The role of globalization in drug development and access to orphan drugs: orphan drug legislation in the US/EU and in Latin America.

Science.gov (United States)

Arnold, Renée J G; Bighash, Lida; Bryón Nieto, Alejandro; Tannus Branco de Araújo, Gabriela; Gay-Molina, Juan Gabriel; Augustovski, Federico

2015-01-01

Compared to a decade ago, nearly three times as many drugs for rare diseases are slated for development. This article addresses the market access issues associated with orphan drug status in Europe and the United States in contrast to the legislation in five Latin American (LA) countries that have made strides in this regard--Mexico, Brazil, Colombia, Chile and Argentina. Based on the success of orphan drug legislation in the EU and US, LA countries should strive to adopt similar strategies with regard to rare diseases and drug development. With the implementation of new targeted regulations, reimbursement strategies, and drug approvals, accessibility to treatment will be improved for people afflicted with rare diseases in these developing countries.

Patents and access to drugs in developing countries: an ethical analysis.

Science.gov (United States)

Sterckx, Sigrid

2004-05-01

More than a third of the world's population has no access to essential drugs. More than half of this group of people live in the poorest regions of Africa and Asia. Several factors determine the accessibility of drugs in developing countries. Hardly any medicines for tropical diseases are being developed, but even existing drugs are often not available to the patients who need them. One of the important determinants of access to drugs is the working of the patent system. This paper first maps out some facts about the global patent regime that has emerged as a consequence of the conclusion of the WTO-TRIPs Agreement in 1994. Attempts to construct a moral justification of the patent system have been based on three grounds: natural rights, distributive justice, and utilitarian arguments. This paper examines to what extent and on which grounds drug patents can be justified. The final section looks at the so-called 'Doha Declaration on the TRIPs Agreement and Public Health', which was adopted by the WTO Ministerial Conference two years ago, recognising the primacy of public health over the interests of patent proprietors.

Drug repurposing in pharmaceutical industry and its impact on market access: market access implications

Science.gov (United States)

Murteira, Susana; Millier, Aurélie; Toumi, Mondher

2014-01-01

Background Drug repurposing is a group of development strategies employed in order to overcome some of the hurdles innate to drug research and development. Drug repurposing includes drug repositioning, reformulation and combination. Objective This study aimed to identify the determinants of successful market access outcome for drug repurposing in the United States of America (USA) and in Europe. Methods The case studies of repurposing strategies were identified through a systematic review of the literature. Price information and reimbursement conditions for all the case studies were collected mainly through access of public datasources. A list of attributes that could be associated with market access outcome (price level and reimbursement conditions) was developed, discussed, and validated by an external expert group. Detailed information for all attributes was researched and collected for each case study. Bivariate regression models were conducted to identify factors associated with price change for all repurposing cases. A similar analysis was performed for reformulation and repositioning cases, in the USA and in Europe, separately. A significance level of 5% was used for all analyses. Results A total of 144 repurposing case studies were included in the statistical analysis for evaluation of mean price change. Combination cases (the combination of two or more individual drug components) were excluded from the statistical analysis due to the low number of cases retrieved. The main attributes associated with a significant price increase for overall repurposing cases were ‘change in administration setting to hospital’ (374%, ptarget product had a different administration route than the source product, and having a similar brand name for repurposed and original products, were variables that impacted a positive price change for repurposed drugs overall. Our research results also suggested that orphan designation could have a positive impact for repositioning in

Making Astronomy Accessible

Science.gov (United States)

Grice, Noreen A.

2011-05-01

A new semester begins, and your students enter the classroom for the first time. You notice a student sitting in a wheelchair or walking with assistance from a cane. Maybe you see a student with a guide dog or carrying a Braille computer. Another student gestures "hello” but then continues hand motions, and you realize the person is actually signing. You wonder why another student is using an electronic device to speak. Think this can't happen in your class? According to the U.S. Census, one out of every five Americans has a disability. And some disabilities, such as autism, dyslexia and arthritis, are considered "invisible” disabilities. This means you have a high probability that one of your students will have a disability. As an astronomy instructor, you have the opportunity to reach a wide variety of learners by using creative teaching strategies. I will share some suggestions on how to make astronomy and your part of the universe more accessible for everyone.

Freely Accessible Chemical Database Resources of Compounds for in Silico Drug Discovery.

Science.gov (United States)

Yang, JingFang; Wang, Di; Jia, Chenyang; Wang, Mengyao; Hao, GeFei; Yang, GuangFu

2018-05-07

In silico drug discovery has been proved to be a solidly established key component in early drug discovery. However, this task is hampered by the limitation of quantity and quality of compound databases for screening. In order to overcome these obstacles, freely accessible database resources of compounds have bloomed in recent years. Nevertheless, how to choose appropriate tools to treat these freely accessible databases are crucial. To the best of our knowledge, this is the first systematic review on this issue. The existed advantages and drawbacks of chemical databases were analyzed and summarized based on the collected six categories of freely accessible chemical databases from literature in this review. Suggestions on how and in which conditions the usage of these databases could be reasonable were provided. Tools and procedures for building 3D structure chemical libraries were also introduced. In this review, we described the freely accessible chemical database resources for in silico drug discovery. In particular, the chemical information for building chemical database appears as attractive resources for drug design to alleviate experimental pressure. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

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

Science.gov (United States)

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

2015-01-01

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

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

Directory of Open Access Journals (Sweden)

Todd Gammie

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

Barriers to antiretroviral treatment access for injecting drug users living with HIV in Chennai, South India.

Science.gov (United States)

Chakrapani, Venkatesan; Velayudham, Jaikumar; Shunmugam, Murali; Newman, Peter A; Dubrow, Robert

2014-01-01

India's National AIDS Control Organization provides free antiretroviral treatment (ART) to people living with HIV (PLHIV), including members of marginalized groups such as injecting drug users (IDUs). To help inform development of interventions to enhance ART access, we explored barriers to free ART access at government ART centers for IDUs living with HIV in Chennai by conducting three focus groups (n = 19 IDUs) and four key informant interviews. Data were explored using framework analysis to identify categories and derive themes. We found interrelated barriers at the family and social, health-care system, and individual levels. Family and social level barriers included lack of family support and fear of societal discrimination, as well as unmet basic needs, including food and shelter. Health-care system barriers included actual or perceived unfriendly hospital environment and procedures such as requiring proof of address and identity from PLHIV, including homeless IDUs; provider perception that IDUs will not adhere to ART, resulting in ART not being initiated; actual or perceived inadequate counseling services and lack of confidentiality; and lack of effective linkages between ART centers, needle/syringe programs, and drug dependence treatment centers. Individual-level barriers included active drug use, lack of self-efficacy in ART adherence, low motivation to initiate ART stemming from a fatalistic attitude, and inadequate knowledge about ART. These findings indicate that to facilitate IDUs gaining access to ART, systemic changes are needed, including steps to make the environment and procedures at government ART centers more IDU-friendly and steps to decrease HIV- and drug use-related stigma and discrimination faced by IDUs from the general public and health-care providers. Housing support for homeless IDUs and linkage of IDUs with drug dependence treatment are also essential.

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

Science.gov (United States)

Gammie, Todd

2015-01-01

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

Patent Pooling for Promoting Access to Antiretroviral Drugs (ARVs) - A Strategic Option for India.

Science.gov (United States)

Satyanarayana, Kanikaram; Srivastava, Sadhana

2010-01-19

The current HIV/AIDS scenario in India is quite grim with an estimated 2.4 million people living with HIV/AIDS (PLHA) in 2008, just behind South Africa and Nigeria. The anti-retroviral drugs (ARVs) remain the main stay of global HIV/AIDS treatment. Over 30 ARVs (single and FDCs) available under six categories viz., NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), Protease inhibitors, the new Fusion inhibitors, Entry inhibitors-CCR5 co-receptor antagonists and HIV integrase strand transfer inhibitors. The major originator companies for these ARVs are: Abbott, Boehringer Ingelheim (BI), Bristol-Myers Squibb (BMS), Gilead, GlaxoSmithKline (GSK), Merck, Pfizer, Roche, and Tibotec. Beginning with zidovidine in 1987, all the drugs are available in the developed countries. In India, about 30 ARVs are available as generics manufactured by Aurobindo, Hyderabad, Andhra Pradesh; Cipla Limited, Goa; Emcure Pharmaceuticals, Pune, Maharashtra; Hetero Drugs, Hyderabad, Andhra Pradesh; Macleods Pharmaceuticals, Daman; Matrix Laboratories, Nashik, Maharashtra; Ranbaxy, Sirmour, Himachal Pradesh; and Strides Arcolab, Bangalore, Karnataka. The National AIDS Control Organization (NACO) set up in 1992 by the Govt. of India provides free ARVs to HIV positive patients in India since 2004. The drugs available in India include both single drugs and FDCs covering both first line and second line ARVs. Even while there are claims of stabilization of the disease load, there is still huge gap of those who require ARVs as only about 150,000 PLHA receive the ARVs from the Govt. and other sources. Access to ARVs therefore is still a cause of serious concern ever since India became fully Trade Related Aspects of Intellectual Property Rights (TRIPS)-complaint in 2005. Therefore, the Indian pharmaceutical companies cannot make generics for those for drugs introduced post-2005 due to product patent regime. Other concerns include heat stable

Orphan drugs for rare diseases: is it time to revisit their special market access status?

Science.gov (United States)

Simoens, Steven; Cassiman, David; Dooms, Marc; Picavet, Eline

2012-07-30

Orphan drugs are intended for diseases with a very low prevalence, and many countries have implemented legislation to support market access of orphan drugs. We argue that it is time to revisit the special market access status of orphan drugs. Indeed, evidence suggests that there is no societal preference for treating rare diseases. Although society appears to assign a greater value to severity of disease, this criterion is equally relevant to many common diseases. Furthermore, the criterion of equity in access to treatment, which underpins orphan drug legislation, puts more value on health improvement in rare diseases than in common diseases and implies that population health is not maximized. Finally, incentives for the development, pricing and reimbursement of orphan drugs have created market failures, including monopolistic prices and the artificial creation of rare diseases. We argue that, instead of awarding special market access status to orphan drugs, there is scope to optimize research and development (R&D) of orphan drugs and to control prices of orphan drugs by means of, for example, patent auctions, advance purchase commitments, pay-as-you-go schemes and dose-modification studies. Governments should consider carefully the right incentive strategy for R&D of orphan drugs in rare diseases.

[Sustainability of Brazilian policy for access to antiretroviral drugs].

Science.gov (United States)

Grangeiro, Alexandre; Teixeira, Luciana; Bastos, Francisco I; Teixeira, Paulo

2006-04-01

The expense of acquiring antiretroviral drugs in Brazil has given rise to debate about the sustainability of the policy of universal access to AIDS medications, despite the evident benefits. The objective of this study was to analyze the evolution of the Ministry of Health's spending on acquiring antiretroviral drugs from 1998 to 2005, the determining factors and the medium-term sustainability of this policy (2006-2008). The study on the evolution of spending on antiretrovirals included analysis of their prices, the year-by-year expenditure, the number of patients utilizing the medication, the mean expenditure per patient and the strategies for reducing the prices maintained during this period. To analyze the sustainability of the policy for access to antiretrovirals, the cost of acquiring the drugs over the period from 2006 to 2008 was estimated, along with the proportion of gross domestic product and federal health expenditure represented by this spending. The data were collected from the Ministry of Health, the Brazilian Institute for Geography and Statistics (IBGE) and the Ministry of Planning. The expenditure on antiretrovirals increased by 66% in 2005, breaking the declining trend observed over the period from 2000 to 2004. The main factors associated with this increase were the weakening of the national generics industry and the unsatisfactory results from the process of negotiating with pharmaceutical companies. The Brazilian policy for universal access is unsustainable at the present growth rates of the gross domestic product, unless the country compromises its investments in other fields.

Patient access to new cancer drugs in the United States and Australia.

Science.gov (United States)

Wilson, Andrew; Cohen, Joshua

2011-01-01

In light of the current debate on the use value and potential impact of comparative effectiveness research on patient access, it may prove insightful to compare a health-care system that systematically bases its reimbursement decisions on comparative effectiveness evidence with the United States (US) system that hitherto has only been informed by such evidence on an ad hoc basis. For a set of 2000-2009 approved new molecular entities and biologics indicated for cancer, we compared patient access between US Medicare and Australian Pharmaceutical Benefits Scheme (PBS) beneficiaries. Here, access is defined in terms of marketing availability, payer coverage, and patient out-of-pocket costs. Although 34 drugs and biologics were approved for cancer in the US, just more than one-third (35%) were ultimately covered by the Australian PBS. The PBS also placed more restrictions on use. On the other hand, prices and patient out-of-pocket costs were greater for the US Medicare population. Our analysis points to a possible trade-off in market access to oncology drugs. Although more oncology drugs are available in the US and a higher percentage of available drugs are covered, the evidence-based approach adopted by Australia has contributed to reduced prices, thereby improving affordability for payers and patients for those medications deemed cost-effective by the reimbursement authority. Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Making connections: New Orleans Evacuees' experiences in obtaining drugs.

Science.gov (United States)

Dunlap, Eloise; Johnson, Bruce D; Kotarba, Joseph A; Fackler, Jennifer

2009-09-01

Between August 29 and September 7, 2005, almost all New Orleans residents were evacuated from the area in the aftermath of Hurricane Katrina. News reports indicate that almost 130,000 New Orleans Evacuees (NOEs) were evacuated to Houston, Texas, the largest recipient of the civilian population from New Orleans. Some of these NOEs were active participants in the illicit drug market in New Orleans prior to the hurricane. The period between the flooding and the nearly complete evacuation of New Orleans as well as their subsequent displacement to Houston and other locations provided unique opportunities to study what occurs when illicit drug markets are disrupted, since populations of illicit drug users and purchasers could no longer routinely obtain their drugs in predictable ways. Utilizing qualitative data from in-depth interviews and focus groups, this article describes the ways NOEs (1) managed their drug acquisition and use following evacuation; (2) located new sources of drugs in Houston and elsewhere by tapping into shared drug culture; and (3) gained access to and learned the argot for drugs in the local drug market in new settings. This report contributes to the nascent literature on disrupted drug markets.

[Improve the accessibility of essential drugs for the populations of one medical region in Burkina Faso].

Science.gov (United States)

Ridde, Valéry; Nitièma, Abdoulaye P; Dadjoari, Moussa

2005-01-01

Despite the formulation of the Bamako initiative in 1992 in Burkina Faso, not until 2001 and the launching of a project by a nongovernmental organization was the policy really implemented in a region of the country. One of the goals of this policy is to improve access to health care by using generic essential drugs. The objective of this article is to summarize the results of the evaluation of the project's ability to improve the population's access to drugs. The project lasted three years (2001-2003) and the interventions took place in 41 basic health centres of three districts. According to WHO, improving access to drugs requires consideration of four essential factors: rational use, affordable prices, financial viability, and effectiveness of the distribution. The average number of drugs prescribed per prescription sheet (n = 1061) was 2.4; 93% of the drugs were prescribed by their generic name (international non-proprietary names); 44% of infant diarrheas were treated with oral rehydration salt. National drug prices were respected but not the directives aiming at exempting from payment or subsidizing certain population sub-groups (children, indigents). The average annual cash flow of the basic health centres was 1.2 million F CFA and it increased by 854% compared to the beginning of the project. The cost-recovery scheme for administrative expenses was 106%. The average annual availability of the 10 essential drugs was 89%. Utilization rates increased (0.13 in 1999 to 0.21 in 2003) but not significantly differently than in other basic health centres of the area not supported by the project (p = 0.084). The project succeeded in improving access to these drugs for the overall population but not for the worst-off. The drugs are now geographically available for all and financially accessible for those who can afford to pay. The intervention strategy supported the sustainability of the project's activities but much remains to be done to provide the poorest with

Access to antiepileptic drug therapy in children in Camagüey Province, Cuba

Science.gov (United States)

Arencibia, Zeina Bárzaga; Leyva, Alberto López; Peña, Yordanka Mejías; Reyes, Alba Rosa González; Nápolez, Maurilys Acosta; Carbonell Perdomo, Demetrio; Manzano, Edita Fernández; Choonara, Imti

2012-01-01

Objective To describe access to antiepileptic drug therapy and estimate the prevalence of epilepsy in children in Camagüey Province, Cuba. Methods All the community pharmacies in the province were visited and information collected about the number of children receiving antiepileptic drugs in 2009. Availability and cost of each antiepileptic drug were determined. The prevalence of epilepsy was estimated by determining the number of children receiving antiepileptic drugs. Results There were 923 children who received a total of 977 antiepileptic drugs in Camagüey Province. The estimated prevalence of epilepsy was 5.18 per thousand children which is lower than previously reported rates in other low and lower-middle income countries. Most of the children (871, 94%) received a single antiepileptic drug. Carbamazepine and valproate were the two most frequently prescribed antiepileptic drugs. Antiepileptic drugs were available from the local pharmacy on 76% of occasions. If the antiepileptic drug was not available from the local pharmacy, the parent had to travel to another pharmacy to obtain the medicine. Conclusions The estimated prevalence of epilepsy in children in Cuba is lower than that estimated in other lower-middle income countries. Access to drug therapy in children with epilepsy can be achieved in lower-middle income countries. PMID:23134098

Making the library accessible for all a practical guide for librarians

CERN Document Server

Vincent, Jane

2014-01-01

Accessibility is becoming an issue that libraries can no longer ignore. Making the Library Accessible for All provides a holistic guide to accessibility that addresses common issues and gives strategies for responding to unique situations. This book is a single-source guide relevant to all library functions that librarians can easily refer to when planning, remediating, or evaluating for accessibility. It has a unique holistic perspective, as well as an emphasis on perceiving people with disabilities as providing resources to meet a common goal rather than as a population to be "served."

Access to augmentative and alternative communication: new technologies and clinical decision-making.

Science.gov (United States)

Fager, Susan; Bardach, Lisa; Russell, Susanne; Higginbotham, Jeff

2012-01-01

Children with severe physical impairments require a variety of access options to augmentative and alternative communication (AAC) and computer technology. Access technologies have continued to develop, allowing children with severe motor control impairments greater independence and access to communication. This article will highlight new advances in access technology, including eye and head tracking, scanning, and access to mainstream technology, as well as discuss future advances. Considerations for clinical decision-making and implementation of these technologies will be presented along with case illustrations.

Delayed access to treatments for rare diseases: who's to blame?

Science.gov (United States)

Feltmate, Karen; Janiszewski, Peter M; Gingerich, Sheena; Cloutier, Michael

2015-04-01

The development and commercialization of drugs for rare diseases, termed 'orphan drugs', has historically been economically unattractive. However, because of the introduction of legislation that provides financial and regulatory incentives for the development of orphan drugs, new developments are making their way through the regulatory approval processes. Unfortunately, delays in availability of new drugs for treating rare disease continue to persist. This paper reviews the approach of several regulatory jurisdictions to orphan drugs in an effort to determine their relative effectiveness in providing patient access. Generally speaking, regulatory authorities across jurisdictions have recognized the need to enhance timely access to safe, effective treatment for patients with rare diseases and have been able to shift the approval timelines for access to new care. The greater impediment to orphan drug access appears to be funding, particularly in publicly sponsored health-care systems. Redundancies in federal and provincial reviews of orphan drugs can result in significant delays in access to new drugs. Clearly, more must be done to accelerate access to the treatments so desperately needed by patients. Public payers must be held accountable for their process and decisions--especially for rare disease therapies. © 2015 Asian Pacific Society of Respirology.

Access to antiretroviral drugs and AIDS management in Senegal.

Science.gov (United States)

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

2003-07-01

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

77 FR 10753 - Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the...

Science.gov (United States)

2012-02-23

...] Draft Guidance for Industry: Food and Drug Administration Records Access Authority Under the Federal... industry entitled ``FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug...). This updated draft guidance is intended to provide individuals in the human and animal food industries...

Venous access and care: harnessing pragmatics in harm reduction for people who inject drugs.

Science.gov (United States)

Harris, Magdalena; Rhodes, Tim

2012-06-01

To explore the facilitators of long-term hepatitis C avoidance among people who inject drugs. We employed a qualitative life history design. Recruitment took place through low-threshold drug services and drug user networks in South East and North London. Participants were interviewed at the recruitment services or in their homes. The sample comprised 35 people who inject drugs, 20 of whom were hepatitis C antibody-negative. Participants' average injecting trajectory was 19 years (6-33), with 66% primarily injecting heroin, and 34% a crack and heroin mix. Nine (26%) of the sample were female and the average age was 39 years (23-53). Two interviews were conducted with each participant, with the second interview incorporating reference to a computer-constructed life history time-line. Interview accounts were audiorecorded, transcribed verbatim and analysed thematically. Hepatitis C risk awareness was recent and deprioritized by the majority of participants. The facilitation of venous access and care was an initial and enduring rationale for safe injecting practices. Difficult venous access resulted in increased contamination of injecting environments and transitions to femoral injecting. Participants expressed an unmet desire for non-judgemental venous access information and advice. Harm reduction interventions which attend to the immediate priorities of people who inject drugs, such as venous access and care, have the potential to re-engage individuals who are jaded or confused by hepatitis C prevention messages. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

Making LibrariesAccessible for Visually Impaired Users: Practical Advice For Librarians

Directory of Open Access Journals (Sweden)

Devney Hamilton

2011-12-01

Full Text Available This article provides an introduction to making university libraries accessible to visually impaired users. It includes a summary of how visually impaired students access information and how libraries can provide access to materials, devices and software, and staff support to ensure visually impaired students ’ equal opportunity to use the library. The practical advice for librarians are based on interviews with 18 visually impaired university students and professionals who specialize in media, library services and information retrieval.

Why orphan drug coverage reimbursement decision-making needs patient and public involvement.

Science.gov (United States)

Douglas, Conor M W; Wilcox, Elizabeth; Burgess, Michael; Lynd, Larry D

2015-05-01

Recently there has been an increase in the active involvement of publics and patients in healthcare and research, which is extending their roles beyond the passive recipients of medicines. However, there has been noticeably less work engaging them into decision-making for healthcare rationing exercises, priority setting, health technology assessment, and coverage decision-making. This is particularly evident in reimbursement decision-making for 'orphan drugs' or drugs for rare diseases. Medicinal products for rare disease offer particular challenges in coverage decision-making because they often lack the 'evidence of efficacy' profiles of common drugs that have been trialed on larger populations. Furthermore, many of these drugs are priced in the high range, and with limited health care budgets the prospective opportunity costs of funding them means that those resources cannot be allocated elsewhere. Here we outline why decision-making for drugs for rare diseases could benefit from increased levels of publics and patients involvement, suggest some possible forms that involvement could take, and advocate for empirical experimentation in this area to evaluate the effects of such involvement. Focus is given to the Canadian context in which we are based; however, potentialities and challenges relating to involvement in this area are likely to be similar elsewhere. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

28 CFR 16.98 - Exemption of the Drug Enforcement Administration (DEA)-limited access.

Science.gov (United States)

2010-07-01

... Administration (DEA)-limited access. 16.98 Section 16.98 Judicial Administration DEPARTMENT OF JUSTICE PRODUCTION... Exemption of the Drug Enforcement Administration (DEA)—limited access. (a) The following systems of records.../Diversion Analysis and Detection System (ARCOS/DADS) (Justice/DEA-003) (2) Controlled Substances Act...

Accessing the digital environment: making policy in academic libraries

African Journals Online (AJOL)

Accessing the digital environment: making policy in academic libraries. Dorette Snyman. Abstract. No Abstract Available Innovation No.23 2001: 13-18. Full Text: EMAIL FULL TEXT EMAIL FULL TEXT · DOWNLOAD FULL TEXT DOWNLOAD FULL TEXT · AJOL African Journals Online. HOW TO USE AJOL... for Researchers ...

Making Information Visible, Accessible, and Understandable: Meta-Data and Registries

National Research Council Canada - National Science Library

Robinson, Clay

2007-01-01

... the interoperability, discovery, and utility of data assets throughout the Department of Defense (DoD). Proper use and understanding of metadata can substantially enhance the utility of data by making it more visible, accessible, and understandable...

77 FR 5027 - Food and Drug Administration Transparency Initiative: Exploratory Program To Increase Access to...

Science.gov (United States)

2012-02-01

...] Food and Drug Administration Transparency Initiative: Exploratory Program To Increase Access to the... entitled ``Food and Drug Administration Transparency Initiative: Exploratory Program to [[Page 5028

Trade agreements and access to drugs in Peru

OpenAIRE

Llamoza, Javier; Químico Farmacéutico, Acción Internacional para la Salud, Lima, Perú.

2009-01-01

Through Free Trade Agreements, the economies of the United States of America (USA) and the European Union (EU) have been achieving a higher standard of protection of the intellectual property rights. This increases unduly the monopolist rights of the industry, restricting competition and limiting the access of new generic drugs. Peru has not been the exception to this process, subscribing a free trade agreement with the USA called Agreement of Commercial Promotion (APC) that involved the ...

Pilfering for survival: how health workers use access to drugs as a coping strategy

Directory of Open Access Journals (Sweden)

Fernandes Maria

2004-04-01

Full Text Available Abstract Background Coping strategies have, in some countries, become so prevalent that it has been widely assumed that the very notion of civil services ethos has completely – and possibly irreversibly – disappeared. This paper describes the importance and the nature of pilfering of drugs by health staff in Mozambique and Cape Verde, as perceived by health professionals from these countries. Their opinions provide pointers as to how to tackle these problems. Methods This study is based on a self-administered questionnaire addressed to a convenience sample of health workers in Mozambique and in Cape Verde. Results The study confirms that misuse of access to pharmaceuticals has become a key element in the coping strategies health personnel develop to deal with difficult living conditions. Different professional groups (misuse their privileged access in different ways, but doctors diversify most. The study identifies the reasons given for misusing access to drugs, shows how the problem is perceived by the health workers, and discusses the implications for finding solutions to the problem. Our findings reflect, from the health workers themselves, a conflict between their self image of what it means to be an honest civil servant who wants to do a decent job, and the brute facts of life that make them betray that image. The manifest unease that this provokes is an important observation as such. Conclusion Our findings suggest that, even in the difficult circumstances observed in many countries, behaviours that depart from traditional civil servant deontology have not been interiorised as a norm. This ambiguity indicates that interventions to mitigate the erosion of proper conduct would be welcome. The time to act is now, before small-scale individual coping grows into large-scale, well-organized crime.

Braille Telecaptioning: Making Real-Time Television Accessible to Deaf-Blind Consumers.

Science.gov (United States)

Biederman-Anderson, L.

1989-01-01

A federal grant has been awarded to develop and test a prototype device to make closed-captioned television available to deaf-blind people. The Braille TeleCaption System, with output available in braille and large print, is currently being tested. Such new technology makes real-time viewing of news, weather, and entertainment accessible to…

ChEMBL web services: streamlining access to drug discovery data and utilities.

