Sample records for drug development programs

  1. Developing an Occupational Drug Abuse Program: Considerations and Approaches. Services Research Monograph Series.

    ERIC Educational Resources Information Center

    Stephen, Mae; Prentice, Robert

    This monograph, developed as a guide for companies interested in establishing drug abuse programs, begins with a brief summary of studies assessing the extent and costs of employee drug use. The next section addresses some practical and conceptual issues about establishing a drug abuse program. Suggestions for implementing a drug abuse program are…

  2. Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study.

    PubMed

    Kesselheim, Aaron S; Wang, Bo; Franklin, Jessica M; Darrow, Jonathan J

    2015-09-23

    To evaluate the use of special expedited development and review pathways at the US Food and Drug Administration over the past two decades. Cohort study. FDA approved novel therapeutics between 1987 and 2014. Publicly available sources provided each drug's year of approval, their innovativeness (first in class versus not first in class), World Health Organization Anatomic Therapeutic Classification, and which (if any) of the FDA's four primary expedited development and review programs or designations were associated with each drug: orphan drug, fast track, accelerated approval, and priority review. Logistic regression models evaluated trends in the proportion of drugs associated with each of the four expedited development and review programs. To evaluate the number of programs associated with each approved drug over time, Poisson models were employed, with the number of programs as the dependent variable and a linear term for year of approval. The difference in trends was compared between drugs that were first in class and those that were not. The FDA approved 774 drugs during the study period, with one third representing first in class agents. Priority review (43%) was the most prevalent of the four programs, with accelerated approval (9%) the least common. There was a significant increase of 2.6% per year in the number of expedited review and approval programs granted to each newly approved agent (incidence rate ratio 1.026, 95% confidence interval 1.017 to 1.035, P<0.001), and a 2.4% increase in the proportion of drugs associated with at least one such program (odds ratio 1.024, 95% confidence interval 1.006 to 1.043, P=0.009). Driving this trend was an increase in the proportion of approved, non-first in class drugs associated with at least one program for drugs (P=0.03 for interaction). In the past two decades, drugs newly approved by the FDA have been associated with an increasing number of expedited development or review programs. Though expedited programs should be strictly limited to drugs providing noticeable clinical advances, this trend is being driven by drugs that are not first in class and thus potentially less innovative. © Kesselheim et al 2015.

  3. Toward More Effective Drug Prevention Programs.

    ERIC Educational Resources Information Center

    Ellickson, Phyllis L.; Robyn, Abby E.

    This report discusses guidelines for developing drug prevention programs. It reflects knowledge acquired in developing and implementing Project ALERT, an adolescent drug prevention program currently being evaluated with more than 6,500 students in California and Oregon schools. The guidelines discussed are based on information about the…

  4. An AIDS risk reduction program for Dutch drug users: an intervention mapping approach to planning.

    PubMed

    van Empelen, Pepijn; Kok, Gerjo; Schaalma, Herman P; Bartholomew, L Kay

    2003-10-01

    This article presents the development of a theory- and evidence-based AIDS prevention program targeting Dutch drug users and aimed at promoting condom use. The emphasis is on the development of the program using a five-step intervention development protocol called intervention mapping (IM). Preceding Step 1 of the IM process, an assessment of the HIV problem among drug users was conducted. The product of IM Step 1 was a series of program objectives specifying what drug users should learn in order to use condoms consistently. In Step 2, theoretical methods for influencing the most important determinants were chosen and translated into practical strategies that fit the program objectives. The main strategy chosen was behavioral journalism. In Step 3, leaflets with role-model stories based on authentic interviews with drug users were developed and pilot tested. Finally, the need for cooperation with program users is discussed in IM Steps 4 and 5.

  5. Building a roadmap to biomarker qualification: challenges and opportunities.

    PubMed

    Amur, Shashi G; Sanyal, Sarmistha; Chakravarty, Aloka G; Noone, Marianne H; Kaiser, James; McCune, Susan; Buckman-Garner, ShaAvhree Y

    2015-01-01

    The traditional route for regulatory acceptance of biomarkers in drug development is through submission of biomarker data in drug approval submissions in the context of a single drug development program. The US FDA's Critical Path Initiative called for establishment of a biomarker qualification process to enable progress in the drug development paradigm. In response to this, the Center for Drug Evaluation and Research (CDER) established a Biomarker Qualification Program (BQP) to qualify a biomarker for a specific context of use (COU). The qualified biomarker can then be used in multiple drug development programs for this COU without re-review. Here, we describe some of the features of the BQP and two new initiatives that have the potential to aid biomarker development through early interactions with the FDA. Finally, we discuss some of the feedback the FDA has received from submitters and the BQP's actions to strengthen the program.

  6. Incentivizing Orphan Product Development: United States Food and Drug Administration Orphan Incentive Programs.

    PubMed

    Le, Tran T

    2017-01-01

    Over 30 years ago, the United States (US) Congress passed the Orphan Drug Act (ODA) to encourage the development of products for rare diseases or conditions ("orphan products"). The Act provided incentives to sponsors for developing products with orphan designation and established a grant program to fund studies of orphan products. Since its enactment in 1983, the ODA has been credited for bringing more than 590 orphan drugs to the market, inspiring the implementation of orphan legislation globally, and enabling the creation of other programs that extend existing knowledge of the natural history of rare diseases and stimulate the development of medical devices for children and patients with rare diseases. This chapter provides a brief overview of the main features and successes of 5 of the orphan incentive programs administered by the US Food and Drug Administration (FDA): the Orphan Drug Designation Program, the Humanitarian Use Device (HUD) Designation Program, the Orphan Products Clinical Trials Grants Program, the Pediatric Device Consortia (PDC) Grant Program, and the Orphan Products Natural History Grants Program.

  7. The New Drug Conditional Approval Process in China: Challenges and Opportunities.

    PubMed

    Yao, Xuefang; Ding, Jinxi; Liu, Yingfang; Li, Penghui

    2017-05-01

    Our aim was to characterize the newly established new drug conditional approval process in China and discuss the challenges and opportunities with respect to new drug research and development and registration. We examined the new approval program through literature review, law analysis, and data analysis. Data were derived from published materials, such as journal articles, government publications, press releases, and news articles, along with statistical data from INSIGHT-China Pharma Databases, the China Food and Drug Administration website, the Center for Drug Evaluation website, the US Food and Drug Administration website, and search results published by Google. Currently, there is a large backlog of New Drug Applications in China, mainly because of the prolonged review time at the China Food and Drug Administration, resulting in a lag in drug approvals. In 2015, the Chinese government implemented the drug review and registration system reform and tackled this issue through various approaches, such as setting up a drug review fee system, adjusting the drug registration classification, and establishing innovative review pathways, including the conditional approval process. In Europe and the United States, programs comparable to the conditional approval program in China have been well developed. The conditional approval program recently established in China is an expedited new drug approval process that is expected to affect new drug development at home and abroad and profoundly influence the public health and the pharmaceutical industry in China. Like any program in its initial stage, the conditional approval program is facing several challenges, including setting up a robust system, formatting new drug clinical research requirements, and improving the regulatory agency's function for drug review and approval. The program is expected to evolve and improve as part of the government mandate of the drug registration system reform. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.

  8. Developing a Drug Testing Policy at a Public University: Participant Perspectives.

    ERIC Educational Resources Information Center

    Griffin, Stephen O.; Keller, Adrienne; Cohn, Alan

    2001-01-01

    Although employee drug testing is widespread among private employers, the development of programs in the public sector has been slower due to constitutional law constraints. A qualitative approach presenting various participant perspectives may aid in developing an employee drug testing program. (Contains 41 references/notes.) (JOW)

  9. Drug use prevention: factors associated with program implementation in Brazilian urban schools.

    PubMed

    Pereira, Ana Paula Dias; Sanchez, Zila M

    2018-03-07

    A school is a learning environment that contributes to the construction of personal values, beliefs, habits and lifestyles, provide convenient settings for the implementation of drug use prevention programs targeting adolescents, who are the population group at highest risk of initiating drug use. The objective of the present study was to investigate the prevalence of factors associated with implementing drug use prevention programs in Brazilian public and private middle and high urban schools. The present population-based cross-sectional survey was conducted with a probability sample of 1151 school administrators stratified by the 5 Brazilian administrative divisions, in 2014. A close-ended, self-reported online questionnaire was used. Logistic regression analysis was used to identify factors associated with implementing drug use prevention programs in schools. A total of 51.1% of the schools had adopted drug use prevention programs. The factors associated with program implementation were as follows: belonging to the public school network; having a library; development of activities targeting sexuality; development of "Health at School Program" activities; offering extracurricular activities; and having an administrator that participated in training courses on drugs. The adoption of drug use prevention practices in Brazilian schools may be expanded with greater orchestration of schools through specialized training of administrators and teachers, expansion of the School Health Program and concomitant development of the schools' structural and curricular attributes.

  10. 77 FR 72365 - National Institute on Drug Abuse; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-05

    ... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... administrative, legislative and program developments in the drug abuse field. Place: National Institutes of... of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs...

  11. 76 FR 51381 - National Institute on Drug Abuse; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-18

    ... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... administrative, legislative and program developments in the drug abuse field. Place: National Institutes of.... (Catalogue of Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs...

  12. The Creative Learning Group Drug Education Program Developed by the Creative Learning Group. Product Development Report No. 6.

    ERIC Educational Resources Information Center

    Thompson, Lorna J.; Kratochvil, Daniel W.

    This report of the development of a drug-educational product which appears to have potential impact, is based upon published materials, documents in the files of the developing agency, and interviews with staff who were involved in the development of the product. The long-range goal of the drug program is to encourage young people to develop…

  13. Factors associated with failure of oncology drugs in late-stage clinical development: A systematic review.

    PubMed

    Jardim, Denis L; Groves, Eric S; Breitfeld, Philip P; Kurzrock, Razelle

    2017-01-01

    We aimed to describe the reasons for failure of experimental anticancer drugs in late-stage clinical development. We searched the PharmaProjects database (https://citeline.com/products/pharmaprojects/) for anticancer drugs discontinued between 01/01/2009 and 06/30/2014. Drug programs that reached phase III trials, but never gained Food and Drug Administration (FDA) approval were compared to 37 anti-cancer drugs achieving FDA approval in this time period. Forty-two drugs fit our criteria for development failures. These failed drugs (49% targeted, 23% cytotoxics, and 28% other) were tested in 43 cancer indications (drug programs). Only 16% (7/43) of failed drug programs adopted a biomarker-driven rationale for patient selection versus 57% (21/37) of successful drug programs (P<0.001). Phase II trial information was available in 32 of 43 failed drug programs and in 32 of 37 successful programs. Nine of the 32 trials (28%) of failed drugs versus 28 of 32 trials (87%) of successful drugs (P<0.001) achieved proof of concept (single agent response rate (RR) ⩾20% or combination therapy showing a ⩾20% RR increase above the median historical RR without the experimental agent (with a minimal absolute increase of 5%) or a randomized phase II trial showing significance (P⩽0.05) for its primary outcome). No pattern of study sites, trial design or funding characteristics emerged from the failed drug analysis. For drugs that reached Phase III, lack of a biomarker-driven strategy and failure to attain proof of concept in phase II are potential risk factors for later discontinuation, especially for targeted agents. Copyright © 2016 Elsevier Ltd. All rights reserved.

  14. Harm reduction in the US: a movement for change.

    PubMed

    Greig, A

    The War on Drugs in the United States has polarized the debate on how to deal effectively with drug use and prevention and makes it difficult to form an agenda to address the harm of drug use. Harm-reduction activists and drug-user groups need to establish common ground to develop programs acceptable to all parties. The harm-reduction approach is based on the premise that adverse consequences of a harmful act, drug use in this case, can be mitigated without necessarily reducing consumption. Needle exchange programs are a good example of this approach. There are 100 such programs in the United States, and the programs are seen as an effective means of reducing HIV transmission. However, the programs remain politically sensitive and Federal funding is outlawed. The War on Drugs programs can conflict with HIV prevention programs; programs that might reduce the incidence of HIV infection but do not criminalize or stigmatize drug use are rarely socially acceptable. In the U.S., about half of all new HIV cases can be attributed to drug use. One-third of the increase in prison populations since 1980 is a consequence of the number of drug-law violators in the prison system. The impact of moral conservatism and how the drug laws are affected by class, race, and gender are discussed. Groups involved with combating drug use and preventing HIV transmission will need to form alliances to develop programs mutually beneficial to their audiences.

  15. The Social Context of Alcohol and Drug Education: Implications for Program Effectiveness.

    ERIC Educational Resources Information Center

    Weisheit, Ralph A.

    1983-01-01

    Argues that the design of current alcohol and drug education programs precludes their having a substantial impact on adolescent alcohol or drug use. Suggests that evaluators consider only limited aspects of these programs which leads to narrow definition of success and restricts input into program development and modification. (LLL)

  16. A Practical Approach to Rural Drug Abuse Programming.

    ERIC Educational Resources Information Center

    Rozelle, George R.; And Others

    1980-01-01

    Reviews characteristics of rural drug abuse and general considerations for rural service delivery. Describes the Prevention Project, a rural drug abuse program in Florida, and explains its development, philosophy, and teaching techniques, including a basic educational module for use with rural youth. Includes recommendations for similar programs.…

  17. 76 FR 24035 - Generic Drug User Fee; Public Meeting; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-29

    ...] Generic Drug User Fee; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS... development of a generic drug user fee program. A user fee program could provide necessary supplemental... announcing its intention to hold a public meeting related to generic drug user fees. The Agency continues to...

  18. 76 FR 44014 - Generic Drug User Fee; Public Meeting; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-22

    ...] Generic Drug User Fee; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS... development of a generic drug user fee program. A user fee program could provide necessary supplemental... generic drug user fees. New legislation would be required for FDA to establish and collect user fees for...

  19. An Assessment of the Drug Abuse Resistance Education (DARE) Program in Fort Wayne, Indiana.

    ERIC Educational Resources Information Center

    Fife, Brian L.

    DARE is a preventive drug education program intended to combat drug use by students before it commences. The elementary school program is the core curriculum of DARE. It is designed to help those enrolled to develop skills that will allow them to resist the pressures to use substances such as illegal drugs, alcohol and tobacco. Students are taught…

  20. Open-source approaches for the repurposing of existing or failed candidate drugs: learning from and applying the lessons across diseases

    PubMed Central

    Allarakhia, Minna

    2013-01-01

    Repurposing has the objective of targeting existing drugs and failed, abandoned, or yet-to-be-pursued clinical candidates to new disease areas. The open-source model permits for the sharing of data, resources, compounds, clinical molecules, small libraries, and screening platforms to cost-effectively advance old drugs and/or candidates into clinical re-development. Clearly, at the core of drug-repurposing activities is collaboration, in many cases progressing beyond the open sharing of resources, technology, and intellectual property, to the sharing of facilities and joint program development to foster drug-repurposing human-capacity development. A variety of initiatives under way for drug repurposing, including those targeting rare and neglected diseases, are discussed in this review and provide insight into the stakeholders engaged in drug-repurposing discovery, the models of collaboration used, the intellectual property-management policies crafted, and human capacity developed. In the case of neglected tropical diseases, it is suggested that the development of human capital be a central aspect of drug-repurposing programs. Open-source models can support human-capital development through collaborative data generation, open compound access, open and collaborative screening, preclinical and possibly clinical studies. Given the urgency of drug development for neglected tropical diseases, the review suggests elements from current repurposing programs be extended to the neglected tropical diseases arena. PMID:23966771

  1. Open-source approaches for the repurposing of existing or failed candidate drugs: learning from and applying the lessons across diseases.

    PubMed

    Allarakhia, Minna

    2013-01-01

    Repurposing has the objective of targeting existing drugs and failed, abandoned, or yet-to-be-pursued clinical candidates to new disease areas. The open-source model permits for the sharing of data, resources, compounds, clinical molecules, small libraries, and screening platforms to cost-effectively advance old drugs and/or candidates into clinical re-development. Clearly, at the core of drug-repurposing activities is collaboration, in many cases progressing beyond the open sharing of resources, technology, and intellectual property, to the sharing of facilities and joint program development to foster drug-repurposing human-capacity development. A variety of initiatives under way for drug repurposing, including those targeting rare and neglected diseases, are discussed in this review and provide insight into the stakeholders engaged in drug-repurposing discovery, the models of collaboration used, the intellectual property-management policies crafted, and human capacity developed. In the case of neglected tropical diseases, it is suggested that the development of human capital be a central aspect of drug-repurposing programs. Open-source models can support human-capital development through collaborative data generation, open compound access, open and collaborative screening, preclinical and possibly clinical studies. Given the urgency of drug development for neglected tropical diseases, the review suggests elements from current repurposing programs be extended to the neglected tropical diseases arena.

  2. How do drug users define their progress in harm reduction programs? Qualitative research to develop user-generated outcomes

    PubMed Central

    Ruefli, Terry; Rogers, Susan J

    2004-01-01

    Background Harm reduction is a relatively new and controversial model for treating drug users, with little formal research on its operation and effectiveness. In order to advance the study of harm reduction programs and our understanding of how drug users define their progress, qualitative research was conducted to develop outcomes of harm reduction programming that are culturally relevant, incremental, (i.e., capable of measuring change), and hierarchical (i.e., capable of showing how clients improve over time). Methods The study used nominal group technique (NGT) to develop the outcomes (phase 1) and focus group interviews to help validate the findings (phase 2). Study participants were recruited from a large harm-reduction program in New York City and involved approximately 120 clients in 10 groups in phase 1 and 120 clients in 10 focus groups in phase 2. Results Outcomes of 10 life areas important to drug users were developed that included between 10 to 15 incremental measures per outcome. The outcomes included ways of 1) making money; 2) getting something good to eat; 3) being housed/homeless; 4) relating to families; 5) getting needed programs/benefits/services; 6) handling health problems; 7) handling negative emotions; 8) handling legal problems; 9) improving oneself; and 10) handling drug-use problems. Findings also provided insights into drug users' lives and values, as well as a window into understanding how this population envisions a better quality of life. Results challenged traditional ways of measuring drug users based solely on quantity used and frequency of use. They suggest that more appropriate measures are based on the extent to which drug users organize their lives around drug use and how much drug use is integrated into their lives and negatively impacts other aspects of their lives. Conclusions Harm reduction and other programs serving active drug users and other marginalized people should not rely on institutionalized, provider-defined solutions to problems in living faced by their clients. PMID:15333130

  3. Missouri Curriculum Guide for Alcohol and Drug Education Programs.

    ERIC Educational Resources Information Center

    Pierce, Don; McClain, Robert

    This document presents the Alcohol and Drug Education Programs (ADEP) curriculum guide developed by the Missouri Department of Mental Health to provide education programs for individuals under the age of 21 convicted of certain alcohol and drug related offenses. An introduction is followed by a section on substances of abuse and their effects.…

  4. Administrator's Handbook for Crime Prevention and Drug Education.

    ERIC Educational Resources Information Center

    Texas Education Agency, Austin. Div. of Crime Prevention and Drug Education.

    Acts of three Texas Legislatures have mandated that the schools of Texas provide a program for all public school students, grades K-12, in crime prevention and drug education. To assist schools in formulating a philosophy about and in developing appropriate programs and techniques for drug education and crime prevention programs, the Texas…

  5. Visions: Drug Education for Healthy 21st Century Living. An Infused K-12 Curriculum.

    ERIC Educational Resources Information Center

    Morton, Claudette, Ed.

    This document completes a major goal of the Montana Rural Drug Free Schools Program, the development of an infused drug education curriculum appropriate for Montana's rural and small schools. These materials were first developed as a user-friendly computer program before this print form was produced, and the reader is encouraged to access the…

  6. Leveraging model-informed approaches for drug discovery and development in the cardiovascular space.

    PubMed

    Dockendorf, Marissa F; Vargo, Ryan C; Gheyas, Ferdous; Chain, Anne S Y; Chatterjee, Manash S; Wenning, Larissa A

    2018-06-01

    Cardiovascular disease remains a significant global health burden, and development of cardiovascular drugs in the current regulatory environment often demands large and expensive cardiovascular outcome trials. Thus, the use of quantitative pharmacometric approaches which can help enable early Go/No Go decision making, ensure appropriate dose selection, and increase the likelihood of successful clinical trials, have become increasingly important to help reduce the risk of failed cardiovascular outcomes studies. In addition, cardiovascular safety is an important consideration for many drug development programs, whether or not the drug is designed to treat cardiovascular disease; modeling and simulation approaches also have utility in assessing risk in this area. Herein, examples of modeling and simulation applied at various stages of drug development, spanning from the discovery stage through late-stage clinical development, for cardiovascular programs are presented. Examples of how modeling approaches have been utilized in early development programs across various therapeutic areas to help inform strategies to mitigate the risk of cardiovascular-related adverse events, such as QTc prolongation and changes in blood pressure, are also presented. These examples demonstrate how more informed drug development decisions can be enabled by modeling and simulation approaches in the cardiovascular area.

  7. Preventing Drug Abuse Among Hispanic Adolescents: Developing a Responsive Intervention Approach.

    PubMed

    Schinke, Steven P; Schwinn, Traci M; Hursh, Hilary A

    2015-10-01

    Intervention research is essential to help Hispanic American adolescents avoid drug use. This article describes an intervention research program aimed at preventing drug use among these youths. Grounded in salient epidemiological data, the program is informed by bicultural competence, social learning, and motivational interviewing theories. The program, called Vamos, is aimed at the risk and protective factors as well as the cultural prerogatives that demark the adolescent years of Hispanic American youths. Innovative in its approach, the program is delivered through a smartphone application (app). By interacting with engaging content presented via the app, youths can acquire the cognitive-behavioral skills necessary to avoid risky situations, urges, and pressures associated with early drug use. The intervention development process is presented in detail, and an evaluation plan to determine the program's efficacy is outlined. Lessons for practice and intervention programming are discussed.

  8. Preventing Drug Abuse Among Hispanic Adolescents: Developing a Responsive Intervention Approach

    PubMed Central

    Schinke, Steven P.; Schwinn, Traci M.; Hursh, Hilary A.

    2014-01-01

    Intervention research is essential to help Hispanic American adolescents avoid drug use. This article describes an intervention research program aimed at preventing drug use among these youths. Grounded in salient epidemiological data, the program is informed by bicultural competence, social learning, and motivational interviewing theories. The program, called Vamos, is aimed at the risk and protective factors as well as the cultural prerogatives that demark the adolescent years of Hispanic American youths. Innovative in its approach, the program is delivered through a smartphone application (app). By interacting with engaging content presented via the app, youths can acquire the cognitive–behavioral skills necessary to avoid risky situations, urges, and pressures associated with early drug use. The intervention development process is presented in detail, and an evaluation plan to determine the program's efficacy is outlined. Lessons for practice and intervention programming are discussed. PMID:26500421

  9. Teamwork for Healthy Campuses. NYS College Alcohol and Other Drug Programs.

    ERIC Educational Resources Information Center

    Harding, Frances M.

    This manual offers information on developing, implementing, and maintaining college alcohol and other drug programs at New York institutions of higher education. The document notes that alcohol is the drug of choice for college students and that therefore alcohol-related issues and programs are the primary focus of the manual. Part 1 of the manual…

  10. Condoning Drug Education Programs at Colleges and Universities.

    ERIC Educational Resources Information Center

    Kaczynski, Daniel J.

    This report presents the evaluation results gathered from a 2-year study of a drug prevention program involving a consortia of nine colleges and universities located in Alabama and Florida. The consortia effort was intended to: (1) strengthen their respective drug prevention activities; (2) develop policies governing alcohol and drugs; (3)…

  11. 76 FR 45261 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-28

    ... Request; Guidance for Industry: Fast Track Drug Development Programs: Designation, Development, and... information to OMB for review and clearance. Guidance for Industry: Fast Track Drug Development Programs... to industry on fast track policies and procedures outlined in section 506 of the FD&C Act. The...

  12. Using Elite Athletes to Promote Drug Abstinence: Evaluation of a Single-Session School-Based Drug Use Prevention Program Delivered by Junior Hockey Players

    ERIC Educational Resources Information Center

    Wong, Jennifer

    2016-01-01

    School-based substance use prevention programs are a common method to approaching drug use in youths. Project SOS is a single-session drug prevention program developed by police officers and delivered by elite junior hockey players to students in grades 6 and 7. The current study evaluates the effects of Project SOS at achieving its objectives of…

  13. A Lifespan Developmental-Stage Approach to Tobacco and Other Drug Abuse Prevention

    PubMed Central

    2013-01-01

    At least by informal design, tobacco and other drug abuse prevention programs are tailored to human developmental stage. However, few papers have been written to examine how programming has been formulated as a function of developmental stage throughout the lifespan. In this paper, I briefly define lifespan development, how it pertains to etiology of tobacco and other drug use, and how prevention programming might be constructed by five developmental stages: (a) young child, (b) older child, (c) young teen, (d) older teen, and (e) adult (emerging, young-to-middle and older adult substages). A search of the literature on tobacco and other drug abuse prevention by developmental stage was conducted, and multiple examples of programs are provided for each stage. A total of 34 programs are described as examples of each stage (five-young children, 12-older children, eight-young teens, four-older teens, and five-adults). Implications for future program development research are stated. In particular, I suggest that programming continue to be developed for all stages in the lifespan, as opposed to focusing on a single stage and that developmentally appropriate features continues to be pursued to maximize program impact. PMID:25298961

  14. PREVENT Cancer Preclinical Drug Development Program (PREVENT) | Division of Cancer Prevention

    Cancer.gov

    The PREVENT program provides a structure for the introduction of new agents, drugs and vaccines to inhibit, retard or reverse the cancer process. The program was designed to optimize translational opportunities from discovery to the clinic, and provide a mechanism to identify and study efficacy and pharmacodynamics biomarkers that will help in phase II trials to evaluate drug

  15. 24 CFR 21.220 - By when must I publish my drug-free workplace statement and establish my drug-free awareness...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false By when must I publish my drug-free... must I publish my drug-free workplace statement and establish my drug-free awareness program? If you... ongoing awareness program as described in § 21.215, you must publish the statement and establish the...

  16. 76 FR 24893 - National Institute on Drug Abuse; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-03

    ... applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Conference... developments in the drug abuse field. Place: National Institutes of Health, Neuroscience Center, 6001 Executive... Federal Domestic Assistance Program Nos.: 93.279, Drug Abuse and Addiction Research Programs, National...

  17. Handbook for Evaluating Drug and Alcohol Prevention Programs: Staff/Team Evaluation of Prevention Programs (STEPP).

    ERIC Educational Resources Information Center

    Hawkins, J. David; Nederhood, Britt

    This handbook was developed for the purpose of providing drug and alcohol prevention program managers with a comprehensive yet easy-to-use tool to help their evaluation efforts. The handbook emphasizes program staff members working together as a team. It provides instruments and activities for determining program effectiveness, as well as…

  18. Tools & Services - SEER Registrars

    Cancer.gov

    View glossary for registrars. Access ICD conversion programs, SEER Abstracting Tool, SEER Data Viewer, SEER interactive drug database for coding oncology drugs, data documentation, variable recodes, and SEER Application Programming Interface for developers.

  19. Developing a Web-Based Intervention to Prevent Drug Use among Adolescent Girls

    PubMed Central

    Schwinn, Traci Marie; Hopkins, Jessica Elizabeth; Schinke, Steven Paul

    2014-01-01

    Objectives Girls’ rates of drug use have met up with, and in some instances, surpassed boys’ use. Though girls and boys share risk and protective factors associated with drug use, girls also have gender-specific risks. Interventions to prevent girls’ drug use must be tailored to address the dynamics of female adolescence. Methods One such intervention, called RealTeen, is a 9-session, web-based drug abuse prevention program designed to address such gender-specific risk factors associated with young girls’ drug use as depressed mood, low self-esteem, and high levels of perceived stress as well as general drug use risk factors of peer and social influences. Web-based delivery enables girls to interact with the program at their own pace and in a location of their choosing. Implications This paper describes the processes and challenges associated with developing and programming a gender-specific, web-based intervention to prevent drug use among adolescent girls. PMID:26778909

  20. Targeted drug discovery and development, from molecular signaling to the global market: an educational program at New York University, 5-year metrics

    PubMed Central

    Lee, Gloria; Plaksin, Joseph; Ramasamy, Ravichandran; Gold-von Simson, Gabrielle

    2018-01-01

    Drug discovery and development (DDD) is a collaborative, dynamic process of great interest to researchers, but an area where there is a lack of formal training. The Drug Development Educational Program (DDEP) at New York University was created in 2012 to stimulate an improved, multidisciplinary DDD workforce by educating early stage scientists as well as a variety of other like-minded students. The first course of the program emphasizes post-compounding aspects of DDD; the second course focuses on molecular signaling pathways. In five years, 196 students (candidates for PhD, MD, Master’s degree, and post-doctoral MD/PhD) from different schools (Medicine, Biomedical Sciences, Dentistry, Engineering, Business, and Education) completed the course(s). Pre/post surveys demonstrate knowledge gain across all course topics. 26 students were granted career development awards (73% women, 23% underrepresented minorities). Some graduates of their respective degree-granting/post-doctoral programs embarked on DDD related careers. This program serves as a framework for other academic institutions to develop compatible programs designed to train a more informed DDD workforce. PMID:29657854

  1. 76 FR 20679 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ...: Fast Track Drug Development Programs: Designation, Development, and Application Review AGENCY: Food and... licenses for fast track designation as provided in the guidance for industry on fast track drug development... appropriate, and other forms of information technology. Guidance for Industry: Fast Track Drug Development...

  2. Drug Research

    NASA Technical Reports Server (NTRS)

    1989-01-01

    NBOD2, a program developed at Goddard Space Flight Center to solve equations of motion coupled N-body systems is used by E.I. DuPont de Nemours & Co. to model potential drugs as a series of elements. The program analyses the vibrational and static motions of independent components in drugs. Information generated from this process is used to design specific drugs to interact with enzymes in designated ways.

  3. Drug Abuse Education Program. Drug Abuse Education, Grades 5,7,9. Bibliography Included.

    ERIC Educational Resources Information Center

    Baltimore City Public Schools, MD.

    A drug abuse education program was implemented in grades five, seven, and nine in the Baltimore City Public Schools. Unit plans outline the curriculum content and learning activities for each of the three grades. The major objective in grade five is to familiarize pupils with various medically used drugs and to develop an understanding that they…

  4. Preventing Drug Abuse among Hispanic Adolescents: Developing a Responsive Intervention Approach

    ERIC Educational Resources Information Center

    Schinke, Steven P.; Schwinn, Traci M.; Hursh, Hilary A.

    2015-01-01

    Intervention research is essential to help Hispanic American adolescents avoid drug use. This article describes an intervention research program aimed at preventing drug use among these youths. Grounded in salient epidemiological data, the program is informed by bicultural competence, social learning, and motivational interviewing theories. The…

  5. 21 CFR 1403.40 - Monitoring and reporting program performance.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Monitoring and reporting program performance. 1403.40 Section 1403.40 Food and Drugs OFFICE OF NATIONAL DRUG CONTROL POLICY UNIFORM ADMINISTRATIVE... developments. Events may occur between the scheduled performance reporting dates which have significant impact...

  6. Parenting skills and family support programs for drug-abusing mothers.

    PubMed

    Kumpfer, Karol L; Fowler, Melissa A

    2007-04-01

    Children born to drug-using mothers can suffer from fetal alcohol or drug syndrome (FAS/FDS) or fetal alcohol or drug effect (FAE/FDE). Such children have a greater likelihood of developing acute or chronic physical, cognitive and behavioral problems. In-utero exposure to tobacco, alcohol or drugs impact on the developing fetus and, after birth, the family environment and family system exert effects on the infants and children of substance-abusing parents. Evidence-based prevention and maternal drug treatment programs focus on enhancing parental childcaring abilities, supporting parent-child attachment and encouraging family support systems to improve children's health and cognitive outcomes. FAS/FDS prevention programs, as well as selective and indicated prenatal and postnatal interventions, can improve the support given both to mother and to child, and evidence-based, in-home parenting and family-skills-training approaches are particularly useful.

  7. The Development of a Korean Drug Dosing Database

    PubMed Central

    Kim, Sun Ah; Kim, Jung Hoon; Jang, Yoo Jin; Jeon, Man Ho; Hwang, Joong Un; Jeong, Young Mi; Choi, Kyung Suk; Lee, Iyn Hyang; Jeon, Jin Ok; Lee, Eun Sook; Lee, Eun Kyung; Kim, Hong Bin; Chin, Ho Jun; Ha, Ji Hye; Kim, Young Hoon

    2011-01-01

    Objectives This report describes the development process of a drug dosing database for ethical drugs approved by the Korea Food & Drug Administration (KFDA). The goal of this study was to develop a computerized system that supports physicians' prescribing decisions, particularly in regards to medication dosing. Methods The advisory committee, comprised of doctors, pharmacists, and nurses from the Seoul National University Bundang Hospital, pharmacists familiar with drug databases, KFDA officials, and software developers from the BIT Computer Co. Ltd. analyzed approved KFDA drug dosing information, defined the fields and properties of the information structure, and designed a management program used to enter dosing information. The management program was developed using a web based system that allows multiple researchers to input drug dosing information in an organized manner. The whole process was improved by adding additional input fields and eliminating the unnecessary existing fields used when the dosing information was entered, resulting in an improved field structure. Results A total of 16,994 drugs sold in the Korean market in July 2009, excluding the exclusion criteria (e.g., radioactivity drugs, X-ray contrast medium), usage and dosing information were made into a database. Conclusions The drug dosing database was successfully developed and the dosing information for new drugs can be continually maintained through the management mode. This database will be used to develop the drug utilization review standards and to provide appropriate dosing information. PMID:22259729

  8. Drug-food interaction counseling programs in teaching hospitals.

    PubMed

    Wix, A R; Doering, P L; Hatton, R C

    1992-04-01

    The results of a survey to characterize drug-food interaction counseling programs in teaching hospitals and solicit opinions on these programs from pharmacists and dietitians are reported. A questionnaire was mailed to the pharmacy director and the director of dietary services at teaching hospitals nationwide. The questionnaire contained 33 questions relating to hospital characteristics, drug-food interaction counseling programs, and the standard calling for such programs issued by the Joint Commission on Accreditation of Healthcare Organizations. Of 792 questionnaires mailed, 425 were returned (response rate, 53.7). A majority of the pharmacists and dietitians (51.2%) did not consider their drug-food interaction counseling program to be formal; some had no program. The pharmacy department was involved more in program development than in the daily operation of such programs. The most frequent methods of identifying patients for counseling were using lists of patients' drugs and using physicians' orders. A mean of only five drugs were targeted per program. Slightly over half the respondents rated the Joint Commission standard less effective than other standards in its ability to improve patient care. A majority of teaching hospitals did not have formal drug-food interaction counseling programs. Pharmacists and dietitians did not view these programs as greatly beneficial and did not believe that the Joint Commission has clearly delineated the requirements for meeting its standard.

  9. A large-scale initiative to disseminate an evidence-based drug abuse prevention program in Italy: Lessons learned for practitioners and researchers.

    PubMed

    Velasco, Veronica; Griffin, Kenneth W; Antichi, Mariella; Celata, Corrado

    2015-10-01

    Across developed countries, experimentation with alcohol, tobacco, and other drugs often begins in the early adolescent years. Several evidence-based programs have been developed to prevent adolescent substance use. Many of the most rigorously tested and empirically supported prevention programs were initially developed and tested in the United States. Increasingly, these interventions are being adopted for use in Europe and throughout the world. This paper reports on a large-scale comprehensive initiative designed to select, adapt, implement, and sustain an evidence-based drug abuse prevention program in Italy. As part of a large-scale regionally funded collaboration in the Lombardy region of Italy, we report on processes through which a team of stakeholders selected, translated and culturally adapted, planned, implemented and evaluated the Life Skills Training (LST) school-based drug abuse prevention program, an evidence-based intervention developed in the United States. We discuss several challenges and lessons learned and implications for prevention practitioners and researchers attempting to undertake similar international dissemination projects. We review several published conceptual models designed to promote the replication and widespread dissemination of effective programs, and discuss their strengths and limitations in the context of planning and implementing a complex, large-scale real-world dissemination effort. Copyright © 2015 Elsevier Ltd. All rights reserved.

  10. School-Based Practices and Programs That Promote Safe and Drug-Free Schools. CASE/CCBD Mini-Library Series on Safe, Drug-Free, and Effective Schools.

    ERIC Educational Resources Information Center

    Guthrie, Patricia M.

    This monograph focuses on school-based practices and programs that promote safe and drug-free schools. It begins with a description of the key characteristics of schools with effective programs and provides a model for school-wide support. Necessary steps for developing an effective system of universal prevention are listed and include: (1)…

  11. Program Administration | Division of Cancer Prevention

    Cancer.gov

    Governance Structure Recognizing the importance of an integrated approach to preventative drug development, there is a unified Governance Structure for the PREVENT Program responsible for coordinating and integrating available resources. With the goal of reaching go/no-go decisions as efficiently as possible, the purpose is to ensure a pragmatic approach to drug development

  12. Drug Abuse Assessment, Program Planning and Resource Development in the Black Community.

    ERIC Educational Resources Information Center

    Gunn, Karen S.

    This paper presents a needs assessment project developed to establish drug-related services in a small black community. A literature review reveals the influence of social issues relevant to the population on research methodology, program planning, and social action. The convergent analysis approach used in the needs assessment is explained and…

  13. 77 FR 71211 - Request for Information: Establish a Public-Private Collaboration, “Drug Development Initiative...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-29

    ... clinical trials with the support of the VA Cooperative Studies Program. To identify and test new drug..., ``Drug Development Initiative'' (DDI), for New Pharmacological Treatments for Post-Traumatic Stress... will delineate the collaboration for PTSD treatment intended to test new drugs to benefit Veterans...

  14. 76 FR 33307 - Generic Drug User Fee; Notice of Public Meeting; Extension of Comment Period

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-08

    ...] Generic Drug User Fee; Notice of Public Meeting; Extension of Comment Period AGENCY: Food and Drug... on the development of a generic drug user fee program. The Agency is taking this action to allow..., 75 FR 47820, FDA published a notice soliciting comment on development of a generic drug user fee...

  15. Integrating Life Skills Into a Theory-Based Drug-Use Prevention Program: Effectiveness among Junior High Students in Taiwan

    ERIC Educational Resources Information Center

    Huang, Chiu-Mieh; Chien, Li-Yin; Cheng, Chin-Feng; Guo, Jong-Long

    2012-01-01

    Background: Drug use has been noted among students in Taiwan during the past decade and schools have a role in preventing or delaying students' drug use. We developed and evaluated a school-based, drug-use prevention program integrating the theory of planned behavior (TPB) and life skills for junior high school students. Methods: We recruited 441…

  16. [Development and effectiveness of a drug dosage calculation training program using cognitive loading theory based on smartphone application].

    PubMed

    Kim, Myoung Soo; Park, Jung Ha; Park, Kyung Yeon

    2012-10-01

    This study was done to develop and evaluate a drug dosage calculation training program using cognitive loading theory based on a smartphone application. Calculation ability, dosage calculation related self-efficacy and anxiety were measured. A nonequivalent control group design was used. Smartphone application and a handout for self-study were developed and administered to the experimental group and only a handout was provided for control group. Intervention period was 4 weeks. Data were analyzed using descriptive analysis, χ²-test, t-test, and ANCOVA with the SPSS 18.0. The experimental group showed more 'self-efficacy for drug dosage calculation' than the control group (t=3.82, p<.001). Experimental group students had higher ability to perform drug dosage calculations than control group students (t=3.98, p<.001), with regard to 'metric conversion' (t=2.25, p=.027), 'table dosage calculation' (t=2.20, p=.031) and 'drop rate calculation' (t=4.60, p<.001). There was no difference in improvement in 'anxiety for drug dosage calculation'. Mean satisfaction score for the program was 86.1. These results indicate that this drug dosage calculation training program using smartphone application is effective in improving dosage calculation related self-efficacy and calculation ability. Further study should be done to develop additional interventions for reducing anxiety.

  17. The Best Prevention: Model Alcohol and Drug Education Program. NHTSA Prevention Guide.

    ERIC Educational Resources Information Center

    National Highway Traffic Safety Administration (DOT), Washington, DC.

    This guide was created for school administrators, parents, teachers, and community groups interested in developing effective alcohol and drug abuse prevention programs for elementary and secondary schools. A comprehensive approach to school-based alcohol and drug prevention is described and various prevention activities which have been selected by…

  18. Establishing a Drug Rehabilitation Center in a Prison Setting.

    ERIC Educational Resources Information Center

    Page, Richard C.

    The implementation of a drug treatment center in a prison environment is described. Such topics as the program initiation, selection of residents, early program operation are discussed. Program activities such as regular group counseling and rational therapy were developed to assist residents in the resolution of personal problems and interactions…

  19. Motivating the Drug Addict in Treatment

    ERIC Educational Resources Information Center

    St. Pierre, C. Andre

    1971-01-01

    Experience with numbers of drug addicts has shown them to be singularly unmotivated to discontinue drug use. To develop motivation, a treatment program is described in terms of motivational progression: (1) confrontation of the problem; (2) development of an intellectual understanding of the problem and its harmful effects; and (3) development of…

  20. The La Salle University FIPSE Grant: A Review and Evaluation of the Alcohol and Other Drug Program, 1 September 88 through 30 September 90.

    ERIC Educational Resources Information Center

    Chapman, Robert J.

    This report presents descriptive and evaluative information on the Alcohol and Other Drug Program (A & D Program) developed at Pennsylvania's La Salle University and supported by the Fund for the Improvement of Postsecondary Education. The program includes an alcohol awareness project, a peer education program, a resident educator with A &…

  1. Low hanging fruit in infectious disease drug development.

    PubMed

    Kraus, Carl N

    2008-10-01

    Cost estimates for developing new molecular entities (NME) are reaching non-sustainable levels and coupled with increasing regulatory requirements and oversight have led many pharmaceutical sponsors to divest their anti-microbial development portfolios [Projan SJ: Why is big Pharma getting out of anti-bacterial drug discovery?Curr Opin Microbiol 2003, 6:427-430] [Spellberg B, Powers JH, Brass EP, Miller LG, Edwards JE, Jr: Trends in antimicrobial drug development: implications for the future.Clin Infect Dis 2004, 38:1279-1286]. Operational issues such as study planning and execution are significant contributors to the overall cost of drug development that can benefit from the leveraging of pre-randomization data in an evidence-based approach to protocol development, site selection and patient recruitment. For non-NME products there is even greater benefit from available data resources since these data may permit smaller and shorter study programs. There are now many available open source intelligence (OSINT) resources that are being integrated into drug development programs, permitting an evidence-based or 'operational epidemiology' approach to study planning and execution.

  2. Medication development for addictive disorders: the state of the science.

    PubMed

    Vocci, Frank J; Acri, Jane; Elkashef, Ahmed

    2005-08-01

    In 1989, the National Institute on Drug Abuse (NIDA) established its Medications Development Program. This program has concentrated on developing pharmacotherapies for opiate and cocaine dependence and, more recently, for methamphetamine and cannabis dependence. The major goals of this program are to optimize existing treatments and to expand treatment options for physicians and patients. This review will concentrate on the development of pharmacotherapies for the following substance abuse disorders: opiate, cocaine, methamphetamine, and cannabis dependence. Left untreated, opiate and stimulant dependence are responsible for significant morbidity and mortality. For example, use of illicit opiates is associated with an increased risk of hepatitis C infection, HIV infection, and other medical consequences, e.g., an overdose. The NIDA Medications Development Program has had success in developing, with pharmaceutical partners, levomethadyl acetate, buprenorphine, and buprenorphine/naloxone for opiate dependence. Moreover, several marketed medications have shown promise in reducing cocaine use. Of interest, these medications likely operate through diverse neurochemical mechanisms, suggesting that combination therapy may be a rational next step that could increase treatment gains further in cocaine-dependent patients. The Medications Development Program has also identified multiple neuronal mechanisms that are altered by chronic administration of drugs of abuse. Advances in neuroscience have identified changes in conditioned cueing, drug priming, stress-induced increases in drug intake, and reduced frontal inhibitory mechanisms as all being possible for the development of, maintenance of, and possible relapse to, addiction. Potential medications that modulate these mechanisms are highlighted.

  3. Cooperative research and development opportunities with the National Cancer Institute

    NASA Technical Reports Server (NTRS)

    Sybert, Kathleen

    1991-01-01

    The Office of Technology Development (OTD) of the National Cancer Institute (NCI) is responsible for negotiating Cooperative Research and Development Agreements (CRADAs), whereby the knowledge resulting from NCI investigators' government-sponsored research is developed in collaboration with universities and/or industry into new products of importance for the diagnosis and treatment of cancer and acquired immunodeficiency syndrome (AIDS). The NCI has recently executed a unique 'clinical trials' CRADA and is developing a model agreement based upon it for the development and commercialization of products for the diagnosis and treatment of cancer and AIDS. NCI drug screening, preclinical testing, clinical trials, and AIDS program capabilities form the basis for this new technology development/technology transfer vehicle. NCI's extensive drug screening program and 'designer foods' program serve as potential sources of investigational new drugs (INDs) and cancer preventatives. Collaborations between NCI and pharmaceutical companies having the facilities, experience, and expertise necessary to develop INDs into approved drugs available to the public are being encouraged where the companies have proprietary rights to INDs, or where NCI has proprietary rights to INDs and invites companies to respond to a collaborator announcement published in the Federal Register. The joint efforts of the NCI and the chosen collaborator are designed to generate the data necessary to obtain pharmaceutic regulatory approval from the Food and Drug Administration (FDA) to market the drugs developed, and thereby make them available to health care providers for the diagnosis and treatment of cancer and AIDS.

  4. Development of Less Toxic Treatment Strategies for Metastatic and Drug-Resistant Breast Cancer Using Noninvasive Optical Monitoring

    DTIC Science & Technology

    2016-09-01

    AWARD NUMBER: W81XWH-15-1-0070 TITLE: Development of Less Toxic Treatment Strategies for Metastatic and Drug- Resistant Breast Cancer Using...0070 Development of Less Toxic Treatment Strategies for Metastatic and Drug- Resistant Breast Cancer Using Noninvasive Optical Monitori g 5c. PROGRAM...drug resistant breast cancer. Non-invasive Diffuse Optical Imaging technologies are able to monitor drug response and resistance through quantitative

  5. What Will Happen if . . . A Programmed Instruction Course on Drugs and Their Effects.

    ERIC Educational Resources Information Center

    Health Services and Mental Health Administration (DHEW), Bethesda, MD.

    Developed by the National Institute of Mental Health, this booklet offers a programed instruction course on drugs and their effects. The purpose of the text is to learn about specific drugs which are currently being used and abused by a large group of people in our society. Narcotics, stimulants, depressants, hallucinogens, and marihuana are…

  6. Recruitment and Retention of Substance-Using Pregnant and Parenting Women: Lessons Learned.

    ERIC Educational Resources Information Center

    Laken, Marilyn Poland; Hutchins, Ellen

    According to current estimates, approximately 5.5 percent of all American pregnant women use an illicit drug during pregnancy. National concern for drug-exposed infants prompted interest in the needs of substance using pregnant women and in the development of drug treatment programs for them. A total of 147 comprehensive programs have been funded…

  7. What Works: The Results of Evaluations on Two Interactive Multimedia Programs.

    ERIC Educational Resources Information Center

    Schmidt, Kathy J.

    The American Institute for Learning (AIL) has developed two interactive multimedia drug-awareness programs for secondary students who have used substances experimentally or are being challenged by others to experiment with drugs. The first, "Addiction and Its Processes," is an awareness program with video and computer capabilities and an…

  8. A Census of Prison-Based Drug Treatment Programs: Implications for Programming, Policy, and Evaluation

    ERIC Educational Resources Information Center

    Welsh, Wayne N.; Zajac, Gary

    2004-01-01

    Despite a growing realization that unmeasured programmatic differences influence prison-based drug treatment effectiveness, few attempts to systematically measure such differences have been made. To improve program planning and evaluation in this area, we developed a census instrument to collect descriptive information about 118 prison-based drug…

  9. 76 FR 52958 - Draft Guidance for Industry on Neglected Tropical Diseases of the Developing World: Developing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-24

    ...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment or prevention of neglected diseases of the developing world. Specifically, this guidance addresses FDA's current thinking regarding the overall drug development program for the treatment or prevention of neglected tropical diseases (NTDs), including clinical trial designs and internal review standards to support approval of drugs.

  10. Careers in Drug and Alcohol Research: AN Innovative Program for Young Appalachian Women

    NASA Astrophysics Data System (ADS)

    Noland, Melody Powers; Leukefeld, Carl; Reid, Caroline

    Supported by a grant from the National Institute on Drug Abuse, the University of Kentucky's Center on Drug and Alcohol Research developed the Young Women in Science Program to encourage young women from Appalachia to pursue scientific careers гп drug and alcohol research. This 3-year program, which involved 26 young women entering the ninth grade in 13 counties in southeastern Kentucky, included a summer residential program, community educational sessions, and matching students with mentors. When participants' scores prior to and after the 3-week residential program were compared, it was found that participants increased their science knowledge and improved their scores on confidence in science. Other significant changes occurred as well. These preliminary data indicated that some positive changes resulted from the program, even though contact time with the young women has been modest to date. The program shows considerable promise for providing the encouragement and skills needed for these young women to pursue careers in drug and alcohol research.

