand binding site in which the analogs could be docked. Overall, these results support drug recognition of the MAB_4384 TetR regulator, alleviating its binding to IR S5/L5 and steering up-regulation of MmpS5/MmpL5. This study provides new mechanistic and structural details of TetR-dependent regulatory mechanisms of efflux pumps and drug resistance in mycobacteria.

77 FR 41952 - Correction to Modification of Regulations Regarding the Definition of Factual Information and...

Science.gov (United States)

2012-07-17

... DEPARTMENT OF COMMERCE International Trade Administration 19 CFR Part 351 Correction to Modification of Regulations Regarding the Definition of Factual Information and Time Limits for Submission of... Regulations Regarding the Definition of Factual Information and Time Limits for Submission of Factual...

Model-Informed Drug Development for Ixazomib, an Oral Proteasome Inhibitor.

Science.gov (United States)

Gupta, Neeraj; Hanley, Michael J; Diderichsen, Paul M; Yang, Huyuan; Ke, Alice; Teng, Zhaoyang; Labotka, Richard; Berg, Deborah; Patel, Chirag; Liu, Guohui; van de Velde, Helgi; Venkatakrishnan, Karthik

2018-02-15

Model-informed drug development (MIDD) was central to the development of the oral proteasome inhibitor ixazomib, facilitating internal decisions (switch from body surface area (BSA)-based to fixed dosing, inclusive phase III trials, portfolio prioritization of ixazomib-based combinations, phase III dose for maintenance treatment), regulatory review (model-informed QT analysis, benefit-risk of 4 mg dose), and product labeling (absolute bioavailability and intrinsic/extrinsic factors). This review discusses the impact of MIDD in enabling patient-centric therapeutic optimization during the development of ixazomib. © 2017 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

Towards a multi-agent system for regulated information exchange in crime investigations

NARCIS (Netherlands)

Dijkstra, Pieter; Prakken, H.; Vey Mestdagh, C.N.J. de

2005-01-01

This paper outlines a multi-agent architecture for regulated information exchange of crime investigation data between police forces. Interactions between police officers about information exchange are analysed as negotiation dialogues with embedded persuasion dialogues. An architecture is then

77 FR 15370 - General Services Administration Acquisition Regulation; Information Collection; Price Reductions...

Science.gov (United States)

2012-03-15

... Services Administration Acquisition Regulation; Information Collection; Price Reductions Clause; Extension... notice of request for comments regarding OMB Control No. 3090-0235, Price Reductions Clause, published in... 16, 2012. ADDRESSES: Submit comments identified by Information Collection 3090- 0235, Price...

Role of endocannabinoids in regulating drug dependence

Directory of Open Access Journals (Sweden)

Daniela Parolaro

2007-01-01

Full Text Available Daniela Parolaro, Daniela Vigano’, Natalia Realini, Tiziana RubinoNeuroscience Center, DBSF, University of Insubria, Busto Arsizio, ItalyAbstract: This review will discuss the latest knowledge of how the endocannabinoid system might be involved in treating addiction to the most common illicit drugs. Experimental models are providing increasing evidence for the pharmacological management of endocannabinoid signaling not only to block the direct reinforcing effects of cannabis, opioids, nicotine and ethanol, but also for preventing relapse to the various drugs of abuse, including opioids, cocaine, nicotine, alcohol and metamphetamine. Preclinical and clinical studies suggest that the endocannabinoid system can be manipulated by the CB1 receptor antagonist SR141716A, that might constitute a new generation of compounds for treating addiction across different classes of abused drugs.Keywords: Endocannabinoids, drug dependence, opioids, nicotine, alcohol, psychostimulants

Data-driven prediction of adverse drug reactions induced by drug-drug interactions.

Science.gov (United States)

Liu, Ruifeng; AbdulHameed, Mohamed Diwan M; Kumar, Kamal; Yu, Xueping; Wallqvist, Anders; Reifman, Jaques

2017-06-08

The expanded use of multiple drugs has increased the occurrence of adverse drug reactions (ADRs) induced by drug-drug interactions (DDIs). However, such reactions are typically not observed in clinical drug-development studies because most of them focus on single-drug therapies. ADR reporting systems collect information on adverse health effects caused by both single drugs and DDIs. A major challenge is to unambiguously identify the effects caused by DDIs and to attribute them to specific drug interactions. A computational method that provides prospective predictions of potential DDI-induced ADRs will help to identify and mitigate these adverse health effects. We hypothesize that drug-protein interactions can be used as independent variables in predicting ADRs. We constructed drug pair-protein interaction profiles for ~800 drugs using drug-protein interaction information in the public domain. We then constructed statistical models to score drug pairs for their potential to induce ADRs based on drug pair-protein interaction profiles. We used extensive clinical database information to construct categorical prediction models for drug pairs that are likely to induce ADRs via synergistic DDIs and showed that model performance deteriorated only slightly, with a moderate amount of false positives and false negatives in the training samples, as evaluated by our cross-validation analysis. The cross validation calculations showed an average prediction accuracy of 89% across 1,096 ADR models that captured the deleterious effects of synergistic DDIs. Because the models rely on drug-protein interactions, we made predictions for pairwise combinations of 764 drugs that are currently on the market and for which drug-protein interaction information is available. These predictions are publicly accessible at http://avoid-db.bhsai.org . We used the predictive models to analyze broader aspects of DDI-induced ADRs, showing that ~10% of all combinations have the potential to induce ADRs

76 FR 78739 - Agency Information Collection (Regulation on Application for Fisher Houses and Other Temporary...

Science.gov (United States)

2011-12-19

... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0630] Agency Information Collection (Regulation on Application for Fisher Houses and Other Temporary Lodging and VHA Fisher House Application... INFORMATION: Title: Regulation on Application for Fisher Houses and Other Temporary Lodging and VHA Fisher...

Norepinephrine transporter function and desipramine: residual drug effects versus short-term regulation.

Science.gov (United States)

Ordway, Gregory A; Jia, Weihong; Li, Jing; Zhu, Meng-Yang; Mandela, Prashant; Pan, Jun

2005-04-30

Previous research has shown that exposure of norepinephrine transporter (NET)-expressing cells to desipramine (DMI) downregulates the norepinephrine transporter, although changes in the several transporter parameters do not demonstrate the same time course. Exposures to desipramine for effects of residual desipramine on norepinephrine transporter binding and uptake were re-evaluated following exposures of PC12 cells to desipramine using different methods to remove residual drug. Using a method that minimizes residual drug, exposure of intact PC12 cells to desipramine for 4h had no effect on uptake capacity or [(3)H]nisoxetine binding to the norepinephrine transporter, while exposures for > or =16 h reduced uptake capacity. Desipramine-induced reductions in binding to the transporter required >24 h or greater periods of desipramine exposure. This study confirms that uptake capacity of the norepinephrine transporter is reduced earlier than changes in radioligand binding, but with a different time course than originally shown. Special pre-incubation procedures are required to abolish effects of residual transporter inhibitor when studying inhibitor-induced transporter regulation.

Health care providers' use of a drug information service for pregnancy-related inquiries.

Science.gov (United States)

Patil, Avinash S; Patil, Neelima P; Lewis, Ashley N; Swamy, Geeta K; Murtha, Amy P

2014-01-01

To characterize pregnancy and lactation-related medication inquiries to a drug information center to identify classes of medications of most concern to providers. A secondary objective was to identify any trends in provider inquiries over the study period. A retrospective descriptive study of pregnancy and lactation-related inquiries to the University of North Carolina Health Care System Drug Information Center database between January 2001 and December 2010. University of North Carolina Health Care System Drug Information Center. Provider inquiries and responses were extracted and characterized by indication for treatment and reason for inquiry. Comparison of the first and second 5-year periods was performed to delineate trends. Descriptive statistics, Fisher's Exact and χ2 tests were used for analysis. Inquiry origin, time, and subject. 433 inquiries were retrieved over the study period from physicians (50%), pharmacists (21%), and nurses (18%). Inquiries were most often made during the antepartum period (34%), followed by the postpartum (28%) and preconception (22%) periods. The most frequent indications for inquiry were psychiatry (15%) and infectious diseases (14%), which remained constant throughout the study period. Safety was the most common reason for inquiry (52%). The responses provided to callers were limited due to lack of information availability 37% of the time. Psychiatry and infectious disease-related indications are the most frequent subjects of provider inquiry regarding medication use in pregnancy. Rates of inquiry remained constant throughout the past decade in most therapeutic areas. These findings are consistent with previous observations in other developed countries and suggest high-yield areas for pharmacist education.

Drug promotion in a resource-constrained Nigerian environment: A cross-sectional study of the influence of pharmaceutical sales representatives on the prescribing behaviors of medical practitioners in Abia State

Directory of Open Access Journals (Sweden)

Gabriel Uche Pascal Iloh

2017-01-01

Full Text Available Background: Pharmaceutical drug promotion is an important component of pharmaceutical care and is one of the factors that may lead to unethical drug prescriptions. As the impetus for rational drug use grows, emphasis should also be focused on prescribing behaviors of physicians, particularly in resource-poor settings. Aim: The study was aimed at describing the influence of drug promotion by pharmaceutical sales representatives (PSRs on the prescribing behaviors of medical practitioners in Abia State, Nigeria. Materials and Methods: A descriptive study was carried out on a cross-section of 185 medical practitioners in Abia State, Nigeria. Data collection was done using a pretested, self-administered questionnaire that elicits information on practice and attitude to drug promotion, types of incentives, frequency of visits, drug promotion methods and information, sources of drug information, and awareness of code of regulation on drug promotion. Results: The age of the participants ranged from 28 to 71 years. There were 166 males and 19 females. The prescribing practices of 47.6% of the medical practitioners were influenced by drug promotion and 66.5% of them had positive attitude to drug promotion. One hundred and sixty-four (88.6% were visited >12 times in the previous year. The most common incentive received was branded stationeries (100.0%; predominant drug promotional method and information were in-person clinic encounter (100.0% and brand names of the drugs (100.0%, respectively. The most common source of drug information was calling a colleague/pharmacist (93.5% while 84.9% of the respondents were aware of code of regulation on drug promotion. The prescribing practice (P = 0.041 and attitude (P = 0.032 to drug promotion were significantly associated with working in public hospitals. Conclusion: Drug promotion by PSRs influenced prescribing practices of medical practitioners with 66.5% of them having positive attitude to drug promotion. The

The effect of fair disclosure regulation on timeliness and informativeness of earnings announcements

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Yeonhee Park

2013-03-01

Full Text Available This paper examines the effect of Korea’s fair disclosure regulation on the timeliness and informativeness of earnings announcements. The present regulation for Korean listed firms requires that if a company’s sales revenue, operating income (or loss and net income (or loss have changed by over 30% compared to the prior year, the firm must disclose this information through a preliminary financial report (PFR even before the company is audited by external auditors. To analyze the effects of this policy, we first investigate the timeliness of preliminary financial report disclosures. We examine the extent to which Korean listed companies actually comply with the requirement for prompt notification of information concerning material changes in financial performance. Second, we investigate the informativeness of preliminary financial reports by analyzing differential stock market reactions to different timings of preliminary financial report disclosures. Our empirical results reveal that more than half of our sample firms release their preliminary financial reports after external audits are completed, thereby potentially invalidating the effectiveness of the regulation. In addition, we find that preliminary financial reports have information value only if they are disclosed prior to annual audit report dates. This finding supports the notion that timeliness increases the informativeness of preliminary financial report disclosure by curbing insiders’ ability to potentially profit from their information advantage.