Science.gov (United States)

Davies, Mark; Nowotka, Michał; Papadatos, George; Dedman, Nathan; Gaulton, Anna; Atkinson, Francis; Bellis, Louisa; Overington, John P

2015-07-01

ChEMBL is now a well-established resource in the fields of drug discovery and medicinal chemistry research. The ChEMBL database curates and stores standardized bioactivity, molecule, target and drug data extracted from multiple sources, including the primary medicinal chemistry literature. Programmatic access to ChEMBL data has been improved by a recent update to the ChEMBL web services (version 2.0.x, https://www.ebi.ac.uk/chembl/api/data/docs), which exposes significantly more data from the underlying database and introduces new functionality. To complement the data-focused services, a utility service (version 1.0.x, https://www.ebi.ac.uk/chembl/api/utils/docs), which provides RESTful access to commonly used cheminformatics methods, has also been concurrently developed. The ChEMBL web services can be used together or independently to build applications and data processing workflows relevant to drug discovery and chemical biology. © The Author(s) 2015. Published by Oxford University Press on behalf of Nucleic Acids Research.

Factors that help injecting drug users to access and benefit from services: A qualitative study

Directory of Open Access Journals (Sweden)

sheard Laura

2007-10-01

Full Text Available Abstract Background International research shows that injecting drug users (IDUs can encounter many barriers when they try to access drug treatment and other services. However, the existing literature is mostly quantitative and does not consider the kinds of factors that injectors themselves identify as enabling them to access and benefit from services. Responding to this gap in knowledge, our paper explores IDUs' own suggestions for improving service engagement and their reports of other factors enabling them to seek help. Methods Semi-structured qualitative interviews were conducted with 75 current illicit drug injectors in three geographically diverse areas of West Yorkshire, England. Recruitment was through needle exchange programmes, with additional snowball sampling to ensure inclusivity of gender, ethnicity and primary drug injected. Transcribed data were analysed thematically using Framework. Results Although participants were often satisfied with current access to services, they made three broad suggestions for improving engagement. These were: providing more services (more providers and more forms of support; better operation of existing services (including better communication systems and more flexibility around individual needs; and staffing-related improvements (particularly, less judgemental and more understanding staff attitudes. Other factors identified as important enablers of help seeking were: having supporting relationships (particularly with family members; personal circumstances/life events (especially becoming a parent; and an injector's state of mind (such as feeling motivated and positive. Conclusion A range of practical suggestions for improving IDUs' access to drug treatment and other services are identified.

Open-access public-private partnerships to enable drug discovery--new approaches.

Science.gov (United States)

Müller, Susanne; Weigelt, Johan

2010-03-01

The productivity of the pharmaceutical industry, as assessed by the number of NMEs produced per US dollar spent in R&D, has been in steady decline during the past 40 years. This decline in productivity not only poses a significant challenge to the pharmaceutical industry, but also to society because of the importance of developing drugs for the treatment of unmet medical needs. The major challenge in progressing a new drug to the market is the successful completion of clinical trials. However, the failure rate of drugs entering trials has not decreased, despite various technological and scientific breakthroughs in recent decades, and despite intense target validation efforts. This lack of success suggests limitations in the fundamental understanding of target biology and human pharmacology. One contributing factor may be the traditional secrecy of the pharmaceutical sector, a characteristic that does not promote scientific discovery in an optimal manner. Access to broader knowledge relating to target biology and human pharmacology is difficult to obtain because interactions between researchers in industry and academia are typically restricted to closed collaborations in which the knowledge gained is confidential.However, open-access collaborative partnerships are gaining momentum in industry, and are also favored by funding agencies. Such open-access collaborations may be a powerful alternative to closed collaborations; the sharing of early-stage research data is expected to enable scientific discovery by engaging a broader section of the scientific community in the exploration of new findings. Potentially, the sharing of data could contribute to an increased understanding of biological processes and a decrease in the attrition of clinical programs.

Physician access to drug profiles to reduce adverse reactions

Science.gov (United States)

Yasnoff, William A.; Tomkins, Edward L.; Dunn, Louise M.

1995-10-01

Adverse drug reactions (ADRs) are a major source of preventable morbidity and mortality, especially among the elderly, who use more drugs and are more sensitive to them. The insurance industry has recently addressed this problem through the implementation of drug interaction alerts to pharmacists in conjunction with immediate online claims adjudication for almost 60% of prescriptions (expected to reach 90% within 5 years). These alerts are based on stored patient drug profiles maintained by pharmacy benefit managers (PBMs) which are updated whenever prescriptions are filled. While these alerts are very helpful, the pharmacist does not prescribe, resulting in time-consuming and costly delays to contact the physician and remedy potential interactions. We have developed and demonstrated the feasibility of the PINPOINT (Pharmaceutical Information Network for prevention of interactions) system for making the drug profile and interaction information easily available to the physician before the prescription is written. We plan to test the cost-effectiveness of the system in a prospective controlled clinical trial.

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

Directory of Open Access Journals (Sweden)

Corbett A Michelle

2007-03-01

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

Sign my e-petition to make changes to misuse of drugs act.

Science.gov (United States)

Griffiths, Matt

2012-02-29

My medicines management article (reflections February 8) highlighted legal muddles over the prescription of controlled drugs. The Medicines Act was amended four years ago to allow independent nurse prescribers to prescribe almost all controlled drugs. But the Misuse of Drugs Act needs to amended to make this legally possible.

[Drug addiction and social exclusion].

Science.gov (United States)

Solal, J F; Schneider, M C

1996-10-01

Destitute drug addicts have not deliberately chosen to be socially excluded; it's more the consequence of a sanitary and social policy which has given a greater importance to the treatment of addiction than to the drug addict's health. Facing Aids, physicians, with their pragmatic attitude, have reversed this drift. On the streets, the drug addict holds handicaps concurrently; medicinal addiction leads to harder sevrance and substitution. Having access to social rights allows to regain an identity, compulsory for an access to health care; but public hospitals have to make casier both the admission and the stay of patients whose therapeutic observance is dependent on a preliminary substitution. Drug addiction and precarity represent a double social challenge that a democratic society must take up without any segregation.

Towards a Transparent, Credible, Evidence-Based Decision-Making Process of New Drug Listing on the Hong Kong Hospital Authority Drug Formulary: Challenges and Suggestions.

Science.gov (United States)

Wong, Carlos King Ho; Wu, Olivia; Cheung, Bernard M Y

2018-02-01

The aim of this article is to describe the process, evaluation criteria, and possible outcomes of decision-making for new drugs listed in the Hong Kong Hospital Authority Drug Formulary in comparison to the health technology assessment (HTA) policy overseas. Details of decision-making processes including the new drug listing submission, Drug Advisory Committee (DAC) meeting, and procedures prior to and following the meeting, were extracted from the official Hong Kong Hospital Authority drug formulary management website and manual. Publicly-available information related to the new drug decision-making process for five HTA agencies [the National Institute of Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), the Australia Pharmaceutical Benefits Advisory Committee (PBAC), the Canadian Agency for Drugs and Technologies in Health (CADTH), and the New Zealand Pharmaceutical Management Agency (PHARMAC)] were reviewed and retrieved from official documents from public domains. The DAC is in charge of systemically and critically appraising new drugs before they are listed on the formulary, reviewing submitted applications, and making the decision to list the drug based on scientific evidence to which safety, efficacy, and cost-effectiveness are the primary considerations. When compared with other HTA agencies, transparency of the decision-making process of the DAC, the relevance of clinical and health economic evidence, and the lack of health economic and methodological input of submissions are the major challenges to the new-drug listing policy in Hong Kong. Despite these challenges, this review provides suggestions for the establishment of a more transparent, credible, and evidence-based decision-making process in the Hong Kong Hospital Authority Drug Formulary. Proposals for improvement in the listing of new drugs in the formulary should be a priority of healthcare reforms.

Moving towards tangible decision-making tools for policy makers: Measuring and monitoring energy access provision

International Nuclear Information System (INIS)

Bhanot, Jaya; Jha, Vivek

2012-01-01

Access to energy services has been recognised as central to achieving economic growth and sustainable development. However, almost 1.3 billion people in the world still lack access to electricity and 2.7 billion lack access to clean cooking facilities. In this backdrop, the issue of energy access is receiving more interest than ever before and this has brought to the fore, the need for a robust decision support tool for policy makers to measure the progress of energy access provision and also to provide direction for future policy making. The paper studies existing definitions of energy access and identifies the key requirements for an appropriate decision-making tool to measure and monitor energy access provision. In this context the paper assesses the strengths and weaknesses of the metrics currently being used to measure energy access in policy, as well as of contemporary monitoring and evaluation frameworks being used in other sectors. Based on these insights, a dashboard of indicators is proposed as an alternate decision support tool for policy makers to measure energy access. The paper concludes with a discussion on what is needed to operationalise this proposed framework. - Highlights: ► No one indicator or metric can successfully capture progress on energy access. ► A service oriented approach is necessary to measure energy access. ► Socio-economic and political contexts influence success of energy access policies.

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

Science.gov (United States)

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

2018-05-12

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

Admission of new oncological drugs to the Slovenian health care system and their accessibility to the patients

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Mitja Kos

2007-09-01

Full Text Available Background: The aim of the present study is to analyze the admission of anticancer drugs to the Slovenian healthcare system, and to evaluate patients’ accessibility to these medications.Methods: Admission and accessibility to anticancer drugs was evaluated by analysing: differences in registration time among USA, selected member states of EU, and Slovenia; time from the registration to the first use in Slovenia; differences between the first use in Slovenia and the first use in selected member states of EU and by analysing the market of oncology drugs. The study included drugs of the ATC groups such as Antitumor medications (cytostatics (ATC = L01 and Endocrine treatment (ATC = L02 that were used in Slovenia for the first time between 1999 to 2005. Registration data for Slovenia and EU was obtained from the registration documention of selected drugs at the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia, and the European Agency for the Evaluation of Medicinal Products (EMEA. Registration data for USA was obtained from the registration documention of selected drugs at the Food and Drug Administration (FDA. The information upon the first use of drugs in Slovenia was acquired from the PharMIS system, and the information upon the first use of drugs in selected member states of EU was obtained from the study on patients’ access to oncology drugs by Nils Wilking and Bengt Jönsson, performed from 2005. Data for the market analysis of oncology drugs was obtained from the PharMIS system.Results: In previous years a delay in registration time between Slovenia and compared states was present for some oncology drugs. Along with the acceptance of Slovenia as a new member state of EU, on 1st May 2004, registration process in Slovenia became a part of the registration system of the European Agency for the Evaluation of Medicinal Products (EMEA. Majority of drugs had a time difference between the registration and the first use

Patient participation in decision-making about cardiovascular preventive drugs - resistance as agency.

Science.gov (United States)

Hultberg, Josabeth; Rudebeck, Carl Edvard

2017-09-01

The aim of the study was to describe and explore patient agency through resistance in decision-making about cardiovascular preventive drugs in primary care. Six general practitioners from the southeast of Sweden audiorecorded 80 consultations. From these, 28 consultations with proposals from GPs for cardiovascular preventive drug treatments were chosen for theme-oriented discourse analysis. The study shows how patients participate in decision-making about cardiovascular preventive drug treatments through resistance in response to treatment proposals. Passive modes of resistance were withheld responses and minimal unmarked acknowledgements. Active modes were to ask questions, contest the address of an inclusive we, present an identity as a non-drugtaker, disclose non-adherence to drug treatments, and to present counterproposals. The active forms were also found in anticipation to treatment proposals from the GPs. Patients and GPs sometimes displayed mutual renouncement of responsibility for decision-making. The decision-making process appeared to expand both beyond a particular phase in the consultations and beyond the single consultation. The recognition of active and passive resistance from patients as one way of exerting agency may prove valuable when working for patient participation in clinical practice, education and research about patient-doctor communication about cardiovascular preventive medication. We propose particular attentiveness to patient agency through anticipatory resistance, patients' disclosures of non-adherence and presentations of themselves as non-drugtakers. The expansion of the decision-making process beyond single encounters points to the importance of continuity of care. KEY POINTS Guidelines recommend shared decision-making about cardiovascular preventive treatment. We need an understanding of how this is accomplished in actual consultations.This paper describes how patient agency in decision-making is displayed through different forms

78 FR 38994 - Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug...

Science.gov (United States)

2013-06-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0749] Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food...

Excluding Orphan Drugs from the 340B Drug Discount Program: the Impact on 18 Critical Access Hospitals

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Madeline Carpinelli Wallack

2012-01-01

Full Text Available Purpose: The 340B Drug Pricing Program is a federal program designed to reduce the amount that safety net providers spend on outpatient drugs. The Patient Protection and Affordable Health Care Act of 2010 extended eligibility for 340B to critical access hospitals (CAHs for all drugs except those designated as “orphan.” Because this policy is unprecedented, this study quantifies the gross financial impact that this exemption has on a group of CAHs. Methods: Drug spending for 2010 from 18 CAHs in Minnesota and Wisconsin are reviewed to identify the prevalence of orphan drug purchases and to calculate the price differentials between the 340B price and the hospitals’ current cost. Results: The 18 CAHs’ purchases of orphan drugs comprise an average of 44% of the total annual drug budgets, but only 5% of units purchased, thus representing a very high proportion of their expenditures. In the aggregate, the 18 hospitals would have saved $3.1 million ($171,000 average per hospital had purchases of drugs with orphan designations been made at the 340B price. Because CAH claims for Medicare are reimbursed on a cost-basis, the Federal government is losing an opportunity for savings. Conclusion: The high prevalence of orphan drug use and considerable potential for cost reduction through the 340B program demonstrate the loss of benefit to the hospitals, Federal government and the states.

Evaluation of Patients Hospitalized in Intensive Care Unit Due to Drug-Related Suicide Attempt and Access to Drugs: A Single Center Prospective Study

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Fatih Doğu Geyik

2014-06-01

Full Text Available Aim: We aimed to evaluate patients who were hospitalized in our intensive care unit due to drug-related suicide attempt (medical or insecticides and their access to these drugs. Methods: We prospectively recorded the demographic characteristics and medical data of 50 patients (32 females and 18 males who were hospitalized in our intensive care unit due to drug-related suicide attempt. Results: 66% of subjects were between the ages of 15 and 24 years with a mean age of 25.4±8.8 years. Multiple drug overdose was observed in 28% of patients. The unemployment rate was higher for women than men (p<0.001. Men obtained drugs from pharmacy more often than women (27.8% vs 6.2%, p=0,03. Of the patients, 86% got the drugs from home medicine cabinet while this rate was 93% among women (n=30. The level of toxicity was higher among patients who got the drugs from pharmacy than in those who used drugs at home (p=0.06. The length of stay in the intensive care unit was longer among patients with toxic level of medication (p=0.001. Conclusion: Patients usually use drugs or insecticides available at home to commit suicide. We believe that in patients with risk of suicide attempt, access to drugs should be limited and state regulations should be applied. (The Me­di­cal Bul­le­tin of Ha­se­ki 2014; 52:111-5

The role of globalization in drug development and access to orphan drugs: orphan drug legislation in the US/EU and in Latin America [v1; ref status: indexed, http://f1000r.es/3ix

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Renée J.G. Arnold

2015-02-01

Full Text Available Compared to a decade ago, nearly three times as many drugs for rare diseases are slated for development. This article addresses the market access issues associated with orphan drug status in Europe and the United States in contrast to the legislation in five Latin American (LA countries that have made strides in this regard--Mexico, Brazil, Colombia, Chile and Argentina. Based on the success of orphan drug legislation in the EU and US, LA countries should strive to adopt similar strategies with regard to rare diseases and drug development. With the implementation of new targeted regulations, reimbursement strategies, and drug approvals, accessibility to treatment will be improved for people afflicted with rare diseases in these developing countries.

Access to orphan drugs in Europe: current and future issues.

Science.gov (United States)

Michel, Morgane; Toumi, Mondher

2012-02-01

Orphan drugs target small populations of patients. In order to make the field more attractive to pharmaceutical companies and encourage R&D in rare diseases, incentives were put forward by the EU, which are discussed in this article. Because they often are the only available option to treat a disease, some orphan drugs are considered to have high value and as such benefit from high prices on national markets. This has made orphan drugs an attractive market for pharmaceutical companies, with approximately 40 approved orphan drugs generating over $200 million each in yearly sales. The resulting burden this puts on national health insurances may lead to a change in regulation and will certainly lead to new national pricing and reimbursement strategies. They will need to be coherent, fair, effective and sustainable so as to be predictable for companies. Reflection on the subject needs to be initiated.

Big Data: transforming drug development and health policy decision making.

Science.gov (United States)

Alemayehu, Demissie; Berger, Marc L

The explosion of data sources, accompanied by the evolution of technology and analytical techniques, has created considerable challenges and opportunities for drug development and healthcare resource utilization. We present a systematic overview these phenomena, and suggest measures to be taken for effective integration of the new developments in the traditional medical research paradigm and health policy decision making. Special attention is paid to pertinent issues in emerging areas, including rare disease drug development, personalized medicine, Comparative Effectiveness Research, and privacy and confidentiality concerns.

Criteria for Drug Reimbursement Decision-Making: An Emerging Public Health Challenge in Bulgaria

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Georgi Iskrov

2016-02-01

Full Text Available Background: During times of fiscal austerity, means of reimbursement decision-making are of particular interest for public health theory and practice. Introduction of advanced health technologies, growing health expenditures and increased public scrutiny over drug reimbursement decisions have pushed governments to consider mechanisms that promote the use of effective health technologies, while constraining costs. Aims: The study’s aim was to explore the current rationale of the drug reimbursement decision-making framework in Bulgaria. Our pilot research focused on one particular component of this process – the criteria used – because of the critical role that criteria are known to have in setting budgets and priorities in the field of public health. The analysis pursued two objectives: to identify important criteria relevant to drug reimbursement decision-making and to unveil relationships between theory and practice. Study Design: Cross-sectional study. Methods: The study was realized through a closed-ended survey on reimbursement criteria among four major public health stakeholders – medical professionals, patients, health authorities, and industry. Empirical outcomes were then cross-compared with the theoretical framework, as defined by current Bulgarian public health legislation. Analysis outlined what is done and what needs to be done in the field of public health reimbursement decision-making. Results: Bulgarian public health stakeholders agreed on 15 criteria to form a tentative optimal framework for drug reimbursement decision-making. The most apparent gap between the empirically found preferences and the official legislation is the lack of consideration for the strength of evidence in reimbursement decisions. Conclusion: Bulgarian policy makers need to address specific gaps, such as formal consideration for strength of evidence, explicit role of efficiency criteria, and means to effectively empower patient and citizen

Heterogeneity of publicly accessible online critical values for therapeutic drugs

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Colt M McClain

2011-01-01

Full Text Available Introduction: Critical values are reported to clinicians when laboratory values are life threatening and require immediate attention. To date no definitive critical value limit recommendations have been produced regarding therapeutic drug monitoring. Some laboratories choose to publish critical value lists online. These publicly available values may be accessed and potentially utilized by laboratory staff, patient care providers, and patients. Materials and Methods: A web-based search of laboratories associated with the Accreditation Council for Graduate Medical Education pathology residency programs was initiated to determine which therapeutic drugs had critical values and to examine the degree of variation in published critical values for these institutions. Results: Of the 107 institutions with university-based pathology training programs, 36 had published critical values online for review. Thirteen therapeutic drugs were investigated and the number of institutions reporting critical value limits for the drug, as well as the median, range, standard deviation, and the coefficient of variation of critical value concentration limits for each drug were determined. A number of the online critical value limits were deemed to be erroneous, most likely due to incorrectly listed units of measurement. Conclusions: There was a large degree of heterogeneity with regard to the chosen critical value limits for therapeutic drugs. This wide variance in critical values appears to be greater than that observed in interassay proficiency testing. Institutions should reexamine the rationale for their current critical value parameters and ensure that critical value limits and associated units are accurately published online.

Drug Utilization Study in Ophthalmology Out‑patient Department of a ...

African Journals Online (AJOL)

PROMOTING ACCESS TO AFRICAN RESEARCH. AFRICAN ... Abstract. Background: Drug utilization studies provide a pharmacoeconomic basis for making evidence‑based health‑care decisions. ... Results: A total of 640 prescriptions were analyzed with the average number of drugs per prescription being 2.4 (0.9).

Development of Decision-Making Automated System for Optimal Placement of Physical Access Control System’s Elements

Science.gov (United States)

Danilova, Olga; Semenova, Zinaida

2018-04-01

The objective of this study is a detailed analysis of physical protection systems development for information resources. The optimization theory and decision-making mathematical apparatus is used to formulate correctly and create an algorithm of selection procedure for security systems optimal configuration considering the location of the secured object’s access point and zones. The result of this study is a software implementation scheme of decision-making system for optimal placement of the physical access control system’s elements.

[Access to drugs and the situation of the pharmaceutical market in Ecuador].

Science.gov (United States)

Ortiz-Prado, Esteban; Galarza, Claudio; León, Fernando Cornejo; Ponce, Jorge

2014-07-01

In the area of public health, it is fundamental to understand the structure and dynamics of the Ecuadorian pharmaceutical market, its segmentation between the public and private sectors, and its relationship with supply and demand, both for generic and brand-name drugs. To achieve this, an observational descriptive study was conducted with information obtained from the available scientific, institutional, technical-administrative, and economic databases. Furthermore, the scientific information concerning the Ecuadorian and regional pharmaceutical market was reviewed through the PubMed and Ovid search engines. In Ecuador, 69.6% of dispensed drugs are brand-name and 30.4% are generics. Of all registered drugs in the country, 1,829 (13.6%) are considered over-the-counter and 11,622 (86.4%) are for sale under medical prescription. In terms of sales, 93.15% correspond to brand-name drugs and only 6.85% to generics. Ninety percent of the pharmacies are located in urban areas and only 10% in rural areas. In the last five years, prices have increased by 12.5% for brand-name drugs and 0.86% for generics. Brand-name drugs are dispensed and consumed 2.3 times more than generics. The majority of pharmacies are located in urban areas, showing that there is a relationship between purchasing power and access to drugs. Although the regulatory authority stipulates that 13% of drugs should be over-the-counter, approximately 60% of the population acquires drugs without a medical prescription.

Models of policy-making and their relevance for drug research.

Science.gov (United States)

Ritter, Alison; Bammer, Gabriele

2010-07-01

Researchers are often frustrated by their inability to influence policy. We describe models of policy-making to provide new insights and a more realistic assessment of research impacts on policy. We describe five prominent models of policy-making and illustrate them with examples from the alcohol and drugs field, before drawing lessons for researchers. Policy-making is a complex and messy process, with different models describing different elements. We start with the incrementalist model, which highlights small amendments to policy, as occurs in school-based drug education. A technical/rational approach then outlines the key steps in a policy process from identification of problems and their causes, through to examination and choice of response options, and subsequent implementation and evaluation. There is a clear role for research, as we illustrate with the introduction of new medications, but this model largely ignores the dominant political aspects of policy-making. Such political aspects include the influence of interest groups, and we describe models about power and pressure groups, as well as advocacy coalitions, and the challenges they pose for researchers. These are illustrated with reference to the alcohol industry, and interest group conflicts in establishing a Medically Supervised Injecting Centre. Finally, we describe the multiple streams framework, which alerts researchers to 'windows of opportunity', and we show how these were effectively exploited in policy for cannabis law reform in Western Australia. Understanding models of policy-making can help researchers maximise the uptake of their work and advance evidence-informed policy.

Contingency Management and deliberative decision-making processes

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Paul S. Regier

2015-06-01

Full Text Available Contingency Management is an effective treatment for drug addiction. The current explanation for its success is rooted in alternative reinforcement theory. We suggest that alternative reinforcement theory is inadequate to explain the success of Contingency Management and produce a model based on demand curves that show how little the monetary rewards offered in this treatment would affect drug use. Instead, we offer an explanation of its success based on the concept that it accesses deliberative decision-making processes. We suggest that Contingency Management is effective because it offers a concrete and immediate alternative to using drugs, which engages deliberative processes, improves the ability of those deliberative processes to attend to non-drug options, and offsets more automatic action-selection systems. This theory makes explicit predictions that can be tested, suggests which users will be most helped by Contingency Management, and suggests improvements in its implementation.

Contingency Management and Deliberative Decision-Making Processes.

Science.gov (United States)

Regier, Paul S; Redish, A David

2015-01-01

Contingency management is an effective treatment for drug addiction. The current explanation for its success is rooted in alternative reinforcement theory. We suggest that alternative reinforcement theory is inadequate to explain the success of contingency management and produce a model based on demand curves that show how little the monetary rewards offered in this treatment would affect drug use. Instead, we offer an explanation of its success based on the concept that it accesses deliberative decision-making processes. We suggest that contingency management is effective because it offers a concrete and immediate alternative to using drugs, which engages deliberative processes, improves the ability of those deliberative processes to attend to non-drug options, and offsets more automatic action-selection systems. This theory makes explicit predictions that can be tested, suggests which users will be most helped by contingency management, and suggests improvements in its implementation.

Drug abuse: newly-emerging drugs and trends.

Science.gov (United States)

Davis, Gregory G

2012-09-01

Drug abusers have access to new, more potent compounds that evade existing laws by virtue of their novel chemical structures. These drugs are available for purchase at stores and over the internet. The drugs are not illegal because they are so new that laws have not yet been passed to ban them. These drugs are leading to emergency department visits for cardiovascular, neurologic, and psychiatric complications. Standard drug screens are not designed to detect these new substances. The internet provides access to drugs for substance abusers but also provides physicians speed of access to the habits of substance abusers.

Access to information and decision making on teenage pregnancy prevention by females in Tshwane

OpenAIRE

J.P.F. Masemola-Yende; Sanah M. Mataboge

2015-01-01

Background: The increase in the number of teenage pregnancies and its negative consequences has encouraged various researchers to explore the possible causes of teenage pregnancy. Findings from previously-conducted research have indicated different preventable factors that predispose female teenagers to pregnancy, such as staff attitudes and the lack of information resulting from poor access to health facilities. Objective: To explore and describe access to information and decision making...

Preferred information sources for clinical decision making: critical care nurses' perceptions of information accessibility and usefulness.

Science.gov (United States)

Marshall, Andrea P; West, Sandra H; Aitken, Leanne M

2011-12-01

Variability in clinical practice may result from the use of diverse information sources to guide clinical decisions. In routine clinical practice, nurses privilege information from colleagues over more formal information sources. It is not clear whether similar information-seeking behaviour is exhibited when critical care nurses make decisions about a specific clinical practice, where extensive practice variability exists alongside a developing research base. This study explored the preferred sources of information intensive care nurses used and their perceptions of the accessibility and usefulness of this information for making decisions in clinically uncertain situations specific to enteral feeding practice. An instrumental case study design, incorporating concurrent verbal protocols, Q methodology and focus groups, was used to determine intensive care nurses' perspectives of information use in the resolution of clinical uncertainty. A preference for information from colleagues to support clinical decisions was observed. People as information sources were considered most useful and most accessible in the clinical setting. Text and electronic information sources were seen as less accessible, mainly because of the time required to access the information within the documents. When faced with clinical uncertainty, obtaining information from colleagues allows information to be quickly accessed and applied within the context of a specific clinical presentation. Seeking information from others also provides opportunities for shared decision-making and potential validation of clinical judgment, although differing views may exacerbate clinical uncertainty. The social exchange of clinical information may meet the needs of nurses working in a complex, time-pressured environment but the extent of the evidence base for information passed through verbal communication is unclear. The perceived usefulness and accessibility of information is premised on the ease of use and access

Negotiating access to medical treatment and the making of patient citizenship: the case of hepatitis C treatment.

