Monitoring the efficacy of drugs for neglected tropical diseases controlled by preventive chemotherapy

PubMed Central

Albonico, M.; Levecke, B.; LoVerde, P.T.; Montresor, A.; Prichard, R.; Vercruysse, J.; Webster, J.P.

2017-01-01

In the last decade, pharmaceutical companies, governments and global health organisations under the leadership of the World Health Organization (WHO) have pledged large-scale donations of anthelmintic drugs, including ivermectin (IVM), praziquantel (PZQ), albendazole (ALB) and mebendazole (MEB). This worldwide scale-up in drug donations calls for strong monitoring systems to detect any changes in anthelmintic drug efficacy. This review reports on the outcome of the WHO Global Working Group on Monitoring of Neglected Tropical Diseases Drug Efficacy, which consists of three subgroups: (i) soil-transmitted helminthiases (ALB and MEB); (ii) onchocerciasis and lymphatic filariasis (IVM); and (iii) schistosomiasis (PZQ). Progress of ongoing work, challenges and research needs for each of the four main drugs used in helminthic preventive chemotherapy (PC) are reported, laying the ground for appropriate implementation of drug efficacy monitoring programmes under the co-ordination and guidelines of the WHO. Best practices for monitoring drug efficacy should be made available and capacity built as an integral part of neglected tropical disease (NTD) programme monitoring. Development of a disease-specific model to predict the impact of PC programmes, to detect outliers and to solicit responses is essential. Research studies on genetic polymorphisms in relation to low-efficacy phenotypes should be carried out to identify markers of putative resistance against all NTD drugs and ultimately to develop diagnostic assays. Development of combination and co-administration of NTD drugs as well as of new drug entities to boost the armamentarium of the few drugs available for NTD control and elimination should be pursued in parallel. PMID:27842865

Examining the pathways for young people with drug and alcohol dependence: a mixed-method design to examine the role of a treatment programme

PubMed Central

Nathan, Sally; Rawstorne, Patrick; Hayen, Andrew; Bryant, Joanne; Baldry, Eileen; Ferry, Mark; Williams, Megan; Shanahan, Marian; Jayasinha, Ranmalie

2016-01-01

Introduction Young people with drug and alcohol problems are likely to have poorer health and other psychosocial outcomes than other young people. Residential treatment programmes have been shown to lead to improved health and related outcomes for young people in the short term. There is very little robust research showing longer term outcomes or benefits of such programmes. This paper describes an innovative protocol to examine the longer term outcomes and experiences of young people referred to a residential life management and treatment programme in Australia designed to address alcohol and drug issues in a holistic manner. Methods and analysis This is a mixed-methods study that will retrospectively and prospectively examine young people's pathways into and out of a residential life management programme. The study involves 3 components: (1) retrospective data linkage of programme data to health and criminal justice administrative data sets, (2) prospective cohort (using existing programme baseline data and a follow-up survey) and (3) qualitative in-depth interviews with a subsample of the prospective cohort. The study will compare findings among young people who are referred and (a) stay 30 days or more in the programme (including those who go on to continuing care and those who do not); (b) start, but stay fewer than 30 days in the programme; (c) are assessed, but do not start the programme. Ethics and dissemination Ethics approval has been sought from several ethics committees including a university ethics committee, state health departments and an Aboriginal-specific ethics committee. The results of the study will be published in peer-reviewed journals, presented at research conferences, disseminated via a report for the general public and through Facebook communications. The study will inform the field more broadly about the value of different methods in evaluating programmes and examining the pathways and trajectories of vulnerable young people. PMID:27225650

Common errors of drug administration in infants: causes and avoidance.

PubMed

Anderson, B J; Ellis, J F

1999-01-01

Drug administration errors are common in infants. Although the infant population has a high exposure to drugs, there are few data concerning pharmacokinetics or pharmacodynamics, or the influence of paediatric diseases on these processes. Children remain therapeutic orphans. Formulations are often suitable only for adults; in addition, the lack of maturation of drug elimination processes, alteration of body composition and influence of size render the calculation of drug doses complex in infants. The commonest drug administration error in infants is one of dose, and the commonest hospital site for this error is the intensive care unit. Drug errors are a consequence of system error, and preventive strategies are possible through system analysis. The goal of a zero drug error rate should be aggressively sought, with systems in place that aim to eliminate the effects of inevitable human error. This involves review of the entire system from drug manufacture to drug administration. The nuclear industry, telecommunications and air traffic control services all practise error reduction policies with zero error as a clear goal, not by finding fault in the individual, but by identifying faults in the system and building into that system mechanisms for picking up faults before they occur. Such policies could be adapted to medicine using interventions both specific (the production of formulations which are for children only and clearly labelled, regular audit by pharmacists, legible prescriptions, standardised dose tables) and general (paediatric drug trials, education programmes, nonpunitive error reporting) to reduce the number of errors made in giving medication to infants.

Commentary: restarting NTD programme activities after the Ebola outbreak in Liberia.

PubMed

Thomas, Brent C; Kollie, Karsor; Koudou, Benjamin; Mackenzie, Charles

2017-05-01

It is widely known that the recent Ebola Virus Disease (EVD) in West Africa caused a serious disruption to the national health system, with many of ongoing disease focused programmes, such as mass drug administration (MDA) for onchocerciasis (ONC), lymphatic filariasis (LF) and schistosomiasis (SCH), being suspended or scaled-down. As these MDA programmes attempt to restart post-EVD it is important to understand the challenges that may be encountered. This commentary addresses the opinions of the major health sectors involved, as well as those of community members, regarding logistic needs and challenges faced as these important public health programmes consider restarting. There appears to be a strong desire by the communities to resume NTD programme activities, although it is clear that some important challenges remain, the most prominent being those resulting from the severe loss of trained staff.

Monitoring the efficacy of drugs for neglected tropical diseases controlled by preventive chemotherapy.

PubMed

Albonico, M; Levecke, B; LoVerde, P T; Montresor, A; Prichard, R; Vercruysse, J; Webster, J P

2015-12-01

In the last decade, pharmaceutical companies, governments and global health organisations under the leadership of the World Health Organization (WHO) have pledged large-scale donations of anthelmintic drugs, including ivermectin (IVM), praziquantel (PZQ), albendazole (ALB) and mebendazole (MEB). This worldwide scale-up in drug donations calls for strong monitoring systems to detect any changes in anthelmintic drug efficacy. This review reports on the outcome of the WHO Global Working Group on Monitoring of Neglected Tropical Diseases Drug Efficacy, which consists of three subgroups: (i) soil-transmitted helminthiases (ALB and MEB); (ii) onchocerciasis and lymphatic filariasis (IVM); and (iii) schistosomiasis (PZQ). Progress of ongoing work, challenges and research needs for each of the four main drugs used in helminthic preventive chemotherapy (PC) are reported, laying the ground for appropriate implementation of drug efficacy monitoring programmes under the co-ordination and guidelines of the WHO. Best practices for monitoring drug efficacy should be made available and capacity built as an integral part of neglected tropical disease (NTD) programme monitoring. Development of a disease-specific model to predict the impact of PC programmes, to detect outliers and to solicit responses is essential. Research studies on genetic polymorphisms in relation to low-efficacy phenotypes should be carried out to identify markers of putative resistance against all NTD drugs and ultimately to develop diagnostic assays. Development of combination and co-administration of NTD drugs as well as of new drug entities to boost the armamentarium of the few drugs available for NTD control and elimination should be pursued in parallel. Copyright © 2015 International Society for Chemotherapy of Infection and Cancer. Published by Elsevier Ltd. All rights reserved.

Effect of generalised access to early diagnosis and treatment and targeted mass drug administration on Plasmodium falciparum malaria in Eastern Myanmar: an observational study of a regional elimination programme.

PubMed

Landier, Jordi; Parker, Daniel M; Thu, Aung Myint; Lwin, Khin Maung; Delmas, Gilles; Nosten, François H

2018-05-12

Potentially untreatable Plasmodium falciparum malaria threatens the Greater Mekong subregion. A previous series of pilot projects in Myanmar, Laos, Cambodia, and Vietnam suggested that mass drug administration was safe, and when added to provision of early diagnosis and treatment, could reduce the reservoir of P falciparum and interrupts transmission. We examined the effects of a scaled-up programme of this strategy in four townships of eastern Myanmar on the incidence of P falciparum malaria. The programme was implemented in the four townships of Myawaddy, Kawkareik, Hlaingbwe, and Hpapun in Kayin state, Myanmar. Increased access to early diagnosis and treatment of malaria was provided to all villages through community-based malaria posts equipped with rapid diagnostic tests, and treatment with artemether-lumefantrine plus single low-dose primaquine. Villages were identified as malarial hotspots (operationally defined as >40% malaria, of which 20% was P falciparum) with surveys using ultrasensitive quantitative PCR either randomly or targeted at villages where the incidence of clinical cases of P falciparum malaria remained high (ie, >100 cases per 1000 individuals per year) despite a functioning malaria post. During each survey, a 2 mL sample of venous blood was obtained from randomly selected adults. Hotspots received targeted mass drug administration with dihydroartemisinin-piperaquine plus single-dose primaquine once per month for 3 consecutive months in addition to the malaria posts. The main outcome was the change in village incidence of clinical P falciparum malaria, quantified using a multivariate, generalised, additive multilevel model. Malaria prevalence was measured in the hotspots 12 months after mass drug administration. Between May 1, 2014, and April 30, 2017, 1222 malarial posts were opened, providing early diagnosis and treatment to an estimated 365 000 individuals. Incidence of P falciparum malaria decreased by 60 to 98% in the four townships. 272 prevalence surveys were undertaken and 69 hotspot villages were identified. By April 2017, 50 hotspots were treated with mass drug administration. Hotspot villages had a three times higher incidence of P falciparum at malarial posts than neighbouring villages (adjusted incidence rate ratio [IRR] 2·7, 95% CI 1·8-4·4). Early diagnosis and treatment was associated with a significant decrease in P falciparum incidence in hotspots (IRR 0·82, 95% CI 0·76-0·88 per quarter) and in other villages (0·75, 0·73-0·78 per quarter). Mass drug administration was associated with a five-times decrease in P falciparum incidence within hotspot villages (IRR 0·19, 95% CI 0·13-0·26). By April, 2017, 965 villages (79%) of 1222 corresponding to 104 village tracts were free from P falciparum malaria for at least 6 months. The prevalence of wild-type genotype for K13 molecular markers of artemisinin resistance was stable over the three years (39%; 249/631). Providing early diagnosis and effective treatment substantially decreased village-level incidence of artemisinin-resistant P falciparum malaria in hard-to-reach, politically sensitive regions of eastern Myanmar. Targeted mass drug administration significantly reduced malaria incidence in hotspots. If these activities could proceed in all contiguous endemic areas in addition to standard control programmes already implemented, there is a possibility of subnational elimination of P falciparum. The Bill & Melinda Gates Foundation, the Regional Artemisinin Initiative (Global Fund against AIDS, Tuberculosis and Malaria), and the Wellcome Trust. Copyright © 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Methods for estimating population coverage of mass distribution programmes: a review of practices in relation to trachoma control.

PubMed

Cromwell, Elizabeth A; Ngondi, Jeremiah; McFarland, Deborah; King, Jonathan D; Emerson, Paul M

2012-10-01

In the context of trachoma control, population coverage with mass drug administration (MDA) using antibiotics is measured using routine data. Due to the limitations of administrative records as well as the potential for bias from incomplete or incorrect records, a literature review of coverage survey methods applied in neglected tropical disease control programmes and immunisation outreach was conducted to inform the design of coverage surveys for trachoma control. Several methods were identified, including the '30 × 7' survey method for the Expanded Programme on Immunization (EPI 30×7), other cluster random sampling (CRS) methods, lot quality assurance sampling (LQAS), purposive sampling and routine data. When compared against one another, the EPI and other CRS methods produced similar population coverage estimates, whilst LQAS, purposive sampling and use of administrative data did not generate estimates consistent with CRS. In conclusion, CRS methods present a consistent approach for MDA coverage surveys despite different methods of household selection. They merit use until standard guidelines are available. CRS methods should be used to verify population coverage derived from LQAS, purposive sampling methods and administrative reports. Copyright © 2012 Royal Society of Tropical Medicine and Hygiene. Published by Elsevier Ltd. All rights reserved.

Examining the pathways for young people with drug and alcohol dependence: a mixed-method design to examine the role of a treatment programme.

PubMed

Nathan, Sally; Rawstorne, Patrick; Hayen, Andrew; Bryant, Joanne; Baldry, Eileen; Ferry, Mark; Williams, Megan; Shanahan, Marian; Jayasinha, Ranmalie

2016-05-25

Young people with drug and alcohol problems are likely to have poorer health and other psychosocial outcomes than other young people. Residential treatment programmes have been shown to lead to improved health and related outcomes for young people in the short term. There is very little robust research showing longer term outcomes or benefits of such programmes. This paper describes an innovative protocol to examine the longer term outcomes and experiences of young people referred to a residential life management and treatment programme in Australia designed to address alcohol and drug issues in a holistic manner. This is a mixed-methods study that will retrospectively and prospectively examine young people's pathways into and out of a residential life management programme. The study involves 3 components: (1) retrospective data linkage of programme data to health and criminal justice administrative data sets, (2) prospective cohort (using existing programme baseline data and a follow-up survey) and (3) qualitative in-depth interviews with a subsample of the prospective cohort. The study will compare findings among young people who are referred and (a) stay 30 days or more in the programme (including those who go on to continuing care and those who do not); (b) start, but stay fewer than 30 days in the programme; (c) are assessed, but do not start the programme. Ethics approval has been sought from several ethics committees including a university ethics committee, state health departments and an Aboriginal-specific ethics committee. The results of the study will be published in peer-reviewed journals, presented at research conferences, disseminated via a report for the general public and through Facebook communications. The study will inform the field more broadly about the value of different methods in evaluating programmes and examining the pathways and trajectories of vulnerable young people. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Neglected tropical diseases and the millennium development goals: why the "other diseases" matter: reality versus rhetoric.

PubMed

Molyneux, David H; Malecela, Mwele N

2011-12-13

Since 2004 there has been an increased recognition of the importance of Neglected Tropical Diseases (NTDs) as impediments to development. These diseases are caused by a variety of infectious agents - viruses, bacteria and parasites - which cause a diversity of clinical conditions throughout the tropics. The World Health Organisation (WHO) has defined seventeen of these conditions as core NTDs. The objectives for the control, elimination or eradication of these conditions have been defined in World Health Assembly resolutions whilst the strategies for the control or elimination of individual diseases have been defined in various WHO documents. Since 2005 there has been a drive for the expanded control of these diseases through an integrated approach of mass drug administration referred to as Preventive Chemotherapy via community-based distribution systems and through schools. This has been made possible by donations from major pharmaceutical companies of quality and efficacious drugs which have a proven track record of safety. As a result of the increased commitment of endemic countries, bilateral donors and non-governmental development organisations, there has been a considerable expansion of mass drug administration. In particular, programmes targeting lymphatic filariasis, onchocerciasis, schistosomiasis, trachoma and soil transmitted helminth infections have expanded to treat 887. 8 million people in 2009. There has been significant progress towards guinea worm eradication, and the control of leprosy and human African trypanosomiasis. This paper responds to what the authors believe are inappropriate criticisms of these programmes and counters accusations of the motives of partners made in recently published papers. We provide a detailed response and update the information on the numbers of global treatments undertaken for NTDs and list the success stories to date.The paper acknowledges that in undertaking any health programme in environments such as post-conflict countries, there are always challenges. It is also recognised that NTD control must always be undertaken within the health system context. However, it is important to emphasise that the availability of donated drugs, the multiple impact of those drugs, the willingness of countries to undertake their distribution, thereby committing their own resources to the programmes, and the proven beneficial results outweigh the problems which are faced in environments where communities are often beyond the reach of health services. Given the availability of these interventions, their cost effectiveness and the broader development impact we believe it would be unethical not to continue programmes of such long term benefit to the "bottom billion".

Issues in Delivering Morbidity Management for Lymphatic Filariasis Elimination: A Study in Pondicherry, South India

PubMed Central

Kumari, A. Krishna; J, Yuvaraj; Das, L. K

2012-01-01

Lymphatic filariasis is a vector borne parasitic disease causing long term disability. The Global Programme to Eliminate Lymphatic Filariasis aims to achieve its objective through two strategies; Mass Drug Administration (MDA) to interrupt transmission and Morbidity Management (MM) to manage disability for those already affected. MDA is going on in full swing in endemic areas; but MM is lagging behind. An exploratory study was conducted in Pondicherry through focus group discussions to find out whether there are delivery issues if any, in the MM programme and get suggestions from end users. The study results show that MM has not received the same attention as MDA and there are shortcomings in the delivery mechanism of the programme. The importance of these findings are discussed and suggestions given for improving the programme. PMID:22654597

Morbidity management in the Global Programme to Eliminate Lymphatic Filariasis: a review of the scientific literature

PubMed Central

Addiss, David G; Brady, Molly A

2007-01-01

The Global Programme to Eliminate Lymphatic Filariasis (GPELF) has two major goals: to interrupt transmission of the parasite and to provide care for those who suffer the devastating clinical manifestations of the disease (morbidity control). This latter goal addresses three filariasis-related conditions: acute inflammatory episodes; lymphoedema; and hydrocele. Research during the last decade has confirmed the importance of bacteria as a cause of acute inflammatory episodes in filariasis-endemic areas, known as acute dermatolymphangioadenitis (ADLA). Current lymphoedema management strategies are based on the central role of ADLA as a trigger for lymphoedema progression. Simple intervention packages are in use that have resulted in dramatic reductions in ADLA rates, a lower prevalence of chronic inflammatory cells in the dermis and subdermis, and improvement in quality of life. During the past decade, the socioeconomic impact of ADLA and lymphoedema in filariasis-endemic areas has received increasing attention. Numerous operational research questions remain to be answered regarding how best to optimize, scale up, monitor, and evaluate lymphoedema management programmes. Of the clinical manifestations targeted by the GPELF, hydrocele has been the focus of the least attention. Basic information is lacking on the effectiveness and complications of hydrocele surgery and risk of post-operative hydrocele recurrence in filariasis-endemic areas. Data on the impact of mass administration of antifilarial drugs on filarial morbidity are inconsistent. Several studies report reductions in acute inflammatory episodes, lymphoedema, and/or hydrocele following mass drug administration, but other studies report no such association. Assessing the public health impact of mass treatment with antifilarial drugs is important for programme advocacy and morbidity control strategies. Thus, although our knowledge of filariasis-related morbidity and its treatment has expanded in recent years, much work remains to be done to address the needs of more than 40 million persons who suffer worldwide from these conditions. PMID:17302976

From Evidence to Policy: The Scottish National Naloxone Programme

ERIC Educational Resources Information Center

McAuley, Andrew; Best, David; Taylor, Avril; Hunter, Carole; Robertson, Roy

2012-01-01

Drug-related death (DRD) is a major public health problem globally, with rates in Scotland higher than any other UK region and among the highest in Europe. One of the most important public health interventions to emerge aimed at tackling rising DRD rates is the distribution of naloxone, the opioid antagonist, for peer administration. The Scottish…

Human schistosomiasis in the post mass drug administration era.

PubMed

Mutapi, Francisca; Maizels, Rick; Fenwick, Alan; Woolhouse, Mark

2017-02-01

Profound changes are occurring in the epidemiology of schistosomiasis, a neglected tropical disease caused by a chronic infection with parasitic helminths of the genus Schistosoma. Schistosomiasis currently affects 240 million people worldwide, mostly in sub-Saharan Africa. The advent and proliferation of mass drug administration (MDA) programmes using the drug praziquantel is resulting in substantial increases in the number of people, mainly children aged 6-14 years, being effectively treated, approaching the point where most people in endemic areas will receive one or more treatments during their lifetimes. Praziquantel treatment not only cures infection but also frees the host from the powerful immunomodulatory action of the parasites. The treatment simultaneously enhances exposure to key parasite antigens, accelerating the development of protective acquired immunity, which would take many years to develop naturally. At a population level, these changes constitute a substantial alteration to schistosome ecology in that the parasites are more likely to be exposed not only to praziquantel directly but also to hosts with altered immune phenotypes. Here, we consider the consequences of this for schistosome biology, immunoepidemiology, and public health. We anticipate that there could be substantial effects on chronic pathology, natural immunity, vaccine development strategies, immune disorders, and drug efficacy. This makes for a complex picture that will only become apparent over decades. We recommend careful monitoring and assessment to accompany the roll-out of MDA programmes to ensure that the considerable health benefits to populations are achieved and sustained. Copyright © 2017 Elsevier Ltd. All rights reserved.

Coverage and Awareness of and Compliance with Mass Drug Administration for Elimination of Lymphatic Filariasis in Burdwan District, West Bengal, India

PubMed Central

Sarkar, Aditya Prasad; Misra, Raghunath; Chakroborty, Amitava; Mondal, Tusar Kanti; Bag, Kanad

2013-01-01

India adopted WHO's strategy of repeated rounds of mass drug administration (MDA) with diethylcarbamazine to eliminate lymphatic filariasis. The present study attempted to assess the coverage and awareness of and compliance with MDA for elimination of lymphatic filariasis in Burdwan district of India, following MDA round in July 2010. A cross-sectional study was conducted among the four randomly-selected clusters in the district of Burdwan, West Bengal, India, covering 603 individuals from 154 households, using a predesigned pretested schedule. The drug distribution coverage, compliance, and effective coverage were 48.76 %, 70.07%, and 34.16% respectively. Only 41.4% of the study population was aware of the MDA activity. This evaluation study noted that MDA is restricted to tablet distribution only. There is an urgent need to improve compliance with drug intake through strengthening of the awareness programme involving both government health workers and community volunteers. PMID:23930334

Mectizan(®) procurement and delivery for onchocerciasis mass drug administration programmes.

PubMed

Ogoussan, Kisito T; Hopkins, Adrian

2011-09-01

The discovery of Mectizan has engendered a safe onchocerciasis chemoprevention tool. To make the drug available promptly to people at risk of onchocerciasis, a procurement and delivery mechanism has been put in place around the Mectizan Donation Program, which oversees the Merck donation of Mectizan. The number of yearly approved treatment doses has increased rapidly since 1988 from 255,000 to more than 80 million in 2007 and 2008. Cumulatively, from 1987 to 2008 more than 697 million treatment doses have been approved corresponding to 1.5 billion Mectizan tablets shipped. Although the current demand for treatment is met, the ultimate goal is to cover all people at risk. A comprehensive drug policy from recipient countries is still needed to back up the current efficient procurement and delivery mechanism in order to attain the ultimate to goal, and is equally important for scaling up mass drug administration as part of national neglected tropical disease control/elimination strategies. Copyright © 2010 Elsevier B.V. All rights reserved.

Recent Advances of Cocktail Chemotherapy by Combination Drug Delivery Systems

PubMed Central

Hu, Quanyin; Sun, Wujin; Wang, Chao; Gu, Zhen

2016-01-01

Combination chemotherapy is widely exploited for enhanced cancer treatment in clinic. However, the traditional cocktail administration of combination regimens often suffers from varying pharmacokinetics among different drugs. The emergence of nanotechnology offers an unparalleled opportunity for developing advanced combination drug delivery strategies with the ability to encapsulate various drugs simultaneously and unify the pharmacokinetics of each drug. This review surveys the most recent advances in combination delivery of multiple small molecule chemotherapeutics using nanocarriers. The mechanisms underlying combination chemotherapy, including the synergistic, additive and potentiation effects, are also discussed with typical examples. We further highlight the sequential and site-specific co-delivery strategies, which provide new guidelines for development of programmable combination drug delivery systems. Clinical outlook and challenges are also discussed in the end. PMID:26546751

Metabolism of norethisterone in the greyhound.

PubMed

Biddle, S T B; O'Donnell, A; Houghton, E; Creaser, C S

2013-10-30

Norethisterone has been used as a successful oral contraceptive in humans for many years. It was recently permitted for use as an oestrus suppressant in racing greyhounds. To monitor the use of norethisterone as part of a routine drug surveillance programme, knowledge of its metabolism was required to enable detection. Gas chromatography/mass spectrometry and selective derivatisation techniques have been used to identify urinary metabolites of norethisterone following oral administration to the greyhound. Metabolites were extracted using solid-phase and liquid-liquid extraction techniques. Several metabolites were identified, including reduced, mono-, di- and trihydroxylated steroids. The major metabolites observed were 17α-ethynyl-5β-estrane-3α,17β-diol, 17α-ethynyl-5α-estrane-3β,17β-diol, three 17α-ethynylestranetriol stereoisomers and two 17α-ethynylestranetetrol stereoisomers. The major metabolites were predominantly excreted as glucuronic acid conjugates and detection of the administration of norethisterone was possible for up to 8 days post-dose using the methods described. The nandrolone metabolites, 19-norepiandrosterone, estranediol and 19-noretiocholanolone, were also identified in the post-administration samples collected up to 8 h after dosing the treated animals. The urinary metabolites identified in this study have further increased the knowledge of steroid metabolism in the greyhound, providing information to support routine drug testing programmes for greyhound racing. Copyright © 2013 John Wiley & Sons, Ltd.

The past matters: estimating intrinsic hookworm transmission intensity in areas with past mass drug administration to control lymphatic filariasis.

PubMed

Werkman, Marleen; Truscott, James E; Toor, Jaspreet; Wright, James E; Anderson, Roy M

2017-05-23

Current WHO guidelines for soil-transmitted helminth (STH) control focus on mass drug administration (MDA) targeting preschool-aged (pre-SAC) and school-aged children (SAC), with the goal of eliminating STH as a public health problem amongst children. Recently, attention and funding has turned towards the question whether MDA alone can result in the interruption of transmission for STH. The lymphatic filariasis (LF) elimination programme, have been successful in reaching whole communities. There is the possibility of building upon the infrastructure created for these LF-programmes to enhance the control of STH. Using hookworm as an example, we explore what further MDA coverage might be required to induce interruption of transmission for hookworm in the wake of a successful LF programme. Analyses based on the model of STH transmission and MDA impact predict the effects of previous LF control by MDA over five years, on a defined baseline prevalence of STH in an area with a defined transmission intensity (the basic reproductive number R 0 ). If the LF MDA programme achieved a high coverage (70, 70 and 60% for pre-SAC, SAC and adults, respectively) we expect that in communities with a hookworm prevalence of 15%, after 5 years of LF control, the intrinsic R 0 value in that setting is 2.47. By contrast, if lower LF coverages were achieved (40, 40 and 30% for pre-SAC, SAC and adults, respectively), with the same prevalence of 15% at baseline (after 5 years of LF MDA), the intrinsic hookworm R 0 value is predicted to be 1.67. The intrinsic R 0 value has a large effect on the expected successes of follow-up STH programmes post LF MDA. Consequently, the outcomes of identical programmes may differ between these communities. To design the optimal MDA intervention to eliminate STH infections, it is vital to have information on historical MDA programmes and baseline prevalence to estimate the intrinsic transmission intensity for the defined setting (R 0 ). The baseline prevalence alone is not sufficient to inform policy for the control of STH, post cessation of LF MDA, since this will be highly dependent on the intensity and effectiveness of past programmes and the intrinsic transmission intensity of the dominant STH species in any given setting.

Assessing Lymphatic Filariasis Data Quality in Endemic Communities in Ghana, Using the Neglected Tropical Diseases Data Quality Assessment Tool for Preventive Chemotherapy.

PubMed

de Souza, Dziedzom K; Yirenkyi, Eric; Otchere, Joseph; Biritwum, Nana-Kwadwo; Ameme, Donne K; Sackey, Samuel; Ahorlu, Collins; Wilson, Michael D

2016-03-01

The activities of the Global Programme for the Elimination of Lymphatic Filariasis have been in operation since the year 2000, with Mass Drug Administration (MDA) undertaken yearly in disease endemic communities. Information collected during MDA-such as population demographics, age, sex, drugs used and remaining, and therapeutic and geographic coverage-can be used to assess the quality of the data reported. To assist country programmes in evaluating the information reported, the WHO, in collaboration with NTD partners, including ENVISION/RTI, developed an NTD Data Quality Assessment (DQA) tool, for use by programmes. This study was undertaken to evaluate the tool and assess the quality of data reported in some endemic communities in Ghana. A cross sectional study, involving review of data registers and interview of drug distributors, disease control officers, and health information officers using the NTD DQA tool, was carried out in selected communities in three LF endemic Districts in Ghana. Data registers for service delivery points were obtained from District health office for assessment. The assessment verified reported results in comparison with recounted values for five indicators: number of tablets received, number of tablets used, number of tablets remaining, MDA coverage, and population treated. Furthermore, drug distributors, disease control officers, and health information officers (at the first data aggregation level), were interviewed, using the DQA tool, to determine the performance of the functional areas of the data management system. The results showed that over 60% of the data reported were inaccurate, and exposed the challenges and limitations of the data management system. The DQA tool is a very useful monitoring and evaluation (M&E) tool that can be used to elucidate and address data quality issues in various NTD control programmes.

Aminoglycosides in septic shock: an overview, with specific consideration given to their nephrotoxic risk.

PubMed

Boyer, Alexandre; Gruson, Didier; Bouchet, Stéphane; Clouzeau, Benjamin; Hoang-Nam, Bui; Vargas, Frédéric; Gilles, Hilbert; Molimard, Mathieu; Rogues, Anne-Marie; Moore, Nicholas

2013-04-01

Aminoglycoside nephrotoxicity has been reported in patients with sepsis, and several risk factors have been described. Once-daily dosing and shorter treatment have reduced nephrotoxicity risk, and simplified aminoglycoside monitoring. This review focuses on nephrotoxicity associated with aminoglycosides in the subset of patients with septic shock or severe sepsis. These patients are radically different from those with less severe sepsis. They may have, for instance, renal impairment due to the shock per se, sepsis-related acute kidney injury, frequent association with pre-existing risk factors for renal failure such as diabetes, dehydration and other nephrotoxic treatments. In this category of patients, these risk factors might modify substantially the benefit-risk ratio of aminoglycosides. In addition, aminoglycoside administration in critically ill patients with sepsis is complicated by an extreme inter- and intra-individual variability in drug pharmacokinetic/pharmacodynamic characteristics: the volume of distribution (Vd) is frequently increased while the elimination constant can be either increased or decreased. Consequently, and although its effect on nephrotoxicity has not been explored, a different administration schedule, i.e. a high-dose once daily (HDOD), and several therapeutic drug monitoring (TDM) options have been proposed in these patients. This review describes the historical perspective of these different options, including those applying to subsets of patients in which aminoglycoside administration is even more complex (obese intensive care unit [ICU] patients, patients needing continuous or discontinuous renal replacement therapy [CRRT/DRRT]). A simple linear dose adjustment according to aminoglycoside serum concentration can be classified as low-intensity TDM. Nomograms have also been proposed, based on the maximum (peak) plasma concentration (Cmax) objectives, weight and creatinine clearance. The Sawchuk and Zaske method (based on the determination of Cmax and an intermediate aminoglycoside assay before minimum plasma concentration) and the Bayesian method were both classified as high-intensity TDM programmes. Given the mean cost of aminoglycoside nephrotoxicity, these programmes may be cost-effective if its prevalence is above 10 %. However, none of these high-intensity TDM programmes have demonstrated a reduction of aminoglycoside-associated nephrotoxicity in patients with septic shock. Therefore, the questions remain as to, first, whether a TDM programme is relevant and, second, what intensity of TDM is achievable in the ICU, i.e. how it can be practically applied in the ICU setting where urgent care and high workload are substantial obstacles to a sophisticated, optimized aminoglycoside administration.

Self-administration of medicine and older people.

PubMed

McGraw, C; Drennan, V

Non-adherence to medication regimens is a significant problem in older patients, which can lead to therapeutic failure and the wastage of resources. Common causes include poor patient memory, physical difficulties, unpleasant side effects and a lack of social support. Strategies such as careful labelling, self-administration of medicine programmes, simplifying drug regimens and the use of medication compliance devices can help to promote patient adherence. Some of these interventions will work for certain patients, however the authors recommend that a multidisciplinary assessment and a regular review of each patient's ability to adhere to medication should be undertaken.

Planning schistosomiasis control: investigation of alternative sampling strategies for Schistosoma mansoni to target mass drug administration of praziquantel in East Africa.

PubMed

Sturrock, Hugh J W; Gething, Pete W; Ashton, Ruth A; Kolaczinski, Jan H; Kabatereine, Narcis B; Brooker, Simon

2011-09-01

In schistosomiasis control, there is a need to geographically target treatment to populations at high risk of morbidity. This paper evaluates alternative sampling strategies for surveys of Schistosoma mansoni to target mass drug administration in Kenya and Ethiopia. Two main designs are considered: lot quality assurance sampling (LQAS) of children from all schools; and a geostatistical design that samples a subset of schools and uses semi-variogram analysis and spatial interpolation to predict prevalence in the remaining unsurveyed schools. Computerized simulations are used to investigate the performance of sampling strategies in correctly classifying schools according to treatment needs and their cost-effectiveness in identifying high prevalence schools. LQAS performs better than geostatistical sampling in correctly classifying schools, but at a cost with a higher cost per high prevalence school correctly classified. It is suggested that the optimal surveying strategy for S. mansoni needs to take into account the goals of the control programme and the financial and drug resources available.

[The role of the practicing veterinarian in the integrated monitoring of the meat production chain].

PubMed

Brand, A; Wierda, A; van der Valk, P C; Vandenbooren, J C

1984-04-01

A more extensive knowledge of the state of health of animals intended for slaughter during the period between birth and transportation to the slaughter-house, is essential to public health, particularly as regards the incidence of zoonoses and administration of drugs. In an integrated system of surveillance of the animal and meat production chain, it will be the duty of the veterinary practitioner to supervise the health of the animals by preventive and curative measures. This system should involve an exchange of information between producer, slaughter-house, veterinarians, those who give guidance on agricultural matters, supervising bodies and research institutes. The stock farmer will keep a record of disease or signs of disease and the use of drugs and submit a health report on delivery of animals to be slaughtered. By herd health programmes, carried out by the veterinary practitioner, optimum health, production and well-being should be achieved. A herd health programme includes objectives, material and methods, evaluation, analysis and advice. On the basis of the results of herd health programmes, the producer of animals intended for slaughter will be able to meet the requirements of the system of surveillance of the animal and meat production chain.

Mass Drug Administration and beyond: how can we strengthen health systems to deliver complex interventions to eliminate neglected tropical diseases?

PubMed

Macpherson, Eleanor E; Adams, Emily R; Bockarie, Moses J; Hollingsworth, T Deirdre; Kelly-Hope, Louise A; Lehane, Mike; Kovacic, Vanja; Harrison, Robert A; Paine, Mark Ji; Reimer, Lisa J; Torr, Stephen J

2015-01-01

Achieving the 2020 goals for Neglected Tropical Diseases (NTDs) requires scale-up of Mass Drug Administration (MDA) which will require long-term commitment of national and global financing partners, strengthening national capacity and, at the community level, systems to monitor and evaluate activities and impact. For some settings and diseases, MDA is not appropriate and alternative interventions are required. Operational research is necessary to identify how existing MDA networks can deliver this more complex range of interventions equitably. The final stages of the different global programmes to eliminate NTDs require eliminating foci of transmission which are likely to persist in complex and remote rural settings. Operational research is required to identify how current tools and practices might be adapted to locate and eliminate these hard-to-reach foci. Chronic disabilities caused by NTDs will persist after transmission of pathogens ceases. Development and delivery of sustainable services to reduce the NTD-related disability is an urgent public health priority. LSTM and its partners are world leaders in developing and delivering interventions to control vector-borne NTDs and malaria, particularly in hard-to-reach settings in Africa. Our experience, partnerships and research capacity allows us to serve as a hub for developing, supporting, monitoring and evaluating global programmes to eliminate NTDs.

The combined effect of the Lymphatic Filariasis Elimination Programme and the Schistosomiasis and Soil-transmitted Helminthiasis Control Programme on soil-transmitted helminthiasis in schoolchildren in Tanzania.

PubMed

Massa, Khalid; Magnussen, Pascal; Sheshe, Amir; Ntakamulenga, Robert; Ndawi, Benedict; Olsen, Annette

2009-01-01

The combined effect of the Lymphatic Filariasis Elimination Programme (LFEP) and the National Schistosomiasis and Soil-transmitted Helminthiasis Control Programme (NSSCP) on soil-transmitted helminthiasis (STH) was evaluated. In September 2004, before mass drug administration (MDA) with ivermectin and albendazole by the LFEP in October, the prevalence and intensity of STH were recorded in 228 pupils in one primary school. After 8 months, all available pupils were re-examined, and the prevalence of Ascaris lumbricoides, Trichuris trichiura and hookworm had decreased from 0.9 to 0.7% (P=0.84), from 4.8 to 0.7% (P=0.004) and from 45.6 to 11.9% (P<0.001), respectively. Overall, 81.2% of the schoolchildren stated that they were treated by the LFEP in October 2004. After the 8 months follow-up, pupils were treated with praziquantel and albendazole by the present project (substitute for the NSSCP). After another 4 months (at 12 months follow-up), the prevalence of hookworm infection was reduced to 4.8% (P=0.003), while the prevalence of T. trichiura was reduced to 0.3% (P=0.54) and the prevalence of A. lumbricoides remained unchanged. Mass co-administration of ivermectin and albendazole by the LFEP had a significant effect on STH, which was further amplified by treatment with praziquantel and albendazole 4 months later.

COMMUNITY MEMBERS' PERCEPTIONS OF MASS DRUG ADMINISTRATION FOR CONTROL OF LYMPHATIC FILARIASIS IN RURAL AND URBAN TANZANIA.

PubMed

Kisoka, William J; Tersbøl, Britt Pinkowsky; Meyrowitsch, Dan W; Simonsen, Paul E; Mushi, Declare L

2016-01-01

Lymphatic filariasis is one of several neglected tropical diseases with severely disabling and stigmatizing manifestations that are referred to as 'neglected diseases of poverty'. It is a mosquito-borne disease found endemically and exclusively in low-income contexts where, concomitantly, general public health care is often deeply troubled and fails to meet the basic health needs of impoverished populations. This presents particular challenges for the implementation of mass drug administration (MDA), which currently is the principal means of control and eventual elimination. Several MDA programmes face the dilemma that they are unable to attain and maintain the required drug coverage across target groups. In recognition of this, a qualitative study was conducted in the Morogoro and Lindi regions of Tanzania to gain an understanding of community experiences with, and perceptions of, the MDA campaign implemented in 2011 by the National Lymphatic Filariasis Elimination Programme. The study revealed a wide variation of perceptions and experiences regarding the aim, rationale and justification of MDA. There were positive sentiments about the usefulness of the drugs, but many study participants were sceptical about the manner in which MDA is implemented. People were particularly disappointed with the limited attempts by implementers to share information and mobilize residents. In addition, negative sentiments towards MDA for lymphatic filariasis reflected a general feeling of desertion and marginalization by the health care system and political authorities. However, the results suggest that if the communities are brought on board with genuine respect for their integrity and informed self-determination, there is scope for major improvements in community support for MDA-based control activities.

The District Nursing Clinical Error Reduction Programme.

PubMed

McGraw, Caroline; Topping, Claire

2011-01-01

The District Nursing Clinical Error Reduction (DANCER) Programme was initiated in NHS Islington following an increase in the number of reported medication errors. The objectives were to reduce the actual degree of harm and the potential risk of harm associated with medication errors and to maintain the existing positive reporting culture, while robustly addressing performance issues. One hundred medication errors reported in 2007/08 were analysed using a framework that specifies the factors that predispose to adverse medication events in domiciliary care. Various contributory factors were identified and interventions were subsequently developed to address poor drug calculation and medication problem-solving skills and incorrectly transcribed medication administration record charts. Follow up data were obtained at 12 months and two years. The evaluation has shown that although medication errors do still occur, the programme has resulted in a marked shift towards a reduction in the associated actual degree of harm and the potential risk of harm.