Effects of emotional tone and visual complexity on processing health information in prescription drug advertising.

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Norris, Rebecca L; Bailey, Rachel L; Bolls, Paul D; Wise, Kevin R

2012-01-01

This experiment explored how the emotional tone and visual complexity of direct-to-consumer (DTC) drug advertisements affect the encoding and storage of specific risk and benefit statements about each of the drugs in question. Results are interpreted under the limited capacity model of motivated mediated message processing framework. Findings suggest that DTC drug ads should be pleasantly toned and high in visual complexity in order to maximize encoding and storage of risk and benefit information.

Glucose Transporters at the Blood-Brain Barrier: Function, Regulation and Gateways for Drug Delivery.

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Patching, Simon G

2017-03-01

Glucose transporters (GLUTs) at the blood-brain barrier maintain the continuous high glucose and energy demands of the brain. They also act as therapeutic targets and provide routes of entry for drug delivery to the brain and central nervous system for treatment of neurological and neurovascular conditions and brain tumours. This article first describes the distribution, function and regulation of glucose transporters at the blood-brain barrier, the major ones being the sodium-independent facilitative transporters GLUT1 and GLUT3. Other GLUTs and sodium-dependent transporters (SGLTs) have also been identified at lower levels and under various physiological conditions. It then considers the effects on glucose transporter expression and distribution of hypoglycemia and hyperglycemia associated with diabetes and oxygen/glucose deprivation associated with cerebral ischemia. A reduction in glucose transporters at the blood-brain barrier that occurs before the onset of the main pathophysiological changes and symptoms of Alzheimer's disease is a potential causative effect in the vascular hypothesis of the disease. Mutations in glucose transporters, notably those identified in GLUT1 deficiency syndrome, and some recreational drug compounds also alter the expression and/or activity of glucose transporters at the blood-brain barrier. Approaches for drug delivery across the blood-brain barrier include the pro-drug strategy whereby drug molecules are conjugated to glucose transporter substrates or encapsulated in nano-enabled delivery systems (e.g. liposomes, micelles, nanoparticles) that are functionalised to target glucose transporters. Finally, the continuous development of blood-brain barrier in vitro models is important for studying glucose transporter function, effects of disease conditions and interactions with drugs and xenobiotics.

Direct-to-consumer advertising skepticism and the use and perceived usefulness of prescription drug information sources.

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DeLorme, Denise E; Huh, Jisu; Reid, Leonard N

2009-01-01

This study investigates advertising skepticism in the context of consumers' prescription drug information seeking behavior. Results of a telephone survey found that: (a) the overall level of direct-to-consumer advertising (DTCA) skepticism among consumers was neutral; (b) DTCA skepticism was unrelated to age, positively related to education and income, and varied by race; (c) however, when all the antecedent variables were considered concurrently, only education emerged as a significant predictor (consumers with higher education were more skeptical of DTCA); (d) DTCA skepticism was not significantly related to perceived importance of prescription drug information; (e) DTCA skepticism was not associated with use of advertising and interpersonal sources of prescription drug information; and (f) DTCA skepticism was negatively related to perceived usefulness of advertising sources but unrelated to perceived usefulness of professional interpersonal sources (i.e., physicians and pharmacists). The article concludes with a discussion of findings and directions for future research.

Insomnia From Drug Treatments: Evidence From Meta-analyses of Randomized Trials and Concordance With Prescribing Information.

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Doufas, Anthony G; Panagiotou, Orestis A; Panousis, Periklis; Wong, Shane Shucheng; Ioannidis, John P A

2017-01-01

To determine whether drugs used to treat diverse conditions cause insomnia symptoms and whether their prescription information is concordant with this evidence. We conducted a survey of meta-analyses (Cochrane Database of Systematic Reviews) and comparisons with package inserts compiled in the Physicians' Desk Reference (PDR). We identified randomized controlled trials (RCTs) in which any drug had been evaluated vs placebo and sleep had been assessed. We collectively referred to insomnia-related outcomes as sleep disturbance. We also searched the PDR to identify any insomnia symptoms listed for drugs with RCT evidence available. Seventy-four Cochrane systematic reviews corresponding to 274 RCTs assessed 88 drugs in 27 different conditions, providing evidence on 109 drug-condition pairs. Of these 88 drugs, 5 decreased sleep problems and 19 increased sleep problems; 64 drugs had no nominally statistically significant effect on sleep. Acetylcholinesterase inhibitors, dopamine agonists, and selective serotonin reuptake inhibitors were the drug classes most importantly associated with sleep disturbance. Of 35 drugs that included disturbed sleep as an adverse effect in the PDR, only 14 had RCT evidence supporting such effect, and 2 had evidence of increasing and decreasing sleep problems in RCTs, although this was not shown in the PDR. We identified weak concordance between the PDR and RCTs (weighted κ=0.31; P<.001). The RCTs offer substantial evidence about the common effects of drugs on the risk of sleep disturbance; currently, prescription information only partially agrees with the available randomized evidence. Copyright © 2016 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

75 FR 36092 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

Science.gov (United States)

2010-06-24

... Good Manufacturing Practice Quality System Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public... existing collection of information, and to allow 60 days for public comment in response to the notice. This...

Factors affecting osteoarthritis patients' self-reported goal-directed drug information-seeking behaviors after exposure to direct-to-consumer advertising from physicians and the internet.

Science.gov (United States)

Liu, Yifei; Farris, Karen B; Doucette, William R

2011-10-01

The objective of this study was to investigate appraisal of means (ie, self-efficacy, outcome expectancy, and affect) in predicting patients' goal-directed behaviors of direct-to-consumer advertising (DTCA)-prompted drug-information search from physicians and the internet. One thousand patients were randomly selected from a nationwide sample frame of 3000 osteoarthritis patients. A self-administered survey assessed exposure to DTCA, drug-information search as goal, self-efficacy, outcome expectancy, affect, and osteoarthritis pain. After 6 weeks, another survey measured the behavior of drug-information search for respondents to the first survey. Study subjects were those who were exposed to DTCA in the previous month, and who set drug-information search as their goal. For each information source, a multiple regression analysis was conducted in which drug-information search was the dependent variable, and self-efficacy, outcome expectancy, affect, and osteoarthritis pain were the independent variables. Among 454 patients who were exposed to DTCA, 174 patients set drug-information search as their goal and were the study subjects. The regression for physicians was not statistically significant. The regression for the internet was significant, accounting for 15% of behavior variance. Self-efficacy was a strong predictor of goal-directed drug-information search from the internet. Appraisal of means was useful to predict the goal-directed behavior of DTCA-prompted drug-information search from the internet. For patients who set drug-information search as a goal, actions to promote drug-information search from the internet need to focus on self-efficacy.

[Legislation concerning alcohol and drug intake in the workplace].

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Goszczyńiska, Eliza

2013-01-01

It is likely that the complex law concerning alcohol and drugs in the workplace is one of the reasons for unwillingness to resolve the problem of intake of such psychoactive substances by employees. 'Iherefore, the author made an attempt to depict Polish legislation in this field based on the review of legal acts and regulations, as well as on their extensive judiciary interpretation. Such an information can be used by employers in developing their workplace policy of diminishing the intake of psychoactive substances by employees. This information can also be helpful for the bodies supporting workplaces in solving problems derived from alcohol and drugs consumption, such as occupational medicine specialists and local governments.

75 FR 75207 - Regulation SBSR-Reporting and Dissemination of Security-Based Swap Information

Science.gov (United States)

2010-12-02

... Dissemination of Security-Based Swap Information; Proposed Rule #0;#0;Federal Register / Vol. 75 , No. 231... Dissemination of Security-Based Swap Information AGENCY: Securities and Exchange Commission. ACTION: Proposed... SBSR--Reporting and Dissemination of Security-Based Swap Information (``Regulation SBSR'') under the...

Should the model for risk-informed regulation be game theory rather than decision theory?

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Bier, Vicki M; Lin, Shi-Woei

2013-02-01

Risk analysts frequently view the regulation of risks as being largely a matter of decision theory. According to this view, risk analysis methods provide information on the likelihood and severity of various possible outcomes; this information should then be assessed using a decision-theoretic approach (such as cost/benefit analysis) to determine whether the risks are acceptable, and whether additional regulation is warranted. However, this view ignores the fact that in many industries (particularly industries that are technologically sophisticated and employ specialized risk and safety experts), risk analyses may be done by regulated firms, not by the regulator. Moreover, those firms may have more knowledge about the levels of safety at their own facilities than the regulator does. This creates a situation in which the regulated firm has both the opportunity-and often also the motive-to provide inaccurate (in particular, favorably biased) risk information to the regulator, and hence the regulator has reason to doubt the accuracy of the risk information provided by regulated parties. Researchers have argued that decision theory is capable of dealing with many such strategic interactions as well as game theory can. This is especially true in two-player, two-stage games in which the follower has a unique best strategy in response to the leader's strategy, as appears to be the case in the situation analyzed in this article. However, even in such cases, we agree with Cox that game-theoretic methods and concepts can still be useful. In particular, the tools of mechanism design, and especially the revelation principle, can simplify the analysis of such games because the revelation principle provides rigorous assurance that it is sufficient to analyze only games in which licensees truthfully report their risk levels, making the problem more manageable. Without that, it would generally be necessary to consider much more complicated forms of strategic behavior (including

40 CFR 2.308 - Special rules governing certain information obtained under the Federal Food, Drug and Cosmetic Act.

Science.gov (United States)

2010-07-01

... information obtained under the Federal Food, Drug and Cosmetic Act. 2.308 Section 2.308 Protection of... § 2.308 Special rules governing certain information obtained under the Federal Food, Drug and Cosmetic... Cosmetic Act, as amended, 21 U.S.C. 301 et seq. (2) Petition means a petition for the issuance of a...

Unwarranted claims of drug efficacy in pharmaceutical sales visits: are drugs approved on the basis of surrogate outcomes promoted appropriately?