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Rhodes, Tim; Harris, Magdalena; Martin, Anthea

2013-09-01

Drawing on qualitative interview accounts with people who have injected drugs, we deploy ideas of biological and therapeutic citizenship to explore how the negotiation of access to hepatitis C treatment enacts patient citizenship potential. We find that the patient citizenship made through hepatitis C treatment divides those who are deserving from those who are not, largely in relation to their presentations of self-control, responsibility and recovery regarding drug use. Accessing treatment requires that patients negotiate their entitlement by reflexively producing the patient citizen role expected of them. In this context of rationed treatment expectation, access to treatment is constructed in relation to gratitude rather than entitlement. Rationed treatment expectation also interplays with a utilitarian approach to hepatitis C expertise. Accounts of the bio-effects of hepatitis C and its treatment as uncertain further weaken the potential for shared illness identity and biosocial membership as well as contributing to treatment delay. We conclude that the construction of hepatitis C treatment as a negotiation of 'recovery towards normality' positions people who continue to use or inject drugs as beyond patient citizenship. Our findings underscore the situated limits of therapeutic and biological citizenship, emphasising that these processes are unavoidably forces of governance. © 2013 The Authors. Sociology of Health & Illness © 2013 Foundation for the Sociology of Health & Illness/John Wiley & Sons Ltd. Published by John Wiley & Sons Ltd.

#DDOD Use Case: Access to Medicare Part D Drug Event File (PDE) for cost transparency

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U.S. Department of Health & Human Services — SUMMARY DDOD use case to request access to Medicare Part D Drug Event File (PDE) for cost transparency to pharmacies and patients. WHAT IS A USE CASE? A “Use Case”...

Evidence on the cost of breast cancer drugs is required for rational decision making

NARCIS (Netherlands)

Berghuis, Anne Margreet Sofie; Koffijberg, Hendrik; Terstappen, Leonardus Wendelinus Mathias Marie; Sleijfer, Stefan; IJzerman, Maarten Joost

2018-01-01

Background: For rational decision making, assessing the cost-effectiveness and budget impact of new drugs and comparing the costs of drugs already on the market is required. In addition to value frameworks, such as the American Society of Clinical Oncology Value Framework and the European Society of

Access to information and decision making on teenage pregnancy prevention by females in Tshwane

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J.P.F. Masemola-Yende

2015-11-01

Full Text Available Background: The increase in the number of teenage pregnancies and its negative consequences has encouraged various researchers to explore the possible causes of teenage pregnancy. Findings from previously-conducted research have indicated different preventable factors that predispose female teenagers to pregnancy, such as staff attitudes and the lack of information resulting from poor access to health facilities. Objective: To explore and describe access to information and decision making on teenage pregnancy prevention by females using a primary healthcare clinic in Tshwane, South Africa. Method: In this study, the researchers used a descriptive qualitative and exploratory research design to explore and describe the verbal reports regarding prevention of teenage pregnancy by females using a primary healthcare clinic in Tshwane, South Africa. Face-to-face semistructured interviews were conducted with 15 female participants aged between 15 and 26, who had been pregnant once or more during their teens. Results: Two themes emerged, namely, access to information and decision making by female teenagers. Five categories that emerged were: access to information on pregnancy prevention; ignoring of provided information; the use of alternative medicine with hormonal contraception; personal reasons for use and non-use of contraception; and decisions made by teenagers to not fall pregnant. Females in this study fell pregnant in their teens, even though they had access to information. Conclusion: Given the complexity of this problem, female teenagers should use their families as primary sources of information for reproductive health promotion and educational institutions should build on this to aid the prevention of teenage pregnancy.

Access to information and decision making on teenage pregnancy prevention by females in Tshwane.

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Masemola-Yende, J P F; Mataboge, Sanah M

2015-11-05

The increase in the number of teenage pregnancies and its negative consequences has encouraged various researchers to explore the possible causes of teenage pregnancy. Findings from previously-conducted research have indicated different preventable factors that predispose female teenagers to pregnancy, such as staff attitudes and the lack of information resulting from poor access to health facilities. To explore and describe access to information and decision making on teenage pregnancy prevention by females using a primary healthcare clinic in Tshwane, South Africa. In this study, the researchers used a descriptive qualitative and exploratory research design to explore and describe the verbal reports regarding prevention of teenage pregnancy by females using a primary healthcare clinic in Tshwane, South Africa. Face-to-face semistructured interviews were conducted with 15 female participants aged between 15 and 26, who had been pregnant once or more during their teens. Two themes emerged, namely, access to information and decision making by female teenagers. Five categories that emerged were: access to information on pregnancy prevention; ignoring of provided information; the use of alternative medicine with hormonal contraception; personal reasons for use and non-use of contraception; and decisions made by teenagers to not fall pregnant. Females in this study fell pregnant in their teens, even though they had access to information. Given the complexity of this problem, female teenagers should use their families as primary sources of information for reproductive health promotion and educational institutions should build on this to aid the prevention of teenage pregnancy.

PDTD: a web-accessible protein database for drug target identification

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Gao Zhenting

2008-02-01

Full Text Available Abstract Background Target identification is important for modern drug discovery. With the advances in the development of molecular docking, potential binding proteins may be discovered by docking a small molecule to a repository of proteins with three-dimensional (3D structures. To complete this task, a reverse docking program and a drug target database with 3D structures are necessary. To this end, we have developed a web server tool, TarFisDock (Target Fishing Docking http://www.dddc.ac.cn/tarfisdock, which has been used widely by others. Recently, we have constructed a protein target database, Potential Drug Target Database (PDTD, and have integrated PDTD with TarFisDock. This combination aims to assist target identification and validation. Description PDTD is a web-accessible protein database for in silico target identification. It currently contains >1100 protein entries with 3D structures presented in the Protein Data Bank. The data are extracted from the literatures and several online databases such as TTD, DrugBank and Thomson Pharma. The database covers diverse information of >830 known or potential drug targets, including protein and active sites structures in both PDB and mol2 formats, related diseases, biological functions as well as associated regulating (signaling pathways. Each target is categorized by both nosology and biochemical function. PDTD supports keyword search function, such as PDB ID, target name, and disease name. Data set generated by PDTD can be viewed with the plug-in of molecular visualization tools and also can be downloaded freely. Remarkably, PDTD is specially designed for target identification. In conjunction with TarFisDock, PDTD can be used to identify binding proteins for small molecules. The results can be downloaded in the form of mol2 file with the binding pose of the probe compound and a list of potential binding targets according to their ranking scores. Conclusion PDTD serves as a comprehensive and

Availability of and access to orphan drugs: an international comparison of pharmaceutical treatments for pulmonary arterial hypertension, Fabry disease, hereditary angioedema and chronic myeloid leukaemia.

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Blankart, Carl Rudolf; Stargardt, Tom; Schreyögg, Jonas

2011-01-01

Market authorization does not guarantee patient access to any given drug. This is particularly true for costly orphan drugs because access depends primarily on co-payments, reimbursement policies and prices. The objective of this article is to identify differences in the availability of orphan drugs and in patient access to them in 11 pharmaceutical markets: Australia, Canada, England, France, Germany, Hungary, the Netherlands, Poland, Slovakia, Switzerland and the US. Four rare diseases were selected for analysis: pulmonary arterial hypertension (PAH), Fabry disease (FD), hereditary angioedema (HAE) and chronic myeloid leukaemia (CML). Indicators for availability were defined as (i) the indications for which orphan drugs had been authorized in the treatment of these diseases; (ii) the application date; and (iii) the date upon which these drugs received market authorization in each country. Indicators of patient access were defined as (i) the outcomes of technology appraisals; (ii) the extent of coverage provided by healthcare payers; and (iii) the price of the drugs in each country. For PAH we analysed bosentan, iloprost, sildenafil, treprostinil (intravenous and inhaled) as well as sitaxentan and ambrisentan; for FD we analysed agalsidase alfa and agalsidase beta; for HAE we analysed icatibant, ecallantide and two complement C1s inhibitors; for CML we analysed imatinib, dasatinib and nilotinib. Most drugs included in this study had received market authorization in all countries, but the range of indications for which they had been authorized differed by country. The broadest range of indications was found in Australia, and the largest variations in indications were found for PAH drugs. Authorization process speed (the time between application and market authorization) was fastest in the US, with an average of 362 days, followed by the EU (394 days). The highest prices for the included drugs were found in Germany and the US, and the lowest in Canada, Australia and

Data Access Services that Make Remote Sensing Data Easier to Use

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Lynnes, Christopher

2010-01-01

This slide presentation reviews some of the processes that NASA uses to make the remote sensing data easy to use over the World Wide Web. This work involves much research into data formats, geolocation structures and quality indicators, often to be followed by coding a preprocessing program. Only then are the data usable within the analysis tool of choice. The Goddard Earth Sciences Data and Information Services Center is deploying a variety of data access services that are designed to dramatically shorten the time consumed in the data preparation step. On-the-fly conversion to the standard network Common Data Form (netCDF) format with Climate-Forecast (CF) conventions imposes a standard coordinate system framework that makes data instantly readable through several tools, such as the Integrated Data Viewer, Gridded Analysis and Display System, Panoply and Ferret. A similar benefit is achieved by serving data through the Open Source Project for a Network Data Access Protocol (OPeNDAP), which also provides subsetting. The Data Quality Screening Service goes a step further in filtering out data points based on quality control flags, based on science team recommendations or user-specified criteria. Further still is the Giovanni online analysis system which goes beyond handling formatting and quality to provide visualization and basic statistics of the data. This general approach of automating the preparation steps has the important added benefit of enabling use of the data by non-human users (i.e., computer programs), which often make sub-optimal use of the available data due to the need to hard-code data preparation on the client side.

Access to highly active antiretroviral therapy (HAART) for injecting drug users in the WHO European Region 2002-2004

DEFF Research Database (Denmark)

Donoghoe, Martin C; Bollerup, Annemarie R; Lazarus, Jeff

2007-01-01

Providing equitable access to highly active antiretroviral treatment (HAART) to injecting drug users (IDUs) is both feasible and desirable. Given the evidence that IDUs can adhere to HAART as well as non-IDUs and the imperative to provide universal and equitable access to HIV/AIDS treatment for all...... who need it, here we examine whether IDUs in the 52 countries in the WHO European Region have equitable access to HAART and whether that access has changed over time between 2002 and 2004. We consider regional and country differences in IDU HAART access; examine preliminary data regarding...

HIV Serostatus and Having Access to a Physician for Regular Hepatitis C Virus Care Among People Who Inject Drugs.

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Beaulieu, Tara; Hayashi, Kanna; Milloy, Michael J; Nosova, Ekaterina; DeBeck, Kora; Montaner, Julio; Kerr, Thomas; Ti, Lianping

2018-05-01

People who inject drugs (PWIDs) and who are living with HIV and hepatitis C virus (HCV) infection are vulnerable to a range of health-related harms, including liver cirrhosis, hepatocellular carcinoma, and death. There is limited evidence describing how HIV serostatus shapes access to a physician for regular HCV care among PWID. Data were collected through the Vancouver Injection Drug Users Study (VIDUS), the AIDS Care Cohort to evaluate Exposure to Survival Services (ACCESS), and the At-Risk Youth Study (ARYS), 3 prospective cohorts involving people who use illicit drugs in Vancouver, Canada, between 2005 and 2015. Using generalized estimating equations, we examined the relationship between HIV-seropositivity and having access to a physician for regular HCV care. We conducted a mediation analysis to examine whether this association was mediated by increased frequency of engagement in health care. In total, 1627 HCV-positive PWID were eligible for analysis; 582 (35.8%) were HIV-positive at baseline; and 31 (1.9%) became HIV-positive during follow-up. In multivariable analyses, after adjusting for a range of confounders, HIV serostatus [adjusted odds ratio = 1.99; 95% confidence interval: 1.77 to 2.24] was significantly associated with having access to HCV care. Approximately 26% of the effect was due to mediation. Our results demonstrate a positive relationship between HIV-seropositivity and having access to a physician for regular HCV care, which is partially explained through increased frequency of engagement in health care. These findings highlight the need to address patterns of inequality in access to HCV care among PWID.

Police bribery and access to methadone maintenance therapy within the context of drug policy reform in Tijuana, Mexico.

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Werb, D; Wagner, K D; Beletsky, L; Gonzalez-Zuniga, Patricia; Rangel, Gudelia; Strathdee, S A

2015-03-01

In 2009, Mexico passed legislation to decriminalize drug possession and improve access to addiction treatment. We undertook research to assess the implementation of the reform among a cohort of people who inject drugs (PWID) in Tijuana. This study specifically sought to determine whether discretionary policing practices like extortion impact access to methadone maintenance therapy (MMT) in Tijuana, a city characterized by high levels of drug-related harms. Generalized estimating equation analyses were used to construct longitudinal confounding models to determine the association between paying a police bribe and MMT enrolment among PWID in Tijuana enrolled in a prospective cohort study. Outcome of interest was MMT enrolment in the past six months. Data on police interactions and MMT enrolment were also obtained. Between October, 2011 and September, 2013, 637 participants provided 1825 observations, with 143 (7.8%) reports of MMT enrolment during the study period. In a final confounding model, recently reporting being forced to pay a bribe to police was significantly associated with an increased likelihood of accessing MMT (adjusted odds ratio=1.69, 95% confidence interval: 1.02-2.81, p=0.043). However, in 56 (39.2%) cases, MMT enrolment ceased within six months. The majority of participant responses cited the fact that MMT was too expensive (69.1%). Levels of MMT access were low. PWID who experienced police extortion were more likely to access MMT at baseline, though this association decreased during the study period. Coupled with the costs of MMT, this may compromise MMT retention among PWID. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Impact of the healthcare payment system on patient access to oral anticancer drugs: an illustration from the French and United States contexts

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2014-01-01

Background Oral anticancer drugs (OADs) allow treating a growing range of cancers. Despite their convenience, their acceptance by healthcare professionals and patients may be affected by medical, economical and organizational factors. The way the healthcare payment system (HPS) reimburses OADs or finances hospital activities may impact patients’ access to such drugs. We discuss how the HPS in France and USA may generate disincentives to the use of OADs in certain circumstances. Discussion French public and private hospitals are financed by National Health Insurance (NHI) according to the nature and volume of medical services provided annually. Patients receiving intravenous anticancer drugs (IADs) in a hospital setting generate services, while those receiving OADs shift a part of service provision from the hospital to the community. In 2013, two million outpatient IADs sessions were performed, representing a cost of €815 million to the NHI, but positive contribution margin of €86 million to hospitals. Substitution of IADs by OADs mechanically induces a shortfall in hospital income related to hospitalizations. Such economic constraints may partially contribute to making physicians reluctant to prescribe OADs. In the US healthcare system, coverage for OADs is less favorable than coverage for injectable anticancer drugs. In 2006, a Cancer Drug Coverage Parity Act was adopted by several states in order to provide patients with better coverage for OADs. Nonetheless, the complexity of reimbursement systems and multiple reimbursement channels from private insurance represent real economic barriers which may prevent patients with low income being treated with OADs. From an organizational perspective, in both countries the use of OADs generates additional activities related to physician consultations, therapeutic education and healthcare coordination between hospitals and community settings, which are not considered in the funding of hospitals activities so far

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

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Bahnassi, Anas

2016-04-01

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

Prescripción, acceso y gasto en medicamentos entre usuarios de servicios de salud en México Medical prescription, drug access and drug expenditure among health service users in Mexico

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RENÉ LEYVA-FLORES

1998-01-01

Full Text Available Objetivo. Analizar la prescripción, el acceso y el gasto en medicamentos entre usuarios de servicios de salud a partir de la Encuesta Nacional de Salud en México, 1994. Material y métodos. Se realizó un análisis descriptivo del acceso y gasto en medicamentos, y se identificaron factores relacionados con la prescripción mediante una regresión logística en 3 324 usuarios. Resultados. El 78% de usuarios recibieron prescripción de medicamentos. El 92% de los usuarios de la seguridad social y 35% de la Secretaría de Salud obtuvieron los medicamentos sin pago directo (p =0.000. La región con mayor índice de pobreza presentó menor acceso gratuito a los medicamentos. Entre los usuarios que gastaron en medicamentos, la mediana del gasto fue de 40.00 pesos (12.50 dólares, lo que resultó mayor en instituciones privadas que en públicas. Conclusiones. El acceso y el gasto en medicamentos se encuentran relacionados con las características socioeconómicas de los grupos de población y con las instituciones donde estos últimos se atendieron. Lograr mayor equidad en el acceso a medicamentos representa uno de los retos del sistema de salud en México.Objective. To analyze the medical prescription, drug access and drug expenditure by patients based on the National Health Survey in Mexico, 1994. Materials and methods. A descriptive analysis of drug access and expenditure was undertaken and predictive factors for medical prescription were identified by logistic regression for 3 324 patients. Results. 78% of the patients received drug prescriptions. 92% of the Social Security patients and 35% of the Ministry of Health patients received drugs free of charge (p =0.000. The region with the highest poverty index received the least amount of drugs free of charge. Regarding drug expenditure of patients who purchased drugs, median expenditure was 40.00 pesos (12.50 USD. Private health service patients spent significantly more than public health service

Barriers to Access to Sterile Syringes as Perceived by Pharmacists and Injecting Drug Users: Implications for Harm Reduction in Lebanon.

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Ghaddar, Ali; Nassar, Karine; Elsoury, Ghadier

2017-09-19

Access to sterile syringes to injecting drug users (IDU) reduces sharing behavior and prevents the transmission of HIV. To describe the barriers to access to sterile syringes for IDUs in Lebanon from the perspectives of pharmacists and IDUs. in this qualitative study conducted in Lebanon, data were collected from 72 syringe purchase tests at pharmacies, 64 interviewees with pharmacists and 2 focus groups with injecting drug users. Two independent researchers analyzed the verbatim transcripts. Results revealed that pharmacists often deny access to sterile syringes to IDUs who are frequently stigmatized and intimidated at pharmacies. While no large gender differences in pharmacists' attitudes and practices were observed, inequalities in syringe access were noticed with men IDUs more often denied purchase. Pharmacists had several barriers to sell syringes to IDUs including fear of disease spread, increased drug use, inappropriately discarded syringes, staff and customer safety, and business concerns. IDUs had several challenges to purchase syringes including stigmatization, intimidation, physical harassment, concern to reveal identity, fear of arrest and syringe price abuse. Identifying the barriers to and facilitators of access to sterile syringes to IDUs is important to guide the development of efficient policies. Findings implicate the importance of empowering IDUs to purchase syringes at pharmacies through reducing the negative attitude towards IDUs and strengthening pharmacists' role in the promotion of health of IDUs. Findings also suggest that the habit of syringe sharing would decrease if the legal and cultural barriers to access are reduced.

Terminal illness and access to Phase 1 experimental agents, surgeries and devices: reviewing the ethical arguments.

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Schüklenk, Udo; Lowry, Christopher

2009-01-01

The advent of AIDS brought about a group of patients unwilling to accept crucial aspects of the methodological standards for clinical research investigating Phase 1 drugs, surgeries or devices. Their arguments against placebo controls in trials, which depended--at the time--on the terminal status of patient volunteers led to a renewed discussion of the ethics of denying patients with catastrophic illnesses access to last-chance experimental drugs, surgeries or devices. Existing ethics and health policy literature on the topic of access to experimental drugs. The positions of those arguing for or against free access to experimental drugs for terminally ill patients are irreconcilable. At stake are questions about the kinds of personal sacrifices society can reasonably expect patients in clinical trials to make to ensure statistically predictive results. These would benefit by necessity a much larger number of current and future patients--the conflict is about individual versus public interests. It is also about the question of whether or not the state can legitimately prevent patients with terminal illnesses from unfettered access to experimental drugs, surgeries or devices in order to motivate them to participate in clinical trials. We review the ethical arguments for and against the provision of access to Phase 1 agents for terminally ill patients. Finding a compromise between providing free or no access to Phase 1 drugs for terminally ill patients. We ought to investigate means to increase access to experimental drugs for terminally ill patients without sacrificing necessary clinical trials' sounds scientific methods.

Syringe access for the prevention of blood borne infections among injection drug users

Directory of Open Access Journals (Sweden)

Rich Josiah D

2003-11-01

Full Text Available Abstract Background Approximately one-third of acquired immunodeficiency syndrome cases in the United States are associated with the practice of sharing of injection equipment and are preventable through the once-only use of syringes, needles and other injection equipment. Discussion Sterile syringes may be obtained legally by 4 methods depending on the state. They may be purchased over the counter, prescribed, obtained at syringe exchange programs or furnished by authorized agencies. Each of these avenues has advantages and disadvantages; therefore, legal access through all means is the most likely way to promote the use of sterile syringes. Summary By assisting illicit drug injectors to obtain sterile syringes the primary care provider is able to reduce the incidence of blood borne infections, and educate patients about safe syringe disposal. The provider is also able to initiate discussion about drug use in a nonjudgmental manner and to offer care to patients who are not yet ready to consider drug treatment.

[Access to high-cost drugs in Brazil from the perspective of physicians, pharmacists and patients].

Science.gov (United States)

Rover, Marina Raijche Mattozo; Vargas-Pelaez, Claudia Marcela; Rocha Farias, Mareni; Nair Leite, Silvana

2016-01-01

To explore perceptions on access to medication supplied by the Specialized Component of Pharmaceutical Assistance (CEAF) within the Brazilian Unified Health System (which includes high-cost drugs) by the actors involved in the healthcare services of this component. A descriptive, qualitative study was carried out by using a focal group with 7 users and 11 semi-structured interviews with health professionals (physicians and pharmacist) in the state of Santa Catarina. According to the participants, access to medicines had improved. Two main perceptions of the CEAF Clinical Guidelines were identified: the requirements constitute a bureaucracy that limits access, and the requisites increase the demand for tests and specialized healthcare services, exceeding the capacity of the healthcare services network. These assumptions generated the search for other means of access that revealed a lack of information and understanding of the right to health among the users. In addition, according to the participants, because of the difficulties of accessing services as a whole, full access to CEAF medicines is a goal that remains to be achieved. Although access to CEAF medicines has improved, there are still some difficulties in guaranteeing treatment access and comprehensiveness. Copyright © 2016 SESPAS. Published by Elsevier Espana. All rights reserved.

Conflict and user involvement in drug misuse treatment decision-making: a qualitative study.

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Fischer, Jan; Neale, Joanne; Bloor, Michael; Jenkins, Nicholas

2008-10-06

This paper examines client/staff conflict and user involvement in drug misuse treatment decision-making. Seventy-nine in-depth interviews were conducted with new treatment clients in two residential and two community drug treatment agencies. Fifty-nine of these clients were interviewed again after twelve weeks. Twenty-seven interviews were also conducted with staff, who were the keyworkers for the interviewed clients. Drug users did not expect, desire or prepare for conflict at treatment entry. They reported few actual conflicts within the treatment setting, but routinely discussed latent conflicts--that is, negative experiences and problematic aspects of current or previous treatment that could potentially escalate into overt disputes. Conflict resulted in a number of possible outcomes, including the premature termination of treatment; staff deciding on the appropriate outcome; the client appealing to the governance structure of the agency; brokered compromise; and staff skilfully eliciting client consent for staff decisions. Although the implementation of user involvement in drug treatment decision-making has the potential to trigger high levels of staff-client conflict, latent conflict is more common than overt conflict and not all conflict is negative. Drug users generally want to be co-operative at treatment entry and often adopt non-confrontational forms of covert resistance to decisions about which they disagree. Staff sometimes deploy user involvement as a strategy for managing conflict and soliciting client compliance to treatment protocols. Suggestions for minimising and avoiding harmful conflict in treatment settings are given.

Drugs for cardiovascular disease in India: perspectives of pharmaceutical executives and government officials on access and development-a qualitative analysis.

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Newman, Charles; Ajay, Vamadevan S; Srinivas, Ravi; Bhalla, Sandeep; Prabhakaran, Dorairaj; Banerjee, Amitava

2016-01-01

India shoulders the greatest global burden of cardiovascular diseases (CVDs), which are the leading cause of mortality worldwide. Drugs are the bedrock of treatment and prevention of CVD. India's pharmaceutical industry is the third largest, by volume, globally, but access to CVD drugs in India is poor. There is a lack of qualitative data from government and pharmaceutical sectors regarding CVD drug development and access in India. By purposive sampling, we recruited either Indian government officials, or pharmaceutical company executives. We conducted a stakeholder analysis via semi-structured, face-to-face interviews in India. Topic guides allow for the exploration of key issues across multiple interviews, along with affording the interviewer the flexibility to examine matters arising from the discussions themselves. After transcription, interviews underwent inductive thematic analysis. Ten participants were interviewed (Government Officials: n = 5, and Pharmaceutical Executives: n = 5). Two themes emerged: i) 'Policy-derived Factors'; ii) 'Patient- derived Factors' with three findings. First, both government and pharmaceutical participants felt that the focus of Indian pharma is shifting to more complex, high-quality generics and to new drug development, but production of generic drugs rather than new molecular entities will remain a major activity. Second, current trial regulations in India may restrict India's potential role in the future development of CVD drugs. Third, it is likely that the Indian government will tighten its intellectual property regime in future, with potentially far-reaching implications on CVD drug development and access. Our stakeholder analysis provides some support for present patent regulations, whilst suggesting areas for further research in order to inform future policy decisions regarding CVD drug development and availability. Whilst interviewees suggested government policy plays an important role in shaping the industry, a

Nanotube structures, methods of making nanotube structures, and methods of accessing intracellular space

Science.gov (United States)

VanDersarl, Jules J.; Xu, Alexander M.; Melosh, Nicholas A.; Tayebi, Noureddine

2016-02-23

In accordance with the purpose(s) of the present disclosure, as embodied and broadly described herein, embodiments of the present disclosure, in one aspect, relate to methods of making a structure including nanotubes, a structure including nanotubes, methods of delivering a fluid to a cell, methods of removing a fluid to a cell, methods of accessing intracellular space, and the like.

Decision making, impulse control and loss of willpower to resist drugs: a neurocognitive perspective.

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Bechara, Antoine

2005-11-01

Here I argue that addicted people become unable to make drug-use choices on the basis of long-term outcome, and I propose a neural framework that explains this myopia for future consequences. I suggest that addiction is the product of an imbalance between two separate, but interacting, neural systems that control decision making: an impulsive, amygdala system for signaling pain or pleasure of immediate prospects, and a reflective, prefrontal cortex system for signaling pain or pleasure of future prospects. After an individual learns social rules, the reflective system controls the impulsive system via several mechanisms. However, this control is not absolute; hyperactivity within the impulsive system can override the reflective system. I propose that drugs can trigger bottom-up, involuntary signals originating from the amygdala that modulate, bias or even hijack the goal-driven cognitive resources that are needed for the normal operation of the reflective system and for exercising the willpower to resist drugs.

How modeling and simulation have enhanced decision making in new drug development.

