Adverse drug reaction and concepts of drug safety in Ayurveda: An overview

Science.gov (United States)

Ajanal, Manjunath; Nayak, Shradda; Prasad, Buduru Sreenivasa; Kadam, Avinash

2013-01-01

Drug safety is a very basic and fundamental concept in medical practice. ADRs play an important role in assessing patient safety in any system of medicine. Pharmacovigilance study is thus significant to understand treatment outcomes. Current raised issue with respect to complementary and alternative system medicine (CAM) like Ayurveda is increased in number of safety reports along with report misinterpretation; this generates the negative impact on system. Although, Ayurveda which is holistic system of medicine from India has elaborated the causes and methods of drug-induced consequences along with preventive measures the available data in classical texts is scattered. The compilation and analysis along with modern concept drug safety is need of the hour. Present literature review was conducted from various compendium of Ayurveda and electronic data base with search terms of ‘Vyapad’, ‘Viruddha’, ‘Ahita’, ‘herb–herb interaction’, ‘idiosyncrasy’, ‘Prakritiviruddha’ etc. The reported information was analysed for the possible correlation on concept of ADR and Pharmacovigilance of current science. Overall review demonstrated that drug interaction, iatrogenic, over dose, administration of unsuitable drugs, reprehensive drug administration with respect to disease, complication from five procedural therapies (Panchakarma) and reprehensible preparation of mineral drug are nearer to the modern causes of ADR. Thus, concept of drug safety and ADR is not new to the Ayurveda. The concept “Drug which is not appropriate to be used as medicine”(Abheshaja) of Ayurveda sounds similar as that of modern pharmacovigilance. PMID:24563588

Patient Drug Safety Reporting: Diabetes Patients' Perceptions of Drug Safety and How to Improve Reporting of Adverse Events and Product Complaints.

Science.gov (United States)

Patel, Puja; Spears, David; Eriksen, Betina Østergaard; Lollike, Karsten; Sacco, Michael

2018-03-01

Global health care manufacturer Novo Nordisk commissioned research regarding awareness of drug safety department activities and potential to increase patient feedback. Objectives were to examine patients' knowledge of pharmaceutical manufacturers' responsibilities and efforts regarding drug safety, their perceptions and experiences related to these efforts, and how these factors influence their thoughts and behaviors. Data were collected before and after respondents read a description of a drug safety department and its practices. We conducted quantitative survey research across 608 health care consumers receiving treatment for diabetes in the United States, Germany, United Kingdom, and Italy. This research validated initial, exploratory qualitative research (across 40 comparable consumers from the same countries) which served to guide design of the larger study. Before reading a drug safety department description, 55% of respondents were unaware these departments collect safety information on products and patients. After reading the description, 34% reported the department does more than they expected to ensure drug safety, and 56% reported "more confidence" in the industry as a whole. Further, 66% reported themselves more likely to report an adverse event or product complaint, and 60% reported that they were more likely to contact a drug safety department with questions. The most preferred communication methods were websites/online forums (39%), email (27%), and telephone (25%). Learning about drug safety departments elevates consumers' confidence in manufacturers' safety efforts and establishes potential for patients to engage in increased self-monitoring and reporting. Study results reveal potentially actionable insights for the industry across patient and physician programs and communications.

Impact of biomarker development on drug safety assessment

International Nuclear Information System (INIS)

Marrer, Estelle; Dieterle, Frank

2010-01-01

Drug safety has always been a key aspect of drug development. Recently, the Vioxx case and several cases of serious adverse events being linked to high-profile products have increased the importance of drug safety, especially in the eyes of drug development companies and global regulatory agencies. Safety biomarkers are increasingly being seen as helping to provide the clarity, predictability, and certainty needed to gain confidence in decision making: early-stage projects can be stopped quicker, late-stage projects become less risky. Public and private organizations are investing heavily in terms of time, money and manpower on safety biomarker development. An illustrative and 'door opening' safety biomarker success story is the recent recognition of kidney safety biomarkers for pre-clinical and limited translational contexts by FDA and EMEA. This milestone achieved for kidney biomarkers and the 'know how' acquired is being transferred to other organ toxicities, namely liver, heart, vascular system. New technologies and molecular-based approaches, i.e., molecular pathology as a complement to the classical toolbox, allow promising discoveries in the safety biomarker field. This review will focus on the utility and use of safety biomarkers all along drug development, highlighting the present gaps and opportunities identified in organ toxicity monitoring. A last part will be dedicated to safety biomarker development in general, from identification to diagnostic tests, using the kidney safety biomarkers success as an illustrative example.

Development of safety analysis technology for integral reactor; evaluation on safety concerns of integral reactor

Energy Technology Data Exchange (ETDEWEB)

Kim, Hee Chul; Kim, Woong Sik; Lee, J. H. [Korea Institute of Nuclear Safety, Taejeon (Korea)

2002-03-01

The Nuclear Desalination Plant (NDP) is being developed to produce electricity and fresh water, and is expected to locate near population zone. In the aspect of safety, it is required to protect the public and environment from the possible releases of fission products and to prevent the fresh water from the contamination of radioactivity. Thus, in this study, the safety characteristics of the integral reactor adopting passive and inherent safety features significantly different from existing nuclear power plants were investigated. Also, safety requirements applicable to the NDP were analyzed based on the regulatory requirements for current light water reactor and advanced reactor designs, and user requirements for small-medium size reactors. Based on these analyses, some safety concerns to be considered in the design stage have been identified and discussed. They include the use of proven technology for new safety features, systematic event classification and selection, strengthening containment function, and the safety impacts on desalination-related systems. The study presents the general safety requirements applicable to licensing of an integral reactor and suggests additional regulatory requirements, which need to be developed, based on the direction to resolution of the safety concerns. The efforts to identify and technically resolve the safety concerns in the design stage will provide the early confidence of SMART safety and the technical basis to evaluate the safety to designers and reviewers in the future. Suggestion on the development of additional regulatory requirements will contribute for the regulator to taking actions for licensing of an integral reactor. 66 refs., 5 figs., 24 tabs. (Author)

A Study on Drug Safety Monitoring Program in India

Science.gov (United States)

Ahmad, A.; Patel, Isha; Sanyal, Sudeepa; Balkrishnan, R.; Mohanta, G. P.

2014-01-01

Pharmacovigilance is useful in assuring the safety of medicines and protecting the consumers from their harmful effects. A number of single drugs as well as fixed dose combinations have been banned from manufacturing, marketing and distribution in India. An important issue about the availability of banned drugs over the counter in India is that sufficient adverse drug reactions data about these drugs have not been reported. The most common categories of drugs withdrawn in the last decade were nonsteroidal antiinflammatory drugs (28%), antidiabetics (14.28%), antiobesity (14.28%), antihistamines (14.28%), gastroprokinetic drugs (7.14%), breast cancer and infertility drugs (7.14%), irritable bowel syndrome and constipation drugs (7.14%) and antibiotics (7.14%). Drug withdrawals from market were made mainly due to safety issues involving cardiovascular events (57.14%) and liver damage (14.28%). Majority of drugs have been banned since 3-5 years in other countries but are still available for sale in India. The present study compares the drug safety monitoring systems in the developed countries such as the USA and UK and provides implications for developing a system that can ensure the safety and efficacy of drugs in India. Absence of a gold standard for a drug safety surveillance system, variations in culture and clinical practice across countries makes it difficult for India to completely adopt another country's practices. There should be a multidisciplinary approach towards drug safety that should be implemented throughout the entire duration spanning from drug discovery to usage by consumers. PMID:25425751

Mothers' Concerns for Personal Safety and Privacy While Breastfeeding: An Unexplored Phenomenon.

Science.gov (United States)

Rosen-Carole, Casey; Allen, Katherine; Fagnano, Maria; Dozier, Ann; Halterman, Jill

2018-04-01

Preliminary qualitative research in upstate NY shows new mothers are worried about safety while breastfeeding. Little is known regarding prevalence of these concerns and their effect on breastfeeding outcomes. (1) Determine frequency of breastfeeding safety and privacy concerns; (2) Explore their association with breastfeeding outcomes. Mothers were surveyed immediately and 1-month postpartum about breastfeeding goals; both surveys addressed privacy and safety concerns at home, work, and in public. Outcome data included breastfeeding intent, exclusivity, and duration. Breastfeeding/non-breastfeeding mothers were compared using Chi-square and multivariate analyses. A total of 279 women enrolled. Of these 82.8% initiated breastfeeding; at 1-month 72% provided any breast milk, and 44% were exclusively breastfeeding. About 99% felt safe breastfeeding at home; 25% reported privacy concerns; and 5% felt "vulnerable or unsafe" while breastfeeding. At 1-month, 49% agreed there was a safe place to breastfeed/express milk at work (20% unsure). Non-breastfeeding mothers expressed more safety concerns outside home/at work: 18% breastfeeding versus 28% non-breastfeeding outside home; 27% breastfeeding versus 40% non-breastfeeding at work. Nearly 54% who reported feeling vulnerable/unsafe with breastfeeding initiated breastfeeding, compared with 86% not reporting this concern (p = 0.008). Fewer women initiating breastfeeding reported vulnerability/safety (3% breastfeeding versus 14% non-breastfeeding, p = 0.008) or privacy (22% breastfeeding versus 40% non-breastfeeding, p = 0.19) concerns. Associations held after controlling for age, race, parity, insurance, geography, and marital-status. Significant associations between initiation, privacy, and safety concerns did not extend to duration or exclusivity. Many breastfeeding women reported safety and privacy concerns, especially outside the home and at work, which may influence breastfeeding initiation. Further study

FDA drug safety communications: a narrative review and clinical considerations for older adults.

Science.gov (United States)

Marcum, Zachary A; Vande Griend, Joseph P; Linnebur, Sunny A

2012-08-01

The US Food and Drug Administration (FDA) has new regulatory authorities intended to enhance drug safety monitoring in the postmarketing period. This has resulted in an increase in communication from the FDA in recent years about the safety profile of certain drugs. It is important to stay abreast of the current literature on drug risks to effectively communicate these risks to patients, other health care providers, and the general public. To summarize 4 new FDA drug safety communications by describing the evidence supporting the risks and the clinical implications for older adults. The FDA Web site was reviewed for new drug safety communications from May 2011 to April 2012 that would be relevant to older adults. Approved labeling for each drug or class was obtained from the manufacturer, and PubMed was searched for primary literature that supported the drug safety concern. FDA drug safety communications for 4 drugs were chosen because of the potential clinical importance in older adults. A warning for citalopram was made because of potential problems with QT prolongation in patients taking less than 40 mg per day. The evidence suggests minor changes in QT interval. Given the flat dose-response curve in treating depression with citalopram, the new 20-mg/d maximum dose in older adults is sensible. Another warning was made for proton pump inhibitors (PPIs) and an increased risk of Clostridium difficile infection. A dose-response relationship was found for this drug risk. With C. difficile infections on the rise in older adults, along with other safety risks of PPI therapy, PPIs should only be used in older adults indicated for therapy for the shortest duration possible. In addition, a warning about dabigatran was made. There is strong evidence from a large clinical trial, as well as case reports, of increased bleeding risk in older adults taking dabigatran, especially in older adults with decreased renal function. This medication should be used with caution in older

Physician attitudes towards pharmacological cognitive enhancement: safety concerns are paramount.

Directory of Open Access Journals (Sweden)

Opeyemi C Banjo

2010-12-01

Full Text Available The ethical dimensions of pharmacological cognitive enhancement have been widely discussed in academic circles and the popular media, but missing from the conversation have been the perspectives of physicians - key decision makers in the adoption of new technologies into medical practice. We queried primary care physicians in major urban centers in Canada and the United States with the aim of understanding their attitudes towards cognitive enhancement. Our primary hypothesis was that physicians would be more comfortable prescribing cognitive enhancers to older patients than to young adults. Physicians were presented with a hypothetical pharmaceutical cognitive enhancer that had been approved by the regulatory authorities for use in healthy adults, and was characterized as being safe, effective, and without significant adverse side effects. Respondents overwhelmingly reported increasing comfort with prescribing cognitive enhancers as the patient age increased from 25 to 65. When asked about their comfort with prescribing extant drugs that might be considered enhancements (sildenafil, modafinil, and methylphenidate or our hypothetical cognitive enhancer to a normal, healthy 40 year old, physicians were more comfortable prescribing sildenafil than any of the other three agents. When queried as to the reasons they answered as they did, the most prominent concerns physicians expressed were issues of safety that were not offset by the benefit afforded the individual, even in the face of explicit safety claims. Moreover, many physicians indicated that they viewed safety claims with considerable skepticism. It has become routine for safety to be raised and summarily dismissed as an issue in the debate over pharmacological cognitive enhancement; the observation that physicians were so skeptical in the face of explicit safety claims suggests that such a conclusion may be premature. Thus, physician attitudes suggest that greater weight be placed upon the

Cyber-pharmacies and emerging concerns on marketing drugs online

Directory of Open Access Journals (Sweden)

Vinod Scaria

2003-08-01

Full Text Available The booming e-commerce and a regulation-less environment online have led to the rise of a new generation of websites that market drugs and other products over the Internet. Some of these drugs are often herbal products or of dubious quality, often marketed with a mix of professional design and unverified/fraudulent claims. Several concerns have arisen from different corners and evidence of malpractice has emerged. But there is a lack of sufficient evidence confirming the concerns.

Best practices: an electronic drug alert program to improve safety in an accountable care environment.

Science.gov (United States)

Griesbach, Sara; Lustig, Adam; Malsin, Luanne; Carley, Blake; Westrich, Kimberly D; Dubois, Robert W

2015-04-01

The accountable care organization (ACO), one of the most promising and talked about new models of care, focuses on improving communication and care transitions by tying potential shared savings to specific clinical and financial benchmarks. An important factor in meeting these benchmarks is an ACO's ability to manage medications in an environment where medical and pharmacy care has been integrated. The program described in this article highlights the critical components of Marshfield Clinic's Drug Safety Alert Program (DSAP), which focuses on prioritizing and communicating safety issues related to medications with the goal of reducing potential adverse drug events. Once the medication safety concern is identified, it is reviewed to evaluate whether an alert warrants sending prescribers a communication that identifies individual patients or a general communication to all physicians describing the safety concern. Instead of basing its decisions regarding clinician notification about drug alerts on subjective criteria, the Marshfield Clinic's DSAP uses an internally developed scoring system. The scoring system includes criteria developed from previous drug alerts, such as level of evidence, size of population affected, severity of adverse event identified or targeted, litigation risk, available alternatives, and potential for duration of medication use. Each of the 6 criteria is assigned a weight and is scored based upon the content and severity of the alert received.  In its first 12 months, the program targeted 6 medication safety concerns involving the following medications: topiramate, glyburide, simvastatin, citalopram, pioglitazone, and lovastatin. Baseline and follow-up prescribing data were gathered on the targeted medications. Follow-up review of prescribing data demonstrated that the DSAP provided quality up-to-date safety information that led to changes in drug therapy and to decreases in potential adverse drug events. In aggregate, nearly 10,000 total

International antiterrorist conventions concerning the safety of air transport

Directory of Open Access Journals (Sweden)

Jacek BARCIK

2008-01-01

Full Text Available In this article the international law regulations are presented concerning the civilian safety of the air transport. The history concerning air terrorism and international antiterrorist conventions was described in detail, involving The Chicago Convention, The Tokyo Convention, The Hague Convention and Montreal Convention.

The importance of Pharmacovigilance for the drug safety: Focus on cardiovascular profile of incretin-based therapy.

Science.gov (United States)

Sportiello, Liberata; Rafaniello, Concetta; Scavone, Cristina; Vitale, Cristiana; Rossi, Francesco; Capuano, Annalisa

2016-01-01

With the recent introduction of the new European Pharmacovigilance legislation, all new drugs must be carefully monitored after admission on the European market, in order to assess the long safety profile. Currently, special attention is given to several hypoglycemic agents with recent market approval (agonists of glucagon-like peptide-1 [GLP-1] receptor and dipeptidyl peptidase 4 inhibitors [DPP-4i]), which act through the potentiation of incretin hormone signaling. Their inclusion in European additional monitoring is also due to safety problems, which seem to characterize their pharmacological class. In fact, these drugs initially showed a good tolerability profile with mainly gastrointestinal adverse events, low risk of hypoglycemia and minor effects on body weight. But, new concerns such as infections, pancreatitis, pancreatic cancer and above all cardiovascular events (especially risk of heart failure requiring hospitalization) are now arising. In this review, we highlighted aspects of the new Pharmacovigilance European dispositions, and then we investigated the tolerability profile of incretin-based therapies, in particular DPP-4 inhibitors. Notably, we focused our attention on new safety concerns, which are emerging mostly in the post-marketing period, as the cardiovascular risk profile. Evidence in literature and opinions of regulatory agencies (e.g., European Medicines Agency and Food and Drug Administration) about risks of incretin-based therapies are yet controversial, and there are many open questions in particular on cancer and cardiovascular effects. Thus, it is important to continue to monitor closely the use of these drugs in clinical practice to improve the knowledge on their long-term safety and their place in diabetes therapy. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Specialty pharmacies and other restricted drug distribution systems: financial and safety considerations for patients and health-system pharmacists.

Science.gov (United States)

Kirschenbaum, Bonnie E

2009-12-15

To discuss the role of restricted drug distribution systems in the implementation of risk evaluation and mitigation strategies (REMS), health-system pharmacists' concerns associated with the use of specialty pharmacies and other restricted drug distribution systems, reimbursement policies for high-cost specialty drugs, supply chain models for traditional and specialty drugs, and emerging trends in the management of and reimbursement for specialty pharmaceuticals. Restricted drug distribution systems established by pharmaceutical manufacturers, specialty pharmacies, or other specialty suppliers may be a component of REMS, which are required by the Food and Drug Administration for the management of known or potential serious risks from certain drugs. Concerns of health-system pharmacists using specialty suppliers include access to pharmaceuticals, operational challenges, product integrity, financial implications, continuity of care, and patient safety. An ambulatory care patient taking a specialty drug product from home to a hospital outpatient clinic or inpatient setting for administration, a practice known as "brown bagging," raises concerns about product integrity and institutional liability. An institution's finances, tolerance for liability, and ability to skillfully manage the processes involved often determine its choice between an approach that prohibits brown bagging but is costly and one that permits the practice under certain conditions and is less costly. The recent shift from a traditional supply chain model to a specialty pharmacy supply chain model for high-cost pharmaceuticals has the potential to increase pharmaceutical costs for health systems. A dialogue is needed between health-system pharmacists and group purchasing organizations to address the latter's role in mitigating the financial implications of this change and to help clarify the safety issues. Some health plans have shifted part of the cost of expensive drugs to patients by establishing a

Systematic drug safety evaluation based on public genomic expression (Connectivity Map) data: myocardial and infectious adverse reactions as application cases.

Science.gov (United States)

Wang, Kejian; Weng, Zuquan; Sun, Liya; Sun, Jiazhi; Zhou, Shu-Feng; He, Lin

2015-02-13

Adverse drug reaction (ADR) is of great importance to both regulatory agencies and the pharmaceutical industry. Various techniques, such as quantitative structure-activity relationship (QSAR) and animal toxicology, are widely used to identify potential risks during the preclinical stage of drug development. Despite these efforts, drugs with safety liabilities can still pass through safety checkpoints and enter the market. This situation raises the concern that conventional chemical structure analysis and phenotypic screening are not sufficient to avoid all clinical adverse events. Genomic expression data following in vitro drug treatments characterize drug actions and thus have become widely used in drug repositioning. In the present study, we explored prediction of ADRs based on the drug-induced gene-expression profiles from cultured human cells in the Connectivity Map (CMap) database. The results showed that drugs inducing comparable ADRs generally lead to similar CMap expression profiles. Based on such ADR-gene expression association, we established prediction models for various ADRs, including severe myocardial and infectious events. Drugs with FDA boxed warnings of safety liability were effectively identified. We therefore suggest that drug-induced gene expression change, in combination with effective computational methods, may provide a new dimension of information to facilitate systematic drug safety evaluation. Copyright © 2015 Elsevier Inc. All rights reserved.

Ayurveda formulations: A roadmap to address the safety concerns

Directory of Open Access Journals (Sweden)

Kishor Patwardhan

2017-10-01

Full Text Available It is a matter of serious concern that the number of case reports pointing at a possible association between the clinical toxicity and the use of Ayurveda formulations is increasing significantly over the years in scientific medical literature. Though most of these cases are connected with the presence of heavy metals such as lead, mercury and arsenic in these formulations, there are also reports suggesting toxicity due to the presence of toxic chemicals of herbal origin. In the year 2008, the Government of India took an initiative of establishing the National Pharmacovigilance Programme for Ayurveda, Siddha and Unani drugs in a structured way. However, due to lack of sustained support, this program has now become defunct. This issue is of vital importance and needs to be addressed effectively on a priority basis. In this communication, we propose the following crucial policy interventions to be introduced at different levels: a. Amendments to Drug and Cosmetic Act, b. Issuing consumer guidelines, c. Issuing prescription guidelines, d. Issuing clinical monitoring guidelines, e. Implementation of good manufacturing guidelines, f. Promoting documentation of clinical safety, g. Identifying the sources of contamination, and, h. Provision for stringent punishment. If these policy interventions are taken up and implemented, a significant positive change in the scenario can be expected in the near future.

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.

Human rights vs. Public safety -- When can you test your workers for drugs?

Energy Technology Data Exchange (ETDEWEB)

Kossowan, B. L.

2002-06-01

Legislative and regulatory aspects of drug testing of employees vs. public safety are discussed. While in Canada federal and provincial laws concerning human rights take precedence over public safety issues, laws and regulations vary from province to province, therefore there is good reason for concern about uncertainty. To compound the uncertainty, certain relevant laws of the United States are different (generally more stringent than corresponding Canadian laws), consequently there is the possibility that certain American companies might feel justified in refusing to do business with Canadian firms that do not follow their rigid standards. The conclusion is that while the situation may be clear enough in a legal situation, it does not always work equally well in practice. Unfortunately, at the present time there is not a whole lot of guidance available for companies to manage the workplace in a practical sense.

Global patient safety and antiretroviral drug-drug interactions in the resource-limited setting.

Science.gov (United States)

Seden, Kay; Khoo, Saye H; Back, David; Byakika-Kibwika, Pauline; Lamorde, Mohammed; Ryan, Mairin; Merry, Concepta

2013-01-01

Scale-up of HIV treatment services may have contributed to an increase in functional health facilities available in resource-limited settings and an increase in patient use of facilities and retention in care. As more patients are reached with medicines, monitoring patient safety is increasingly important. Limited data from resource-limited settings suggest that medication error and antiretroviral drug-drug interactions may pose a significant risk to patient safety. Commonly cited causes of medication error in the developed world include the speed and complexity of the medication use cycle combined with inadequate systems and processes. In resource-limited settings, specific factors may contribute, such as inadequate human resources and high disease burden. Management of drug-drug interactions may be complicated by limited access to alternative medicines or laboratory monitoring. Improving patient safety by addressing the issue of antiretroviral drug-drug interactions has the potential not just to improve healthcare for individuals, but also to strengthen health systems and improve vital communication among healthcare providers and with regulatory agencies.

Pre-Exposure Prophylaxis for HIV Prevention : Safety Concerns

NARCIS (Netherlands)

Tetteh, Raymond A; Yankey, Barbara A; Nartey, Edmund T; Lartey, Margaret; Leufkens, Hubert G M; Dodoo, Alexander N O

Available evidence supports the efficacy of pre-exposure prophylaxis (PrEP) in decreasing the incidence of human immunodeficiency virus (HIV) infection among high-risk individuals, especially when used in combination with other behavioural preventive methods. Safety concerns about PrEP present

[Post-marketing drug safety-risk management plan(RMP)].

Science.gov (United States)

Ezaki, Asami; Hori, Akiko

2013-03-01

The Guidance for Risk Management Plan(RMP)was released by the Ministry of Health, Labour and Welfare in April 2012. The RMP consists of safety specifications, pharmacovigilance plans and risk minimization action plans. In this paper, we outline post-marketing drug safety operations in PMDA and the RMP, with examples of some anticancer drugs.

Safety concerns and risk management of multiple sclerosis therapies

DEFF Research Database (Denmark)

Soelberg Sorensen, P.

2017-01-01

Currently, more than ten drugs have been approved for treatment of relapsing-remitting multiple sclerosis (MS). Newer treatments may be more effective, but have less favorable safety record. Interferon-β preparations and glatiramer acetate treatment require frequent subcutaneous or intramuscular...... disease activity can choose between dimethyl fumarate and teriflunomide or the “old injectable.” Patients with very active MS may choose a more effective drug as the initial treatment. In case of side effects on one drug, switch to another drug can be tried. Suboptimal effect of the first drug indicates...... escalation to a highly efficacious drug. A favorable benefit-risk balance can be maintained by appropriate patient selection and appropriate risk management on therapy. New treatments will within the coming 1-2 years change our current treatment algorithm for relapsing-remitting MS....

Food safety concerns of fast food consumers in urban Ghana.

Science.gov (United States)

Omari, Rose; Frempong, Godfred

2016-03-01

In Ghana, out-of-home ready-to-eat foods including fast food generally have been associated with food safety problems. Notwithstanding, fast food production and consumption are increasing in Ghana and therefore this study sought to determine the food safety issues of importance to consumers and the extent to which they worry about them. First, through three focus group discussions on consumers' personal opinions about food safety issues, some emergent themes were obtained, which were used to construct an open-ended questionnaire administered face-to-face to 425 respondents systematically sampled from 20 fast food restaurants in Accra. Findings showed that most fast food consumers were concerned about food hazards such as pesticide residue in vegetables, excessive use of artificial flavour enhancers and colouring substances, bacterial contamination, migrated harmful substances from plastic packages, and general unhygienic conditions under which food is prepared and sold. Consumers also raised concerns about foodborne diseases such as cholera, typhoid, food poisoning, diarrhoea, bird flu and swine flu. The logistic regression model showed that being male increased the likelihood of worrying about general food safety issues and excessive use of flavour enhancers than in females while being youthful increased the likelihood of being worried about typhoid fever than in older consumers. These findings imply that consumers in urban Ghana are aware and concerned about current trends of food safety and foodborne disease challenges in the country. Therefore, efforts targeted at improving food safety and reducing incidences of foodborne diseases should not only focus on public awareness creation but should also design more comprehensive programmes to ensure the making of food safety rules and guidelines and enforcing compliance to facilitate availability and consumers' choice of safe foods. Copyright © 2015 Elsevier Ltd. All rights reserved.

'Speaking up' about patient safety concerns and unprofessional behaviour among residents: validation of two scales.

Science.gov (United States)

Martinez, William; Etchegaray, Jason M; Thomas, Eric J; Hickson, Gerald B; Lehmann, Lisa Soleymani; Schleyer, Anneliese M; Best, Jennifer A; Shelburne, Julia T; May, Natalie B; Bell, Sigall K

2015-11-01

To develop and test the psychometric properties of two new survey scales aiming to measure the extent to which the clinical environment supports speaking up about (a) patient safety concerns and (b) unprofessional behaviour. Residents from six large US academic medical centres completed an anonymous, electronic survey containing questions regarding safety culture and speaking up about safety and professionalism concerns. Confirmatory factor analysis supported two separate, one-factor speaking up climates (SUCs) among residents; one focused on patient safety concerns (SUC-Safe scale) and the other focused on unprofessional behaviour (SUC-Prof scale). Both scales had good internal consistency (Cronbach's α>0.70) and were unique from validated safety and teamwork climate measures (rspeaking up behaviour about safety and professionalism concerns (r=0.21, pspeaking up behaviour among residents. These two scales may fill an existing gap in residency and safety culture assessments by measuring the openness of communication about safety and professionalism concerns, two important aspects of safety culture that are under-represented in existing metrics. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Food colors: Existing and emerging food safety concerns.

Science.gov (United States)

Oplatowska-Stachowiak, Michalina; Elliott, Christopher T

2017-02-11

Food colors are added to different types of commodities to increase their visual attractiveness or to compensate for natural color variations. The use of these additives is strictly regulated in the European Union, the United States, and many other countries worldwide. There is a growing concern about the safety of some commonly used legal food colorants and there is a trend to replace the synthetic forms with natural products. Additionally, a number of dyes with known or suspected genotoxic or carcinogenic properties have been shown to be added illegally to foods. Robust monitoring programs based on reliable detection methods are required to assure the food is free from harmful colors. The aim of this review is to present an up to date status of the various concerns arising from use of color additives in food. The most important food safety concerns in the field of food colors are lack of uniform regulation concerning legal food colors worldwide, possible link of artificial colors to hyperactive behavior, replacement of synthetic colors with natural ones, and the presence of harmful illegal dyes-both known but also new, emerging ones in food. The legal status of food color additives in the EU, United States, and worldwide is summarized. The reported negative health effects of both legal and illegal colors are presented. The European Rapid Alert System for Food and Feed notifications and US import alerts concerning food colors are analyzed and trends in fraudulent use of color additives identified. The detection methods for synthetic colors are also reviewed.

Concern about the Expanding Prescription Drug Epidemic: A Survey of Licensed Prescribers and Dispensers.

Science.gov (United States)

Wright, R Eric; Reed, Nia; Carnes, Neal; Kooreman, Harold E

2016-01-01

Prescription drug misuse and abuse has reached epidemic levels in the U.S., and stands as a leading cause of death. As the primary gatekeepers to the medications contributing to this epidemic, it is critical to understand the views of licensed health care professionals. In this study, we examine health care professionals' concern regarding prescription drug abuse in their communities and the impact their concern has had on their prescribing and dispensing practices. An online survey of licensed health care providers. Conducted in Indiana. This study was a state-wide evaluation of Indiana's prescription drug monitoring program. The questionnaire asked respondents how concerned they were about prescription drug abuse in their community. Variation in the level of concern was examined using ordinary least squares regression and information about the respondents' demographic background and clinical experience. In addition, we used logistic regression to examine whether concern was associated with changing prescribing and/or dispensing behavior. The majority of providers indicated they were "moderately" or "extremely concerned" about prescription drug abuse in their communities. The level of concern, however, varied significantly by profession, with pharmacists, physicians, nurse practitioners/physician assistants being more concerned than dentists. Additional analyses indicate that providers with higher levels of concern were those who also reported recently changing their prescribing and/or dispensing behavior. The voluntary nature and geographical focus of the study limits the generalizability of the findings. Concern about prescription drug abuse is generally high across the major health care professions; however, a significant minority of providers, particularly among dentists, expressed little or no concern about the epidemic. Increasing health care providers' general level of concern about prescription drug abuse may be an effective public health tool for

Nonsteroidal anti-inflammatory drug gastropathy: new avenues for safety.

Science.gov (United States)

Roth, Sanford H

2011-01-01

Chronic oral or systemic nonselective nonsteroidal anti-inflammatory drug (NSAID) therapy, ubiquitously used by physicians to treat osteoarthritis-associated pain, is associated with a wide range of symptomatic adverse events, the most frequent and serious of which is gastropathy. Although cardiovascular and renal problems are a very real concern, they are significantly less frequent. These complications can be life-threatening in at-risk populations such as older adults, who are common users of long-term oral systemic NSAID therapy. Topical NSAID formulations deliver effective doses of analgesics directly to the affected joints, thereby limiting systemic exposure and potentially the risk of systemic adverse events, such as gastropathy and serious cardiovascular events. There are currently two topical NSAIDs approved by the US Food and Drug Administration for osteoarthritis-associated pain, as well as for the signs and symptoms of osteoarthritis. This review discusses the relative safety, and the gastrointestinal, cardiovascular, and renal risks of chronic oral or systemic NSAID therapy and topical NSAID formulations in patients with osteoarthritis.

76 FR 59142 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

Science.gov (United States)

2011-09-23

...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the...., [[Page 59143

Systematic drug safety evaluation based on public genomic expression (Connectivity Map) data: Myocardial and infectious adverse reactions as application cases

International Nuclear Information System (INIS)

Wang, Kejian; Weng, Zuquan; Sun, Liya; Sun, Jiazhi; Zhou, Shu-Feng; He, Lin

2015-01-01

Adverse drug reaction (ADR) is of great importance to both regulatory agencies and the pharmaceutical industry. Various techniques, such as quantitative structure–activity relationship (QSAR) and animal toxicology, are widely used to identify potential risks during the preclinical stage of drug development. Despite these efforts, drugs with safety liabilities can still pass through safety checkpoints and enter the market. This situation raises the concern that conventional chemical structure analysis and phenotypic screening are not sufficient to avoid all clinical adverse events. Genomic expression data following in vitro drug treatments characterize drug actions and thus have become widely used in drug repositioning. In the present study, we explored prediction of ADRs based on the drug-induced gene-expression profiles from cultured human cells in the Connectivity Map (CMap) database. The results showed that drugs inducing comparable ADRs generally lead to similar CMap expression profiles. Based on such ADR-gene expression association, we established prediction models for various ADRs, including severe myocardial and infectious events. Drugs with FDA boxed warnings of safety liability were effectively identified. We therefore suggest that drug-induced gene expression change, in combination with effective computational methods, may provide a new dimension of information to facilitate systematic drug safety evaluation. - Highlights: • Drugs causing common toxicity lead to similar in vitro gene expression changes. • We built a model to predict drug toxicity with drug-specific expression profiles. • Drugs with FDA black box warnings were effectively identified by our model. • In vitro assay can detect severe toxicity in the early stage of drug development

Systematic drug safety evaluation based on public genomic expression (Connectivity Map) data: Myocardial and infectious adverse reactions as application cases

Energy Technology Data Exchange (ETDEWEB)

Wang, Kejian, E-mail: kejian.wang.bio@gmail.com [Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, Shanghai (China); Weng, Zuquan [Japan National Institute of Occupational Safety and Health, Kawasaki (Japan); Sun, Liya [Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, Shanghai (China); Sun, Jiazhi; Zhou, Shu-Feng [Department of Pharmaceutical Sciences, College of Pharmacy, University of South Florida, Tampa, FL (United States); He, Lin, E-mail: helin@Bio-X.com [Bio-X Institutes, Key Laboratory for the Genetics of Developmental and Neuropsychiatric Disorders, Shanghai Jiao Tong University, Shanghai (China)

2015-02-13

Adverse drug reaction (ADR) is of great importance to both regulatory agencies and the pharmaceutical industry. Various techniques, such as quantitative structure–activity relationship (QSAR) and animal toxicology, are widely used to identify potential risks during the preclinical stage of drug development. Despite these efforts, drugs with safety liabilities can still pass through safety checkpoints and enter the market. This situation raises the concern that conventional chemical structure analysis and phenotypic screening are not sufficient to avoid all clinical adverse events. Genomic expression data following in vitro drug treatments characterize drug actions and thus have become widely used in drug repositioning. In the present study, we explored prediction of ADRs based on the drug-induced gene-expression profiles from cultured human cells in the Connectivity Map (CMap) database. The results showed that drugs inducing comparable ADRs generally lead to similar CMap expression profiles. Based on such ADR-gene expression association, we established prediction models for various ADRs, including severe myocardial and infectious events. Drugs with FDA boxed warnings of safety liability were effectively identified. We therefore suggest that drug-induced gene expression change, in combination with effective computational methods, may provide a new dimension of information to facilitate systematic drug safety evaluation. - Highlights: • Drugs causing common toxicity lead to similar in vitro gene expression changes. • We built a model to predict drug toxicity with drug-specific expression profiles. • Drugs with FDA black box warnings were effectively identified by our model. • In vitro assay can detect severe toxicity in the early stage of drug development.

78 FR 20327 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

Science.gov (United States)

2013-04-04

... Management Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice... of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management... Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee...

Aviation Safety Concerns for the Future

Science.gov (United States)

Smith, Brian E.; Roelen, Alfred L. C.; den Hertog, Rudi

2016-01-01

The Future Aviation Safety Team (FAST) is a multidisciplinary international group of aviation professionals that was established to identify possible future aviation safety hazards. The principle was adopted that future hazards are undesirable consequences of changes, and a primary activity of FAST became identification and prioritization of possible future changes affecting aviation. Since 2004, FAST has been maintaining a catalogue of "Areas of Change" (AoC) that could potentially influence aviation safety. The horizon for such changes is between 5 to 20 years. In this context, changes must be understood as broadly as possible. An AoC is a description of the change, not an identification of the hazards that result from the change. An ex-post analysis of the AoCs identified in 2004 demonstrates that changes catalogued many years previous were directly implicated in the majority of fatal aviation accidents over the past ten years. This paper presents an overview of the current content of the AoC catalogue and a subsequent discussion of aviation safety concerns related to these possible changes. Interactions among these future changes may weaken critical functions that must be maintained to ensure safe operations. Safety assessments that do not appreciate or reflect the consequences of significant interaction complexity will not be fully informative and can lead to inappropriate trade-offs and increases in other risks. The FAST strongly encourages a system-wide approach to safety risk assessment across the global aviation system, not just within the domain for which future technologies or operational concepts are being considered. The FAST advocates the use of the "Areas of Change" concept, considering that several possible future phenomena may interact with a technology or operational concept under study producing unanticipated hazards.

Cause-specific cardiovascular risk associated with nonsteroidal antiinflammatory drugs among healthy individuals

DEFF Research Database (Denmark)

Fosbøl, Emil Loldrup; Folke, Fredrik; Jacobsen, Søren

2010-01-01

Studies have raised concern on the cardiovascular safety of nonsteroidal antiinflammatory drugs (NSAIDs). We studied safety of NSAID therapy in a nationwide cohort of healthy individuals.......Studies have raised concern on the cardiovascular safety of nonsteroidal antiinflammatory drugs (NSAIDs). We studied safety of NSAID therapy in a nationwide cohort of healthy individuals....

Drug safety: withdrawn medications are only part of the picture.

Science.gov (United States)

Rawson, Nigel S B

2016-02-13

In a research article published in BMC Medicine, Onakpoya and colleagues provide a historical review of withdrawals of medications for safety reasons. However, withdrawn medications are only one part of the picture about how regulatory agencies manage drug risks. Moreover, medications introduced before the increased pre-marketing regulations and post-marketing monitoring systems instituted after the thalidomide tragedy have little relevance when considering the present drug safety picture because the circumstances under which they were introduced were completely different. To more fully understand drug safety management and regulatory agency actions, withdrawals should be evaluated within the setting and timeframe in which the medications are approved, which requires information about approvals and safety warnings. Studies are needed that provide a more comprehensive current picture of the identification and evaluation of drug safety risks as well as how regulatory agencies deal with them. Please see related research article: http://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-016-0553-2.

Safety and efficacy of drugs in pregnancy.

Science.gov (United States)

Knoppert, David

2011-01-01

Although most drugs are used to treat chronic or pregnancy-induced conditions during pregnancy and lactation, very few are studied in pregnant or breastfeeding women. The information we have on drugs taken during pregnancy and lactation is usually obtained after market approval through published case reports or case series and from pregnancy exposure or retrospective birth defect registries. Furthermore, generic drugs approved for use in this vulnerable population may be approved based on results from a male trial population. This disregards the changes that can occur during pregnancy which can affect the pharmacokinetics of drugs. In an effort to improve the information provided to prescribers, in 2008 the United States Food and Drug Administration proposed a change in product labelling where information from pregnancy exposure registries would be required. As of 2009, European Medicines Agency requires additional statements on use during pregnancy within drug labelling information. In Canada, it is anticipated that the efficacy and safety of drugs in pregnancy will be included under the Drug Safety and Effectiveness Network initiative, and that this will offer a unified approach for such assessments. Pregmedic, a non-profit organization for the advancement of safe and effective use of drugs in pregnancy, has presented a number of proposals and draft guidelines to Health Canada on the inclusion of pregnant women in pharmacokinetic studies and the establishment of registries for women who take drugs during pregnancy. Pregmedic advocates for ensuring that drugs indicated for women are studied in women.

A primer of drug safety surveillance: an industry perspective. Part I: Information flow, new drug development, and federal regulations.

Science.gov (United States)

Allan, M C

1992-01-01

To place the fundamentals of clinical drug safety surveillance in a conceptual framework that will facilitate understanding and application of adverse drug event data to protect the health of the public and support a market for pharmaceutical manufacturers' products. Part I of this series provides a background for the discussion of drug safety by defining the basic terms and showing the flow of safety information through a pharmaceutical company. The customers for adverse drug event data are identified to provide a basis for providing quality service. The development of a drug product is briefly reviewed to show the evolution of safety data. Drug development and safety are defined by federal regulations. These regulations are developed by the FDA with information from pharmaceutical manufacturers. The intent of the regulations and the accompanying guidelines is described. An illustration from the news media is cited to show an alternative, positive approach to handling an adverse event report. This review uses primary sources from the federal laws (regulations), commentaries, and summaries. Very complex topics are briefly summarized in the text and additional readings are presented in an appendix. Secondary sources, ranging from newspaper articles to judicial summaries, illustrate the interpretation of adverse drug events and opportunities for drug safety surveillance intervention. The reference materials used were articles theoretically or practically applicable in the day-to-day practice of drug safety surveillance. The role of clinical drug safety surveillance in product monitoring and drug development is described. The process of drug safety surveillance is defined by the Food and Drug Administration regulations, product labeling, product knowledge, and database management. Database management is subdivided into the functions of receipt, retention, retrieval, and review of adverse event reports. Emphasis is placed on the dynamic interaction ;of the components

76 FR 40735 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

Science.gov (United States)

2011-07-11

...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the... East, Adelphi, MD. The conference center telephone number is: 301 985-7300. Contact Person: Kalyani...

75 FR 10490 - Joint Meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management...

Science.gov (United States)

2010-03-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory... Drug Safety and Risk Management Advisory Committee. General Function of the Committees: To provide...

Cardiovascular safety of non-steroidal anti-inflammatory drugs among healthy individuals

DEFF Research Database (Denmark)

Fosbøl, Emil Loldrup; Køber, Lars; Torp-Pedersen, Christian

2010-01-01

Studies have raised concern on the cardiovascular safety of NSAIDs. We studied safety of NSAID therapy in a nationwide cohort of healthy individuals.......Studies have raised concern on the cardiovascular safety of NSAIDs. We studied safety of NSAID therapy in a nationwide cohort of healthy individuals....

77 FR 65000 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Science.gov (United States)

2012-10-24

...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... Use (ETASU) before CDER's Drug Safety and Risk Management Advisory Committee (DSaRM). The Agency plans...

78 FR 30929 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Science.gov (United States)

2013-05-23

...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... (REMS) with elements to assure safe use (ETASU) before its Drug Safety and Risk Management Advisory...

College Student Drug Use: Patterns, Concerns, Consequences, and Interest in Intervention

Science.gov (United States)

Palmer, Rebekka S.; McMahon, Thomas J.; Moreggi, Danielle I.; Rounsaville, Bruce J.; Ball, Samuel A.

2012-01-01

Although previous surveys have indicated high rates of illicit and prescription drug misuse among college students, few have assessed negative consequences, personal concerns, or interest in interventions for drug use. In a survey of 262 college students who self-reported lifetime use of an illicit drug, 69% reported at least one negative…

78 FR 2677 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

Science.gov (United States)

2013-01-14

...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the... before February 7, 2013. Time allotted for each presentation may be limited. If the number of registrants...

76 FR 59143 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

Science.gov (United States)

2011-09-23

...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the..., Adelphi, MD. The conference center telephone number is 301-985-7300. Contact Person: Kalyani Bhatt, Center...

Driving and dementia: Efficient approach to driving safety concerns in family practice.

Science.gov (United States)

Lee, Linda; Molnar, Frank

2017-01-01

To provide primary care physicians with an approach to driving safety concerns when older persons present with memory difficulties. The approach is based on an accredited memory clinic training program developed by the Centre for Family Medicine Primary Care Collaborative Memory Clinic. One of the most challenging aspects of dementia care is the assessment of driving safety. Drivers with dementia are at higher risk of motor vehicle collisions, yet many drivers with mild dementia might be safely able to continue driving for several years. Because safe driving is dependent on multiple cognitive and functional skills, clinicians should carefully consider many factors when determining if cognitive concerns affect driving safety. Specific findings on corroborated history and office-based cognitive testing might aid in the physician's decisions to refer for comprehensive on-road driving evaluation and whether to notify transportation authorities in accordance with provincial reporting requirements. Sensitive communication and a person-centred approach are essential. Primary care physicians must consider many factors when determining if cognitive concerns might affect driving safety in older drivers. Copyright© the College of Family Physicians of Canada.

77 FR 75176 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Science.gov (United States)

2012-12-19

...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug... being rescheduled due to the postponement of the October 29-30, 2012, Drug Safety and Risk Management... Committee: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide...

Drug safety data mining with a tree-based scan statistic.

Science.gov (United States)

Kulldorff, Martin; Dashevsky, Inna; Avery, Taliser R; Chan, Arnold K; Davis, Robert L; Graham, David; Platt, Richard; Andrade, Susan E; Boudreau, Denise; Gunter, Margaret J; Herrinton, Lisa J; Pawloski, Pamala A; Raebel, Marsha A; Roblin, Douglas; Brown, Jeffrey S

2013-05-01

In post-marketing drug safety surveillance, data mining can potentially detect rare but serious adverse events. Assessing an entire collection of drug-event pairs is traditionally performed on a predefined level of granularity. It is unknown a priori whether a drug causes a very specific or a set of related adverse events, such as mitral valve disorders, all valve disorders, or different types of heart disease. This methodological paper evaluates the tree-based scan statistic data mining method to enhance drug safety surveillance. We use a three-million-member electronic health records database from the HMO Research Network. Using the tree-based scan statistic, we assess the safety of selected antifungal and diabetes drugs, simultaneously evaluating overlapping diagnosis groups at different granularity levels, adjusting for multiple testing. Expected and observed adverse event counts were adjusted for age, sex, and health plan, producing a log likelihood ratio test statistic. Out of 732 evaluated disease groupings, 24 were statistically significant, divided among 10 non-overlapping disease categories. Five of the 10 signals are known adverse effects, four are likely due to confounding by indication, while one may warrant further investigation. The tree-based scan statistic can be successfully applied as a data mining tool in drug safety surveillance using observational data. The total number of statistical signals was modest and does not imply a causal relationship. Rather, data mining results should be used to generate candidate drug-event pairs for rigorous epidemiological studies to evaluate the individual and comparative safety profiles of drugs. Copyright © 2013 John Wiley & Sons, Ltd.

78 FR 16271 - Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and...

Science.gov (United States)

2013-03-14

...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the... presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably...

Pharmaceutical quality of "party pills" raises additional safety concerns in the use of illicit recreational drugs.

Science.gov (United States)

Young, Simon A; Thrimawithana, Thilini R; Antia, Ushtana; Fredatovich, John D; Na, Yonky; Neale, Peter T; Roberts, Amy F; Zhou, Huanyi; Russell, Bruce

2013-06-14

To determine the content and release kinetics of 1-benzylpiperazine (BZP) and 1-(3-trifluoromethyl-phenyl)piperazine (TFMPP) from "party pill" formulations. From these data, the possible impact of pharmaceutical quality upon the safety of such illicit formulations may be inferred. The amount of BZP and TFMPP in party pill formulations was determined using a validated HPLC method. The in-vitro release kinetics of selected party pill brands were determined using a USP dissolution apparatus (75 rpm, 37.5 degrees Celsius). The release data were then fitted to a first order release model using PLOT software and the time taken to achieve 90% release reported. Many of the tested party pill brands contained amounts of BZP and TFMPP that varied considerably from that stated on the packaging; including considerable TFMPP content in some brands not labelled to contain this drug. Dissolution studies revealed that there was considerable variability in the release kinetics between brands; in one case 90% release required >30 minutes. Lack of quality control in party pill manufacture may have led to the toxic effects reported by users unaware of the true content and release of drug from pills. More stringent regulation in the manufacture and quality control of "new generation party pills" is essential to the harm reduction campaign.

Regulatory aspects of oncology drug safety evaluation: Past practice, current issues, and the challenge of new drugs

International Nuclear Information System (INIS)

Rosenfeldt, Hans; Kropp, Timothy; Benson, Kimberly; Ricci, M. Stacey; McGuinn, W. David; Verbois, S. Leigh

2010-01-01

The drug development of new anti-cancer agents is streamlined in response to the urgency of bringing effective drugs to market for patients with limited life expectancy. FDA's regulation of oncology drugs has evolved from the practices set forth in Arnold Lehman's seminal work published in the 1950s through the current drafting of a new International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) safety guidance for anti-cancer drug nonclinical evaluations. The ICH combines the efforts of the regulatory authorities of Europe, Japan, and the United States and the pharmaceutical industry from these three regions to streamline the scientific and technical aspects of drug development. The recent development of new oncology drug classes with novel mechanisms of action has improved survival rates for some cancers but also brings new challenges for safety evaluation. Here we present the legacy of Lehman and colleagues in the context of past and present oncology drug development practices and focus on some of the current issues at the center of an evolving harmonization process that will generate a new safety guidance for oncology drugs, ICH S9. The purpose of this new guidance will be to facilitate oncology drug development on a global scale by standardizing regional safety requirements.

The safety of treatment options available for gout.