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Habibi, Roojin; Lexchin, Joel; Mintzes, Barbara; Holbrook, Anne

2017-11-01

This study compares physicians' recall of the claims of benefits on cardiovascular disease and diabetes made by pharmaceutical sales representatives for drugs approved on the basis of a surrogate outcome, i.e., an off-label claim, compared with those approved on the basis of a serious morbidity or mortality (clinical) outcome. Physicians in primary care practices in Montreal, Vancouver, Sacramento and Toulouse, who saw sales representatives as part of their usual practice and served a non-referral population, were contacted in blocks of 25 from a randomized list of all physicians practising in the relevant metropolitan area. We compared how frequently physicians reported that sales reps made claims of serious morbidity or mortality (clinically meaningful) benefits for drugs approved on the basis of surrogate outcomes vs. drugs approved on the basis of clinical outcomes. There were 448 promotions for 58 unique brand name cardiovascular and diabetes drugs. Claims of clinically meaningful benefit were reported in 156 (45%) of the 347 promotions for surrogate outcome drugs, constituting unwarranted efficacy claims, i.e., off-label promotion. Claims of clinical benefit were reported in 72 of the 101 promotions (71%) for drugs approved on the basis of clinical outcomes, adjusted OR = 0.3 (95% CI 0.2, 0.6), P sales visit promotions for drugs approved only on the basis of surrogate outcomes extended beyond the regulator-approved efficacy information for the product in almost half of promotions. Unapproved claims of drug efficacy constitute a form of off-label promotion and merit greater attention from regulators. © 2017 The British Pharmacological Society.

A Unique Fungal Two-Component System Regulates Stress Responses, Drug Sensitivity, Sexual Development, and Virulence of Cryptococcus neoformans

Science.gov (United States)

Bahn, Yong-Sun; Kojima, Kaihei; Cox, Gary M.

2006-01-01

The stress-activated mitogen-activated protein kinase (MAPK) pathway is widely used by eukaryotic organisms as a central conduit via which cellular responses to the environment effect growth and differentiation. The basidiomycetous human fungal pathogen Cryptococcus neoformans uniquely uses the stress-activated Pbs2-Hog1 MAPK system to govern a plethora of cellular events, including stress responses, drug sensitivity, sexual reproduction, and virulence. Here, we characterized a fungal “two-component” system that controls these fundamental cellular functions via the Pbs2-Hog1 MAPK cascade. A typical response regulator, Ssk1, modulated all Hog1-dependent phenotypes by controlling Hog1 phosphorylation, indicating that Ssk1 is the major upstream signaling component of the Pbs2-Hog1 pathway. A second response regulator, Skn7, governs sensitivity to Na+ ions and the antifungal agent fludioxonil, negatively controls melanin production, and functions independently of Hog1 regulation. To control these response regulators, C. neoformans uses multiple sensor kinases, including two-component–like (Tco) 1 and Tco2. Tco1 and Tco2 play shared and distinct roles in stress responses and drug sensitivity through the Hog1 MAPK system. Furthermore, each sensor kinase mediates unique cellular functions for virulence and morphological differentiation. Our findings highlight unique adaptations of this global two-component MAPK signaling cascade in a ubiquitous human fungal pathogen. PMID:16672377

A study on the relevance and influence of the existing regulation and risk informed/performance based regulation

Energy Technology Data Exchange (ETDEWEB)

Cheong, B. J.; Koh, Y. J.; Kim, H. S.; Koh, S. H.; Kang, D. H.; Kang, T. W. [Cheju National Univ., Jeju (Korea, Republic of)

2004-02-15

The goal of this study is to estimate the Relevance and Influence of the Existing Regulation and the RI-PBR to the institutionalization of the regulatory system. This study reviews the current regulatory system and the status of the RI-PBR implementation of the US NRC and Korea based upon SECY Papers, Risk Informed Regulation Implementation Plan (RIRIP) of the US NRC and other domestic studies. Also the recent trends of the individual technologies regarding the RI-PBR and RIA are summarized.

76 FR 31415 - Federal Acquisition Regulation; Buy American Exemption for Commercial Information Technology...

Science.gov (United States)

2011-05-31

... 9000-AL62 Federal Acquisition Regulation; Buy American Exemption for Commercial Information Technology... from the Buy American Act for acquisition of information technology that is a commercial item. DATES: Effective Date: May 31, 2011. FOR FURTHER INFORMATION CONTACT: Ms. Cecelia L. Davis, Procurement Analyst, at...

Herb–Drug Interactions: Challenges and Opportunities for Improved Predictions

Science.gov (United States)

Brantley, Scott J.; Argikar, Aneesh A.; Lin, Yvonne S.; Nagar, Swati

2014-01-01

Supported by a usage history that predates written records and the perception that “natural” ensures safety, herbal products have increasingly been incorporated into Western health care. Consumers often self-administer these products concomitantly with conventional medications without informing their health care provider(s). Such herb–drug combinations can produce untoward effects when the herbal product perturbs the activity of drug metabolizing enzymes and/or transporters. Despite increasing recognition of these types of herb–drug interactions, a standard system for interaction prediction and evaluation is nonexistent. Consequently, the mechanisms underlying herb–drug interactions remain an understudied area of pharmacotherapy. Evaluation of herbal product interaction liability is challenging due to variability in herbal product composition, uncertainty of the causative constituents, and often scant knowledge of causative constituent pharmacokinetics. These limitations are confounded further by the varying perspectives concerning herbal product regulation. Systematic evaluation of herbal product drug interaction liability, as is routine for new drugs under development, necessitates identifying individual constituents from herbal products and characterizing the interaction potential of such constituents. Integration of this information into in silico models that estimate the pharmacokinetics of individual constituents should facilitate prospective identification of herb–drug interactions. These concepts are highlighted with the exemplar herbal products milk thistle and resveratrol. Implementation of this methodology should help provide definitive information to both consumers and clinicians about the risk of adding herbal products to conventional pharmacotherapeutic regimens. PMID:24335390

Signals from the Fourth Dimension Regulate Drug Relapse.

Science.gov (United States)

Mulholland, Patrick J; Chandler, L Judson; Kalivas, Peter W

2016-07-01

Despite the enormous societal burden of alcohol and drug addiction and abundant research describing drug-induced maladaptive synaptic plasticity, there are few effective strategies for treating substance use disorders. Recent awareness that synaptic plasticity involves astroglia and the extracellular matrix is revealing new possibilities for understanding and treating addiction. We first review constitutive corticostriatal adaptations that are elicited by and shared between all abused drugs from the perspective of tetrapartite synapses, and integrate recent discoveries regarding cell type-specificity in striatal neurons. Next, we describe recent discoveries that drug-seeking is associated with transient synaptic plasticity that requires all four synaptic elements and is shared across drug classes. Finally, we prognosticate how considering tetrapartite synapses can provide new treatment strategies for addiction. Copyright © 2016 Elsevier Ltd. All rights reserved.

Sustainable Regulation of Information Sharing with Electronic Data Interchange by a Trust-Embedded Contract

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Guanghua Han

2017-06-01

Full Text Available This paper studies the risks in demand information sharing applications by electronic soft-orders using electronic data interchange (EDI systems in e-commerce and aims to suggest a sustainable regulation mechanism with a trust-embedded contract. In a supply chain with one retailer and one supplier, the retailer solicits private forecasted demand and places soft-orders via EDI to the supplier. To ensure abundant supply, the retailer has an incentive to inflate her soft-orders, which potentially harms the credible information sharing and sustainability of business cooperation. Normally, the degree to which the supplier relies on the retailer’s order information is specified by trust, which is evaluated according to the retailer’s reputation and supplier’s intuition in this study. Based on standard game theory, we find that both the retailer’s order and the quantity of supplier prepared materials are independent of the retailer’s forecast. Therefore, EDI based information sharing in e-commerce without a regulation mechanism leads to inefficient demand information sharing. Since both the supplier and retailer are proved to faces huge of potential profit losses due to the failure of information sharing, the commerce by EDI based information sharing is full of risk and unsustainable. Therefore, a regulation mechanism that leaded by the retailer is proposed to establish ‘win-win’ sustainable cooperation. Numerical experiments highlight the value of trust, the impact of reputation and intuition in decisions, and the effectiveness of the regulation mechanism by a cost-sharing contract.

78 FR 46347 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

Science.gov (United States)

2013-07-31

... Good Manufacturing Practice Quality System Regulation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment... information, and to allow 60 days for public comment in response to the notice. This notice solicits comments...

Prescription Drug Abuse and Youth. Information Brief.

Science.gov (United States)

Department of Justice, Washington, DC. National Drug Intelligence Center.

Prescription drugs, a category of psychotherapeutics that comprises prescription-type pain relievers, tranquilizers, stimulants, and sedatives, are among the substances most commonly abused by young people in the United States. Prescription drugs are readily available and can easily be obtained by teenagers who abuse these drugs to experience a…

Effect of warning placement on the information processing of college students reading an OTC drug facts panel.

Science.gov (United States)

Bhansali, Archita H; Sangani, Darshan S; Mhatre, Shivani K; Sansgiry, Sujit S

2018-01-01

To compare three over-the-counter (OTC) Drug Facts panel versions for information processing optimization among college students. University of Houston students (N = 210) participated in a cross-sectional survey from January to May 2010. A current FDA label was compared to two experimental labels developed using the theory of CHREST to test information processing by re-positioning the warning information within the Drug Facts panel. Congruency was defined as placing like information together. Information processing was evaluated using the OTC medication Label Evaluation Process Model (LEPM): label comprehension, ease-of-use, attitude toward the product, product evaluation, and purchase intention. Experimental label with chunked congruent information (uses-directions-other information-warnings) was rated significantly higher than the current FDA label and had the best average scores among the LEPM information processing variables. If replications uphold these findings, the FDA label design might be revised to improve information processing.

Annual Report of Recorded Phone Calls to Iran's Drug and Poison Information Centers (2014-2015

Directory of Open Access Journals (Sweden)

Talat Ghane

2015-09-01

Conclusion: Iranian people seems to have numerous unmet drug information needs. This may especially be the case for antibiotics, nutrients and anti-depressants. Pharmaceutical products are the main subjects of poisoning-related calls to DPICs in Iran. Public education on usage, safety and storage of drugs as well as strict terms of sale should be implemented.

The international regulation of Informal Value Transfer Systems

Directory of Open Access Journals (Sweden)

Anand Ajay Shah

2007-12-01

Full Text Available After the 11th September 2001 attacks on the United States international attention quickly focused on the sources and methods of terrorist financing. Among the methods terrorists and other criminal actors use to transfer funds are Informal Value Transfer Systems (IVTS which operate either outside the formal financial sector, or through use of the formal financial sector, but without leaving a full record of the transaction. Though the vast majority of funds moved through IVTS are the earnings of migrant workers and immigrant communities, the lack of uniform worldwide regulation of IVTS provides ample opportunity for abuse and misuse. The international community primarily responded to IVTS concerns through the Financial Action Task Force on Money Laundering, which issued a series of recommendations and best practices for states in regulating IVTS operations. While these recommendations are a secure beginning to regulation of IVTS operating within ethnic communities, they fail to address the more modern forms of IVTS that have come about in the post-Cold War globalised world. Comprehensive recommendations governing all types of IVTS, as well as concerted international cooperation and coordination are necessary to address this global phenomenon.