Science.gov (United States)

Miller, Raymond; Ewy, Wayne; Corrigan, Brian W; Ouellet, Daniele; Hermann, David; Kowalski, Kenneth G; Lockwood, Peter; Koup, Jeffrey R; Donevan, Sean; El-Kattan, Ayman; Li, Cheryl S W; Werth, John L; Feltner, Douglas E; Lalonde, Richard L

2005-04-01

The idea of model-based drug development championed by Lewis Sheiner, in which pharmacostatistical models of drug efficacy and safety are developed from preclinical and available clinical data, offers a quantitative approach to improving drug development and development decision-making. Examples are presented that support this paradigm. The first example describes a preclinical model of behavioral activity to predict potency and time-course of response in humans and assess the potential for differentiation between compounds. This example illustrates how modeling procedures expounded by Lewis Sheiner provided the means to differentiate potency and the lag time between drug exposure and response and allow for rapid decision making and dose selection. The second example involves planning a Phase 2a dose-ranging and proof of concept trial in Alzheimer's disease (AD). The issue was how to proceed with the study and what criteria to use for a go/no go decision. The combined knowledge of AD disease progression, and preclinical and clinical information about the drug were used to simulate various clinical trial scenarios to identify an efficient and effective Phase 2 study. A design was selected and carried out resulting in a number of important learning experiences as well as extensive financial savings. The motivation for this case in point was the "Learn-Confirm" paradigm described by Lewis Sheiner. The final example describes the use of Pharmacokinetic and Pharmacodynamic (PK/PD) modeling and simulation to confirm efficacy across doses. In the New Drug Application for gabapentin, data from two adequate and well-controlled clinical trials was submitted to the Food and Drug Administration (FDA) in support of the approval of the indication for the treatment of post-herpetic neuralgia. The clinical trial data was not replicated for each of the sought dose levels in the drug application presenting a regulatory dilemma. Exposure response analysis submitted in the New Drug

Meth mouth severity in response to drug-use patterns and dental access in methamphetamine users.

Science.gov (United States)

Brown, Ronni E; Morisky, Donald E; Silverstein, Steven J

2013-06-01

Meth mouth is the rapid development of tooth decay in methamphetamine users. Our study questioned whether drug-use patterns and dental care access are risk factors affecting the severity of meth mouth. Participants received dental examinations, and the number of decayed, missing and filled teeth (DMFT) were counted and used to measure meth mouth severity.

Gaining Access to Hidden Populations: Strategies for Gaining Cooperation of Drug Sellers/Dealers and Their Families in Ethnographic Research

Science.gov (United States)

Dunlap, Eloise; Johnson, Bruce D.

2009-01-01

Summary This article examines strategies for gaining the cooperation of drug sellers and their families in order to conduct ethnographic research. The strategies were developed during an eight year study of drug dealers in New York City. A key element in gaining the ability to talk with and observe drug dealers and their family members was the availability of funds to compensate respondents for interviews and other expenses associated with building and maintaining rapport. Access to more successful crack sellers and dealers rested upon the right contacts. The “right contact” is a critical element. Locating a trusted “go-between” was adapted from strategies employed by cocaine sellers to arrange transactions involving large quantities of drugs. Such transactions rely upon a trusted associate of a dealer, the “go-between,” who performs various roles and assumes risks the dealer wishes to avoid. The role of the go-between became important when ethnographers attempted to reach drug dealers for research purposes. Favors and trust are central components in the equation of access to the dealer and his family. Favors are a part of drug dealers' interaction patterns: everyone owes someone else a favor. Such reciprocity norms exist independently of the amount of drugs involved and outlast any particular transaction. Reputations and favors are related. This framework of favors, trust, and reciprocity provides a basis for the ethnographer to gain an introduction to dealers and sellers. The “go-between” is critical because he/she explains the ethnographer's role to the dealer and helps arrange an initial meeting between the ethnographer and the seller. Once the go-between has provided an initial introduction, the ethnographer marshals the communication skills necessary to convince the dealer to allow further contact and conversations. This article examines the ritual of initial conversation within its cultural framework. Developing rapport requires showing

IMPACT OF HEALTH TECHNOLOGY ASSESSMENT IN LITIGATION CONCERNING ACCESS TO HIGH-COST DRUGS.

Science.gov (United States)

Aleman, Alicia; Perez Galan, Ana

2017-01-01

The impact of health technology assessment (HTA) in the judicialization of the right of health has not been deeply studied in Latin American countries. The purpose of this study is to review the process of judicialization of the access to high cost drugs in Uruguay and assess the impact HTAs have had on this process. The methodology used for this study included a comprehensive literature search in electronic databases, local journals, internal documents developed in the Ministry of Health, as well as conducting interviews with key informants. Judicialization of the access of high cost drugs has been increasing since 2010. The strategy of the Ministry of Health of Uruguay to decrease this problem included the organization of roundtables with judges and other stakeholders on the basis of HTA, the training of defense lawyers in the use and interpretation of HTA, and the participation of a professional who develops HTA in the preparation of the defense arguments. A year after the implementation of this strategy, 25 percent of writs of protection were won by the Ministry of Health. Even though the strategy implemented was effective in reducing the loss of litigations, it was not effective in reducing the growing number of writs of protection. It is essential to address this problem in a broad debate and to promote understanding between the parties.

Analysis of access to hypertensive and diabetic drugs in the Family Health Strategy, State of Pernambuco, Brazil.

Science.gov (United States)

Barreto, Maria Nelly Sobreira de Carvalho; Cesse, Eduarda Ângela Pessoa; Lima, Rodrigo Fonseca; Marinho, Michelly Geórgia da Silva; Specht, Yuri da Silva; de Carvalho, Eduardo Maia Freese; Fontbonne, Annick

2015-01-01

To evaluate the access to drugs for hypertension and diabetes and the direct cost of buying them among users of the Family Health Strategy (FHS) in the state of Pernambuco, Brazil. Population-based, cross-sectional study of a systematic random sample of 785 patients with hypertension and 823 patients with diabetes mellitus who were registered in 208 randomly selected FHS teams in 35 municipalities of the state of Pernambuco. The selected municipalities were classified into three levels with probability proportional to municipality size (LS, large-sized; MS, medium-sized; SS, small-sized). To verify differences between the cities, we used the χ2 test. Pharmacological treatment was used by 91.2% patients with hypertension whereas 85.6% patients with diabetes mellitus used oral antidiabetic drugs (OADs), and 15.4% used insulin. The FHS team itself provided antihypertensive medications to 69.0% patients with hypertension, OADs to 75.0% patients with diabetes mellitus, and insulin treatment to 65.4%. The 36.9% patients with hypertension and 29.8% with diabetes mellitus that had to buy all or part of their medications reported median monthly cost of R$ 18.30, R$ 14.00, and R$ 27.61 for antihypertensive drugs, OADs, and insulin, respectively. It is necessary to increase efforts to ensure access to these drugs in the primary health care network.

Analysis of access to hypertensive and diabetic drugs in the Family Health Strategy, State of Pernambuco, Brazil

Directory of Open Access Journals (Sweden)

Maria Nelly Sobreira de Carvalho Barreto

2015-06-01

Full Text Available OBJECTIVE: To evaluate the access to drugs for hypertension and diabetes and the direct cost of buying them among users of the Family Health Strategy (FHS in the state of Pernambuco, Brazil.METHODS: Population-based, cross-sectional study of a systematic random sample of 785 patients with hypertension and 823 patients with diabetes mellitus who were registered in 208 randomly selected FHS teams in 35 municipalities of the state of Pernambuco. The selected municipalities were classified into three levels with probability proportional to municipality size (LS, large-sized; MS, medium-sized; SS, small-sized. To verify differences between the cities, we used the χ2 test.RESULTS: Pharmacological treatment was used by 91.2% patients with hypertension whereas 85.6% patients with diabetes mellitus used oral antidiabetic drugs (OADs, and 15.4% used insulin. The FHS team itself provided antihypertensive medications to 69.0% patients with hypertension, OADs to 75.0% patients with diabetes mellitus, and insulin treatment to 65.4%. The 36.9% patients with hypertension and 29.8% with diabetes mellitus that had to buy all or part of their medications reported median monthly cost of R$ 18.30, R$ 14.00, and R$ 27.61 for antihypertensive drugs, OADs, and insulin, respectively.CONCLUSION: It is necessary to increase efforts to ensure access to these drugs in the primary health care network.

How do the EMA and FDA decide which anticancer drugs make it to the market? A comparative qualitative study on decision makers' views.

Science.gov (United States)

Tafuri, G; Stolk, P; Trotta, F; Putzeist, M; Leufkens, H G; Laing, R O; De Allegri, M

2014-01-01

The process leading to a regulatory outcome is guided by factors both related and unrelated to the data package, defined in this analysis as 'formal and informal factors', respectively. The aim of this qualitative study was to analyse which formal and informal factors drive the decision-making process of the European Medicines Agency (EMA) and Food and Drug Administration (FDA) regulators with regard to anticancer drugs, using in-depth semi-structured interviews with regulators of the two agencies. In line with the theory and practice of qualitative research, no set sample size was defined a priori. Respondent enrolment continued until saturation and redundancy were reached. Data were collected through means of in-depth semi-structured interviews conducted either in a face-to-face setting or via Skype(®) with each regulator. The interviews were audio-recorded and verbatim transcribed. The analysis was manually carried out on the transcribed text. Data were independently coded and categorized by two researchers. Interpretation of the findings emerged through a process of triangulation between the two. Seven EMA and six FDA regulators, who had extensive experience with making decisions about anticancer medicines, were interviewed between April and June 2012. There is an open dialogue between the FDA and EMA, with the two moving closer and exchanging information, not opinions. Differences in decision-making between the agencies may be due to a different evaluation of end points. Different interaction modalities with industry and patients represent an additional source of divergence with a potential impact on decision-making. The key message of our respondents was that the agencies manage uncertainty in a different way: unlike the EMA, the FDA has a prevailing attitude to take risks in order to guarantee quicker access to new treatments. Although formal factors are the main drivers for regulatory decisions, the influence of informal factors plays an important role in

Accessible Knowledge - Knowledge on Accessibility

DEFF Research Database (Denmark)

Kirkeby, Inge Mette

2015-01-01

Although serious efforts are made internationally and nationally, it is a slow process to make our physical environment accessible. In the actual design process, architects play a major role. But what kinds of knowledge, including research-based knowledge, do practicing architects make use of when...... designing accessible environments? The answer to the question is crucially important since it affects how knowledge is distributed and how accessibility can be ensured. In order to get first-hand knowledge about the design process and the sources from which they gain knowledge, 11 qualitative interviews...... were conducted with architects with experience of designing for accessibility. The analysis draws on two theoretical distinctions. The first is research-based knowledge versus knowledge used by architects. The second is context-independent knowledge versus context-dependent knowledge. The practitioners...

An early examination of access to select orphan drugs treating rare diseases in health insurance exchange plans.

Science.gov (United States)

Robinson, Sandy W; Brantley, Kelly; Liow, Christine; Teagarden, J Russell

2014-10-01

Patients with rare diseases often face significant health care access challenges, particularly since the number of available treatment options for rare diseases is limited. The implementation of health insurance exchanges promises improved access to health care. However, when purchasing a plan, patients with rare diseases need to consider multiple factors, such as insurance premium, access to providers, coverage of a specific medication or treatment, tier placement of drug, and out-of-pocket costs.  To provide an early snapshot of the exchange plan landscape from the perspective of patients with select rare diseases by evaluating the degree of access to medications in a subset of exchange plans based on coverage, tier placement, associated cost sharing, and utilization management (UM) applied.  The selection of drugs for this analysis began by identifying rare diseases with FDA-approved treatment options using the National Institutes of Health Office of Rare Diseases' webpage and further identification of a subset of drugs based on select criteria to ensure a varied sample, including the characteristics and prevalence of the condition. The medications were categorized based on whether alternative therapies have FDA approval for the same indication and whether there are comparators based on class or therapeutic area. The list was narrowed to 11 medications across 7 diseases, and the analysis was based on how these drugs are listed in exchange plan outpatient pharmacy benefit formularies. This analysis focused on 84 plans in 15 states with the highest expected exchange enrollment and included a variety of plan types to ensure that variability in the marketplace was represented. To best approximate plans that will have the greatest enrollment, the analysis focused on silver and bronze plan formularies because consumers in this market are expected to be sensitive to premiums. Data on drug coverage, tier placement, cost, and UM were collected from these plans

Making USGS Science Data more Open, Accessible, and Usable: Leveraging ScienceBase for Success

Science.gov (United States)

Chang, M.; Ignizio, D.; Langseth, M. L.; Norkin, T.

2016-12-01

In 2013, the White House released initiatives requiring federally funded research to be made publicly available and machine readable. In response, the U.S. Geological Survey (USGS) has been developing a unified approach to make USGS data available and open. This effort has involved the establishment of internal policies and the release of a Public Access Plan, which outlines a strategy for the USGS to move forward into the modern era in scientific data management. Originally designed as a catalog and collaborative data management platform, ScienceBase (www.sciencebase.gov) is being leveraged to serve as a robust data hosting solution for USGS researchers to make scientific data accessible. With the goal of maintaining persistent access to formal data products and developing a management approach to facilitate stable data citation, the ScienceBase Data Release Team was established to ensure the quality, consistency, and meaningful organization of USGS data through standardized workflows and best practices. These practices include the creation and maintenance of persistent identifiers for data, improving the use of open data formats, establishing permissions for read/write access, validating the quality of standards compliant metadata, verifying that data have been reviewed and approved prior to release, and connecting to external search catalogs such as the USGS Science Data Catalog (data.usgs.gov) and data.gov. The ScienceBase team is actively building features to support this effort by automating steps to streamline the process, building metrics to track site visits and downloads, and connecting published digital resources in line with USGS and Federal policy. By utilizing ScienceBase to achieve stewardship quality and employing a dedicated team to help USGS scientists improve the quality of their data, the USGS is helping to meet today's data quality management challenges and ensure that reliable USGS data are available to and reusable for the public.

Access to benznidazole for Chagas disease in the United States-Cautious optimism?

Directory of Open Access Journals (Sweden)

Jonathan D Alpern

2017-09-01

Full Text Available Drugs for neglected tropical diseases (NTD are being excessively priced in the United States. Benznidazole, the first-line drug for Chagas disease, may become approved by the Food and Drug Administration (FDA and manufactured by a private company in the US, thus placing it at risk of similar pricing. Chagas disease is an NTD caused by Trypanosoma cruzi; it is endemic to Latin America, infecting 8 million individuals. Human migration has changed the epidemiology causing nonendemic countries to face increased challenges in diagnosing and managing patients with Chagas disease. Only 2 drugs exist with proven efficacy: benznidazole and nifurtimox. Benznidazole has historically faced supply problems and drug shortages, limiting accessibility. In the US, it is currently only available under an investigational new drug (IND protocol from the CDC and is provided free of charge to patients. However, 2 companies have stated that they intend to submit a New Drug Application (NDA for FDA approval. Based on recent history of companies acquiring licensing rights for NTD drugs in the US with limited availability, it is likely that benznidazole will become excessively priced by the manufacturer-paradoxically making it less accessible. However, if the companies can be taken at their word, there may be reason for optimism.

Access to benznidazole for Chagas disease in the United States-Cautious optimism?

Science.gov (United States)

Alpern, Jonathan D; Lopez-Velez, Rogelio; Stauffer, William M

2017-09-01

Drugs for neglected tropical diseases (NTD) are being excessively priced in the United States. Benznidazole, the first-line drug for Chagas disease, may become approved by the Food and Drug Administration (FDA) and manufactured by a private company in the US, thus placing it at risk of similar pricing. Chagas disease is an NTD caused by Trypanosoma cruzi; it is endemic to Latin America, infecting 8 million individuals. Human migration has changed the epidemiology causing nonendemic countries to face increased challenges in diagnosing and managing patients with Chagas disease. Only 2 drugs exist with proven efficacy: benznidazole and nifurtimox. Benznidazole has historically faced supply problems and drug shortages, limiting accessibility. In the US, it is currently only available under an investigational new drug (IND) protocol from the CDC and is provided free of charge to patients. However, 2 companies have stated that they intend to submit a New Drug Application (NDA) for FDA approval. Based on recent history of companies acquiring licensing rights for NTD drugs in the US with limited availability, it is likely that benznidazole will become excessively priced by the manufacturer-paradoxically making it less accessible. However, if the companies can be taken at their word, there may be reason for optimism.

Distance, accessibility and costs. Decision-making during childbirth in rural Sierra Leone: A qualitative study.

Directory of Open Access Journals (Sweden)

Laura Treacy

Full Text Available Sierra Leone has one of the highest maternal mortality ratios in the world. Efforts to reduce maternal mortality have included initiatives to encourage more women to deliver at health facilities. Despite the introduction of the free health care initiative for pregnant women, many women still continue to deliver at home, with few having access to a skilled birth attendant. In addition, inequalities between rural and urban areas in accessing and utilising health facilities persist. Further insight into how and why women make decisions around childbirth will help guide future plans and initiatives in improving maternal health in Sierra Leone. The objective of this study was to explore the perceptions and decision-making processes of women and their communities during childbirth in rural Sierra Leone.Data were collected through seven focus group discussions and 22 in-depth interviews with recently pregnant women and their community members in two rural villages. Data were analysed using systematic text condensation. Findings revealed that decision-making processes during childbirth are dynamic, intricate and need to be understood within the broader social context that they take place. Factors such as distance and lack of transport, perceived negative behaviour of hospital staff, direct and indirect financial obstacles, as well as the position of women in society all interact and influence how and what decisions are made.Pregnant women face multiple interacting vulnerabilities that influence their healthcare-seeking decisions during pregnancy and childbirth. Future initiatives to improve access and utilisation of safe healthcare services for pregnant women need to be based on adequate knowledge of structural constraints and health inequities that affect women in rural Sierra Leone.

Chronic cranial window with access port for repeated cellular manipulations, drug application, and electrophysiology

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Christopher Joel Roome

2014-11-01

Full Text Available Chronic cranial windows have been instrumental in advancing optical studies in vivo, permitting long-term, high-resolution imaging in various brain regions. However, once a window is attached it is difficult to regain access to the brain under the window for cellular manipulations. Here we describe a simple device that combines long term in vivo optical imaging with direct brain access via glass or quartz pipettes and metal, glass, or quartz electrodes for cellular manipulations like dye or drug injections and electrophysiological stimulations or recordings while keeping the craniotomy sterile. Our device comprises a regular cranial window glass coverslip with a drilled access hole later sealed with biocompatible silicone. This chronic cranial window with access port is cheap, easy to manufacture, can be mounted just as the regular chronic cranial window, and is self-sealing after retraction of the pipette or electrode. We demonstrate that multiple injections can be performed through the silicone port by repetitively bolus loading calcium sensitive dye into mouse barrel cortex and recording spontaneous cellular activity over a period of weeks. As an example to the extent of its utility for electrophysiological recording, we describe how simple removal of the silicone seal can permit patch pipette access for whole-cell patch clamp recordings in vivo. During these chronic experiments we do not observe any infections under the window or impairment of animal health.

Effectiveness of Drug Education Components: Knowledge, Attitudes, Decision Making, Motivations, and Self-Esteem.

Science.gov (United States)

Roberts, Scott W.

1995-01-01

This study examined the effectiveness of school-based drug education in affecting knowledge, attitudes, decision making, motivation, and self-esteem. Pre- and postintervention surveys of fourth through eighth graders indicated that self-esteem did not improve significantly. Knowledge and attitude scores improved significantly, with a positive…

Capillary column switching restricted-access media-liquid chromatography-electrospray ionization-tandem mass spectrometry system for simultaneous and direct analysis of drugs in biofluids.

Science.gov (United States)

Santos-Neto, Alvaro J; Markides, Karin E; Sjöberg, Per J R; Bergquist, Jonas; Lancas, Fernando M

2007-08-15

Capillary online restricted-access media-liquid chromatography-electrospray ionization-tandem mass spectrometry (RAM-LC-ESI-MS/MS) for direct analysis of drugs and metabolites spiked in biological fluids was developed. Using a column switching setup it was possible to perform effective sample preparation and analysis of raw biological fluids (plasma and urine) without matrix effects in the electrospray mass spectrometric detection step. The peak focusing efficiency of the extraction column was more effective in backflush compared to foreflush mode. The system was able to concentrate diminished samples of polar drugs and their metabolites reaching quantifiable results as low as 1 ng/mL utilizing a sample volume of only 333 nL of biofluids. New column hardware was developed to circumvent clogging problems experienced with plasma injections. The glass fiber filter frit, which is commonly used, was replaced with a short piece of 20 microm i.d. fused silica capillary. The extraction columns were able to handle up to 60 injections and showed a high loading capacity, making the saturation of the MS detector the limiting factor on the linear dynamic range. The simultaneous separation and detection of 10 drugs and metabolites was obtained in 8 min of analysis, including the online sample preparation and enrichment step.

Patients' considerations in the decision-making process of initiating disease-modifying anti-rheumatic drugs

NARCIS (Netherlands)

Nota, Ingrid; Drossaert, Constance H.C.; Taal, Erik; van de Laar, Mart A F J

2015-01-01

Objectives To explore what considerations patients have when deciding about disease-modifying anti-rheumatic drugs (DMARDs) and what information patients need to participate in the decision-making process. Methods In-depth face-to-face interviews were conducted with 32 inflammatory arthritis

Restricted access magnetic materials prepared by dual surface modification for selective extraction of therapeutic drugs from biological fluids

Energy Technology Data Exchange (ETDEWEB)

Wang Yu; Wang Yuxia; Chen Lei [School of Pharmaceutical Science and Technology, Tianjin University, Tianjin 300072 (China); Wan Qianhong, E-mail: qhwan@tju.edu.cn [School of Pharmaceutical Science and Technology, Tianjin University, Tianjin 300072 (China)

2012-02-15

Magnetic porous particles with dual functionality have been prepared by a two-step procedure and evaluated as novel restricted access materials for extraction of therapeutic agents from biological fluids. The magnetic silica particles served as scaffolds were first modified with diol groups, which were then converted to octadecyl esters through reaction with stearoyl chloride. In the second step, the octadecyl esters on the exterior surface were hydrolyzed by the action of lipase to yield magnetic particles with hydrophobic reversed-phase ligands on the inner surface and biocompatible diol groups on the outer surface. The restricted access behavior of the resulting materials was confirmed by differential binding of small molecules such as methotrexate (MTX), leucovorin (LV) and folic acid (FA) relative to bovine serum albumin. While MTX, LV and FA were all bound to the magnetic particles with high affinity, the adsorption of the protein was markedly reduced due to size exclusion effect. The utility of the magnetic particles for sample preparation was tested in solid-phase extraction of MTX, LV and FA from spiked human serum and the effects of the SPE conditions on the recovery of the analytes were systematically studied. Moreover, the magnetic particle-based sample preparation procedure coupled with reversed-phase liquid chromatography analysis was validated in terms of specificity, linearity and reproducibility. The method was shown to be free from interference of endogenous compounds and linear over the concentration range of 0.5-10 {mu}g/mL for the three drugs studied. The limits of detection for the three drugs in serum were in the range of 0.160-0.302 {mu}g/mL. Reproducibility expressed as the RSD of the recovery for ten replicated extractions at three different concentrations was found to be less than 8.93%. With a unique combination of surface functionality with magnetic cores, the restricted access magnetic particles may be adapted in automated and high

Geographic approaches to quantifying the risk environment: a focus on syringe exchange program site access and drug-related law enforcement activities

Science.gov (United States)

Cooper, Hannah LF; Bossak, Brian; Tempalski, Barbara; Des Jarlais, Don C.; Friedman, Samuel R.

2009-01-01

The concept of the “risk environment” – defined as the “space … [where] factors exogenous to the individual interact to increase the chances of HIV transmission” – draws together the disciplines of public health and geography. Researchers have increasingly turned to geographic methods to quantify dimensions of the risk environment that are both structural and spatial (e.g., local poverty rates). The scientific power of the intersection between public health and geography, however, has yet to be fully mined. In particular, research on the risk environment has rarely applied geographic methods to create neighbourhood-based measures of syringe exchange programs (SEPs) or of drug-related law enforcement activities, despite the fact that these interventions are widely conceptualized as structural and spatial in nature and are two of the most well-established dimensions of the risk environment. To strengthen research on the risk environment, this paper presents a way of using geographic methods to create neighbourhood-based measures of (1) access to SEP sites and (2) exposure to drug-related arrests, and then applies these methods to one setting (New York City). NYC-based results identified substantial cross-neighbourhood variation in SEP site access and in exposure to drug-related arrest rates (even within the subset of neighbourhoods nominally experiencing the same drug-related police strategy). These geographic measures – grounded as they are in conceptualizations of SEPs and drug-related law enforcement strategies – can help develop new arenas of inquiry regarding the impact of these two dimensions of the risk environment on injectors’ health, including exploring whether and how neighbourhood-level access to SEP sites and exposure to drug-related arrests shape a range of outcomes among local injectors. PMID:18963907

Community Impact of Pharmacy-Randomized Intervention to Improve Access to Syringes and Services for Injection Drug Users

Science.gov (United States)

Crawford, Natalie D.; Amesty, Silvia; Rivera, Alexis V.; Harripersaud, Katherine; Turner, Alezandria; Fuller, Crystal M.

2014-01-01

Objectives: In an effort to reduce HIV transmission among injection drug users (IDUs), New York State deregulated pharmacy syringe sales in 2001 through the Expanded Syringe Access Program by removing the requirement of a prescription. With evidence suggesting pharmacists' ability to expand their public health role, a structural, pharmacy-based…

Optimal Implementation of Prescription Drug Monitoring Programs in the Emergency Department

Directory of Open Access Journals (Sweden)

Garrett DePalma

2018-02-01

Full Text Available The opioid epidemic is the most significant modern-day, public health crisis. Physicians and lawmakers have developed methods and practices to curb opioid use. This article describes one method, prescription drug monitoring programs (PDMP, through the lens of how to optimize use for emergency departments (ED. EDs have rapidly become a central location to combat opioid abuse and drug diversion. PDMPs can provide emergency physicians with comprehensive prescribing information to improve clinical decisions around opioids. However, PDMPs vary tremendously in their accessibility and usability in the ED, which limits their effectiveness at the point of care. Problems are complicated by varying state-to-state requirements for data availability and accessibility. Several potential solutions to improving the utility of PDMPs in EDs include integrating PDMPs with electronic health records, implementing unsolicited reporting and prescription context, improving PDMP accessibility, data analytics, and expanding the scope of PDMPs. These improvements may help improve clinical decision-making for emergency physicians through better data, data presentation, and accessibility.

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

Science.gov (United States)

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

2008-07-01

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

Homeless drug users and information technology: a qualitative study with potential implications for recovery from drug dependence.

Science.gov (United States)

Neale, Joanne; Stevenson, Caral

2014-09-01

Having access to information and communication technologies (ICTs) is a prerequisite to meaningful participation in society. This paper seeks to: i. explore the engagement of homeless drug users (HDUs) with ICTs and ii. discuss the findings with reference to recovery from drug dependence. The study design was qualitative and longitudinal, involving data collected in 2012-13 via 52 semi-structured interviews with 30 homeless drug users (25 men; five women). Participants were recruited from 17 hostels in two English cities. Interview data were analyzed using Framework. HDUs had access to ICTs, used ICTs, and wanted to engage with them more. Experiences of digital exclusion were a function of participants' inability to afford ICTs, the relatively cheap and poor quality technology available to them, limited knowledge about ICTs, and lack of support in using them. That HDUs were often unable to take full advantage of technology because they had nobody to explain what their devices could do or to show them how they worked was ironic given that using ICTs to (re)establish and maintain relationships were functions of technology that HDUs particularly liked. The physical, human, cultural, and social capital of HDUs influenced their access to, and use of, ICTs. Equally, ICTs were themselves an important recovery resource. Services and others should endeavor to provide HDUs with easy access to good quality technology, as well as offers of support and education so that all individuals have the knowledge and confidence to make optimum use of the technology that is available to them.

Evidence on the cost of breast cancer drugs is required for rational decision making.