Science.gov (United States)

Schlesinger, Naomi

2017-04-01

Gout is the most common inflammatory arthritis in humans. Gout treatment includes rapid initiation of anti-inflammatory medications for acute attacks and chronically treating with urate lowering drugs as well as chronic anti-inflammatory prophylaxis. Areas covered: This review aims to provide an overview and discussion of the safety concerns of current treatment options available for gout. Expert opinion: Gout is a curable disease with appropriate treatment. The advent of new therapies provides encouraging opportunities to improve gout management. However, clinicians should be aware of some of the safety concerns of medications used to treat acute and chronic gout. When prescribing medications for gout one has to be mindful of the presence of comorbidities commonly affecting gout patients that may affect drug safety and efficacy, especially in the elderly and in patients treated with multiple drugs. The benefits of gout drugs, usually, outweigh their safety concerns. Studies are needed in gout patients with chronic kidney disease and/or cardiovascular disease, so that escalation of dosing /combination of anti-inflammatory drugs needed to suppress gouty inflammation as well as escalation of dosing/combination of urate lowering drugs needed to achieve target serum urate level will lead to better understanding of gout treatment safety issues.

78 FR 36711 - Food and Drug Administration Safety and Innovation Act Title VII-Drug Supply Chain; Standards for...

Science.gov (United States)

2013-06-19

... inspections, and drive safety and quality throughout the supply chain. Implementation of these authorities... authorities granted to FDA under Title VII and their importance in ensuring drug safety, effectiveness, and.... FDA-2013-N-0683, FDA-2013-N-0684, and FDA-2013-N-0685] Food and Drug Administration Safety and...

Mathematical modeling of efficacy and safety for anticancer drugs clinical development.

Science.gov (United States)

Lavezzi, Silvia Maria; Borella, Elisa; Carrara, Letizia; De Nicolao, Giuseppe; Magni, Paolo; Poggesi, Italo

2018-01-01

Drug attrition in oncology clinical development is higher than in other therapeutic areas. In this context, pharmacometric modeling represents a useful tool to explore drug efficacy in earlier phases of clinical development, anticipating overall survival using quantitative model-based metrics. Furthermore, modeling approaches can be used to characterize earlier the safety and tolerability profile of drug candidates, and, thus, the risk-benefit ratio and the therapeutic index, supporting the design of optimal treatment regimens and accelerating the whole process of clinical drug development. Areas covered: Herein, the most relevant mathematical models used in clinical anticancer drug development during the last decade are described. Less recent models were considered in the review if they represent a standard for the analysis of certain types of efficacy or safety measures. Expert opinion: Several mathematical models have been proposed to predict overall survival from earlier endpoints and validate their surrogacy in demonstrating drug efficacy in place of overall survival. An increasing number of mathematical models have also been developed to describe the safety findings. Modeling has been extensively used in anticancer drug development to individualize dosing strategies based on patient characteristics, and design optimal dosing regimens balancing efficacy and safety.

Psychometrics of the AAN Caregiver Driving Safety Questionnaire and contributors to caregiver concern about driving safety in older adults.

Science.gov (United States)

Carvalho, Janessa O; Springate, Beth; Bernier, Rachel A; Davis, Jennifer

2018-03-01

ABSTRACTBackground:The American Academy of Neurology (AAN) updated their practice parameters in the evaluation of driving risk in dementia and developed a Caregiver Driving Safety Questionnaire, detailed in their original manuscript (Iverson Gronseth, Reger, Classen, Dubinsky, & Rizzo, 2010). They described four factors associated with decreased driving ability in dementia patients: history of crashes or citations, informant-reported concerns, reduced mileage, and aggressive driving. An informant-reported AAN Caregiver Driving Safety Questionnaire was designed with these elements, and the current study was the first to explore the factor structure of this questionnaire. Additionally, we examined associations between these factors and cognitive and behavioral measures in patients with mild cognitive impairment or early Alzheimer's disease and their informants. Exploratory factor analysis revealed a four-component structure, consistent with the theory behind the AAN scale composition. These four factor scores also were significantly associated with performance on cognitive screening instruments and informant reported behavioral dysfunction. Regressions revealed that behavioral dysfunction predicted caregiver concerns about driving safety beyond objective patient cognitive dysfunction. In this first known quantitative exploration of the scale, our results support continued use of this scale in office driving safety assessments. Additionally, patient behavioral changes predicted caregiver concerns about driving safety over and above cognitive status, which suggests that caregivers may benefit from psychoeducation about cognitive factors that may negatively impact driving safety.

Design concepts and safety concerns of the small and medium size reactors (SMR)

International Nuclear Information System (INIS)

Seul, Kwang Won; Lee, Jae Hun; Kim, Hho Jung

1998-01-01

The small and medium size reactors (SMR) and interface facilities such as desalination plant are expected to be located near the population area because of restrictions in transporting the plant products such as fresh water to long distance area. To protect the public around the plant facility from the possible release of radioactive materials, the design development of the SMR is focusing on an enhancement of the safety and reliability as well as the economics. In this study, the major safety concepts of the SMR designs significantly different from the current PWR designs are investigated and the safety concerns applicable to the integrated SMR design of Korea (called SMART), were identified. Those safety issues include the use of proven technology, application of strengthening defense in depth, event categorization and selection, simplification of emergency planning, determination of accident source terms and so on. The efforts to resolve the safety concerns in the design stage will provide an improvement of the safety of the SMART design

Determining animal drug combinations based on efficacy and safety.

Science.gov (United States)

Kratzer, D D; Geng, S

1986-08-01

A procedure for deriving drug combinations for animal health is used to derive an optimal combination of 200 mg of novobiocin and 650,000 IU of penicillin for nonlactating cow mastitis treatment. The procedure starts with an estimated second order polynomial response surface equation. That surface is translated into a probability surface with contours called isoprobs. The isoprobs show drug amounts that have equal probability to produce maximal efficacy. Safety factors are incorporated into the probability surface via a noncentrality parameter that causes the isoprobs to expand as safety decreases, resulting in lower amounts of drug being used.

Long-term criticality safety concerns associated with surplus fissile material disposition

International Nuclear Information System (INIS)

Choi, J.S.

1995-01-01

A substantial inventory of surplus fissile material would result from ongoing and planned dismantlement of US and Russian nuclear weapons. This surplus fissile material could be dispositioned by irradiation in nuclear reactors, and the resulting spent MOx fuel would be similar in radiation characteristics to regular LWR spent UO2 fuel. The surplus fissile material could also be immobilized into high-level waste forms, such as borosilicate glass, synroc, or metal-alloy matrix. The MOx spent fuel, or the immobilized waste forms, could then be directly disposed of in a geologic repository. Long-term criticality safety concerns arise because the fissile contents (i.e., Pu-239 and its decay daughter U-235) in these waste forms are higher than in LWR spent UO2 fuel. MOx spent fuel could contain 3 to 4 wt% of reactor-grade plutonium, compared to only 0.9 wt% of plutonium in LWR spent UO2 fuel. At some future time (tens of thousand of years), when the waste forms had deteriorated due to intruding groundwater, the water could mix with the long-lived fissile materials to form into a critical system. If the critical system is self-sustaining, somewhat like the natural-occurring reactor in OKLO, fission products produced could readily be available for dissolution and release out to the accessible environment, adversely affecting public health and safety. This paper will address ongoing activities to evaluate long-term criticality safety concerns associated with disposition of fissile material in a geologic setting. Issues to be addressed include the identification of a worst-case water-intrusion scenario and waste-form geometries which present the most concern for long-term criticality safety; and suggests of technical solutions for such concerns

75 FR 23782 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Science.gov (United States)

2010-05-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide...

The safety concept of the Federal Government concerning waste management

International Nuclear Information System (INIS)

Pfaffelhuber, J.K.

1976-01-01

The safety concept of the FRG concerning waste management is based on the ultimate aim of having in operation until 1985 nuclear power plants with a capacity of approx. 45,000 MWe, i.e. 50 nuclear power plants with an annual fuel consumption of 1,500 tons. A critical survey shows that there is still a great number of questions to be solved, concerning the fuel cycle in particular in terms of industrial standards, and that various problems ought to be the subject of R and D activities. Activities in the field of waste management so far are concerned only with project studies and details of project definition studies. On the one hand, the principles of the safety concept for waste management are to make possible and to guarantee the operation of nuclear facilities, and on the other hand, they are to subject those facilities which serve the purpose of waste disposal to similar safety regulations as the nuclear power plants are subjected to. The integrated waste disposal system of the Federal government for CWRs until the mid eighties is described. R+D activities are still necessary, in particular concerning reprocessing techniques, techniques in the reprocessing of Pu, the conditioning of highly active wastes, testing final storage techniques, and in the field of retention of gaseous radioactive nuclides (iodine, krypton, tritium) and of safeguarding waste disposal parks against terrorists and sabotage. The legal basis for the protection of the citizen is the Atomic Energy Act and its ordinances, EURATOM basic standards, and ICRP recommendations, some of which were tightened up for the FRG. Some recommendations of the Strahlenschutzkommision - radiation exposure, storage and separation of 85 Kr, 129 J, 131 J, and 133 Xe - are dealt with in detail. (HPH/LN) [de

Nonsteroidal anti-inflammatory drug gastropathy: new avenues for safety

Directory of Open Access Journals (Sweden)

Roth SH

2011-05-01

Full Text Available Sanford H RothArizona Research and Education, Arthritis Laboratory, Arizona State University, Phoenix, AZ, USAAbstract: Chronic oral or systemic nonselective nonsteroidal anti-inflammatory drug (NSAID therapy, ubiquitously used by physicians to treat osteoarthritis-associated pain, is associated with a wide range of symptomatic adverse events, the most frequent and serious of which is gastropathy. Although cardiovascular and renal problems are a very real concern, they are significantly less frequent. These complications can be life-threatening in at-risk populations such as older adults, who are common users of long-term oral systemic NSAID therapy. Topical NSAID formulations deliver effective doses of analgesics directly to the affected joints, thereby limiting systemic exposure and potentially the risk of systemic adverse events, such as gastropathy and serious cardiovascular events. There are currently two topical NSAIDs approved by the US Food and Drug Administration for osteoarthritis-associated pain, as well as for the signs and symptoms of osteoarthritis. This review discusses the relative safety, and the gastrointestinal, cardiovascular, and renal risks of chronic oral or systemic NSAID therapy and topical NSAID formulations in patients with osteoarthritis.Keywords: NSAIDs, osteoarthritis, topical administration, synovial fluid, peptic ulcer, Helicobacter pylori

Shelf life and safety concerns of bakery products--a review.

Science.gov (United States)

Smith, James P; Daifas, Daphne Phillips; El-Khoury, Wassim; Koukoutsis, John; El-Khoury, Anis

2004-01-01

Bakery products are an important part of a balanced diet and, today, a wide variety of such products can be found on supermarket shelves. This includes unsweetened goods (bread, rolls, buns, crumpets, muffins and bagels), sweet goods (pancakes, doughnuts, waffles and cookies) and filled goods (fruit and meat pies, sausage rolls, pastries, sandwiches, cream cakes, pizza and quiche). However, bakery products, like many processed foods, are subject to physical, chemical and microbiological spoilage. While physical and chemical spoilage limits the shelf life of low and intermediate moisture bakery products, microbiological spoilage by bacteria, yeast and molds is the concern in high moisture products i.e., products with a water activity (a(w)) > 0.85. Furthermore, several bakery products also have been implicated infoodborne illnesses involving Salmonella spp., Listeria monoctyogenes and Bacillus cereus, while Clostridium botulinum is a concern in high moisture bakery products packaged under modified atmospheres. This extensive review is divided into two parts. Part I focuses on the spoilage concerns of low, intermediate and high moisture bakery products while Part II focuses on the safety concerns of high moisture bakery products only. In both parts, traditional and novel methods of food preservation that can be used by the bakery industry to extend the shelf life and enhance the safety of products are discussed in detail.

Summary of Tiger Team Assessment and Technical Safety Appraisal recurring concerns in the Operations Area

International Nuclear Information System (INIS)

1993-01-01

Fourteen Tiger Team Assessment and eight Technical Safety Appraisal (TSA) final reports have been received and reviewed by the DOE Training Coordination Program during Fiscal Year 1992. These assessments and appraisals included both reactor and non-reactor nuclear facilities in their reports. The Tiger Team Assessments and TSA reports both used TSA performance objectives, and list ''concerns'' as a result of their findings. However, the TSA reports categorized concerns into the following functional areas: (1) Organization and Administration, (2) Radiation Protection, (3) Nuclear Criticality Safety, (4) Occupational Safety, (5) Engineering/Technical Support, (6) Emergency Preparedness, (7) Safety Assessments, (8) Quality Verification, (9) Fire Protection, (10) Environmental Protection, and (11) Energetic Materials Safety. Although these functional areas match most of the TSA performance objectives, not all of the TSA performance objectives are addressed. For example, the TSA reports did not include Training, Maintenance, and Operations as functional areas. Rather, they included concerns that related to these topics throughout the 11 functional areas identified above. For consistency, the Operations concerns that were identified in each of the TSA report functional areas have been included in this summary with the corresponding TSA performance objective

Safety concerns and hidden agenda behind HPV vaccines: another generation of drug-dependent society?

Science.gov (United States)

Khatami, Mahin

2016-12-01

Analyses of data and hidden agenda behind repeated failed outcomes of cancer research and therapy, status of American health, safety concerns for HPV vaccines and future research considerations are summarized in this commentary. A closer look at cancer science reveals that highly power structure (system) in medical establishment vs. anti-system and chaos in cancer research ('medical/scientific ponzi schemes') is potent recipe for failed therapeutics that kills patients but generates huge corporate profit. American health status ranks last among other developed nations despite the highest amount that USA invests in healthcare. This is a wake-up call to make sure that the evil part of human being does not prevent the health services that the public deserves. Otherwise, 'it does not matter how many resources you have, if you don't know, or don't want to know, how to use them, they will never be enough'. Answer to cancer and improved public health is possible only by switching the current corruptive and abusive culture of 'who you know' to a culture of 'what you know'. Policy makers and professionals in decision making roles are urged to return to common sense and logics that our Forefathers used to serve the public.

Drug research methodology. Volume 2, The identification of drugs of interest in highway safety

Science.gov (United States)

1980-03-01

This report presents findings of a workshop on the identification of drugs that should be the focus of near-term highway safety research. Drugs of interest are those that have a potential to increase the likelihood of traffic crashes and their attend...

77 FR 2606 - Pipeline Safety: Random Drug Testing Rate

Science.gov (United States)

2012-01-18

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket ID PHMSA-2012-0004] Pipeline Safety: Random Drug Testing Rate AGENCY: Pipeline and Hazardous Materials... pipelines and operators of liquefied natural gas facilities must select and test a percentage of covered...

75 FR 9018 - Pipeline Safety: Random Drug Testing Rate

Science.gov (United States)

2010-02-26

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket ID PHMSA-2010-0034] Pipeline Safety: Random Drug Testing Rate AGENCY: Pipeline and Hazardous Materials... pipelines and operators of liquefied natural gas facilities must select and test a percentage of covered...

Safety concerns and suggested design approaches to the HTGR Reformer process concept

Energy Technology Data Exchange (ETDEWEB)

Green, R.C.

1981-09-01

This report is a safety review of the High Temperature Gas-Cooled Reactor Reformer Application Study prepared by Gas-Cooled Reactor Associates (GCRA) of La Jolla, California. The objective of this review was to identify safety concerns and suggests design approaches to minimize risk in the High Temperature Gas-Cooled Reactor Reformer (HTGR-R) process concept.

Safety concerns and suggested design approaches to the HTGR Reformer process concept

International Nuclear Information System (INIS)

Green, R.C.

1981-09-01

This report is a safety review of the High Temperature Gas-Cooled Reactor Reformer Application Study prepared by Gas-Cooled Reactor Associates (GCRA) of La Jolla, California. The objective of this review was to identify safety concerns and suggests design approaches to minimize risk in the High Temperature Gas-Cooled Reactor Reformer (HTGR-R) process concept

List of reports from BMFT, CEA, EPRI, JSTA and USNRC concerning reactor safety research

International Nuclear Information System (INIS)

1982-02-01

This list reviews reports from the Federal Republic of Germany, from France from Japan and from the United States of America concerning special problems in the field of reactor safety research. According to the cooperation in the Gesellschaft fuer Reaktorsicherheit (GRS). The list pursues the following order: Country of origin, problem area concerned, according to the Reactor Safety Research Programm of the BMFT, reporting organization. The list of reports appears quarterly. (orig.) [de

Questionnaire responses concerning safety issues in MR examination

International Nuclear Information System (INIS)

Yamaguchi-Sekino, Sachiko; Nakai, Toshiharu; Muranaka, Hiroyuki

2011-01-01

Recently, the rising numbers of medical implants and scanners with higher static magnetic field have increased safety concerns for magnetic resonance (MR) examination. To determine future safety focus, we distributed anonymous questionnaires to 3250 members of the Japanese Society for Magnetic Resonance in Medicine (JSMRM) and received 978 responses. Safety issues on the questionnaire concentrated on the handling of patients with implants (Q7-18, appendix), acoustic trauma due to scanning (Q19-21, appendix), and MR compatibility within the scanner room (Q22-25, appendix). Ninety-three percent of respondents indicated they had encountered cases with implants or medical materials of unknown MR compatibility; 21.7% reported heating problems and 15.0%, nerve stimulation problems, in patients with implants during MR examination. Although 88.7% of respondents recognized the term ''MR compatibility'', 68.2% indicated limited detailed understanding of the term. Eleven percent had had cases with suspected acoustic injury from MR scanner noise. Scanner noise levels were not clarified in any way in 37.4% cases, but 69.5% applied ear protection to patients. Labeling of ''MR compatibility'' of equipment brought into the MR scanner room was reported by 71.9%. More than 50% experienced MR compatibility issues related to equipment brought into the MR scanner room. With regard to safety issues on metallic objects which are implanted in MR workers, 88.1% indicated they would continue current operations even the implant is inside the body. Respondents identified lectures and seminars by professional societies, safety training by manufacturers, and information from the Internet and literature as the 3 main sources for up-dating safety information for MR examination. (author)

Exploring Machine Learning Techniques Using Patient Interactions in Online Health Forums to Classify Drug Safety

Science.gov (United States)

Chee, Brant Wah Kwong

2011-01-01

This dissertation explores the use of personal health messages collected from online message forums to predict drug safety using natural language processing and machine learning techniques. Drug safety is defined as any drug with an active safety alert from the US Food and Drug Administration (FDA). It is believed that this is the first…

Pooling, meta-analysis, and the evaluation of drug safety

Directory of Open Access Journals (Sweden)

Leizorovicz Alain

2002-03-01

Full Text Available Abstract Background The "integrated safety report" of the drug registration files submitted to health authorities usually summarizes the rates of adverse events observed for a new drug, placebo or active control drugs by pooling the safety data across the trials. Pooling consists of adding the numbers of events observed in a given treatment group across the trials and dividing the results by the total number of patients included in this group. Because it considers treatment groups rather than studies, pooling ignores validity of the comparisons and is subject to a particular kind of bias, termed "Simpson's paradox." In contrast, meta-analysis and other stratified analyses are less susceptible to bias. Methods We use a hypothetical, but not atypical, application to demonstrate that the results of a meta-analysis can differ greatly from those obtained by pooling the same data. In our hypothetical model, a new drug is compared to 1 a placebo in 4 relatively small trials in patients at high risk for a certain adverse event and 2 an active reference drug in 2 larger trials of patients at low risk for this event. Results Using meta-analysis, the relative risk of experiencing the adverse event with the new drug was 1.78 (95% confidence interval [1.02; 3.12] compared to placebo and 2.20 [0.76; 6.32] compared to active control. By pooling the data, the results were, respectively, 1.00 [0.59; 1.70] and 5.20 [2.07; 13.08]. Conclusions Because these findings could mislead health authorities and doctors, regulatory agencies should require meta-analyses or stratified analyses of safety data in drug registration files.

LMFBR conceptual design study: an overview of environmental and safety concerns

International Nuclear Information System (INIS)

Brenchley, D.L.

1981-06-01

The US Department of Energy (DOE) initiated the Liquid Metal Fast Breeder (LMFBR) Conceptual Design Study (CDS) with the objective of maintaining a viable breeder option. The project is scheduled to be completed in FY-1981 but decisions regarding plant construction will be delayed until at least 1985. This report provides a review of the potential environmental and safety engineering concerns for the CDS and recommends specific action for the Environmental and Safety Engineering Division of DOE

LMFBR conceptual design study: an overview of environmental and safety concerns

Energy Technology Data Exchange (ETDEWEB)

Brenchley, D.L.

1981-06-01

The US Department of Energy (DOE) initiated the Liquid Metal Fast Breeder (LMFBR) Conceptual Design Study (CDS) with the objective of maintaining a viable breeder option. The project is scheduled to be completed in FY-1981 but decisions regarding plant construction will be delayed until at least 1985. This report provides a review of the potential environmental and safety engineering concerns for the CDS and recommends specific action for the Environmental and Safety Engineering Division of DOE.

Safety learning from drugs of the same class

DEFF Research Database (Denmark)

Stefansdottir, G; Knol, M J; Arnardottir, A H

2012-01-01

This study was aimed at assessing the extent of safety learning from data pertaining to other drugs of the same class. We studied drug classes for which the first and second drugs were centrally registered in the European Union from 1995 to 2008. We assessed whether adverse drug reactions (ADRs......) associated with one of the drugs also appeared in the Summary of Product Characteristics (SPC) of the other drug, either initially or during the postmarketing phase. We identified 977 ADRs from 19 drug pairs, of which 393 ADRs (40.2%) were listed in the SPCs of both drugs of a pair. Of these 393 that were...... present in both SPCs of a drug pair, 241 (61.3%) were present when the drug entered the market and 152 (30.7%) appeared in the postmarketing phase. The mention of ADRs in the SPCs of both same-class drugs in the postmarketing phase was associated with type A ADRs, marketing in the same regulator country...

Projecting future drug expenditures--2009.

Science.gov (United States)

Hoffman, James M; Shah, Nilay D; Vermeulen, Lee C; Doloresco, Fred; Martin, Patrick K; Blake, Sharon; Matusiak, Linda; Hunkler, Robert J; Schumock, Glen T

2009-02-01

Drug expenditure trends in 2007 and 2008, projected drug expenditures for 2009, and factors likely to influence drug expenditures are discussed. Various factors are likely to influence drug expenditures in 2009, including drugs in development, the diffusion of new drugs, drug safety concerns, generic drugs, Medicare Part D, and changes in the drug supply chain. The increasing availability of important generic drugs and drug safety concerns continue to moderate growth in drug expenditures. The drug supply chain remains dynamic and may influence drug expenditures, particularly in specialized therapeutic areas. Initial data suggest that the Medicare Part D benefit has influenced drug expenditures, but the ultimate impact of the benefit on drug expenditures remains unclear. From 2006 to 2007, total U.S. drug expenditures increased by 4.0%, with total spending rising from $276 billion to $287 billion. Drug expenditures in clinics continue to grow more rapidly than in other settings, with a 9.9% increase from 2006 to 2007. Hospital drug expenditures increased at a moderate rate of only 1.6% from 2006 to 2007; through the first nine months of 2008, hospital drug expenditures increased by only 2.8% compared with the same period in 2007. In 2009, we project a 0-2% increase in drug expenditures in outpatient settings, a 1-3% increase in expenditures for clinic-administered drugs, and a 1-3% increase in hospital drug expenditures.

Safety concerns in composite manufacturing and machining

Science.gov (United States)

Asmatulu, Eylem; Alonayni, Abdullah; Alamir, Mohammed

2018-03-01

Because of the superior properties, composites have been used in many industrial applications, including aerospace, wind turbines, ships, cars, fishing rods, storage tanks, swimming pool panels, and baseball bats. Each application may require different combinations of reinforcements and matrices, which make the manufacturing safety even more challenging while working on these substances. In this study, safety issues in composite manufacturing and machining were investigated in detail, and latest developments were provided for workers. The materials most frequently used in composite manufacturing, such as matrix (polyester, vinylester, phenolic, epoxies, methyl ethyl ketone peroxide, benzoil peroxide, hardeners, and solvents), and reinforcement materials (carbon, glass and Kevlar fibers, honeycomb and foams) can be highly toxic to human body. These materials can also be very toxic to the environment when dumped out uncontrollably, creating major future health and environmental concerns. Throughout the manufacturing process, workers inhale vapors of the liquid matrix, hardeners and solvents / thinners, as well as reinforcement materials (chopped fibers and particles) in airborne. Milling, cutting and machining of the composites can further increase the toxic inhalations of airborne composite particles, resulting in major rashes, irritation, skin disorders, coughing, severe eye and lung injury and other serious illnesses. The major portions of these hazardous materials can be controlled using appropriate personal protective equipment for the chemicals and materials used in composite manufacturing and machining. This study provides best possible safety practices utilized in composite manufacturing facilities for workers, engineers and other participants.

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

Science.gov (United States)

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.

Drug research methodology. Volume 1, The alcohol-highway safety experience and its applicability to other drugs

Science.gov (United States)

1980-03-01

This report presents the findings of a workshop concerning the alcohol and highway safety experience, which includes research efforts to define the drinking-driving problem and societal responses to reduce the increased highway safety risk attributab...

Drug development in neuropsychopharmacology.

Science.gov (United States)

Fritze, Jürgen

2008-03-01

Personalized medicine is still in its infancy concerning drug development in neuropsychopharmacology. Adequate biomarkers with clinical relevance to drug response and/or tolerability and safety largely remain to be identified. Possibly, this kind of personalized medicine will first gain clinical relevance in the dementias. The clinical relevance of the genotyping of drug-metabolizing enzymes as suggested by drug licensing authorities for the pharmacokinetic evaluation of medicinal products needs to be proven in sound clinical trials.

Drug research methodology. Volume 5, Experimentation in drugs and highway safety : the study of drug effects on skills related to driving

Science.gov (United States)

1980-06-01

This report presents the findings of a workshop on experimental research in the area of drugs and highway safety. Complementing studies of drug use in different driving populations, experimentation here refers to studies performed under controlled co...

Statement on safety requirements concerning the long-term operation of the Muehleberg nuclear power station

International Nuclear Information System (INIS)

2012-12-01

This report published by the Swiss Federal Nuclear Safety Inspectorate ENSI investigates the safety requirements with respect to the long-term operation of the Muehleberg nuclear power station in Switzerland. Relevant international requirements and Swiss legal stipulations concerning the long-term operation of the power station are stated. The management of aging processes is looked at. The regular verification of the integrity of various plant components such as containments, piping, steam generation system, etc. is looked at in detail. The state-of-the-art concerning deterministic accident analyses and refitting technology are discussed, as are automated safety systems. The applicable laws, decrees and guidelines are listed in appendices

Shoe concerns and foot problems of wearers of safety footwear.

Science.gov (United States)

Marr, S J; Quine, S

1993-05-01

In Australia workers in many industries are required to wear safety footwear (footwear incorporating a steel toe cap). An investigation of the problems reported by 321 workers (70 per cent male) employed in a broad range of work activities and required to wear safety footwear was conducted in 1990 and 1991. Respondents were interviewed by a professionally trained podiatrist using a structured questionnaire followed by a foot examination. An extremely high percentage (91 per cent) of subjects reported one or more foot problems (which were verified by the podiatrist), and most considered that the safety footwear either caused the problem or adversely affected an existing foot condition. The main shoe concerns reported were excessive heat (65 per cent of all respondents), inflexible soles (52 per cent), weight (48 per cent) and pressure from steel toe cap (47 per cent). Certain gender differences were identified. General recommendations are made.

Pancreatic Safety of Incretin-Based Drugs - FDA and EMA Assessment

NARCIS (Netherlands)

Egan, Amy G.; Blind, Eberhard; Dunder, Kristina; de Graeff, Pieter A.; Hummer, B. Timothy; Bourcier, Todd; Rosebraugh, Curtis

2014-01-01

After evaluating a safety signal regarding pancreatitis and pancreatic cancer in patients using incretin-based drugs, the Food and Drug Administration and the European Medicines Agency conclude that assertions of a causal association are inconsistent with the data. With approximately 25.8 million

Holes in the safety net: a case study of access to prescription drugs and specialty care.

Science.gov (United States)

Stanley, Ava; Cantor, Joel C; Guarnaccia, Peter

2008-07-01

The health care safety net in the United States is intended to fill gaps in health care services for uninsured and other vulnerable populations. This paper presents a case study of New Brunswick, NJ, a small city rich in safety net resources, to examine the adequacy of the American model of safety net care. We find substantial gaps in access to care despite the presence of a medical school, an abundance of primary care and specialty physicians, two major teaching hospitals, a large federally qualified health center and other safety net resources in this community of about 50,000 residents. Using a blend of random-digit-dial and area probability sampling, a survey of 595 households was conducted in 2001 generating detailed information about the health, access to care, demographic and other characteristics of 1,572 individuals. Confirming the great depth of the New Brunswick health care safety net, the survey showed that more than one quarter of local residents reported a hospital or community clinic as their usual source of care. Still, barriers to prescription drugs were reported for 11.0% of the area population and more than two in five (42.8%) local residents who perceived a need for specialty care reported difficulty getting those services. Bivariate analyses show significantly elevated risk of access problems among Hispanic and black residents, those in poor health, those relying on hospital and community clinics or with no usual source of care, and those living at or below poverty. In multivariate analysis, lack of health insurance was the greatest risk factor associated with both prescription drug and specialty access problems. Few local areas can claim the depth of safety net resources as New Brunswick, NJ, raising serious concerns about the adequacy of the American safety net model, especially for people with complex and chronic health care needs.

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

The practice of pre-marketing safety assessment in drug development.

Science.gov (United States)

Chuang-Stein, Christy; Xia, H Amy

2013-01-01

The last 15 years have seen a substantial increase in efforts devoted to safety assessment by statisticians in the pharmaceutical industry. While some of these efforts were driven by regulations and public demand for safer products, much of the motivation came from the realization that there is a strong need for a systematic approach to safety planning, evaluation, and reporting at the program level throughout the drug development life cycle. An efficient process can help us identify safety signals early and afford us the opportunity to develop effective risk minimization plan early in the development cycle. This awareness has led many pharmaceutical sponsors to set up internal systems and structures to effectively conduct safety assessment at all levels (patient, study, and program). In addition to process, tools have emerged that are designed to enhance data review and pattern recognition. In this paper, we describe advancements in the practice of safety assessment during the premarketing phase of drug development. In particular, we share examples of safety assessment practice at our respective companies, some of which are based on recommendations from industry-initiated working groups on best practice in recent years.

77 FR 10666 - Pipeline Safety: Post Accident Drug and Alcohol Testing

Science.gov (United States)

2012-02-23

... 199 [Docket No. PHMSA-2011-0335] Pipeline Safety: Post Accident Drug and Alcohol Testing AGENCY... operators of Liquefied Natural Gas (LNG) facilities to conduct post- accident drug and alcohol tests of..., operators must drug and alcohol test each covered employee whose performance either contributed to the...

Effects of organizational safety practices and perceived safety climate on PPE usage, engineering controls, and adverse events involving liquid antineoplastic drugs among nurses.

Science.gov (United States)

DeJoy, David M; Smith, Todd D; Woldu, Henok; Dyal, Mari-Amanda; Steege, Andrea L; Boiano, James M

2017-07-01

Antineoplastic drugs pose risks to the healthcare workers who handle them. This fact notwithstanding, adherence to safe handling guidelines remains inconsistent and often poor. This study examined the effects of pertinent organizational safety practices and perceived safety climate on the use of personal protective equipment, engineering controls, and adverse events (spill/leak or skin contact) involving liquid antineoplastic drugs. Data for this study came from the 2011 National Institute for Occupational Safety and Health (NIOSH) Health and Safety Practices Survey of Healthcare Workers which included a sample of approximately 1,800 nurses who had administered liquid antineoplastic drugs during the past seven days. Regression modeling was used to examine predictors of personal protective equipment use, engineering controls, and adverse events involving antineoplastic drugs. Approximately 14% of nurses reported experiencing an adverse event while administering antineoplastic drugs during the previous week. Usage of recommended engineering controls and personal protective equipment was quite variable. Usage of both was better in non-profit and government settings, when workers were more familiar with safe handling guidelines, and when perceived management commitment to safety was higher. Usage was poorer in the absence of specific safety handling procedures. The odds of adverse events increased with number of antineoplastic drugs treatments and when antineoplastic drugs were administered more days of the week. The odds of such events were significantly lower when the use of engineering controls and personal protective equipment was greater and when more precautionary measures were in place. Greater levels of management commitment to safety and perceived risk were also related to lower odds of adverse events. These results point to the value of implementing a comprehensive health and safety program that utilizes available hazard controls and effectively communicates

Trust in the pharmaceutical sector : Analysis of drug safety controversies by means of drug life cycles

NARCIS (Netherlands)

Hernández, J.F.

2015-01-01

Before obtaining a marketing approval, the efficacy and safety profile of drugs is studied in specific populations and under well-controlled circumstances. After marketing approval, the drug is made available and used in ‘real world conditions’, which are known to deviate from the trial setting.

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.

Safety concerns us all

CERN Multimedia

SC/GS/S

2004-01-01

In spite of periodic safety inspections, risks can never be entirely excluded. The Safety Commission invites you to inform your supervisor or Territorial Safety Officer (TSO) of any hazardous situations you may be aware of. Actions to be taken following the fall of two windowpanes A few weeks ago, a windowpane fell from the third floor of an office building, causing minor damage to a car parked outside. No one was hurt in the incident. The putty holding the window in place had gradually deteriorated over time, and strong winds undoubtedly triggered the incident. A few weeks later, a sudden draft caused a window on the fifth floor of the same building to shatter and fall to the ground below. No one was hurt and there was no material damage. The incident was caused by a fan set into the opening window: as the window slammed shut, the weight of the fan caused the glass to break. What can we do to improve safety? examine the windows of our offices and workshops and report any problems or faults, such as dam...

Automated discovery of safety and efficacy concerns for joint & muscle pain relief treatments from online reviews.

Science.gov (United States)

Adams, David Z; Gruss, Richard; Abrahams, Alan S

2017-04-01

Product issues can cost companies millions in lawsuits and have devastating effects on a firm's sales, image and goodwill, especially in the era of social media. The ability for a system to detect the presence of safety and efficacy (S&E) concerns early on could not only protect consumers from injuries due to safety hazards, but could also mitigate financial damage to the manufacturer. Prior studies in the field of automated defect discovery have found industry-specific techniques appropriate to the automotive, consumer electronics, home appliance, and toy industries, but have not investigated pain relief medicines and medical devices. In this study, we focus specifically on automated discovery of S&E concerns in over-the-counter (OTC) joint and muscle pain relief remedies and devices. We select a dataset of over 32,000 records for three categories of Joint & Muscle Pain Relief treatments from Amazon's online product reviews, and train "smoke word" dictionaries which we use to score holdout reviews, for the presence of safety and efficacy issues. We also score using conventional sentiment analysis techniques. Compared to traditional sentiment analysis techniques, we found that smoke term dictionaries were better suited to detect product concerns from online consumer reviews, and significantly outperformed the sentiment analysis techniques in uncovering both efficacy and safety concerns, across all product subcategories. Our research can be applied to the healthcare and pharmaceutical industry in order to detect safety and efficacy concerns, reducing risks that consumers face using these products. These findings can be highly beneficial to improving quality assurance and management in joint and muscle pain relief. Copyright © 2017 Elsevier B.V. All rights reserved.

Tolerability and safety of antifungal drugs

Directory of Open Access Journals (Sweden)

Francesco Scaglione

2013-08-01

Full Text Available When treating critically ill patients, as those with fungal infections, attention should be focused on the appropriate use of drugs, especially in terms of dose, safety, and tolerability. The fungal infection itself and the concomitant physiological disorders concur to increase the risk of mortality in these patients, therefore the use of any antifungal agent should be carefully evaluated, considering both the direct action on the target fungus and the adverse effects eventually caused. Among antifungal drugs, echinocandins have the greatest tolerability. In fact, unlike amphotericin B, showing nephrotoxicity, and azoles, which are hepatotoxic, the use of echinocandins doesn’t result in major adverse events.http://dx.doi.org/10.7175/rhc.v4i2s.873

Why trash don't pass? pharmaceutical licensing and safety performance of drugs.

Science.gov (United States)

Banerjee, Tannista; Nayak, Arnab

2017-01-01

This paper examines how asymmetric information in pharmaceutical licensing affects the safety standards of licensed drugs. Pharmaceutical companies often license potential drug molecules at different stages of drug development from other pharmaceutical or biotechnology companies and complete the remaining of research stages before submitting the new drug application(NDA) to the food and drug administration. The asymmetric information associated with the quality of licensed molecules might result in the molecules which are less likely to succeed to be licensed out, while those with greater potential of success being held internally for development. We identify the NDAs submitted between 1993 and 2004 where new molecular entities were acquired through licensing. Controlling for other drug area specific and applicant firm specific factors, we investigate whether drugs developed with licensed molecules face higher probability of safety based recall and ultimate withdrawal from the market than drugs developed internally. Results suggest the opposite of Akerlof's (Q J Econ 84:488-500, 1970) lemons problem. Licensed molecules rather have less probability of facing safety based recalls and ultimate withdrawal from the market comparing to internally developed drug molecules. This suggests that biotechnology and small pharmaceutical firms specializing in pharmaceutical research are more efficient in developing good potential molecules because of their concentrated research. Biotechnology firms license out good potential molecules because it increases their market value and reputation. In addition, results suggest that both the number of previous approved drugs in the disease area, and also the applicant firms' total number of previous approvals in all disease areas reduce the probability that an additional approved drug in the same drug area will potentially be harmful.

A primer of drug safety surveillance: an industry perspective. Part II: Product labeling and product knowledge.

Science.gov (United States)

Allan, M C

1992-01-01

To place the fundamentals of clinical drug safety surveillance in a conceptual framework that will facilitate understanding and application of adverse drug event data to protect the health of the public and support a market for pharmaceutical manufacturers' products. Part II of this series discusses specific issues regarding product labeling, such as developing the labeling, changing the labeling, and the legal as well as commercial ramifications of the contents of the labeling. An adverse event report scenario is further analyzed and suggestions are offered for maintaining the product labeling as an accurate reflection of the drug safety surveillance data. This article also emphasizes the necessity of product knowledge in adverse event database management. Both scientific and proprietary knowledge are required. Acquiring product knowledge is a part of the day-to-day activities of drug safety surveillance. A knowledge of the history of the product may forestall adverse publicity, as shown in the illustration. This review uses primary sources from the federal laws (regulations), commentaries, and summaries. Very complex topics are briefly summarized in the text. Secondary sources, ranging from newspaper articles to judicial summaries, illustrate the interpretation of adverse drug events and opportunities for drug safety surveillance intervention. The reference materials used were articles theoretically or practically applicable in the day-to-day practice of drug safety surveillance. The role of clinical drug safety surveillance in product monitoring and drug development is described. The process of drug safety surveillance is defined by the Food and Drug Administration regulations, product labeling, product knowledge, and database management. Database management is subdivided into the functions of receipt, retention, retrieval, and review of adverse event reports. Emphasis is placed on the dynamic interaction of the components of the process. Suggestions are offered

Observational Pharmacoepidemiology in the Drug Safety and Effectiveness Evaluation

Directory of Open Access Journals (Sweden)

José Cabrita

2017-04-01

Full Text Available Observational epidemiological studies have been used in the medicines context for more than 40 years, contributing to characterize drug use patterns and safety, efficacy and effectiveness profiles. Its use has been increased in recognition of the clinical trials limitations to assess the therapeutic and iatrogenic potential of the medicines after its commercialization. The evolution of the regulatory framework for pharmacovigilance, requiring post-marketing studies, post-authorization safety studies (PASS and the post-authorization efficacy studies (PAES to approve certain drugs, reinforced the importance of observational pharmacoepidemiology for the characterization of the medicines safety and effectiveness profiles. Pharmacoepidemiological research can be carried out from field studies designed to obtain the necessary information or in databases with health records of population samples that already contain the information. This 2nd option is more efficient and more and more frequent. Although, observational research from field studies continues to have its space, the increasing availability of databases allowed a new development to observational pharmacoepidemiology. Indeed, access to automated records databases with up-to-date information on medical prescriptions and global health care to representative population samples with long follow-up periods is a valuable tool for the study of drug use patterns and therapeutic and iatrogenic potential in routine clinical practice. In this context, observational pharmacoepidemiology reinforces its role as a scientific area particularly suitable for evaluating the safety and the effectiveness of the medicines in the “real world”, making a relevant contribution to overcome the gap in translating the evidence from the clinical trials for clinical practice.

75 FR 17417 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management...

Science.gov (United States)

2010-04-06

...] Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory... Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. This meeting was... Drug Safety and Risk Management Advisory Committee would be held on May 12, 2010. On page 10490, in the...

Engineering Hematopoietic Cells for Cancer Immunotherapy: Strategies to Address Safety and Toxicity Concerns.

Science.gov (United States)

Resetca, Diana; Neschadim, Anton; Medin, Jeffrey A

2016-09-01

Advances in cancer immunotherapies utilizing engineered hematopoietic cells have recently generated significant clinical successes. Of great promise are immunotherapies based on chimeric antigen receptor-engineered T (CAR-T) cells that are targeted toward malignant cells expressing defined tumor-associated antigens. CAR-T cells harness the effector function of the adaptive arm of the immune system and redirect it against cancer cells, overcoming the major challenges of immunotherapy, such as breaking tolerance to self-antigens and beating cancer immune system-evasion mechanisms. In early clinical trials, CAR-T cell-based therapies achieved complete and durable responses in a significant proportion of patients. Despite clinical successes and given the side effect profiles of immunotherapies based on engineered cells, potential concerns with the safety and toxicity of various therapeutic modalities remain. We discuss the concerns associated with the safety and stability of the gene delivery vehicles for cell engineering and with toxicities due to off-target and on-target, off-tumor effector functions of the engineered cells. We then overview the various strategies aimed at improving the safety of and resolving toxicities associated with cell-based immunotherapies. Integrating failsafe switches based on different suicide gene therapy systems into engineered cells engenders promising strategies toward ensuring the safety of cancer immunotherapies in the clinic.

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

ISSUES OF FETUS DRUG SAFETY

Directory of Open Access Journals (Sweden)

A.V. Ostrovskaya

2010-01-01

Full Text Available The article is focused on the issue of fetus drug safety. Development of a child’s health depends both on hereditary information and environment factors. The reason for deviation from the process of normal prenatal development could be any xenobiotics, physical factors and some medications having a pathogenic effect during pregnancy on the embryo and fetus. Due to that, the physician’s preventive work based on the knowledge of embryogenesis processes and critical development periods. Key words: teratogenic action, medications, prenatal development, congenital malformation, newborns, children.(Pediatric Pharmacology. – 2010; 7(1:25-28

Safety concerns for superconducting magnets of upcoming fusion experiments

International Nuclear Information System (INIS)

Turner, L.R.

1983-01-01

-Several fusion experiments being constructed (Tore Supra) or contemplated (DCT 8, Alcator DCT) feature superconducting coils. These coils introduce the following safety concerns: 1. Internally Cooled Conductor (ICC). ICC's are found to be highly stable against short heat pulses, even when the coolant is stagnant or moving at low steady-state velocity. However, a large heat pulse is certain to quench the conductor. Thus, determining the stability limits is vital. 2. Helium II Cooling. Helium II has both unique advantages as a coolant and unique safety problems. 3. Shorted Turns. In magnets with shorts from operational accidents, the current can switch back and forth between the short and the shorted turns, as those alternatively go normal and superconducting. 4. Hybrid Superconducting-Normal Conducting Coil System. The possibility of unequal currents in the different magnets and thus of unexpected forces on the superconducting magnets is much greater than for an all-superconducting system. Analysis of these problems are presented

The health and safety concerns of immigrant women workers in the Toronto sportswear industry.

Science.gov (United States)

Gannagé, C M

1999-01-01

Immigrant women's conditions of work have worsened with new government and managerial strategies to restructure the Canadian apparel industry. Changes in occupational health and safety legislation have both given and taken away tools that immigrant women workers could use to improve the quality of their working lives. The author outlines a methodology for eliciting the health and safety concerns of immigrant women workers.

Modulation of Brain Activity with Noninvasive Transcranial Direct Current Stimulation (tDCS): Clinical Applications and Safety Concerns

Science.gov (United States)

Zhao, Haichao; Qiao, Lei; Fan, Dongqiong; Zhang, Shuyue; Turel, Ofir; Li, Yonghui; Li, Jun; Xue, Gui; Chen, Antao; He, Qinghua

2017-01-01

Transcranial direct current stimulation (tDCS) is a widely-used tool to induce neuroplasticity and modulate cortical function by applying weak direct current over the scalp. In this review, we first introduce the underlying mechanism of action, the brief history from discovery to clinical scientific research, electrode positioning and montages, and parameter setup of tDCS. Then, we review tDCS application in clinical samples including people with drug addiction, major depression disorder, Alzheimer's disease, as well as in children. This review covers the typical characteristics and the underlying neural mechanisms of tDCS treatment in such studies. This is followed by a discussion of safety, especially when the current intensity is increased or the stimulation duration is prolonged. Given such concerns, we provide detailed suggestions regarding safety procedures for tDCS operation. Lastly, future research directions are discussed. They include foci on the development of multi-tech combination with tDCS such as with TMS and fMRI; long-term behavioral and morphological changes; possible applications in other research domains, and more animal research to deepen the understanding of the biological and physiological mechanisms of tDCS stimulation. PMID:28539894

Reporter Concerns in 300 Mode-Related Incident Reports from NASA's Aviation Safety Reporting System

Science.gov (United States)

McGreevy, Michael W.

1996-01-01

A model has been developed which represents prominent reporter concerns expressed in the narratives of 300 mode-related incident reports from NASA's Aviation Safety Reporting System (ASRS). The model objectively quantifies the structure of concerns which persist across situations and reporters. These concerns are described and illustrated using verbatim sentences from the original narratives. Report accession numbers are included with each sentence so that concerns can be traced back to the original reports. The results also include an inventory of mode names mentioned in the narratives, and a comparison of individual and joint concerns. The method is based on a proximity-weighted co-occurrence metric and object-oriented complexity reduction.

List of reports concerning reactor safety research from BMFT, CEA, EPRI, JSTA, and USNRC

International Nuclear Information System (INIS)

1982-12-01

This list reviews reports from the Federal Republic of Germany, from France, from Japan and from the United States of America concerning special problems in the field of Reactor Safety Research. According to the cooperation of the Bundesminister fuer Forschung und Technologie (BMFT) with the Commissariat a l'Energie Atomique (CEA), the Japan Science and Technologie Agency (JSTA), the Electric Power Research Institute (EPRI) and the United States Nuclear Regulatory Commission, these Reports are available in the Gesellschaft fuer Reaktorsicherheit (GRS). The list pursues the following order: Country of origin, problem area concerned, according to the Reactor Safety Research Programm of the BMFT, reporting organization. The list of reports appears quarterly. (orig./HP) [de

Drug safety: Pregnancy rating classifications and controversies.

Science.gov (United States)

Wilmer, Erin; Chai, Sandy; Kroumpouzos, George

2016-01-01

This contribution consolidates data on international pregnancy rating classifications, including the former US Food and Drug Administration (FDA), Swedish, and Australian classification systems, as well as the evidence-based medicine system, and discusses discrepancies among them. It reviews the new Pregnancy and Lactation Labeling Rule (PLLR) that replaced the former FDA labeling system with narrative-based labeling requirements. PLLR emphasizes on human data and highlights pregnancy exposure registry information. In this context, the review discusses important data on the safety of most medications used in the management of skin disease in pregnancy. There are also discussions of controversies relevant to the safety of certain dermatologic medications during gestation. Copyright © 2016 Elsevier Inc. All rights reserved.

Application of the Pareto principle to identify and address drug-therapy safety issues.

Science.gov (United States)

Müller, Fabian; Dormann, Harald; Pfistermeister, Barbara; Sonst, Anja; Patapovas, Andrius; Vogler, Renate; Hartmann, Nina; Plank-Kiegele, Bettina; Kirchner, Melanie; Bürkle, Thomas; Maas, Renke

2014-06-01

Adverse drug events (ADE) and medication errors (ME) are common causes of morbidity in patients presenting at emergency departments (ED). Recognition of ADE as being drug related and prevention of ME are key to enhancing pharmacotherapy safety in ED. We assessed the applicability of the Pareto principle (~80 % of effects result from 20 % of causes) to address locally relevant problems of drug therapy. In 752 cases consecutively admitted to the nontraumatic ED of a major regional hospital, ADE, ME, contributing drugs, preventability, and detection rates of ADE by ED staff were investigated. Symptoms, errors, and drugs were sorted by frequency in order to apply the Pareto principle. In total, 242 ADE were observed, and 148 (61.2 %) were assessed as preventable. ADE contributed to 110 inpatient hospitalizations. The ten most frequent symptoms were causally involved in 88 (80.0 %) inpatient hospitalizations. Only 45 (18.6 %) ADE were recognized as drug-related problems until discharge from the ED. A limited set of 33 drugs accounted for 184 (76.0 %) ADE; ME contributed to 57 ADE. Frequency-based listing of ADE, ME, and drugs involved allowed identification of the most relevant problems and development of easily to implement safety measures, such as wall and pocket charts. The Pareto principle provides a method for identifying the locally most relevant ADE, ME, and involved drugs. This permits subsequent development of interventions to increase patient safety in the ED admission process that best suit local needs.