  11. Integrating risk minimization planning throughout the clinical development and commercialization lifecycle: an opinion on how drug development could be improved

    PubMed Central

    Morrato, Elaine H; Smith, Meredith Y

    2015-01-01

    Pharmaceutical risk minimization programs are now an established requirement in the regulatory landscape. However, pharmaceutical companies have been slow to recognize and embrace the significant potential these programs offer in terms of enhancing trust with health care professionals and patients, and for providing a mechanism for bringing products to the market that might not otherwise have been approved. Pitfalls of the current drug development process include risk minimization programs that are not data driven; missed opportunities to incorporate pragmatic methods and market-based insights, outmoded tools and data sources, lack of rapid evaluative learning to support timely adaption, lack of systematic approaches for patient engagement, and questions on staffing and organizational infrastructure. We propose better integration of risk minimization with clinical drug development and commercialization work streams throughout the product lifecycle. We articulate a vision and propose broad adoption of organizational models for incorporating risk minimization expertise into the drug development process. Three organizational models are discussed and compared: outsource/external vendor, embedded risk management specialist model, and Center of Excellence. PMID:25750537

  12. The Andrews’ Principles of Risk, Need, and Responsivity as Applied in Drug Abuse Treatment Programs: Meta-Analysis of Crime and Drug Use Outcomes

    PubMed Central

    Prendergast, Michael L.; Pearson, Frank S.; Podus, Deborah; Hamilton, Zachary K.; Greenwell, Lisa

    2013-01-01

    Objectives The purpose of the present meta-analysis was to answer the question: Can the Andrews principles of risk, needs, and responsivity, originally developed for programs that treat offenders, be extended to programs that treat drug abusers? Methods Drawing from a dataset that included 243 independent comparisons, we conducted random-effects meta-regression and ANOVA-analog meta-analyses to test the Andrews principles by averaging crime and drug use outcomes over a diverse set of programs for drug abuse problems. Results For crime outcomes, in the meta-regressions the point estimates for each of the principles were substantial, consistent with previous studies of the Andrews principles. There was also a substantial point estimate for programs exhibiting a greater number of the principles. However, almost all of the 95% confidence intervals included the zero point. For drug use outcomes, in the meta-regressions the point estimates for each of the principles was approximately zero; however, the point estimate for programs exhibiting a greater number of the principles was somewhat positive. All of the estimates for the drug use principles had confidence intervals that included the zero point. Conclusions This study supports previous findings from primary research studies targeting the Andrews principles that those principles are effective in reducing crime outcomes, here in meta-analytic research focused on drug treatment programs. By contrast, programs that follow the principles appear to have very little effect on drug use outcomes. Primary research studies that experimentally test the Andrews principles in drug treatment programs are recommended. PMID:24058325

  13. Preventing adolescent drug use: long-term results of a junior high program.

    PubMed Central

    Ellickson, P L; Bell, R M; McGuigan, K

    1993-01-01

    OBJECTIVES. Although several studies have reported short-term gains for drug-use prevention programs targeted at young adolescents, few have assessed the long-term effects of such programs. Such information is essential for judging how long prevention benefits last. This paper reports results over a 6-year period for a multisite randomized trial that achieved reductions in drug use during the junior high school years. METHODS. The 11-lesson curriculum, which was tested in 30 schools in eight highly diverse West Coast communities, focused on helping 7th and 8th grade students develop the motivation and skills to resist drugs. Schools were randomly assigned to treatment and control conditions. About 4000 students were assessed in grade 7 and six times thereafter through grade 12. Program effects were adjusted for pretest covariates and school effects. RESULTS. Once the lessons stopped, the program's effects on drug use stopped. Effects on cognitive risk factors persisted for a longer time (many through grade 10), but were not sufficient to produce corresponding reductions in use. CONCLUSIONS. It is unlikely that early prevention gains can be maintained without additional prevention efforts during high school. Future research is needed to develop and test such efforts. PMID:8498624

  14. Medicinal Chemistry Projects Requiring Imaginative Structure-Based Drug Design Methods.

    PubMed

    Moitessier, Nicolas; Pottel, Joshua; Therrien, Eric; Englebienne, Pablo; Liu, Zhaomin; Tomberg, Anna; Corbeil, Christopher R

    2016-09-20

    Computational methods for docking small molecules to proteins are prominent in drug discovery. There are hundreds, if not thousands, of documented examples-and several pertinent cases within our research program. Fifteen years ago, our first docking-guided drug design project yielded nanomolar metalloproteinase inhibitors and illustrated the potential of structure-based drug design. Subsequent applications of docking programs to the design of integrin antagonists, BACE-1 inhibitors, and aminoglycosides binding to bacterial RNA demonstrated that available docking programs needed significant improvement. At that time, docking programs primarily considered flexible ligands and rigid proteins. We demonstrated that accounting for protein flexibility, employing displaceable water molecules, and using ligand-based pharmacophores improved the docking accuracy of existing methods-enabling the design of bioactive molecules. The success prompted the development of our own program, Fitted, implementing all of these aspects. The primary motivation has always been to respond to the needs of drug design studies; the majority of the concepts behind the evolution of Fitted are rooted in medicinal chemistry projects and collaborations. Several examples follow: (1) Searching for HDAC inhibitors led us to develop methods considering drug-zinc coordination and its effect on the pKa of surrounding residues. (2) Targeting covalent prolyl oligopeptidase (POP) inhibitors prompted an update to Fitted to identify reactive groups and form bonds with a given residue (e.g., a catalytic residue) when the geometry allows it. Fitted-the first fully automated covalent docking program-was successfully applied to the discovery of four new classes of covalent POP inhibitors. As a result, efficient stereoselective syntheses of a few screening hits were prioritized rather than synthesizing large chemical libraries-yielding nanomolar inhibitors. (3) In order to study the metabolism of POP inhibitors by cytochrome P450 enzymes (CYPs)-for toxicology studies-the program Impacts was derived from Fitted and helped us to reveal a complex metabolism with unforeseen stereocenter isomerizations. These efforts, combined with those of other docking software developers, have strengthened our understanding of the complex drug-protein binding process while providing the medicinal chemistry community with useful tools that have led to drug discoveries. In this Account, we describe our contributions over the past 15 years-within their historical context-to the design of drug candidates, including BACE-1 inhibitors, POP covalent inhibitors, G-quadruplex binders, and aminoglycosides binding to nucleic acids. We also remark the necessary developments of docking programs, specifically Fitted, that enabled structure-based design to flourish and yielded multiple fruitful, rational medicinal chemistry campaigns.

  15. Remaining Off Alcohol and Drugs: A Self-Management Skills Program for Abstinence.

    ERIC Educational Resources Information Center

    Dunphy, Peter Hughes

    The Remaining Off Alcohol and Drugs Program (ROAD) was developed to teach newly abstinent chemical misusing clients how to remain alcohol and drug free. It provides its participants with a repertoire of knowledge, skills and behaviors that they can use in dealing with the most common problems caused by discontinuing chemical use and which can be…

  16. Design of study without drugs--a Surinamese school-based drug-prevention program for adolescents.

    PubMed

    Ishaak, Fariel; de Vries, Nanne Karel; van der Wolf, Kees

    2015-10-12

    The aim of this study was to design the content and accompanying materials for a school-based program--Study without Drugs--for adolescents in junior secondary schools in Suriname based on the starting points and tasks of the fourth step of the Intervention Mapping protocol (which consists of six steps). A program based on this protocol should include a combination of theory, empirical evidence, and qualitative and quantitative research. Two surveys were conducted when designing the program. In Survey I, teachers and students were asked to complete a questionnaire to determine which school year they thought would be most appropriate for implementing a drug-prevention program for adolescents (we completed a similar survey as part of previous research). An attempt was made to identify suitable culturally sensitive elements to include in the program. In Survey II, the same teachers were asked to complete a questionnaire to determine the programs' scope, sequence, structure, and topics as well as the general didactic principles to serve as a basis for program design. After outlining the program plan, lessons, and materials, we conducted a formative pretest evaluation among teachers, students, and parents. That evaluation included measures related to the program's attractiveness, comprehensibility, and usefulness. The resulting lessons were presented to the teachers for assessment. The drug-prevention program we developed comprises 10 activities and lasts 2-2.5 months in an actual school setting. The activities take place during Dutch, biology, physical education, art, religion, and social studies lessons. We based the structure of the lessons in the program on McGuire's Persuasion Communication Model, which takes into account important didactic principles. Evaluations of the program materials and lesson plans by students, teachers, and parents were mostly positive. We believe that using the fourth step of the Intervention Mapping protocol to develop a drug-prevention intervention for adolescents has a produced promising, feasible program.

  17. 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...

  18. Family Skills Training for Parents and Children. Juvenile Justice Bulletin.

    ERIC Educational Resources Information Center

    Kumpfer, Karol L.; Tait, Connie M.

    Originally designed as a drug abuse prevention program for drug-abusing parents and their children, the Strengthening Families Program (SFP) has developed into a family-change program. Presented in 14 2-hour-long, consecutive weekly sessions, SFP has two versions: for elementary school children and their parents and for parents and youth 10-14…

  19. Advanced Research Projects Agency counterdrug program

    NASA Astrophysics Data System (ADS)

    Pennella, John J.

    1994-03-01

    The Department of Defense (DoD), in support of the National Drug Control Strategy, has designated that detecting and countering the production, trafficking and use of illegal drugs is a high priority national security mission. The Advanced Research Projects Agency (ARPA) Counterdrug Program is assisting DoD in this objective by developing technology and prototype systems to enhance the capabilities of the DoD and civilian law enforcement agencies, consistent with the DoD mission and the supply reduction goals of the National Drug Control Strategy. The objective of this paper is to summarize the current ARPA Counterdrug Program, with special emphasis on the current efforts and future plans for developing technology to meet the National needs for Non-Intrusive Inspection.

  20. 77 FR 49446 - Gastrointestinal Drugs Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-16

    ... Person: Cindy Hong, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New... development programs necessary to support approval of parenteral lipid emulsion products as nutritional...

  1. 49 CFR 1.50 - Office of Drug & Alcohol Policy & Compliance.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... international drug testing and control issues and is the principal advisor to the Secretary on rules related to the drug and alcohol testing of safety-sensitive transportation employees in aviation, trucking... developing drug and alcohol testing programs and implementing the President's National Drug Control Strategy. ...

  2. Conflict of Interest in the Evaluation and Dissemination of “Model” School-based Drug and Violence Prevention Programs

    PubMed Central

    Gorman, Dennis M.; Conde, Eugenia

    2010-01-01

    Conflict of interest refers to a set of conditions in which professional judgment concerning the validity of research might be influenced by a secondary competing interest. The competing interest that has received most attention in the literature addressing the prevalence and effects of such conflicts on the practice of empirical research has been that of financial relationships between investigators and research sponsors. The potential for conflicts of interest to arise in the evaluation of drug prevention programs was raised by Moskowitz in this journal in 1993, but to date there has been no attempt made to estimate the scope of this problem. The present study addressed this issue using a sample of “model” school-based drug and violence prevention interventions by first, identifying the types or relationships that exist between program developers and program distributors, and, second, by assessing how many of the evaluations of these programs published in peer-reviewed journals had been conducted by the developers of the programs compared to independent evaluation teams. The data presented indicate that there are relatively few published evaluations that do not involve program developers and that there are few instances in which there is complete separation between the program developer and program distributor. Using the open systems model of the Institute of Medicine Committee on Research Integrity as a framework, it is argued that the culture and norms of the program developer and those of the program evaluator are fundamentally distinct and therefore failure to separate these roles produces high potential for conflict of interest to arise. PMID:17945143

  3. Field evaluation of the Los Angeles Police Department drug detection procedure.

    DOT National Transportation Integrated Search

    1986-12-01

    The Los Angeles Police Department (LAPD) has developed a drug recognition program designed to provide trained officers the ability to detect drug-impaired drivers and to identify the responsible drug class (e.g., stimulant, depressant, etc. ). As par...

  4. Older adults' drug benefit beliefs: construct definition and measure development.

    PubMed

    Cline, Richard R; Gupta, Kiran; Singh, Reshmi L

    2008-03-01

    The Medicare Prescription Drug, Improvement and Modernization Act of 2003 provides coverage of outpatient prescription drugs for Medicare beneficiaries. Although much has been learned since the program's implementation, a context within which this information can be understood is lacking. The purpose of this study was to develop a reliable and valid multi-item instrument measuring beliefs about Medicare prescription drug benefits. Survey items were generated using focus group transcripts, other surveys on the Medicare Part "D" program, and past studies of choice and satisfaction in drug insurance programs. Using data from the survey pilot test, item and reliability analyses were used to reduce and refine an initial pool of items. Data then were collected from a cross-sectional, mail survey of older adults living in Minnesota. Data were analyzed using exploratory factor analysis. Summated rating scales then were constructed and assessed further using reliability analyses. Construct validity of summated scales was examined by comparing scale scores across response categories of survey items that collected information on general political attitudes, perceptions of the Medicare Part "D" program, health status, and health care utilization and demographics. The adjusted response rate for the main survey was 55.98% (744/1329). Iterative factor analysis produced 2 interpretable scales. The first, termed "access/equity" (13 items, Cronbach's alpha=0.89) measures beliefs that a Medicare drug benefit should both provide affordable prescription drugs for beneficiaries and do this in a manner that is equitable for all participants. The second, termed "comprehensibility" (6 items, Cronbach's alpha=0.80) assesses beliefs that regulations governing a Medicare drug benefit should be easily understood. Discriminant validity tests suggest that these measures behave in a manner consistent with related research in these areas. Measures of 2 facets of older adults' drug benefit beliefs were developed using a multiple step procedure. Future research could focus on developing a better understanding of other facets of these beliefs and sound methods of measurement.

  5. Creating a new class of pharmaceutical services provider for underserved areas: the Tanzania accredited drug dispensing outlet experience.

    PubMed

    Rutta, Edmund; Senauer, Katie; Johnson, Keith; Adeya, Grace; Mbwasi, Romuald; Liana, Jafary; Kimatta, Suleiman; Sigonda, Margareth; Alphonce, Emmanuel

    2009-01-01

    In developing countries, the most accessible source of treatment for common conditions is often an informal drug shop, where drug sellers are untrained and operations are unmonitored. We sought to describe a public-private initiative in Tanzania that created a new class of provider in government-accredited drug outlets, which improved the quality of medicines and pharmaceutical services in previously underserved areas. The accredited drug-dispensing outlet program combines changing behavior and expectations of community members who use, own, regulate, and work in drug shops. Success resulted from including community stakeholders from the beginning of the process. Addressing shortages in qualified health care providers by training and accrediting private sector drug dispensers to recognize common conditions and provide quality pharmaceutical products and services is feasible in a developing country, when supported by an appropriate policy and regulatory environment. Scaling up and sustaining the program will be a challenge.

  6. Pharmacist Web-Based Training Program on Medication Use in Chronic Kidney Disease Patients: Impact on Knowledge, Skills, and Satisfaction

    ERIC Educational Resources Information Center

    Legris, Marie-eve; Seguin, Noemie Charbonneau; Desforges, Katherine; Sauve, Patricia; Lord, Anne; Bell, Robert; Berbiche, Djamal; Desrochers, Jean-Francois; Lemieux, Jean-Philippe; Morin-Belanger, Claudia; Paradis, Francois Ste-Marie; Lalonde, Lyne

    2011-01-01

    Introduction: Chronic kidney disease (CKD) patients are multimorbid elderly at high risk of drug-related problems. A Web-based training program was developed based on a list of significant drug-related problems in CKD patients requiring a pharmaceutical intervention. The objectives were to evaluate the impact of the program on community…

  7. Web-Based Cognitive Behavioral Relapse Prevention Program With Tailored Feedback for People With Methamphetamine and Other Drug Use Problems: Development and Usability Study.

    PubMed

    Takano, Ayumi; Miyamoto, Yuki; Kawakami, Norito; Matsumoto, Toshihiko

    2016-01-06

    Although drug abuse has been a serious public health concern, there have been problems with implementation of treatment for drug users in Japan because of poor accessibility to treatment, concerns about stigma and confidentiality, and costs. Therapeutic interventions using the Internet and computer technologies could improve this situation and provide more feasible and acceptable approaches. The objective of the study was to show how we developed a pilot version of a new Web-based cognitive behavioral relapse prevention program with tailored feedback to assist people with drug problems and assessed its acceptance and usability. We developed the pilot program based on existing face-to-face relapse prevention approaches using an open source Web application to build an e-learning website, including relapse prevention sessions with videos, exercises, a diary function, and self-monitoring. When users submitted exercise answers and their diary, researchers provided them with personalized feedback comments using motivational interviewing skills. People diagnosed with drug dependence were recruited in this pilot study from a psychiatric outpatient ward and nonprofit rehabilitation facilities and usability was evaluated using Internet questionnaires. Overall, website usability was assessed by the Web Usability Scale. The adequacy of procedures in the program, ease of use, helpfulness of content, and adverse effects, for example, drug craving, mental distress, were assessed by original structured questionnaires and descriptive form questions. In total, 10 people participated in the study and completed the baseline assessment, 60% completed all relapse prevention sessions within the expected period. The time needed to complete one session was about 60 minutes and most of the participants took 2 days to complete the session. Overall website usability was good, with reasonable scores on subscales of the Web Usability Scale. The participants felt that the relapse prevention sessions were easy to use and helpful, but that the length of the videos was too long. The participant who until recently used drugs was satisfied with the self-monitoring, but others that had already maintained abstinence for more than a year felt this activity was unhelpful and were bored tracking and recording information on daily drug use. Feedback comments from researchers enhanced participants' motivation and further insight into the disease. Serious adverse effects caused by the intervention were not observed. Some possible improvements to the program were suggested. The Web-based relapse prevention program was easy to use and acceptable to drug users in this study. This program will be helpful for drug users who do not receive behavioral therapy. After the pilot program is revised, further large-scale research is needed to assess its efficacy among drug users who have recently used drugs.

  8. Drug Abuse Control--Administrative Guidelines.

    ERIC Educational Resources Information Center

    Los Angeles City Schools, CA.

    These guidelines were developed to assist administrators, teachers, and other staff members of the Los Angeles Public Schools in the formulation of an effective program designed to alleviate drug abuse. Staff responsibilities are spelled out. Specific attention is directed to the problems of drug abuse, drug possession and drug selling. The…

  9. Successful implementation of a guideline program for the rational use of lipid-lowering drugs.

    PubMed

    Stuart, M E; Handley, M A; Chamberlain, M A; Wallach, R W; Penna, P M; Stergachis, A

    1991-01-01

    Following the National Cholesterol Educational Program's (NCEP) 1988 screening and treatment recommendations, an educational and behavior-change program at Group Health Cooperative of Puget Sound (GHC) was developed to guide the use of lipid-lowering drugs within the larger context of cardiac risk reduction. The program has been successful in advancing a rational program to enhance care and manage costs of the use of lipid-lowering agents at GHC. Cost savings have been significant over the past two years. The educational design of the program includes training and ongoing education of a core group of "lipid gurus," who educate colleagues in area medical centers in a rational approach to hyperlipidemia. Patient education and patient participation in decision-making was emphasized. Program evaluation has demonstrated that physicians and patients are satisfied with the program, and inappropriate drug expenditures have been prevented. Key elements of the program include a critical review of outcome studies in the medical literature, use of information systems, algorithms and written materials organized into a well-designed, ongoing educational program, and development of a core group of physicians and pharmacists to administer the program at the clinic level.

  10. Pharmacogenomics to Revive Drug Development in Cardiovascular Disease.

    PubMed

    Dubé, Marie-Pierre; de Denus, Simon; Tardif, Jean-Claude

    2016-02-01

    Investment in cardiovascular drug development is on the decline as large cardiovascular outcomes trials require considerable investments in time, efforts and financial resources. Pharmacogenomics has the potential to help revive the cardiovascular drug development pipeline by providing new and better drug targets at an earlier stage and by enabling more efficient outcomes trials. This article will review some of the recent developments highlighting the value of pharmacogenomics for drug development. We discuss how genetic biomarkers can enable the conduct of more efficient clinical outcomes trials by enriching patient populations for good responders to the medication. In addition, we assess past drug development programs which support the added value of selecting drug targets that have established genetic evidence supporting the targeted mechanism of disease. Finally, we discuss how pharmacogenomics can provide valuable evidence linking a drug target to clinically relevant outcomes, enabling novel drug discovery and drug repositioning opportunities.

  11. Progress Report on Neglected Tropical Disease Drug Donation Programs.

    PubMed

    Cohen, Joshua P; Silva, Lisseth; Cohen, Alisa; Awatin, Josephine; Sturgeon, Robert

    2016-05-01

    Neglected tropical diseases (NTDs) impose a significant burden on public health, particularly in developing nations. Many can be treated cost-effectively with drugs donated or offered at or below marginal cost. In 2012, the World Health Organization published an NTD roadmap that outlined a strategy for the prevention, control, and eradication of 17 NTDs by 2020. Inspired by this roadmap, executives from 13 pharmaceutical companies, government agencies, and other interested parties signed the London Declaration on Neglected Tropical Diseases in January 2012. In this paper, we will assess progress in meeting commitments on drug donations laid out in the London Declaration. We conducted Medline and LexisNexis searches of peer-reviewed publications and trade journals, as well as product development partnership and government reports. Subsequently, we designed a survey instrument and surveyed 10 company signatories (companies with drug donation programs) to the London Declaration to determine current donations and pledges. Nine of 10 companies with donation programs responded to the survey. The respondents reported substantial progress in meeting the goals laid out in the London Declaration. Survey respondents maintained 17 drug donation programs across 10 disease categories. In 2014, companies donated >1 billion treatments, with a dollar value of nearly $1.5 billion. However, not all donated products were distributed to patients in need. In addition, 4 of the 17 programs were slated to end before 2020, three of the 17 programs did not report explicit program objectives, and 7 of 17 did not measure the impact of programs in terms of numbers of patients treated. None of our survey respondents reported on whether the programs were leading to a reduction in disease prevalence. Donations are a necessary but insufficient condition for patient access to neglected disease drugs. Additional resources must be allocated to ensure delivery of donated products to patients. In addition, drug donation programs should provide explicit descriptions of program objectives, measurements of the impacts of their programs, and extension of all donation commitments through 2020. To achieve this, multiple stakeholders with a vested interest in reducing the burden of neglected diseases must collaborate in a multipronged approach toward NTD elimination. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

  12. The basics of preclinical drug development for neurodegenerative disease indications.

    PubMed

    Steinmetz, Karen L; Spack, Edward G

    2009-06-12

    Preclinical development encompasses the activities that link drug discovery in the laboratory to initiation of human clinical trials. Preclinical studies can be designed to identify a lead candidate from several hits; develop the best procedure for new drug scale-up; select the best formulation; determine the route, frequency, and duration of exposure; and ultimately support the intended clinical trial design. The details of each preclinical development package can vary, but all have some common features. Rodent and nonrodent mammalian models are used to delineate the pharmacokinetic profile and general safety, as well as to identify toxicity patterns. One or more species may be used to determine the drug's mean residence time in the body, which depends on inherent absorption, distribution, metabolism, and excretion properties. For drugs intended to treat Alzheimer's disease or other brain-targeted diseases, the ability of a drug to cross the blood brain barrier may be a key issue. Toxicology and safety studies identify potential target organs for adverse effects and define the Therapeutic Index to set the initial starting doses in clinical trials. Pivotal preclinical safety studies generally require regulatory oversight as defined by US Food and Drug Administration (FDA) Good Laboratory Practices and international guidelines, including the International Conference on Harmonization. Concurrent preclinical development activities include developing the Clinical Plan and preparing the new drug product, including the associated documentation to meet stringent FDA Good Manufacturing Practices regulatory guidelines. A wide range of commercial and government contract options are available for investigators seeking to advance their candidate(s). Government programs such as the Small Business Innovative Research and Small Business Technology Transfer grants and the National Institutes of Health Rapid Access to Interventional Development Pilot Program provide funding and services to assist applicants in preparing the preclinical programs and documentation for their drugs. Increasingly, private foundations are also funding preclinical work. Close interaction with the FDA, including a meeting to prepare for submission of an Investigational New Drug application, is critical to ensure that the preclinical development package properly supports the planned phase I clinical trial.

  13. The basics of preclinical drug development for neurodegenerative disease indications

    PubMed Central

    Steinmetz, Karen L; Spack, Edward G

    2009-01-01

    Preclinical development encompasses the activities that link drug discovery in the laboratory to initiation of human clinical trials. Preclinical studies can be designed to identify a lead candidate from several hits; develop the best procedure for new drug scale-up; select the best formulation; determine the route, frequency, and duration of exposure; and ultimately support the intended clinical trial design. The details of each preclinical development package can vary, but all have some common features. Rodent and nonrodent mammalian models are used to delineate the pharmacokinetic profile and general safety, as well as to identify toxicity patterns. One or more species may be used to determine the drug's mean residence time in the body, which depends on inherent absorption, distribution, metabolism, and excretion properties. For drugs intended to treat Alzheimer's disease or other brain-targeted diseases, the ability of a drug to cross the blood brain barrier may be a key issue. Toxicology and safety studies identify potential target organs for adverse effects and define the Therapeutic Index to set the initial starting doses in clinical trials. Pivotal preclinical safety studies generally require regulatory oversight as defined by US Food and Drug Administration (FDA) Good Laboratory Practices and international guidelines, including the International Conference on Harmonisation. Concurrent preclinical development activities include developing the Clinical Plan and preparing the new drug product, including the associated documentation to meet stringent FDA Good Manufacturing Practices regulatory guidelines. A wide range of commercial and government contract options are available for investigators seeking to advance their candidate(s). Government programs such as the Small Business Innovative Research and Small Business Technology Transfer grants and the National Institutes of Health Rapid Access to Interventional Development Pilot Program provide funding and services to assist applicants in preparing the preclinical programs and documentation for their drugs. Increasingly, private foundations are also funding preclinical work. Close interaction with the FDA, including a meeting to prepare for submission of an Investigational New Drug application, is critical to ensure that the preclinical development package properly supports the planned phase I clinical trial. PMID:19534731

  14. [Response to treatment of patients abusing the "dappou drug" who participated in a group relapse prevention program: a comparison with patients abusing methamphetamine].

    PubMed

    Hikitsuchi, Emi; Matsumoto, Toshihiko; Wada, Kiyoshi; Tanibuchi, Yuko; Takano, Ayumi; Imamura, Fumi; Kawachi, Hiraku; Wakabayashi, Asako; Kato, Takashi

    2014-12-01

    In this study, we compared the efficacy of a group relapse prevention program using the cognitive behavioral therapy-based workbook, Serigaya Methamphetamine Relapse Prevention Program (SMARPP), between patients abusing the so-called "dappou drugs" (designer drug in Japan, and those abusing methamphetamine (MAP). Both groups participated in the SMARPP at the Center Hospital, National Center of Neurology and Psychiatry. Results showed that, no significant differences were found in the rates of participation in the program or self-reported frequency of drug or alcohol use between the patients abusing "dappou drugs" or MAP. However, patients using "dappou drugs" reported no significant increase in their confidence in their ability to resist the temptation to use drugs on the self- report drug abuse scales after the SMARPP intervention, while patients abusing MAP reported a significant positive difference in their ability to resist temptation. In addition, insight into substance abuse problems and motivation to participate in further treatment slightly declined in those using "dappou drugs," while there was a significant increase reported by the patients using MAP. These results suggested that the SMARPP might not be as effective for patients abusing "dappou drugs" as for those abusing MAP. The development of a relapse prevention program specifically designed for patients abusing "dappou drugs" is required.

  15. RAS - Screens & Assays - Drug Discovery

    Cancer.gov

    The RAS Drug Discovery group aims to develop assays that will reveal aspects of RAS biology upon which cancer cells depend. Successful assay formats are made available for high-throughput screening programs to yield potentially effective drug compounds.

  16. Policies and Programs for the 1990's: A Team Approach to the Prevention of Alcohol, Other Drug, and Traffic Safety Problems in Higher Education. 1989 Workshops.

    ERIC Educational Resources Information Center

    Hazelden Services, Inc., Minneapolis, MN.

    This is a workshop training manual designed to help higher education institutional teams develop policies and programs aimed at preventing the abuse of alcohol and use of illegal drugs on their campuses. Three circular diagrams display the community groups that can be involved in drug abuse prevention, higher education institutions that play a…

  17. A Drug-Free Success Story.

    ERIC Educational Resources Information Center

    Macready, Harold

    1990-01-01

    Roosevelt Vocational School (Florida), which prepares special needs students for employment, won President's Drug Free Schools Award. Its program teaches drug prevention and emphasizes the importance of being drug free to job safety. Components include the Chemical Abuse Reduced through Education information and referral system, staff development,…

  18. Impact of Drug Education. Hearing before the Subcommittee on Children, Family, Drugs and Alcoholism of the Committee on Labor and Human Resources. United States Senate, Ninety-Ninth Congress, Second Session on Examining the Need for Drug Abuse Prevention Programs in Public Schools and on Proposals to Provide Assistance for the Development and Expansion of Drug Prevention Programs in Elementary and Secondary Schools in the United States.

    ERIC Educational Resources Information Center

    Congress of the U.S., Washington, DC. Senate Committee on Labor and Human Resources.

    This document contains witness testimonies and prepared statements from the Senate hearing called to examine what drug abuse prevention curriculum will effectively teach public school children to say "no" to drugs. Opening statements are included from Senators Paula Hawkins, John Kerry, Alfonse D'Amato, Dennis DeConcini, Charles…

  19. The Commercial Market For Priority Review Vouchers.

    PubMed

    Ridley, David B; Régnier, Stephane A

    2016-05-01

    In 2007 the US Congress created the priority review voucher program to encourage the development of drugs for neglected diseases. Under the program, the developer of a drug that treats a neglected disease receives both a faster review of the drug by the Food and Drug Administration and a voucher for a faster review of a different drug. The developer can sell the voucher. We estimated the commercial value of the voucher using US sales of new treatments approved in the period 2007-09. A third of the commercial value of a voucher comes from capturing market share from competitors, nearly half from the value of earlier sales because of the expedited review, and less than a quarter from lengthening the time between approval and the launch of a generic competitor. We estimate that if only one priority review voucher is available in a year, it will be worth more than $200 million, but if four vouchers are available, the value could fall below $100 million. Congress should be cautious about expanding the voucher program, because increasing the number of vouchers sharply decreases the expected price. Lower voucher prices could undermine the incentive to develop new medicines for neglected diseases. Project HOPE—The People-to-People Health Foundation, Inc.

  20. Preventing alcohol and drug exposed births in Washington state: intervention findings from three parent-child assistance program sites.

    PubMed

    Grant, Therese M; Ernst, Cara C; Streissguth, Ann; Stark, Kenneth

    2005-01-01

    Home visitation interventions show promise for helping at-risk mothers, yet few programs have been developed and evaluated specifically for alcohol and drug-abusing pregnant women. This study examines outcomes among 216 women enrolled in the Washington State Parent-Child Assistance Program, a three-year intervention program for women who abuse alcohol and drugs during an index pregnancy. Pretest-posttest comparison was made across three sites: the original demonstration (1991-1995), and the Seattle and Tacoma replications (1996-2003). In the original demonstration, the client group performed significantly better than controls. Compared to the original demonstration, outcomes at replication sites were maintained (for regular use of contraception and use of reliable method; and number of subsequent deliveries), or improved (for alcohol/drug treatment completed; alcohol/ drug abstinence; subsequent delivery unexposed to alcohol/drugs). Improved outcomes at replication sites are not attributable to enrolling lower-risk women. Public policies and programs initiated over the study period may have had a positive effect on outcomes. Study findings suggest that this community-based intervention model is effective over time and across venues.

  1. Perceptions of practicing pharmacists in Idaho about a potential behind-the-counter drug program.

    PubMed

    Hunt, Timothy L; Culbertson, Vaughn L; Erramouspe, John; Casperson, Kerry

    2010-09-01

    In late 2007, the Food and Drug Administration (FDA) held public hearings exploring the establishment of a new behind-the-counter (BTC) drug program. However, little is known about the views of pharmacists regarding such a program. To assess the overall perceptions of Idaho's practicing pharmacists about the creation of a formal BTC drug program, the appropriateness of including certain drug categories, specific barriers to its adoption, and the impact of the new program on access to medicines. A survey of practicing pharmacists in Idaho was conducted by mail, utilizing anonymous responses. Key questions exploring the views of pharmacists about the new BTC drug program utilized 5-point Likert scales. Data were also collected on respondent characteristics. A total of 357 practicing pharmacists in Idaho (31% response rate) returned the mail survey; 84% of pharmacists agreed that the FDA should be exploring an expanded BTC program, and 88% of pharmacists agreed that this program would improve access to some prescription-only products and convenience for patients. Almost 71% of pharmacists reported a personal willingness to both initiate and monitor certain BTC drug therapies. When focusing on specific drug categories for BTC status, the highest support was for selected agents within smoking cessation therapies (85%), nasal corticosteroids for allergies (81%), and vaccines (75%). Pharmacists who reported low barriers to the adoption of a new BTC program were significantly more likely to support this program than were those reporting high barriers. Only 39% of pharmacists agreed that adequate facilities were currently available for private evaluation and counseling of BTC patients. Pharmacists in a statewide survey of perceptions regarding a new BTC drug program overwhelmingly believe that patients would benefit. Pharmacists strongly support the development of the new program, and more than two thirds indicate that they would likely participate, given the necessary supporting institutional framework. Perceived barriers are related to willingness to participate and likely can be minimized through education and provision of private consulting areas.

  2. 75 FR 5798 - National Institute on Drug Abuse; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug..., Targeted Library Synthesis and Screening at Novel Targets for Potential Drug Addiction (R21/R33). Date... Panel, Diversity-promoting Institutions' Drug Abuse Research Development Program. Date: February 25...

  3. Application of artificial intelligence to pharmacy and medicine.

    PubMed

    Dasta, J F

    1992-04-01

    Artificial intelligence (AI) is a branch of computer science dealing with solving problems using symbolic programming. It has evolved into a problem solving science with applications in business, engineering, and health care. One application of AI is expert system development. An expert system consists of a knowledge base and inference engine, coupled with a user interface. A crucial aspect of expert system development is knowledge acquisition and implementing computable ways to solve problems. There have been several expert systems developed in medicine to assist physicians with medical diagnosis. Recently, several programs focusing on drug therapy have been described. They provide guidance on drug interactions, drug therapy monitoring, and drug formulary selection. There are many aspects of pharmacy that AI can have an impact on and the reader is challenged to consider these possibilities because they may some day become a reality in pharmacy.

  4. Youth Sport Programs: An Avenue to Foster Positive Youth Development

    ERIC Educational Resources Information Center

    Fraser-Thomas, Jessica L.; Cote, Jean; Deakin, Janice

    2005-01-01

    Concern about the growth in adolescent problem behaviours (e.g. delinquency, drug use) has led to increased interest in positive youth development, and a surge in funding for "after school programs." We evaluate the potential of youth sport programs to foster positive development, while decreasing the risk of problem behaviours.…

  5. Development of a metrics dashboard for monitoring involvement in the 340B Drug Pricing Program.

    PubMed

    Karralli, Rusol; Tipton, Joyce; Dumitru, Doina; Scholz, Lisa; Masilamani, Santhi

    2015-09-01

    An electronic tool to support hospital organizations in monitoring and addressing financial and compliance challenges related to participation in the 340B Drug Pricing Program is described. In recent years there has been heightened congressional and regulatory scrutiny of the federal 340B program, which provides discounted drug prices on Medicaid-covered drugs to safety net hospitals and other 340B-eligible healthcare organizations, or "covered entities." Historically, the 340B program has lacked a metrics-driven reporting framework to help covered entities capture the value of 340B program involvement, community benefits provided to underserved populations, and costs associated with compliance with 340B eligibility requirements. As part of an initiative by a large health system to optimize its 340B program utilization and regulatory compliance efforts, a team of pharmacists led the development of an electronic dashboard tool to help monitor 340B program activities at the system's 340B-eligible facilities. After soliciting input from an array of internal and external 340B program stakeholders, the team designed the dashboard and associated data-entry tools to facilitate the capture and analysis of 340B program-related data in four domains: cost savings and revenue, program maintenance costs, community benefits, and compliance. A large health system enhanced its ability to evaluate and monitor 340B program-related activities through the use of a dashboard tool capturing key metrics on cost savings achieved, maintenance costs, and other aspects of program involvement. Copyright © 2015 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

  6. 78 FR 48691 - Food and Drug Administration Patient Network Annual Meeting; Demystifying Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-09

    ... 240-316-3200 ext. 207. If you need special accommodations due to a disability, please specify those... impact the drug development and review paradigm. Though several programs exist that facilitate patient...

  7. 76 FR 81952 - National Institute on Drug Abuse; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-29

    ... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse..., legislative and program developments in the drug abuse field. Place: National Institutes of Health...: Teresa Levitin, Ph.D., Director, Office of Extramural Affairs, National Institute on Drug Abuse, NIH...

  8. Workshop to review problem-behavior research programs : alcohol, drugs, and highway safety

    DOT National Transportation Integrated Search

    1981-05-01

    The report presents the proceedings of a workshop on alcohol, drugs, and highway safety. The purpose of this workshop was to develop specific recommendations for the planning and implementation of NHTSA research, development, and demonstration projec...

  9. Moving evidence-based drug abuse prevention programs from basic science to practice: "bridging the efficacy-effectiveness interface".

    PubMed

    August, Gerald J; Winters, Ken C; Realmuto, George M; Tarter, Ralph; Perry, Cheryl; Hektner, Joel M

    2004-01-01

    This article examines the challenges faced by developers of youth drug abuse prevention programs in transporting scientifically proven or evidence-based programs into natural community practice systems. Models for research on the transfer of prevention technology are described with specific emphasis given to the relationship between efficacy and effectiveness studies. Barriers that impede the successful integration of efficacy methods within effectiveness studies (e.g., client factors, practitioner factors, intervention structure characteristics, and environmental and organizational factors) are discussed. We present a modified model for program development and evaluation that includes a new type of research design, the hybrid efficacy-effectiveness study that addresses program transportability. The utility of the hybrid study is illustrated in the evaluation of the Early Risers "Skills for Success" prevention program.

  10. 24 CFR 21.215 - What must I include in my drug-free awareness program?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... dangers of drug abuse in the workplace; (b) Your policy of maintaining a drug-free workplace; (c) Any... may impose upon them for drug abuse violations occurring in the workplace. ... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false What must I include in my drug-free...

  11. 24 CFR 21.215 - What must I include in my drug-free awareness program?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... dangers of drug abuse in the workplace; (b) Your policy of maintaining a drug-free workplace; (c) Any... may impose upon them for drug abuse violations occurring in the workplace. ... 24 Housing and Urban Development 1 2011-04-01 2011-04-01 false What must I include in my drug-free...

  12. INTEGRATING HEALTH TECHNOLOGY ASSESSMENT PRINCIPLES IN FORMULARY MANAGEMENT.

    PubMed

    Teng, Monica; Khoo, Ai Leng; Zhao, Ying Jiao; Lin, Liang; Lim, Boon Peng

    2016-01-01

    Effective formulary management in healthcare institutions safeguards rational drug use and optimizes health outcomes. We implemented a formulary management program integrating the principles of health technology assessment (HTA) to improve the safe, appropriate, and cost-effective use of medicine in Singapore. A 3-year formulary management program was initiated in 2011 in five public healthcare institutions. This program was managed by a project team comprising HTA researchers. The project team worked with institutional pharmacy and therapeutics (P&T) committees to: (i) develop tools for formulary drug review and decision making; (ii) enhance the HTA knowledge and skills of formulary pharmacists and members of P&T committees; (iii) devise a prioritization framework to overcome resource constraints and time pressure; and (iv) conceptualize and implement a framework to review existing formulary. Tools that facilitate drug request submission, drug review, and decision making were developed for formulary drug inclusion. A systematic framework to review existing formulary was also developed and tested in selected institutions. A competency development plan was rolled out over 2 years to enhance formulary pharmacists' proficiency in systematic literature search and review, meta-analysis, and pharmacoeconomic evaluation. The plan comprised training workshops and on-the-job knowledge transfer between the project team and institutional formulary pharmacists through collaborating on selected drug reviews. A resource guide that consolidated the tools and templates was published to encourage the adoption of best practices in formulary management. Based on the concepts of HTA, we implemented an evidence-based approach to optimize formulary management.

  13. Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration.

    PubMed

    Green, Dionna J; Liu, Xiaomei I; Hua, Tianyi; Burnham, Janelle M; Schuck, Robert; Pacanowski, Michael; Yao, Lynne; McCune, Susan K; Burckart, Gilbert J; Zineh, Issam

    2017-12-08

    Clinical trial enrichment involves prospectively incorporating trial design elements that increase the probability of detecting a treatment effect. The use of enrichment strategies in pediatric drug development has not been systematically assessed. We analyzed the use of enrichment strategies in pediatric trials submitted to the US Food and Drug Administration from 2012-2016. In all, 112 efficacy studies associated with 76 drug development programs were assessed and their overall success rates were 78% and 75%, respectively. Eighty-eight trials (76.8%) employed at least one enrichment strategy; of these, 66.3% employed multiple enrichment strategies. The highest trial success rates were achieved when all three enrichment strategies (practical, predictive, and prognostic) were used together within a single trial (87.5%), while the lowest success rate was observed when no enrichment strategy was used (65.4%). The use of enrichment strategies in pediatric trials was found to be associated with trial and program success in our analysis. © 2017 American Society for Clinical Pharmacology and Therapeutics.

  14. Australian school-based prevention programs for alcohol and other drugs: a systematic review.

    PubMed

    Teesson, Maree; Newton, Nicola C; Barrett, Emma L

    2012-09-01

    To reduce the occurrence and costs related to substance use and associated harms it is important to intervene early. Although a number of international school-based prevention programs exist, the majority show minimal effects in reducing drug use and related harms. Given the emphasis on early intervention and prevention in Australia, it is timely to review the programs currently trialled in Australian schools. This paper reports the type and efficacy of Australian school-based prevention programs for alcohol and other drugs. Cochrane, PsychInfo and PubMed databases were searched. Additional materials were obtained from authors, websites and reference lists. Studies were selected if they described programs developed and trialled in Australia that address prevention of alcohol and other drug use in schools. Eight trials of seven intervention programs were identified. The programs targeted alcohol, cannabis and tobacco and most were based on social learning principles. All were universal. Five of the seven intervention programs achieved reductions in alcohol, cannabis and tobacco use at follow up. Existing school-based prevention programs have shown to be efficacious in the Australian context. However, there are only a few programs available, and these require further evaluative research. This is critical, given that substance use is such a significant public health problem. The findings challenge the commonly held view that school-based prevention programs are not effective. © 2012 Australasian Professional Society on Alcohol and other Drugs.

  15. Drug efficiency: a new concept to guide lead optimization programs towards the selection of better clinical candidates.

    PubMed

    Braggio, Simone; Montanari, Dino; Rossi, Tino; Ratti, Emiliangelo

    2010-07-01

    As a result of their wide acceptance and conceptual simplicity, drug-like concepts are having a major influence on the drug discovery process, particularly in the selection of the 'optimal' absorption, distribution, metabolism, excretion and toxicity and physicochemical parameters space. While they have an undisputable value when assessing the potential of lead series or in evaluating inherent risk of a portfolio of drug candidates, they result much less useful in weighing up compounds for the selection of the best potential clinical candidate. We introduce the concept of drug efficiency as a new tool both to guide the drug discovery program teams during the lead optimization phase and to better assess the developability potential of a drug candidate.

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

    PubMed

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

    1990-04-01

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

  17. The use of the United States FDA programs as a strategy to advance the development of drug products for neglected tropical diseases.

    PubMed

    Sachs-Barrable, Kristina; Conway, Jocelyn; Gershkovich, Pavel; Ibrahim, Fady; Wasan, Kishor M

    2014-11-01

    Neglected tropical diseases (NTDs) are infections which are endemic in poor populations in lower- and middle-income countries (LMIC). Approximately one billion people have now or are at risk of getting an NTD and yet less than 5% of research dollars are focused on providing treatments and prevention of these highly debilitating and deadly conditions. The United States Food and Drug Administration (FDA) Orphan Drug Designation program (ODDP) provides orphan status to drugs and biologics, defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases and/or disorders that affect fewer than 200 000 people in the United States, or that affect more than 200 000 persons but are not expected to recover the costs of developing and marketing a treatment drug. These regulations have led to the translation of rare disease knowledge into innovative rare disease therapies. The FDA Guidance for Industry on developing drugs for the treatment and prevention of NTDs describes the following regulatory strategies: Orphan Product Designation, Fast Track Designation, Priority Review Designation, Accelerated Approval and Tropical Disease Priority Review Voucher. This paper will discuss how these regulations and especially the ODDP can improve the clinical development and accessibility of drug products for NTDs.

  18. Working together: Expanding the availability of naloxone for peer administration to prevent opioid overdose deaths in the Australian Capital Territory and beyond.

    PubMed

    Lenton, Simon; Dietze, Paul; Olsen, Anna; Wiggins, Nicole; McDonald, David; Fowlie, Carrie

    2015-07-01

    Since the mid-1990s, there have been calls to make naloxone, a prescription-only medicine in many countries, available to heroin and other opioid users and their peers and family members to prevent overdose deaths. In Australia there were calls for a trial of peer naloxone in 2000, yet at the end of that year, heroin availability and harm rapidly declined, and a trial did not proceed. In other countries, a number of peer naloxone programs have been successfully implemented. Although a controlled trial had not been conducted, evidence of program implementation demonstrated that trained injecting drug-using peers and others could successfully administer naloxone to reverse heroin overdose, with few, if any, adverse effects. In 2009 Australian drug researchers advocated the broader availability of naloxone for peer administration in cases of opioid overdose. Industrious local advocacy and program development work by a number of stakeholders, notably by the Canberra Alliance for Harm Minimisation and Advocacy, a drug user organisation, contributed to the rollout of Australia's first prescription naloxone program in the Australian Capital Territory (ACT). Over the subsequent 18 months, prescription naloxone programs were commenced in four other Australian states. The development of Australia's first take-home naloxone program in the ACT has been an 'ice-breaker' for development of other Australian programs. Issues to be addressed to facilitate future scale-up of naloxone programs concern scheduling and cost, legal protections for lay administration, prescribing as a barrier to scale-up; intranasal administration, administration by service providers and collaboration between stakeholders. © 2014 Australasian Professional Society on Alcohol and other Drugs.

  19. 75 FR 14176 - National Institute on Drug Abuse; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-24

    ... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... announcements and reports of administrative, legislative and program developments in the drug abuse field. Place... Person: Teresa Levitin, PhD, Director, Office of Extramural Affairs, National Institute on Drug Abuse...

  20. 75 FR 42100 - National Institute on Drug Abuse; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-20

    ... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse..., legislative and program developments in the drug abuse field. Place: National Institutes of Health...: Teresa Levitin, PhD, Director, Office of Extramural Affairs, National Institute on Drug Abuse, NIH, DHHS...

  1. 77 FR 52752 - National Institute on Drug Abuse; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-30

    ... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse..., legislative and program developments in the drug abuse field. Place: National Institutes of Health... Drug Abuse, NIH, DHHS, Room 4243, MSC 9550, 6001 Executive Boulevard, Bethesda, MD 20892-89550, (301...

  2. Factors associated with the implementation of programs for drug abuse prevention in schools

    PubMed Central

    Pereira, Ana Paula Dias; Paes, Ângela Tavares; Sanchez, Zila M

    2016-01-01

    ABSTRACT OBJECTIVE To analyze if characteristics of managers, schools, and curriculum are associated with the implementation of programs for drug abuse prevention in elementary and high schools. METHODS Cross-sectional study, with random sample of 263 school managers. Data were collected between 2012 and 2013 by a program that sends forms via internet. A closed self-filling questionnaire was applied online. Statistical analysis included Chi-square tests and logistic regression models. The outcome variable was the presence of program for drug abuse prevention inserted in the daily life and educational program of the school. The explanatory variables were divided into: demographic data of the manager; characteristics of the school and of the curriculum; health education; and drug use in the school. RESULTS We found that 42.5% (95%CI 36.1–49.1) of the evaluated schools had programs for drug abuse prevention. With the multiple logistic regression model, we observed that the more time the manager has worked with education, the chance of the school having a program increased at about 4.0%. Experimenting with innovative teaching techniques also increased at about six times the chance of the school developing a program for drug abuse prevention. The difficulties in the implementation of the programs were more present in state and municipal schools, when compared with private schools, due to, for instance: lack of teaching materials, lack of money, and competing demands for teaching other subjects. CONCLUSIONS The implementation of programs for drug abuse prevention in the city of Sao Paulo is associated with the experience of the manager in education and with the teaching strategies of the school. PMID:27509010

  3. Understanding Attitude Change in Developing Effective Substance Abuse Prevention Programs for Adolescents.

    ERIC Educational Resources Information Center

    Scott, Cynthia G.