Harm reduction programmes in the Asia--Pacific Region.

PubMed

Reid, Gary; Devaney, Madonna L; Baldwin, Simon

2008-01-01

This paper reports on the public health intervention of harm reduction to address drug use issues in the Asia-Pacific region. It is based on the report 'Situational analysis of illicit drug issues and responses in Asia and the Pacific', commissioned by the Australian National Council on Drugs Asia Pacific Drug Issues Committee. A comprehensive desk-based review based on published and unpublished literature and key informant data. Drug use in the Asia--Pacific region is widespread, resulting in serious adverse health consequences. Needle and syringe programmes are found in some parts of Asia, but not in the six Pacific Island countries reviewed. Outreach and peer education programmes are implemented, but overall appear minor in size and scope. Substitution therapy programmes appear to be entering a new era of acceptance in some parts of Asia. Primary health care specifically for drug users overall is limited. Harm reduction programmes in the Asia--Pacific region are either small in scale or do not exist. Most programmes lack the technical capacity, human resources and a limited scope of operations to respond effectively to the needs of drug users. Governments in this region should be encouraged to endorse evidence-based harm reduction programmes.

The impact of a multiple intelligences teaching approach drug education programme on drug refusal skills of Nigerian pupils.

PubMed

Nwagu, Evelyn N; Ezedum, Chuks E; Nwagu, Eric K N

2015-09-01

The rising incidence of drug abuse among youths in Nigeria is a source of concern for health educators. This study was carried out on primary six pupils to determine the effect of a Multiple Intelligences Teaching Approach Drug Education Programme (MITA-DEP) on pupils' acquisition of drug refusal skills. A programme of drug education based on the Multiple Intelligences Teaching Approach (MITA) was developed. An experimental group was taught using this programme while a control group was taught using the same programme but developed based on the Traditional Teaching Approach. Pupils taught with the MITA acquired more drug refusal skills than those taught with the Traditional Teaching Approach. Urban pupils taught with the MITA acquired more skills than rural pupils. There was no statistically significant difference in the mean refusal skills of male and female pupils taught with the MITA. © The Author(s) 2014.

New treatment paradigms in psoriatic arthritis: an update on new therapeutics approved by the U.S. Food and Drug Administration.

PubMed

Felquer, Maria L Acosta; Soriano, Enrique R

2015-03-01

The purpose of this study is to give an overview of the new treatments approved by the U.S. Food and Drug Administration (FDA) for use in psoriatic arthritis (PsA). FDA has approved three new drugs for PsA: Certolizumab-pegol: a PEGylated Fc-free tumour necrosis factor inhibitor (TNFi); ustekinumab: an anti interleukin (IL)-12 and IL-23 mAb; and apremilast and oral phosphodiesterase 4 inhibitor. On well designed and extensive developing programmes, all three drugs proved to be effective for the treatment of most PsA manifestations, including peripheral arthritis, skin involvement, enthesitis, dactylitis, quality of life and radiographic progression in patients failing traditional disease modifying drugs (DMARDs) and TNFi. Safety profile of all three drugs seems to be reassuring until now, although long-term data are still not available. Although Certolizumab-pegol is likely to be placed among the other TNFi, ustekinumab and apremilast, due to lower efficacy on arthritis, are being more frequently used as second-line therapy after TNFi failure, especially among rheumatologists. There are new therapeutic options approved for the treatment of PsA. For the first time, well proved effective therapies with a different mechanism of action than the inhibition of TNF alpha are available for the treatment of this progressive disease.

Effect of sampling and diagnostic effort on the assessment of schistosomiasis and soil-transmitted helminthiasis and drug efficacy: a meta-analysis of six drug efficacy trials and one epidemiological survey.

PubMed

Levecke, Bruno; Brooker, Simon J; Knopp, Stefanie; Steinmann, Peter; Sousa-Figueiredo, Jose Carlos; Stothard, J Russell; Utzinger, Jürg; Vercruysse, Jozef

2014-12-01

It is generally recommended to perform multiple stool examinations in order to improve the diagnostic accuracy when assessing the impact of mass drug administration programmes to control human intestinal worm infections and determining efficacy of the drugs administered. However, the collection and diagnostic work-up of multiple stool samples increases costs and workload. It has been hypothesized that these increased efforts provide more accurate results when infection and drug efficacy are summarized by prevalence (proportion of subjects infected) and cure rate (CR, proportion of infected subjects that become egg-negative after drug administration), respectively, but not when these indicators are expressed in terms of infection intensity and egg reduction rate (ERR). We performed a meta-analysis of six drug efficacy trials and one epidemiological survey. We compared prevalence and intensity of infection, CR and ERR based on collection of one or two stool samples that were processed with single or duplicate Kato-Katz thick smears. We found that the accuracy of prevalence estimates and CR was lowest with the minimal sampling effort, but that this was not the case for estimating infection intensity and ERR. Hence, a single Kato-Katz thick smear is sufficient for reporting infection intensity and ERR following drug treatment.

Drug treatment or alleviating the negative consequences of imprisonment? A critical view of prison-based drug treatment in Denmark.

PubMed

Kolind, Torsten; Frank, Vibeke Asmussen; Dahl, Helle

2010-01-01

The availability of prison-based drug treatment has increased markedly throughout Europe over the last 15 years in terms of both volume and programme diversity. However, prison drug treatment faces problems and challenges because of the tension between ideologies of rehabilitation and punishment. This article reports on a study of four cannabis treatment programmes and four psychosocial drug treatment programmes in four Danish prisons during 2007. The data include the transcripts of 22 semi-structured qualitative interviews with counsellors and prison employees, prison statistics, and information about Danish laws and regulations. These treatment programmes reflect the 'treatment guarantee' in Danish prisons. However, they are simultaneously embedded in a new policy of zero tolerance and intensified disciplinary sanctions. This ambivalence is reflected in the experiences of treatment counsellors: reluctantly, they feel associated with the prison institution in the eyes of the prisoners; they experience severe opposition from prison officers; and the official goals of the programmes, such as making clients drug free and preparing them for a life without crime, are replaced by more pragmatic aims such as alleviating the pain of imprisonment felt by programme clients. The article concludes that at a time when prison-based drug treatment is growing, it is crucial that we thoroughly research and critically discuss its content and the restrictions facing such treatment programmes. One way of doing this is through research with counsellors involved in delivering drug treatment services. By so doing, the programmes can become more pragmatic and focused, and alternatives to prison-based drug treatment can be seriously considered.

"War on drugs" continues in United States under new leadership.

PubMed Central

Gorman, D M

1993-01-01

Criticism of the "war on drugs" pursued under Republican administrations has grown in the United States. With the election of Bill Clinton many experts expected a shift from law enforcement policies to an approach favouring treatment and prevention. The budget announced in April, however, revealed no such shift in allocation of resources. Although the war on drugs has apparently failed to reduce the supply of cheap heroin and cocaine to the United States, the prevention strategy favoured by its opponents--school based prevention programmes--has not yet been shown to be effective in dealing with the concentration of drug misuse among the socially disadvantaged. In looking for new strategies Clinton must satisfy both liberals and conservatives in Congress, and community policing might therefore prove to be a politically expedient option. Images p369-a p370-a PMID:8374422

Linking farmers to community stores to increase consumption of local produce: a case study of the Navajo Nation.

PubMed

Setala, Ashley; Gittelsohn, Joel; Speakman, Kristen; Oski, Jane; Martin, Tammy; Moore, Regina; Tohannie, Marcella; Bleich, Sara N

2011-09-01

To understand the barriers to farmer participation in Farm-to-Table (F2T) programmes and to identify possible solutions to these obstacles. Cross-sectional analysis of farmer perspectives on F2T programmes. Three service units on the Navajo Nation (Chinle, Tuba City and Fort Defiance). Forty-four Navajo farmers. Most participants reported that farming on the Navajo Nation is getting harder (61 %) but that it is very important to maintain Navajo farming traditions (98 %). A modest number of farmers (43 %) expressed interest in participating in an F2T programme. All farmers reported that childhood obesity was a very serious or serious problem in the Navajo Nation. The farmers expressed support for an F2T programme if key barriers to farming, including water access and pest control, could be addressed. Key barriers to participation identified included lack of fruits and vegetables to sell, sale price of crops and lack of certification of produce by the US Food and Drug Administration. Navajo farmers are aware of the burden of childhood obesity on the Navajo Nation and feel that an F2T programme could be beneficial. To successfully implement a Farm-to-Table programme, the barriers to participation identified will need to be addressed.

Utilization of a hospital information system for outpatient prescription screening process at the PKU Muhammadiyah Yogyakarta Hospital

NASA Astrophysics Data System (ADS)

Ismail, R.; Perwitasari, D. A.; Supadmi, W.; Risdiana, I.

2017-11-01

Prescription screening includes administrative and clinical precision of the drug, dosage, frequency and route of administration, therapeutic duplication, allergic or sensitive reactions, and actual or potential interactions. The study was aimed to identify the obstacles and compliance level of users, as well as the design of a prescription screening information system and its users’ perceptions. This study used qualitative and quantitative research design with action research studies involving pharmacists, pharmacy technicians, a programmer and clinical practice student pharmacists. The obstacle of pharmacists in doing prescription screening was the long duration in the process of manual prescription review. The compliance of pharmacists in manual prescription review was under 50%. The prescription information system was created by the programmer on the proposal of pharmacists in the form of front view, pharmacy display, sales display, prescription display, prescription display per period and display of recapped prescriptions. Perception of the usefulness was very high with a value of 4.5±0.577 and perception of ease of use was very high with a value of 4.214±0.534 from 28 respondents. The prescription information system was created by a programmer upon the recommendations of pharmacists. Perception of the usefulness and ease of use was very high.

The social cost of illegal drug consumption in Spain.

PubMed

García-Altés, Anna; Ollé, Josep Ma; Antoñanzas, Fernando; Colom, Joan

2002-09-01

The objective of this study was to estimate the social cost of the consumption of illegal drugs in Spain. We performed a cost-of-illness study, using a prevalence approximation and a societal perspective. The estimation of costs and consequences referred to 1997. As direct costs we included health-care costs, prevention, continuing education, research, administrative costs, non-governmental organizations and crime-related costs. As indirect costs we included lost productivity associated with mortality and the hospitalization of patients. Estimation of intangible costs was not included. The minimum cost of illegal drug consumption in Spain is 88,800 million pesetas (PTA) (467 million dollars). Seventy-seven per cent of the costs correspond to direct costs. Of those, crime-related costs represent 18%, while the largest part corresponds to the health-care costs (50% of direct costs). From the perspective of the health-care system, the minimum cost of illegal drug consumption is 44,000 million PTA (231 million dollars). The cost of illegal drug consumption represents 0.07% of the Spanish GDP. This gross figure compares with 2250 million PTA (12.5 million dollars) invested in prevention programmes during the same year, and with 12,300 million PTA (68.3 million dollars) spent on specific programmes and resources for the drug addict population. Although there are limitations intrinsic in this type of study and the estimations obtained in the present analysis are likely to be an underestimate of the real cost of this condition, we estimate that illegal drug consumption costs the Spanish economy at least 0.2% of GDP.

Controlling lymphatic filariasis and soil-transmitted helminthiasis together in South Asia: opportunities and challenges

PubMed Central

Padmasiri, EA; Montresor, A; Biswas, G; de Silva, NR

2017-01-01

Summary Lymphatic filariasis (LF) and the major soil-transmitted helminth (STH) infections are co-endemic in many countries, particularly in Asia. Control strategies for both groups of infections have increasingly focused on the use of mass chemotherapy. With the use of albendazole, there is now a tool that is common to both. However, there are also important differences in their modes of transmission and epidemiology, and as a result, in the overall control strategies. The Global Programme for the Elimination of Lymphatic Filariasis aims to eliminate LF through time-limited, Mass Drug Administration programmes. STH control activities are more diffuse, aiming to piggy-back de-worming onto existing services such as school health activities; controlling morbidity, rather than eliminating infection, is the stated goal. In order to maximize health benefits to communities that are endemic for one or both of these infections, it is vitally important that policy makers and programme managers have a clear understanding of both commonalities and differences, and implement control programmes that allocate available resources in an optimal manner. PMID:16546228

Challenges in adopting evidence-based school drug education programmes.

PubMed

Cahill, Helen W

2007-11-01

The paper discusses the school-based challenges that may moderate the implementation of evidence-based drug education in schools. Knowledge about what constitutes an effective evidence-based drug education programme is discussed in relation to the challenge of delivery in the school setting. Research demonstrates that drug education should be engaging, incorporate interactive learning strategies, stimulate higher-order thinking, promote learning and be transferable to real life circumstances. This may difficult to accomplish in practice, as a range of contextual challenges and ideological assumptions may moderate the teacher's capacity to deliver a programme of this nature. Collaborative learning strategies are not the norm in schools and therefore teachers may find interactive drug education programmes difficult to adopt. Conflicting ideological assumptions about effective epistemological approaches to drug education may also direct the way in which teachers modify programmes in the local context. Teachers need professional training and support if they are to adopt successfully evidence-based school drug education programmes. This support may be enhanced if it includes whole school approaches to effective pedagogy and the development of pro-social classroom environments. Drug education research should take account of the complexities of implementation in the school setting and investigate further the professional and organisational support that teachers require in order to maintain high-quality provision in the school context.

Distributed Leadership and Research Degree Administration: Understanding the Role of a Good Programme Administrator for Professional Doctorate Programmes

ERIC Educational Resources Information Center

Hawkes, Denise; Johansson, Carol; McSweeney, Catherine

2017-01-01

Studies of the interaction between professional and academic staff in leadership in higher education institutions have focused on distributed leadership. Whilst such studies have considered the leadership of the whole university, aspects of this model also apply to the relationship between programme leaders and administrators. This paper aims to…

Maintenance of tobacco cessation programmes in public hospitals in Catalonia, Spain.

PubMed

Ballbè, Montse; Martínez, Cristina; Saltó, Esteve; Cabezas, Carmen; Riccobene, Anna; Valverde, Araceli; Gual, Antoni; Fernández, Esteve

2015-03-01

The provision of smoking cessation interventions in hospitals has been strongly recommended. The aim of this study is to determine the maintenance of smoking cessation programmes for inpatients and hospital workers in hospitals of Catalonia (Spain) seven years after the implementation of a Tobacco Cessation Programme. A cross-sectional survey was conducted in all hospitals that offer public service in Catalonia, Spain (n=73). An online questionnaire was sent to all coordinators of the smoke-free hospital project or managers of each hospital. The survey included questions about the type of hospital, type of programmes implemented and availability and source of smoking cessation drugs. Responses to the questionnaire were submitted by 58 hospitals (79.5%). 74% and 93.1% of the hospitals had smoking cessation programmes for inpatients and workers, respectively. Most of the hospitals maintained the programmes and started routinely buying smoking cessation drugs after a period of receiving them free-of-charge. However, 17.2% of the hospitals refused to buy these drugs and 24% never had these drugs available. Through a supportive Tobacco Cessation Programme, most hospitals have smoking cessation programmes for both patients and workers. Most of them have incorporated smoking cessation drugs as a regular resource in their services' portfolio. The lack of these resources may jeopardise the maintenance of well-established programmes in hospitals. Copyright © 2014 Elsevier Ltd. All rights reserved.

Fixed-dose combination drugs for tuberculosis: application in standardised treatment regimens.

PubMed

Blomberg, Bjørn; Fourie, Bernard

2003-01-01

Short-course chemotherapy is highly efficacious in treating tuberculosis (TB). However, the length (>/=6 months) and complexity (three or four different drugs) of the treatment makes adherence difficult. Erratic treatment not only fails to cure patients but also creates chronically contagious cases, who may excrete drug-resistant TB bacteria. The Directly Observed Treatment Short-course (DOTS) strategy recommended by WHO provides a comprehensive organisational and infrastructural framework for the rational use of diagnosis, drug supply, as well as case and programme management services, in TB control. WHO and other organisations recommend fixed-dose combination formulations (FDCs) as a further step to facilitate the optimal drug treatment of TB. Using FDCs in TB control will simplify the doctor's prescription and patient's drug intake, as well as the drug supply management of the programme. By preventing monotherapy and facilitating the ingestion of adequate doses of the constituent anti-TB drugs, FDCs are expected to help prevent the emergence of drug resistance. This article presents the international recommendations for the use of FDCs in TB programmes. The fundamental issue is to obtain drug supplies of good quality. A laboratory network for quality testing, including bioavailability testing of FDCs exists, and the recently established Global TB Drug Facility (GDF) supplies quality TB drugs, including 4-drug FDCs, to countries requesting assistance. This articles deals with the requirements for a successful transition to FDC-based treatment. It emphasises the need for appropriately revised programme documentation (programme manual, training modules, treatment guidelines and forms), training of staff at all levels, carefully calculated drug needs, and a plan for the exhaustion of existing stocks of loose tablets and the phasing-in of FDCs at all levels of the programme at the same time. Loose drugs for individualised treatment of patients with adverse effects should be kept at district or central health institutions.

[Elimination in South-East Asia? The role of antimalarial drugs].

PubMed

Nosten, François

2016-03-01

Artemisinin resistance in P. falciparum is spreading in South East Asia and threatens the recent progresses made in the fight against malaria. A race against time has started to eliminate P.falciparum in this region before it becomes resistant to all available treatments. Antimalarials have a central role in the current elimination programme in eastern Burma on the border with Thailand. The combination of artemether and lumefantrine is used in association with primaquine for the early treatment of clinical cases. The slowly eliminated dihydro-artemisinin and piperaquine is the drug of choice in mass drug administration in the foci of high prevalence of sub-microscopic and asymptomatic infections. Initial results after 18 months of activities are promising: the participation of the population was excellent and there was a sharp reduction of P.falciparum incidence without evidence of worsening resistance.

Preliminary evaluation of STRIDE programme in primary schools of Malaysia.

PubMed

Hanjeet, K; Wan Rozita, W M; How, T B; Santhana Raj, L; Baharudin, Omar

2007-12-01

The Students' Resilience and Interpersonal Skills Development Education (STRIDE) is a preventive drug education programme. The rational of this programme is that preventive drug education has to begin early in age, before the development of social attitudes and behaviour of students. A pre and a post intervention surveys were performed to evaluate the impact of this programme. Nine schools from three states were identified to participate in the intervention. These schools were selected based on their locations in high-drug-use areas (where the prevalence of drug use exceeds 0.5% of the student population). The new intervention curriculum was put into practice for three months in the nine schools. The overall scores obtained by each respondent to assess their knowledge on drugs and its implications were analysed. The results showed that the programme made a positive impact from the pre to post intervention programme by using the Wilcoxon Signed Rank Test (p < 0.05). A high percentage of the questions showed significant evidence through the McNemar matched pair Chi-Squared test with Bonferonni correction that there were positive shifts in the answers by comparing the pre and post intervention results (p < 0.05). Recommendations have been discussed with the Ministry of Education to integrate this programme into the national primary school curriculum.

32 CFR 701.53 - FOIA fee schedule.

Code of Federal Regulations, 2011 CFR

2011-07-01

... monitoring by a human, that human time may be also assessed as computer search. The terms “programmer/operator” shall not be limited to the traditional programmers or operators. Rather, the terms shall be.... technician, administrative support, operator, programmer, database administrator, or action officer). (2...

Some pharmacological aspects of drug dependence.

PubMed

Chesher, G B

1975-12-06

The self-administration of drugs to achieve altered states of consciousness is recognized as normal human behaviour. Community attitudes towards drug use vary according to the drug and often bear little relationship to the known pharmacological and toxicological effects of the drug. For an objective assessment of the potential dangers associated with drug use, a distinction is made between drug use and drug abuse. It is stressed that the progression from drug use to drug abuse involves social and psychological factors in addition to the pharmacological factors which are outlined in this paper. The sequential development of drug dependency is described under the headings: Induction; continued consumption; compulsive consumption; withdrawal; abstinence; reinduction. Man uses psychotropic drugs because he finds the effects rewarding. Some experimental models to explore the neurophysiological basis of the reward are described. Experiments employing inhibitors of protein synthesis suggest that the phenomena of tolerance and physical dependence involve the synthesis of new protein. It has been suggested that the new protein might be new receptor molecules for the drug or neurotransmitter substances. These new receptors might constitute a "drug memory" and provide a possible explanation for high relapse rate of drug dependent subjects. A pharmacological basis for the methadone maintenance programme of management of narcotic dependent subjects is briefly outlined.

Reducing drug related deaths: a pre-implementation assessment of knowledge,barriers and enablers for naloxone distribution through general practice

PubMed Central

2014-01-01

Background The Scottish Naloxone Programme aims to reduce Scotland’s high number of drug-related deaths (DRDs) caused by opiate overdose. It is currently implemented through specialist drug services but General Practitioners (GPs) are likely to have contact with drug using patients and their families and are therefore in an ideal position to direct them to naloxone schemes, or provide it themselves. This research gathered baseline data on GP’s knowledge of and willingness to be involved in DRD prevention, including naloxone administration, prior to the implementation of primary care based delivery. Methods Mixed methods were used comprising a quantitative, postal survey and qualitative telephone interviews. A questionnaire was sent to 500 GPs across Scotland. An initial mailing was followed by a reminder. A shortened questionnaire containing seven key questions was posted as a final reminder. Telephone interviews were conducted with 17 GPs covering a range of demographic characteristics and drug user experience. Results A response rate of 55% (240/439) was achieved. There was some awareness of the naloxone programme but little involvement (3.3%), 9% currently provided routine overdose prevention, there was little involvement in displaying overdose prevention information (<20%). Knowledge of DRD risk was mixed. There was tentative willingness to be involved in naloxone prescribing with half of respondents willing to provide this to drug users or friends/family. However half were uncertain GP based naloxone provision was essential to reduce DRDs. Factors enabling naloxone distribution were: evidence of effectiveness, appropriate training, and adding to the local formulary. Interviewees had limited awareness of what naloxone distribution in primary care may involve and considered naloxone supply as a specialist service rather than a core GP role. Wider attitudinal barriers to involvement with this group were expressed. Conclusions There was poor awareness of the Scottish National Naloxone Programme in participants. Results indicated GPs did not currently feel sufficiently skilled or knowledgeable to be involved in naloxone provision. Appropriate training was identified as a key requirement. PMID:24428947

Food significantly reduces plasma concentrations of first-line anti-tuberculosis drugs.

PubMed

Kumar, Agibothu Kupparam Hemanth; Chandrasekaran, Vedachalam; Kumar, Angadi Kiran; Kawaskar, M; Lavanya, J; Swaminathan, Soumya; Ramachandran, Geetha

2017-04-01

Concomitant feeding and anti-tuberculosis (TB) drug administration are likely to reduce nausea and enhance compliance to treatment. However, food could lower plasma drug concentrations. This study was undertaken to examine the effect of food on two-hour plasma concentrations of rifampicin (RMP), isoniazid (INH) and pyrazinamide (PZA), and pharmacokinetics of these drugs in adult TB patients. Newly diagnosed adult TB patients were recruited from the Revised National Tuberculosis Control Programme (RNTCP) treatment centres in Chennai Corporation, Chennai, India. Two-hour post-dosing plasma concentrations were determined in 25 patients, and a semi-intensive pharmacokinetic study was undertaken in six patients. RMP, INH and PZA concentrations were determined by high-performance liquid chromatography. The geometric mean two-hour concentrations with food and under fasting conditions were 2.2 and 5.5 μg/ml for RMP (P<0.001), 3.9 and 11.3 μg/ml for INH (P<0.001), and 18.0 and 28.2 μg/ml for PZA (P<0.001), respectively. Drug administration with food caused the plasma concentration to decrease by 50, 45 and 34 per cent for RMP, INH and PZA, respectively. Significant decreases in peak concentrations and exposures of drugs and delay in time to attain peak concentrations of drugs when taken with food were also observed. Our findings showed that food lowered anti-TB drug concentrations significantly and delayed absorption. Patients may be explained the beneficial effects of taking anti-TB drugs in a fasting state and advised to do so. There is a need for more research on optimization of dosing to maximize efficacy and safety of currently used drugs.

Fabrication of core-shell micro/nanoparticles for programmable dual drug release by emulsion electrospraying

NASA Astrophysics Data System (ADS)

Wang, Yazhou; Zhang, Yiqiong; Wang, Bochu; Cao, Yang; Yu, Qingsong; Yin, Tieying

2013-06-01

The study aimed at constructing a novel drug delivery system for programmable multiple drug release controlled with core-shell structure. The core-shell structure consisted of chitosan nanoparticles as core and polyvinylpyrrolidone micro/nanocoating as shell to form core-shell micro/nanoparticles, which was fabricated by ionic gelation and emulsion electrospray methods. As model drug agents, Naproxen and rhodamine B were encapsulated in the core and shell regions, respectively. The core-shell micro/nanoparticles thus fabricated were characterized and confirmed by scanning electron microscope, transmission electron microscope, and fluorescence optical microscope. The core-shell micro/nanoparticles showed good release controllability through drug release experiment in vitro. It was noted that a programmable release pattern for dual drug agents was also achieved by adjusting their loading regions in the core-shell structures. The results indicate that emulsion electrospraying technology is a promising approach in fabrication of core-shell micro/nanoparticles for programmable dual drug release. Such a novel multi-drug delivery system has a potential application for the clinical treatment of cancer, tuberculosis, and tissue engineering.

Future delivery of the Drug Interventions Programme: do the benefits justify the costs?

PubMed

Osborne, Andrew

2013-10-01

The Drug Interventions Programme is an initiative employed by the Home Office in 2003 to integrate the Criminal Justice System with drug treatment services with the ultimate goal of reducing acquisitive crime. Drug Action Teams employ this scheme on a local level by providing a broad range of services for misusers in the community. Although much attention has been placed on societal gains, there is an added benefit in improving the health outcomes of those referred. Opioid replacement therapy decreases illicit heroin use, reduces mortality and maintains contact with misusers allowing for psychosocial intervention. The Drug Interventions Programme provides direct access to such treatment in an otherwise high-risk and disengaged population. Anecdotal evidence of the programme is positive; with improved mental and physical health in offenders and a reduction in hospital admissions. However, monitoring health outcomes in offenders is challenging as long-term follow-up is difficult, poor compliance is an issue and coercive referrals may introduce a reporting bias. Drug Action Team services are cost-effective due a lower consumption of health and social care and reduced offending levels. The Drug Interventions Programme has been successful in maintaining offenders in treatment and the Home Office claim its role in reducing crime is cost-saving. Future delivery of the initiative is at risk due to spending reductions, competing interests and a focus towards payment by results. Opposition to future implementation of the Drug Interventions Programme must be met with evidence for its effectiveness in order to ensure its continued investment. Copyright © 2013 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.

Recreational drug use in the Asia Pacific region: improvement in our understanding of the problem through the UNODC programmes.

PubMed

Dargan, P I; Wood, D M

2012-09-01

Until recently, there were limited data available on the epidemiology of recreational drug use in the Asia Pacific region. However, in the last few years, a number of United Nations Office on Drugs and Crime (UNODC) programmes have improved data collection networks, particularly in East and Southeast Asia. There are still significant data gaps from some countries, including India and China, and data reported from some countries in the region are based on expert estimates on recreational drug use rather than formally collected data. However, the availability of improved epidemiological data has enabled many countries in the region, both individually and through regional UNODC programmes, to start to understand the issues that need to be addressed. We will summarise in this mini-review the data available within the UNODC World Drug Report and from the other UNODC programmes in the region on the production and use of recreational drugs in the Asia Pacific region.

Single dose treatment of malaria - current status and perspectives.

PubMed

Mischlinger, Johannes; Agnandji, Selidji T; Ramharter, Michael

2016-07-01

Despite increased international efforts for control and ultimate elimination, malaria remains a major health problem. Currently, artemisinin-based combination therapies are the treatment of choice for uncomplicated malaria exhibiting high efficacy in clinical trial settings in sub-Saharan Africa. However, their administration over a three-day period is associated with important problems of treatment adherence resulting in markedly reduced effectiveness of currently recommended antimalarials under real world settings. Antimalarial drug candidates and antimalarial drug combinations currently under advanced clinical development for the indication as single dose antimalarial therapy. Expert commentary: Several new drug candidates and combinations are currently undergoing pivotal proof-of-concept studies or clinical development programmes. The development of a single dose combination therapy would constitute a breakthrough in the control of malaria. Such an innovative treatment approach would simultaneously close the effectiveness gap of current three-day therapies and revolutionize population based interventions in the context of malaria elimination campaigns.

Community-directed mass drug administration is undermined by status seeking in friendship networks and inadequate trust in health advice networks.

PubMed

Chami, Goylette F; Kontoleon, Andreas A; Bulte, Erwin; Fenwick, Alan; Kabatereine, Narcis B; Tukahebwa, Edridah M; Dunne, David W

2017-06-01

Over 1.9 billion individuals require preventive chemotherapy through mass drug administration (MDA). Community-directed MDA relies on volunteer community medicine distributors (CMDs) and their achievement of high coverage and compliance. Yet, it is unknown if village social networks influence effective MDA implementation by CMDs. In Mayuge District, Uganda, census-style surveys were conducted for 16,357 individuals from 3,491 households in 17 villages. Praziquantel, albendazole, and ivermectin were administered for one month in community-directed MDA to treat Schistosoma mansoni, hookworm, and lymphatic filariasis. Self-reported treatment outcomes, socioeconomic characteristics, friendship networks, and health advice networks were collected. We investigated systematically missed coverage and noncompliance. Coverage was defined as an eligible person being offered at least one drug by CMDs; compliance included ingesting at least one of the offered drugs. These outcomes were analyzed as a two-stage process using a Heckman selection model. To further assess if MDA through CMDs was working as intended, we examined the probability of accurate drug administration of 1) praziquantel, 2) both albendazole and ivermectin, and 3) all drugs. This analysis was conducted using bivariate Probit regression. Four indicators from each social network were examined: degree, betweenness centrality, closeness centrality, and the presence of a direct connection to CMDs. All models accounted for nested household and village standard errors. CMDs were more likely to offer medicines, and to accurately administer the drugs as trained by the national control programme, to individuals with high friendship degree (many connections) and high friendship closeness centrality (households that were only a short number of steps away from all other households in the network). Though high (88.59%), additional compliance was associated with directly trusting CMDs for health advice. Effective treatment provision requires addressing CMD biases towards influential, well-embedded individuals in friendship networks and utilizing health advice networks to increase village trust in CMDs. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

The Application of a Total Quality Management Approach to Support Student Recruitment in Schools of Music

ERIC Educational Resources Information Center

Weinstein, Larry

2009-01-01

One of the greatest challenges music programme administrators face is that of recruiting students for their programmes. This article suggests that administrators should investigate the benefits of implementing a comprehensive total quality management programme in their institutions. The core values, techniques and tools embodied in the Total…

Compassionate use of orphan drugs.

PubMed

Hyry, Hanna I; Manuel, Jeremy; Cox, Timothy M; Roos, Jonathan C P

2015-08-21

EU regulation 726/2004 authorises manufacturers to provide drugs to patients on a temporary basis when marketing authorisation sought centrally for the entire EU is still pending. Individual Member States retain the right to approve and implement such 'compassionate use' programmes which companies will usually provide for free. Nevertheless some companies have opted not to partake in such programmes, in effect restricting access to drugs for patients in need. Here we survey the state of compassionate use programmes in the EU with particular reference to the rare disease field, and provide legal and ethical arguments to encourage their increased compassionate use in the EU and beyond. We contend that if enacted, these recommendations will be mutually beneficial to companies as well as patients. Requests for information from the European Medicines Agency were made under the UK Freedom of Information Act 2000. Legal, ethical and economic/pragmatic analysis identified means by which provision of therapy in compassionate use programmes might be increased. More than 50 notifications of compassionate use programmes have been submitted to the EMA by Member States since 2006. About 40 % relate to orphan drugs. As there is a compulsory register of programmes but not of outcomes, their success is difficult to evaluate but, for example, the French programme expedited treatment for more than 20,000 (orphan and non-orphan) patients over a period of three years. Compelling self-interested, legal and ethical arguments can be mounted to encourage manufacturers to offer therapies on a compassionate use basis and these are often equally applicable to provision on a humanitarian aid basis. The EU's compassionate use programmes are instrumental in ensuring continuity of access to drugs until approval and reimbursement decisions are finalised. We propose the creation of a registry of drugs offered on a compassionate use basis; further transparency would allow such programmes to be evaluated and direct patients to sources of treatment.

Effects of a lifestyle programme on ambulatory blood pressure and drug dosage in treated hypertensive patients: a randomized controlled trial.

PubMed

Burke, Valerie; Beilin, Lawrie J; Cutt, Hayley E; Mansour, Jacqueline; Wilson, Amy; Mori, Trevor A

2005-06-01

To assess effects of multifactorial lifestyle modification on antihypertensive drug needs in treated hypertensive individuals. Randomized controlled trial. Research studies unit. Overweight hypertensive patients, receiving one or two antihypertensive drugs, were recruited by advertising, and allocated randomly to a usual care group (controls; n = 118) or a lifestyle modification group (programme group; n = 123). A 4-month programme of weight loss, a low-sodium 'Dietary Approaches to Stop Hypertension'-type diet with added fish, physical activity and moderation of alcohol intake. After 4 months, if mean 24-h ambulatory blood pressure (ABP) was less than 135/85 mmHg, antihypertensive drugs were withdrawn over 4 weeks and long-term home blood pressure monitoring was begun. Antihypertensive drug requirements, ABP, weight, waist girth at 4 months and 1-year follow-up. Ninety control group and 102 programme group participants completed the study. Mean 24-h ABP changed after 4 months by -1.0/-0.3 +/- 0.5/0.4 mmHg in controls and -4.1/-2.1 +/- 0.7/0.5 mmHg with the lifestyle programme (P < 0.01). At follow-up, changes in the two groups were not significantly different (4.1/1.3 +/- 1.1/1.0 mmHg in controls; 2.5/-0.1 +/- 1.1/0.8 mmHg in the programme group; P = 0.73). At 4 months, drug withdrawal differed significantly between the groups (P = 0.038) in men (control 44%; programme 66%) but not in women (65 and 64%, respectively; P = 0.964). At follow-up, sex-related differences were not significant, and 41% in the control group and 43% in the programme group maintained drug-withdrawal status. With the programme, net weight loss was 3.3 kg (P < 0.001) at 4 months and 3.0 kg (P < 0.001) at follow-up; respective net decreases in waist girth were 3.3 cm (P < 0.001) and 3.5 cm (P < 0.001). A 4-month multifactorial lifestyle modification in patients with treated hypertension reduced blood pressure in the short-term. Decreased central obesity persisted 1 year later and could reduce overall cardiovascular risk.

Programme development of drug abuse control in Baluchistan, Pakistan.

PubMed

Zaidi, S M; Ashraf, S M; Afridi, A A

1982-01-01

The drug abuse control programme in Baluchistan is inter-disciplinary and progressive. Its main thrust consists of constant vigilance on border check-points by law enforcement agencies, developing in-patient and out-patient facilities for treatment and rehabilitation of addicted persons, and a preventive education programme using the mass media and students from higher educational institutions.

The use and impact of cancer medicines in routine clinical care: methods and observations in a cohort of elderly Australians

PubMed Central

Pearson, Sallie-Anne; Schaffer, Andrea

2014-01-01

Introduction After medicines have been subsidised in Australia we know little about their use in routine clinical practice, impact on resource utilisation, effectiveness or safety. Routinely collected administrative health data are available to address these issues in large population-based pharmacoepidemiological studies. By bringing together cross-jurisdictional data collections that link drug exposure to real-world outcomes, this research programme aims to evaluate the use and impact of cancer medicines in a subset of elderly Australians in the real-world clinical setting. Methods and analysis This ongoing research programme involves a series of retrospective cohort studies of Australian Government Department of Veterans’ Affairs (DVA) clients. The study population includes 104 635 veterans who reside in New South Wales, Australia, and were aged 65 years and over as of 1 July 2004. We will investigate trends in cancer medicines use according to cancer type and other sociodemographic characteristics as well as predictors of the initiation of cancer medicines and other treatment modalities, survival and adverse outcomes among patients with cancer. The programme is underpinned by the linkage of eight health administrative databases under the custodianship of the DVA and the New South Wales Ministry of Health, including cancer notifications, medicines dispensing data, hospitalisation data and health services data. The cancer notifications database is available from 1994 with all other databases available from 2005 onwards. Ethics and dissemination Ethics approval has been granted by the DVA and New South Wales Population and Health Service Research Ethics Committees. Results Results will be reported in peer-reviewed publications, conference presentations and policy forums. The programme has high translational potential, providing invaluable evidence about cancer medicines in an elderly population who are under-represented in clinical trials. PMID:24793244

Controlling lymphatic filariasis and soil-transmitted helminthiasis together in South Asia: opportunities and challenges.

PubMed

Padmasiri, E A; Montresor, A; Biswas, G; de Silva, N R

2006-09-01

Lymphatic filariasis (LF) and the major soil-transmitted helminth (STH) infections are co-endemic in many countries, particularly in Asia. Control strategies for both groups of infections have increasingly focused on the use of mass chemotherapy. With the use of albendazole, there is now a tool that is common to both. However, there are also important differences in their modes of transmission and epidemiology, and, as a result, in the overall control strategies. The Global Programme for the Elimination of Lymphatic Filariasis aims to eliminate LF through time-limited mass drug administration programmes. Control activities for STH are more diffuse, aiming to piggy-back de-worming onto existing services, such as school health activities; controlling morbidity, rather than eliminating infection, is the stated goal. In order to maximize health benefits to communities that are endemic for one or both of these infections, it is vitally important that policy makers and programme managers have a clear understanding of both commonalities and differences, and implement control strategies that allocate available resources in an optimal manner.

Antifungal treatment in haematological and oncological patients: Need for quality assessment in routine care.

PubMed

Lachenmayr, Sarah J; Berking, Sophie; Horns, Heidi; Strobach, Dorothea; Ostermann, Helmut; Berger, Karin

2018-03-25

Invasive fungal infections in haematological and oncological patients have a major impact on morbidity, mortality and treatment costs. Therefore, rational use of antifungal agents is important for optimal patient care and resource use. The study's objective was to analyse antifungal usage in a German tertiary teaching hospital, department of haematology and oncology, to evaluate quality of antifungal treatment and to assess the need for an antifungal stewardship programme. This retrospective observational study included patients ≥18 years receiving systemic antifungals for prophylaxis or therapy of invasive fungal infection between January and June 2016. Appropriateness of antifungal prescriptions was evaluated in accordance with guidelines of the German Society of Haematology and Oncology (DGHO) and drug labelling. In total, 104/1278 (8.1%) patients received antifungals. One hundred seventy-one antifungals were prescribed: 48 for prophylaxis, 104 for empirical and 19 for targeted therapy. In 127 (74.3%) prescriptions, indication was appropriate, and in 132 (77.2%), choice of drug. Antifungals were correctly dosed in 131 prescriptions (76.6%). Thirty-four antifungals (20.0%) were co-administrated with interacting drugs (5 mild to moderate, 29 severe interactions). Results of this analysis demonstrate that use of systemic antifungals in routine care differs in a substantial number of patients from guideline and labelling recommendations. To optimise antifungal use, the implementation of antifungal stewardship programmes seems to be justified. © 2018 Blackwell Verlag GmbH.

Problems of cost recovery implementation in district health care: a case study from Niger.

PubMed

Meuwissen, Liesbeth Emm

2002-09-01

This article describes and analyzes the impact of the introduction of a cost recovery system in 11 health centres of Tillabéri district, Niger, West Africa, between August 1997 and August 1999. The study is based on data collected by the health workers, observations of district activities and policy meetings and literature from similar programmes in the region. The central question addressed by this article is why a well-formulated programme, which was implemented accordingly, failed to succeed. The system described fits within the national health policy framework in Niger, which opted to introduce fixed attendance fees in health centres. The system was introduced as a part of a comprehensive package to improve the accessibility, quality and organization of the districts' health care. Discussed are the problems encountered in the functioning of the system, such as the unpredictability of the cost recovery rate, the drop in patients' attendance and the undermining effect of serious and regular shortages of essential generic drugs at the wholesale dealer. Further discussed are the supervision and control of the financial and drug administration and the participation of the population, which are identified as key areas of interest for sustainability of any cost recovery system.