Safety and effectiveness of drug therapy for the acutely agitated patient (Part I

Directory of Open Access Journals (Sweden)

Gianluca Airoldi

2013-04-01

Full Text Available Acute agitation occurs in a variety of medical and psychiatric conditions, and the management of agitated, abusive, or violent patients is a common problem in the emergency department. Rapid control of potentially dangerous behaviors by physical restraint and pharmacologic tranquillization is crucial to ensure the safety of the patient and health-care personnel and to allow diagnostic procedures and treatment of the underlying condition. The purpose of this article (the first in a 2-part series is to review the extensive safety data published on the antipsychotic medications currently available for managing situations of this type, including older neuroleptics like haloperidol, chlorpromazine, and pimozide as well as a number of the newer atypical antipsychotics (olanzapine, risperidone, ziprasidone. Particular attention is focused on the ability of these drugs to lengthen the QT interval in surface electrocardiograms. This adverse effect is of major concern, especially in light of the reported relation between QT interval and the risk of sudden death. In patients with the congenital long-QT syndrome, a long QT interval is associated with a fatal paroxysmal ventricular arrhythmia knownas torsades de pointes. Therefore, careful evaluation of the QT-prolonging properties and arrhythmogenic potential of antipsychotic drugs is urgently needed. Clinical assessment of drug-induced QT-interval prolongation is strictly dependent on the quality of electrocardiographic data and the appropriateness of electrocardiographic analyses. Unfortunately, measurement imprecision and natural variability preclude a simple use of the actually measured QT interval as a surrogate marker of drug-induced proarrhythmia. Because the QT interval changes with heart rate, a rate-corrected QT interval (QTc is commonly used when evaluating a drug’s effect. In clinical settings, themost widely used formulas for rate-correction are those of Bazett (QTc=QT/RR^0.5 and Fridericia

Guideline for examination concerning the evaluation of safety in light water power reactor installations

International Nuclear Information System (INIS)

1978-01-01

This guideline was drawn up as the guide for examination when the safety evaluation of nuclear reactors is carried out at the time of approving the installation of light water power reactors. Accordingly in case of the examination of safety, it must be confirmed that the contents of application are in conformity with this guideline. If they are in conformity, it is judged that the safety evaluation of the policy in the basic design of a reactor facility is adequate, and also that the evaluation concerning the separation from the public in surroundings is adequate as the condition of location of the reactor facility. This guideline is concerned with light water power reactors now in use, but the basic concept may be the reference for the examination of the other types of reactors. If such a case occurs that the safety evaluation does not conform to this guideline, it is not excluded when the appropriate reason is clarified. The purpose of safety evaluation, the scope to be evaluated, the selection of the events to be evaluated, the criteria for judgement, the matters taken into consideration at the time of analysis, the concrete events of abnormal transient change and accident in operation, and the concrete events of serious accident and hypothetic accident are stipulated. The explanation and two appendices are attached. (Kako, I.)

ED accreditation update. Physicians, medical staff may report safety concerns without fear of disciplinary action.

Science.gov (United States)

2007-11-01

Educating your staff about The Joint Commission's requirements for concerns about hospital safety and quality of care requires the ED manager to set a tone of openness and cooperation, while at the same time emphasizing your department's role in addressing such concerns: * The ED should be the first place that staff members communicate quality and safety concerns. It is only when a problem is not addressed that they should take the issue to hospital administration and, if necessary, The Joint Commission. * A single event should not trigger a report to The Joint Commission, unless it is unusually serious. Otherwise, only a series of events should trigger a report. * Reassure your staff that you care about what is reported and will act quickly on it. Educate your staff about the reporting forms, and follow up with random audits to ensure compliance.

Drug research methodology. Volume 4, Epidemiology in drugs and highway safety : the study of drug use among drivers and its role in traffic crashes

Science.gov (United States)

1980-06-01

This report presents the findings of a workshop on epidemiology in drugs and highway safety. A cross-disciplinary panel of experts (1) identified methodological issues and constraints present in research to define the nature and magnitude of the drug...

76 FR 63929 - Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and...

Science.gov (United States)

2011-10-14

...] Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and... Administration (FDA). The meeting will be open to the public. Name of Committees: Drug Safety and Risk Management... Safe Use (ETASU) before its Drug Safety and Risk Management Advisory Committee (DSaRM). On December 1...

Summary of Tiger Team Assessment and Technical Safety Appraisal recurring concerns in the Maintenance Area

International Nuclear Information System (INIS)

1993-01-01

Tiger Team Assessments and Technical Safety Appraisals (TSA) were reviewed and evaluated for concerns in the Maintenance Area (MA). Two hundred and thirty one (231) maintenance concerns were identified by the Tiger Team Assessments and TSA reports. These recurring concerns appear below. A summary of the Noteworthy Practices that were identified and a compilation of the maintenance concerns for each performance objective that were not considered as recurring are also included. Where the Tiger Team Assessment and TSA identified the operating contractor or facility by name, the concern has been modified to remove the name while retaining the intent of the comment

Genetically modified foods: safety, risks and public concerns-a review.

Science.gov (United States)

Bawa, A S; Anilakumar, K R

2013-12-01

Genetic modification is a special set of gene technology that alters the genetic machinery of such living organisms as animals, plants or microorganisms. Combining genes from different organisms is known as recombinant DNA technology and the resulting organism is said to be 'Genetically modified (GM)', 'Genetically engineered' or 'Transgenic'. The principal transgenic crops grown commercially in field are herbicide and insecticide resistant soybeans, corn, cotton and canola. Other crops grown commercially and/or field-tested are sweet potato resistant to a virus that could destroy most of the African harvest, rice with increased iron and vitamins that may alleviate chronic malnutrition in Asian countries and a variety of plants that are able to survive weather extremes. There are bananas that produce human vaccines against infectious diseases such as hepatitis B, fish that mature more quickly, fruit and nut trees that yield years earlier and plants that produce new plastics with unique properties. Technologies for genetically modifying foods offer dramatic promise for meeting some areas of greatest challenge for the 21st century. Like all new technologies, they also pose some risks, both known and unknown. Controversies and public concern surrounding GM foods and crops commonly focus on human and environmental safety, labelling and consumer choice, intellectual property rights, ethics, food security, poverty reduction and environmental conservation. With this new technology on gene manipulation what are the risks of "tampering with Mother Nature"?, what effects will this have on the environment?, what are the health concerns that consumers should be aware of? and is recombinant technology really beneficial? This review will also address some major concerns about the safety, environmental and ecological risks and health hazards involved with GM foods and recombinant technology.

Analyzing research trends on drug safety using topic modeling.

Science.gov (United States)

Zou, Chen

2018-04-06

Published drug safety data has evolved in the past decade due to scientific and technological advances in the relevant research fields. Considering that a vast amount of scientific literature has been published in this area, it is not easy to identify the key information. Topic modeling has emerged as a powerful tool to extract meaningful information from a large volume of unstructured texts. Areas covered: We analyzed the titles and abstracts of 4347 articles in four journals dedicated to drug safety from 2007 to 2016. We applied Latent Dirichlet allocation (LDA) model to extract 50 main topics, and conducted trend analysis to explore the temporal popularity of these topics over years. Expert Opinion/Commentary: We found that 'benefit-risk assessment and communication', 'diabetes' and 'biologic therapy for autoimmune diseases' are the top 3 most published topics. The topics relevant to the use of electronic health records/observational data for safety surveillance are becoming increasingly popular over time. Meanwhile, there is a slight decrease in research on signal detection based on spontaneous reporting, although spontaneous reporting still plays an important role in benefit-risk assessment. The topics related to medical conditions and treatment showed highly dynamic patterns over time.

Legacy data sharing to improve drug safety assessment: the eTOX project

DEFF Research Database (Denmark)

Sanz, Ferran; Pognan, François; Steger-Hartmann, Thomas

2017-01-01

The sharing of legacy preclinical safety data among pharmaceutical companies and its integration with other information sources offers unprecedented opportunities to improve the early assessment of drug safety. Here, we discuss the experience of the eTOX project, which was established through...

The Internet and drug safety: what are the implications for pharmacovigilance?

Science.gov (United States)

Cobert, B; Silvey, J

1999-02-01

Use of the Internet is becoming widespread throughout the world. Its use in the domain of drug safety and pharmacovigilance is spreading rapidly. Governments and industry have taken the lead in developing extensive web sites. The US Food and Drug Administration (FDA), the European Agency for the Evaluation of Medicinal Products (EMEA) and other agencies have developed sites containing enormous amounts of information both on pharmacovigilance in general and on specific drugs in particular. Under the US 'Freedom of Information Act' the FDA has put major parts of its adverse event database on line. Regulatory documents are also available from the FDA site or from hyperlinks described in the site. The US Center for Drug Evaluation and Research updates its site most days and maintains a free automated e-mail announcement service of these updates. Similarly, the EMEA updates its site frequently and publishes extensive material including regulatory documents, guidelines, European Public Assessment Reports on newly approved medications and other useful information. A free update service by e-mail is also available. Although English is the primary language used on the EMEA site, some of the information is available in other languages. Pharmaceutical companies are not using the Internet for pharmacovigilance yet. Rather, the Internet is being used for promotion of their products and for informing consumers on general information on diseases, for financial and investor data and for employment opportunities, etc. Other organisations such as lobbies, consumer groups and medical journals are also beginning to use the Internet. The electronic transmission of safety information, using the standards developed by the International Conference on Harmonization, is currently being tested for the transmission of individual patient adverse event information between companies and governments. In addition, the FDA has begun to accept adverse events from healthcare providers and consumers

Drug discrimination: A versatile tool for characterization of CNS safety pharmacology and potential for drug abuse.

Science.gov (United States)

Swedberg, Michael D B

2016-01-01

Drug discrimination studies for assessment of psychoactive properties of drugs in safety pharmacology and drug abuse and drug dependence potential evaluation have traditionally been focused on testing novel compounds against standard drugs for which drug abuse has been documented, e.g. opioids, CNS stimulants, cannabinoids etc. (e.g. Swedberg & Giarola, 2015), and results are interpreted such that the extent to which the test drug causes discriminative effects similar to those of the standard training drug, the test drug would be further characterized as a potential drug of abuse. Regulatory guidance for preclinical assessment of abuse liability by the European Medicines Agency (EMA, 2006), the U.S. Food and Drug Administration (FDA, 2010), the International Conference of Harmonization (ICH, 2009), and the Japanese Ministry of Health Education and Welfare (MHLW, 1994) detail that compounds with central nervous system (CNS) activity, whether by design or not, need abuse and dependence liability assessment. Therefore, drugs with peripheral targets and a potential to enter the CNS, as parent or metabolite, are also within scope (see Swedberg, 2013, for a recent review and strategy). Compounds with novel mechanisms of action present a special challenge due to unknown abuse potential, and should be carefully assessed against defined risk criteria. Apart from compounds sharing mechanisms of action with known drugs of abuse, compounds intended for indications currently treated with drugs with potential for abuse and or dependence are also within scope, regardless of mechanism of action. Examples of such compounds are analgesics, anxiolytics, cognition enhancers, appetite control drugs, sleep control drugs and drugs for psychiatric indications. Recent results (Swedberg et al., 2014; Swedberg & Raboisson, 2014; Swedberg, 2015) on the metabotropic glutamate receptor type 5 (mGluR5) antagonists demonstrate that compounds causing hallucinatory effects in humans did not exhibit

Educational audit on drug dose calculation learning in a Tanzanian ...

African Journals Online (AJOL)

Background: Patient safety is a key concern for nurses; ability to calculate drug ... Specific objectives were to assess learning from targeted teaching, to identify problem areas in perfor- .... this could result in reduced risk of drug dose error in.

Drug-Drug/Drug-Excipient Compatibility Studies on Curcumin using Non-Thermal Methods

Directory of Open Access Journals (Sweden)

Moorthi Chidambaram

2014-05-01

Full Text Available Purpose: Curcumin is a hydrophobic polyphenol isolated from dried rhizome of turmeric. Clinical usefulness of curcumin in the treatment of cancer is limited due to poor aqueous solubility, hydrolytic degradation, metabolism, and poor oral bioavailability. To overcome these limitations, we proposed to fabricate curcumin-piperine, curcumin-quercetin and curcumin-silibinin loaded polymeric nanoformulation. However, unfavourable combinations of drug-drug and drug-excipient may result in interaction and rises the safety concern. Hence, the present study was aimed to assess the interaction of curcumin with excipients used in nanoformulations. Methods: Isothermal stress testing method was used to assess the compatibility of drug-drug/drug-excipient. Results: The combination of curcumin-piperine, curcumin-quercetin, curcumin-silibinin and the combination of other excipients with curcumin, piperine, quercetin and silibinin have not shown any significant physical and chemical instability. Conclusion: The study concludes that the curcumin, piperine, quercetin and silibinin is compatible with each other and with other excipients.

The use of drugs in food animals: benefits and risks

National Research Council Canada - National Science Library

...; however, their use has also raised public health safety concerns. The Use of Drugs in Food Animals provides an overview of why and how drugs are used in the major food-producing animal industries--poultry, dairy, beef, swine, and aquaculture...

Exploiting pluripotent stem cell technology for drug discovery, screening, safety, and toxicology assessments.

Science.gov (United States)

McGivern, Jered V; Ebert, Allison D

2014-04-01

In order for the pharmaceutical industry to maintain a constant flow of novel drugs and therapeutics into the clinic, compounds must be thoroughly validated for safety and efficacy in multiple biological and biochemical systems. Pluripotent stem cells, because of their ability to develop into any cell type in the body and recapitulate human disease, may be an important cellular system to add to the drug development repertoire. This review will discuss some of the benefits of using pluripotent stem cells for drug discovery and safety studies as well as some of the recent applications of stem cells in drug screening studies. We will also address some of the hurdles that need to be overcome in order to make stem cell-based approaches an efficient and effective tool in the quest to produce clinically successful drug compounds. Copyright © 2013 Elsevier B.V. All rights reserved.

The principle of safety evaluation in medicinal drug - how can toxicology contribute to drug discovery and development as a multidisciplinary science?

Science.gov (United States)

Horii, Ikuo

2016-01-01

Pharmaceutical (drug) safety assessment covers a diverse science-field in the drug discovery and development including the post-approval and post-marketing phases in order to evaluate safety and risk management. The principle in toxicological science is to be placed on both of pure and applied sciences that are derived from past/present scientific knowledge and coming new science and technology. In general, adverse drug reactions are presented as "biological responses to foreign substances." This is the basic concept of thinking about the manifestation of adverse drug reactions. Whether or not toxic expressions are extensions of the pharmacological effect, adverse drug reactions as seen from molecular targets are captured in the category of "on-target" or "off-target", and are normally expressed as a biological defense reaction. Accordingly, reactions induced by pharmaceuticals can be broadly said to be defensive reactions. Recent molecular biological conception is in line with the new, remarkable scientific and technological developments in the medical and pharmaceutical areas, and the viewpoints in the field of toxicology have shown that they are approaching toward the same direction as well. This paper refers to the basic concept of pharmaceutical toxicology, the differences for safety assessment in each stage of drug discovery and development, regulatory submission, and the concept of scientific considerations for risk assessment and management from the viewpoint of "how can multidisciplinary toxicology contribute to innovative drug discovery and development?" And also realistic translational research from preclinical to clinical application is required to have a significant risk management in post market by utilizing whole scientific data derived from basic and applied scientific research works. In addition, the significance for employing the systems toxicology based on AOP (Adverse Outcome Pathway) analysis is introduced, and coming challenges on precision

Development of novel, 384-well high-throughput assay panels for human drug transporters: drug interaction and safety assessment in support of discovery research.

Science.gov (United States)

Tang, Huaping; Shen, Ding Ren; Han, Yong-Hae; Kong, Yan; Balimane, Praveen; Marino, Anthony; Gao, Mian; Wu, Sophie; Xie, Dianlin; Soars, Matthew G; O'Connell, Jonathan C; Rodrigues, A David; Zhang, Litao; Cvijic, Mary Ellen

2013-10-01

Transporter proteins are known to play a critical role in affecting the overall absorption, distribution, metabolism, and excretion characteristics of drug candidates. In addition to efflux transporters (P-gp, BCRP, MRP2, etc.) that limit absorption, there has been a renewed interest in influx transporters at the renal (OATs, OCTs) and hepatic (OATPs, BSEP, NTCP, etc.) organ level that can cause significant clinical drug-drug interactions (DDIs). Several of these transporters are also critical for hepatobiliary disposition of bilirubin and bile acid/salts, and their inhibition is directly implicated in hepatic toxicities. Regulatory agencies took action to address transporter-mediated DDI with the goal of ensuring drug safety in the clinic and on the market. To meet regulatory requirements, advanced bioassay technology and automation solutions were implemented for high-throughput transporter screening to provide structure-activity relationship within lead optimization. To enhance capacity, several functional assay formats were miniaturized to 384-well throughput including novel fluorescence-based uptake and efflux inhibition assays using high-content image analysis as well as cell-based radioactive uptake and vesicle-based efflux inhibition assays. This high-throughput capability enabled a paradigm shift from studying transporter-related issues in the development space to identifying and dialing out these concerns early on in discovery for enhanced mechanism-based efficacy while circumventing DDIs and transporter toxicities.

Ordinance of 14 March 1983 concerning the Federal Commission for the Safety of Nuclear Installations

International Nuclear Information System (INIS)

1983-01-01

The Frederal Council issued a new Ordinance concerning the Federal Commission for the Safety of Nuclear Installations. This Ordinance replaces an Ordinance of 13 June 1960 and takes into account the distribution of tasks decided several years ago between the Commission, which operates on a part-time basis, and the principal Division for the Safety of Nuclear Installations attached to the Federal Office of Energy. (NEA) [fr

Drug packaging in 2014: authorities should direct more efforts towards medication safety.

Science.gov (United States)

2015-05-01

In 2014, Prescrire examined the packaging quality of about 250 drugs. A few advances stand out, mainly involving recent drugs, but on the whole, the situation is worrisome in terms of medication safety. Although pharmaceutical companies and drug regulatory agencies seem to be taking more account of the risk of accidental poisoning in children, the level of protection remains low overall in the absence of stringent measures on the part of the authorities. New drugs too often have poor-quality or even dangerous packaging at the time of their market introduction. And the packaging quality of older drugs is disturbing. Pharmaceutical companies no longer invest in the packaging of these products, and agencies often fail to take advantage of the opportunities provided by their reassessment to improve the situation. The inappropriate labelling of certain injectable drugs remains a source of medication errors, sometimes resulting in very serious consequences. In 2014, signs of progress in the packaging of several drugs show that its role in medication safety is better appreciated. But the persistence of dangers in the pharmaceuticals market, created by "unfinished", overly complex or poor-quality packaging, raises the question of the responsibility of pharmaceutical companies and agencies for past and present accidents.

Drug safety is a barrier to the discovery and development of new androgen receptor antagonists.

Science.gov (United States)

Foster, William R; Car, Bruce D; Shi, Hong; Levesque, Paul C; Obermeier, Mary T; Gan, Jinping; Arezzo, Joseph C; Powlin, Stephanie S; Dinchuk, Joseph E; Balog, Aaron; Salvati, Mark E; Attar, Ricardo M; Gottardis, Marco M

2011-04-01

Androgen receptor (AR) antagonists are part of the standard of care for prostate cancer. Despite the almost inevitable development of resistance in prostate tumors to AR antagonists, no new AR antagonists have been approved for over a decade. Treatment failure is due in part to mutations that increase activity of AR in response to lower ligand concentrations as well as to mutations that result in AR response to a broader range of ligands. The failure to discover new AR antagonists has occurred in the face of continued research; to enable progress, a clear understanding of the reasons for failure is required. Non-clinical drug safety studies and safety pharmacology assays were performed on previously approved AR antagonists (bicalutamide, flutamide, nilutamide), next generation antagonists in clinical testing (MDV3100, BMS-641988), and a pre-clinical drug candidate (BMS-501949). In addition, non-clinical studies with AR mutant mice, and EEG recordings in rats were performed. Non-clinical findings are compared to disclosures of clinical trial results. As a drug class, AR antagonists cause seizure in animals by an off-target mechanism and are found in vitro to inhibit GABA-A currents. Clinical trials of candidate next generation AR antagonists identify seizure as a clinical safety risk. Non-clinical drug safety profiles of the AR antagonist drug class create a significant barrier to the identification of next generation AR antagonists. GABA-A inhibition is a common off-target activity of approved and next generation AR antagonists potentially explaining some side effects and safety hazards of this class of drugs. Copyright © 2010 Wiley-Liss, Inc.

Comparing Safety and Efficacy of "Third-Generation" Antiepileptic Drugs: Long-Term Extension and Post-marketing Treatment.

Science.gov (United States)

Kwok, Charlotte S; Johnson, Emily L; Krauss, Gregory L

2017-11-01

Four "third-generation" antiepileptic drugs (AEDs) were approved for adjunctive treatment of refractory focal onset seizures during the past 10 years. Long-term efficacy and safety of the drugs were demonstrated in large extension studies and in reports of subgroups of patients not studied in pivotal trials. Reviewing extension study and post-marketing outcome series for the four newer AEDs-lacosamide, perampanel, eslicarbazepine acetate and brivaracetam-can guide clinicians in treating and monitoring patients. AED extension studies evaluate treatment retention, drug tolerability, and drug safety during individualized treatment with flexible dosing and thus provide information not available in rigid pivotal trials. Patient retention in the studies ranged from 75 to 80% at 1 year and from 36 to 68% at 2-year treatment intervals. Safety findings were generally similar to those of pivotal trials, with no major safety risks identified and with several specific adverse drug effects, such as hyponatremia, reported. The third-generation AEDs, some through new mechanisms and others with improved tolerability compared to related AEDs, provide new options in efficacy and tolerability.

Report on the handling of safety information concerning flammable gases and ferrocyanide at the Hanford waste tanks

International Nuclear Information System (INIS)

1990-07-01

This report discusses concerns safety issues, and management at Hanford Tank Farm. Concerns center on the issue of flammable gas generation which could ignite, and on possible exothermic reactions of ferrocyanide compounds which were added to single shell tanks in the 1950's. It is believed that information concerning these issues has been mis-handled and the problems poorly managed

Report on the handling of safety information concerning flammable gases and ferrocyanide at the Hanford waste tanks

Energy Technology Data Exchange (ETDEWEB)

1990-07-01

This report discusses concerns safety issues, and management at Hanford Tank Farm. Concerns center on the issue of flammable gas generation which could ignite, and on possible exothermic reactions of ferrocyanide compounds which were added to single shell tanks in the 1950's. It is believed that information concerning these issues has been mis-handled and the problems poorly managed. (CBS)

Enhancing food safety: the role of the Food and Drug Administration

National Research Council Canada - National Science Library

Wallace, Robert B; Oria, Maria

2010-01-01

.... Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources...

A Decade in the MIST: Learnings from Investigations of Drug Metabolites in Drug Development under the "Metabolites in Safety Testing" Regulatory Guidance.

Science.gov (United States)

Schadt, Simone; Bister, Bojan; Chowdhury, Swapan K; Funk, Christoph; Hop, Cornelis E C A; Humphreys, W Griffith; Igarashi, Fumihiko; James, Alexander D; Kagan, Mark; Khojasteh, S Cyrus; Nedderman, Angus N R; Prakash, Chandra; Runge, Frank; Scheible, Holger; Spracklin, Douglas K; Swart, Piet; Tse, Susanna; Yuan, Josh; Obach, R Scott

2018-06-01

Since the introduction of metabolites in safety testing (MIST) guidance by the Food and Drug Administration in 2008, major changes have occurred in the experimental methods for the identification and quantification of metabolites, ways to evaluate coverage of metabolites, and the timing of critical clinical and nonclinical studies to generate this information. In this cross-industry review, we discuss how the increased focus on human drug metabolites and their potential contribution to safety and drug-drug interactions has influenced the approaches taken by industry for the identification and quantitation of human drug metabolites. Before the MIST guidance was issued, the method of choice for generating comprehensive metabolite profile was radio chromatography. The MIST guidance increased the focus on human drug metabolites and their potential contribution to safety and drug-drug interactions and led to changes in the practices of drug metabolism scientists. In addition, the guidance suggested that human metabolism studies should also be accelerated, which has led to more frequent determination of human metabolite profiles from multiple ascending-dose clinical studies. Generating a comprehensive and quantitative profile of human metabolites has become a more urgent task. Together with technological advances, these events have led to a general shift of focus toward earlier human metabolism studies using high-resolution mass spectrometry and to a reduction in animal radiolabel absorption/distribution/metabolism/excretion studies. The changes induced by the MIST guidance are highlighted by six case studies included herein, reflecting different stages of implementation of the MIST guidance within the pharmaceutical industry. Copyright © 2018 by The American Society for Pharmacology and Experimental Therapeutics.

A regulatory science viewpoint on botanical–drug interactions

Directory of Open Access Journals (Sweden)

Manuela Grimstein

2018-04-01

Full Text Available There is a continued predisposition of concurrent use of drugs and botanical products. Consumers often self-administer botanical products without informing their health care providers. The perceived safety of botanical products with lack of knowledge of the interaction potential poses a challenge for providers and both efficacy and safety concerns for patients. Botanical–drug combinations can produce untoward effects when botanical constituents modulate drug metabolizing enzymes and/or transporters impacting the systemic or tissue exposure of concomitant drugs. Examples of pertinent scientific literature evaluating the interaction potential of commonly used botanicals in the US are discussed. Current methodologies that can be applied to advance our efforts in predicting drug interaction liability is presented. This review also highlights the regulatory science viewpoint on botanical–drug interactions and labeling implications. Keywords: Drug interaction, Botanical product, St. John's wort, Fruit juices, Regulatory science

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.

Thermal safety of ultrasound-enhanced ocular drug delivery: A modeling study

Energy Technology Data Exchange (ETDEWEB)

Nabili, Marjan, E-mail: mnabili@gwmail.gwu.edu [Department of Electrical and Computer Engineering, The George Washington University, 800 22nd Street NW, Room 5000, Washington, DC 20052 (United States); Geist, Craig, E-mail: cgeist@mfa.gwu.edu, E-mail: zderic@gwu.edu [Department of Ophthalmology, The George Washington University, 2150 Pennsylvania Avenue NW, Floor 2A, Washington, DC 20037 (United States); Zderic, Vesna, E-mail: cgeist@mfa.gwu.edu, E-mail: zderic@gwu.edu [Department of Biomedical Engineering, The George Washington University, 800 22nd Street NW, Room 6670, Washington, DC 20052 (United States)

2015-10-15

Purpose: Delivery of sufficient amounts of therapeutic drugs into the eye for treatment of various ocular diseases is often a challenging task. Ultrasound was shown to be effective in enhancing ocular drug delivery in the authors’ previous in vitro and in vivo studies. Methods: The study reported here was designed to investigate the safety of ultrasound application and its potential thermal effects in the eye using PZFlex modeling software. The safety limit in this study was set as a temperature increase of no more than 1.5 °C based on regulatory recommendations and previous experimental safety studies. Acoustic and thermal specifications of different human eye tissues were obtained from the published literature. The tissues of particular interest in this modeling safety study were cornea, lens, and the location of optic nerve in the posterior eye. Ultrasound application was modeled at frequencies of 400 kHz–1 MHz, intensities of 0.3–1 W/cm{sup 2}, and exposure duration of 5 min, which were the parameters used in the authors’ previous drug delivery experiments. The baseline eye temperature was 37 °C. Results: The authors’ results showed that the maximal tissue temperatures after 5 min of ultrasound application were 38, 39, 39.5, and 40 °C in the cornea, 39.5, 40, 42, and 43 °C in the center of the lens, and 37.5, 38.5, and 39 °C in the back of the eye (at the optic nerve location) at frequencies of 400, 600, 800 kHz, and 1 MHz, respectively. Conclusions: The ocular temperatures reached at higher frequencies were considered unsafe based on current recommendations. At a frequency of 400 kHz and intensity of 0.8 W/cm{sup 2} (parameters shown in the authors’ previous in vivo studies to be optimal for ocular drug delivery), the temperature increase was small enough to be considered safe inside different ocular tissues. However, the impact of orbital bone and tissue perfusion should be included in future modeling efforts to determine the safety

Thermal safety of ultrasound-enhanced ocular drug delivery: A modeling study

International Nuclear Information System (INIS)

Nabili, Marjan; Geist, Craig; Zderic, Vesna

2015-01-01

Purpose: Delivery of sufficient amounts of therapeutic drugs into the eye for treatment of various ocular diseases is often a challenging task. Ultrasound was shown to be effective in enhancing ocular drug delivery in the authors’ previous in vitro and in vivo studies. Methods: The study reported here was designed to investigate the safety of ultrasound application and its potential thermal effects in the eye using PZFlex modeling software. The safety limit in this study was set as a temperature increase of no more than 1.5 °C based on regulatory recommendations and previous experimental safety studies. Acoustic and thermal specifications of different human eye tissues were obtained from the published literature. The tissues of particular interest in this modeling safety study were cornea, lens, and the location of optic nerve in the posterior eye. Ultrasound application was modeled at frequencies of 400 kHz–1 MHz, intensities of 0.3–1 W/cm 2 , and exposure duration of 5 min, which were the parameters used in the authors’ previous drug delivery experiments. The baseline eye temperature was 37 °C. Results: The authors’ results showed that the maximal tissue temperatures after 5 min of ultrasound application were 38, 39, 39.5, and 40 °C in the cornea, 39.5, 40, 42, and 43 °C in the center of the lens, and 37.5, 38.5, and 39 °C in the back of the eye (at the optic nerve location) at frequencies of 400, 600, 800 kHz, and 1 MHz, respectively. Conclusions: The ocular temperatures reached at higher frequencies were considered unsafe based on current recommendations. At a frequency of 400 kHz and intensity of 0.8 W/cm 2 (parameters shown in the authors’ previous in vivo studies to be optimal for ocular drug delivery), the temperature increase was small enough to be considered safe inside different ocular tissues. However, the impact of orbital bone and tissue perfusion should be included in future modeling efforts to determine the safety of this

[Evaluation of the safety of innovative drugs against viruses and infectious agents].

Science.gov (United States)

Kobayashi, Tetsu; Yusa, Keisuke; Kawasaki, Nana

2013-01-01

Recently, several novel cellular therapy products and biological drugs are being developed to treat various previously untreatable diseases. One of the most important issues regarding these innovations is how to ensure safety over infectious agents, including viruses and prions, in the earliest treatments with these products. The object of this study is a risk assessment of cases of human infectious with the agents and to present a sample risk management plan based on a collaboration among the National Institute of Health Sciences, universities, marketing authorization holders, and scientific societies. There are three subjects of study: (1) the viral safety of cellular therapy products, (2) the viral safety of biological drugs, and (3) the safety of prions. In this report, we describe the objects of the study, the project members, the study plan outline, and the ongoing plans. The results of the viral risk identification and the risk analysis of cellular therapy products will also be described, based on a review of the literature and case reports obtained during the first year of this project.

Assessment of pharmacovigilance approaches for monitoring the safety of antimalarial drugs in pregnancy

NARCIS (Netherlands)

Dellicour, S.O.M.C.

2014-01-01

Post-marketing surveillance of drugs used in pregnancy is challenging, especially in developing countries where resources for pharmacovigilance are rare. There is a need to establish simple but effective systems to monitor safety of drugs given during pregnancy in resource constrained countries.

Integrated safety analysis of rolapitant with coadministered drugs from phase II/III trials

DEFF Research Database (Denmark)

Barbour, S; Smit, T.; Wang, X

2017-01-01

adverse events by use versus non-use of drug substrates of CYP2D6 or BCRP. Patients and methods: Patients were randomized to receive either 180 mg oral rolapitant or placebo approximately 1-2 hours before chemotherapy in combination with a 5-hydroxytryptamine type 3 RA and dexamethasone. Data...... cytochrome P450 (CYP) 3A4, but it does inhibit CYP2D6 and breast cancer resistance protein (BCRP). To analyze potential drug-drug interactions between rolapitant and concomitant medications, this integrated safety analysis of four double-blind, randomized phase II or III studies of rolapitant examined...... for treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) during cycle 1 were pooled across the four studies and summarized in the overall population and by concomitant use/non-use of CYP2D6 or BCRP substrate drugs. Results: In the integrated safety population, 828...

Occupational Safety and Health Concerns in Logging: A Cross-Sectional Assessment in Virginia

Directory of Open Access Journals (Sweden)

Sunwook Kim

2017-11-01

Full Text Available Increased logging mechanization has helped improve logging safety and health, yet related safety risks and concerns are not well understood. A cross-sectional study was completed among Virginia loggers. Participants (n = 122 completed a self-administered questionnaire focusing on aspects of safety and health related to logging equipment. Respondents were at a high risk of workplace injuries, with reported career and 12-month injury prevalences of 51% and 14%, respectively. Further, nearly all (98% respondents reported experiencing musculoskeletal symptoms. Over half (57.4% of respondents reported symptoms related to diesel exhaust exposure in their career. Few (15.6%, however, perceived their jobs to be dangerous. Based on the opinions and suggestions of respondents, three priority areas were identified for interventions: struck-by/against hazards, situational awareness (SA during logging operations, and visibility hazards. To address these hazards, and to have a broader and more substantial positive impact on safety and health, we discuss the need for proactive approaches such as incorporating proximity technologies in a logging machine or personal equipment, and enhancing logging machine design to enhance safety, ergonomics, and SA.

A regulatory science viewpoint on botanical-drug interactions.

Science.gov (United States)

Grimstein, Manuela; Huang, Shiew-Mei

2018-04-01

There is a continued predisposition of concurrent use of drugs and botanical products. Consumers often self-administer botanical products without informing their health care providers. The perceived safety of botanical products with lack of knowledge of the interaction potential poses a challenge for providers and both efficacy and safety concerns for patients. Botanical-drug combinations can produce untoward effects when botanical constituents modulate drug metabolizing enzymes and/or transporters impacting the systemic or tissue exposure of concomitant drugs. Examples of pertinent scientific literature evaluating the interaction potential of commonly used botanicals in the US are discussed. Current methodologies that can be applied to advance our efforts in predicting drug interaction liability is presented. This review also highlights the regulatory science viewpoint on botanical-drug interactions and labeling implications. Copyright © 2018. Published by Elsevier B.V.

The Patient's Voice in Pharmacovigilance: Pragmatic Approaches to Building a Patient-Centric Drug Safety Organization.

Science.gov (United States)

Smith, Meredith Y; Benattia, Isma

2016-09-01

Patient-centeredness has become an acknowledged hallmark of not only high-quality health care but also high-quality drug development. Biopharmaceutical companies are actively seeking to be more patient-centric in drug research and development by involving patients in identifying target disease conditions, participating in the design of, and recruitment for, clinical trials, and disseminating study results. Drug safety departments within the biopharmaceutical industry are at a similar inflection point. Rising rates of per capita prescription drug use underscore the importance of having robust pharmacovigilance systems in place to detect and assess adverse drug reactions (ADRs). At the same time, the practice of pharmacovigilance is being transformed by a host of recent regulatory guidances and related initiatives which emphasize the importance of the patient's perspective in drug safety. Collectively, these initiatives impact the full range of activities that fall within the remit of pharmacovigilance, including ADR reporting, signal detection and evaluation, risk management, medication error assessment, benefit-risk assessment and risk communication. Examples include the fact that manufacturing authorization holders are now expected to monitor all digital sources under their control for potential reports of ADRs, and the emergence of new methods for collecting, analysing and reporting patient-generated ADR reports for signal detection and evaluation purposes. A drug safety department's ability to transition successfully into a more patient-centric organization will depend on three defining attributes: (1) a patient-centered culture; (2) deployment of a framework to guide patient engagement activities; and (3) demonstrated proficiency in patient-centered competencies, including patient engagement, risk communication and patient preference assessment. Whether, and to what extent, drug safety departments embrace the new patient-centric imperative, and the methods and

Enacting laws concerning radiation safety management for students using X-rays and electron beams under 1 MeV

International Nuclear Information System (INIS)

Nishizawa, Kunihide; Shibata, Michihiro; Saze, Takuya

2004-01-01

Laws concerning radiation safety management were analyzed from the point of view of defining precisely what is meant by radiation and what is meant by the subject. There are no laws to protect students from radiation hazards when using X-rays and electron beams under 1 MeV for research and/or education. The Law concerning Technical Standards for Preventing Radiation Hazards gives the authorities the power to enact new rules and regulations that will protect the students. The Radiation Council must take charge for enactment of all laws regarding radiation safety management. (author)

ENSI’s synopsis concerning the enhancement of safety margins; Zusammenfassung des ENSI zur Erhöhung der Sicherheitsmargen

Energy Technology Data Exchange (ETDEWEB)

NONE

2015-06-15

This press release issued by the Swiss Federal Nuclear Safety Inspectorate ENSI discusses the results of its probabilistic safety analysis on the safety margins for Swiss nuclear power stations that was made after the Fukushima nuclear accident. External incidents such as earthquakes and flooding and their impact on the power stations are analysed by the ERSIM project concerning the enhancement of safety margins. Three shut-down scenarios are discussed. The safety margins with respect to earthquakes and flooding for all four nuclear power station sites are discussed in detail.

Prescription for antibiotics at drug shops and strategies to improve quality of care and patient safety

DEFF Research Database (Denmark)

Mbonye, Anthony K; Buregyeya, Esther; Rutebemberwa, Elizeus

2016-01-01

OBJECTIVES: The main objective of this study was to assess practices of antibiotic prescription at registered drug shops with a focus on upper respiratory tract infections among children in order to provide data for policy discussions aimed at improving quality of care and patient safety......-line drug for treatment of pneumonia in children according to the guidelines. CONCLUSIONS: There is urgent need to regulate drug shop practices of prescribing and selling antibiotics, for the safety of patients seeking care at these outlets....

Factors to Consider When Balancing Campus Safety Concerns with Students' Civil Rights

Science.gov (United States)

Ingersoll, Julia S.

2017-01-01

On April 16, 2007, a student at Virginia Tech University, known to be mentally ill, went on a rampage shooting 49 people on campus before taking his own life. When it was over, 32 people were dead, and the concept of a safe campus was forever changed. The incident revealed the inherent conflicts between campus safety concerns and students' civil…

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

76 FR 64354 - Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small...

Science.gov (United States)

2011-10-18

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0529] Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small Business... amounts on small business, as set forth in the FDA Food Safety Modernization Act (FSMA). In particular...

76 FR 45818 - Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small...

Science.gov (United States)

2011-08-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0529] Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small Business... burden of fee amounts on small business, as set forth in the FDA Food Safety Modernization Act (FSMA...

Safety and efficacy of generic drugs with respect to brand formulation

OpenAIRE

Gallelli, Luca; Palleria, Caterina; De Vuono, Antonio; Mumoli, Laura; Vasapollo, Piero; Piro, Brunella; Russo, Emilio

2013-01-01

Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price. However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to gener...

Safety and efficacy of generic drugs with respect to brand formulation.

Science.gov (United States)

Gallelli, Luca; Palleria, Caterina; De Vuono, Antonio; Mumoli, Laura; Vasapollo, Piero; Piro, Brunella; Russo, Emilio

2013-12-01

Generic drugs are equivalent to the brand formulation if they have the same active substance, the same pharmaceutical form and the same therapeutic indications and a similar bioequivalence respect to the reference medicinal product. The use of generic drugs is indicated from many countries in order to reduce medication price. However some points, such as bioequivalence and the role of excipients, may be clarified regarding the clinical efficacy and safety during the switch from brand to generic formulations. In conclusion, the use of generic drugs could be related with an increased days of disease (time to relapse) or might lead to a therapeutic failure; on the other hand, a higher drug concentration might expose patients to an increased risk of dose-dependent side-effects.

Type I error probability spending for post-market drug and vaccine safety surveillance with binomial data.

Science.gov (United States)

Silva, Ivair R

2018-01-15

Type I error probability spending functions are commonly used for designing sequential analysis of binomial data in clinical trials, but it is also quickly emerging for near-continuous sequential analysis of post-market drug and vaccine safety surveillance. It is well known that, for clinical trials, when the null hypothesis is not rejected, it is still important to minimize the sample size. Unlike in post-market drug and vaccine safety surveillance, that is not important. In post-market safety surveillance, specially when the surveillance involves identification of potential signals, the meaningful statistical performance measure to be minimized is the expected sample size when the null hypothesis is rejected. The present paper shows that, instead of the convex Type I error spending shape conventionally used in clinical trials, a concave shape is more indicated for post-market drug and vaccine safety surveillance. This is shown for both, continuous and group sequential analysis. Copyright © 2017 John Wiley & Sons, Ltd.

Parental safety concerns--a barrier to sport and physical activity in children?

Science.gov (United States)

Boufous, Soufiane; Finch, Caroline; Bauman, Adrian

2004-10-01

To examine the extent to which parents and carers perceive injury and safety risks as serious enough to prevent or discourage their children, aged 5-12 years, from participating in sports/physical activity and to identify factors that influence these perceptions. An analysis of the 2001 New South Wales Child Health Survey. More than one-quarter of parents/ carers of active children aged 5-12 years reported discouraging or preventing children from playing a particular sport (34.7% for boys and 16.6% for girls) because of injury and safety concerns. In boys, the most frequently discouraged sport was rugby league (23.2%), followed by rugby union (7.5%) and Australian rules football (2.8%). Among girls, the most frequently discouraged activities were rollerblading (2.7%), rugby league (2.3%) and soccer (2.1%). Multivariate analysis shows that factors independently associated with parents' decision to prevent/discourage their child from engaging in sport/physical activity include their child's age and gender, language spoken at home, presence of disability, and the respondent's relation to the child. Efforts need to be made to modify some sports/ activities, such as football codes, in order to minimise injury and to ensure that children continue enjoying their favourite activity well into adulthood. Guidelines designed to promote physical activity among children and young adolescents need to take into account parental concerns regarding the associated risk of injury.

Application of the threshold of toxicological concern (TTC) to the safety evaluation of cosmetic ingredients

NARCIS (Netherlands)

Kroes, R.; Renwick, A.G.; Feron, V.; Galli, C.L.; Gibney, M.; Greim, H.; Guy, R.H.; Lhuguenot, J.C.; Sandt, J.J.M. van de

2007-01-01

The threshold of toxicological concern (TTC) has been used for the safety assessment of packaging migrants and flavouring agents that occur in food. The approach compares the estimated oral intake with a TTC value derived from chronic oral toxicity data for structurally-related compounds.

Documentation of pediatric drug safety in manufacturers' product monographs: a cross-sectional evaluation of the canadian compendium of pharmaceuticals and specialities.

Science.gov (United States)

Uppal, Navjeet K; Dupuis, Lee L; Parshuram, Christopher S

2008-01-01

To describe the provision of pediatric drug safety information in a national formulary of manufacturers' drug product monographs. We performed a cross-sectional evaluation of comprehensive product monographs contained in the 2005 Canadian Compendium of Pharmaceuticals and Specialities (CPS). We abstracted data describing indications for prescription, statements about pediatric safety, available preparations, and provision of dosing guidelines. For each monograph we classified pediatric safety data as either present, present but limited or absent. We then described the pediatric safety data in CPS monographs for drugs listed in the published formulary of the Hospital for Sick Children, Toronto, Ontario, Canada. A total of 2232 product monographs were screened; 684 were excluded and 1548 (66%) were further analyzed. 1462 (94%) had indications that did not exclude children. Pediatric safety information was present in 592 (38%), present but limited in 148 (10%), and absent in 808 (52%) drug monographs. Safety statements were absent in 224 (14%) drug monographs that provided both dosing guidelines and formulations suitable for administration to children, and in 214 (52%) of 411 drugs in the pediatric hospital formulary. We evaluated a widely available national source of pediatric prescribing information. Safety data for children was not mentioned in more than half of the product monographs. Moreover, the provision of safety data was discordant with indications for prescription, the availability of pediatric formulations, and dosing guidelines within the monographs, and with inclusion in a pediatric hospital formulary. Our study suggests that the presentation of pediatric safety data in drug product monographs can be improved to better inform prescribing and to optimize pharmacotherapy in children.

New Drugs and Treatment Targets in Psoriasis

DEFF Research Database (Denmark)

Kofoed, Kristian; Skov, Lone; Zachariae, Claus

2015-01-01

, and phosphodiesterase inhibitors. We review published clinical trials, and conference abstracts presented during the last years, concerned with new drugs under development for the treatment of psoriasis. In conclusion, our psoriasis armamentarium will be filled with several new effective therapeutic options the coming...... years. We need to be aware of the limitations of drug safety data when selecting new novel treatments. Monitoring and clinical registries are still important tools....

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...

Impact of a transient instability of the ecstasy market on health concerns and drug use patterns in The Netherlands.

Science.gov (United States)

Brunt, Tibor M; Niesink, Raymond J M; van den Brink, Wim

2012-03-01

A recent decline in MDMA-like substances in ecstasy tablets has been reported by a number of countries in the European Union. This study describes the instability of the ecstasy market in The Netherlands during 2008 and 2009, and investigates whether this had any impact on drug testing or patterns of drug use. The health concerns of drug users handing in drug samples at drug testing facilities was measured using intervention time-series analysis. In addition, these ecstasy users were asked about changes in their drug use. Nationally, the unstable market situation for ecstasy has increased the number of users handing in ecstasy tablets for testing because of health concern. There was no change in the number of users handing in cocaine or gamma hydroxybutyrate (GHB). Respondents reported no major changes in their drug use resulting from the shortage of MDMA-like substances. These findings provide further insight in drug policy based on both harm reduction and use reduction. In the event of reduced ecstasy quality, ecstasy users in The Netherlands have increasingly used drug testing as a potential harm reduction tool, rather than changing their patterns of drug use. This might indicate that a transient reduction of drug quality does not serve as a good drug use reduction strategy for ecstasy users. Copyright © 2011 Elsevier B.V. All rights reserved.

Who was concerned about radiation, food safety, and natural disasters after the great East Japan earthquake and Fukushima catastrophe? A nationwide cross-sectional survey in 2012.

Science.gov (United States)

Sugimoto, Takashi; Shinozaki, Tomohiro; Naruse, Takashi; Miyamoto, Yuki

2014-01-01

Disaster-related concerns by sub-populations have not been clarified after the great East Japan earthquake and the Fukushima nuclear power plant incidents. This paper assesses who was concerned about radiation, food safety, and natural disasters among the general population in order to buffer such concerns effectively. The hypothesis that women, parents, and family caregivers were most concerned about radiation, food safety, and natural disaster was tested using a varying-intercept multivariable logistic regression with 5809 responses from a nationwide cross-sectional survey random-sampled in March 2012. Many people were at least occasionally concerned about radiation (53.5%), food safety (47.3%), and about natural disaster (69.5%). Women were more concerned than men about radiation (OR = 1.67; 95% CI = 1.35-2.06), food safety (1.70; 1.38-2.10), and natural disasters (1.74; 1.39-2.19). Parents and family care needs were not significant. Married couples were more concerned about radiation (1.53; 1.33-1.77), food safety (1.38; 1.20-1.59), and natural disasters (1.30; 1.12-1.52). Age, child-cohabitation, college-completion, retirement status, homemaker status, and the house-damage certificate of the last disaster were also associated with at least one concern. Participants from the Kanto region were more concerned about radiation (2.08; 1.58-2.74) and food safety (1.30; 1.07-1.59), which demonstrate similar positive associations to participants from Tohoku where a disaster relief act was invoked (3.36; 2.25-5.01 about radiation, 1.49; 1.08-2.06 about food safety). Sectioning the populations by gender and other demographics will clarify prospective targets for interventions, allow for a better understanding of post-disaster concerns, and help communicate relevant information effectively.

Who was concerned about radiation, food safety, and natural disasters after the great East Japan earthquake and Fukushima catastrophe? A nationwide cross-sectional survey in 2012.

Directory of Open Access Journals (Sweden)

Takashi Sugimoto

Full Text Available BACKGROUND: Disaster-related concerns by sub-populations have not been clarified after the great East Japan earthquake and the Fukushima nuclear power plant incidents. This paper assesses who was concerned about radiation, food safety, and natural disasters among the general population in order to buffer such concerns effectively. METHODS: The hypothesis that women, parents, and family caregivers were most concerned about radiation, food safety, and natural disaster was tested using a varying-intercept multivariable logistic regression with 5809 responses from a nationwide cross-sectional survey random-sampled in March 2012. RESULTS: Many people were at least occasionally concerned about radiation (53.5%, food safety (47.3%, and about natural disaster (69.5%. Women were more concerned than men about radiation (OR = 1.67; 95% CI = 1.35-2.06, food safety (1.70; 1.38-2.10, and natural disasters (1.74; 1.39-2.19. Parents and family care needs were not significant. Married couples were more concerned about radiation (1.53; 1.33-1.77, food safety (1.38; 1.20-1.59, and natural disasters (1.30; 1.12-1.52. Age, child-cohabitation, college-completion, retirement status, homemaker status, and the house-damage certificate of the last disaster were also associated with at least one concern. Participants from the Kanto region were more concerned about radiation (2.08; 1.58-2.74 and food safety (1.30; 1.07-1.59, which demonstrate similar positive associations to participants from Tohoku where a disaster relief act was invoked (3.36; 2.25-5.01 about radiation, 1.49; 1.08-2.06 about food safety. CONCLUSIONS: Sectioning the populations by gender and other demographics will clarify prospective targets for interventions, allow for a better understanding of post-disaster concerns, and help communicate relevant information effectively.