Science.gov (United States)

Berghuis, Anne Margreet Sofie; Koffijberg, Hendrik; Terstappen, Leonardus Wendelinus Mathias Marie; Sleijfer, Stefan; IJzerman, Maarten Joost

2018-01-01

For rational decision making, assessing the cost-effectiveness and budget impact of new drugs and comparing the costs of drugs already on the market is required. In addition to value frameworks, such as the American Society of Clinical Oncology Value Framework and the European Society of Medical Oncology-Magnitude of Clinical benefit Scale, this also requires a transparent overview of actual drug prices. While list prices are available, evidence on treatment cost is not. This paper aims to synthesise evidence on the reimbursement and costs of high-cost breast cancer drugs in The Netherlands (NL). A literature review was performed to identify currently reimbursed breast cancer drugs in the NL. Treatment costs were determined by multiplying list prices with the average length of treatment and dosing schedule. Comparing list prices to the estimated treatment cost resulted in substantial differences in the ranking of costliness of the drugs. The average mean treatment length was unknown for 11/31 breast cancer drugs (26.2%). The differences in the 15 highest-cost drugs were largest for Bevacizumab, Lapatinib and everolimus, with list prices of €541, €158, €1,168 and estimated treatment cost of €174,400, €18,682 and €31,207, respectively. The lowest-cost (patented) targeted drug is €1,818 more expensive than the highest-cost (off-patent) generic drug according to the estimated drug treatment cost. A lack of evidence on the reimbursement and cost of high-cost breast cancer drugs complicates rapid and transparent evidence synthesis, necessary to focus strategies aiming to limit the increasing healthcare costs. Interestingly, the findings show that off-patent generics (such as paclitaxel or doxorubicin), although substantially cheaper than patented drugs, are still relatively costly. Extending standardisation and increasing European and national regulations on presenting information on costs per cancer drug is highly recommended.

Some Numbers behind Canada's Decision to Adopt an Orphan Drug Policy: US Orphan Drug Approvals in Canada, 1997-2012.

Science.gov (United States)

Herder, Matthew; Krahn, Timothy Mark

2016-05-01

We examined whether access to US-approved orphan drugs in Canada has changed between 1997 (when Canada chose not to adopt an orphan drug policy) and 2012 (when Canada reversed its policy decision). Specifically, we looked at two dimensions of access to US-approved orphan drugs in Canada: (1) regulatory access; and (2) temporal access. Whereas only 63% of US-approved orphan drugs were granted regulatory approval in 1997, we found that regulatory access to US-approved orphan drugs in Canada increased to 74% between 1997 and 2012. However, temporal access to orphan drugs is slower in Canada: in a head-on comparison of 40 matched drugs, only two were submitted and four were approved first in Canada; moreover, the mean review time in Canada (423 days) was longer than that in the US (mean = 341 days), a statistically significant difference (t[39] = 2.04, p = 0.048). These results raise questions about what motivated Canada's apparent shift in orphan drug policy. Copyright © 2016 Longwoods Publishing.

Dopaminergic Drug Effects on Probability Weighting during Risky Decision Making.

Science.gov (United States)

Ojala, Karita E; Janssen, Lieneke K; Hashemi, Mahur M; Timmer, Monique H M; Geurts, Dirk E M; Ter Huurne, Niels P; Cools, Roshan; Sescousse, Guillaume

2018-01-01

Dopamine has been associated with risky decision-making, as well as with pathological gambling, a behavioral addiction characterized by excessive risk-taking behavior. However, the specific mechanisms through which dopamine might act to foster risk-taking and pathological gambling remain elusive. Here we test the hypothesis that this might be achieved, in part, via modulation of subjective probability weighting during decision making. Human healthy controls ( n = 21) and pathological gamblers ( n = 16) played a decision-making task involving choices between sure monetary options and risky gambles both in the gain and loss domains. Each participant played the task twice, either under placebo or the dopamine D 2 /D 3 receptor antagonist sulpiride, in a double-blind counterbalanced design. A prospect theory modelling approach was used to estimate subjective probability weighting and sensitivity to monetary outcomes. Consistent with prospect theory, we found that participants presented a distortion in the subjective weighting of probabilities, i.e., they overweighted low probabilities and underweighted moderate to high probabilities, both in the gain and loss domains. Compared with placebo, sulpiride attenuated this distortion in the gain domain. Across drugs, the groups did not differ in their probability weighting, although gamblers consistently underweighted losing probabilities in the placebo condition. Overall, our results reveal that dopamine D 2 /D 3 receptor antagonism modulates the subjective weighting of probabilities in the gain domain, in the direction of more objective, economically rational decision making.

Dopaminergic Drug Effects on Probability Weighting during Risky Decision Making

Science.gov (United States)

Timmer, Monique H. M.; ter Huurne, Niels P.

2018-01-01

Abstract Dopamine has been associated with risky decision-making, as well as with pathological gambling, a behavioral addiction characterized by excessive risk-taking behavior. However, the specific mechanisms through which dopamine might act to foster risk-taking and pathological gambling remain elusive. Here we test the hypothesis that this might be achieved, in part, via modulation of subjective probability weighting during decision making. Human healthy controls (n = 21) and pathological gamblers (n = 16) played a decision-making task involving choices between sure monetary options and risky gambles both in the gain and loss domains. Each participant played the task twice, either under placebo or the dopamine D2/D3 receptor antagonist sulpiride, in a double-blind counterbalanced design. A prospect theory modelling approach was used to estimate subjective probability weighting and sensitivity to monetary outcomes. Consistent with prospect theory, we found that participants presented a distortion in the subjective weighting of probabilities, i.e., they overweighted low probabilities and underweighted moderate to high probabilities, both in the gain and loss domains. Compared with placebo, sulpiride attenuated this distortion in the gain domain. Across drugs, the groups did not differ in their probability weighting, although gamblers consistently underweighted losing probabilities in the placebo condition. Overall, our results reveal that dopamine D2/D3 receptor antagonism modulates the subjective weighting of probabilities in the gain domain, in the direction of more objective, economically rational decision making. PMID:29632870

Judging the morality of utilitarian actions: How poor utilitarian accessibility makes judges irrational.

Science.gov (United States)

Kusev, Petko; van Schaik, Paul; Alzahrani, Shrooq; Lonigro, Samantha; Purser, Harry

2016-12-01

Is it acceptable and moral to sacrifice a few people's lives to save many others? Research on moral dilemmas in psychology, experimental philosophy, and neuropsychology has shown that respondents judge utilitarian personal moral actions (footbridge dilemma) as less appropriate than equivalent utilitarian impersonal moral actions (trolley dilemma). Accordingly, theorists (e.g., Greene et al., 2001) have argued that judgments of appropriateness in personal moral dilemmas are more emotionally salient and cognitively demanding (taking more time to be rational) than impersonal moral dilemmas. Our novel findings show an effect of psychological accessibility (driven by partial contextual information; Kahneman, 2003) on utilitarian moral behavior and response time for rational choices. Enhanced accessibility of utilitarian outcomes through comprehensive information about moral actions and consequences boosted utility maximization in moral choices, with rational choices taking less time. Moreover, our result suggests that previous results indicating emotional interference, with rational choices taking more time to make, may have been artifacts of presenting partial information.

Guidelines for Making Web Content Accessible to All Users

Science.gov (United States)

Thompson, Terrill; Primlani, Saroj; Fiedor, Lisa

2009-01-01

The main goal of accessibility standards and guidelines is to design websites everyone can use. The "IT Accessibility Constituent Group" developed this set of draft guidelines to help EQ authors, reviewers, and staff and the larger EDUCAUSE community ensure that web content is accessible to all users, including those with disabilities. This…

Finding the loopholes: a cross-sectional qualitative study of systemic barriers to treatment access for women drug court participants.

Science.gov (United States)

Morse, Diane S; Silverstein, Jennifer; Thomas, Katherine; Bedel, Precious; Cerulli, Catherine

2015-12-01

Therapeutic diversion courts seek to address justice-involved participants' underlying problems leading to their legal system involvement, including substance use disorder, psychiatric illness, and intimate partner violence. The courts have not addressed systemic hurdles, which can contribute to a cycle of substance use disorder and recidivism, which in turn hinder health and wellness. The study purpose is to explore the systemic issues faced by women participants in drug treatment court from multiple perspectives to understand how these issues may relate to health and wellness in their lives. Qualitative thematic framework analysis of five separate focus groups consisting of female drug treatment court participants, community providers, and court staff ( n = 25). Themes were mapped across the socio-ecological framework and contextualized according to social determinants of health. Numerous systemic factors impacted women's access to treatment. Laws and legal policies (governance) excluded those who could potentially have benefitted from therapeutic court and did not allow consideration of parenting issues. Macroeconomic policies limit housing options for those with convictions. Social policies limited transportation, education, and employment options. Public policies limited healthcare and social protection and ability to access available resources. Culture and societal values, including stigma, limited treatment options. By understanding the social determinant of health for women in drug treatment court and stakeholder's perceptions, the legal system can implement public policy to better address the health needs of women drug court participants.

Restricted access magnetic materials prepared by dual surface modification for selective extraction of therapeutic drugs from biological fluids

International Nuclear Information System (INIS)

Wang Yu; Wang Yuxia; Chen Lei; Wan Qianhong

2012-01-01

Magnetic porous particles with dual functionality have been prepared by a two-step procedure and evaluated as novel restricted access materials for extraction of therapeutic agents from biological fluids. The magnetic silica particles served as scaffolds were first modified with diol groups, which were then converted to octadecyl esters through reaction with stearoyl chloride. In the second step, the octadecyl esters on the exterior surface were hydrolyzed by the action of lipase to yield magnetic particles with hydrophobic reversed-phase ligands on the inner surface and biocompatible diol groups on the outer surface. The restricted access behavior of the resulting materials was confirmed by differential binding of small molecules such as methotrexate (MTX), leucovorin (LV) and folic acid (FA) relative to bovine serum albumin. While MTX, LV and FA were all bound to the magnetic particles with high affinity, the adsorption of the protein was markedly reduced due to size exclusion effect. The utility of the magnetic particles for sample preparation was tested in solid-phase extraction of MTX, LV and FA from spiked human serum and the effects of the SPE conditions on the recovery of the analytes were systematically studied. Moreover, the magnetic particle-based sample preparation procedure coupled with reversed-phase liquid chromatography analysis was validated in terms of specificity, linearity and reproducibility. The method was shown to be free from interference of endogenous compounds and linear over the concentration range of 0.5-10 μg/mL for the three drugs studied. The limits of detection for the three drugs in serum were in the range of 0.160-0.302 μg/mL. Reproducibility expressed as the RSD of the recovery for ten replicated extractions at three different concentrations was found to be less than 8.93%. With a unique combination of surface functionality with magnetic cores, the restricted access magnetic particles may be adapted in automated and high

Temporary authorization for use: does the French patient access programme for unlicensed medicines impact market access after formal licensing?

Science.gov (United States)

Degrassat-Théas, Albane; Paubel, Pascal; Parent de Curzon, Olivier; Le Pen, Claude; Sinègre, Martine

2013-04-01

To reach the French market, a new drug requires a marketing authorization (MA) and price and reimbursement agreements. These hurdles could delay access to new and promising drugs. Since 1992, French law authorizes the use of unlicensed drugs on an exceptional and temporary basis through a compassionate-use programme, known as Temporary Authorization for Use (ATU). This programme was implemented to improve early access to drugs under development or authorized abroad. However, it is suspected to be inflationary, bypassing public bodies in charge of health technology assessment (HTA) and of pricing. The aim of this study is to observe the market access after the formal licensing of drugs that went through this compassionate-use programme. We included all ATUs that received an MA between 1 January 2005 and 30 June 2010. We first examined market access delays from these drugs using the standard administrative path. We positioned this result in relation to launch delays observed in France (for all outpatient drugs) and in other major European markets. Second, we assessed the bargaining power of a hospital purchaser after those drugs had obtained an MA by calculating the price growth rate after the approval. During the study period, 77 ATUs were formally licensed. The study concluded that, from the patient's perspective, licensing and public bodies' review time was shortened by a combined total of 36 months. The projected 11-month review time of public bodies may be longer than delays usually observed for outpatient drugs. Nonetheless, the study revealed significant benefits for French patient access based on comparable processing to launch time with those of other European countries with tight price control policies. In return, a 12 % premium, on average, is paid to pharmaceutical companies while drugs are under this status (sub-analysis on 56 drugs). In many instances, the ATU programme responds to a public health need by accelerating the availability of new drugs

Miracle drug: Brazil approves never-tested cancer medicine.

Science.gov (United States)

Kuchenbecker, Ricardo S; Mota, Daniel M

2017-07-01

Background Brazil recently approved synthetic phosphoetanolamine, a popularly dubbed 'cancer pill', a substance that has been shown to kill cancer cells in lab animal models but was not yet formally accessed in humans, and thus despite the existence of any evidence of its efficacy and safety. Methods The authors describe the recent decision of Brazil to aprove phosphoetanolamine in the context of growing 'judicialization' to promote access to medicines and thus reinforcing a growing sense of legal uncertainty. Results The approval of phosphoetanolamine despite the existence of any evidence of its efficacy and safety represents to the authors one of the saddest and surrealistic episodes in Brazil's recent public health history. Brazil's current economic crisis is fueling the 'judicialization' to promote access to medicines and thus reinforcing a growing sense of legal uncertainty in the context of rising economic constrains and a progressive failing state. The authors state that the Phosphoetanolamine's approval bill violates current legal prohibition of commercialisation of drugs without the Brazilian national drug regulatory agency's approval and thus may represent a potential menace to Brazil's pharmacogovernance and the country's governance to health technology assessment at the Brazilian national health systems. Conclusion Phosphoetanolamine's approval illustrates that the combination of flawed decision making, economic crisis and political interference may threaten weak governance mechanisms for drug regulation and health technology assessment and thus representing an extra burden in the sustainability of universal access-based national health systems.

The Utility of Impulsive Bias and Altered Decision Making as Predictors of Drug Efficacy and Target Selection: Rethinking Behavioral Screening for Antidepressant Drugs.

Science.gov (United States)

Marek, Gerard J; Day, Mark; Hudzik, Thomas J

2016-03-01

Cognitive dysfunction may be a core feature of major depressive disorder, including affective processing bias, abnormal response to negative feedback, changes in decision making, and increased impulsivity. Accordingly, a translational medicine paradigm predicts clinical action of novel antidepressants by examining drug-induced changes in affective processing bias. With some exceptions, these concepts have not been systematically applied to preclinical models to test new chemical entities. The purpose of this review is to examine whether an empirically derived behavioral screen for antidepressant drugs may screen for compounds, at least in part, by modulating an impulsive biasing of responding and altered decision making. The differential-reinforcement-of-low-rate (DRL) 72-second schedule is an operant schedule with a documented fidelity for discriminating antidepressant drugs from nonantidepressant drugs. However, a theoretical basis for this empirical relationship has been lacking. Therefore, this review will discuss whether response bias toward impulsive behavior may be a critical screening characteristic of DRL behavior requiring long inter-response times to obtain rewards. This review will compare and contrast DRL behavior with the five-choice serial reaction time task, a test specifically designed for assessing motoric impulsivity, with respect to psychopharmacological testing and the neural basis of distributed macrocircuits underlying these tasks. This comparison suggests that the existing empirical basis for the DRL 72-second schedule as a pharmacological screen for antidepressant drugs is complemented by a novel hypothesis that altering impulsive response bias for rodents trained on this operant schedule is a previously unrecognized theoretical cornerstone for this screening paradigm. Copyright © 2016 by The American Society for Pharmacology and Experimental Therapeutics.

"Bureaucracy & Beliefs": Assessing the Barriers to Accessing Opioid Substitution Therapy by People Who Inject Drugs in Ukraine.

Science.gov (United States)

Bojko, Martha J; Mazhnaya, Alyona; Makarenko, Iuliia; Marcus, Ruthanne; Dvoriak, Sergii; Islam, Zahedul; Altice, Frederick L

Opioid substitution therapy (OST) is an evidence-based HIV prevention strategy for people who inject drugs (PWIDs). Yet, only 2.7% of Ukraine's estimated 310,000 PWIDs receive it despite free treatment since 2004. The multi-level barriers to entering OST among opioid dependent PWIDs have not been examined in Ukraine. A multi-year mixed methods implementation science project included focus group discussions with 199 PWIDs in 5 major Ukrainian cities in 2013 covering drug treatment attitudes and beliefs and knowledge of and experiences with OST. Data were transcribed, translated into English and coded. Coded segments related to OST access, entry, knowledge, beliefs and attitudes were analyzed among 41 PWIDs who were eligible for but had never received OST. A number of programmatic and structural barriers were mentioned by participants as barriers to entry to OST, including compulsory drug user registration, waiting lists, and limited number of treatment slots. Participants also voiced strong negative attitudes and beliefs about OST, especially methadone. Their perceptions about methadone's side effects as well as the stigma of being a methadone client were expressed as obstacles to treatment. Despite expressed interest in treatment, Ukrainian OST-naïve PWIDs evade OST for reasons that can be addressed through changes in program-level and governmental policies and social-marketing campaigns. Voiced OST barriers can effectively inform public health and policy directives related to HIV prevention and treatment in Ukraine to improve evidence-based treatment access and availability.

Insights into the government's role in food system policy making: improving access to healthy, local food alongside other priorities.

Science.gov (United States)

Wegener, Jessica; Raine, Kim D; Hanning, Rhona M

2012-11-12

Government actors have an important role to play in creating healthy public policies and supportive environments to facilitate access to safe, affordable, nutritious food. The purpose of this research was to examine Waterloo Region (Ontario, Canada) as a case study for "what works" with respect to facilitating access to healthy, local food through regional food system policy making. Policy and planning approaches were explored through multi-sectoral perspectives of: (a) the development and adoption of food policies as part of the comprehensive planning process; (b) barriers to food system planning; and (c) the role and motivation of the Region's public health and planning departments in food system policy making. Forty-seven in-depth interviews with decision makers, experts in public health and planning, and local food system stakeholders provided rich insight into strategic government actions, as well as the local and historical context within which food system policies were developed. Grounded theory methods were used to identify key overarching themes including: "strategic positioning", "partnerships" and "knowledge transfer" and related sub-themes ("aligned agendas", "issue framing", "visioning" and "legitimacy"). A conceptual framework to illustrate the process and features of food system policy making is presented and can be used as a starting point to  engage multi-sectoral stakeholders in plans and actions to facilitate access to healthy food.

Spiritual self-schema therapy, drug abuse, and HIV.

Science.gov (United States)

Marcotte, David; Avants, S Kelly; Margolin, Arthur

2003-01-01

This case report describes the use of Spiritual Self-Schema (3-S) therapy in the treatment of an HIV-positive inner-city drug user maintained on methadone and referred for additional treatment due to unremitting cocaine use. 3-S therapy is a manual-guided intervention based on cognitive self-schema theory. Its goal is to help the patient create, elaborate, and make accessible a cognitive schema--the "spiritual" self-schema-that is incompatible with drug use and other HIV risk behaviors. 3-S therapy facilitates a cognitive shift from the habitual activation of the "addict" self-schema, with its drug-related cognitions, scripts and action plans, to the "spiritual" self-schema, with its associated repertoire of harm reduction beliefs and behaviors.

Why miltefosine-a life-saving drug for leishmaniasis-is unavailable to people who need it the most.

Science.gov (United States)

Sunyoto, Temmy; Potet, Julien; Boelaert, Marleen

2018-01-01

Miltefosine, the only oral drug approved for the treatment of leishmaniasis-a parasitic disease transmitted by sandflies-is considered as a success story of research and development (R&D) by a public-private partnership (PPP). It epitomises the multiple market failures faced by a neglected disease drug: patients with low ability to pay, neglect by authorities and uncertain market size. Originally developed as an anticancer agent in the 1990s, the drug was registered in India in 2002 to treat the fatal visceral leishmaniasis. At the time, miltefosine was considered a breakthrough in the treatment, making it feasible to eliminate a regional disease. Today, access to miltefosine remains far from secure. The initial PPP agreement which includes access to the public sector is not enforced. The reality on the ground has been challenging: shortages due to inefficient supply chains, and use of a substandard product which led to a high number of treatment failures and deaths. Miltefosine received orphan drug status in the USA; when it was registered there in 2014, a priority review voucher (PRV) was awarded. The PRV, meant to facilitate drug development for neglected disease, was subsequently sold to another company for US$125 million without, to date, any apparent impact on drug access. At the heart of these concerns are questions on how to protect societal benefit of a drug developed with public investment, while clinicians worldwide struggle with its lack of affordability, limited availability and sustainability of access. This article analyses the reasons behind the postregistration access failure of miltefosine and provides the lessons learnt.

Sexual Behaviors, Experiences of Sexual Violence, and Substance Use among Women Who inject Drugs: Accessing Health and Prevention Services in Puerto Rico.

Science.gov (United States)

Collazo-Vargas, Erika M; Dodge, Brian; Herbenick, Debby; Guerra-Reyes, Lucia; Mowatt, Rasul; Otero-Cruz, Ilia M; Rodríguez-Díaz, Carlos

2018-06-01

People who inject drugs (PWID) face numerous gender-specific health risks, which increase their susceptibility to adverse outcomes, including violence. There is a need for research on female PWID to capture their unique experiences and understand behavioral and gender-based differences. This study aimed to understand which drug use and sexual behaviors are the most prevalent among female PWID accessing health services in Puerto Rico and to gather preliminary information on those individuals' experiences of sexual violence. Utilizing a transformative theoretical perspective, a mixed-methods study was conducted with a sample of 90 Puerto Rican women who reported recent (past 12 months) injection drug use (IDU) This manuscript focused on Phase 1, in which participants completed an interviewer-administered survey eliciting information about sexual behaviors, drug use, experiences of sexual violence, and access to healthcare services. Phase 2 involved an in-depth interview focused on sexual health and access to healthcare services. Female PWID were found to engage in a variety of sexual behaviors throughout their lifespans and at their most recent sexual events. There were significant differences across age groups for participants, those being time of most recent sexual event (p = 0.007), partner's sex (p = 0.039), relationship with partner (p = 0.023), contraception method used (p = 0.057), and reports of partner orgasm (p = 0.055). Over half of all participants reported having experienced sexual violence in their lifetime. This study extends the literature on PWID in Puerto Rico by underscoring the diversity of female PWID sexual experiences and needs while illustrating how those experiences are often mediated by drug use. The findings highlight the need for further research on female PWID in Puerto Rico to better develop programs that include sexual violence prevention as part of future interventions for this population.

Inducing optimal substitution between antibiotics under open access to the resource of antibiotic susceptibility.

Science.gov (United States)

Herrmann, Markus; Nkuiya, Bruno

2017-06-01

This paper designs a bio-economic model to examine the use of substitute antibiotic drugs (analogs) sold by an industry that has open access to the resource of the antibiotic class's susceptibility (treatment effectiveness). Antibiotics are characterized by different expected recovery rates and production costs, which in conjunction with the class's treatment susceptibility determines their relative effectiveness. Our analysis reveals that the high-quality antibiotic drug loses its comparative advantage over time making the low-quality drug the treatment of last resort in the market equilibrium and the social optimum when antibiotic susceptibility cannot replenish. However, when antibiotic susceptibility is renewable, both antibiotics may be used in the long run, and the comparative advantage of the high-quality drug may be restored in the social optimum that allows lowering infection in the long run. We develop the optimal tax/subsidy scheme that would induce antibiotic producers under open access to behave optimally and account for the social cost of infection and value of antibiotic susceptibility. We show that the welfare loss associated with the uncorrected open-access allocation is highest; when the resource of antibiotic susceptibility is non-renewable, high morbidity costs are incurred by individuals, and low social discount rates apply. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Access to resources shapes maternal decision making: evidence from a factorial vignette experiment.

Directory of Open Access Journals (Sweden)

Geoff Kushnick

Full Text Available The central assumption of behavioral ecology is that natural selection has shaped individuals with the capacity to make decisions that balance the fitness costs and benefits of behavior. A number of factors shape the fitness costs and benefits of maternal care, but we lack a clear understanding how they, taken together, play a role in the decision-making process. In animal studies, the use of experimental methods has allowed for the tight control of these factors. Standard experimentation is inappropriate in human behavioral ecology, but vignette experiments may solve the problem. I used a confounded factorial vignette experiment to gather 640 third-party judgments about the maternal care decisions of hypothetical women and their children from 40 female karo Batak respondents in rural Indonesia. This allowed me to test hypotheses derived from parental investment theory about the relative importance of five binary factors in shaping maternal care decisions with regard to two distinct scenarios. As predicted, access to resources--measured as the ability of a woman to provide food for her children--led to increased care. A handful of other factors conformed to prediction, but they were inconsistent across scenarios. The results suggest that mothers may use simple heuristics, rather than a full accounting for costs and benefits, to make decisions about maternal care. Vignettes have become a standard tool for studying decision making, but have made only modest inroads to evolutionarily informed studies of human behavior.

Access to resources shapes maternal decision making: evidence from a factorial vignette experiment.

Science.gov (United States)

Kushnick, Geoff

2013-01-01

The central assumption of behavioral ecology is that natural selection has shaped individuals with the capacity to make decisions that balance the fitness costs and benefits of behavior. A number of factors shape the fitness costs and benefits of maternal care, but we lack a clear understanding how they, taken together, play a role in the decision-making process. In animal studies, the use of experimental methods has allowed for the tight control of these factors. Standard experimentation is inappropriate in human behavioral ecology, but vignette experiments may solve the problem. I used a confounded factorial vignette experiment to gather 640 third-party judgments about the maternal care decisions of hypothetical women and their children from 40 female karo Batak respondents in rural Indonesia. This allowed me to test hypotheses derived from parental investment theory about the relative importance of five binary factors in shaping maternal care decisions with regard to two distinct scenarios. As predicted, access to resources--measured as the ability of a woman to provide food for her children--led to increased care. A handful of other factors conformed to prediction, but they were inconsistent across scenarios. The results suggest that mothers may use simple heuristics, rather than a full accounting for costs and benefits, to make decisions about maternal care. Vignettes have become a standard tool for studying decision making, but have made only modest inroads to evolutionarily informed studies of human behavior.

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

Science.gov (United States)

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

2011-10-01

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

Making access to TV contingent on physical activity: effects on liking and relative reinforcing value of TV and physical activity in overweight and obese children.

Science.gov (United States)

Goldfield, Gary S

2012-02-01

This study examined the effects of making access to television (TV) viewing contingent on physical activity on the liking and reinforcing value of TV and attitudes towards physical activity in overweight and obese children. Secondary data analysis from a randomized controlled trial designed to increase physical activity and reduce TV viewing in 30, 8-12 years old overweight or obese children by making access to TV contingent on physical activity (intervention) or free access to TV (control). Liking of TV and physical activity was measured by a 100 point visual analog scale, while the relative reinforcing value of TV in relation to physical activity was assessed using a questionnaire based on behavioural choice paradigm that provided children an opportunity to work (button presses) to gain access to TV or physical activity according to a progressive ratio schedule of reinforcement. Enjoyment, Adequacy, Predilection and Motivation for physical activity was assessed by self-report questionnaire. Making access to TV contingent on physical activity showed a trend that approached statistical significance towards increased enjoyment of physical activity and did not adversely affect change in the liking or the relative reinforcing value of TV viewing. Making access to TV contingent on physical activity had no adverse effects on the liking or reinforcing value of TV and even showed a suggestive effect of increased enjoyment of physical activity. Thus, given this intervention markedly increased physical activity and reduced TV viewing in overweight and obese children, long-term evaluations of this interventions to assess sustainability of these behavioral changes and associated health benefits are warranted.