Meeting the goal of concurrent adolescent and adult licensure of HIV prevention and treatment strategies.

PubMed

Hume, Michelle; Lewis, Linda L; Nelson, Robert M

2017-12-01

The ability of adolescents to access safe and effective new products for HIV prevention and treatment is optimised by adolescent licensure at the same time these products are approved and marketed for adults. Many adolescent product development programmes for HIV prevention or treatment products may proceed simultaneously with adult phase III development programmes. Appropriately implemented, this strategy is not expected to delay licensure as information regarding product efficacy can often be extrapolated from adults to adolescents, and pharmacokinetic properties of drugs in adolescents are expected to be similar to those in adults. Finally, adolescents enrolled in therapeutic HIV prevention and treatment research can be considered adults, based on US Food and Drug Administration (FDA) regulations and the appropriate application of state law. The FDA permits local jurisdictions to apply state and local HIV/sexually transmitted infection minor treatment laws so that adolescents who are HIV-positive or at risk of contracting HIV may be enrolled in therapeutic or prevention trials without obtaining parental permission. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Is anthelmintic resistance a concern for the control of human soil-transmitted helminths?

PubMed Central

Vercruysse, Jozef; Albonico, Marco; Behnke, Jerzy M.; Kotze, Andrew C.; Prichard, Roger K.; McCarthy, James S.; Montresor, Antonio; Levecke, Bruno

2011-01-01

The major human soil-transmitted helminths (STH), Ascaris lumbricoides, hookworms (Necator americanus and Ancylostoma duodenale) and Trichuris trichiura have a marked impact on human health in many parts of the world. Current efforts to control these parasites rely predominantly on periodic mass administration of anthelmintic drugs to school age children and other at-risk groups. After many years of use of these same drugs for controlling roundworms in livestock, high levels of resistance have developed, threatening the sustainability of these livestock industries in some locations. Hence, the question arises as to whether this is likely to also occur in the human STH, thereby threatening our ability to control these parasites. This is particularly important because of the recent increase in mass control programmes, relying almost exclusively on benzimidazole anthelmintics. It will be important to ensure that resistance is detected as it emerges in order to allow the implementation of mitigation strategies, such as use of drug combinations, to ensure that the effectiveness of the few existing anthelmintic drugs is preserved. In this review we address these issues by firstly examining the efficacy of anthelmintics against the human STH, and assessing whether there are any indications to date that resistance has emerged. We then consider the factors that influence the effect of current drug-use patterns in selecting for resistant parasite populations. We describe the tools currently available for resistance monitoring (field-based coprological methods), and those under development (in vitro bioassays and molecular tests), and highlight confounding factors that need to be taken into account when interpreting such resistance-monitoring data. We then highlight means to ensure that the currently available tools are used correctly, particularly with regard to study design, and we set appropriate drug-efficacy thresholds. Finally, we make recommendations for monitoring drug efficacy in the field, as components of control programmes, in order to maximise the ability to detect drug resistance, and if it arises to change control strategy and prevent the spread of resistance. PMID:24533260

A cross-sectional survey of soil-transmitted helminthiases in two Myanmar villages receiving mass drug administration: epidemiology of infection with a focus on adults.

PubMed

Dunn, Julia C; Bettis, Alison A; Wyine, Nay Yee; Lwin, Aye Moe Moe; Lwin, Soe Thiha; Su, Khine Khine; Sein, Myint Myint; Tun, Aung; Maung, Nay Soe; Anderson, Roy M

2017-08-04

Soil-transmitted helminths (STH) are still highly prevalent in southeast Asia. The country of Myanmar has had ongoing mass drug administration (MDA) programmes since 2003 in an attempt to control STH and reduce STH-related morbidities. Whilst the MDA programmes have reported high nationwide coverage, there have been no epidemiological surveys that included measurements from adults. This paper details three cross-sectional surveys that took place over the course of a year in two villages endemic for STH and receiving MDA in lower Myanmar. At baseline, 27.81% of participants were infected with at least one type of STH. The most prevalent STH was Trichuris trichiura (18.12%) followed by hookworm (8.71%) and Ascaris lumbricoides (5.34%). Most infections were of low intensity, measured by eggs per gram of faeces (EPG). Gender stratification revealed that A. lumbricoides prevalence was significantly higher in females, whereas hookworm prevalence was significantly higher in males. The distribution of EPG in the study sample was highly overdispersed, suggesting that most people release few eggs whereas a few people release many eggs. Adults harbour a major proportion of the overall STH burden; 65.15% of STH infections were harboured by adults. STH infection remains at medium prevalence in the study villages despite past and recent MDA. Recorded prevalence of STH in school-aged children has not substantially decreased since the last monitoring and evaluation activities in Myanmar in 2013. Analyses suggest that adults are a major contributor to the total STH prevalence and EPG burden, probably perpetuating transmission.

Schistosomiasis and soil-transmitted helminthiasis in Rwanda: an update on their epidemiology and control.

PubMed

Rujeni, Nadine; Morona, Domenica; Ruberanziza, Eugene; Mazigo, Humphrey D

2017-03-01

Even though Rwanda lies within a region that has a high prevalence of schistosomiasis and soil-transmitted helminth (STH) infections, epidemiological information regarding these infections in the country remains scarce. The present review attempts to compile the available data on schistosomiasis and STHs, from 1940 to 2014, to provide an insight on the epidemiological profile of these infections. This information will, in turn, support the design and implementation of sustainable control measures. The available records indicate that only Schistosoma mansoni and all the major species of STHs are endemic in Rwanda. In 2008, the national prevalence of S. mansoni was reported to be 2.7%, ranging from 0 to 69.5%, and that of STH infections was 65.8% (diagnosed using the Kato-Katz technique). The prevalence of these infections varies from one district to another, with schoolchildren remaining a highly affected group. The main control approach is mass drug administration using albendazole and praziquantel, mostly targeting school-aged children in school environments. In 2008, adult individuals living in areas with a prevalence of S. mansoni ≥30% were also included in the mass drug administration programme. However, despite Rwanda achieving an almost 100% coverage of this programme in 2008-2010, the transmission of S. mansoni and STHs continues to take place, as illustrated by the most recent surveys. If Rwanda is to achieve sustainable control and elimination of schistosomiasis and STHs, there is a need to revise the country's control strategy and adopt an integrated control approach that involves a combination of measures.

A Research Agenda for Helminth Diseases of Humans: Intervention for Control and Elimination

PubMed Central

Prichard, Roger K.; Basáñez, María-Gloria; Boatin, Boakye A.; McCarthy, James S.; García, Héctor H.; Yang, Guo-Jing; Sripa, Banchob; Lustigman, Sara

2012-01-01

Recognising the burden helminth infections impose on human populations, and particularly the poor, major intervention programmes have been launched to control onchocerciasis, lymphatic filariasis, soil-transmitted helminthiases, schistosomiasis, and cysticercosis. The Disease Reference Group on Helminth Infections (DRG4), established in 2009 by the Special Programme for Research and Training in Tropical Diseases (TDR), was given the mandate to review helminthiases research and identify research priorities and gaps. A summary of current helminth control initiatives is presented and available tools are described. Most of these programmes are highly dependent on mass drug administration (MDA) of anthelmintic drugs (donated or available at low cost) and require annual or biannual treatment of large numbers of at-risk populations, over prolonged periods of time. The continuation of prolonged MDA with a limited number of anthelmintics greatly increases the probability that drug resistance will develop, which would raise serious problems for continuation of control and the achievement of elimination. Most initiatives have focussed on a single type of helminth infection, but recognition of co-endemicity and polyparasitism is leading to more integration of control. An understanding of the implications of control integration for implementation, treatment coverage, combination of pharmaceuticals, and monitoring is needed. To achieve the goals of morbidity reduction or elimination of infection, novel tools need to be developed, including more efficacious drugs, vaccines, and/or antivectorial agents, new diagnostics for infection and assessment of drug efficacy, and markers for possible anthelmintic resistance. In addition, there is a need for the development of new formulations of some existing anthelmintics (e.g., paediatric formulations). To achieve ultimate elimination of helminth parasites, treatments for the above mentioned helminthiases, and for taeniasis and food-borne trematodiases, will need to be integrated with monitoring, education, sanitation, access to health services, and where appropriate, vector control or reduction of the parasite reservoir in alternative hosts. Based on an analysis of current knowledge gaps and identification of priorities, a research and development agenda for intervention tools considered necessary for control and elimination of human helminthiases is presented, and the challenges to be confronted are discussed. PMID:22545163

Knowledge and experience of young people of drug abuse 1969-84.

PubMed

Wright, J D; Pearl, L

1986-01-18

An anonymous questionnaire survey of the knowledge and experience of drug abuse among fourth year pupils in three Wolverhampton secondary schools in 1969, 1974, 1979, and 1984 showed familiarity with the names of drugs but considerable ignorance and misunderstanding about how the drugs were taken and their dangers. The proportion of pupils who knew someone taking illicit drugs almost doubled over the period from 15% in 1969 to 28% in 1984, and the proportion of those who had been offered illicit drugs almost trebled, from 5% in 1969 to 14% in 1984. Television remained the most important source of information about drugs. Peer group and social pressures continued to be the most important reason for starting to take drugs. The results of this study endorse the need for continued evaluation of programmes of education about drugs. Such programmes must be part of a wider programme of health and social education, define clear goals, and be sensitive to culture, locality, and ability.

Public-private partnerships in neglected tropical disease control: the role of nongovernmental organisations.

PubMed

Bush, S; Hopkins, A D

2011-09-01

Successful public-private partnerships for health control have usually included nongovernmental development organisations (NGDOs), and these have long been in the forefront of pinpointing particular social and health issues. The immensely successful control and elimination programmes for onchocerciasis are a case in point. NGDOs were the driving force in early advocacy for onchocerciasis control in West Africa, leading eventually to the remarkably effective and long lasting partnership of the Onchocerciasis Control Programme (OCP). With the donation of Mectizan(®), NGDOs were the driving force in developing onchocerciasis control in non-OCP countries, especially programmes for community based action. These were, further modified by the African Programme for Onchocerciasis Control (APOC) to become the successful Community Directed Interventions. NGDOs came together to coordinate activities in partnership with the World Health Organisation (WHO). Innovations by NGDOs led to integration of mass drug administration for Vitamin A deficiency and then for other parasitic diseases, leading to the current trend of preventive chemotherapy. The success of the NGDO Group for Onchocerciasis Control has led to the creation of similar groups for trachoma control and lymphatic filariasis elimination. These groups have now come together to form an NGDO Network for Neglected Tropical Disease control. Copyright © 2011 Elsevier B.V. All rights reserved.

Lymphatic filariasis: patients and the global elimination programme.

PubMed

Mackenzie, C D; Lazarus, W M; Mwakitalu, M E; Mwingira, U; Malecela, M N

2009-10-01

The defining images of lymphatic filariasis are the horrendous disfigurements of lymphoedema, elephantiasis and hydrocele. These clinical presentations, although obviously important and life changing, are not, however, the only outcomes of this wide-spread filarial infection. The other effects of the disease range from severe, acute but short-term bouts of sickness to psychological impairment, poverty and family hardship. It is important to support cases of the disease through all means available, such as reparative hydrocelectomy, hygiene training and facilitation, and the provision of adequate chemotherapy. Although only a minority of the residents in any endemic community is affected with the severe clinical manifestations of this parasitic infection, these cases are central to, and important advocates for, the current global effort to eliminate the infection through mass drug administrations (MDA). Their clinical improvement acts as an important catalyst for the general population and encourages high compliance in the MDA. This communication discusses the central role that filariasis patients have played in the Tanzania Lymphatic Filariasis Elimination Programme to date, and covers some of the clinical successes achieved in the past 10 years. The abolition of the clinical manifestations of filarial infection remains the ultimate goal of the Global Programme to Eliminate Lymphatic Filariasis, and maintaining a focus on the affected individuals and their clinical condition is vital to that programme's overall success.

Quality medicines for the poor: experience of the Delhi programme on rational use of drugs.

PubMed

Chaudhury, R Roy; Parameswar, R; Gupta, U; Sharma, S; Tekur, U; Bapna, J S

2005-03-01

Prior to 1994, most Delhi hospitals and dispensaries experienced constant shortages of essential medicines. There was erratic prescribing of expensive branded products, frequent complaints about poor drug quality and low patient satisfaction. Delhi took the lead in developing a comprehensive Drug Policy in 1994 and was the only Indian state to have such a comprehensive policy. The policy's main objective is to improve the availability and accessibility of quality essential drugs for all those in need. The Delhi Society for the Promotion of Rational Use of Drugs (DSPRUD), a non-governmental organization, worked in close collaboration with the Delhi Government and with universities to implement various components of the policy. The first Essential Drugs List (EDL) was developed, a centralized pooled procurement system was set up and activities promoting rational use of drugs were initiated. In 1997, the Delhi Programme was designated the INDIA-WHO Essential Drugs Programme by the World Health Organization. The EDL was developed by a committee consisting of a multidisciplinary group of experts using balanced criteria of efficacy, safety, suitability and cost. The first list contained 250 drugs for hospitals and 100 drugs for dispensaries; the list is revised every 2 years. The pooled procurement system, including the rigorous selection of suppliers with a minimum annual threshold turnover and the introduction of Good Manufacturing Practice inspections, resulted in the supply of good quality drugs and in holding down the procurement costs of many drugs. Bulk purchasing of carefully selected essential drugs was estimated to save nearly 30% of the annual drugs bill for the Government of Delhi, savings which were mobilized for procuring more drugs, which in turn improved availability of drugs (more than 80%) at health facilities. Further, training programmes for prescribers led to a positive change in prescribing behaviour, with more than 80% of prescriptions being from the EDL and patients receiving 70-95% of the drugs prescribed. These changes were achieved by changing managerial systems with minimal additional expenditure. The 'Delhi Model' has clearly demonstrated that such a programme can be introduced and implemented and can lead to a better use and availability of medicines.

Pharmacist-industry relationships.

PubMed

Saavedra, Keene; O'Connor, Bonnie; Fugh-Berman, Adriane

2017-12-01

The purpose of this study was to document, in their own words, beliefs and attitudes that American pharmacists have towards the pharmaceutical industry and pharmacists' interactions with industry. An ethnographic-style qualitative study was conducted utilizing open-ended interviews with four hospital pharmacists, two independent pharmacists, two retail pharmacists and one administrative pharmacist in the Washington, DC, metropolitan area to elicit descriptions of and attitudes towards pharmacists' relationships with industry. Analysis of the qualitative material followed established ethnographic conventions of narrative thematic analysis. All pharmacists reported interactions with pharmaceutical company representatives. Most had received free resources or services from industry, including educational courses. Respondents uniformly believed that industry promotional efforts are primarily directed towards physicians. Although respondents felt strongly that drug prices were excessive and that 'me-too' drugs were of limited use, they generally had a neutral-to-positive view of industry-funded adherence/compliance programmes, coupons, vouchers, and copay payment programmes. Interviewees viewed direct-to-consumer advertising negatively, but had a generally positive view of industry-funded drug information. Pharmacists may represent a hitherto under-identified cohort of health professionals who are targeted for industry influence; expanding roles for pharmacists may make them even more attractive targets for future industry attention. Pharmacy schools should ensure that students learn to rely on unbiased information sources and should teach students about conflicts of interest and the risks of interacting with industry. Further research should be conducted on the extent to which pharmacists' attitudes towards their duties and towards drug assessment and recommendation are influenced by the pharmaceutical industry. © 2017 Royal Pharmaceutical Society.

Nurses' knowledge of pharmacology behind drugs they commonly administer.

PubMed

Ndosi, Mwidimi E; Newell, Rob

2009-02-01

To determine if nurses had adequate pharmacology knowledge of the drugs they commonly administer. Literature suggests that nurses have insufficient pharmacology knowledge. We also know that nurses and teachers of pharmacology are not satisfied with the amount of pharmacology taught in preregistration programmes in the UK. There is a lack of primary research on nurses' knowledge of pharmacology for the purpose of drug administration. We used a non-experimental causal comparative and correlational design. We recruited a convenience sample of 42 nurses working in surgical wards of a foundation hospital in the North of England. Data were collected by structured interview and questionnaire methods. During the interview, the participants made a blinded selection of one out of four drugs they commonly administer and answered standard questions which focused on specific pharmacology knowledge. Their answers were given a score out of 10 (100%) to determine their actual pharmacology knowledge. The sample comprised of 18 (42.9%) junior nurses and 24 (57.1%) senior nurses. They had a median experience of 10.87 years postregistration. Their mean knowledge score was six ranging between two and nine (SD 1.9). Only 11 (26.1%) nurses scored eight or above and the majority 24 (57.2%) scored below seven, indicating inadequate knowledge. Knowledge of the mechanism of action and drug interactions was poor. There was a correlation between knowledge and experience. The results of this study suggest that nurses have inadequate knowledge of pharmacology. The results will contribute to the evidence of nurses' knowledge of pharmacology in the UK. This study supports the need for supplementary pharmacology education for nurses in clinical settings, focusing on common drugs they administer. This will increase nurses' knowledge and confidence in drug administration and safer medicines management.

Multiple model predictive control for optimal drug administration of mixed immunotherapy and chemotherapy of tumours.

PubMed

Sharifi, N; Ozgoli, S; Ramezani, A

2017-06-01

Mixed immunotherapy and chemotherapy of tumours is one of the most efficient ways to improve cancer treatment strategies. However, it is important to 'design' an effective treatment programme which can optimize the ways of combining immunotherapy and chemotherapy to diminish their imminent side effects. Control engineering techniques could be used for this. The method of multiple model predictive controller (MMPC) is applied to the modified Stepanova model to induce the best combination of drugs scheduling under a better health criteria profile. The proposed MMPC is a feedback scheme that can perform global optimization for both tumour volume and immune competent cell density by performing multiple constraints. Although current studies usually assume that immunotherapy has no side effect, this paper presents a new method of mixed drug administration by employing MMPC, which implements several constraints for chemotherapy and immunotherapy by considering both drug toxicity and autoimmune. With designed controller we need maximum 57% and 28% of full dosage of drugs for chemotherapy and immunotherapy in some instances, respectively. Therefore, through the proposed controller less dosage of drugs are needed, which contribute to suitable results with a perceptible reduction in medicine side effects. It is observed that in the presence of MMPC, the amount of required drugs is minimized, while the tumour volume is reduced. The efficiency of the presented method has been illustrated through simulations, as the system from an initial condition in the malignant region of the state space (macroscopic tumour volume) transfers into the benign region (microscopic tumour volume) in which the immune system can control tumour growth. Copyright © 2017 Elsevier B.V. All rights reserved.

Current status and approaches to developing press-coated chronodelivery drug systems.

PubMed

Lin, Shan-Yang; Kawashima, Yoshiaki

2012-02-10

The past several decades have seen the development of many controlled-release preparations featuring constant release rates to maintain drug concentrations in the human body, regardless of the patient's physiological condition. However, long-term constant drug concentrations in the blood and tissue can cause problems such as resistance, tolerability, and drug side effects. People vary considerably in their physiological and biochemical conditions during any 24 h period, due to the circadian rhythm, and thus, the constant delivery of a drug into the body seems both unnecessary and undesirable. If the drug release profile mimics a living system's pulsatile hormone secretion, then it may improve drug efficacy, and reduce the toxicity of a specific drug administration schedule. Medication and treatments provided according to the body's circadian rhythms will result in better outcomes. This may be provided by a chronopharmaceutical dosage regimen with pulsatile release that matches the circadian rhythm resulting from a disease state, so optimizing the therapeutic effect while minimizing side effects. The press coating technique is a simple and unique technology used to provide tablets with a programmable lag phase, followed by a fast, or rate-controlled, drug release after administration. The technique offers many advantages, and no special coating solvent or coating equipment is required for manufacturing this type of tablet. The present review article introduces chronopharmaceutical press-coated products from a patient physiological needs perspective. The contents of this article include biological rhythms and pulsatile hormone secretion in humans, the reasons for using pulsatile drug delivery for disease treatment, recent chronopharmaceutical preparations appearing on the market, updated compilation of all research articles and press-coated delivery techniques, factors affecting the performance and drug release characteristics of press-coated delivery systems, and recent challenges for the press coating technique. We also provide a brief overview of press-coating approaches intended for chronotherapy. Copyright © 2011 Elsevier B.V. All rights reserved.

The economic benefits resulting from the first 8 years of the Global Programme to Eliminate Lymphatic Filariasis (2000-2007).

PubMed

Chu, Brian K; Hooper, Pamela J; Bradley, Mark H; McFarland, Deborah A; Ottesen, Eric A

2010-06-01

Between 2000-2007, the Global Programme to Eliminate Lymphatic Filariasis (GPELF) delivered more than 1.9 billion treatments to nearly 600 million individuals via annual mass drug administration (MDA) of anti-filarial drugs (albendazole, ivermectin, diethylcarbamazine) to all at-risk for 4-6 years. Quantifying the resulting economic benefits of this significant achievement is important not only to justify the resources invested in the GPELF but also to more fully understand the Programme's overall impact on some of the poorest endemic populations. To calculate the economic benefits, the number of clinical manifestations averted was first quantified and the savings associated with this disease prevention then analyzed in the context of direct treatment costs, indirect costs of lost-labor, and costs to the health system to care for affected individuals. Multiple data sources were reviewed, including published literature and databases from the World Health Organization, International Monetary Fund, and International Labour Organization An estimated US$21.8 billion of direct economic benefits will be gained over the lifetime of 31.4 million individuals treated during the first 8 years of the GPELF. Of this total, over US$2.3 billion is realized by the protection of nearly 3 million newborns and other individuals from acquiring lymphatic filariasis as a result of their being born into areas freed of LF transmission. Similarly, more than 28 million individuals already infected with LF benefit from GPELF's halting the progression of their disease, which results in an associated lifetime economic benefit of approximately US$19.5 billion. In addition to these economic benefits to at-risk individuals, decreased patient services associated with reduced LF morbidity saves the health systems of endemic countries approximately US$2.2 billion. MDA for LF offers significant economic benefits. Moreover, with favorable program implementation costs (largely a result of the sustained commitments of donated drugs from the pharmaceutical industry) it is clear that the economic rate of return of the GPELF is extremely high and that this Programme continues to prove itself an excellent investment in global health.

Seventeen years' experience of a voluntarily based drug rationalisation programme in hospital.

PubMed Central

Baker, J. A.; Lant, A. F.; Sutters, C. A.

1988-01-01

A study was carried out analysing the operation of a drug rationalisation programme in a central London teaching district that had evolved from experience over 17 years. Creation of a limited list of about 700 drugs had been achieved by local consensus. Drug selection was based on appraisal of efficacy, safety, and cost and was undertaken by means of collaborative participation of most consultant specialists in the district. Educative and other non-restrictive strategies for reinforcing the rationalisation policy had achieved a consistently high rate of compliance in prescribing recommended drugs. The concept of selectivity in drug use and its continuous local reappraisal had a beneficial impact on the prescribing habits of doctors at all levels of seniority as well as on the training of medical undergraduates and nurses in the therapeutic use of medicines. Peer review and self audit were encouraged by use of an extensive monitoring system which incorporated continuous "facilitative" dialogue between ward pharmacists and prescribers. Two models of drug rationalisation programme were studied, the second of which together with other local initiatives had been associated with substantial and sustained reductions in drug spending each year over nine years since 1978. It is concluded that the second drug rationalisation programme model substantially improves the cost effective use of drugs in hospital and furthermore has the potential of being extended to general practice, especially in types of prescribing that are common to both forms of patient care. PMID:3139150

Parenting Programmes for Preventing Tobacco, Alcohol or Drugs Misuse in Children Less than 18: A Systematic Review

ERIC Educational Resources Information Center

Petrie, Jane; Bunn, Frances; Byrne, Geraldine

2007-01-01

We conducted a systematic review of controlled studies of parenting programmes to prevent tobacco, alcohol or drug abuse in children less than 18. We searched Cochrane Central Register of Controlled Trials, specialized Register of Cochrane Drugs and Alcohol Group, Pub Med, psych INFO, CINALH and SIGLE. Two reviewers independently screened studies,…

Highly active antiretroviral therapy and tuberculosis control in Africa: synergies and potential.

PubMed Central

Harries, Anthony D.; Hargreaves, Nicola J.; Chimzizi, Rehab; Salaniponi, Felix M.

2002-01-01

HIV/AIDS (human immunodeficiency virus/acquired immunodeficiency syndrome) and TB (tuberculosis) are two of the world's major pandemics, the brunt of which falls on sub-Saharan Africa. Efforts aimed at controlling HIV/AIDS have largely focused on prevention, little attention having been paid to care. Work on TB control has concentrated on case detection and treatment. HIV infection has complicated the control of tuberculosis. There is unlikely to be a decline in the number of cases of TB unless additional strategies are developed to control both this disease and HIV simultaneously. Such strategies would include active case-finding in situations where TB transmission is high, the provision of a package of care for HIV-related illness, and the application of highly active antiretroviral therapy. The latter is likely to have the greatest impact, but for this therapy to become more accessible in Africa the drugs would have to be made available through international support and a programme structure would have to be developed for its administration. It could be delivered by means of a structure based on the five-point strategy called DOTS, which has been adopted for TB control. However, it may be unrealistic to give TB control programmes the responsibility for running such a programme. A better approach might be to deliver highly active antiretroviral therapy within a comprehensive HIV/AIDS management strategy complementing the preventive work already being undertaken by AIDS control programmes. TB programmes could contribute towards the development and implementation of this strategy. PMID:12132003

Long Term Control of Scabies Fifteen Years after an Intensive Treatment Programme

PubMed Central

Marks, Michael; Taotao-Wini, Betty; Satorara, Lorraine; Engelman, Daniel; Nasi, Titus; Mabey, David C.; Steer, Andrew C.

2015-01-01

Introduction Scabies is a major public health problem in the Pacific and is associated with an increased risk of bacterial skin infections, glomerulonephritis and rheumatic fever. Mass drug administration with ivermectin is a promising strategy for the control of scabies. Mass treatment with ivermectin followed by active case finding was conducted in five communities in the Solomon Islands between 1997 and 2000 and resulted in a significant reduction in the prevalence of both scabies and bacterial skin infections. Methods We conducted a prospective follow-up study of the communities where the original scabies control programme had been undertaken. All residents underwent a standardised examination for the detection of scabies and impetigo. Results Three hundred and thirty eight residents were examined, representing 69% of the total population of the five communities. Only 1 case of scabies was found, in an adult who had recently returned from the mainland. The prevalence of active impetigo was 8.8% overall and 12.4% in children aged 12 years or less. Discussion We found an extremely low prevalence of scabies 15 years after the cessation of a scabies control programme. The prevalence of impetigo had also declined further since the end of the control programme. Our results suggest that a combination of mass treatment with ivermectin and intensive active case finding may result in long term control of scabies. Larger scale studies and integration with other neglected tropical disease control programmes should be priorities for scabies control efforts. PMID:26624616

Long Term Control of Scabies Fifteen Years after an Intensive Treatment Programme.

PubMed

Marks, Michael; Taotao-Wini, Betty; Satorara, Lorraine; Engelman, Daniel; Nasi, Titus; Mabey, David C; Steer, Andrew C

2015-12-01

Scabies is a major public health problem in the Pacific and is associated with an increased risk of bacterial skin infections, glomerulonephritis and rheumatic fever. Mass drug administration with ivermectin is a promising strategy for the control of scabies. Mass treatment with ivermectin followed by active case finding was conducted in five communities in the Solomon Islands between 1997 and 2000 and resulted in a significant reduction in the prevalence of both scabies and bacterial skin infections. We conducted a prospective follow-up study of the communities where the original scabies control programme had been undertaken. All residents underwent a standardised examination for the detection of scabies and impetigo. Three hundred and thirty eight residents were examined, representing 69% of the total population of the five communities. Only 1 case of scabies was found, in an adult who had recently returned from the mainland. The prevalence of active impetigo was 8.8% overall and 12.4% in children aged 12 years or less. We found an extremely low prevalence of scabies 15 years after the cessation of a scabies control programme. The prevalence of impetigo had also declined further since the end of the control programme. Our results suggest that a combination of mass treatment with ivermectin and intensive active case finding may result in long term control of scabies. Larger scale studies and integration with other neglected tropical disease control programmes should be priorities for scabies control efforts.

Measures to prevent and reduce drug abuse among young people in Burma.

PubMed

Khant, U

1985-01-01

Opium and to a certain extent cannabis were the only drugs of abuse in Burma until the early 1970s when heroin addiction spread rapidly among young people, reaching epidemic proportions. Heroin addiction has caused serious social and health problems that prompted the authorities to adopt new legislation in 1974, the Narcotic and Dangerous Drugs Law, which provided for compulsory treatment and severe penalties for drug-related infractions, including the death sentence for certain categories of drug trafficking. The authorities in Burma consider that legislation, drug-law enforcement, prevention, treatment and rehabilitation, and community measures are important and interrelated strategies in combating drug abuse among young people. Various forms of drug-abuse preventive programmes are carried out for such groups as youths, parents, community leaders and professionals dealing with the problems of the young. Preventive school programmes include lectures and discussions; exhibitions; essay writing and other forms of competition for students; in-service training for teachers; healthy alternatives to drug use; a scheme for talented students; and participation in a national mass movement for literacy. Young people are also encouraged to take active part in various community programmes such as the "Red Cross" and voluntary fire brigades as well as in specially designed programmes that are carried out at the local level to prevent and reduce drug abuse. As the extended family still prevails in Burma, with parents and elders being respected by the young, this important resource is utilized in coping with drug abuse among young people.(ABSTRACT TRUNCATED AT 250 WORDS)

A political analysis of corporate drug donations: the example of Malarone in Kenya.

PubMed

Shretta, R; Walt, G; Brugha, R; Snow, R

2001-06-01

This paper describes the introduction of the Malarone Donation Programme in KENYA: Using a policy analysis approach it illustrates the political nature of donation programmes and how they are affected by a large and varied group of national, regional and international stakeholders, with different levels of influence and experience. The paper shows that interaction between these different groups may affect the development and implementation of the donation programme. It ends by raising some more general questions about public/private partnerships and corporate donation programmes, and their potential impact on national drug policies.

Opiate addiction in adult offspring through possible imprinting after obstetric treatment.

PubMed Central

Jacobson, B; Nyberg, K; Grönbladh, L; Eklund, G; Bygdeman, M; Rydberg, U

1990-01-01

OBJECTIVE--To test the hypothesis that opiate addiction in adults might stem partly from an imprinting process during birth when certain drugs are given to the mother. DESIGN--Retrospective study by logistic regression of opiate addicts with siblings as controls. SETTING--Stockholm, Sweden. SUBJECTS--200 Opiate addicts born in Stockholm during 1945-66, comprising 41 identified during interviews of probands for an earlier study; 75 patients whose death from opiate addiction had been confirmed during 1978-88; and 84 accepted for the methadone programme. 262 Siblings (controls) born in Stockholm during the same period, 24 of whom were excluded for drug addiction or being brought up outside the family. Birth records were unavailable for eight, leaving 230 siblings and 139 corresponding probands. MAIN OUTCOME MEASURES--Administration of opiates, barbiturates, and nitrous oxide (for greater than 1 h) to mothers of all subjects during labour within 10 hours before birth as a risk factor for adult opiate addiction. RESULTS--In subjects who had subsequently become addicts a significant proportion of mothers had received opiates or barbiturates, or both, compared with unmatched siblings (25% v 16%, chi 2 = 5.83, df = 1, p = 0.02), and these mothers had received nitrous oxide for longer and more often. After controlling for hospital of birth, order of birth, duration of labour, presentation other than vertex, surgical intervention, asphyxia, meconium stained amniotic fluid, and birth weight the relative risk for offspring subsequently becoming an adult opiate addict increased with the number of administrations of any of the three drugs. When the addicts were matched with their own siblings the estimated relative risk was 4.7 (95% confidence interval 1.8 to 12.4, p for trend = 0.002) for three administrations compared with when no drug was given. CONCLUSIONS--The results are compatible with the imprinting hypothesis. Therefore, for obstetric pain relief methods are preferable that do not permit substantial passage of drugs through the placenta. PMID:2249068

21 CFR 870.1425 - Programmable diagnostic computer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Programmable diagnostic computer. 870.1425 Section... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1425 Programmable diagnostic computer. (a) Identification. A programmable diagnostic computer is a device that can be...

21 CFR 870.1425 - Programmable diagnostic computer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Programmable diagnostic computer. 870.1425 Section... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1425 Programmable diagnostic computer. (a) Identification. A programmable diagnostic computer is a device that can be...

21 CFR 870.1425 - Programmable diagnostic computer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Programmable diagnostic computer. 870.1425 Section... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1425 Programmable diagnostic computer. (a) Identification. A programmable diagnostic computer is a device that can be...

21 CFR 870.1425 - Programmable diagnostic computer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Programmable diagnostic computer. 870.1425 Section... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1425 Programmable diagnostic computer. (a) Identification. A programmable diagnostic computer is a device that can be...

21 CFR 870.1425 - Programmable diagnostic computer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Programmable diagnostic computer. 870.1425 Section... (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Diagnostic Devices § 870.1425 Programmable diagnostic computer. (a) Identification. A programmable diagnostic computer is a device that can be...

Infection control in households of drug-resistant tuberculosis patients co-infected with HIV in Mumbai, India.

PubMed

Albuquerque, T; Isaakidis, P; Das, M; Saranchuk, P; Andries, A; Misquita, D P; Khan, S; Dubois, S; Peskett, C; Browne, M

2014-03-21

Mumbai has a population of 21 million, and an increasingly recognised epidemic of drug-resistant tuberculosis (DR-TB). To describe TB infection control (IC) measures implemented in households of DR-TB patients co-infected with the human immunodeficiency virus (HIV) under a Médecins Sans Frontières programme. IC assessments were carried out in patient households between May 2012 and March 2013. A simplified, standardised assessment tool was utilised to assess the risk of TB transmission and guide interventions. Administrative, environmental and personal protective measures were tailored to patient needs. IC assessments were carried out in 29 houses. Measures included health education, segregating sleeping areas of patients, improving natural ventilation by opening windows, removing curtains and obstacles to air flow, installing fans and air extractors and providing surgical masks to patients for limited periods. Environmental interventions were carried out in 22 houses. TB IC could be a beneficial component of a comprehensive TB and HIV care programme in households and communities. Although particularly challenging in slum settings, IC measures that are feasible, affordable and acceptable can be implemented in such settings using simplified and standardised tools. Appropriate IC interventions at household level may prevent new cases of DR-TB, especially in households of patients with a lower chance of cure.

The role of an intergovernmental regional organization in combating drug trafficking: a perspective of the Colombo Plan Bureau.

PubMed

Abarro, P A

1987-01-01

The Colombo Plan was established in 1950 as a regional intergovernmental organization for co-operative economic and social development in Asia and the Pacific comprising 26 member States. The permanent secretariat is the Colombo Plan Bureau to which is attached the Drug Advisory Programme (DAP) headed by a drug adviser, who consults with Governments and helps develop co-operative programmes for drug abuse prevention and control. DAP functions in close liaison and co-operation with organizations of the United Nations system and other regional and international organizations in pursuing activities in line with the international strategy and policies for drug control of the United Nations. DAP assists member States in creating public awareness of the dangers of drug abuse and drug trafficking through the use of mass media, seminars, workshops and conferences and study exchange programmes. It assists Governments in updating their drug laws and in establishing special drug units and national co-ordinating bodies on drug abuse control. DAP encourages and supports the utilization of community resources and the activities of non-governmental organizations and voluntary bodies for the prevention and reduction of drug abuse, as well as the use of mass media for more co-ordinated efforts in this area. It assists member States in developing human resources and technical expertise of personnel in the various disciplines of law enforcement, prevention, treatment and rehabilitation, through training, seminars, study exchange fellowship programmes and research. DAP also assists in promoting co-operation at the regional and interregional levels, and is involved in developing and strengthening co-operation between agencies of member States that deal with drug problems.

21 CFR 892.1870 - Radiographic film/cassette changer programmer.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Radiographic film/cassette changer programmer. 892... SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1870 Radiographic film/cassette changer programmer. (a) Identification. A radiographic film/cassette changer programmer is a...

21 CFR 892.1870 - Radiographic film/cassette changer programmer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Radiographic film/cassette changer programmer. 892... SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1870 Radiographic film/cassette changer programmer. (a) Identification. A radiographic film/cassette changer programmer is a...

21 CFR 892.1870 - Radiographic film/cassette changer programmer.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Radiographic film/cassette changer programmer. 892... SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1870 Radiographic film/cassette changer programmer. (a) Identification. A radiographic film/cassette changer programmer is a...

21 CFR 892.1870 - Radiographic film/cassette changer programmer.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Radiographic film/cassette changer programmer. 892... SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1870 Radiographic film/cassette changer programmer. (a) Identification. A radiographic film/cassette changer programmer is a...

21 CFR 892.1870 - Radiographic film/cassette changer programmer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Radiographic film/cassette changer programmer. 892... SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.1870 Radiographic film/cassette changer programmer. (a) Identification. A radiographic film/cassette changer programmer is a...

21 CFR 870.3700 - Pacemaker programmers.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Pacemaker programmers. 870.3700 Section 870.3700...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3700 Pacemaker programmers. (a) Identification. A pacemaker programmer is a device used to change noninvasively one or more of...

21 CFR 870.3700 - Pacemaker programmers.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Pacemaker programmers. 870.3700 Section 870.3700...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3700 Pacemaker programmers. (a) Identification. A pacemaker programmer is a device used to change noninvasively one or more of...

21 CFR 870.3700 - Pacemaker programmers.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Pacemaker programmers. 870.3700 Section 870.3700...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3700 Pacemaker programmers. (a) Identification. A pacemaker programmer is a device used to noninvasively change one or more of...

21 CFR 870.3700 - Pacemaker programmers.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Pacemaker programmers. 870.3700 Section 870.3700...) MEDICAL DEVICES CARDIOVASCULAR DEVICES Cardiovascular Prosthetic Devices § 870.3700 Pacemaker programmers. (a) Identification. A pacemaker programmer is a device used to noninvasively change one or more of...

[Drug politics in the USA].

PubMed

Gaier, N

2001-11-08

About 40 million Americans over 65 years of age are enrolled in the Medicare programme. However, this programme (with some exceptions approved by the Congress) does not provide prescription drug coverage for the outpatients. Furthermore, the recent rate of drug expenditure increase has been twice higher compared to overall health care expenditures. Even though the Medicare beneficiaries are offered various forms of supplemental prescription drug coverage, there exist attempts to reform this national programme. Several such proposals, however, failed during the last 15 years (US Congress). A recent two-stage strategy for a comprehensive Medicare reform was proposed by president Bush jr. It would solve the prescription drug coverage (even without the Medicare beneficiary enrollment in supplemental private programmes) through direct support to federal states in the first stage; in the second stage, a comprehensive Medicare reform would take place and the prescription drug coverage would be subsidized in proportion to the annual income of the beneficiaries. The required cost of this reform would be about 160 thousand million $ over a decade. This plan brought about opposing proposals both from the Democrats and Republicans in the Congress. The fate of the reform will depend on the representation of the two political parties both in the House of Representatives and the Senate as well as on the political power of influential groups.