    1996-01-01

    Alcohol and drug use may be a significant part of the adolescent, high school experience. Programs should be based on an understanding of attitudes and patterns of use, and how change occurs. Elaboration Likelihood Model of Persuasion is a framework with which to examine attitude change and provide a base for building sound drug prevention…

  4. Going the Distance: Delivery of High School Drug Prevention via Distance Education

    ERIC Educational Resources Information Center

    Wyrick, David L.; Fearnow-Kenney, Melodie; Wyrick, Cheryl Haworth; Orsini, Muhsin Michael; Strack, Robert W.; Milroy, Jeffrey J.

    2010-01-01

    The purpose of this project was to develop a technology that can be used in schools where there are insufficient resources to implement a quality drug prevention program. The specific technology--distance education via teleconferencing--allows a highly qualified teacher to deliver programs in such settings with increased quality. A promising high…

  5. An Interdisciplinary Approach for the Integration and Diffusion of Substance Abuse Prevention Programs

    ERIC Educational Resources Information Center

    Bechtel, Lori J.; Vicary, Judith; Swisher, John; Smith, Edward; Hopkins, Abigail; Henry, Kimberly; Minner, Daphne

    2006-01-01

    Effective substance abuse prevention programs help students develop knowledge as well as psychosocial competencies that can help them resist or delay the initiation of alcohol, tobacco and other drug (ATOD) use. This paper describes the integration process used in a five-year project, Adoption of Drug Abuse Prevention Training (ADAPT), to study…

  6. Piquing Student Interest with Pharmacology: An Interdisciplinary Program Helps High School Students Learn Biology and Chemistry Principles

    ERIC Educational Resources Information Center

    Halpin, Myra J.; Hoeffler, Leanne; Schwartz-Bloom, Rochelle D.

    2005-01-01

    To help students learn science concepts, Pharmacology Education Partnership (PEP)--a science education program that incorporates relevant topics related to drugs and drug abuse into standard biology and chemistry curricula was developed. The interdisciplinary PEP curriculum provides six modules to teach biology and chemistry principles within the…

  7. Translating evidence based violence and drug use prevention to obesity prevention: development and construction of the pathways program.

    PubMed

    Sakuma, Kari-Lyn K; Riggs, Nathaniel R; Pentz, Mary Ann

    2012-04-01

    Effective school-based obesity prevention programs are needed to prevent and reduce the growing obesity risk among youth. Utilizing the evidence-rich areas of violence and substance use prevention, translation science may provide an efficient means for developing curricula across multiple health behaviors. This paper introduces Pathways to Health, a school-based obesity prevention program that was developed by translating from evidence-based violence and drug use prevention programs, Promoting Alternative THinking Strategies and the Midwestern Prevention Project STAR (STAR). We illustrate how a hypothesized underlying behavior change mechanism in two domains of risk behavior, violence and substance use, can be applied to obesity prevention. A 4-step translational process is provided and may be relevant for use in developing other curricula to address multiple health risk behaviors. Practical application and decision points are also provided.

  8. Translating evidence based violence and drug use prevention to obesity prevention: development and construction of the Pathways program

    PubMed Central

    Sakuma, Kari-Lyn K.; Riggs, Nathaniel R.; Pentz, Mary Ann

    2012-01-01

    Effective school-based obesity prevention programs are needed to prevent and reduce the growing obesity risk among youth. Utilizing the evidence-rich areas of violence and substance use prevention, translation science may provide an efficient means for developing curricula across multiple health behaviors. This paper introduces Pathways to Health, a school-based obesity prevention program that was developed by translating from evidence-based violence and drug use prevention programs, Promoting Alternative THinking Strategies and the Midwestern Prevention Project STAR (STAR). We illustrate how a hypothesized underlying behavior change mechanism in two domains of risk behavior, violence and substance use, can be applied to obesity prevention. A 4-step translational process is provided and may be relevant for use in developing other curricula to address multiple health risk behaviors. Practical application and decision points are also provided. PMID:21987475

  9. Current Status of Human Resource Training Program for Fostering RIBiomics Professionals

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Lee, Dong-Eun; Jang, Beom-Su; Choi, Dae Seong

    RI-Biomics is a state-of-the-art radiation fusion technology for evaluating in-vivo dynamics such as absorption, distribution, metabolism and excretion (ADME) of new drug candidates and biomaterials using radioisotope (RI), and quantitative evaluation of their efficacy via molecular imaging techniques and animal models. The RI-Biomics center is the sole comprehensive research and experiment complex in Korea that can simultaneously perform the radio-synthesis of drug candidate with radioisotope, analysis, and molecular imaging evaluation with animal model. Molecular imaging techniques, including nuclear imaging (SPECT and PET), near-infrared fluorescent (NIRF) imaging, and magnetic resonance imaging (MRI), are the cutting-edge technologies for evaluating drug candidates. Sincemore » they allow in vivo real-time imaging of the diseased site, monitoring the biodistribution of drug and determining the optimal therapeutic efficacy following treatments, we have integrated RI-ADME and molecular imaging to provide useful information for drug evaluation and to accelerate the development of new drugs and biomaterials. The RI-Biomics center was established with total investment of 18 million $ during four years from 2009 to 2012 in order to develop a comprehensive analyzing system using RI for new drug development as an axis for national growth in the next generation. The RI-Biomics center has labeling synthesis facility for the radiosynthesis of drug candidate with radioisotope such as Tc-99m, I-125, I-131, F-18, H-3 and C-14 using hot cell. It also includes RI-general analysis facilities, such as Radio-HPLC, LC/MS, GC/MS, gamma counter that can analyzing the radio-synthesized materials, and animal image analysis facilities that developed small animal imaging equipment such as SPECT/PET/CT, 7 T MRI, in-vivo optical imaging system and others. In order to achieve the system to verify safety and effectiveness of the new drugs using RI, it is necessary to establish a human resource training program for fostering RI-Biomics professionals in the following key fields; (1) Radio-pharmaceuticals synthesis and labeled compound development, (2) Development of RI-ADME in the living object and image assessment technology. Personnel training program that carries out theoretical education and practical training in the field related to RI-Biomics in parallel is being conducted. Internship training for university students has been administered twice already while educational program for the existing professionals in the RI-Biomics field will be carried out during the summer of 2014. The human resource training program for combination of RIADME and different molecular imaging techniques can offer synergistic advantages to facilitate understanding RIADME and fostering RI-ADME professionals. (authors)« less

  10. The Development of Videos in Culturally Grounded Drug Prevention for Rural Native Hawaiian Youth

    ERIC Educational Resources Information Center

    Okamoto, Scott K.; Helm, Susana; McClain, Latoya L.; Dinson, Ay-Laina

    2012-01-01

    The purpose of this study was to adapt and validate narrative scripts to be used for the video components of a culturally grounded drug prevention program for rural Native Hawaiian youth. Scripts to be used to film short video vignettes of drug-related problem situations were developed based on a foundation of pre-prevention research funded by the…

  11. A systematic review of combined student- and parent-based programs to prevent alcohol and other drug use among adolescents.

    PubMed

    Newton, Nicola C; Champion, Katrina E; Slade, Tim; Chapman, Cath; Stapinski, Lexine; Koning, Ina; Tonks, Zoe; Teesson, Maree

    2017-05-01

    Alcohol and other drug use among adolescents is a serious concern, and effective prevention is critical. Research indicates that expanding school-based prevention programs to include parenting components could increase prevention outcomes. This paper aims to identify and describe existing combined student- and parent-based programs for the prevention of alcohol and other drug use to evaluate the efficacy of existing programs. The PsycINFO, Medline, Central Register of Controlled trials and Cochrane databases were searched in April 2015 and additional articles were obtained from reference lists. Studies were included if they evaluated a combined universal intervention for students (aged 11-18 years old) and their parents designed to prevent alcohol and/or other drug use, and were delivered in a school-based setting. Risk of bias was assessed by two independent reviewers. Because of the heterogeneity of the included studies, it was not possible to conduct a meta-analysis and a qualitative description of the studies was provided. From a total of 1654 screened papers, 22 research papers met inclusion criteria, which included 13 trials of 10 programs. Of these, nine programs demonstrated significant intervention effects in terms of delaying or reducing adolescent alcohol and/or other drug use in at least one trial. This is the first review of combined student- and parent-based interventions to prevent and reduce alcohol and other drug use. Whilst existing combined student- and parent-based programs have shown promising results, key gaps in the literature have been identified and are discussed in the context of the development of future prevention programs. [Newton NC, Champion KE, Slade T, Chapman C, Stapinski L, Koning I, Tonks Z, Teesson M. A systematic review of combined student- and parent-based programs to prevent alcohol and other drug use among adolescents. Drug Alcohol Rev 2017;36:337-351]. © 2017 Australasian Professional Society on Alcohol and other Drugs.

  12. "Creating hope" and other incentives for drug development for children.

    PubMed

    Connor, Edward; Cure, Pablo

    2011-01-19

    Enhancing drug development for pediatric disease is a priority and a public responsibility. The Creating Hope Act of 2010 is important new proposed legislation that adds drugs and biologics for treating rare diseases in children to those for neglected tropical diseases as eligible for a priority review voucher from the U.S. Food and Drug Administration. The Act enhances existing incentive programs through specific financial benefits to companies who seek a pediatric indication for a new drug to treat an orphan disease that occurs specifically in children.

  13. Ayurgenomics for stratified medicine: TRISUTRA consortium initiative across ethnically and geographically diverse Indian populations.

    PubMed

    Prasher, Bhavana; Varma, Binuja; Kumar, Arvind; Khuntia, Bharat Krushna; Pandey, Rajesh; Narang, Ankita; Tiwari, Pradeep; Kutum, Rintu; Guin, Debleena; Kukreti, Ritushree; Dash, Debasis; Mukerji, Mitali

    2017-02-02

    Genetic differences in the target proteins, metabolizing enzymes and transporters that contribute to inter-individual differences in drug response are not integrated in contemporary drug development programs. Ayurveda, that has propelled many drug discovery programs albeit for the search of new chemical entities incorporates inter-individual variability "Prakriti" in development and administration of drug in an individualized manner. Prakriti of an individual largely determines responsiveness to external environment including drugs as well as susceptibility to diseases. Prakriti has also been shown to have molecular and genomic correlates. We highlight how integration of Prakriti concepts can augment the efficiency of drug discovery and development programs through a unique initiative of Ayurgenomics TRISUTRA consortium. Five aspects that have been carried out are (1) analysis of variability in FDA approved pharmacogenomics genes/SNPs in exomes of 72 healthy individuals including predominant Prakriti types and matched controls from a North Indian Indo-European cohort (2) establishment of a consortium network and development of five genetically homogeneous cohorts from diverse ethnic and geo-climatic background (3) identification of parameters and development of uniform standard protocols for objective assessment of Prakriti types (4) development of protocols for Prakriti evaluation and its application in more than 7500 individuals in the five cohorts (5) Development of data and sample repository and integrative omics pipelines for identification of genomic correlates. Highlight of the study are (1) Exome sequencing revealed significant differences between Prakriti types in 28 SNPs of 11 FDA approved genes of pharmacogenomics relevance viz. CYP2C19, CYP2B6, ESR1, F2, PGR, HLA-B, HLA-DQA1, HLA-DRB1, LDLR, CFTR, CPS1. These variations are polymorphic in diverse Indian and world populations included in 1000 genomes project. (2) Based on the phenotypic attributes of Prakriti we identified anthropometry for anatomical features, biophysical parameters for skin types, HRV for autonomic function tests, spirometry for vital capacity and gustometry for taste thresholds as objective parameters. (3) Comparison of Prakriti phenotypes across different ethnic, age and gender groups led to identification of invariant features as well as some that require weighted considerations across the cohorts. Considering the molecular and genomics differences underlying Prakriti and relevance in disease pharmacogenomics studies, this novel integrative platform would help in identification of differently susceptible and drug responsive population. Additionally, integrated analysis of phenomic and genomic variations would not only allow identification of clinical and genomic markers of Prakriti for application in personalized medicine but also its integration in drug discovery and development programs. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  14. The Devil Is in the Details: Examining the Evidence for "Proven" School-Based Drug Abuse Prevention Programs

    ERIC Educational Resources Information Center

    Gandhi, Allison Gruner; Murphy-Graham, Erin; Petrosino, Anthony; Chrismer, Sara Schwartz; Weiss, Carol H.

    2007-01-01

    In an effort to promote evidence-based practice, government officials, researchers, and program developers have developed lists of model programs in the prevention field. This article reviews the evidence used by seven best-practice lists to select five model prevention programs. The authors' examination of this research raises questions about the…

  15. Female Ex-Offender Perspectives on Drug Initiation, Relapse, and Desire to Remain Drug Free

    PubMed Central

    Nyamathi, Adeline M.; Srivastava, Neha; Salem, Benissa E.; Wall, Sarah; Kwon, Jordan; Ekstrand, Maria; Hall, Elizabeth; Turner, Susan F.; Faucette, Mark

    2016-01-01

    Recently-released homeless women residing in temporary residential drug treatment programs are at a critical juncture in the process of recovery, transition and reentry. The purpose of this study was to explore factors influencing initial use of drugs and relapse triggers among a sample of incarcerated women exiting jails and prisons, and who are residing in a residential drug treatment (RDT) program and preparing for reentry into their communities. Among this population, relapse to drug use and recidivism are common. A qualitative study was conducted utilizing focus groups to understand the perspectives of formerly incarcerated, currently homeless women residing in a RDT program. Content analysis generated the development of three broad categories: a) factors associated with first drug use; b) factors involved in relapse; c) factors influencing desire to remain drug free. A discussion follows highlighting the importance of targeted interventions at RDT sites that integrate physical, psychological and social needs to optimize reentry into communities. This would include a focus on building self-esteem, life skills, and providing access to resources such as housing, employment, and healthcare. PMID:27195929

  16. Parent Engagement in Youth Drug Prevention in Chinese Families: Advancement in Program Development and Evaluation

    PubMed Central

    Tsang, Sandra K. M.

    2011-01-01

    The escalating youth drug abuse problem in Hong Kong has attracted intense attention from the government, schools, and youth service professionals. Most preventive efforts have focused directly on positive youth development, very often through school programs delivered to secondary school students. There have been limited efforts to engage parents even though it is obvious that the family is actually the primary context of children and youth development. This paper will assert the importance of parental engagement in youth drug-prevention work, discuss some barriers in such parental involvement, present some promising local attempts and their strengths and limitations, and propose that sustained efforts are needed to build up theory-driven and evidence-based resources for Chinese communities on the subject. PMID:22194665

  17. Stress Levels of Recovering Drug Addicts.

    ERIC Educational Resources Information Center

    LaMon, Brent C.; Alonzo, Anthony

    It appears that chronic drug use may develop as a means of coping in which individuals use self-medication to produce a more desirable state of being. Because drugs are often used to cope with stress, this study examined stress among recovering male drug addicts (N=23) from an urban substance abuse program by administering a self-report inventory…

  18. 78 FR 45252 - National Institute on Drug Abuse; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-26

    ... U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Drug Abuse... on Drug Abuse. Date: September 4, 2013. Closed: 8:30 AM to 10:30 AM. Agenda: To review and evaluate... program developments in the drug abuse field. Place: National Institutes of Health, Neuroscience Center...

  19. Proposed 'grant-and-access' program with price caps could stimulate development of drugs for very rare diseases.

    PubMed

    Valverde, Ana M; Reed, Shelby D; Schulman, Kevin A

    2012-11-01

    The 1983 Orphan Drug Act created incentives for the development of orphan drugs. Despite its successes, including a substantial increase in new drugs, approved orphan drugs still treat fewer than 5 percent of registered rare diseases. In addition, concerns have arisen about the high prices of many of these therapies, which can cost hundreds of thousands of dollars per patient each year. In this article, we propose a new "grant-and-access pathway," in which drug developers could opt to compete for federal grants to subsidize the costs of clinical testing. In return for the grant funding, companies would no longer claim orphan drug tax credits and would agree to price caps for marketed products based on the duration and costs associated with drug development, expected market size, and target rate of return. We identify scenarios in which such a policy could provide a net benefit to society.

  20. Effective Alcohol, Tobacco and Other Drug Intervention and Prevention Using Online Game-Based, E-Learning: An Evidence-Informed Program That Works

    ERIC Educational Resources Information Center

    Schweizer, Heidi; Hayslett, Carrianne; Bansal, Naveen; Ronco, Sharron; Schafer, Richard

    2014-01-01

    Background: The host of costly individual and societal consequences of alcohol, tobacco, and other drugs (ATOD) use underscores the importance of ATOD prevention education. "It's Up 2U" is an evidence-informed, game-based, e-learning ATOD prevention program developed by Children's Health Education Center (CHEC) targeting middle school…

  1. Discovery of Bioactive Compounds by the UIC-ICBG Drug Discovery Program in the 18 Years Since 1998.

    PubMed

    Zhang, Hong-Jie; Li, Wan-Fei; Fong, Harry H S; Soejarto, Djaja Doel

    2016-10-31

    The International Cooperative Biodiversity Groups (ICBG) Program based at the University of Illinois at Chicago (UIC) is a program aimed to address the interdependent issues of inventory and conservation of biodiversity, drug discovery and sustained economic growth in both developing and developed countries. It is an interdisciplinary program involving the extensive synergies and collaborative efforts of botanists, chemists and biologists in the countries of Vietnam, Laos and the USA. The UIC-ICBG drug discovery efforts over the past 18 years have resulted in the collection of a cumulative total of more than 5500 plant samples (representing more than 2000 species), that were evaluated for their potential biological effects against cancer, HIV, bird flu, tuberculosis and malaria. The bioassay-guided fractionation and separation of the bioactive plant leads resulted in the isolation of approximately 300 compounds of varying degrees of structural complexity and/or biological activity. The present paper summarizes the significant drug discovery achievements made by the UIC-ICBG team of multidisciplinary collaborators in the project over the period of 1998-2012 and the projects carried on in the subsequent years by involving the researchers in Hong Kong.

  2. Academic Linkage and Credentialing. Drug Program Report.

    ERIC Educational Resources Information Center

    Contee, Jerome A., Ed.

    This report describes several examples of successful academic linkages between state training offices and postsecondary institutions that result in enhanced professional development opportunities for drug abuse workers. The role of federal and state governments in drug abuse training is discussed along with several articles that are designed to…

  3. Implementation of a drug-use and disease-state management program.

    PubMed

    Skledar, S J; Hess, M M

    2000-12-15

    A drug-use and disease-state management (DUDSM) program was instituted in 1996 at a teaching hospital associated with a large nonprofit health care system. The program's goals are to optimize pharmacotherapeutic regimens, evaluate health outcomes of identified disease states, and evaluate the economic impact of pharmacotherapeutic options for given disease states by developing practice guidelines. Through a re-engineering process, resources within the pharmacy department were identified that could be devoted to the DUDSM program, including the use of clinical pharmacy specialists, promotion of staff pharmacists into the DUDSM program, a pharmacy technician, and information systems support. A strength of the program is its systematic approach for developing and implementing new initiatives, as well as monitoring compliance with all initiatives on an ongoing basis. The initiative-design process incorporates continuous quality improvement principles, outcome design and evaluation, competency assessment for all pharmacists, multidisciplinary collaboration, and sophisticated information systems. Seventy-five initiatives have been implemented, ranging from simple dose-optimization strategies for specific drugs to complicated practice guidelines for managing specific disease states. Improved patient outcomes have been documented, including reduced length of stay, postsurgical wound infection, adverse drug reactions, and medication errors. Documented cost savings exceeded $4 million annually for fiscal years 1996-97 through 1999-2000. Overall compliance with DUDSM initiatives exceeds 80%, and physician service profiling has been initiated to monitor variant prescribing. The DUDSM program has successfully integrated practice guidelines into therapeutic decision-making, resulting in improved patient-care outcomes and cost savings.

  4. Success for Every Teen: Programs that Help Adolescents Avoid Pregnancy, Gangs, Drug Abuse, and School Drop-Out. An Ounce of Prevention Fund Paper.

    ERIC Educational Resources Information Center

    Ounce of Prevention Fund.

    This booklet describes two prevention programs, Peer Power, a program for girls, and Awareness and Development for Adolescent Males (ADAM), a program for boys. It is noted that these programs, designed to reach students before high school age, help young adolescents stay in school, delay sexual activity and pregnancy, and develop realistic career…

  5. Integrative relational machine-learning for understanding drug side-effect profiles

    PubMed Central

    2013-01-01

    Background Drug side effects represent a common reason for stopping drug development during clinical trials. Improving our ability to understand drug side effects is necessary to reduce attrition rates during drug development as well as the risk of discovering novel side effects in available drugs. Today, most investigations deal with isolated side effects and overlook possible redundancy and their frequent co-occurrence. Results In this work, drug annotations are collected from SIDER and DrugBank databases. Terms describing individual side effects reported in SIDER are clustered with a semantic similarity measure into term clusters (TCs). Maximal frequent itemsets are extracted from the resulting drug x TC binary table, leading to the identification of what we call side-effect profiles (SEPs). A SEP is defined as the longest combination of TCs which are shared by a significant number of drugs. Frequent SEPs are explored on the basis of integrated drug and target descriptors using two machine learning methods: decision-trees and inductive-logic programming. Although both methods yield explicit models, inductive-logic programming method performs relational learning and is able to exploit not only drug properties but also background knowledge. Learning efficiency is evaluated by cross-validation and direct testing with new molecules. Comparison of the two machine-learning methods shows that the inductive-logic-programming method displays a greater sensitivity than decision trees and successfully exploit background knowledge such as functional annotations and pathways of drug targets, thereby producing rich and expressive rules. All models and theories are available on a dedicated web site. Conclusions Side effect profiles covering significant number of drugs have been extracted from a drug ×side-effect association table. Integration of background knowledge concerning both chemical and biological spaces has been combined with a relational learning method for discovering rules which explicitly characterize drug-SEP associations. These rules are successfully used for predicting SEPs associated with new drugs. PMID:23802887

  6. Integrative relational machine-learning for understanding drug side-effect profiles.

    PubMed

    Bresso, Emmanuel; Grisoni, Renaud; Marchetti, Gino; Karaboga, Arnaud Sinan; Souchet, Michel; Devignes, Marie-Dominique; Smaïl-Tabbone, Malika

    2013-06-26

    Drug side effects represent a common reason for stopping drug development during clinical trials. Improving our ability to understand drug side effects is necessary to reduce attrition rates during drug development as well as the risk of discovering novel side effects in available drugs. Today, most investigations deal with isolated side effects and overlook possible redundancy and their frequent co-occurrence. In this work, drug annotations are collected from SIDER and DrugBank databases. Terms describing individual side effects reported in SIDER are clustered with a semantic similarity measure into term clusters (TCs). Maximal frequent itemsets are extracted from the resulting drug x TC binary table, leading to the identification of what we call side-effect profiles (SEPs). A SEP is defined as the longest combination of TCs which are shared by a significant number of drugs. Frequent SEPs are explored on the basis of integrated drug and target descriptors using two machine learning methods: decision-trees and inductive-logic programming. Although both methods yield explicit models, inductive-logic programming method performs relational learning and is able to exploit not only drug properties but also background knowledge. Learning efficiency is evaluated by cross-validation and direct testing with new molecules. Comparison of the two machine-learning methods shows that the inductive-logic-programming method displays a greater sensitivity than decision trees and successfully exploit background knowledge such as functional annotations and pathways of drug targets, thereby producing rich and expressive rules. All models and theories are available on a dedicated web site. Side effect profiles covering significant number of drugs have been extracted from a drug ×side-effect association table. Integration of background knowledge concerning both chemical and biological spaces has been combined with a relational learning method for discovering rules which explicitly characterize drug-SEP associations. These rules are successfully used for predicting SEPs associated with new drugs.

  7. Brains Rule!: A Model Program for Developing Professional Stewardship among Neuroscientists

    ERIC Educational Resources Information Center

    Zardetto-Smith, Andrea M.; Mu, Keli; Carruth, Laura L.; Frantz, Kyle J.

    2006-01-01

    Brains Rule! Neuroscience Expositions, funded through a National Institute on Drug Abuse Science Education Drug Abuse Partnership Award, has developed a successful model for informal neuroscience education. Each Exposition is a "reverse science fair" in which neuroscientists present short neuroscience teaching modules to students. This…

  8. Using Media Resources to Explore Drug Use in Society: A Special 5th Grade Drug Education Lesson That Makes Use of Library Media Resources.

    ERIC Educational Resources Information Center

    Packer, Kenneth L.; And Others

    This teaching guide, written for elementary school teachers and librarians, combines drug education for fifth grade students with library skill development. Following a preface to the guide, the affective model upon which the program is based (development of positive self-image and self-concept, and communication and coping skills) is presented.…

  9. Threshold virus dynamics with impulsive antiretroviral drug effects

    PubMed Central

    Lou, Jie; Lou, Yijun; Wu, Jianhong

    2013-01-01

    The purposes of this paper are twofold: to develop a rigorous approach to analyze the threshold behaviors of nonlinear virus dynamics models with impulsive drug effects and to examine the feasibility of virus clearance following the Manuals of National AIDS Free Antiviral Treatment in China. An impulsive system of differential equations is developed to describe the within-host virus dynamics of both wild-type and drug-resistant strains when a combination of antiretroviral drugs is used to induce instantaneous drug effects at a sequence of dosing times equally spaced while drug concentrations decay exponentially after the dosing time. Threshold parameters are derived using the basic reproduction number of periodic epidemic models, and are used to depict virus clearance/persistence scenarios using the theory of asymptotic periodic systems and the persistence theory of discrete dynamical systems. Numerical simulations using model systems parametrized in terms of the antiretroviral therapy recommended in the aforementioned Manuals illustrate the theoretical threshold virus dynamics, and examine conditions under which the impulsive antiretroviral therapy leads to treatment success. In particular, our results show that only the drug-resistant strain can dominate (the first-line treatment program guided by the Manuals) or both strains may be rapidly eliminated (the second-line treatment program), thus the work indicates the importance of implementing the second-line treatment program as soon as possible. PMID:21987085

  10. Drug-Involved Mexican-Origin Girls’ HIV Prevention Needs: A Pilot Study

    PubMed Central

    Lopez, Vera; Dustman, Patricia; Williams, Tiffany

    2017-01-01

    The purpose of this pilot study was to collect data to inform the development of an HIV prevention program for drug-involved Mexican-Origin (MO) adolescent girls. Eighteen in-depth semi-structured interviews were conducted with drug-involved MO girls in addition to focus group discussions with 19 other drug-involved MO girls and 8 clinical service providers (CSPs) in 2009–2010. Emergent themes indicated that HIV prevention programs for drug-involved MO girls should be girl-centered, focused on relationship development, and include trained peer facilitators who share the same cultural and “street” background as the girls. The program should omit scare tactics associated with risky sexual behaviors and emphasize individual empowerment skills useful to negotiate sexual decisions successfully. In addition, a girl-centered intervention for MO girls should address important concerns for this group, including resistance skills and strategies regarding relationships with older men, teenage motherhood, sexual infidelity, sexual coercion, and dating violence. Participants noted that intervention activities should be interactive with an emphasis on guiding girls as they learn to assess critically personal risk while at the same time learning skills and resources to address these issues in real life. PMID:26362876

  11. International epidemiology of HIV and AIDS among injecting drug users.

    PubMed

    Des Jarlais, D C; Friedman, S R; Choopanya, K; Vanichseni, S; Ward, T P

    1992-10-01

    HIV/AIDS and iv drug use (IVDU) are of significant multinational scope and growing. Supporting increased IVDU in many countries are countries' geographical proximity to illicit drug trafficking distribution routes, law enforcement efforts which increase the demand for more efficient drug distribution and consumption, and countries' infrastructural and social modernization. Given the failures of intensified law enforcement efforts to thwart the use and proliferation of illegal drugs, countries with substantial IVDU should look away from preventing use to preventing HIV transmission within drug user populations. With HIV seroprevalence rates rapidly reaching 40-50% in some developing country IVDU groups, a variety of prevention programs is warranted. Such programs should be supported and implemented while prevention remains feasible. This paper examines the variation in HIV seroprevalence among IVD users, rapid HIV spread among users, HIV among IVDUs in Bangkok, emerging issues in HIV transmission among IVDUs, non-AIDS manifestations of HIV infection among IVDUs, prevention programs and effectiveness, and harm reduction.

  12. Discovery of Boolean metabolic networks: integer linear programming based approach.

    PubMed

    Qiu, Yushan; Jiang, Hao; Ching, Wai-Ki; Cheng, Xiaoqing

    2018-04-11

    Traditional drug discovery methods focused on the efficacy of drugs rather than their toxicity. However, toxicity and/or lack of efficacy are produced when unintended targets are affected in metabolic networks. Thus, identification of biological targets which can be manipulated to produce the desired effect with minimum side-effects has become an important and challenging topic. Efficient computational methods are required to identify the drug targets while incurring minimal side-effects. In this paper, we propose a graph-based computational damage model that summarizes the impact of enzymes on compounds in metabolic networks. An efficient method based on Integer Linear Programming formalism is then developed to identify the optimal enzyme-combination so as to minimize the side-effects. The identified target enzymes for known successful drugs are then verified by comparing the results with those in the existing literature. Side-effects reduction plays a crucial role in the study of drug development. A graph-based computational damage model is proposed and the theoretical analysis states the captured problem is NP-completeness. The proposed approaches can therefore contribute to the discovery of drug targets. Our developed software is available at " http://hkumath.hku.hk/~wkc/APBC2018-metabolic-network.zip ".

  13. Treating Teens: A Guide to Adolescent Drug Programs.

    ERIC Educational Resources Information Center

    Drug Strategies, Washington, DC.

    This guide looks at drug abuse in the context of adolescent development and provides a framework for understanding what has been learned about effective adolescent drug treatment over the last decade. The guide, which underscores the need to address developmental issues when treating adolescents, provides concrete ways to assess treatment…

  14. Measuring Effects of a Skills Training Intervention for Drug Abusers.

    ERIC Educational Resources Information Center

    Hawkins, J. David; And Others

    1986-01-01

    A test was conducted of a supplemental skills training and social-network-development aftercare program with 130 drug abusers from four residential therapeutic communities. The intervention produced positive effects on subjects' performance at the conclusion of treatment. Performance improved in situations involving avoidance of drug use, coping…

  15. Higher Education Center for Alcohol and Other Drug Prevention.

    ERIC Educational Resources Information Center

    Higher Education Center for Alcohol and Other Drug Prevention, Newton, MA.

    This brochure describes the mission, approach, and services of the Higher Education Center for Alcohol and Other Drug Prevention. The Center is the nation's primary resource center for assisting higher education institutions in the development, implementation, and evaluation of alcohol and drug violence prevention policies and programs that…

  16. Test implementation of a school-oriented drug prevention program "Study without Drugs": pre- and post-testing for effectiveness.

    PubMed

    Ishaak, Fariel; de Vries, Nanne Karel; van der Wolf, Kees

    2014-06-11

    In this article, the test implementation of a school-oriented drug prevention program "Study without Drugs" is discussed. The aims of this study were to determine the results of the process evaluation and to determine whether the proposed school-oriented drug prevention program during a pilot project was effective for the participating pupils. Sixty second-grade pupils at a junior high school in Paramaribo, Suriname participated in the test implementation. They were divided into two classes. For the process evaluation the students completed a structured questionnaire focusing on content and teaching method after every lesson. Lessons were qualified with a score from 0-10. The process was also evaluated by the teachers through structured interviews. Attention was paid to reach, dose delivered, dose received, fidelity, connection, achieved effects/observed behaviors, areas for improvement, and lesson strengths. The effect evaluation was conducted by using the General Liniair Model (repeated measure). The research (-design) was a pre-experimental design with pre-and post-test. No class or sex differences were detected among the pupils with regard to the assessment of content, methodology, and qualification of the lessons. Post-testing showed that participating pupils obtained an increased knowledge of drugs, their drug-resisting skills were enhanced, and behavior determinants (attitude, subjective norm, self-efficacy, and intention) became more negative towards drugs. From the results of the test implementation can be cautiously concluded that the program "Study without Drugs" may yield positive results when applied in schools). Thus, this pilot program can be considered a step towards the development and implementation of an evidence-based school-oriented program for pupils in Suriname.

  17. The NARCONON drug education curriculum for high school students: a non-randomized, controlled prevention trial.

    PubMed

    Lennox, Richard D; Cecchini, Marie A

    2008-03-19

    An estimated 13 million youths aged 12 to 17 become involved with alcohol, tobacco and other drugs annually. The number of 12- to 17-year olds abusing controlled prescription drugs increased an alarming 212 percent between 1992 and 2003. For many youths, substance abuse precedes academic and health problems including lower grades, higher truancy, drop out decisions, delayed or damaged physical, cognitive, and emotional development, or a variety of other costly consequences. For thirty years the Narconon program has worked with schools and community groups providing single educational modules aimed at supplementing existing classroom-based prevention activities. In 2004, Narconon International developed a multi-module, universal prevention curriculum for high school ages based on drug abuse etiology, program quality management data, prevention theory and best practices. We review the curriculum and its rationale and test its ability to change drug use behavior, perceptions of risk/benefits, and general knowledge. After informed parental consent, approximately 1000 Oklahoma and Hawai'i high school students completed a modified Center for Substance Abuse Prevention (CSAP) Participant Outcome Measures for Discretionary Programs survey at three testing points: baseline, one month later, and six month follow-up. Schools assigned to experimental conditions scheduled the Narconon curriculum between the baseline and one-month follow-up test; schools in control conditions received drug education after the six-month follow-up. Student responses were analyzed controlling for baseline differences using analysis of covariance. At six month follow-up, youths who received the Narconon drug education curriculum showed reduced drug use compared with controls across all drug categories tested. The strongest effects were seen in all tobacco products and cigarette frequency followed by marijuana. There were also significant reductions measured for alcohol and amphetamines. The program also produced changes in knowledge, attitudes and perception of risk. The eight-module Narconon curriculum has thorough grounding in substance abuse etiology and prevention theory. Incorporating several historically successful prevention strategies this curriculum reduced drug use among youths.

  18. The development of a comprehensive risk-management program for prescription opioid analgesics: researched abuse, diversion and addiction-related surveillance (RADARS).

    PubMed

    Cicero, Theodore J; Dart, Richard C; Inciardi, James A; Woody, George E; Schnoll, Sidney; Muñoz, Alvaro

    2007-03-01

    OBJECTIVE. Beginning in the late 1990's a marked increase in abuse of OxyContin emerged, which led to the development and establishment of a proactive surveillance program to monitor and characterize abuse, named the Researched Abuse, Diversion and Addiction Related Surveillance (RADARS) System. The main goal of RADARS was to develop proactive, timely and geographically sensitive methods to assess the abuse and diversion of OxyContin, along with a number of other Schedule II and III opioids with the aim of using this information to guide risk reduction interventions. Thus, its major focus was the detection of abuse of OxyContin and other commonly prescribed opioid analgesics at the three-digit ZIP code level across the country utilizing a number of different detection systems. The detection systems selected were: (1) Quarterly-surveys of drug abuse experts who are knowledgeable about cases of prescription drug abuse; (2) Surveys of law enforcement agencies that detect diversion of prescription drugs; and (3) Poison Control Center reports of intentional misuse or abuse of prescription opioids. Collectively, the three systems provide overlapping coverage of over 80% of the nation's 973 three-digit ZIP codes. Preliminary results indicate that prescription drug abuse is prevalent nationwide, but it seems to be heavily localized in rural, suburban and small urban areas. Our results also indicate that hydrocodone and extended and immediate release oxycodone products are by far the most widely abused drugs in the country, but the abuse of all prescription opioids seems to have grown over the 14 quarters since the inception of RADARS. The next step in these studies is to develop regionally specific, risk-minimization-strategies, which is the goal of all risk-management programs. If successful, RADARS will serve as a prototype of such programs for any new drug approved that has measurable abuse potential.

  19. An Empirical Review of Major Legislation Affecting Drug Development: Past Experiences, Effects, and Unintended Consequences

    PubMed Central

    Kesselheim, Aaron S

    2011-01-01

    Context: With the development of transformative drugs at a low point, numerous commentators have recommended new legislation that uses supplementary market exclusivity as an incentive to promote innovation in the pharmaceutical market. Methods: This report provides an historical perspective on proposals for encouraging drug research. Four legislative programs have been primarily designed to offer market exclusivity to promote public health goals in the pharmaceutical or biomedical sciences: the Bayh-Dole Act of 1980, the Orphan Drug Act of 1983, the Hatch-Waxman Act of 1984, and the pediatric exclusivity provisions of the FDA Modernization Act of 1997. I reviewed quantitative and qualitative studies that reported on the outcomes from these programs and evaluated the quality of evidence generated. Findings: All four legislative programs generally have been regarded as successful, although such conclusions are largely based on straightforward descriptive reports rather than on more rigorous comparative data or analyses that sufficiently account for confounding. Overall, solid data demonstrate that market exclusivity incentives can attract interest from parties involved in drug development. However, using market exclusivity to promote innovation in the pharmaceutical market can be prone to misuse, leading to improper gains. In addition, important collateral effects have emerged with substantial negative public health implications. Conclusions: Using market exclusivity to promote pharmaceutical innovation can lead to positive outcomes, but the practice is also characterized by waste and collateral effects. Certain practices, such as mechanisms for reevaluation and closer ties of incentives programs to public health outcomes, can help address these problems. PMID:21933276

  20. An empirical review of major legislation affecting drug development: past experiences, effects, and unintended consequences.

    PubMed

    Kesselheim, Aaron S

    2011-09-01

    With the development of transformative drugs at a low point, numerous commentators have recommended new legislation that uses supplementary market exclusivity as an incentive to promote innovation in the pharmaceutical market. This report provides an historical perspective on proposals for encouraging drug research. Four legislative programs have been primarily designed to offer market exclusivity to promote public health goals in the pharmaceutical or biomedical sciences: the Bayh-Dole Act of 1980, the Orphan Drug Act of 1983, the Hatch-Waxman Act of 1984, and the pediatric exclusivity provisions of the FDA Modernization Act of 1997. I reviewed quantitative and qualitative studies that reported on the outcomes from these programs and evaluated the quality of evidence generated. All four legislative programs generally have been regarded as successful, although such conclusions are largely based on straightforward descriptive reports rather than on more rigorous comparative data or analyses that sufficiently account for confounding. Overall, solid data demonstrate that market exclusivity incentives can attract interest from parties involved in drug development. However, using market exclusivity to promote innovation in the pharmaceutical market can be prone to misuse, leading to improper gains. In addition, important collateral effects have emerged with substantial negative public health implications. Using market exclusivity to promote pharmaceutical innovation can lead to positive outcomes, but the practice is also characterized by waste and collateral effects. Certain practices, such as mechanisms for reevaluation and closer ties of incentives programs to public health outcomes, can help address these problems. © 2011 Milbank Memorial Fund. Published by Wiley Periodicals Inc.

  1. Accrediting retail drug shops to strengthen Tanzania's public health system: an ADDO case study.

    PubMed

    Rutta, Edmund; Liana, Jafary; Embrey, Martha; Johnson, Keith; Kimatta, Suleiman; Valimba, Richard; Lieber, Rachel; Shekalaghe, Elizabeth; Sillo, Hiiti

    2015-01-01

    Retail drug sellers are a major source of health care and medicines in many countries. In Tanzania, drug shops are widely used, particularly in rural and underserved areas. Previously, the shops were allowed to sell only over-the-counter medicines, but sellers who were untrained and unqualified often illegally sold prescription drugs of questionable quality. In 2003, we worked with Tanzania's Ministry of Health and Social Welfare to develop a public-private partnership based on a holistic approach that builds the capacity of owners, dispensers, and institutions that regulate, own, or work in retail drug shops. For shop owners and dispensers, this was achieved by combining training, business incentives, supervision, and regulatory enforcement with efforts to increase client demand for and expectations of quality products and services. The accredited drug dispensing outlet (ADDO) program's goal is to improve access to affordable, quality medicines and pharmaceutical services in retail drug outlets in rural or peri-urban areas with few or no registered pharmacies. The case study characterizes how the ADDO program achieved that goal based on the World Health Organization's health system strengthening building blocks: 1) service delivery, 2) health workforce, 3) health information systems, 4) access to essential medicines, 5) financing, and 6) leadership and governance. The ADDO program has proven to be scalable, sustainable, and transferable: Tanzania has rolled out the program nationwide; the ADDO program has been institutionalized as part of the country's health system; shops are profitable and meeting consumer demands; and the ADDO model has been adapted and implemented in Uganda and Liberia. The critical element that was essential to the ADDO program's success is stakeholder engagement-the successful buy-in and sustained commitment came directly from the effort, time, and resources spent to fully connect with vital stakeholders at all levels. Beyond improving the quality of medicines and dispensing services, availability of essential medicines, and the regulatory system, the impact of a nationwide accredited drug seller approach on the pharmaceutical sector promises to provide a model framework for private-sector pharmaceutical delivery in the developing world that is sustainable without ongoing donor support.

  2. Economics of new oncology drug development.

    PubMed

    DiMasi, Joseph A; Grabowski, Henry G

    2007-01-10

    Review existing studies and provide new results on the development, regulatory, and market aspects of new oncology drug development. We utilized data from the US Food and Drug Administration (FDA), company surveys, and publicly available commercial business intelligence databases on new oncology drugs approved in the United States and on investigational oncology drugs to estimate average development and regulatory approval times, clinical approval success rates, first-in-class status, and global market diffusion. We found that approved new oncology drugs to have a disproportionately high share of FDA priority review ratings, of orphan drug designations at approval, and of drugs that were granted inclusion in at least one of the FDA's expedited access programs. US regulatory approval times were shorter, on average, for oncology drugs (0.5 years), but US clinical development times were longer on average (1.5 years). Clinical approval success rates were similar for oncology and other drugs, but proportionately more of the oncology failures reached expensive late-stage clinical testing before being abandoned. In relation to other drugs, new oncology drug approvals were more often first-in-class and diffused more widely across important international markets. The market success of oncology drugs has induced a substantial amount of investment in oncology drug development in the last decade or so. However, given the great need for further progress, the extent to which efforts to develop new oncology drugs will grow depends on future public-sector investment in basic research, developments in translational medicine, and regulatory reforms that advance drug-development science.

  3. DrugPath: a database for academic investigators to match oncology molecular targets with drugs in development.

    PubMed

    Shah, Eric D; Fisch, Brandon M A; Arceci, Robert J; Buckley, Jonathan D; Reaman, Gregory H; Sorensen, Poul H; Triche, Timothy J; Reynolds, C Patrick

    2014-05-01

    Academic laboratories are developing increasingly large amounts of data that describe the genomic landscape and gene expression patterns of various types of cancers. Such data can potentially identify novel oncology molecular targets in cancer types that may not be the primary focus of a drug sponsor's initial research for an investigational new drug. Obtaining preclinical data that point toward the potential for a given molecularly targeted agent, or a novel combination of agents requires knowledge of drugs currently in development in both the academic and commercial sectors. We have developed the DrugPath database ( http://www.drugpath.org ) as a comprehensive, free-of-charge resource for academic investigators to identify agents being developed in academics or industry that may act against molecular targets of interest. DrugPath data on molecular targets overlay the Michigan Molecular Interactions ( http://mimi.ncibi.org ) gene-gene interaction map to facilitate identification of related agents in the same pathway. The database catalogs 2,081 drug development programs representing 751 drug sponsors and 722 molecular and genetic targets. DrugPath should assist investigators in identifying and obtaining drugs acting on specific molecular targets for biological and preclinical therapeutic studies.

  4. Sustainability: Building Program and Coalition Support. A Prevention 101 Series Publication

    ERIC Educational Resources Information Center

    Glider, Peggy

    2010-01-01

    Given the prevalence of alcohol and other drug abuse and violence on campuses and in communities, programs and coalitions developed to prevent or intervene in these problems are faced with a challenging and long-term task. While the development of coalitions or campus-based prevention programs is a healthy start, these efforts must be sustained…

  5. A Framework for Developing Drug Abuse Prevention Strategies for Young People in Ghetto Areas.

    ERIC Educational Resources Information Center

    Dembo, Richard; Burgos, William

    The present paper considers critical factors in the experience of young people that need to be taken into account in order to understand them and to develop prevention programs. Drawing on research and the literature on socialization, social psychology, and drug abuse, an ethnographically informed social context model of the actor is developed and…

  6. Drugs' development in acute heart failure: what went wrong?

    PubMed

    Teneggi, Vincenzo; Sivakumar, Nithy; Chen, Deborah; Matter, Alex

    2018-05-08

    Acute heart failure (AHF) is a major burden disease, with a complex physiopathology, unsatisfactory diagnosis, treatment and a very poor prognosis. In the last two decades, a number of drugs have progressed from preclinical to early and late clinical development, but only a few of them have been approved and added to a stagnant pharmacological armamentarium. We have reviewed the data published on drugs developed for AHF since early 2000s, trying to recognise factors that have worked for a successful approval or for the stoppage of the program, in an attempt to delineate future trajectories for AHF drug development. Our review has identified limitations at both preclinical and clinical levels. At the preclinical level, the major shortcoming is represented by animal models looking at short-term endpoints which do not recapitulate the complexity of the human disease. At the clinical level, the main weakness is given by the disconnect between short-term endpoints assessed in the early stage of drug development, and medium-long-term endpoints requested in Phase 3 for regulatory approval. This is further amplified by the lack of validation and standardisation of short- and long-term endpoints; absence of predictive biomarkers; conduct of studies on heterogeneous populations; and use of different eligibility criteria, time of assessments, drug schedules and background therapies. Key goals remain a better understanding of AHF and the construction of a successful drug development program. A reasonable way to move forward resides in a strong collaboration between main stakeholders of therapeutic innovation: scientific community, industry and regulatory agencies.

  7. An Online Drug Abuse Prevention Program for Adolescent Girls: Posttest and 1-Year Outcomes.

    PubMed

    Schwinn, Traci M; Schinke, Steven P; Hopkins, Jessica; Keller, Bryan; Liu, Xiang

    2018-03-01

    Early adolescent girls' rates of drug use have matched, and in some instances, surpassed boys' rates. Though girls and boys share risk factors for drug use, girls also have gender-specific risks. Tailored interventions to prevent girls' drug use are warranted. This study developed and tested a web-based, drug abuse prevention program for adolescent girls. The nationwide sample of 13- and 14-year-old girls (N = 788) was recruited via Facebook ads. Enrolled girls were randomly assigned to the intervention or control condition. All girls completed pretest measures online. Following pretest, intervention girls interacted with the 9-session, gender-specific prevention program online. The program aimed to reduce girls' drug use and associated risk factors by improving their cognitive and behavioral skills around such areas as coping with stress, managing mood, maintaining a healthy body image, and refusing drug use offers. Girls in both conditions again completed measures at posttest and 1-year follow-up. At posttest, and compared to girls in the control condition, girls who received the intervention smoked fewer cigarettes and reported higher self-esteem, goal setting, media literacy, and self-efficacy. At 1-year follow-up, and compared to girls in the control condition, girls who received the intervention reported engaging in less binge drinking and cigarette smoking; girls assigned to the intervention condition also had higher alcohol, cigarette, and marijuana refusal skills, coping skills, and media literacy and lower rates of peer drug use. This study's findings support the use of tailored, online drug abuse prevention programming for early adolescent girls.

  8. Partnership, knowledge translation, and substance abuse prevention with a First Nations community.

    PubMed

    Baydala, Lola; Fletcher, Fay; Worrell, Stephanie; Kajner, Tania; Letendre, Sherry; Letendre, Liz; Rasmussen, Carmen

    2014-01-01

    Having identified substance abuse as an issue of concern in their community, the Alexis Nakota Sioux Nation invited University of Alberta researchers to partner on the cultural adaptation, delivery, and evaluation of a school-based drug and alcohol abuse prevention program. Researchers conducted a literature review of available drug and alcohol prevention programs for children and youth, identifying the Life Skills Training (LST) program as a viable model for cultural adaptation. Four program objectives were developed: (1) Review and cultural adaptation of the elementary and junior high LST programs, (2) delivery of the adapted programs, (3) measurement of changes in students' knowledge of the negative effects of drug and alcohol use, attitudes toward drugs and alcohol, drug and alcohol refusal and life skills, and changes in self-esteem/self-concept, and (4) documentation of the community's experience of the project. Using the principles of community-based participatory research (CBPR), we employed both qualitative and quantitative methods to evaluate the impact of the project. Qualitative evaluation of the program adaptation and implementation were both positive. Qualitative measures of program impact on students revealed a positive effect, whereas results of the quantitative measures were mixed. Culturally adapted, evidence-based programs can have a positive effect on Aboriginal youth and their communities. Strategies to expand knowledge translation (KT) when working with Aboriginal communities include working to create an "ethical space" that draws on the strengths of both Western and Indigenous worldviews.

  9. Making care affordable.

    PubMed

    Solomon, S

    1999-01-01

    The YRG Centre for AIDS Research and Education (CARE) in Chennai, India runs an integrated care program ensuring appropriate and affordable care to everyone who needs it. The program includes both voluntary counseling/testing and hospital/home-based care. YRG CARE developed several strategies for the care program, which include 1) different fees for an HIV test, 2) free counseling service, 3) different charges for other care services, 4) a subsidized pharmacy (involving purchasing drugs directly from manufacturers and wholesalers, ordering free samples from manufacturers, and acquiring drugs through the drug component of its clinical research projects, from overseas hospitals, and from YRG CARE hospital and community-based patients who have not used them), and 5) subsidized meals.