Drug Interaction API

Data.gov (United States)

U.S. Department of Health & Human Services — The Interaction API is a web service for accessing drug-drug interactions. No license is needed to use the Interaction API. Currently, the API uses DrugBank for its...

Insights into the Government’s Role in Food System Policy Making: Improving Access to Healthy, Local Food Alongside Other Priorities

Directory of Open Access Journals (Sweden)

Kim D. Raine

2012-11-01

Full Text Available Government actors have an important role to play in creating healthy public policies and supportive environments to facilitate access to safe, affordable, nutritious food. The purpose of this research was to examine Waterloo Region (Ontario, Canada as a case study for “what works” with respect to facilitating access to healthy, local food through regional food system policy making. Policy and planning approaches were explored through multi-sectoral perspectives of: (a the development and adoption of food policies as part of the comprehensive planning process; (b barriers to food system planning; and (c the role and motivation of the Region’s public health and planning departments in food system policy making. Forty-seven in-depth interviews with decision makers, experts in public health and planning, and local food system stakeholders provided rich insight into strategic government actions, as well as the local and historical context within which food system policies were developed. Grounded theory methods were used to identify key overarching themes including: “strategic positioning”, “partnerships” and “knowledge transfer” and related sub-themes (“aligned agendas”, “issue framing”, “visioning” and “legitimacy”. A conceptual framework to illustrate the process and features of food system policy making is presented and can be used as a starting point to  engage multi-sectoral stakeholders in plans and actions to facilitate access to healthy food.

Insights into the Government’s Role in Food System Policy Making: Improving Access to Healthy, Local Food Alongside Other Priorities

Science.gov (United States)

Wegener, Jessica; Raine, Kim D.; Hanning, Rhona M.

2012-01-01

Government actors have an important role to play in creating healthy public policies and supportive environments to facilitate access to safe, affordable, nutritious food. The purpose of this research was to examine Waterloo Region (Ontario, Canada) as a case study for “what works” with respect to facilitating access to healthy, local food through regional food system policy making. Policy and planning approaches were explored through multi-sectoral perspectives of: (a) the development and adoption of food policies as part of the comprehensive planning process; (b) barriers to food system planning; and (c) the role and motivation of the Region’s public health and planning departments in food system policy making. Forty-seven in-depth interviews with decision makers, experts in public health and planning, and local food system stakeholders provided rich insight into strategic government actions, as well as the local and historical context within which food system policies were developed. Grounded theory methods were used to identify key overarching themes including: “strategic positioning”, “partnerships” and “knowledge transfer” and related sub-themes (“aligned agendas”, “issue framing”, “visioning” and “legitimacy”). A conceptual framework to illustrate the process and features of food system policy making is presented and can be used as a starting point to engage multi-sectoral stakeholders in plans and actions to facilitate access to healthy food. PMID:23202834

Increasing Access to Subsidized Artemisinin-based Combination Therapy through Accredited Drug Dispensing Outlets in Tanzania

Directory of Open Access Journals (Sweden)

Gabra Michael

2011-06-01

Full Text Available Abstract Background In Tanzania, many people seek malaria treatment from retail drug sellers. The National Malaria Control Program identified the accredited drug dispensing outlet (ADDO program as a private sector mechanism to supplement the distribution of subsidized artemisinin-based combination therapies (ACTs from public facilities and increase access to the first-line antimalarial in rural and underserved areas. The ADDO program strengthens private sector pharmaceutical services by improving regulatory and supervisory support, dispenser training, and record keeping practices. Methods The government's pilot program made subsidized ACTs available through ADDOs in 10 districts in the Morogoro and Ruvuma regions, covering about 2.9 million people. The program established a supply of subsidized ACTs, created a price system with a cost recovery plan, developed a plan to distribute the subsidized products to the ADDOs, trained dispensers, and strengthened the adverse drug reactions reporting system. As part of the evaluation, 448 ADDO dispensers brought their records to central locations for analysis, representing nearly 70% of ADDOs operating in the two regions. ADDO drug register data were available from July 2007-June 2008 for Morogoro and from July 2007-September 2008 for Ruvuma. This intervention was implemented from 2007-2008. Results During the pilot, over 300,000 people received treatment for malaria at the 448 ADDOs. The percentage of ADDOs that dispensed at least one course of ACT rose from 26.2% during July-September 2007 to 72.6% during April-June 2008. The number of malaria patients treated with ACTs gradually increased after the start of the pilot, while the use of non-ACT antimalarials declined; ACTs went from 3% of all antimalarials sold in July 2007 to 26% in June 2008. District-specific data showed substantial variation among the districts in ACT uptake through ADDOs, ranging from ACTs representing 10% of all antimalarial sales

Best Practices for Making Scientific Data Discoverable and Accessible through Integrated, Standards-Based Data Portals

Science.gov (United States)

Lucido, J. M.

2013-12-01

Scientists in the fields of hydrology, geophysics, and climatology are increasingly using the vast quantity of publicly-available data to address broadly-scoped scientific questions. For example, researchers studying contamination of nearshore waters could use a combination of radar indicated precipitation, modeled water currents, and various sources of in-situ monitoring data to predict water quality near a beach. In discovering, gathering, visualizing and analyzing potentially useful data sets, data portals have become invaluable tools. The most effective data portals often aggregate distributed data sets seamlessly and allow multiple avenues for accessing the underlying data, facilitated by the use of open standards. Additionally, adequate metadata are necessary for attribution, documentation of provenance and relating data sets to one another. Metadata also enable thematic, geospatial and temporal indexing of data sets and entities. Furthermore, effective portals make use of common vocabularies for scientific methods, units of measure, geologic features, chemical, and biological constituents as they allow investigators to correctly interpret and utilize data from external sources. One application that employs these principles is the National Ground Water Monitoring Network (NGWMN) Data Portal (http://cida.usgs.gov/ngwmn), which makes groundwater data from distributed data providers available through a single, publicly accessible web application by mediating and aggregating native data exposed via web services on-the-fly into Open Geospatial Consortium (OGC) compliant service output. That output may be accessed either through the map-based user interface or through the aforementioned OGC web services. Furthermore, the Geo Data Portal (http://cida.usgs.gov/climate/gdp/), which is a system that provides users with data access, subsetting and geospatial processing of large and complex climate and land use data, exemplifies the application of International Standards

QUALITATIVE DRUG: WHAT SHOULD IT LOOK LIKE?

Directory of Open Access Journals (Sweden)

V. V. Iakusevich

2006-01-01

Full Text Available Drug quality in modern market is discussed. There is an increase of a number of drugs that don’t meet to the quality requirements.Most of them are produced by Russian manufacturers, which number has also increased recently. According to official data 6-10%of all medicines are counterfeit. Quality reduction is also connected with a huge number (80% of reproduced drugs (generics. Considerable part among generics doesn’t pass required evaluation of equivalence with original product. Approved deviations (according to Russian regulative rules in pharmacological equivalence may reach 5%, and in pharmacokinetic equivalence -25%. Evidences of pharmacodynamic (therapeutic equivalence are not required at all. At the same time, author advocates the production of qualitative generics that can providemodern and accessible treatment. Generic quality should be confirmed by randomized studies with cross-over designed comparison with original drug in parallel groups. The examples of the generics with such evidences are demonstrated. The requirements to the data about drugs are given to help the physician to make a right independent estimation of its quality.

'It's risky to walk in the city with syringes': understanding access to HIV/AIDS services for injecting drug users in the former Soviet Union countries of Ukraine and Kyrgyzstan

Directory of Open Access Journals (Sweden)

Harmer Andrew

2011-07-01

Full Text Available Abstract Background Despite massive scale up of funds from global health initiatives including the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund and other donors, the ambitious target agreed by G8 leaders in 2005 in Gleneagles to achieve universal access to HIV/AIDS treatment by 2010 has not been reached. Significant barriers to access remain in former Soviet Union (FSU countries, a region now recognised as a priority area by policymakers. There have been few empirical studies of access to HIV/AIDS services in FSU countries, resulting in limited understanding and implementation of accessible HIV/AIDS interventions. This paper explores the multiple access barriers to HIV/AIDS services experienced by a key risk group-injecting drug users (IDUs. Methods Semi-structured interviews were conducted in two FSU countries-Ukraine and Kyrgyzstan-with clients receiving Global Fund-supported services (Ukraine n = 118, Kyrgyzstan n = 84, service providers (Ukraine n = 138, Kyrgyzstan n = 58 and a purposive sample of national and subnational stakeholders (Ukraine n = 135, Kyrgyzstan n = 86. Systematic thematic analysis of these qualitative data was conducted by country teams, and a comparative synthesis of findings undertaken by the authors. Results Stigmatisation of HIV/AIDS and drug use was an important barrier to IDUs accessing HIV/AIDS services in both countries. Other connected barriers included: criminalisation of drug use; discriminatory practices among government service providers; limited knowledge of HIV/AIDS, services and entitlements; shortages of commodities and human resources; and organisational, economic and geographical barriers. Conclusions Approaches to thinking about universal access frequently assume increased availability of services means increased accessibility of services. Our study demonstrates that while there is greater availability of HIV/AIDS services in Ukraine and Kyrgyzstan, this does not equate with greater

'It's risky to walk in the city with syringes': understanding access to HIV/AIDS services for injecting drug users in the former Soviet Union countries of Ukraine and Kyrgyzstan

LENUS (Irish Health Repository)

Spicer, Neil

2011-07-13

Abstract Background Despite massive scale up of funds from global health initiatives including the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) and other donors, the ambitious target agreed by G8 leaders in 2005 in Gleneagles to achieve universal access to HIV\\/AIDS treatment by 2010 has not been reached. Significant barriers to access remain in former Soviet Union (FSU) countries, a region now recognised as a priority area by policymakers. There have been few empirical studies of access to HIV\\/AIDS services in FSU countries, resulting in limited understanding and implementation of accessible HIV\\/AIDS interventions. This paper explores the multiple access barriers to HIV\\/AIDS services experienced by a key risk group-injecting drug users (IDUs). Methods Semi-structured interviews were conducted in two FSU countries-Ukraine and Kyrgyzstan-with clients receiving Global Fund-supported services (Ukraine n = 118, Kyrgyzstan n = 84), service providers (Ukraine n = 138, Kyrgyzstan n = 58) and a purposive sample of national and subnational stakeholders (Ukraine n = 135, Kyrgyzstan n = 86). Systematic thematic analysis of these qualitative data was conducted by country teams, and a comparative synthesis of findings undertaken by the authors. Results Stigmatisation of HIV\\/AIDS and drug use was an important barrier to IDUs accessing HIV\\/AIDS services in both countries. Other connected barriers included: criminalisation of drug use; discriminatory practices among government service providers; limited knowledge of HIV\\/AIDS, services and entitlements; shortages of commodities and human resources; and organisational, economic and geographical barriers. Conclusions Approaches to thinking about universal access frequently assume increased availability of services means increased accessibility of services. Our study demonstrates that while there is greater availability of HIV\\/AIDS services in Ukraine and Kyrgyzstan, this does not equate with

Industry Perspectives on Market Access of Innovative Drugs: The Relevance for Oncology Drugs

OpenAIRE

Pauwels, Kim; Huys, Isabelle; Casteels, Minne; Simoens, Steven

2016-01-01

Key Points - Representatives of the pharmaceutical industry call for a broader recognition of value within the assessment and appraisal of innovative drugs - Focus on value within the assessment and appraisal of drugs is jeopardized by financial drives as the side of industry and at the side of the payers - A well–considered value-framework, with attention for patient reported outcomes, societal preferences and dynamic approach on the drug life cycle, needs to be incorporated in ass...

More Than a Pretty Picture: Making WISE Data Accessible to the Public

Science.gov (United States)

Ali, Nancy; Mendez, B.; Fricke, K.; Wright, E. L.; Eisenhardt, P. R.; Cutri, R. M.; Hurt, R.; WISE Team

2011-01-01

NASA's Wide-field Infrared Survey Explorer (WISE) has surveyed the sky in four bands of infrared light, creating a treasure trove of data. This data is of interest not only to the professional astronomical community, but also to educators, students and the general public. The Education and Public Outreach (E/PO) program for WISE is creating opportunities to make WISE data accessible to these audiences through the Internet as well as through teacher professional development programs. Shortly after WISE took its first light image in January 2010, images have been featured weekly on the WISE website. These images serve to engage the general public through "pretty pictures” that are accompanied by educational captions. Social media such as Facebook and Twitter are used to further engage the public with the images. For a more comprehensive view of WISE images, we are creating a guided tour of the infrared sky on the WorldWide Telescope. The public will be able to use the free WorldWide Telescope software to interact with WISE images and listen to narration that describes features of the Universe as seen in infrared light. We are also developing resources for teachers and students to access WISE data when in becomes public in 2011 to learn about astronomical imaging and to conduct authentic scientific investigations.

Limiting the access to direct-acting antivirals against HCV: an ethical dilemma.

Science.gov (United States)

Gentile, Ivan; Maraolo, Alberto E; Niola, Massimo; Graziano, Vincenzo; Borgia, Guglielmo; Paternoster, Mariano

2016-11-01

Hepatitis C virus (HCV) infection affects about 200 million people worldwide and represents a leading cause of liver-related mortality. Eradication of HCV infection, achieved mainly through direct-acting antivirals (DAA), results in a decrease of mortality and an improvement of quality of life. These drugs have a maximal efficacy and an optimal tolerability. However, their high cost precludes a universal access even in wealthy countries. Areas covered: This article deals with the policies adopted for the use of the new anti-HCV drugs, especially in Europe and most of all in Italy, supposedly the developed country with the highest HCV prevalence. The literature search was performed using Pubmed and Web of Science. Moreover, national regulatory institutional websites were consulted. Expert commentary: The current policy of limitation to the access of the DAA presents a series of ethical issues that makes it non-applicable. A 'treat-all' strategy should resolve all ethical dilemmas, by virtue of the wide benefits of anti-HCV treatment not only for the advanced stage of infection, but also for the initial stages. A reduction in price of the drugs is the actual condition to achieve such a change.

Abuse of antiretroviral drugs combined with addictive drugs by ...

African Journals Online (AJOL)

Reports of the use of antiretroviral drugs (ARVs) to produce a highly addictive drug called nyaope or whoonga are of major concern as ARVs are easily accessible in sub-Saharan Africa, including to pregnant women. Use of illicit drugs by pregnant women may result in serious adverse effects in their infants. We have ...

Market Access Advancements and Challenges in “Drug-Companion Diagnostic Test” Co-Development in Europe

Directory of Open Access Journals (Sweden)

Ildar Akhmetov

2015-06-01

Full Text Available The pharma ecosphere is witnessing a measured transformation from the one-size-fits-all or blockbuster model of drugs to more informed and tailored personalized treatments that facilitate higher safety and efficacy for a relevant sub-population. However, with several breakthroughs still in a nascent stage, market access becomes a crucial factor for commercial success, especially when it comes to co-creating value for pertinent stakeholders. This article highlights diverse issues from stakeholder perspectives in Europe, specifically the ones which require immediate resolution. Furthermore, the article also discusses case studies articulating potential solutions for the issues discussed.

Urging Affordable Access to High-Value Cancer Drugs

Science.gov (United States)

This infographic highlights some of the main messages from the President’s Cancer Panel report Promoting Value, Affordability, and Innovation in Cancer Drug Treatment. The graphic includes the panel’s recommendations to maximize the value and affordability of cancer drug treatment.

IMPLICATIONS OF GLOBAL PRICING POLICIES ON ACCESS TO INNOVATIVE DRUGS: THE CASE OF TRASTUZUMAB IN SEVEN LATIN AMERICAN COUNTRIES.

Science.gov (United States)

Pichon-Riviere, Andres; Garay, Osvaldo Ulises; Augustovski, Federico; Vallejos, Carlos; Huayanay, Leandro; Bueno, Maria del Pilar Navia; Rodriguez, Alarico; de Andrade, Carlos José Coelho; Buendía, Jefferson Antonio; Drummond, Michael

2015-01-01

Differential pricing, based on countries' purchasing power, is recommended by the World Health Organization to secure affordable medicines. However, in developing countries innovative drugs often have similar or even higher prices than in high-income countries. We evaluated the potential implications of trastuzumab global pricing policies in terms of cost-effectiveness (CE), coverage, and accessibility for patients with breast cancer in Latin America (LA). A Markov model was designed to estimate life-years (LYs), quality-adjusted life-years (QALYs), and costs from a healthcare perspective. To better fit local cancer prognosis, a base case scenario using transition probabilities from clinical trials was complemented with two alternative scenarios with transition probabilities adjusted to reflect breast cancer epidemiology in each country. Incremental discounted benefits ranged from 0.87 to 1.00 LY and 0.51 to 0.60 QALY and incremental CE ratios from USD 42,104 to USD 110,283 per QALY (2012 U.S. dollars), equivalent to 3.6 gross domestic product per capita (GDPPC) per QALY in Uruguay and to 35.5 GDPPC in Bolivia. Probabilistic sensitivity analysis showed 0 percent probability that trastuzumab is CE if the willingness-to-pay threshold is one GDPPC per QALY, and remained so at three GDPPC threshold except for Chile and Uruguay (4.3 percent and 26.6 percent, respectively). Trastuzumab price would need to decrease between 69.6 percent to 94.9 percent to became CE in LA. Although CE in other settings, trastuzumab was not CE in LA. The use of health technology assessment to prioritize resource allocation and support price negotiations is critical to making innovative drugs available and affordable in developing countries.

A novel compact mass detection platform for the open access (OA) environment in drug discovery and early development.

Science.gov (United States)

Gao, Junling; Ceglia, Scott S; Jones, Michael D; Simeone, Jennifer; Antwerp, John Van; Zhang, Li-Kang; Ross, Charles W; Helmy, Roy

2016-04-15

A new 'compact mass detector' co-developed with an instrument manufacturer (Waters Corporation) as an interface for liquid chromatography (LC), specifically Ultra-high performance LC(®) (UPLC(®) or UHPLC) analysis was evaluated as a potential new Open Access (OA) LC-MS platform in the Drug Discovery and Early Development space. This new compact mass detector based platform was envisioned to provide increased reliability and speed while exhibiting significant cost, noise, and footprint reductions. The new detector was evaluated in batch mode (typically 1-3 samples per run) to monitor reactions and check purity, as well as in High Throughput Screening (HTS) mode to run 24, 48, and 96 well plates. The latter workflows focused on screening catalysis conditions, process optimization, and library work. The objective of this investigation was to assess the performance, reliability, and flexibility of the compact mass detector in the OA setting for a variety of applications. The compact mass detector results were compared to those obtained by current OA LC-MS systems, and the capabilities and benefits of the compact mass detector in the open access setting for chemists in the drug discovery and development space are demonstrated. Copyright © 2016 Elsevier B.V. All rights reserved.

Cafe Variome: general-purpose software for making genotype-phenotype data discoverable in restricted or open access contexts.

Science.gov (United States)

Lancaster, Owen; Beck, Tim; Atlan, David; Swertz, Morris; Thangavelu, Dhiwagaran; Veal, Colin; Dalgleish, Raymond; Brookes, Anthony J

2015-10-01

Biomedical data sharing is desirable, but problematic. Data "discovery" approaches-which establish the existence rather than the substance of data-precisely connect data owners with data seekers, and thereby promote data sharing. Cafe Variome (http://www.cafevariome.org) was therefore designed to provide a general-purpose, Web-based, data discovery tool that can be quickly installed by any genotype-phenotype data owner, or network of data owners, to make safe or sensitive content appropriately discoverable. Data fields or content of any type can be accommodated, from simple ID and label fields through to extensive genotype and phenotype details based on ontologies. The system provides a "shop window" in front of data, with main interfaces being a simple search box and a powerful "query-builder" that enable very elaborate queries to be formulated. After a successful search, counts of records are reported grouped by "openAccess" (data may be directly accessed), "linkedAccess" (a source link is provided), and "restrictedAccess" (facilitated data requests and subsequent provision of approved records). An administrator interface provides a wide range of options for system configuration, enabling highly customized single-site or federated networks to be established. Current uses include rare disease data discovery, patient matchmaking, and a Beacon Web service. © 2015 WILEY PERIODICALS, INC.

Drugs + HIV, Learn the Link

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Full Text Available ... Drugged Driving Drug Testing Drugs and the Brain Genetics Global Health Health Consequences of Drug Misuse Hepatitis ( ... Party" "Text Message" NIDA Home Site Map Accessibility Privacy FOIA(NIH) Working at NIDA FAQs Contact Subscribe ...

When access to drugs meets catch-up: Insights from the use of CL threats to improve access to ARV drugs in Brazil

NARCIS (Netherlands)

Ramani, Shyama V.; Urias, E.

2018-01-01

Access to affordable lifesaving medicines is considered a human right. This leads to a question largely understudied in the catch-up literature on accumulation of industrial capabilities. Can the need to improve access to an essential commodity impact the sectoral catch-up trajectory of the

Understanding and Making Use of Academic Authors’ Open Access Rights

Directory of Open Access Journals (Sweden)

David Hansen

2012-09-01

Full Text Available INTRODUCTION Authors of academic works do not take full advantage of the self-archiving rights that they retain in their publications, though research shows that many academic authors are well-aligned (at least in principle with open access (OA principles. This article explains how institutionally-assisted self-archiving in open access repositories can effectively take advantage of retained rights and highlights at least one method of facilitating this process through automated means. METHODS To understand the scope of author-retained rights (including the right to purchase hybrid or other open access options at some sample universities, author-rights data through the SHERPA/RoMEO API was combined with individual article citations (from Thomson Reuters' Web of Science for works published over a one-year period (2011 and authored by individuals affiliated with five major U.S. research universities. RESULTS Authors retain significant rights in the articles that they create. Of the 29,322 unique articles authored over the one year period at the five universities, 28.83 percent could be archived in final PDF form and 87.95 percent could be archived as the post-print version. Nearly 43.47 percent also provided authors the choice of purchasing a hybrid paid open access option. DISCUSSION A significant percentage of current published output could be archived with little or no author intervention. With prior approval through an open access policy or otherwise, article manuscripts or final PDFs can be obtained and archived by library staff, and hybrid paid-OA options could be negotiated and exploited by library administrators. CONCLUSION Although mandates, legislation, and other policy tools may be useful to promote open access, many institutions already have the ability to increase the percentage of accessible works by taking advantage of retained author rights and hybrid OA options.

Club Drugs

Science.gov (United States)

... uses. Other uses of these drugs are abuse. Club drugs are also sometimes used as "date rape" drugs, to make someone unable to say no to or fight back against sexual assault. Abusing these drugs can ...

Sustainable rare diseases business and drug access: no time for misconceptions.

Science.gov (United States)

Rollet, Pierrick; Lemoine, Adrien; Dunoyer, Marc

2013-07-23

Legislative incentives enacted in Europe through the Regulation (EC) No. 141/2000 to incentivize orphan drug development have over the last 12 years constituted a powerful impetus toward R&D directed at the rare diseases population. However, despite therapeutic promises contained in these projects and significant economic impact linked to burgeoning R&D expenditures, the affordability and value of OMPs has become a topic of health policy debate in Europe fueled by the perception that OMPs have high acquisition costs, and by misconceptions around pricing dynamics and rare-diseases business models. In order to maintain sustainable patient access to new and innovative therapies, it is essential to address these misconceptions, and to ensure the successful continuation of a dynamic OMPs R&D within rare-diseases public health policy. Misconceptions abound regarding the pricing of rare diseases drugs and reflect a poor appreciation of the R&D model and the affordability and value of OMPs. Simulation of potential financial returns of small medium sized rare diseases companies focusing on high priced drugs show that their economic returns are likely to be close to their cost of capital. Research in rare diseases is a challenging endeavour characterised by high fixed costs in which companies accrue substantial costs for several years before potentially generating returns from the fruits of their investments. Although heavily dependent upon R&D capabilities of each individual company or R&D organization, continuous flow of R&D financial investment should allow industry to increasingly include efficiencies in research and development in cost considerations to its customers. Industry should also pro-actively work on facilitating development of a specific value based pricing approach to help understanding what constitute value in rare diseases. Policy makers must reward innovation based upon unmet need and patient outcome. Broader understanding by clinicians, the public, and

Making the innovation case in Open Access scholary communication

CERN Multimedia

CERN. Geneva

2005-01-01

It seems almost unnecessary to have to elaborate additional reasons for the adoption of Open Access scholarly communication (OA sc) as manifested through Open Access journals and self-archiving practices. To those active within the OA arena, the case has been convincingly made, and current arguments merely need to be disseminated beyond the Library and Information Science (LIS) sphere. However, it is my contention that a convincing argument for OA sc needs to be launched from the Science Policy perspective if any government mandated pro-OA policy changes are to be effected. This paper, then, is an attempt at taking the OA discussion beyond the LIS arena and into the realm of Science and Innovation Policy. Using Innovation Theory as its theoretical framework, it is argued that Open Access scholarly communication can only serve to bolster Innovation Systems, be they national, regional, or sectoral. The case of South Africa is taken as an illustrative example, though the case can and will be generalised to beyon...

Multiscale Modeling in the Clinic: Drug Design and Development

Energy Technology Data Exchange (ETDEWEB)

Clancy, Colleen E.; An, Gary; Cannon, William R.; Liu, Yaling; May, Elebeoba E.; Ortoleva, Peter; Popel, Aleksander S.; Sluka, James P.; Su, Jing; Vicini, Paolo; Zhou, Xiaobo; Eckmann, David M.

2016-02-17

A wide range of length and time scales are relevant to pharmacology, especially in drug development, drug design and drug delivery. Therefore, multi-scale computational modeling and simulation methods and paradigms that advance the linkage of phenomena occurring at these multiple scales have become increasingly important. Multi-scale approaches present in silico opportunities to advance laboratory research to bedside clinical applications in pharmaceuticals research. This is achievable through the capability of modeling to reveal phenomena occurring across multiple spatial and temporal scales, which are not otherwise readily accessible to experimentation. The resultant models, when validated, are capable of making testable predictions to guide drug design and delivery. In this review we describe the goals, methods, and opportunities of multi-scale modeling in drug design and development. We demonstrate the impact of multiple scales of modeling in this field. We indicate the common mathematical techniques employed for multi-scale modeling approaches used in pharmacology and present several examples illustrating the current state-of-the-art regarding drug development for: Excitable Systems (Heart); Cancer (Metastasis and Differentiation); Cancer (Angiogenesis and Drug Targeting); Metabolic Disorders; and Inflammation and Sepsis. We conclude with a focus on barriers to successful clinical translation of drug development, drug design and drug delivery multi-scale models.

Hypothesis driven drug design: improving quality and effectiveness of the design-make-test-analyse cycle.

Science.gov (United States)

Plowright, Alleyn T; Johnstone, Craig; Kihlberg, Jan; Pettersson, Jonas; Robb, Graeme; Thompson, Richard A

2012-01-01

In drug discovery, the central process of constructing and testing hypotheses, carefully conducting experiments and analysing the associated data for new findings and information is known as the design-make-test-analyse cycle. Each step relies heavily on the inputs and outputs of the other three components. In this article we report our efforts to improve and integrate all parts to enable smooth and rapid flow of high quality ideas. Key improvements include enhancing multi-disciplinary input into 'Design', increasing the use of knowledge and reducing cycle times in 'Make', providing parallel sets of relevant data within ten working days in 'Test' and maximising the learning in 'Analyse'. Copyright © 2011 Elsevier Ltd. All rights reserved.