Stimuli-free programmable drug release for combination chemo-therapy

NASA Astrophysics Data System (ADS)

Fan, Li; Jin, Boquan; Zhang, Silu; Song, Chaojun; Li, Quan

2016-06-01

Combinational chemotherapy capable of targeted delivery and programmable multi-drug release leads to enhanced drug efficacy, and is highly desired for cancer treatment. However, effective approaches for achieving both features in a single treatment are limited. In the present work, we demonstrated programmed delivery of both chemotherapeutic and immunotherapeutic agents with tumor cell targeting capability by using SiO2 based self-decomposable nanoparticulate systems. The programmable drug delivery is realized by manipulating drug loading configurations instead of relying on external stimuli. Both in vitro and in vivo results showed specific drug binding to FAT1-expressing colon cancer cells. The loaded dual drugs were demonstrated to be delivered in a sequential manner with specific time intervals between their peak releases, which maximize the synergistic effect of the chemotherapeutics. These features led to significantly enhanced drug efficacy and reduced system toxicity. The tumor weight decreased by 1/350, together with a moderate increase in rats' body weight, which were observed when adopting the dual drug loaded nanoparticles, as compared to those of the control groups. The present system provides a simple and feasible method for the design of targeting and combination chemotherapy with programmed drug release.Combinational chemotherapy capable of targeted delivery and programmable multi-drug release leads to enhanced drug efficacy, and is highly desired for cancer treatment. However, effective approaches for achieving both features in a single treatment are limited. In the present work, we demonstrated programmed delivery of both chemotherapeutic and immunotherapeutic agents with tumor cell targeting capability by using SiO2 based self-decomposable nanoparticulate systems. The programmable drug delivery is realized by manipulating drug loading configurations instead of relying on external stimuli. Both in vitro and in vivo results showed specific drug binding to FAT1-expressing colon cancer cells. The loaded dual drugs were demonstrated to be delivered in a sequential manner with specific time intervals between their peak releases, which maximize the synergistic effect of the chemotherapeutics. These features led to significantly enhanced drug efficacy and reduced system toxicity. The tumor weight decreased by 1/350, together with a moderate increase in rats' body weight, which were observed when adopting the dual drug loaded nanoparticles, as compared to those of the control groups. The present system provides a simple and feasible method for the design of targeting and combination chemotherapy with programmed drug release. Electronic supplementary information (ESI) available. See DOI: 10.1039/c5nr06305a

US Food and Drug Administration's Risk Evaluation and Mitigation Strategy for extended-release and long-acting opioids: pros and cons, and a European perspective.

PubMed

Mercadante, Sebastiano; Craig, David; Giarratano, Antonello

2012-12-24

Prescriptions for opioid analgesics to manage moderate-to-severe chronic non-cancer pain have increased markedly over the last decade. An unintentional consequence of greater prescription opioid utilization has been the parallel increase in misuse, abuse and overdose, which are serious risks associated with all opioid analgesics. In response to disturbing rises in prescription opioid abuse, the US Food and Drug Administration (FDA) has proposed the implementation of aggressive Risk Evaluation and Mitigation Strategies (REMS). While REMS could dramatically change the development, release, marketing and prescription of extended-release opioids, questions remain on how these programmes may influence prescribing practices, patient safety and ultimately patient access to these agents. The extent of the availability and misuse of prescription opioids in Europe is difficult to assess from the data currently available, due in large part to the considerable differences in prescribing patterns and regulations between countries. Balancing the availability of prescription opioids for those patients who have pain, while discouraging illicit use, is a complex challenge and requires effective efforts on many levels, particularly in Europe where policies are quite different between countries.

Prolonged persistence of residual Wuchereria bancrofti infection after cessation of diethylcarbamazine-fortified salt programme.

PubMed

Ramaiah, K D; Thiruvengadam, B; Vanamail, P; Subramanian, S; Gunasekaran, S; Nilamani, N; Das, P K

2009-08-01

A diethylcarbamazine (DEC)-fortified salt intervention programme was implemented between 1982 and 1986 in Karaikal district, Union territory of Pondicherry, south India, to control Culex transmitted bancroftian filariasis. The intervention reduced the microfilaria (Mf) rate from 4.49% to 0.08%. To eliminate the residual microfilaraemia, the health department detected and treated Mf carriers from 1987 to 2005 and mass-administered drugs in 2004 and 2005. Surveillance from 1987 to 2005 revealed persistent microfilaraemia in 0.03-0.42% of the population. In 2006, we conducted a more detailed Mf survey and a child antigenaemia (Ag) survey in 15 urban wards and 17 rural villages. These surveys showed an overall Mf rate of 0.46% in the high-risk urban areas and 0.18% in the rural areas; none of the sampled children was positive for Ag. All detected Mf carriers were >20 years old. The age of the youngest Mf carrier was 30 years in urban and 21 years in rural areas, which suggests that transmission was interrupted and there was no incidence of new Mf case after cessation of DEC salt programme. Eleven of 15 urban and 15 of 17 villages were totally free from microfilaraemia. Nevertheless, three of 15 surveyed urban localities and two of 17 villages showed >1% Mf rate. Thus, it seems that (i) post-intervention very low levels of microfilaraemia can continue as long as 20 years; (ii) 0.60-0.70% Mf rate is a safe level and at this level recrudescence of infection may not occur; (iii) there can be isolated localities with >1% Mf rate and their detection for further intervention measures could be challenging in larger control/elimination programmes and (iv) the residual infection mostly gets concentrated in the adult population, in underdeveloped urban areas and in historically highly endemic or large endemic rural areas. These groups and areas should be targeted with rigorous intervention measures such as mass drug administration to eliminate the residual infection.

Vaccines in Argentina: a regulatory view.

PubMed

Pérez, A C; Diez, R A

2003-07-28

In Argentina, vaccines for immuno-preventable diseases are regulated by the national regulatory agency, the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (the National Administration of Drugs, Food and Medical Devices, or ANMAT) created in 1992 to ensure efficacy and safety of drugs, food and medical devices available in the country, according to Law 16,463 and Decree 150/92. ANMAT has licensed 84 out of 157 vaccines registered in Argentina. Since 1994, ANMAT evaluated, approved and inspected 20 clinical trials with vaccines (1.8% of the 1062 trials approved by the agency since that time). The National System of Pharmaco-vigilance has received 318 communications of eventual adverse post-vaccination events (0.3% of the total). In addition, ANMAT provides support to the National Immunisation Programme. The current procedure is to follow international guidelines in the field, to be prepared for new, rapidly changing scenarios.

Nippostronglylus brasiliensis infection in the rat: effect of iron and protein deficiency and dexamethasone on the efficacy of benzimidazole anthelmintics.

PubMed Central

Duncombe, V M; Bolin, T D; Davis, A E; Kelly, J D

1977-01-01

Malnutrition, anaemia, and gut parasites are commonly interrelated. Using the Nippostrongylus brasiliensis-rat model, the effect of iron and protein deficiency on the efficacy of benzimidazole anthelmintics was studied. It was demonstrated that the anthelmintics mebendazole and fenbendazole were significantly less effective in eradicating parasites when animals were deficient in iron and protein. This decreased efficacy of anthelmintics in iron and protein deficiency could not be overcome by intraperitoneal administration of the drug. Since nutritional deficiencies may act via impairment of the immune response, anthelmintic efficacy was determined in adequately nourished rats treated with the immunosuppressive drug dexamethasone. A similar decrease in efficacy of mebendazole was shown when these animals were treated with dexamethasone. Thus it is possible that lowered anthelmintic efficacy in iron and protein deficient animals is mediated by immune deficiency. These findings may be relevant to anthelmintic programmes in malnourished communities. PMID:590849

Choosing the right incentive strategy for research and development in neglected diseases.

PubMed Central

Maurer, Stephen M.

2006-01-01

For the first time in history, worldwide neglected disease budgets may be large enough to deliver a new drug every few years. That said, sponsors will only succeed if they extract maximum value from every dollar spent. This paper reviews possible cost-containment strategies and provides an evidence-based framework for choosing between them. Current proposals can be categorized as "end-to-end" proposals which require the sponsor to set a single reward for companies that complete the entire drug discovery process or "pay-as-you-go" schemes in which sponsors offer repeated rewards as drug candidates progress through the pipeline. A generic weakness of end-to-end proposals is that rewards are likely to be 20-30% higher than they would be in an equivalent pay-as-you-go programme. However, the benefits of pay-as-you-go programmes may be lost if commercial pharmaceutical companies are substantially better at choosing successful programmes than are their non-profit counterparts. The efficiency of pay-as-you-go methods depends on sponsors' willingness to withdraw funding from failed drug discovery programmes. PMID:16710547

The effectiveness and cost-effectiveness of diversion and aftercare programmes for offenders using class A drugs: a systematic review and economic evaluation.

PubMed

Hayhurst, Karen P; Leitner, Maria; Davies, Linda; Flentje, Rachel; Millar, Tim; Jones, Andrew; King, Carlene; Donmall, Michael; Farrell, Michael; Fazel, Seena; Harris, Rochelle; Hickman, Matthew; Lennox, Charlotte; Mayet, Soraya; Senior, Jane; Shaw, Jennifer

2015-01-01

The societal costs of problematic class A drug use in England and Wales exceed £15B; drug-related crime accounts for almost 90% of costs. Diversion plus treatment and/or aftercare programmes may reduce drug-related crime and costs. To assess the effectiveness and cost-effectiveness of diversion and aftercare for class A drug-using offenders, compared with no diversion. Adult class A drug-using offenders diverted to treatment or an aftercare programme for their drug use. Programmes to identify and divert problematic drug users to treatment (voluntary, court mandated or monitored services) at any point within the criminal justice system (CJS). Aftercare follows diversion and treatment, excluding care following prison or non-diversionary drug treatment. Thirty-three electronic databases and government online resources were searched for studies published between January 1985 and January 2012, including MEDLINE, PsycINFO and ISI Web of Science. Bibliographies of identified studies were screened. The UK Drug Data Warehouse, the UK Drug Treatment Outcomes Research Study and published statistics and reports provided data for the economic evaluation. Included studies evaluated diversion in adult class A drug-using offenders, in contact with the CJS. The main outcomes were drug use and offending behaviour, and these were pooled using meta-analysis. The economic review included full economic evaluations for adult opiate and/or crack, or powder, cocaine users. An economic decision analytic model, estimated incremental costs per unit of outcome gained by diversion and aftercare, over a 12-month time horizon. The perspectives included the CJS, NHS, social care providers and offenders. Probabilistic sensitivity analysis and one-way sensitivity analysis explored variance in parameter estimates, longer time horizons and structural uncertainty. Sixteen studies met the effectiveness review inclusion criteria, characterised by poor methodological quality, with modest sample sizes, high attrition rates, retrospective data collection, limited follow-up, no random allocation and publication bias. Most study samples comprised US methamphetamine users. Limited meta-analysis was possible, indicating a potential small impact of diversion interventions on reducing drug use [odds ratio (OR) 1.68, 95% confidence interval (CI) 1.12 to 2.53 for reduced primary drug use, and OR 2.60, 95% CI 1.70 to 3.98 for reduced use of other drugs]. The cost-effectiveness review did not identify any relevant studies. The economic evaluation indicated high uncertainty because of variance in data estimates and limitations in the model design. The primary analysis was unclear whether or not diversion was cost-effective. The sensitivity analyses indicated some scenarios where diversion may be cost-effective. Nearly all participants (99.6%) in the effectiveness review were American (Californian) methamphetamine users, limiting transfer of conclusions to the UK. Data and methodological limitations mean it is unclear whether or not diversion is effective or cost-effective. High-quality evidence for the effectiveness and cost-effectiveness of diversion schemes is sparse and does not relate to the UK. Importantly this research identified a range of methodological limitations in existing evidence. These highlight the need for research to conceptualise, define and develop models of diversion programmes and identify a core outcome set. A programme of feasibility, pilot and definitive trials, combined with process evaluation and qualitative research is recommended to assess the effectiveness and cost-effectiveness of diversionary interventions in class A drug-using offenders. The National Institute for Health Research Health Technology Assessment programme.

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2013-09-11

...: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration...

Illiberal or Simply Unorthodox? Public Administration Education in Hungary: A Comparative Perspective

ERIC Educational Resources Information Center

Hajnal, Gyorgy

2016-01-01

Over the past decades, Public Administration (PA) education programmes in Europe shifted their focus from a predominantly law-oriented approach to a more multidisciplinary, social science and managerial one. This paper deals with the tenacity of traditional, law-oriented PA education programmes that can be found in a limited, but not…

Influence of body mass index on prescribing costs and potential cost savings of a weight management programme in primary care.

PubMed

2008-07-01

Prescribed medications represent a high and increasing proportion of UK health care funds. Our aim was to quantify the influence of body mass index (BMI) on prescribing costs, and then the potential savings attached to implementing a weight management intervention. Paper and computer-based medical records were reviewed for all drug prescriptions over an 18-month period for 3400 randomly selected adult patients (18-75 years) stratified by BMI, from 23 primary care practices in seven UK regions. Drug costs from the British National Formulary at the time of the review were used. Multivariate regression analysis was applied to estimate the cost for all drugs and the 'top ten' drugs at each BMI point. This allowed the total and attributable prescribing costs to be estimated at any BMI. Weight loss outcomes achieved in a weight management programme (Counterweight) were used to model potential effects of weight change on drug costs. Anticipated savings were then compared with the cost programme delivery. Analysis was carried out on patients with follow-up data at 12 and 24 months as well as on an intention-to-treat basis. Outcomes from Counterweight were based on the observed lost to follow-up rate of 50%, and the assumption that those patients would continue a generally observed weight gain of 1 kg per year from baseline. The minimum annual cost of all drug prescriptions at BMI 20 kg/m(2) was pound 50.71 for men and pound 62.59 for women. Costs were greater by pound 5.27 (men) and pound 4.20 (women) for each unit increase in BMI, to a BMI of 25 (men pound 77.04, women pound 78.91), then by pound 7.78 and pound 5.53, respectively, to BMI 30 (men pound 115.93 women pound 111.23), then by pound 8.27 and pound 4.95 to BMI 40 (men pound 198.66, women pound 160.73). The relationship between increasing BMI and costs for the top ten drugs was more pronounced. Minimum costs were at a BMI of 20 (men pound 8.45, women pound 7.80), substantially greater at BMI 30 (men pound 23.98, women pound 16.72) and highest at BMI 40 (men pound 63.59, women pound 27.16). Attributable cost of overweight and obesity accounted for 23% of spending on all drugs with 16% attributable to obesity. The cost of the programme was estimated to be approximately pound 60 per patient entered. Modelling weight reductions achieved by the Counterweight weight management programme would potentially reduce prescribing costs by pound 6.35 (men) and pound 3.75 (women) or around 8% of programme costs at one year, and by pound 12.58 and pound 8.70, respectively, or 18% of programme costs after two years of intervention. Potential savings would be increased to around 22% of the cost of the programme at year one with full patient retention and follow-up. Drug prescriptions rise from a minimum at BMI of 20 kg/m(2) and steeply above BMI 30 kg/m(2). An effective weight management programme in primary care could potentially reduce prescription costs and lead to substantial cost avoidance, such that at least 8% of the programme delivery cost would be recouped from prescribing savings alone in the first year.

Sharing of Needles and Syringes among Men Who Inject Drugs: HIV Risk in Northwest Bangladesh.

PubMed

Pasa, M Kamal; Alom, Kazi Robiul; Bashri, Zubaida; Vermund, Sten H

2016-01-01

Injection drug use is prevalent in northwestern Bangladesh. We sought to explore the context of needle/syringe sharing among persons who inject drugs (PWID), examining risk exposures to blood-borne infections like the human immunodeficiency virus (HIV) and hepatitis in a region where these dual epidemics are likely to expand. We used a qualitative research approach to learn about injection practices, conducting 60 in-depth interviews among PWID. We then conducted 12 focus group discussions (FGDs) that generated a checklist of salient issues, and followed up with personal observations of typical days at the drug-use venues. Content and interpretative frameworks were used to analyze qualitative information and socio-demographic information, using SPSS software. We found that needle/syringe-sharing behaviours were integrated into the overall social and cultural lives of drug users. Sharing behaviours were an central component of PWID social organization. Sharing was perceived as an inherent element within reciprocal relationships, and sharing was tied to beliefs about drug effects, economic adversity, and harassment due to their drug user status. Carrying used needles/syringes to drug-use venues was deemed essential since user-unfriendly needle-syringe distribution schedules of harm reduction programmes made it difficult to access clean needles/syringes in off-hours. PWID had low self-esteem. Unequal power relationships were reported between the field workers of harm reduction programmes and PWID. Field workers expressed anti-PWID bias and judgmental attitudes, and also had had misconceptions about HIV and hepatitis transmission. PWID were especially disturbed that no assistance was forthcoming from risk reduction programme staff when drug users manifested withdrawal symptoms. Interventions must take social context into account when scaling up programmes in diverse settings. The social organization of PWID include values that foster needle-syringe sharing. Utilization and impact of risk reduction programmes might be improved with expanded clean needle/syringe distribution at times and venues convenient for PWID, better trained and non-judgmental staff, and medical assistance for health problems, including drug withdrawal symptoms.

Use of pharmacoeconomics in prescribing research. Part 1: costs--moving beyond the acquisition price for drugs.

PubMed

Robertson, J; Lang, D; Hill, S

2003-02-01

This paper addresses pharmacoeconomics in prescribing research and reflects the increasing use of techniques of economic evaluation to aid drug purchasing decisions in a variety of settings -- for national drug subsidization programmes, provincial purchasing plans, insurance programmes, and for hospital and area health authority formulary decisions. First, we focus on the cost component of an economic evaluation and discuss methodological issues that are relevant to all pharmacoeconomic analyses.

Tuberculosis knowledge among injecting drug users visiting syringe exchange programme in Tallinn, Estonia.

PubMed

Rüütel, Kristi; Parker, R David; Sobolev, Igor; Loit, Helle-Mai

2012-12-01

The purpose of the current study was to describe tuberculosis (TB) knowledge, beliefs, and experience with TB services among injecting drug users. Participants for this anonymous, cross-sectional study were recruited from a community based syringe exchange programme in Tallinn, Estonia. A structured questionnaire was completed and included information on socio-demographics, health history, drug use, and knowledge about TB and HIV. The study included 407 people (79% male, mean age 27.9 years, mean injection drug use 9.4 years). 32.9% of participants reported HIV infection and 1.7% lifetime history of TB. 26.4% participants (n=106) reported symptoms suggestive of TB. 93% of participants recognized correctly that TB is air-borne infection and 91% that HIV is a risk factor for TB. Only 40% of the participants knew that TB diagnostics and treatment in Estonia are free of charge for everybody and 58% reported they knew where to get health care services in case they suspected that they had TB. TB transmission and treatment adherence knowledge was better among those in contact with either health care or harm reduction services, e.g the community based syringe exchange programme. Similar to HIV services, TB prevention and education should be integrated into harm reduction and drug treatment programmes to facilitate early diagnosis and treatment of TB among injecting drug users.

Comparison of community-wide, integrated mass drug administration strategies for schistosomiasis and soil-transmitted helminthiasis: a cost-effectiveness modelling study.

PubMed

Lo, Nathan C; Bogoch, Isaac I; Blackburn, Brian G; Raso, Giovanna; N'Goran, Eliézer K; Coulibaly, Jean T; Becker, Sören L; Abrams, Howard B; Utzinger, Jürg; Andrews, Jason R

2015-10-01

More than 1·5 billion people are affected by schistosomiasis or soil-transmitted helminthiasis. WHO's recommendations for mass drug administration (MDA) against these parasitic infections emphasise treatment of school-aged children, using separate treatment guidelines for these two helminthiases groups. We aimed to evaluate the cost-effectiveness of expanding integrated MDA to the entire community in four settings in Côte d'Ivoire. We extended previously published, dynamic, age-structured models of helminthiases transmission to simulate costs and disability averted with integrated MDA (of praziquantel and albendazole) for schistosomiasis and soil-transmitted helminthiasis. We calibrated the model to data for prevalence and intensity of species-specific helminth infection from surveys undertaken in four communities in Côte d'Ivoire between March, 1997, and September, 2010. We simulated a 15-year treatment programme with 75% coverage in only school-aged children; school-aged children and preschool-aged children; adults; and the entire community. Treatment costs were estimated at US$0·74 for school-aged children and $1·74 for preschool-aged children and adults. The incremental cost-effectiveness ratio (ICER) was calculated in 2014 US dollars per disability-adjusted life-year (DALY) averted. Expanded community-wide treatment was highly cost effective compared with treatment of only school-aged children (ICER $167 per DALY averted) and WHO guidelines (ICER $127 per DALY averted), and remained highly cost effective even if treatment costs for preschool-aged children and adults were ten times greater than those for school-aged children. Community-wide treatment remained highly cost effective even when elimination of helminth infections was not achieved. These findings were robust across the four diverse communities in Côte d'Ivoire, only one of which would have received annual MDA for both schistosomiasis and soil-transmitted helminthiasis under the latest WHO guidelines. Treatment every 6 months was also highly cost effective in three out of four communities. Integrated, community-wide MDA programmes for schistosomiasis and soil-transmitted helminthiasis can be highly cost effective, even in communities with low disease burden in any helminth group. These results support an urgent need to re-evaluate current global guidelines for helminthiases control programmes to include community-wide treatment, increased treatment frequency, and consideration for lowered prevalence thresholds for integrated treatment. Stanford University Medical Scholars Programme, Mount Sinai Hospital-University Health Network AMO Innovation Fund. Copyright © 2015 Lo et al. Open Access article distributed under the terms of CC BY. Published by Elsevier Ltd.. All rights reserved.

Programmable release of multiple protein drugs from aptamer-functionalized hydrogels via nucleic acid hybridization.

PubMed

Battig, Mark R; Soontornworajit, Boonchoy; Wang, Yong

2012-08-01

Polymeric delivery systems have been extensively studied to achieve localized and controlled release of protein drugs. However, it is still challenging to control the release of multiple protein drugs in distinct stages according to the progress of disease or treatment. This study successfully demonstrates that multiple protein drugs can be released from aptamer-functionalized hydrogels with adjustable release rates at predetermined time points using complementary sequences (CSs) as biomolecular triggers. Because both aptamer-protein interactions and aptamer-CS hybridization are sequence-specific, aptamer-functionalized hydrogels constitute a promising polymeric delivery system for the programmable release of multiple protein drugs to treat complex human diseases.

Learning Problems in Transnational Business Education and Training: The Case of the MBA in Thailand

ERIC Educational Resources Information Center

Pimpa, Nattavud

2009-01-01

The transnational Master of Business Administration (MBA) programme has been one of the most popular official business training programmes amongst Thai business practitioners. Although the numbers of transnational business schools and MBA programmes are rapidly increasing, the programmes face numerous challenges from both local and global factors.…

Patent extension policy for paediatric indications: an evaluation of the impact within three drug classes in a state Medicaid programme.

PubMed

Nelson, Richard E; McAdam-Marx, Carrie; Evans, Megan L; Ward, Robert; Campbell, Benjamin; Brixner, Diana; Lafleur, Joanne

2011-05-01

The Food and Drug Administration Modernization Act (FDAMA) of 1997, Best Pharmaceuticals for Children Act (BPCA) of 2002 and Pediatric Research Equity Act of 2007 provide an extended period of 6 months of marketing exclusivity (i.e. patent extension) to prescription drug manufacturers that conduct paediatric studies. Branded drugs in the statin, ACE inhibitor and selective serotonin reuptake inhibitor (SSRI) classes were three of many classes with drugs granted patent extensions. We estimated the cost impact of the 6-month exclusivity extension policy on the Utah Medicaid drug programme by comparing actual costs to projected costs had the 6-month exclusivity extension not been granted for these drugs and thus less expensive generic alternatives been available sooner. Using these results, we then projected the cost impact of this policy on Medicaid programmes in the US during the 18 months following patent expiration. The Utah Medicaid prescription claims obtained for statins, ACE inhibitors and SSRIs included reimbursement amount, number of units dispensed, days supplied, date of service and drug strength. Actual expenditures for each drug were calculated for the 6 months before and 12 months after generic availability. The percentage difference between the brand name prescription reimbursement amount to Medicaid in the last 2 months of the 6-month extension and the generic prescription reimbursement amount to Medicaid in the first 2 months following exclusivity expiration was then calculated for each drug. This was done using data from the 5 months surrounding the exclusivity expiration by regressing the log-transformed Utah Medicaid reimbursement amount on an indicator for patent expiration, controlling for number of units, volume of sales, month filled and strength. This was used to estimate what the initial generic prescription price would have been without the 6-month patent extension and what costs would have been in the 18 months following the original expiration date if the patent extension had not been granted. Medicaid rebates were assumed to be 15.1% for branded products and 11% for generics. The 6-month extension policy was estimated to cost Utah's Medicaid $US2.2 (95% CI 1.9, 2.4) million for these three drug classes over the 18 months following the original patent expiration date (year 2007 values). Projected to the US Medicaid population, this cost was $US430 (95% CI 371, 475) million. For the individual drugs that we examined, the percentage cost decrease in reimbursement amount resulting from exclusivity expiration and generic entry ranged from 24.4% (p < 0.001) for enalapril to 3.8% (p = 0.0951) for pravastatin sodium. Makers of the branded drugs evaluated were given market exclusivity extensions for conducting studies of their medications in children. The costs found in this study are just a small portion of the total paid, which include those born by other payers. Whether the benefits of this policy outweigh these costs is an open question, but these results suggest that the costs to Medicaid and thus taxpayers are substantial.

Pharmacokinetics-on-a-Chip Using Label-Free SERS Technique for Programmable Dual-Drug Analysis.

PubMed

Fei, Jiayuan; Wu, Lei; Zhang, Yizhi; Zong, Shenfei; Wang, Zhuyuan; Cui, Yiping

2017-06-23

Synergistic effects of dual or multiple drugs have attracted great attention in medical fields, especially in cancer therapies. We provide a programmable microfluidic platform for pharmacokinetic detection of multiple drugs in multiple cells. The well-designed microfluidic platform includes two 2 × 3 microarrays of cell chambers, two gradient generators, and several pneumatic valves. Through the combined use of valves and gradient generators, each chamber can be controlled to infuse different kinds of living cells and drugs with specific concentrations as needed. In our experiments, 6-mercaptopurine (6MP) and methimazole (MMI) were chosen as two drug models and their pharmacokinetic parameters in different living cells were monitored through intracellular SERS spectra, which reflected the molecular structure of these drugs. The dynamic change of SERS fingerprints from 6MP and MMI molecules were recorded during drug metabolism in living cells. The results indicated that both 6MP and MMI molecules were diffused into the cells within 4 min and excreted out after 36 h. Moreover, the intracellular distribution of these drugs was monitored through SERS mapping. Thus, our microfluidic platform simultaneously accomplishes the functions to monitor pharmacokinetic action, distribution, and fingerprint of multiple drugs in multiple cells. Owing to its real-time, rapid-speed, high-precision, and programmable capability of multiple-drug and multicell analysis, such a microfluidic platform has great potential in drug design and development.

Information systems for administration, clinical documentation and quality assurance in an Austrian disease management programme.

PubMed

Beck, Peter; Truskaller, Thomas; Rakovac, Ivo; Bruner, Fritz; Zanettin, Dominik; Pieber, Thomas R

2009-01-01

5.9% of the Austrian population is affected by diabetes mellitus. Disease Management is a structured treatment approach that is suitable for application to the diabetes mellitus area and often is supported by information technology. This article describes the information systems developed and implemented in the Austrian disease management programme for type 2 diabetes. Several workflows for administration as well as for clinical documentation have been implemented utilizing the Austrian e-Health infrastructure. De-identified clinical data is available for creating feedback reports for providers and programme evaluation.

Specifications of the International Cooperation Administration for DDT water-dispersible powder for use in malaria control programmes

PubMed Central

Pearce, George W.; Gooden, E. L.; Johnson, Donald R.

1959-01-01

Background information is presented on the development of specifications for 75% DDT water-dispersible powder for use in malaria control programmes supported by the International Cooperation Administration (ICA) of the United States Government. Early difficulties with DDT powders used in these programmes were investigated and it was found that the most critical requirements involved packaging, suspensibility and storage stability. ICA specifications were evolved to meet these requirements. The suspensibility test developed is described, and the importance of inspection of the material procured is discussed. PMID:14431217

Which Master of Business Administration (MBA)? Factors Influencing Prospective Students' Choice of MBA Programme--An Empirical Study

ERIC Educational Resources Information Center

Blackburn, Greg

2011-01-01

Factors which influence students' selection of a Master of Business Administration programme are identified and the variation in their relative importance across the student population investigated. This research also identifies the features of a university which attracts students, as well as examining the students' perceptions of the management…

Evaluation of Organization and Administration of Intramural Sports Programmes in Secondary Schools in Ibadan Metropolis

ERIC Educational Resources Information Center

Abayomi, B. O.; Oyeniyi, Pat Ola; Ainazx, O. O.

2017-01-01

The paper appraised the organization and administration of intramural sports programmes in secondary schools in Ibadan metropolis. The descriptive research design of survey type was employed for the study. The population was all secondary school students and teachers in Ibadan Metropolis. The sample consisted of 500 respondents, 40 public…

Institutional stakeholder perceptions of barriers to addiction treatment under Mexico's drug policy reform.

PubMed

Werb, Dan; Strathdee, Steffanie A; Meza, Emilo; Rangel Gomez, Maria Gudelia; Palinkas, Lawrence; Medina-Mora, Maria Elena; Beletsky, Leo

2017-05-01

Mexico has experienced disproportionate drug-related harms given its role as a production and transit zone for illegal drugs destined primarily for the USA. In response, in 2009, the Mexican federal government passed legislation mandating pre-arrest diversion of drug-dependent individuals towards addiction treatment. However, this federal law was not specific about how the scale-up of the addiction treatment sector was to be operationalised. We therefore conducted in-depth qualitative interviews with key 'interactors' in fields affected by the federal legislation, including participants from the law enforcement, public health, addiction treatment, and governmental administration sectors. Among 19 participants from the municipal, state and federal levels were interviewed and multiple barriers to policy reform were identified. First, there is a lack of institutional expertise to implement the reform. Second, the operationalisation of the reform was not accompanied by a coordinated action plan. Third, the law is an unfunded mandate. Institutional barriers are likely hampering the implementation of Mexico's policy reform. Addressing the concerns expressed by interactors through the scale-up of services, the provision of increased training and education programmes for stakeholders and a coordinated action plan to operationalise the policy reform are likely needed to improve the policy reform process.

Microchips and controlled-release drug reservoirs.

PubMed

Staples, Mark

2010-01-01

This review summarizes and updates the development of implantable microchip-containing devices that control dosing from drug reservoirs integrated with the devices. As the expense and risk of new drug development continues to increase, technologies that make the best use of existing therapeutics may add significant value. Trends of future medical care that may require advanced drug delivery systems include individualized therapy and the capability to automate drug delivery. Implantable drug delivery devices that promise to address these anticipated needs have been constructed in a variety of ways using micro- and nanoelectromechanical systems (MEMS or NEMS)-based technology. These devices expand treatment options for addressing unmet medical needs related to dosing. Within the last few years, advances in several technologies (MEMS or NEMS fabrication, materials science, polymer chemistry, and data management) have converged to enable the construction of miniaturized implantable devices for controlled delivery of therapeutic agents from one or more reservoirs. Suboptimal performance of conventional dosing methods in terms of safety, efficacy, pain, or convenience can be improved with advanced delivery devices. Microchip-based implantable drug delivery devices allow localized delivery by direct placement of the device at the treatment site, delivery on demand (emergency administration, pulsatile, or adjustable continuous dosing), programmable dosing cycles, automated delivery of multiple drugs, and dosing in response to physiological and diagnostic feedback. In addition, innovative drug-medical device combinations may protect labile active ingredients within hermetically sealed reservoirs. Copyright (c) 2010 John Wiley & Sons, Inc.

Improving Coverage and Compliance in Mass Drug Administration for the Elimination of LF in Two ‘Endgame’ Districts in Indonesia Using Micronarrative Surveys

PubMed Central

Krentel, Alison; Damayanti, Rita; Titaley, Christiana Rialine; Suharno, Nugroho; Bradley, Mark; Lynam, Timothy

2016-01-01

Background As the Global Programme to Eliminate Lymphatic Filariasis (LF) approaches its 2020 goal, an increasing number of districts will enter the endgame phase where drug coverage rates from mass drug administration (MDA) are used to assess whether MDA can be stopped. As reported, the gap between reported and actual drug coverage in some contexts has overestimated the true rates, thus causing premature administration of transmission assessment surveys (TAS) that detect ongoing LF transmission. In these cases, districts must continue with additional rounds of MDA. Two districts in Indonesia (Agam District, Depok City) fit this criteria—one had not met the pre-TAS criteria and the other, had not passed the TAS criteria. In both cases, the district health teams needed insight into their drug delivery programs in order to improve drug coverage in the subsequent MDA rounds. Methodology/Principal Findings To inform the subsequent MDA round, a micronarrative survey tool was developed to capture community members’ experience with MDA and the social realm where drug delivery and compliance occur. A baseline survey was implemented after the 2013 MDA in endemic communities in both districts using the EPI sampling criteria (n = 806). Compliance in the last MDA was associated with perceived importance of the LF drugs for health (p<0.001); perceived safety of the LF drugs (p<0.001) and knowing someone in the household has complied (p<0.001). Results indicated that specialized messages were needed to reach women and younger men. Both districts used these recommendations to implement changes to their MDA without additional financial support. An endline survey was performed after the 2014 MDA using the same sampling criteria (n = 811). Reported compliance in the last MDA improved in both districts from 57% to 77% (p<0.05). Those who reported having ever taken the LF drug rose from 79% to 90% (p<0.001) in both sites. Conclusions/Significance Micronarrative surveys were shown to be a valid and effective tool to detect operational issues within MDA programs. District health staff felt ownership of the results, implementing feasible changes to their programs that resulted in significant improvements to coverage and compliance in the subsequent MDA. This kind of implementation research using a micronarrative survey tool could benefit underperforming MDA programs as well as other disease control programs where a deeper understanding is needed to improve healthcare delivery. PMID:27812107

Progress and Impact of 13 Years of the Global Programme to Eliminate Lymphatic Filariasis on Reducing the Burden of Filarial Disease

PubMed Central

Ramaiah, K. D.; Ottesen, Eric A.

2014-01-01

Background A Global Programme to Eliminate Lymphatic Filariasis was launched in 2000, with mass drug administration (MDA) as the core strategy of the programme. After completing 13 years of operations through 2012 and with MDA in place in 55 of 73 endemic countries, the impact of the MDA programme on microfilaraemia, hydrocele and lymphedema is in need of being assessed. Methodology/Principal findings During 2000–2012, the MDA programme made remarkable achievements – a total of 6.37 billion treatments were offered and an estimated 4.45 billion treatments were consumed by the population living in endemic areas. Using a model based on empirical observations of the effects of treatment on clinical manifestations, it is estimated that 96.71 million LF cases, including 79.20 million microfilaria carriers, 18.73 million hydrocele cases and a minimum of 5.49 million lymphedema cases have been prevented or cured during this period. Consequently, the global prevalence of LF is calculated to have fallen by 59%, from 3.55% to 1.47%. The fall was highest for microfilaraemia prevalence (68%), followed by 49% in hydrocele prevalence and 25% in lymphedema prevalence. It is estimated that, currently, i.e. after 13 years of the MDA programme, there are still an estimated 67.88 million LF cases that include 36.45 million microfilaria carriers, 19.43 million hydrocele cases and 16.68 million lymphedema cases. Conclusions/Significance The MDA programme has resulted in significant reduction of the LF burden. Extension of MDA to all at-risk countries and to all regions within those countries where MDA has not yet reached 100% geographic coverage is imperative to further reduce the number of microfilaraemia and chronic disease cases and to reach the global target of interrupting transmission of LF by 2020. PMID:25412180

Access to antiretroviral drugs and AIDS management in Senegal.

PubMed

Desclaux, Alice; Ciss, Mounirou; Taverne, Bernard; Sow, Papa S; Egrot, Marc; Faye, Mame A; Lanièce, Isabelle; Sylla, Omar; Delaporte, Eric; Ndoye, Ibrahima

2003-07-01

Description and analysis of the Senegalese Antiretroviral Drug Access Initiative (ISAARV), the first governmental highly active antiretroviral therapy (HAART) treatment programme in Africa, launched in 1998. ISAARV was initially an experimental project designed to evaluate the feasibility, efficacy and acceptability of HAART in an African context. It was based on four principles: collective definition of the strategy, with involvement of the health professionals who would be called on to execute the programme; matching the objectives to available means (gradual enrollment according to drug availability); monitoring by several research programmes; and ongoing adaptation of treatment and follow-up according to the latest international recommendations. Persons qualifying for antiretroviral (ARV) therapy are selected on the basis of immunological and clinical criteria, regardless of economic and social considerations. A system of subsidies was created to favor access to ARV. Following the ARV price reductions that occurred in November 2000, 100% subsidies were created for the poorest participants. Optimal adherence was ensured by monthly follow-up by pharmacists and support groups held by social workers and patient associations. The chosen supply and distribution system allowed drug dispensing to be strictly controlled. The ISAARV programme demonstrates that HAART can be successfully prescribed in Africa. This experience has served as the basis for the creation of a national treatment programme in Senegal planned to treat 7000 patients by 2006.

Defining the Impact of Public Administration Programmes for Public Sector Organizations

ERIC Educational Resources Information Center

Broucker, Bruno

2015-01-01

In times of financial and economic crises, public organizations seem to cut their budgets for training and education, especially when the impact of a programme is questioned. Therefore, PA programmes need to clarify what impact can be expected and what individual and organizational processes are influencing the impact of a PA programme on the…

Intermittent preventive treatment of malaria during pregnancy in central Mozambique.

PubMed

Brentlinger, Paula E; Dgedge, Martinho; Correia, Maria Ana Chadreque; Rojas, Ana Judith Blanco; Saúte, Francisco; Gimbel-Sherr, Kenneth H; Stubbs, Benjamin A; Mercer, Mary Anne; Gloyd, Stephen

2007-11-01

New WHO strategies for control of malaria in pregnancy (MiP) recommend intermittent preventive treatment (IPTp), bednet use and improved case management. A pilot MiP programme in Mozambique was designed to determine requirements for scale-up. The Ministry of Health worked with a nongovernmental organization and an academic institution to establish and monitor a pilot programme in two impoverished malaria-endemic districts. Implementing the pilot programme required provision of additional sulfadoxine-pyrimethamine (SP), materials for directly observed SP administration, bednets and a modified antenatal card. National-level formulary restrictions on SP needed to be waived. The original protocol required modification because imprecision in estimation of gestational age led to missed SP doses. Multiple incompatibilities with other health initiatives (including programmes for control of syphilis, anaemia and HIV) were discovered and overcome. Key outputs and impacts were measured; 92.5% of 7911 women received at least 1 dose of SP, with the mean number of SP doses received being 2.2. At the second antenatal visit, 13.5% of women used bednets. In subgroups (1167 for laboratory analyses; 2600 births), SP use was significantly associated with higher haemoglobin levels (10.9 g/dL if 3 doses, 10.3 if none), less malaria parasitaemia (prevalence 7.5% if 3 doses, 39.3% if none), and fewer low-birth-weight infants (7.3% if 3 doses, 12.5% if none). National-level scale-up will require attention to staffing, supplies, bednet availability, drug policy, gestational-age estimation and harmonization of vertical initiatives.

Role of drug testing as an early warning programme: the experience of the Republic of Korea.