Level of Evidence Associated with FDA Safety Communications with Drug Labeling Changes: 2010-2014

Directory of Open Access Journals (Sweden)

Benjamin Hixon

2017-02-01

Full Text Available Purpose: Approximately 800,000 safety reports are submitted to the FDA annually, however, only significant issues generate drug safety communications (DSC. The purpose of this study was to determine the type of clinical evidence used to warrant a change in drug labeling for drugs with DSC between January 1, 2010 and December 31, 2014. Methods: Selected data was obtained from the FDA website. The primary endpoint of the study was the frequency of the types of clinical evidence used in FDA communications, as reported through the FDA DSC. Results were evaluated via descriptive statistics, and chi-squared for nominal data. Results: A total of 2521 drug safety labeling changes were identified and 99 (3.9% of safety communications met the inclusion criteria. The majority of the labeling changes were associated with single agents (83.8%. The three most frequently reported labeling changes were warnings (68.7%, precautions (58.6%, and patient package insert/medication guide (23.2%. Case reports resulted in the greatest number of documented literature types (n = 791, followed by randomized controlled trials (n = 76, and case control/cohort studies (n = 74. Significantly more evidence for DSCs were classified as Level of Evidence B (LOE B, 68.6%, compared to LOE A (17.1%, and LOE C (14.1% (p = 0.007. Conclusions: The majority of drug labeling change initiators was associated with LOE equivalent to B. Practitioners should evaluate data associated with labeling changes to determine how to interpret the information for their patients. Conflict of Interest We declare no conflicts of interest or financial interests that the authors or members of their immediate families have in any product or service discussed in the manuscript, including grants (pending or received, employment, gifts, stock holdings or options, honoraria, consultancies, expert testimony, patents and royalties.   Type: Original Research

The Influence of Safety, Efficacy, and Medical Condition Severity on Natural versus Synthetic Drug Preference.

Science.gov (United States)

Meier, Brian P; Lappas, Courtney M

2016-11-01

Research indicates that there is a preference for natural v. synthetic products, but the influence of this preference on drug choice in the medical domain is largely unknown. We present 5 studies in which participants were asked to consider a hypothetical situation in which they had a medical issue requiring pharmacological therapy. Participants ( N = 1223) were asked to select a natural, plant-derived, or synthetic drug. In studies 1a and 1b, approximately 79% of participants selected the natural v. synthetic drug, even though the safety and efficacy of the drugs were identical. Furthermore, participants rated the natural drug as safer than the synthetic drug, and as that difference increased, the odds of choosing the natural over synthetic drug increased. In studies 2 and 3, approximately 20% of participants selected the natural drug even when they were informed that it was less safe (study 2) or less effective (study 3) than the synthetic drug. Finally, in study 4, approximately 65% of participants chose a natural over synthetic drug regardless of the severity of a specific medical condition (mild v. severe hypertension), and this choice was predicted by perceived safety and efficacy differences. Overall, these data indicate that there is a bias for natural over synthetic drugs. This bias could have implications for drug choice and usage. © The Author(s) 2015.

The impact of assay technology as applied to safety assessment in reducing compound attrition in drug discovery.

Science.gov (United States)

Thomas, Craig E; Will, Yvonne

2012-02-01

Attrition in the drug industry due to safety findings remains high and requires a shift in the current safety testing paradigm. Many companies are now positioning safety assessment at each stage of the drug development process, including discovery, where an early perspective on potential safety issues is sought, often at chemical scaffold level, using a variety of emerging technologies. Given the lengthy development time frames of drugs in the pharmaceutical industry, the authors believe that the impact of new technologies on attrition is best measured as a function of the quality and timeliness of candidate compounds entering development. The authors provide an overview of in silico and in vitro models, as well as more complex approaches such as 'omics,' and where they are best positioned within the drug discovery process. It is important to take away that not all technologies should be applied to all projects. Technologies vary widely in their validation state, throughput and cost. A thoughtful combination of validated and emerging technologies is crucial in identifying the most promising candidates to move to proof-of-concept testing in humans. In spite of the challenges inherent in applying new technologies to drug discovery, the successes and recognition that we cannot continue to rely on safety assessment practices used for decades have led to rather dramatic strategy shifts and fostered partnerships across government agencies and industry. We are optimistic that these efforts will ultimately benefit patients by delivering effective and safe medications in a timely fashion.

Adolescent Brain Development and Drugs

Science.gov (United States)

Winters, Ken C.; Arria, Amelia

2011-01-01

Research now suggests that the human brain is still maturing during adolescence. The developing brain may help explain why adolescents sometimes make decisions that are risky and can lead to safety or health concerns, including unique vulnerabilities to drug abuse. This article explores how this new science may be put to use in our prevention and…

The neuropharmacology of ADHD drugs in vivo: insights on efficacy and safety.

Science.gov (United States)

Heal, D J; Cheetham, S C; Smith, S L

2009-12-01

Results from in vivo techniques, especially intracerebral microdialysis in freely-moving rats, have provided insights into potential mechanisms responsible for the efficacy and safety of catecholaminergic drugs for ADHD treatment. The drugs reviewed come from distinct pharmacological classes: psychostimulant releasing agents, eg d-amphetamine; psychostimulant reuptake inhibitors, eg dl-threo-methylphenidate (dl-MPH), and non-stimulant reuptake inhibitors, eg atomoxetine. Psychostimulants, which currently deliver the best efficacy in treating ADHD, exhibit the following characteristics on extraneuronal catecholamine concentrations in rodent brain in vivo: 1) They enhance the efflux and function of both noradrenaline and dopamine in the central nervous system. 2) The increase of dopamine efflux that they produce is not limited to cortical regions. 3) They have a rapid onset of action with no ceiling on drug effect. d-Amphetamine has a mechanism independent of neuronal firing rate, displacing intraneuronal stores of catecholamines, delaying their reuptake and inhibiting catabolism by monoamine oxidase. dl-MPH has an enigmatic, extraneuronal action that is neuronal firing rate-dependent and reuptake transporter-mediated, yet paradoxically, almost as powerful as that of d-amphetamine. In safety terms, these powerful catecholaminergic effects also make the psychostimulants liable for abuse. Since efficacy and safety derive from the same pharmacological mechanisms, it has not yet been possible to separate these two components. However, the development of once-daily psychostimulant formulations and a prodrug, lisdexamfetamine, has improved patient compliance and markedly reduced scope for their diversion/abuse. This review will discuss the in vivo pharmacological profiles of approved catecholaminergic drugs for treatment of ADHD and implications for their clinical efficacy and abuse liability.

Regulatory considerations concerning IND radiopharmaceutical drug products

International Nuclear Information System (INIS)

Nissel, M.

1985-01-01

The Food and Drug Administration is charged by the Food, Drug, and Cosmetic Act, as presently amended, to assure that any drug introduced into interstate commerce is safe and effective for the purposes for which it is labeled. A radiopharmaceutical is, by definition, a new drug unless there is in effect an approved New Drug Application (NDA) for it. Before the data for the NDA are compiled, investigative studies have to be done. Before such studies can be performed in humans, an exemption from the Act is necessary. This exemption, technically the Claimed Exemption for an Investigational New Drug, is termed the IND. Both the scientific and the administrative requirements for an IND are discussed. For radiopharmaceutical drug products (RDP's), the radiation hazards, as well as the pharmacological ones, must be documented. Should the early studies demonstrate a potential for efficacy in a certain condition or disease state, an investigative protocol for an extended clinical trial is presented. The necessary requirements for Institutional Review Board (IRB) approval and consent forms are discussed. For certain research purposes, uniquely for radioactive drugs, an IND is not required for certain specific studies; the requirements for such a research study, conducted under the auspices of an approved radioactive drug research committee, are outlined

Posiva's application for a decision in principle concerning a disposal facility for spent nuclear fuel. STUK's statement and preliminary safety appraisal

International Nuclear Information System (INIS)

Ruokola, E.

2000-03-01

In May 1999, Posiva Ltd submitted to the Government an application, pursuant to the Nuclear Energy Act, for a Decision in Principle on a disposal facility for spent nuclear fuel from the Finnish nuclear power plants. The Ministry of Trade and Industry requested the Radiation and Nuclear Safety Authority (STUK) to draw up a preliminary safety appraisal concerning the proposed disposal facility. In the beginning of this report, STUK's statement to the Ministry and Industry concerning the proposed disposal facility is given. In that statement, STUK concludes that the Decision in Principle is currently justified from the standpoint of safety. The statement is followed by a safety appraisal, where STUK deems, how the proposed disposal concept, site and facility comply with the safety requirements included in the Government's Decision (478/1999). STUK's preliminary safety appraisal was supported by contributions from a number of outside experts. A collective opinion by an international group of ten distinguished experts is appended to this report. (orig.)

Safety Profile of the Newest Antiepileptic Drugs: A Curated Literature Review.

Science.gov (United States)

Palleria, Caterina; Cozza, Giuseppe; Khengar, Rajeshree; Libri, Vincenzo; De Sarro, Giovambattista

2017-01-01

Despite the introduction of new antiepileptic drugs (AEDs), the quality of life and therapeutic response for patients with epilepsy remain unsatisfactory. In addition, whilst several antiepileptic drugs (AEDs) have been approved and consequently marketed in recent years, little is known about their long-term safety and tolerability. Availability of the newest AEDs, characterized by improved pharmacokinetic profiles, has positively impacted the treatment approach for patients with partial seizures in clinical practice. However, the main cause of treatment failure is still poor patient compliance due to the occurrence of adverse drug reactions (ADRs) that lead to treatment withdrawal in about 25% of cases before achieving maximal efficacy, and is associated with increasing health care costs. In this Review, we conducted an online database search using Medline, PubMed, Embase, and the Cochrane Online Library to review the available studies highlighting the clinical relevance of side effects, pharmacological interactions, safety and tolerability of the newest AEDs: Brivaracetam (BRV), Cannabidiol (CBD), Eslicarbazepine acetate (ESL), Lacosamide (LCM), and Perampanel (PER). The principal benefit of the newest AEDs, in addition to reduced frequency and seizure severity, is the low number and severity of ADRs reported compared to more historic drugs. Early detection of ADRs could lead to an improvement in patients' quality of life, therefore it is important to monitor ADRs and to adequately perform post marketing surveillance in the clinical practice setting. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Does the Early Adopter of Drugs Exist? A Population Based Study of General Practitioners’ Prescribing of New Drugs.20 th International Conference on Pharmacoepiemiology and Risk Management. Bordeaux, France. Pharmacoepidemiology and Drug Safety, 2004;13:Sl 1:158

DEFF Research Database (Denmark)

Dybdahl, Torben; Andersen, Morten; Søndergaard, Jens

2004-01-01

20 th International Conference on Pharmacoepiemiology and Risk Management. Bordeaux, France. Pharmacoepidemiology and Drug Safety, 2004;13:Sl 1:158......20 th International Conference on Pharmacoepiemiology and Risk Management. Bordeaux, France. Pharmacoepidemiology and Drug Safety, 2004;13:Sl 1:158...

How do pharmaceutical companies handle consumer adverse drug reaction reports? An overview based on a survey of French drug safety managers and officers.

Science.gov (United States)

Fleuranceau-Morel, P

2002-01-01

It is surprising to see how consumer Adverse Drug Reaction (ADR) reports have been continuously increasing for the last few years in Europe. This probably results from the influence of United States (US) market where the patients feels justified in telephoning the pharmaceutical companies directly with queries regarding their treatment. The growing number of alternative sources of information (e.g. health and popular magazines, spots on radio and TV etc.) to which a consumer is exposed has added to this growth too. The changing relationship between patients and doctors may also contribute to this phenomenon. It is then interesting to evaluate the way pharmaceutical companies currently deal with consumer ADR reports. The management of consumer ADR reporting was investigated by means of a questionnaire sent to 46 French drug safety managers and drug safety officers (DSOs) of multinational pharmaceutical companies. The analysis of the survey stressed the fact that pharmaceutical companies should be prepared to face up to an increase in the number of consumer ADR reports. It clearly appears that the consumers who telephone to register side-effects should be forwarded to a trained DSO with medical or pharmaceutical background and the communication skills acquired through specific training. This person should also be able to release adequate product information validated by his/her own company. The influence of the US market seems to be changing the way pharmaceutical companies deal with consumer ADR reports. Nowadays, these reports are entered into a drug safety database by most of the companies without previously having contacted the patient's general practitioner (GP) or specialist for medical confirmation. Lastly, the drug safety managers and DSOs consulted have divided opinions about the usefulness of call centres and e-mails as tools for ADR reporting. But both tools are globally rejected by the pharmaceutical companies as a reliable means of reporting. As stated

Drug Safety Monitoring in Children: Performance of Signal Detection Algorithms and Impact of Age Stratification

NARCIS (Netherlands)

O.U. Osokogu (Osemeke); C. Dodd (Caitlin); A.C. Pacurariu (Alexandra C.); F. Kaguelidou (Florentia); D.M. Weibel (Daniel); M.C.J.M. Sturkenboom (Miriam)

2016-01-01

textabstractIntroduction: Spontaneous reports of suspected adverse drug reactions (ADRs) can be analyzed to yield additional drug safety evidence for the pediatric population. Signal detection algorithms (SDAs) are required for these analyses; however, the performance of SDAs in the pediatric

From Drug Safety to Drug Security: A Contemporary Shift in the Policing of Health.

Science.gov (United States)

Hornberger, Julia

2018-01-29

The counterfeiting of medication is increasingly seen as a major threat to health, especially in the light of both the everyday reliance on and a broadening of world-wide access to pharmaceuticals. Exaggerated or real, this threat has inaugurated, this article argues, a shift from a drug safety regime to a drug security regime that governs the flow of pharmaceuticals and brings together markets, police, and health actors in new ways. This entails a shift from soft disciplinary means aimed at incremental and continued inclusion of defaulters, to one of drastically sovereign measures of exclusion and banishment aimed at fake goods and the people associated with them, in the name of health. Through a multi-sited ethnographic study, this article shows how such new drug security efforts play themselves out especially in (South) Africa, highlighting a modus operandi of spectacular performativity and of working through suspicion and association rather than factuality, producing value less so for those in need of health than for a petty security industry itself. © 2018 by the American Anthropological Association.

Working towards consensus on methods used to elicit participant-reported safety data in uncomplicated malaria clinical drug studies: a Delphi technique study.

Science.gov (United States)

Mandimika, Nyaradzo; Barnes, Karen I; Chandler, Clare I R; Pace, Cheryl; Allen, Elizabeth N

2017-01-28

Eliciting adverse event (AE) and non-study medication data reports from clinical research participants is integral to evaluating drug safety. However, using different methods to question participants yields inconsistent results, compromising the interpretation, comparison and pooling of data across studies. This is particularly important given the widespread use of anti-malarials in vulnerable populations, and their increasing use in healthy, but at-risk individuals, as preventive treatment or to reduce malaria transmission. Experienced and knowledgeable anti-malarial drug clinical researchers were invited to participate in a Delphi technique study, to facilitate consensus on what are considered optimal (relevant, important and feasible) methods, tools, and approaches for detecting participant-reported AE and non-study medication data in uncomplicated malaria treatment studies. Of 72 invited, 25, 16 and 10 panellists responded to the first, second and third rounds of the Delphi, respectively. Overall, 68% (68/100) of all questioning items presented for rating achieved consensus. When asking general questions about health, panellists agreed on the utility of a question/concept about any change in health, taking care to ensure that such questions/concepts do not imply causality. Eighty-nine percent (39/44) of specific signs and symptoms questions were rated as optimal. For non-study medications, a general question and most structured questioning items were considered an optimal approach. The use of mobile phones, patient diaries, rating scales as well as openly engaging with participants to discuss concerns were also considered optimal complementary data-elicitation tools. This study succeeded in reaching consensus within a section of the anti-malarial drug clinical research community about using a general question concept, and structured questions for eliciting data about AEs and non-study medication reports. The concepts and items considered in this Delphi to be

On-chip food safety monitoring: multi-analyte screening with imaging surface plasmon resonance-based biosensor

NARCIS (Netherlands)

Rebe, S.

2010-01-01

Food safety is an increasing health concern, recognised and promoted by many
institutions across the globe. Food products can be contaminated with pathogenic
microorganisms, environmental pollutants, veterinary drug residues, allergens and toxins.
Public health concerns which have

Safety of Etoricoxib, Celecoxib, and Nonselective Nonsteroidal Antiinflammatory Drugs in Ankylosing Spondylitis and Other Spondyloarthritis Patients

DEFF Research Database (Denmark)

Kristensen, L E; Jakobsen, A K; Askling, J

2015-01-01

OBJECTIVE: Safety data regarding the use of etoricoxib and other nonsteroidal antiinflammatory drugs (NSAIDs) in ankylosing spondylitis (AS) and other spondyloarthritis (SpA) patients are rather limited. Our objective was to estimate and compare rates of gastrointestinal, renovascular, and cardio......OBJECTIVE: Safety data regarding the use of etoricoxib and other nonsteroidal antiinflammatory drugs (NSAIDs) in ankylosing spondylitis (AS) and other spondyloarthritis (SpA) patients are rather limited. Our objective was to estimate and compare rates of gastrointestinal, renovascular...

Online availability and safety of drugs in shortage: a descriptive study of internet vendor characteristics.

Science.gov (United States)

Liang, Bryan A; Mackey, Tim K

2012-02-09

Unprecedented drug shortages announced by the US Food and Drug Administration (FDA) have severely affected therapeutic access, patient safety, and public health. With continued shortages, patients may seek drugs online. To assess the prevalence of online marketing for current FDA shortage drugs and potential patient safety risks. We performed a descriptive study of the prevalence of online marketing for shortage drugs-that is, offers for sale of each drug, including characteristics of online drug sellers and intermediary sites marketing these drugs. Of the 72 FDA shortage-listed drugs, 68 (94%) were offered for sale online. We found 291 offers for these drugs, the vast majority (n = 207, 71.1%) by online drug sellers selling direct to consumers. Intermediary sites included data aggregators (n = 22, 8%), forum links (n = 23, 8%), and personal page data links (n = 34, 12%), as well as Flickr social media links (n = 5, 2%), all advertising drugs without a prescription. Of the 91 online drug sellers identified, 31 (34%) had more than 1 shortage drug offered for sale, representing most (n = 148, 71%) of all online drug seller sales offers. The majority of these online drug sellers (n = 21, 68%) were on the National Association of Boards of Pharmacy (NABP) Not Recommended Sites list. Finally, for shortage drugs with an online drug seller (n = 58, 85%), 53 (91%) had at least one site on the Not Recommended list and 21 (36%) had only sites on the Not Recommended list. FDA shortage drugs are widely marketed over the Internet. Suspect online drug sellers and intermediaries dominate these sales offers. As a critical risk management issue, patients, providers, and policymakers should be extremely cautious in procuring shortage drugs through Internet sourcing.

Effect and Safety of Shihogyejitang for Drug Resistant Childhood Epilepsy

Directory of Open Access Journals (Sweden)

Jinsoo Lee

2016-01-01

Full Text Available Objective. Herbal medicine has been widely used to treat drug resistant epilepsy. Shihogyejitang (SGT has been commonly used to treat epilepsy. We investigated the effect and safety of SGT in children with drug resistant epilepsy. Design. We reviewed medical records of 54 patients with epilepsy, who failed to respond to at least two antiepileptic drugs and have been treated with SGT between April 2006 and June 2014 at the Department of Pediatric Neurology, I-Tomato Hospital, Korea. Effect was measured by the response rate, seizure-free rate, and retention rate at six months. We also checked adverse events, change in antiepileptic drugs use, and the variables related to the outcome. Results. Intent-to-treat analysis showed that, after six months, 44.4% showed a >50% seizure reduction, 24.1% including seizure-free, respectively, and 53.7% remained on SGT. Two adverse events were reported, mild skin rash and fever. Focal seizure type presented significantly more positive responses when compared with other seizure types at six months (p=0.0284, Fisher’s exact test. Conclusion. SGT is an effective treatment with excellent tolerability for drug resistant epilepsy patients. Our data provide evidence that SGT may be used as alternative treatment option when antiepileptic drug does not work in epilepsy children.

Safety of diabetes drugs in patients with heart failure.

Science.gov (United States)

Carrasco-Sánchez, F J; Ostos-Ruiz, A I; Soto-Martín, M

2018-03-01

Heart failure (HF) and diabetes mellitus are 2 clinical conditions that often coexist, particularly in patients older than 65 years. Diabetes mellitus promotes the development of HF and confers a poorer prognosis. Hypoglycaemic agents (either by their mechanism of action, hypoglycaemic action or adverse effects) can be potentially dangerous for patients with HF. In this study, we performed a review of the available evidence on the safety of diabetes drugs in HF, focused on the main observational and experimental studies. Recent studies on cardiovascular safety have evaluated, although as a secondary objective, the impact of new hypoglycaemic agents on HF, helping us understand the neutrality, risks and potential benefits of these agents. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

Preclinical Data on Efficacy of 10 Drug-Radiation Combinations: Evaluations, Concerns, and Recommendations

Directory of Open Access Journals (Sweden)

Helen B. Stone

2016-02-01

Full Text Available BACKGROUND: Clinical testing of new therapeutic interventions requires comprehensive, high-quality preclinical data. Concerns regarding quality of preclinical data have been raised in recent reports. This report examines the data on the interaction of 10 drugs with radiation and provides recommendations for improving the quality, reproducibility, and utility of future studies. The drugs were AZD6244, bortezomib, 17-DMAG, erlotinib, gefitinib, lapatinib, oxaliplatin/Lipoxal, sunitinib (Pfizer, Corporate headquarters, New York, NY, thalidomide, and vorinostat. METHODS: In vitro and in vivo data were tabulated from 125 published papers, including methods, radiation and drug doses, schedules of administration, assays, measures of interaction, presentation and interpretation of data, dosimetry, and conclusions. RESULTS: In many instances, the studies contained inadequate or unclear information that would hamper efforts to replicate or intercompare the studies, and that weakened the evidence for designing and conducting clinical trials. The published reports on these drugs showed mixed results on enhancement of radiation response, except for sunitinib, which was ineffective. CONCLUSIONS: There is a need for improved experimental design, execution, and reporting of preclinical testing of agents that are candidates for clinical use in combination with radiation. A checklist is provided for authors and reviewers to ensure that preclinical studies of drug-radiation combinations meet standards of design, execution, and interpretation, and report necessary information to ensure high quality and reproducibility of studies. Improved design, execution, common measures of enhancement, and consistent interpretation of preclinical studies of drug-radiation interactions will provide rational guidance for prioritizing drugs for clinical radiotherapy trials and for the design of such trials.

Nuclear safety. Concerns about the nuclear power reactors in Cuba

International Nuclear Information System (INIS)

Wells, Jim; Aloise, Gene; Flaherty, Thomas J.; Fitzgerald, Duane; Zavala, Mario; Hayward, Mary Alice

1992-09-01

the atmosphere, contains defective welds. Another said that reactor operator trainees have received training on inadequate reactor simulators. In contrast, a representative of the Cuban government told us that Cuba wants to build its reactor in accordance with safety standards. Also, according to information provided to us by a representative of the Russian government, Cuba's reactor has been constructed according to safety rules that take into account, among other things, the possible impacts of an earthquake. State Department, NRC, and DOE officials have expressed a number of concerns about the construction and operation of Cuba's nuclear power reactors. According to State Department officials, the United States maintains a comprehensive embargo on any U.S. transactions with Cuba and discourages other countries from providing assistance, except for safety purposes, to Cuba's nuclear power program. The United States would prefer that the construction of the reactors never be completed and wants Cuba to sign the Non-Proliferation Treaty or the Treaty of Tlatelolco, both of which bind signatories to blanket nonproliferation commitments for their entire nuclear program, before the United States considers reversing its policy of discouraging other countries from assisting Cuba with the construction of the reactors. The United States has asked Russia to cease providing any nuclear assistance until Cuba has signed either treaty. NRC officials are aware of, but could not verify, the Cuban emigres' allegations of safety deficiencies because available information was limited. They said, however, that if the allegations were true, the cited deficiencies could affect the safety of the reactors operation. In addition, they expressed concern about the ability of Cuba's industrial infrastructure to support the nuclear power reactors, the lack of a regulatory structure, the adequacy of training for reactor operators, the quality of the civil construction, and the design of the

Online Availability and Safety of Drugs in Shortage: A Descriptive Study of Internet Vendor Characteristics

Science.gov (United States)

Mackey, Tim K

2012-01-01

Background Unprecedented drug shortages announced by the US Food and Drug Administration (FDA) have severely affected therapeutic access, patient safety, and public health. With continued shortages, patients may seek drugs online. Objective To assess the prevalence of online marketing for current FDA shortage drugs and potential patient safety risks. Methods We performed a descriptive study of the prevalence of online marketing for shortage drugs—that is, offers for sale of each drug, including characteristics of online drug sellers and intermediary sites marketing these drugs. Results Of the 72 FDA shortage-listed drugs, 68 (94%) were offered for sale online. We found 291 offers for these drugs, the vast majority (n = 207, 71.1%) by online drug sellers selling direct to consumers. Intermediary sites included data aggregators (n = 22, 8%), forum links (n = 23, 8%), and personal page data links (n = 34, 12%), as well as Flickr social media links (n = 5, 2%), all advertising drugs without a prescription. Of the 91 online drug sellers identified, 31 (34%) had more than 1 shortage drug offered for sale, representing most (n = 148, 71%) of all online drug seller sales offers. The majority of these online drug sellers (n = 21, 68%) were on the National Association of Boards of Pharmacy (NABP) Not Recommended Sites list. Finally, for shortage drugs with an online drug seller (n = 58, 85%), 53 (91%) had at least one site on the Not Recommended list and 21 (36%) had only sites on the Not Recommended list. Conclusions FDA shortage drugs are widely marketed over the Internet. Suspect online drug sellers and intermediaries dominate these sales offers. As a critical risk management issue, patients, providers, and policymakers should be extremely cautious in procuring shortage drugs through Internet sourcing. PMID:22321731

Mining FDA drug labels using an unsupervised learning technique--topic modeling.

Science.gov (United States)

Bisgin, Halil; Liu, Zhichao; Fang, Hong; Xu, Xiaowei; Tong, Weida

2011-10-18

The Food and Drug Administration (FDA) approved drug labels contain a broad array of information, ranging from adverse drug reactions (ADRs) to drug efficacy, risk-benefit consideration, and more. However, the labeling language used to describe these information is free text often containing ambiguous semantic descriptions, which poses a great challenge in retrieving useful information from the labeling text in a consistent and accurate fashion for comparative analysis across drugs. Consequently, this task has largely relied on the manual reading of the full text by experts, which is time consuming and labor intensive. In this study, a novel text mining method with unsupervised learning in nature, called topic modeling, was applied to the drug labeling with a goal of discovering "topics" that group drugs with similar safety concerns and/or therapeutic uses together. A total of 794 FDA-approved drug labels were used in this study. First, the three labeling sections (i.e., Boxed Warning, Warnings and Precautions, Adverse Reactions) of each drug label were processed by the Medical Dictionary for Regulatory Activities (MedDRA) to convert the free text of each label to the standard ADR terms. Next, the topic modeling approach with latent Dirichlet allocation (LDA) was applied to generate 100 topics, each associated with a set of drugs grouped together based on the probability analysis. Lastly, the efficacy of the topic modeling was evaluated based on known information about the therapeutic uses and safety data of drugs. The results demonstrate that drugs grouped by topics are associated with the same safety concerns and/or therapeutic uses with statistical significance (P<0.05). The identified topics have distinct context that can be directly linked to specific adverse events (e.g., liver injury or kidney injury) or therapeutic application (e.g., antiinfectives for systemic use). We were also able to identify potential adverse events that might arise from specific

Mining FDA drug labels using an unsupervised learning technique - topic modeling

Science.gov (United States)

2011-01-01

Background The Food and Drug Administration (FDA) approved drug labels contain a broad array of information, ranging from adverse drug reactions (ADRs) to drug efficacy, risk-benefit consideration, and more. However, the labeling language used to describe these information is free text often containing ambiguous semantic descriptions, which poses a great challenge in retrieving useful information from the labeling text in a consistent and accurate fashion for comparative analysis across drugs. Consequently, this task has largely relied on the manual reading of the full text by experts, which is time consuming and labor intensive. Method In this study, a novel text mining method with unsupervised learning in nature, called topic modeling, was applied to the drug labeling with a goal of discovering “topics” that group drugs with similar safety concerns and/or therapeutic uses together. A total of 794 FDA-approved drug labels were used in this study. First, the three labeling sections (i.e., Boxed Warning, Warnings and Precautions, Adverse Reactions) of each drug label were processed by the Medical Dictionary for Regulatory Activities (MedDRA) to convert the free text of each label to the standard ADR terms. Next, the topic modeling approach with latent Dirichlet allocation (LDA) was applied to generate 100 topics, each associated with a set of drugs grouped together based on the probability analysis. Lastly, the efficacy of the topic modeling was evaluated based on known information about the therapeutic uses and safety data of drugs. Results The results demonstrate that drugs grouped by topics are associated with the same safety concerns and/or therapeutic uses with statistical significance (P<0.05). The identified topics have distinct context that can be directly linked to specific adverse events (e.g., liver injury or kidney injury) or therapeutic application (e.g., antiinfectives for systemic use). We were also able to identify potential adverse events that

Anti-Obesity Drugs: A Review about Their Effects and Safety

Directory of Open Access Journals (Sweden)

Jun Goo Kang

2012-02-01

Full Text Available The current recommendations for the treatment of obese people include increased physical activity and reduced calories intake. When the behavioral approach is not sufficient, a pharmacologic treatment is recommended. In past years, numerous drugs have been approved for the treatment of obesity; however, most of them have been withdrawn from the market because of their adverse effects. In fact, amphetamine, rimonabant and sibutramine licenses have been withdrawn due to an increased risk of psychiatric disorders and non-fatal myocardial infarction or stroke. Even if orlistat is not as effective as other drugs in reducing body weight, orlistat is presently the only available choice for the treatment of obesity because of its safety for cardiovascular events and positive effects on diabetic control. Hopefully, more effective and better tolerated anti-obesity drugs will be developed through an improved understanding of the multiple mechanisms and complex physiological systems targeting appetite.

Use of nonsteroidal anti-inflammatory drugs among healthy people and specific cerebrovascular safety

DEFF Research Database (Denmark)

Fosbøl, Emil L; Olsen, Anne-Marie Schjerning; Olesen, Jonas Bjerring

2014-01-01

BACKGROUND: Nonsteroidal anti-inflammatory drugs can increase bleeding and thrombosis, but little is known about the cerebrovascular safety of these drugs, especially among healthy people. AIMS: The aim of this study was to examine the risk of ischemic and hemorrhagic stroke associated with the use...... stroke). RESULTS: We selected 1,028,437 healthy individuals (median age 39 years). At least one nonsteroidal anti-inflammatory drug was claimed by 44·7% of the study population, and the drugs were generally used for a short period of time and in low doses. High-dose ibuprofen and diclofenac were......·35-3·42)]. CONCLUSIONS: In healthy individuals, use of commonly available nonsteroidal anti-inflammatory drugs such as ibuprofen, diclofenac, and naproxen was associated with increased risk of stroke....

Health and safety concerns of textiles with nanomaterials

Science.gov (United States)

Almeida, L.; Ramos, D.

2017-10-01

There is a growing concern related to the effects of nanomaterials in health and safety.Nanotechnologies are already present in many consumer products, including textiles. “Nanotextiles” can be considered as traditional textiles with the incorporation of nanoparticles. They present often functionalities such as antibacterial, ultraviolet radiation protection, water and dirt repellency, self-cleaning or flame retardancy. Nanoparticles can be released from the textile materials due to different effects (abrasion and other mechanical stresses, sweat, irradiation, washing, temperature changes, etc.). It is then expectable that “nanotextiles” may release individual nanoparticles, agglomerates of nanoparticles or small particles of textile with or without nanoparticles, depending on the type of integration of the nanoparticles in textiles. The most important exposure route of the human body to nanoparticles in case of textiles is skin contact. Several standards are being developed under the auspices of the European Committee for Standardization. In this paper, it is presented the development and application of a test method to evaluate the skin exposure to nanoparticles, to evaluate the transfer of the nanoparticles from the textile to the skin by the effect of abrasion and sweat.

Safety assessments and public concern for genetically modified food products: the American view.

Science.gov (United States)

Harlander, Susan K

2002-01-01

In the relatively short time since their commercial introduction in 1996, genetically modified (GM) crops have been rapidly adopted in the United States GM crops are regulated through a coordinated framework developed in 1992 and administered by three agencies-the US Department of Agriculture (USDA) that ensures the products are safe to grow, the Environmental Protection Agency (EPA) that ensures the products are safe for the environment, and the Food and Drug Administration (FDA) that ensures the products are safe to eat. Rigorous food and environmental safety assessments must be completed before GM crops can be commercialized. Fifty-one products have been reviewed by the FDA, including several varieties of corn, soybeans, canola, cotton, rice, sugar beets, potatoes, tomatoes, squash, papaya, and flax. Because FDA considers these crops "substantially equivalent" to their conventional counterparts, no special labeling is required for GM crops in the United States and they are managed as commodities with no segregation or identity preservation. GM crops have thus made their way through commodity distribution channels into thousands of ingredients used in processed foods. It has been estimated that 70% to 85% of processed foods on supermarket shelves in the United States today contain one or more ingredients potentially derived from GM crops. The food industry and retail industry have been monitoring the opinions of their consumers on the GM issue for the past several years. Numerous independent groups have also surveyed consumer concerns about GM foods. The results of these surveys are shared and discussed here.

75 FR 36427 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management...

Science.gov (United States)

2010-06-25

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice...

Parental concern about vaccine safety in Canadian children partially immunized at age 2: a multivariable model including system level factors.

Science.gov (United States)

MacDonald, Shannon E; Schopflocher, Donald P; Vaudry, Wendy

2014-01-01

Children who begin but do not fully complete the recommended series of childhood vaccines by 2 y of age are a much larger group than those who receive no vaccines. While parents who refuse all vaccines typically express concern about vaccine safety, it is critical to determine what influences parents of 'partially' immunized children. This case-control study examined whether parental concern about vaccine safety was responsible for partial immunization, and whether other personal or system-level factors played an important role. A random sample of parents of partially and completely immunized 2 y old children were selected from a Canadian regional immunization registry and completed a postal survey assessing various personal and system-level factors. Unadjusted odds ratios (OR) and adjusted ORs (aOR) were calculated with logistic regression. While vaccine safety concern was associated with partial immunization (OR 7.338, 95% CI 4.138-13.012), other variables were more strongly associated and reduced the strength of the relationship between concern and partial immunization in multivariable analysis (aOR 2.829, 95% CI 1.151-6.957). Other important factors included perceived disease susceptibility and severity (aOR 4.629, 95% CI 2.017-10.625), residential mobility (aOR 3.908, 95% CI 2.075-7.358), daycare use (aOR 0.310, 95% CI 0.144-0.671), number of needles administered at each visit (aOR 7.734, 95% CI 2.598-23.025) and access to a regular physician (aOR 0.219, 95% CI 0.057-0.846). While concern about vaccine safety may be addressed through educational strategies, this study suggests that additional program and policy-level strategies may positively impact immunization uptake.

Nonsteroidal anti-inflammatory drug gastropathy: new avenues for safety

OpenAIRE

Roth, Sandford

2011-01-01

Sanford H RothArizona Research and Education, Arthritis Laboratory, Arizona State University, Phoenix, AZ, USAAbstract: Chronic oral or systemic nonselective nonsteroidal anti-inflammatory drug (NSAID) therapy, ubiquitously used by physicians to treat osteoarthritis-associated pain, is associated with a wide range of symptomatic adverse events, the most frequent and serious of which is gastropathy. Although cardiovascular and renal problems are a very real concern, they are significantly less...

Sports injuries, drowning and exposure to radiation concern Canada Safety Council meeting

International Nuclear Information System (INIS)

Oliver, Caroline.

1979-01-01

Hazards associated with surface sports, aquatic sports and exposure to radiation were considered at a meeting of the Canada Safety Council in late 1979. The session on radiation noted that 6 of 20000 radiation workers wearing dosimeters were exposed to a dose in excess of 5 rem, the annual limit set by the Atomic Energy Control Board. Radiographers were in the job classification receiving the highest doses of ionizing radiation. Concern was expressed for the emission of damaging radiation from broken mercury vapour lamps. Increased regulation rather than training was seen as the most effective solution. (T.I.)

A decade of e-cigarettes: Limited research & unresolved safety concerns.

Science.gov (United States)

Kaisar, Mohammad Abul; Prasad, Shikha; Liles, Tylor; Cucullo, Luca

2016-07-15

It is well known that tobacco consumption is a leading cause of preventable deaths worldwide and has been linked to major diseases ranging from cancer to chronic obstructive pulmonary disease, atherosclerosis, stroke and a host of neurological/neurodegenerative disorders. In the past decade a number of alternative vaping products have hit the market, rapidly gaining consumers especially among the younger population. Electronic nicotine delivery systems or e-cigarettes have become the sought-after product due to the belief that they are much safer than traditional cigarettes. However, inadequate research and lack of regulatory guidelines for both the manufacturing process and the content of the vaping solution of the e-cigarette has become a major concern. Highly debated and unresolved questions such as whether e-cigarettes may help smokers quit and whether e-cigarettes will promote the use of nicotine among non-smokers add to the confusion of the safety of e-cigarettes. In this review article, we summarize the current understanding (and lack thereof) of the potential health impacts of e-cigarettes. We will also highlight the most recent studies (in vivo/in vitro) which seem to conflict with the broad safety claims put forward by the manufacturers. Finally, we provide potential solutions to overcome the research gap of the short and long-term health impact of e-cigarettes. Published by Elsevier Ireland Ltd.

A decade of e-cigarettes: Limited research & unresolved safety concerns

International Nuclear Information System (INIS)

Kaisar, Mohammad Abul; Prasad, Shikha; Liles, Tylor; Cucullo, Luca

2016-01-01

It is well known that tobacco consumption is a leading cause of preventable deaths worldwide and has been linked to major diseases ranging from cancer to chronic obstructive pulmonary disease, atherosclerosis, stroke and a host of neurological/neurodegenerative disorders. In the past decade a number of alternative vaping products have hit the market, rapidly gaining consumers especially among the younger population. Electronic nicotine delivery systems or e-cigarettes have become the sought-after product due to the belief that they are much safer than traditional cigarettes. However, inadequate research and lack of regulatory guidelines for both the manufacturing process and the content of the vaping solution of the e-cigarette has become a major concern. Highly debated and unresolved questions such as whether e-cigarettes may help smokers quit and whether e-cigarettes will promote the use of nicotine among non-smokers add to the confusion of the safety of e-cigarettes. In this review article, we summarize the current understanding (and lack thereof) of the potential health impacts of e-cigarettes. We will also highlight the most recent studies (in vivo/in vitro) which seem to conflict with the broad safety claims put forward by the manufacturers. Finally, we provide potential solutions to overcome the research gap of the short and long-term health impact of e-cigarettes.

A Decade of e-Cigarettes: Limited Research & Unresolved Safety Concerns

Science.gov (United States)

Kaisar, Mohammad Abul; Prasad, Shikha; Liles, Tylor; Cucullo, Luca

2016-01-01

It is well known that tobacco consumption is a leading cause of preventable deaths worldwide and has been linked to major diseases ranging from cancer to chronic obstructive pulmonary disease, atherosclerosis, stroke and a host of neurological/neurodegenerative disorders. In the past decade a number of alternative vaping products have hit the market, rapidly gaining consumers especially among the younger population. Electronic nicotine delivery systems or e-cigarettes have become the sought-after product due to the belief that they are much safer than traditional cigarettes. However, inadequate research and lack of regulatory guidelines for both the manufacturing process and the content of the vaping solution of the e-cigarette has become a major concern. Highly debated and unresolved questions such as whether e-cigarettes may help smokers quit and whether e-cigarettes will promote the use of nicotine among non-smokers add to the confusion of the safety of e-cigarettes. In this review article, we summarize the current understanding (and lack thereof) of the potential health impacts of e-cigarettes. We will also highlight the most recent studies (in vivo/in vitro) which seem to conflict with the broad safety claims put forward by the manufacturers. Finally, we provide potential solutions to overcome the research gap of the short and long-term health impact of e-cigarettes. PMID:27477296

Study concerning the power plant control and safety equipment by integrated distributed systems

International Nuclear Information System (INIS)

Optea, I.; Oprea, M.; Stanescu, P.

1995-01-01

The paper deals with the trends existing in the field of nuclear control and safety equipment and systems, proposing a high-efficiency integrated system. In order to enhance the safety of the plant and reliability of the structure system and components, we present a concept based on the latest computer technology with an open, distributed system, connected by a local area network with high redundancy. A modern conception for the control and safety system is to integrate all the information related to the reactor protection, active engineered safeguard and auxiliary systems parameters, offering a fast flow of information between all the agencies concerned so that situations can be quickly assessed. The integrated distributed control is based on a high performance operating system for realtime applications, flexible enough for transparent networking and modular for demanding configurations. The general design considerations for nuclear reactors instrumentation reliability and testing methods for real-time functions under dynamic regime are presented. Taking into account the fast progress in information technology, we consider the replacement of the old instrumentation of Cernavoda-1 NPP by a modern integrated system as an economical and efficient solution for the next units. (Author) 20 Refs

Suspected adverse drug reactions in elderly patients reported to the Committee on Safety of Medicines.

OpenAIRE

Castleden, C M; Pickles, H

1988-01-01

1. Spontaneous reports of suspected adverse drug reactions (ADRs) reported to the Committee on Safety of Medicines (CSM) have been studied in relation to patient age. 2. The proportion of reports received for the elderly increased between 1965 and 1983. 3. There was a correlation between the use of drugs and the number of ADR reports. Thus age-related prescription figures for two non-steroidal anti-inflammatory drugs (NSAI) and co-trimoxazole matched ADR reports for each drug in each age grou...

76 FR 20686 - Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug...

Science.gov (United States)

2011-04-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0164] Draft Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

Gender differences and demographic influences in perceived concern for driver safety and support for impaired driving countermeasures.

Science.gov (United States)

Butters, Jennifer; Mann, Robert E; Wickens, Christine M; Boase, Paul

2012-12-01

Driving safety, impaired driving, and legislation to address these concerns remain important issues. It is imperative countermeasures be targeted toward the most appropriate groups. This paper explores the potential relationship between gender and driving attitudes toward safety issues and impaired-driving countermeasures. The data are from the 2007 Impaired Driving Survey commissioned by Transport Canada and Mothers Against Drunk Driving (MADD) Canada. The survey is a, stratified by region, telephone survey of 1,514 Canadian drivers 18years of age and older with a valid driver's license who had driven within the past 30days. The findings illustrate a consistent impact of gender on these issues. Other variables were also identified as relevant factors although less consistently. Current findings suggest that strategies for building support for interventions, or for changing risk perception/concern for risky driving behaviors should be tailored by gender to maximize the potential for behavior change. This information may assist program and policy developers through the identification of more or less receptive target groups. Future research directions are also presented. Copyright © 2012 National Safety Council and Elsevier Ltd. All rights reserved.

Nordic projects concerning nuclear safety

International Nuclear Information System (INIS)

Soerensen, H.C.

1988-11-01

The report describes the nature of the work done in the first half of 1988 within the field of nuclear safety (1985-89) under the Nordic program for 1985-89. Five programmes and their documentation, are described and complete lists of addresses and of persons involved is given. (AB)

The role of the Australian Adverse Drug Reactions Advisory Committee (ADRAC) in monitoring drug safety

International Nuclear Information System (INIS)

Boyd, Ian W.

2002-01-01

The Australian adverse drug reaction reporting system is acknowledged as one of the best in the world. Despite its small population of less than 20 million people, Australia's current ADR reporting rate of over 12000 reports per year places it in the top few nations in terms of reports per capita. The ADRAC program has been in operation for over 30 years. Australia was a founding member of the WHO International Drug Monitoring Programme which commenced in 1968 and currently there are about 153000 reports in the ADRAC database. Reports from health professionals have uncovered a number of significant safety problems over the years. Of particular importance are flucloxacillin-induced hepatitis, amoxycillin/clavulanate-induced hepatitis, and the association of cystitis with tiaprofenic acid. The number and quality of the reports has allowed an understanding of the characteristics of the reactions and, using ADRAC reporters as a major source of cases, case-control studies have been completed which have identified risk factors. ADRAC's review of Australian reports has highlighted many important associations that have been disseminated through the Australian Adverse Drug Reactions Bulletin

Socializing Young People to Ethics via Play Experience: Browser Games and Parental Concerns for Safety Online

Directory of Open Access Journals (Sweden)

Divina Meigs

2009-01-01

Full Text Available This paper considers an online game and its relation to safety and privacy, in order to examine social and ethical issues raised by parental concern over harmful content. To gain real insights on the responsibility of adults, it develops a hands-on approach that takes into account the major stakeholders, especially young people and the related circle of people around them. Therefore the research question that is raised is: how do browser games provide reassurance to parents about their children’s safety and privacy? The issue of safety online is explored in three parts, using an ethnographic research framework: it explores a specific online game, it provides a profile of participants, it analyses their types of actions in relation to safety and privacy, and discusses the results in terms of incidence of risk, peer-monitoring and community control. The findings show that there is a rather strong tendency to self-regulation, but that tendency is partly due to a strong presence of mediating adults and peers. The results are discussed in terms of incidence of risk, peer-monitoring and networked means of control on the one hand, and in terms of scientific contribution to socialization theory on the other hand. They lead to final considerations on the repertoire of ethical strategies set up online and its meaning for the concerns of adults towards online risk as well as the need for policies on regulation and self-regulation. They also lead to extensions on the socialization to norms and the appropriation of ethics by young people.

Safety of antiretroviral drugs in pregnancy and breastfeeding for mother and child

NARCIS (Netherlands)

Newell, Marie-Louise; Bunders, Madeleine J.

2013-01-01

Purpose of reviewThe introduction of combination ART to prevent mother-to-child-transmission (MTCT) has substantially decreased MTCT rates. However, there are concerns regarding safety of ART exposure for the mother, pregnancy outcome and infant. Changing MTCT prevention guidelines, with expanded

Safety profile of drugs used in the treatment of osteoporosis: a systematical review of the literature

Directory of Open Access Journals (Sweden)

M. Varenna

2013-10-01

Full Text Available The range of osteoporosis treatments is increasingly large and, like any disease, the pharmacological management of patients should involve a risk/benefit evaluation to attain the greatest reduction in risk of fracture with the lowest incidence of adverse events. The aim of this review is to critically appraise the literature about the safety issues of the main pharmacological treatments of osteoporosis. This document is the result of a consensus of experts based on a systematic review of regulatory documents, randomized controlled trials, metaanalyses, pharmacovigilance surveys and case series related to possible adverse drug reactions to osteoporosis treatment with calcium and vitamin D supplements, bisphosphonates, strontium ranelate, selective estrogen receptor modulators, denosumab, and teriparatide. As expected, randomized controlled trials showed only the most common adverse events due to the samples size and the short observation time. Case series and observational studies are able to provide data about uncommon side effects, but in some cases a sure cause-effect relationship needs still to be confirmed. Consistently with methodological limitations, the newer drugs have a tolerance profile that has not been fully explored yet. Osteoporosis treatments showed an overall good tolerance profile with rare serious adverse events that, however, must be well known by the clinician who prescribes these drugs. The concern about possible adverse events should be weighed against the reduction of morbidity and mortality associated with a significant fracture risk reduction.

[New drugs: money-back guarantee?].

Science.gov (United States)

Steenhoek, Adri; Koopmanschap, Marc A; Franken, Margreet G; Rutten, Frans F H

2011-01-01

When a new medical technology, for example a new drug, is introduced onto the market there should be a discussion of the balance between "uncertainty versus value to society and demand". The new technology is sometimes given the benefit of the doubt due to a lack of information. Follow-up investigation is actually essential but is seldom mandatory and hardly ever spontaneously initiated. Specific measures, based on stimulation or penalization, could reduce the degree of uncertainty concerning the efficacy, safety and efficiency of a new technology. A serious option when a new drug produces disappointing results is to pay the manufacturer less.

What can nanosafety learn from drug development? The feasibility of “safety by design”

DEFF Research Database (Denmark)

Hjorth, Rune; van Hove, Lilian; Wickson, Fern

2017-01-01

“Safety by design” (SbD) is an intuitively appealing concept that is on the rise within nanotoxicology and nanosafety research, as well as within nanotechnology research policy. It leans on principles established within drug discovery and development (DDD) and seeks to address safety early, as well...... as throughout product development. However, it remains unclear what the concept of SbD exactly entails for engineered nanomaterials (ENMs) or how it is envisioned to be implemented. Here, we review the concept as it is emerging in European research and compare its resemblance with the safety testing...