  10. Emerging targets for addiction neuropharmacology: From mechanisms to therapeutics.

    PubMed

    Ubaldi, Massimo; Cannella, Nazzareno; Ciccocioppo, Roberto

    2016-01-01

    Drug abuse represents a considerable burden of disease and has enormous economic impacts on societies. Over the years, few medications have been developed for clinical use. Their utilization is endowed with several limitations, including partial efficacy or significant side effects. On the other hand, the successful advancement of these compounds provides an important proof of concept for the feasibility of drug development programs in addiction. In recent years, a wealth of information has been generated on the psychological mechanisms, genetic or epigenetic predisposing factors, and neurobiological adaptations induced by drug consumption that interact with each other to contribute to disease progression. It is now clear that addiction develops through phases, from initial recreational use to excessive consumption and compulsive drug seeking, with a shift from positive to negative reinforcement driving motivated behaviors. A greater understanding of these mechanisms has opened new vistas in drug development programs. Researchers' attention has been shifted from investigation of classical targets associated with reward to biological substrates responsible for negative reinforcement, impulse loss of control, and maladaptive mechanisms resulting from protracted drug use. From this research, several new biological targets for the development of innovative therapies have started to emerge. This chapter offers an overview of targets currently under scrutiny for the development of new medications for addiction. This work is not exhaustive but rather it provides a few examples of how this research has advanced in recent years by virtue of studies carried out in our laboratory. © 2016 Elsevier B.V. All rights reserved.

  11. Scotland's national naloxone program: The prison experience.

    PubMed

    Horsburgh, Kirsten; McAuley, Andrew

    2018-05-01

    Launched in 2011, the Scottish national naloxone program marked an important development in public health policy. Central to its design were strategies to engage prisoners given their elevated risk of drug-related death in the weeks following liberation. Implementation across Scottish prisons has posed particular challenges linked to both operational issues within prison establishments and individual factors affecting staff delivering, and prisoners engaging, with the program. Barriers have been overcome through innovation and partnership working. This commentary has described how the development of the program in prisons has adapted to these challenges to a point where a largely consistent model is in place and where prisoners-on-release are reaping the benefits in terms of reduced opioid-related mortality. © 2017 Australasian Professional Society on Alcohol and other Drugs.

  12. Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization.

    PubMed

    Amur, S; LaVange, L; Zineh, I; Buckman-Garner, S; Woodcock, J

    2015-07-01

    The discovery, development, and use of biomarkers for a variety of drug development purposes are areas of tremendous interest and need. Biomarkers can become accepted for use through submission of biomarker data during the drug approval process. Another emerging pathway for acceptance of biomarkers is via the biomarker qualification program developed by the Center for Drug Evaluation and Research (CDER, US Food and Drug Administration). Evidentiary standards are needed to develop and evaluate various types of biomarkers for their intended use and multiple stakeholders, including academia, industry, government, and consortia must work together to help develop this evidence. The article describes various types of biomarkers that can be useful in drug development and evidentiary considerations that are important for qualification. A path forward for coordinating efforts to identify and explore needed biomarkers is proposed for consideration. © 2015 American Society for Clinical Pharmacology and Therapeutics.

  13. Case histories in pharmaceutical risk management.

    PubMed

    McCormick, Cynthia G; Henningfield, Jack E; Haddox, J David; Varughese, Sajan; Lindholm, Anders; Rosen, Susan; Wissel, Janne; Waxman, Deborah; Carter, Lawrence P; Seeger, Vickie; Johnson, Rolley E

    2009-12-01

    The development and implementation of programs in the U.S. to minimize risks and assess unintended consequences of new medications has been increasingly required by the Food and Drug Administration (FDA) since the mid 1990s. This paper provides four case histories of risk management and post-marketing surveillance programs utilized recently to address problems associated with possible abuse, dependence and diversion. The pharmaceutical sponsors of each of these drugs were invited to present their programs and followed a similar template for their summaries that are included in this article. The drugs and presenting companies were OxyContin, an analgesic marketed by Purdue Pharma L.P., Daytrana and Vyvanse, ADHD medications marketed by Shire Pharmaceuticals, Xyrem for narcolepsy marketed by Jazz Pharmaceuticals, and Subutex and Suboxone for opioid dependence marketed by Reckitt Benckiser Pharmaceuticals Inc. These case histories and subsequent discussions provide invaluable real-world examples and illustrate both the promise of risk management programs in providing a path to market and/or for keeping on the market drugs with serious potential risks. They also illustrate the limitations of such programs in actually controlling unintended consequences, as well as the challenge of finding the right balance of reducing risks without posing undue barriers to patient access. These experiences are highly relevant as the FDA increasingly requires pharmaceutical sponsors to develop and implement the more formalized and enforceable versions of the risk management term Risk Evaluation and Mitigation Strategies (REMS).

  14. A Winning Combination: An Alcohol, Other Drug, and Traffic Safety Handbook for College Campuses.

    ERIC Educational Resources Information Center

    Anderson, David, Ed.

    This manual addresses the social and legal issues facing college administrators today in dealing with alcohol and other drug problems. It is a guide for colleges and universities to develop individualized alcohol, drug, and traffic safety programs. The first part, entitled "Insights," presents background articles by professionals in higher…

  15. 24 CFR 761.10 - Definitions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... THE SECRETARY, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT (HOUSING ASSISTANCE PROGRAMS AND PUBLIC AND INDIAN HOUSING PROGRAMS) DRUG ELIMINATION PROGRAMS General § 761.10 Definitions. The definitions Department, HUD, and Public Housing Agency (PHA) are defined in part 5 of this title. Controlled substance...

  16. 24 CFR 761.10 - Definitions.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... THE SECRETARY, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT (HOUSING ASSISTANCE PROGRAMS AND PUBLIC AND INDIAN HOUSING PROGRAMS) DRUG ELIMINATION PROGRAMS General § 761.10 Definitions. The definitions Department, HUD, and Public Housing Agency (PHA) are defined in part 5 of this title. Controlled substance...

  17. 24 CFR 761.10 - Definitions.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... THE SECRETARY, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT (HOUSING ASSISTANCE PROGRAMS AND PUBLIC AND INDIAN HOUSING PROGRAMS) DRUG ELIMINATION PROGRAMS General § 761.10 Definitions. The definitions Department, HUD, and Public Housing Agency (PHA) are defined in part 5 of this title. Controlled substance...

  18. 24 CFR 761.10 - Definitions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... THE SECRETARY, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT (HOUSING ASSISTANCE PROGRAMS AND PUBLIC AND INDIAN HOUSING PROGRAMS) DRUG ELIMINATION PROGRAMS General § 761.10 Definitions. The definitions Department, HUD, and Public Housing Agency (PHA) are defined in part 5 of this title. Controlled substance...

  19. 24 CFR 761.10 - Definitions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... THE SECRETARY, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT (HOUSING ASSISTANCE PROGRAMS AND PUBLIC AND INDIAN HOUSING PROGRAMS) DRUG ELIMINATION PROGRAMS General § 761.10 Definitions. The definitions Department, HUD, and Public Housing Agency (PHA) are defined in part 5 of this title. Controlled substance...

  20. [Designing a software for drug management in special situations at a hospital's drug administration service].

    PubMed

    Sánchez Cuervo, Marina; Muñoz García, María; Gómez de Salazar López de Silanes, María Esther; Bermejo Vicedo, Teresa

    2015-03-01

    to describe the features of a computer program for management of drugs in special situations (off-label and compassionate use) in a Department of Hospital Pharmacy (PD). To describe the methodology followed for its implementation in the Medical Services. To evaluate their use after 2 years of practice. the design was carried out by pharmacists of the PD. The stages of the process were: selection of a software development company, establishment of a working group, selection of a development platform, design of an interactive Viewer, definition of functionality and data processing, creation of databases, connection, installation and configuration, application testing and improvements development. A directed sequential strategy was used for implementation in the Medical Services. The program's utility and experience of use were evaluated after 2 years. a multidisciplinary working group was formed and developed Pk_Usos®. The program works in web environment with a common viewer for all users enabling real time checking of the request files' status and that adapts to the management of medications in special situations procedure. Pk_Usos® was introduced first in the Oncology Department, with 15 oncologists as users of the program. 343 patients had 384 treatment requests managed, of which 363 are authorized throughout two years. PK_Usos® is the first software designed for the management of drugs in special situations in the PD. It is a dynamic and efficient tool for all professionals involved in the process by optimization of times. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

  1. Has Malaysia's antidrug effort been effective?

    PubMed

    Scorzelli, J F

    1992-01-01

    It is a common belief that a massive effort in law enforcement, preventive education and rehabilitation will result in the elimination of a country's drug problem. Based on this premise. Malaysia in 1983 implemented such a multifaceted anti-drug strategy, and the results of a 1987 study by the author suggested that Malaysia's effort had begun to contribute to a steady decrease in the number of identified drug abusers. Although the number of drug-addicted individuals declined, the country's recidivism rates were still high. Because of this high relapse rate, Malaysia expanded their rehabilitation effort and developed a community transition program. In order to determine the impact of these changes on the country's battle against drug abuse, a follow-up study was conducted in 1990. The results of this study did not clearly demonstrate that the Malaysian effort had been successful in eliminating the problem of drug abuse, and raised some questions concerning the effectiveness of the country's drug treatment programs.

  2. Characteristics of substance abuse treatment programs providing services for HIV/AIDS, hepatitis C virus infection, and sexually transmitted infections: the National Drug Abuse Treatment Clinical Trials Network.

    PubMed

    Brown, Lawrence S; Kritz, Steven Allan; Goldsmith, R Jeffrey; Bini, Edmund J; Rotrosen, John; Baker, Sherryl; Robinson, Jim; McAuliffe, Patrick

    2006-06-01

    Illicit drug users sustain the epidemics of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), hepatitis C (HCV), and sexually transmitted infections (STIs). Substance abuse treatment programs present a major intervention point in stemming these epidemics. As a part of the "Infections and Substance Abuse" study, established by the National Drug Abuse Treatment Clinical Trials Network, sponsored by National Institute on Drug Abuse, three surveys were developed; for treatment program administrators, for clinicians, and for state and District of Columbia health and substance abuse department administrators, capturing service availability, government mandates, funding, and other key elements related to the three infection groups. Treatment programs varied in corporate structure, source of revenue, patient census, and medical and non-medical staffing; medical services, counseling services, and staff education targeted HIV/AIDS more often than HCV or STIs. The results from this study have the potential to generate hypotheses for further health services research to inform public policy.

  3. Fetal effects of psychoactive drugs.

    PubMed

    Salisbury, Amy L; Ponder, Kathryn L; Padbury, James F; Lester, Barry M

    2009-09-01

    Psychoactive drug use by pregnant women has the potential to effect fetal development; the effects are often thought to be drug-specific and gestational age dependent. This article describes the effects of three drugs with similar molecular targets that involve monoaminergic transmitter systems: cocaine, methamphetamine, and selective serotonin re-uptake inhibitors (SSRIs) used to treat maternal depression during pregnancy. We propose a possible common epigenetic mechanism for their potential effects on the developing child. We suggest that exposure to these substances acts as a stressor that affects fetal programming, disrupts fetal placental monoamine transporter expression and alters neuroendocrine and neurotransmitter system development. We also discuss neurobehavioral techniques that may be useful in the early detection of the effects of in utero drug exposure.

  4. Implementation guidelines for drug and alcohol regulations in mass transit

    DOT National Transportation Integrated Search

    2002-08-01

    These guidelines will assist transit agencies in developing drug and alcohol testing programs that comply with regulations of the Federal Transit Administration (FTA). The guidelines provide a comprehensive, up-to-date summary of the regulatory requi...

  5. UCLA Translational Biomarker Development Program (UTBD)

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Czernin, Johannes

    2014-09-01

    The proposed UTBD program integrates the sciences of diagnostic nuclear medicine and (radio)chemistry with tumor biology and drug development. UTBD aims to translate new PET biomarkers for personalized medicine and to provide examples for the use of PET to determine pharmacokinetic (PK) and pharmacodynamic (PD) drug properties. The program builds on an existing partnership between the Ahmanson Translational Imaging Division (ATID) and the Crump Institute of Molecular Imaging (CIMI), the UCLA Department of Chemistry and the Division of Surgical Oncology. ATID provides the nuclear medicine training program, clinical and preclinical PET/CT scanners, biochemistry and biology labs for probe and drugmore » development, radiochemistry labs, and two cyclotrons. CIMI provides DOE and NIH-funded training programs for radio-synthesis (START) and molecular imaging (SOMI). Other participating entities at UCLA are the Department of Chemistry and Biochemistry and the Division of Surgical Oncology. The first UTBD project focuses on deoxycytidine kinase, a rate-limiting enzyme in nucleotide metabolism, which is expressed in many cancers. Deoxycytidine kinase (dCK) positive tumors can be targeted uniquely by two distinct therapies: 1) nucleoside analog prodrugs such as gemcitabine (GEM) are activated by dCK to cytotoxic antimetabolites; 2) recently developed small molecule dCK inhibitors kill tumor cells by starving them of nucleotides required for DNA replication and repair. Since dCK-specific PET probes are now available, PET imaging of tumor dCK activity could improve the use of two different classes of drugs in a wide variety of cancers.« less

  6. Maine: Cooperation between the Division of Special Education and Division of Alcohol and Drug Education Services.

    ERIC Educational Resources Information Center

    Rice, Sharon C.

    1989-01-01

    In 1984, Maine established the Task Force on Special Education and Chemical Dependency, which developed a report recommending, in part: collaboration between special education and local alcohol and drug abuse prevention programs; training for general and special education staff; and development of a vehicle for identification, assessment,…

  7. Meta-analysis of the effectiveness of school substance abuse prevention programs in Spain.

    PubMed

    Espada, José P; Gonzálvez, María T; Orgilés, Mireia; Lloret, Daniel; Guillén-Riquelme, Alejandro

    2015-01-01

    There has been an increase in adolescent substance use that has led to the development and implementation of prevention programs. New evidence is needed in order to improve them and optimize the resources. The aim of this paper is to use a meta-analysis to analyze the effectiveness of school drug prevention programs in Spain. Twenty-one studies that evaluated drug abuse prevention programs in schools, were published between 2002 and 2013, and that met the selection criteria were identified. Preventive program effectiveness was low ( d = 0.16), although it was higher at the follow-up ( d = 0.30). The programs were most effective in changing attitudes ( d = 0.44) towards drugs. The models of health education ( d = 0.48) and social learning ( d = 0.20) were also very effective, especially in combination with oral, written, and audiovisual support material ( d = 0.21) and the implementation of joint programs by health education professionals and faculty members ( d = 0.25). Is possible to determine the need for more rigorous evaluations of interventions to establish useful programs.

  8. Developing and Implementing a Positive Behavioral Reinforcement Intervention in Prison-Based Drug Treatment: Project BRITE

    PubMed Central

    Burdon, William M.; De Lore, Jef St.; Prendergast, Michael L.

    2012-01-01

    Within prison settings, the reliance on punishment for controlling inappropriate or non-compliant behavior is self-evident. What is not so evident is the similarity between this reliance on punishment and the use of positive reinforcements to increase desired behaviors. However, seldom do inmates receive positive reinforcement for engaging in prosocial behaviors or, for inmates receiving drug treatment, behaviors that are consistent with or support their recovery. This study provides an overview of the development and implementation of a positive behavioral reinforcement intervention in male and female prison-based drug treatment programs. The active involvement of institutional staff, treatment staff, and inmates enrolled in the treatment programs in the development of the intervention along with the successful branding of the intervention were effective at promoting support and participation. However, these factors may also have ultimately impacted the ability of the randomized design to reliably demonstrate the effectiveness of the intervention. PMID:22185038

  9. Developing and implementing a positive behavioral reinforcement intervention in prison-based drug treatment: Project BRITE.

    PubMed

    Burdon, William M; St De Lore, Jef; Prendergast, Michael L

    2011-09-01

    Within prison settings, the reliance on punishment for controlling inappropriate or noncompliant behavior is self-evident. What is not so evident is the similarity between this reliance on punishment and the use of positive reinforcements to increase desired behaviors. However, seldom do inmates receive positive reinforcement for engaging in prosocial behaviors or, for inmates receiving drug treatment, behaviors that are consistent with or support their recovery. This study provides an overview of the development and implementation of a positive behavioral reinforcement intervention in male and female prison-based drug treatment programs. The active involvement of institutional staff, treatment staff, and inmates enrolled in the treatment programs in the development of the intervention along with the successful branding of the intervention were effective at promoting support and participation. However, these factors may also have ultimately impacted the ability of the randomized design to reliably demonstrate the effectiveness of the intervention.

  10. Role of Academic Drug Discovery in the Quest for New CNS Therapeutics.

    PubMed

    Yokley, Brian H; Hartman, Matthew; Slusher, Barbara S

    2017-03-15

    There was a greater than 50% decline in central nervous system (CNS) drug discovery and development programs by major pharmaceutical companies from 2009 to 2014. This decline was paralleled by a rise in the number of university led drug discovery centers, many in the CNS area, and a growth in the number of public-private drug discovery partnerships. Diverse operating models have emerged as the academic drug discovery centers adapt to this changing ecosystem.

  11. Preparing a prescription drug monitoring program data set for research purposes.

    PubMed

    O'Kane, Nicole; Hallvik, Sara E; Marino, Miguel; Van Otterloo, Joshua; Hildebran, Christi; Leichtling, Gillian; Deyo, Richard A

    2016-09-01

    To develop a complete and consistent prescription drug monitoring program (PDMP) data set for use by drug safety researchers in evaluating patterns of high-risk use and potential abuse of scheduled drugs. Using publically available data references from the US Food and Drug Administration and the Centers for Disease Control and Prevention, we developed a strategic methodology to assign drug categories based on pharmaceutical class for the majority of prescriptions in the PDMP data set. We augmented data elements required to calculate morphine milligram equivalents and assigned duration of action (short-acting or long acting) properties for a majority of opioids in the data set. About 10% of prescriptions in the PDMP data set did not have a vendor-assigned drug category, and 20% of opioid prescriptions were missing data needed to calculate risk metrics. Using inclusive methods, 19 133 167 (>99.9%) of prescriptions in the PDMP data set were assigned a drug category. For the opioid category, augmenting data elements resulted in 10 760 669 (99.8%) having required values to calculate morphine milligram equivalents and evaluate duration of action properties. Drug safety researchers who require a complete and consistent PDMP data set can use the methods described here to ensure that prescriptions of interest are assigned consistent drug categories and complete opioid risk variable values. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  12. 76 FR 68197 - Clinical Development Programs for Sedation Products; Public Workshop; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-03

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0547] Clinical Development Programs for Sedation Products; Public Workshop; Request for Comments AGENCY: Food and... clinically meaningful (e.g., subjective and objective assessments of memory, recall, anxiety, agitation, or...

  13. Novel Hypoxia-Directed Cancer Therapeutics

    DTIC Science & Technology

    2017-07-01

    as anti-cancer therapies. 15. SUBJECT TERMS Hypoxia-inducible factors, mass-spectrometry, drug discovery, kidney cancer 16. SECURITY CLASSIFICATION...programs required for driving solid tumor growth in cancers of kidney , pancreas, stomach, colon and skin. We seek the discovery of drug-like...drug discovery, kidney cancer. 5 What opportunities for training and professional development has the project provided? How were the

  14. Growing Up And Feeling Powerful As An American Indian.

    ERIC Educational Resources Information Center

    Mason, Velma Garcia; Baker, George

    Prepared for American Indian school children in grades 4-8, this booklet is a reading resource on drug abuse prevention. The material is based on a concept of primary drug abuse prevention developed by Native American experts involved in various drug abuse programs: "primary prevention is a process of recognition and respect for Native cultural…

  15. Treatment Services for Drug Dependent Women. Volume 1. Treatment Research Monograph Series.

    ERIC Educational Resources Information Center

    Beschner, George M., Ed.; And Others

    This book is the first of two volumes designed to highlight and integrate current knowledge about drug dependent women, with a focus on needed services and appropriate delivery systems, as well as to provide useful information for counselors and treatment program developers. The special problems, needs, and characteristics of women drug abusers…

  16. Psychosocial Correlates of Clinicians' Prescription Drug Monitoring Program Utilization.

    PubMed

    Pugliese, John A; Wintemute, Garen J; Henry, Stephen G

    2018-05-01

    The purpose of this study is to extend prior research on barriers to use of a prescription drug monitoring program by examining psychosocial correlates of intended use among physicians and pharmacists. Overall, 1,904 California physicians and pharmacists responded to a statewide survey (24.1% response rate) from August 2016 to January 2017. Participants completed an online survey examining attitudes toward prescription drug misuse and abuse, prescribing practices, prescription drug monitoring program design and ease of use, professional obligations, and normative beliefs regarding prescription drug monitoring program use. Data were analyzed in 2017. Perceived prescription drug monitoring program usefulness and normative beliefs fully mediated the relationship between concern about prescription drug abuse and intentions to use the prescription drug monitoring program. Clinicians' sense of professional and moral obligation to use the prescription drug monitoring program was unrelated to intention to use the prescription drug monitoring program despite a positive relationship with concern about misuse and abuse. Compared with physicians, pharmacists reported greater concern about prescription drug misuse, greater professional and moral obligation to use prescription drug monitoring program, and greater rating of prescription drug monitoring program usefulness. Interventions that target normative beliefs surrounding prescription drug monitoring program use and how to use prescription drug monitoring programs effectively are likely to be more effective than those that target professional obligations or moralize to the medical community. Published by Elsevier Inc.

  17. [Regulatory science: modern trends in science and education for pharmaceutical products].

    PubMed

    Beregovykh, V V; Piatigorskaia, N V; Aladysheva, Zh I

    2012-01-01

    This article reviews modern trends in development of new instruments, standards and approaches to drugs safety, efficacy and quality assessment in USA and EU that can be called by unique term--"regulatory science" which is a new concept for Russian Federation. New education programs (curricula) developed by USA and EU universities within last 3 years are reviewed. These programs were designed in order to build workforce capable to utilize science approach for drug regulation. The principal mechanisms for financing research in regulatory science used by Food and Drug Administration are analyzed. There are no such science and relevant researches in Russian Federation despite the high demand as well as needs for the system for higher education and life-long learning education of specialists for regulatory affairs (or compliance).

  18. Comparing oncology clinical programs by use of innovative designs and expected net present value optimization: Which adaptive approach leads to the best result?

    PubMed

    Parke, Tom; Marchenko, Olga; Anisimov, Vladimir; Ivanova, Anastasia; Jennison, Christopher; Perevozskaya, Inna; Song, Guochen

    2017-01-01

    Designing an oncology clinical program is more challenging than designing a single study. The standard approaches have been proven to be not very successful during the last decade; the failure rate of Phase 2 and Phase 3 trials in oncology remains high. Improving a development strategy by applying innovative statistical methods is one of the major objectives of a drug development process. The oncology sub-team on Adaptive Program under the Drug Information Association Adaptive Design Scientific Working Group (DIA ADSWG) evaluated hypothetical oncology programs with two competing treatments and published the work in the Therapeutic Innovation and Regulatory Science journal in January 2014. Five oncology development programs based on different Phase 2 designs, including adaptive designs and a standard two parallel arm Phase 3 design were simulated and compared in terms of the probability of clinical program success and expected net present value (eNPV). In this article, we consider eight Phase2/Phase3 development programs based on selected combinations of five Phase 2 study designs and three Phase 3 study designs. We again used the probability of program success and eNPV to compare simulated programs. For the development strategies, we considered that the eNPV showed robust improvement for each successive strategy, with the highest being for a three-arm response adaptive randomization design in Phase 2 and a group sequential design with 5 analyses in Phase 3.

  19. Preserving an Incentive for Global Health R&D: The Priority Review Voucher Secondary Market.

    PubMed

    Robertson, Andrew S

    2016-05-01

    In December 2014, the United States government expanded the Priority Review Voucher ("PRV" or "voucher") program to include Ebola and other related Filoviruses. By doing so, lawmakers provided a potentially powerful incentive for drug companies to invest time and money in the development of novel medicines for terrifying diseases. This expansion is one of several additions made to the PRV programs since 2012. Many companies rely on voucher resale to recoup research and development ("R&D") costs; however, it is unclear whether the PRV program could be overextended, thereby diluting the value of the incentives. In this paper, I use historical approval data from the Food and Drug Administration ("FDA") and United States drug revenue data to better understand the secondary market value of a PRV. The data suggests that that purchase prices of a PRV could continue to climb; despite this, the market size for these vouchers is limited. The implications of these findings are discussed further.

  20. 10 CFR 707.5 - Submission, approval, and implementation of a baseline workplace substance abuse program.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... workplace substance abuse program. 707.5 Section 707.5 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE... substance abuse program. (a) Each contractor subject to this part shall develop a written program consistent... employees concerning problems of substance abuse, including illegal drug use, and the availability of...

  1. 10 CFR 707.5 - Submission, approval, and implementation of a baseline workplace substance abuse program.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... workplace substance abuse program. 707.5 Section 707.5 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE... substance abuse program. (a) Each contractor subject to this part shall develop a written program consistent... employees concerning problems of substance abuse, including illegal drug use, and the availability of...

  2. 10 CFR 707.5 - Submission, approval, and implementation of a baseline workplace substance abuse program.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... workplace substance abuse program. 707.5 Section 707.5 Energy DEPARTMENT OF ENERGY WORKPLACE SUBSTANCE ABUSE... substance abuse program. (a) Each contractor subject to this part shall develop a written program consistent... employees concerning problems of substance abuse, including illegal drug use, and the availability of...

  3. The role of academic institutions in the development of drugs for rare and neglected diseases.

    PubMed

    Coles, L D; Cloyd, J C

    2012-08-01

    There are approximately 7,000 rare disorders, many of which are life-threatening. Diagnosis is often problematic, and therapies are few. Before the passage of the Orphan Drug Act in 1983, neither the pharmaceutical industry nor universities devoted much effort to research on rare diseases. Important changes have occurred within and outside universities that position them to play a significant role in developing orphan drugs. Several models are being employed to promote drug-related research, including disease-focused, discovery-focused, development-focused, and industry-partnership-focused approaches. However, significant barriers challenge universities' ability to fully contribute to orphan drug development. Academic institutions, along with industry, government, and not-for-profit organizations, must address these issues in order to advance the field. New initiatives designed to increase university-based orphan drug research include creating mechanisms to ensure program continuity, building research and regulatory support infrastructure, facilitating commercialization, expanding government support, and developing mutually beneficial partnerships among academe, industry, and government.

  4. Antimicrobial formulary management: meeting the challenge in the community hospital.

    PubMed

    Rush, D R

    1991-01-01

    We established a casework approach to develop an antibiotic formulary for a large community hospital. The program consists of a combination of comprehensive clinical and administrative strategies designed to reduce antimicrobial expenditures and improve the quality of antibiotic prescribing. Strategies included a background document summarizing each pharmacologic group of antimicrobial drugs and formulary preferences, presentations to medical and surgical departments, development of drug use evaluation strategies that complement the development of the formulary, and a monitoring program for nonformulary antibiotic use. The development of a customized microbiologic/antibiotic susceptibility report card specific to the institution's inpatient and outpatient microflora was an integral part of the program. This tool also allowed for the continuous compilation of comparison data and development of prescribing tips. Predetermined criteria were established providing physicians with microorganism susceptibility reports and preferred treatment alternatives linked to pharmacoeconomic concerns. These strategies can be implemented with or without direct clinical pharmacotherapy specialist involvement at the individual patient care level.

  5. Project YES: A Break from Tradition.

    ERIC Educational Resources Information Center

    Jones, Dennis Floyd; And Others

    1995-01-01

    To aid at-risk children, summer intervention programs must emphasize links between physical well-being and drug awareness, nutrition, health, and safety. West Virginia's Project YES (Youth Enrichment Services) is a comprehensive, community-based program highlighting many aspects of child development. The article describes the program's history,…

  6. Adolescent Neurocognitive Development, Self-Regulation, and School-Based Drug Use Prevention

    PubMed Central

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

    2014-01-01

    Adolescence is marked by several key development-related changes, including neurocognitive changes. Cognitive abilities associated with self-regulation are not fully developed until late adolescence or early adulthood whereas tendencies to take risks and seek thrilling and novel experience seem to increase significantly throughout this phase, resulting in a discrepancy between increased susceptibility to poor regulation and lower ability to exercise self-control. Increased vulnerability to drug use initiation, maintenance, and dependence during adolescence may be explained based on this imbalance in the self-regulation system. In this paper, we highlight the relevance of schools as a setting for delivering adolescent drug use prevention programs that are based on recent findings from neuroscience concerning adolescent brain development. We discuss evidence from school-based as well as laboratory research that suggests that suitable training may improve adolescents’ executive brain functions that underlie self-regulation abilities and, as a result, help prevent drug use and abuse. We note that considerable further research is needed in order (1) to determine that self-regulation training has effects at the neurocognitive level and (2) to effectively incorporate self-regulation training based on neuropsychological models into school-based programming. PMID:23408284

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

    PubMed

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

    2013-06-01

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

  8. Public preferences and organized interests in health policy: state pharmacy assistance programs as innovations.

    PubMed

    Gray, Virginia; Lowery, David; Godwin, Erik K

    2007-02-01

    While Congress debated prescription drug coverage for more than a decade before amending the Medicare program in 2003, thirty-one states provided such benefits to their citizens. Why were the same special interests that were reputedly so effective in delaying prescription drug coverage at the national level seemingly incapable of stopping the majority of states from passing the same kinds of legislation? To answer this question, we develop and test a number of hypotheses about the determinants of health policy using Heckman models with data on the adoption, revision, and generosity of state prescription drug programs from 1990 through 2001. We find strong evidence that organized interests had little influence on the adoption of state pharmaceutical assistance programs but can influence their likelihood of revision and the generosity of their benefits. We conclude by discussing the balance of public preferences and organized interests' preferences on state health policy.

  9. Army Drug Development Program. Phase 1. Clinical Testing

    DTIC Science & Technology

    1981-02-01

    drug administration, the subjects fasted from 2400 to 0600, at which time they were given 360 ml Sustacal (Mead Johnson product ...Such factors as time of day, meals, alcohol, other drugs, and lack of proper sleep may affect the level of drug in your blood on...Sustacal (Mead Johnson product ) containing a total of 360 calories. Subjects ingested a single oral 750 mg dose of WR 180,409•H3PO4 in

  10. Does harm reduction programming make a difference in the lives of highly marginalized, at-risk drug users?

    PubMed Central

    Rogers, Susan J; Ruefli, Terry

    2004-01-01

    Harm reduction is a controversial model for treating drug users, with little formal research available on its operation and effectiveness. In order to advance the field, we first conducted participatory research of harm reduction with 120 clients using nominal-group technique to develop culturally relevant outcomes to measure progress. Second, we conducted focus group interviews with a different group of clients to help validate the outcomes. Third, we used the outcomes in an evaluation of the largest harm reduction program in New York City, which involved a representative sample of 261 and entailed baseline, post, and six follow-up assessments. The participatory research resulted in outcomes of 10 life areas important to drug users. Evaluation results showed that program participants made positive improvements across most outcomes, with the most substantial progress made in how clients dealt with drug-use problems. Along with their participation in the program, progress in some outcomes was also associated with clients' type of drug use (i.e., stable vs. chaotic), where more stable drug use was associated with better ways of making an income and types of housing. Surprisingly, progress was not associated with the kinds or numbers of services received or the length of time in the program. This was attributed to the service delivery model of harm reduction, in which clients are less inclined to associate their success with a single staff person or with a single service or intervention received than with the program as a whole. PMID:15171790

  11. Factors Associated with Illegal Drug Use in Rural Georgia.

    ERIC Educational Resources Information Center

    Napier, Ted L.; And Others

    To ascertain the incidence of drug use in a rural area and to provide insight into the covariates of illegal drug use which might be useful in developing prevention programs, data were collected in the spring of 1981 from 2,060 or 83.2% of all students grades 8 through 12 in a southern Georgia county. Data were collected during regularly scheduled…

  12. The "Flavor" of the Social Ecology Paradigm in Use: Building on Mutual Social Support in Preventing Drug Abuse.

    ERIC Educational Resources Information Center

    Thorsheim, Howard I.; Roberts, Bruce B.

    The "Bottled Pain" project, a drug abuse prevention program in 24 Lutheran congregations in southern Minnesota, is based on a social ecology paradigm designed to prevent drug abuse through the development of socially supportive relationshps and through using the environment as a natural strength within the community. According to the…

  13. Considerations for a business model for the effective integration of novel biomarkers into drug development.

    PubMed

    Frueh, Felix W

    2008-11-01

    It is 10 years since the introduction of trastuzumab into the US market, and we are still waiting for a validation of the business case for biomarker-driven drug development. While many reasons for the lack of duplication of this model may exist, the need for accelerated innovation in drug development paired with the opportunity of integrating biomarker-driven research into drug development programs may lead to new and creative ways of fostering the cooperation between drug developers and test manufacturers. The rapid increase in knowledge about biomarkers and our understanding of disease and disease mechanisms open unprecedented prospects to make not only better, more informed decisions regarding patient care, but also strategic decisions during drug development. This requires that a biomarker strategy becomes an integral part of (early) drug development and that new, innovative paths are tried towards a model that combines the scientific approach with an economically feasible implementation strategy. Collaborative research, the use of new communication tools, the exploration of alternative ways to position a product in the market, and other considerations are part of such a strategy. This perspective article illustrates the current landscape and takes a look at some of these new ways for more effectively integrating biomarkers into drug development.

  14. NCI–RTOG Translational Program Strategic Guidelines for the Early-Stage Development of Radiosensitizers

    PubMed Central

    2013-01-01

    The addition of chemotherapeutic agents to ionizing radiation has improved survival in many malignancies. Cure rates may be further improved by adding novel targeted agents to current radiotherapy or radiochemotherapy regimens. Despite promising laboratory data, progress in the clinical development of new drugs with radiation has been limited. To define and address the problems involved, a collaborative effort between individuals within the translational research program of the Radiation Oncology Therapy Group and the National Cancer Institute was established. We discerned challenges to drug development with radiation including: 1) the limited relevance of preclinical work, 2) the pharmaceutical industry’s diminished interest, and 3) the important individual skills and institutional commitments required to ensure a successful program. The differences between early-phase trial designs with and without radiation are noted as substantial. The traditional endpoints for early-phase clinical trials—acute toxicity and maximum-tolerated dose—are of limited value when combining targeted agents with radiation. Furthermore, response rate is not a useful surrogate marker of activity in radiation combination trials.Consequently, a risk-stratified model for drug-dose escalation with radiation is proposed, based upon the known and estimated adverse effects. The guidelines discuss new clinical trial designs, such as the time-to-event continual reassessment method design for phase I trials, randomized phase II “screening” trials, and the use of surrogate endpoints, such as pathological response. It is hoped that by providing a clear pathway, this article will accelerate the rate of drug development with radiation. PMID:23231975

  15. Incorporation of in silico biodegradability screening in early drug development--a feasible approach?

    PubMed

    Steger-Hartmann, Thomas; Länge, Reinhard; Heuck, Klaus

    2011-05-01

    The concentration of a pharmaceutical found in the environment is determined by the amount used by the patient, the excretion and metabolism pattern, and eventually by its persistence. Biological degradation or persistence of a pharmaceutical is experimentally tested rather late in the development of a pharmaceutical, often shortly before submission of the dossier to regulatory authorities. To investigate whether the aspect of persistence of a compound could be assessed early during drug development, we investigated whether biodegradation of pharmaceuticals could be predicted with the help of in silico tools. To assess the value of in silico prediction, we collected results for the OECD 301 degradation test ("ready biodegradability") of 42 drugs or drug synthesis intermediates and compared them to the prediction of the in silico tool BIOWIN. Of these compounds, 38 were predictable with BIOWIN, which is a module of the Estimation Programs Interface (EPI) Suite™ provided by the US EPA. The program failed to predict the two drugs which proved to be readily biodegradable in the degradation tests. On the other hand, BIOWIN predicted two compounds to be readily biodegradable which, however, proved to be persistent in the test setting. The comparison of experimental data with the predicted one resulted in a specificity of 94% and a sensitivity of 0%. The results of this study do not indicate that application of the biodegradation prediction tool BIOWIN is a feasible approach to assess the ready biodegradability during early drug development.

  16. 42 CFR 456.703 - Drug use review program.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 4 2010-10-01 2010-10-01 false Drug use review program. 456.703 Section 456.703... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS UTILIZATION CONTROL Drug Use Review (DUR) Program and Electronic Claims Management System for Outpatient Drug Claims § 456.703 Drug use review program. (a) General...

  17. 42 CFR 456.703 - Drug use review program.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 4 2014-10-01 2014-10-01 false Drug use review program. 456.703 Section 456.703... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS UTILIZATION CONTROL Drug Use Review (DUR) Program and Electronic Claims Management System for Outpatient Drug Claims § 456.703 Drug use review program. (a) General...

  18. 42 CFR 456.703 - Drug use review program.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 4 2012-10-01 2012-10-01 false Drug use review program. 456.703 Section 456.703... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS UTILIZATION CONTROL Drug Use Review (DUR) Program and Electronic Claims Management System for Outpatient Drug Claims § 456.703 Drug use review program. (a) General...

  19. 42 CFR 456.703 - Drug use review program.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 4 2013-10-01 2013-10-01 false Drug use review program. 456.703 Section 456.703... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS UTILIZATION CONTROL Drug Use Review (DUR) Program and Electronic Claims Management System for Outpatient Drug Claims § 456.703 Drug use review program. (a) General...

  20. 42 CFR 456.703 - Drug use review program.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 4 2011-10-01 2011-10-01 false Drug use review program. 456.703 Section 456.703... (CONTINUED) MEDICAL ASSISTANCE PROGRAMS UTILIZATION CONTROL Drug Use Review (DUR) Program and Electronic Claims Management System for Outpatient Drug Claims § 456.703 Drug use review program. (a) General...

  1. 14 CFR 120.117 - Implementing a drug testing program.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Implementing a drug testing program. 120... AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.117 Implementing a drug testing.... (4) A part 145 certificate holder who has your own drug testing program Obtain an Antidrug and...

  2. 14 CFR 120.117 - Implementing a drug testing program.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 3 2011-01-01 2011-01-01 false Implementing a drug testing program. 120... AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.117 Implementing a drug testing... 145 certificate holder who has your own drug testing program Obtain an Antidrug and Alcohol Misuse...

  3. 14 CFR 120.117 - Implementing a drug testing program.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 3 2012-01-01 2012-01-01 false Implementing a drug testing program. 120... AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.117 Implementing a drug testing... 145 certificate holder who has your own drug testing program Obtain an Antidrug and Alcohol Misuse...

  4. 14 CFR 120.117 - Implementing a drug testing program.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 3 2014-01-01 2014-01-01 false Implementing a drug testing program. 120... AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.117 Implementing a drug testing... Specification, Letter of Authorization, or Drug and Alcohol Testing Program Registration from the FAA: If you...

  5. 14 CFR 120.117 - Implementing a drug testing program.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 3 2013-01-01 2013-01-01 false Implementing a drug testing program. 120... AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.117 Implementing a drug testing... 145 certificate holder who has your own drug testing program Obtain an Antidrug and Alcohol Misuse...

  6. 28 CFR 550.53 - Residential Drug Abuse Treatment Program (RDAP).

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Residential Drug Abuse Treatment Program... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.53 Residential Drug Abuse Treatment... components: (1) Unit-based component. Inmates must complete a course of activities provided by drug abuse...

  7. 28 CFR 550.53 - Residential Drug Abuse Treatment Program (RDAP).

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Residential Drug Abuse Treatment Program... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.53 Residential Drug Abuse Treatment... components: (1) Unit-based component. Inmates must complete a course of activities provided by drug abuse...

  8. 28 CFR 550.53 - Residential Drug Abuse Treatment Program (RDAP).

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Residential Drug Abuse Treatment Program... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.53 Residential Drug Abuse Treatment... components: (1) Unit-based component. Inmates must complete a course of activities provided by drug abuse...

  9. 28 CFR 550.53 - Residential Drug Abuse Treatment Program (RDAP).

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Residential Drug Abuse Treatment Program... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.53 Residential Drug Abuse Treatment... components: (1) Unit-based component. Inmates must complete a course of activities provided by drug abuse...

  10. 28 CFR 550.53 - Residential Drug Abuse Treatment Program (RDAP).

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Residential Drug Abuse Treatment Program... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.53 Residential Drug Abuse Treatment... components: (1) Unit-based component. Inmates must complete a course of activities provided by drug abuse...

  11. [Risk reduction and drug use in detention: study about the detainees of Liancourt Penitentiary].

    PubMed

    Sannier, Olivier; Verfaillie, Florent; Lavielle, Dorothée

    2012-07-01

    The prison population is drug users. Recent debates around the provision of devices to reduce the risks associated with drug use (syringe exchange programs and snort kit) lead us to question local practices of the prison population. An anonymous questionnaire was offered to the prison population of the Liancourt penitentiary. The questions addressed the use of drugs before and during incarceration, knowledge of HIV and B and C hepatitis status, taking an opiate substitution treatment and advice on the implementation of syringe exchange programs and snort kit. A percentage of 54.4 of the prisoners responded to the questionnaire. An amount of 60.1 % of respondents consumed at least one drug before incarceration and 43.6 % of respondents consumed at least one drug during their incarceration. Cannabis was the most consumed drug before and during incarceration. Barely half of respondents reported knowing their HIV and hepatitis B and C status. Over 10 % of respondents said they were interesting in establishing needle exchange programs or snort kit. The prison concentrate drug users and is not a repressive tool of efficient risk reduction. The strategies implemented by the medical unit of Liancourt prison require adaptations that warrant development of health resources. Then, only new tools to reduce risks associated with drug use can be established. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

  12. Improving graduation rates for African Americans in drug court: Importance of human relationships and barriers to gaining and sustaining employment.

    PubMed

    Gallagher, John Robert; Nordberg, Anne; Dibley, Alyssa R

    2017-11-16

    Drug courts have been an important part of the criminal justice system since 1989. They continue to expand throughout the United States because nearly three decades of research has shown that they are more effective than other interventions, such as traditional probation. There is a pattern, though, in some drug courts where African Americans are less likely to graduate than their Caucasian counterparts. This qualitative study explores this phenomenon by asking African American participants (n = 31) their views on the most helpful aspects of drug court and how drug court could be more helpful in supporting them in graduating the program. Participants felt that the respect and compassion they received from the drug court judge and their case managers, as well as the camaraderie they developed with other participants, was an aspect of drug court that supported them in graduating the program. Next, participants felt that graduation rates would improve if drug court better supported them in gaining employment or sustaining the employment they already had. Implications for drug court practice are discussed.

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

    PubMed

    Chuang-Stein, Christy; Xia, H Amy

    2013-01-01

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

  14. The Tuberculosis Drug Discovery and Development Pipeline and Emerging Drug Targets

    PubMed Central

    Mdluli, Khisimuzi; Kaneko, Takushi; Upton, Anna

    2015-01-01

    The recent accelerated approval for use in extensively drug-resistant and multidrug-resistant-tuberculosis (MDR-TB) of two first-in-class TB drugs, bedaquiline and delamanid, has reinvigorated the TB drug discovery and development field. However, although several promising clinical development programs are ongoing to evaluate new TB drugs and regimens, the number of novel series represented is few. The global early-development pipeline is also woefully thin. To have a chance of achieving the goal of better, shorter, safer TB drug regimens with utility against drug-sensitive and drug-resistant disease, a robust and diverse global TB drug discovery pipeline is key, including innovative approaches that make use of recently acquired knowledge on the biology of TB. Fortunately, drug discovery for TB has resurged in recent years, generating compounds with varying potential for progression into developable leads. In parallel, advances have been made in understanding TB pathogenesis. It is now possible to apply the lessons learned from recent TB hit generation efforts and newly validated TB drug targets to generate the next wave of TB drug leads. Use of currently underexploited sources of chemical matter and lead-optimization strategies may also improve the efficiency of future TB drug discovery. Novel TB drug regimens with shorter treatment durations must target all subpopulations of Mycobacterium tuberculosis existing in an infection, including those responsible for the protracted TB treatment duration. This review summarizes the current TB drug development pipeline and proposes strategies for generating improved hits and leads in the discovery phase that could help achieve this goal. PMID:25635061

  15. A four-year surveillance program for detection of Plasmodium falciparum chloroquine resistance in Honduras

    PubMed Central

    Fontecha, Gustavo A; Sanchez, Ana L; Mendoza, Meisy; Banegas, Engels; Mejía-Torres, Rosa E

    2014-01-01

    Countries could use the monitoring of drug resistance in malaria parasites as an effective early warning system to develop the timely response mechanisms that are required to avert the further spread of malaria. Drug resistance surveillance is essential in areas where no drug resistance has been reported, especially if neighbouring countries have previously reported resistance. Here, we present the results of a four-year surveillance program based on the sequencing of the pfcrt gene of Plasmodium falciparum populations from endemic areas of Honduras. All isolates were susceptible to chloroquine, as revealed by the pfcrt “CVMNK” genotype in codons 72-76. PMID:25075788

  16. A four-year surveillance program for detection of Plasmodium falciparum chloroquine resistance in Honduras.

    PubMed

    Fontecha, Gustavo A; Sanchez, Ana L; Mendoza, Meisy; Banegas, Engels; Mejía-Torres, Rosa E

    2014-07-01

    Countries could use the monitoring of drug resistance in malaria parasites as an effective early warning system to develop the timely response mechanisms that are required to avert the further spread of malaria. Drug resistance surveillance is essential in areas where no drug resistance has been reported, especially if neighbouring countries have previously reported resistance. Here, we present the results of a four-year surveillance program based on the sequencing of the pfcrt gene of Plasmodium falciparum populations from endemic areas of Honduras. All isolates were susceptible to chloroquine, as revealed by the pfcrt "CVMNK" genotype in codons 72-76.

  17. The US Food and Drug Administration's expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements.

    PubMed

    Wallach, Joshua D; Ross, Joseph S; Naci, Huseyin

    2018-06-01

    The US Food and Drug Administration has several regulatory programs and pathways to expedite the development and approval of therapeutic agents aimed at treating serious or life-debilitating conditions. A common feature of these programs is the regulatory flexibility, which allows for a customized approval approach that enables market authorization on the basis of less rigorous evidence, in exchange for requiring postmarket evidence generation. An increasing share of therapeutic agents approved by the Food and Drug Administration in recent years are associated with expedited programs. In this article, we provide an overview of the evidentiary standards required by the Food and Drug Administration's expedited development and review programs, summarize the findings of the recent academic literature demonstrating some of the limitations of these programs, and outline potential opportunities to address these limitations. Recent evidence suggests that therapeutic agents in the Food and Drug Administration's expedited programs are approved on the basis of fewer and smaller studies that may lack comparator groups and random allocation, and rather than focusing on clinical outcomes for study endpoints, rely instead on surrogate markers of disease. Once on the market, agents receiving expedited approvals are often quickly incorporated into clinical practice, and evidence generated in the postmarket period may not necessarily address the evidentiary limitations at the time of market entry. Furthermore, not all pathways require additional postmarket studies. Evidence suggests that drugs in expedited approval programs are associated with a greater likelihood that the Food and Drug Administration will take a safety action following market entry. There are several opportunities to improve the timeliness, information value, and validity of the pre- and postmarket studies of therapeutic agents receiving expedited approvals. When use of nonrandomized and uncontrolled studies cannot be avoided prior to market entry, randomized trials should be mandatory in the postmarket period, unless there are strong justifications for not carrying out such studies. In the premarket period, validity of the surrogate markers can be improved by more rigorously evaluating their correlation with patient-relevant clinical outcomes. Opportunities to reduce the duration, complexity, and cost of postmarket randomized trials should not compromise their validity and instead incorporate pragmatic "real-world" design elements. Despite recent enthusiasm for widely using real-world evidence, adaptive designs, and pragmatic trials in the regulatory setting, caution is warranted until large-scale empirical evaluations demonstrate their validity compared to more traditional trial designs.

  18. Strategic planning for clinical services: St. Joseph Hospital and Health Care Center.

    PubMed

    Linggi, A; Pelham, L D

    1986-09-01

    A pharmacy department at a 340-bed community hospital based its strategic plan for developing patient-oriented services on a sound drug distribution system, a credible work-measurement program, and fiscal responsibility. In 1982 the department of pharmacy and i.v. therapy implemented a strategic plan for improving pharmaceutical services. The plan involved developing goals and objectives for the department; marketing the department's services and fiscal management to hospital administrators, medical staff, and nursing staff; building teamwork among the pharmacy staff; and improving the drug distribution system before instituting clinical services. Hiring of additional pharmacy staff was justified on the basis of work-measurement data. By adjusting staffing levels every two weeks based on work-measurement data, the department increased the efficiency of drug distribution activities; the pharmacy also implemented cost-saving programs like selection of therapeutic alternates and formulary restrictions. The savings were then reinvested in labor-intensive patient-oriented pharmaceutical services. A staff development program using staff pharmacists as preceptors expanded the breadth and depth of pharmacists' clinical skills. The planning efforts were successful because the needs of hospital administrators, the pharmacy department, and staff members were addressed.