[Rational drug use: an economic approach to decision making].

Science.gov (United States)

Mota, Daniel Marques; da Silva, Marcelo Gurgel Carlos; Sudo, Elisa Cazue; Ortún, Vicente

2008-04-01

The present article approaches rational drug use (RDU) from the economical point of view. The implementation of RDU implies in costs and involves acquisition of knowledge and behavioral changes of several agents. The difficulties in implementing RDU may be due to shortage problems, information asymmetry, lack of information, uncertain clinical decisions, externalities, time-price, incentives for drug prescribers and dispensers, drug prescriber preferences and marginal utility. Health authorities, among other agencies, must therefore regularize, rationalize and control drug use to minimize inefficiency in pharmaceutical care and to prevent exposing the population to unnecessary health risks.

Transparency in Canadian public drug advisory committees.

Science.gov (United States)

Rosenberg-Yunger, Zahava R S; Bayoumi, Ahmed M

2014-11-01

Transparency in health care resource allocation decisions is a criterion of a fair process. We used qualitative methods to explore transparency across 11 Canadian drug advisory committees. We developed seven criteria to assess transparency (disclosure of members' names, disclosure of membership selection criteria, disclosure of conflict of interest guidelines and members' conflicts, public posting of decisions not to fund drugs, public posting of rationales for decisions, stakeholder input, and presence of an appeals mechanism) and two sub-criteria for when rationales were posted (direct website link and readability). We interviewed a purposeful sample of key informants who were conversant in English and a current or past member of either a committee or a stakeholder group. We analyzed data using a thematic approach. Interviewing continued until saturation was reached. We examined documents from 10 committees and conducted 27 interviews. The median number of criteria addressed by committees was 2 (range 0-6). Major interview themes included addressing: (1) accessibility issues, including stakeholders' degree of access to the decision making process and appeal mechanisms; (2) communication issues, including improving internal and external communication and public access to information; and (3) confidentiality issues, including the use of proprietary evidence. Most committees have some mechanisms to address transparency but none had a fully transparent process. The most important ways to improve transparency include creating formal appeal mechanisms, improving communication, and establishing consistent rules about the use of, and public access to, proprietary evidence. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Public Access and Open Access: Is There a Difference? | Poster

Science.gov (United States)

By Robin Meckley, Contributing Writer, and Tracie Frederick, Guest Writer Open access and public access—are they different concepts or are they the same? What do they mean for the researchers at NCI at Frederick? “Open-access (OA) literature is digital, online, free of charge, and free of most copyright and licensing restrictions. What makes it possible is the Internet and the consent of the author or copyright-holder,” according to an open access website maintained by Peter Suber, director, Harvard Open Access Project.

Open Access

Science.gov (United States)

Suber, Peter

2012-01-01

The Internet lets us share perfect copies of our work with a worldwide audience at virtually no cost. We take advantage of this revolutionary opportunity when we make our work "open access": digital, online, free of charge, and free of most copyright and licensing restrictions. Open access is made possible by the Internet and copyright-holder…

Affective decision-making moderates the effects of automatic associations on alcohol use among drug offenders.

Science.gov (United States)

Cappelli, Christopher; Ames, Susan; Shono, Yusuke; Dust, Mark; Stacy, Alan

2017-09-01

This study used a dual-process model of cognition in order to investigate the possible influence of automatic and deliberative processes on lifetime alcohol use in a sample of drug offenders. The objective was to determine if automatic/implicit associations in memory can exert an influence over an individual's alcohol use and if decision-making ability could potentially modify the influence of these associations. 168 participants completed a battery of cognitive tests measuring implicit alcohol associations in memory (verb generation) as well as their affective decision-making ability (Iowa Gambling Task). Structural equation modeling procedures were used to test the relationship between implicit associations, decision-making, and lifetime alcohol use. Results revealed that among participants with lower levels of decision-making, implicit alcohol associations more strongly predicted higher lifetime alcohol use. These findings provide further support for the interaction between a specific decision function and its influence over automatic processes in regulating alcohol use behavior in a risky population. Understanding the interaction between automatic associations and decision processes may aid in developing more effective intervention components.

Drugs + HIV, Learn the Link

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Full Text Available ... Drugged Driving Drug Testing Drugs and the Brain Genetics Global Health Health Consequences of Drug Misuse Hepatitis ( ... service of the U.S. Department of Health and Human Services (HHS), offers access to the latest, federally approved ... & Alcohol Chat Day HBO Addiction Project ...

Decision Making Regarding Access to Training and Development in Medium-Sized Enterprises: An Exploratory Study Using the Critical Incident Technique

Science.gov (United States)

Coetzer, Alan; Redmond, Janice; Sharafizad, Jalleh

2012-01-01

Purpose: The purpose of this paper is to develop an understanding of factors that impinge on managerial decision-making processes regarding employee access to structured training and development (T&D) opportunities that are at least partially funded by the firm. Design/methodology/approach: Semi-structured interviews incorporating the Critical…

Addressing the impact of economic sanctions on Iranian drug shortages in the joint comprehensive plan of action: promoting access to medicines and health diplomacy.

Science.gov (United States)

Setayesh, Sogol; Mackey, Tim K

2016-06-08

The U.S Congress initiated sanctions against Iran after the 1979 U.S. Embassy hostage crisis in Tehran, and since then the scope of multilateral sanctions imposed by the United States, the European Union, and the United Nations Security Council have progressively expanded throughout the intervening years. Though primarily targeted at Iran's nuclear proliferation activities, sanctions have nevertheless resulted in negative public health outcomes for ordinary Iranian citizens. This includes creating vital domestic shortages to life-saving medicines, leaving an estimated 6 million Iranian patients with limited treatment access for a host of diseases. Sanctions have also crippled Iran's domestic pharmaceutical industry, leading to the disruption of generic medicines production and forcing the country to import medicines and raw materials that are of lower or questionable quality. Countries such as the United States have responded to this medical crisis by implementing export control exemptions with the aim of easing the trade of humanitarian goods (including certain pharmaceuticals and medical devices). However, despite these efforts, pharmaceutical firms and international banking institutions remain cautious about doing business with Iran, leaving the country faced with continuing shortages. We conducted a review of key characteristics of the Iranian drug shortage that identified 73 shortage drugs that closely tracked with the disease burden in the country. Additionally, 44 % of these drugs were also classified as essential medicines by the World Health Organization. A vast majority of these drugs were also covered under export control exemptions that theoretically should make them easier to procure, but nevertheless will still in shortage. Based on our review of the sanctions regulatory framework and key characteristics of the Iranian drug shortage, we propose policy intervention leveraging the recently negotiated P5 + 1 agreement that begins the process of

Drug dealers' rational choices on which customers to rip-off.

Science.gov (United States)

Jacques, Scott; Allen, Andrea; Wright, Richard

2014-03-01

Drug dealers are infamous for overcharging customers and handing over less than owed. One reason rip-offs frequently occur is blackmarket participants have limited access to formal means of dispute resolution and, as such, are attractive prey. Yet drug dealers do not cheat every customer. Though this is implicitly understood in the literature, sparse theoretical attention has been given to which customers are ripped-off and why. To address that lacuna, this paper uses the rationality perspective to analyze qualitative data obtained in interviews with 25 unincarcerated drug sellers operating in disadvantaged neighborhoods of St. Louis, Missouri. We find that dealers typically rip-off six types of customers: persons who are strangers, first-time or irregular customers; do not have sufficient money on hand to make a purchase; are uninformed about going market rates; are deemed unlikely to retaliate; are offensive; or are addicted to drugs. Dealers target these groups due to perceiving them as unlikely to be repeat business; not worth the hassle of doing business with; unlikely to realize they are being ripped-off; in the wrong and thus deserving of payback; and, unwilling to retaliate or take their money elsewhere. Our findings are discussed in relation to their practical implications, including the importance of giving blackmarket participants greater access to law, and how customers may prevent being ripped-off. Copyright © 2013 Elsevier B.V. All rights reserved.

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

Science.gov (United States)

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

2017-06-08

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

Nowhere to go: How stigma limits the options of female drug users after release from jail

Directory of Open Access Journals (Sweden)

Freudenberg Nicholas

2009-05-01

Full Text Available Abstract Background Drug and alcohol using women leaving prison or jail face many challenges to successful re-integration in the community and are severely hampered in their efforts by the stigma of drug or alcohol use compounded by the stigma of incarceration. Methods This qualitative study is based on individual semi-structured interviews and focus groups with 17 women who had recently left jail about the challenges they faced on reentry. Results Our analysis identified three major themes, which are related by the overarching influence of stigma: survival (jobs and housing, access to treatment services, and family and community reintegration. Conclusion Stigma based on drug use and incarceration works to increase the needs of women for health and social services and at the same time, restricts their access to these services. These specific forms of stigma may amplify gender and race-based stigma. Punitive drug and social policies related to employment, housing, education, welfare, and mental health and substance abuse treatment make it extremely difficult for women to succeed.

Accessibility of antiretroviral therapy in Ghana: Convenience of access

African Journals Online (AJOL)

Joyce Addo-Atuah * Joyce Addo-Atuah, BPharm, MSc, PhD, Assistant Professor, Touro College of Pharmacy, New York, USA. She was a PhD candidate at the University of Tennessee (UT), Memphis, USA, when the study was undertaken in Ghana. joyce.addo-atuah@touro.edu, Dick Gourley Dick Gourley, PharmD, Professor and Dean, UT College of Pharmacy during the study and major research advisor. , Greta Gourley Greta Gourley, PharmD/PhD, retired Associate Professor of Pharmaceutical Sciences at UT College of Pharmacy and research advisor. , Shelley I. White-Means Shelley I. White-Means, PhD, Professor and Chair, Health Outcomes and Policy Research Division of UT College of Pharmacy at time of the study and research advisor. , Robin J. Womeodu Robin J. Womeodu, MD, F.A.C.P., Associate Professor of Internal Medicine and Preventive Medicine at UT College of Medicine at time of study and research advisor. , Richard J. Faris Richard J. Faris, Assistant Professor at UT College of Pharmacy at time of study and research advisor. &

2012-05-30

May 30, 2012 ... The accuracy of any instructions, formulae, and drug doses ... The convenience of accessing antiretroviral therapy (ART) is ...... tious diseases, paediatrics, chest diseases, dermatology, public .... CD4 count, (2) a full blood count, (3) a liver function test, (4) ..... America: measures of the African brain drain.

The Mathematical Microscope - Making the inaccessible accessible

DEFF Research Database (Denmark)

Ottesen, Johnny T.

2011-01-01

  In this chapter we introduce a new term, the "Mathematical Microscope", as a method of using mathematics in accessing information about reality when this information is otherwise inaccessible. Furthermore, we discuss how models and experiments are related: none of which are important without th...... of mathematical modeling is discussed for type 1 and type 2 diabetes, depression, cardiovascular diseases and the interactions between the combinations of these, the so-called gray triangle in the metabolic syndrome....

Comparing patient access to pharmaceuticals in the UK and US

NARCIS (Netherlands)

J.P. Cohen (Joshua); C. Cairns (Catherine); C. Paquette (Cherie); H. Faden

2006-01-01

textabstractBackground: The debate on access to new drugs has focused on the time lag between applications for approval and granting of marketing authorisation. This delay was identified as the first barrier with respect to patient access to new drugs, encompassing the hurdles of safety, efficacy

Patient-Centered Drug Approval: The Role of Patient Advocacy in the Drug Approval Process.

Science.gov (United States)

Mattingly, T Joseph; Simoni-Wastila, Linda

2017-10-01

Recent approval of eteplirsen for Duchenne muscular dystrophy (DMD), a rare disease with few treatment alternatives, has reignited the debate over the U.S. drug approval process. The evolution of legal and regulatory restrictions to the marketing and sale of pharmaceuticals has spanned more than a century, and throughout this history, patient advocacy has played a significant role. Scientific evidence from clinical trials serves as the foundation for drug approval, but the patient voice has become increasingly influential. Although the gold standard for establishing safety and efficacy through randomized controlled trials has been in place for more than 50 years, it poses several limitations for rare disorders where patient recruitment for traditional clinical trials is a major barrier. Organized efforts by patient advocacy groups to help patients with rare diseases access investigational therapy have had a legislative and regulatory effect. After approval by the FDA, patient access to therapy may still be limited by cost. A managed care organization (MCO) with the fiduciary responsibility of managing the health of a population must weigh coverage decisions for costly therapies with questionable effectiveness against alternatives within the constraint of a finite budget. Even when the FDA deems a drug safe and effective, an MCO may determine that the drug should only be made available at a tier level where out-of-pocket costs are still too high for many patients. This limitation of availability may be due to cost, other treatment alternatives, or outcomes from existing clinical evidence. However, if the MCO makes a costly new treatment for a rare disease readily available, it may temporarily satisfy a small contingency at the cost of all of its members. This article examines the risks and benefits of patient-centered drug approval and the potential economic effect of patient-centered drug approval on population health. There is no funding to disclose. Mattingly

Phylotastic! Making tree-of-life knowledge accessible, reusable and convenient.

Science.gov (United States)

Stoltzfus, Arlin; Lapp, Hilmar; Matasci, Naim; Deus, Helena; Sidlauskas, Brian; Zmasek, Christian M; Vaidya, Gaurav; Pontelli, Enrico; Cranston, Karen; Vos, Rutger; Webb, Campbell O; Harmon, Luke J; Pirrung, Megan; O'Meara, Brian; Pennell, Matthew W; Mirarab, Siavash; Rosenberg, Michael S; Balhoff, James P; Bik, Holly M; Heath, Tracy A; Midford, Peter E; Brown, Joseph W; McTavish, Emily Jane; Sukumaran, Jeet; Westneat, Mark; Alfaro, Michael E; Steele, Aaron; Jordan, Greg

2013-05-13

-user demonstration tools. While these products have substantial limitations, they suggest considerable potential for a distributed system that makes phylogenetic knowledge readily accessible in computable form. Widespread use of phylotastic systems will create an electronic marketplace for sharing phylogenetic knowledge that will spur innovation in other areas of the ToL enterprise, such as annotation of sources and methods and third-party methods of quality assessment.

Drug Facts

Science.gov (United States)

... Makes Someone More Likely to Get Addicted to Drugs? Does Addiction Run in Families? Why Is It So Hard ... the text to you. This website talks about drug abuse, addiction, and treatment. Watch Videos Information About Drugs Alcohol ...

Drug Facts

Medline Plus

Full Text Available ... symptoms of someone with a drug use problem? How Does Drug Use Become an Addiction? What Makes Someone More Likely to Get Addicted to Drugs? Does Addiction Run in Families? Why Is It So Hard to ...

Does Imaging Modality Used For Percutaneous Renal Access Make a Difference?

DEFF Research Database (Denmark)

Andonian, Sero; Scoffone, Cesare; Louie, Michael K

2013-01-01

OBJECTIVE To assess peri-operative outcomes of percutaneous nephrolithotomy (PCNL) using ultrasound or fluoroscopic guidance for percutaneous access. METHODS A prospectively collected international CROES database containing 5806 patients treated with PCNL was used for the study. Patients were...... divided into two groups based on the methods of percutaneous access: ultrasound vs. fluoroscopy. Patient characteristics, operative data and post-operative outcomes were compared. RESULTS Percutaneous access was obtained using ultrasound guidance only in 453 patients (13.7%) and fluoroscopic guidance only...

Developing a multi-criteria approach for drug reimbursement decision making: an initial step forward.

Science.gov (United States)

Dionne, Francois; Mitton, Craig; Dempster, Bill; Lynd, Larry D

2015-01-01

Coverage decisions for a new drug revolve around the balance between perceived value and price. But what is the perceived value of a new drug? Traditionally, the assessment of such value has largely revolved around the estimation of cost-effectiveness. However, very few will argue that the cost-effectiveness ratio presents a fulsome picture of 'value'. Multi-criteria decision analysis (MCDA) has been advocated as an alternative to cost-effectiveness analysis and it has been argued that it better reflects real world decision-making. The objective of this project was to address the issue of the lack of a satisfactory methodology to measure value for drugs by developing a framework to operationalize an MCDA approach incorporating societal values as they pertain to the value of drugs. Two workshops were held, one in Toronto in conjunction with the CAPT annual conference, and one in Ottawa, as part of the annual CADTH Symposium. Notes were taken at both workshops and the data collected was analyzed using a grounded theory approach. The intent was to reflect, as accurately as possible, what was said at the workshops, without normative judgement. Results to date are a set of guiding principles and criteria. There are currently ten criteria: Comparative effectiveness, Adoption feasibility, Risks of adverse events, Patient autonomy, Societal benefit, Equity, Strength of evidence, Incidence/prevalence/severity of condition, Innovation, and Disease prevention/ health promotion. Much progress has been made and it is now time to share the results. Feedback will determine the final shape of the framework proposed.

Drug Facts

Medline Plus

Full Text Available ... Makes Someone More Likely to Get Addicted to Drugs? Does Addiction Run in Families? Why Is It So Hard ... the text to you. This website talks about drug abuse, addiction, and treatment. Watch Videos Information About Drugs Alcohol ...

Information and shared decision-making are top patients' priorities

Directory of Open Access Journals (Sweden)

Bronstein Alexander

2006-02-01

Full Text Available Abstract Background The profound changes in medical care and the recent stress on a patient-centered approach mandate evaluation of current patient priorities. Methods Hospitalized and ambulatory patients at an academic medical center in central Israel were investigated. Consecutive patients (n = 274 indicated their first and second priority for a change or improvement in their medical care out of a mixed shortlist of 6 issues, 3 related to patient-physician relationship (being better informed and taking part in decisions; being seen by the same doctor each time; a longer consultation time and 3 issues related to the organizational aspect of care (easier access to specialists/hospital; shorter queue for tests; less charges for drugs. Results Getting more information from the physician and taking part in decisions was the most desirable patient choice, selected by 27.4% as their first priority. The next choices – access and queue – also relate to more patient autonomy and control over that of managed care regulations. Patients studied were least interested in continuity of care, consultation time or cost of drugs. Demographic or clinical variables were not significantly related to patients' choices. Conclusion Beyond its many benefits, being informed by their doctor and shared decision making is a top patient priority.

[Orphan drugs].

Science.gov (United States)

Golocorbin Kon, Svetlana; Vojinović, Aleksandra; Lalić-Popović, Mladena; Pavlović, Nebojsa; Mikov, Momir

2013-01-01

Drugs used for treatment of rare diseases are known worldwide under the term of orphan drugs because pharmaceutical companies have not been interested in "adopting" them, that is in investing in research, developing and producing these drugs. This kind of policy has been justified by the fact that these drugs are targeted for small markets, that only a small number of patients is available for clinical trials, and that large investments are required for the development of drugs meant to treat diseases whose pathogenesis has not yet been clarified in majority of cases. The aim of this paper is to present previous and present status of orphan drugs in Serbia and other countries. THE BEGINNING OF ORPHAN DRUGS DEVELOPMENT: This problem was first recognized by Congress of the United States of America in January 1983, and when the "Orphan Drug Act" was passed, it was a turning point in the development of orphan drugs. This law provides pharmaceutical companies with a series of reliefs, both financial ones that allow them to regain funds invested into the research and development and regulatory ones. Seven years of marketing exclusivity, as a type of patent monopoly, is the most important relief that enables companies to make large profits. There are no sufficient funds and institutions to give financial support to the patients. It is therefore necessary to make health professionals much more aware of rare diseases in order to avoid time loss in making the right diagnosis and thus to gain more time to treat rare diseases. The importance of discovery, development and production of orphan drugs lies in the number of patients whose life quality can be improved significantly by administration of these drugs as well as in the number of potential survivals resulting from the treatment with these drugs.

Ethical and epistemic issues in direct-to-consumer drug advertising: where is patient agency?

Science.gov (United States)

Womack, Catherine A

2013-05-01

Arguments for and against direct-to-consumer drug advertising (DTCA) center on two issues: (1) the epistemic effects on patients through access to information provided by the ads; and (2) the effects of such information on patients' abilities to make good choices in the healthcare marketplace. Advocates argue that DTCA provides useful information for patients as consumers, including information connecting symptoms to particular medical conditions, information about new drug therapies for those conditions. Opponents of DTCA point out substantial omissions in information provided by the ads and argue that the framing of the ads may mislead patients about the indications, uses, and effectiveness of the drugs advertised. They also suggest that DTCA has a number of potentially negative effects on the doctor-patient relationship. The standard arguments appear to assume a simplistic correlation-more information means more agency for patients. However, empirical studies on medical decision making suggest that this relationship is much more complex and nuanced. I examine recent research on ways in which patients are vulnerable with respect to DTCA. In order to address the complex issues of information acquisition and consumer decision-making in the health care marketplace, the focus should not be simply on what information patients need in order to make medical decisions, but also on the conditions under which patients actually are able to make medical decisions requiring complex medication information. This requires examining both the cognitive limitations of patients with respect to drug information and investigating patients' preferences and needs in a variety of medical contexts.

Canadians' access to insurance for prescription medicines

National Research Council Canada - National Science Library

2000-01-01

...-economic circumstances and drug needs. Volume two presents an analysis of the un-insured and under-insured by measuring the extent to which Canadians have access to insurance for prescription drug expenses and the quality of that coverage...

Elements of well-being affected by criminalizing the drug user.

Science.gov (United States)

Iguchi, Martin Y.; London, Jennifer A.; Forge, Nell Griffith; Hickman, Laura; Fain, Terry; Riehman, Kara

2002-01-01

OBJECTIVE: The authors examine the possible adverse consequences of incarceration on drug offenders, their families, and their communities. OBSERVATIONS: State and federal policies on drug felons may affect eight elements of personal and community well-being: children and families, access to health benefits, access to housing benefits, access to assistance for higher education, immigration status, employment, eligibility to vote, and drug use or recidivism. CONCLUSIONS: Minorities have a high chance of felony conviction and an increasing lack of access to resources, suggesting that patterns of drug conviction and health disparities may be mutually reinforcing. Large numbers of people sent to prison for drug offenses are now completing their terms and reentering communities. Their reentry will disproportionately affect minority communities. Without resources (education, job opportunities, insurance, health care, housing, and the right to vote) drug abusers face a higher risk of recidivism and increase the burden on their communities. PMID:12435838

Quantum Chess: Making Quantum Phenomena Accessible

Science.gov (United States)

Cantwell, Christopher

Quantum phenomena have remained largely inaccessible to the general public. There tends to be a scare factor associated with the word ``Quantum''. This is in large part due to the alien nature of phenomena such as superposition and entanglement. However, Quantum Computing is a very active area of research and one day we will have games that run on those quantum computers. Quantum phenomena such as superposition and entanglement will seem as normal as gravity. Is it possible to create such games today? Can we make games that are built on top of a realistic quantum simulation and introduce players of any background to quantum concepts in a fun and mentally stimulating way? One of the difficulties with any quantum simulation run on a classical computer is that the Hilbert space grows exponentially, making simulations of an appreciable size physically impossible due largely to memory restrictions. Here we will discuss the conception and development of Quantum Chess, and how to overcome some of the difficulties faced. We can then ask the question, ``What's next?'' What are some of the difficulties Quantum Chess still faces, and what is the future of quantum games?

Making metabolism accessible and meaningful: is the definition of a central metabolic dogma within reach?

Science.gov (United States)

LaRossa, Robert A

2015-04-01

Intermediary metabolism, a dominant research area before the emergence of molecular biology, is attracting renewed interest for fundamental and applied reasons as documented here. Nonetheless, the field may appear to be a thicket precluding entry to all but the most determined. Here we present a metabolic overview that makes this important and fascinating area accessible to a broad range of the molecular biological and biotechnological communities that are being attracted to biological problems crying out for metabolic solutions. This is accomplished by identifying seven key concepts, a so-called metabolic central dogma, that provide a core understanding analogous to the "Central Dogma of Molecular Biology" which focused upon maintenance and flow of genetic information.

Ensuring safe access to medication for palliative care while preventing prescription drug abuse: innovations for American inner cities, rural areas, and communities overwhelmed by addiction

Directory of Open Access Journals (Sweden)

Francoeur RB

2011-09-01

Full Text Available Richard B FrancoeurSchool of Social Work, Adelphi University, Garden City, NY, USA; Center for the Psychosocial Study of Health and Illness, Columbia University, New York, NY, USAAbstract: This article proposes and develops novel components of community-oriented programs for creating and affording access to safe medication dispensing centers in existing retail pharmacies and in permanent or travelling pharmacy clinics that are guarded by assigned or off-duty police officers. Pharmacists at these centers would work with police, medical providers, social workers, hospital administrators, and other professionals in: planning and overseeing the safe storage of controlled substance medications in off-site community safe-deposit boxes; strengthening communication and cooperation with the prescribing medical provider; assisting the prescribing medical provider in patient monitoring (checking the state prescription registry, providing pill counts and urine samples; expanding access to lower-cost, and in some cases, abuse-resistant formulations of controlled substance medications; improving transportation access for underserved patients and caregivers to obtain prescriptions; and integrating community agencies and social networks as resources for patient support and monitoring. Novel components of two related community-oriented programs, which may be hosted outside of safe medication dispensing centers, are also suggested and described: (1 developing medication purchasing cooperatives (ie, to help patients, families, and health institutions afford the costs of medications, including tamper- or abuse-resistant/deterrent drug formulations; and (2 expanding the role of inner-city methadone maintenance treatment programs in palliative care (ie, to provide additional patient monitoring from a second treatment team focusing on narcotics addiction, and potentially, to serve as an untapped source of opioid medication for pain that is less subject to abuse

Confidence and Information Access in Clinical Decision-Making: An Examination of the Cognitive Processes that affect the Information-seeking Behavior of Physicians.

Science.gov (United States)

Uy, Raymonde Charles; Sarmiento, Raymond Francis; Gavino, Alex; Fontelo, Paul

2014-01-01

Clinical decision-making involves the interplay between cognitive processes and physicians' perceptions of confidence in the context of their information-seeking behavior. The objectives of the study are: to examine how these concepts interact, to determine whether physician confidence, defined in relation to information need, affects clinical decision-making, and if information access improves decision accuracy. We analyzed previously collected data about resident physicians' perceptions of information need from a study comparing abstracts and full-text articles in clinical decision accuracy. We found that there is a significant relation between confidence and accuracy (φ=0.164, p<0.01). We also found various differences in the alignment of confidence and accuracy, demonstrating the concepts of underconfidence and overconfidence across years of clinical experience. Access to online literature also has a significant effect on accuracy (p<0.001). These results highlight possible CDSS strategies to reduce medical errors.

Moving toward a universally accessible web: Web accessibility and education.

Science.gov (United States)

Kurt, Serhat

2017-12-08

The World Wide Web is an extremely powerful source of information, inspiration, ideas, and opportunities. As such, it has become an integral part of daily life for a great majority of people. Yet, for a significant number of others, the internet offers only limited value due to the existence of barriers which make accessing the Web difficult, if not impossible. This article illustrates some of the reasons that achieving equality of access to the online world of education is so critical, explores the current status of Web accessibility, discusses evaluative tools and methods that can help identify accessibility issues in educational websites, and provides practical recommendations and guidelines for resolving some of the obstacles that currently hinder the achievability of the goal of universal Web access.