PubMed

Chung, Heesun

2005-01-01

Drug testing plays an important role in the provision of information to health authorities on trends in drug abuse. In the Republic of Korea, the testing of urine and postmortem specimens has been used as part of a programme to monitor and control the abuse of non-controlled drugs, i.e., substances that were not originally included in the lists of controlled substances in that country. Zipeprol, dextromethorphan, carisoprodol and nalbuphine are examples of such drugs, which are widely used as medicines. Increasing levels of abuse of these drugs, including abuse that resulted in fatalities, were confirmed in the Republic of Korea by the results of drug testing. Based on the accumulated data from postmortem specimens, the health authorities in the Republic of Korea subsequently introduced controls on these drugs. A significant drop in fatalities related to the abuse of these non-controlled drugs underlined the importance of timely action for improving community health. In the context of drug testing, the analysis of non-controlled and new drugs always presents a scientific challenge, because specific analytical methods for testing for those drugs are not available. In the Republic of Korea, as part of the drug abuse warning programme, it was necessary to establish methods for the detection and quantification in biological fluids of all four non-controlled drugs and their metabolites in order to monitor the trends in drug abuse. The present paper puts forward epidemiological and clinical data on abuse and fatalities associated with zipeprol, dextromethorphan, carisoprodol and nalbuphine, as well as details of the analytical methods developed.

Implementation of a reference standard and proficiency testing programme by the World Wide Antimalarial Resistance Network (WWARN)

PubMed Central

2010-01-01

Background The Worldwide Antimalarial Resistance Network (WWARN) is a global collaboration to support the objective that anyone affected by malaria receives effective and safe drug treatment. The Pharmacology module aims to inform optimal anti-malarial drug selection. There is an urgent need to define the drug exposure - effect relationship for most anti-malarial drugs. Few anti-malarials have had their therapeutic blood concentration levels defined. One of the main challenges in assessing safety and efficacy data in relation to drug concentrations is the comparability of data generated from different laboratories. To explain differences in anti-malarial pharmacokinetics in studies with different measurement laboratories it is necessary to confirm the accuracy of the assay methods. This requires the establishment of an external quality assurance process to assure results that can be compared. This paper describes this process. Methods The pharmacology module of WWARN has established a quality assurance/quality control (QA/QC) programme consisting of two separate components: 1. A proficiency testing programme where blank human plasma spiked with certified reference material (CRM) in different concentrations is sent out to participating bioanalytical laboratories. 2. A certified reference standard programme where accurately weighed amounts of certified anti-malarial reference standards, metabolites, and internal standards are sent to participating bioanalytical and in vitro laboratories. Conclusion The proficiency testing programme is designed as a cooperative effort to help participating laboratories assess their ability to carry out drug analysis, resolve any potential problem areas and to improve their results - and, in so doing, to improve the quality of anti-malarial pharmacokinetic data published and shared with WWARN. By utilizing the same source of standards for all laboratories, it is possible to minimize bias arising from poor quality reference standards. By providing anti-malarial drug standards from a central point, it is possible to lower the cost of these standards. PMID:21184684

76 FR 82311 - Food and Drug Administration Transparency Initiative: Food and Drug Administration Report on Good...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0247] Food and Drug Administration Transparency Initiative: Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency; Availability AGENCY: Food and Drug...

Behavioural change in injecting drug users: evaluation of an HIV/AIDS education programme.

PubMed

Martin, G S; Serpelloni, G; Galvan, U; Rizzetto, A; Gomma, M; Morgante, S; Rezza, G

1990-01-01

The results obtained from the training and follow-up of 189 IDUs who participated in a programme consisting of an audiovisual presentation, pre-/post-testing and individual counselling are presented. Syringe sharing decreased from 35% at initial contact to 12% after 6 months. Sexual behaviour proved more resistant to change. However, condom use in at-risk situations increased from 49% to 70%. IDUs under continuous methadone treatment were less likely to engage high risk drug injecting practices than the other IDUs. Results indicate that an educational programme addressed toward risk reduction may determine relevant behavioural change among IDUs.

The contribution of mass drug administration to global health: past, present and future.

PubMed

Webster, Joanne P; Molyneux, David H; Hotez, Peter J; Fenwick, Alan

2014-01-01

Mass drug administration (MDA) is a means of delivering safe and inexpensive essential medicines based on the principles of preventive chemotherapy, where populations or sub-populations are offered treatment without individual diagnosis. High-coverage MDA in endemic areas aims to prevent and alleviate symptoms and morbidity on the one hand and can reduce transmission on the other, together improving global health. MDA is the recommended strategy of the World Health Organisation to control or eliminate several neglected tropical diseases (NTDs). More than 700 million people now receive these essential NTD medicines annually. The combined cost of integrated NTD MDA has been calculated to be in the order of $0.50 per person per year. Activities have recently been expanded due, in part, to the proposed attempt to eliminate certain NTDs in the coming two decades. More than 1.9 billion people need to receive MDA annually across several years if these targets are to be met. Such extensive coverage will require additional avenues of financial support, expanded monitoring and evaluation focusing on impact and drug efficacy, as well as new diagnostic tools and social science strategies to encourage adherence. MDA is a means to help reduce the burden of disease, and hence poverty, among the poorest sector of populations. It has already made significant improvements to global health and productivity and has the potential for further successes, particularly where incorporated into sanitation and education programmes. However logistical, financial and biological challenges remain.

[How to optimize the efficiency of international sanitary aid in the Democratic Republic of Congo].

PubMed

Kuwekita, Joseph Manzambi; Bruyère, Olivier; Guillaume, Michèle; Gosset, Christiane; Reginster, Jean-Yves

2015-01-01

Analysis of national health insurance accounts in the Democratic Republic of Congo (DRC) clearly shows the importance of international sanitary aid, particularlyfor thefunding ofgeneral referral hospitals, the management of inpatients with AIDS, administration of health zones andfunding of preventive care providers. It The targeted changes described in this article could possibly optimize the efficiency ofinternational aidfor the DRC population, mainly for disorders considered to be a health care priority (i.e. malaria, AIDS, tuberculosis) as well as in the fight against malnutrition. Recommendations target the implementation of procedures for control offood chain security, changes in lifestyle and dietary habits of the population but also comprise extensive restructuring of the health care administration. A dramatic change of the structure in charge of drug distribution as well as eradication of the transfer of part of public health structure income to public health administrative personnel could result in the allocation of significantfunds to thefight against the most important diseases. Better collaboration between the various departments in charge of health care professional training, together with enhanced responsibility of health care personnel is essential. Independent and respected non-governmental organizations should be involved in an audit process, targeting all aspects of the current DRC health system. Eventually, in an equal opportunity perspective, taking into consideration the very high degree of poverty ofDRC inhabitants, implementation of health insurance programmes, use ofgeneric drugs and generalization ofmicro-credit initiatives should also be implemented.

Personalised, predictive and preventive medication process in hospitals—still rather missing: professional opinion survey on medication safety in Czech hospitals (based on professional opinions of recognised Czech health care experts)

PubMed Central

2014-01-01

The survey had the following aims: (1) to rationalise the hypothesis that risks and losses relating to medication process' errors in Czech hospitals are at least comparable with the other developed countries and EU countries especially, (2) to get a valid professional opinion/estimate on the rate of adverse drug events happening in Czech hospitals, (3) to point out that medication errors represent real and serious risks and (4) to induce the hospital management readiness to execute fundamental changes and improvements to medication processes. We read through a lot of studies inquiring into hospitals' medication safety. Then, we selected the studies which brought reliable findings and formulated credible conclusions. Finally, we addressed reputable Czech experts in health care and asked them structured questions whether the studies' findings and conclusions corresponded with our respondents' own experience in the Czech hospital clinical practice and what their own estimates of adverse drug events' consequences were like. Based on the reputable Czech health care expert opinions/estimates, the rate of a false drug administration may exceed 5%, and over 7% of those cause serious health complications to Czech hospital inpatients. Measured by an average length of stay (ALOS), the Czech inpatients, harmed by a false drug administration, stay in hospital for more than 2.6 days longer than necessary. Any positive changes to a currently used, traditional, ways of drug dispensing and administration, along with computerisation, automation, electronic traceability, validation, or verification, must well pay off. Referring to the above results, it seems to be wise to follow the EU priorities in health and health care improvements. Thus, a right usage of the financial means provided by the EC—in terms of its new health programmes for the period 2014–2020 (e.g. Horizon 2020)—has a good chance of a good result in doing the right things right, at the right time and in the right way. All citizens of the EU may benefit using the best practice. PMID:24834138

Access to orphan drugs despite poor quality of clinical evidence

PubMed Central

Dupont, Alain G; Van Wilder, Philippe B

2011-01-01

AIM We analysed the Belgian reimbursement decisions of orphan drugs as compared with those of innovative drugs for more common but equally severe diseases, with special emphasis on the quality of clinical evidence. METHODS Using the National Health Insurance Agency administrative database, we evaluated all submitted orphan drug files between 2002 and 2007. A quality analysis of the clinical evidence in the orphan reimbursement files was performed. The evaluation reports of the French ‘Haute Autorité de Santé’, including the five-point scale parameter ‘Service Médical Rendu (SMR), were examined to compare disease severity. Chi-squared tests (at P < 0.05 significance level) were used to compare the outcome of the reimbursement decisions between orphan and non-orphan innovative medicines. RESULTS Twenty-five files of orphan drugs and 117 files of non-orphan drugs were evaluated. Twenty-two of 25 (88%) submissions of orphan drugs were granted reimbursement as opposed to 74 of the 117 (63%) non-orphan innovative medicines (P = 0.02). Only 52% of the 25 orphan drug files included a randomized controlled trial as opposed to 84% in a random control sample of 25 non-orphan innovative submissions (P < 0.01). The duration of drug exposure was in most cases far too short in relation to the natural history of the disease. CONCLUSIONS Orphan drug designation predicts reimbursement despite poor quality of clinical evidence. The evidence gap at market authorization should be reduced by post-marketing programmes, in which the centralized regulatory and the local reimbursement authorities collaborate in an efficient way across the European Union member states. PMID:21395641

Use and Cost of Psychotropic Drugs among Recipients with Autism in a State Medicaid Fee-for-Service Programme

ERIC Educational Resources Information Center

Khanna, R.; Jariwala, K.; West-Strum, D.

2013-01-01

Background: There has been a significant increase in the prevalence of autism in the USA in the past few decades. The purpose of this study was to provide recent estimates of psychotropic drug use and costs among individuals with autism enrolled in the Medicaid programme. Method: A cross-sectional analysis of 2007 Mississippi (MS) Medicaid…

76 FR 55928 - Food and Drug Administration Health Professional Organizations Conference

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Food and Drug Administration Health Professional Organizations Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. The Food and Drug Administration (FDA) is announcing a...

75 FR 18219 - Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0142] Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and Supplier Controls; Public Educational Forum AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public...

Implementation of Content and Language Integrated Learning (CLIL) Programmes in Public Administration: Russian Students' and Matriculants' Opinion about Their First CLIL Experience

ERIC Educational Resources Information Center

Rubtcova, Mariia; Kaisarova, Valentina

2016-01-01

Content and Language Integrated Learning (CLIL) is a pedagogic approach that has developed in response to the demand for integrating education in both school/university subjects and language skills. Our paper is devoted to the implementation of CLIL programmes in Public Administration within a particular sociolinguistic context: that of Russian…

Ribonucleotide reductase as a drug target against drug resistance Mycobacterium leprae: A molecular docking study.

PubMed

Mohanty, Partha Sarathi; Bansal, Avi Kumar; Naaz, Farah; Gupta, Umesh Datta; Dwivedi, Vivek Dhar; Yadava, Umesh

2018-06-01

Leprosy is a chronic infection of skin and nerve caused by Mycobacterium leprae. The treatment is based on standard multi drug therapy consisting of dapsone, rifampicin and clofazamine. The use of rifampicin alone or with dapsone led to the emergence of rifampicin-resistant Mycobacterium leprae strains. The emergence of drug-resistant leprosy put a hurdle in the leprosy eradication programme. The present study aimed to predict the molecular model of ribonucleotide reductase (RNR), the enzyme responsible for biosynthesis of nucleotides, to screen new drugs for treatment of drug-resistant leprosy. The study was conducted by retrieving RNR of M. leprae from GenBank. A molecular 3D model of M. leprae was predicted using homology modelling and validated. A total of 325 characters were included in the analysis. The predicted 3D model of RNR showed that the ϕ and φ angles of 251 (96.9%) residues were positioned in the most favoured regions. It was also conferred that 18 α-helices, 6 β turns, 2 γ turns and 48 helix-helix interactions contributed to the predicted 3D structure. Virtual screening of Food and Drug Administration approved drug molecules recovered 1829 drugs of which three molecules, viz., lincomycin, novobiocin and telithromycin, were taken for the docking study. It was observed that the selected drug molecules had a strong affinity towards the modelled protein RNR. This was evident from the binding energy of the drug molecules towards the modelled protein RNR (-6.10, -6.25 and -7.10). Three FDA-approved drugs, viz., lincomycin, novobiocin and telithromycin, could be taken for further clinical studies to find their efficacy against drug resistant leprosy. Copyright © 2018 Elsevier B.V. All rights reserved.

75 FR 15439 - Food and Drug Administration/Xavier University Global Medical Device Conference

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

78 FR 15957 - Food and Drug Administration/Xavier University Global Medical Device Conference

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

77 FR 10537 - Food and Drug Administration/Xavier University Global Medical Device Conference

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-22

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food and Drug Administration (FDA...

Scale-up of a comprehensive harm reduction programme for people injecting opioids: lessons from north-eastern India

PubMed Central

Lalmuanpuii, Melody; Biangtung, Langkham; Mishra, Ritu Kumar; Reeve, Matthew J; Tzudier, Sentimoa; Singh, Angom L; Sinate, Rebecca

2013-01-01

Abstract Problem Harm reduction packages for people who inject illicit drugs, including those infected with human immunodeficiency virus (HIV), are cost-effective but have not been scaled up globally. In the north-eastern Indian states of Manipur and Nagaland, the epidemic of HIV infection is driven by the injection of illicit drugs, especially opioids. These states needed to scale up harm reduction programmes but faced difficulty doing so. Approach In 2004, the Bill & Melinda Gates Foundation funded Project ORCHID to scale up a harm reduction programme in Manipur and Nagaland. Local setting In 2003, an estimated 10 000 and 16 000 people were injecting drugs in Manipur and Nagaland, respectively. The prevalence of HIV infection among people injecting drugs was 24.5% in Manipur and 8.4% in Nagaland. Relevant changes By 2012, the harm reduction programme had been scaled up to an average of 9011 monthly contacts outside clinics (80% of target); an average of 1709 monthly clinic visits (15% of target, well above the 5% monthly goal) and an average monthly distribution of needles and syringes of 16 each per programme participant. Opioid agonist maintenance treatment coverage was 13.7% and retention 6 months after enrolment was 63%. Antiretroviral treatment coverage for HIV-positive participants was 81%. Lessons learnt A harm reduction model consisting of community-owned, locally relevant innovations and business approaches can result in good harm reduction programme scale-up and influence harm reduction policy. Project ORCHID has influenced national harm reduction policy in India and contributed to the development of harm reduction guidelines. PMID:23599555

Integrating multiple programme and policy approaches to hepatitis C prevention and care for injection drug users: a comprehensive approach.

PubMed

Birkhead, Guthrie S; Klein, Susan J; Candelas, Alma R; O'Connell, Daniel A; Rothman, Jeffrey R; Feldman, Ira S; Tsui, Dennis S; Cotroneo, Richard A; Flanigan, Colleen A

2007-10-01

New York State is home to an estimated 230,000 individuals chronically infected with hepatitis C virus (HCV) and roughly 171,500 active injection drug users (IDUs). HCV/HIV co-infection is common and models of service delivery that effectively meet IDUs' needs are required. A HCV strategic plan has stressed integration. HCV prevention and care are integrated within health and human service settings, including HIV/AIDS organisations and drug treatment programmes. Other measures that support comprehensive HCV services for IDUs include reimbursement, clinical guidelines, training and HCV prevention education. Community and provider collaborations inform programme and policy development. IDUs access 5 million syringes annually through harm reduction/syringe exchange programmes (SEPs) and a statewide syringe access programme. Declines in HCV prevalence amongst IDUs in New York City coincided with improved syringe availability. New models of care successfully link IDUs at SEPs and in drug treatment to health care. Over 7000 Medicaid recipients with HCV/HIV co-infection had health care encounters related to their HCV in a 12-month period and 10,547 claims for HCV-related medications were paid. The success rate of transitional case management referrals to drug treatment is over 90%. Training and clinical guidelines promote provider knowledge about HCV and contribute to quality HCV care for IDUs. Chart reviews of 2570 patients with HIV in 2004 documented HCV status 97.4% of the time, overall, in various settings. New HCV surveillance systems are operational. Despite this progress, significant challenges remain. A comprehensive, public health approach, using multiple strategies across systems and mobilizing multiple sectors, can enhance IDUs access to HCV prevention and care. A holisitic approach with integrated services, including for HCV-HIV co-infected IDUs is needed. Leadership, collaboration and resources are essential.

Sexual Orientation Topics in Educational Leadership Programmes across the USA

ERIC Educational Resources Information Center

Jennings, Todd

2012-01-01

This investigation examines the inclusion of sexual orientation topics within the formal curriculum of 55 public college and university educational administration/leadership programmes across the USA. The findings indicate that programmes place a low priority upon sexual orientation compared to other diversity topics and that 59.5% of programmes…

32 CFR 518.20 - Collection of fees and fee rates.

Code of Federal Regulations, 2011 CFR

2011-07-01

... assessed as computer search. The terms “programmer/operator” shall not be limited to the traditional programmers or operators. Rather, the terms shall be interpreted in their broadest sense to incorporate any..., programmer, database administrator, or action officer). (ii) Machine time. Machine time involves only direct...

32 CFR 286.29 - Collection of fees and fee rates.

Code of Federal Regulations, 2011 CFR

2011-07-01

... human time may be also assessed as computer search. The terms “programmer/operator” shall not be limited to the traditional programmers or operators. Rather, the terms shall be interpreted in their broadest... support, operator, programmer, database administrator, or action officer). (ii) Machine time. Machine time...

[Alcohol and drugs in Central Europe--problems and possible solutions].

PubMed

Nespor, K; Cs emy, L

1994-08-22

The high alcohol consumption and increasing abuse of other addictive inducing substances in Central Europe calls for broadley conceived preventive programmes and cheap and widely applicable therapeutic strategies (early treatment at the first contact level, self-help manuals, self-aid organizations). Social instability along with greater availability of alcohol and drugs create a dangerous combination. In addition to strategies of stress prevention at the societal level also strategy at the individual level is important (e.g. relaxation training, yoga, psychotherapy). It is also important to change the "image" of western society and commercial interests of those who make profits on alcohol and drugs should be under control and advertising should be greatly restricted if not prohibited. Prevention of problems caused by alcohol and drugs in particular in youths must be combined and really effective strategies should be used such as peer programmes. The authors mention also their own preventive programme FIT IN and print materials oriented specifically on certain population groups.

Endogenous pH-responsive nanoparticles with programmable size changes for targeted tumor therapy and imaging applications.

PubMed

Wu, Wei; Luo, Li; Wang, Yi; Wu, Qi; Dai, Han-Bin; Li, Jian-Shu; Durkan, Colm; Wang, Nan; Wang, Gui-Xue

2018-01-01

Nanotechnology-based antitumor drug delivery systems, known as nanocarriers, have demonstrated their efficacy in recent years. Typically, the size of the nanocarriers is around 100 nm. It is imperative to achieve an optimum size of these nanocarriers which must be designed uniquely for each type of delivery process. For pH-responsive nanocarriers with programmable size, changes in pH (~6.5 for tumor tissue, ~5.5 for endosomes, and ~5.0 for lysosomes) may serve as an endogenous stimulus improving the safety and therapeutic efficacy of antitumor drugs. This review focuses on current advanced pH-responsive nanocarriers with programmable size changes for anticancer drug delivery. In particular, pH-responsive mechanisms for nanocarrier retention at tumor sites, size reduction for penetrating into tumor parenchyma, escaping from endo/lysosomes, and swelling or disassembly for drug release will be highlighted. Additional trends and challenges of employing these nanocarriers in future clinical applications are also addressed.

76 FR 6477 - Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug...

An Examination of Critical Problems Associated with the Implementation of the Universal Basic Education (UBE) Programme in Nigeria

ERIC Educational Resources Information Center

Ejere, Emmanuel Iriemi

2011-01-01

It is hardly debatable that implementation is the bane of public policies and programmes in Nigeria. A well formulated policy or programme is useless if not properly implemented as its stated objectives will not be realized. The Universal Basic Education (UBE) programme was introduced in Nigeria in September 1999 by the Obasanjo's administration.…

75 FR 73107 - Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0590] Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

77 FR 21784 - Science Board to the Food and Drug Administration; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No FDA-2012-N-0001] Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Science...

78 FR 30317 - Science Board to the Food and Drug Administration; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-22

...] Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Science Board to the Food and Drug Administration (Science Board). General Function of the Committee: The...

78 FR 6332 - Science Board to the Food and Drug Administration; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-30

...] Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Science Board to the Food and Drug Administration (Science Board). General Function of the Committee: The...

77 FR 51031 - Science Board to the Food and Drug Administration; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-23

...] Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Science Board to the Food and Drug Administration (Science Board). General Function of the Committee: The...

Comparison of the Effects of Intermittent Boluses to Simple Continuous Infusion on Patients' Global Perceived Effect in Intrathecal Therapy for Pain: A Randomized Double-Blind Crossover Study.

PubMed

Eldabe, Sam; Duarte, Rui V; Madzinga, Grace; Batterham, Alan M; Brookes, Morag E; Gulve, Ashish P; Perruchoud, Christophe; Raphael, Jon H; Lorenzana, David; Buchser, Eric

2017-05-01

Intrathecal drug delivery (ITDD) is commonly used for intractable pain management. A paucity of good-quality studies in chronic noncancer patients and concerns over increased dosages have focused interest on different modes of administration. The aim of this international multicenter randomized double-blind crossover trial was to compare the efficacy of the same daily dose of drugs administered by intermittent boluses vs simple continuous infusion. Eligible patients implanted with a programmable ITDD device were randomized to receive two weeks of either intermittent boluses or a simple continuous flow in period 1, followed by a crossover to the alternative mode of administration. The primary outcome measure was the Patients' Global Impression of Change (PGIC) scale. The mean proportion of positive responders (at least "minimally improved") was 38.4% in the continuous condition vs 37.3% in the bolus (difference in proportions = 1.1%, 95% confidence interval [CI] = -21.8-24.0%, P  = 0.93). The mean PGIC in the continuous condition was 3.8 vs 3.9 in the bolus (mean difference = -0.1, -0.6-0.4, P  = 0.72). Exploratory analyses revealed a tendency for the mean proportion of positive responders to be higher at low vs high flow rates for both bolus and continuous administrations. Two patients were withdrawn from the study due to adverse events during the bolus phase, both with symptoms of increased pain, and one patient with additional symptoms of numbness and urinary retention. The mean PGIC and proportion of positive responders was not substantially different after intermittent bolus vs continuous administration. © 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Bioavailability of voriconazole in hospitalised patients.

PubMed

Veringa, Anette; Geling, Sanne; Span, Lambert F R; Vermeulen, Karin M; Zijlstra, Jan G; van der Werf, Tjip S; Kosterink, Jos G W; Alffenaar, Jan-Willem C

2017-02-01

An important element in antimicrobial stewardship programmes is early switch from intravenous (i.v.) to oral antimicrobial treatment, especially for highly bioavailable drugs. The antifungal agent voriconazole is available both in i.v. and oral formulations and bioavailability is estimated to be >90% in healthy volunteers, making this drug a suitable candidate for such a transition. Recently, two studies have shown that the bioavailability of voriconazole is substantially lower in patients. However, for both studies various factors that could influence the voriconazole serum concentration, such as inflammation, concomitant intake of food with oral voriconazole, and gastrointestinal complications, were not included in the evaluation. Therefore, in this study a retrospective chart review was performed in adult patients treated with both oral and i.v. voriconazole at the same dose and within a limited (≤5 days) time interval in order to evaluate the effect of switching the route of administration on voriconazole serum concentrations. A total of 13 patients were included. The mean voriconazole trough concentration was 2.28 mg/L [95% confidence interval (CI) 1.29-3.26 mg/L] for i.v. voriconazole administration and 2.04 mg/L (95% CI 0.78-3.30 mg/L) for oral administration. No significant difference was found in the mean oral and i.v. trough concentrations of voriconazole (P = 0.390). The mean bioavailability was 83.0% (95% CI 59.0-107.0%). These findings suggest that factors other than bioavailability may cause the observed difference in voriconazole trough concentrations between oral and i.v. administration in the earlier studies and stress the need for an antimicrobial stewardship team to guide voriconazole dosing. Copyright © 2016 Elsevier B.V. and International Society of Chemotherapy. All rights reserved.

76 FR 25358 - 2011 Parenteral Drug Association/Food and Drug Administration Glass Quality Conference; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] 2011 Parenteral Drug Association/Food and Drug Administration Glass Quality Conference; Public Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. SUMMARY: The Food...

Perceptions and attitudes toward SLMTA amongst laboratory and hospital professionals in Ethiopia.

PubMed

Lulie, Adino D; Hiwotu, Tilahun M; Mulugeta, Achamyeleh; Kebede, Adisu; Asrat, Habtamu; Abebe, Abnet; Yenealem, Dereje; Abose, Ebise; Kassa, Wondwossen; Kebede, Amha; Linde, Mary K; Ayana, Gonfa

2014-01-01

Strengthening Laboratory Management Toward Accreditation (SLMTA) is a competency-based management training programme. Assessing health professionals' views of SLMTA provides feedback to inform program planning, implementation and evaluation of SLMTA's training, communication and mentorship components. To assess laboratory professionals' and hospital chief executive officers' (CEOs) perceptions and attitudes toward the SLMTA programme in Ethiopia. A cross-sectional descriptive survey was conducted in March 2013 using a structured questionnaire to collect qualitative data from 72 laboratory professionals and hospital CEOs from 17 health facilities, representing all regions and two city administrations in Ethiopia. Focus groups were conducted with laboratory professionals and hospital administration to gain insight into the strengths and challenges of the SLMTA programme so as to guide future planning and implementation. Ethiopian laboratory professionals at all levels had a supportive attitude toward the SLMTA programme. They believed that SLMTA substantially improved laboratory services and acted as a catalyst for total healthcare reform and improvement. They also noted that the SLMTA programme achieved marked progress in laboratory supply chain, sample referral, instrument maintenance and data management systems. In contrast, nearly half of the participating hospital CEOs, especially those associated with low-scoring laboratories, were sceptical about the SLMTA programme, believing that the benefits of SLMTA were outweighed by the level of human resources and time commitment required. They also voiced concerns about the cost and sustainability of SLMTA. This study highlights the need for stronger engagement and advocacy with hospital administration and the importance of addressing concerns about the cost and sustainability of the SLMTA programme.

77 FR 52744 - Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Workshop

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meeting. The Food and Drug Administration's (FDA) Office of Orphan Products Development...

76 FR 9027 - Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0057] Draft Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Administration Privacy Act Record Systems. 21.20 Section 21.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF PRIVACY Food and Drug Administration Privacy Act Record Systems § 21.20 Procedures for notice of Food and Drug Administration Privacy Act Record...

78 FR 9928 - Food and Drug Administration Drug Shortages Task Force and Strategic Plan; Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-12

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0124] Food and Drug Administration Drug Shortages Task Force and Strategic Plan; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. SUMMARY: To assist the Food...

21 CFR 7.45 - Food and Drug Administration-requested recall.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Industry Responsibilities § 7.45 Food and Drug Administration-requested recall. (a) The Commissioner of... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Food and Drug Administration-requested recall. 7.45 Section 7.45 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

21 CFR 20.1 - Testimony by Food and Drug Administration employees.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Testimony by Food and Drug Administration employees. 20.1 Section 20.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... laws administered by the Food and Drug Administration, shall give any testimony before any tribunal...

Drug prevention programmes for young people: where have we been and where should we be going?

PubMed

Midford, Richard

2010-10-01

Substance use by young people has long been a concern of western society, but opinion is mixed as to which prevention approach offers the greatest benefit, and whether indeed there is any benefit at all. This paper reviews the nature of prevention programmes, the research evidence that underpins these programmes and the prevention objectives against which effectiveness is measured. The aim of this is to create better understanding of the elements that maximize programme effectiveness, what can be achieved by prevention programmes and how programmes can be improved. There is a range of prevention approaches for which there is evidence of effectiveness. Some are classroom-based; some focus upon parenting; some have substantial whole-of-school and community elements; and some target risk and protective factors in early childhood. All, however, are based substantially on the social influence model. In an attempt to improve practice lists of effective programmes have been developed, but there are concerns about the science behind selection. On balance, there is consistent evidence that social influence prevention programmes do have a small, positive effect on drug use, but this then raises the question as to whether harm, rather than use, would be the more worthwhile target for prevention. Prevention that seeks to reduce harm has been demonstrably effective, but has found little support in some jurisdictions. Research has created a progressively better understanding of how to optimize programme effectiveness and what can be achieved realistically by even the most effective programmes. However, further research is required to identify which, if any, particular approach offers greater promise. The effectiveness of harm reduction should be compared with more traditional abstinence and the additional effects of whole of school, parent and community elements need to be measured more accurately. Contemporary social influence prevention programmes are flawed, but the approach is still the best way of influencing drug use behaviour in young people as a whole. Evidence-based refinement is the best option for greater benefit. © 2009 The Author, Addiction © 2009 Society for the Study of Addiction.

28 CFR 0.102 - Drug enforcement policy coordination.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Drug enforcement policy coordination. 0... JUSTICE Drug Enforcement Administration § 0.102 Drug enforcement policy coordination. The Administrator of the Drug Enforcement Administration shall report to the Attorney General, through the Deputy Attorney...

28 CFR 0.102 - Drug enforcement policy coordination.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 1 2014-07-01 2014-07-01 false Drug enforcement policy coordination. 0... JUSTICE Drug Enforcement Administration § 0.102 Drug enforcement policy coordination. The Administrator of the Drug Enforcement Administration shall report to the Attorney General, through the Deputy Attorney...

28 CFR 0.102 - Drug enforcement policy coordination.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 1 2013-07-01 2013-07-01 false Drug enforcement policy coordination. 0... JUSTICE Drug Enforcement Administration § 0.102 Drug enforcement policy coordination. The Administrator of the Drug Enforcement Administration shall report to the Attorney General, through the Deputy Attorney...

78 FR 35937 - Food and Drug Administration Decisions for Investigational Device Exemption Clinical...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-14

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0790] Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug...

The safety of magnetic resonance imaging in patients with programmable implanted intrathecal drug delivery systems: a 3-year prospective study.

PubMed

De Andres, Jose; Villanueva, Vicente; Palmisani, Stefano; Cerda-Olmedo, German; Lopez-Alarcon, Maria Dolores; Monsalve, Vicente; Minguez, Ana; Martinez-Sanjuan, Vicente

2011-05-01

It is common clinical practice to perform magnetic resonance imaging (MRI) in patients with indwelling programmable intrathecal drug delivery (IDD) systems, although the safety of the procedure has never been documented. We performed a single-center, 3-year, prospective evaluation in patients with a programmable implanted IDD to assess patient discomfort, IDD technical failures, and adverse effects during and after exposure to MRI. Forty-three consecutive patients with an implanted programmable IDD system (SynchroMed® EL Implantable Infusion Pump, Model 8626L-18, and SynchroMed® II Model 8637-20, 8637-40; Medtronic, Inc., Minneapolis, MN) requiring a scheduled MRI evaluation were studied during a 3-year period. All MRI scans were performed with a 1.5-tesla clinical use magnet and a specific absorption rate of no more than 0.9 W/kg. Radiograph control was used to confirm postexposure pump rotor movement and detect system dislocations. IDD system failures, patient satisfaction, and discomfort were recorded. None of the patients experienced signs of drug overinfusion that could lead to hemodynamic, respiratory, or neurologic alterations. Radiologic evaluation after MRI revealed no spatial displacements of the intrathecal catheter tip or body pump, and programmer telemetry confirmed the infusion recovery. Patients' satisfaction after the procedure was high. Performing an MRI scan with the proposed protocol in patients with an implanted Medtronic programmable IDD system resulted in virtually no technical or medical complications. © 2011 International Anesthesia Research Society

Beyond providing drugs: the Mectizan® donation stimulates new strategies in service delivery and in strengthening health systems.

PubMed

Hopkins, Adrian

2012-05-01

The donation of Mectizan® by Merck & Co Inc. in 1987 "as much as was needed for as long as was needed for onchocerciasis control" was a major change from traditional corporate drug donations. The company realised that those who needed the drug most would never be able to purchase it, and so gave it away. The donation enabled the Onchocerciasis Control Programme in West Africa to add Mectizan distribution to its ongoing control strategy. For the first time there was hope for those living in other areas of Africa, Latin America and Yemen. Governments and non-governmental development organizations quickly got together to begin treatment in these new areas. Two new programmes and partnerships were created; the African Programme for Onchocerciasis Control and the Onchocerciasis Elimination Programme for the Americas. These programmes have been in the forefront of developing new strategies, including the Community Directed approach, which has now expanded into other disease control programmes at the community level, such as Vitamin A distribution and malaria control. This donation has led not only to the probability of elimination of onchocerciasis in the Americas in the near future, but is stimulating approaches to the elimination in Africa, in areas considered impossible five years ago. Other major pharmaceutical donations have followed, initiating the plan to eliminate lymphatic filariasis worldwide, and also stimulating interest in controlling other "neglected tropical diseases," which affect the poorest billion of the world's population, making this now a reality.

78 FR 15019 - Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0196] Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice, request for comments. SUMMARY: The Food and...

75 FR 29561 - Memorandum of Understanding Between the Food and Drug Administration and Drugs.Com

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-26

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0004] [FDA 225-09-0012] Memorandum of Understanding Between the Food and Drug Administration and Drugs.Com... Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and Drugs.Com. The...

21 CFR 20.2 - Production of records by Food and Drug Administration employees.

Code of Federal Regulations, 2010 CFR

2010-04-01

... upon an officer or employee of the Food and Drug Administration commanding the production of any record... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Production of records by Food and Drug Administration employees. 20.2 Section 20.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND...

Drug Release from Phase-Changeable Nanodroplets Triggered by Low-Intensity Focused Ultrasound

PubMed Central

Cao, Yang; Chen, Yuli; Yu, Tao; Guo, Yuan; Liu, Fengqiu; Yao, Yuanzhi; Li, Pan; Wang, Dong; Wang, Zhigang; Chen, Yu; Ran, Haitao

2018-01-01

Background: As one of the most effective triggers with high tissue-penetrating capability and non-invasive feature, ultrasound shows great potential for controlling the drug release and enhancing the chemotherapeutic efficacy. In this study, we report, for the first time, construction of a phase-changeable drug-delivery nanosystem with programmable low-intensity focused ultrasound (LIFU) that could trigger drug-release and significantly enhance anticancer drug delivery. Methods: Liquid-gas phase-changeable perfluorocarbon (perfluoropentane) and an anticancer drug (doxorubicin) were simultaneously encapsulated in two kinds of nanodroplets. By triggering LIFU, the nanodroplets could be converted into microbubbles locally in tumor tissues for acoustic imaging and the loaded anticancer drug (doxorubicin) was released after the microbubble collapse. Based on the acoustic property of shell materials, such as shell stiffness, two types of nanodroplets (lipid-based nanodroplets and PLGA-based nanodroplets) were activated by different acoustic pressure levels. Ultrasound irradiation duration and power of LIFU were tested and selected to monitor and control the drug release from nanodroplets. Various ultrasound energies were introduced to induce the phase transition and microbubble collapse of nanodroplets in vitro (3 W/3 min for lipid nanodroplets; 8 W/3 min for PLGA nanodroplets). Results: We detected three steps in the drug-releasing profiles exhibiting the programmable patterns. Importantly, the intratumoral accumulation and distribution of the drug with LIFU exposure were significantly enhanced, and tumor proliferation was substantially inhibited. Co-delivery of two drug-loaded nanodroplets could overcome the physical barriers of tumor tissues during chemotherapy. Conclusion: Our study provides a new strategy for the efficient ultrasound-triggered chemotherapy by nanocarriers with programmable LIFU capable of achieving the on-demand drug release. PMID:29507623

Administration costs of intravenous biologic drugs for rheumatoid arthritis.

PubMed

Soini, Erkki J; Leussu, Miina; Hallinen, Taru

2013-01-01

Cost-effectiveness studies explicitly reporting infusion times, drug-specific administration costs for infusions or real-payer intravenous drug cost are few in number. Yet, administration costs for infusions are needed in the health economic evaluations assessing intravenously-administered drugs. To estimate the drug-specific administration and total cost of biologic intravenous rheumatoid arthritis (RA) drugs in the adult population and to compare the obtained costs with published cost estimates. Cost price data for the infusions and drugs were systematically collected from the 2011 Finnish price lists. All Finnish hospitals with available price lists were included. Drug administration and total costs (administration cost + drug price) per infusion were analysed separately from the public health care payer's perspective. Further adjustments for drug brand, dose, and hospital type were done using regression methods in order to improve the comparability between drugs. Annual expected drug administration and total costs were estimated. A literature search not limited to RA was performed to obtain the per infusion administration cost estimates used in publications. The published costs were converted to Finnish values using base-year purchasing power parities and indexing to the year 2011. Information from 19 (95%) health districts was obtained (107 analysable prices out of 176 observations). The average drug administration cost for infliximab, rituximab, abatacept, and tocilizumab infusion in RA were €355.91; €561.21; €334.00; and €293.96, respectively. The regression-adjusted (dose, hospital type; using semi-log ordinary least squares) mean administration costs for infliximab and rituximab infusions in RA were €289.12 (95% CI €222.61-375.48) and €542.28 (95% CI €307.23-957.09). The respective expected annual drug administration costs were €2312.96 for infliximab during the first year, €1879.28 for infliximab during the forthcoming years, and €1843.75 for rituximab. The obtained average administration costs per infusion were higher (1.8-3.3 times depending on the drug) than the previously published purchasing power adjusted and indexed average administration costs for infusions in RA. The administration costs of RA infusions vary between drugs, and more effort should be made to find realistic drug-specific estimates for cost-effectiveness evaluations. The frequent assumption of intravenous drug administration costs equalling outpatient visit cost can underestimate the costs.

76 FR 11490 - Withdrawal of Approval of New Animal Drug Applications; Phenylbutazone; Pyrantel; Tylosin...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0033... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... INFORMATION CONTACT: John Bartkowiak, Center for Veterinary Medicine (HFV-212), Food and Drug Administration...

Defining harm reduction.

PubMed

Single, E

1995-01-01

Harm reduction attempts to reduce the adverse consequences of drug use among persons who continue to use drugs. It developed in response to the excesses of a "zero tolerance approach". Harm reduction emphasizes practical rather than idealized goals. It has been expanded from illicit drugs to legal drugs and is grounded in the evolving public health and advocacy movements. Harm reduction has proved to be effective and it has gained increasing official acceptance; for example, it is now the basis of Canada's Drug Strategy. However, the concept is still poorly defined, as virtually any drug policy or programme, even abstinence-oriented programmes, attempt to reduce drug-related harm. The principle feature of harm reduction is the acceptance of the fact that some drug users cannot be expected to cease their drug use at the present time. Harm reduction is neutral about the long term goals of intervention while according a high priority to short-term realizable goals. Harm reduction should be neutral about legalization. The essence of the concept is to ameliorate adverse consequences of drug use while, at least in the short term, drug use continues.

Changes in patterns of injecting drug use in Hungary: a shift to synthetic cathinones.

PubMed

Péterfi, Anna; Tarján, Anna; Horváth, Gergely Csaba; Csesztregi, Tamás; Nyírády, Adrienn

2014-01-01

The spread of synthetic cathinone injecting is a new phenomenon observed in recent years in Hungary. Until 2010, when the first anecdotal reports on cathinone injecting appeared, injecting was associated with the use of heroin and amphetamine. In this paper we review available evidence of the changes in the drug market and a concurrent shift in patterns of injecting drug use that have been taking place in Hungary since 2010. Remarkable changes have been observed in police seizures data since 2010. While new psychoactive substances have appeared, the availability of heroin has dropped significantly. A qualitative study in 2011 revealed that these market changes correlate with changes in patterns of injecting drug use: decreasing heroin use and the appearance of mephedrone injecting were reported by treatment and needle and syringe programme (NSP) personnel. These changes are detectable in other routine epidemiological data collection systems in the following years as well (i.e. treatment, drug-related deaths, NSP clientele). Heroin-related treatment demand dropped, as did heroin-related mortality. Parallel to this, a growing number of clients appeared in treatment and in NSPs who were primarily injecting cathinones. The shift to cathinones can be observed in amphetamine and heroin injectors as well. Monitoring changes in patterns of injecting drug use are especially important because of the vulnerability of this drug-user population and the consequences of this high-risk route of drug administration. The realignment observed in Hungary is to be further investigated with regard to its determinants, changes in risk behaviour, and in treatment needs. Copyright © 2014 John Wiley & Sons, Ltd.