[Investigation of the cognition and behavior on drug safety in Beijing middle school students].

Science.gov (United States)

Cheng, Y C; Pan, Y P; Zhang, Y; Pan, Y T; Ding, C Y; Cao, Y; Zhuo, L; Fang, R F; Gao, A Y; Guo, J; Li, A J; Fu, Q; Ma, J; Zhan, S Y

2017-12-18

To understand the cognition and behavior of drug safety in Beijing middle school students and provide advice for relevant education. A cross-sectional survey using paper questionnaires was carried out on the student body of nine Beijing middle schools. Multi-stage proportionate stratified cluster sampling was adopted to enroll participants. In addition to demographic questions, the questionnaire included 17 questions assessing the cognition and behavior of safe drug use, prioritizing questions that aligned with the health education guideline for primary and secondary school students from Chinese Ministry of Education. Descriptive statistical methods were applied using the SAS 9.2 software. Of the 4 220 students investigated, 2 097(49.7%) were males and 2 123(50.3%) were females. The average age was (14.3±1.7) years. 2 030(48.1%) students were from downtown areas, 1 511(35.8%) were from urban-rural linking areas and 679(16.1%) were from rural areas. Half (51.5%) of the respondents were junior high school students, and the others were from senior high schools (34.2%) and vocational high schools (14.3%). Most of the students (89.6%) lived off campus. The awareness rate of drug safety knowledge was 74.4%, the median score of drug safety behavior was 4 points (full score was 5 points) and there was a statistically positive correlation between the two (Spearman's correlation coefficient was 0.156, Pmiddle school students is good, but problems still exist in medication adherence, the management of expired drugs and the antibiotics cognition, which need to be fixed through specific, pointed way of education. And more efforts should be made to improve the cognition in rural regions, vocational high schools and on campus students.

The U.S. commercial air tour industry: a review of aviation safety concerns.

Science.gov (United States)

Ballard, Sarah-Blythe

2014-02-01

The U.S. Title 14 Code of Federal Regulations defines commercial air tours as "flight[s] conducted for compensation or hire in an airplane or helicopter where a purpose of the flight is sightseeing." The incidence of air tour crashes in the United States is disproportionately high relative to similar commercial aviation operations, and air tours operating under Part 91 governance crash significantly more than those governed by Part 135. This paper reviews the government and industry response to four specific areas of air tour safety concern: surveillance of flight operations, pilot factors, regulatory standardization, and maintenance quality assurance. It concludes that the government and industry have successfully addressed many of these tenet issues, most notably by: advancing the operations surveillance infrastructure through implementation of en route, ground-based, and technological surveillance methods; developing Aeronautical Decision Making and cue-based training programs for air tour pilots; consolidating federal air tour regulations under Part 136; and developing public-private partnerships for raising maintenance operating standards and improving quality assurance programs. However, opportunities remain to improve air tour safety by: increasing the number and efficiency of flight surveillance programs; addressing pilot fatigue with more restrictive flight hour limitations for air tour pilots; ensuring widespread uptake of maintenance quality assurance programs, especially among high-risk operators not currently affiliated with private air tour safety programs; and eliminating the 25-mile exception allowing Part 91 operators to conduct commercial air tours without the safety oversight required of Part 135 operators.

Advances in Predictive Toxicology for Discovery Safety through High Content Screening.

Science.gov (United States)

Persson, Mikael; Hornberg, Jorrit J

2016-12-19

High content screening enables parallel acquisition of multiple molecular and cellular readouts. In particular the predictive toxicology field has progressed from the advances in high content screening, as more refined end points that report on cellular health can be studied in combination, at the single cell level, and in relatively high throughput. Here, we discuss how high content screening has become an essential tool for Discovery Safety, the discipline that integrates safety and toxicology in the drug discovery process to identify and mitigate safety concerns with the aim to design drug candidates with a superior safety profile. In addition to customized mechanistic assays to evaluate target safety, routine screening assays can be applied to identify risk factors for frequently occurring organ toxicities. We discuss the current state of high content screening assays for hepatotoxicity, cardiotoxicity, neurotoxicity, nephrotoxicity, and genotoxicity, including recent developments and current advances.

Safety, efficacy, and drug survival of biologics and biosimilars for moderate-to-severe plaque psoriasis

DEFF Research Database (Denmark)

Egeberg, A; Ottosen, M B; Gniadecki, R

2018-01-01

BACKGROUND: Real-life data on newer biologic and biosimilar agents for moderate-to-severe psoriasis are lacking. OBJECTIVES: To examine safety, efficacy, and time to discontinuation (drug survival) of biologics (adalimumab, etanercept, infliximab, secukinumab, and ustekinumab) and compare origina...... the long-term safety of novel biologics for psoriasis. This article is protected by copyright. All rights reserved....

Suicidality and risk of suicide--definition, drug safety concerns, and a necessary target for drug development: a brief report.

Science.gov (United States)

Meyer, Roger E; Salzman, Carl; Youngstrom, Eric A; Clayton, Paula J; Goodwin, Frederick K; Mann, J John; Alphs, Larry D; Broich, Karl; Goodman, Wayne K; Greden, John F; Meltzer, Herbert Y; Normand, Sharon-Lise T; Posner, Kelly; Shaffer, David; Oquendo, Maria A; Stanley, Barbara; Trivedi, Madhukar H; Turecki, Gustavo; Beasley, Charles M; Beautrais, Annette L; Bridge, Jeffrey A; Brown, Gregory K; Revicki, Dennis A; Ryan, Neal D; Sheehan, David V

2010-08-01

To address issues concerning potential treatment-emergent "suicidality," a consensus conference was convened March 23-24, 2009. This gathering of participants from academia, government, and industry brought together experts in suicide prevention, clinical trial design, psychometrics, pharmacoepidemiology, and genetics, as well as research psychiatrists involved in studies in studies of psychiatric disorders associated with elevated suicide risk across the life cycle. The process involved reviews of the relevant literature, and a series of 6 breakout sessions focused on specific questions of interest. Each of the participants at the meeting received references relevant to the formal presentations (as well as the slides for the presentations) for their review prior to the meeting. In addition, the assessment instruments of suicidal ideation/behavior were reviewed in relationship to standard measures of validity, reliability, and clinical utility, and these findings were discussed at length in relevant breakout groups, in the final plenary session, and in the preparation of the article. Consensus and dissenting views were noted. Discussion and questions followed each formal presentation during the plenary sessions. Approximately 6 questions per breakout group were prepared in advance by members of the Steering Committee and each breakout group chair. Consensus in the breakout groups was achieved by nominal group process. Consensus recommendations and any dissent were reviewed for each breakout group at the final plenary session. All plenary sessions were recorded and transcribed by a court stenographer. Following the transcript, with input by each of the authors, the final paper went through 14 drafts. The output of the meeting was organized into this brief report and the accompanying full article from which it is distilled. The full article was developed by the authors with feedback from all participants at the meeting and represents a consensus view. Any areas of

A comparative analysis of drug safety withdrawals in the UK and the US (1971-1992): implications for current regulatory thinking and policy.

Science.gov (United States)

Abraham, John; Davis, Courtney

2005-09-01

By going beyond individual case studies and solely quantitative surveys, this paper systematically examines why there were over twice as many new prescription drugs withdrawn from the market on grounds of safety in the UK as there were in the US between 1971 and 1992. Drawing on interviews with regulators, industry scientists and others involved, and on regulatory data never before accessed outside governments and companies, five key hypotheses which might explain this difference in drug safety withdrawals are analysed. These are: (1) simply because the UK approved more new drugs than the US; (2) because of an industrial corporate strategy to seek approval of 'less safe' drugs in the UK earlier; (3) because British regulators were more vigilant at spotting post-marketing safety problems than their US counterparts; (4) because the slowness of the US in approving new drugs enabled regulators there to learn from, and avoid, safety problems that had already emerged in the UK or European market; and (5) because more stringent regulation in the US meant that they approved fewer unsafe drugs on to the market in the first place. It is concluded that the main explanation for fewer drug safety withdrawals in the US is that the regulatory agency there applied more stringent pre-market review and/or standards, which took longer than UK regulatory checks, but prevented unsafe drugs marketed in the UK from entering the US market. Contrary to the claims frequently made by the pharmaceutical industry and regulatory agencies on both sides of the Atlantic, these results imply that it is likely that acceleration of regulatory review times in the US and the UK since the early 1990s is compromising drug safety.

2011 Annual Meeting of the Safety Pharmacology Society: an overview.

Science.gov (United States)

Cavero, Icilio

2012-03-01

The keynote address of 2011 Annual Meeting of the Safety Pharmacology Society examined the known and the still to be known on drug-induced nephrotoxicity. The nominee of the Distinguished Service Award Lecture gave an account of his career achievements particularly on the domain of chronically instrumented animals for assessing cardiovascular safety. The value of Safety Pharmacology resides in the benefits delivered to Pharma organizations, regulators, payers and patients. Meticulous due diligence concerning compliance of Safety Pharmacology studies to best practices is an effective means to ensure that equally stringent safety criteria are applied to both in-licensed and in-house compounds. Innovative technologies of great potential for Safety Pharmacology presented at the meeting are organs on chips (lung, heart, intestine) displaying mechanical and biochemical features of native organs, electrical field potential (MEA) or impedance (xCELLigence Cardio) measurements in human induced pluripotent stem cell-derived cardiomyocytes for unveiling cardiac electrophysiological and mechanical liabilities, functional human airway epithelium (MucilAir™) preparations with unique 1-year shelf-life for acute and chronic in vitro evaluation of drug efficacy and toxicity. Custom-designed in silico and in vitro assay platforms defining the receptorome space occupied by chemical entities facilitate, throughout the drug discovery phase, the selection of candidates with optimized safety profile on organ function. These approaches can now be complemented by advanced computational analysis allowing the identification of compounds with receptorome, or clinically adverse effect profiles, similar to those of the drug candidate under scrutiny for extending the safety assessment to potential liability targets not captured by classical approaches. Nonclinical data supporting safety can be quite reassuring for drugs with a discovered signal of risk. However, for marketing authorization

Traditional use and safety of herbal medicines

Directory of Open Access Journals (Sweden)

Davyson de L. Moreira

Full Text Available In the European Union, traditional herbal medicines that are regarded as "acceptably safe, albeit not having a recognized level of efficacy" fit into a special category of drugs ("traditional herbal medicine products" for which requirements of non-clinical and clinical studies are less rigorous. A regulation proposal published by the Brazilian National Health Surveillance (Anvisa defines a similar drug category ("traditional phytotherapeutic products" for registration purposes. Regarding herbal medicines, both agencies seem to be lenient regarding proof of efficacy, and consider long-standing folk use as evidence of safety and a waiver of a thorough toxicological evaluation. Nonetheless, several herbal products and constituents with a long history of folk usage are suspected carcinogenic and/or hepatotoxic. Herbal products have also been shown to inhibit and/or induce drug-metabolizing enzymes. Since herbal medicines are often used in conjunction with conventional drugs, kinetic and clinical interactions are a cause for concern. A demonstration of the safety of herbal medicines for registration purposes should include at least in vitroand in vivogenotoxicity assays, long-term rodent carcinogenicity tests (for drugs intended to be continuously used for > 3 months or intermittently for > 6 months, reproductive and developmental toxicity studies (for drugs used by women of childbearing age, and investigation of the effects on drug-metabolizing enzymes.

List of reports from the BMFT, CEA, EPRI, JSTA and USNRC concerning reactor safety research

International Nuclear Information System (INIS)

1981-09-01

This list reviews reports from the Federal Republic of Germany, from France, from Japan and from the United States of America concerning special Problems in the field of Reactor Safety Research. According to the cooperation of the Bundesminister fuer Forschung und Technologie (BMFT) with the Commissariat a l'Energie Atomique (CEA) the Japan Science and Technology Agency (JSTA) the Electric Power Research Institute (EPRI) and the United States Nuclear Regulatory Commission these reports are available in the Gesellschaft fuer Reaktorsicherheit (GRS). The list pursues the following order: Country of origin, problem area concerned, according to the Reactor Saftety Research Program of the BMFT, reporting organization. The list of reports appears quarterly. (orig./HP) [de

Drug safety alerts of pharmacovigilance programme of India: A scope for targeted spontaneous reporting in India

Directory of Open Access Journals (Sweden)

Prasad Thota

2018-01-01

Conclusion: In India, spontaneous reporting of ADRs existed since 1998 under passive surveillance method, but there is an urgent need to initiate TSR, which is a complementary method to spontaneous reporting on these drug safety alerts for further regulatory action by Central Drugs Standard Control Organization.

Post-marketing safety and effectiveness evaluation of the intravenous anti-influenza neuraminidase inhibitor peramivir. II: a pediatric drug use investigation.

Science.gov (United States)

Komeda, Takuji; Ishii, Shingo; Itoh, Yumiko; Ariyasu, Yasuyuki; Sanekata, Masaki; Yoshikawa, Takayoshi; Shimada, Jingoro

2015-03-01

Peramivir is the only intravenous formulation among anti-influenza neuraminidase inhibitors currently available. Peramivir was approved for manufacturing and marketing in Japan in January 2010. In October 2010, an additional indication for pediatric use was approved. We conducted a pediatric drug use investigation of peramivir from October 2010 to February 2012 and evaluated its real-world safety and effectiveness in pediatric patients. We collected the data of 1254 peramivir-treated pediatric patients from 161 facilities across Japan and examined the safety in 1199 patients and effectiveness in 1188 patients. In total, 245 adverse events were observed with an incidence rate of 14.01% (168/1199). Of these, 115 events were adverse drug reactions (ADRs) with an incidence rate of 7.67% (92/1199). Common ADRs were diarrhea and abnormal behavior, with incidence rates of 2.50% (30/1199) and 2.25% (27/1199), respectively. Fourteen serious ADRs were observed in 12 patients (1.00%), including 5 cases each of abnormal behavior and neutrophil count decreased. While 87.0% (100 events) of ADRs occurred within 3 days after the initiation of peramivir administration, 87.8% (101 events) resolved or improved within 7 days after onset. Multivariate analyses indicated that the presence or absence of underlying diseases/complications was significantly related to ADR incidence. With regard to effectiveness, the median time to alleviation of both influenza symptoms and fever was 3 days, including the first day of administration. Thus, this study confirms the pediatric safety of peramivir without any concerns about effectiveness under routine clinical settings. Copyright © 2014 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Items to be reflected to the nuclear power safety measures in Japan (concerning the examination, design and operation management) (excluding the items to be reflected to the standards)

Energy Technology Data Exchange (ETDEWEB)

1980-10-01

In connection with the Three Mile Island nuclear power accident in March, 1979, in the United States, in order to introduce the lessons from it in the nuclear power safety regulations in Japan, 52 items to be reflected to the nuclear power safety measures were chosen by the Nuclear Safety Commission. Of these, 16 items were examined by the Committee on Examination of Reactor Safety. It was decided that these results would be introduced in the nuclear safety regulations, by the Nuclear Safety Commission. The following 16 items are described. For the examination, four items concerning the automatic operation of safety systems and others; for the design, five items concerning a small rupture accident, the monitoring of the state of primary coolant, control room layout and others; for the operation management, seven items concerning the inspection at the time of repair, the prevention of faulty handlings by operators and others.

Sponsors’ and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials

Science.gov (United States)

Perez, Raymond; Archdeacon, Patrick; Roach, Nancy; Goodwin, Robert; Jarow, Jonathan; Stuccio, Nina; Forrest, Annemarie

2017-01-01

Background/aims: The Food and Drug Administration’s final rule on investigational new drug application safety reporting, effective from 28 March 2011, clarified the reporting requirements for serious and unexpected suspected adverse reactions occurring in clinical trials. The Clinical Trials Transformation Initiative released recommendations in 2013 to assist implementation of the final rule; however, anecdotal reports and data from a Food and Drug Administration audit indicated that a majority of reports being submitted were still uninformative and did not result in actionable changes. Clinical Trials Transformation Initiative investigated remaining barriers and potential solutions to full implementation of the final rule by polling and interviewing investigators, clinical research staff, and sponsors. Methods: In an opinion-gathering effort, two discrete online surveys designed to assess challenges and motivations related to management of expedited (7- to 15-day) investigational new drug safety reporting processes in oncology trials were developed and distributed to two populations: investigators/clinical research staff and sponsors. Data were collected for approximately 1 year. Twenty-hour-long interviews were also conducted with Clinical Trials Transformation Initiative–nominated interview participants who were considered as having extensive knowledge of and experience with the topic. Interviewees included 13 principal investigators/study managers/research team members and 7 directors/vice presidents of pharmacovigilance operations from 5 large global pharmaceutical companies. Results: The investigative site’s responses indicate that too many individual reports are still being submitted, which are time-consuming to process and provide little value for patient safety assessments or for informing actionable changes. Fewer but higher quality reports would be more useful, and the investigator and staff would benefit from sponsors’“filtering” of

Sponsors' and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials.

Science.gov (United States)

Perez, Raymond; Archdeacon, Patrick; Roach, Nancy; Goodwin, Robert; Jarow, Jonathan; Stuccio, Nina; Forrest, Annemarie

2017-06-01

The Food and Drug Administration's final rule on investigational new drug application safety reporting, effective from 28 March 2011, clarified the reporting requirements for serious and unexpected suspected adverse reactions occurring in clinical trials. The Clinical Trials Transformation Initiative released recommendations in 2013 to assist implementation of the final rule; however, anecdotal reports and data from a Food and Drug Administration audit indicated that a majority of reports being submitted were still uninformative and did not result in actionable changes. Clinical Trials Transformation Initiative investigated remaining barriers and potential solutions to full implementation of the final rule by polling and interviewing investigators, clinical research staff, and sponsors. In an opinion-gathering effort, two discrete online surveys designed to assess challenges and motivations related to management of expedited (7- to 15-day) investigational new drug safety reporting processes in oncology trials were developed and distributed to two populations: investigators/clinical research staff and sponsors. Data were collected for approximately 1 year. Twenty-hour-long interviews were also conducted with Clinical Trials Transformation Initiative-nominated interview participants who were considered as having extensive knowledge of and experience with the topic. Interviewees included 13 principal investigators/study managers/research team members and 7 directors/vice presidents of pharmacovigilance operations from 5 large global pharmaceutical companies. The investigative site's responses indicate that too many individual reports are still being submitted, which are time-consuming to process and provide little value for patient safety assessments or for informing actionable changes. Fewer but higher quality reports would be more useful, and the investigator and staff would benefit from sponsors'"filtering" of reports and increased sponsor communication. Sponsors

Caffeine-based food supplements and beverages: Trends of consumption for performance purposes and safety concerns.

Science.gov (United States)

Bessada, Sílvia M F; Alves, Rita C; Oliveira, M Beatriz P P

2018-07-01

Nowadays, daily food supplementation regarding the improvement of physical and mental performance is a growing trend in sport practitioners, young students and active people. Food supplements are foodstuffs, labeled under food law and not obliged to safety assessments before their commercialization. Several products are commercialized claiming ergogenic effects as marketing strategies. Caffeine is often one of their main ingredients, as it increases both physical performance and concentration. This manuscript presents a general overview of the current caffeine-based food supplements and energy drinks available in the Portuguese market, as well as the consuming trends regarding their ergogenic effects, performance purposes, and active ingredients. Product claims, recommended daily intakes, caffeine pharmacology, and safety concerns aspects are also discussed aspects. Copyright © 2018 Elsevier Ltd. All rights reserved.

Magnetic resonance imaging: hazard, risk and safety

International Nuclear Information System (INIS)

Narayan, Pradeep; Suri, S.; Singh, P.

2001-01-01

The hazard and risk associated with magnetic resonance imaging is a matter of concern. In 1982, the Food and Drug Administration (FDA), USA issued guidelines to Hospital's Investigational Review Board (IRBs) in 'Guidelines for Evaluating Electromagnetic Exposure Risks for Trials of Clinical Nuclear Magnetic Resonance (NMR)'. In 1997, the Berufsgenossenschaft (BG), professional association for precision engineering and electronics of Germany, in their preliminary proposal for safety limits extended their concerns on static magnetic field. Owing to both time varying and static magnetic fields applied in Magnetic Resonance Imaging (MRI) this became of immediate concern to user community to assess the potential hazard and risk associated with the NMR system

report transparency and nuclear safety 2007- CISBIO

International Nuclear Information System (INIS)

2007-01-01

This report presents the activities of CISBIO, nuclear base installation, for the year 2007. CISBIO realizes at Saclay most of the radiopharmaceuticals and drugs distributed in France for the nuclear medicine. The actions concerning the safety, the radiation protection, the significant events, the release control and the environmental impacts and the wastes stored on the center are discussed. (A.L.B.)

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

Alternatives to currently used antimalarial drugs: in search of a magic bullet.

Science.gov (United States)

Bhagavathula, Akshaya Srikanth; Elnour, Asim Ahmed; Shehab, Abdulla

2016-11-04

Malaria is a major cause of morbidity and mortality in many African countries and parts of Asia and South America. Novel approaches to combating the disease have emerged in recent years and several drug candidates are now being tested clinically. However, it is long before these novel drugs can hit the market, especially due to a scarcity of safety and efficacy data.To reduce the malaria burden, the Medicines for Malaria Venture (MMV) was established in 1999 to develop novel medicines through industry and academic partners' collaboration. However, no reviews were focused following various preclinical and clinical studies published since the MMV initiation (2000) to till date.We identify promising approaches in the global portfolio of antimalarial medicines, and highlight challenges and patient specific concerns of these novel molecules. We discuss different clinical studies focusing on the evaluation of novel drugs against malaria in different human trials over the past five years.The drugs KAE609 and DDD107498 are still being evaluated in Phase I trials and preclinical developmental studies. Both the safety and efficacy of novel compounds such as KAF156 and DSM265 need to be assessed further, especially for use in pregnant women. Synthetic non-artemisinin ozonides such as OZ277 raised concerns in terms of its insufficient efficacy against high parasitic loads. Aminoquinoline-based scaffolds such as ferroquine are promising but should be combined with good partner drugs for enhanced efficacy. AQ-13 induced electrocardiac events, which led to prolonged QTc intervals. Tafenoquine, the only new anti-relapse scaffold for patients with a glucose-6-phosphate dehydrogenase deficiency, has raised significant concerns due to its hemolytic activity. Other compounds, including methylene blue (potential transmission blocker) and fosmidomycin (DXP reductoisomerase inhibitor), are available but cannot be used in children.At this stage, we are unable to identify a single magic

Items to be reflected to the nuclear power safety measures in Japan (concerning the examination, design and operation management) (excluding the items to be reflected to the standards)

International Nuclear Information System (INIS)

1980-01-01

In connection with the Three Mile Island nuclear power accident in March, 1979, in the United States, in order to introduce the lessons from it in the nuclear power safety regulations in Japan, 52 items to be reflected to the nuclear power safety measures were chosen by the Nuclear Safety Commission. Of these, 16 items were examined by the Committee on Examination of Reactor Safety. It was decided that these results would be introduced in the nuclear safety regulations, by the Nuclear Safety Commission. The following 16 items are described. For the examination, four items concerning the automatic operation of safety systems and others; for the design, five items concerning a small rupture accident, the monitoring of the state of primary coolant, control room layout and others; for the operation management, seven items concerning the inspection at the time of repair, the prevention of faulty handlings by operators and others. (J.P.N.)

THE INFLUENCE OF MEDIA EXPOSURE, SAFETY AND HEALTH CONCERNS, AND SELF-EFFICACY ON ENVIRONMENTAL ATTITUDES TOWARDS ELECTRONIC GREEN PRODUCTS

Directory of Open Access Journals (Sweden)

Iman Khalid A. Qader

2011-07-01

Full Text Available As the high-tech industry evolves at a rapid pace, vast amounts of hazardous materials are used in fuelling its global expansion. These rapid changes in production processes are significantly depleting natural resources. With the surge of popular interest and awareness pertaining to environmental issues, organisations may be in peril if consumers' attitudes towards their products are ignored. This study intends to understand consumers' environmental attitudes towards electronic green products and to identify the effect of three factors, namely, media exposure, safety and health concerns, and self- efficacy, on this attitude. Data were collected via a self-administered questionnaire among 170 respondents in a public university. The results of the study indicated that safety and health concerns as well as self-efficacy had significant positive impacts on consumers' environmental attitudes. Surprisingly, however, media exposure did not exhibit any significant influence on consumers' environmental attitude. It is recommended that campaign and awareness projects focus on safety and health issues. Additionally, media should play a more active role in increasing environmental awareness among consumers.

Botanical-drug interactions: a scientific perspective.

Science.gov (United States)

de Lima Toccafondo Vieira, Manuela; Huang, Shiew-Mei

2012-09-01

There is a continued predisposition of concurrent use of drugs and botanical products. A general lack of knowledge of the interaction potential together with an under-reporting of botanical use poses a challenge for the health care providers and a safety concern for patients. Botanical-drug interactions increase the patient risk, especially with regard to drugs with a narrow therapeutic index (e.g., warfarin, cyclosporine, and digoxin). Examples of case reports and clinical studies evaluating botanical-drug interactions of commonly used botanicals in the US are presented. The potential pharmacokinetic and pharmacodynamic bases of such interactions are discussed, as well as the challenges associated with the interpretation of the available data and prediction of botanical-drug interactions. Recent FDA experiences with botanical products and interactions including labeling implications as a risk management strategy are highlighted. Georg Thieme Verlag KG Stuttgart · New York.

Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.

Science.gov (United States)

Schick, Andreas; Miller, Kathleen L; Lanthier, Michael; Dal Pan, Gerald; Nardinelli, Clark

2017-06-01

An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions. We study this question using an internal FDA database containing every new small molecule drug submitted to the FDA's Center for Drug Evaluation and Research (CDER) on or after November 21, 1997, and approved and commercially launched before December 31, 2009. Serious post-marketing safety actions include whether these drugs ever experienced either a post-marketing boxed warning or a withdrawal from the market due to safety concerns. A random effects logistic regression model was used to test whether any pre-marketing characteristics were associated with either post-marketing safety action. A total of 219 new molecular entities were analyzed. Among these drugs, 11 experienced a safety withdrawal and 30 received boxed warnings by July 31, 2016. Contrary to prevailing hypotheses, we find that neither clinical trial sample sizes nor review time windows are associated with the addition of a post-marketing boxed warning or safety withdrawal. However, we do find that new drugs approved with either a boxed warning or priority review are more likely to experience post-marketing boxed warnings. Furthermore, drugs approved with boxed warnings tend to receive post-marketing boxed warnings resulting from new safety information that are unrelated to the original warning. Drugs approved with a boxed warning are 3.88 times more likely to receive a post-marketing boxed warning, while drugs approved with a priority review are 3.51 times more likely to receive a post

HTGR safety research concerns at NRC

International Nuclear Information System (INIS)

Minogue, R.B.

1982-01-01

A general discussion of HTGR technical and safety-related problems is given. The broad areas of current research programs specific to the Fort St. Vrain reactor and applicable to HTGR technology are summarized

The nuts and bolts of pills and portions: the functions of a drug safety working group.

Science.gov (United States)

Nath, Noleen S; Jones, Ellen H; Stride, Peter; Premaratne, Manuja; Thaker, Darshit; Lim, Ivan

2011-11-01

Hospitalised patients commonly experience adverse drug events (ADEs) and medication errors. Runciman reported that ADEs in hospitals account for 20% of reported adverse events and contribute to 27% of deaths where death followed an adverse event. Hughes recommends multidisciplinary hospital drug committees to assess performance and raise standards. The new Code of Conduct of the Medical Board of Australia recommends participation in systems for surveillance and monitoring of adverse events, and to improve patient safety. We describe the functions and role of a Drug Safety Working Group (DSWG) in a suburban hospital, which aims to audit and promote a culture of prescribing and medication administration that is prudent and cautious to minimise the risk of harm to patients. We believe that regular prescription monitoring and feedback to Resident Medical Officers (RMOs) improves medication management in our hospital.

Perception vs. reality: an investigation of the misperceptions concerning the extent of peer novel drug use.

Science.gov (United States)

Sanders, Amber; Stogner, John M; Miller, Bryan Lee

2013-01-01

Misperceptions of peer substance use have previously been implicated as significant influences on individual use of both alcohol and illicit drugs. However, research on perceived social norms and related interventions are typically limited to binge drinking and marijuana and no empirical studies have explored misperceptions related to "novel drugs." The present study explored the extent of use and perceptions of use among a college sample (N = 2,349) for three categories of novel drugs: synthetic cannabinoids (Spice, K2, Mr. Miyagi, Pot-Pourri, etc.), synthetic cathinones (commonly known as "bath salts"), and Salvia divinorum. Results indicate that overall perceived use was significantly higher than actual reported use. The frequency of overestimation of peer use was particularly large for the emerging drugs when compared to alcohol and marijuana. This finding is concerning as these misperceptions have the potential to influence students toward experimentation with these substances and suggests that a possible target for intervention is misperceptions of emerging novel substances.

Surveys of research projects concerning nuclear facility safety financed by the Federal Ministry for the Environment, Nature Protection and Reactor Safety, 1991

International Nuclear Information System (INIS)

1992-09-01

Each progress report is a collection of individual reports, categorized by subject matter. They are a documentation of the contractor's progress, rendered by themselves on standardized forms, published, for the sake of general information on progress made in investigations concerning reactor safety, by the project attendance department of the GRS. The individual reports have serial numbers. Each report includes particulars of the objective, work carried out, results obtained and plans for project continuation. (orig.) [de

Surveys of research projects concerning nuclear facility safety, financed by the Federal Ministry for the Environment, Nature Protection and Reactor Safety, 1988

International Nuclear Information System (INIS)

1989-11-01

Each progress report is a collection of individual reports, categorized by subject matter. They are a documentation of the contractor's progress, rendered by themselves on standardized forms, published, for the sake of general information on progress made in investigations concerning reactor safety, by the project attendance department of the GRS. The individual reports have serial numbers. Each report includes particulars of the objective, work carried out, results obtained and plans for project continuation. (orig.) [de

Surveys of research projects concerning nuclear facility safety, financed by the Federal Ministry for the Environment, Nature Protection and Reactor Safety, 1987

International Nuclear Information System (INIS)

1988-06-01

Each progress report is a collection of individual reports, categorized by subject matter. They are a documentation of the contractor's progress, rendered by themselves on standardized forms, published, for the sake of general information on progress made in investigations concerning reactor safety, by the project attendance department of the GRS. The individual reports have serial numbers. Each report includes particulars of the objective, work carried out, results obtained and plans for project continuation. (orig.) [de

Safety and problems in using radioactive drugs in hospitals

International Nuclear Information System (INIS)

Arimizu, Noboru

1975-01-01

The safety and the control problem of non-closed RI (radiopharmaceuticals) of which use has rapidly been increased, were studied. At present, the hospitals with an independent clinic for the nuclear medicine are very limited and many doctors, nurses and safety controllers who are working in the clinic belong to other clinics. As for the diagnosis using RI examination, the dangers of the persons who are working with radioimmunoassay, especially using Au-antigen kit were studied. Furthermore, the problems concerning the reduction of exposure dose by the use of a short half-life RI, such as sup(99m)Tc and the dangers of external exposure on the persons who use the isotope were studied. In addition, the control of RI ward for RI therapy was discussed. The author considered the specialization and fixation of doctors, nurses and technicians are becoming of necessity with the advancement of RI therapy. In addition, the necessity of training nurses for the nuclear medicine was insisted on. (Tsukamoto, Y.)

Safety and problems in using radioactive drugs in hospitals

Energy Technology Data Exchange (ETDEWEB)

Arimizu, N [National Inst. of Radiological Sciences, Chiba (Japan)

1975-01-01

The safety and the control problem of non-closed RI (radiopharmaceuticals) of which use has rapidly been increased, were studied. At present, the hospitals with an independent clinic for the nuclear medicine are very limited and many doctors, nurses and safety controllers who are working in the clinic belong to other clinics. As for the diagnosis using RI examination, the dangers of the persons who are working with radioimmunoassay, especially using Au-antigen kit were studied. Furthermore, the problems concerning the reduction of exposure dose by the use of a short half-life RI, such as sup(99m)Tc and the dangers of external exposure on the persons who use the isotope were studied. In addition, the control of RI ward for RI therapy was discussed. The author considered the specialization and fixation of doctors, nurses and technicians are becoming of necessity with the advancement of RI therapy. In addition, the necessity of training nurses for the nuclear medicine was insisted on.

Prospective drug safety monitoring using the UK primary-care General Practice Research Database: theoretical framework, feasibility analysis and extrapolation to future scenarios.

Science.gov (United States)

Johansson, Saga; Wallander, Mari-Ann; de Abajo, Francisco J; García Rodríguez, Luis Alberto

2010-03-01

recruitment and 12 months for data management and case validation). To reach the estimated target exposure necessary to raise or rule out a signal of concern to public health, we determined that a recruitment period 2-3 times longer than that used in this study would be required. Based on the real market uptake of six commonly used medicinal products launched between 2001 and 2006 in the UK (budesonide/eformoterol [fixed-dose combination], duloxetine, ezetimibe, metformin/rosiglitazone [fixed-dose combination], tiotropium bromide and tadalafil) the target exposure would not have been reached until the fifth year of marketing using a single database. It is feasible to set up a system that actively monitors drug safety using a healthcare database and an independent endpoint adjudication committee. However, future successful implementation will require multiple databases to be queried so that larger study populations are included. This requires further development and harmonization of international healthcare databases.

The Swedish Nuclear Power Inspectorate's Regulations concerning Safety in connection with the Disposal of Nuclear Material and Nuclear Waste. General Recommendations concerning the Application of the Swedish Nuclear Power Inspectorate's Regulations above

International Nuclear Information System (INIS)

2002-06-01

An english translation of the original Swedish regulations concerning the safety in disposal of nuclear wastes is published in this booklet, together with recommendations on how these regulations can be applied

New safety valve addresses environmental concerns

International Nuclear Information System (INIS)

Taylor, J.; Austin, R.

1992-01-01

This paper reports that Conoco Pipeline is using a unique relief valve to reduce costs while improving environmental protection at its facilities. Conoco Pipeline Co. Inc. began testing new relief valves in 1987 to present over-pressuring its pipelines while enhancing the safety, environmental integrity and profitability of its pipelines. Conoco worked jointly with Rupture Pin Technology Inc., Oklahoma City, to seek a solution to a series of safety, environmental, and operational risks in the transportation of crude oil and refined products through pipelines. Several of the identified problems were traced to a single equipment source: the reliability of rupture discs used at pipeline stations to relieve pressure by diverting flow to tanks during over-pressure conditions. Conoco's corporate safety and environmental policies requires solving problems that deal with exposure to hydrocarbon vapors, chemical spills or the atmospheric release of fugitive emissions, such as during rupture disc maintenance. The company had used rupture pin valves as vent relief devices in conjunction with development by Rick Austin of inert gas methods to protect the inner casing wall and outer carrier pipeline wall in pipeline road crossings. The design relies on rupture pin valves set at 5 psi to isolate vent openings from the atmosphere prior to purging the annular space between the pipeline and casing with inert gas to prevent corrosion. Speciality Pipeline Inspection and Engineering Inc., Houston, is licensed to distribute the equipment for the new cased-crossing procedure

Health and safety concerns os migrant workers: the experience of tunisian workers in modena, Italy

Directory of Open Access Journals (Sweden)

Faïçal Daly

2004-06-01

Full Text Available This paper examines the relatively under-researched field of healthand safety of migrant workers, with special reference to Tunisian construction workers in the city of Modena in the Italian region of Emilia-Romagna. The empirical material comes from questionnaires and interviews with Tunisian migrants, plus smaller numbers of interviews with employers and trade union representatives in Modena. The paper starts by critically reviewing the scattered literature onthe health and safety of minority workers, most of which refers to the United States and the United Kingdom. The discussion then moves to a consideration of migrant health and safety questions in the contexts of racism, discrimination, social class, working conditions, labour market segmentation and (non- regulation. Specialattention is given to the failed role of trade unions in defending the rights of minority workers, in advanced countries generally and in Italy in particular. A case study is then made of the construction sector in Italy, enriched by personal accounts of the experiences of Tunisian migrant workers in Modena. Employer and tradeunion interviews reveal a lack of concern and ability to tackle the relevant issues. Barriers to health and safety awareness training are outlined. In the conclusion, recommendations are made for policy initiatives in this area.

Response to ONS/EH-OA concerns

International Nuclear Information System (INIS)

Rice, P.D.

1991-01-01

The DOE's independent Office of Nuclear Safety (ONS) conducted an independent assessment of WSRC's readiness for K-Reactor restart. DOE-ONS identified six areas of concern, with specific findings in each area. The six concerns deal with: (1) Technical Specification surveillance, (2) human factors issues, (3) emergency lighting, (4) fire protection issues, (5) the Unreviewed Safety Question process, and (6) the critique process. This report addresses each of these six concerns and Westinghouse's actions to resolve them

Social Media Impact of the Food and Drug Administration's Drug Safety Communication Messaging About Zolpidem: Mixed-Methods Analysis.

Science.gov (United States)

Sinha, Michael S; Freifeld, Clark C; Brownstein, John S; Donneyong, Macarius M; Rausch, Paula; Lappin, Brian M; Zhou, Esther H; Dal Pan, Gerald J; Pawar, Ajinkya M; Hwang, Thomas J; Avorn, Jerry; Kesselheim, Aaron S

2018-01-05

The Food and Drug Administration (FDA) issues drug safety communications (DSCs) to health care professionals, patients, and the public when safety issues emerge related to FDA-approved drug products. These safety messages are disseminated through social media to ensure broad uptake. The objective of this study was to assess the social media dissemination of 2 DSCs released in 2013 for the sleep aid zolpidem. We used the MedWatcher Social program and the DataSift historic query tool to aggregate Twitter and Facebook posts from October 1, 2012 through August 31, 2013, a period beginning approximately 3 months before the first DSC and ending 3 months after the second. Posts were categorized as (1) junk, (2) mention, and (3) adverse event (AE) based on a score between -0.2 (completely unrelated) to 1 (perfectly related). We also looked at Google Trends data and Wikipedia edits for the same time period. Google Trends search volume is scaled on a range of 0 to 100 and includes "Related queries" during the relevant time periods. An interrupted time series (ITS) analysis assessed the impact of DSCs on the counts of posts with specific mention of zolpidem-containing products. Chow tests for known structural breaks were conducted on data from Twitter, Facebook, and Google Trends. Finally, Wikipedia edits were pulled from the website's editorial history, which lists all revisions to a given page and the editor's identity. In total, 174,286 Twitter posts and 59,641 Facebook posts met entry criteria. Of those, 16.63% (28,989/174,286) of Twitter posts and 25.91% (15,453/59,641) of Facebook posts were labeled as junk and excluded. AEs and mentions represented 9.21% (16,051/174,286) and 74.16% (129,246/174,286) of Twitter posts and 5.11% (3,050/59,641) and 68.98% (41,138/59,641) of Facebook posts, respectively. Total daily counts of posts about zolpidem-containing products increased on Twitter and Facebook on the day of the first DSC; Google searches increased on the week of the

Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project.

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Perez, Raymond P; Finnigan, Shanda; Patel, Krupa; Whitney, Shanell; Forrest, Annemarie

2016-12-15

Use of electronic clinical trial portals has increased in recent years to assist with sponsor-investigator communication, safety reporting, and clinical trial management. Electronic portals can help reduce time and costs associated with processing paperwork and add security measures; however, there is a lack of information on clinical trial investigative staff's perceived challenges and benefits of using portals. The Clinical Trials Transformation Initiative (CTTI) sought to (1) identify challenges to investigator receipt and management of investigational new drug (IND) safety reports at oncologic investigative sites and coordinating centers and (2) facilitate adoption of best practices for communicating and managing IND safety reports using electronic portals. CTTI, a public-private partnership to improve the conduct of clinical trials, distributed surveys and conducted interviews in an opinion-gathering effort to record investigator and research staff views on electronic portals in the context of the new safety reporting requirements described in the US Food and Drug Administration's final rule (Code of Federal Regulations Title 21 Section 312). The project focused on receipt, management, and review of safety reports as opposed to the reporting of adverse events. The top challenge investigators and staff identified in using individual sponsor portals was remembering several complex individual passwords to access each site. Also, certain tasks are time-consuming (eg, downloading reports) due to slow sites or difficulties associated with particular operating systems or software. To improve user experiences, respondents suggested that portals function independently of browsers and operating systems, have intuitive interfaces with easy navigation, and incorporate additional features that would allow users to filter, search, and batch safety reports. Results indicate that an ideal system for sharing expedited IND safety information is through a central portal used by

Pharmacokinetic Interactions between Drugs and Botanical Dietary Supplements.

Science.gov (United States)

Sprouse, Alyssa A; van Breemen, Richard B

2016-02-01

The use of botanical dietary supplements has grown steadily over the last 20 years despite incomplete information regarding active constituents, mechanisms of action, efficacy, and safety. An important but underinvestigated safety concern is the potential for popular botanical dietary supplements to interfere with the absorption, transport, and/or metabolism of pharmaceutical agents. Clinical trials of drug-botanical interactions are the gold standard and are usually carried out only when indicated by unexpected consumer side effects or, preferably, by predictive preclinical studies. For example, phase 1 clinical trials have confirmed preclinical studies and clinical case reports that St. John's wort (Hypericum perforatum) induces CYP3A4/CYP3A5. However, clinical studies of most botanicals that were predicted to interact with drugs have shown no clinically significant effects. For example, clinical trials did not substantiate preclinical predictions that milk thistle (Silybum marianum) would inhibit CYP1A2, CYP2C9, CYP2D6, CYP2E1, and/or CYP3A4. Here, we highlight discrepancies between preclinical and clinical data concerning drug-botanical interactions and critically evaluate why some preclinical models perform better than others in predicting the potential for drug-botanical interactions. Gaps in knowledge are also highlighted for the potential of some popular botanical dietary supplements to interact with therapeutic agents with respect to absorption, transport, and metabolism. Copyright © 2016 by The American Society for Pharmacology and Experimental Therapeutics.

Aviation Safety: FAA and DOD Response to Similar Safety Concerns

National Research Council Canada - National Science Library

2002-01-01

.... The Federal Aviation Administration (FAA) and the military services often face common safety issues as they oversee the operation of similar aircraft or even dissimilar aircraft that use common parts and materials...

Strategies for Prevention and Intervention of Drug Abuse among Students in Secondary Schools in Kenya

Science.gov (United States)

Marais, Petro; Maithya, Redempta

2015-01-01

Drug abuse is becoming an increasing problem among students in Kenya. The major cause for concern is that a high proportion of the Kenyan youth in secondary schools are involved in drugs (NACADA 2012). As a result, these young people eventually become addicted, posing a threat to their own health and safety. This study sought to establish the…

Efficacy and safety of rabeprazole in non-steroidal anti-inflammatory drug-induced ulcer in Japan.

Science.gov (United States)

Mizokami, Yuji

2009-10-28

To investigate the efficacy and safety of rabeprazole under continuous non-steroidal anti-inflammatory drug (NSAID) administration for NSAID-induced ulcer in Japan. Subjects comprised patients undergoing NSAID treatment in whom upper gastrointestinal endoscopy revealed an ulcerous lesion (open ulcer) with diameter > or = 3 mm, who required continuous NSAID treatment. Endoscopies were performed at the start of treatment, during the treatment period, and at the conclusion (or discontinuation) of treatment. Findings were evaluated as size (maximum diameter) and stage based on the Sakita-Miwa classification. An ulcer was regarded as cured when the "white coating" was seen to have disappeared under endoscopy. As criteria for evaluating safety, all medically untoward symptoms and signs (adverse events, laboratory abnormalities, accidental symptoms, etc.) occurring after the start of rabeprazole treatment were handled as adverse events. Endoscopic cure rate in 38 patients in the efficacy analysis (endoscopic evaluation) was 71.1% (27/38). Among those 38 patients, 35 had gastric ulcer with a cure rate of 71.4% (25/35), and 3 had duodenal ulcer with a cure rate of 66.7% (2/3). Three adverse drug reactions were reported from 64 patients in the safety analysis (interstitial pneumonia, low white blood cell count and pruritus); thus, the incidence rate for adverse drug reactions was 4.7% (3/64). The treatment efficacy of rabeprazole for NSAID-induced ulcer under continuous NSAID administration was confirmed.

The safety, efficacy and regulatory triangle in drug development: Impact for animal models and the use of animals.

Science.gov (United States)

van Meer, Peter J K; Graham, Melanie L; Schuurman, Henk-Jan

2015-07-15

Nonclinical studies in animals are conducted to demonstrate proof-of-concept, mechanism of action and safety of new drugs. For a large part, in particular safety assessment, studies are done in compliance with international regulatory guidance. However, animal models supporting the initiation of clinical trials have their limitations, related to uncertainty regarding the predictive value for a clinical condition. The 3Rs principles (refinement, reduction and replacement) are better applied nowadays, with a more comprehensive application with respect to the original definition. This regards also regulatory guidance, so that opportunities exist to revise or reduce regulatory guidance with the perspective that the optimal balance between scientifically relevant data and animal wellbeing or a reduction in animal use can be achieved. In this manuscript we review the connections in the triangle between nonclinical efficacy/safety studies and regulatory aspects, with focus on in vivo testing of drugs. These connections differ for different drugs (chemistry-based low molecular weight compounds, recombinant proteins, cell therapy or gene therapy products). Regarding animal models and their translational value we focus on regulatory aspects and indications where scientific outcomes warrant changes, reduction or replacement, like for, e.g., biosimilar evaluation and safety testing of monoclonal antibodies. On the other hand, we present applications where translational value has been clearly demonstrated, e.g., immunosuppressives in transplantation. Especially for drugs of more recent date like recombinant proteins, cell therapy products and gene therapy products, a regulatory approach that allows the possibility to conduct combined efficacy/safety testing in validated animal models should strengthen scientific outcomes and improve translational value, while reducing the numbers of animals necessary. Copyright © 2015 Elsevier B.V. All rights reserved.

Anticancer drugs during pregnancy.

Science.gov (United States)

Miyamoto, Shingo; Yamada, Manabu; Kasai, Yasuyo; Miyauchi, Akito; Andoh, Kazumichi

2016-09-01

Although cancer diagnoses during pregnancy are rare, they have been increasing with the rise in maternal age and are now a topic of international concern. In some cases, the administration of chemotherapy is unavoidable, though there is a relative paucity of evidence regarding the administration of anticancer drugs during pregnancy. As more cases have gradually accumulated and further research has been conducted, we are beginning to elucidate the appropriate timing for the administration of chemotherapy, the regimens that can be administered with relative safety, various drug options and the effects of these drugs on both the mother and fetus. However, new challenges have arisen, such as the effects of novel anticancer drugs and the desire to bear children during chemotherapy. In this review, we outline the effects of administering cytotoxic anticancer drugs and molecular targeted drugs to pregnant women on both the mother and fetus, as well as the issues regarding patients who desire to bear children while being treated with anticancer drugs. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Suicidality and risk of suicide--definition, drug safety concerns, and a necessary target for drug development: a consensus statement.

Science.gov (United States)

Meyer, Roger E; Salzman, Carl; Youngstrom, Eric A; Clayton, Paula J; Goodwin, Frederick K; Mann, J John; Alphs, Larry D; Broich, Karl; Goodman, Wayne K; Greden, John F; Meltzer, Herbert Y; Normand, Sharon-Lise T; Posner, Kelly; Shaffer, David; Oquendo, Maria A; Stanley, Barbara; Trivedi, Madhukar H; Turecki, Gustavo; Beasley, Charles M; Beautrais, Annette L; Bridge, Jeffrey A; Brown, Gregory K; Revicki, Dennis A; Ryan, Neal D; Sheehan, David V

2010-08-01

To address issues concerning potential treatment-emergent "suicidality," a consensus conference was convened March 23-24, 2009. This gathering of participants from academia, government, and industry brought together experts in suicide prevention, clinical trial design, psychometrics, pharmacoepidemiology, and genetics, as well as research psychiatrists involved in studies of major depression, bipolar disorder, schizophrenia, substance abuse/dependence, and other psychiatric disorders associated with elevated suicide risk across the life cycle. The process involved reviews of the relevant literature, and a series of 6 breakout sessions focused on specific questions of interest. Each of the participants at the meeting received references relevant to the formal presentations (as well as the slides for the presentations) for their review prior to the meeting. In addition, the assessment instruments of suicidal ideation/behavior were reviewed in relationship to standard measures of validity, reliability, and clinical utility, and these findings were discussed at length in relevant breakout groups, in the final plenary session, and in the preparation of the article. Consensus and dissenting views were noted. Discussion and questions followed each formal presentation during the plenary sessions. Approximately 6 questions per breakout group were prepared in advance by members of the Steering Committee and each breakout group chair. Consensus in the breakout groups was achieved by nominal group process. Consensus recommendations and any dissent were reviewed for each breakout group at the final plenary session. All plenary sessions were recorded and transcribed by a court stenographer. Following the transcript, with input by each of the authors, the final paper went through 14 drafts. The output of the meeting was organized into this scholarly article, which has been developed by the authors with feedback from all participants at the meeting and represents a consensus view

Specific issues, exact locations: case study of a community mapping project to improve safety in a disadvantaged community.