  19. Implementing Preventive Chemotherapy through an Integrated National Neglected Tropical Disease Control Program in Mali

    PubMed Central

    Dembélé, Massitan; Bamani, Sanoussi; Dembélé, Robert; Traoré, Mamadou O.; Goita, Seydou; Traoré, Mamadou Namory; Sidibe, Abdoul Karim; Sam, Letitia; Tuinsma, Marjon; Toubali, Emily; MacArthur, Chad; Baker, Shawn K.; Zhang, Yaobi

    2012-01-01

    Background Mali is endemic for all five targeted major neglected tropical diseases (NTDs). As one of the five ‘fast-track’ countries supported with the United States Agency for International Development (USAID) funds, Mali started to integrate the activities of existing disease-specific national control programs on these diseases in 2007. The ultimate objectives are to eliminate lymphatic filariasis, onchocerciasis and trachoma as public health problems and to reduce morbidity caused by schistosomiasis and soil-transmitted helminthiasis through regular treatment to eligible populations, and the specific objectives were to achieve 80% program coverage and 100% geographical coverage yearly. The paper reports on the implementation of the integrated mass drug administration and the lessons learned. Methodology/Principal Findings The integrated control program was led by the Ministry of Health and coordinated by the national NTD Control Program. The drug packages were designed according to the disease endemicity in each district and delivered through various platforms to eligible populations involving the primary health care system. Treatment data were recorded and reported by the community drug distributors. After a pilot implementation of integrated drug delivery in three regions in 2007, the treatment for all five targeted NTDs was steadily scaled up to 100% geographical coverage by 2009, and program coverage has since been maintained at a high level: over 85% for lymphatic filariasis, over 90% for onchocerciasis and soil-transmitted helminthiasis, around 90% in school-age children for schistosomiasis, and 76–97% for trachoma. Around 10 million people have received one or more drug packages each year since 2009. No severe cases of adverse effects were reported. Conclusions/Significance Mali has scaled up the drug treatment to national coverage through integrated drug delivery involving the primary health care system. The successes and lessons learned in Mali can be valuable assets to other countries starting up their own integrated national NTD control programs. PMID:22448294

  20. NEuro COgnitive REhabilitation for Disease of Addiction (NECOREDA) Program: From Development to Trial

    PubMed Central

    Rezapour, Tara; Hatami, Javad; Farhoudian, Ali; Sofuoglu, Mehmet; Noroozi, Alireza; Daneshmand, Reza; Samiei, Ahmadreza; Ekhtiari, Hamed

    2015-01-01

    Despite extensive evidence for cognitive deficits associated with drug use and multiple publications supporting the efficacy of cognitive rehabilitation treatment (CRT) services for drug addictions, there are a few well-structured tools and organized programs to improve cognitive abilities in substance users. Most published studies on cognitive rehabilitation for drug dependent patients used rehabilitation tools, which have been previously designed for other types of brain injuries such as schizophrenia or traumatic brain injuries and not specifically designed for drug dependent patients. These studies also suffer from small sample size, lack of follow-up period assessments and or comprehensive treatment outcome measures. To address these limitations, we decided to develop and investigate the efficacy of a paper and pencil cognitive rehabilitation package called NECOREDA (Neurocognitive Rehabilitation for Disease of Addiction) to improve neurocognitive deficits associated with drug dependence particularly caused by stimulants (e.g. amphetamine type stimulants and cocaine) and opiates. To evaluate the feasibility of NECOREDA program, we conducted a pilot study with 10 opiate and methamphetamine dependent patients for 3 months in outpatient setting. NECOREDA was revised based on qualitative comments received from clients and treatment providers. Final version of NECOREDA is composed of brain training exercises called “Brain Gym” and psychoeducational modules called “Brain Treasures” which is implemented in 16 training sessions interleaved with 16 review and practice sessions. NECOREDA will be evaluated as an add-on intervention to methadone maintenance treatment in a randomized clinical trial among opiate dependent patients starting from August 2015. We discuss methodological features of NECOREDA development and evaluation in this article. PMID:26649167

  1. Patents, Innovation, and the Welfare Effects of Medicare Part D*

    PubMed Central

    Gailey, Adam; Lakdawalla, Darius; Sood, Neeraj

    2013-01-01

    Purpose To evaluate the efficiency consequences of the Medicare Part D program. Methods We develop and empirically calibrate a simple theoretical model to examine the static and dynamic welfare effects of Medicare Part D. Findings We show that Medicare Part D can simultaneously reduce static deadweight loss from monopoly pricing of drugs and improve incentives for innovation. We estimate that even after excluding the insurance value of the program, the welfare gain of Medicare Part D roughly equals its social costs. The program generates $5.11 billion of annual static deadweight loss reduction, and at least $3.0 billion of annual value from extra innovation. Implications Medicare Part D and other public prescription drug programs can be welfare-improving, even for risk-neutral and purely self-interested consumers. Furthermore, negotiation for lower branded drug prices may further increase the social return to the program. Originality This study demonstrates that pure efficiency motives, which do not even surface in the policy debate over Medicare Part D, can nearly justify the program on their own merits. PMID:20575239

  2. Drug-device combination products in the twenty-first century: epinephrine auto-injector development using human factors engineering.

    PubMed

    Edwards, Eric S; Edwards, Evan T; Simons, F Estelle R; North, Robert

    2015-05-01

    The systematic application of human factors engineering (HFE) principles to the development of drug-device combination products, including epinephrine auto-injectors (EAIs), has the potential to improve the effectiveness and safety of drug administration. A PubMed search was performed to assess the role of HFE in the development of drug-device combination products. The following keywords were used in different combinations: 'human factors engineering,' 'human factors,' 'medical products,' 'epinephrine/adrenaline auto-injector,' 'healthcare' and 'patient safety.' This review provides a summary of HFE principles and their application to the development of drug-device combination products as advised by the US FDA. It also describes the HFE process that was applied to the development of Auvi-Q, a novel EAI, highlighting specific steps that occurred during the product-development program. For drug-device combination products, device labeling and usability are critical and have the potential to impact clinical outcomes. Application of HFE principles to the development of drug-delivery devices has the potential to improve product quality and reliability, reduce risk and improve patient safety when applied early in the development process. Additional clinical and real-world studies will confirm whether the application of HFE has helped to develop an EAI that better meets the needs of patients at risk of anaphylaxis.

  3. Harm reduction in the USA: the research perspective and an archive to David Purchase.

    PubMed

    Des Jarlais, Don C

    2017-07-26

    The history of harm reduction in the USA has led to the development of some of the most important methods for treating persons for drug use disorders, such as methadone and buprenorphine for opiate use disorder. However, there has been fierce political resistance to implementation and scale-up of harm reduction in the USA. This resistance is rooted in historical demonization of particular psychoactive drugs that were associated with stigmatized racial/ethnic groups.With the discovery of acquired immunodeficiency syndrome (AIDS) in 1981, harm reduction became important not only for treating substance use disorders, but for reducing transmission of blood-borne infection. However, within the context of the crack cocaine epidemic in the 1980s, it was very difficult to implement any programs that appeared to "condone" drug use.It was not until the late 1980s that syringe exchange programs began at the state and local level in the USA. With funding primarily from state and local governments and the support of the North American Syringe Exchange Network (NASEN), there are now approximately 200 programs for syringe exchange in the USA. Research has shown that these programs have been extremely effective in reducing human immunodeficiency virus (HIV) transmission among persons who inject drugs (PWID). The programs in the USA also offer many additional services for drug users, including condom distribution, referrals to substance abuse treatment, HIV, hepatitis C virus (HCV), hepatitis B virus (HBV) counseling and testing, overdose education and naloxone distribution to reverse for overdose.Currently, the USA is experiencing an opioid/heroin epidemic, with significant increases in overdose deaths among drug users. Much of this epidemic is occurring in suburban and rural of the country without harm reduction services. The current challenges for harm reduction and harm reduction research involve expansion of services to suburban and rural areas and implementation science on how to effectively and efficiently address HCV transmission and overdose. Most importantly, continued research efforts are needed to reduce the stigma of psychoactive drug use. While political opposition continues, harm reduction activists and researchers have developed a highly effective partnership based on a common core values.

  4. INEL BNCT Research Program, March/April 1992

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Venhuizen, J.R.

    1992-09-01

    This report presents summaries for two months of current research for the Idaho National Engineering Laboratory (INEL) Boron Neutron Capture Therapy (BNCT) Program. Information is presented on development and murino screening experiments of low-density lipoprotein, carboranyl alanine, and liposome boron containing compounds. Pituitary tumor call culture studies are described. Drug stability, pharmacology and toxicity evaluation of borocaptate sodium (BSH) and boronopheoylalanine (BPA) are described. Treatment protocol development via the large animal (canine) model studies and physiological response evaluation in rats are discussed. Supporting technology development and technical support activities for boron drug biochemistry and purity, analytical and measurement dosimetry, andmore » noninvasive boron quantification activities are included for the current time period. Current publications for the two months are listed.« less

  5. Mathematical simulations for bioanalytical assay development: the (un-)necessity and (im-)possibility of free drug quantification.

    PubMed

    Staack, Roland F; Jordan, Gregor; Heinrich, Julia

    2012-02-01

    For every drug development program it needs to be discussed whether discrimination between free and total drug concentrations is required to accurately describe its pharmacokinetic behavior. This perspective describes the application of mathematical simulation approaches to guide this initial decision based on available knowledge about target biology, binding kinetics and expected drug concentrations. We provide generic calculations that can be used to estimate the necessity of free drug quantification for different drug molecules. In addition, mathematical approaches are used to simulate various assay conditions in bioanalytical ligand-binding assays: it is demonstrated that due to the noncovalent interaction between the binding partners and typical assay-related interferences in the equilibrium, a correct quantification of the free drug concentration is highly challenging and requires careful design of different assay procedure steps.

  6. North Carolina Agricultural and Technical State University Drug Education Policy.

    ERIC Educational Resources Information Center

    Welborne, Sullivan; And Others

    This drug education policy statement for North Carolina Agricultural and Technical State University establishes two educational objectives: to develop an educational program that increases the university community's knowledge and competency regarding controlled substances and to increase the skills required to take corrective action for potential…

  7. 78 FR 19724 - National Institute on Drug Abuse: Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

    .... The meeting will be open to the public as indicated below, with attendance limited to space available... confidential trade secrets or commercial property such as patentable material, and personal information..., legislative and program developments in the drug abuse field. Place: National Institutes of Health...

  8. Antibody-linked drug destroys tumor cells and tumor blood vessels in many types of cancer | Center for Cancer Research

    Cancer.gov

    A team led by Brad St. Croix, Ph.D., Senior Associate Scientist, Mouse Cancer Genetics Program, has developed an antibody-drug conjugate (ADC) that destroys both tumor cells and the blood vessels that nourish them. The drug significantly shrank breast tumors, colon tumors and several other types of cancer and prolonged survival. Learn more...  

  9. Rational, computer-enabled peptide drug design: principles, methods, applications and future directions.

    PubMed

    Diller, David J; Swanson, Jon; Bayden, Alexander S; Jarosinski, Mark; Audie, Joseph

    2015-01-01

    Peptides provide promising templates for developing drugs to occupy a middle space between small molecules and antibodies and for targeting 'undruggable' intracellular protein-protein interactions. Importantly, rational or in cerebro design, especially when coupled with validated in silico tools, can be used to efficiently explore chemical space and identify islands of 'drug-like' peptides to satisfy diverse drug discovery program objectives. Here, we consider the underlying principles of and recent advances in rational, computer-enabled peptide drug design. In particular, we consider the impact of basic physicochemical properties, potency and ADME/Tox opportunities and challenges, and recently developed computational tools for enabling rational peptide drug design. Key principles and practices are spotlighted by recent case studies. We close with a hypothetical future case study.

  10. Developing drug formularies for the "National Medical Holding" JSC.

    PubMed

    Akhmadyar, N S; Khairulin, B E; Amangeldy-Kyzy, S; Ospanov, M A

    2015-01-01

    One of the main problems of drug provision of multidisciplinary hospitals is the necessity to improve the efficiency of budget spending. Despite the efforts undertaken in Kazakhstan for improving the mechanism of drug distribution (creation of the Kazakhstan National Formulary, Unified National Health System, the handbook of medicines (drugs) costs in the electronic register of inpatients (ERI), having a single distributor), the number of unresolved issues still remain."National Medical Holding" JSC (NMH) was established in 2008 and unites 6 innovational healthcare facilities with up to 1431 beds (700 children and 731 adults), located in the medical cluster - which are "National Research Center for Maternal and Child Health" JSC (NRCMC), "Republic Children's Rehabilitation Center" JSC (RCRC), "Republican Diagnostic Center" JSC (RDC), "National Centre for Neurosurgery" JSC (NCN), "National Research Center for Oncology and Transplantation" JSC (NRCOT) and "National Research Cardiac Surgery Center" JSC (NRCSC). The main purpose of NMH is to create an internationally competitive "Hospital of the Future", which will provide the citizens of Kazakhstan and others with a wide range of medical services based on advanced medical technology, modern hospital management, international quality and safety standards. These services include emergency care, outpatient diagnostic services, obstetrics and gynecology, neonatal care, internal medicine, neurosurgery, cardiac surgery, transplantation, cancer care for children and adults, as well as rehabilitation treatment. To create a program of development of a drug formulary of NMH and its subsidiaries. In order to create drug formularies of NMH, analytical, software and statistical methods were used.AII subsidiary organizations of NMH (5 out of 6) except for the NRCOT have been accredited by Joint Commission International (JCI) standards, which ensure the safety of patients and clinical staff, by improving the technological infrastructure, management systems, production environments, and developing program for medications management and use (MMU), etc.MMU is the Chapter 7 of the 5th edition of the standard JCI [1] which is an up-to-date recognized international standard for hospital drug supply and includes 7 points of medication management lifecycle for inpatient hospitals: drug management and organization; selection and procurement; storage; prescription; preparation and distribution; administering medications; monitoring.Due to the developed MMU program of subsidiary organizations the drug provision system was rationalized, starting from defining the individual therapy of a patient and ending with the drug procurement strategy. The practical activity was introduced to the use of drugs committeees with reliable evidence-based performance with obligatory consideration of cost-benefit analysis for each diagnosis-related group. Pre-collected applications for drugs for the year 2015 were submitted in a uniform format in accordance with the structure of the Republican form of the drug [2]. In view of the evidence-base physicians-clinical pharmacologists performed discussions and review of 851 drugs included on the uniform format of the list. Totally 51 (6%) positions were excluded from the list; it was suggested that the format of the application for Paracetamol and Ibuprofen in injectable form be revised; the committee revised the sections on the list for "Antianaemia drugs", iron preparations and methods of prevention of venous thromboembolism with oral anticoagulants.On the basis of this work, the new format, consisting of 449 international nonproprietary names was developed, representing 795 positions with pediatric formulations. In view of the exisitng data and the move to bring to the common standards and uniformity prices of drugs purchased for 2016, the NMH program of clinical pharmacology content with on-line and open access to physicians was created. Within 60 days the DSCHC work was carried out with consultations, selection, definition of requirements of generic and therapeutic substitution. Summing up, drug applications for 2016 with dosage forms include 802 positions and the total bid in monetary terms was by 4,7% lower than in 2015.For the establishment of NMH rational and balanced system of medicine provision to patients and in order to increase availability of quality, safe and effective drugs, we need to have an open and transparent program of the MMU, developed in accordance with the standards of JCI, with the NMH drug formulary, indicating the reference price values of the lower units (tablet, capsule, ampoule, vial, etc.), including the drug lists for a single distributor.To improve drug supply of the NMH DSCHC we have to further cooperation with clinical pharmacologists for the rational use of medicines, guided by the principles of evidence-based medicine.

  11. Pressure for drug development in lysosomal storage disorders - a quantitative analysis thirty years beyond the US orphan drug act.

    PubMed

    Mechler, Konstantin; Mountford, William K; Hoffmann, Georg F; Ries, Markus

    2015-04-18

    Lysosomal storage disorders are a heterogeneous group of approximately 50 monogenically inherited orphan conditions. A defect leads to the storage of complex molecules in the lysosome, and patients develop a complex multisystemic phenotype of high morbidity often associated with premature death. More than 30 years ago the Orphan Drug Act of 1983 passed the United States legislation intended to facilitate the development of drugs for rare disorders. We directed our efforts in assessing which lysosomal diseases had drug development pressure and what distinguished those with successful development and approvals from diseases not treated or without orphan drug designation. Analysis of the FDA database for orphan drug designations through descriptive and comparative statistics. Between 1983 and 2013, fourteen drugs for seven conditions received FDA approval. Overall, orphan drug status was designated 70 times for 20 conditions. Approved therapies were enzyme replacement therapies (N = 10), substrate reduction therapies (N = 1), small molecules facilitating lysosomal substrate transportation (N = 3). FDA approval was significantly associated with a disease prevalence higher than 0.5/100,000 (p = 0.00742) and clinical development programs that did not require a primary neurological endpoint (p = 0.00059). Orphan drug status was designated for enzymes, modified enzymes, fusion proteins, chemical chaperones, small molecules leading to substrate reduction, or facilitating subcellular substrate transport, stem cells as well as gene therapies. Drug development focused on more common diseases. Primarily neurological diseases were neglected. Small clinical trials with either somatic or biomarker endpoints were successful. Enzyme replacement therapy was the most successful technology. Four factors played a key role in successful orphan drug development or orphan drug designations: 1) prevalence of disease 2) endpoints 3) regulatory precedent, and 4) technology platform. Successful development seeded further innovation.

  12. An appraisal of drug development timelines in the Era of precision oncology

    PubMed Central

    Jardim, Denis Leonardo; Schwaederle, Maria; Hong, David S.; Kurzrock, Razelle

    2016-01-01

    The effects of incorporating a biomarker-based (personalized or precision) selection strategy on drug development timelines for new oncology drugs merit investigation. Here we accessed documents from the Food and Drug Administration (FDA) database for anticancer agents approved between 09/1998 and 07/2014 to compare drugs developed with and without a personalized strategy. Sixty-three drugs were included (28 [44%] personalized and 35 [56%] non-personalized). No differences in access to FDA-expedited programs were observed between personalized and non-personalized drugs. A personalized approach for drug development was associated with faster clinical development (Investigational New Drug [IND] to New Drug Application [NDA] submission; median = 58.8 months [95% CI 53.8–81.8] vs. 93.5 months [95% CI 73.9–112.9], P =.001), but a similar approval time (NDA submission to approval; median=6.0 months [95% CI 5.5–8.4] vs. 6.1 months [95% CI 5.9–8.3], P = .756) compared to a non-personalized strategy. In the multivariate model, class of drug stratified by personalized status (targeted personalized vs. targeted non-personalized vs. cytotoxic) was the only independent factor associated with faster total time of clinical drug development (clinical plus approval phase, median = 64.6 vs 87.1 vs. 112.7 months [cytotoxic], P = .038). Response rates (RR) in early trials were positively correlated with RR in registration trials (r = 0.63, P = <.001), and inversely associated with total time of drug development (r = −0.29, P = .049). In conclusion, targeted agents were developed faster than cytotoxic agents. Shorter times to approval were associated, in multivariate analysis, with a biomarker-based clinical development strategy. PMID:27419632

  13. Design Considerations for the Development of Interactive Video (IV) in Nurse Education.

    ERIC Educational Resources Information Center

    Chandra, Peter; And Others

    A computer assisted learning (CAL) program in the area of intravenous drug administration developed by the Nightingale Project is currently being used in a number of nursing schools and hospitals throughout the United Kingdom. The success of this program and the emergence of interactive video as a significant training medium persuaded the…

  14. Core competencies for pharmaceutical physicians and drug development scientists

    PubMed Central

    Silva, Honorio; Stonier, Peter; Buhler, Fritz; Deslypere, Jean-Paul; Criscuolo, Domenico; Nell, Gerfried; Massud, Joao; Geary, Stewart; Schenk, Johanna; Kerpel-Fronius, Sandor; Koski, Greg; Clemens, Norbert; Klingmann, Ingrid; Kesselring, Gustavo; van Olden, Rudolf; Dubois, Dominique

    2013-01-01

    Professional groups, such as IFAPP (International Federation of Pharmaceutical Physicians and Pharmaceutical Medicine), are expected to produce the defined core competencies to orient the discipline and the academic programs for the development of future competent professionals and to advance the profession. On the other hand, PharmaTrain, an Innovative Medicines Initiative project, has become the largest public-private partnership in biomedicine in the European Continent and aims to provide postgraduate courses that are designed to meet the needs of professionals working in medicines development. A working group was formed within IFAPP including representatives from PharmaTrain, academic institutions and national member associations, with special interest and experience on Quality Improvement through education. The objectives were: to define a set of core competencies for pharmaceutical physicians and drug development scientists, to be summarized in a Statement of Competence and to benchmark and align these identified core competencies with the Learning Outcomes (LO) of the PharmaTrain Base Course. The objectives were successfully achieved. Seven domains and 60 core competencies were identified and aligned accordingly. The effective implementation of training programs using the competencies or the PharmaTrain LO anywhere in the world may transform the drug development process to an efficient and integrated process for better and safer medicines. The PharmaTrain Base Course might provide the cognitive framework to achieve the desired Statement of Competence for Pharmaceutical Physicians and Drug Development Scientists worldwide. PMID:23986704

  15. 28 CFR 550.56 - Community Transitional Drug Abuse Treatment Program (TDAT).

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Community Transitional Drug Abuse... JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.56 Community Transitional Drug Abuse Treatment Program (TDAT). (a) For inmates to successfully complete all components of...

  16. 28 CFR 550.56 - Community Transitional Drug Abuse Treatment Program (TDAT).

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Community Transitional Drug Abuse... JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.56 Community Transitional Drug Abuse Treatment Program (TDAT). (a) For inmates to successfully complete all components of...

  17. 28 CFR 550.56 - Community Transitional Drug Abuse Treatment Program (TDAT).

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Community Transitional Drug Abuse... JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.56 Community Transitional Drug Abuse Treatment Program (TDAT). (a) For inmates to successfully complete all components of...

  18. 28 CFR 550.56 - Community Transitional Drug Abuse Treatment Program (TDAT).

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Community Transitional Drug Abuse... JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.56 Community Transitional Drug Abuse Treatment Program (TDAT). (a) For inmates to successfully complete all components of...

  19. 28 CFR 550.56 - Community Transitional Drug Abuse Treatment Program (TDAT).

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Community Transitional Drug Abuse... JUSTICE INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.56 Community Transitional Drug Abuse Treatment Program (TDAT). (a) For inmates to successfully complete all components of...

  20. Evaluation of a peer-led drug abuse risk reduction project for runaway/homeless youths.

    PubMed

    Fors, S W; Jarvis, S

    1995-01-01

    The purpose of this study was to evaluate the Drug Prevention in Youth risk reduction program that was implemented in shelters for runaway/homeless youths in the Southeastern United States. The program focuses on knowledge, attitudes and skills that can help this group of high risk young people minimize the serious negative consequences of drug abuse. An evaluation strategy was developed so comparisons could be made between peer-led, adult-led and non-intervention groups. Dependent samples t tests and least squares ANCOVAS were used to measure pretest-posttest differences both within and between groups. Results indicate that the peer-led groups were more successful than the other two groups, and that program effects were the most powerful with the youngest group of shelter clients. Process evaluation revealed important factors related to group leader training and group management. It is concluded that well-trained and motivated peer/near peer leaders have particularly valuable contributions to make with regard to drug abuse risk reduction for shelter clients.

  1. Improving Healthy Living Youth Development Program Outreach in Extension: Lessons Learned from the 4-H Health Rocks! Program

    ERIC Educational Resources Information Center

    Kumaran, Muthusami; Fogarty, Kate; Fung, Whitney M.; Terminello, Amanda

    2015-01-01

    This article discusses a qualitative evaluation of the Florida 4-H Health Rocks! program aimed at youth alcohol, tobacco, and other drug use prevention. A questionnaire was distributed to Extension professionals across Florida to gain insight into the strengths and barriers they faced with programming. Programmatic strengths included targeting a…

  2. Knowing the Ropes and Showing the Ropes. Facilitator's Guide.

    ERIC Educational Resources Information Center

    Storer, John H.

    This document consists of a facilitator's guide and related materials for implementing a program that teaches social, communication, and study skills to middle school and junior high school students. The goal of the program, which incorporates peer tutoring, is the prevention of drug and alcohol abuse. This program was developed in Iowa to address…

  3. Mortality among Hispanic drug users in Puerto Rico.

    PubMed

    Robles, Rafaela R; Matos, Tomás D; Colón, Héctor M; Sahai, Hardeo; Reyes, Juan C; Marrero, C Amalia; Calderón, José M

    2003-12-01

    This paper assesses mortality rate for a cohort of drug users in Puerto Rico compared with that of the Island's general population, examining causes of death and estimating relative risk of death. Date and cause of death were obtained from death certificates during 1998. Vital status was confirmed through contact with subjects, family, and friends. HIV/AIDS was the major cause of death (47.7%), followed by homicide (14.6%), and accidental poisoning (6.3%). Females had higher relative risk of death than males in all age categories. Not living with a sex partner and not receiving drug treatment were related to higher mortality due to HIV/AIDS. Drug injection was the only variable explaining relative risk of death due to overdose. Puerto Rico needs to continue developing programs to prevent HIV/AIDS among drug users. Special attention should be given to young women, who appear to be in greatest need of programs to prevent early mortality.

  4. Test implementation of a school-oriented drug prevention program “Study without Drugs”: pre- and post-testing for effectiveness

    PubMed Central

    2014-01-01

    Background In this article, the test implementation of a school-oriented drug prevention program “Study without Drugs” is discussed. The aims of this study were to determine the results of the process evaluation and to determine whether the proposed school-oriented drug prevention program during a pilot project was effective for the participating pupils. Methods Sixty second-grade pupils at a junior high school in Paramaribo, Suriname participated in the test implementation. They were divided into two classes. For the process evaluation the students completed a structured questionnaire focusing on content and teaching method after every lesson. Lessons were qualified with a score from 0–10. The process was also evaluated by the teachers through structured interviews. Attention was paid to reach, dose delivered, dose received, fidelity, connection, achieved effects/observed behaviors, areas for improvement, and lesson strengths. The effect evaluation was conducted by using the General Liniair Model (repeated measure). The research (-design) was a pre-experimental design with pre-and post-test. Results No class or sex differences were detected among the pupils with regard to the assessment of content, methodology, and qualification of the lessons. Post-testing showed that participating pupils obtained an increased knowledge of drugs, their drug-resisting skills were enhanced, and behavior determinants (attitude, subjective norm, self-efficacy, and intention) became more negative towards drugs. Conclusions From the results of the test implementation can be cautiously concluded that the program “Study without Drugs” may yield positive results when applied in schools). Thus, this pilot program can be considered a step towards the development and implementation of an evidence-based school-oriented program for pupils in Suriname. PMID:24920468

  5. Computational identification of potential multi-drug combinations for reduction of microglial inflammation in Alzheimer disease

    PubMed Central

    Anastasio, Thomas J.

    2015-01-01

    Like other neurodegenerative diseases, Alzheimer Disease (AD) has a prominent inflammatory component mediated by brain microglia. Reducing microglial inflammation could potentially halt or at least slow the neurodegenerative process. A major challenge in the development of treatments targeting brain inflammation is the sheer complexity of the molecular mechanisms that determine whether microglia become inflammatory or take on a more neuroprotective phenotype. The process is highly multifactorial, raising the possibility that a multi-target/multi-drug strategy could be more effective than conventional monotherapy. This study takes a computational approach in finding combinations of approved drugs that are potentially more effective than single drugs in reducing microglial inflammation in AD. This novel approach exploits the distinct advantages of two different computer programming languages, one imperative and the other declarative. Existing programs written in both languages implement the same model of microglial behavior, and the input/output relationships of both programs agree with each other and with data on microglia over an extensive test battery. Here the imperative program is used efficiently to screen the model for the most efficacious combinations of 10 drugs, while the declarative program is used to analyze in detail the mechanisms of action of the most efficacious combinations. Of the 1024 possible drug combinations, the simulated screen identifies only 7 that are able to move simulated microglia at least 50% of the way from a neurotoxic to a neuroprotective phenotype. Subsequent analysis shows that of the 7 most efficacious combinations, 2 stand out as superior both in strength and reliability. The model offers many experimentally testable and therapeutically relevant predictions concerning effective drug combinations and their mechanisms of action. PMID:26097457

  6. 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

  7. Genomes2Drugs: Identifies Target Proteins and Lead Drugs from Proteome Data

    PubMed Central

    Toomey, David; Hoppe, Heinrich C.; Brennan, Marian P.; Nolan, Kevin B.; Chubb, Anthony J.

    2009-01-01

    Background Genome sequencing and bioinformatics have provided the full hypothetical proteome of many pathogenic organisms. Advances in microarray and mass spectrometry have also yielded large output datasets of possible target proteins/genes. However, the challenge remains to identify new targets for drug discovery from this wealth of information. Further analysis includes bioinformatics and/or molecular biology tools to validate the findings. This is time consuming and expensive, and could fail to yield novel drugs if protein purification and crystallography is impossible. To pre-empt this, a researcher may want to rapidly filter the output datasets for proteins that show good homology to proteins that have already been structurally characterised or proteins that are already targets for known drugs. Critically, those researchers developing novel antibiotics need to select out the proteins that show close homology to any human proteins, as future inhibitors are likely to cross-react with the host protein, causing off-target toxicity effects later in clinical trials. Methodology/Principal Findings To solve many of these issues, we have developed a free online resource called Genomes2Drugs which ranks sequences to identify proteins that are (i) homologous to previously crystallized proteins or (ii) targets of known drugs, but are (iii) not homologous to human proteins. When tested using the Plasmodium falciparum malarial genome the program correctly enriched the ranked list of proteins with known drug target proteins. Conclusions/Significance Genomes2Drugs rapidly identifies proteins that are likely to succeed in drug discovery pipelines. This free online resource helps in the identification of potential drug targets. Importantly, the program further highlights proteins that are likely to be inhibited by FDA-approved drugs. These drugs can then be rapidly moved into Phase IV clinical studies under ‘change-of-application’ patents. PMID:19593435

  8. 49 CFR 219.601 - Railroad random drug testing programs.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false Railroad random drug testing programs. 219.601... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.601 Railroad random drug testing programs. (a) Submission. Each railroad must submit for FRA...

  9. 49 CFR 219.601 - Railroad random drug testing programs.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 4 2012-10-01 2012-10-01 false Railroad random drug testing programs. 219.601... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.601 Railroad random drug testing programs. (a) Submission. Each railroad must submit for FRA...

  10. 49 CFR 219.601 - Railroad random drug testing programs.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 4 2014-10-01 2014-10-01 false Railroad random drug testing programs. 219.601... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.601 Railroad random drug testing programs. (a) Submission. Each railroad must submit for FRA...

  11. 49 CFR 219.601 - Railroad random drug testing programs.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 4 2013-10-01 2013-10-01 false Railroad random drug testing programs. 219.601... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.601 Railroad random drug testing programs. (a) Submission. Each railroad must submit for FRA...

  12. 49 CFR 219.601 - Railroad random drug testing programs.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 4 2011-10-01 2011-10-01 false Railroad random drug testing programs. 219.601... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Random Alcohol and Drug Testing Programs § 219.601 Railroad random drug testing programs. (a) Submission. Each railroad must submit for FRA...

  13. A Drug and Alcohol Aftercare Service: Linking Adolescents, Families and Schools.

    ERIC Educational Resources Information Center

    Fertman, Carl I.; Toca, Olivia A.

    1988-01-01

    Describes first-year service process and implementation evaluation of aftercare service for adolescents who had completed drug and alcohol treatment programs. Results showed that aftercare service, developed cooperatively by schools and community agencies to support and link adolescents, parents, and schools during adolescents' recovery, helped…

  14. 75 FR 60759 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-01

    ... Drug Program Monthly and Quarterly Drug Reporting Format; Use: In order for payment to be made under...: Private Sector: Business or other for-profits; Number of Respondents: 580; Total Annual Responses: 9,280..., 2010. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and...

  15. 76 FR 45271 - Review and Qualification of Clinical Outcome Assessments; Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-28

    ... announcing a public workshop to discuss measurement principles for clinical outcome assessments (COAs) for... appropriate drug development program. Because the qualification process is separate from the drug marketing... other DDTs. This workshop will focus on FDA review principles specific to all type of COAs, i.e., PRO...

  16. 7 CFR 1940.968 - Rural Economic Development Review Panel Grant (Panel Grant).

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... AGENCY, DEPARTMENT OF AGRICULTURE (CONTINUED) PROGRAM REGULATIONS (CONTINUED) GENERAL System for Delivery... of Agriculture regulations, 7 CFR, parts 3016 and 3017, as appropriate. (4) Drug-free work place. The State must provide for a drug-free workplace in accordance with the requirements of FmHA Instruction...

  17. 7 CFR 1940.968 - Rural Economic Development Review Panel Grant (Panel Grant).

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... AGENCY, DEPARTMENT OF AGRICULTURE (CONTINUED) PROGRAM REGULATIONS (CONTINUED) GENERAL System for Delivery... of Agriculture regulations, 7 CFR, parts 3016 and 3017, as appropriate. (4) Drug-free work place. The State must provide for a drug-free workplace in accordance with the requirements of FmHA Instruction...

  18. Development of a Course of Study in FDA Drug Regulatory Procedures

    ERIC Educational Resources Information Center

    Jacobs, Robin Wills; King, James C.

    1977-01-01

    It is evident that more colleges of pharmacy should establish some major course of study in the area of governmental drug regulatory procedures. This study is aimed at expanding cooperative educational programs through an FDA residency for pharmacy students and preparing a didactic course in FDA procedures. (LBH)

  19. Early access programs: Benefits, challenges, and key considerations for successful implementation

    PubMed Central

    Patil, Sanjaykumar

    2016-01-01

    Early access programs, (EAPs) are adopted by an increasing number of pharma companies due to several benefits offered by these programs. EAPs offer ethical, compliant, and controlled mechanisms of access to investigational drugs outside of the clinical trial space and before the commercial launch of the drug, to patients with life-threatening diseases having no treatment options available. In addition to the development of positive relationships with key opinion leaders (KOL), patients, advocacy groups and regulators, the data captured from the implementation of EAPs supports in the formulation of global commercialization strategies. This white paper outlines various circumstances to be considered for the implementation of EAPs named patient programs, the regulatory landscape, the benefits and challenges associated with implementing these programs and the key considerations for their successful implementation. PMID:26955570

  20. Econotherapeutics.

    PubMed

    Roark, M K; Reed, W E

    1995-01-01

    A program that represents the efforts of a hospital pharmacy management company to control drug costs is described. The program, Econotherapeutics, was developed in response to a changed health care reimbursement system that focused on the costs of products rather than the revenue generated by these products. For antimicrobial agents, a hospital-specific antibiogram is used to encourage cost-effective prescribing. A pharmacist intervention program, medical staff presentations, drug usage evaluation, management systems, and educational programs for pharmacists are all essential parts of the program. Centralized data gathering has allowed cost comparison of specific antimicrobial agents so that differences between variable cost estimates and costs based on actual use can be evaluated. Actual dose and dosage interval were used to calculate average cost per treatment day in a 121-hospital sample. Our cost data support the choice of cefotaxime over ceftriaxone.

  1. Object relations and differential treatment response to methadone maintenance.

    PubMed

    Nicholson, B; Treece, C

    1981-07-01

    The authors report results from a psychiatric study of narcotic addicts in which the relationship between specified aspects of object relations development and treatment response to methadone maintenance was examined. Two groups were defined as high and low drug users (in addition to the prescribed methadone dose) depending upon the frequency and intensity of additional drug use; a middle group was excluded. Thirty subjects participated. The dimensions of separation/individuation, narcissistic development, and self and object representations were measured by 12 scaled variables; scores of the high and low drug users were compared by t-test. In all cases, the high use group was found to be more impaired than the low use group. However, the dimensions differed greatly in their ability to differentiate the groups. The strongest group differences were found in the area of narcissistic development, with the high user group significantly more impaired than the low user group. The strength of these findings lends empirical support to the notion that an addict population can be differentiated on diagnostic and ego psychological measures. This has important implications for methadone maintenance treatment programs, and, possibly, for drug programs in general.

  2. Sports medicine and drug control programs of the U.S. Olympic Committee.

    PubMed

    Clarke, K S

    1984-05-01

    The Amateur Sports Act of 1978 reconstituted the U.S. Olympic Committee ( USOC ), giving it new responsibilities and opportunities as a unifying force in amateur sports, including sports medicine. Sports medicine is the sum of attentions that promote and protect the health of the active person. Olympic sports medicine includes attention to the needs of both the elite athlete and the developing athlete. In some instances the attentions are the same; in others they are not. Those in Olympic sports medicine must thereby reduce the increasing array of general concepts and issues to the applicable specifics of the respective occasion, sport, and individual. The USOC Sports Medicine Program is guided by a 15-person volunteer Sports Medicine Council and implemented by a core Sports Medicine Division staff. Services are provided at the Olympic training centers in Colorado Springs and Lake Placid and extended through a budding network of colleagues in the field to clusters of athletes across the nations. Organizationally , the Division is composed of departments of biomechanics, sports physiology, clinical services, and educational services. Special projects are developed as warranted to provide focal attention to sports psychology, nutrition, chronobiology, vision enhancement, and drug control. The USOC Drug Control Program was born at the 1983 Pan American Games in Caracas after a long gestation period. Drug education in sports has been a frequent activity for the past 20 yr. sometimes focusing on illicit drugs (e.g., marijuana and cocaine) and sometimes on sports performance drugs (e.g., amphetamines and anabolic steroids).(ABSTRACT TRUNCATED AT 250 WORDS)

  3. Quality-improvement analytics for intravenous infusion pumps.

    PubMed

    Skledar, Susan J; Niccolai, Cynthia S; Schilling, Dennis; Costello, Susan; Mininni, Nicolette; Ervin, Kelly; Urban, Alana

    2013-04-15

    The implementation of a smart-pump continuous quality-improvement (CQI) program across a large health system is described, with an emphasis on key metrics for outcomes analyses and program refinement. Three years ago, the University of Pittsburgh Medical Center health system launched a CQI initiative to help ensure the safe use of 6000 smart pumps in its 14 inpatient facilities. A centralized team led by pharmacists is responsible for the retrieval and interpretation of smart-pump data, which is continuously transmitted to a main server. CQI findings are regularly posted on the health system's interdisciplinary intranet. Monitored metrics include rates of compliance with preprogrammed infusion limits, the top 20 drugs involved in alerts, drugs associated with alert-override rates of ≥90%, numbers of alerts by infusion type, nurse responses to alerts, and alert rate per drug library update. Based on the collected CQI data and site-specific requests, four systemwide updates of the smart-pump drug library were performed during the first 18 months of the program, reducing "nuisance alerts" by about 10% per update cycle and enabling targeted interventions to reduce rapid-infusion errors, other adverse drug events (ADEs), and pump-programming workarounds. Over one 12-month period, bedside alerts prompted nurses to reprogram or cancel continuous infusions an average of 400 times per month, potentially averting i.v. medication ADEs. A smart-pump CQI program is an effective tool for enhancing the safety of i.v. medication administration. The ongoing refinement of the drug library through the development and implementation of key interventions promotes the growth and sustainability of the smart-pump initiative systemwide.

  4. Fusion of nonclinical and clinical data to predict human drug safety.

    PubMed

    Johnson, Dale E

    2013-03-01

    Adverse drug reactions continue to be a major cause of morbidity in both patients receiving therapeutics and in drug R&D programs. Predicting and possibly eliminating these adverse events remains a high priority in industry, government agencies and healthcare systems. With small molecule candidates, the fusion of nonclinical and clinical data is essential in establishing an overall system that creates a true translational science approach. Several new advances are taking place that attempt to create a 'patient context' mechanism early in drug research and development and ultimately into the marketplace. This 'life-cycle' approach has as its core the development of human-oriented, nonclinical end points and the incorporation of clinical knowledge at the drug design stage. The next 5 years should witness an explosion of what the author views as druggable and safe chemical space, pharmacosafety molecular targets and the most important aspect, an understanding of unique susceptibilities in patients developing adverse drug reactions. Our current knowledge of clinical safety relies completely on pharmacovigilance data from approved and marketed drugs, with a few exceptions of drugs failing in clinical trials. Massive data repositories now and soon to be available via cloud computing should stimulate a major effort in expanding our view of clinical drug safety and its incorporation into early drug research and development.

  5. Elementary Student Self Efficacy Scale Development and Validation Focused on Student Learning, Peer Relations, and Resisting Drug Use

    ERIC Educational Resources Information Center

    Fertman, Carl I.; Primack, Brian A.

    2009-01-01

    The purpose of this study was to investigate the psychometric properties of a child self efficacy scale for learning, peer interactions, and resisting pressure to use drugs, to use in an elementary school drug prevention education program based on social cognitive theory. A diverse cohort of 392 4th and 5th grade students completed the 20-item…

  6. Making drugs accessible.

    PubMed

    1999-01-01

    Making drugs accessible for common HIV-associated illnesses in West Africa is discussed. HIV-positive people in Ouagadougou, Burkina Faso, could not afford drugs for treating their illnesses; thus, volunteers from La Bergerie-FUC, a Christian organization, have established a day care center for HIV-positive people. A French church supplies the drugs; oral rehydration salts are provided through the Ministry of Health. Since the organization did not have enough drugs to meet the needs of all its patients, two strategies were developed to improve its drug supply. The first strategy was to raise money to buy drugs through the support of a local NGO, the Initiative Privee et Communautaire de lutte contre le SIDA (IPC). IPC initially refused to support them, but, eventually agreed to fund drug purchasing as a pilot project. The second strategy was to look at ways of reducing the cost of drugs, which resulted in a list of essential drugs for HIV-associated infections. The list was approved by Care and Support Committee of the national AIDS program for use by other organizations. The organizations have created a national network to improve the delivery of community-based care and support services in Burkina Faso. Recently, the national AIDS program has asked this network to help them change the national essential drugs list to include essential drugs for treating common HIV-associated infections.

  7. Drug companies cut HIV drug prices in the developing world.

    PubMed

    Yamey, G

    2000-05-20

    The UN has reported that five multinational pharmaceutical companies would cut down HIV drug prices in the developing world. One of these drug companies is GlaxoWellcome, which has promised to reduce the price of zidovudine and lamivudine to US$2 in the poorest nations, a fifth of its price in the US. Although Peter Piot, director of the UN Program on HIV/AIDS, welcomed the companies' promises, he warned that price cuts alone will not curb the epidemic. He stated that this initiative is only one critical factor in what must become a much broader and more urgent effort to help people living with HIV/AIDS. Moreover, health and development agencies expressed concern that AIDS drugs will still be unaffordable for the vast majority of those in need in developing countries. In addition, poor countries lack the infrastructure to deliver these drugs safely and effectively. During the time of the UN announcement, US President Bill Clinton also signed an executive order allowing sub-Saharan Africa to adopt legal measures to obtain cheap HIV drugs. Meanwhile, South Africa's reaction to the offer to cut antiretroviral drug prices has been lukewarm.

  8. Development of a gene expression database and related analysis programs for evaluation of anticancer compounds.

    PubMed

    Ushijima, Masaru; Mashima, Tetsuo; Tomida, Akihiro; Dan, Shingo; Saito, Sakae; Furuno, Aki; Tsukahara, Satomi; Seimiya, Hiroyuki; Yamori, Takao; Matsuura, Masaaki

    2013-03-01

    Genome-wide transcriptional expression analysis is a powerful strategy for characterizing the biological activity of anticancer compounds. It is often instructive to identify gene sets involved in the activity of a given drug compound for comparison with different compounds. Currently, however, there is no comprehensive gene expression database and related application system that is; (i) specialized in anticancer agents; (ii) easy to use; and (iii) open to the public. To develop a public gene expression database of antitumor agents, we first examined gene expression profiles in human cancer cells after exposure to 35 compounds including 25 clinically used anticancer agents. Gene signatures were extracted that were classified as upregulated or downregulated after exposure to the drug. Hierarchical clustering showed that drugs with similar mechanisms of action, such as genotoxic drugs, were clustered. Connectivity map analysis further revealed that our gene signature data reflected modes of action of the respective agents. Together with the database, we developed analysis programs that calculate scores for ranking changes in gene expression and for searching statistically significant pathways from the Kyoto Encyclopedia of Genes and Genomes database in order to analyze the datasets more easily. Our database and the analysis programs are available online at our website (http://scads.jfcr.or.jp/db/cs/). Using these systems, we successfully showed that proteasome inhibitors are selectively classified as endoplasmic reticulum stress inducers and induce atypical endoplasmic reticulum stress. Thus, our public access database and related analysis programs constitute a set of efficient tools to evaluate the mode of action of novel compounds and identify promising anticancer lead compounds. © 2012 Japanese Cancer Association.

  9. Economic costs of drug abuse: financial, cost of illness, and services.

    PubMed

    Cartwright, William S

    2008-03-01

    This article examines costs as they relate to the financial costs of providing drug abuse treatment in private and public health plans, costs to society relating to drug abuse, and many smaller costing studies of various stakeholders in the health care system. A bibliography is developed from searches across PubMed, Web of Science, and other bibliographic sources. The review indicates that a wide collection of cost findings is available to policy makers. For example, the financial aspects of health plans have been dominated by considerations of actuarial costs of parity for drug abuse treatment. Cost-of-illness methods have been developed and extended to drug abuse costing to measure the national level of burden and are important to the economic evaluation of interventions at the program level. Costing is done in many small and focused studies, reflecting the interests of different stakeholders in the health care system. For costs in programs and health plans, as well as cost offsets of the impact of substance abuse treatment on medical expenditures, findings are surprisingly important to policy makers. Maintaining ongoing research that is highly policy relevant from the point of view of health services, more is needed on costing concepts and measurement applications.

  10. Roadside drug testing: An evaluation of the Alere DDS® 2 mobile test system.

    PubMed

    Rohrig, Timothy P; Moore, Christine M; Stephens, Kimberly; Cooper, Kelsey; Coulter, Cynthia; Baird, Tyson; Garnier, Margaux; Miller, Samuel; Tuyay, James; Osawa, Kei; Chou, Joshua; Nuss, Carson; Collier, Jeff; Wittman, Karen Cudlin

    2018-04-01

    The number of drivers using drugs has increased over the last few years, and is likely to continue its upward trend. Testing drivers for alcohol use is routine and standardized, but the same is not true for the identification of driving under the influence of drugs (DUID). The Drug Evaluation and Classification Program (DECP) was developed to train police officers to recognize the signs and symptoms of recent drug use and remains an invaluable program; however, there are insufficient numbers of these highly trained drug recognition experts (DREs) available to attend every potential drug involved traffic incident. While blood and urine samples are used to test for drugs in a driver, both have disadvantages, particularly as they pertain to the length of time required after a traffic stop to sample collection. Therefore, the development of oral fluid testing devices which can be operated at the roadside and have the potential to assist officers in the identification of drug use is a major advancement in DUID cases. This project evaluated the performance of one instrumental oral fluid roadside testing device (Alere DDS®2) compared to DRE opinion, oral fluid laboratory-based analysis, and routine blood testing. The results showed that there was a good correlation with DRE observations and the device performance was >80% in all drug categories compared to laboratory-based analytical testing, both in oral fluid and blood, with few exceptions. The instrument can be considered a useful tool to assist law enforcement in identifying a drugged driver. Because the device does not test for all potentially impairing drugs, the opinion of the police officer regarding the condition of the driver should still be considered the most important aspect for arrest and further action. Copyright © 2017 John Wiley & Sons, Ltd.

  11. Translating Evidence Based Violence and Drug Use Prevention to Obesity Prevention: Development and Construction of the Pathways Program

    ERIC Educational Resources Information Center

    Sakuma, Kari-Lyn K.; Riggs, Nathaniel R.; Pentz, Mary Ann

    2012-01-01

    Effective school-based obesity prevention programs are needed to prevent and reduce the growing obesity risk among youth. Utilizing the evidence-rich areas of violence and substance use prevention, translation science may provide an efficient means for developing curricula across multiple health behaviors. This paper introduces Pathways to Health,…

  12. A Guide for the Management of Special Education Programs. 1.0 Program Organization. Newday Operations Guide for Drug Dependent Minor Programs.

    ERIC Educational Resources Information Center

    Santa Cruz County Superintendent of Schools, CA.

    Presented is the first component, Program Organization, of a special day class educational program emphasizing rehabilitation, remedial instruction, and return to regular school programs for drug dependent minors. Included are statistics on drug use in California and the administrative code under which drug dependent minors are eligible for…

  13. The development of a stable, coated pellet formulation of a water-sensitive drug, a case study: development of a stable core formulation.

    PubMed

    Fitzpatrick, Shaun; Taylor, Scott; Booth, Steven W; Newton, Michael J

    2006-01-01

    A development program has been carried out to provide a stable extrusion/spheronisation pellet formulation for a highly water-soluble drug, sitagliptin, which undergoes a change in physical form on processing and is subject to hydrolytic decomposition. A conventional extrusion/spheronization formulation resulted in significant degradation of the drug. The inclusion of glyceryl monostearate into the formulation was found to reduce the water levels required to such a level that there was no significant degradation of the drug during processing to form pellets. The use of a ram extruder to screen formulations with small quantities minimizes the need for the drug in the formulation-screening process, and the results from this method of extrusion were found to be translatable to the use of a screen extruder, which allowed scale-up of the process.