76 FR 47085 - Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-04

.... FDA-2011-N-0526] Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer... programmers. The agency is also summarizing its proposed findings regarding the degree of risk of illness or.... Background--Regulatory Authorities The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the...

Mass drug administration for malaria

PubMed Central

Poirot, Eugenie; Skarbinski, Jacek; Sinclair, David; Kachur, S Patrick; Slutsker, Laurence; Hwang, Jimee

2013-01-01

Background Mass drug administration (MDA), defined as the empiric administration of a therapeutic antimalarial regimen to an entire population at the same time, has been a historic component of many malaria control and elimination programmes, but is not currently recommended. With renewed interest in MDA and its role in malaria elimination, this review aims to summarize the findings from existing research studies and program experiences of MDA strategies for reducing malaria burden and transmission. Objectives To assess the impact of antimalarial MDA on population asexual parasitaemia prevalence, parasitaemia incidence, gametocytaemia prevalence, anaemia prevalence, mortality and MDA-associated adverse events. Search methods We searched the Cochrane Infectious Disease Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE+, EMBASE, to February 2013. We also searched CABS Abstracts, LILACS, reference lists, and recent conference proceedings. Selection criteria Cluster-randomized trials and non-randomized controlled studies comparing therapeutic MDA versus placebo or no MDA, and uncontrolled before-and-after studies comparing post-MDA to baseline data were selected. Studies administering intermittent preventive treatment (IPT) to sub-populations (for example, pregnant women, children or infants) were excluded. Data collection and analysis Two authors independently reviewed studies for inclusion, extracted data and assessed risk of bias. Studies were stratified by study design and then subgrouped by endemicity, by co-administration of 8-aminoquinoline plus schizonticide drugs and by plasmodium species. The quality of evidence was assessed using the GRADE approach. Main results Two cluster-randomized trials, eight non-randomized controlled studies and 22 uncontrolled before-and-after studies are included in this review. Twenty-two studies (29 comparisons) compared MDA to placebo or no intervention of which two comparisons were conducted in areas of low endemicity (≤5%), 12 in areas of moderate endemicity (6-39%) and 15 in areas of high endemicity (≥ 40%). Ten studies evaluated MDA plus other vector control measures. The studies used a wide variety of MDA regimens incorporating different drugs, dosages, timings and numbers of MDA rounds. Many of the studies are now more than 30 years old. Areas of low endemicity (≤5%) Within the first month post-MDA, a single uncontrolled before-and-after study conducted in 1955 on a small Taiwanese island reported a much lower prevalence of parasitaemia following a single course of chloroquine compared to baseline (1 study, very low quality evidence). This lower parasite prevalence was still present after more than 12 months (one study, very low quality evidence). In addition, one cluster-randomized trial evaluating MDA in a low endemic setting reported zero episodes of parasitaemia at baseline, and throughout five months of follow-up in both the control and intervention arms (one study, very low quality evidence). Areas of moderate endemicity (6-39%) Within the first month post-MDA, the prevalence of parasitaemia was much lower in three non-randomized controlled studies from Kenya and India in the 1950s (RR 0.03, 95% CI 0.01 to 0.08, three studies, moderate quality evidence), and in three uncontrolled before-and-after studies conducted between 1954 and 1961 (RR 0.29, 95% CI 0.17 to 0.48, three studies,low quality evidence). The longest follow-up in these settings was four to six months. At this time point, the prevalence of parasitaemia remained substantially lower than controls in the two non-randomized controlled studies (RR 0.18, 95% CI 0.10 to 0.33, two studies, low quality evidence). In contrast, the two uncontrolled before-and-after studies found mixed results: one found no difference and one found a substantially higher prevalence compared to baseline (not pooled, two studies, very low quality evidence). Areas of high endemicity (≥40%) Within the first month post-MDA, the single cluster-randomized trial from the Gambia in 1999 found no significant difference in parasite prevalence (one study, low quality evidence). However, prevalence was much lower during the MDA programmes in three non-randomized controlled studies conducted in the 1960s and 1970s (RR 0.17, 95% CI 0.11 to 0.27, three studies, moderate quality evidence), and within one month of MDA in four uncontrolled before-and-after studies (RR 0.37, 95% CI 0.28 to 0.49, four studies,low quality evidence). Four trials reported changes in prevalence beyond three months. In the Gambia, the single cluster-randomized trial found no difference at five months (one trial, moderate quality evidence). The three uncontrolled before-and-after studies had mixed findings with large studies from Palestine and Cambodia showing sustained reductions at four months and 12 months, respectively, and a small study from Malaysia showing no difference after four to six months of follow-up (three studies,low quality evidence). 8-aminoquinolines We found no studies directly comparing MDA regimens that included 8-aminoquinolines with regimens that did not. In a crude subgroup analysis with a limited number of studies, we were unable to detect any evidence of additional benefit of primaquine in moderate- and high-transmission settings. Plasmodium species In studies that reported species-specific outcomes, the same interventions resulted in a larger impact on Plasmodium falciparum compared to P. vivax. Authors' conclusions MDA appears to reduce substantially the initial risk of malaria parasitaemia. However, few studies showed sustained impact beyond six months post-MDA, and those that did were conducted on small islands or in highland settings. To assess whether there is an impact of MDA on malaria transmission in the longer term requires more quasi experimental studies with the intention of elimination, especially in low- and moderate-transmission settings. These studies need to address any long-term outcomes, any potential barriers for community uptake, and contribution to the development of drug resistance. PLAIN LANGUAGE SUMMARY Administration of antimalarial drugs to whole populations Malaria is the most important mosquito-borne disease caused by a parasite, accounting for an estimated 660,000 deaths annually. Fortunately, malaria is both preventable and treatable. Several malaria control tools currently exist, and new and innovative approaches are continually under development. The administration of drugs against malaria to whole populations, termed mass drug administration (MDA), was a component of many malaria elimination programmes in the 1950s, and is once again attracting interest as a malaria elimination tool. As a consequence, it is important to review the currently available literature in order to assess the potential for this strategy to reduce malaria burden and transmission, and to identify gaps in our understanding. This review assessed the impact of MDA on several malaria-specific outcome measures. Thirty-two studies were included in this review, from sites in Asia, Africa, Europe and the Americas. The review found that although MDA can reduce the initial risk of malaria-specific outcomes, these reductions are often not sustained. However, a few studies conducted on small islands or in highland areas did show sustained impact more than six months after MDA. Adverse events were inadequately addressed in most studies. Notable severe drug reactions, including haemolysis, haemoglobinuria, severe anaemia and death, were reported with 8-aminoquinoline plus schizonticide drug co-administration, while severe skin reactions were reported with sulphadoxine-pyrimethamine plus artesunate plus primaquine. Assessing the true impact of MDA programmes can be a challenge due to the heterogeneity of the study methods employed. Nonetheless, this review can help guide future antimalarial MDA interventions and their evaluation. PMID:24318836

[Anatomophysiological bases of drug administration. Dosage forms and routes of administration].

PubMed

Carillo Norte, Juan Antonio; Gañán Presmanes, Yolanda

2010-12-01

The administration of the right dose to the right patient is of paramount importance to obtain an optimal drug response within the scope of clinical pharmacology and tailored medicine. The marketing of safer and more efficient drug entities, along with the development of new drug administration devices provide a major boost for the diagnosis and treatment of diseases, beyond our imagination. However dose adjustment is not enough to produced the desired effect, and drug therapy should include an appropriate route of drug administration. Currently, there are many different and sophisticated methods to incorporate drugs into the patients that nurses should be familiar with. When there is no contraindication, oral route of drug administration is of choice and most frequently used as a physiological pathway of drug intake.

Sexuality Education: Findings and Recommendations from an Analysis of 10 United States Programmes

ERIC Educational Resources Information Center

Cushman, Nicole; Kantor, Leslie M.; Schroeder, Elizabeth; Eicher, Lesley; Gambone, Gina

2014-01-01

In this study, we identified 10 sexuality education programmes from different locations in the USA that aim to give young people knowledge and skills to develop healthy relationships, as well as avoid pregnancy and disease. We conducted in-depth interviews with programme administrators to develop a series of case studies and provide concrete…

Feasibility and cost-effectiveness of standardised second-line drug treatment for chronic tuberculosis patients: a national cohort study in Peru.

PubMed

Suárez, Pedro G; Floyd, Katherine; Portocarrero, Jaime; Alarcón, Edith; Rapiti, Elisabetta; Ramos, Gilbert; Bonilla, Cesar; Sabogal, Ivan; Aranda, Isabel; Dye, Christopher; Raviglione, Mario; Espinal, Marcos A

2002-06-08

There are no data on the feasibility and cost-effectiveness of using second-line drugs to treat patients with chronic tuberculosis, many of whom are infected with multidrug resistant (MDR) strains of Mycobacterium tuberculosis, in low or middle-income countries. A national programme to treat chronic tuberculosis patients with a directly observed standardised 18-month daily regimen, consisting of kanamycin (3 months only), ciprofloxacin, ethionamide, pyrazinamide, and ethambutol, was established in Peru in 1997. Compliance and treatment outcomes were analysed for the cohort started on treatment between October, 1997, and March, 1999. Total and average costs were assessed. Cost-effectiveness was estimated as the cost per DALY gained. 466 patients were enrolled; 344 were tested for drug susceptibility and 298 (87%) had MDR tuberculosis. 225 patients (48%) were cured, 57 (12%) died, 131 (28%) did not respond to treatment, and 53 (11%) defaulted. Of the 413 (89%) patients who complied with treatment, 225 (55%) were cured. Among MDR patients, resistance to five or more drugs was significantly associated with an unfavourable outcome (death, non-response to treatment, or default; odds ratio 3.37, 95% CI 1.32-8.60; p=0.01). The programme cost US $0.6 million per year, 8% of the National Tuberculosis Programme budget, and US $2381 per patient for those who completed treatment. The mean cost per DALY gained was $211 ($165 at drug prices projected for 2002). Treating chronic tuberculosis patients with high levels of MDR with second-line drugs can be feasible and cost-effective in middle-income countries, provided a strong tuberculosis control programme is in place.

21 CFR 20.120 - Records available in Food and Drug Administration Public Reading Rooms.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Public Reading Rooms. 20.120 Section 20.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF....120 Records available in Food and Drug Administration Public Reading Rooms. (a) The Food and Drug Administration operates two public reading rooms. The Freedom of Information Staff's Public Reading Room is...

78 FR 6824 - Considerations Regarding Food and Drug Administration Review and Regulation of Drugs for the...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-31

... Amyotrophic Lateral Sclerosis; Public Hearing AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public hearing; request for comments. SUMMARY: The Food and Drug Administration (FDA or the Agency) is... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0035...

21 CFR 20.120 - Records available in Food and Drug Administration Public Reading Rooms.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Public Reading Rooms. 20.120 Section 20.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF....120 Records available in Food and Drug Administration Public Reading Rooms. (a) The Food and Drug Administration operates two public reading rooms. The Freedom of Information Staff's Public Reading Room is...

78 FR 51732 - The Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] The Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug...

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

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2013-06-19

...: Food and Drug Administration, HHS. ACTION: Notification of public meeting; request for comments. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing a public meeting regarding FDA's... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I [Docket Nos...

78 FR 21085 - Establishment of a Public Docket for Administrative Detention Under the Food and Drug...

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2013-04-09

... Administration Safety and Innovation Act AGENCY: Food and Drug Administration, HHS. ACTION: Establishment of... authority with respect to drugs under the Food and Drug Administration Safety and Innovation Act (FDASIA....regulations.gov . Submit written comments to the Division of Dockets Management (HFA- 305), Food and Drug...

75 FR 386 - Memorandum of Understanding Between the United States Department of Health and Human Services...

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2010-01-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0667... Services, Food and Drug Administration, Center for Drug Evaluation and Research and Northeastern University AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA...

75 FR 1274 - Implantation or Injectable Dosage Form New Animal Drugs; Florfenicol and Flunixin

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 [Docket No... AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration... Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276...

75 FR 13766 - Food and Drug Administration and Process Analytical Technology for Pharma Manufacturing: Food and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-23

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28 CFR Appendix B to Part 61 - Drug Enforcement Administration Procedures Relating to the Implementation of the National...

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Drug Enforcement Administration... ENVIRONMENTAL POLICY ACT Pt. 61, App. B Appendix B to Part 61—Drug Enforcement Administration Procedures.... This part applies to all organizational elements of the Drug Enforcement Administration [DEA]. 2...

An observational study of drug administration errors in a Malaysian hospital (study of drug administration errors).

PubMed

Chua, S S; Tea, M H; Rahman, M H A

2009-04-01

Drug administration errors were the second most frequent type of medication errors, after prescribing errors but the latter were often intercepted hence, administration errors were more probably to reach the patients. Therefore, this study was conducted to determine the frequency and types of drug administration errors in a Malaysian hospital ward. This is a prospective study that involved direct, undisguised observations of drug administrations in a hospital ward. A researcher was stationed in the ward under study for 15 days to observe all drug administrations which were recorded in a data collection form and then compared with the drugs prescribed for the patient. A total of 1118 opportunities for errors were observed and 127 administrations had errors. This gave an error rate of 11.4 % [95% confidence interval (CI) 9.5-13.3]. If incorrect time errors were excluded, the error rate reduced to 8.7% (95% CI 7.1-10.4). The most common types of drug administration errors were incorrect time (25.2%), followed by incorrect technique of administration (16.3%) and unauthorized drug errors (14.1%). In terms of clinical significance, 10.4% of the administration errors were considered as potentially life-threatening. Intravenous routes were more likely to be associated with an administration error than oral routes (21.3% vs. 7.9%, P < 0.001). The study indicates that the frequency of drug administration errors in developing countries such as Malaysia is similar to that in the developed countries. Incorrect time errors were also the most common type of drug administration errors. A non-punitive system of reporting medication errors should be established to encourage more information to be documented so that risk management protocol could be developed and implemented.

Prescriptions for contraindicated category X drugs in pregnancy among women enrolled in TennCare.

PubMed

Cooper, William O; Hickson, Gerald B; Ray, Wayne A

2004-03-01

Filling of prescriptions for medications labelled as category X by the United States Food and Drug Administration (considered to be contraindicated for use in pregnancy) was identified among 95 284 women enrolled in TennCare, Tennessee's programme for Medicaid enrollees and individuals without health insurance. Using administrative claims data, 391 women (4.10/1000) were identified as having filled category X prescriptions during pregnancy. This included 118 women (1.24/1000) who filled prescriptions for non-contraceptive oestrogens, 81 (0.85/1000) for sedatives, and 71 (0.75/1000) for statins. While many women had physician visits with a diagnosis consistent with a possible indication for an individual drug outside of pregnancy, none of these indications is included for use during pregnancy. Older women and disabled women were more likely than younger women (P < 0.0001) and women enrolled for other reasons (P < 0.0001) to fill category X prescriptions. Nearly two-thirds of the 391 women filled prescriptions after clinical signs or pregnancy tests would indicate pregnancy; nearly 40% filled a category X prescription after a pregnancy-related physician visit. Although the absolute rate of category X medication use in pregnancy is low, substantial numbers of women and their fetuses are exposed during pregnancy. Women above the age of 35 years and women enrolled in TennCare because of disabilities were more likely to fill prescriptions for category X medications during pregnancy than others, implying that risk communication to practitioners and women should focus on identification of these women to reduce their risk of exposure.

Drug Education and Prevention: Has Progress Been Made?

ERIC Educational Resources Information Center

Coggans, Niall

2006-01-01

Ten years after publication of the UK Government's strategy for drug misuse in 1995, Tackling Drugs Together, the impact of drug education and prevention programmes remains less than desired. The 1995 strategy envisaged a new emphasis on education and prevention and there have been developments since then in drug education, especially with…

Doctor pharmaceutical utilization behaviour changed by the global budget programme strategies on hypertensive outpatient prescription.

PubMed

Wei, Ching-Kuo; Wang, Shun-Mu; Yeh, Ming-Kung

2012-04-01

This study was to examine changes in doctor pharmaceutical utilization behaviour in response to Taiwan's newly implemented National Health Insurance individual hospital global budget (GB) programme and the changes in health care costs and prescription trends for hypertensive (HT) patients. We analysed hospital outpatient prescription utilization with a pre-post individual hospital GB group and comparison group (the hospitals who did not join the programme) to evaluate the impact of GB strategies on hypertensive expenditure. Descriptive analyses were performed based on the average daily medication expenditure for each prescription, and average number of items per prescription. This study reviewed 16,770,057 outpatient records and prescription records of 213,568 hypertensive patients. The average total medication expense (+17.6%), HT medication expense (+8.8%), daily medication expense (+16.3%), and daily HT medication expense (+6.3%) significantly increased after the action. After the individual hospital GB action, hospital doctors participating in action switched their patients' prescription drugs to other less expensive drugs such as rennin-angiotensin-aldosterone system inhibitors (-1.1%). The increase in volume of medications prescribed for control group were significantly larger for both alfa- and beta-adrenergic blocking agents (1.5%), and calcium channel blocking agents (3.9%). The individual hospital GB programme slowed down the trend of prescription drug cost increasing rate and reduced the prescription drug volume in hospitals. © 2010 Blackwell Publishing Ltd.

76 FR 61366 - Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0247] Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to Increase...: Food and Drug Administration, HHS. [[Page 61367

77 FR 60125 - Generic Drug Facilities, Sites and Organizations

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1006] Generic Drug Facilities, Sites and Organizations AGENCY: Food and Drug Administration, HHS. ACTION: Notice of Requirement. SUMMARY: The Food and Drug Administration (FDA) is notifying generic drug facilities...

21 CFR 1316.10 - Administrative probable cause.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Administrative probable cause. 1316.10 Section 1316.10 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Inspections § 1316.10 Administrative probable cause. If the judge...

Educating educators about alcoholism and drug addiction: the role of employee assistance programmes.

PubMed

Van den Bergh, N

1990-01-01

The historical development of employee assistance programmes (EAPs) from occupational alcoholism programmes is outlined. Services for the three prevention levels of a 'broad brush' programme are described. The 'at-risk' characteristics of academia in potentiating alcoholism and addiction are noted, including several intrinsic characteristics of academics which could predispose to substance abuse. Ways in which EAPs enhance organizational goals are noted and several crucial steps in designing an academic EAP are suggested.

NATIONAL POLICIES TO MEET THE CHALLENGE OF SUBSTANCE ABUSE : PROGRAMMES AND IMPLEMENTATION

PubMed Central

Malhotra, Anil; Mohan, Ashwin

2000-01-01

Drug abuse has become a growing issue of concern to humanity. India has a large consumer base of drug and alcohol abusers. This has serious repercussions in terms of morbidity & mortality. Hence the need for a national policy. In India, the Narcotic Drugs and Psychotropic Substances Act. 1985 (NDPS) provides the framework for drug abuse control in the country. A large number of measures have been undertaken as part of demand reduction activities. These include framing policies and programmes, setting up of centres, developing pilot projects, etc. However, the implementation still needs a lot to be desired. The efforts have not yet been streamlined and no revision of policies has taken place based on experience. This paper critically reviews the initiatives taken thus far to control drug abuse in our country. PMID:21407973

75 FR 73951 - Amendments to General Regulations of the Food and Drug Administration

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 14, and 17 [Docket No. FDA-2010-N-0560] RIN 0910-AG55 Amendments to General Regulations of the Food and Drug Administration AGENCY: Food and Drug Administration, HHS. ACTION: Direct final rule. SUMMARY: The Food and Drug...

75 FR 73984 - Amendments to General Regulations of the Food and Drug Administration

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 14, and 17 [Docket No. FDA-2010-N-0560] RIN 0910-AG55 Amendments to General Regulations of the Food and Drug Administration AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug...

78 FR 102 - Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1056] Guidance for Industry and Food and Drug Administration Staff; eCopy Program for Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

77 FR 11550 - Draft Guidance for Industry on Notification to Food and Drug Administration of Issues That May...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0140] Draft Guidance for Industry on Notification to Food and Drug Administration of Issues That May Result in a Prescription Drug Shortage; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

77 FR 20826 - Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-06

...] Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry... Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and Food and... written requests for single copies of the guidance document entitled ``Guidance for Industry and Food and...

21 CFR 20.20 - Policy on disclosure of Food and Drug Administration records.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Administration records. 20.20 Section 20.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... the record will be so used, may be requested when: (1) The requested record is contained in a Privacy... Administration records. (a) The Food and Drug Administration will make the fullest possible disclosure of records...

76 FR 59705 - Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-27

... Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New..., and Development (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51...

77 FR 61417 - Guidance for Industry on Acute Bacterial Sinusitis: Developing Drugs for Treatment; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-09

... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0375...

77 FR 64346 - Nonprescription Drugs Advisory Committee; Amendment of Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-19

... for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Building 31... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Nonprescription Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION...

75 FR 1275 - New Animal Drugs; Ractopamine

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 [Docket No. FDA-2009-N-0665] New Animal Drugs; Ractopamine AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0391] Generic Drug Facilities, Sites, and Organizations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that the generic drug facility self...

75 FR 81455 - New Animal Drugs; Deslorelin

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 522 [Docket No. FDA-2010-N-0002] New Animal Drugs; Deslorelin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

76 FR 17025 - New Animal Drugs; Oxytetracycline

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520 and 529 [Docket No. FDA-2011-N-0003] New Animal Drugs; Oxytetracycline AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

76 FR 57906 - New Animal Drugs; Gamithromycin

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-19

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 522 and 556 [Docket No. FDA-2011-N-0003] New Animal Drugs; Gamithromycin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

77 FR 32897 - New Animal Drugs; Change of Sponsor's Name

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-04

.... FDA-2012-N-0002] New Animal Drugs; Change of Sponsor's Name AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug... 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and...

Effects of sharing information on drug administration errors in pediatric wards: a pre–post intervention study

PubMed Central

Chua, Siew-Siang; Choo, Sim-Mei; Sulaiman, Che Zuraini; Omar, Asma; Thong, Meow-Keong

2017-01-01

Background and purpose Drug administration errors are more likely to reach the patient than other medication errors. The main aim of this study was to determine whether the sharing of information on drug administration errors among health care providers would reduce such problems. Patients and methods This study involved direct, undisguised observations of drug administrations in two pediatric wards of a major teaching hospital in Kuala Lumpur, Malaysia. This study consisted of two phases: Phase 1 (pre-intervention) and Phase 2 (post-intervention). Data were collected by two observers over a 40-day period in both Phase 1 and Phase 2 of the study. Both observers were pharmacy graduates: Observer 1 just completed her undergraduate pharmacy degree, whereas Observer 2 was doing her one-year internship as a provisionally registered pharmacist in the hospital under study. A drug administration error was defined as a discrepancy between the drug regimen received by the patient and that intended by the prescriber and also drug administration procedures that did not follow standard hospital policies and procedures. Results from Phase 1 of the study were analyzed, presented and discussed with the ward staff before commencement of data collection in Phase 2. Results A total of 1,284 and 1,401 doses of drugs were administered in Phase 1 and Phase 2, respectively. The rate of drug administration errors reduced significantly from Phase 1 to Phase 2 (44.3% versus 28.6%, respectively; P<0.001). Logistic regression analysis showed that the adjusted odds of drug administration errors in Phase 1 of the study were almost three times that in Phase 2 (P<0.001). The most common types of errors were incorrect administration technique and incorrect drug preparation. Nasogastric and intravenous routes of drug administration contributed significantly to the rate of drug administration errors. Conclusion This study showed that sharing of the types of errors that had occurred was significantly associated with a reduction in drug administration errors. PMID:28356748

Modelling strategies to break transmission of lymphatic filariasis--aggregation, adherence and vector competence greatly alter elimination.

PubMed

Irvine, M A; Reimer, L J; Njenga, S M; Gunawardena, S; Kelly-Hope, L; Bockarie, M; Hollingsworth, T D

2015-10-22

With ambitious targets to eliminate lymphatic filariasis over the coming years, there is a need to identify optimal strategies to achieve them in areas with different baseline prevalence and stages of control. Modelling can assist in identifying what data should be collected and what strategies are best for which scenarios. We develop a new individual-based, stochastic mathematical model of the transmission of lymphatic filariasis. We validate the model by fitting to a first time point and predicting future timepoints from surveillance data in Kenya and Sri Lanka, which have different vectors and different stages of the control programme. We then simulate different treatment scenarios in low, medium and high transmission settings, comparing once yearly mass drug administration (MDA) with more frequent MDA and higher coverage. We investigate the potential impact that vector control, systematic non-compliance and different levels of aggregation have on the dynamics of transmission and control. In all settings, increasing coverage from 65 to 80 % has a similar impact on control to treating twice a year at 65 % coverage, for fewer drug treatments being distributed. Vector control has a large impact, even at moderate levels. The extent of aggregation of parasite loads amongst a small portion of the population, which has been estimated to be highly variable in different settings, can undermine the success of a programme, particularly if high risk sub-communities are not accessing interventions. Even moderate levels of vector control have a large impact both on the reduction in prevalence and the maintenance of gains made during MDA, even when parasite loads are highly aggregated, and use of vector control is at moderate levels. For the same prevalence, differences in aggregation and adherence can result in very different dynamics. The novel analysis of a small amount of surveillance data and resulting simulations highlight the need for more individual level data to be analysed to effectively tailor programmes in the drive for elimination.

Psychiatry and political-institutional abuse from the historical perspective: the ethical lessons of the Nuremberg Trial on their 60th anniversary.

PubMed

López-Muñoz, Francisco; Alamo, Cecilio; Dudley, Michael; Rubio, Gabriel; García-García, Pilar; Molina, Juan D; Okasha, Ahmed

2007-05-09

Sixty years ago at the Nuremberg Trials, 23 Nazi leaders were tried as war criminals, in what was known as "The Doctors' Trial". This trial exposed a perverse system of the criminal use of medicine in the fields of public health and human research. These practices, in which racial hygiene constituted one of the fundamental principles and euthanasia programmes were the most obvious consequence, violated the majority of known bioethical principles. Psychiatry played a central role in these programmes, and the mentally ill were the principal victims. The aim of the present work is to review, from the historical perspective, the antecedents of the shameful euthanasia programmes for the mentally ill, the procedures involved in their implementation and the use of mentally ill people as research material. The Nuremberg Code, a direct consequence of the Doctors' Trial, is considered to be the first international code of ethics for research with human beings, and represented an attempt to prevent any repeat of the tragedy that occurred under Nazism. Nevertheless, the last 60 years have seen continued government-endorsed psychiatric abuse and illegitimate use of psychoactive drugs in countries such as the Soviet Union or China, and even in some with a long democratic tradition, such as the United States. Even today, the improper use of psychiatry on behalf of governments is seen to be occurring in numerous parts of the globe: religious repression in China, enforced hospitalization in Russia, administration of psychoactive drugs in immigrant detention centres in Australia, and the application of the death penalty by lethal injection and psychiatric participation in coercive interrogation at military prisons, in relation to the USA. The Declaration of Madrid in 1996 constituted the most recent attempt to eradicate, from the ethical point of view, these horrendous practices. Various strategies can be used to combat such abuses, though it is uncertain how effective they are in preventing them.

76 FR 45402 - Advisory Committee; Medical Imaging Drugs Advisory Committee; Re-Establishment

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-29

..., Advisory committees, Color additives, Drugs, Radiation protection. Therefore, under the Federal Food, Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 14 [Docket No... AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration...

21 CFR 20.107 - Food and Drug Administration manuals.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Food and Drug Administration manuals. 20.107 Section 20.107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.107 Food and Drug...

21 CFR 20.107 - Food and Drug Administration manuals.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Food and Drug Administration manuals. 20.107 Section 20.107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.107 Food and Drug...

21 CFR 20.107 - Food and Drug Administration manuals.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Food and Drug Administration manuals. 20.107 Section 20.107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.107 Food and Drug...

21 CFR 20.107 - Food and Drug Administration manuals.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Food and Drug Administration manuals. 20.107 Section 20.107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.107 Food and Drug...

76 FR 40808 - Oral Dosage Form New Animal Drugs; Amprolium

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-12

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Amprolium AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

76 FR 2807 - New Animal Drugs; Change of Sponsor

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-18

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 510 [Docket No. FDA-2010-N-0002] New Animal Drugs; Change of Sponsor AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to...

76 FR 59023 - Oral Dosage Form New Animal Drugs; Tylosin

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Tylosin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

75 FR 79295 - New Animal Drugs; Mupirocin

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 524 [Docket No. FDA-2010-N-0002] New Animal Drugs; Mupirocin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to...

75 FR 67031 - Oral Dosage Form New Animal Drugs; Domperidone

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2010-N-0002] Oral Dosage Form New Animal Drugs; Domperidone AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

77 FR 3927 - Oral Dosage Form New Animal Drugs; Deracoxib

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-26

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Deracoxib AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

78 FR 22 - New Animal Drugs; Meloxicam; Nicarbazin

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520 and 558 [Docket No. FDA-2012-N-0002] New Animal Drugs; Meloxicam; Nicarbazin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

76 FR 6326 - New Animal Drugs; Masitinib

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-04

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 516 [Docket No. FDA-2011-N-0003] New Animal Drugs; Masitinib AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to...

77 FR 15960 - Oral Dosage Form New Animal Drugs; Pergolide

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-19

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Pergolide AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

76 FR 18648 - Oral Dosage Form New Animal Drugs; Robenacoxib

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Robenacoxib AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

76 FR 78149 - Oral Dosage Form New Animal Drugs; Estriol

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Estriol AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug...

21 CFR 20.107 - Food and Drug Administration manuals.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Food and Drug Administration manuals. 20.107 Section 20.107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.107 Food and Drug...

77 FR 4224 - New Animal Drugs; Change of Sponsor's Name

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-27

.... FDA-2011-N-0003] New Animal Drugs; Change of Sponsor's Name AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug.... 801-808. List of Subjects in 21 CFR Part 510 Administrative practice and procedure, Animal drugs...

78 FR 42088 - Anesthetic and Analgesic Drug Products Advisory Committee; Cancellation

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-15

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Anesthetic and Analgesic Drug Products Advisory Committee; Cancellation AGENCY: Food and Drug Administration..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31...

77 FR 59930 - Clinical Development Programs for Disease-Modifying Agents for Peripheral Neuropathy; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-01

... for comments. SUMMARY: The Food and Drug Administration (FDA), Center for Drug Evaluation and Research... Contacts: Randi Clark, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver...

78 FR 13686 - Draft Guidance for Industry and Review Staff on Pediatric Information Incorporated Into Human...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-28

... Prescription Drug and Biological Products Labeling; Availability AGENCY: Food and Drug Administration, HHS... (BPCA) and the Pediatric Research Equity Act (PREA), as amended by the Food and Drug Administration... Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New...

Understanding the Tobacco Control Act: efforts by the US Food and Drug Administration to make tobacco-related morbidity and mortality part of the USA's past, not its future.

PubMed

Husten, Corinne G; Deyton, Lawrence R

2013-05-04

The USA has a rich history of public health efforts to reduce morbidity and mortality from tobacco use. Comprehensive tobacco-prevention programmes, when robustly implemented, reduce the prevalence of youth and adult smoking, decrease cigarette consumption, accelerate declines in tobacco-related deaths, and diminish health-care costs from tobacco-related diseases. Effective public health interventions include raising the price of tobacco products, smoke-free policies, counter-marketing campaigns, advertising restrictions, augmenting access to treatment for tobacco use through insurance coverage and telephone help lines, and comprehensive approaches to prevent children and adolescents from accessing tobacco products. The US Food and Drug Administration (FDA) has six major areas of regulatory authority: regulation of tobacco products; regulation of the advertising, marketing, and promotion of tobacco products; regulation of the distribution and sales of tobacco products; enforcement of the provisions of the Tobacco Control Act and tobacco regulations; regulatory science to support FDA authorities and activities; and public education about the harms of tobacco products and to support FDA regulatory actions. With passing of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) in June, 2009, important new regulatory approaches were added to the tobacco prevention and control arsenal. Copyright © 2013 Elsevier Ltd. All rights reserved.

Does mass drug administration for the integrated treatment of neglected tropical diseases really work? Assessing evidence for the control of schistosomiasis and soil-transmitted helminths in Uganda

PubMed Central

2011-01-01

Background Less is known about mass drug administration [MDA] for neglected tropical diseases [NTDs] than is suggested by those so vigorously promoting expansion of the approach. This paper fills an important gap: it draws upon local level research to examine the roll out of treatment for two NTDs, schistosomiasis and soil-transmitted helminths, in Uganda. Methods Ethnographic research was undertaken over a period of four years between 2005-2009 in north-west and south-east Uganda. In addition to participant observation, survey data recording self-reported take-up of drugs for schistosomiasis, soil-transmitted helminths and, where relevant, lymphatic filariasis and onchocerciasis was collected from a random sample of at least 10% of households at study locations. Data recording the take-up of drugs in Ministry of Health registers for NTDs were analysed in the light of these ethnographic and social survey data. Results The comparative analysis of the take-up of drugs among adults revealed that although most long term residents have been offered treatment at least once since 2004, the actual take up of drugs for schistosomiasis and soil-transmitted helminths varies considerably from one district to another and often also within districts. The specific reasons why MDA succeeds in some locations and falters in others relates to local dynamics. Issues such as population movement across borders, changing food supply, relations between drug distributors and targeted groups, rumours and conspiracy theories about the 'real' purpose of treatment, subjective experiences of side effects from treatment, alternative understandings of affliction, responses to social control measures and historical experiences of public health control measures, can all make a huge difference. The paper highlights the need to adapt MDA to local circumstances. It also points to specific generalisable issues, notably with respect to health education, drug distribution and more effective use of existing public health legislation. Conclusion While it has been an achievement to have offered free drugs to so many adults, current standard practices of monitoring, evaluation and delivery of MDA for NTDs are inconsistent and inadequate. Efforts to integrate programmes have exacerbated the difficulties. Improved assessment of what is really happening on the ground will be an essential step in achieving long-term overall reduction of the NTD burden for impoverished communities. PMID:21211001

Relationship of drug-addicted patients' personality disorders to social problem-solving changes during the rehabilitation process.

PubMed

Kolesnikova, Jelena; Miezitis, Solveiga; Osis, Guntars

2013-08-01

Drug-addicted patients exhibit various personality disorders that interfere with their adaptation to society, as well as their ability to participate in the rehabilitation process. The Latvian Rehabilitation Programme for drug addicts includes social problem-solving training to help patients reintegrate into society. However, the role of personality disorders has not been investigated in relation to this process. The aim of the study is to assess whether personality disorders predict changes in dimensions of social problem-solving after 6 months of rehabilitation for drug-addicted patients. The sample of this study consists of 31 drug-addicted patients from the Latvian rehabilitation centres aged 21-35 (females 21%, males 79%). Two inventories are used: the Social Problem-Solving Inventory--Revised (SPSI-R) and Millon(TM) Clinical Multiaxial Inventory--III (MCMI-III) adapted into Russian. Results of the study indicated that some MCMI-III personality disorders (Schizoid and Histrionic) negatively predicted SPSI-R Positive problem orientation, and narcissistic disorder positively predicted SPSI-R Avoidance style after 6 months in the Latvian Rehabilitation Programme. The other personality disorders did not predict social problem-solving dimensions. The results of the study suggest that some personality disorders are related to changes in social problem-solving dimensions for drug-addicted patients. Hence, it is important to consider the implications of particular personality disorders to facilitate the implementation of social problem-solving rehabilitation programmes.

78 FR 14557 - Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0010] Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption Guidance for Retinal Prostheses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

77 FR 49449 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food...

78 FR 76842 - Food and Drug Administration/American Academy of Ophthalmology Workshop on Developing Novel...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-19

... for Premium Intraocular Lenses; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``FDA... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001...

75 FR 22819 - Considerations Regarding Food and Drug Administration Review and Regulation of Articles for the...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-30

... Diseases; Public Hearing AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public hearing; request for comment. SUMMARY: The Food and Drug Administration (FDA) is announcing a public hearing... with rare diseases, a recent public law (Agriculture, Rural Development, Food and Drug Administration...

78 FR 54901 - Food and Drug Administration/American Academy of Ophthalmology Workshop on Developing Novel...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-06

... for Premium Intraocular Lenses; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA) is announcing the following public... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The...

76 FR 17138 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-25

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practices; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop...

77 FR 49448 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food...

76 FR 6142 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-03

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0598... Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing... CONTACT: Johnny Vilela, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr...

78 FR 12329 - Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements; Draft...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-22

... Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0114...

76 FR 789 - Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0635] Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

75 FR 47603 - Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0395] Draft Guidance for Industry and Food and Drug Administration Staff; Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Availability AGENCY: Food and Drug Administration, HHS...

76 FR 50740 - Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0514] Draft Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Section 522 Postmarket Surveillance Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

75 FR 39537 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0101...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... CONTACT: Elizabeth Berbakos, Office of Information Management, Food and Drug Administration, 1350 Piccard...

77 FR 26162 - Amendments to Sterility Test Requirements for Biological Products

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-03

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 600, 610, and... AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration...), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852- 1448, 301-827-6210...

75 FR 79383 - Unapproved Animal Drugs

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0528] Unapproved Animal Drugs AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. SUMMARY: The Food and Drug Administration (FDA, the Agency) is soliciting comments from stakeholders on...

Illegal drugs in Grenada: arrests and drug treatment from 2001-2009.

PubMed

Fagorala, A

2013-09-01

Illegal drug use and abuse has increased in the Caribbean since the 1990s. In Grenada, statistical indicators such as admission rates to treatment facilities and drug arrests have provided evidence for the increased rates of illegal drug use and abuse. This study reviewed these statistical indicators and explored drug treatment options in Grenada from 2001 to 2009. A search of statistical records from the Drug Control Secretariat and the Grenada Drug Information Network/National Observatory on Drugs (GRENDIN/NOD) was performed. Literature review of relevant articles from search engines was used to support findings. Additionally, semi-structured interviews of key stakeholders from government and health agencies involved in drug prevention in Grenada were conducted to obtain information on recent developments surrounding drug arrests and treatments in Grenada. From 2001 to 2009, there were a 118% and a 23% increase in the arrest rate for males and females,respectively. There was also an increase in demand for drug treatment at the sole drug treatment facility. Preventive measures in schools and several forms of media programmes have raised awareness. However,drug use/abuse/activities still persist at a significant rate. Programmes that target improvement of treatment facilities and increased inter-agency collaboration may be successful in enhancing drug arrests and treatments.

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

PubMed

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

2014-11-01

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

76 FR 79701 - Bristol-Myers Squibb Co. et al.; Withdrawal of Approval of 70 New Drug Applications and 97...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-22

...: Florine Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0411... Drug Applications; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction...

78 FR 15955 - Draft Guidance for Industry and Review Staff on Formal Dispute Resolution: Appeals Above the...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-13

... Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New... and Development (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22...

76 FR 64951 - Apothecon et al.; Withdrawal of Approval of 103 New Drug Applications and 35 Abbreviated New Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-19

... INFORMATION CONTACT: Florine Purdie, Center for Drug Evaluation and Research, Food and Drug Administration... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0026... Applications; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The...

78 FR 68854 - Over-the-Counter Ophthalmic Drug Products-Emergency Use Eyewash Products; Rescheduling of Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-15

...: Mary C. Gross, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New... Elaine Abraham, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1038...