Science.gov (United States)

Qummouh, Rana; Rose, Vanessa; Hall, Pat

2012-12-01

Safety is a health issue and a significant concern in disadvantaged communities. This paper describes an example of community-initiated action to address perceptions of fear and safety in a suburb in south-west Sydney which led to the development of a local, community-driven research project. As a first step in developing community capacity to take action on issues of safety, a joint resident-agency group implemented a community safety mapping project to identify the extent of safety issues in the community and their exact geographical location. Two aerial maps of the suburb, measuring one metre by two metres, were placed on display at different locations for four months. Residents used coloured stickers to identify specific issues and exact locations where crime and safety were a concern. Residents identified 294 specific safety issues in the suburb, 41.9% (n=123) associated with public infrastructure, such as poor lighting and pathways, and 31.9% (n=94) associated with drug-related issues such as drug activity and discarded syringes. Good health promotion practice reflects community need. In a very practical sense, this project responded to community calls for action by mapping resident knowledge on specific safety issues and exact locations and presenting these maps to local decision makers for further action.

A review of over-the-counter drug therapy.

Science.gov (United States)

Esmay, J B; Wertheimer, A I

1979-01-01

The authors review the extent of the use of nonprescription drugs as well as possible variables influencing such consumption. Various studies indicate that age, sex, personality characteristics, perceptions of health status, socioeconomic factors, parental example, and pharmacists all play parts in determining over-the-counter (OTC) drug utilization. Several sources express concern about the inaccessibility of accurate OTC drug information to the consumer. Indeed, even the FDA has occasional difficulty obtaining reliable facts on both the numbers and formulae of such products. Several studies indicate that consumers acquire information about their home remedies through advertising, friends and relatives, physicians, pharmacists, and product labels. By far the most influential of these is advertising, and much concern has been voiced over consumers' unquestioning faith in drug ads. Examples are cited of deceptive, inaccurate, and unfair advertising practices used by some OTC drug manufacturers. The pros and cons of the "drug-oriented society" theory are discussed, including an analysis of its underlying origins. Testing of the safety and efficacy of nonrescription remedies has proved to be controversial, especially when considering the ramifications of the placebo effect. Different surveys report widespread misuse of OTC's by consumers through overuse, taking several drugs concurrently, and using home remedies to treat potentially serious diseases.

Challenges and strategies to facilitate formulation development of pediatric drug products: Safety qualification of excipients.

Science.gov (United States)

Buckley, Lorrene A; Salunke, Smita; Thompson, Karen; Baer, Gerri; Fegley, Darren; Turner, Mark A

2018-02-05

A public workshop entitled "Challenges and strategies to facilitate formulation development of pediatric drug products" focused on current status and gaps as well as recommendations for risk-based strategies to support the development of pediatric age-appropriate drug products. Representatives from industry, academia, and regulatory agencies discussed the issues within plenary, panel, and case-study breakout sessions. By enabling practical and meaningful discussion between scientists representing the diversity of involved disciplines (formulators, nonclinical scientists, clinicians, and regulators) and geographies (eg, US, EU), the Excipients Safety workshop session was successful in providing specific and key recommendations for defining paths forward. Leveraging orthogonal sources of data (eg. food industry, agro science), collaborative data sharing, and increased awareness of the existing sources such as the Safety and Toxicity of Excipients for Paediatrics (STEP) database will be important to address the gap in excipients knowledge needed for risk assessment. The importance of defining risk-based approaches to safety assessments for excipients vital to pediatric formulations was emphasized, as was the need for meaningful stakeholder (eg, patient, caregiver) engagement. Copyright © 2017 Elsevier B.V. All rights reserved.

Surveys of research projects concerning nuclear facility safety, financed by the Bundesminister des Innern. 9th annual report on SR-projects 1984

International Nuclear Information System (INIS)

1985-06-01

The FRG's Ministry of the Interior finances studies, expertises and investigations in the field of nuclear safety. The results of such work are meant to clarify questions left open concerning the execution of licensing procedures for nuclear facilities. The GRS (Reactor Safety Company) regularly provides information on the state of such studies, on the authority of the Ministry of the Interior. Each progress report is a collection of individual reports, categorized by subject matter. They are a documentation of the contractor's progress, rendered by themselves on standardized forms, published, for the sake of general information on progress made in investigations concerning reactor safety, by the project attendance department of the GRS. The individual reports have serial numbers. Each report includes particulars of the objective, work carried out, results obtained and plans for project continuation. (orig./HP) [de

Drug Safety: Managing Multiple Drugs

Science.gov (United States)

... This series is produced by Consumers Union and Consumer Reports Best Buy Drugs , a public information project sup- ported by grants from the Engelberg Foundation and the National Library of Medicine of ... Consumer and Prescriber Education Grant Program which is funded ...

Mathematical calculation skills required for drug administration in undergraduate nursing students to ensure patient safety: A descriptive study: Drug calculation skills in nursing students.

Science.gov (United States)

Bagnasco, Annamaria; Galaverna, Lucia; Aleo, Giuseppe; Grugnetti, Anna Maria; Rosa, Francesca; Sasso, Loredana

2016-01-01

In the literature we found many studies that confirmed our concerns about nursing students' poor maths skills that directly impact on their ability to correctly calculate drug dosages with very serious consequences for patient safety. The aim of our study was to explore where students had most difficulty and identify appropriate educational interventions to bridge their mathematical knowledge gaps. This was a quali-quantitative descriptive study that included a sample of 726 undergraduate nursing students. We identified exactly where students had most difficulty and identified appropriate educational interventions to bridge their mathematical knowledge gaps. We found that the undergraduate nursing students mainly had difficulty with basic maths principles. Specific learning interventions are needed to improve their basic maths skills and their dosage calculation skills. For this purpose, we identified safeMedicate and eDose (Authentic World Ltd.), only that they are only available in English. In the near future we hope to set up a partnership to work together on the Italian version of these tools. Copyright © 2015 Elsevier Ltd. All rights reserved.

Safety concerns related to modular/prefabricated building construction.

Science.gov (United States)

Fard, Maryam Mirhadi; Terouhid, Seyyed Amin; Kibert, Charles J; Hakim, Hamed

2017-03-01

The US construction industry annually experiences a relatively high rate of fatalities and injuries; therefore, improving safety practices should be considered a top priority for this industry. Modular/prefabricated building construction is a construction strategy that involves manufacturing of the whole building or some of its components off-site. This research focuses on the safety performance of the modular/prefabricated building construction sector during both manufacturing and on-site processes. This safety evaluation can serve as the starting point for improving the safety performance of this sector. Research was conducted based on Occupational Safety and Health Administration investigated accidents. The study found 125 accidents related to modular/prefabricated building construction. The details of each accident were closely examined to identify the types of injury and underlying causes. Out of 125 accidents, there were 48 fatalities (38.4%), 63 hospitalized injuries (50.4%), and 14 non-hospitalized injuries (11.2%). It was found that, the most common type of injury in modular/prefabricated construction was 'fracture', and the most common cause of accidents was 'fall'. The most frequent cause of cause (underlying and root cause) was 'unstable structure'. In this research, the accidents were also examined in terms of corresponding location, occupation, equipment as well as activities during which the accidents occurred. For improving safety records of the modular/prefabricated construction sector, this study recommends that future research be conducted on stabilizing structures during their lifting, storing, and permanent installation, securing fall protection systems during on-site assembly of components while working from heights, and developing training programmes and standards focused on modular/prefabricated construction.

Drug-Induced Dental Caries: A Disproportionality Analysis Using Data from VigiBase.

Science.gov (United States)

de Campaigno, Emilie Patras; Kebir, Inès; Montastruc, Jean-Louis; Rueter, Manuela; Maret, Delphine; Lapeyre-Mestre, Maryse; Sallerin, Brigitte; Despas, Fabien

2017-12-01

Dental caries is defined as a pathological breakdown of the tooth. It is an infectious phenomenon involving a multifactorial aetiology. The impact of drugs on cariogenic risk has been poorly investigated. In this study, we identified drugs suspected to induce dental caries as adverse drug reactions (ADRs) and then studied a possible pathogenic mechanism for each drug that had a statistically significant disproportionality. We extracted individual case safety reports of dental caries associated with drugs from VigiBase ® (the World Health Organization global individual case safety report database). We calculated disproportionality for each drug with a reporting odds ratio (ROR) and 99% confidence interval. We analysed the pharmacodynamics of each drug that had a statistically significant disproportionality. In VigiBase ® , 5229 safety reports for dental caries concerning 733 drugs were identified. Among these drugs, 88 had a significant ROR, and for 65 of them (73.9%), no information about dental caries was found in the summaries of the product characteristics, the Micromedex ® DRUGDEX, or the Martindale databases. Regarding the pharmacological classes of drugs involved in dental caries, we identified bisphosphonates, atropinic drugs, antidepressants, corticoids, immunomodulating drugs, antipsychotics, antiepileptics, opioids and β 2 -adrenoreceptor agonist drugs. Regarding possible pathogenic mechanisms for these drugs, we identified changes in salivary flow/composition for 54 drugs (61.4%), bone metabolism changes for 31 drugs (35.2%), hyperglycaemia for 32 drugs (36.4%) and/or immunosuppression for 23 drugs (26.1%). For nine drugs (10.2%), the mechanism was unclear. We identified 88 drugs with a significant positive disproportionality for dental caries. Special attention has to be paid to bisphosphonates, atropinic drugs, immunosuppressants and drugs causing hyperglycaemia.

Drug-drug interactions and adverse drug reactions in polypharmacy among older adults: an integrative review 1

Science.gov (United States)

Rodrigues, Maria Cristina Soares; de Oliveira, Cesar

2016-01-01

ABSTRACT Objective: to identify and summarize studies examining both drug-drug interactions (DDI) and adverse drug reactions (ADR) in older adults polymedicated. Methods: an integrative review of studies published from January 2008 to December 2013, according to inclusion and exclusion criteria, in MEDLINE and EMBASE electronic databases were performed. Results: forty-seven full-text studies including 14,624,492 older adults (≥ 60 years) were analyzed: 24 (51.1%) concerning ADR, 14 (29.8%) DDI, and 9 studies (19.1%) investigating both DDI and ADR. We found a variety of methodological designs. The reviewed studies reinforced that polypharmacy is a multifactorial process, and predictors and inappropriate prescribing are associated with negative health outcomes, as increasing the frequency and types of ADRs and DDIs involving different drug classes, moreover, some studies show the most successful interventions to optimize prescribing. Conclusions: DDI and ADR among older adults continue to be a significant issue in the worldwide. The findings from the studies included in this integrative review, added to the previous reviews, can contribute to the improvement of advanced practices in geriatric nursing, to promote the safety of older patients in polypharmacy. However, more research is needed to elucidate gaps. PMID:27598380

Cause for Concern: A Mixed-Methods Study of Campus Safety and Security Practices in United States-Mexico Border Institutions of Higher Education

Science.gov (United States)

Holmes, Ryan Clevis

2014-01-01

Campus safety has been a source of concern since the 1990s. However, in 2007, the tragedy at the Virginia Polytechnic and State University sent a sense of alarm through many institutions of higher education. Immediately following this tragedy, institutions across the country began to evaluate and question their safety and security practices. While…

Determination of safety margins for whole blood concentrations of alcohol and nineteen drugs in driving under the influence cases.

Science.gov (United States)

Kristoffersen, Lena; Strand, Dag Helge; Liane, Veronica Horpestad; Vindenes, Vigdis; Tvete, Ingunn Fride; Aldrin, Magne

2016-02-01

Legislative limits for driving under the influence of 20 non-alcohol drugs were introduced in Norway in February 2012. Per se limits corresponding to blood alcohol concentrations (BAC) of 0.2g/kg were established for 20 psychoactive drugs, and limits for graded sanctions corresponding to BACs of 0.5 and 1.2g/kg were determined for 13 of these drugs. This new legislation made it possible for the courts to make sentences based on the analytical results, similar to the situation for alcohol. To ensure that the reported concentration is as least as high as the true concentration, with a 99% safety level, safety margins had to be calculated for each of the substances. Diazepam, tetrahydrocannabinol (THC) and alcohol were used as model substances to establish a new model for estimating the safety margins. The model was compared with a previous used model established several years ago, by a similar yet much simpler model, and they were found to be in agreement. The measurement uncertainties depend on the standard batch used, the work list and the measurements' replicate. A Bayesian modelling approach was used to determine the parameters in the model, using a dataset of 4700 diazepam positive specimens and 5400 THC positive specimens. Different safety margins were considered for low and high concentration levels of diazepam (≤2μM (0.6mg/L) and >2μM) and THC (≤0.01μM (0.003mg/L) and >0.01μM). The safety margins were for diazepam 19.5% (≤2μM) and 34% (>2μM), for THC 19.5% (≤0.01μM) and 24.9% (>0.01μM). Concentration dependent safety margins for BAC were based on a dataset of 29500 alcohol positive specimens, and were in the range 10.4% (0.1g/kg) to 4.0% (4.0g/kg) at a 99% safety level. A simplified approach was used to establish safety margins for the compounds amphetamine, MDMA, methamphetamine, alprazolam, phenazepam, flunitrazepam, clonazepam, nitrazepam, oxazepam, buprenorphine, GHB, methadone, ketamine, cocaine, morphine, zolpidem and zopiclone. The

[Cyclooxygenase inhibitors and antiplatelet effect of acetylsalicylic acid. selective approach to nonsteroidal anti-inflammatory drugs in cardiological practice].

Science.gov (United States)

Lomakin, N V; Gruzdev, A K

2011-01-01

Nonsteroidal anti-inflammatory drugs (NSAIDs) represent class of medicines which is wide concerning chemical structure and mechanism of action. In the light of contradictory data on efficacy and safety of NSAID in cardiovascular patients selection of most appropriate NSAID (basing on profile of efficacy and safety) in patients receiving continuous therapy with low dose aspirin appears to be a problem. In this paper we discuss peculiarities of drug interaction between cyclooxygenase inhibitors and acetylsalicylic acid, and principles of selection of adequate NSAI.

The home electronic media environment and parental safety concerns: relationships with outdoor time after school and over the weekend among 9-11 year old children.

Science.gov (United States)

Wilkie, Hannah J; Standage, Martyn; Gillison, Fiona B; Cumming, Sean P; Katzmarzyk, Peter T

2018-04-05

Time spent outdoors is associated with higher physical activity levels among children, yet it may be threatened by parental safety concerns and the attraction of indoor sedentary pursuits. The purpose of this study was to explore the relationships between these factors and outdoor time during children's discretionary periods (i.e., after school and over the weekend). Data from 462 children aged 9-11 years old were analysed using generalised linear mixed models. The odds of spending > 1 h outdoors after school, and > 2 h outdoors on a weekend were computed, according to demographic variables, screen-based behaviours, media access, and parental safety concerns. Interactions with sex and socioeconomic status (SES) were explored. Boys, low SES participants, and children who played on their computer for  1 h outside after school than girls, high SES children and those playing on a computer for ≥2 h, respectively. Counterintuitive results were found for access to media devices and crime-related safety concerns as both of these were positively associated with time spent outdoors after school. A significant interaction for traffic-related concerns*sex was found; higher road safety concerns were associated with lower odds of outdoor time after school in boys only. Age was associated with weekend outdoor time, which interacted with sex and SES; older children were more likely to spend > 2 h outside on weekends but this was only significant among girls and high SES participants. Our results suggest that specific groups of children are less likely to spend their free time outside, and it would seem that only prolonged recreational computer use has a negative association with children's outdoor time after school. Further research is needed to explore potential underlying mechanisms, and parental safety concerns in more detail.

Dabigatran – an exemplar case history demonstrating the need for comprehensive models to optimise the use of new drugs

Directory of Open Access Journals (Sweden)

Brian eGodman

2014-06-01

Full Text Available Background: There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are effectiveness, safety and/ or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular atrial fibrillation (AF, exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies showed dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. These concerns resulted in extensive activities pre- to post-launch to manage its introduction. Objective: To (i review authority activities across countries, (ii use the findings to develop new models to better manage the entry of new drugs, and (iii review the implications based on post-launch activities. Methodology: (i Descriptive review and appraisal of activities regarding dabigatran, (ii development of guidance for key stakeholder groups through an iterative process, (iii refining guidance following post launch studies. Results: Plethora of activities to manage dabigatran including extensive pre-launch activities, risk sharing arrangements, prescribing restrictions and monitoring of prescribing post launch. Reimbursement has been denied in some countries due to concerns with its budget impact and/or excessive bleeding. Development of a new model and future guidance is proposed to better manage the entry of new drugs, centring on three pillars of pre-, peri- and post-launch activities. Post-launch activities include increasing use of patient registries to monitor the safety and effectiveness of new drugs in clinical practice. Conclusion: Models for introducing new drugs are essential to optimise their prescribing especially where concerns. Without such models, new drugs may be withdrawn prematurely and/ or struggle for

Novel engineered systems for oral, mucosal and transdermal drug delivery.

Science.gov (United States)

Li, Hairui; Yu, Yuan; Faraji Dana, Sara; Li, Bo; Lee, Chi-Ying; Kang, Lifeng

2013-08-01

Technological advances in drug discovery have resulted in increasing number of molecules including proteins and peptides as drug candidates. However, how to deliver drugs with satisfactory therapeutic effect, minimal side effects and increased patient compliance is a question posted before researchers, especially for those drugs with poor solubility, large molecular weight or instability. Microfabrication technology, polymer science and bioconjugate chemistry combine to address these problems and generate a number of novel engineered drug delivery systems. Injection routes usually have poor patient compliance due to their invasive nature and potential safety concerns over needle reuse. The alternative non-invasive routes, such as oral, mucosal (pulmonary, nasal, ocular, buccal, rectal, vaginal), and transdermal drug delivery have thus attracted many attentions. Here, we review the applications of the novel engineered systems for oral, mucosal and transdermal drug delivery.

College Rampage Renews School Safety Concerns

Science.gov (United States)

Maxwell, Lesli A.

2007-01-01

Coming just four days before the anniversary of the Columbine school shootings, the mass slayings by a student gunman at Virginia Polytechnic Institute last week revived vexing questions and raised familiar fears for educators across the country who grapple daily with ensuring the safety of their students and staffs. The April 16 killings provoked…

Optimization of Drug Delivery by Drug-Eluting Stents.

Directory of Open Access Journals (Sweden)

Franz Bozsak

Full Text Available Drug-eluting stents (DES, which release anti-proliferative drugs into the arterial wall in a controlled manner, have drastically reduced the rate of in-stent restenosis and revolutionized the treatment of atherosclerosis. However, late stent thrombosis remains a safety concern in DES, mainly due to delayed healing of the endothelial wound inflicted during DES implantation. We present a framework to optimize DES design such that restenosis is inhibited without affecting the endothelial healing process. To this end, we have developed a computational model of fluid flow and drug transport in stented arteries and have used this model to establish a metric for quantifying DES performance. The model takes into account the multi-layered structure of the arterial wall and incorporates a reversible binding model to describe drug interaction with the cells of the arterial wall. The model is coupled to a novel optimization algorithm that allows identification of optimal DES designs. We show that optimizing the period of drug release from DES and the initial drug concentration within the coating has a drastic effect on DES performance. Paclitaxel-eluting stents perform optimally by releasing their drug either very rapidly (within a few hours or very slowly (over periods of several months up to one year at concentrations considerably lower than current DES. In contrast, sirolimus-eluting stents perform optimally only when drug release is slow. The results offer explanations for recent trends in the development of DES and demonstrate the potential for large improvements in DES design relative to the current state of commercial devices.

Long-Term Safety of Drug-Eluting and Bare-Metal Stents

DEFF Research Database (Denmark)

Palmerini, Tullio; Benedetto, Umberto; Biondi-Zoccai, Giuseppe

2015-01-01

BACKGROUND: Previous meta-analyses have investigated the relative safety and efficacy profiles of different types of drug-eluting stents (DES) and bare-metal stents (BMS); however, most prior trials in these meta-analyses reported follow-up to only 1 year, and as such, the relative long-term safety....... RESULTS: Fifty-one trials that included a total of 52,158 randomized patients with follow-up duration ≥3 years were analyzed. At a median follow-up of 3.8 years, cobalt-chromium everolimus-eluting stents (EES) were associated with lower rates of mortality, definite stent thrombosis (ST), and myocardial...... infarction than BMS, paclitaxel-eluting stents (PES), and sirolimus-eluting stents (SES) and less ST than BES. Phosphorylcholine-based zotarolimus-eluting stents had lower rates of definite ST than SES and lower rates of myocardial infarction than BMS and PES. The late rates of target...

A rural/urban comparison of privacy and confidentiality concerns associated with providing sensitive location information in epidemiologic research involving persons who use drugs.

Science.gov (United States)

Rudolph, Abby E; Young, April M; Havens, Jennifer R

2017-11-01

Analyses that link contextual factors with individual-level data can improve our understanding of the "risk environment"; however, the accuracy of information provided by participants about locations where illegal/stigmatized behaviors occur may be influenced by privacy/confidentiality concerns that may vary by setting and/or data collection approach. We recruited thirty-five persons who use drugs from a rural Appalachian town and a Mid-Atlantic city to participate in in-depth interviews. Through thematic analyses, we identified and compared privacy/confidentiality concerns associated with two survey methods that (1) collect self-reported addresses/cross-streets and (2) use an interactive web-based map to find/confirm locations in rural and urban settings. Concerns differed more by setting than between methods. For example, (1) rural participants valued interviewer rapport and protections provided by the Certificate of Confidentiality more; (2) locations considered to be sensitive differed in rural (i.e., others' homes) and urban (i.e., where drugs were used) settings; and (3) urban participants were more likely to view providing cross-streets as an acceptable alternative to providing exact addresses for sensitive locations and to prefer the web-based map approach. Rural-urban differences in privacy/confidentiality concerns reflect contextual differences (i.e., where drugs are used/purchased, population density, and prior drug-related arrests). Strategies to alleviate concerns include: (1) obtain a Certificate of Confidentiality, (2) collect geographic data at the scale necessary for proposed analyses, and (3) permit participants to provide intersections/landmarks in close proximity to actual locations rather than exact addresses or to skip questions where providing an intersection/landmark would not obfuscate the actual address. Copyright © 2017 Elsevier Ltd. All rights reserved.

Development of the international status of science and technology concerning methods and tools for operational and long-term safety cases

International Nuclear Information System (INIS)

Seher, Holger; Beuth, Thomas; Bracke, Guido; Kock, Ingo; Mayer, Kim-Marisa; Moog, Helge C.; Uhlmann, Stephan; Weyand, Torben

2016-09-01

The project ''development of the international status of science and technology concerning methods and tools for operational and long-term safety cases'' covers the following key aspects: global aspects of the methodology for scenario assumption for the operational phase following closure, potential analysis of the derives safety cases for the project Gorleben, determination of the solid phase composition of high-level radioactive wastes using geochemical modeling calculations, search for an adequate approach for the calculation of density and viscosity of saline solutions for the future use in GRS computer codes, international approaches for an integral analysis for the host rocks clay and granite in relation to the safety requirements of BMUB.

Posiva's application for a decision in principle concerning a disposal facility for spent nuclear fuel. STUK's statement and preliminary safety appraisal

Energy Technology Data Exchange (ETDEWEB)

Ruokola, E. [ed.

2000-03-01

In May 1999, Posiva Ltd submitted to the Government an application, pursuant to the Nuclear Energy Act, for a Decision in Principle on a disposal facility for spent nuclear fuel from the Finnish nuclear power plants. The Ministry of Trade and Industry requested the Radiation and Nuclear Safety Authority (STUK) to draw up a preliminary safety appraisal concerning the proposed disposal facility. In the beginning of this report, STUK's statement to the Ministry and Industry concerning the proposed disposal facility is given. In that statement, STUK concludes that the Decision in Principle is currently justified from the standpoint of safety. The statement is followed by a safety appraisal, where STUK deems, how the proposed disposal concept, site and facility comply with the safety requirements included in the Government's Decision (478/1999). STUK's preliminary safety appraisal was supported by contributions from a number of outside experts. A collective opinion by an international group of ten distinguished experts is appended to this report. (orig.)

Addiction and Women Gender Differences Concerning Drug Abuse and its Treatment

Directory of Open Access Journals (Sweden)

Fatemeh Safari

2003-05-01

Full Text Available This article focuses on the quantitative grounds for the emergence and spread of addiction among women, its medical, social and psychological problems, impediments for the treatment of addiction among women as well as gender differences concerning drug abuse and its treatment. This article is a translation of a statistical research on addiction among women and a number of other researches. Based on conclusions drawn from the said researches, women become inclined to addiction mostly by their husbands due to their cordial relationships. Moreover, the negative attitudes of peer groups can overshadow girls and women more than boys and men. From the viewpoint of psychological disorders, the relationship between disorders resulting from psychological pressure after an incident and addiction is stronger among girls and women compared to boys and men. Addiction among women in addition to certain ailments such as malnutrition, hypertension and cancer, can expose them to dangerous diseases such as Hepatitis and AIDS. There is more possibility for addicted women to be infected with AIDS and other sexually transmitted diseases compared to men and they are more exposed to female ailments compared to other women. As far as treatment impediments are concerned, women face a greater social stigma due to their addiction compared to men. Social approach considering addicted women as an indecent person is a major impediment for their treatment. Taking care of the child is also another obstacle for their treatment. There is less possibility for women to receive support from their families for quitting their addiction compared to men. Treatment programs also unwantedly may create obstacles for the treatment of women such as financial constraints, administrative bureaucracy, concentration of treatment programs for men and lack of sensitivity towards women’s addiction. The psychological impediments to treatment include internalizing the notion that addiction is a

India's power program and its concern over environmental safety

International Nuclear Information System (INIS)

Prasad, G.E.; Mittra, J.

2001-01-01

India's need of electrical power is enormous and per capita consumption of power is to be increased at least by ten times to reach the level of world average. Thermal Power generation faces two fold problems. First, there is scarcity of good quality fuel and second, increasing environmental pollution. India's self reliant, three stage, 'closed-fuel-cycle' nuclear power program is promising better solution to the above problems. To ensure Radiation Protection and Safety of Radiation Sources, Indian Nuclear Power program emphasizes upon design and engineering safety by incorporating necessary safety features in the design, operational safety through structured training program and typically through software packages to handle rare unsafe events and regulation by complying safety directives. A health survey among the radiation workers indicates that there is no extra threat to the public from nuclear power program. Based on latest technology, as available in case of nuclear power option, it is quite possible to meet high energy requirement with least impact on the environment.. (authors)

Impact of Robotic Antineoplastic Preparation on Safety, Workflow, and Costs

Science.gov (United States)

Seger, Andrew C.; Churchill, William W.; Keohane, Carol A.; Belisle, Caryn D.; Wong, Stephanie T.; Sylvester, Katelyn W.; Chesnick, Megan A.; Burdick, Elisabeth; Wien, Matt F.; Cotugno, Michael C.; Bates, David W.; Rothschild, Jeffrey M.

2012-01-01

Purpose: Antineoplastic preparation presents unique safety concerns and consumes significant pharmacy staff time and costs. Robotic antineoplastic and adjuvant medication compounding may provide incremental safety and efficiency advantages compared with standard pharmacy practices. Methods: We conducted a direct observation trial in an academic medical center pharmacy to compare the effects of usual/manual antineoplastic and adjuvant drug preparation (baseline period) with robotic preparation (intervention period). The primary outcomes were serious medication errors and staff safety events with the potential for harm of patients and staff, respectively. Secondary outcomes included medication accuracy determined by gravimetric techniques, medication preparation time, and the costs of both ancillary materials used during drug preparation and personnel time. Results: Among 1,421 and 972 observed medication preparations, we found nine (0.7%) and seven (0.7%) serious medication errors (P = .8) and 73 (5.1%) and 28 (2.9%) staff safety events (P = .007) in the baseline and intervention periods, respectively. Drugs failed accuracy measurements in 12.5% (23 of 184) and 0.9% (one of 110) of preparations in the baseline and intervention periods, respectively (P < .001). Mean drug preparation time increased by 47% when using the robot (P = .009). Labor costs were similar in both study periods, although the ancillary material costs decreased by 56% in the intervention period (P < .001). Conclusion: Although robotically prepared antineoplastic and adjuvant medications did not reduce serious medication errors, both staff safety and accuracy of medication preparation were improved significantly. Future studies are necessary to address the overall cost effectiveness of these robotic implementations. PMID:23598843

Prediction of Clinically Relevant Safety Signals of Nephrotoxicity through Plasma Metabolite Profiling

Directory of Open Access Journals (Sweden)

W. B. Mattes

2013-01-01

Full Text Available Addressing safety concerns such as drug-induced kidney injury (DIKI early in the drug pharmaceutical development process ensures both patient safety and efficient clinical development. We describe a unique adjunct to standard safety assessment wherein the metabolite profile of treated animals is compared with the MetaMap Tox metabolomics database in order to predict the potential for a wide variety of adverse events, including DIKI. To examine this approach, a study of five compounds (phenytoin, cyclosporin A, doxorubicin, captopril, and lisinopril was initiated by the Technology Evaluation Consortium under the auspices of the Drug Safety Executive Council (DSEC. The metabolite profiles for rats treated with these compounds matched established reference patterns in the MetaMap Tox metabolomics database indicative of each compound’s well-described clinical toxicities. For example, the DIKI associated with cyclosporine A and doxorubicin was correctly predicted by metabolite profiling, while no evidence for DIKI was found for phenytoin, consistent with its clinical picture. In some cases the clinical toxicity (hepatotoxicity, not generally seen in animal studies, was detected with MetaMap Tox. Thus metabolite profiling coupled with the MetaMap Tox metabolomics database offers a unique and powerful approach for augmenting safety assessment and avoiding clinical adverse events such as DIKI.

Surveys of research projects concerning nuclear facility safety, financed by the Federal Ministry of the Interior

International Nuclear Information System (INIS)

1986-05-01

Each progress report is a collection of individual reports, categorized by subject matter. They are a documentation of the contractor's progress, rendered by themselves on standardized forms, published, for the sake of general information on progress made in investigations concerning reactor safety, by the project attendance department of the GRS. The individual reports have serial numbers. Each report includes particulars of the objective, work carried out, results obtained and plans for project continuation. (orig./HP) [de

Suspected adverse drug reactions in elderly patients reported to the Committee on Safety of Medicines.

Science.gov (United States)

Castleden, C M; Pickles, H

1988-10-01

1. Spontaneous reports of suspected adverse drug reactions (ADRs) reported to the Committee on Safety of Medicines (CSM) have been studied in relation to patient age. 2. The proportion of reports received for the elderly increased between 1965 and 1983. 3. There was a correlation between the use of drugs and the number of ADR reports. Thus age-related prescription figures for two non-steroidal anti-inflammatory drugs (NSAI) and co-trimoxazole matched ADR reports for each drug in each age group. 4. The reported ADR was more likely to be serious or fatal in the elderly. 5. The commonest ADRs reported for the elderly affected the gastrointestinal (GIT) and haemopoietic systems, where more reports were received than would be expected from prescription figures. 6. The drug suspected of causing a GIT reaction was a NSAI in 75% of the reports. 7. Ninety-one per cent of fatal reports of GIT bleeds and perforations associated with NSAI drugs were in patients over 60 years of age.

Safety and effectiveness of 24-week treatment with iguratimod, a new oral disease-modifying antirheumatic drug, for patients with rheumatoid arthritis: interim analysis of a post-marketing surveillance study of 2679 patients in Japan.

Science.gov (United States)

Mimori, Tsuneyo; Harigai, Masayoshi; Atsumi, Tatsuya; Fujii, Takao; Kuwana, Masataka; Matsuno, Hiroaki; Momohara, Shigeki; Takei, Syuji; Tamura, Naoto; Takasaki, Yoshinari; Ikeuchi, Satoshi; Kushimoto, Satoru; Koike, Takao

2017-09-01

To determine the real-world safety and effectiveness of iguratimod (IGU) for rheumatoid arthritis (RA), a 52-week, Japanese, post-marketing surveillance study was conducted. An interim analysis at week 24 was performed. This study included all RA patients who received IGU following its introduction to the market. All adverse events (AEs) and adverse drug reactions (ADRs) were collected. Effectiveness was evaluated by the change in Disease Activity Score 28-C-reactive protein (DAS28-CRP) from baseline to week 24. Safety was analyzed in 2679 patients. The overall incidences of AEs, ADRs, and serious ADRs were 38.41, 31.65, and 3.21%, respectively; the most commonly reported serious ADRs were pneumonia/bacterial pneumonia, interstitial lung disease, and Pneumocystis jiroveci pneumonia. Concomitant glucocorticoid use and comorbid conditions associated with respiratory disease were identified as risk factors for serious infections. Pulmonary alveolar hemorrhage and increased international normalized ratio of prothrombin time were observed with concomitant use of IGU and warfarin. The DAS28-CRP decreased from baseline to week 24. Although a safety concern was identified with concomitant use of IGU and warfarin, this real-world study showed no other new safety concerns and similar effectiveness to clinical trials. IGU is a new therapeutic option for RA patients.

A safety concern related to CANDU moderator subcooling and status of KAERI moderator circulation test (MCT) experiments

International Nuclear Information System (INIS)

Rhee, Bo W.; Kim, Hyoung T.; Kim, Tongbeum; Im, Sunghyuk

2015-01-01

The flow inside the moderator tank of a CANDU-6 reactor during full power steady state operation has been suspected to be operating in the buoyancy/inertial driven mixed convection regime as illustrated in the middle figure. At some regions of the moderator tank where the buoyancy driven upward flow and the inertial momentum driven downward flows interface counter-currently, there exist some interface regions between these two flows like the middle one, and the local temperatures at these interface regions are known to oscillate with different amplitude at various fluctuation frequencies as shown. According to a numerical simulation of the moderator flow and temperature distribution at full power steady state carried out by previous researches showed that any small disturbances in the flow or temperature may initiate the system unstable and aggravate the asymmetric flow and temperature patterns. The tests at the 3-D Moderator Test Facility (MTF) that is a representative scaled-down of CANDU reactors, reproduced the expected and observed moderator behavior in the reactor as well as the local temperature fluctuations arising from the delicate balance of forced and buoyancy induced flow. This observation raised a safety concern as the local moderator temperature at some regions showed fluctuations with an amplitude that may jeopardize the safety margin, i.e. the difference between the available subcooling and the subcooling requirement. The scope of this paper is to review the basis of the safety concern related to this moderator subcooling and local temperature fluctuation and describe the current status of MCT erection and some of the experiments carried so far

Institutional ethical review and ethnographic research involving injection drug users: a case study.

Science.gov (United States)

Small, Will; Maher, Lisa; Kerr, Thomas

2014-03-01

Ethnographic research among people who inject drugs (PWID) involves complex ethical issues. While ethical review frameworks have been critiqued by social scientists, there is a lack of social science research examining institutional ethical review processes, particularly in relation to ethnographic work. This case study describes the institutional ethical review of an ethnographic research project using observational fieldwork and in-depth interviews to examine injection drug use. The review process and the salient concerns of the review committee are recounted, and the investigators' responses to the committee's concerns and requests are described to illustrate how key issues were resolved. The review committee expressed concerns regarding researcher safety when conducting fieldwork, and the investigators were asked to liaise with the police regarding the proposed research. An ongoing dialogue with the institutional review committee regarding researcher safety and autonomy from police involvement, as well as formal consultation with a local drug user group and solicitation of opinions from external experts, helped to resolve these issues. This case study suggests that ethical review processes can be particularly challenging for ethnographic projects focused on illegal behaviours, and that while some challenges could be mediated by modifying existing ethical review procedures, there is a need for legislation that provides legal protection of research data and participant confidentiality. Copyright © 2013 Elsevier Ltd. All rights reserved.

India's power programs and its concern over environmental safety

International Nuclear Information System (INIS)

Prasad, G.E.; Mittra, J.; Sarma, M.S.R.

2000-01-01

India's need for electrical power is enormous and per capita consumption of power is to be increased at least by 10 times to reach the level of the world average. Thermal power generation faces two-fold problems. First, there is scarcity of good quality fuel and second, increasing environmental pollution. India 's self reliant, . three stage, 'closed-fuel-cycle' nuclear power program is promising a better solution to the above problems. To ensure Radiation Protection and Safety of Radiation Sources, the Indian Nuclear Power program emphasizes upon design and engineering safety by incorporating' necessary safety features in the design, operational safety through a structured training program and typically through software packages to handle rare unsafe events and regulation by complying safety directives. A health survey among the radiation workers indicates that there is no extra threat to the public from the nuclear power program. Based on the latest technology, as available in case of the nuclear power option, it is quite possible to meet high energy requirements with least impact on the environment. (authors)

in OECD countries concerning biological drugs

African Journals Online (AJOL)

Jane

2011-08-22

Aug 22, 2011 ... the pharmaceutical sector about biological drugs come under the umbrella of innovation system of each country. ... The cost of biotechnology R and D within public research centres and ... Existence of a suitable system to protect intellectual property ... biotechnology that provide the capital for industry and.

Cardiovascular safety of non-steroidal anti-inflammatory drugs: network meta-analysis.

Science.gov (United States)

Trelle, Sven; Reichenbach, Stephan; Wandel, Simon; Hildebrand, Pius; Tschannen, Beatrice; Villiger, Peter M; Egger, Matthias; Jüni, Peter

2011-01-11

To analyse the available evidence on cardiovascular safety of non-steroidal anti-inflammatory drugs. Network meta-analysis. Bibliographic databases, conference proceedings, study registers, the Food and Drug Administration website, reference lists of relevant articles, and reports citing relevant articles through the Science Citation Index (last update July 2009). Manufacturers of celecoxib and lumiracoxib provided additional data. All large scale randomised controlled trials comparing any non-steroidal anti-inflammatory drug with other non-steroidal anti-inflammatory drugs or placebo. Two investigators independently assessed eligibility. The primary outcome was myocardial infarction. Secondary outcomes included stroke, death from cardiovascular disease, and death from any cause. Two investigators independently extracted data. 31 trials in 116 429 patients with more than 115 000 patient years of follow-up were included. Patients were allocated to naproxen, ibuprofen, diclofenac, celecoxib, etoricoxib, rofecoxib, lumiracoxib, or placebo. Compared with placebo, rofecoxib was associated with the highest risk of myocardial infarction (rate ratio 2.12, 95% credibility interval 1.26 to 3.56), followed by lumiracoxib (2.00, 0.71 to 6.21). Ibuprofen was associated with the highest risk of stroke (3.36, 1.00 to 11.6), followed by diclofenac (2.86, 1.09 to 8.36). Etoricoxib (4.07, 1.23 to 15.7) and diclofenac (3.98, 1.48 to 12.7) were associated with the highest risk of cardiovascular death. Although uncertainty remains, little evidence exists to suggest that any of the investigated drugs are safe in cardiovascular terms. Naproxen seemed least harmful. Cardiovascular risk needs to be taken into account when prescribing any non-steroidal anti-inflammatory drug.

[Drug supply chain safety in hospitals: current data and experience of the Grenoble university hospital].

Science.gov (United States)

Bedouch, P; Baudrant, M; Detavernier, M; Rey, C; Brudieu, E; Foroni, L; Allenet, B; Calop, J

2009-01-01

Drug supply chain safety has become a priority for public health which implies a collective process. This process associates all health professionals including the pharmacist who plays a major role. The objective of this present paper is to describe the several approaches proven effective in the reduction of drug-related problem in hospital, illustrated by the Grenoble University Hospital experience. The pharmacist gets involved first in the general strategy of hospital drug supply chain, second by his direct implication in clinical activities. The general strategy of drug supply chain combines risk management, coordination of the Pharmacy and Therapeutics Committee, selection and purchase of drugs and organisation of drug supply chain. Computer management of drug supply chain is a major evolution. Nominative drug delivering has to be a prior objective and its implementation modalities have to be defined: centralized or decentralized in wards, manual or automated. Also, new technologies allow the automation of overall drug distribution from central pharmacy and the implementation of automated drug dispensing systems into wards. The development of centralised drug preparation allows a safe compounding of high risk drugs, like cytotoxic drugs. The pharmacist should develop his clinical activities with patients and other health care professionals in order to optimise clinical decisions (medication review, drug order analysis) and patients follow-up (therapeutic monitoring, patient education, discharge consultation).

Indicators of club management practices and biological measurements of patrons' drug and alcohol use.

Science.gov (United States)

Byrnes, Hilary F; Miller, Brenda A; Johnson, Mark B; Voas, Robert B

2014-12-01

Electronic music and dance events in nightclubs attract patrons with heavy alcohol/drug use. Public health concerns are raised from risks related to these behaviors. Practices associated with increased risk in these club settings need to be identified. The relationship between club management practices and biological measures of patrons' alcohol/drug use is examined. Observational data from 25 events across six urban clubs were integrated with survey data (N = 738 patrons, 42.8% female) from patrons exiting these events, 2010-2012. Five indicators of club management practices were examined using mixed model regressions: club security, bar crowding, safety signs, serving intoxicated patrons, and isolation. Analyses revealed that serving intoxicated patrons and safety signs were related to substance use. Specifically, serving intoxicated patrons was related to heavy alcohol and drug use at exit, while safety signs were marginally related to less exit drug use. CONCLUSIONS/IMPORTANCE: Findings indicate observable measures in nightclubs provide important indicators for alcohol/drug use, suggesting practices to target. Study strengths include the use of biological measures of substance use on a relatively large scale. Limitations and future directions are discussed.

Identification of UV-absorbing extractables from rubber closures used in containers of injectable powder and safety assessment of leachables in the drug.

Science.gov (United States)

Wei, Yulei; Wu, Ying; Zhu, Tingli; Li, Zhiyan; Zhang, Yilan

2017-05-10

Rubber closures have been of great concern to regulatory authorities on account of their potential safety risks to patients. The aim of our work is to provide part of data about the compatibility of the injectable powder and its packaging materials for the drug registration. In this report, methodologies were established to study the system of the preparation. Firstly, three major extractables were isolated by semi-preparative HPLC method combined with silica gel-based chromatographic methods. NMR spectra including 1D NMR ( 1 H, 13 C, DEPT135) and 2D NMR (COSY, HSQC, HMBC) were introduced to identify the extractables, besides HPLC, GC-MS, ESI-MS/MS and HRMS. The extractables were determined to be N-(2-(2,2,4,4-tetramethylcyclohexyl)allyl) benzo[d]thiazol-2-amine (1), 2,6-Di-tert-butyl-4-methylphenol (2) and sulfur (3) respectively. Then, to address safety concerns, approaches including QSAR analysis, the TTC and comprehensive literature evaluation methods to toxicological safety evaluation of the target compounds were established, where the safety threshold such as TTC and PDE values were developed. Finally, the migration testing of the extractables were performed to assess the leaching behavior of the rubber closures. An optimized analysis method was proposed using SPE and HPLC with an ultraviolet detector, which demonstrated good linearity, acceptable accuracy and precision. The levels of the target compounds in the powder were measured and the calculated worst case exposure of extractable 2 exceeded the TTC limit of 1.5μg/day, indicating that the products may possess potential health risks to patients. In contrast to previous studies, various NMR techniques, which were rarely applied to identify unknown extractables from rubber closures in the literature, were discussed for the structural elucidation of rubber closures extractables. Among the target compounds, extractable 1 was a new compound, whose isolation and structural elucidation were first reported here

Drug safety evaluation of defibrotide.

Science.gov (United States)

Richardson, Paul G; Corbacioglu, Selim; Ho, Vincent Trien-Vinh; Kernan, Nancy A; Lehmann, Leslie; Maguire, Craig; Maglio, Michelle; Hoyle, Margaret; Sardella, Marco; Giralt, Sergio; Holler, Ernst; Carreras, Enric; Niederwieser, Dietger; Soiffer, Robert

2013-01-01

Hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), is a potentially life-threatening complication of chemotherapeutic conditioning used in preparation for hematopoietic stem-cell transplantation (SCT). Defibrotide (DF) has been shown in Phase II and III trials to improve complete response in patients with severe VOD (sVOD). None of the articles, to date, provide a comprehensive review of the safety of DF in VOD and/or a range of other conditions. This article reviews current clinical findings on DF, primarily in terms of safety for use in treatment and prophylaxis of VOD, and relevant safety data for its use in other diseases. The literature review was conducted using a PubMed search with the fixed term 'defibrotide' in combination with ≥ 1 of 'safety', 'veno-occlusive disease' (with and without 'treatment', 'prevention'), 'oncology', 'myeloma', 'microangiopathy', 'anti-thrombotic' and 'peripheral vascular disorder'. Related articles from the EBMT and ASH conference websites were also included. DF was well tolerated in majority of the studies. The safety profile of DF is largely favourable with toxicities comparable to control populations in the setting of SCT complicated by sVOD.

Safety and effectiveness of drug therapy for the acutely agitated patient (Part 2

Directory of Open Access Journals (Sweden)

Gianluca Airoldi

2013-04-01

Full Text Available Acute agitation occurs in a variety of medical and psychiatric conditions, and the management of agitated, abusive, or violent patients is a common problem in the emergency department. Rapid control of potentially dangerous behaviors by physical restraint and pharmacologic tranquillization is crucial to ensure the safety of the patient and health-care personnel and to allow diagnostic procedures and treatment of the underlying condition. The purpose of this article (the second in a 2-part series is to review published data on the efficacy and safety of antipsychotic medications currently available for managing situations of this type. Arrhythmias caused by QT-prolonging drugs occur infrequently, and multiple factors are often involved, including concomitant use of other drugs affecting the same pathway (most antipsychotic drugs prolong the QT interval by blocking potassium IKr current in HERG channels of myocardial cells, electrolyte disorders and, possibly, genetic predisposition. Judicious use of typical antipsychotics (mainly haloperidol and benzodiazepines (mainly lorazepam, given intramuscularly alone or in combination, has proved to be safe and effective for controlling acute motor agitation related to psychiatric illness; cocaine, methamphetamine, and ethanol toxicity; ethanol withdrawal; and other factors. They are still widely used and are particularly useful when limited data are available on the patient’s history of cardiovascular disease, current use of medication, and/or the likelihood of illicit drug or alcohol intoxication; when the diagnosis involves medical comorbidity or intoxication; or when there is no specific treatment (e.g., personality disorders, learning disabilities, mental retardation, organic brain damage. If rapid tranquillization is necessary before a formal diagnosis can be made and there are uncertainties regarding the patient’s medical history, lorazepam is often considered the first-line drug of choice. In

Why consumers behave as they do with respect to food safety and risk information

NARCIS (Netherlands)

Verbeke, W.; Frewer, L.J.; Scholderer, J.; Brabander, de H.F.

2007-01-01

In recent years, it seems that consumers are generally uncertain about the safety and quality of their food and their risk perception differs substantially from that of experts. Hormone and veterinary drug residues in meat persist to occupy a high position in European consumers¿ food concern

Food Safety Concerns and other Factors Affecting Iran’s Pistachio Exports to EU, Australia, and Japan

OpenAIRE

Ashktorab, Niloofar; Saghaian, Sayed Hossein; Shahnoushi, Naser

2013-01-01

In this paper, the impact of food safety concerns on Iran’s pistachio export demand was investigated. Panel data and panel cointegration analyses were used to estimate the export demand function of Iran’s pistachio nuts to the European Union (EU), Japan, and Australia for the period of 1997 to 2006 so that the relationship between factors affecting Iran’s pistachio exports can be examined. The results show the existence of long-run relationships among the variables that have a significant imp...

Progress report concerning safety research for nuclear reactor facilities

International Nuclear Information System (INIS)

1978-01-01

Examination and evaluation of safety research results for nuclear reactor facilities have been performed, as more than a year has elapsed since the plan had been initiated in April, 1976, by the special sub-committee for the safety of nuclear reactor facilities. The research is carried out by being divided roughly into 7 items, and seems to be steadily proceeding, though it does not yet reach the target. The above 7 items include researches for (1) criticality accident, (2) loss of coolant accident, (3) safety for light water reactor fuel, (4) construction safety for reactor facilities, (5) reduction of release of radioactive material, (6) safety evaluation based on the probability theory for reactor facilities, and (7) aseismatic measures for reactor facilities. With discussions on the progress and the results of the research this time, research on the behaviour on fuel in abnormal transients including in-core and out-core experiments has been added to the third item, deleting the power-cooling mismatch experiment in Nuclear Safety Research Reactor of JAERI. Also it has been decided to add two research to the seventh item, namely measured data collection, classification and analysis, and probability assessment of failures due to an earthquake. For these 7 items, the report describes the concrete contents of research to be performed in fiscal years of 1977 and 1978, by discussing on most rational and suitable contents conceivable at present. (Wakatsuki, Y.)

Food irradiation: benefits and concerns

International Nuclear Information System (INIS)

Thayer, D.W.