Role of MRP transporters in regulating antimicrobial drug inefficacy and oxidative stress-induced pathogenesis during HIV-1 and TB infections.

Science.gov (United States)

Roy, Upal; Barber, Paul; Tse-Dinh, Yuk-Ching; Batrakova, Elena V; Mondal, Debasis; Nair, Madhavan

2015-01-01

Multi-Drug Resistance Proteins (MRPs) are members of the ATP binding cassette (ABC) drug-efflux transporter superfamily. MRPs are known to regulate the efficacy of a broad range of anti-retroviral drugs (ARV) used in highly active antiretroviral therapy (HAART) and antibacterial agents used in Tuberculus Bacilli (TB) therapy. Due to their role in efflux of glutathione (GSH) conjugated drugs, MRPs can also regulate cellular oxidative stress, which may contribute to both HIV and/or TB pathogenesis. This review focuses on the characteristics, functional expression, and modulation of known members of the MRP family in HIV infected cells exposed to ARV drugs and discusses their known role in drug-inefficacy in HIV/TB-induced dysfunctions. Currently, nine members of the MRP family (MRP1-MRP9) have been identified, with MRP1 and MRP2 being the most extensively studied. Details of the other members of this family have not been known until recently, but differential expression has been documented in inflammatory tissues. Researchers have found that the distribution, function, and reactivity of members of MRP family vary in different types of lymphocytes and macrophages, and are differentially expressed at the basal and apical surfaces of both endothelial and epithelial cells. Therefore, the prime objective of this review is to delineate the role of MRP transporters in HAART and TB therapy and their potential in precipitating cellular dysfunctions manifested in these chronic infectious diseases. We also provide an overview of different available options and novel experimental strategies that are being utilized to overcome the drug resistance and disease pathogenesis mediated by these membrane transporters.

Role of MRP Transporters in Regulating Antimicrobial Drug Inefficacy and Oxidative Stress-induced Pathogenesis during HIV-1 and TB Infections

Directory of Open Access Journals (Sweden)

Upal eRoy

2015-09-01

Full Text Available Multi-Drug Resistance Proteins (MRPs are members of the ATP binding cassette (ABC drug-efflux transporter superfamily. MRPs are known to regulate the efficacy of a broad range of anti-retroviral drugs (ARV used in highly active antiretroviral therapy (HAART and antibacterial agents used in Tuberculus Bacilli (TB therapy. Due to their role in efflux of glutathione (GSH conjugated drugs, MRPs can also regulate cellular oxidative stress, which may contribute to both HIV and/or TB pathogenesis. This review focuses on the characteristics, functional expression, and modulation of known members of the MRP family in HIV infected cells exposed to ARV drugs and discusses their known role in drug-inefficacy in HIV/TB-induced dysfunctions. Currently, nine members of the MRP family (MRP1-MRP9 have been identified, with MRP1 and MRP2 being the most extensively studied. Details of the other members of this family have not been known until recently, but differential expression has been documented in inflammatory tissues. Researchers have found that the distribution, function and reactivity of members of MRP family vary in different types of lymphocytes and macrophages, and are differentially expressed at the basal and apical surfaces of both endothelial and epithelial cells. Therefore, the prime objective of this review is to delineate the role of MRP transporters in HAART and TB therapy and their potential in precipitating cellular dysfunctions manifested in these chronic infectious diseases. We also provide an overview of different available options and novel experimental strategies that are being utilized to overcome the drug resistance and disease pathogenesis mediated by these membrane transporters.

Neurocircuitry of drug reward

Science.gov (United States)

Ikemoto, Satoshi; Bonci, Antonello

2013-01-01

In recent years, neuroscientists have produced profound conceptual and mechanistic advances on the neurocircuitry of reward and substance use disorders. Here, we will provide a brief review of intracranial drug self-administration and optogenetic self-stimulation studies that identified brain regions and neurotransmitter systems involved in drug- and reward-related behaviors. Also discussed is a theoretical framework that helps to understand the functional properties of the circuitry involved in these behaviors. The circuitry appears to be homeostatically regulated and mediate anticipatory processes that regulate behavioral interaction with the environment in response to salient stimuli. That is, abused drugs or, at least, some may act on basic motivation and mood processes, regulating behavior-environment interaction. Optogenetics and related technologies have begun to uncover detailed circuit mechanisms linking key brain regions in which abused drugs act for rewarding effects. PMID:23664810

49 CFR 40.287 - What information is an employer required to provide concerning SAP services to an employee who...

Science.gov (United States)

2010-10-01

... provide concerning SAP services to an employee who has a DOT drug and alcohol regulation violation? 40.287... § 40.287 What information is an employer required to provide concerning SAP services to an employee who... (including an applicant or new employee) who violates a DOT drug and alcohol regulation a listing of SAPs...

Drug repurposing based on drug-drug interaction.

Science.gov (United States)

Zhou, Bin; Wang, Rong; Wu, Ping; Kong, De-Xin

2015-02-01

Given the high risk and lengthy procedure of traditional drug development, drug repurposing is gaining more and more attention. Although many types of drug information have been used to repurpose drugs, drug-drug interaction data, which imply possible physiological effects or targets of drugs, remain unexploited. In this work, similarity of drug interaction was employed to infer similarity of the physiological effects or targets for the drugs. We collected 10,835 drug-drug interactions concerning 1074 drugs, and for 700 of them, drug similarity scores based on drug interaction profiles were computed and rendered using a drug association network with 589 nodes (drugs) and 2375 edges (drug similarity scores). The 589 drugs were clustered into 98 groups with Markov Clustering Algorithm, most of which were significantly correlated with certain drug functions. This indicates that the network can be used to infer the physiological effects of drugs. Furthermore, we evaluated the ability of this drug association network to predict drug targets. The results show that the method is effective for 317 of 561 drugs that have known targets. Comparison of this method with the structure-based approach shows that they are complementary. In summary, this study demonstrates the feasibility of drug repurposing based on drug-drug interaction data. © 2014 John Wiley & Sons A/S.

Destinations without regulations: Informal practices in Romanian rural tourism

Directory of Open Access Journals (Sweden)

Maria Miruna Rădan-Gorska

2013-12-01

Full Text Available This article is an ethnographic account of the informal practices I encountered during my fieldwork in three touristic destinations in the Romanian countryside. In these places, as in other parts of rural Romania, over half of the accommodation units are unregistered, making tourism ‘on the black’ [market] widespread. This research is focused on unregistered businesses, as well as on those that aim to be law-abiding, but sometimes engage in informal practices. A typology of informal practices is outlined, dividing them into intended, unintended, and contextual. These categories are illustrated with evidence from interview data and from mass media accounts. Informality is discussed in relation to the legislative framework and to the actions of those authorities responsible with enforcing regulations. Local sense-making strategies are taken into account in explaining informal practices, as well as the wider national and historical contexts. The positive and negative implications of informality are examined and the article concludes by making a number of suggestions that could help to develop more appropriate norms and policies regarding rural guesthouses.

Communicating Risk Information in Direct-to-Consumer Prescription Drug Television Ads: A Content Analysis.

Science.gov (United States)

Sullivan, Helen W; Aikin, Kathryn J; Poehlman, Jon

2017-11-10

Direct-to-consumer (DTC) television ads for prescription drugs are required to disclose the product's major risks in the audio or audio and visual parts of the presentation (sometimes referred to as the "major statement"). The objective of this content analysis was to determine how the major statement of risks is presented in DTC television ads, including what risk information is presented, how easy or difficult it is to understand the risk information, and the audio and visual characteristics of the major statement. We identified 68 DTC television ads for branded prescription drugs, which included a unique major statement and that aired between July 2012 and August 2014. We used subjective and objective measures to code 50 ads randomly selected from the main sample. Major statements often presented numerous risks, usually in order of severity, with no quantitative information about the risks' severity or prevalence. The major statements required a high school reading level, and many included long and complex sentences. The major statements were often accompanied by competing non-risk information in the visual images, presented with moderately fast-paced music, and read at a faster pace than benefit information. Overall, we discovered several ways in which the communication of risk information could be improved.

Future regulatory research needs on risk-informed and performance-based regulation

International Nuclear Information System (INIS)

Kim, Wong Sik; Kim, Hho Jung

2004-01-01

The USNRC has pursued the incorporation of risk-informed and performance-based regulation (RIPBR) into nuclear safety regulatory system, as an alternative to improve existing nuclear safety regulation of nuclear power plants, which is deterministic and prescriptive. It focuses on the use of risk insight from probabilistic safety assessment (PSA). Recently, it becomes necessary to find a way to improve regulatory efficiency and effectiveness in order to cover the increasing regulatory needs in Korea. Also, the utility has optimized design and operation of the plant using PSA insight and equipment performance information. According to the increase of the necessity for regulatory improvement using risk and performance information, KINS (Korea Institute of Nuclear Safety) is developing, as a part of a mid and long-term project of Nuclear R and D program, how to adopt the RIPBR in Korean nuclear regulatory system. As the interim results, three basic directions and several principles that are necessary to implement RIPBR model were already identified from the previous study. This paper suggests a direction to future regulatory research on RIPBR based on the previous studies including the review of international trend of RIPBR and the evaluation of risk-informed regulatory environment

49 CFR Appendix H to Part 40 - DOT Drug and Alcohol Testing Management Information System (MIS) Data Collection Form

Science.gov (United States)

2010-10-01

..., App. H Appendix H to Part 40—DOT Drug and Alcohol Testing Management Information System (MIS) Data... 49 Transportation 1 2010-10-01 2010-10-01 false DOT Drug and Alcohol Testing Management Information System (MIS) Data Collection Form H Appendix H to Part 40 Transportation Office of the Secretary...

Protein kinase C isozymes as regulators of sensitivity to and self-administration of drugs of abuse-studies with genetically modified mice.

Science.gov (United States)

Olive, Michael Foster; Newton, Philip M

2010-09-01

Studies using targeted gene deletion in mice have revealed distinct roles for individual isozymes of the protein kinase C (PKC) family of enzymes in regulating sensitivity to various drugs of abuse. These changes in drug sensitivity are associated with altered patterns of drug self-administration. The purpose of this review is to summarize behavioral studies conducted on mice carrying targeted deletions of genes encoding specific PKC isozymes (namely the beta, gamma, delta, and epsilon isozymes), and to critically evaluate the possibility of using pharmacological inhibitors of specific PKC isozymes as modulators of the sensitivity to various drugs of abuse, as well as potential aids in the treatment of substance use disorders.

Automatically Recognizing Medication and Adverse Event Information From Food and Drug Administration's Adverse Event Reporting System Narratives.