78 FR 15956 - Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0595... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug...

78 FR 78366 - Draft Guidance for Industry on Naming of Drug Products Containing Salt Drug Substances; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-26

... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver... for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1566...

Evaluation of the medical student research programme in Norwegian medical schools. A survey of students and supervisors

PubMed Central

Hunskaar, Steinar; Breivik, Jarle; Siebke, Maje; Tømmerås, Karin; Figenschau, Kristian; Hansen, John-Bjarne

2009-01-01

Background The Medical Student Research Programme is a national education and grant scheme for medical students who wish to carry out research in parallel with their studies. The purpose of the programme is to increase recruitment of people with a standard medical degree to medical research. The Research Programme was established in 2002 and underwent a thorough evaluation during the spring of 2007. The evaluation should investigate if the programme had fulfilled its objectives of increased recruitment to medical research, in addition to the students' and supervisors' satisfaction of the programme, and unwanted differences between the universities. Methods Data was collected from students, supervisors and administrative staff via web-based questionnaires. Information about admission, implementation, results achieved and satisfaction was analysed and compared between the four Norwegian medical schools. In addition, the position of the scheme in relation to the national Quality Reform of Higher Education was analysed. Results At the end of 2006, the Medical Student Research Programme had recruited 265 medical students to research. These consisted of 214 active students, 35 who had completed their studies and only 17 who had dropped out. Both students and supervisors were generally very satisfied with the scheme, including the curriculum, the results achieved and the administrative service. The majority of students wanted to continue their research towards a PhD and, of those who had completed the Medical Student Research Programme, practically all had published one or several scientific papers. The survey showed only small differences between the four medical schools, despite their choice of somewhat different solutions in terms of administration and organisation. The Medical Student Research Programme satisfies the majority of the demands of the Quality Reform, however as an integrated research programme aimed at a PhD it presupposes access to PhD courses before the completion of medical studies, as well as the ability to include undergraduate scientific work in a PhD thesis. Conclusion The Medical Student Research Programme has led to an increase in the recruitment of graduated physicians to medical research in Norway. It will only be possible to evaluate whether this in turn will result in a larger number of PhDs in 3–5 years; this will also depend on the access to grants and fellowships. PMID:19602226

78 FR 44251 - Regulatory Agenda

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-23

... Administration, Center for Drug Evaluation and Research, WO 22, Room 5487, 10903 New Hampshire Avenue, Silver..., Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New... Drug Administration, Center for Drug Evaluation and Research, WO 22, Room 5487, 10903 New Hampshire...

21 CFR 1316.09 - Application for administrative inspection warrant.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Application for administrative inspection warrant. 1316.09 Section 1316.09 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Inspections § 1316.09 Application for...

The role of personal opinions and experiences in compliance with mass drug administration for lymphatic filariasis elimination in Kenya.

PubMed

Njomo, Doris W; Amuyunzu-Nyamongo, Mary; Magambo, Japheth K; Njenga, Sammy M

2012-01-01

The main strategy adopted for Lymphatic Filariasis (LF) elimination globally is annual mass drug administration (MDA) for 4 to 6 rounds. At least 65% of the population at risk should be treated in each round for LF elimination to occur. In Kenya, MDA using diethylcarbamazine citrate (DEC) and albendazole data shows declining compliance (proportion of eligible populations who receive and swallow the drugs) levels (85%-62.8%). The present study's aim was to determine the role of personal opinions and experiences in compliance with MDA. This was a retrospective cross-sectional study conducted between January and September 2009 in two districts based on December 2008 MDA round. In each district, one location with high and one with low compliance was selected. Through systematic sampling, nine villages were selected and interviewer-based questionnaires administered to 965 household heads or adult representatives also systematically sampled. The qualitative data were generated from opinion leaders, LF patients with clinical signs and community drug distributors (CDDs) all purposively selected and interviewed. Sixteen focus group discussions (FGDs) were also conducted with single-sex adult and youth male and female groups. Chi square test was used to assess the statistical significance of differences in compliance with treatment based on the records reviewed. The house-to-house method of drug distribution influenced compliance. Over one-quarter (27%) in low compared to 15% in high compliance villages disliked this method. Problems related to size, number and taste of the drugs were more common in low (16.4%) than in high (14.4%) compliance villages. Reasons for failure to take the drugs were associated with compliance (p<0.001). The reasons given included: feeling that the drugs were not necessary, CDD not visiting to issue the drugs, being absent and thinking that the drugs were meant for only the patients with LF clinical signs. A dislike for modern medicine prevailed more in low (6.7%) than in high (1.2%) compliance villages. Experience of side effects influenced compliance (P<0.001). The common side effects experienced included giddiness, fever, headache and vomiting. Social support, alcohol and substance use were not associated with compliance in both types of villages (p>0.05). Community sensitization on treatment, drugs used, their regimen and distribution method involving all leaders should be strengthened by the Programme Implementers. The communities need to be made aware of the potential side effects of the drugs and that health personnel are on standby for the management of side effects in order to build confidence and increase the compliance levels.

76 FR 72953 - Science Board to the Food and Drug Administration; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No: FDA-2011-N-0002] Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration... pace with technical and scientific evolutions in the fields of regulatory science, on formulating an...

76 FR 30727 - Food and Drug Administration Food Safety Modernization Act: Focus on Inspections and Compliance

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-26

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0366] Food and Drug Administration Food Safety Modernization Act: Focus on Inspections and Compliance AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. SUMMARY: The...

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

Federal Register 2010, 2011, 2012, 2013, 2014

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; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment...

75 FR 31450 - Memorandum of Understanding by and Between the United States Food and Drug Administration and the...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-03

... Administration and the International Anesthesia Research Society for the Safety of Key Inhaled and Intravenous Drugs in Pediatrics Public-Private Partnership AGENCY: Food and Drug Administration, HHS. ACTION: Notice... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0004...

78 FR 277 - Food and Drug Administration Actions Related to Nicotine Replacement Therapies and Smoking...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-03

... Dependence; Public Hearing; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notification of public hearing; Extension of comment period. SUMMARY: The Food and Drug Administration (FDA) is... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 15 [Docket No...

75 FR 48699 - Memorandum of Understanding Between United States Food and Drug Administration and the Centers...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0004] [FDA 225-10-0010] Memorandum of Understanding Between United States Food and Drug Administration and the Centers for Medicare and Medicaid Services AGENCY: Food and Drug Administration, HHS. ACTION...

78 FR 28228 - Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-14

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0057] Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data; Availability AGENCY: Food and Drug Administration...

78 FR 5185 - Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-24

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD) Designations... public comment ``Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use...

77 FR 14403 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0167] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Norovirus Serological Reagents; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

76 FR 77542 - Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0847] Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device Designations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

76 FR 51993 - Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-19

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0215] Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion Diagnostic Devices; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension...

78 FR 50064 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0380...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... CONTACT: Jonna Capezzuto, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50-400B...

75 FR 74063 - Supplemental Funding Under the Food and Drug Administration's Convener of Active Medical Product...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0576] Supplemental Funding Under the Food and Drug Administration's Convener of Active Medical Product Surveillance Discussions (U13) RFA- FD-09-012; Request for Supplemental Application AGENCY: Food and Drug Administration...

76 FR 36543 - Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-22

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0469] Draft Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering To Optimize Medical Device Design; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

77 FR 33746 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0110...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... CONTACT: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr...

76 FR 75551 - Draft Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0800... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD...

77 FR 40069 - Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0563... Labeled for Human Use; Enforcement Action Dates AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing its intention to take enforcement...

78 FR 14305 - Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication During...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0147] Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication During the Review of Medical Device Submissions; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

77 FR 41413 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0530... Program and Meetings With FDA Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft...

78 FR 5713 - New Animal Drugs; Cefpodoxime; Meloxicam

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, and 522 [Docket No. FDA-2012-N-0002] New Animal Drugs; Cefpodoxime; Meloxicam AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration (FDA) is...

76 FR 79198 - Generic Drug User Fee; Public Meeting; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0381] Generic Drug User Fee; Public Meeting; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a notice that appeared...

77 FR 44177 - Antimicrobial Animal Drug Sales and Distribution Reporting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 514 [Docket No. FDA-2012-N-0447] Antimicrobial Animal Drug Sales and Distribution Reporting AGENCY: Food and Drug Administration, HHS. ACTION: Advance notice of proposed rulemaking. SUMMARY: The Food and Drug Administration...

Schistosomiasis and soil-transmitted helminth control in Niger: cost effectiveness of school based and community distributed mass drug administration [corrected].

PubMed

Leslie, Jacqueline; Garba, Amadou; Oliva, Elisa Bosque; Barkire, Arouna; Tinni, Amadou Aboubacar; Djibo, Ali; Mounkaila, Idrissa; Fenwick, Alan

2011-10-01

In 2004 Niger established a large scale schistosomiasis and soil-transmitted helminths control programme targeting children aged 5-14 years and adults. In two years 4.3 million treatments were delivered in 40 districts using school based and community distribution. Four districts were surveyed in 2006 to estimate the economic cost per district, per treatment and per schistosomiasis infection averted. The study compares the costs of treatment at start up and in a subsequent year, identifies the allocation of costs by activity, input and organisation, and assesses the cost of treatment. The cost of delivery provided by teachers is compared to cost of delivery by community distributers (CDD). The total economic cost of the programme including programmatic, national and local government costs and international support in four study districts, over two years, was US$ 456,718; an economic cost/treatment of $0.58. The full economic delivery cost of school based treatment in 2005/06 was $0.76, and for community distribution was $0.46. Including only the programme costs the figures are $0.47 and $0.41 respectively. Differences at sub-district are more marked. This is partly explained by the fact that a CDD treats 5.8 people for every one treated in school. The range in cost effectiveness for both direct and direct and indirect treatments is quantified and the need to develop and refine such estimates is emphasised. The relative cost effectiveness of school and community delivery differs by country according to the composition of the population treated, the numbers targeted and treated at school and in the community, the cost and frequency of training teachers and CDDs. Options analysis of technical and implementation alternatives including a financial analysis should form part of the programme design process.

21 CFR 1316.07 - Requirement for administrative inspection warrant; exceptions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Requirement for administrative inspection warrant; exceptions. 1316.07 Section 1316.07 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Inspections § 1316.07 Requirement for...

78 FR 69133 - Drug Enforcement Administration

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-18

... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances..., California 94085, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances: Drug Schedule...

75 FR 34464 - Memorandum of Understanding Between the Food and Drug Administration and Drugs.Com; Correction of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-17

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0004] FDA 225-09-0012 Memorandum of Understanding Between the Food and Drug Administration and Drugs.Com... date of the memorandum of understanding (MOU) between FDA and Drugs.Com that published in the Federal...

75 FR 37818 - Issues in the Design and Conduct of Clinical Trials for Antibacterial Drug Development; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-30

... Moser or Lori Benner, Center for Drug Evaluation and Research, Food and Drug Administration, Office of... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001... AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug...

Assessing Progress in Reducing the At-Risk Population after 13 Years of the Global Programme to Eliminate Lymphatic Filariasis

PubMed Central

Hooper, Pamela J.; Chu, Brian K.; Mikhailov, Alexei; Ottesen, Eric A.; Bradley, Mark

2014-01-01

Background In 1997, the World Health Assembly adopted Resolution 50.29, committing to the elimination of lymphatic filariasis (LF) as a public health problem, subsequently targeted for 2020. The initial estimates were that 1.2 billion people were at-risk for LF infection globally. Now, 13 years after the Global Programme to Eliminate Lymphatic Filariasis (GPELF) began implementing mass drug administration (MDA) against LF in 2000—during which over 4.4 billion treatments have been distributed in 56 endemic countries—it is most appropriate to estimate the impact that the MDA has had on reducing the population at risk of LF. Methodology/Principal Findings To assess GPELF progress in reducing the population at-risk for LF, we developed a model based on defining reductions in risk of infection among cohorts of treated populations following each round of MDA. The model estimates that the number of people currently at risk of infection decreased by 46% to 789 million through 2012. Conclusions/Significance Important progress has been made in the global efforts to eliminate LF, but significant scale-up is required over the next 8 years to reach the 2020 elimination goal. PMID:25411843

Genomic Insights into Cardiomyopathies: A Comparative Cross-Species Review

PubMed Central

Simpson, Siobhan; Rutland, Paul; Rutland, Catrin Sian

2017-01-01

In the global human population, the leading cause of non-communicable death is cardiovascular disease. It is predicted that by 2030, deaths attributable to cardiovascular disease will have risen to over 20 million per year. This review compares the cardiomyopathies in both human and non-human animals and identifies the genetic associations for each disorder in each species/taxonomic group. Despite differences between species, advances in human medicine can be gained by utilising animal models of cardiac disease; likewise, gains can be made in animal medicine from human genomic insights. Advances could include undertaking regular clinical checks in individuals susceptible to cardiomyopathy, genetic testing prior to breeding, and careful administration of breeding programmes (in non-human animals), further development of treatment regimes, and drugs and diagnostic techniques. PMID:29056678

A Comparison of Adverse Drug Reaction Profiles in Patients on Antiretroviral and Antitubercular Treatment in Zimbabwe.

PubMed

Masuka, Josiah T; Chipangura, Precious; Nyambayo, Priscilla P; Stergachis, Andy; Khoza, Star

2018-01-01

Few studies describe the adverse drug event profiles in patients simultaneously receiving antiretroviral and anti-tubercular medicines in resource-limited countries. To describe and compare the adverse drug reaction profiles in patients on highly active antiretroviral therapy only (HAART), HAART and isoniazid preventive therapy (HHART), and HAART and antitubercular treatment (ATTHAART). We analysed individual case safety reports (ICSRs) for patients on antiretroviral therapy and antitubercular treatment submitted to the national pharmacovigilance centre during the targeted spontaneous reporting (TSR) programme from 1 September 2012 through 31 August 2016. All reports considered certain, probable or possible were included in the analysis. A total of 1076 ICSRs were included in the analysis. Most of the reports were from the HAART only group (n = 882; 82.0%), followed by patients on HHART (n = 132; 12.3%), and ATTHAART (n = 62; 5.7%). The ATTHAART (35.5%) and HHAART (34.1%) had a higher frequency of hepatic disorders than the HAART group (5.0%) (p < 0.0001). A higher frequency of rash was reported in the HHAART (35.6%) and HAART groups (29.4%) than the ATTHAART group (14.5%) (p = 0.011). Peripheral neuropathy occurred more frequently in the ATTHAART group (19.3%) than other groups (p = 0.001) while Stevens-Johnson syndrome (14.7%; p < 0.001), gynaecomastia (18.2%; p < 0.001), and lipodystrophy (4.5%; p = 0.012) occurred more frequently in the HAART group. The HHAART group was associated with a higher frequency of psychosis (4.5%; p = 0.002). Antiretroviral therapy was associated with a higher frequency of Stevens-Johnson syndrome, gynaecomastia, and lipodystrophy. Co-administration of antiretroviral and antitubercular medicines was associated with a higher frequency of drug-induced liver injury and peripheral neuropathy. Similarly, co-administration of isoniazid preventive therapy and antiretroviral drugs was associated with a higher risk for psychosis. There is a need to carefully manage TB/HIV co-infected patients, due to the higher risk of adverse drug reactions which may lead to poor treatment adherence and outcomes.

76 FR 76738 - Generic Drug User Fee; Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0381] Generic Drug User Fee; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. The Food and Drug Administration (FDA) is announcing a public meeting to...

77 FR 15961 - Oral Dosage Form New Animal Drugs; Phenylpropanolamine

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-19

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 [Docket No. FDA-2011-N-0003] Oral Dosage Form New Animal Drugs; Phenylpropanolamine AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal...

77 FR 55414 - New Animal Drugs; Enrofloxacin; Tylvalosin

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-10

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520, 522, and 556 [Docket No. FDA-2012-N-0002] New Animal Drugs; Enrofloxacin; Tylvalosin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal...

78 FR 17595 - New Animal Drugs; Changes of Sponsor

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-22

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, 529, and 558 [Docket No. FDA-2013-N-0002] New Animal Drugs; Changes of Sponsor AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is...

75 FR 71450 - Oncologic Drugs Advisory Committee; Amendment of Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Oncologic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an amendment to the notice of a...

77 FR 37911 - Oncologic Drugs Advisory Committee; Amendment of Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-25

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Oncologic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the...

78 FR 21058 - New Animal Drugs; Change of Sponsor

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, 526, 529, and 558 [Docket No. FDA-2013-N-0002] New Animal Drugs; Change of Sponsor AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is...

78 FR 70062 - Withdrawal of Approval of New Animal Drug Applications; Carbarsone; Roxarsone

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-22

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0002] Withdrawal of Approval of New Animal Drug Applications; Carbarsone; Roxarsone AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of...

21 CFR 21.3 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Definitions. 21.3 Section 21.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF PRIVACY General... products regulated by the Food and Drug Administration or with which the Food and Drug Administration has...

21 CFR 21.3 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Definitions. 21.3 Section 21.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF PRIVACY General... products regulated by the Food and Drug Administration or with which the Food and Drug Administration has...

21 CFR 21.3 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Definitions. 21.3 Section 21.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF PRIVACY General... products regulated by the Food and Drug Administration or with which the Food and Drug Administration has...

21 CFR 21.3 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Definitions. 21.3 Section 21.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF PRIVACY General... products regulated by the Food and Drug Administration or with which the Food and Drug Administration has...

77 FR 29216 - New Animal Drugs; Ceftiofur Sodium; Lincomycin Powder; Naracin; Tylosin

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-17

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522...; Tylosin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug...: George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl...

76 FR 30176 - Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-24

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee...

75 FR 54016 - New Animal Drugs; Change of Sponsor's Name and Address

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-03

.... FDA-2010-N-0002] New Animal Drugs; Change of Sponsor's Name and Address AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal... in 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and...

76 FR 40612 - New Animal Drugs; Change of Sponsor's Name and Address

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-11

.... FDA-2011-N-0003] New Animal Drugs; Change of Sponsor's Name and Address AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal... Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements...

76 FR 19375 - Safety and Efficacy of Hypnotic Drugs; Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Safety and Efficacy of Hypnotic Drugs; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting. The Food and Drug Administration (FDA) is announcing a public meeting to...

77 FR 60442 - Withdrawal of Approval of New Animal Drug Applications; Butorphanol; Doxapram; Triamcinolone...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-03

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0981] Withdrawal of Approval of New Animal Drug Applications; Butorphanol; Doxapram; Triamcinolone; Tylosin AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

77 FR 14401 - Draft Guidance on Drug Safety Information-FDA's Communication to the Public; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2005-D-0339] Draft Guidance on Drug Safety Information--FDA's Communication to the Public; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

77 FR 41415 - Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-13

... INFORMATION CONTACT: Astrid Lopez-Goldberg, Center for Drug Evaluation and Research, Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0563] Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration and...

78 FR 43209 - Narcolepsy Public Meeting on Patient-Focused Drug Development

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-19

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0815] Narcolepsy Public Meeting on Patient-Focused Drug Development AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. SUMMARY: The Food and Drug Administration (FDA...

78 FR 58313 - Fibromyalgia Public Meeting on Patient-Focused Drug Development

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1041] Fibromyalgia Public Meeting on Patient-Focused Drug Development AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. SUMMARY: The Food and Drug Administration (FDA...

78 FR 64956 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee...

75 FR 22146 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Advisory Committee for Reproductive Health Drugs; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Advisory...

76 FR 70462 - Advisory Committee for Reproductive Health Drugs; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-14

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Advisory Committee for Reproductive Health Drugs; Notice of Meeting AGENCY: Food and Drug Administration... Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Advisory...

21 CFR 1316.12 - Refusal to allow inspection with an administrative warrant.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Refusal to allow inspection with an administrative warrant. 1316.12 Section 1316.12 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Inspections § 1316.12 Refusal to allow...

Lymphatic filariasis in Papua New Guinea: distribution at district level and impact of mass drug administration, 1980 to 2011

PubMed Central

2013-01-01

Background Lymphatic filariasis (LF) caused by Wuchereria bancrofti is present at high prevalence in some parts of Papua New Guinea. However, there has been no rigorous data-based representative assessment of nationwide prevalence of LF. The LF programme has been daunted by the scope of the problem, and progress on mass drug administration (MDA) has been slow and lacking in resources. Methods A systematic literature review identified LF surveys in Papua New Guinea between 1980 and 2011. Results were extracted by location, time period and test used (blood slide, immunochromatographic test (ICT) or Og4C3 ELISA) and combined by district. Three criteria schemes based on the Global Programme to Eliminate Lymphatic Filariasis guidelines, with modifications, were developed to classify and prioritize districts by prevalence level. Results of repeated surveys in the same sites were used to investigate the impact of MDA on LF prevalence over the time period. Results There were 312 distinct survey sites identified in 80 of the 89 districts over the 31-year period. The overall LF prevalence in the sites tested was estimated at 18.5 to 27.5% by blood slide for microfilariae (Mf), 10.1% to 12.9% by ICT and 45.4% to 48.8% by Og4C3. Biases in site selection towards areas with LF, and change in type of assay used, affected the prevalence estimates, but overall decline in prevalence over the time period was observed. Depending on the criteria used, 34 to 36 districts (population 2.7 to 2.9 million) were classed as high endemic (≥5% prevalence), 15 to 25 districts (1.7 to 1.9 million) as low endemic (<5%) and 20 to 31 (1.3 to 2.2 million) as non-endemic. Nine districts (0.7 million) had no information. The strong impact of MDA, especially on microfilaria (Mf) prevalence, was noted in sites with repeat surveys. Conclusions This analytical review of past surveys of LF in Papua New Guinea enables better estimation of the national burden, identifies gaps in knowledge, quantifies and locates the population at risk, and can be used to predict the likely impact of MDA and/or vector control. Better targeting of districts by level of prevalence will strengthen the control programme, facilitate monitoring of the disease trend and increase the likelihood of reaching the target of LF elimination by 2020. PMID:23311302

21 CFR 21.31 - Records stored by the National Archives and Records Administration.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Records stored by the National Archives and Records Administration. 21.31 Section 21.31 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... § 21.31 Records stored by the National Archives and Records Administration. (a) Food and Drug...

75 FR 21000 - Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-22

...] (formerly Docket No. 02D-0049) Draft Guidance for the Public, Food and Drug Administration Advisory Committee Members, and Food and Drug Administration Staff: Public Availability of Advisory Committee Members... and Drug Administration Amendments Act of 2007, Public Law No. 110-85), and section 701 (21 U.S.C. 371...

77 FR 14404 - Guidance for the Public, Food and Drug Administration (FDA) Advisory Committee Members, and FDA...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2002-D-0094; (formerly Docket No. 02D-0049)] Guidance for the Public, Food and Drug Administration (FDA) Advisory... Food and Drug Administration (FDA) is announcing the availability of a guidance for the public, FDA...

77 FR 70166 - Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-23

...; Establishment of a Public Docket AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is establishing a public docket for information pertaining to FDA's... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-1090...

75 FR 17418 - Memorandum of Understanding Between the Food and Drug Administration, United States Department of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0004] Memorandum of Understanding Between the Food and Drug Administration, United States Department of Health and... understanding (MOU) between the Food and Drug Administration, U.S. Department of Health and Human Services and...

Research gaps for three main tropical diseases in the People’s Republic of China

PubMed Central

2013-01-01

This scoping review analyzes the research gaps of three diseases: schistosomiasis japonica, malaria and echinococcosis. Based on available data in the P.R. China, we highlight the gaps between control capacity and prevalence levels, and between diagnostic/drug development and population need for treatment at different stages of the national control programme. After reviewing the literature from 848 original studies and consultations with experts in the field, the gaps were identified as follows. Firstly, the malaria research gaps include (i) deficiency of active testing in the public community and no appropriate technique to evaluate elimination, (ii) lack of sensitive diagnostic tools for asymptomatic patients, (iii) lack of safe drugs for mass administration. Secondly, gaps in research of schistosomiasis include (i) incongruent policy in the implementation of integrated control strategy for schistosomiasis, (ii) lack of effective tools for Oncomelania sp. snail control, (iii) lack of a more sensitive and cheaper diagnostic test for large population samples, (iv) lack of new drugs in addition to praziquantel. Thirdly, gaps in research of echinococcosis include (i) low capacity in field epidemiology studies, (ii) lack of sanitation improvement studies in epidemic areas, (iii) lack of a sensitivity test for early diagnosis, (iv) lack of more effective drugs for short-term treatment. We believe these three diseases can eventually be eliminated in mainland China if all the research gaps are abridged in a short period of time. PMID:23895635

Strategies and tools for the control/elimination of lymphatic filariasis.

PubMed Central

Ottesen, E. A.; Duke, B. O.; Karam, M.; Behbehani, K.

1997-01-01

Lymphatic filariasis infects 120 million people in 73 countries worldwide and continues to be a worsening problem, especially in Africa and the Indian subcontinent. Elephantiasis, lymphoedema, and genital pathology afflict 44 million men, women and children; another 76 million have parasites in their blood and hidden internal damage to their lymphatic and renal systems. In the past, tools and strategies for the control of the condition were inadequate, but over the last 10 years dramatic research advances have led to new understanding about the severity and impact of the disease, new diagnostic and monitoring tools, and, most importantly, new treatment tools and control strategies. The new strategy aims both at transmission control through community-wide (mass) treatment programmes and at disease control through individual patient management. Annual single-dose co-administration of two drugs (ivermectin + diethylcarbamazine (DEC) or albendazole) reduces blood microfilariae by 99% for a full year; even a single dose of one drug (ivermectin or DEC) administered annually can result in 90% reductions; field studies confirm that such reduction of microfilarial loads and prevalence can interrupt transmission. New approaches to disease control, based on preventing bacterial superinfection, can now halt or even reverse the lymphoedema and elephantiasis sequelae of filarial infection. Recognizing these remarkable technical advances, the successes of recent control programmes, and the biological factors favouring elimination of this infection, the Fiftieth World Health Assembly recently called on WHO and its Member States to establish as a priority the global elimination of lymphatic filariasis as a public health problem. PMID:9509621

Can coverage of schistosomiasis and soil transmitted helminthiasis control programmes targeting school-aged children be improved? New approaches.

PubMed

Massa, K; Olsen, A; Sheshe, A; Ntakamulenga, R; Ndawi, B; Magnussen, P

2009-11-01

Control programmes generally use a school-based strategy of mass drug administration to reduce morbidity of schistosomiasis and soil-transmitted helminthiasis (STH) in school-aged populations. The success of school-based programmes depends on treatment coverage. The community-directed treatment (ComDT) approach has been implemented in the control of onchocerciasis and lymphatic filariasis in Africa and improves treatment coverage. This study compared the treatment coverage between the ComDT approach and the school-based treatment approach, where non-enrolled school-aged children were invited for treatment, in the control of schistosomiasis and STH among enrolled and non-enrolled school-aged children. Coverage during the first treatment round among enrolled children was similar for the two approaches (ComDT: 80.3% versus school: 82.1%, P=0.072). However, for the non-enrolled children the ComDT approach achieved a significantly higher coverage than the school-based approach (80.0 versus 59.2%, P<0.001). Similar treatment coverage levels were attained at the second treatment round. Again, equal levels of treatment coverage were found between the two approaches for the enrolled school-aged children, while the ComDT approach achieved a significantly higher coverage in the non-enrolled children. The results of this study showed that the ComDT approach can obtain significantly higher treatment coverage among the non-enrolled school-aged children compared to the school-based treatment approach for the control of schistosomiasis and STH.

Effectiveness of the 'Healthy School and Drugs' prevention programme on adolescents' substance use: a randomized clustered trial.

PubMed

Malmberg, Monique; Kleinjan, Marloes; Overbeek, Geertjan; Vermulst, Ad; Monshouwer, Karin; Lammers, Jeroen; Vollebergh, Wilma A M; Engels, Rutger C M E

2014-06-01

To evaluate the effectiveness of the Healthy School and Drugs programme on alcohol, tobacco and marijuana use among Dutch early adolescents. Randomized clustered trial with two intervention conditions (i.e. e-learning and integral). General population of 11-15-year-old adolescents in the Netherlands. A total of 3784 students of 23 Dutch secondary schools. Structured digital questionnaires were administered pre-intervention and at 32 months follow-up. The primary outcome measures were new incidences of alcohol (life-time and 1-month prevalence), tobacco (life-time and 1-month prevalence) and marijuana use (life-time prevalence). Main effect analyses showed no programme effects on incidences of alcohol consumption (life-time prevalence: e-learning condition: B = 0.102, P = 0.549; integral condition: B = -0.157, P = 0.351; 1-month prevalence: e-learning condition: B = 0.191, P = 0.288; integral condition: B = -0.140, P = 0.445), tobacco consumption (life-time prevalence: e-learning condition: B = 0.164, P = 0.444; integral condition: B = 0.160, P = 0.119; 1-month prevalence: e-learning condition: B = 0.088, P = 0.746; integral condition: B = 0.261, P = 0.093), or marijuana consumption (life-time prevalence: e-learning condition: B = 0.070, P = 0.732; integral condition: B = 0.186, P = 0.214). The non-significant impact of the Healthy School and Drugs programme (a Dutch school-based prevention programme for early adolescents) on incidences of alcohol, tobacco and marijuana use indicates that the programme is either ineffective or implemented inadequately. © 2014 Society for the Study of Addiction.

Addressing policy needs for prevention and control of type 2 diabetes in India.

PubMed

Atre, Sachin

2015-09-01

India carries nearly one-fifth of the global burden of diabetes cases, the majority of which are of type 2 diabetes. Recognising the need for controlling diabetes, the Government of India has initiated a national level programme for prevention and control of diabetes along with other non-communicable diseases in 2008. Despite being piloted and implemented, there is hardly any published literature about the national level situation of diabetes and its control efforts. The present article is written with the aim to fill this gap to some extent and to provide a situational analysis of the diabetes problem in India in a holistic way, addressing policy needs for the national programme. It focuses on three main areas, namely, awareness of diabetes, costs of drugs for its treatment and healthcare-system related issues. It argues that poor coverage and weak implementation of the national level programme are major forces that push patients to seek help in the weakly regulated private sector. Approaching the private sector is likely to increase the cost of care, which in turn can lead to an increased financial burden for patients and their families due to factors such as patients' lack of awareness about diabetes, poor drug price regulation and prescriptions including combinations and/or patented products of medicines used for treating diabetes by the private sector. This article addresses several needs such as strengthening the national programme and increasing its reach to unreached districts, exerting drug price regulation and implementing community-based participatory programmes for prevention and management of type 2 diabetes. It also underscores a need for piloting and implementing a robust national level electronic reporting system for diabetes programmes. © Royal Society for Public Health 2015.

Programmes for tobacco and alcohol users in Australian work-places.

PubMed

Richmond, R; Heather, N; Holt, P

1996-12-01

This article presents findings from a survey of programmes available for tobacco and alcohol users working in 455 of Australia's top 600 companies. Companies were twice as likely to have programmes for smokers (43%) as for problem drinkers (24%) and these programmes were more apparent in large companies. The majority of programmes for smoking were delivered within a health promotion context which included other life-style issues, such as nutrition, exercise, weight management and stress management. Although Employee Assistance Programs (EAPs) were the most commonly available type of work-place programme for excessive drinkers and other drug users, followed by Alcoholics Anonymous and local hospital clinics, only 6% had an EAP for alcohol. Only 21% of programmes for smokers and 12% for excessive alcohol users were evaluated. Around one-quarter of companies knew the costs of smoking programmes, and 9% reported costs of conducting programmes for excessive alcohol consumers.

78 FR 27116 - Draft Guidance for Industry on Charging for Investigational Drugs Under an Investigational New...

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76 FR 48714 - New Animal Drugs; Change of Sponsor; Moxidectin

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78 FR 42381 - Administrative Detention of Drugs Intended for Human or Animal Use

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49 CFR 219.602 - FRA Administrator's determination of random drug testing rate.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Random Alcohol and Drug Testing Programs § 219.602 FRA Administrator's determination of random drug... percentage rate for random drug testing must be 50 percent of covered employees. (b) The FRA Administrator's decision to increase or decrease the minimum annual percentage rate for random drug testing is based on the...

49 CFR 219.602 - FRA Administrator's determination of random drug testing rate.

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2014-10-01

... Random Alcohol and Drug Testing Programs § 219.602 FRA Administrator's determination of random drug... percentage rate for random drug testing must be 50 percent of covered employees. (b) The FRA Administrator's decision to increase or decrease the minimum annual percentage rate for random drug testing is based on the...

49 CFR 219.602 - FRA Administrator's determination of random drug testing rate.

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2011-10-01

... Random Alcohol and Drug Testing Programs § 219.602 FRA Administrator's determination of random drug... percentage rate for random drug testing must be 50 percent of covered employees. (b) The FRA Administrator's decision to increase or decrease the minimum annual percentage rate for random drug testing is based on the...

49 CFR 219.602 - FRA Administrator's determination of random drug testing rate.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Random Alcohol and Drug Testing Programs § 219.602 FRA Administrator's determination of random drug... percentage rate for random drug testing must be 50 percent of covered employees. (b) The FRA Administrator's decision to increase or decrease the minimum annual percentage rate for random drug testing is based on the...

49 CFR 219.602 - FRA Administrator's determination of random drug testing rate.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Random Alcohol and Drug Testing Programs § 219.602 FRA Administrator's determination of random drug... percentage rate for random drug testing must be 50 percent of covered employees. (b) The FRA Administrator's decision to increase or decrease the minimum annual percentage rate for random drug testing is based on the...

76 FR 11794 - Drugs for Human Use; Unapproved and Misbranded Oral Drugs Labeled for Prescription Use and...

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2011-03-03

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0100... Relief of Symptoms of Cold, Cough, or Allergy; Enforcement Action Dates AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing its intention...

75 FR 65495 - Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability

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... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0529...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... framework for interactions between the Center for Drug Evaluation and Research (CDER) and DDT sponsors to...

78 FR 24754 - Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

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21 CFR 874.5220 - Ear, nose, and throat drug administration device.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Ear, nose, and throat drug administration device. 874.5220 Section 874.5220 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5220 Ear, nose...

21 CFR 874.5220 - Ear, nose, and throat drug administration device.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Ear, nose, and throat drug administration device. 874.5220 Section 874.5220 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5220 Ear, nose...

21 CFR 874.5220 - Ear, nose, and throat drug administration device.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Ear, nose, and throat drug administration device. 874.5220 Section 874.5220 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5220 Ear, nose...

21 CFR 874.5220 - Ear, nose, and throat drug administration device.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Ear, nose, and throat drug administration device. 874.5220 Section 874.5220 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5220 Ear, nose...

21 CFR 874.5220 - Ear, nose, and throat drug administration device.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ear, nose, and throat drug administration device. 874.5220 Section 874.5220 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES Therapeutic Devices § 874.5220 Ear, nose...

78 FR 44572 - Draft Guidance for Industry on Pre-Launch Activities Importation Requests; Availability

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21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

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2011-04-01

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21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

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2012-04-01

... Administration Privacy Act Record Systems. 21.20 Section 21.20 Food and Drugs FOOD AND DRUG ADMINISTRATION... Act Record Systems § 21.20 Procedures for notice of Food and Drug Administration Privacy Act Record... of each year a notice concerning each Privacy Act Record System as defined in § 21.3(c) that is not...

21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

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2013-04-01

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21 CFR 21.20 - Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

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2014-04-01

... Administration Privacy Act Record Systems. 21.20 Section 21.20 Food and Drugs FOOD AND DRUG ADMINISTRATION... Act Record Systems § 21.20 Procedures for notice of Food and Drug Administration Privacy Act Record... of each year a notice concerning each Privacy Act Record System as defined in § 21.3(c) that is not...

Drug supply indicators: Pitfalls and possibilities for improvements to assist comparative analysis.

PubMed

Singleton, Nicola; Cunningham, Andrew; Groshkova, Teodora; Royuela, Luis; Sedefov, Roumen

2018-06-01

Interventions to tackle the supply of drugs are seen as standard components of illicit drug policies. Therefore drug market-related administrative data, such as seizures, price, purity and drug-related offending, are used in most countries for policy monitoring and assessment of the drug situation. International agencies, such as the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) and the UN Office of Drugs and Crime, also monitor and report on the drug situation cross-nationally and therefore seek to collect and make available key data in a uniform manner from the countries they cover. However, these data are not primarily collected for this purpose, which makes interpretation and comparative analysis difficult. Examples of limitations of these data sources include: the extent to which they reflect operational priorities rather than market changes; question marks over the robustness of and consistency in data collection methods, and issues around the timeliness of data availability. Such problems are compounded by cultural, social and contextual differences between countries. Making sense of such data is therefore challenging and extreme care needs to be taken using it. Nevertheless, these data provide an important window on a hidden area, so improving the quality of the data collected and expanding its scope should be a priority for those seeking to understand or monitor drug markets and supply reduction. In addition to highlighting some of the potential pitfalls in using supply indicators for comparative analysis, this paper presents a selection of options for improvements based on the current EMCDDA programme of work to improve their supply-related monitoring and analysis. The conceptual framework developed to steer this work may have wider application. Adopting this approach has the potential to provide a richer picture of drug markets, at both national and international levels, and make it easier to compare data between countries. Copyright © 2018 Elsevier B.V. All rights reserved.

77 FR 60440 - Clinical Investigator Training Course

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2012-10-03

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21 CFR 1316.11 - Execution of warrants.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Execution of warrants. 1316.11 Section 1316.11 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Inspections § 1316.11 Execution of warrants. An administrative...

76 FR 8775 - Agency Information Collection Activities: Proposed Collection; Comments Requested: Drug...

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Academic Workload Planning for Open and Distance Learning (ODL) Universities: The Experience of National Open University of Nigeria (NOUN)

ERIC Educational Resources Information Center

Inegbedion, Juliet Obhajajie

2017-01-01

The quality of the programmes and courses in ODL depends on the academics that plan the programmes, develop the curriculum, manage courses and programmes and carry out administrative duties. It is observed that the academics often complain of work overload. It also appears there is a mix-up in integrating the mode of planning workload in the…

National Mass Drug Administration Costs for Lymphatic Filariasis Elimination

PubMed Central

Goldman, Ann S.; Guisinger, Victoria H.; Aikins, Moses; Amarillo, Maria Lourdes E.; Belizario, Vicente Y.; Garshong, Bertha; Gyapong, John; Kabali, Conrad; Kamal, Hussein A.; Kanjilal, Sanjat; Kyelem, Dominique; Lizardo, Jefrey; Malecela, Mwele; Mubyazi, Godfrey; Nitièma, P. Abdoulaye; Ramzy, Reda M. R.; Streit, Thomas G.; Wallace, Aaron; Brady, Molly A.; Rheingans, Richard; Ottesen, Eric A.; Haddix, Anne C.

2007-01-01

Background Because lymphatic filariasis (LF) elimination efforts are hampered by a dearth of economic information about the cost of mass drug administration (MDA) programs (using either albendazole with diethylcarbamazine [DEC] or albendazole with ivermectin), a multicenter study was undertaken to determine the costs of MDA programs to interrupt transmission of infection with LF. Such results are particularly important because LF programs have the necessary diagnostic and treatment tools to eliminate the disease as a public health problem globally, and already by 2006, the Global Programme to Eliminate LF had initiated treatment programs covering over 400 million of the 1.3 billion people at risk. Methodology/Principal Findings To obtain annual costs to carry out the MDA strategy, researchers from seven countries developed and followed a common cost analysis protocol designed to estimate 1) the total annual cost of the LF program, 2) the average cost per person treated, and 3) the relative contributions of the endemic countries and the external partners. Costs per person treated ranged from $0.06 to $2.23. Principal reasons for the variation were 1) the age (newness) of the MDA program, 2) the use of volunteers, and 3) the size of the population treated. Substantial contributions by governments were documented – generally 60%–90% of program operation costs, excluding costs of donated medications. Conclusions/Significance MDA for LF elimination is comparatively inexpensive in relation to most other public health programs. Governments and communities make the predominant financial contributions to actual MDA implementation, not counting the cost of the drugs themselves. The results highlight the impact of the use of volunteers on program costs and provide specific cost data for 7 different countries that can be used as a basis both for modifying current programs and for developing new ones. PMID:17989784

[The application of new technologies to hospital pharmacy in Spain].