1990-01-01

The benefits and concerns about treating foods with ionizing radiation are reviewed. Radioactivity cannot be induced in foods by treatment with gamma rays from 137 Cs or 60 Co, X-ray sources of 5 MeV or lower energy, or electrons of 10 MeV or lower energy. The evidence supports the safety and efficacy of using ionizing radiation for insect disinfestation of grains; dried spices, vegetables and fruits; and fresh fruit. Species and dose dependent phytotoxic and vitamin changes may occur in some fruits at greater doses than currently approved by the U.S. Food and Drug Administration. Irradiation can inactivate protozoan or helminth parasites and significantly decrease the probability of viable food-borne bacterial pathogens in fish, poultry, and red meats. The titers of amino acids, fatty acids, and vitamins of chicken meat sterilized by thermal, electron-beam, or gamma radiation are presented. On the whole, the data support the safely and efficacy of the process

Epigenetics and cancer: implications for drug discovery and safety assessment

International Nuclear Information System (INIS)

Moggs, Jonathan G.; Goodman, Jay I.; Trosko, James E.; Roberts, Ruth A.

2004-01-01

It is necessary to determine whether chemicals or drugs have the potential to pose a threat to human health. Research conducted over the last two decades has led to the paradigm that chemicals can cause cancer either by damaging DNA or by altering cellular growth, probably via receptor-mediated changes in gene expression. However, recent evidence suggests that gene expression can be altered markedly via several diverse epigenetic mechanisms that can lead to permanent or reversible changes in cellular behavior. Key molecular events underlying these mechanisms include the alteration of DNA methylation and chromatin, and changes in the function of cell surface molecules. Thus, for example, DNA methyltransferase enzymes together with chromatin-associated proteins such as histone modifying enzymes and remodelling factors can modify the genetic code and contribute to the establishment and maintenance of altered epigenetic states. This is relevant to many types of toxicity including but not limited to cancer. In this paper, we describe the potential for interplay between genetic alteration and epigenetic changes in cell growth regulation and discuss the implications for drug discovery and safety assessment

Drug and alcohol task force

International Nuclear Information System (INIS)

Gordey, T.; Sunstrum, M.

2006-01-01

Worker absenteeism due to substance abuse costs the Alberta economy approximately $720 million a year. It is estimated that 20 per cent of all drivers in fatal crashes were using alcohol, and the use of cannabis and cocaine in Alberta has more than doubled over the last 15 years. In addition, 1 in 10 Alberta workers have reported using alcohol while at work and 4 per cent have reported using alcohol 4 hours prior to coming to work during the previous 12 months. In an effort to ensure appropriate health and safety for workers in the Canadian petroleum industry, 6 trade associations in the sector have joined together as the Enform Alcohol and Drug Initiative and are now working to develop a common approach to drug and alcohol guidelines and workplace rules. The task group will determine if existing policies and guidelines are sufficient to ensure a safe workplace and will consider standardizing the testing, application and rehabilitation of workers with respect to the use of drugs and alcohol. In the past, disciplinary actions have often been reversed because employers have not been consistent or did not follow established alcohol and drug policies or test to specific standards. Various work rules for inappropriate alcohol and drug use were reviewed, as well as education and communication strategies regarding policy content. Standards for testing criteria were discussed, as well as issues concerning duty-to-accommodate circumstances. An excerpt of concentration standards was presented. It was concluded that a matrix for companies to assess and determine safety sensitive positions is needed. refs., tabs., figs

Drug and alcohol task force

Energy Technology Data Exchange (ETDEWEB)

Gordey, T [ConocoPhillips Canada Resources Corp., Calgary, AB (Canada); Sunstrum, M [Enform, Calgary, AB (Canada)

2006-07-01

Worker absenteeism due to substance abuse costs the Alberta economy approximately $720 million a year. It is estimated that 20 per cent of all drivers in fatal crashes were using alcohol, and the use of cannabis and cocaine in Alberta has more than doubled over the last 15 years. In addition, 1 in 10 Alberta workers have reported using alcohol while at work and 4 per cent have reported using alcohol 4 hours prior to coming to work during the previous 12 months. In an effort to ensure appropriate health and safety for workers in the Canadian petroleum industry, 6 trade associations in the sector have joined together as the Enform Alcohol and Drug Initiative and are now working to develop a common approach to drug and alcohol guidelines and workplace rules. The task group will determine if existing policies and guidelines are sufficient to ensure a safe workplace and will consider standardizing the testing, application and rehabilitation of workers with respect to the use of drugs and alcohol. In the past, disciplinary actions have often been reversed because employers have not been consistent or did not follow established alcohol and drug policies or test to specific standards. Various work rules for inappropriate alcohol and drug use were reviewed, as well as education and communication strategies regarding policy content. Standards for testing criteria were discussed, as well as issues concerning duty-to-accommodate circumstances. An excerpt of concentration standards was presented. It was concluded that a matrix for companies to assess and determine safety sensitive positions is needed. refs., tabs., figs.

Predictors of Likelihood of Speaking Up about Safety Concerns in Labour and Delivery

Science.gov (United States)

Lyndon, Audrey; Sexton, J. Bryan; Simpson, Kathleen Rice; Rosenstein, Alan; Lee, Kathryn A.; Wachter, Robert M.

2011-01-01

Background Despite widespread emphasis on promoting “assertive communication” by caregivers as essential to patient safety improvement efforts, fairly little is known about when and how clinicians speak up to address safety concerns. In this cross-sectional study we use a new measure of speaking up to begin exploring this issue in maternity care. Methods We developed a scenario-based measure of clinician’s assessment of potential harm and likelihood of speaking up in response to perceived harm. We embedded this scale in a survey with measures of safety climate, teamwork climate, disruptive behaviour, work stress, and personality traits of bravery and assertiveness. The survey was distributed to all registered nurses and obstetricians practicing in two US Labour & Delivery units. Results The response rate was 54% (125 of 230 potential respondents). Respondents were experienced clinicians (13.7 ± 11 years in specialty). Higher perception of harm, respondent role, specialty experience, and site predicted likelihood of speaking up when controlling for bravery and assertiveness. Physicians rated potential harm in common clinical scenarios lower than nurses did (7.5 vs. 8.4 on 2–10 scale; p<0.001). Some participants (12%) indicated they were unlikely to speak up despite perceiving high potential for harm in certain situations. Discussion This exploratory study found nurses and physicians differed in their harm ratings, and harm rating was a predictor of speaking up. This may partially explain persistent discrepancies between physicians and nurses in teamwork climate scores. Differing assessments of potential harms inherent in everyday practice may be a target for teamwork intervention in maternity care. PMID:22927492

78 FR 10181 - Global Quality Systems-An Integrated Approach To Improving Medical Product Safety; Public Workshop

Science.gov (United States)

2013-02-13

...] Global Quality Systems--An Integrated Approach To Improving Medical Product Safety; Public Workshop... (AFDO), is announcing a public workshop entitled ``Global Quality Systems--An Integrated Approach to... topics concerning FDA requirements related to the production and marketing of drugs and/or devices...

Predictive toxicology in drug safety

National Research Council Canada - National Science Library

Xu, Jinghai J; Urban, Laszlo

2011-01-01

.... It provides information on the present knowledge of drug side effects and their mitigation strategy during drug discovery, gives guidance for risk assessment, and promotes evidence-based toxicology...

Safety of Therapeutic Fever Induction in Cancer Patients Using Approved PAMP Drugs

Directory of Open Access Journals (Sweden)

Uwe Rudolf Max Reuter

2018-04-01

Full Text Available William Coley, between 1895 and 1936, treated hundreds of cancer patients using infusions of fever inducing bacerial extracts. Similar experiments were done by Klyuyeva and co-workers in the 1940ies in Russia using trypanosoma extracts. Many remissions and cures were reported. We have conjectured that pathogen associated molecular pattern substances (PAMP are the molecular explanation for the beneficial treatments in both groups. We could show that a combination of PAMP can eradicate solid tumours in cancer mice if applied several times. Accordingly, we suggested to combine PAMP containing approved drugs to treat cancer patients using a protocol similar to the old fever induction regimen. In this retrospective phase-1 study we report on the fever induction capacity and safety of applications of bacterial extracts, combinations of bacterial extracts with approved drugs, and combinations of approved drugs in 131 mainly cancer patients. Adverse reactions were those which can be expected during a feverish infection and mild. Over 523 fever inductions, no severe adverse reaction was observed.

School climate factors contributing to student and faculty perceptions of safety in select Arizona schools.

Science.gov (United States)

Bosworth, Kris; Ford, Lysbeth; Hernandaz, Diley

2011-04-01

To ensure that schools are safe places where students can learn, researchers and educators must understand student and faculty safety concerns. This study examines student and teacher perceptions of school safety. Twenty-two focus groups with students and faculty were conducted in 11 secondary schools. Schools were selected from a stratified sample to vary in location, proximity to Indian reservations, size, and type. The data analysis was based on grounded theory. In 9 of 11 schools, neither faculty nor students voiced overwhelming concerns about safety. When asked what makes school safe, students tended to report physical security features. School climate and staff actions also increased feelings of safety. Faculty reported that relationships and climate are key factors in making schools safe. High student performance on standardized tests does not buffer students from unsafe behavior, nor does living in a dangerous neighborhood necessarily lead to more drug use or violence within school walls. School climate seemed to explain the difference between schools in which students and faculty reported higher versus lower levels of violence and alcohol and other drug use. The findings raise provocative questions about school safety and provide insight into elements that lead to perceptions of safety. Some schools have transcended issues of location and neighborhood to provide an environment perceived as safe. Further study of those schools could provide insights for policy makers, program planners, and educational leaders. © 2011, American School Health Association.

Non-clinical studies in the process of new drug development - Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies.

Science.gov (United States)

Andrade, E L; Bento, A F; Cavalli, J; Oliveira, S K; Schwanke, R C; Siqueira, J M; Freitas, C S; Marcon, R; Calixto, J B

2016-12-12

The process of drug development involves non-clinical and clinical studies. Non-clinical studies are conducted using different protocols including animal studies, which mostly follow the Good Laboratory Practice (GLP) regulations. During the early pre-clinical development process, also known as Go/No-Go decision, a drug candidate needs to pass through several steps, such as determination of drug availability (studies on pharmacokinetics), absorption, distribution, metabolism and elimination (ADME) and preliminary studies that aim to investigate the candidate safety including genotoxicity, mutagenicity, safety pharmacology and general toxicology. These preliminary studies generally do not need to comply with GLP regulations. These studies aim at investigating the drug safety to obtain the first information about its tolerability in different systems that are relevant for further decisions. There are, however, other studies that should be performed according to GLP standards and are mandatory for the safe exposure to humans, such as repeated dose toxicity, genotoxicity and safety pharmacology. These studies must be conducted before the Investigational New Drug (IND) application. The package of non-clinical studies should cover all information needed for the safe transposition of drugs from animals to humans, generally based on the non-observed adverse effect level (NOAEL) obtained from general toxicity studies. After IND approval, other GLP experiments for the evaluation of chronic toxicity, reproductive and developmental toxicity, carcinogenicity and genotoxicity, are carried out during the clinical phase of development. However, the necessity of performing such studies depends on the new drug clinical application purpose.

Exploiting heterogeneous publicly available data sources for drug safety surveillance: computational framework and case studies.

Science.gov (United States)

Koutkias, Vassilis G; Lillo-Le Louët, Agnès; Jaulent, Marie-Christine

2017-02-01

Driven by the need of pharmacovigilance centres and companies to routinely collect and review all available data about adverse drug reactions (ADRs) and adverse events of interest, we introduce and validate a computational framework exploiting dominant as well as emerging publicly available data sources for drug safety surveillance. Our approach relies on appropriate query formulation for data acquisition and subsequent filtering, transformation and joint visualization of the obtained data. We acquired data from the FDA Adverse Event Reporting System (FAERS), PubMed and Twitter. In order to assess the validity and the robustness of the approach, we elaborated on two important case studies, namely, clozapine-induced cardiomyopathy/myocarditis versus haloperidol-induced cardiomyopathy/myocarditis, and apixaban-induced cerebral hemorrhage. The analysis of the obtained data provided interesting insights (identification of potential patient and health-care professional experiences regarding ADRs in Twitter, information/arguments against an ADR existence across all sources), while illustrating the benefits (complementing data from multiple sources to strengthen/confirm evidence) and the underlying challenges (selecting search terms, data presentation) of exploiting heterogeneous information sources, thereby advocating the need for the proposed framework. This work contributes in establishing a continuous learning system for drug safety surveillance by exploiting heterogeneous publicly available data sources via appropriate support tools.

New Automated System Available for Reporting Safety Concerns | Poster

Science.gov (United States)

A new system has been developed for reporting safety issues in the workplace. The Environment, Health, and Safety’s (EHS’) Safety Inspection and Issue Management System (SIIMS) is an online resource where any employee can report a problem or issue, said Siobhan Tierney, program manager at EHS.

On the Issue of Regional Policy in the Sphere of Ecological Safety (Based on the Documents Concerning the Republic of Kalmykia

Directory of Open Access Journals (Sweden)

Elza I. Mantaeva

2018-03-01

Full Text Available The regional government should provide ecological safety in order to ensure stable social and economic development of the country. The article outlines theoretical approach and recommendations on practice concerning ecological issues, investigates state policy aiming to preserve nature and analyses sources of threat to ecological safety in the region. The modern paradigm of the country’s and region’s development is characterized by the combination of ecological and economic policy. The ecological policy providing measures for efficient use of natural resources, their protection and restoration is implemented in the economic strategy of highly developed countries and encourages stable social and economic development of the country and the region. Some researchers assert that Russia’s most regions do not possess sufficient resources necessary to implement structural shifts which can eliminate the main threats to ecological safety. The Republic of Kalmykia can be included into this list. It is rich in natural resources but they are not restored due to the lack of regulation for efficient consumption. The main concerns of the republic are water supply, desertification, and pollution of atmosphere, waste disposal, and protection of wildlife and environment, preservation of hunting ground, forest management. The republic generates no electricity so it is delivered by neighboring regions. The republic should use the renewable ways of producing energy which can contribute to the energy and ecological safety and can attract new investment funds. There is an urgent need for stricter state regulation to ensure socioeconomic development and ecological safety in Kalmykia.

78 FR 23273 - Determination That the OXYCONTIN (Oxycodone Hydrochloride) Drug Products Covered by New Drug...

Science.gov (United States)

2013-04-18

... mitigation strategy (REMS) http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationfor... Blueprint for Prescriber Education for Extended- Release and Long-Acting Opioid Analgesics'' ( http://www...

Review of the Methods to Obtain Paediatric Drug Safety Information: Spontaneous Reporting and Healthcare Databases, Active Surveillance Programmes, Systematic Reviews and Meta-analyses

Science.gov (United States)

Gentili, Marta; Pozzi, Marco; Peeters, Gabrielle; Radice, Sonia; Carnovale, Carla

2018-02-06

Knowledge of drugs safety collected during the pre-marketing phase is inevitably limited because the randomized clinical trials (RCTs) are rarely designed to evaluate safety. The small and selective groups of enrolled individuals and the limited duration of trials may hamper the ability to characterize fully the safety profiles of drugs. Additionally, information about rare adverse drug reactions (ADRs) in special groups is often incomplete or not available for most of the drugs commonly used in the daily clinical practice. In the paediatric setting several highimpact safety issues have emerged. Hence, in recent years, there has been a call for improved post-marketing pharmacoepidemiological studies, in which cohorts of patients are monitored for sufficient time in order to determine the precise risk-benefit ratio. In this review, we discuss the current available strategies enhancing the post-marketing monitoring activities of the drugs in the paediatric setting and define criteria whereby they can provide valuable information to improve the management of therapy in daily clinical practice including both safety and efficacy aspects. The strategies we cover include the signal detection using international pharmacovigilance and/or healthcare databases, the promotion of active surveillance initiatives which can generate complete, informative data sets for the signal detection and systematic review/meta-analysis. Together, these methods provide a comprehensive picture of causality and risk improving the management of therapy in a paediatric setting and they should be considered as a unique tool to be integrated with post-marketing activities. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Pharmacovigilance and drug safety in Calabria (Italy): 2012 adverse events analysis.

Science.gov (United States)

Giofrè, Chiara; Scicchitano, Francesca; Palleria, Caterina; Mazzitello, Carmela; Ciriaco, Miriam; Gallelli, Luca; Paletta, Laura; Marrazzo, Giuseppina; Leporini, Christian; Ventrice, Pasquale; Carbone, Claudia; Saullo, Francesca; Rende, Pierandrea; Menniti, Michele; Mumoli, Laura; Chimirri, Serafina; Patanè, Marinella; Esposito, Stefania; Cilurzo, Felisa; Staltari, Orietta; Russo, Emilio; De Sarro, Giovambattista

2013-12-01

Pharmacovigilance (PV) is designed to monitor drugs continuously after their commercialization, assessing and improving their safety profile. The main objective is to increase the spontaneous reporting of adverse drug reactions (ADRs), in order to have a wide variety of information. The Italian Drug Agency (Agenzia Italiana del Farmaco [AIFA]) is financing several projects to increase reporting. In Calabria, a PV information center has been created in 2010. We obtained data using the database of the National Health Information System AIFA relatively to Italy and Calabria in the year 2012. Descriptive statistics were performed to analyze the ADRs. A total number of 461 ADRs have been reported in the year 2012 with an increase of 234% compared with 2011 (138 reports). Hospital doctors are the main source of this reporting (51.62%). Sorafenib (Nexavar(®)), the combination of amoxicillin/clavulanic acid and ketoprofen represent the drugs most frequently reported causing adverse reactions. Adverse events in female patients (61.83%) were more frequently reported, whereas the age groups "41-65" (39.07%) and "over 65" (27.9%) were the most affected. Calabria has had a positive increase in the number of ADRs reported, although it has not yet reached the gold standard set by World Health Organization (about 600 reports), the data have shown that PV culture is making inroads in this region and that PV projects stimulating and increasing PV knowledge are needed.

Pharmacovigilance and drug safety 2011 in Calabria (Italy: Adverse events analysis

Directory of Open Access Journals (Sweden)

Francesca Scicchitano

2012-01-01

Full Text Available Background : Pharmacovigilance assesses the safety profile of drugs. Its main aim is the increase of spontaneous reporting of adverse drug reactions (ADRs. The Italian Drug Agency (AIFA; Agenzia Italiana del Farmaco is financing several projects to the aim of increasing reporting, and in Calabria a Pharmacovigilance Information Centre has been created. Materials and Methods: We analyzed the AIFA database relatively to Calabria in the year 2011 and we have analyzed ADRs using descriptive statistics. We have also collected a questionnaire-based interview in order to describe the background knowledge in the field. Results : Regarding the number of AIFA reported ADRs from Calabria, a 38% increase (138 vs. 100 in comparison to 2010 was evidenced. Hospital Doctors represent the main source of signaling (71.7 %. Ketoprofene and the combination amoxicillin/clavulanic acid represent the most frequently reported drugs causing ADRs. Our questionnaires indicated that despite the health professionals have met at least once an ADR only a small percentage of them was reported to the authorities (37%. There is a very good knowledge of the ADR concept and reporting system (90% of interviewed distinguish an ADR and knows how to report it, and there is a strong interest in participating to training courses in the field (95% are interested. Conclusions : Despite Calabria has had a positive increase in the number of reported ADRs, the total number is very low and the pharmacovigilance culture is far from being achieved in this region.

Pharmacovigilance and drug safety 2011 in Calabria (Italy): Adverse events analysis.

Science.gov (United States)

Scicchitano, Francesca; Giofrè, Chiara; Palleria, Caterina; Mazzitello, Carmela; Ciriaco, Miriam; Gallelli, Luca; Paletta, Laura; Marrazzo, Giuseppina; De Fazio, Salvatore; Menniti, Michele; Curia, Rubens; Arena, Concetta; Chimirri, Serafina; Patanè, Marinella; Esposito, Stefania; Cilurzo, Felisa; Staltari, Orietta; Russo, Emilio; De Sarro, Giovambattista

2012-09-01

Pharmacovigilance assesses the safety profile of drugs. Its main aim is the increase of spontaneous reporting of adverse drug reactions (ADRs). The Italian Drug Agency (AIFA; Agenzia Italiana del Farmaco) is financing several projects to the aim of increasing reporting, and in Calabria a Pharmacovigilance Information Centre has been created. We analyzed the AIFA database relatively to Calabria in the year 2011 and we have analyzed ADRs using descriptive statistics. We have also collected a questionnaire-based interview in order to describe the background knowledge in the field. Regarding the number of AIFA reported ADRs from Calabria, a 38% increase (138 vs. 100) in comparison to 2010 was evidenced. Hospital Doctors represent the main source of signaling (71.7 %). Ketoprofene and the combination amoxicillin/clavulanic acid represent the most frequently reported drugs causing ADRs. Our questionnaires indicated that despite the health professionals have met at least once an ADR only a small percentage of them was reported to the authorities (37%). There is a very good knowledge of the ADR concept and reporting system (90% of interviewed distinguish an ADR and knows how to report it), and there is a strong interest in participating to training courses in the field (95% are interested). Despite Calabria has had a positive increase in the number of reported ADRs, the total number is very low and the pharmacovigilance culture is far from being achieved in this region.

Production of neutrons in particle accelerators: a PNRI safety concern

International Nuclear Information System (INIS)

Garcia, Corazon M.; Cayabo, Lynette B.; Artificio, Thelma P.; Melendez, Johnylen V.; Piquero, Myrna E.; Parami, Vangeline K.

2002-09-01

In the safety assessment made for the first cyclotron facility in the Philippines, that is the cyclotron in the P.E.T. (Positron Emission Tomography) center of the St. Luke's Medical Center, the concern on the production of neutrons associated with the operation of particle accelerators has been identified. This takes into consideration the principles in the operation of particle accelerators and the associated production of neutrons resulting from their operation, the hazards and risks in their operation. The Bureau of Health Devices and Technology (BHDT) of the Department of Health in the Philippines regulates and controls the presently existing six (6) linear accelerators distributed in different hospitals in the country, being classified as x-ray producing devices. From the results of this study, it is evident that the production of neutrons from the operation of accelerators, produces neutrons and that activation due to neutrons can form radioactive materials. The PNRI (Philippine Nuclear Research Institute) being mandated by law to regulate and control any equipment or devices producing or utilizing radioactive materials should take the proper steps to subject all accelerator facilities and devices in the Philippines such as linear accelerators under its regulatory control in the same manner as it did with the first cyclotron in the country. (Author)

Concern for older parts

International Nuclear Information System (INIS)

Titus, E.; Spink, T.; Cookson, B.; Tenera, L.P.

1992-01-01

For the last half decade, regulatory expectations of the procurement process for nuclear commercial-grade safety-related materials have increase. The changes have been driven by concern for fraudulent or misrepresented parts and the loss of original equipment manufacturers. The industry responded to these concerns by developing improved procurement programs that changed how parts were specified and received and provided for verification of attributes that were critical to the successful performance of safety functions(s). Like its counterparts, Duquesne Light Company (DLCo), Beaver Valley power station began applying these enhanced requirements to procurements initiated after January 1, 1990, in response to the Nuclear Management and Resources Council initiative on dedication. Procurements prior to this data were not subject to the new requirements

Regulatory overview report 2013 concerning nuclear safety in Swiss nuclear installations

International Nuclear Information System (INIS)

2014-06-01

The Swiss Federal Nuclear Safety Inspectorate (ENSI) acting as the regulatory body of the Swiss Federation assesses and monitors nuclear facilities in Switzerland: these include five nuclear power plants, the interim storage facilities based at each plant, the Central Interim Storage Facility (ZWILAG) at Wuerenlingen together with the nuclear facilities at the Paul Scherrer Institute (PSI) and the two universities of Basel and Lausanne. Using a combination of inspections, regulatory meetings, examinations and analyses together with reports from the licensees of individual facilities, ENSI obtains the overview required concerning nuclear safety. It ensures that the facilities comply with regulations. Its regulatory responsibilities include the transport of radioactive materials from and to nuclear facilities and the preparations for a deep geological repository for nuclear waste. ENSI maintains its own emergency organisation, an integral part of the national emergency structure. It provides the public with information on particular events in nuclear facilities. This Surveillance Report describes operational experience, systems technology, radiological protection and management in all the nuclear facilities. Generic issues relevant to all facilities such as probabilistic safety analyses are described. In 2013, the five nuclear power plants in Switzerland (Beznau Units 1 and 2, Muehleberg, Goesgen and Leibstadt) were all operated safely and had complied with their approved operating conditions. The nuclear safety at all plants was rated as being good. 34 events were reported. During operation, no reactor scrams were recorded. On the INES scale, ranging from 0-7, ENSI rated all reportable events as Level 0. The ENSI safety evaluation reflects both reportable events and the results of the approximately 460 inspections conducted during 2013. ZWILAG consists of several storage halls, a conditioning plant and a plasma plant. At the end of 2013, the cask storage hall

Safety Issues Concerning the Medical Use of Cannabis and Cannabinoids

Directory of Open Access Journals (Sweden)

Mark A Ware

2005-01-01

Full Text Available Safety issues are a major barrier to the use of cannabis and cannabinoid medications for clinical purposes. Information on the safety of herbal cannabis may be derived from studies of recreational cannabis use, but cannabis exposure and effects may differ widely between medical and recreational cannabis users. Standardized, quality-controlled cannabinoid products are available in Canada, and safety profiles of approved medications are available through the Canadian formulary. In the present article, the evidence behind major safety issues related to cannabis use is summarized, with the aim of promoting informed dialogue between physicians and patients in whom cannabinoid therapy is being considered. Caution is advised in interpreting these data, because clinical experience with cannabinoid use is in the early stages. There is a need for long-term safety monitoring of patients using cannabinoids for a wide variety of conditions, to further guide therapeutic decisions and public policy.

Safety regulations concerning instrumentation and control systems for research reactors

International Nuclear Information System (INIS)

El-Shanshoury, A.I.

2009-01-01

A brief study on the safety and reliability issues related to instrumentation and control systems in nuclear reactor plants is performed. In response, technical and strategic issues are used to accomplish instrumentation and control systems safety. For technical issues there are ; systems aspects of digital I and C technology, software quality assurance, common-mode software, failure potential, safety and reliability assessment methods, and human factors and human machine interfaces. The strategic issues are the case-by-case licensing process and the adequacy of the technical infrastructure. The purpose of this work was to review the reliability of the safety systems related to these technical issues for research reactors

Illicit Internet availability of drugs subject to recall and patient safety consequences.

Science.gov (United States)

Mackey, Tim K; Aung, Phyo; Liang, Bryan A

2015-12-01

Permanently recalled drugs are a public health concern if they remain accessible in violation of applicable regulation. Illicit online pharmacies act as an alternative form of access and have been associated with the sale to patients of counterfeit/falsified/fraudulent/substandard drugs. We wished to determine if permanently recalled and significantly restricted drugs were illegally marketed for sale online. The study was conducted in two phases with two objectives. The first phase attempted to identify drugs subject to permanent recall in certain major pharmaceutical markets as well as those listed as recalled or significantly restricted by the United Nations. We also examined the market authorization status of identified drugs in China and India. The second phase used structured searches on the Internet to determine if identified drugs were marketed for sale online. The World Wide Web. After identification of permanently recalled and restricted drugs we conducted Internet searches for illegal "no prescription" marketing events. We assessed the form of marketing, whether a site offered direct-to-patient sale, use of social media marketing, and the site's compliance status with external monitoring bodies. Number of recalled drugs marketed as available for purchase on the Internet. We identified 16 class I equivalent permanently recalled or restricted drugs, 56.3 % (n = 9) of which maintained market authorization in either China or India. Half (n = 8) were marketed for sale online without a prescription direct-to-patient. Use of social media marketing was mixed, with only 18.8 % (n = 3) of recalled drugs having a presence on Facebook, though 50.0 % (n = 8) had content on Twitter. We also found the majority (68.8 %, n = 11) were available and marketed for sale by vendors on the wholesale/business-to-business website alibaba.com primarily as active pharmaceutical ingredient. Despite efforts in several countries to restrict access to these drugs or permanently remove

Permitting product liability litigation for FDA-approved drugs and devices promotes patient safety.

Science.gov (United States)

Kesselheim, A S

2010-06-01

In 2008 and 2009, the Supreme Court reviewed the question of whether patients injured by dangerous prescription drugs or medical devices can bring tort lawsuits against pharmaceutical and device manufacturers. The Court ruled that claims against device manufacturers were preempted while claims against pharmaceutical manufacturers were not. The threat of product liability lawsuits promotes patient safety by encouraging manufacturers to take greater responsibility in providing clear warnings about known adverse effects of their products.

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.

Geological disposal of nuclear waste: II. From laboratory data to the safety analysis – Addressing societal concerns

International Nuclear Information System (INIS)

Grambow, Bernd; Bretesché, Sophie

2014-01-01

Highlights: • Models for repository safety can only partly be validated. • Long term risks need to be translated in the context of societal temporalities. • Social sciences need to be more strongly involved into safety assessment. - Abstract: After more than 30 years of international research and development, there is a broad technical consensus that geologic disposal of highly-radioactive waste will provide for the safety of humankind and the environment, now, and far into the future. Safety analyses have demonstrated that the risk, as measured by exposure to radiation, will be of little consequence. Still, there is not yet an operating geologic repository for highly-radioactive waste, and there remains substantial public concern about the long-term safety of geologic disposal. In these two linked papers, we argue for a stronger connection between the scientific data (paper I, Grambow et al., 2014) and the safety analysis, particularly in the context of societal expectations (paper II). In this paper (II), we assess the meaning of the technical results and derived models (paper I) for the determination of the long-term safety of a repository. We consider issues of model validity and their credibility in the context of a much broader historical, epistemological and societal context. Safety analysis is treated in its social and temporal dimensions. This perspective provides new insights into the societal dimension of scenarios and risk analysis. Surprisingly, there is certainly no direct link between increased scientific understanding and a public position for or against different strategies of nuclear waste disposal. This is not due to the public being poorly informed, but rather due to cultural cognition of expertise and historical and cultural perception of hazards to regions selected to host a geologic repository. The societal and cultural dimension does not diminish the role of science, as scientific results become even more important in distinguishing

Safety aspects of protease inhibitors for chronic hepatitis C: adverse events and drug-to-drug interactions

Directory of Open Access Journals (Sweden)

Rosângela Teixeira

Full Text Available The standard of care therapy of chronic hepatitis C with the combination of pegylated interferon and ribavirin for 24 or 48 weeks was a remarkable accomplishment of the past decade. However, sustained virological responses rates of about 80% (genotypes 2-3 and 50% (geno 3 type 1 were not satisfactory especially for patients infected with genotype 1. Important advances in the biology of HCV have made possible the development of the direct-acting antiviral agents boceprevir and telaprevir with substantial increase in the rates of sustained virological response with shorter duration of therapy for a large number of patients. However, the complexity of triple therapy is higher and several new side effects are expected suggesting greater expertise in the patient management. Anemia and disgeusia are frequent with boceprevir while cutaneous rash, ranging from mild to severe, is expected with telaprevir. Higher risk of drug-drug interactions demand further clinical consideration of the previous well-known adverse events of pegylated interferon and ribavirin. Identification and prompt management of these potential new problems with boceprevir and telaprevir are crucial in clinical practice for optimizing treatment and assuring safety outcomes to HCV-genotype 1 patients.

Safety aspects of protease inhibitors for chronic hepatitis C: adverse events and drug-to-drug interactions

Directory of Open Access Journals (Sweden)

Rosângela Teixeira

2013-04-01

Full Text Available The standard of care therapy of chronic hepatitis C with the combination of pegylated interferon and ribavirin for 24 or 48 weeks was a remarkable accomplishment of the past decade. However, sustained virological responses rates of about 80% (genotypes 2-3 and 50% (geno 3 type 1 were not satisfactory especially for patients infected with genotype 1. Important advances in the biology of HCV have made possible the development of the direct-acting antiviral agents boceprevir and telaprevir with substantial increase in the rates of sustained virological response with shorter duration of therapy for a large number of patients. However, the complexity of triple therapy is higher and several new side effects are expected suggesting greater expertise in the patient management. Anemia and disgeusia are frequent with boceprevir while cutaneous rash, ranging from mild to severe, is expected with telaprevir. Higher risk of drug-drug interactions demand further clinical consideration of the previous well-known adverse events of pegylated interferon and ribavirin. Identification and prompt management of these potential new problems with boceprevir and telaprevir are crucial in clinical practice for optimizing treatment and assuring safety outcomes to HCV-genotype 1 patients.

76 FR 72955 - Wyeth Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for MYLOTARG

Science.gov (United States)

2011-11-28

... not considered candidates for other cytotoxic chemotherapy. On May 21, 2010, FDA requested that Wyeth... to verify clinical benefit to patients and raised new concerns about the drug's safety. In a letter... first- line chemotherapy for patients with newly diagnosed acute myelogenous leukemia failed to verify...

Evaluation of Electronic Healthcare Databases for Post-Marketing Drug Safety Surveillance and Pharmacoepidemiology in China.

Science.gov (United States)

Yang, Yu; Zhou, Xiaofeng; Gao, Shuangqing; Lin, Hongbo; Xie, Yanming; Feng, Yuji; Huang, Kui; Zhan, Siyan

2018-01-01

Electronic healthcare databases (EHDs) are used increasingly for post-marketing drug safety surveillance and pharmacoepidemiology in Europe and North America. However, few studies have examined the potential of these data sources in China. Three major types of EHDs in China (i.e., a regional community-based database, a national claims database, and an electronic medical records [EMR] database) were selected for evaluation. Forty core variables were derived based on the US Mini-Sentinel (MS) Common Data Model (CDM) as well as the data features in China that would be desirable to support drug safety surveillance. An email survey of these core variables and eight general questions as well as follow-up inquiries on additional variables was conducted. These 40 core variables across the three EHDs and all variables in each EHD along with those in the US MS CDM and Observational Medical Outcomes Partnership (OMOP) CDM were compared for availability and labeled based on specific standards. All of the EHDs' custodians confirmed their willingness to share their databases with academic institutions after appropriate approval was obtained. The regional community-based database contained 1.19 million people in 2015 with 85% of core variables. Resampled annually nationwide, the national claims database included 5.4 million people in 2014 with 55% of core variables, and the EMR database included 3 million inpatients from 60 hospitals in 2015 with 80% of core variables. Compared with MS CDM or OMOP CDM, the proportion of variables across the three EHDs available or able to be transformed/derived from the original sources are 24-83% or 45-73%, respectively. These EHDs provide potential value to post-marketing drug safety surveillance and pharmacoepidemiology in China. Future research is warranted to assess the quality and completeness of these EHDs or additional data sources in China.

Complicating factors in safety testing of drug metabolites: Kinetic differences between generated and preformed metabolites

International Nuclear Information System (INIS)

Prueksaritanont, Thomayant; Lin, Jiunn H.; Baillie, Thomas A.

2006-01-01

This paper aims to provide a scientifically based perspective on issues surrounding the proposed toxicology testing of synthetic drug metabolites as a means of ensuring adequate nonclinical safety evaluation of drug candidates that generate metabolites considered either to be unique to humans or are present at much higher levels in humans than in preclinical species. We put forward a number of theoretical considerations and present several specific examples where the kinetic behavior of a preformed metabolite given to animals or humans differs from that of the corresponding metabolite generated endogenously from its parent. The potential ramifications of this phenomenon are that the results of toxicity testing of the preformed metabolite may be misleading and fail to characterize the true toxicological contribution of the metabolite when formed from the parent. It is anticipated that such complications would be evident in situations where (a) differences exist in the accumulation of the preformed versus generated metabolites in specific tissues, and (b) the metabolite undergoes sequential metabolism to a downstream product that is toxic, leading to differences in tissue-specific toxicity. Owing to the complex nature of this subject, there is a need to treat drug metabolite issues in safety assessment on a case-by-case basis, in which a knowledge of metabolite kinetics is employed to validate experimental paradigms that entail administration of preformed metabolites to animal models

Ayurpharmacoepidemiology en Route to Safeguarding Safety and Efficacy of Ayurvedic Drugs in Global Outlook

Science.gov (United States)

Debnath, Parikshit; Banerjee, Subhadip; Adhikari, Anjan; Debnath, Pratip K.

2016-01-01

Ayurpharmacoepidemiology is a new field developed by synergy of the fields of clinical pharmacology, epidemiology, and ayurveda. It will use the effects of ayurvedic medicinal products on large populations to describe and analyze the practices, evaluate the safety and efficacy, and carry out medicoeconomic evaluations. Good pharmacoepidemiology practices in ayurveda is projected to assist with issues of ayurpharmacoepidemiologic research. The embraced good pharmacoepidemiology practices guideline in this viewpoint will be able to provide valuable evidence about the health effects of ayurvedic herbs/drugs and consider different fields like pharmacovigilance, pharmacoeconomics, and drug discovery with ayurvedic reverse pharmacology approach, also pass out significant data for further basic sciences study in ayurveda biology, ayurgenomics, ayurnutrigenomics, and systems biology. Several unanswered questions about ayurvedic drug use and informed interventions or policies that can be addressed by informatics database, which will eventually demonstrate the credibility and rationality of ayurceuticals in the future. PMID:26721554

Effectively managing public concerns about immunization safety

Directory of Open Access Journals (Sweden)

2002-01-01

Full Text Available Los beneficios de la vacunación frente a las enfermedades prevenibles de este modo son muy superiores a sus mínimos riesgos. Con el fin de mantener o fortalecer los programas nacionales de vacunación, los trabajadores de todos los niveles de la salud pública deberían recibir formación sobre los temas relacionados con la vacunación y estar preparados para responder a las dudas planteadas por el público. Una respuesta rápida y franca a los temores del público acerca de las vacunas podría garantizar la integridad de los programas de vacunación en todo el continente americano, según el documento "Directrices para enfrentarse a los temores sobre la seguridad de las vacunaciones" (Guidelines for Managing Immunization Safety Concerns, elaborado por la División de Vacunas e Inmunización de la Organización Panamericana de la Salud (OPS y resumido aquí. Todo acontecimiento médico que se considere posiblemente relacionado con una vacuna debe ser investigado en el ámbito local. Si su distribución temporal y los síntomas respaldan la sospecha de que pueda estar relacionado con una vacuna, se debe iniciar una investigación más formal y, una vez finalizada, el acontecimiento debe ser clasificado en una de las cuatro categorías siguientes: 1 relacionado con el programa, 2 relacionado con la vacuna, 3 no relacionado, o 4 desconocido (investigación no concluyente. Dependiendo de la categoría a la que haya sido asignado el acontecimiento, las acciones posteriores pueden consistir en tranquilizar a los padres, a los cuidadores y a otros adultos; comunicarse con el público y con otros trabajadores de la salud; instaurar tratamiento; corregir los errores del programa, como pueden ser la manipulación de la vacuna, su almacenamiento, su administration o los problemas relacionados con la jeringuilla; comentar con los fabricantes problemas relacionados con la calidad y eficacia de la vacuna; retirar la vacuna del mercado, o iniciar nuevas

Nuclear safety in Slovak Republic. Status of safety improvements

International Nuclear Information System (INIS)

Toth, A.

1999-01-01

Status of the safety improvements at Bohunice V-1 units concerning WWER-440/V-230 design upgrading were as follows: supplementing of steam generator super-emergency feed water system; higher capacity of emergency core cooling system; supplementing of automatic links between primary and secondary circuit systems; higher level of secondary system automation. The goal of the modernization program for Bohunice V-1 units WWER-440/V-230 was to increase nuclear safety to the level of the proposals and IAEA recommendations and to reach probability goals of the reactor concerning active zone damage, leak of radioactive materials, failures of safety systems and damage shields. Upgrading program for Mochovce NPP - WWER-440/V-213 is concerned with improving the integrity of the reactor pressure vessel, steam generators 'leak before break' methods applied for the NPP, instrumentation and control of safety systems, diagnostic systems, replacement of in-core monitoring system, emergency analyses, pressurizers safety relief valves, hydrogen removal system, seismic evaluations, non-destructive testing, fire protection. Implementation of quality assurance has a special role in improvement of operational safety activities as well as safety management and safety culture, radiation protection, decommissioning and waste management and training. The Year 2000 problem is mentioned as well

Definitive closure of nuclear power plants. Aspects concerning physical safety

International Nuclear Information System (INIS)

Rodriguez, C.; Puntarulo, L.; Canibano, J.

1988-01-01

This paper analyzes the various safety requirements that must be fulfilled by nuclear power plants for their operation without restrictions, such as safeguards, nuclear safety and physical protection. Physical protection, the subject most extensively dealt by the authors, is defined as safety measures aimed at providing protection against deliberate hostile deeds, such as robberies or non-authorized transport of radioactive materials or sabotage in nuclear facilities, performed either by individuals or by groups of individuals. (Author)

Ethical considerations and proposed guidelines for the use of radio frequency identification: especially concerning its use for promoting public safety and national security.

Science.gov (United States)

Anderson, Amber McKee; Labay, Vladimir

2006-04-01

Radio Frequency Identification (RFID) is quickly growing in its applications. A variety of uses for the technology are beginning to be developed, including chips which can be used in identification cards, in individual items, and for human applications, allowing a chip to be embedded under the skin. Such chips could provide numerous benefits ranging from day-to-day convenience to the increased ability of the federal government to adequately ensure the safety of its citizens. However, there are also valid concerns about the potential of this technology to infringe on privacy, creating fears of a surveillance society. These are concerns that must be addressed quickly, with sensitivity to individual interests and societal welfare, allowing humanity to reap the benefits of convenience and safety without paying an unacceptable price in the loss of privacy.

Considerations concerning the reliability of reactor safety equipment

International Nuclear Information System (INIS)

Furet, J.; Guyot, Ch.

1967-01-01

A review is made of the circumstances which favor a good collection of maintenance data at the C.E.A. The large amount of data to be treated has made necessary the use of a computer for analyzing automatically the results collected. Here, only particular aspects of the reliability from the point of view of the electronics used for nuclear reactor control will be dealt with: sale and unsafe failures; probability of survival (in the case of reactor safety); availability. The general diagrams of the safety assemblies which have been drawn up for two types of reactor (power reactor and low power experimental reactor) are given. Results are presented of reliability analysis which could be applied to the use of functional modular elements, developed industrially in France. Improvement of this reliability appears to be fairly limited by an increase in the redundancy; on the other hand it is shown how it may be very markedly improved by the use of automatic tests with different frequencies for detecting unsafe failures rates of measurements for the sub-assemblies and for the logic sub-assemblies. Finally examples are given to show the incidence of the complexity and of the use of different technologies in reactor safety equipment on the reliability. (authors) [fr

The complications of controlling agency time discretion: FDA review deadlines and postmarket drug safety.

Science.gov (United States)

Carpenter, Daniel; Chattopadhyay, Jacqueline; Moffitt, Susan; Nall, Clayton

2012-01-01

Public agencies have discretion on the time domain, and politicians deploy numerous policy instruments to constrain it. Yet little is known about how administrative procedures that affect timing also affect the quality of agency decisions. We examine whether administrative deadlines shape decision timing and the observed quality of decisions. Using a unique and rich dataset of FDA drug approvals that allows us to examine decision timing and quality, we find that this administrative tool induces a piling of decisions before deadlines, and that these “just-before-deadline” approvals are linked with higher rates of postmarket safety problems (market withdrawals, severe safety warnings, safety alerts). Examination of data from FDA advisory committees suggests that the deadlines may impede quality by impairing late-stage deliberation and agency risk communication. Our results both support and challenge reigning theories about administrative procedures, suggesting they embody expected control-expertise trade-offs, but may also create unanticipated constituency losses.

Patient safety: Safety culture and patient safety ethics

DEFF Research Database (Denmark)

Madsen, Marlene Dyrløv

2006-01-01

,demonstrating significant, consistent and sometimes large differences in terms of safety culture factors across the units participating in the survey. Paper 5 is the results of a study of the relation between safety culture, occupational health andpatient safety using a safety culture questionnaire survey......Patient safety - the prevention of medical error and adverse events - and the initiative of developing safety cultures to assure patients from harm have become one of the central concerns in quality improvement in healthcare both nationally andinternationally. This subject raises numerous...... challenging issues of systemic, organisational, cultural and ethical relevance, which this dissertation seeks to address through the application of different disciplinary approaches. The main focus of researchis safety culture; through empirical and theoretical studies to comprehend the phenomenon, address...

Drug monitoring in child and adolescent psychiatry for improved efficacy and safety of psychopharmacotherapy

Directory of Open Access Journals (Sweden)

Fegert Jörg M

2009-04-01

Full Text Available Abstract Most psychotropic drugs used in the treatment of children and adolescents are applied "off label" with a direct risk of under- or overdosing and a delayed risk of long-term side effects. The selection of doses in paediatric psychiatric patients requires a consideration of pharmacokinetic parameters and the development of central nervous system, and warrants specific studies in children and adolescents. Because these are lacking for most of the psychotropic drugs applied in the Child and Adolescent and Psychiatry, therapeutic drug monitoring (TDM is a valid tool to optimise pharmacotherapy and to enable to adjust the dosage of drugs according to the characteristics of the individual patient. Multi-centre TDM studies enable the identification of age- and development-dependent therapeutic ranges of blood concentrations and facilitate a highly qualified standardized documentation in the child and adolescent health care system. In addition, they will provide data for future research on psychopharmacological treatment in children and adolescents, as a baseline for example for clinically relevant interactions with various co-medications. Therefore, a German-Austrian-Swiss "Competence Network on Therapeutic Drug Monitoring in Child and Adolescent Psychiatry" was founded 1 introducing a comprehensive internet data base for the collection of demographic, safety and efficacy data as well as blood concentrations of psychotropic drugs in children and adolescents.

Predicting Drug Safety and Communicating Risk: Benefits of a Bayesian Approach.

Science.gov (United States)

Lazic, Stanley E; Edmunds, Nicholas; Pollard, Christopher E

2018-03-01

Drug toxicity is a major source of attrition in drug discovery and development. Pharmaceutical companies routinely use preclinical data to predict clinical outcomes and continue to invest in new assays to improve predictions. However, there are many open questions about how to make the best use of available data, combine diverse data, quantify risk, and communicate risk and uncertainty to enable good decisions. The costs of suboptimal decisions are clear: resources are wasted and patients may be put at risk. We argue that Bayesian methods provide answers to all of these problems and use hERG-mediated QT prolongation as a case study. Benefits of Bayesian machine learning models include intuitive probabilistic statements of risk that incorporate all sources of uncertainty, the option to include diverse data and external information, and visualizations that have a clear link between the output from a statistical model and what this means for risk. Furthermore, Bayesian methods are easy to use with modern software, making their adoption for safety screening straightforward. We include R and Python code to encourage the adoption of these methods.

Effect of Safety Issues with HIV Drugs on the Approval Process of Other Drugs in the Same Class An Analysis of European Public Assessment Reports : an analysis of European public assessment reports

NARCIS (Netherlands)

Arnardottir, Arna H.; Haaijer-Ruskamp, Flora M.; Straus, Sabine M. J.; de Graeff, Pieter A.; Mol, Peter G. M.

2011-01-01

Background: Knowledge on the safety of new medicines is limited at the time of market entry. Nearly half of all drugs used to treat HIV registered in the EU required >= 1 Direct Healthcare Professional Communication (DHPC) in the past 10 years for safety issues identified post-approval. Objective:

Niosomal encapsulation of ethambutol hydrochloride for increasing its efficacy and safety.

Science.gov (United States)

El-Ridy, Mohammed Shafik; Yehia, Soad Aly; Kassem, Mahfouz Abd-El-Megeid; Mostafa, Dina Mahmoud; Nasr, Essam Amin; Asfour, Marwa Hasanin

2015-01-01

Tuberculosis (TB) is a worldwide health concern. In 2011, about 8.7 million new cases developed TB and 1.4 million people died from it. Enhancement of ethambutol hydrochloride activity and safety in treatment of TB through niosomal encapsulation. Niosomes were prepared by the thin-film hydration method. They were characterized, investigated for in vitro release, lung disposition and in vivo biological evaluation. Entrapment efficiency of ethambutol hydrochloride ranged from 12.20% to 25.81%. Zeta potential values inferred stability of neutral and negatively charged formulations. In vitro release was biphasic. Lung targeting was increased by niosomal encapsulation. Biological evaluation revealed superiority of niosomal ethambutol hydrochloride over the free drug. Neutral and negatively charged niosomal vesicles are dispersed homogenously unlike positively charged vesicles. Niosomal encapsulation results in controlled drug release. Niosomal formulations targeted more drugs to mice lungs for a prolonged period of time resulting in: decreased root-specific lung weight, bacterial counts in lung homogenates and optimizing pathological effect on guinea pigs lungs, livers and spleens. Encapsulation of ethambutol hydrochloride in niosomal formulations for the treatment of TB provides higher efficacy and safety compared with the free drug.

Influence of companion diagnostics on efficacy and safety of targeted anti-cancer drugs: systematic review and meta-analyses.