Science.gov (United States)

Polepalli Ramesh, Balaji; Belknap, Steven M; Li, Zuofeng; Frid, Nadya; West, Dennis P; Yu, Hong

2014-06-27

The Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS) is a repository of spontaneously-reported adverse drug events (ADEs) for FDA-approved prescription drugs. FAERS reports include both structured reports and unstructured narratives. The narratives often include essential information for evaluation of the severity, causality, and description of ADEs that are not present in the structured data. The timely identification of unknown toxicities of prescription drugs is an important, unsolved problem. The objective of this study was to develop an annotated corpus of FAERS narratives and biomedical named entity tagger to automatically identify ADE related information in the FAERS narratives. We developed an annotation guideline and annotate medication information and adverse event related entities on 122 FAERS narratives comprising approximately 23,000 word tokens. A named entity tagger using supervised machine learning approaches was built for detecting medication information and adverse event entities using various categories of features. The annotated corpus had an agreement of over .9 Cohen's kappa for medication and adverse event entities. The best performing tagger achieves an overall performance of 0.73 F1 score for detection of medication, adverse event and other named entities. In this study, we developed an annotated corpus of FAERS narratives and machine learning based models for automatically extracting medication and adverse event information from the FAERS narratives. Our study is an important step towards enriching the FAERS data for postmarketing pharmacovigilance.

SAFE USE OF DRUGS DURING PREGNANCY IN FOCUS OF INTERNATIONAL PRACTICE OF PHARMACOVIGILANCE SYSTEM AND TERATOLOGICAL INFORMATION SERVICE ORGANIZATION

Directory of Open Access Journals (Sweden)

K. A. Lutsevich

2012-01-01

Full Text Available The safe use of drugs during pregnancy is essential to optimize the health of both pregnant woman and her future child. At the same time obstetrician-gynecologists often face the lack of evidence-based information on the use of drugs and leave the issue to the woman herself — whether the treatment benefit to the mother outweighs risks to the unborn child — relying on the limited amount of scientific data. Preconception discussion of actual risks and safe treatment reduces patient fears and maximizes the emphasis on the therapy safety. At the same time, the lack of adequate information on safety for the majority of drugs used by pregnant women combined with the need to make appropriate treatment decisions and communicate drug risk information to a potentially vulnerable population is the most challenging and critical issue of pregnant women's health.

Fair Balance? An Analysis of the Functional Equivalence of Risk and Benefit Information in Prescription Drug Direct-to-Consumer Television Advertising

Science.gov (United States)

Baird-Harris, Kay

2009-01-01

Prescription drug direct-to-consumer advertising (DTCA) has been a subject of controversy in recent years. Though government regulations require equivalent prominence of risks and benefits, there is concern about the ability of consumers with limited health literacy to fully comprehend the risks and benefits associated with drug use. Evaluating…

Legislation concerning alcohol and drug intake in the workplace

Directory of Open Access Journals (Sweden)

Eliza Goszczyńska

2013-08-01

Full Text Available It is likely that the complex law concerning alcohol and drugs in the workplace is one of the reasons for unwillingness to resolve the problem of intake of such psychoactive substances by employees. Therefore, the author made an attempt to depict Polish legislation in this field based on the review of legal acts and regulations, as well as on their extensive judiciary interpretation. Such an information can be used by employers in developing their workplace policy of diminishing the intake of psychoactive substances by employees. This information can also be helpful for the bodies supporting workplaces in solving problems derived from alcohol and drugs consumption, such as occupational medicine specialists and local governments. Med Pr 2013;64(4:593–608

77 FR 36543 - General Services Administration Acquisition Regulation (GSAR) Part 523; Information Collection...

Science.gov (United States)

2012-06-19

... handling of such items throughout GSA's supply chain system. The information is used in GSA warehouses, stored in an NSN database and provided to GSA customers. Non-Collection and/or a less frequently... any of the following methods: Regulations.gov : http://www.regulations.gov . Submit comments via the...

Evaluation and appraisal of drug information services in a rural secondary level care hospital, Anantapur, AP

Directory of Open Access Journals (Sweden)

Rohit Bhavsar

2012-01-01

Full Text Available Background: Drug Information Center (DIC is an information center which provides drug information (DI to healthcare professionals. The aim was to evaluate the performance of DIC for improving the quality and quantity of information services provided to the healthcare professionals. The service was provided free of cost to the customers. Materials and Methods: This descriptive study was conducted for the period of 6 months from February to August 2011 excluding May due to vacation. Customers were asked: how did they find the service provided to them? Was it good, satisfactory, or need improvement? There were written feedback forms to be filled by the customers, including customer satisfaction questions. The official publication of the DIC, RIPER PDIC Bulletin was screened for its types of articles/number of drug news published. The bulletin is circulated for free to the healthcare professionals electronically. Results and Discussion: A total of 232 queries were obtained during the study period of 6 months. Average number of queried received to the DIC was 39 per month. Most preferred mode of queries was personal access (89%. Majority of queries were received from nurses, i.e., 162 (70% queries and 81% of all queries were drug oriented for improving knowledge. There were only 19% of the queries for individual patients; doctors asked most of those queries. Only 3% queries answered were rated as need improvement by the healthcare professionals. Rest were considered as either Good (56% or satisfactory (49%. Range of drug news published in each bulletin was 3-4 and most of the other articles include expert opinion to improve practice or training. Conclusion: The DI services were satisfactorily used for academic interests. Nurses used the service for the highest compared to other health care professionals. Future studies should plan to establish the usefulness of DI to improve healthcare practice.

"Mind-Blowing:" Fostering Self-Regulated Learning in Information Literacy Instruction

Science.gov (United States)

Houtman, Eveline

2015-01-01

The new ACRL "Framework for Information Literacy for Higher Education" brings a new emphasis into our instruction on student metacognition and dispositions. In this article I introduce self-regulated learning, a related concept from the field of education; it encompasses metacognition, emotions, motivations and behaviors. I discuss how…

Prenatal drug exposure and teratological risk: one-year experience of an Italian Teratology Information Service.

Science.gov (United States)

De Santis, Marco; Cesari, Elena; Ligato, Maria Serena; Nobili, Elena; Straface, Gianluca; Cavaliere, Annafranca; Caruso, Alessandro

2008-02-01

Concern about exposure to drugs, radiation, or infection during pregnancy occur often because pregnancy is not always planned. A teratology information service offers rapid scientific counseling to all those worried about prenatal exposure. The aim of this study is to present data on the most common pharmaceutical products responsible for teratogenic risk in the one-year experience of a teratology information service in Italy. The survey was conducted among 8664 callers who contacted our Teratology Information Service in Rome between January and December 2006. Data on maternal age, gravidity, parity, maternal health status, and details of exposure (dose and timing) were collected and stored in a specific data base. Scientific counseling on prenatal exposure was given to the caller by a specialized service operator, specifying the type of risk and suggesting appropriate tests for prenatal diagnosis. Most of the people called regarding drug exposure; increased risk was present in only 5% of the pregnant women calling during pregnancy. Selective serotonin reuptake inhibitors (SSRIs) are the first category that are actually considered of increased risk to the fetus. The second category is represented by antiepileptic drugs. This experience confirms previous data that there is a high teratological risk perception among both women and physicians. The drugs estimated to present increased risk are medications used for chronic neurological diseases, mainly mood disorders and epilepsy. Preconceptional counseling for these women could be an effective strategy to prevent such exposure and to improve maternal and fetal outcome.

PKC signaling regulates drug resistance of the fungal pathogen Candida albicans via circuitry comprised of Mkc1, calcineurin, and Hsp90.

Directory of Open Access Journals (Sweden)

Shantelle L LaFayette

2010-08-01

Full Text Available Fungal pathogens exploit diverse mechanisms to survive exposure to antifungal drugs. This poses concern given the limited number of clinically useful antifungals and the growing population of immunocompromised individuals vulnerable to life-threatening fungal infection. To identify molecules that abrogate resistance to the most widely deployed class of antifungals, the azoles, we conducted a screen of 1,280 pharmacologically active compounds. Three out of seven hits that abolished azole resistance of a resistant mutant of the model yeast Saccharomyces cerevisiae and a clinical isolate of the leading human fungal pathogen Candida albicans were inhibitors of protein kinase C (PKC, which regulates cell wall integrity during growth, morphogenesis, and response to cell wall stress. Pharmacological or genetic impairment of Pkc1 conferred hypersensitivity to multiple drugs that target synthesis of the key cell membrane sterol ergosterol, including azoles, allylamines, and morpholines. Pkc1 enabled survival of cell membrane stress at least in part via the mitogen activated protein kinase (MAPK cascade in both species, though through distinct downstream effectors. Strikingly, inhibition of Pkc1 phenocopied inhibition of the molecular chaperone Hsp90 or its client protein calcineurin. PKC signaling was required for calcineurin activation in response to drug exposure in S. cerevisiae. In contrast, Pkc1 and calcineurin independently regulate drug resistance via a common target in C. albicans. We identified an additional level of regulatory control in the C. albicans circuitry linking PKC signaling, Hsp90, and calcineurin as genetic reduction of Hsp90 led to depletion of the terminal MAPK, Mkc1. Deletion of C. albicans PKC1 rendered fungistatic ergosterol biosynthesis inhibitors fungicidal and attenuated virulence in a murine model of systemic candidiasis. This work establishes a new role for PKC signaling in drug resistance, novel circuitry through which

Legal features of the drug advertising.

Science.gov (United States)

Pashkov, Vitalii M; Olefir, Andrii A; Bytyak, Oleksiy Y

In the article discribed current trends of advertising in the pharmaceutical market and foreign experience of legal regulation of these relations. As for the advertising of medicines identified it's symptoms, types, basic rules and prohibitions. Modern pharmaceutical companies can not successfully carry out economic activities without advertising. Besides we can mention some fundamental changes in society (information overload, universal access to internet, social media, freedom of movement of goods, labor and finance), also self-medication becomes more popular. At the same time, the number of deaths after improper and uncontrolled use of drugs ranks fifth in the world among the causes of death. Investigate current trends of advertising on the pharmaceutical market, find advertising signs, basic restrictions and prohibitions on advertising of medicines, as well as foreign experience of legal regulation of these relations. Despite the fact that pharmaceutical advertising were studied by such scholars as M. Abraham, L. Bradley, C. Dunn, J. Donoh'yu, D. Castro, M. Lipski, K. Taylor and others, number of issues related features of drug advertising, remained without proper theoretical studies. Based on the analysis can come to the conclusion that advertising of medicinal products are the subject of special attention from the state. Drugs, unlike other products, are a group of specialized consumer products. Risks increase when patients under the influence of «aggressive» advertising resort to self-medication. If a complete ban on advertising of medicines is inappropriate, you should set stricter requirements for the content of advertising and product placement rules. That is, in the national legislation to implement regulatory requirements of Directive 2001/83 / EC. Legal regulation of drug advertising can be improved by such legal means: - should provide for a mechanism of public control over the observance of ethical standards in the advertising of medicinal products

Synthesis of the panel information principles for nuclear regulators: the journalist's view

International Nuclear Information System (INIS)

Lippman, T.W.