PubMed

Bermejo Vicedo, T; Pérez Menéndez Conde, C; Alvarez, Ana; Codina, Carlos; Delgado, Olga; Herranz, Ana; Hidalgo Correas, Francisco; Martín, Isabel; Martínez, Julio; Luis Poveda, José; Queralt Gorgas, María; Sanjurjo Sáez, María

2007-01-01

To describe the degree of introduction of new technologies in the medication use process in pharmacy services in Spain. A descriptive study via a survey into the degree of introduction of computer systems for: management, computerized physician order entry (CPOE), automated unit dose drug dispensing, preparation of parenteral nutrition solutions, recording drug administration, pharmaceutical care and foreseen improvements. The survey was sent by electronic mail to the heads of the pharmacy services of 207 hospitals throughout Spain. Response index: 82 hospitals (38.6%). 29 hospitals (36.7%) have a modular management system, 24 (30.4%) an integrated one and 34 (44.9%) a modular-integrated one. CPOE is utilised in 17 (22.4%). According to the size of the hospital, between 17.9 and 26.7% of unit dose dispensing is done online with a management software; between 5.1 and 33.3% of unit dose dispensing is automated. Automation of unit dose dispensing centred in the pharmacy service varies between 10 and 33.3%. Between 13.2 and 35.7% of automated in-ward dispensing systems are utilised. Administration records are kept manually on a computerised sheet at 23 (31.5%) of the hospitals; at 4 (5.4%) on CPOE and 7 (9.5%) online on the integral management programme and 4 (5.4%) on specific nursing softwares. Sixty-three per cent foresee the implementation of improvements in the short to medium term. The introduction of new technologies is being developed in Spain aiming to improve the safety and management of drugs, and there is a trend towards increasing their deployment in the near future. It is hoped that their fomentation could help to bring about process reengineering within pharmacy services in order to increase the time available for devotion to pharmaceutical care.

21 CFR 20.120 - Records available in Food and Drug Administration Public Reading Rooms.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Records available in Food and Drug Administration Public Reading Rooms. 20.120 Section 20.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.120 Records available in Food and Drug...

21 CFR 20.120 - Records available in Food and Drug Administration Public Reading Rooms.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Records available in Food and Drug Administration Public Reading Rooms. 20.120 Section 20.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.120 Records available in Food and Drug...

21 CFR 20.120 - Records available in Food and Drug Administration Public Reading Rooms.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Records available in Food and Drug Administration Public Reading Rooms. 20.120 Section 20.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.120 Records available in Food and Drug...

Fragment-Based Drug Discovery in Academia: Experiences From a Tuberculosis Programme

NASA Astrophysics Data System (ADS)

Heikkila, Timo J.; Surade, Sachin; Silvestre, Hernani L.; Dias, Marcio V. B.; Ciulli, Alessio; Bromfield, Karen; Scott, Duncan; Howard, Nigel; Wen, Shijun; Wei, Alvin Hung; Osborne, David; Abell, Chris; Blundell, Tom L.

The problems associated with neglected diseases are often compounded by increasing incidence of antibiotic resistance. Patient negligence and abuse of antibiotics has lead to explosive growth in cases of tuberculosis, with some M. tuberculosis strains becoming virtually untreatable. Structure-based drug development is viewed as cost-effective and time-consuming method for discovery and development of hits to lead compounds. In this review we will discuss the suitability of fragment-based methods for developing new chemotherapeutics against neglected diseases, providing examples from our tuberculosis programme.

21 CFR 1316.08 - Consent to inspection.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Consent to inspection. 1316.08 Section 1316.08 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Inspections § 1316.08 Consent to inspection. (a) An administrative...

21 CFR 20.3 - Certification and authentication of Food and Drug Administration records.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Certification and authentication of Food and Drug... authentication of Food and Drug Administration records. (a) Upon request, the Food and Drug Administration will... or for authentication of records shall be sent in writing to the Freedom of Information Staff (HFI-35...

78 FR 12762 - Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-25

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001...; Notice of Meeting. AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will...

21 CFR 20.110 - Data and information about Food and Drug Administration employees.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Data and information about Food and Drug Administration employees. 20.110 Section 20.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.110...

21 CFR 20.108 - Agreements between the Food and Drug Administration and other departments, agencies, and...

Code of Federal Regulations, 2010 CFR

2010-04-01

... Specific Categories of Records § 20.108 Agreements between the Food and Drug Administration and other... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Agreements between the Food and Drug Administration and other departments, agencies, and organizations. 20.108 Section 20.108 Food and Drugs FOOD AND...

76 FR 36133 - Draft Guidances for Industry and Food and Drug Administration Staff: Classification of Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0429] Draft Guidances for Industry and Food and Drug Administration Staff: Classification of Products as Drugs... Action'' in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act...

76 FR 45814 - Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2012

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0547] Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2012 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the rates and...

The 6th Meeting of the Global Alliance to Eliminate Lymphatic Filariasis: A half-time review of lymphatic filariasis elimination and its integration with the control of other neglected tropical diseases

PubMed Central

2010-01-01

The 6th Meeting of the Global Alliance to Eliminate Lymphatic Filariasis (GAELF6) was held 1-3 June, 2010 in Seoul, Korea, with 150 participants from 38 countries. The year 2010 marks the midpoint between the first GAELF meeting, in 2000, and the World Health Organization (WHO) 2020 goal of global elimination of lymphatic filariasis (LF) as a public health problem. The theme of the meeting, "Half-time in LF Elimination: Teaming Up with Neglected Tropical Diseases (NTDs)," reflected significant integration of LF elimination programmes into a comprehensive initiative to control NTDs. Presentations on LF epidemiology, treatment, research, and programmes highlighted both accomplishments and remaining challenges. The WHO strategy to interrupt LF transmission is based on annual mass drug administration (MDA) using two-drug combinations. After mapping the geographic distribution of LF, MDA is implemented for ≥ 5 years, followed by a period of post-MDA surveillance, and, ultimately, verification of LF elimination. Morbidity management further reduces disease burden. Of 81 countries considered LF-endemic in 2000, 52 (64.2%) have begun MDA; 10 (12.3%) others with low-level transmission are unlikely to require MDA. In 2008, ~695 million people were offered treatment (51.7% of the at-risk population); ~496 million participated. Approximately 22 million people have been protected from LF infection and disease, with savings of ~US $24.2 billion. Morbidity management programmes have been implemented in 27 (33.3%) countries. Significant challenges to LF elimination remain. These include: initiating MDA in the remaining 19 countries that require it; achieving full geographic coverage in countries where MDA has started; finding alternative strategies to address the problem of Loa loa co-endemicity in Central Africa; developing strategies to treat urban populations; initiating and sustaining MDA in settings of armed conflict; developing refined guidelines and procedures for stopping MDA, for post-MDA surveillance, and for verifying the elimination of LF; and integrating morbidity management into all LF elimination programmes. Scientific research and enhanced advocacy for NTDs remain critical for addressing these challenges. GAELF6 was characterized by enthusiasm and recognition that "teaming up with NTDs" offers opportunities for new partnerships, fresh perspectives, enhanced advocacy, and greater programmatic integration in a rapidly changing global health environment. PMID:20961435

Role of mass drug administration in elimination of Plasmodium falciparum malaria: a consensus modelling study.

PubMed

Brady, Oliver J; Slater, Hannah C; Pemberton-Ross, Peter; Wenger, Edward; Maude, Richard J; Ghani, Azra C; Penny, Melissa A; Gerardin, Jaline; White, Lisa J; Chitnis, Nakul; Aguas, Ricardo; Hay, Simon I; Smith, David L; Stuckey, Erin M; Okiro, Emelda A; Smith, Thomas A; Okell, Lucy C

2017-07-01

Mass drug administration for elimination of Plasmodium falciparum malaria is recommended by WHO in some settings. We used consensus modelling to understand how to optimise the effects of mass drug administration in areas with low malaria transmission. We collaborated with researchers doing field trials to establish a standard intervention scenario and standard transmission setting, and we input these parameters into four previously published models. We then varied the number of rounds of mass drug administration, coverage, duration, timing, importation of infection, and pre-administration transmission levels. The outcome of interest was the percentage reduction in annual mean prevalence of P falciparum parasite rate as measured by PCR in the third year after the final round of mass drug administration. The models predicted differing magnitude of the effects of mass drug administration, but consensus answers were reached for several factors. Mass drug administration was predicted to reduce transmission over a longer timescale than accounted for by the prophylactic effect alone. Percentage reduction in transmission was predicted to be higher and last longer at lower baseline transmission levels. Reduction in transmission resulting from mass drug administration was predicted to be temporary, and in the absence of scale-up of other interventions, such as vector control, transmission would return to pre-administration levels. The proportion of the population treated in a year was a key determinant of simulated effectiveness, irrespective of whether people are treated through high coverage in a single round or new individuals are reached by implementation of several rounds. Mass drug administration was predicted to be more effective if continued over 2 years rather than 1 year, and if done at the time of year when transmission is lowest. Mass drug administration has the potential to reduce transmission for a limited time, but is not an effective replacement for existing vector control. Unless elimination is achieved, mass drug administration has to be repeated regularly for sustained effect. Bill & Melinda Gates Foundation. Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

77 FR 76049 - Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Correction

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2012-12-26

..., Office of Planning & Informatics, Center for Drug Evaluation and Research, Food and Drug Administration... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0643...: Food and Drug Administration, HHS. ACTION: Notice; correction. [[Page 76050

78 FR 14304 - Adrian Vela: Debarment Order

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0777] Adrian Vela: Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the...

77 FR 39245 - Sami Arshak Yanikian: Debarment Order

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0063] Sami Arshak Yanikian: Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and...

21 CFR 1316.13 - Frequency of administrative inspections.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 9 2014-04-01 2014-04-01 false Frequency of administrative inspections. 1316.13 Section 1316.13 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE... as circumstances may require, based in part on the registrant's history of compliance with the...

21 CFR 1316.13 - Frequency of administrative inspections.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 9 2011-04-01 2011-04-01 false Frequency of administrative inspections. 1316.13 Section 1316.13 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE... as circumstances may require, based in part on the registrant's history of compliance with the...

21 CFR 1316.13 - Frequency of administrative inspections.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 9 2013-04-01 2013-04-01 false Frequency of administrative inspections. 1316.13 Section 1316.13 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE... as circumstances may require, based in part on the registrant's history of compliance with the...

21 CFR 1316.13 - Frequency of administrative inspections.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Frequency of administrative inspections. 1316.13 Section 1316.13 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE... as circumstances may require, based in part on the registrant's history of compliance with the...

21 CFR 20.101 - Administrative enforcement records.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Administrative enforcement records. 20.101 Section 20.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.101 Administrative enforcement...

76 FR 65371 - Schedules of Controlled Substances: Temporary Placement of Three Synthetic Cathinones Into...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-21

... DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-357...: Drug Enforcement Administration, Department of Justice. ACTION: Final Order. SUMMARY: The Administrator of the Drug Enforcement Administration (DEA) is issuing this final order to temporarily schedule...

76 FR 55616 - Schedules of Controlled Substances: Temporary Placement of Three Synthetic Cathinones Into...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-08

... DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-357...: Drug Enforcement Administration, Department of Justice. ACTION: Notice of Intent. SUMMARY: The Administrator of the Drug Enforcement Administration (DEA) is issuing this notice of intent to temporarily...

21 CFR 1316.13 - Frequency of administrative inspections.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Frequency of administrative inspections. 1316.13 Section 1316.13 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE... as circumstances may require, based in part on the registrant's history of compliance with the...

21 CFR 868.5165 - Nitric oxide administration apparatus.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Nitric oxide administration apparatus. 868.5165 Section 868.5165 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5165 Nitric oxide administration...

21 CFR 868.5165 - Nitric oxide administration apparatus.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nitric oxide administration apparatus. 868.5165 Section 868.5165 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5165 Nitric oxide administration...

Opioid Addiction: Social Problems Associated and Implications of Both Current and Possible Future Treatments, including Polymeric Therapeutics for Giving Up the Habit of Opioid Consumption.

PubMed

Benéitez, M Cristina; Gil-Alegre, M Esther

2017-01-01

Detoxification programmes seek to implement the most secure and compassionate ways of withdrawing from opiates so that the inevitable withdrawal symptoms and other complications are minimized. Once detoxification has been achieved, the next stage is to enable the patient to overcome his or her drug addiction by ensuring consumption is permanently and completely abandoned, only after which can the subject be regarded as fully recovered. A systematic search on the common databases of relevant papers published until 2016 inclusive. Our study of the available oral treatments for opioid dependence has revealed that no current treatment can actually claim to be fully effective. These treatments require daily oral administration and, consequently, regular visits to dispensaries, which in most cases results in a lack of patient compliance, which causes fluctuations in drug plasma levels. We then reviewed alternative treatments in the available scientific literature on polymeric sustained release formulations. Research has been done not only on release systems for detoxification but also on release systems for giving up the habit of taking opioids. These efforts have obtained the recent authorization of polymeric systems for use in patients that could help them to reduce their craving for drugs.

Multimodal system designed to reduce errors in recording and administration of drugs in anaesthesia: prospective randomised clinical evaluation.

PubMed

Merry, Alan F; Webster, Craig S; Hannam, Jacqueline; Mitchell, Simon J; Henderson, Robert; Reid, Papaarangi; Edwards, Kylie-Ellen; Jardim, Anisoara; Pak, Nick; Cooper, Jeremy; Hopley, Lara; Frampton, Chris; Short, Timothy G

2011-09-22

To clinically evaluate a new patented multimodal system (SAFERSleep) designed to reduce errors in the recording and administration of drugs in anaesthesia. Prospective randomised open label clinical trial. Five designated operating theatres in a major tertiary referral hospital. Eighty nine consenting anaesthetists managing 1075 cases in which there were 10,764 drug administrations. Use of the new system (which includes customised drug trays and purpose designed drug trolley drawers to promote a well organised anaesthetic workspace and aseptic technique; pre-filled syringes for commonly used anaesthetic drugs; large legible colour coded drug labels; a barcode reader linked to a computer, speakers, and touch screen to provide automatic auditory and visual verification of selected drugs immediately before each administration; automatic compilation of an anaesthetic record; an on-screen and audible warning if an antibiotic has not been administered within 15 minutes of the start of anaesthesia; and certain procedural rules-notably, scanning the label before each drug administration) versus conventional practice in drug administration with a manually compiled anaesthetic record. Primary: composite of errors in the recording and administration of intravenous drugs detected by direct observation and by detailed reconciliation of the contents of used drug vials against recorded administrations; and lapses in responding to an intermittent visual stimulus (vigilance latency task). Secondary: outcomes in patients; analyses of anaesthetists' tasks and assessments of workload; evaluation of the legibility of anaesthetic records; evaluation of compliance with the procedural rules of the new system; and questionnaire based ratings of the respective systems by participants. The overall mean rate of drug errors per 100 administrations was 9.1 (95% confidence interval 6.9 to 11.4) with the new system (one in 11 administrations) and 11.6 (9.3 to 13.9) with conventional methods (one in nine administrations) (P = 0.045 for difference). Most were recording errors, and, though fewer drug administration errors occurred with the new system, the comparison with conventional methods did not reach significance. Rates of errors in drug administration were lower when anaesthetists consistently applied two key principles of the new system (scanning the drug barcode before administering each drug and keeping the voice prompt active) than when they did not: mean 6.0 (3.1 to 8.8) errors per 100 administrations v 9.7 (8.4 to 11.1) respectively (P = 0.004). Lapses in the vigilance latency task occurred in 12% (58/471) of cases with the new system and 9% (40/473) with conventional methods (P = 0.052). The records generated by the new system were more legible, and anaesthetists preferred the new system, particularly in relation to long, complex, and emergency cases. There were no differences between new and conventional systems in respect of outcomes in patients or anaesthetists' workload. The new system was associated with a reduction in errors in the recording and administration of drugs in anaesthesia, attributable mainly to a reduction in recording errors. Automatic compilation of the anaesthetic record increased legibility but also increased lapses in a vigilance latency task and decreased time spent watching monitors. Trial registration Australian New Zealand Clinical Trials Registry No 12608000068369.

21 CFR 201.129 - Drugs; exemption for radioactive drugs for research use.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drugs; exemption for radioactive drugs for research use. 201.129 Section 201.129 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... Drugs; exemption for radioactive drugs for research use. A radioactive drug intended for administration...

Evaluation of drug administration errors in a teaching hospital

PubMed Central

2012-01-01

Background Medication errors can occur at any of the three steps of the medication use process: prescribing, dispensing and administration. We aimed to determine the incidence, type and clinical importance of drug administration errors and to identify risk factors. Methods Prospective study based on disguised observation technique in four wards in a teaching hospital in Paris, France (800 beds). A pharmacist accompanied nurses and witnessed the preparation and administration of drugs to all patients during the three drug rounds on each of six days per ward. Main outcomes were number, type and clinical importance of errors and associated risk factors. Drug administration error rate was calculated with and without wrong time errors. Relationship between the occurrence of errors and potential risk factors were investigated using logistic regression models with random effects. Results Twenty-eight nurses caring for 108 patients were observed. Among 1501 opportunities for error, 415 administrations (430 errors) with one or more errors were detected (27.6%). There were 312 wrong time errors, ten simultaneously with another type of error, resulting in an error rate without wrong time error of 7.5% (113/1501). The most frequently administered drugs were the cardiovascular drugs (425/1501, 28.3%). The highest risks of error in a drug administration were for dermatological drugs. No potentially life-threatening errors were witnessed and 6% of errors were classified as having a serious or significant impact on patients (mainly omission). In multivariate analysis, the occurrence of errors was associated with drug administration route, drug classification (ATC) and the number of patient under the nurse's care. Conclusion Medication administration errors are frequent. The identification of its determinants helps to undertake designed interventions. PMID:22409837

Evaluation of drug administration errors in a teaching hospital.

PubMed

Berdot, Sarah; Sabatier, Brigitte; Gillaizeau, Florence; Caruba, Thibaut; Prognon, Patrice; Durieux, Pierre

2012-03-12

Medication errors can occur at any of the three steps of the medication use process: prescribing, dispensing and administration. We aimed to determine the incidence, type and clinical importance of drug administration errors and to identify risk factors. Prospective study based on disguised observation technique in four wards in a teaching hospital in Paris, France (800 beds). A pharmacist accompanied nurses and witnessed the preparation and administration of drugs to all patients during the three drug rounds on each of six days per ward. Main outcomes were number, type and clinical importance of errors and associated risk factors. Drug administration error rate was calculated with and without wrong time errors. Relationship between the occurrence of errors and potential risk factors were investigated using logistic regression models with random effects. Twenty-eight nurses caring for 108 patients were observed. Among 1501 opportunities for error, 415 administrations (430 errors) with one or more errors were detected (27.6%). There were 312 wrong time errors, ten simultaneously with another type of error, resulting in an error rate without wrong time error of 7.5% (113/1501). The most frequently administered drugs were the cardiovascular drugs (425/1501, 28.3%). The highest risks of error in a drug administration were for dermatological drugs. No potentially life-threatening errors were witnessed and 6% of errors were classified as having a serious or significant impact on patients (mainly omission). In multivariate analysis, the occurrence of errors was associated with drug administration route, drug classification (ATC) and the number of patient under the nurse's care. Medication administration errors are frequent. The identification of its determinants helps to undertake designed interventions.

The effect of an intervention aimed at reducing errors when administering medication through enteral feeding tubes in an institution for individuals with intellectual disability.

PubMed

Idzinga, J C; de Jong, A L; van den Bemt, P M L A

2009-11-01

Previous studies, both in hospitals and in institutions for clients with an intellectual disability (ID), have shown that medication errors at the administration stage are frequent, especially when medication has to be administered through an enteral feeding tube. In hospitals a specially designed intervention programme has proven to be effective in reducing these feeding tube-related medication errors, but the effect of such a programme within an institution for clients with an ID is unknown. Therefore, a study was designed to measure the influence of such an intervention programme on the number of medication administration errors in clients with an ID who also have enteral feeding tubes. A before-after study design with disguised observation to document administration errors was used. The study was conducted from February to June 2008 within an institution for individuals with an ID in the Western part of The Netherlands. Included were clients with enteral feeding tubes. The intervention consisted of advice on medication administration through enteral feeding tubes by the pharmacist, a training programme and introduction of a 'medication through tube' box containing proper materials for crushing and suspending tablets. The outcome measure was the frequency of medication administration errors, comparing the pre-intervention period with the post-intervention period. A total of 245 medication administrations in six clients (by 23 nurse attendants) have been observed in the pre-intervention measurement period and 229 medication administrations in five clients (by 20 nurse attendants) have been observed in the post-intervention period. Before the intervention, 158 (64.5%) medication administration errors were observed, and after the intervention, this decreased to 69 (30.1%). Of all potential confounders and effect modifiers, only 'medication dispensed in automated dispensing system ("robot") packaging' contributed to the multivariate model; effect modification was shown for this determinant. Multilevel analysis using this multivariate model resulted in an odds ratio of 0.33 (95% confidence interval 0.13-0.71) for the error percentage in the post-intervention period compared with the pre-intervention period. The intervention was found to be effective in an institution for clients with an ID. However, additional efforts are needed to reduce the proportion of administration errors which is still high after the intervention.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-19

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

76 FR 43690 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

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2011-07-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0149] (Formerly 2007D-0309) Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph Electrodes; Availability AGENCY: Food and Drug...

75 FR 12546 - Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Labeling...

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2010-03-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0120... Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug... Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD...

78 FR 33847 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

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2013-06-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0172... Request; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

78 FR 13067 - Agency Information Collection Activities: Proposed Collection; Comment Request; Foreign Clinical...

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2013-02-26

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0172... Not Conducted Under an Investigational New Drug Application AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public...

75 FR 10806 - Training Program for Regulatory Project Managers; Information Available to Industry

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2010-03-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0108] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) Center for Drug Evaluation...

78 FR 78974 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

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2013-12-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1558... Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

78 FR 8544 - Training Program for Regulatory Project Managers; Information Available to Industry

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2013-02-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2003-N-0453] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration's (FDA's) Center for Drug...

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

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2013-04-05

...] Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration... an educational conference co-sponsored with the Society of Clinical Research Associates (SOCRA). The...: 510-287-2739; or Society of Clinical Research Associates (SOCRA), 530 West Butler Ave., Suite 109...

76 FR 36019 - Amendments to Sterility Test Requirements for Biological Products

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2011-06-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 600, 610, and... AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug... Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852...

77 FR 26766 - Karen L. Blyth: Debarment Order

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0880] Karen L. Blyth: Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The U.S. Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and...

77 FR 26765 - David H.M. Phelps: Debarment Order

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0879] David H.M. Phelps: Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The U.S. Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and...

76 FR 26305 - Agency Information Collection Activities; Proposed Collection; Comment Request; Certification To...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0275... Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing...

78 FR 36194 - Draft Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-17

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0490] Draft Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally... Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the...

76 FR 52334 - Arthritis Advisory Committee; Notice of Postponement of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-22

...: Philip A. Bautista, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Arthritis Advisory Committee; Notice of Postponement of Meeting AGENCY: Food and Drug Administration, HHS...

21 CFR 1316.41 - Scope of subpart D.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Scope of subpart D. 1316.41 Section 1316.41 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES Administrative Hearings § 1316.41 Scope of subpart D. Procedures in any administrative...

21 CFR 10.10 - Summaries of administrative practices and procedures.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Summaries of administrative practices and procedures. 10.10 Section 10.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATIVE PRACTICES AND PROCEDURES General Provisions § 10.10 Summaries of...

28 CFR 16.102 - Exemption of Drug Enforcement Administration and Immigration and Naturalization Service Joint...

Code of Federal Regulations, 2010 CFR

2010-07-01

... Administration and Immigration and Naturalization Service Joint System of Records. 16.102 Section 16.102 Judicial... Systems Under the Privacy Act § 16.102 Exemption of Drug Enforcement Administration and Immigration and..., the Immigration and Naturalization Service or the Drug Enforcement Administration will occasionally...

Effectiveness of a computer based medication calculation education and testing programme for nurses.

PubMed

Sherriff, Karen; Burston, Sarah; Wallis, Marianne

2012-01-01

The aim of the study was to evaluate the effect of an on-line, medication calculation education and testing programme. The outcome measures were medication calculation proficiency and self efficacy. This quasi-experimental study involved the administration of questionnaires before and after nurses completed annual medication calculation testing. The study was conducted in two hospitals in south-east Queensland, Australia, which provide a variety of clinical services including obstetrics, paediatrics, ambulatory, mental health, acute and critical care and community services. Participants were registered nurses (RNs) and enrolled nurses with a medication endorsement (EN(Med)) working as clinicians (n=107). Data pertaining to success rate, number of test attempts, self-efficacy, medication calculation error rates and nurses' satisfaction with the programme were collected. Medication calculation scores at first test attempt showed improvement following one year of access to the programme. Two of the self-efficacy subscales improved over time and nurses reported satisfaction with the online programme. Results of this study may facilitate the continuation and expansion of medication calculation and administration education to improve nursing knowledge, inform practise and directly improve patient safety. Crown Copyright © 2011. Published by Elsevier Ltd. All rights reserved.

Implementation of a national anti-tuberculosis drug resistance survey in Tanzania.

PubMed

Chonde, Timothy M; Doulla, Basra; van Leth, Frank; Mfinanga, Sayoki G M; Range, Nyagosya; Lwilla, Fred; Mfaume, Saidi M; van Deun, Armand; Zignol, Matteo; Cobelens, Frank G; Egwaga, Saidi M

2008-12-30

A drug resistance survey is an essential public health management tool for evaluating and improving the performance of National Tuberculosis control programmes. The current manuscript describes the implementation of the first national drug resistance survey in Tanzania. Description of the implementation process of a national anti-tuberculosis drug resistance survey in Tanzania, in relation to the study protocol and Standard Operating Procedures. Factors contributing positively to the implementation of the survey were a continuous commitment of the key stakeholders, the existence of a well organized National Tuberculosis Programme, and a detailed design of cluster-specific arrangements for rapid sputum transportation. Factors contributing negatively to the implementation were a long delay between training and actual survey activities, limited monitoring of activities, and an unclear design of the data capture forms leading to difficulties in form-filling. Careful preparation of the survey, timing of planned activities, a strong emphasis on data capture tools and data management, and timely supervision are essential for a proper implementation of a national drug resistance survey.

Estimation of the cost of large-scale school deworming programmes with benzimidazoles

PubMed Central

Montresor, A.; Gabrielli, A.F.; Engels, D.

2017-01-01

Summary This study estimates the cost of distributing benzimidazole tablets in the context of school deworming programmes: we analysed studies reporting the cost of school deworming from seven countries in four WHO regions. The estimated cost for drug procurement to cover one million children (including customs clearance and international transport) is approximately US$20 000. The estimated financial costs (including the cost of training of personnel, drug transport, social mobilization and monitoring) is, on average, equivalent to US$33 000 per million school-age children with minimal variation in different countries and continents. The estimated economic costs of distribution (including the time spent by teachers, and health personnel at central, provincial and district level) to cover one million children approximately corresponds to US$19 000. This study shows the minimal cost of school deworming activities, but also shows the significant contribution (corresponding to a quarter of the entire cost of the programme) provided by health and education systems in endemic countries even in the case of drug donations and donor support of distribution costs. PMID:19926104

Provider perspectives on drug-resistant tuberculosis and human immunodeficiency virus care in South Africa: a qualitative case study.

PubMed

Daftary, A; Padayatchi, N

2016-11-01

To examine influences on health care workers' (HCWs') capacity to deliver health care for multi- and/or extensively drug-resistant tuberculosis (MDR/XDR-TB) and human immunodeficiency virus (HIV) infection in South Africa. Qualitative data were collected via group and individual interviews with a purposive sample of 17 HCWs at a centralised, tertiary TB facility and analysed using grounded theory. Four themes were identified: 1) personal infection control practices among HCWs may be weakened by a workplace culture comprising low motivation, disparate risk perceptions and practices across workforce hierarchies, physical discomfort, and problems managing patients with treatment-induced hearing loss. 2) Patient-provider interactions are likely stronger among nurses, and in HIV vs. MDR/XDR-TB service delivery, due to greater attention to patient empowerment and support. Stigma associated with MDR/XDR-TB, considered worse than HIV, may be perpetuated within non-specialised facilities less familiar with MDR/XDR-TB. 3) HCWs who struggle with the daily tedium of MDR/XDR-TB treatment supervision are becoming increasingly supportive of treatment literacy and self-administration. 4) Effective integration of HIV and MDR/XDR-TB services may be impeded by administrative restrictions, workplace norms and provider mindsets. Comprehensive, decentralised management of MDR/XDR-TB and HIV coinfection requires the creation of patient-provider trust and treatment literacy in MDR/XDR-TB programmes, and defying workplace norms that could provoke nosocomial TB exposure and fragmented service provision.

Soil transmitted helminths and scabies in Zanzibar, Tanzania following mass drug administration for lymphatic filariasis - a rapid assessment methodology to assess impact

PubMed Central

2012-01-01

Background Ivermectin and albendazole are used in annual mass drug administration (MDA) for the lymphatic filariasis elimination programmes in African countries co-endemic for onchocerciasis, but have additional impact on soil transmitted helminths and the ectoparasitic mite which causes scabies. Assessing these collateral impacts at scale is difficult due to the insensitivity of available parasite detection techniques. Methods The numbers of cases diagnosed with intestinal helminths and scabies and who received prescriptions for treatment were evaluated in 50 health centres in Zanzibar. Records were examined from 2000, prior to the initiation of MDA to 2005, after six rounds of MDA for lymphatic filariasis had taken place. Results Health centre records showed a consistent decline in the number of cases of intestinal helminths and scabies diagnosed by community health workers in Zanzibar and the number of prescriptions issued across five age groups. A 90-98% decline in soil transmitted helminths and 68-98% decline in scabies infections were recorded. Poisson regression models aggregated to both the island-level and district-level indicated that the decline was statistically significant. Conclusions The described method of examining health centre records has the potential for use on a large scale, despite limitations, as a rapid method to evaluate the impacts resulting from both lymphatic filariasis and onchocerciasis MDA. This would result in a reduction in the need for parasitological evaluations to determine prevalence and intensity. PMID:23259465

Bridging the gap: the role of pharmacists in managing the drug supply cycle within non-governmental organizations.

PubMed

Villacorta-Linaza, Rocio

2009-10-01

Access to essential medicines remains one of the biggest problems that developing countries are facing in health care systems. Non-governmental organizations (NGOs) are implementing health programmes on the ground in areas affected by natural disasters or conflict. A vital component of these health programmes is the drug supply system. Based on a field research conducted in Pakistan 2007 and a field work experience in Afghanistan within an international NGO-Merlin-this paper analysed the four functions of the Drug Supply Cycle (Selection, Procurement, Distribution and Use) focusing attention on the importance in management support systems once the emergency phase is over. It shows the core role that the pharmacist plays within NGOs as a member of the health staff with the ability to improve the management of the Drug Supply Cycle. Copyright (c) 2009 John Wiley & Sons, Ltd.

The drug discovery portal: a computational platform for identifying drug leads from academia.

PubMed

Clark, Rachel L; Johnston, Blair F; Mackay, Simon P; Breslin, Catherine J; Robertson, Murray N; Sutcliffe, Oliver B; Dufton, Mark J; Harvey, Alan L

2010-05-01

The Drug Discovery Portal (DDP) is a research initiative based at the University of Strathclyde in Glasgow, Scotland. It was initiated in 2007 by a group of researchers with expertise in virtual screening. Academic research groups in the university working in drug discovery programmes estimated there was a historical collection of physical compounds going back 50 years that had never been adequately catalogued. This invaluable resource has been harnessed to form the basis of the DDP library, and has attracted a high-percentage uptake from the Universities and Research Groups internationally. Its unique attributes include the diversity of the academic database, sourced from synthetic, medicinal and phytochemists working an academic laboratories and the ability to link biologists with appropriate chemical expertise through a target-matching virtual screening approach, and has resulted in seven emerging hit development programmes between international contributors.

Shortage of Peritoneal Dialysis Solution and the Food and Drug Administration's Response.

PubMed

Jensen, Valerie; Throckmorton, Douglas C

2015-08-07

Although the number of new drug shortages has been lower in recent years than in the past, severe shortages have occurred that have affected large numbers of patients. A new law entitled the Food and Drug Administration Safety and Innovation Act was enacted in July of 2012, which requires companies to notify the Food and Drug Administration of anticipated shortages. This notification requirement has allowed the Food and Drug Administration to work closely with manufacturers earlier to mitigate and, often, prevent shortages. However, not all shortages are able to be prevented, and the shortage of peritoneal dialysis solution is one that has had a significant effect on patients. The Food and Drug Administration continues to use all available tools to address this shortage with manufacturers, including temporary availability of imported peritoneal dialysis solution from Ireland. Mitigating shortages is a top priority for the Food and Drug Administration, and communication with all stakeholders is essential. Copyright © 2015 by the American Society of Nephrology.

Solid‐in‐oil nanodispersions for transdermal drug delivery systems

PubMed Central

Kitaoka, Momoko; Wakabayashi, Rie; Kamiya, Noriho

2016-01-01

Abstract Transdermal administration of drugs has advantages over conventional oral administration or administration using injection equipment. The route of administration reduces the opportunity for drug evacuation before systemic circulation, and enables long‐lasting drug administration at a modest body concentration. In addition, the skin is an attractive route for vaccination, because there are many immune cells in the skin. Recently, solid‐in‐oil nanodisperison (S/O) technique has demonstrated to deliver cosmetic and pharmaceutical bioactives efficiently through the skin. S/O nanodispersions are nanosized drug carriers designed to overcome the skin barrier. This review discusses the rationale for preparation of efficient and stable S/O nanodispersions, as well as application examples in cosmetic and pharmaceutical materials including vaccines. Drug administration using a patch is user‐friendly, and may improve patient compliance. The technique is a potent transcutaneous immunization method without needles. PMID:27529824

Solid-in-oil nanodispersions for transdermal drug delivery systems.

PubMed

Kitaoka, Momoko; Wakabayashi, Rie; Kamiya, Noriho; Goto, Masahiro

2016-11-01

Transdermal administration of drugs has advantages over conventional oral administration or administration using injection equipment. The route of administration reduces the opportunity for drug evacuation before systemic circulation, and enables long-lasting drug administration at a modest body concentration. In addition, the skin is an attractive route for vaccination, because there are many immune cells in the skin. Recently, solid-in-oil nanodisperison (S/O) technique has demonstrated to deliver cosmetic and pharmaceutical bioactives efficiently through the skin. S/O nanodispersions are nanosized drug carriers designed to overcome the skin barrier. This review discusses the rationale for preparation of efficient and stable S/O nanodispersions, as well as application examples in cosmetic and pharmaceutical materials including vaccines. Drug administration using a patch is user-friendly, and may improve patient compliance. The technique is a potent transcutaneous immunization method without needles. © 2016 The Authors. Biotechnology Journal published by WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

21 CFR 19.10 - Food and Drug Administration Conflict of Interest Review Board.

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2010-04-01

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2010-04-01

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Privacy issues and the monitoring of sumatriptan in the New Zealand Intensive Medicines Monitoring Programme.

PubMed

Coulter, D M

2001-12-01

The purpose of this paper is to describe how the New Zealand (NZ) Intensive Medicines Monitoring Programme (IMMP) functions in relation to NZ privacy laws and to describe the attitudes of patients to drug safety monitoring and the privacy of their personal and health information. The IMMP undertakes prospective observational event monitoring cohort studies on new drugs. The cohorts are established from prescription data and the events are obtained using prescription event monitoring and spontaneous reporting. Personal details, prescribing history of the monitored drugs and adverse events data are stored in databases long term. The NZ Health Information Privacy Code is outlined and the monitoring of sumatriptan is used to illustrate how the IMMP functions in relation to the Code. Patient responses to the programme are described. Sumatriptan was monitored in 14,964 patients and 107,646 prescriptions were recorded. There were 2344 reports received describing 3987 adverse events. A majority of the patients were involved in the recording of events data either personally or by telephone interview. There were no objections to the monitoring process on privacy grounds. Given the fact that all reasonable precautions are taken to ensure privacy, patients perceive drug safety to have greater priority than any slight risk of breach of confidentiality concerning their personal details and health information.

Malaysia and harm reduction: the challenges and responses.

PubMed

Reid, Gary; Kamarulzaman, Adeeba; Sran, Sangeeta Kaur

2007-03-01

In Malaysia the response to illicit drug use has been largely punitive with the current goal of the Malaysian government being to achieve a drug-free society by 2015. This paper outlines the results of a desk-based situation assessment conducted over a 3-week period in 2004. Additional events, examined in 2005, were also included to describe more recent policy developments and examine how these came about. Despite punitive drug policy there has been a substantial rise in the number of drug users in the country. Over two-thirds of HIV/AIDS cases are among injecting drug users (IDUs) and there has been an exponential rise in the number of cases reported. Further, data suggest high risk drug use practices are widespread. Harm reduction initiatives have only recently been introduced in Malaysia. The successful piloting of substitution therapies, in particular methadone and buprenorphine, is cause for genuine hope for the rapid development of such interventions. In 2005 the government announced it will allow methadone maintenance programmes to operate beyond the pilot phase and needle and syringe exchange programmes will be established to serve the needs of IDUs.

Cure rate is not a valid indicator for assessing drug efficacy and impact of preventive chemotherapy interventions against schistosomiasis and soil-transmitted helminthiasis

PubMed Central

Montresor, Antonio

2017-01-01

Every year, in endemic countries, several million individuals are given anthelminthic drugs in the context of preventive chemotherapy programmes for morbidity control of schistosomiasis and soil-transmitted helminthiasis. The capacity of accurately evaluating the efficacy of the drugs used as well as the health impact produced by treatment is of utmost importance for the appropriate planning and implementation of these interventions. The cure rate is an indicator of drug efficacy that was originally developed for assessing the clinical efficacy of antibiotics on selected bacterial diseases. Over time, this indicator has also been widely applied to anthelminthic drugs and consequently used to monitor and evaluate preventive chemotherapy interventions. In the author's opinion, however, measurement of cure rate provides information of limited usefulness in the context of helminth control programmes. The present article analyses the peculiarities of helminth infections and those of the drugs used in preventive chemotherapy, explaining the reasons why the cure rate is not an adequate indicator in this specific public health context. PMID:21612808

Advanced Analgesic Drug Delivery and Nanobiotechnology.

PubMed

Stoicea, Nicoleta; Fiorda-Diaz, Juan; Joseph, Nicholas; Shabsigh, Muhammad; Arias-Morales, Carlos; Gonzalez-Zacarias, Alicia A; Mavarez-Martinez, Ana; Marjoribanks, Stephen; Bergese, Sergio D

2017-07-01

Transdermal administration of analgesic medications offers several benefits over alternative routes of administration, including a decreased systemic drug load with fewer side effects, and avoidance of drug degradation by the gastrointestinal tract. Transdermal administration also offers a convenient mode of drug administration over an extended period of time, particularly desirable in pain medicine. A transdermal administration route may also offer increased safety for drugs with a narrow therapeutic window. The primary barrier to transdermal drug absorption is the skin itself. Transdermal nanotechnology offers a novel method of achieving enhanced dermal penetration with an extended delivery profile for analgesic drugs, due to their small size and relatively large surface area. Several materials have been used to enhance drug duration and transdermal penetration. The application of nanotechnology in transdermal delivery of analgesics has raised new questions regarding safety and ethical issues. The small molecular size of nanoparticles enables drug delivery to previously inaccessible body sites. To ensure safety, the interaction of nanoparticles with the human body requires further investigation on an individual drug basis, since different formulations have unique properties and side effects.