  14. Resident assistant training program for increasing alcohol, other drug, and mental health first-aid efforts.

    PubMed

    Thombs, Dennis L; Gonzalez, Jennifer M Reingle; Osborn, Cynthia J; Rossheim, Matthew E; Suzuki, Sumihiro

    2015-05-01

    In college and university residence halls, resident assistants (RAs) are expected to serve as first-aid providers to students who may have alcohol, other drug, mental health, and academic problems. Despite this responsibility, evidence-based, first-aid programs have not been developed and tested for the RA workforce. The current study examined effects of an investigational first-aid program designed specifically for RAs. The online Peer Hero Training program is a novel approach to RA training in its use of interactive video dramatizations of incidents involving substance-using or distressed residents. A 9-month randomized trial conducted on eight US campuses compared RAs who participated in the Peer Hero Training program to RAs who received training-as-usual. Participation in the Peer Hero Training program significantly increased RA first-aid efforts for residential students who may have had alcohol, other drug, mental health, or academic problems 6 months after baseline. Compared with those in the training-as-usual condition, RAs in the Peer Hero Training program made more than 10 times as many first-aid efforts for possible alcohol problems, almost 14 times the number of first-aid efforts for possible drug use, almost 3 times the number of first-aid efforts for possible mental health problems, and 3 times the number of first-aid efforts for academic problems. There was no evidence that measured RA attitudes mediated the effects of the intervention. Results of this preliminary evaluation trial suggest that online training using interactive video dramatizations is a viable approach to strengthening RAs' ability to provide alcohol, other drugs, and mental health first-aid to undergraduates.

  15. 42 CFR 423.159 - Electronic prescription drug program.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 3 2012-10-01 2012-10-01 false Electronic prescription drug program. 423.159... SERVICES (CONTINUED) MEDICARE PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost Control and Quality Improvement Requirements § 423.159 Electronic prescription drug program. (a) Definitions...

  16. 42 CFR 423.159 - Electronic prescription drug program.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 3 2014-10-01 2014-10-01 false Electronic prescription drug program. 423.159... SERVICES (CONTINUED) MEDICARE PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost Control and Quality Improvement Requirements § 423.159 Electronic prescription drug program. (a) Definitions...

  17. 42 CFR 423.159 - Electronic prescription drug program.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 3 2013-10-01 2013-10-01 false Electronic prescription drug program. 423.159... SERVICES (CONTINUED) MEDICARE PROGRAM (CONTINUED) VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost Control and Quality Improvement Requirements § 423.159 Electronic prescription drug program. (a) Definitions...

  18. Natural Products as a Foundation for Drug Discovery

    PubMed Central

    Beutler, John A.

    2009-01-01

    Natural products have contributed to the development of many drugs for diverse indications. While most U.S. pharmaceutical companies have reduced or eliminated their in-house natural product groups, new paradigms and new enterprises have evolved to carry on a role for natural products in the pharmaceutical industry. Many of the reasons for the decline in popularity of natural products are being addressed by the development of new techniques for screening and production. This overview aims to inform pharmacologists of current strategies and techniques that make natural products a viable strategic choice for inclusion in drug discovery programs. PMID:20161632

  19. 42 CFR 423.159 - Electronic prescription drug program.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 3 2011-10-01 2011-10-01 false Electronic prescription drug program. 423.159... SERVICES (CONTINUED) MEDICARE PROGRAM VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Cost Control and Quality Improvement Requirements § 423.159 Electronic prescription drug program. (a) Definitions. For purposes of this...

  20. Evaluation of a Peer-Led Drug Abuse Risk Reduction Project for Runaway/Homeless Youths.

    ERIC Educational Resources Information Center

    Fors, Stuart W.; Jarvis, Sara

    1995-01-01

    Evaluates the Drug Prevention in Youth risk reduction program that was implemented in shelters for runaway/homeless youths in the southeastern United States. An evaluation strategy was developed allowing for comparisons between peer-led, adult-led and nonintervention groups. Well-trained and motivated peer/near-peer leaders made particularly…

  1. Educational Policy and the Drug Problem--A Redistributive Politics Issue

    ERIC Educational Resources Information Center

    Caliguri, Joseph P.

    1975-01-01

    The drug problem exists as a cluster of problems affecting broad interests or groups. The issues are redistributive in that everything relates to everything else. It seems apparent that a cluster of policies and programs need development as well as genuine citizen participation in the formulation of these policies. (Author)

  2. An Analysis of Resources To Aid Drug-Exposed Infants and Their Families.

    ERIC Educational Resources Information Center

    Budetti, Peter; And Others

    This document describes a comprehensive service delivery model for drug-exposed infants and their families, provides a compendium of programs and funding sources that target the needs of these families, and delineates areas in need of financial support and further exploration. Development of the model required a literature review, interviews, and…

  3. 24 CFR 761.20 - Selection requirements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false Selection requirements. 761.20... AND PUBLIC AND INDIAN HOUSING PROGRAMS) DRUG ELIMINATION PROGRAMS Application and Selection § 761.20 Selection requirements. (a) PHDEP selection. Every PHA, RMC and consortium that meets the requirements of...

  4. Patterns of drug treatment entry by Latino male injection drug users from different national/geographical backgrounds.

    PubMed

    Reynoso-Vallejo, Humberto; Chassler, Deborah; Witas, Julie; Lundgren, Lena M

    2008-02-01

    This study examined patterns of treatment entry by Puerto Rican, Central American, Dominican, and other Latino male injection drug users (IDUs) in the state of Massachusetts over the time period 1996-2002. Specifically, it explored whether these populations had different patterns relative to three paths: entry into detoxification only, entry into residential treatment, or entry into methadone maintenance. Using a state-level MIS dataset on all substance abuse treatment entries to all licensed treatment programs, bi-variate and logistic regression methods were employed to examine patterns of drug treatment utilization among Latino men residing in Massachusetts. Three logistic regression models, which controlled for age, education, homelessness, employment, history of mental health treatment, health insurance, criminal justice involvement, having injected drugs in the past month, and number of treatment entries, indicated that Puerto Rican men were significantly less likely to only use detoxification services and residential treatment services, and significantly more likely to enter methadone maintenance compared to Latino men from Central American, Dominican, or other Latino backgrounds. For example, Central American men were 2.4 times more likely to enter only detoxification programs and 54% less likely to enter methadone maintenance programs than Puerto Rican male IDUs. For program planning, include the need to (a) develop varied drug treatment services to meet the needs of non-homogenous Latino groups within the population, (b) tailor outreach efforts to effectively reach all Latino groups, and (c) increase awareness among practitioners of differential patterns of treatment utilization.

  5. Alcohol and drug use disorders among homeless veterans: prevalence and association with supported housing outcomes.

    PubMed

    Tsai, Jack; Kasprow, Wesley J; Rosenheck, Robert A

    2014-02-01

    This study examines the prevalence of alcohol and drug disorders among homeless veterans entering the Housing and Urban Development-Veterans Affairs Supported Housing (HUD-VASH) program and its association with both housing and clinical outcomes. A total of 29,143 homeless veterans were categorized as either having: no substance use disorder, only an alcohol use disorder, only a drug use disorder, or both alcohol and drug use disorders. Veterans were compared on housing and clinical status prior to admission to HUD-VASH and a smaller sample of 14,086 HUD-VASH clients were compared on their outcomes 6 months after program entry. Prior to HUD-VASH, 60% of program entrants had a substance use disorder and 54% of those with a substance use disorder had both alcohol and drug use disorders. Homeless veterans with both alcohol and drug use disorders had more extensive homeless histories than others, and those with any substance use disorder stayed more nights in transitional housing or residential treatment in the previous month. After six months in HUD-VASH, clients with substance use disorders continued to report more problems with substance use, even after adjusting for baseline differences, but there were no differences in housing outcomes. These findings suggest that despite strong associations between substance use disorders and homelessness, the HUD-VASH program is able to successfully house homeless veterans with substance use disorders although additional services may be needed to address their substance abuse after they become housed. Published by Elsevier Ltd.

  6. Nature's Medicines: Traditional Knowledge and Intellectual Property Management. Case Studies from the National Institutes of Health (NIH), USA

    PubMed Central

    Gupta, Ranjan; Gabrielsen, Bjarne; Ferguson, Steven M.

    2009-01-01

    With the emergence and re-emergence of infectious diseases and development of multi-drug resistance, there is a dire need to find newer cures and to produce more drugs and vaccines in the pipeline. To meet these increasing demands biomedical researchers and pharmaceutical companies are combining advanced methods of drug discovery, such as combinatorial chemistry, high-throughput screening and genomics, with conventional approaches using natural products and traditional knowledge. However, such approaches require much international cooperation and understanding of international laws and conventions as well as local customs and traditions. This article reviews the forty years of cumulative experience at the National Institutes of Health (initiated by the National Cancer Institute) in natural products drug discovery. It presents (1) three major cooperative programs (2) the legal mechanisms for cooperation and (3) illustrative case studies from these programs. We hope that these discussions and our lessons learned would be helpful to others seeking to develop their own models of cooperation for the benefit of global health. PMID:16475917

  7. Compound Separation

    NASA Technical Reports Server (NTRS)

    1981-01-01

    Jet Propulsion Laboratory developed a new one-step liquid-liquid extraction technique which cuts processing time, reduces costs and eliminates much of the equipment required. Technique employs disposable extraction columns, originally developed as an aid to the Los Angeles Police Department, which allow more rapid detection of drugs as part of the department's drug abuse program. Applications include medical treatment, pharmaceutical preparation and forensic chemistry. NASA waived title to Caltech, and Analytichem International is producing Extubes under Caltech license.

  8. Enabling complex queries to drug information sources through functional composition.

    PubMed

    Peters, Lee; Mortensen, Jonathan; Nguyen, Thang; Bodenreider, Olivier

    2013-01-01

    Our objective was to enable an end-user to create complex queries to drug information sources through functional composition, by creating sequences of functions from application program interfaces (API) to drug terminologies. The development of a functional composition model seeks to link functions from two distinct APIs. An ontology was developed using Protégé to model the functions of the RxNorm and NDF-RT APIs by describing the semantics of their input and output. A set of rules were developed to define the interoperable conditions for functional composition. The operational definition of interoperability between function pairs is established by executing the rules on the ontology. We illustrate that the functional composition model supports common use cases, including checking interactions for RxNorm drugs and deploying allergy lists defined in reference to drug properties in NDF-RT. This model supports the RxMix application (http://mor.nlm.nih.gov/RxMix/), an application we developed for enabling complex queries to the RxNorm and NDF-RT APIs.

  9. Fragment-based drug discovery and molecular docking in drug design.

    PubMed

    Wang, Tao; Wu, Mian-Bin; Chen, Zheng-Jie; Chen, Hua; Lin, Jian-Ping; Yang, Li-Rong

    2015-01-01

    Fragment-based drug discovery (FBDD) has caused a revolution in the process of drug discovery and design, with many FBDD leads being developed into clinical trials or approved in the past few years. Compared with traditional high-throughput screening, it displays obvious advantages such as efficiently covering chemical space, achieving higher hit rates, and so forth. In this review, we focus on the most recent developments of FBDD for improving drug discovery, illustrating the process and the importance of FBDD. In particular, the computational strategies applied in the process of FBDD and molecular-docking programs are highlighted elaborately. In most cases, docking is used for predicting the ligand-receptor interaction modes and hit identification by structurebased virtual screening. The successful cases of typical significance and the hits identified most recently are discussed.

  10. Integrating life skills into a theory-based drug-use prevention program: effectiveness among junior high students in Taiwan.

    PubMed

    Huang, Chiu-Mieh; Chien, Li-Yin; Cheng, Chin-Feng; Guo, Jong-Long

    2012-07-01

    Drug use has been noted among students in Taiwan during the past decade and schools have a role in preventing or delaying students' drug use. We developed and evaluated a school-based, drug-use prevention program integrating the theory of planned behavior (TPB) and life skills for junior high school students. We recruited 441 seventh graders from randomly selected schools: N = 143 experimental groups, N = 142 conventional groups, and N = 156 control groups. The experimental group received ten 45-minute sessions of theory-based interventions. The conventional group got traditional didactic teaching and drug refusal skills. The control group received no intervention. Compared to the control group, experimental group students showed greater improvement in attitude, subjective norm, perceived behavioral control, life skills, and intention not to use drugs. Compared to the conventional group, the experimental group had significantly higher posttest scores for 4 of the 5 outcomes, including life skills (96.53 vs. 90.92, p < .001), attitude (27.43 vs. 24.40, p = .012), subjective norm (29.51 vs. 28.06, p = .002), and perceived behavioral control (18.59 vs. 16.81, p < .001). The conventional group scored significantly higher in behavioral intention than did the control group. Study results demonstrated the effectiveness of a drug-use prevention program integrating the TPB and life skills. © 2012, American School Health Association.

  11. Bioinformatics in translational drug discovery.

    PubMed

    Wooller, Sarah K; Benstead-Hume, Graeme; Chen, Xiangrong; Ali, Yusuf; Pearl, Frances M G

    2017-08-31

    Bioinformatics approaches are becoming ever more essential in translational drug discovery both in academia and within the pharmaceutical industry. Computational exploitation of the increasing volumes of data generated during all phases of drug discovery is enabling key challenges of the process to be addressed. Here, we highlight some of the areas in which bioinformatics resources and methods are being developed to support the drug discovery pipeline. These include the creation of large data warehouses, bioinformatics algorithms to analyse 'big data' that identify novel drug targets and/or biomarkers, programs to assess the tractability of targets, and prediction of repositioning opportunities that use licensed drugs to treat additional indications. © 2017 The Author(s).

  12. Expanded Access Programs

    PubMed Central

    Van Campen, Luann E.; Garnett, Timothy

    2015-01-01

    Expanded access is a regulatory mechanism by which an investigational drug can be made available outside of a clinical trial to treat patients with serious or life-threatening conditions for which there are no satisfactory treatment options. An expanded access program (EAP) is the formal plan under which preapproval access to an investigational drug can be provided to a group of patients. Although an EAP is a regulated program, the decision to authorize an EAP is the responsibility of the biopharmaceutical sponsor. Because of the significant impact an EAP can have on current patients, drug development, and future patients, we propose that a sponsor’s decision must be based not only on regulatory criteria but also on ethical and practical considerations regarding implementation of an EAP. Such an approach will help ensure that decisions and plans uphold ethical precepts such as fairness, promoting good, and minimizing risk of harm. PMID:29473010

  13. HIV drug resistance early warning indicators in cohorts of individuals starting antiretroviral therapy between 2004 and 2009: World Health Organization global report from 50 countries.

    PubMed

    Bennett, Diane E; Jordan, Michael R; Bertagnolio, Silvia; Hong, Steven Y; Ravasi, Giovanni; McMahon, James H; Saadani, Ahmed; Kelley, Karen F

    2012-05-01

    The World Health Organization developed a set of human immunodeficiency virus drug resistance (HIVDR) early warning indicators (EWIs) to assess antiretroviral therapy clinic and program factors associated with HIVDR. EWIs are monitored by abstracting data routinely recorded in clinical records, and the results enable clinics and program managers to identify problems that should be addressed to minimize preventable emergence of HIVDR in clinic populations. As of June 2011, 50 countries monitored EWIs, covering 131 686 patients initiating antiretroviral treatment between 2004 and 2009 at 2107 clinics. HIVDR prevention is associated with patient care (appropriate prescribing and patient monitoring), patient behavior (adherence), and clinic/program management efforts to reduce treatment interruptions (follow up, retention on first-line ART, procurement and supply management of antiretroviral drugs). EWIs measure these factors and the results have been used to optimize patient and population treatment outcomes.

  14. A Guide for the Management of Speical Education Programs. 4.0 Drug Information for Educators, Parents, and Students. Newday Operations Guide for Drug Dependent Minor Programs.

    ERIC Educational Resources Information Center

    Santa Cruz County Superintendent of Schools, CA.

    Presented is the fourth component of a special day class program for drug dependent minors, Drug Information for Educators, Parents, and Students. The first section, intended for educators, includes a drug abuse chart, information on the drug subculture, information on patterns of drug abuse and misconceptions about drugs, and suggested activities…

  15. A Partnership Training Program: Studying Targeted Drug Delivery Using Nanoparticles In Breast Cancer Diagnosis and Therapy

    DTIC Science & Technology

    2015-12-01

    have been approved by FDA or are under development. Their use aims to minimize drug degradation, prevent undesirable side effects , and increase drug...efficacy, while simultaneously reducing side effects , owing to properties such as more targeted localization in tumors and active cellular uptake...with Dr. Vreeland suggested that the lipid was below the transition temperature of the lipid, which likely contributed to the poor size distribution

  16. Using a Drug Interaction Program (Drug Interactions Advisor™) in a Community Hospital

    PubMed Central

    Harvey, A. C.; Diehl, G. R.; Finlayson, W. B.

    1987-01-01

    To test the usefulness of a drugs-interaction program in a community hospital one hundred patients in three medical wards were surveyed with respect to their drug regime. The drugs listed for each patient were entered into Drug Interactions Advisor™ a commercial interactions program running on an Apple IIE. Interacting drugs were listed with the severity of the interaction in each case. Of one hundred patients fifty-one had drugs which could potentially interact and in fifty-one percent of cases a change in therapy would have been advised by Drug Interactions Advisor™. The completeness of the data base was assessed as to its inclusion of drugs actually given and it dealt with eighty-nine percent. The program was tested against ten known interactions and it identified six. Multiple drug therapy is a major problem nowadays and will increase with the aging of the population. Drug interactions programs exploit computer technology to make drug surveillance easier. Without computers such surveillance is difficult if not impossible.

  17. Pharmacogenomics in early-phase clinical development

    PubMed Central

    Burt, Tal; Dhillon, Savita

    2015-01-01

    Pharmacogenomics (PGx) offers the promise of utilizing genetic fingerprints to predict individual responses to drugs in terms of safety, efficacy and pharmacokinetics. Early-phase clinical trial PGx applications can identify human genome variations that are meaningful to study design, selection of participants, allocation of resources and clinical research ethics. Results can inform later-phase study design and pipeline developmental decisions. Nevertheless, our review of the clinicaltrials.gov database demonstrates that PGx is rarely used by drug developers. Of the total 323 trials that included PGx as an outcome, 80% have been conducted by academic institutions after initial regulatory approval. Barriers for the application of PGx are discussed. We propose a framework for the role of PGx in early-phase drug development and recommend PGx be universally considered in study design, result interpretation and hypothesis generation for later-phase studies, but PGx results from underpowered studies should not be used by themselves to terminate drug-development programs. PMID:23837482

  18. Detection and management of drug-resistant tuberculosis in HIV-infected patients from lower income countries

    PubMed Central

    Ballif, Marie; Nhandu, Venerandah; Wood, Robin; Dusingize, Jean Claude; Carter, E. Jane; Cortes, Claudia P.; McGowan, Catherine C.; Diero, Lameck; Graber, Claire; Renner, Lorna; Hawerlander, Denise; Kiertiburanakul, Sasisopin; Du, Quy Tuan; Sterling, Timothy R.; Egger, Matthias; Fenner, Lukas

    2015-01-01

    Setting Drug resistance threatens tuberculosis (TB) control, particularly among HIV-infected persons. Objective We surveyed antiretroviral therapy (ART) programs from lower-income countries on prevention and management of drug-resistant TB. Design We used online questionnaires to collect program-level data in 47 ART programs in Southern Africa (14), East Africa (8), West Africa (7), Central Africa (5), Latin America (7) and Asia-Pacific (6 programs) in 2012. Patient-level data were collected on 1,002 adult TB patients seen at 40 of the participating ART programs. Results Phenotypic drug susceptibility testing was available at 36 (77%) ART programs, but only used for 22% of all TB patients. Molecular drug resistance testing was available at 33 (70%) programs and used for 23% of all TB patients. Twenty ART programs (43%) provided directly observed therapy (DOT) during the whole treatment, 16 (34%) during intensive phase only and 11 (23%) did not follow DOT. Fourteen (30%) ART programs reported no access to second-line TB regimens; 18 (38%) reported TB drug shortages. Conclusions Capacity to diagnose and treat drug-resistant TB was limited across ART programs in lower income countries. DOT was not always implemented and drug supply was regularly interrupted, which may contribute to the global emergence of drug resistance. PMID:25299866

  19. Drug target ontology to classify and integrate drug discovery data.

    PubMed

    Lin, Yu; Mehta, Saurabh; Küçük-McGinty, Hande; Turner, John Paul; Vidovic, Dusica; Forlin, Michele; Koleti, Amar; Nguyen, Dac-Trung; Jensen, Lars Juhl; Guha, Rajarshi; Mathias, Stephen L; Ursu, Oleg; Stathias, Vasileios; Duan, Jianbin; Nabizadeh, Nooshin; Chung, Caty; Mader, Christopher; Visser, Ubbo; Yang, Jeremy J; Bologa, Cristian G; Oprea, Tudor I; Schürer, Stephan C

    2017-11-09

    One of the most successful approaches to develop new small molecule therapeutics has been to start from a validated druggable protein target. However, only a small subset of potentially druggable targets has attracted significant research and development resources. The Illuminating the Druggable Genome (IDG) project develops resources to catalyze the development of likely targetable, yet currently understudied prospective drug targets. A central component of the IDG program is a comprehensive knowledge resource of the druggable genome. As part of that effort, we have developed a framework to integrate, navigate, and analyze drug discovery data based on formalized and standardized classifications and annotations of druggable protein targets, the Drug Target Ontology (DTO). DTO was constructed by extensive curation and consolidation of various resources. DTO classifies the four major drug target protein families, GPCRs, kinases, ion channels and nuclear receptors, based on phylogenecity, function, target development level, disease association, tissue expression, chemical ligand and substrate characteristics, and target-family specific characteristics. The formal ontology was built using a new software tool to auto-generate most axioms from a database while supporting manual knowledge acquisition. A modular, hierarchical implementation facilitate ontology development and maintenance and makes use of various external ontologies, thus integrating the DTO into the ecosystem of biomedical ontologies. As a formal OWL-DL ontology, DTO contains asserted and inferred axioms. Modeling data from the Library of Integrated Network-based Cellular Signatures (LINCS) program illustrates the potential of DTO for contextual data integration and nuanced definition of important drug target characteristics. DTO has been implemented in the IDG user interface Portal, Pharos and the TIN-X explorer of protein target disease relationships. DTO was built based on the need for a formal semantic model for druggable targets including various related information such as protein, gene, protein domain, protein structure, binding site, small molecule drug, mechanism of action, protein tissue localization, disease association, and many other types of information. DTO will further facilitate the otherwise challenging integration and formal linking to biological assays, phenotypes, disease models, drug poly-pharmacology, binding kinetics and many other processes, functions and qualities that are at the core of drug discovery. The first version of DTO is publically available via the website http://drugtargetontology.org/ , Github ( http://github.com/DrugTargetOntology/DTO ), and the NCBO Bioportal ( http://bioportal.bioontology.org/ontologies/DTO ). The long-term goal of DTO is to provide such an integrative framework and to populate the ontology with this information as a community resource.

  20. Darbepoetin alfa therapeutic interchange protocol for anemia in dialysis.

    PubMed

    Brophy, Donald F; Ripley, Elizabeth Bd; Kockler, Denise R; Lee, Seina; Proeschel, Lori A

    2005-11-01

    Erythropoiesis-stimulating proteins, such as erythropoietin alfa and darbepoetin alfa, have positively impacted anemia management. These medications improve patient outcomes and quality of life. Their costs, however, remain a major barrier for health systems. To evaluate the development, implementation, and cost-effectiveness of an inpatient therapeutic interchange protocol for erythropoiesis-stimulating proteins at a large, tertiary care, university-affiliated health system. Virginia Commonwealth University Health System (VCUHS) developed and implemented a therapeutic interchange program to convert therapy for all inpatients undergoing dialysis from erythropoietin alfa to darbepoetin alfa for treatment of chronic kidney disease-related anemia. An evaluation of the economic impact of this program on drug expenditures over a fiscal quarter (2003) was conducted using historical comparator data (2002). Preliminary evaluation of the program demonstrated cost-savings and reduced drug utilization of erythropoiesis-stimulating proteins in hospitalized dialysis patients. For the first quarter of 2003 compared with the first quarter of 2002, VCUHS realized a cost-savings of nearly 10,000 US dollars, which was related to the program's aggressive screening procedure. When these data were normalized for equal numbers of patients in each group receiving one of the drugs, the actual cost-savings was over 2000 US dollars. These cost-savings are largely due to reduced utilization of these expensive biotechnology products with implementation of a dosing protocol. VCUHS has successfully developed and implemented a darbepoetin alfa therapeutic interchange protocol for hospitalized dialysis patients. This has translated into reduced use of erythropoiesis-stimulating proteins, resulting in cost-savings for the health system.

  1. An Outreach Program in Drug Education; Teaching a Rational Approach to Drug Use

    ERIC Educational Resources Information Center

    Sorensen, James L.; Joffe, Stephen J.

    1975-01-01

    Aimed at encouraging rational decision making about drug use, a peer oriented drug education program was conducted in a community youth project. Youth and leaders shared feelings and knowledge about drugs. Compared with four program dropouts, six participants exhibited more positive attitudes toward the drug group, its leaders and themselves.…

  2. 76 FR 59574 - Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Federal Drug Testing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-27

    ... 2105-AE13 Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Federal Drug...) published an interim final rule (IFR) authorizing the use of a new Federal Drug Testing Custody and Control Form (CCF) in its drug testing program. Use of the form is authorized beginning October 1, 2010. This...

  3. 28 CFR 550.50 - Purpose and scope.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Drug Abuse Treatment Program § 550.50 Purpose and scope. The purpose of this subpart is to describe the Bureau's drug abuse treatment programs. All Bureau institutions have a drug abuse treatment specialist who, under the Drug Abuse Program Coordinator's supervision, provides drug abuse education and non...

  4. 28 CFR 550.50 - Purpose and scope.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Drug Abuse Treatment Program § 550.50 Purpose and scope. The purpose of this subpart is to describe the Bureau's drug abuse treatment programs. All Bureau institutions have a drug abuse treatment specialist who, under the Drug Abuse Program Coordinator's supervision, provides drug abuse education and non...

  5. 28 CFR 550.50 - Purpose and scope.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Drug Abuse Treatment Program § 550.50 Purpose and scope. The purpose of this subpart is to describe the Bureau's drug abuse treatment programs. All Bureau institutions have a drug abuse treatment specialist who, under the Drug Abuse Program Coordinator's supervision, provides drug abuse education and non...

  6. 28 CFR 550.50 - Purpose and scope.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Drug Abuse Treatment Program § 550.50 Purpose and scope. The purpose of this subpart is to describe the Bureau's drug abuse treatment programs. All Bureau institutions have a drug abuse treatment specialist who, under the Drug Abuse Program Coordinator's supervision, provides drug abuse education and non...

  7. 28 CFR 550.50 - Purpose and scope.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Drug Abuse Treatment Program § 550.50 Purpose and scope. The purpose of this subpart is to describe the Bureau's drug abuse treatment programs. All Bureau institutions have a drug abuse treatment specialist who, under the Drug Abuse Program Coordinator's supervision, provides drug abuse education and non...

  8. Drug policy in Nicaragua, between need-oriented activities and aggression.

    PubMed

    Laporte, J R; Tognoni, G

    1985-01-01

    In this case study from Nicaragua, an account is given of how the Essential Drugs Program developed in a context which relectss exceptional political, economic and military pressures. The overall picture could provide a useful guide to the issues behind such an apparently simple concept as the essential drugs list. The criteria for including drugs in the National Formulary were those of the WHO report on essential drugs: proven efficacy, acceptable risks associated with their use, favorable cost, and need. A proposal of the basic list of drugs, classified in therapeutic groups and according to their priority and level of use, was prepared by a central Committee for the National Drug Formulary. An annotated Formulary was prepared to ensure consistency with rigorous scientific standards and to meet the needs of daily practice. The annotated therapeutic formulary has been distributed to all physicians, other health workers responsible for peripheral health centers, pharmacists, and medical students. It has been adopted as the main reference textbook for teaching clinical pharmacology and therapeutics to medical students. A training program in clinical pharmacology has been started at the University Autonoma de Barcelona. It pays particular attention to drug evaluation, drug epidemiology methods, and retrieval and preparation of drug information for health workers.

  9. Tips for Implementing a Student Assistance Program.

    ERIC Educational Resources Information Center

    Cooley, Van E.

    1993-01-01

    SAFARI (Student Assistance for At-Risk Individuals) is a nationally recognized, comprehensive K-12 program that addresses drug and alcohol use, sociological concerns, conflicts experienced by students, and at-risk behaviors interfering with academic success. Two neighboring Indiana school districts have combined resources to develop a program…

  10. Student Assistance Programs and High Risk Youth.

    ERIC Educational Resources Information Center

    Casale, Jenni

    This manual discusses a method for developing a comprehensive drug abuse prevention and intervention program for students in special education. The first section contains introductory material regarding high risk students in general and implications for special education. The second section outlines material on specific types of high-risk…

  11. 24 CFR 761.15 - Qualifying for funding.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 24 Housing and Urban Development 4 2012-04-01 2012-04-01 false Qualifying for funding. 761.15... AND PUBLIC AND INDIAN HOUSING PROGRAMS) DRUG ELIMINATION PROGRAMS Grant Funding § 761.15 Qualifying for funding. (a) Qualifications for PHDEP funding—(1) Eligible applicants. The following are eligible...

  12. 24 CFR 761.15 - Qualifying for funding.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 24 Housing and Urban Development 4 2013-04-01 2013-04-01 false Qualifying for funding. 761.15... AND PUBLIC AND INDIAN HOUSING PROGRAMS) DRUG ELIMINATION PROGRAMS Grant Funding § 761.15 Qualifying for funding. (a) Qualifications for PHDEP funding—(1) Eligible applicants. The following are eligible...

  13. Peer Assistance Program for Teenage Substance Users.

    ERIC Educational Resources Information Center

    Stanbrook, Linda M.

    A peer assistance program for teenage substance users was developed in which students interviewed their peers to determine substance use attitudes and frequency of substance use. Student interviewers read and studied drug curriculum materials in their health class; were taught active listening skills and counseling techniques; practiced answering…

  14. 76 FR 19998 - Supplemental Funding Under the Food and Drug Administration Pediatric Device Consortia Grant Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-11

    ... adults. Children differ from adults in terms of their size, growth, development, and body chemistry... devices designed specifically with children in mind. Such needs include the original development of...

  15. Eric Freed Named Deputy Director of HIV Drug Resistance Program | Poster

    Cancer.gov

    Editor’s note: The text for this article was adapted from an e-mail announcement to the Center for Cancer Research community from Robert Wiltrout, Ph.D., on September 8, 2014. Robert Wiltrout, Ph.D., director, NCI Center for Cancer Research (CCR), recently announced the appointment of Eric Freed, Ph.D., as deputy director of the HIV Drug Resistance Program (HIV DRP). Freed will join Stephen Hughes, Ph.D., director of HIV DRP, in leading this CCR program that focuses on understanding HIV replication and pathogenesis, with the goal of developing more effective strategies for treating HIV infections, and also builds on the existing strength of HIV and retrovirus research within NCI.

  16. Psychosocial interventions for pregnant women in outpatient illicit drug treatment programs compared to other interventions.

    PubMed

    Terplan, M; Lui, S

    2007-10-17

    Illicit drug use in pregnancy is a complex social and public health problem. It is important to develop and evaluate effective treatments. There is evidence for the effectiveness of psychosocial in this population; however, to our knowledge, no systematic review on the subject has been undertaken. To evaluate the effectiveness of psychosocial interventions in pregnant women enrolled in illicit drug treatment programs on birth and neonatal outcomes, on attendance and retention in treatment, as well as on maternal and neonatal drug abstinence. In short, do psychosocial interventions translate into less illicit drug use, greater abstinence, better birth outcomes, or greater clinic attendance.? We searched the Cochrane Drugs and Alcohol Group's trial register (May 2006), the Cochrane Central Register of Trials (Central- The Cochrane Library, Issue 3, 2005); MEDLINE (1.1996-8.2006); EMBASE (1.1996-8.2006); CINAHL (1.1982-8.2006), and reference lists of articles. Randomised studies comparing any psychosocial intervention versus pharmacological interventions or placebo or non-intervention or another psychosocial intervention for treating illicit drug use in pregnancy. Two reviewers independently assessed trial quality and extracted data. Nine trials involving 546 pregnant women were included. Five studies considered contingency management (CM), and four studies considered manual based interventions such as motivational interviewing (MI). The main finding was that contingency management led to better study retention. There was only minimal effect of CM on illicit drug abstinence. In contrast, motivational interviewing led towards poorer study retention, although this did not approach statistical significance. For both, no difference in birth or neonatal outcomes was found, but this was an outcome rarely captured in the studies. The present evidence suggests that CM strategies are effective in improving retention of pregnant women in illicit drug treatment programs as well as in transiently reducing illicit drug use. There is insufficient evidence to support the use of MI. Overall the available evidence has low numbers and, therefore, it is impossible to accurately assess the effect of psychosocial interventions on obstetrical and neonatal outcomes. It is important to develop a better evidence base to evaluate psychosocial modalities of treatment in this important population.

  17. 32 CFR 634.13 - Alcohol and drug abuse programs.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 32 National Defense 4 2012-07-01 2011-07-01 true Alcohol and drug abuse programs. 634.13 Section... and drug abuse programs. (a) Commanders will refer military personnel suspected of drug or alcohol abuse for evaluation in the following circumstances: (1) Behavior indicative of alcohol or drug abuse...

  18. 32 CFR 634.13 - Alcohol and drug abuse programs.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 4 2010-07-01 2010-07-01 true Alcohol and drug abuse programs. 634.13 Section... and drug abuse programs. (a) Commanders will refer military personnel suspected of drug or alcohol abuse for evaluation in the following circumstances: (1) Behavior indicative of alcohol or drug abuse...

  19. 32 CFR 634.13 - Alcohol and drug abuse programs.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 4 2014-07-01 2013-07-01 true Alcohol and drug abuse programs. 634.13 Section... and drug abuse programs. (a) Commanders will refer military personnel suspected of drug or alcohol abuse for evaluation in the following circumstances: (1) Behavior indicative of alcohol or drug abuse...

  20. 32 CFR 634.13 - Alcohol and drug abuse programs.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 32 National Defense 4 2013-07-01 2013-07-01 false Alcohol and drug abuse programs. 634.13 Section... and drug abuse programs. (a) Commanders will refer military personnel suspected of drug or alcohol abuse for evaluation in the following circumstances: (1) Behavior indicative of alcohol or drug abuse...

  1. 32 CFR 634.13 - Alcohol and drug abuse programs.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 32 National Defense 4 2011-07-01 2011-07-01 false Alcohol and drug abuse programs. 634.13 Section... and drug abuse programs. (a) Commanders will refer military personnel suspected of drug or alcohol abuse for evaluation in the following circumstances: (1) Behavior indicative of alcohol or drug abuse...

  2. A Residential School's Outdoor Education Program for Emotionally Handicapped Adolescents. Final Project Report of the Rhinecliff Union Free School District, Holy Cross Campus.

    ERIC Educational Resources Information Center

    Rigothi, Anthony, Ed.

    Concept definition and activity description constituted the major focus of implementation proceedings of this outdoor education program designed for a residential school serving secondary students with emotional and drug related problems. Major program objectives were the development of greater academic growth and more positive self-concept for…

  3. Foreign Aid: An Introduction to U.S. Programs and Policy

    DTIC Science & Technology

    2009-02-10

    additionally meeting U.S. humanitarian objectives. Microcredit programs may help develop local economies while at the same time providing food and...training and expertise to fledgling microcredit institutions. In recent years, antiretroviral drugs (ARVs) provided through PEPFAR programs to...For instance, grants are sometimes provided to microcredit organizations which in turn provide loans to microentrepreneurs. Through the USAID-funded

  4. Foreign Aid: An Introduction to U.S. Programs and Policy

    DTIC Science & Technology

    2009-04-09

    Microcredit programs may help develop local economies while at the same time providing food and education to the children of entrepreneurs...and expertise to fledgling microcredit institutions. In recent years, antiretroviral drugs (ARVs) provided through PEPFAR programs to individuals...instance, grants are sometimes provided to microcredit organizations which in turn provide loans to microentrepreneurs. Through the USAID-funded Eurasia

  5. Challenges in the clinical development of new antiepileptic drugs.

    PubMed

    Franco, Valentina; French, Jacqueline A; Perucca, Emilio

    2016-01-01

    Despite the current availability in the market of over two dozen antiepileptic drugs (AEDs), about one third of people with epilepsy fail to achieve complete freedom from seizures with existing medications. Moreover, currently available AEDs have significant limitations in terms of safety, tolerability and propensity to cause or be a target for clinically important adverse drug interactions. A review of the evidence shows that there are many misperceptions about the viability of investing into new therapies for epilepsy. In fact, there are clear incentives to develop newer and more efficacious medications. Developing truly innovative drugs requires a shift in the paradigms for drug discovery, which is already taking place by building on greatly expanded knowledge about the mechanisms involved in epileptogenesis, seizure generation, seizure spread and development of co-morbidities. AED development can also benefit by a review of the methodology currently applied in clinical AED development, in order to address a number of ethical and scientific concerns. As discussed in this article, many processes of clinical drug development, from proof-of-concept-studies to ambitious programs aimed at demonstrating antiepileptogenesis and disease-modification, can be facilitated by a greater integration of preclinical and clinical science, and by application of knowledge acquired during decades of controlled epilepsy trials. Copyright © 2015 Elsevier Ltd. All rights reserved.

  6. Emotional Intelligence: An Untapped Resource for Alcohol and Other Drug Related Prevention among Adolescents and Adults

    PubMed Central

    Coelho, Ken Russell

    2012-01-01

    Alcohol and Other Drug abuse in adolescents and adults continues to be a major public health problem in the United States. Care in intervention programs aimed at high risk populations identified occurs after the maladaptive behavioral delinquency has occurred, and only then is an individual afforded the opportunity to join an intervention program. The focus of this paper is to illustrate and highlight the value of prevention programs which emphasize altering maladaptive behavior before the behavior becomes problematic. Emotional Intelligence is not only an indicator of alcohol and other drug abuse, but is linked to emotional competence, social and emotional learning, the development of healthy and life promoting behavior, and has been proven to reduce some of the risk factors associated with alcohol and other drug abuse in adolescents and adults. This paper seeks to recognize the significance of Emotional Intelligence as a desirable health promoting attribute and to establish the importance of its conceptual use in a prevention based model for reducing associated high risk behaviors. PMID:22570777

  7. 49 CFR 40.123 - What are the MRO's responsibilities in the DOT drug testing program?

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... drug testing program? 40.123 Section 40.123 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the Verification Process § 40.123 What are the MRO's responsibilities in the DOT drug testing program? As an MRO...

  8. 49 CFR 40.123 - What are the MRO's responsibilities in the DOT drug testing program?

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... drug testing program? 40.123 Section 40.123 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the Verification Process § 40.123 What are the MRO's responsibilities in the DOT drug testing program? As an MRO...

  9. 49 CFR 40.123 - What are the MRO's responsibilities in the DOT drug testing program?

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... drug testing program? 40.123 Section 40.123 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the Verification Process § 40.123 What are the MRO's responsibilities in the DOT drug testing program? As an MRO...

  10. 49 CFR 40.123 - What are the MRO's responsibilities in the DOT drug testing program?

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... drug testing program? 40.123 Section 40.123 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the Verification Process § 40.123 What are the MRO's responsibilities in the DOT drug testing program? As an MRO...

  11. 49 CFR 40.123 - What are the MRO's responsibilities in the DOT drug testing program?

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... drug testing program? 40.123 Section 40.123 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Medical Review Officers and the Verification Process § 40.123 What are the MRO's responsibilities in the DOT drug testing program? As an MRO...

  12. 75 FR 19353 - Notice of Funding Availability: Rural Development Voucher Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-14

    ... DEPARTMENT OF AGRICULTURE Rural Housing Service Notice of Funding Availability: Rural Development... Availability SUMMARY: This notice informs the public that the U.S. Department of Agriculture (USDA) in Fiscal... the requirements in the Agriculture, Rural Development, Food and Drug Administration, and Related...

  13. Meta-analyses of seven of the National Institute on Drug Abuse's principles of drug addiction treatment.

    PubMed

    Pearson, Frank S; Prendergast, Michael L; Podus, Deborah; Vazan, Peter; Greenwell, Lisa; Hamilton, Zachary

    2012-07-01

    Of the 13 principles of drug addiction treatment disseminated by the National Institute on Drug Abuse (NIDA), 7 were meta-analyzed as part of the Evidence-based Principles of Treatment (EPT) project. By averaging outcomes over the diverse programs included in the EPT, we found that 5 of the NIDA principles examined are supported: matching treatment to the client's needs, attending to the multiple needs of clients, behavioral counseling interventions, treatment plan reassessment, and counseling to reduce risk of HIV. Two of the NIDA principles are not supported: remaining in treatment for an adequate period and frequency of testing for drug use. These weak effects could be the result of the principles being stated too generally to apply to the diverse interventions and programs that exist or unmeasured moderator variables being confounded with the moderators that measured the principles. Meta-analysis should be a standard tool for developing principles of effective treatment for substance use disorders. Copyright © 2012 Elsevier Inc. All rights reserved.

  14. SADC establishes a regional action plan.

    PubMed

    Klouda, T

    1997-02-01

    The regional meeting held on AIDS strategy in Lilongwe, Malawi, in December, 1996, made important advances. The 12 countries of the SADC (Southern Africa Development Community) joined the European Union to institute a regional action plan for the reduction of susceptibility of people to HIV because of social, cultural, and environmental factors; the vulnerability of people with HIV infection to social and other difficulties; and the vulnerability of institutions because of the foregoing impacts. At the conference the issues explored were employment, mining, medical drugs, education, and tourism. An employment charter was seen as crucial for the success of AIDS and workplace activities. Facilitation of travel across borders was important for the reduction of susceptibility to HIV infection. Enhancement of regional policies for essential drugs was vital for drugs for the treatment of AIDS. The clarification of the regional role was critical for regional support of national action (strengthening technical and institutional capacities) and for regional joint action such as studies on research, harmonization of data collection on HIV/AIDS; organization of training; development of information and education on HIV/AIDS; facilitation of manufacturing of drugs and condoms; and the development of a regional information and education program about HIV/AIDS. The conference also clarified HIV/AIDS programs in relation to other health and socioeconomic problems.

  15. Prevention of Drug Use. Grades 4-6. Education for Self-Responsibility II.

    ERIC Educational Resources Information Center

    Texas Education Agency, Austin.

    This Education for Self Responsibility (ESR) curriculum guide is designed to help students learn to make intelligent decisions about health and well being, and to act responsibly when confronted with opportunities to try drugs. The program focuses on ways in which Grades 4-6 teachers can emphasize: personal development; interpersonal relations;…

  16. Preparation of Chemicals and Bulk Drug Substances for the U.S. Army Drug Development Program.

    DTIC Science & Technology

    1997-12-01

    4(R)-rio (,) -dihydroartemisininoxy]-; artemisinin ; dihydroartemisinin; artelinic acid, methyl ester; artelinic acid. -I- TABLE OF CONTENTS I...acid, 4-(4-chloro- phenyl) -4(R) -[10(P) -dihydro- artemisininoxy]-......................... 49 10. Artemisinin ................................. 58 11...dihydroartemisininoxy]-; artemisinin ; dihydroartemisinin; artelinic acid, methyl ester; artelinic acid. -V- II FOREWORD opinions, interpretations, conclusions and

  17. Social Marketing Strategies for Campus Prevention of Alcohol and Other Drug Problems.

    ERIC Educational Resources Information Center

    Zimmerman, Robert

    This document sets out one segment of a comprehensive approach intended to assist institutions of higher education in developing and carrying out alcohol abuse and other drug prevention programs. Social marketing is described as a tool of environmental management, that seeks to produce a specified behavior in a target audience. Intended for a…

  18. The pediatric studies initiative: after 15 years have we reached the limits of the law?

    PubMed

    Milne, Christopher-Paul; Davis, Jonathan

    2014-02-01

    Despite considerable disincentives for conducting drug studies in children, 15 years ago the Food and Drug Administration, pediatric health advocates and congressional sponsors created a carrot-and-stick policy approach of voluntary and mandatory programs to encourage the pharmaceutical industry to include children in the drug development process. After several rounds of reauthorization of the laws on a temporary basis, the enabling statutes have been made permanent. The purpose of this analysis is to review the advances that resulted from the law and the areas where further progress is needed. A brief review of the history and results of the pediatric studies initiative was conducted by the authors and a determination made about the accomplishments of the law and remaining challenges. Indicators of the changes that resulted from this pediatric studies initiative are both indirect, such as the increase in the number of indication supplements for new populations, and direct, such as the decrease in the percentage of medicines used off-label in children. Although the pediatric studies initiative has significantly improved therapeutic options for children, concern still exists that drug companies are reluctant to include children in drug development unless continuously incentivized, whether positively or negatively. Two challenges are particularly problematic: neonatal studies and child-friendly formulations. Although the latest round of legislation should provide opportunities to address these problems, significantly more effort will be needed to achieve real culture change. Ultimately, the solution will require full program implementation by the Food and Drug Administration and close collaboration by many key stakeholders to ensure that pediatric studies become a routine part of the drug development process. © 2013 Elsevier HS Journals, Inc. All rights reserved.

  19. Prevention of Youthful Marijuana Use.

    PubMed

    Cermak, Timmen L; Banys, Peter

    2016-01-01

    Considerable money and effort have been expended in attempts to prevent drug use by youth, with disappointing results. Too often, prevention programs have singled out youth with simplistic messages of exaggerated risk and the same politically acceptable solution for all-abstinence. Historically, prevention efforts have been less effective by not being soundly based in science and failing also to address adult drug and alcohol use as part of the problem. The Institute of Medicine continuum of care model developed in 1994 offers a framework for a more sophisticated, three-tiered approach to prevention, defined as all services provided prior to a clinical diagnosis of a substance use disorder. By dividing prevention efforts into universal (delivered to broad populations without consideration of individual risk for developing substance use disorder), selected (targeting sub-groups of individuals identified on the basis of characteristics known to create an elevated risk for substance use disorder), and indicated (addressing individuals identified on the basis of manifest risk behaviors), prevention can be better tailored to meet different levels of need. Student Assistance Programs (SAPs) and community coalitions provide examples of how IOM's continuum of care model can be integrated into drug prevention programs for youth.

  20. Innovative Adolescent Chemical Dependency Treatment and Its Outcome: A Model Based on Outward Bound Programming.

    ERIC Educational Resources Information Center

    McPeake, John D.; And Others

    1991-01-01

    Describes adolescent chemical dependency treatment model developed at Beech Hill Hospital (New Hampshire) which integrated Twelve Step-oriented alcohol and drug rehabilitation program with experiential education school, Hurricane Island Outward Bound School. Describes Beech Hill Hurricane Island Outward Bound School Adolescent Chemical Dependency…

  1. Responsible Conduct of Scientific Research: A One-Semester Course for Graduate Students.

    ERIC Educational Resources Information Center

    Hoshiko, T.

    1993-01-01

    Describes a course developed in part to satisfy the requirement that a program in the principles of scientific integrity be part of any training program funded by the National Institutes of Health (NIH) or the Alcohol, Drug Abuse, and Mental Health Administration. Contains 17 references. (DDR)

  2. KINPLOT: An Interactive Pharmacokinetics Graphics Program for Digital Computers.

    ERIC Educational Resources Information Center

    Wilson, Robert C.; And Others

    1982-01-01

    Inability to see the relevance of mathematics to understanding the time course of drugs in the body may discourage interest in pharmacokinetics. A UNC-developed computer graphics simulation program helps visualize the nature of pharmacokinetic-patient interactions, generates classroom handouts, and is used in the pharmaceuticals industry to…

  3. Leveraging Big Data in Pediatric Development Programs: Proceedings From the 2016 American College of Clinical Pharmacology Annual Meeting Symposium.

    PubMed

    Mulugeta, Lily Yeruk; Yao, Lynne; Mould, Diane; Jacobs, Brian; Florian, Jeffrey; Smith, Brian; Sinha, Vikram; Barrett, Jeffrey S

    2018-01-10

    This article discusses the use of big data in pediatric drug development. The article covers key topics discussed at the ACCP annual meeting symposium in 2016 including the extent to which big data or real-world data can inform clinical trial design and substitute for efficacy and safety data typically obtained in clinical trials. The current states of use, opportunities, and challenges with the use of big data in future pediatric drug development are discussed. © 2018 American Society for Clinical Pharmacology and Therapeutics.

  4. Drug utilization review: mechanisms to improve its effectiveness and broaden its scope. The U.S. Pharmacopeia Drug Utilization Review Advisory Panel.

    PubMed

    2000-01-01

    To address important problems and needed changes in online and retrospective drug utilization review (DUR) programs. Emphasis is placed on reliability of DUR criteria and the shift of traditional retrospective DUR programs toward disease management and health care outcomes. Published literature evaluating the role of online and retrospective DUR programs. Particular attention was given to studies assessing DUR criteria reliability and new interventions with retrospective DUR programs. A literature review was conducted along with an expert summary from the U.S. Pharmacopeia Drug Utilization Review Advisory Panel. Studies have revealed variations in DUR criteria that could be affecting clinical practice and patient care. Appropriate formal methodologies and use of consistent procedures in developing online prospective DUR programs and systems could help resolve these problems. Traditional retrospective DUR is also shifting to incorporate disease management and methodologies from health outcomes and pharmacoeconomics studies. Refinements are needed to improve the reliability and validity of online DUR criteria and to minimize false positive messages. Databases created as a result of DUR efforts have been used in new and innovative ways to incorporate health outcomes data and disease management interventions. Additional outcomes data, combined with quality assurance efforts, should increase the utility of DUR/disease management efforts in evaluating health systems while improving the effectiveness and efficiency of pharmacists' health care interventions.