Science.gov (United States)

Ocana, Alberto; Ethier, Josee-Lyne; Díez-González, Laura; Corrales-Sánchez, Verónica; Srikanthan, Amirrtha; Gascón-Escribano, María J; Templeton, Arnoud J; Vera-Badillo, Francisco; Seruga, Bostjan; Niraula, Saroj; Pandiella, Atanasio; Amir, Eitan

2015-11-24

Companion diagnostics aim to identify patients that will respond to targeted therapies, therefore increasing the clinical efficacy of such drugs. Less is known about their influence on safety and tolerability of targeted anti-cancer agents. Randomized trials evaluating targeted agents for solid tumors approved by the US Food and Drug Administration since year 2000 were assessed. Odds ratios (OR) and and 95% confidence intervals (CI) were computed for treatment-related death, treatment-discontinuation related to toxicity and occurrence of any grade 3/4 adverse events (AEs). The 12 most commonly reported individual AEs were also explored. ORs were pooled in a meta-analysis. Analysis comprised 41 trials evaluating 28 targeted agents. Seventeen trials (41%) utilized companion diagnostics. Compared to control groups, targeted drugs in experimental arms were associated with increased odds of treatment discontinuation, grade 3/4 AEs, and toxic death irrespective of whether they utilized companion diagnostics or not. Compared to drugs without available companion diagnostics, agents with companion diagnostics had a lower magnitude of increased odds of treatment discontinuation (OR = 1.12 vs. 1.65, p diagnostics were greatest for diarrhea (OR = 1.29 vs. 2.43, p diagnostics are associated with improved safety, and tolerability. Differences were most marked for gastrointestinal, cutaneous and neurological toxicity.

Anthraquinones As Pharmacological Tools and Drugs.

Science.gov (United States)

Malik, Enas M; Müller, Christa E

2016-07-01

Anthraquinones (9,10-dioxoanthracenes) constitute an important class of natural and synthetic compounds with a wide range of applications. Besides their utilization as colorants, anthraquinone derivatives have been used since centuries for medical applications, for example, as laxatives and antimicrobial and antiinflammatory agents. Current therapeutic indications include constipation, arthritis, multiple sclerosis, and cancer. Moreover, biologically active anthraquinones derived from Reactive Blue 2 have been utilized as valuable tool compounds for biochemical and pharmacological studies. They may serve as lead structures for the development of future drugs. However, the presence of the quinone moiety in the structure of anthraquinones raises safety concerns, and anthraquinone laxatives have therefore been under critical reassessment. This review article provides an overview of the chemistry, biology, and toxicology of anthraquinones focusing on their application as drugs. © 2016 Wiley Periodicals, Inc.

Measuring and improving patient safety through health information technology: The Health IT Safety Framework.

Science.gov (United States)

Singh, Hardeep; Sittig, Dean F

2016-04-01

Health information technology (health IT) has potential to improve patient safety but its implementation and use has led to unintended consequences and new safety concerns. A key challenge to improving safety in health IT-enabled healthcare systems is to develop valid, feasible strategies to measure safety concerns at the intersection of health IT and patient safety. In response to the fundamental conceptual and methodological gaps related to both defining and measuring health IT-related patient safety, we propose a new framework, the Health IT Safety (HITS) measurement framework, to provide a conceptual foundation for health IT-related patient safety measurement, monitoring, and improvement. The HITS framework follows both Continuous Quality Improvement (CQI) and sociotechnical approaches and calls for new measures and measurement activities to address safety concerns in three related domains: 1) concerns that are unique and specific to technology (e.g., to address unsafe health IT related to unavailable or malfunctioning hardware or software); 2) concerns created by the failure to use health IT appropriately or by misuse of health IT (e.g. to reduce nuisance alerts in the electronic health record (EHR)), and 3) the use of health IT to monitor risks, health care processes and outcomes and identify potential safety concerns before they can harm patients (e.g. use EHR-based algorithms to identify patients at risk for medication errors or care delays). The framework proposes to integrate both retrospective and prospective measurement of HIT safety with an organization's existing clinical risk management and safety programs. It aims to facilitate organizational learning, comprehensive 360 degree assessment of HIT safety that includes vendor involvement, refinement of measurement tools and strategies, and shared responsibility to identify problems and implement solutions. A long term framework goal is to enable rigorous measurement that helps achieve the safety

[Blood components: Are they drugs or special medicines?].

Science.gov (United States)

Garraud, O; Tissot, J-D

2016-09-01

Blood transfusion and plasma derived-drugs significantly differ from other medicines in that their availability strictly depends on blood and plasma collected from healthy donors. Blood collection must comply with a double objective: to maintain donor heath safety, and to avoid any transmitted infections in recipients. This raises several ethical concerns that appear to be different from usual ethical and deontological issues linked to other pharmaceutical and industrial processes. The main concern is the non-commercialization of the human body. Words and concept are of major importance in this context. This short review aims at presenting the main issues relevant to those questions with respect to the various stakeholders. Copyright © 2016. Published by Elsevier SAS.

Losing nuclear expertise - A safety concern

International Nuclear Information System (INIS)

Ziakova, M.

2002-01-01

Full text: Since the mid of eighties several important changes in human beings behaviour, which influence nuclear field, can be observed - the loss of interest in studying technical disciplines (namely nuclear), strong pressure of environmental movements, stagnation of electricity consumption and deregulation of electric markets. All these factors create conditions which are leading to the decrease of job positions related to the nuclear field connected particularly with research, design and engineering. Loss of interest in studying nuclear disciplines together with the decrease of number of job positions has led to the declining of university enrolments, closing of university departments and research reactors. In this manner just a very small number of appropriately educated new experts are brought In the same moment the additional internal factor - the relative ageing of the human workforce on both sites operators of nuclear facilities and research and engineering organisations can be observed. All these factors, if not addressed properly, could lead to the loss of nuclear expertise and the loss of nuclear expertise represents the direct thread to the nuclear safety. The latest studies have shown that at present NPPs cannot be replaced by other kinds of electric sources and in no case by renewable ones in an efficient manner. Therefore it is necessary to carefully manage knowledge gathered in the nuclear field during the years and to keep on the nuclear safety research, education and training to ensure and upgrade safe and reliable operation of existing and future nuclear facilities. This is responsibility of both the governments of the states using nuclear applications and owners of nuclear facilities. (author)

Post-marketing safety and effectiveness evaluation of the intravenous anti-influenza neuraminidase inhibitor peramivir (I): a drug use investigation.

Science.gov (United States)

Komeda, Takuji; Ishii, Shingo; Itoh, Yumiko; Ariyasu, Yasuyuki; Sanekata, Masaki; Yoshikawa, Takayoshi; Shimada, Jingoro

2014-11-01

Peramivir is the only intravenous formulation among anti-influenza neuraminidase inhibitors currently available. Peramivir was approved for manufacturing and marketing in Japan in January 2010. We conducted a drug use investigation of peramivir from October 2010 to February 2012 and evaluated its safety and effectiveness under routine clinical settings. We collected data of 1309 patients from 189 facilities across Japan and examined safety in 1174 patients and effectiveness in 1158 patients. In total, 143 adverse events were observed with an incidence rate of 7.33% (86/1174). Of these, 78 events were adverse drug reactions (ADRs) with an incidence rate of 4.34% (51/1174). The most frequently reported ADRs were diarrhea, vomiting, and nausea, with incidence rates of 1.87% (22/1174), 0.85% (10/1174), and 0.68% (8/1174), respectively. Moreover, no ADR was reported as serious. ADR onset was within 3 days after the start of peramivir administration in 91.0% (71 events) of the 78 ADRs, and ADRs were resolved or improved within 7 days after onset in 96.2% (75 events) of the 78 ADRs. Neither patient characteristics nor treatment factors appeared to significantly affect drug safety. With regard to effectiveness, the median time to alleviation of both influenza symptoms and fever was 3 days, including the first day of administration. The present study demonstrates the safety and effectiveness of peramivir under routine clinical settings. Copyright © 2014 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Considerations for the nonclinical safety evaluation of antibody drug conjugates for oncology.

Science.gov (United States)

Roberts, Stanley A; Andrews, Paul A; Blanset, Diann; Flagella, Kelly M; Gorovits, Boris; Lynch, Carmel M; Martin, Pauline L; Kramer-Stickland, Kimberly; Thibault, Stephane; Warner, Garvin

2013-12-01

Antibody drug conjugates (ADCs) include monoclonal antibodies that are linked to cytotoxic small molecules. A number of these agents are currently being developed as anti-cancer agents designed to improve the therapeutic index of the cytotoxin (i.e., cytotoxic small molecule or cytotoxic agent) by specifically delivering it to tumor cells. This paper presents primary considerations for the nonclinical safety evaluation of ADCs and includes strategies for the evaluation of the entire ADC or the various individual components (i.e., antibody, linker or the cytotoxin). Considerations are presented on how to design a nonclinical safety assessment program to identify the on- and off-target toxicities to enable first-in-human (FIH) studies. Specific discussions are also included that provide details as to the need and how to conduct the studies for evaluating ADCs in genetic toxicology, tissue cross-reactivity, safety pharmacology, carcinogenicity, developmental and reproductive toxicology, biotransformation, toxicokinetic monitoring, bioanalytical assays, immunogenicity testing, test article stability and the selection of the FIH dose. Given the complexity of these molecules and our evolving understanding of their properties, there is no single all-encompassing nonclinical strategy. Instead, each ADC should be evaluated on a case-by-case scientifically-based approach that is consistent with ICH and animal research guidelines. Copyright © 2013 Elsevier Inc. All rights reserved.

75 FR 56548 - Joint Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee and the Drug...

Science.gov (United States)

2010-09-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee and the Drug Safety... and Central Nervous System Drugs Advisory Committee and the Drug Safety and Risk Management Advisory...

Drug interactions in African herbal remedies.

Science.gov (United States)

Cordier, Werner; Steenkamp, Vanessa

2011-01-01

Herbal usage remains popular as an alternative or complementary form of treatment, especially in Africa. However, the misconception that herbal remedies are safe due to their "natural" origins jeopardizes human safety, as many different interactions can occur with concomitant use with other pharmaceuticals on top of potential inherent toxicity. Cytochrome P450 enzymes are highly polymorphic, and pose a problem for pharmaceutical drug tailoring to meet an individual's specific metabolic activity. The influence of herbal remedies further complicates this. The plants included in this review have been mainly researched for determining their effect on cytochrome P450 enzymes and P-glycoprotein drug transporters. Usage of herbal remedies, such as Hypoxis hemerocallidea, Sutherlandia frutescens and Harpagophytum procumbensis popular in Africa. The literature suggests that there is a potential for drug-herb interactions, which could occur through alterations in metabolism and transportation of drugs. Research has primarily been conducted in vitro, whereas in vivo data are lacking. Research concerning the effect of African herbals on drug metabolism should also be approached, as specific plants are especially popular in conjunction with certain treatments. Although these interactions can be beneficial, the harm they pose is just as great.

24 CFR 21.225 - What actions must I take concerning employees who are convicted of drug violations in the workplace?

Science.gov (United States)

2010-04-01

... calendar days of learning about an employee's conviction, you must either— (1) Take appropriate personnel... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false What actions must I take concerning employees who are convicted of drug violations in the workplace? 21.225 Section 21.225 Housing and Urban...

Prescription drug samples--does this marketing strategy counteract policies for quality use of medicines?

Science.gov (United States)

Groves, K E M; Sketris, I; Tett, S E

2003-08-01

Prescription drug samples, as used by the pharmaceutical industry to market their products, are of current interest because of their influence on prescribing, and their potential impact on consumer safety. Very little research has been conducted into the use and misuse of prescription drug samples, and the influence of samples on health policies designed to improve the rational use of medicines. This is a topical issue in the prescription drug debate, with increasing costs and increasing concerns about optimizing use of medicines. This manuscript critically evaluates the research that has been conducted to date about prescription drug samples, discusses the issues raised in the context of traditional marketing theory, and suggests possible alternatives for the future.

Drug-eluting stents to prevent stent thrombosis and restenosis.

Science.gov (United States)

Im, Eui; Hong, Myeong-Ki

2016-01-01

Although first-generation drug-eluting stents (DES) have significantly reduced the risk of in-stent restenosis, they have also increased the long-term risk of stent thrombosis. This safety concern directly triggered the development of new generation DES, with innovations in stent platforms, polymers, and anti-proliferative drugs. Stent platform materials have evolved from stainless steel to cobalt or platinum-chromium alloys with an improved strut design. Drug-carrying polymers have become biocompatible or biodegradable and even polymer-free DES were introduced. New limus-family drugs (such as everolimus, zotarolimus or biolimus) were adopted to enhance stent performances. As a result, these new DES demonstrated superior vascular healing responses on intracoronary imaging studies and lower stent thrombotic events in actual patients. Recently, fully-bioresorbable stents (scaffolds) have been introduced, and expanding their applications. In this article, the important concepts and clinical results of new generation DES and bioresorbable scaffolds are described.

Report for spreading culture of medical radiation safety in Korea: Mainly the activities of the Korean alliance for radiation safety and culture in medicine (KARSM)

International Nuclear Information System (INIS)

Yoon, Yong Su; Kim, Jung Min; Kim, Ji Hyun; Choi, In Seok; Sung, Dong Wook; Do, Kyung Hyun; Jung, Seung Eun; Kim, Hyung Soo

2013-01-01

There are many concerns about radiation exposure in Korea after Fukushima Nuclear Plant Accident on 2011 in Japan. As some isotope materials are detected in Korea, people get worried about the radioactive material. In addition, the mass media create an air of anxiety that jump on the people’s fear instead of scientific approach. Therefore, for curbing this flow, health, medical institute from the world provide a variety of information about medical radiation safety and hold the campaign which can give people the image that medical radiation is safe. At this, the Korean Food and Drug Administration(KFDA) suggested that make the alliance of medical radiation safety and culture on August, 2011. Seven societies and institutions related medical radiation started to research and advertise the culture of medical radiation safety in Korea. In this report, mainly introduce the activities of the Korean Alliance for Radiation Safety and Culture in Medicine(KARSM) for spreading culture of medical radiation safety from 2011 to 2012

Report for spreading culture of medical radiation safety in Korea: Mainly the activities of the Korean alliance for radiation safety and culture in medicine (KARSM)

Energy Technology Data Exchange (ETDEWEB)

Yoon, Yong Su; Kim, Jung Min; Kim, Ji Hyun; Choi, In Seok [Dept. of Radiologic Science, Korea University, Seoul (Korea, Republic of); Sung, Dong Wook [Dept. of Radiology, Kyunghee University Hospital, Seoul (Korea, Republic of); Do, Kyung Hyun [Dept. of Radiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul (Korea, Republic of); Jung, Seung Eun [Dept. of Radiology, College of Medicine, The Catholic University of Korea, Seoul (Korea, Republic of); Kim, Hyung Soo [Dept. of Radiation Safety, National Institute of Food and Drug Safety Evaluation, Korea Food and Drug Administration, Seoul (Korea, Republic of)

2013-09-15

There are many concerns about radiation exposure in Korea after Fukushima Nuclear Plant Accident on 2011 in Japan. As some isotope materials are detected in Korea, people get worried about the radioactive material. In addition, the mass media create an air of anxiety that jump on the people’s fear instead of scientific approach. Therefore, for curbing this flow, health, medical institute from the world provide a variety of information about medical radiation safety and hold the campaign which can give people the image that medical radiation is safe. At this, the Korean Food and Drug Administration(KFDA) suggested that make the alliance of medical radiation safety and culture on August, 2011. Seven societies and institutions related medical radiation started to research and advertise the culture of medical radiation safety in Korea. In this report, mainly introduce the activities of the Korean Alliance for Radiation Safety and Culture in Medicine(KARSM) for spreading culture of medical radiation safety from 2011 to 2012.

Anesthetic drug wastage in the operation room: A cause for concern

Directory of Open Access Journals (Sweden)

Kapil Chaudhary

2012-01-01

Full Text Available Context: The cost of anesthetic technique has three main components, i.e., disposable supplies, equipments, and anesthetic drugs. Drug budgets are an easily identifiable area for short-term savings. Aim: To assess and estimate the amount of anesthetic drug wastage in the general surgical operation room. Also, to analyze the financial implications to the hospital due to drug wastage and suggest appropriate steps to prevent or minimize this wastage. Settings and Design: A prospective observational study conducted in the general surgical operation room of a tertiary care hospital. Materials and Methods: Drug wastage was considered as the amount of drug left unutilized in the syringes/vials after completion of a case and any ampoule or vial broken while loading. An estimation of the cost of wasted drug was made. Results: Maximal wastage was associated with adrenaline and lignocaine (100% and 93.63%, respectively. The drugs which accounted for maximum wastage due to not being used after loading into a syringe were adrenaline (95.24%, succinylcholine (92.63%, lignocaine (92.51%, mephentermine (83.80%, and atropine (81.82%. The cost of wasted drugs for the study duration was 46.57% (Rs. 16,044.01 of the total cost of drugs issued/loaded (Rs. 34,449.44. Of this, the cost of wastage of propofol was maximum being 56.27% (Rs. 9028.16 of the total wastage cost, followed by rocuronium 17.80% (Rs. 2856, vecuronium 5.23% (Rs. 840, and neostigmine 4.12% (Rs. 661.50. Conclusions: Drug wastage and the ensuing financial loss can be significant during the anesthetic management of surgical cases. Propofol, rocuronium, vecuronium, and neostigmine are the drugs which contribute maximally to the total wastage cost. Judicious use of these and other drugs and appropriate prudent measures as suggested can effectively decrease this cost.

Prescription Drugs, Over-the-Counter Drugs, Supplements and Herbal Products

Science.gov (United States)

... at risk? Zika virus and pregnancy Folic acid Medicine safety and pregnancy Birth defects prevention Learn how ... the-counter drugs, supplements and herbal products Prescription drugs, over-the-counter drugs, supplements and herbal products ...

Clinical Relation Extraction Toward Drug Safety Surveillance Using Electronic Health Record Narratives: Classical Learning Versus Deep Learning.

Science.gov (United States)

Munkhdalai, Tsendsuren; Liu, Feifan; Yu, Hong

2018-04-25

Medication and adverse drug event (ADE) information extracted from electronic health record (EHR) notes can be a rich resource for drug safety surveillance. Existing observational studies have mainly relied on structured EHR data to obtain ADE information; however, ADEs are often buried in the EHR narratives and not recorded in structured data. To unlock ADE-related information from EHR narratives, there is a need to extract relevant entities and identify relations among them. In this study, we focus on relation identification. This study aimed to evaluate natural language processing and machine learning approaches using the expert-annotated medical entities and relations in the context of drug safety surveillance, and investigate how different learning approaches perform under different configurations. We have manually annotated 791 EHR notes with 9 named entities (eg, medication, indication, severity, and ADEs) and 7 different types of relations (eg, medication-dosage, medication-ADE, and severity-ADE). Then, we explored 3 supervised machine learning systems for relation identification: (1) a support vector machines (SVM) system, (2) an end-to-end deep neural network system, and (3) a supervised descriptive rule induction baseline system. For the neural network system, we exploited the state-of-the-art recurrent neural network (RNN) and attention models. We report the performance by macro-averaged precision, recall, and F1-score across the relation types. Our results show that the SVM model achieved the best average F1-score of 89.1% on test data, outperforming the long short-term memory (LSTM) model with attention (F1-score of 65.72%) as well as the rule induction baseline system (F1-score of 7.47%) by a large margin. The bidirectional LSTM model with attention achieved the best performance among different RNN models. With the inclusion of additional features in the LSTM model, its performance can be boosted to an average F1-score of 77.35%. It shows that

Biosensor: an emerging safety tool for meat industry.

Science.gov (United States)

Singh, Pradeep Kumar; Jairath, Gauri; Ahlawat, Satyavir Singh; Pathera, Ashok; Singh, Prashant

2016-04-01

The meat industry associated with the health hazards like deadly pathogens, veterinary drugs, pesticide residues, toxins and heavy metals is in need of a tool to tackle the awful situation and ensure safer product to consumer. The growth in the industry, global trade scenario, stringent laws and consumer awareness has placed an extra onus on the meat industry to meet out the expectations and demands. Biosensors are the latest tool of detection in the fast growing industries including the food industry. Hence an attempt is envisaged here to review the possibility of harnessing biosensors as tool of safety to safe guard the consumer health and address safety issues in reference to the common threats of concern in the meat industry.

Zero-inflated Poisson model based likelihood ratio test for drug safety signal detection.

Science.gov (United States)

Huang, Lan; Zheng, Dan; Zalkikar, Jyoti; Tiwari, Ram

2017-02-01

In recent decades, numerous methods have been developed for data mining of large drug safety databases, such as Food and Drug Administration's (FDA's) Adverse Event Reporting System, where data matrices are formed by drugs such as columns and adverse events as rows. Often, a large number of cells in these data matrices have zero cell counts and some of them are "true zeros" indicating that the drug-adverse event pairs cannot occur, and these zero counts are distinguished from the other zero counts that are modeled zero counts and simply indicate that the drug-adverse event pairs have not occurred yet or have not been reported yet. In this paper, a zero-inflated Poisson model based likelihood ratio test method is proposed to identify drug-adverse event pairs that have disproportionately high reporting rates, which are also called signals. The maximum likelihood estimates of the model parameters of zero-inflated Poisson model based likelihood ratio test are obtained using the expectation and maximization algorithm. The zero-inflated Poisson model based likelihood ratio test is also modified to handle the stratified analyses for binary and categorical covariates (e.g. gender and age) in the data. The proposed zero-inflated Poisson model based likelihood ratio test method is shown to asymptotically control the type I error and false discovery rate, and its finite sample performance for signal detection is evaluated through a simulation study. The simulation results show that the zero-inflated Poisson model based likelihood ratio test method performs similar to Poisson model based likelihood ratio test method when the estimated percentage of true zeros in the database is small. Both the zero-inflated Poisson model based likelihood ratio test and likelihood ratio test methods are applied to six selected drugs, from the 2006 to 2011 Adverse Event Reporting System database, with varying percentages of observed zero-count cells.

The impact of medicinal drugs on traffic safety: a systematic review of epidemiological studies.

Science.gov (United States)

Orriols, Ludivine; Salmi, Louis-Rachid; Philip, Pierre; Moore, Nicholas; Delorme, Bernard; Castot, Anne; Lagarde, Emmanuel

2009-08-01

To evaluate the quality of epidemiological research into effects of medicinal drugs on traffic safety and the current knowledge in this area. The bibliographic search was done in Medline electronic database using the keywords: ((accident* or crash*) and traffic and drug*) leading to 1141 references. Additional references were retrieved from the Safetylit website and the reference lists of selected studies. Original articles published in English or French, between 1 April 1979 and 31 July 2008, were considered for inclusion. We excluded descriptive studies, studies limited to alcohol or illicit drug involvement and investigations of injuries other than from traffic crashes. Studies based on laboratory tests, driving simulators or on-the-road driving tests were also excluded. Eligible studies had to evaluate the causal relationship between the use of medicinal drugs and the risk of traffic crashes. Study quality was assessed by two independent experts, according to a grid adapted from the strengthening the reporting of observational studies in epidemiology (STROBE) statement. Twenty two studies of variable methodological quality were included. Definition of drug exposure varied across studies and depended on the data sources. Potential confounding due to the interaction between the effects of the medicinal drug and disease-related symptoms was often not controlled. The risk of motor-vehicle crashes related to benzodiazepines has been amply studied and demonstrated. Results for other medicinal drugs remain controversial. There is a need for large studies, investigating the role of individual substances in the risk of road traffic crashes. Copyright 2009 John Wiley & Sons, Ltd.

Safety of Traditional Arab Herbal Medicine

Directory of Open Access Journals (Sweden)

Bashar Saad

2006-01-01

Full Text Available Herbal remedies are widely used for the treatment and prevention of various diseases and often contain highly active pharmacological compounds. Many medicinal herbs and pharmaceutical drugs are therapeutic at one dose and toxic at another. Toxicity related to traditional medicines is becoming more widely recognized as these remedies become popular in the Mediterranean region as well as worldwide. Most reports concerning the toxic effects of herbal medicines are associated with hepatotoxicity although reports of other toxic effects including kidney, nervous system, blood, cardiovascular and dermatologic effects, mutagenicity and carcinogenicity have also been published in the medical literature. This article presents a systematic review on safety of traditional Arab medicine and the contribution of Arab scholars to toxicology. Use of modern cell biological, biochemical, in vitro and in vivo techniques for the evaluation of medicinal plants safety is also discussed.

Radiation safety concerns during interventional radiology

International Nuclear Information System (INIS)

Victor Raj, D.; Livingstone, Roshan Samuel

2001-01-01

Interventional radiological procedures are on the increase by virtue of the fact that these procedures replace highly invasive surgical and other procedures. Radiation dose to patients and hospital workers are of significance since these procedures tend to impart large dose to them. Moreover, long term risk from radiation absorbed by patients is of concern since the life expectancy of major fraction of patients is long after undergoing the procedure. This study intends to measure radiation dose imparted to patients as well as personnel- radiologists, technologists, nurses, etc. and estimate the risk factor involved

Safety studies of homoeopathic drugs in acute, sub-acute and chronic toxicity in rats

Directory of Open Access Journals (Sweden)

Surender Singh

2017-01-01

Full Text Available Background: Homoeopathic drugs are frequently recommended in day to day life as therapeutic agents by homoeopathic practitioners. However, safety of homoeopathic drugs remains a challenge because of the high variability of chemical components involved. Aim: The objective of the present study was to investigate the acute, subacute, and chronic oral toxicity of different homoeopathic drugs (Ferrum phosphoricum 3X, Ferrum phosphoricum 6X, Calcarea phosphoricum 6X, and Magnesium phosphoricum 6X in experimental models. Materials and Methods: In acute oral toxicity study, homoeopathic drugs were administered orally at 2000mg/kg body weight, and animals were observed for toxic symptoms till 10 days as per the OECD guidelines. For subacute and chronic toxicity study, homoeopathic drugs were administered for 28 and 180 days, respectively, as per the OECD guidelines. At the end of 28 and 180 days, the animals were sacrificed and toxicity parameters were assessed. Histopathological evaluation of different organs was also performed to assess any toxicity. Results: In acute toxicity study, no mortality was found at a dose of 2000 mg/kg which indicates that oral LD50of homoeopathic drugs were more than 2000 mg/kg. The administration of drugs at a dose of 70 mg/kg body weight for 28 and 180 days did not produce any significant change in haematological and biochemical parameters of male and female rats as compared to normal control group. No pathological changes were observed in histology of various organs of treated rats as compared to normal control animals. Conclusion: These homoeopathic drugs are safe & produce no toxicity when administered for longer duration.

77 FR 44256 - Draft Guidance for Industry and Food and Drug Administration Staff; Safety Considerations for 510...

Science.gov (United States)

2012-07-27

...] Draft Guidance for Industry and Food and Drug Administration Staff; Safety Considerations for 510(k... serious and sometimes fatal consequences to patients. This guidance provides recommendations to 510(k... unintended connections between enteral and nonenteral devices. This draft guidance is not final nor is it in...

Applications of Dynamic Clamp to Cardiac Arrhythmia Research: Role in Drug Target Discovery and Safety Pharmacology Testing

Directory of Open Access Journals (Sweden)

Francis A. Ortega

2018-01-01

Full Text Available Dynamic clamp, a hybrid-computational-experimental technique that has been used to elucidate ionic mechanisms underlying cardiac electrophysiology, is emerging as a promising tool in the discovery of potential anti-arrhythmic targets and in pharmacological safety testing. Through the injection of computationally simulated conductances into isolated cardiomyocytes in a real-time continuous loop, dynamic clamp has greatly expanded the capabilities of patch clamp outside traditional static voltage and current protocols. Recent applications include fine manipulation of injected artificial conductances to identify promising drug targets in the prevention of arrhythmia and the direct testing of model-based hypotheses. Furthermore, dynamic clamp has been used to enhance existing experimental models by addressing their intrinsic limitations, which increased predictive power in identifying pro-arrhythmic pharmacological compounds. Here, we review the recent advances of the dynamic clamp technique in cardiac electrophysiology with a focus on its future role in the development of safety testing and discovery of anti-arrhythmic drugs.

Nuclear safety in France in 2001

International Nuclear Information System (INIS)

Anon.

2002-01-01

This article presents the milestones of 2001 concerning nuclear safety in France: 1) the new organization of nuclear safety in France, IPSN (institute of protection and nuclear safety) and OPRI (office for protection against ionizing radiation) have merged into an independent organization: IRSN (institute of radiation protection and nuclear safety); 2) a draft bill has been proposed by the government to impose to nuclear operators new obligations concerning the transfer of information to the public; 3) nuclear safety authorities have drafted a new procedure in order to cope with the demand concerning modification of nuclear fuel management particularly the increase of the burn-up; 4) new evolutions concerning the management of a major nuclear crisis as a consequence of the terrorist attack on New-york and the accident at the AZF plant in Toulouse; 5) a point is made concerning the work of the WENRA association about the harmonization of the nuclear safety policies of its different members. (A.C.)

Patient safety in the care of mentally ill people in Switzerland: Action plan 2016

Science.gov (United States)

Richard, Aline; Mascherek, Anna C; Schwappach, David L B

2017-01-01

Background: Patient safety in mental healthcare has not attracted great attention yet, although the burden and the prevalence of mental diseases are high. The risk of errors with potential for harm of patients, such as aggression against self and others or non-drug treatment errors is particularly high in this vulnerable group. Aim: To develop priority topics and strategies for action to foster patient safety in mental healthcare. Method: The Swiss patient safety foundation together with experts conducted round table discussions and a Delphi questionnaire to define topics along the treatment pathway, and to prioritise these topics. Finally, fields of action were developed. Results: An action plan was developed including the definition and prioritization of 9 topics where errors may occur. A global rating task revealed errors concerning diagnostics and structural errors as most important. This led to the development of 4 fields of action (awareness raising, research, implementation, and education and training) including practice-oriented potential starting points to enhance patient safety. Conclusions: The action plan highlights issues of high concern for patient safety in mental healthcare. It serves as a starting point for the development of strategies for action as well as of concrete activities.

Data-driven drug safety signal detection methods in pharmacovigilance using electronic primary care records: A population based study

Directory of Open Access Journals (Sweden)

Shang-Ming Zhou

2017-04-01

Data-driven analytic methods are a valuable aid to signal detection of ADEs from large electronic health records for drug safety monitoring. This study finds the methods can detect known ADE and so could potentially be used to detect unknown ADE.

Placental Drug Transport-on-a-Chip: A Microengineered In Vitro Model of Transporter-Mediated Drug Efflux in the Human Placental Barrier.

Science.gov (United States)

Blundell, Cassidy; Yi, Yoon-Suk; Ma, Lin; Tess, Emily R; Farrell, Megan J; Georgescu, Andrei; Aleksunes, Lauren M; Huh, Dongeun

2018-01-01

The current lack of knowledge about the effect of maternally administered drugs on the developing fetus is a major public health concern worldwide. The first critical step toward predicting the safety of medications in pregnancy is to screen drug compounds for their ability to cross the placenta. However, this type of preclinical study has been hampered by the limited capacity of existing in vitro and ex vivo models to mimic physiological drug transport across the maternal-fetal interface in the human placenta. Here the proof-of-principle for utilizing a microengineered model of the human placental barrier to simulate and investigate drug transfer from the maternal to the fetal circulation is demonstrated. Using the gestational diabetes drug glyburide as a model compound, it is shown that the microphysiological system is capable of reconstituting efflux transporter-mediated active transport function of the human placental barrier to limit fetal exposure to maternally administered drugs. The data provide evidence that the placenta-on-a-chip may serve as a new screening platform to enable more accurate prediction of drug transport in the human placenta. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Dabigatran - Metabolism, Pharmacologic Properties and Drug Interactions.

Science.gov (United States)

Antonijevic, Nebojsa M; Zivkovic, Ivana D; Jovanovic, Ljubica M; Matic, Dragan M; Kocica, Mladen J; Mrdovic, Igor B; Kanjuh, Vladimir I; Culafic, Milica D

2017-01-01

The superiority of dabigatran has been well proven in the standard dosing regimen in prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) and extended venous thromboembolism (VTE) treatment. Dabigatran, an anticoagulant with a good safety profile, reduces intracranial bleeding in patients with atrial fibrillation and decreases major and clinically relevant non-major bleeding in acute VTE treatment. However, several important clinical issues are not fully covered by currently available directions with regard to dabigatran administration. The prominent one is reflected in the fact that dynamic impairment in renal function due to dehydratation may lead to haemorragic complications on the one hand, while on the other hand glomerular hyperfiltration may be a possible cause of dabigatran subdosing, hence reducing the drug's efficacy. Furthermore, limitations of the Cockcroft-Gault formula, considered a standard equation for assessing the renal function, may imply that other calculations are likely to obtain more accurate estimates of the kidney function in specific patient populations. Method and Conclusions: Although not routinely recommended, a possibility of monitoring dabigatran in special clinical settings adds to optimization of its dosage regimens, timely perioperative care and administration of urgently demanded thrombolytic therapy, therefore significantly improving this drug's safety profile. Despite the fact that dabigatran has fewer reported interactions with drugs, food constituents, and dietary supplements, certain interactions still remain, requiring considerable caution, notably in elderly, high bleeding risk patients, patients with decreased renal function and those on complex drug regimens. Additionally, upon approval of idarucizumab, an antidote to dabigatran solution, hitherto being a major safety concern, has been finally reached, which plays a vital role in life-threatening bleeding and emergency

[HERA-QUEST: HTA evaluation of generic pharmaceutical products to improve quality, economic efficiency, patient safety and transparency in drug product changes in hospitals].

Science.gov (United States)

Gyalrong-Steur, Miriam; Kellermann, Anita; Bernard, Rudolf; Berndt, Georg; Bindemann, Meike; Nusser-Rothermundt, Elfriede; Amann, Steffen; Brakebusch, Myga; Brüggmann, Jörg; Tydecks, Eva; Müller, Markus; Dörje, Frank; Kochs, Eberhard; Riedel, Rainer

2017-04-01

In view of the rising cost pressure and an increasing number of drug shortages, switches between generic drug preparations have become a daily routine in hospitals. To ensure consistently high treatment quality and best possible patient safety, the equivalence of the new and the previous drug preparation must be ensured before any change in the purchase of pharmaceutical products takes place. So far, no easily usable, transparent and standardized instrument for this kind of comparison between generic drug products has been available. A group of pharmaceutical experts has developed the drug HTA (health technology assessment) model "HERA" (HTA Evaluation of geneRic phArmaceutical products) through a multi-step process. The instrument is designed to perform both a qualitative and economic comparison of equivalent drug preparations ("aut idem" substitution) before switching products. The economic evaluation does not only consider unit prices and consumption quantity, but also the processing costs associated with a product change process. The qualitative comparison is based on the evaluation of 34 quality criteria belonging to six evaluation fields (e.g., approval status, practical handling, packaging design). The objective evaluation of the quality criteria is complemented by an assessment of special features of the individual hospital for complex drug switches, including the feedback of the physicians utilizing the drug preparation. Thus potentially problematic switches of pharmaceutical products can be avoided at the best possible rate, contributing to the improvement of patient safety. The novel drug HTA model HERA is a tool used in clinical practice that can add to an increase in quality, therapeutic safety and transparency of drug use while simultaneously contributing to the economic optimization of drug procurement in hospitals. Combining these two is essential for hospitals facing the tension between rising cost pressure and at the same time increasing demands

Raspberry ketone in food supplements – High intake, few toxicity data – A cause for safety concern?

DEFF Research Database (Denmark)

Bredsdorff, Lea; Wedebye, Eva Bay; Nikolov, Nikolai Georgiev

2015-01-01

Raspberry ketone (4-(4-hydroxyphenyl)-2-butanone) is marketed on the Internet as a food supplement. The recommended intake is between 100 and 1400 mg per day. The substance is naturally occurring in raspberries (up to 4.3 mg/kg) and is used as a flavouring substance. Toxicological studies...... on raspberry ketone are limited to acute and subchronic studies in rats. When the lowest recommended daily dose of raspberry ketone (100 mg) as a food supplement is consumed, it is 56 times the established threshold of toxicological concern (TTC) of 1800 μg/day for Class 1 substances. The margin of safety (MOS......) based on a NOAEL of 280 mg/kg bw/day for lower weight gain in rats is 165 at 100 mg and 12 at 1400 mg. The recommended doses are a concern taking into account the TTC and MOS. Investigations of raspberry ketone in quantitative structure-activity relationship (QSAR) models indicated potential cardiotoxic...

Ethical concerns and career satisfaction in obstetrics and gynecology: a review of recent findings from the Collaborative Ambulatory Research Network.

Science.gov (United States)

Farrow, Victoria A; Leddy, Meaghan A; Lawrence, Hal; Schulkin, Jay

2011-09-01

Obstetricians-gynecologists (ob-gyns) are frequently confronted with situations that have ethical implications (e.g., whether to accept gifts or samples from drug companies or disclosing medical errors to patients). Additionally, various factors, including specific job-related tasks, costs, and benefits, may impact ob-gyns' career satisfaction. Ethical concerns and career satisfaction can play a role in the quality of women's health care. This article summarizes the studies published between 2005 and 2009 by the Research Department of the American College of Obstetricians and Gynecologists, which encompass ethical concerns regarding interactions with pharmaceutical representatives and patient safety/medical error reporting, as well as ob-gyn career satisfaction. Additionally, a brief discussion regarding ethical concerns in the ob-gyn field, in general, highlights key topics for the last 30 years. Ethical dilemmas continue to be of concern for ob-gyns. Familiarity with guidelines on appropriate interactions with industry is associated with lower percentages of potentially problematic relationships with pharmaceutical industries. Physicians report that the expense of patient safety initiatives is one of the top barriers for improving patient safety, followed by fear of liability. Overall, respondents reported being satisfied with their careers. However, half of the respondents reported that they were extremely concerned about the impact of professional liability costs on the duration of their careers. Increased familiarity with guidelines may lead to a decreased ob-gyn reliance on pharmaceutical representatives and free samples, whereas specific and practical tools may help them implement patient safety techniques. The easing of malpractice insurance and threat of litigation may enhance career satisfaction among ob-gyns. This article will discuss related findings in recent years. Obstetricians & Gynecologists and Family Physicians. After the completing the CME

Brief report: Associations between in-person and electronic bullying victimization and missing school because of safety concerns among U.S. high school students.

Science.gov (United States)

Steiner, Riley J; Rasberry, Catherine N

2015-08-01

Although associations between bullying and health risk behaviors are well-documented, research on bullying and education-related outcomes, including school attendance, is limited. This study examines associations between bullying victimization (in-person and electronic) and missing school because of safety concerns among a nationally representative sample of U.S. high school students. We used logistic regression analyses to analyze data from the 2013 national Youth Risk Behavior Survey of students in grades 9-12. In-person and electronic victimization were each associated with increased odds of missing school due to safety concerns compared to no bullying victimization. Having been bullied both in-person and electronically was associated with greater odds of missing school compared to electronic bullying only for female students and in-person bullying only for male students. Collaborations between health professionals and educators to prevent bullying may improve school attendance. Published by Elsevier Ltd.

Patients' concern about their medicine after a generic switch

DEFF Research Database (Denmark)

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

2014-01-01

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

Ocular Drug Delivery Barriers—Role of Nanocarriers in the Treatment of Anterior Segment Ocular Diseases

Science.gov (United States)

Bachu, Rinda Devi; Chowdhury, Pallabitha; Al-Saedi, Zahraa H. F.; Karla, Pradeep K.; Boddu, Sai H. S.

2018-01-01

Ocular drug delivery is challenging due to the presence of anatomical and physiological barriers. These barriers can affect drug entry into the eye following multiple routes of administration (e.g., topical, systemic, and injectable). Topical administration in the form of eye drops is preferred for treating anterior segment diseases, as it is convenient and provides local delivery of drugs. Major concerns with topical delivery include poor drug absorption and low bioavailability. To improve the bioavailability of topically administered drugs, novel drug delivery systems are being investigated. Nanocarrier delivery systems demonstrate enhanced drug permeation and prolonged drug release. This review provides an overview of ocular barriers to anterior segment delivery, along with ways to overcome these barriers using nanocarrier systems. The disposition of nanocarriers following topical administration, their safety, toxicity and clinical trials involving nanocarrier systems are also discussed. PMID:29495528

Report transparency and nuclear safety 2007 - CISBIO; Rapport transparence et securite nucleaire 2007 - CISBIO

Energy Technology Data Exchange (ETDEWEB)

NONE

2007-07-01

This report presents the activities of CISBIO, nuclear base installation, for the year 2007. CISBIO realizes at Saclay most of the radiopharmaceuticals and drugs distributed in France for the nuclear medicine. The actions concerning the safety, the radiation protection, the significant events, the release control and the environmental impacts and the wastes stored on the center are discussed. (A.L.B.)

Surveys of research projects concerning nuclear facility safety, financed by the Federal Ministry for the Environment, Nature Protection and Reactor Safety, 1989. (14. annual report on SR-projects)

International Nuclear Information System (INIS)

1990-11-01

Each progress report is a collection of individual reports, categorized by subject matter. They are a documentation of the contractor's progress, rendered by themselves on standardized forms, published, for the sake of general information on progress made in investigations concerning reactor safety, by the project attendance department of the GRS. The individual reports have serial numbers. Each report includes particulars of the objective, work carried out, results obtained and plans for project continuation. (orig.) [de

Exposures Resulting in Safety and Health Concerns for Child Laborers in Less Developed Countries

Directory of Open Access Journals (Sweden)

Derek G. Shendell

2016-01-01

Full Text Available Objectives. Worldwide, over 200 million children are involved in child labor, with another 20 million children subjected to forced labor, leading to acute and chronic exposures resulting in safety and health (S&H risks, plus removal from formal education and play. This review summarized S&H issues in child labor, including forced or indentured domestic labor as other sectors of child labor. Specifically, we focused on exposures leading to S&H risks. Methods. We used PubMed, Scopus, Science Direct, and Google Scholar. References were in English, published in 1990–2015, and included data focused on exposures and S&H concerns of child labor. Results. Seventy-six journal articles were identified, 67 met criteria, 57 focused on individual countries, and 10 focused on data from multiple countries (comparing 3–83 countries. Major themes of concern were physical exposures including ergonomic hazards, chemical exposure hazards, and missed education. Childhood labor, especially forced, exploitative labor, created a significant burden on child development, welfare, and S&H. Conclusions. More field researche data emphasizing longitudinal quantitative effects of exposures and S&H risks are needed. Findings warranted developing policies and educational interventions with proper monitoring and evaluation data collection, plus multiple governmental, international organization and global economic reform efforts, particularly in lower-income, less developed countries.

AtriplaR/anti-TB combination in TB/HIV patients. Drug in focus

Directory of Open Access Journals (Sweden)

Semvua Hadija H

2011-11-01

Full Text Available Abstract Background Co-administration of anti-tuberculosis and antiretroviral therapy is often inevitable in high-burden countries where tuberculosis is the most common opportunistic infection associated with HIV/AIDS. Concurrent use of rifampicin and several antiretroviral drugs is complicated by pharmacokinetic drug-drug interaction. Method Pubmed and Google search following the key words tuberculosis, HIV, emtricitabine, tenofovir efavirenz, interaction were used to find relevant information on each drug of the fixed dose combination AtriplaR Results Information on generic name, trade name, pharmacokinetic parameter, metabolism and the pharmacokinetic interaction with Anti-TB drugs of emtricitabine, tenofovir, and efavirenz was obtained. Conclusion Fixed dose combination of emtricitabine/tenofovir/efavirenz (ATRIPLAR which has been approved by Food and Drug Administration shows promising results as far as safety and efficacy is concerned in TB/HIV co-infection patients, hence can be considered effective and safe antiretroviral drug in TB/HIV management for adult and children above 3 years of age.

Safety and proliferation concerns as constraints on nuclear power

International Nuclear Information System (INIS)

Gordon, L.

1981-01-01

Issues of safety and proliferation with respect to the nuclear option are discussed in this chapter. The basic premises underlying the author's analysis are: energy supply and use is a means to promote desired forms of development and not an end in itself; avoidance of nuclear mysticiam; avoidance of permanent discrimination; recognition of incommensurables; technological sophistication; and nuclear proliferation motivations apart from nuclear power development. A rational energy planner in a developing country will have to weigh carefully the interwoven factors of comparative costs and safety. Apart from cost considerations, the principal motivation for developing nuclear power is energy security

Issues in the management of acute agitation: how much current guidelines consider safety?

Directory of Open Access Journals (Sweden)

Bruno ePacciardi

2013-05-01

Full Text Available Agitated behavior constitutes up to 10% of emergency psychiatric interventions. Pharmacological tranquilization is often used as a valid treatment for agitation but a strong evidence base does not underpin it. Available literature shows different recommendations, supported by research data, theoretical considerations or clinical experience. Rapid tranquilization is mainly based on parenteral drug treatment and the few existing guidelines on this topic, when suggesting the use of first generation antipsychotics and benzodiazepines, include drugs with questionable tolerability profile such as chlorpromazine, haloperidol, midazolam and lorazepam. In order to systematically evaluate safety concerns related to the adoption of such guidelines, we reviewed them independently from principal diagnosis while examining tolerability data for suggested treatments. There is a growing evidence about safety profile of second generation antipsychotics for rapid tranquilization but further controlled studies providing definitive data in this area are urgently needed.

Machine and Woodworking Tool Safety. Module SH-24. Safety and Health.

Science.gov (United States)

Center for Occupational Research and Development, Inc., Waco, TX.

This student module on machine and woodworking tool safety is one of 50 modules concerned with job safety and health. This module discusses specific practices and precautions concerned with the efficient operation and use of most machine and woodworking tools in use today. Following the introduction, 13 objectives (each keyed to a page in the…

A Cost Analysis of Hospitalizations for Infections Related to Injection Drug Use at a County Safety-Net Hospital in Miami, Florida

OpenAIRE

Tookes, Hansel; Diaz, Chanelle; Li, Hua; Khalid, Rafi; Doblecki-Lewis, Susanne

2015-01-01

Background Infections related to injection drug use are common. Harm reduction strategies such as syringe exchange programs and skin care clinics aim to prevent these infections in injection drug users (IDUs). Syringe exchange programs are currently prohibited by law in Florida. The goal of this study was to estimate the mortality and cost of injection drug use-related bacterial infections over a 12-month period to the county safety-net hospital in Miami, Florida. Additionally, the prevalence...

Metabolism of designer drugs of abuse.

Science.gov (United States)

Staack, Roland F; Maurer, Hans H

2005-06-01

Abuse of designer drugs is widespread among young people, especially in the so-called "dance club scene" or "rave scene", worldwide. Severe and even fatal poisonings have been attributed to the consumption of such drugs of abuse. However, in contrast to new medicaments, which are extensively studied in controlled clinical studies concerning metabolism, including cytochrome P450 isoenzyme differentiation, and further pharmacokinetics, designer drugs are consumed without any safety testing. This paper reviews the metabolism of new designer drugs of abuse that have emerged on the black market during the last years. Para-methoxyamphetamine (PMA), para-methoxymethamphetamine (PMMA) and 4-methylthioamphetamine (4-MTA), were taken into consideration as new "classical" amphetamine-derived designer drugs. Furthermore, N-benzylpiperazine (BZP), 1-(3, 4-methylenedioxybenzyl)piperazine (MDBP), 1-(3-trifluoromethylphenyl)piperazine (TFMPP), 1-(3-chlorophenyl)piperazine (mCPP) and 1-(4-methoxyphenyl)piperazine (MeOPP) were taken into consideration as derivatives of the class of piperazine-derived designer drugs, as well as alpha-pyr-rolidinopropiophenone (PPP), 4'-methoxy-alpha-pyrrolidinopropiophenone (MOPPP), 3', 4'-methylenedioxy-alpha-pyrrolidino-propiophenone (MDPPP), 4'-methyl-alpha-pyrrolidinopropiophenone (MPPP), and 4'-methyl-alpha-pyrrolidinoexanophenone (MPHP) as derivatives of the class of alpha-pyrrolidinophenone-derived designer drugs. Papers describing identification of in vivo or in vitro human or animal metabolites and cytochrome P450 isoenzyme dependent metabolism have been considered and summarized.

Safety, training focus of combined organization

Energy Technology Data Exchange (ETDEWEB)

Toop, L.

2006-03-15

This article presented details of Enform, a company that coordinates safety programs and training for new employees in the oil and gas industry. Enform was created when the Petroleum Industry Training Services merged with the Canadian Petroleum Safety Council. The aim of Enform is to ensure continuous improvements in health and safety within the industry by reducing working injuries and promoting health and safety practices. The companies merged to eliminate duplication of services and allow associates further opportunities for advanced training. In 2005, Enform trained an estimated 155,000 students, and a number of new courses were introduced and updated. A franchise program was extended and a training council was formed to offer direction and guidance to the oil industry. Enform focuses on sharing information among companies, as well as working to harmonize safety regulations across provincial borders. A task force was recently created by the company with a specific focus on drug and alcohol abuse. Other concerns include driver safety and driver interactions with wildlife. Enform is mainly focused on the traditional oil industry, and has had little entry into the oil sands industry. It was concluded that increased activity in the oil and gas industry will remain Enform's biggest challenge in the next few years. Plans for Enform's increased involvement in the offshore oil and gas industry were also discussed. 4 figs.

Drug repurposing based on drug-drug interaction.

Science.gov (United States)