1994-01-01

The four journalists who participated in the OECD Nuclear Energy Agency seminar were M. Thomas Lippman, United States; Ms. Anna Schytt, Sweden; M. Michel Lemeret, Belgium; and M. Francis Sorin, France. Although the nuclear industry is structured differently in each of these countries, the journalists who have written about it for many years agreed on certain basic points. In order to have the confidence of the public, nuclear regulators must function openly, provide accurate and dispassionate information, have a reservoir of available technical knowledge and be independent of government and politics. Their purpose should be to regulate, rather than to promote the nuclear energy industry. The participants agreed that it is part of the regulators' role to provide information to the public on a regular basis, to forestall misunderstanding and potential panic. But this must be done in a way that does not appear to be promoting the nuclear power industry as such. (author)

Application of Geographic Information System (GIS) in Drug Logistics Management Information System (LMIS) at District Level in Malawi: Opportunities and Challenges

Science.gov (United States)

Chikumba, Patrick Albert

District pharmacies in Malawi use a computerised IS to monitor the flow of products from a warehouse to health service delivery points and determine understocked or overstocked products at each health facility. Currently, all drug LMIS reports are in tabular forms. The GIS can help health and drug logistics officers to get additional spatial information, such as locations of health facilities and environmental factors, to the existing reports in the form of maps. This paper highlights some opportunities and challenges of applying the GIS in the drug LMIS, which basically involve technologies, organisation, and standards and data integration. It has been found that this idea is very good but it requires much effort, commitment and resources for successful implementation.

Analysis of concept and application or Risk-Informed Performed-Based Regulation (RI-PBR)

International Nuclear Information System (INIS)

Kim, W. S.; Sung, K. Y.; Lee, C. J.; Kim, H. J.

2002-01-01

For improving regulation of nuclear power plants, the USNRC is adopting the Risk-Informed Performance-Based Regulation (RI-PBR) as an alternative, in parallel with implementing current deterministic regulation. This paper introduces a research plan for 'Institutionalization of RI-PBR' that is being conducted by KINS as a national project for evaluating feasibility for application of the alternative to Korean regulation system. Analysis of regulation characteristics, case study and experience on RI-PBR were presented as interim research results. In addition, the future plan of development of RI-PBR concept as understandable to the public and evaluation of level of techniques needed for implementation of RI-PBR was introduced

Use of risk information to safety regulation. Reprocessing facilities

Energy Technology Data Exchange (ETDEWEB)

NONE

2013-08-15

A procedure of probabilistic risk assessment (PRA) for a reprocessing facility has been under the development aiming to utilize risk information for safety regulations in this project. Activities in the fiscal year 2012 are summarized in the paper. A major activity is a fundamental study on a concept of serious accidents, requirements of serious accident management, and a policy of utilizing risk information for fabrication and reprocessing facilities. Other than the activity a study on release and transport of aerial radioactive materials at a serious accident in a reprocessing facility has been conducted. The outline and results are provided in the chapter 1 and 2 respectively. (author)

Use of risk information to safety regulation. Fabrication facilities

Energy Technology Data Exchange (ETDEWEB)

NONE

2013-08-15

A procedure of ISA (Integrated Safety Analysis) for uranium fuel fabrication/enrichment facilities has been under the development aiming to utilize risk information for safety regulations in this project. Activities in the fiscal year 2012 are summarized in the paper. There are two major activities in the year. First one is a study on ISA procedure for external events such as earthquakes. Second one is that for chemical consequences such as UF6 and HF. Other than the activities a fundamental study on a policy of utilizing risk information was conducted. The outline and results are provided in the chapter 1 and 2 respectively. (author)

Will growth in cryptomarket drug buying increase the harms of illicit drugs?

Science.gov (United States)

Aldridge, Judith; Stevens, Alex; Barratt, Monica J

2018-05-01

Cryptomarkets-on-line, anonymous market-places for illicit goods and services that specialize mainly in drugs-account for a small but rapidly growing share of the illicit drug market in many countries. Policy responses so far are based generally on the assumption that their rise will only increase drug harms. In this contribution for debate, we question this assumption. We provide a narrative review of the emerging literature connected to drug cryptomarkets. We use MacCoun & Reuter's formula to understand the effect of population-level increases in use on total harm as depending on the level of harm associated with each unit of use. We then consider the potential for cryptomarkets to increase or decrease the harms and benefits related to each unit of drug use, with specific attention to the quality of drugs sold and the non-drug-related harms and benefits for customers. It is likely that cryptomarkets will increase both the amount and the range of substances that are sold. However, we argue that the effects on harms will depend upon whether cryptomarkets also increase the quality and safety of products that are sold, provide harm-reducing information to consumers and reduce transactional conflict involved in drug purchasing. There is an emerging and rapidly growing evidence base connected to the macro and micro harms and benefits of cryptomarkets for drug users. Future researchers should use appropriately matched comparative designs to establish more firmly the differential harms and benefits of sourcing drugs both on- and off-line. While it is unlikely that the on-line drug trade can be eradicated completely, cryptomarkets will respond to regulation and enforcement in ways that have complex, and sometimes unanticipated, effects on both harms and benefits. © 2017 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

Patient counseling materials: The effect of patient health literacy on the comprehension of printed prescription drug information.

Science.gov (United States)

Patel, Amit; Bakina, Daria; Kirk, Jim; von Lutcken, Scott; Donnelly, Tom; Stone, William; Ashley-Collins, Heather; Tibbals, Karen; Ricker, Lynn; Adler, Jeffrey; Ewing, John; Blechman, Michelle; Fox, Sherry; Leopold, Will; Ryan, Daniel; Wray, Donna; Turkoz, Heather

2018-05-16

Counseling patients with written materials relies equally on patients' health literacy to understand their disease and its treatment, and the written materials' effectiveness communicating clearly in accessible and actionable ways. Only about 12% of the US population is adequately health literate. To explore the impact of reducing the health literacy demands of written patient health information. 805 patients were screened for health literacy, and recruited for balanced cohorts of adequate and low literacy, and high and normal blood pressure. Half of each patient cohort received either standard or "health literacy-friendly" drug summaries (i.e. Patient Package Inserts, or PPIs or "leaflets") along with a standardized health literacy assessment scale. The literacy-friendly drug summary improved comprehension of drug-related information overall from 50% to 71% correct responses. Adequate literacy patients improved from 58% correct to 90%, while lower literacy patients improved from 42% to 52% correct in response to the health literacy-friendly PPIs. Health literacy demands require special attention in developing and using written drug summary materials. Additionally, pharmacists should be provided additional information and counseling support materials to facilitate communications with low health literacy level patients. Copyright © 2018 Elsevier Inc. All rights reserved.

Modeling of non-steroidal anti-inflammatory drug effect within signaling pathways and miRNA-regulation pathways.

Directory of Open Access Journals (Sweden)

Jian Li

Full Text Available To date, it is widely recognized that Non-Steroidal Anti-Inflammatory Drugs (NSAIDs can exert considerable anti-tumor effects regarding many types of cancers. The prolonged use of NSAIDs is highly associated with diverse side effects. Therefore, tailoring down the NSAID application onto individual patients has become a necessary and relevant step towards personalized medicine. This study conducts the systemsbiological approach to construct a molecular model (NSAID model containing a cyclooxygenase (COX-pathway and its related signaling pathways. Four cancer hallmarks are integrated into the model to reflect different developmental aspects of tumorigenesis. In addition, a Flux-Comparative-Analysis (FCA based on Petri net is developed to transfer the dynamic properties (including drug responsiveness of individual cellular system into the model. The gene expression profiles of different tumor-types with available drug-response information are applied to validate the predictive ability of the NSAID model. Moreover, two therapeutic developmental strategies, synthetic lethality and microRNA (miRNA biomarker discovery, are investigated based on the COX-pathway. In conclusion, the result of this study demonstrates that the NSAID model involving gene expression, gene regulation, signal transduction, protein interaction and other cellular processes, is able to predict the individual cellular responses for different therapeutic interventions (such as NS-398 and COX-2 specific siRNA inhibition. This strongly indicates that this type of model is able to reflect the physiological, developmental and pathological processes of an individual. The approach of miRNA biomarker discovery is demonstrated for identifying miRNAs with oncogenic and tumor suppressive functions for individual cell lines of breast-, colon- and lung-tumor. The achieved results are in line with different independent studies that investigated miRNA biomarker related to diagnostics of cancer

The liberal state and the rogue agency: FDA's regulation of drugs for mood disorders, 1950s-1970s.

Science.gov (United States)

Shorter, Edward

2008-01-01

The theory of the liberal state does not generally contemplate the possibility that regulatory agencies will turn into "rogues," regulating against the interests of their clients and, indeed, the public interest. In the years between circa 1955 and 1975 this seems to have happened to one of the prime regulatory agencies of the US federal government: the Food and Drug Administration (FDA). Intent upon transforming itself from a traditional "cop" agency to a regulatory giant, the FDA campaigned systematically to bring down some safe and effective drugs. This article concentrates on hearings in the area of psychopharmacology regarding several antianxiety drugs, namely meprobamate (Miltown), chlordiazepoxide (Librium) and diazepam (Valium). In addition, from 1967 to 1973 this regulatory vengefulness occurred on a broad scale in the Drug Efficacy Study Implementation (DESI), an administrative exercise that removed from the market almost half of the psychopharmacopoeia. The article explores possible bureaucratic motives for these actions.

PCSK9: Regulation and Target for Drug Development for Dyslipidemia.

Science.gov (United States)

Burke, Amy C; Dron, Jacqueline S; Hegele, Robert A; Huff, Murray W

2017-01-06

Proprotein convertase subtilisin/kexin type-9 (PCSK9) is a secreted zymogen expressed primarily in the liver. PCSK9 circulates in plasma, binds to cell surface low-density lipoprotein (LDL) receptors, is internalized, and then targets the receptors to lysosomal degradation. Studies of naturally occurring PCSK9 gene variants that caused extreme plasma LDL cholesterol (LDL-C) deviations and altered atherosclerosis risk unleashed a torrent of biological and pharmacological research. Rapid progress in understanding the physiological regulation of PCSK9 was soon translated into commercially available biological inhibitors of PCSK9 that reduced LDL-C levels and likely also cardiovascular outcomes. Here we review the swift evolution of PCSK9 from novel gene to drug target, to animal and human testing, and finally to outcome trials and clinical applications. In addition, we explore how the genetics-guided path to PCSK9 inhibitor development exemplifies a new paradigm in pharmacology. Finally, we consider some potential challenges as PCSK9 inhibition becomes established in the clinic.