  5. HIV Prevention and Rehabilitation Models for Women Who Inject Drugs in Russia and Ukraine

    PubMed Central

    Skipalska, Halyna; Suvorova, Svetlana; Sukovatova, Olga; Zakharov, Konstantin; Hodgdon, Sara

    2012-01-01

    Women who inject drugs require gender-specific approaches to drug rehabilitation, modification of risk behaviors, and psychosocial adaptation. Improved outcomes have been demonstrated when the specific needs of women's subpopulations have been addressed. Special services for women include prenatal care, child care, women-only programs, supplemental workshops on women-focused topics, mental health services, and comprehensive programs that include several of the above components. To address the special needs of women injecting drug user (IDU) subpopulations, such as HIV-positive pregnant women and women with young children, recently released female prisoners, and street-involved girls and young women, HealthRight International and its local partners in Russia and Ukraine have developed innovative service models. This paper presents each of these models and discusses their effectiveness and implementation challenges specific to local contexts in Russia and Ukraine. PMID:23304535

  6. Electronic Health Record Design and Implementation for Pharmacogenomics: a Local Perspective

    PubMed Central

    Peterson, Josh F.; Bowton, Erica; Field, Julie R.; Beller, Marc; Mitchell, Jennifer; Schildcrout, Jonathan; Gregg, William; Johnson, Kevin; Jirjis, Jim N; Roden, Dan M.; Pulley, Jill M.; Denny, Josh C.

    2014-01-01

    Purpose The design of electronic health records (EHR) to translate genomic medicine into clinical care is crucial to successful introduction of new genomic services, yet there are few published guides to implementation. Methods The design, implemented features, and evolution of a locally developed EHR that supports a large pharmacogenomics program at a tertiary care academic medical center was tracked over a 4-year development period. Results Developers and program staff created EHR mechanisms for ordering a pharmacogenomics panel in advance of clinical need (preemptive genotyping) and in response to a specific drug indication. Genetic data from panel-based genotyping were sequestered from the EHR until drug-gene interactions (DGIs) met evidentiary standards and deemed clinically actionable. A service to translate genotype to predicted drug response phenotype populated a summary of DGIs, triggered inpatient and outpatient clinical decision support, updated laboratory records, and created gene results within online personal health records. Conclusion The design of a locally developed EHR supporting pharmacogenomics has generalizable utility. The challenge of representing genomic data in a comprehensible and clinically actionable format is discussed along with reflection on the scalability of the model to larger sets of genomic data. PMID:24009000

  7. 14 CFR 120.115 - Employee Assistance Program (EAP).

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... (CONTINUED) AIR CARRIERS AND OPERATORS FOR COMPENSATION OR HIRE: CERTIFICATION AND OPERATIONS DRUG AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.115 Employee Assistance Program (EAP). (a... the employee and supervisor EAP training in the employer's drug testing program. [Doc. No. FAA-2008...

  8. 77 FR 41416 - Food and Drug Administration/Xavier University Global Outsourcing Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-13

    ... International Initiatives, FDA Inspection Trends, Supply Chain Development, Quality Agreements, Supplier... the World Establishing a Meaningful Supplier Qualification Program Supply Chain Development Finished... Agreements Business Process Management Global Standards Association Near Term Solutions The conference...

  9. Preventing Drug Abuse Among Adolescent Girls: Outcome Data from an Internet-Based Intervention

    PubMed Central

    Schinke, Steven P.; Di Noia, Jennifer

    2009-01-01

    This study developed and tested an Internet-based gender-specific drug abuse prevention program for adolescent girls. A sample of seventh, eighth, and ninth grade girls (N = 236) from 42 states and 4 Canadian provinces were randomly assigned to an intervention or control group. All girls completed an online pretest battery. Following pretest, intervention girls interacted with a 12-session, Internet-based gender-specific drug prevention program. Girls in both groups completed the measurement battery at posttest and 6-month follow-up. Analysis of posttest scores revealed no differences between groups for 30-day reports of alcohol, marijuana, poly drug use, or total substance use (alcohol and drugs). At 6-month follow-up, between-group effects were found on measures of 30-day alcohol use, marijuana use, poly drug use, and total substance use. Relative to girls in the control group, girls exposed to the Internet-based intervention reported lower rates of use for these substances. Moreover, girls receiving the intervention achieved gains over girls in the control group on normative beliefs and self-efficacy at posttest and 6-month follow-up, respectively. PMID:19728091

  10. Adaptive Interventions in Drug Court: A Pilot Experiment

    PubMed Central

    Marlowe, Douglas B.; Festinger, David S.; Arabia, Patricia L.; Dugosh, Karen L.; Benasutti, Kathleen M.; Croft, Jason R.; McKay, James R.

    2009-01-01

    This pilot study (N = 30) experimentally examined the effects of an adaptive intervention in an adult misdemeanor drug court. The adaptive algorithm adjusted the frequency of judicial status hearings and clinical case-management sessions according to pre-specified criteria in response to participants' ongoing performance in the program. Results revealed the adaptive algorithm was acceptable to both clients and staff, feasible to implement with greater than 85% fidelity, and showed promise for eliciting clinically meaningful improvements in drug abstinence and graduation rates. Estimated effect sizes ranged from 0.40 to 0.60 across various dependent measures. Compared to drug court as-usual, participants in the adaptive condition were more likely to receive responses from the drug court team for inadequate performance in the program and received those responses after a substantially shorter period of time. This suggests the adaptive algorithm may have more readily focused the drug court team's attention on poorly-performing individuals, thus allowing the team to “nip problems in the bud” before they developed too fully. These preliminary data justify additional research evaluating the effects of the adaptive algorithm in a fully powered experimental trial. PMID:19724664

  11. A phenomenological approach to assessing a DUI/DWI program.

    PubMed

    Narag, Raymund E; Maxwell, Sheila Royo; Lee, Byung

    2013-02-01

    In an effort to find a more proactive solution to the problem of drunk driving, a midwestern city has implemented a Driving Under the Influence or Driving While Impaired (DUI/DWI) Court program, a derivative of the popular drug courts. Eligible participants are those who have had two or more drunk-driving offenses but who have not been convicted of a violent offense. Participants volunteer for a 36-week program in exchange for a suspension of their prison sentence. Program elements include drug/alcohol monitoring, support groups, counseling, and extensive supervision. Using a phenomenological approach, this article describes the challenges faced by 20 participants, how they navigated the program requirements, their key realizations about their conditions, and their views on the viability and effectiveness of the program. The article uses qualitative interviews of participants and stakeholders collected for a process evaluation of the DUI program, and official records collected for programming purposes. Findings from this research can be used broadly for programming purposes and can be used by other court jurisdictions that are developing similar programs.

  12. An Introduction to the National DARE Parent Program. Program Brief.

    ERIC Educational Resources Information Center

    Illinois State Police, Springfield.

    Drug Abuse Resistance Education (DARE) is a preventive drug education program intended to stop drug use before it begins. Its purpose is to help children say "no" to drug, alcohol, and tobacco use by teaching them techniques to resist peer pressure. The newest addition to the concept is the DARE Parent Program (DPP), created to stimulate…

  13. A novel, bottom-up approach to promote evidence-based HIV prevention for people who inject drugs in Ukraine: protocol for the MICT (‘Bridge’) HIV prevention exchange project

    PubMed Central

    2014-01-01

    Background Ukraine has one of the most severe HIV epidemics in Eastern Europe, with an estimated 1.6% of the adult population living with the virus. Injection drug use accounts for 36% of new HIV cases. Nongovernmental organizations in Ukraine have little experience with effective, theory-based behavioral risk reduction interventions necessary to reduce the scope of the HIV epidemic among Ukrainians who inject drugs. This study seeks to promote the use of evidence-based HIV prevention strategies among Ukrainian organizations working with drug users. Methods/design This study combines qualitative and quantitative methods to explore a model of HIV prevention intervention development and implementation that disseminates common factors of effective behavioral risk reduction interventions and enables service providers to develop programs that reflect their specific organizational contexts. Eight agencies, located in regions of Ukraine with the highest HIV and drug use rates and selected to represent key organizational context criteria (e.g., agency size, target population, experience with HIV prevention), will be taught common factors as the basis for intervention development. We will use qualitative methods, including interviews and observations, to document the process of intervention development and implementation at each agency. Using risk assessments with intervention participants, we will also assess intervention effectiveness. The primary outcome analyses will determine the extent to which agencies develop and implement an intervention for drug users that incorporates common factors of effective behavioral interventions. Effectiveness analyses will be conducted, and effect size of each intervention will be compared to that of published HIV prevention interventions for drug users with demonstrated effectiveness. This study will explore the role of organizational context on intervention development and implementation, including resource allocation decisions, problem-solving around intervention development, and barriers and facilitators to inclusion of common factors and delivery of a high quality intervention. Discussion This innovative approach to HIV prevention science dissemination and intervention development draws on providers’ ability to quickly develop innovative programs and reach populations in greatest need of services. It has the potential to enhance providers’ ability to use HIV prevention science to develop sustainable interventions in response to a rapidly changing epidemic. PMID:24491185

  14. Recommendations from the Investigational New Drug/Investigational Device Exemption Task Force of the clInical and Translational Science Award Consortium: developing and implementing a sponsor-investigators training program.

    PubMed

    Holbein, M E Blair; Berglund, Jelena Petrovic; O'Reilly, Erin K; Hartman, Karen; Speicher, Lisa A; Adamo, Joan E; O'Riordan, Gerri; Brown, Jennifer Swanton; Schuff, Kathryn G

    2014-06-01

    The objective of this study was to provide recommendations for provision of training for sponsor and investigators at Academic Health Centers. A subgroup of the Investigational New Drug/Investigational Device Exemption (IND/IDE) Task Force of the Clinical and Translational Science Award (CTSA) program Regulatory Knowledge Key Function Committee was assembled to specifically address how clinical investigators who hold an IND/IDE and thus assume the role of sponsor-investigators are adequately trained to meet the additional regulatory requirements of this role. The participants who developed the recommendations were representatives of institutions with IND/IDE support programs. Through an informal survey, the task force determined that a variety and mix of models are used to provide support for IND/IDE holders within CTSA institutions. In addition, a CTSA consortium-wide resources survey was used. The participants worked from the models and survey results to develop consensus recommendations to address institutional support, training content, and implementation. The CTSA IND/IDE Task Force recommendations are as follows: (1) Institutions should assess the scope of Food and Drug Administration-regulated research, perform a needs analysis, and provide resources to implement a suitable training program; (2) The model of training program should be tailored to each institution; (3) The training should specifically address the unique role of sponsor-investigators, and the effectiveness of training should be evaluated regularly by methods that fit the model adopted by the institution; and (4) Institutional leadership should mandate sponsor-investigator training and effectively communicate the necessity and availability of training.

  15. Use of the Internet to Obtain Drugs without a Prescription Among Treatment-involved Adolescents and Young Adults*

    PubMed Central

    Festinger, David S.; Dugosh, Karen L.; Clements, Nicolle; Flynn, Anna B.; Falco, Mathea; McLellan, A. Thomas; Arria, Amelia M.

    2016-01-01

    Nonmedical use of prescription drugs is common and poses risks such as injury, overdose, and development of abuse and dependence. Internet pharmacies offer prescription drugs without a prescription, creating a source of illicit drugs accessible to anyone with an Internet connection. We examined this issue in a convenience sample of 1,860 adolescents and young adults from 24 residential and outpatient treatment programs. Few individuals obtained drugs from the Internet (n = 26, 2.3%). Pain relievers were the most frequently purchased type of drug. The majority of adolescents and young adult online purchasers made the purchases from their own or a friend’s house. PMID:28194089

  16. Pharmacological mechanism-based drug safety assessment and prediction.

    PubMed

    Abernethy, D R; Woodcock, J; Lesko, L J

    2011-06-01

    Advances in cheminformatics, bioinformatics, and pharmacology in the context of biological systems are now at a point that these tools can be applied to mechanism-based drug safety assessment and prediction. The development of such predictive tools at the US Food and Drug Administration (FDA) will complement ongoing efforts in drug safety that are focused on spontaneous adverse event reporting and active surveillance to monitor drug safety. This effort will require the active collaboration of scientists in the pharmaceutical industry, academe, and the National Institutes of Health, as well as those at the FDA, to reach its full potential. Here, we describe the approaches and goals for the mechanism-based drug safety assessment and prediction program.

  17. Clinician impression versus prescription drug monitoring program criteria in the assessment of drug-seeking behavior in the emergency department.

    PubMed

    Weiner, Scott G; Griggs, Christopher A; Mitchell, Patricia M; Langlois, Breanne K; Friedman, Franklin D; Moore, Rebecca L; Lin, Shuo Cheng; Nelson, Kerrie P; Feldman, James A

    2013-10-01

    We compare emergency provider impression of drug-seeking behavior with objective criteria from a state prescription drug monitoring program, assess change in opioid pain reliever prescribing after prescription drug monitoring program review, and examine clinical factors associated with suspected drug-seeking behavior. This was a prospective observational study of emergency providers assessing a convenience sample of patients aged 18 to 64 years who presented to either of 2 academic medical centers with chief complaint of back pain, dental pain, or headache. Drug-seeking behavior was objectively defined as present when a patient had greater than or equal to 4 opioid prescriptions by greater than or equal to 4 providers in the 12 months before emergency department evaluation. Emergency providers completed data forms recording their impression of the likelihood of drug-seeking behavior, patient characteristics, and plan for prescribing pre- and post-prescription drug monitoring program review. Descriptive statistics were generated. We calculated agreement between emergency provider impression of drug-seeking behavior and prescription drug monitoring program definition, and sensitivity, specificity, and positive predictive value of emergency provider impression, using prescription drug monitoring program criteria as the criterion standard. A multivariate logistic regression analysis was conducted to determine clinical factors associated with drug-seeking behavior. Thirty-eight emergency providers with prescription drug monitoring program access participated. There were 544 patient visits entered into the study from June 2011 to January 2013. There was fair agreement between emergency provider impression of drug-seeking behavior and prescription drug monitoring program (κ=0.30). Emergency providers had sensitivity 63.2% (95% confidence interval [CI] 54.8% to 71.7%), specificity 72.7% (95% CI 68.4% to 77.0%), and positive predictive value 41.2% (95% CI 34.4% to 48.2%) for identifying drug-seeking behavior. After exposure to prescription drug monitoring program data, emergency providers changed plans to prescribe opioids at discharge in 9.5% of cases (95% CI 7.3% to 12.2%), with 6.5% of patients (n=35) receiving opioids not previously planned and 3.0% (n=16) no longer receiving opioids. Predictors for drug-seeking behavior by prescription drug monitoring program criteria were patient requests opioid medications by name (odds ratio [OR] 1.91; 95% CI 1.13 to 3.23), multiple visits for same complaint (OR 2.5; 95% CI 1.49 to 4.18), suspicious history (OR 1.88; 95% CI 1.1 to 3.19), symptoms out of proportion to examination (OR 1.83; 95% CI 1.1 to 3.03), and hospital site (OR 3.1; 95% CI 1.76 to 5.44). Emergency providers had fair agreement with objective criteria from the prescription drug monitoring program in suspecting drug-seeking behavior. Program review changed management plans in a small number of cases. Multiple clinical factors were predictive of drug-seeking behavior. Copyright © 2013 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

  18. Evolution of antiretroviral drug costs in Brazil in the context of free and universal access to AIDS treatment.

    PubMed

    Nunn, Amy S; Fonseca, Elize M; Bastos, Francisco I; Gruskin, Sofia; Salomon, Joshua A

    2007-11-13

    Little is known about the long-term drug costs associated with treating AIDS in developing countries. Brazil's AIDS treatment program has been cited widely as the developing world's largest and most successful AIDS treatment program. The program guarantees free access to highly active antiretroviral therapy (HAART) for all people living with HIV/AIDS in need of treatment. Brazil produces non-patented generic antiretroviral drugs (ARVs), procures many patented ARVs with negotiated price reductions, and recently issued a compulsory license to import one patented ARV. In this study, we investigate the drivers of recent ARV cost trends in Brazil through analysis of drug-specific prices and expenditures between 2001 and 2005. We compared Brazil's ARV prices to those in other low- and middle-income countries. We analyzed trends in drug expenditures for HAART in Brazil from 2001 to 2005 on the basis of cost data disaggregated by each ARV purchased by the Brazilian program. We decomposed the overall changes in expenditures to compare the relative impacts of changes in drug prices and drug purchase quantities. We also estimated the excess costs attributable to the difference between prices for generics in Brazil and the lowest global prices for these drugs. Finally, we estimated the savings attributable to Brazil's reduced prices for patented drugs. Negotiated drug prices in Brazil are lowest for patented ARVs for which generic competition is emerging. In recent years, the prices for efavirenz and lopinavir-ritonavir (lopinavir/r) have been lower in Brazil than in other middle-income countries. In contrast, the price of tenofovir is US$200 higher per patient per year than that reported in other middle-income countries. Despite precipitous price declines for four patented ARVs, total Brazilian drug expenditures doubled, to reach US$414 million in 2005. We find that the major driver of cost increases was increased purchase quantities of six specific drugs: patented lopinavir/r, efavirenz, tenofovir, atazanavir, enfuvirtide, and a locally produced generic, fixed-dose combination of zidovudine and lamivudine (AZT/3TC). Because prices declined for many of the patented drugs that constitute the largest share of drug costs, nearly the entire increase in overall drug expenditures between 2001 and 2005 is attributable to increases in drug quantities. Had all drug quantities been held constant from 2001 until 2005 (or for those drugs entering treatment guidelines after 2001, held constant between the year of introduction and 2005), total costs would have increased by only an estimated US$7 million. We estimate that in the absence of price declines for patented drugs, Brazil would have spent a cumulative total of US$2 billion on drugs for HAART between 2001 and 2005, implying a savings of US$1.2 billion from price declines. Finally, in comparing Brazilian prices for locally produced generic ARVs to the lowest international prices meeting global pharmaceutical quality standards, we find that current prices for Brazil's locally produced generics are generally much higher than corresponding global prices, and note that these prices have risen in Brazil while declining globally. We estimate the excess costs of Brazil's locally produced generics totaled US$110 million from 2001 to 2005. Despite Brazil's more costly generic ARVs, the net result of ARV price changes has been a cost savings of approximately US$1 billion since 2001. HAART costs have nevertheless risen steeply as Brazil has scaled up treatment. These trends may foreshadow future AIDS treatment cost trends in other developing countries as more people start treatment, AIDS patients live longer and move from first-line to second and third-line treatment, AIDS treatment becomes more complex, generic competition emerges, and newer patented drugs become available. The specific application of the Brazilian model to other countries will depend, however, on the strength of their health systems, intellectual property regulations, epidemiological profiles, AIDS treatment guidelines, and differing capacities to produce drugs locally.

  19. Professional ideologies and the development of syringe exchange: Wales as a case study.

    PubMed

    Keene, J M; Stimson, G V

    1997-12-01

    This paper is derived from an evaluative study of HIV prevention programs for drug injectors across Wales. It considers how different professional territories and ideologies, concepts of drug misuse and models of HIV prevention may influence policy development. The research involved monitoring the introduction and development of agency and community based syringe exchange schemes and initiatives taken by community pharmacists. Interviews with staff, managers and administrators, and descriptions of service history, development and delivery inform the discussion. HIV prevention varied in different areas of Wales depending on the particular professional group involved, local ideologies regarding drug use treatment, and the extent to which HIV prevention was seen either as a specialist area of expertise and specific remit of drug workers or a generic health care task. Drug agencies with an abstinence policy rejected syringe exchange; instead, prevention in those areas developed in ad hoc ways as health care workers and pharmacists attempted to develop a community based service. Drug agencies with a pre-existing harm minimisation model easily integrated syringe exchange into their work and played the major part in establishing the service, but there was difficulty in extending it beyond their professional caseloads. As there were disincentives to use treatment agencies, and their catchment areas were limited, these factors influenced effective service provision.

  20. The development of videos in culturally grounded drug prevention for rural native Hawaiian youth.

    PubMed

    Okamoto, Scott K; Helm, Susana; McClain, Latoya L; Dinson, Ay-Laina

    2012-12-01

    The purpose of this study was to adapt and validate narrative scripts to be used for the video components of a culturally grounded drug prevention program for rural Native Hawaiian youth. Scripts to be used to film short video vignettes of drug-related problem situations were developed based on a foundation of pre-prevention research funded by the National Institute on Drug Abuse. Seventy-four middle- and high-school-aged youth in 15 focus groups adapted and validated the details of the scripts to make them more realistic. Specifically, youth participants affirmed the situations described in the scripts and suggested changes to details of the scripts to make them more culturally specific. Suggested changes to the scripts also reflected preferred drug resistance strategies described in prior research, and varied based on the type of drug offerer described in each script (i.e., peer/friend, parent, or cousin/sibling). Implications for culturally grounded drug prevention are discussed.

  1. UCSF Small Molecule Discovery Center: innovation, collaboration and chemical biology in the Bay Area.

    PubMed

    Arkin, Michelle R; Ang, Kenny K H; Chen, Steven; Davies, Julia; Merron, Connie; Tang, Yinyan; Wilson, Christopher G M; Renslo, Adam R

    2014-05-01

    The Small Molecule Discovery Center (SMDC) at the University of California, San Francisco, works collaboratively with the scientific community to solve challenging problems in chemical biology and drug discovery. The SMDC includes a high throughput screening facility, medicinal chemistry, and research labs focused on fundamental problems in biochemistry and targeted drug delivery. Here, we outline our HTS program and provide examples of chemical tools developed through SMDC collaborations. We have an active research program in developing quantitative cell-based screens for primary cells and whole organisms; here, we describe whole-organism screens to find drugs against parasites that cause neglected tropical diseases. We are also very interested in target-based approaches for so-called "undruggable", protein classes and fragment-based lead discovery. This expertise has led to several pharmaceutical collaborations; additionally, the SMDC works with start-up companies to enable their early-stage research. The SMDC, located in the biotech-focused Mission Bay neighborhood in San Francisco, is a hub for innovative small-molecule discovery research at UCSF.

  2. Integrating ADNI Results into Alzheimer’s Disease Drug Development Programs

    PubMed Central

    Cummings, Jeffrey L.

    2010-01-01

    The Alzheimer’s Disease Neuroimaging Initiative (ADNI) is providing critical new information on biomarkers in cognitively normal elderly, persons with mild cognitive impairment (MCI), and patients with mild Alzheimer’s disease (AD). The data provide insights into the progression of the pathology of AD over time, assist in understanding which biomarkers might be most useful in clinical trials, and facilitate development of disease-modifying treatments. ADNI results are intended to support new AD Treatments development; this paper considers how ADNI information can be integrated in AD drug development programs. Cerebrospinal fluid (CSF) amyloid beta protein (Aβ) measures can be used in Phase I studies to detect any short term effects on Aβ levels in the CSF. Phase II studies may benefit most from biomarker measures that can inform decisions about Phase III. CSF Aβ levels, CSF total tau and phospotau measures, fluorodexoyglucose positron emission tomography (FDG PET), Pittsburgh Compound B (PIB) amyloid imaging, or magnetic resonance imaging (MRI) may be employed to select patient in enriched trials or as outcomes for specific disease-modifying interventions. Use of biomarkers may allow Phase II trials to be conducted more efficiently with smaller populations of patients or shorted treatment times. New drug applications (NDA) may include biomarker outcomes of phase III trials. ADNI patients are highly educated and are nearly all of Caucasian ethnicity limiting the generalizability of the results to other populations commonly included in global clinical trials. ADNI has inspired or collaborates with biomarker investigations worldwide and together these studies will provide biomarker information that can reduce development times and costs, improve drug safety, optimize drug efficacy, and bring new treatments to patients with or at risk for AD. PMID:20447734

  3. Adverse drug events and medication problems in "Hospital at Home" patients.

    PubMed

    Mann, Elizabeth; Zepeda, Orlando; Soones, Tacara; Federman, Alex; Leff, Bruce; Siu, Albert; Boockvar, Kenneth

    2018-03-26

    "Hospital at Home(HaH)" programs provide an alternative to traditional hospitalization. However, the incidence of adverse drug events in these programs is unknown. This study describes adverse drug events and potential adverse drug events in a new HaH program. We examined the charts of the first 50 patients admitted. We found 45 potential adverse drug events and 14 adverse drug events from admission to 30 days after HaH discharge. None of the adverse drug events were severe. Some events, like problems with medication administration, may be unique to the hospital at home setting. Monitoring for adverse drug events is feasible and important for hospital at home programs.

  4. Evaluation of the impact of the drug evaluation and classification program on enforcement and adjudication

    DOT National Transportation Integrated Search

    1992-12-01

    This study examined the effect of the Drug Evaluation and Classification (DEC) Program on impaired driving (DWI) enforcement and adjudication. Drug Recognition Experts (DREs) in DEC programs evaluate suspects when drugs other than alcohol are suspect...

  5. 14 CFR 120.115 - Employee Assistance Program (EAP).

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... (CONTINUED) AIR CARRIERS AND OPERATORS FOR COMPENSATION OR HIRE: CERTIFICATION AND OPERATIONS DRUG AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.115 Employee Assistance Program (EAP). (a... employer's drug testing plan submitted to the FAA for approval. ...

  6. 14 CFR 120.115 - Employee Assistance Program (EAP).

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... (CONTINUED) AIR CARRIERS AND OPERATORS FOR COMPENSATION OR HIRE: CERTIFICATION AND OPERATIONS DRUG AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.115 Employee Assistance Program (EAP). (a... employer's drug testing plan submitted to the FAA for approval. ...

  7. 14 CFR 120.115 - Employee Assistance Program (EAP).

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... (CONTINUED) AIR CARRIERS AND OPERATORS FOR COMPENSATION OR HIRE: CERTIFICATION AND OPERATIONS DRUG AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.115 Employee Assistance Program (EAP). (a... employer's drug testing plan submitted to the FAA for approval. ...

  8. 14 CFR 120.115 - Employee Assistance Program (EAP).

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... (CONTINUED) AIR CARRIERS AND OPERATORS FOR COMPENSATION OR HIRE: CERTIFICATION AND OPERATIONS DRUG AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.115 Employee Assistance Program (EAP). (a... employer's drug testing plan submitted to the FAA for approval. ...

  9. Perception of Generic Prescription Drugs and Utilization of Generic Drug Discount Programs

    PubMed Central

    Omojasola, Anthony; Hernandez, Mike; Sansgiry, Sujit; Jones, Lovell

    2012-01-01

    Objective Our study aimed to assess patient’s perceptions of generic drugs and utilization of generic drug discount programs. Design, Setting and Participants A survey was administered to adult participants at community health centers and community-based organizations in Houston, Texas, USA (n=525). Main Outcome Measures Multivariate logistic regression was used to quantify the strength of association between generic drug perception and utilization of generic drug discount programs. Results Respondents who agreed that “Generic prescription drugs are as effective as brand name prescription drugs,” were 3 times as likely to utilize generic drug discount programs (AOR: 3.0, 95% CI: 1.8–4.8, P<.001). Compared to non-Hispanic Whites, African Americans (OR: 10.2; 95% CI: 1.4–76.4) and Hispanics (OR: 10.3; 95% CI: 1.3–79.4) were 10 times as likely to agree that generic drugs have more side effects than brand name drugs. Conclusion Race/ethnicity had no impact in utilization of generic drug discount programs, despite racial disparities in perception toward generic drugs’ side effects and generic drugs being inferior to brand name drugs. PMID:23140080

  10. Dimensions and Characteristics of Personnel Manager Perceptions of Effective Drug-Testing Programs.

    ERIC Educational Resources Information Center

    Gomez-Mejia, Luis R.; Balkin, David B.

    1987-01-01

    Examined characteristics of drug-testing programs that were associated with personnel managers' judgments of the programs' effectiveness using data gathered from human resource managers (N=190). Results showed drug-testing programs considered to be effective were supported by ancillary activities (such as employee assistance programs), targeted…

  11. Delivering health information about self-medication to older adults: use of touchscreen-equipped notebook computers.

    PubMed

    Neafsey, P J; Strickler, Z; Shellman, J; Padula, A T

    2001-11-01

    Preventing Drug Interactions in Active Older Adults is an educational intervention to prevent prescription and over-the-counter (OTC) drug and alcohol interactions in active, community-living older adults. The objectives of the program are to increase older adults' knowledge of potential interactions of prescription medications with OTC drugs and alcohol and to increase their confidence (self-efficacy) about how to avoid such interactions. An interactive multimedia computer software program (Personal Education Program or PEP) was designed for the learning styles and psychomotor skills of older adults. Focus groups of older adults evaluated PEP components in a formative manner during development. The program content dealing with antacids, calcium supplements, and acid reducers was pilot tested with 60 older adults recruited from local senior centers. Participants used the PEP on notebook computers equipped with infrared-sensitive touchscreens. Users of PEP had greater knowledge and self-efficacy scores than controls. Participants indicated a high degree of satisfaction with the PEP and reported their intent to make specific changes in self-medication behaviors.

  12. Ethical imperatives of timely access to orphan drugs: is possible to reconcile economic incentives and patients' health needs?

    PubMed

    Rodriguez-Monguio, R; Spargo, T; Seoane-Vazquez, E

    2017-01-05

    More than 6,800 rare diseases and conditions have been identified in the US, which affect 25-30 million Americans. In 1983, the US Congress enacted the Orphan Drug Act (ODA) to encourage the development and marketing of drugs to treat rare diseases and conditions. This study analyzed all orphan designations and FDA approvals since 1983 through 2015, discussed the effectiveness of incentives for the development of treatments for rare diseases, and reflected on the ethical imperatives for timely access to orphan drugs. Study data were derived from the Food and Drug Administration (FDA) Orange Book and the Office of Orphan Drugs Development. A search was conducted to assess literature on the ethical principles and economic incentives for the development of orphan drugs. In the period 1983-2015, the FDA granted 3,647 orphan drug designations and 554 orphan drug approvals. The orphan drug approvals corresponded to 438 different brand names. Cancer was the therapeutic area with the highest number of approvals. The increased number of patients with rare diseases and the growth in the cost of orphan drugs pose a significant economic burden for patients, public programs and private third party payers. Regulatory differences to qualify for orphan designation and various population thresholds employed by the FDA and the European Medicines Agency lead to further unmet health needs for patients with rare diseases and aggravate health inequities. There is no societal consensus on the population and economic thresholds, the drug effectiveness indicator(s), or the societal value to be placed for the approval and reimbursement of orphan drugs. Orphan drug development and marketing in the US concentrate in few therapeutic areas. Despite the increase in the number of FDA approved orphan drugs, the unmet needs of patients with rare diseases evidence that the current incentives are not efficiently stimulating orphan drug development. There is need to balance economic incentives to stimulate the development and marketing of orphan drugs without jeopardizing patients' access to treatment. Thus, aligning pharmaceutical companies' incentives with societal budgetary constraints is necessary and the ethical imperatives of timely access to orphan drugs need to be agreed upon.

  13. The Social Construction of "Evidence-Based" Drug Prevention Programs: A Reanalysis of Data from the Drug Abuse Resistance Education (DARE) Program

    ERIC Educational Resources Information Center

    Gorman, Dennis M.; Huber, J. Charles, Jr.

    2009-01-01

    This study explores the possibility that any drug prevention program might be considered "evidence-based" given the use of data analysis procedures that optimize the chance of producing statistically significant results by reanalyzing data from a Drug Abuse Resistance Education (DARE) program evaluation. The analysis produced a number of…

  14. 10 CFR 607.215 - What must I include in my drug-free awareness program?

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... awareness program to inform employees about— (a) The dangers of drug abuse in the workplace; (b) Your policy... assistance programs; and (d) The penalties that you may impose upon them for drug abuse violations occurring... 10 Energy 4 2010-01-01 2010-01-01 false What must I include in my drug-free awareness program? 607...

  15. 34 CFR 84.215 - What must I include in my drug-free awareness program?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... awareness program to inform employees about— (a) The dangers of drug abuse in the workplace; (b) Your policy... assistance programs; and (d) The penalties that you may impose upon them for drug abuse violations occurring... 34 Education 1 2011-07-01 2011-07-01 false What must I include in my drug-free awareness program...

  16. 34 CFR 84.215 - What must I include in my drug-free awareness program?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... awareness program to inform employees about— (a) The dangers of drug abuse in the workplace; (b) Your policy... assistance programs; and (d) The penalties that you may impose upon them for drug abuse violations occurring... 34 Education 1 2010-07-01 2010-07-01 false What must I include in my drug-free awareness program...

  17. 34 CFR 84.215 - What must I include in my drug-free awareness program?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... awareness program to inform employees about— (a) The dangers of drug abuse in the workplace; (b) Your policy... assistance programs; and (d) The penalties that you may impose upon them for drug abuse violations occurring... 34 Education 1 2014-07-01 2014-07-01 false What must I include in my drug-free awareness program...

  18. 34 CFR 84.215 - What must I include in my drug-free awareness program?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... awareness program to inform employees about— (a) The dangers of drug abuse in the workplace; (b) Your policy... assistance programs; and (d) The penalties that you may impose upon them for drug abuse violations occurring... 34 Education 1 2013-07-01 2013-07-01 false What must I include in my drug-free awareness program...

  19. 34 CFR 84.215 - What must I include in my drug-free awareness program?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... awareness program to inform employees about— (a) The dangers of drug abuse in the workplace; (b) Your policy... assistance programs; and (d) The penalties that you may impose upon them for drug abuse violations occurring... 34 Education 1 2012-07-01 2012-07-01 false What must I include in my drug-free awareness program...

  20. Evaluation of skill-based training program on rational drug treatment for medical interns

    PubMed Central

    Venkatesan, Murugan; Dongre, Amol R; Ganapathy, Kalaiselvan

    2017-01-01

    Context: A module-based training program for medical interns using World Health Organization guide for good prescription along with the individual feedback on their prescription was developed and implemented. Objective: The objective of the study was to obtain the medical interns’ reactions to newly developed skill-based training program on rational treatment. Study Setting: This study was conducted at the Department of Community Medicine. Participants: A total of 96 medical interns were included in the study. Study Design: A cross-sectional study consisting of retro-prefeedback and open-ended questions about self-assessment of perceived skill on rational treatment. Analysis: Collected data were entered in Epi Info (3.5.4) and analyzed. Results: After training, there was a significant increase in self-perceived posttest scores of setting up the therapeutic objective for the treatment (2.9–4.9), ability to select the correct drug (2.8–5.1), ability to select right dose, schedule, and duration of drugs (2.5–4.9). and overall prescription skill (2.9–4.9). There is a significant decrease in self-perceived scores in the skill of practicing polypharmacy (4.1–2.5). Conclusions: Overall, the training program was taken well and interns perceived their skill on rational treatment was improved as shown by the feedback. PMID:29564272

  1. PharMillenium '99--the second world pharmaceutical congress and exhibition. Accelerating the pipeline: from drug discovery to market. 1-3 February 1999, Washington DC, USA.

    PubMed

    Fernandes, M

    1999-04-01

    This highly interactive meeting effectively covered critical issues on every transaction from drug discovery through to development and commercialization. The program included company-specific descriptions of new discovery products, together with seminars by clinical research and site management organizations on the acceleration of development, pharmaco-economics, branding of products, direct-to-consumer advertising, global marketing, management, information technology and business strategy. There were approximately 50 sessions covered by 70 speakers.

  2. Distribution and licensing of drug discovery tools – NIH perspectives

    PubMed Central

    Kim, J. P.

    2009-01-01

    Now, more than ever, drug discovery conducted at industrial or academic facilities requires rapid access to state-of-the-art research tools. Unreasonable restrictions or delays in the distribution or use of such tools can stifle new discoveries, thus limiting the development of future biomedical products. In grants and its own research programs the National Institutes of Health (NIH) is implementing its new policy to facilitate the exchanges of these tools for research discoveries and product development. PMID:12546842

  3. 76 FR 3913 - National Institute on Drug Abuse; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-21

    ... evaluation of individual intramural programs and projects conducted by the National Institute on Drug Abuse... individual investigators. Place: Intramural Research Program, National Institute on Drug Abuse, NIH, Johns... Psychologist, Clinical Pharmacology Branch, Intramural Research Program, National Institute on Drug Abuse...

  4. Development of a novel drug release system, time-controlled explosion system (TES). I. Concept and design.

    PubMed

    Ueda, S; Hata, T; Asakura, S; Yamaguchi, H; Kotani, M; Ueda, Y

    1994-01-01

    A novel controlled drug release system. Time-Controlled Explosion System (TES) has been developed. TES has a four-layered spherical structure, which consists of core, drug, swelling agent and water insoluble polymer membrane. TES is characterized by a rapid drug release with a precisely programmed lag time; i.e. expansion of the swelling agent by water penetrating through the outer membrane, destruction of the membrane by stress due to swelling force and subsequent rapid drug release. For establishing the concept and development strategy, TES was designed using metoprolol and polystyrene balls (size: 3.2 mm in diameter) as a model drug and core particles. Among the polymers screened, low-substituted hydroxypropylcellulose (L-HPC) and ethylcellulose (EC) were selected for a swelling agent and an outer water insoluble membrane, respectively. The release profiles of metoprolol from the system were not affected by the pH of the dissolution media. Lag time was controlled by the thickness of the outer EC membrane; thus, a combination of TES particles possessing different lag times could offer any desired release profile of the model compound, metoprolol.

  5. Giving Drugs a Second Chance: Overcoming Regulatory and Financial Hurdles in Repurposing Approved Drugs As Cancer Therapeutics

    PubMed Central

    Hernandez, J. Javier; Pryszlak, Michael; Smith, Lindsay; Yanchus, Connor; Kurji, Naheed; Shahani, Vijay M.; Molinski, Steven V.

    2017-01-01

    The repositioning or “repurposing” of existing therapies for alternative disease indications is an attractive approach that can save significant investments of time and money during drug development. For cancer indications, the primary goal of repurposed therapies is on efficacy, with less restriction on safety due to the immediate need to treat this patient population. This report provides a high-level overview of how drug developers pursuing repurposed assets have previously navigated funding efforts, regulatory affairs, and intellectual property laws to commercialize these “new” medicines in oncology. This article provides insight into funding programs (e.g., government grants and philanthropic organizations) that academic and corporate initiatives can leverage to repurpose drugs for cancer. In addition, we highlight previous examples where secondary uses of existing, Food and Drug Administration- or European Medicines Agency-approved therapies have been predicted in silico and successfully validated in vitro and/or in vivo (i.e., animal models and human clinical trials) for certain oncology indications. Finally, we describe the strategies that the pharmaceutical industry has previously employed to navigate regulatory considerations and successfully commercialize their drug products. These factors must be carefully considered when repurposing existing drugs for cancer to best benefit patients and drug developers alike. PMID:29184849

  6. Giving Drugs a Second Chance: Overcoming Regulatory and Financial Hurdles in Repurposing Approved Drugs As Cancer Therapeutics.

    PubMed

    Hernandez, J Javier; Pryszlak, Michael; Smith, Lindsay; Yanchus, Connor; Kurji, Naheed; Shahani, Vijay M; Molinski, Steven V

    2017-01-01

    The repositioning or "repurposing" of existing therapies for alternative disease indications is an attractive approach that can save significant investments of time and money during drug development. For cancer indications, the primary goal of repurposed therapies is on efficacy, with less restriction on safety due to the immediate need to treat this patient population. This report provides a high-level overview of how drug developers pursuing repurposed assets have previously navigated funding efforts, regulatory affairs, and intellectual property laws to commercialize these "new" medicines in oncology. This article provides insight into funding programs (e.g., government grants and philanthropic organizations) that academic and corporate initiatives can leverage to repurpose drugs for cancer. In addition, we highlight previous examples where secondary uses of existing, Food and Drug Administration- or European Medicines Agency-approved therapies have been predicted in silico and successfully validated in vitro and/or in vivo (i.e., animal models and human clinical trials) for certain oncology indications. Finally, we describe the strategies that the pharmaceutical industry has previously employed to navigate regulatory considerations and successfully commercialize their drug products. These factors must be carefully considered when repurposing existing drugs for cancer to best benefit patients and drug developers alike.

  7. Drug discovery and development for rare genetic disorders.

    PubMed

    Sun, Wei; Zheng, Wei; Simeonov, Anton

    2017-09-01

    Approximately 7,000 rare diseases affect millions of individuals in the United States. Although rare diseases taken together have an enormous impact, there is a significant gap between basic research and clinical interventions. Opportunities now exist to accelerate drug development for the treatment of rare diseases. Disease foundations and research centers worldwide focus on better understanding rare disorders. Here, the state-of-the-art drug discovery strategies for small molecules and biological approaches for orphan diseases are reviewed. Rare diseases are usually genetic diseases; hence, employing pharmacogenetics to develop treatments and using whole genome sequencing to identify the etiologies for such diseases are appropriate strategies to exploit. Beginning with high throughput screening of small molecules, the benefits and challenges of target-based and phenotypic screens are discussed. Explanations and examples of drug repurposing are given; drug repurposing as an approach to quickly move programs to clinical trials is evaluated. Consideration is given to the category of biologics which include gene therapy, recombinant proteins, and autologous transplants. Disease models, including animal models and induced pluripotent stem cells (iPSCs) derived from patients, are surveyed. Finally, the role of biomarkers in drug discovery and development, as well as clinical trials, is elucidated. © 2017 Wiley Periodicals, Inc.

  8. Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review: Perspectives From Industry, the Food and Drug Administration, and the Patient.

    PubMed

    Basch, Ethan; Geoghegan, Cindy; Coons, Stephen Joel; Gnanasakthy, Ari; Slagle, Ashley F; Papadopoulos, Elektra J; Kluetz, Paul G

    2015-06-01

    Data reported directly by patients about how they feel and function are rarely included in oncology drug labeling in the United States, in contrast to Europe and to nononcology labeling in the United States, where this practice is more common. Multiple barriers exist, including challenges unique to oncology trials, and industry's concerns regarding cost, logistical complexities, and the Food and Drug Administration's (FDA's) rigorous application of its 2009 guidance on the use of patient-reported outcome (PRO) measures. A panel consisting of representatives of industry, FDA, the PRO Consortium, clinicians, and patients was assembled at a 2014 workshop cosponsored by FDA to identify practical recommendations for overcoming these barriers. Key recommendations included increasing proactive encouragement by FDA to clinical trial sponsors for including PROs in drug development programs; provision of comprehensive PRO plans by sponsors to FDA early in drug development; promotion of an oncology-specific PRO research agenda; development of an approach to existing ("legacy") PRO measures, when appropriate (focused initially on symptoms and functional status); and increased FDA and industry training in PRO methodology. FDA has begun implementing several of these recommendations.

  9. Free software to analyse the clinical relevance of drug interactions with antiretroviral agents (SIMARV®) in patients with HIV/AIDS.

    PubMed

    Giraldo, N A; Amariles, P; Monsalve, M; Faus, M J

    Highly active antiretroviral therapy has extended the expected lifespan of patients with HIV/AIDS. However, the therapeutic benefits of some drugs used simultaneously with highly active antiretroviral therapy may be adversely affected by drug interactions. The goal was to design and develop a free software to facilitate analysis, assessment, and clinical decision making according to the clinical relevance of drug interactions in patients with HIV/AIDS. A comprehensive Medline/PubMed database search of drug interactions was performed. Articles that recognized any drug interactions in HIV disease were selected. The publications accessed were limited to human studies in English or Spanish, with full texts retrieved. Drug interactions were analyzed, assessed, and grouped into four levels of clinical relevance according to gravity and probability. Software to systematize the information regarding drug interactions and their clinical relevance was designed and developed. Overall, 952 different references were retrieved and 446 selected; in addition, 67 articles were selected from the citation lists of identified articles. A total of 2119 pairs of drug interactions were identified; of this group, 2006 (94.7%) were drug-drug interactions, 1982 (93.5%) had an identified pharmacokinetic mechanism, and 1409 (66.5%) were mediated by enzyme inhibition. In terms of clinical relevance, 1285 (60.6%) drug interactions were clinically significant in patients with HIV (levels 1 and 2). With this information, a software program that facilitates identification and assessment of the clinical relevance of antiretroviral drug interactions (SIMARV ® ) was developed. A free software package with information on 2119 pairs of antiretroviral drug interactions was designed and developed that could facilitate analysis, assessment, and clinical decision making according to the clinical relevance of drug interactions in patients with HIV/AIDS. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. Developability assessment of clinical drug products with maximum absorbable doses.

    PubMed

    Ding, Xuan; Rose, John P; Van Gelder, Jan

    2012-05-10

    Maximum absorbable dose refers to the maximum amount of an orally administered drug that can be absorbed in the gastrointestinal tract. Maximum absorbable dose, or D(abs), has proved to be an important parameter for quantifying the absorption potential of drug candidates. The purpose of this work is to validate the use of D(abs) in a developability assessment context, and to establish appropriate protocol and interpretation criteria for this application. Three methods for calculating D(abs) were compared by assessing how well the methods predicted the absorption limit for a set of real clinical candidates. D(abs) was calculated for these clinical candidates by means of a simple equation and two computer simulation programs, GastroPlus and an program developed at Eli Lilly and Company. Results from single dose escalation studies in Phase I clinical trials were analyzed to identify the maximum absorbable doses for these compounds. Compared to the clinical results, the equation and both simulation programs provide conservative estimates of D(abs), but in general D(abs) from the computer simulations are more accurate, which may find obvious advantage for the simulations in developability assessment. Computer simulations also revealed the complex behavior associated with absorption saturation and suggested in most cases that the D(abs) limit is not likely to be achieved in a typical clinical dose range. On the basis of the validation findings, an approach is proposed for assessing absorption potential, and best practices are discussed for the use of D(abs) estimates to inform clinical formulation development strategies. Copyright © 2012 Elsevier B.V. All rights reserved.

  11. The National Training System: A Year of Transition. 1981-1982. Drug Program Report.

    ERIC Educational Resources Information Center

    Contee, Jerome, A., Ed.

    This report, the final publication of the Career Development Center (CDC), contains selected highlights of the transitional activities undertaken in 1981-82 by the CDC and the National Drug Abuse Center (NDAC). The theme of these activities has been "Capacity Building," defined as the ability of the states to continue and maintain the core of…

  12. Alcohol and Other Drug Use: The Connection to Youth Suicide. Abstracts of Selected Research.

    ERIC Educational Resources Information Center

    Laws, Kathy; Turner, Amy

    This publication provides the reader with an overview of the research done on the connection between the use of alcohol and other drugs and the ideation and/or completion of suicide among adolescents. It also provides information and resources on how to develop a youth suicide prevention program. The introduction gives a brief overview of the…

  13. Culturally Specific Youth Substance Abuse Resistance Skills: Applicability across the U.S.-Mexico Border

    ERIC Educational Resources Information Center

    Marsiglia, Flavio F.; Kulis, Stephen; Rodriguez, Gregorio Martinez; Becerra, David; Castillo, Jason

    2009-01-01

    This article reports on the prevalence and frequency of use of a set of drug-resistance strategies among a sample of Mexican adolescents. The keepin' it REAL (refuse, explain, avoid, and leave) strategies are part of a model drug-prevention intervention program originally developed by and for youth in the United States. The present study tests the…

  14. Developing and Using a Vocational Training and Education Resource Manual.

    ERIC Educational Resources Information Center

    Whittington, Marna C.

    In addition to eliminating illicit drug use, rehabilitation programs must help clients find both a meaningful way to spend the time that was formerly spent hustling money for drugs and a legitimate way to earn the money that was formerly provided by hustling. One solution to both these problems is to help ex-addicts make the transition to…

  15. The Doubles: A Case Study on Developing a Technology-Based Substance Abuse Education Curriculum

    ERIC Educational Resources Information Center

    Epstein, Joel; Collins, Karen Kadela; Pancella, Thom

    2004-01-01

    The Doubles, funded by the National Institute on Drug Abuse, is a seven-episode series of media tools designed to teach third and fourth grade students about the science of drug addiction. The program's curriculum is delivered via a set of videos, interactive CD-ROMs, workbooks, or an Internet site. This article examines the process used to…

  16. 38 CFR 52.180 - Administration of drugs.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2011-07-01 2011-07-01 false Administration of drugs... of drugs. The program management must assist with the management of medication and have a system for disseminating drug information to participants and program staff. (a) Procedures. (1) The program management...

  17. 38 CFR 52.180 - Administration of drugs.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2012-07-01 2012-07-01 false Administration of drugs... of drugs. The program management must assist with the management of medication and have a system for disseminating drug information to participants and program staff. (a) Procedures. (1) The program management...

  18. 38 CFR 52.180 - Administration of drugs.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2010-07-01 2010-07-01 false Administration of drugs... of drugs. The program management must assist with the management of medication and have a system for disseminating drug information to participants and program staff. (a) Procedures. (1) The program management...

  19. 38 CFR 52.180 - Administration of drugs.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2014-07-01 2014-07-01 false Administration of drugs... of drugs. The program management must assist with the management of medication and have a system for disseminating drug information to participants and program staff. (a) Procedures. (1) The program management...

  20. 38 CFR 52.180 - Administration of drugs.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 38 Pensions, Bonuses, and Veterans' Relief 2 2013-07-01 2013-07-01 false Administration of drugs... of drugs. The program management must assist with the management of medication and have a system for disseminating drug information to participants and program staff. (a) Procedures. (1) The program management...

  1. 76 FR 65517 - National Institute on Drug Abuse Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-21

    ... individual intramural programs and projects conducted by the National Institute on Drug Abuse, including.... Place: Intramural Research Program, National Institute on Drug Abuse, NIH, Johns Hopkins Bayview Campus..., Intramural Research Program, National Institute on Drug Abuse, NIH, DHHS, 251 Bayview Boulevard, Baltimore...

  2. 78 FR 55265 - National Institute on Drug Abuse; Notice of Closed Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-10

    ... individual intramural programs and projects conducted by the National Institute on Drug Abuse, including.... Place: Intramural Research Program, National Institute on Drug Abuse, NIH, Johns Hopkins Bayview Campus..., Intramural Research Program, National Institute on Drug Abuse, NIH, DHHS, 251 Bayview Boulevard, Baltimore...

  3. Detection and management of drug-resistant tuberculosis in HIV-infected patients in lower-income countries.

    PubMed

    Ballif, M; Nhandu, V; Wood, R; Dusingize, J C; Carter, E J; Cortes, C P; McGowan, C C; Diero, L; Graber, C; Renner, L; Hawerlander, D; Kiertiburanakul, S; Du, Q T; Sterling, T R; Egger, M; Fenner, L

    2014-11-01

    Drug resistance threatens tuberculosis (TB) control, particularly among human immunodeficiency virus (HIV) infected persons. To describe practices in the prevention and management of drug-resistant TB under antiretroviral therapy (ART) programs in lower-income countries. We used online questionnaires to collect program-level data on 47 ART programs in Southern Africa (n = 14), East Africa (n = 8), West Africa (n = 7), Central Africa (n = 5), Latin America (n = 7) and the Asia-Pacific (n = 6 programs) in 2012. Patient-level data were collected on 1002 adult TB patients seen at 40 of the participating ART programs. Phenotypic drug susceptibility testing (DST) was available in 36 (77%) ART programs, but was only used for 22% of all TB patients. Molecular DST was available in 33 (70%) programs and was used in 23% of all TB patients. Twenty ART programs (43%) provided directly observed therapy (DOT) during the entire course of treatment, 16 (34%) during the intensive phase only, and 11 (23%) did not follow DOT. Fourteen (30%) ART programs reported no access to second-line anti-tuberculosis regimens; 18 (38%) reported TB drug shortages. Capacity to diagnose and treat drug-resistant TB was limited across ART programs in lower-income countries. DOT was not always implemented and drug supplies were regularly interrupted, which may contribute to the global emergence of drug resistance.

  4. 21 CFR 1405.215 - What must I include in my drug-free awareness program?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... awareness program to inform employees about— (a) The dangers of drug abuse in the workplace; (b) Your policy... assistance programs; and (d) The penalties that you may impose upon them for drug abuse violations occurring... 21 Food and Drugs 9 2013-04-01 2013-04-01 false What must I include in my drug-free awareness...

  5. 21 CFR 1405.215 - What must I include in my drug-free awareness program?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... awareness program to inform employees about— (a) The dangers of drug abuse in the workplace; (b) Your policy... assistance programs; and (d) The penalties that you may impose upon them for drug abuse violations occurring... 21 Food and Drugs 9 2014-04-01 2014-04-01 false What must I include in my drug-free awareness...

  6. 21 CFR 1405.215 - What must I include in my drug-free awareness program?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... awareness program to inform employees about— (a) The dangers of drug abuse in the workplace; (b) Your policy... assistance programs; and (d) The penalties that you may impose upon them for drug abuse violations occurring... 21 Food and Drugs 9 2011-04-01 2011-04-01 false What must I include in my drug-free awareness...

  7. 21 CFR 1405.215 - What must I include in my drug-free awareness program?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... awareness program to inform employees about— (a) The dangers of drug abuse in the workplace; (b) Your policy... assistance programs; and (d) The penalties that you may impose upon them for drug abuse violations occurring... 21 Food and Drugs 9 2010-04-01 2010-04-01 false What must I include in my drug-free awareness...

  8. 21 CFR 1405.215 - What must I include in my drug-free awareness program?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... awareness program to inform employees about— (a) The dangers of drug abuse in the workplace; (b) Your policy... assistance programs; and (d) The penalties that you may impose upon them for drug abuse violations occurring... 21 Food and Drugs 9 2012-04-01 2012-04-01 false What must I include in my drug-free awareness...

  9. Drug Education Programs in Selected Indiana High Schools.

    ERIC Educational Resources Information Center

    Lippe, Emmett Wayne

    The purpose of this study was to gather and analyze data concerning the implementation of drug education programs in 14 selected Indiana senior high schools. It focused on several aspects of the drug education programs including the description of the type of program; the determination of need for the program; school policies related to student…

  10. Pharmaceuticals in Australia: priorities in a teaching hospital.

    PubMed

    Kearney, B J

    1993-01-01

    In spite of rigorous government programs for control of the pricing and dissemination of pharmaceutical products in Australia, the list of new drugs continues to grow and prices to increase. To regain control over drug usage at Royal Adelaide Hospital, the Hospital Drug Committee developed a rating method that judged drugs on the basis of their cost-benefit to patients. The ratio of a total quality score to a total cost score becomes the determinant of additions to the hospital formulary. The background for the Australian approach to pharmaceuticals and the new evaluation technique at the teaching hospital are described in this report.

  11. Commentary: Why Pharmaceutical Scientists in Early Drug Discovery Are Critical for Influencing the Design and Selection of Optimal Drug Candidates.

    PubMed

    Landis, Margaret S; Bhattachar, Shobha; Yazdanian, Mehran; Morrison, John

    2018-01-01

    This commentary reflects the collective view of pharmaceutical scientists from four different organizations with extensive experience in the field of drug discovery support. Herein, engaging discussion is presented on the current and future approaches for the selection of the most optimal and developable drug candidates. Over the past two decades, developability assessment programs have been implemented with the intention of improving physicochemical and metabolic properties. However, the complexity of both new drug targets and non-traditional drug candidates provides continuing challenges for developing formulations for optimal drug delivery. The need for more enabled technologies to deliver drug candidates has necessitated an even more active role for pharmaceutical scientists to influence many key molecular parameters during compound optimization and selection. This enhanced role begins at the early in vitro screening stages, where key learnings regarding the interplay of molecular structure and pharmaceutical property relationships can be derived. Performance of the drug candidates in formulations intended to support key in vivo studies provides important information on chemotype-formulation compatibility relationships. Structure modifications to support the selection of the solid form are also important to consider, and predictive in silico models are being rapidly developed in this area. Ultimately, the role of pharmaceutical scientists in drug discovery now extends beyond rapid solubility screening, early form assessment, and data delivery. This multidisciplinary role has evolved to include the practice of proactively taking part in the molecular design to better align solid form and formulation requirements to enhance developability potential.

  12. Molecular Modeling in Drug Design for the Development of Organophosphorus Antidotes/Prophylactics.

    DTIC Science & Technology

    1985-08-01

    10 1. INTERFACING OF PROGRAMS ......................... 10 2. PARAMETERIZATION OF ALLINGERS MM2 PROGRAM ....... 11 3. MUSCARINIC AGONISTS...CALCULATION OF PARTIAL CHARGES ..................... 45 10. DERIVATIONOF ELECTROSTATIC POTENTIAL CONTOURS... 53 CONCLUSIONS...60 APPENDIX A - MNDO CHARGE CALCULATIONS ..................... 62 6mwwm &&A-Q- 5.- FIGURES PAGE FIGURE 1 - CHOLINERGIC RECEPTOR MODEL OF KIER

  13. Measuring Social Innovation.

    ERIC Educational Resources Information Center

    Sviridoff, Mitchell

    In this report a program of supported work developed by the Employment and Training Administration of the Department of Labor and the Ford Foundation is discussed. Supported work is designed for the disadvantaged, people who face barriers in seeking and holding regular jobs. A pilot program for former drug addicts was begun in 1972 by the Vera…

  14. Missouri Curriculum Guide for Alcohol-Related Traffic Offenders' Program.

    ERIC Educational Resources Information Center

    Pierce, Don; McClain, Robert

    This document contains the second edition of the Alcohol or Drug Related Traffic Offenders' Program (ARTOP) curriculum guide developed by the Missouri Department of Mental Health to reduce alcohol-related traffic offenses by presenting factual information about the physical effects of alcohol on the body and on driving skills. The materials…

  15. The Federal Employees Health Benefits Program: A Model for Competition in Rural America?

    ERIC Educational Resources Information Center

    Mueller, Keith J.; McBride, Timothy D.; Andrews, Courtney; Fraser, Roslyn; Xu, Liyan

    2005-01-01

    The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) created the Medicare Advantage (MA) program, which promotes the entry of private Preferred Provider Organization (PPO) plans into regions that have not previously had Medicare managed care plans. The assumption that a competitive environment will develop is based on…

  16. Veterinary Oncologist | Center for Cancer Research

    Cancer.gov

    The NCI is implementing a program intended to connect and closely coordinate the Division of Cancer Treatment and Diagnosis’ (DCTD’s) immunotherapeutics and other drug development activities with the translational oriented clinical trials of the Center for Cancer Research’s (CCR’s) Comparative Oncology Program (COP), especially the treatment of dogs with natural occurring

  17. Pharmaceutical Biotechnology: A New Graduate Course at the University of Florida College of Pharmacy.

    ERIC Educational Resources Information Center

    Schreier, Hans; And Others

    1990-01-01

    The University of Florida's efforts to include aspects of genetically engineered drugs into undergraduate teaching and develop a graduate program focusing on the pharmaceutical aspects of technology are outlined, including constituent contributions, attendance, and evaluation. The program's current status and plans for a lab course are discussed.…

  18. Construction of an Integrated Positive Youth Development Conceptual Framework for the Prevention of the Use of Psychotropic Drugs among Adolescents

    PubMed Central

    Lee, Tak Yan

    2011-01-01

    This is a theoretical paper with an aim to construct an integrated conceptual framework for the prevention of adolescents' use and abuse of psychotropic drugs. This paper first reports the subjective reasons for adolescents' drug use and abuse in Hong Kong and reviews the theoretical underpinnings. Theories of drug use and abuse, including neurological, pharmacological, genetic predisposition, psychological, and sociological theories, were reviewed. It provides a critical re-examination of crucial factors that support the construction of a conceptual framework for primary prevention of adolescents' drug use and abuse building on, with minor revision, the model of victimization and substance abuse among women presented by Logan et al. This revised model provides a comprehensive and coherent framework synthesized from theories of drug abuse. This paper then provides empirical support for integrating a positive youth development perspective in the revised model. It further explains how the 15 empirically sound constructs identified by Catalano et al. and used in a positive youth development program, the Project P.A.T.H.S., relate generally to the components of the revised model to formulate an integrated positive youth development conceptual framework for primary prevention of adolescent drug use. Theoretical and practical implications as well as limitations and recommendations are discussed. PMID:22194671

  19. 28 CFR 550.51 - Drug abuse education course.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Drug abuse education course. 550.51... DRUG PROGRAMS Drug Abuse Treatment Program § 550.51 Drug abuse education course. (a) Purpose of the drug abuse education course. All institutions provide a drug abuse education course to: (1) Inform...

  20. 28 CFR 550.51 - Drug abuse education course.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Drug abuse education course. 550.51... DRUG PROGRAMS Drug Abuse Treatment Program § 550.51 Drug abuse education course. (a) Purpose of the drug abuse education course. All institutions provide a drug abuse education course to: (1) Inform...

  1. 28 CFR 550.51 - Drug abuse education course.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Drug abuse education course. 550.51... DRUG PROGRAMS Drug Abuse Treatment Program § 550.51 Drug abuse education course. (a) Purpose of the drug abuse education course. All institutions provide a drug abuse education course to: (1) Inform...

  2. 28 CFR 550.51 - Drug abuse education course.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Drug abuse education course. 550.51... DRUG PROGRAMS Drug Abuse Treatment Program § 550.51 Drug abuse education course. (a) Purpose of the drug abuse education course. All institutions provide a drug abuse education course to: (1) Inform...

  3. 28 CFR 550.51 - Drug abuse education course.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Drug abuse education course. 550.51... DRUG PROGRAMS Drug Abuse Treatment Program § 550.51 Drug abuse education course. (a) Purpose of the drug abuse education course. All institutions provide a drug abuse education course to: (1) Inform...

  4. The UIC ICBG (University of Illinois at Chicago International Cooperative Biodiversity Group) Memorandum of Agreement: a model of benefit-sharing arrangement in natural products drug discovery and development.

    PubMed

    Soejarto, D D; Gyllenhaal, C; Fong, H H S; Xuan, L T; Hiep, N T; Hung, N V; Bich, T Q; Southavong, B; Sydara, K; Pezzuto, J M

    2004-02-01

    The Convention on Biodiversity mandates a new approach to the discovery of natural product drugs, one that incorporates concepts of national ownership of genetic resources, intellectual property rights in traditional knowledge, and sharing of economic benefits with countries that are the source of new natural products. The International Cooperative Biodiversity Group (ICBG) program was established to support experimentation in implementation of the Convention through development and execution of international agreements for bioprospecting. The agreement of one such ICBG program, between the University of Illinois at Chicago and institutions in Vietnam and Laos, is presented here. The core elements contained in the single, five-way Memorandum of Agreement are the arrangements for intellectual property rights, treatment of informed consent, and plans for benefit-sharing (including the sharing of short- and long-term royalty benefits, capacity building, and community reciprocity). Program participants were able to develop a practical and flexible agreement that satisfies the wishes of all institutions that are parties to it.

  5. The development of a healing model of care for an Indigenous drug and alcohol residential rehabilitation service: a community-based participatory research approach.

    PubMed

    Munro, Alice; Shakeshaft, Anthony; Clifford, Anton

    2017-12-04

    Given the well-established evidence of disproportionately high rates of substance-related morbidity and mortality after release from incarceration for Indigenous Australians, access to comprehensive, effective and culturally safe residential rehabilitation treatment will likely assist in reducing recidivism to both prison and substance dependence for this population. In the absence of methodologically rigorous evidence, the delivery of Indigenous drug and alcohol residential rehabilitation services vary widely, and divergent views exist regarding the appropriateness and efficacy of different potential treatment components. One way to increase the methodological quality of evaluations of Indigenous residential rehabilitation services is to develop partnerships with researchers to better align models of care with the client's, and the community's, needs. An emerging research paradigm to guide the development of high quality evidence through a number of sequential steps that equitably involves services, stakeholders and researchers is community-based participatory research (CBPR). The purpose of this study is to articulate an Indigenous drug and alcohol residential rehabilitation service model of care, developed in collaboration between clients, service providers and researchers using a CBPR approach. This research adopted a mixed methods CBPR approach to triangulate collected data to inform the development of a model of care for a remote Indigenous drug and alcohol residential rehabilitation service. Four iterative CBPR steps of research activity were recorded during the 3-year research partnership. As a direct outcome of the CBPR framework, the service and researchers co-designed a Healing Model of Care that comprises six core treatment components, three core organisational components and is articulated in two program logics. The program logics were designed to specifically align each component and outcome with the mechanism of change for the client or organisation to improve data collection and program evaluation. The description of the CBPR process and the Healing Model of Care provides one possible solution about how to provide better care for the large and growing population of Indigenous people with substance.

  6. 77 FR 39194 - Combined Drug and Alcohol Testing Programs

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-02

    ...-0688; Notice No. 12-04] RIN 2120-AK01 Combined Drug and Alcohol Testing Programs AGENCY: Federal... tour operations to combine the drug and alcohol testing required for each operation into one testing... programs while maintaining the level of safety intended by the current drug and alcohol testing regulations...

  7. 14 CFR 120.105 - Employees who must be tested.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... (CONTINUED) AIR CARRIERS AND OPERATORS FOR COMPENSATION OR HIRE: CERTIFICATION AND OPERATIONS DRUG AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.105 Employees who must be tested. Each... an employer as defined in this subpart must be subject to drug testing under a drug testing program...

  8. 14 CFR 120.105 - Employees who must be tested.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... (CONTINUED) AIR CARRIERS AND OPERATORS FOR COMPENSATION OR HIRE: CERTIFICATION AND OPERATIONS DRUG AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.105 Employees who must be tested. Each... an employer as defined in this subpart must be subject to drug testing under a drug testing program...

  9. 75 FR 22809 - Mandatory Guidelines for Federal Workplace Drug Testing Programs

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Mandatory Guidelines for Federal Workplace Drug Testing... for Federal Workplace Drug Testing Programs (Mandatory Guidelines) from May 1, 2010, to October 1... drug testing programs as soon as possible that they will not be expected to implement the revisions to...

  10. 14 CFR 120.105 - Employees who must be tested.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... (CONTINUED) AIR CARRIERS AND OPERATORS FOR COMPENSATION OR HIRE: CERTIFICATION AND OPERATIONS DRUG AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.105 Employees who must be tested. Each... an employer as defined in this subpart must be subject to drug testing under a drug testing program...

  11. 14 CFR 120.105 - Employees who must be tested.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... (CONTINUED) AIR CARRIERS AND OPERATORS FOR COMPENSATION OR HIRE: CERTIFICATION AND OPERATIONS DRUG AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.105 Employees who must be tested. Each... an employer as defined in this subpart must be subject to drug testing under a drug testing program...

  12. 14 CFR 120.105 - Employees who must be tested.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... (CONTINUED) AIR CARRIERS AND OPERATORS FOR COMPENSATION OR HIRE: CERTIFICATION AND OPERATIONS DRUG AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.105 Employees who must be tested. Each... an employer as defined in this subpart must be subject to drug testing under a drug testing program...

  13. Prediction on the inhibition ratio of pyrrolidine derivatives on matrix metalloproteinase based on gene expression programming.

    PubMed

    Li, Yuqin; You, Guirong; Jia, Baoxiu; Si, Hongzong; Yao, Xiaojun

    2014-01-01

    Quantitative structure-activity relationships (QSAR) were developed to predict the inhibition ratio of pyrrolidine derivatives on matrix metalloproteinase via heuristic method (HM) and gene expression programming (GEP). The descriptors of 33 pyrrolidine derivatives were calculated by the software CODESSA, which can calculate quantum chemical, topological, geometrical, constitutional, and electrostatic descriptors. HM was also used for the preselection of 5 appropriate molecular descriptors. Linear and nonlinear QSAR models were developed based on the HM and GEP separately and two prediction models lead to a good correlation coefficient (R (2)) of 0.93 and 0.94. The two QSAR models are useful in predicting the inhibition ratio of pyrrolidine derivatives on matrix metalloproteinase during the discovery of new anticancer drugs and providing theory information for studying the new drugs.

  14. Social contexts of drug offers among American Indian youth and their relationship to substance use: an exploratory study.

    PubMed

    Kulis, Stephen; Okamoto, Scott K; Rayle, Andrea Dixon; Sen, Soma

    2006-01-01

    In this exploratory study the authors examined the social contexts of American Indian youths' encounters with drug offers and their relationship to substance use. Using an inventory of drug use-related problem situations developed specifically for American Indian youth, questionnaires were completed by 71 American Indian youth at public middle schools in a Southwest metropolitan area. Regression analyses highlight the importance of situational and relational contexts in understanding substance use among the youth in this sample. Exposure to drug offers through parents, other adults, cousins, friends and other peers was associated with different types of substance use. Exposure through parents was particularly salient in predicting the drug use of female respondents. The study underscores the need for development of culturally grounded prevention programs in schools, reservations, and nonreservation communities. Copyright (c) 2006 APA, all rights reserved.

  15. Pharmacy Education in Vietnam

    PubMed Central

    Bedouch, Pierrick; Nguyen, Thi-Hoai; Nguyen, Thi-Lien-Huong; Hoang, Thi-Kim-Huyen; Calop, Jean; Allenet, Benoît

    2013-01-01

    Pharmacy education programs in Vietnam are complex and offer various career pathways. All include theory and laboratory modules in general, foundation, and pharmaceutical knowledge; placements in health facilities; and a final examination. The various pharmacy degree programs allow specialization in 1 or more of 5 main fields: (1) drug management and supply, (2) drug development and production, (3) pharmacology and clinical pharmacy, (4) traditional medicine and pharmacognosy, and (5) drug quality control, which are offered as main specialization options during the reformed undergraduate and postgraduate programs. However, pharmacy education in Vietnam in general remains product oriented and clinical pharmacy training has not received adequate attention. Only students who have obtained the bachelor of pharmacy degree, which requires a minimum of 5 years of study, are considered as fully qualified pharmacists. In contrast, an elementary diploma in pharmacy awarded after 1 year of pharmacy study permits entry into more junior pharmacy positions. Since the 2000s, there has been a surge in the number and types of schools offering pharmacy qualifications at various levels. PMID:23966717

  16. Using Positive Youth Development Constructs to Design a Drug Education Curriculum for Junior Secondary Students in Hong Kong

    PubMed Central

    Lam, Ching Man; Lau, Patrick S. Y.; Law, Ben M. F.; Poon, Y. H.

    2011-01-01

    This paper outlines the design of a new curriculum for positive youth development (P.A.T.H.S. II) in Hong Kong. The paper discusses the conceptual base for designing a drug-education curriculum for junior-secondary students using four positive youth development constructs—cognitive competence, emotional competence, beliefs in the future, and self-efficacy. The program design is premised on the belief that adolescents do have developmental assets; therefore, the curriculum is designed to develop their psychosocial competencies. The goal of the curriculum is to develop the selfhood of these youths and ultimately achieve the goal of successful adolescent development. PMID:22194667

  17. A Critical Analysis of the Brazilian Response to HIV/AIDS: Lessons Learned for Controlling and Mitigating the Epidemic in Developing Countries

    PubMed Central

    Berkman, Alan; Garcia, Jonathan; Muñoz-Laboy, Miguel; Paiva, Vera; Parker, Richard

    2005-01-01

    The Brazilian National AIDS Program is widely recognized as the leading example of an integrated HIV/AIDS prevention, care, and treatment program in a developing country. We critically analyze the Brazilian experience, distinguishing those elements that are unique to Brazil from the programmatic and policy decisions that can aid the development of similar programs in other low- and middle-income and developing countries. Among the critical issues that are discussed are human rights and solidarity, the interface of politics and public health, sexuality and culture, the integration of prevention and treatment, the transition from an epidemic rooted among men who have sex with men to one that increasingly affects women, and special prevention and treatment programs for injection drug users. PMID:15933232

  18. Evaluation of drug interaction microcomputer software: comparative study.

    PubMed

    Poirier, T I; Giudici, R

    1991-01-01

    Twelve drug interaction microcomputer software programs were evaluated and compared using general and specific criteria. This article summarizes and compares the features, ratings, advantages, and disadvantages of each program. Features of an ideal drug interaction program are noted. Recommended programs based on three price ranges are suggested.

  19. Collaborative Development of 2-Hydroxypropyl-β-Cyclodextrin for the Treatment of Niemann-Pick Type C1 Disease

    PubMed Central

    Ottinger, Elizabeth A.; Kao, Mark L.; Carrillo-Carrasco, Nuria; Yanjanin, Nicole; Shankar, Roopa Kanakatti; Janssen, Marjo; Brewster, Marcus; Scott, Ilona; Xu, Xin; Cradock, Jim; Terse, Pramod; Dehdashti, Seameen; Marugan, Juan; Zheng, Wei; Portilla, Lili; Hubbs, Alan; Pavan, William J.; Heiss, John; Vite, Charles H.; Walkley, Steven U.; Ory, Daniel S.; Silber, Steven A.; Porter, Forbes D.; Austin, Christopher P.; McKew, John C.

    2014-01-01

    In 2010, the National Institutes of Health (NIH) established the Therapeutics for Rare and Neglected Diseases (TRND) program within the National Center for Advancing Translational Science (NCATS), which was created to stimulate drug discovery and development for rare and neglected tropical diseases through a collaborative model between the NIH, academic scientists, nonprofit organizations, and pharmaceutical and biotechnology companies. This paper describes one of the first TRND programs, the development of 2-hydroxypropyl-β-cyclodextrin (HP-β-CD) for the treatment of Niemann-Pick disease type C1 (NPC1). NPC is a neurodegenerative, autosomal recessive rare disease caused by a mutation in either the NPC1 (about 95% of cases) or the NPC2 gene (about 5% of cases). These mutations affect the intracellular trafficking of cholesterol and other lipids, which leads to a progressive accumulation of unesterified cholesterol and glycosphingolipids in the CNS and visceral organs. Affected individuals typically exhibit ataxia, swallowing problems, seizures, and progressive impairment of motor and intellectual function in early childhood, and usually die in adolescence. There is no disease modifying therapy currently approved for NPC1 in the US. A collaborative drug development program has been established between TRND, public and private partners that has completed the pre-clinical development of HP-β-CD through IND filing for the current Phase I clinical trial that is underway. Here we discuss how this collaborative effort helped to overcome scientific, clinical and financial challenges facing the development of new drug treatments for rare and neglected diseases, and how it will incentivize the commercialization of HP-β-CD for the benefit of the NPC patient community. PMID:24283970

  20. Methamphetamine

    MedlinePlus

    ... OPERATIONS Diversion Control Programs Most Wanted Fugitives Training Intelligence Submit a Tip DRUG INFO Drug Fact Sheets ... Operations Diversion Control Programs Most Wanted Fugitives Training Intelligence Submit a Tip Drug Info Drug Fact Sheets ...

  1. Narcotics

    MedlinePlus

    ... OPERATIONS Diversion Control Programs Most Wanted Fugitives Training Intelligence Submit a Tip DRUG INFO Drug Fact Sheets ... Operations Diversion Control Programs Most Wanted Fugitives Training Intelligence Submit a Tip Drug Info Drug Fact Sheets ...

  2. Hydrocodone

    MedlinePlus

    ... OPERATIONS Diversion Control Programs Most Wanted Fugitives Training Intelligence Submit a Tip DRUG INFO Drug Fact Sheets ... Operations Diversion Control Programs Most Wanted Fugitives Training Intelligence Submit a Tip Drug Info Drug Fact Sheets ...

  3. Heroin Photos

    MedlinePlus

    ... OPERATIONS Diversion Control Programs Most Wanted Fugitives Training Intelligence Submit a Tip DRUG INFO Drug Fact Sheets ... Operations Diversion Control Programs Most Wanted Fugitives Training Intelligence Submit a Tip Drug Info Drug Fact Sheets ...

  4. 78 FR 39190 - Revisions to Fitness for Duty Programs' Drug Testing Requirements

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-01

    ...-0225] RIN 3150-AI67 Revisions to Fitness for Duty Programs' Drug Testing Requirements AGENCY: Nuclear... regarding drug testing requirements in NRC licensees' fitness for duty programs. The regulatory basis...

  5. 28 CFR 550.52 - Non-residential drug abuse treatment services.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Non-residential drug abuse treatment... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.52 Non-residential drug abuse treatment services. All institutions must have non-residential drug abuse treatment services, provided...

  6. 28 CFR 550.52 - Non-residential drug abuse treatment services.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Non-residential drug abuse treatment... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.52 Non-residential drug abuse treatment services. All institutions must have non-residential drug abuse treatment services, provided...

  7. 28 CFR 550.52 - Non-residential drug abuse treatment services.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Non-residential drug abuse treatment... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.52 Non-residential drug abuse treatment services. All institutions must have non-residential drug abuse treatment services, provided...

  8. 28 CFR 550.52 - Non-residential drug abuse treatment services.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Non-residential drug abuse treatment... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.52 Non-residential drug abuse treatment services. All institutions must have non-residential drug abuse treatment services, provided...

  9. 28 CFR 550.52 - Non-residential drug abuse treatment services.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Non-residential drug abuse treatment... INSTITUTIONAL MANAGEMENT DRUG PROGRAMS Drug Abuse Treatment Program § 550.52 Non-residential drug abuse treatment services. All institutions must have non-residential drug abuse treatment services, provided...

  10. Controlling the Cost of Drugs: the Canadian Experience

    PubMed Central

    Fulda, Thomas K.; Dickens, Paul F.

    1979-01-01

    In 1969 Canada began programs at both the national and provincial levels to lower prescription drug prices. These programs may have contributed to a significant decline between 1970 and 1974 of 39 percent in the average price of 16 drugs selected for study. During this time, the average price for the same drugs in the United States declined only 1.4 percent. One major program, a change in the compulsory patent licensing, is described and analyzed. Other Canadian programs, designed to promote competition in the drug industry, and their effects are discussed. PMID:10309114

  11. 75 FR 32858 - Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-10

    ... Medicare Advantage and the Medicare Prescription Drug Benefit Programs; Corrections AGENCY: Centers for... Advantage and the Medicare Prescription Drug Benefit Programs'' which appeared in the April 15, 2010 Federal... and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs...

  12. USING PHOTOVOICE WITH YOUTH TO DEVELOP A DRUG PREVENTION PROGRAM IN A RURAL HAWAIIAN COMMUNITY

    PubMed Central

    Helm, Susana; Lee, Wayde; Hanakahi, Vanda; Gleason, Krissy; McCarthy, Kayne

    2015-01-01

    Introduction Substance use represents a significant and persistent health disparity among Native Hawaiian youth and communities. A community-university participatory action research project was conducted to develop a Native Hawaiian model of drug prevention. Methods Ten youth participated in eight Photovoice focus groups. Focus group transcripts and the youths’ SHOWED (see, happening, our, why, empower, do) worksheets were analyzed. Results Emergent analyses are described regarding focus group theme identification and the meaning of each theme. Youth-selected exemplary photographs and researcher-selected exemplary quotations are provided. Implications Native Hawaiian drug prevention will be place-based in culturally significant community locations, experiential, and guided by multigenerational teaching and learning. PMID:25768388

  13. Development of Applications about Hazards and Preventions of Drug Based On Android

    NASA Astrophysics Data System (ADS)

    Hartatik; Febriyanto, F.; Munawaroh, H.

    2018-03-01

    The number of drug abuse was increase among the younger generation, it caused younger generation fall into drug abuse, and it will lead to physical and mental damage. The lack of knowledge of drugs danger is one of the most potential problems, so in this study we made an application about the types, dangers, and how to avoid its abusement. The application built using PHP programming language with codeiniter framework on admin part, while the parsing data between mobile application server using Javascript Object Notation (JSON). This application has been tested and 85% respondents stated that this application provides positive benefits especially for the socialization of drug abuse.

  14. National addictions vigilance intervention and prevention program (NAVIPPRO): a real-time, product-specific, public health surveillance system for monitoring prescription drug abuse.

    PubMed

    Butler, Stephen F; Budman, Simon H; Licari, Andrea; Cassidy, Theresa A; Lioy, Katherine; Dickinson, James; Brownstein, John S; Benneyan, James C; Green, Traci Craig; Katz, Nathaniel

    2008-12-01

    The National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO) is a scientific, comprehensive risk management program for scheduled therapeutics. NAVIPPRO provides post-marketing surveillance, signal detection, signal verification and prevention and intervention programs. Here we focus on one component of NAVIPPRO surveillance, the Addiction Severity Index-Multimedia Version (ASI-MV) Connect, a continuous, real-time, national data stream that assesses pharmaceutical abuse by patients entering substance abuse treatment by collecting product-specific, geographically-detailed information. We evaluate population characteristics for data collected through the ASI-MV Connect in 2007 and 2008 and assess the representativeness, geographic coverage, and timeliness of report of the data. Analyses based on 41,923 admissions to 265 treatment centers in 29 states were conducted on product-specific opioid abuse rates, source of drug, and route of administration. ASI-MV Connect data revealed that 11.5% of patients reported abuse of at least one opioid analgesic product in the 30 days prior to entering substance abuse treatment; differences were observed among sub-populations of prescription opioid abusers, among products, and also within various geographic locations. The ASI-MV Connect component of NAVIPPRO represents a potentially valuable data stream for post-marketing surveillance of prescription drugs. Analyses conducted with data obtained from the ASI-MV Connect allow for the characterization of product-specific and geospatial differences for drug abuse and can serve as a tool to monitor responses of the abuse population to newly developed "abuse deterrent" drug formulations. Additional data, evaluation, and comparison to other systems are important next steps in establishing NAVIPPRO as a comprehensive, post-marketing surveillance system for prescription drugs. Copyright (c) 2008 John Wiley & Sons, Ltd.

  15. Catalyst, 2000-01.

    ERIC Educational Resources Information Center

    Ryan, Barbara E., Ed.

    2001-01-01

    "Catalyst" is a publication designed to assist higher education in developing alcohol and other drug prevention polices and programs that will foster students' academic and social development and promote campus and community safety. Issue 1 of volume 6 introduces a series of "Presidential Profiles" in which university presidents describe their…

  16. United States Food and Drug Administration and Department of Defense shelf-life extension program of pharmaceutical products: progress and promise.

    PubMed

    Khan, Saeed R; Kona, Ravikanth; Faustino, Patrick J; Gupta, Abhay; Taylor, Jeb S; Porter, Donna A; Khan, Mansoor

    2014-05-01

    The Department of Defense (DoD)-United States Food and Drug Administration (FDA) shelf-life extension program (SLEP) was established in 1986 through an intra-agency agreement between the DoD and the FDA to extend the shelf life of product nearing expiry. During the early stages of development, special attention was paid to program operation, labeling requirements, and the cost benefits associated with this program. In addition to the substantial cost benefits, the program also provides the FDA's Center for Drug Evaluation and Research with significant scientific understanding and pharmaceutical resource. As a result of this unique resource, numerous regulatory research opportunities to improve public health present themselves from this distinctive scientific database, which includes examples of products shelf life, their long-term stability issues, and various physical and chemical tests to identify such failures. The database also serves as a scientific resource for mechanistic understanding and identification of test failures leading to the development of new formulations or more robust packaging. It has been recognized that SLEP is very important in maintaining both national security and public welfare by confirming that the stockpiled pharmaceutical products meet quality standards after the "expiration date" assigned by the sponsor. SLEP research is an example of regulatory science that is needed to best ensure product performance past the original shelf life. The objective of this article is to provide a brief history and background and most importantly the public health benefits of the SLEP. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

  17. Can health systems be enhanced for optimal health services through disease-specific programs? Results of field studies in Viet Nam and Cambodia.

    PubMed

    Egami, Y; Fujita, N; Akashi, H; Matsumoto, Y; Ohara, H; Takeuchi, M

    2012-02-01

    Developing better health systems is the key to delivering optimal health services, although more evidence of effective strategies to do so is needed. Field surveys were conducted in Viet Nam and Cambodia to identify best practices in addressing health system bottlenecks to scale up disease control programs. The two countries were compared over time using a framework for analysis developed by the authors. In Viet Nam, a health system was in place for decades at the central to municipal levels, although it was fragile until the 1990s, when the government started taking measures. In Cambodia, the previous health system had been destroyed during previous internal conflict. In the post-conflict period, the health system was rebuilt with support for programs followed by centralization of health services. In different settings, different measures were taken to deal with similar bottlenecks. In Cambodia, vertical programs were dominant, so the government sought to centralize drug management to deal with shortages of essential drugs, while Viet Nam sought to mobilize resources to ensure drug distribution at all levels. This study shows there is no single successful approach to health systems, and a systemic approach needs to be taken because elimination of one bottleneck may reveal another. Efforts to enhance disease-specific programs may not always contribute to overall enhancement of the health system, and the best possible approach may not be the same in different countries. Further study is needed to explore common issues and principles for effective strategies to enhance health systems in different contexts.

  18. Stockpiling anti-viral drugs for a pandemic: the role of Manufacturer Reserve Programs.

    PubMed

    Harrington, Joseph E; Hsu, Edbert B

    2010-05-01

    To promote stockpiling of anti-viral drugs by non-government organizations such as hospitals, drug manufacturers have introduced Manufacturer Reserve Programs which, for an annual fee, provide the right to buy in the event of a severe outbreak of influenza. We show that these programs enhance drug manufacturer profits but could either increase or decrease the amount of pre-pandemic stockpiling of anti-viral drugs.

  19. Developing new products in cystic fibrosis: needs and obstacles for activities of small and middle-sized companies.

    PubMed

    Schlangen, Miriam; Reimann, Andreas L G

    2011-06-01

    Small and middle-sized enterprises (SMEs) can make important contributions to medical progress through the development of new safe and effective drugs that address the greatest unmet needs of patients. Regulatory inconsistencies across agencies in various countries, however, remain major challenges in cystic fibrosis (CF) drug development. Clear and consistent treatment guidelines, well educated clinical trial sites, a patient registry and grant funding for early development programs are important success-factors for an efficient development process. SMEs developing products for CF need partners in the CF community to assist with disease education and awareness for ongoing clinical trials. SMEs should collaborate and communicate with the CF community in a legally compliant way to take a patient-centric approach to drug design, development and administration. Furthermore, they can help to develop educational tools and fund medical education activities to increase the understanding of the underlying defects and mechanisms of CF disease. Copyright © 2011 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

  20. Development and validation of a streamlined method designed to detech residues of 62 veterinary drugs in bovine kidney using ultrahigh performance liquid chromatography - tandem mass spectrometry

    USDA-ARS?s Scientific Manuscript database

    In the USA, the US Department of Agriculture’s Food Safety Inspection Service (FSIS) conducts the National Residue Program designed to monitor veterinary drug and other chemical residues in beef and other slaughtered food animals. Currently, FSIS uses a 7-plate bioassay in the laboratory to screen f...

  1. An evaluation framework for funding drugs for rare diseases.

    PubMed

    Winquist, Eric; Bell, Chaim M; Clarke, Joe T R; Evans, Gerald; Martin, Janet; Sabharwal, Mona; Gadhok, Anita; Stevenson, Helen; Coyle, Doug

    2012-01-01

    For rare diseases it may be difficult to generate data from randomized trials to support funding of a drug. Enzyme replacement therapies for diseases of inherited metabolic enzyme deficiency provide an example of this dilemma. The Ontario Public Drug Programs convened the Drugs for Rare Diseases Working Group to develop a policy for assessing these drugs. The Drugs for Rare Diseases Working Group developed terms of reference expecting that the ideal policy product would be transparent and consistent and address unique aspects of the treatment of a specific rare condition while being adaptable to other dissimilar conditions. The perspective was that of a public payer addressing requests for funding generated for a specific drug, and included respect for the principles of "accountability for reasonableness" of Daniels and Sabin. A seven-step framework was developed and tested by using the case study of idursulfase for mucopolysaccharidosis II (Hunter disease). Estimation of clinical effectiveness was done by using decision modeling. The model developed informed funding recommendations and ultimately led to an agreement with the manufacturer allowing funding of idursulfase in Ontario. This policy framework attempts to address the policy challenges of funding drugs for rare diseases. The framework will be used to assess other drugs in future and will inevitably require modification with experience. It is hoped that it may be of value to other policymakers. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  2. Public-private partnerships as driving forces in the quest for innovative medicines

    PubMed Central

    2013-01-01

    Background Despite progress in translational research, we are still falling short in developing the innovative medicines required to address major public health needs. Furthermore, the failure rate, time, and cost required for registration of a new drug are pushing the economics of the industry to the breaking point. New models of drug development based on collaborative endeavours are badly needed to improve this dire situation. Findings In 2004, the US Food and Drug Administration (FDA) introduced the Critical Path Initiative with the intent of modernizing drug development by implementing public-private partnerships (PPP) to share data, expertise, and resources. In response to FDA’s initiative, in the following year the non-profit Critical Path Institute (C-Path) was formed. At the same time, the National Institutes of Health (NIH) Public-Private Partnership program was established. In Europe, the Innovative Medicines Initiative (IMI) supported jointly by the European Union and the European Federation of Pharmaceutical Industries and Associations was launched in 2008. These independent efforts have a common long-term objective, namely to facilitate the emergence of innovative medicines by developing new tools for drug discovery, new indicators for drug efficacy or safety, and new approaches for patient stratification. Herein, we present evidence that PPP already exert a positive impact on the drug development process. Conclusions Public-private partnerships represent attractive means to leverage resources dispersed across industry, academia, and voluntary health organizations in order to address multiple challenges of drug development in an era of constrained resources and increased regulatory pressure. PMID:23369569

  3. Comparing errors in ED computer-assisted vs conventional pediatric drug dosing and administration.

    PubMed

    Yamamoto, Loren; Kanemori, Joan

    2010-06-01

    Compared to fixed-dose single-vial drug administration in adults, pediatric drug dosing and administration requires a series of calculations, all of which are potentially error prone. The purpose of this study is to compare error rates and task completion times for common pediatric medication scenarios using computer program assistance vs conventional methods. Two versions of a 4-part paper-based test were developed. Each part consisted of a set of medication administration and/or dosing tasks. Emergency department and pediatric intensive care unit nurse volunteers completed these tasks using both methods (sequence assigned to start with a conventional or a computer-assisted approach). Completion times, errors, and the reason for the error were recorded. Thirty-eight nurses completed the study. Summing the completion of all 4 parts, the mean conventional total time was 1243 seconds vs the mean computer program total time of 879 seconds (P < .001). The conventional manual method had a mean of 1.8 errors vs the computer program with a mean of 0.7 errors (P < .001). Of the 97 total errors, 36 were due to misreading the drug concentration on the label, 34 were due to calculation errors, and 8 were due to misplaced decimals. Of the 36 label interpretation errors, 18 (50%) occurred with digoxin or insulin. Computerized assistance reduced errors and the time required for drug administration calculations. A pattern of errors emerged, noting that reading/interpreting certain drug labels were more error prone. Optimizing the layout of drug labels could reduce the error rate for error-prone labels. Copyright (c) 2010 Elsevier Inc. All rights reserved.

  4. Exploring the Impact of a Wilderness-Based Positive Youth Development Program for Urban Youth

    ERIC Educational Resources Information Center

    Norton, Christine Lynn; Watt, Toni Terling

    2014-01-01

    Young people today face a multitude of challenges, especially when growing up in an urban environment. Risk factors such as poverty, exposure to gangs, drugs, and community and family violence threaten healthy development. The positive youth development (PYD) approach attempts to combat these personal and environmental challenges by providing…

  5. Methamphetamine Lab Incidents, 2004-2014

    MedlinePlus

    ... OPERATIONS Diversion Control Programs Most Wanted Fugitives Training Intelligence Submit a Tip DRUG INFO Drug Fact Sheets ... Operations Diversion Control Programs Most Wanted Fugitives Training Intelligence Submit a Tip Drug Info Drug Fact Sheets ...

  6. A computer program for calculation of doses and prices of injectable medications based on body weight or body surface area

    PubMed Central

    2004-01-01

    Abstract A computer program (CalcAnesth) was developed with Visual Basic for the purpose of calculating the doses and prices of injectable medications on the basis of body weight or body surface area. The drug names, concentrations, and prices are loaded from a drug database. This database is a simple text file, that the user can easily create or modify. The animal names and body weights can be loaded from a similar database. After typing the dose and the units into the user interface, the results will be automatically displayed. The program is able to open and save anesthetic protocols, and export or print the results. This CalcAnesth program can be useful in clinical veterinary anesthesiology and research. The rationale for dosing on the basis of body surface area is also discussed in this article. PMID:14979437

  7. Applying Computer Technology to Substance Abuse Prevention Science Results of a Preliminary Examination

    ERIC Educational Resources Information Center

    Marsch, Lisa A.; Bickel, Warren K.; Badger, Gary J.

    2007-01-01

    This manuscript reports on the development and evaluation of a computer-based substance abuse prevention program for middle school-aged adolescents, called "HeadOn: Substance Abuse Prevention for Grades 6-8TM". This self-guided program was designed to deliver effective drug abuse prevention science to youth via computer-based educational…

  8. Working with Youth in High-Risk Environments: Experiences in Prevention. OSAP Prevention Monograph-12.

    ERIC Educational Resources Information Center

    Marcus, Carol E., Ed.; Swisher, John D., Ed.

    This report focuses on prevention programs developed with support from the Office for Substance Abuse Prevention's (OSAP) High-Risk Youth Demonstration Grant Program. Included are an Introduction (Eric Goplerud and others) and the following reports: (1) "Athletes Coaching Teens for Substance Abuse Prevention: Alcohol and Other Drug Use and Risk…

  9. Pennsylvania SBIRT Medical and Residency Training: Developing, Implementing, and Evaluating an Evidenced-Based Program

    ERIC Educational Resources Information Center

    Pringle, Janice L.; Melczak, Michael; Johnjulio, William; Campopiano, Melinda; Gordon, Adam J.; Costlow, Monica

    2012-01-01

    Medical residents do not receive adequate training in screening, brief intervention, and referral to treatment (SBIRT) for alcohol and other drug use disorders. The federally funded Pennsylvania SBIRT Medical and Residency Training program (SMaRT) is an evidence-based curriculum with goals of training residents in SBIRT knowledge and skills and…

  10. Implementation of the Communities That Care Prevention System by Coalitions in the Community Youth Development Study

    ERIC Educational Resources Information Center

    Arthur, Michael W.; Hawkins, J. David; Brown, Eric C.; Briney, John S.; Oesterle, Sabrina; Abbott, Robert D.

    2010-01-01

    Although advances in prevention science over the past two decades have produced a growing list of tested and effective programs and policies for preventing adolescent delinquency and drug use, widespread dissemination and high-quality implementation of effective programs and policies in communities has not been achieved. The Community Youth…

  11. 14 CFR 120.113 - Medical Review Officer, Substance Abuse Professional, and Employer Responsibilities.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ...: CERTIFICATION AND OPERATIONS DRUG AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.113... provision of MRO services as part of its drug testing program. (b) Medical Review Officer (MRO). The MRO... working days after verifying a positive drug test result or refusal to submit to a test. (2) During the...

  12. 14 CFR 120.113 - Medical Review Officer, Substance Abuse Professional, and Employer Responsibilities.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ...: CERTIFICATION AND OPERATIONS DRUG AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.113... provision of MRO services as part of its drug testing program. (b) Medical Review Officer (MRO). The MRO... working days after verifying a positive drug test result or refusal to submit to a test. (2) During the...

  13. 14 CFR 120.113 - Medical Review Officer, Substance Abuse Professional, and Employer Responsibilities.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ...: CERTIFICATION AND OPERATIONS DRUG AND ALCOHOL TESTING PROGRAM Drug Testing Program Requirements § 120.113... provision of MRO services as part of its drug testing program. (b) Medical Review Officer (MRO). The MRO... working days after verifying a positive drug test result or refusal to submit to a test. (2) During the...

  14. 28 CFR 83.215 - What must I include in my drug-free awareness program?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...-free awareness program to inform employees about— (a) The dangers of drug abuse in the workplace; (b..., and employee assistance programs; and (d) The penalties that you may impose upon them for drug abuse... 28 Judicial Administration 2 2012-07-01 2012-07-01 false What must I include in my drug-free...

  15. 28 CFR 83.215 - What must I include in my drug-free awareness program?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...-free awareness program to inform employees about— (a) The dangers of drug abuse in the workplace; (b..., and employee assistance programs; and (d) The penalties that you may impose upon them for drug abuse... 28 Judicial Administration 2 2011-07-01 2011-07-01 false What must I include in my drug-free...

  16. 28 CFR 83.215 - What must I include in my drug-free awareness program?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...-free awareness program to inform employees about— (a) The dangers of drug abuse in the workplace; (b..., and employee assistance programs; and (d) The penalties that you may impose upon them for drug abuse... 28 Judicial Administration 2 2014-07-01 2014-07-01 false What must I include in my drug-free...

  17. 28 CFR 83.215 - What must I include in my drug-free awareness program?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...-free awareness program to inform employees about— (a) The dangers of drug abuse in the workplace; (b..., and employee assistance programs; and (d) The penalties that you may impose upon them for drug abuse... 28 Judicial Administration 2 2013-07-01 2013-07-01 false What must I include in my drug-free...

  18. 28 CFR 83.215 - What must I include in my drug-free awareness program?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...-free awareness program to inform employees about— (a) The dangers of drug abuse in the workplace; (b..., and employee assistance programs; and (d) The penalties that you may impose upon them for drug abuse... 28 Judicial Administration 2 2010-07-01 2010-07-01 false What must I include in my drug-free...

  19. VSU Campus Alcohol and Drug Policies and Procedures. Revised 1990. Program Design and Questionnaire.

    ERIC Educational Resources Information Center

    Virginia State Univ., Petersburg.

    This document comprises the Virginia State University (VSU) Campus Alcohol and Drug Policies and Procedures booklet; a program design for a VSU drug education, treatment, and prevention program; and a drug and alcohol student survey. The booklet covering policies and procedures contains: a message from the president; a policy statement; a review…

  20. 78 FR 22552 - Agency Forms Undergoing Paperwork Reduction Act Review

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-16

    ... Evaluation Program (MPEP) for Mycobacterium tuberculosis and Nontuberculous Mycobacteria Drug Susceptibility... tuberculosis (TB), prevention of multi- drug resistance, and surveillance programs, CDC is requesting approval... Performance Evaluation Program for Mycobacterium tuberculosis and Non-tuberculous Mycobacterium Drug...

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