Unofficial policy: access to housing, housing information and social services among homeless drug users in Hartford, Connecticut

Directory of Open Access Journals (Sweden)

Corbett A Michelle

2007-03-01

Full Text Available Abstract Background Much research has shown that the homeless have higher rates of substance abuse problems than housed populations and that substance abuse increases individuals' vulnerability to homelessness. However, the effects of housing policies on drug users' access to housing have been understudied to date. This paper will look at the "unofficial" housing policies that affect drug users' access to housing. Methods Qualitative interviews were conducted with 65 active users of heroin and cocaine at baseline, 3 and 6 months. Participants were purposively sampled to reflect a variety of housing statuses including homeless on the streets, in shelters, "doubled-up" with family or friends, or permanently housed in subsidized, unsubsidized or supportive housing. Key informant interviews and two focus group interviews were conducted with 15 housing caseworkers. Data were analyzed to explore the processes by which drug users receive information about different housing subsidies and welfare benefits, and their experiences in applying for these. Results A number of unofficial policy mechanisms limit drug users' access to housing, information and services, including limited outreach to non-shelter using homeless regarding housing programs, service provider priorities, and service provider discretion in processing applications and providing services. Conclusion Unofficial policy, i.e. the mechanisms used by caseworkers to ration scarce housing resources, is as important as official housing policies in limiting drug users' access to housing. Drug users' descriptions of their experiences working with caseworkers to obtain permanent, affordable housing, provide insights as to how access to supportive and subsidized housing can be improved for this population.

77 FR 69483 - Federal Acquisition Regulation; Information Collection; Summary Subcontract Report

Science.gov (United States)

2012-11-19

... be posted without change to http://www.regulations.gov , including any personal and/or business... appropriate technological collection techniques or other forms of information technology. DATES: Submit... small business, small disadvantaged business, historically underutilized business zone (HUBZone) small...

With God's Help I Can Do It: Crack Users' Formal and Informal Recovery Experiences in El Salvador

Science.gov (United States)

Dickson-Gomez, Julia; Bodnar, Gloria; Guevara, Carmen Eugenia; Rodriguez, Karla; De Mendoza, Lorena Rivas; Corbett, A. Michelle

2013-01-01

Crack use has increased dramatically in El Salvador in the last few decades. As with other developing countries with sudden onsets of drug problems, El Salvador has few medical staff trained in addictions treatment. Little research has examined drug users' attempts to reduce or abstain from drug use in countries where government-regulated formal medical treatment for drug addiction is scarce. This paper uses qualitative and quantitative data gathered from active crack users to explore their formal and informal strategies to reduce or abstain from drugs, and compares these with components of informal and formal treatment in developed countries. PMID:20735191

The silent information regulator 1 (Sirt1) is a positive regulator of the Notch pathway in Drosophila

Czech Academy of Sciences Publication Activity Database

Horváth, Matěj; Mihajlović, Zorana; Slaninová, Věra; Perez-Gomez, Raquel; Moshkin, Y.; Krejčí, Alena

2016-01-01

Roč. 473, č. 22 (2016), s. 4129-4143 ISSN 0264-6021 R&D Projects: GA ČR(CZ) GA14-08583S Institutional support: RVO:60077344 Keywords : Drosophila * silent information regulator 1 * Notch pathway Subject RIV: EB - Genetics ; Molecular Biology Impact factor: 3.797, year: 2016

75 FR 26739 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Part 244...

Science.gov (United States)

2010-05-12

... Control Number 0704-0253) AGENCY: Defense Acquisition Regulations System, Department of Defense. ACTION... proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information..., withhold, or withdraw purchasing system approval at the conclusion of a purchasing system review...

The patient's safety and access to experimental drugs after the termination of clinical trials: regulations and trends.

Science.gov (United States)

da Silva, Ricardo Eccard; Amato, Angélica Amorim; Sousa, Thiago do Rego; de Carvalho, Marta Rodrigues; Novaes, Maria Rita Carvalho Garbi

2018-05-12

Participants' rights and safety must be guaranteed not only while a clinical trial is being conducted but also when a clinical trial finishes. The criteria for post-trial access to experimental drugs, however, are unclear in various countries. The objectives of this study were (i) to ascertain if there were regulations or guidelines related to patients' access to drugs after the end of clinical trials in the countries selected in the study and (ii) to analyze trends in post-trial access in countries classified by their level of economic development. This study is a retrospective review. The data are from the records of clinical trials from 2014 registered in the World Health Organization's International Clinical Trials Registry Platform (ICTRP) database. Among the countries selected, provision of drugs post-trial is mandatory only in Argentina, Brazil, Chile, Finland, and Peru. The plans for post-trial access tend to be more present in low- and middle-income and upper middle-income countries, in comparison with high-income countries. Studies involving vulnerable populations are 2.53 times more likely to have plans for post-trial access than studies which do not. The guaranteeing of post-trial access remains mandatory in few countries. Considering that individuals seen as vulnerable have been included in clinical trials without plans for post-trial access, stakeholders must discuss the need to develop regulations mandating the guaranteeing of post-trial access in specified situations.

Drug Facts

Medline Plus

Full Text Available ... Treatment and Recovery Resources? Prevention Help Children and Teens Stay Drug-Free Talking to Kids About Drugs: What to Say if You Used Drugs in the Past Drug Use ... Videos Information About Drugs Alcohol ...

An Effective Tri-Clustering Algorithm Combining Expression Data with Gene Regulation Information

Directory of Open Access Journals (Sweden)

Ao Li

2009-04-01

Full Text Available Motivation: Bi-clustering algorithms aim to identify sets of genes sharing similar expression patterns across a subset of conditions. However direct interpretation or prediction of gene regulatory mechanisms may be difficult as only gene expression data is used. Information about gene regulators may also be available, most commonly about which transcription factors may bind to the promoter region and thus control the expression level of a gene. Thus a method to integrate gene expression and gene regulation information is desirable for clustering and analyzing. Methods: By incorporating gene regulatory information with gene expression data, we define regulated expression values (REV as indicators of how a gene is regulated by a specific factor. Existing bi-clustering methods are extended to a three dimensional data space by developing a heuristic TRI-Clustering algorithm. An additional approach named Automatic Boundary Searching algorithm (ABS is introduced to automatically determine the boundary threshold. Results: Results based on incorporating ChIP-chip data representing transcription factor-gene interactions show that the algorithms are efficient and robust for detecting tri-clusters. Detailed analysis of the tri-cluster extracted from yeast sporulation REV data shows genes in this cluster exhibited significant differences during the middle and late stages. The implicated regulatory network was then reconstructed for further study of defined regulatory mechanisms. Topological and statistical analysis of this network demonstrated evidence of significant changes of TF activities during the different stages of yeast sporulation, and suggests this approach might be a general way to study regulatory networks undergoing transformations.

A direction to adopting risk-informed and performance-based regulation (RIPBR) in Korea

International Nuclear Information System (INIS)

Kim, W.S.; Sung, K.Y.; Lee, C.J.; Choi, Y.H.; Choi, Y.S.; Kim, H.J.

2004-01-01

The USNRC has pursued the incorporation of new regulatory approach of risk-informed and performance-based regulation (RIPBR) into nuclear safety regulation, as an alternative to improve existing nuclear safety regulation of nuclear power plants, which is deterministic and prescriptive. It focuses on the use of risk insight from probabilistic safety assessment (PSA). Recently, it becomes necessary to find a way to improve regulatory efficiency and effectiveness in order to cover the increasing regulatory needs in Korea. Also, the utility has optimized design and operation of the plant using PSA insight and equipment performance information. According to the increase of the necessity for regulatory improvement using risk and performance information, KINS (Korea Institute of Nuclear Safety) is developing, as a part of mid- and long-term project of Nuclear development program, how to adopt the RIPBR in Korean nuclear regulation. This paper presents the interim result of the study that comprises the assessment of feasibility to adopt the RIPBR, and basic directions and principles for implementing RIPBR model. It is concluded that adopting RIPBR is essential for risk management of the plant, public acceptance to nuclear safety, improvement of existing regulation, minimization of unnecessary regulatory burden, and effective use of regulatory resources, etc. Three basic directions and several principles that are necessary to implement RIPBR model are identified from the study. The application of the directions and principles to the assessment of RIPBR model to be established in the near future is expected to result in making the adoption of new regulatory system more objective and consistent. (authors)

21 CFR 601.50 - Confidentiality of data and information in an investigational new drug notice for a biological...

Science.gov (United States)

2010-04-01

... investigational new drug notice for a biological product. 601.50 Section 601.50 Food and Drugs FOOD AND DRUG... biological product. (a) The existence of an IND notice for a biological product will not be disclosed by the... availability for public disclosure of all data and information in an IND file for a biological product shall be...

77 FR 51804 - Federal Acquisition Regulation; Information Collection; Change Order Accounting

Science.gov (United States)

2012-08-27

...; Information Collection; Change Order Accounting AGENCY: Department of Defense (DOD), General Services... requirement concerning change order accounting. Public comments are particularly invited on: Whether this... 9000- 0026, Change Order Accounting by any of the following methods: Regulations.gov : http://www...

78 FR 63462 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement...

Science.gov (United States)

2013-10-24

... Relating to Organizational Conflict of Interest-Major Defense Acquisition Program; OMB Control Number 0704...] Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Organizational Conflict... submit comments, identified by OMB Control Number 0704-0477, using any of the following methods: [cir...

Functional proteomic analysis of corticosteroid pharmacodynamics in rat liver: Relationship to hepatic stress, signaling, energy regulation, and drug metabolism.

Science.gov (United States)

Ayyar, Vivaswath S; Almon, Richard R; DuBois, Debra C; Sukumaran, Siddharth; Qu, Jun; Jusko, William J

2017-05-08

Corticosteroids (CS) are anti-inflammatory agents that cause extensive pharmacogenomic and proteomic changes in multiple tissues. An understanding of the proteome-wide effects of CS in liver and its relationships to altered hepatic and systemic physiology remains incomplete. Here, we report the application of a functional pharmacoproteomic approach to gain integrated insight into the complex nature of CS responses in liver in vivo. An in-depth functional analysis was performed using rich pharmacodynamic (temporal-based) proteomic data measured over 66h in rat liver following a single dose of methylprednisolone (MPL). Data mining identified 451 differentially regulated proteins. These proteins were analyzed on the basis of temporal regulation, cellular localization, and literature-mined functional information. Of the 451 proteins, 378 were clustered into six functional groups based on major clinically-relevant effects of CS in liver. MPL-responsive proteins were highly localized in the mitochondria (20%) and cytosol (24%). Interestingly, several proteins were related to hepatic stress and signaling processes, which appear to be involved in secondary signaling cascades and in protecting the liver from CS-induced oxidative damage. Consistent with known adverse metabolic effects of CS, several rate-controlling enzymes involved in amino acid metabolism, gluconeogenesis, and fatty-acid metabolism were altered by MPL. In addition, proteins involved in the metabolism of endogenous compounds, xenobiotics, and therapeutic drugs including cytochrome P450 and Phase-II enzymes were differentially regulated. Proteins related to the inflammatory acute-phase response were up-regulated in response to MPL. Functionally-similar proteins showed large diversity in their temporal profiles, indicating complex mechanisms of regulation by CS. Clinical use of corticosteroid (CS) therapy is frequent and chronic. However, current knowledge on the proteome-level effects of CS in liver and

Developments on ASME Code Cases to Risk-Informed Repair/Replacement Activities in Support of Risk-Informed Regulation Initiatives

International Nuclear Information System (INIS)

Balkey, Kenneth R.; Holston, William C.

2002-01-01

ASME Code Case N-658, 'Risk-Informed Safety Classification for Use in Risk-Informed Repair/Replacement Activities' and Code Case N-660, 'Alternative Repair/Replacement Requirements For Items Classified In Accordance With Risk-Informed Processes' are being completed to expand the breadth of risk-informed requirements for pressure-retaining items. This initiative, which is built from prior ASME Section XI risk-informed inservice inspection developments over the past decade, has been undertaken in conjunction with U.S. risk-informed regulation efforts. The U.S. Nuclear Regulatory Commission (NRC) is working with the industry on risk informing Title 10 Code of Federal Regulations Part 50 (10CFR50). The Nuclear Regulatory Commission's basic proposal is to allow modification of some of the special treatment requirements of 10CFR50. Their effort is proceeding via an Advanced Notice of Public Rulemaking, March 3, 2000, and an announcement of Availability of Draft Rule Wording, November 29, 2001, to add 10 CFR 50.69, 'Risk-Informed Treatment of Structures, Systems and Components'. A parallel task by the Nuclear Energy Institute (NEI) to develop a guideline on how to implement the results of the rulemaking is also well underway via NEI 00-04 (Draft Revision B), 'Option 2 Implementation Guideline', May 2001. This paper summarizes the content and status of approval of the proposed ASME Code Cases, including how they relate to the above NRC and NEI efforts. Some initial results from trial application of the Code Cases will also be cited. (authors)

Electrostimulated Release of Neutral Drugs from Polythiophene Nanoparticles: Smart Regulation of Drug-Polymer Interactions.

Science.gov (United States)

Puiggalí-Jou, Anna; Micheletti, Paolo; Estrany, Francesc; Del Valle, Luis J; Alemán, Carlos

2017-09-01

Poly(3,4-ethylenedioxythiophene) (PEDOT) nanoparticles are loaded with curcumin and piperine by in situ emulsion polymerization using dodecyl benzene sulfonic acid both as a stabilizer and a doping agent. The loaded drugs affect the morphology, size, and colloidal stability of the nanoparticles. Furthermore, kinetics studies of nonstimulated drug release have evidenced that polymer···drug interactions are stronger for curcumin than for piperine. This observation suggests that drug delivery systems based on combination of the former drug with PEDOT are much appropriated to show an externally tailored release profile. This is demonstrated by comparing the release profiles obtained in presence and absence of electrical stimulus. Results indicate that controlled and time-programmed release of curcumin is achieved in a physiological medium by applying a negative voltage of -1.25 V to loaded PEDOT nanoparticles. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

78 FR 52429 - New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications; Diethylcarbamazine...

Science.gov (United States)

2013-08-23

... 558 [Docket No. FDA-2013-N-0839] New Animal Drugs; Withdrawal of Approval of New Animal Drug...: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of three new animal drug applications (NADAs) at the sponsors' request...

The availability of reliable information about medicines in Serbia for health professionals summary of product characteristics

Directory of Open Access Journals (Sweden)

Đukić Ljiljana C.

2015-01-01

Full Text Available Introduction Today, there are many drugs for the treatment of a large number of indicator areas. Significant financial resources are invested in research with the aim of introducing reliable therapeutics to therapy. Therefore, it is necessary to provide health care professionals exact information about new therapies. The overall process of scientific data, ideas and information exchange is possible through numerous communications of modern IT tools. Methodology According to the Law, key information on registered drug is included in the Summary of Product Characteristics (SPC for health professionals, which is harmonized with EU directives and regulations (SmPC.Protocol content and structure of the information provided in SPC is determined in the guidelines of the EU, therefore, a unique set of data is established for all the drugs registered in Serbia. Topic This paper presents the key segments of SPC, with special reference to the description of the regulations that are required for data related to indications, mechanism of action, dosage, contraindications, side effects, interactions and other important information regarding the profile of the drug, which are standardized and harmonized with the structure of identical documents which operate at the EU level, or EMEA. Conclusions SPC is the regulatory determined technical document on medicinal products in the RS in which there are listed scientifically proven, clinical and pharmacological data and information on the profile of the drug, which are essential for health professionals - doctors and pharmacists in the implementation of pharmacotherapy in our society. This document is the starting point for the development of applied Pharmacoinformatics and it includes a range of activities important for the development of appropriate manuals and makes available data and information for monitoring indicators of the national policy on drugs and modern effective drugs treatment.

Drug Retention Times

Energy Technology Data Exchange (ETDEWEB)

Center for Human Reliability Studies

2007-05-01

The purpose of this monograph is to provide information on drug retention times in the human body. The information provided is based on plausible illegal drug use activities that might be engaged in by a recreational drug user.

A case of psychosis after use of a detoxification kit and a review of techniques, risks, and regulations associated with the subversion of urine drug tests.

Science.gov (United States)

Mittal, Moneeshindra Singh; Kalia, Rachna; Khan, Ahsan Y

2011-01-01

The practice of drug testing in the workplace has been adopted for US federal government employees, and many state and local governments as well as private businesses have followed suit. However, a parallel industry dedicated to subverting the results of urine drug testing has emerged with little or no regulation. First, the case of a 19-year-old man who developed psychosis after the use of a detoxification kit is presented. Second, a review of the existing literature on the techniques, risks, and regulations associated with the use of drug tampering kits is provided. PubMed, Cochrane Database, and Google Scholar were searched using the keywords UDS, urine toxicology, pass the drug test, and clean UA, with no restrictions on publication date. Case reports, letters to the editor, and original research and review articles in multiple languages were reviewed, as were federal regulations and acts on the topic. The search yielded 4,082 results, of which 49 articles were selected for relevance. Some articles were later omitted as they had cited the original article and had nothing new to offer. Three commonly used tampering techniques are in vivo adulteration, urine substitution, and in vitro adulteration. Review of the literature regarding the risks involved with use of tampering kits yielded no results. In 1986, an executive order was issued requiring all federal employees to refrain from illicit drug use, and the 1988 Drug-Free Workplace Act precipitated the Substance Abuse and Mental Health Services Administration guidelines and their subsequent revisions. Recently, many states have made regulatory efforts to bring drug test defrauding under the ambit of law. Clinicians need to be aware of the tampering techniques and the possibility of false-negative urine drug tests. Cognizance of inherent risks involved with using these techniques including psychiatric and/or medical complications is also warranted. The manufacture, sale, and use of these products have little or

78 FR 20664 - Society of Clinical Research Associates-Food and Drug Administration: Food and Drug...

Science.gov (United States)

2013-04-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice AGENCY: Food and Drug...

77 FR 22247 - Veterinary Feed Directive; Draft Text for Proposed Regulation

Science.gov (United States)

2012-04-13

.... FDA-2010-N-0155] Veterinary Feed Directive; Draft Text for Proposed Regulation AGENCY: Food and Drug... the efficiency of FDA's Veterinary Feed Directive (VFD) program. The Agency is making this draft text..., rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Sharon Benz, Center for Veterinary...

Exploiting Large-Scale Drug-Protein Interaction Information for Computational Drug Repurposing

Science.gov (United States)

2014-06-20

studies that have reported antimalarial activities of azole compounds [39-43] lend support to our model predictions. The highest-scored non-malarial...Table 4, verapamil and cimetidine, do not have antimal- arial activities themselves but exhibit synergism when used in combination with antimalarial ... activators . Because of their high frequencies among the antimalarial drugs, according to Eq. 3, the drug-protein interactions contributing most to the

Emotion Regulation and Aggressive Behavior in Preschoolers: The Mediating Role of Social Information Processing

Science.gov (United States)

Helmsen, Johanna; Koglin, Ute; Petermann, Franz

2012-01-01

This study examined whether the relation between maladaptive emotion regulation and aggression was mediated by deviant social information processing (SIP). Participants were 193 preschool children. Emotion regulation and aggression were rated by teachers. Deviant SIP (i.e., attribution of hostile intent, aggressive response generation, aggressive…

AIDSinfo Drug Database

Science.gov (United States)

... AIDS Drugs Clinical Trials Apps skip to content Drugs Home Drugs Find information on FDA-approved HIV/ ... infection drugs and investigational HIV/AIDS drugs. Search Drugs Search drug Search Icon What's this? Close Popup ...

Reducing information asymmetry in the power industry: Mandatory and voluntary information disclosure regulations of sulfur dioxide emission

International Nuclear Information System (INIS)

Zhu Xufeng; Zhang Chao

2012-01-01

This paper focuses on the institutional framework for sulfur dioxide emission information disclosure (SDEID) in power industries. The authors argue that mandatory and voluntary SDEID are two complementary regulatory instruments for emission reduction in the power industry. An analytical framework of SDEID with six facets is suggested in this paper to demonstrate relevant legal provisions and regulatory policies of mandatory and voluntary SDEID of power industries in the US. Empirical research shows that mandatory and voluntary SDEID of the power industry have been regulated simultaneously in the US. The foundation of power companies' willingness to disclose emission information voluntarily is the combination of mandatory scientific monitoring with market regulation in the current SDEID system in the US. In comparison, the SDEID of power industries has yet to be widely implemented in developing countries. Finally, the paper provides some implications to developing countries that plan to learn institutional arrangements from developed countries. - Highlights: ► Mandatory and voluntary SDEID are two complementary regulatory instruments. ► An analytical framework is suggested to demonstrate SDEID of power industry in the US. ► Voluntary disclosure can be attributed to scientific monitoring and market regulation. ► We provide implications to developing countries learning from developed countries.

Antifungal therapy: drug-drug interactions at your fingertips

NARCIS (Netherlands)

Lempers, V.J.; Bruggemann, R.J.

2016-01-01

The Information Age has revolutionized the ability of healthcare professionals (HCPs) to oversee a substantial body of clinically relevant information literally at one's fingertips. In the field of clinical pharmacology, this may be particularly useful for managing drug-drug interactions (DDIs). A

Medicines Information and the Regulation of the Promotion of Pharmaceuticals.

Science.gov (United States)

Leonardo Alves, Teresa; Lexchin, Joel; Mintzes, Barbara

2018-05-02

Many factors contribute to the inappropriate use of medicines, including not only a lack of information but also inaccurate and misleading promotional information. This review examines how the promotion of pharmaceuticals directly affects the prescribing and use of medicines. We define promotion broadly as all actions taken directly by pharmaceutical companies with the aim of enhancing product sales. We look in greater detail at promotion techniques aimed at prescribers, such as sales representatives, pharmaceutical advertisements in medical journals and use of key opinion leaders, along with the quality of information provided and the effects thereof. We also discuss promotion to the public, through direct-to-consumer advertising, and its effects. Finally, we consider initiatives to regulate promotion that come from industry, government and nongovernmental organizations.