Lessons from Helen Keller: How to Make the Comics Accessible?

Science.gov (United States)

Dupire, Jérôme; Boude, Yvan

2017-01-01

This paper addresses the lack of accessibility of the comics for deaf or hard-of-hearing readers. Comics are a major cultural object, used in many different contexts with, as much as different purposes (leisure, education, advertising, etc.). We report here the results of an experimentation during a communication operation, including a regular exhibition made of panels and a digital mirroring of the contents, with extra materials and information. This digital part, accessible through our institution website, is the basement of this paper.

Hub and spoke model: making rural healthcare in India affordable, available and accessible.

Science.gov (United States)

Devarakonda, Srichand

2016-01-01

Quality health care should be within everyone's reach, especially in a developing country. While India has the largest private health sector in the world, only one-fifth of healthcare expenditure is publically financed; it is mostly an out-of-pocket expense. About 70% of Indians live in rural areas making about $3 per day, and a major portion of that goes towards food and shelter and, thus, not towards health care. Transportation facilities in rural India are poor, making access to medical facilities difficult, and infrastructure facilities are minimal, making the available medical care insufficient. The challenge presented to India was to provide health care that was accessible, available and affordable to people in rural areas and the low-income bracket. The intent of this article is to determine whether the hub and spoke model (HSM), when implemented in the healthcare industry, can expand the market reach and increase profits while reducing costs of operations for organizations and, thereby, cost to customers. This article also discusses the importance of information and communications technologies (ICT) in the HSM approach, which the handful of published articles in this topic have failed to discuss. This article opts for an exploratory study, including review of published literature, web articles, viewpoints of industry experts, published journals, and in-depth interviews. This article will discuss how and why the HSM works in India's healthcare industry while isolating its strengths and weaknesses, and analyzing the impact of India's success. India's HSM implementation has become a paramount example of an acceptable model that, while exceeding the needs and expectations of its patients, is cost-effective and has obtained operational and health-driven results. Despite being an emerging nation, India takes the top spot in terms of affordability of ICT as well as for having the highest number of computer-literate graduates and healthcare workers in the world

Pharmacotherapies for decreasing maladaptive choice in drug addiction: Targeting the behavior and the drug.

Science.gov (United States)

Perkins, Frank N; Freeman, Kevin B

2018-01-01

Drug addiction can be conceptualized as a disorder of maladaptive decision making in which drugs are chosen at the expense of pro-social, nondrug alternatives. The study of decision making in drug addiction has focused largely on the role of impulsivity as a facilitator of addiction, in particular the tendency for drug abusers to choose small, immediate gains over larger but delayed outcomes (i.e., delay discounting). A parallel line of work, also focused on decision making in drug addiction, has focused on identifying the determinants underlying the choice to take drugs over nondrug alternatives (i.e., drug vs. nondrug choice). Both tracks of research have been valuable tools in the development of pharmacotherapies for treating maladaptive decision making in drug addiction, and a number of common drugs have been studied in both designs. However, we have observed that there is little uniformity in the administration regimens of potential treatments between the designs, which hinders congruence in the development of single treatment strategies to reduce both impulsive behavior and drug choice. The current review provides an overview of the drugs that have been tested in both delay-discounting and drug-choice designs, and focuses on drugs that reduced the maladaptive choice in both designs. Suggestions to enhance congruence between the findings in future studies are provided. Finally, we propose the use of a hybridized, experimental approach that may enable researchers to test the effectiveness of therapeutics at decreasing impulsive and drug choice in a single design. Published by Elsevier Inc.

Adverse Drug Event Monitoring at the Food and Drug Administration: Your Report Can Make a Difference

OpenAIRE

Ahmad, Syed Rizwanuddin

2003-01-01

The Food and Drug Administration (FDA) is responsible not only for approving drugs but also for monitoring their safety after they reach the market. The complete adverse event profile of a drug is not known at the time of approval because of the small sample size, short duration, and limited generalizability of pre-approval clinical trials. This report describes the FDA's postmarketing surveillance system, to which many clinicians submit reports of adverse drug events encountered while treati...

Availability and Accessibility in an Open Access Institutional Repository: A Case Study

Science.gov (United States)

Lee, Jongwook; Burnett, Gary; Vandegrift, Micah; Baeg, Jung Hoon; Morris, Richard

2015-01-01

Introduction: This study explores the extent to which an institutional repository makes papers available and accessible on the open Web by using 170 journal articles housed in DigiNole Commons, the institutional repository at Florida State University. Method: To analyse the repository's impact on availability and accessibility, we conducted…

Understanding and improving access to prompt and effective malaria treatment and care in rural Tanzania: the ACCESS Programme.

Science.gov (United States)

Hetzel, Manuel W; Iteba, Nelly; Makemba, Ahmed; Mshana, Christopher; Lengeler, Christian; Obrist, Brigit; Schulze, Alexander; Nathan, Rose; Dillip, Angel; Alba, Sandra; Mayumana, Iddy; Khatib, Rashid A; Njau, Joseph D; Mshinda, Hassan

2007-06-29

Prompt access to effective treatment is central in the fight against malaria. However, a variety of interlinked factors at household and health system level influence access to timely and appropriate treatment and care. Furthermore, access may be influenced by global and national health policies. As a consequence, many malaria episodes in highly endemic countries are not treated appropriately. The ACCESS Programme aims at understanding and improving access to prompt and effective malaria treatment and care in a rural Tanzanian setting. The programme's strategy is based on a set of integrated interventions, including social marketing for improved care seeking at community level as well as strengthening of quality of care at health facilities. This is complemented by a project that aims to improve the performance of drug stores. The interventions are accompanied by a comprehensive set of monitoring and evaluation activities measuring the programme's performance and (health) impact. Baseline data demonstrated heterogeneity in the availability of malaria treatment, unavailability of medicines and treatment providers in certain areas as well as quality problems with regard to drugs and services. The ACCESS Programme is a combination of multiple complementary interventions with a strong evaluation component. With this approach, ACCESS aims to contribute to the development of a more comprehensive access framework and to inform and support public health professionals and policy-makers in the delivery of improved health services.

Access to housing subsidies, housing status, drug use and HIV risk among low-income U.S. urban residents

Directory of Open Access Journals (Sweden)

Dickson-Gomez Julia

2011-11-01

Full Text Available Abstract Background Much research has shown an association between homelessness and unstable housing and HIV risk but most has relied on relatively narrow definitions of housing status that preclude a deeper understanding of this relationship. Fewer studies have examined access to housing subsidies and supportive housing programs among low-income populations with different personal characteristics. This paper explores personal characteristics associated with access to housing subsidies and supportive housing, the relationship between personal characteristics and housing status, and the relationship between housing status and sexual risk behaviors among low-income urban residents. Methods Surveys were conducted with 392 low-income residents from Hartford and East Harford, Connecticut through a targeted sampling plan. We measured personal characteristics (income, education, use of crack, heroin, or cocaine in the last 6 months, receipt of welfare benefits, mental illness diagnosis, arrest, criminal conviction, longest prison term served, and self-reported HIV diagnosis; access to housing subsidies or supportive housing programs; current housing status; and sexual risk behaviors. To answer the aims above, we performed univariate analyses using Chi-square or 2-sided ANOVA's. Those with significance levels above (0.10 were included in multivariate analyses. We performed 2 separate multiple regressions to determine the effects of personal characteristics on access to housing subsidies and access to supportive housing respectively. We used multinomial main effects logistic regression to determine the effects of housing status on sexual risk behavior. Results Being HIV positive or having a mental illness predicted access to housing subsidies and supportive housing, while having a criminal conviction was not related to access to either housing subsidies or supportive housing. Drug use was associated with poorer housing statuses such as living on the

Restricted access magnetic materials prepared by dual surface modification for selective extraction of therapeutic drugs from biological fluids

Science.gov (United States)

Wang, Yu; Wang, Yuxia; Chen, Lei; Wan, Qian-Hong

2012-02-01

Magnetic porous particles with dual functionality have been prepared by a two-step procedure and evaluated as novel restricted access materials for extraction of therapeutic agents from biological fluids. The magnetic silica particles served as scaffolds were first modified with diol groups, which were then converted to octadecyl esters through reaction with stearoyl chloride. In the second step, the octadecyl esters on the exterior surface were hydrolyzed by the action of lipase to yield magnetic particles with hydrophobic reversed-phase ligands on the inner surface and biocompatible diol groups on the outer surface. The restricted access behavior of the resulting materials was confirmed by differential binding of small molecules such as methotrexate (MTX), leucovorin (LV) and folic acid (FA) relative to bovine serum albumin. While MTX, LV and FA were all bound to the magnetic particles with high affinity, the adsorption of the protein was markedly reduced due to size exclusion effect. The utility of the magnetic particles for sample preparation was tested in solid-phase extraction of MTX, LV and FA from spiked human serum and the effects of the SPE conditions on the recovery of the analytes were systematically studied. Moreover, the magnetic particle-based sample preparation procedure coupled with reversed-phase liquid chromatography analysis was validated in terms of specificity, linearity and reproducibility. The method was shown to be free from interference of endogenous compounds and linear over the concentration range of 0.5-10 μg/mL for the three drugs studied. The limits of detection for the three drugs in serum were in the range of 0.160-0.302 μg/mL. Reproducibility expressed as the RSD of the recovery for ten replicated extractions at three different concentrations was found to be less than 8.93%. With a unique combination of surface functionality with magnetic cores, the restricted access magnetic particles may be adapted in automated and high

Market entry, power, pharmacokinetics: what makes a successful drug innovation?

Science.gov (United States)

Alt, Susanne; Helmstädter, Axel

2018-02-01

Depending on the timing of market entry, radical innovations can be distinguished from incremental innovations. Whereas a radical innovation typically is the first available derivative of a drug class, incremental innovations are launched later and show a certain benefit compared with the radical innovation. Here, we use historical market data relating to pharmacokinetic (PK), pharmacodynamic (PD), and other drug-related properties to investigate which derivatives within certain drug classes have been most successful on the market. Based on our investigations, we suggest naming the most successful drugs 'overtaking innovation', because they often exceed the market share of all the other derivatives. Seven drug classes showed that the overtaking innovation is never a radical innovation, but rather an early incremental innovation, with advantages in manageability and/or tolerance. Copyright © 2017 Elsevier Ltd. All rights reserved.

Drug interaction databases in medical literature

DEFF Research Database (Denmark)

Kongsholm, Gertrud Gansmo; Nielsen, Anna Katrine Toft; Damkier, Per

2015-01-01

PURPOSE: It is well documented that drug-drug interaction databases (DIDs) differ substantially with respect to classification of drug-drug interactions (DDIs). The aim of this study was to study online available transparency of ownership, funding, information, classifications, staff training...... available transparency of ownership, funding, information, classifications, staff training, and underlying documentation varies substantially among various DIDs. Open access DIDs had a statistically lower score on parameters assessed....... and the three most commonly used subscription DIDs in the medical literature. The following parameters were assessed for each of the databases: Ownership, classification of interactions, primary information sources, and staff qualification. We compared the overall proportion of yes/no answers from open access...

High notes: the role of drugs in the making of Jazz.

Science.gov (United States)

Singer, Merrill; Mirhej, Greg

2006-01-01

This paper examines the role played by illicit drugs, especially marijuana and heroin, in the historic development and evolution of Jazz in the United States during the twentieth century. In addition to an assessment of the extent of drug use and kinds of drugs used by Jazz musicians and singers, the impact and costs of drug use on the lives of people in Jazz, and the changing patterns of drug use during several eras of Jazz production, the paper contextualizes drug use among Jazz performers and societal response to it in light of prevailing ethnic inequalities and critical medical anthropological theory.

Molecularly precise dendrimer-drug conjugates with tunable drug release for cancer therapy.

Science.gov (United States)

Zhou, Zhuxian; Ma, Xinpeng; Murphy, Caitlin J; Jin, Erlei; Sun, Qihang; Shen, Youqing; Van Kirk, Edward A; Murdoch, William J

2014-10-06

The structural preciseness of dendrimers makes them perfect drug delivery carriers, particularly in the form of dendrimer-drug conjugates. Current dendrimer-drug conjugates are synthesized by anchoring drug and functional moieties onto the dendrimer peripheral surface. However, functional groups exhibiting the same reactivity make it impossible to precisely control the number and the position of the functional groups and drug molecules anchored to the dendrimer surface. This structural heterogeneity causes variable pharmacokinetics, preventing such conjugates to be translational. Furthermore, the highly hydrophobic drug molecules anchored on the dendrimer periphery can interact with blood components and alter the pharmacokinetic behavior. To address these problems, we herein report molecularly precise dendrimer-drug conjugates with drug moieties buried inside the dendrimers. Surprisingly, the drug release rates of these conjugates were tailorable by the dendrimer generation, surface chemistry, and acidity. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Equity in access to ARV drugs in Malawi

African Journals Online (AJOL)

2007-05-01

May 1, 2007 ... included):'We found that financial resources are not regarded as .... The dangers implied in this statement are obvious. ..... Mwansambo, A., & Chizimba, R. (2004) Consolidated report on equity in access to ARVs. Lilongwe:.

Making Spatial Statistics Service Accessible On Cloud Platform

OpenAIRE

Mu, X.; Wu, J.; Li, T; Zhong, Y.; Gao, X.

2014-01-01

Web service can bring together applications running on diverse platforms, users can access and share various data, information and models more effectively and conveniently from certain web service platform. Cloud computing emerges as a paradigm of Internet computing in which dynamical, scalable and often virtualized resources are provided as services. With the rampant growth of massive data and restriction of net, traditional web services platforms have some prominent problems existi...

'Silk Road', the virtual drug marketplace: a single case study of user experiences.

Science.gov (United States)

Van Hout, Marie Claire; Bingham, Tim

2013-09-01

The online promotion of 'drug shopping' and user information networks is of increasing public health and law enforcement concern. An online drug marketplace called 'Silk Road' has been operating on the 'Deep Web' since February 2011 and was designed to revolutionise contemporary drug consumerism. A single case study approach explored a 'Silk Road' user's motives for online drug purchasing, experiences of accessing and using the website, drug information sourcing, decision making and purchasing, outcomes and settings for use, and perspectives around security. The participant was recruited following a lengthy relationship building phase on the 'Silk Road' chat forum. The male participant described his motives, experiences of purchasing processes and drugs used from 'Silk Road'. Consumer experiences on 'Silk Road' were described as 'euphoric' due to the wide choice of drugs available, relatively easy once navigating the Tor Browser (encryption software) and using 'Bitcoins' for transactions, and perceived as safer than negotiating illicit drug markets. Online researching of drug outcomes, particularly for new psychoactive substances was reported. Relationships between vendors and consumers were described as based on cyber levels of trust and professionalism, and supported by 'stealth modes', user feedback and resolution modes. The reality of his drug use was described as covert and solitary with psychonautic characteristics, which contrasted with his membership, participation and feelings of safety within the 'Silk Road' community. 'Silk Road' as online drug marketplace presents an interesting displacement away from 'traditional' online and street sources of drug supply. Member support and harm reduction ethos within this virtual community maximises consumer decision-making and positive drug experiences, and minimises potential harms and consumer perceived risks. Future research is necessary to explore experiences and backgrounds of other users. Copyright © 2013

[Alternatives to the drug research and development model].

Science.gov (United States)

Velásquez, Germán

2015-03-01

One-third of the global population lacks access to medications; the situation is worse in poor countries, where up to 50% of the population lacks access. The failure of current incentive systems based in intellectual property to offer the necessary pharmaceutical products, especially in the global south, is a call to action. Problems related to drug access cannot be solved solely through improvements or modifications in the existing incentive models. The intellectual property system model does not offer sufficient innovation for developing countries; new mechanisms that effectively promote innovation and drug access simultaneously are needed. A binding international agreement on research and development, negotiated under the auspices of the World Health Organization, could provide an adequate framework for guaranteeing priority-setting, coordination, and sustainable financing of drugs at reasonable prices for developing countries.

Access to hepatitis C treatment for people who inject drugs in low and middle income settings: Evidence from 5 countries in Eastern Europe and Asia.

Science.gov (United States)

Luhmann, Niklas; Champagnat, Julie; Golovin, Sergey; Maistat, Ludmila; Agustian, Edo; Inaridze, Ina; Myint, Wai Moe; Butsashvili, Maia; Bouscaillou, Julie

2015-11-01

People who inject drugs (PWID) are disproportionately affected by the hepatitis C (HCV) epidemic. Of the estimated 16 million PWID worldwide, approximately 8 million live with chronic HCV, and around 26% and 23% of the global HCV infections among PWID occur in East/Southeast Asia and Eastern Europe respectively. Globally, few PWID have access to treatment for HCV. We conducted a systematic literature review and internet survey in 2014 to document the burden of disease, access to diagnosis and treatment and the existence of national policy and treatment guidelines for HCV. We included Georgia, Russia, Ukraine, Myanmar and Indonesia as countries with injection drug use epidemics. HCV antibody prevalence among the general population ranged from 0.80% in Indonesia to 5% in Georgia, and among PWID from 48.1% in Myanmar to 92% in Georgia. PWID carried a significant burden of disease, ranging from 2.7% in Indonesia to 40.4% in Russia. Yearly treatment uptake was under 1% for the general population and PWID in all countries. Diagnostic tools and disease staging investigations as well as pegylated interferon/ribavirin treatment were available at a range of prices. Despite policy and treatment protocols for HCV in the majority of countries, strategies focusing on PWID were largely absent. PWID are a priority group for treatment, and access to treatment should be based on sound national policy, accessible public treatment programmes and functional surveillance systems. Copyright © 2015 Elsevier B.V. All rights reserved.

Increasing understanding of the relationship between geographic access and gendered decision-making power for treatment-seeking for febrile children in the Chikwawa district of Malawi

Directory of Open Access Journals (Sweden)

Victoria L. Ewing

2016-10-01

Full Text Available Abstract Background This study used qualitative methods to investigate the relationship between geographic access and gendered intra-household hierarchies and how these influence treatment-seeking decision-making for childhood fever within the Chikwawa district of Malawi. Previous cross-sectional survey findings in the district indicated that distance from facility and associated costs are important determinants of health facility attendance in the district. This paper uses qualitative data to add depth of understanding to these findings by exploring the relationship between distance from services, anticipated costs and cultural norms of intra-household decision-making, and to identify potential intervention opportunities to reduce challenges experienced by those in remote locations. Qualitative data collection included 12 focus group discussions and 22 critical incident interviews conducted in the local language, with primary caregivers of children who had recently experienced a febrile episode. Results Low geographic accessibility to facilities inhibited care-seeking, sometimes by extending the ‘assessment period’ for a child’s illness episode, and led to delays in seeking formal treatment, particularly when the illness occurred at night. Although carers attempted to avoid incurring costs, cash was often needed for transport and food. Whilst in all communities fathers were normatively responsible for treatment costs, mothers generally had greater access to and control over resources and autonomy in decision-making in the matrilineal and matrilocal communities in the central part of the district, which were also closer to formal facilities. Conclusions This study illustrates the complex interplay between geographic access and gender dynamics in shaping decisions on whether and when formal treatment is sought for febrile children in Chikwawa District. Geographic marginality and cultural norms intersect in remote areas both to increase the

Understanding Nonprescription and Prescription Drug Misuse in Late Adolescence/Young Adulthood

Directory of Open Access Journals (Sweden)

Sasha A. Fleary

2013-01-01

Full Text Available This study explored the extent to which nonprescription and prescription drugs misuse among adolescents/young adults are related to their perception that it is safer than illicit drugs, ease of access, and lower societal stigma. Adolescents/young adults (; , completed an online survey about their nonprescription and prescription drug misuse, other substance use, and correlates of use. Perceived risk, societal stigma, and access to nonprescription and prescription drugs were predictive of misuse. Results support program planners working towards targeting perceived risk and societal stigma in reducing misuse and the need to restrict and monitor access to nonprescription and prescription drugs for adolescents/young adults.

Drugs + HIV, Learn the Link

Medline Plus

Full Text Available ... Drugs Publications Search Publications Orderable DrugFacts Research Reports Mind Over Matter Science of Addiction Funding Funding Opportunities ... After the Party" "Text Message" NIDA Home Site Map Accessibility Privacy FOIA(NIH) Working at NIDA FAQs ...

Understanding and improving access to prompt and effective malaria treatment and care in rural Tanzania: the ACCESS Programme

Directory of Open Access Journals (Sweden)

Alba Sandra

2007-06-01

Full Text Available Abstract Background Prompt access to effective treatment is central in the fight against malaria. However, a variety of interlinked factors at household and health system level influence access to timely and appropriate treatment and care. Furthermore, access may be influenced by global and national health policies. As a consequence, many malaria episodes in highly endemic countries are not treated appropriately. Project The ACCESS Programme aims at understanding and improving access to prompt and effective malaria treatment and care in a rural Tanzanian setting. The programme's strategy is based on a set of integrated interventions, including social marketing for improved care seeking at community level as well as strengthening of quality of care at health facilities. This is complemented by a project that aims to improve the performance of drug stores. The interventions are accompanied by a comprehensive set of monitoring and evaluation activities measuring the programme's performance and (health impact. Baseline data demonstrated heterogeneity in the availability of malaria treatment, unavailability of medicines and treatment providers in certain areas as well as quality problems with regard to drugs and services. Conclusion The ACCESS Programme is a combination of multiple complementary interventions with a strong evaluation component. With this approach, ACCESS aims to contribute to the development of a more comprehensive access framework and to inform and support public health professionals and policy-makers in the delivery of improved health services.

Towards a sustainable system of drug development

NARCIS (Netherlands)

Moors, Ellen H.M.; Cohen, Adam F.; Schellekens, Huub

2014-01-01

Drug development has become the exclusive activity of large pharmaceutical companies. However, the output of new drugs has been decreasing for the past decade and the prices of new drugs have risen steadily, leading to access problems for many patients. By analyzing the history of drug development

Drug Facts

Medline Plus

Full Text Available ... Nicotine Facts Other Drugs of Abuse What is Addiction? What are some signs and symptoms of someone ... use problem? How Does Drug Use Become an Addiction? What Makes Someone More Likely to Get Addicted ...

Drug pricing and reimbursement information management: processes and decision making in the global economy.

Science.gov (United States)

Tsourougiannis, Dimitrios

2017-01-01

Background : Cost-containment initiatives are re-shaping the pharmaceutical business environment and affecting market access as well as pricing and reimbursement decisions. Effective price management procedures are too complex to accomplish manually. Prior to February 2013, price management within Astellas Pharma Europe Ltd was done manually using an Excel database. The system was labour intensive, slow to update, and prone to error. An innovative web-based pricing information management system was developed to address the shortcomings of the previous system. Development : A secure web-based system for submitting, reviewing and approving pricing requests was designed to: track all pricing applications and approval status; update approved pricing information automatically; provide fixed and customizable reports of pricing information; collect pricing and reimbursement rules from each country; validate pricing and reimbursement rules monthly. Several sequential phases of development emphasized planning, time schedules, target dates, budgets and implementation of the entire system. A test system was used to pilot the electronic (e)-pricing system with three affiliates (four users) in February 2013. Outcomes : The web-based system was introduced in March 2013, currently has about 227 active users globally and comprises more than 1000 presentations of 150 products. The overall benefits of switching from a manual to an e-pricing system were immediate and highly visible in terms of efficiency, transparency, reliability and compliance. Conclusions : The e-pricing system has improved the efficiency, reliability, compliance, transparency and ease of access to multinational drug pricing and approval information.

Making interdisciplinary solid Earth modeling and analysis tools accessible in a diverse undergraduate and graduate classroom

Science.gov (United States)

Becker, T. W.

2011-12-01

I present results from ongoing, NSF-CAREER funded educational and research efforts that center around making numerical tools in seismology and geodynamics more accessible to a broader audience. The goal is not only to train students in quantitative, interdisciplinary research, but also to make methods more easily accessible to practitioners across disciplines. I describe the two main efforts that were funded, the Solid Earth Research and Teaching Environment (SEATREE, geosys.usc.edu/projects/seatree/), and a new Numerical Methods class. SEATREE is a modular and user-friendly software framework to facilitate using solid Earth research tools in the undergraduate and graduate classroom and for interdisciplinary, scientific collaboration. We use only open-source software, and most programming is done in the Python computer language. We strive to make use of modern software design and development concepts while remaining compatible with traditional scientific coding and existing, legacy software. Our goals are to provide a fully contained, yet transparent package that lets users operate in an easy, graphically supported "black box" mode, while also allowing to look under the hood, for example to conduct numerous forward models to explore parameter space. SEATREE currently has several implemented modules, including on global mantle flow, 2D phase velocity tomography, and 2D mantle convection and was used at the University of Southern California, Los Angeles, and at a 2010 CIDER summer school tutorial. SEATREE was developed in collaboration with engineering and computer science undergraduate students, some of which have gone on to work in Earth Science projects. In the long run, we envision SEATREE to contribute to new ways of sharing scientific research, and making (numerical) experiments truly reproducible again. The other project is a set of lecture notes and Matlab exercises on Numerical Methods in solid Earth, focusing on finite difference and element methods. The

Innovative Approaches to Increase Access to Medicines in Developing Countries

Directory of Open Access Journals (Sweden)

Hilde Stevens

2017-12-01

Full Text Available Access to essential medicines is problematic for one third of all persons worldwide. The price of many medicines (i.e., drugs, vaccines, and diagnostics is unaffordable to the majority of the population in need, especially in least-developed countries, but also increasingly in middle-income countries. Several innovative approaches, based on partnerships, intellectual property, and pricing, are used to stimulate innovation, promote healthcare delivery, and reduce global health disparities. No single approach suffices, and therefore stakeholders need to further engage in partnerships promoting knowledge and technology transfer in assuring essential medicines to be manufactured, authorized, and distributed in low- and middle-income countries (LMICs in an effort of making them available at affordable and acceptable conditions.

Making Patron Data Work Harder: User Search Terms as Access Points?

OpenAIRE

Jason A. Clark

2008-01-01

Montana State University (MSU) Libraries are experimenting with re-using patron-generated data to create browseable access points for the Electronic Theses and Dissertations (ETD) collection. A beta QueryCatcher module logs recent search terms and the number of associated hits. These terms are used to create browseable lists and tagclouds which enhance access to the ETD collection. Gathering and reusing information about user behavior is an emerging trend in web application development. This ...

The open-access debate Rüdiger Voss extols the virtues of open access

CERN Multimedia

Voss, Rüdiger

2007-01-01

"Publishers are under increasing pressure to make journal papers freee to all by abolishing subscriptions and making authors pay a fee instead. Rüdiger Voss welcomes the benefits that "open access" publishing brings, while John Enderby warns that this new publishing model comes at a price."

Making drug policy together: reflections on evidence, engagement and participation.

Science.gov (United States)

Roberts, Marcus

2014-09-01

This commentary considers the relationship between evidence, engagement and participation in drug policy governance. It argues that the use of various forms of evidence (for example, statistical data and service user narratives) is critical for meaningful stakeholder engagement and public participation in drug policy, as well as effective policy design and implementation. The respective roles of these different kinds of evidence in consultation processes need to be better understood. It discusses the limits of evidence, which it suggests is rarely conclusive or decisive for drug policy. This is partly because of the incompleteness of most research agendas and the lack of consensus among researchers, but also because issues in drug policy are inherently contestable, involving considerations that lie outside the competency of drug policy specialist as such. In particular, this is because they involve normative and evaluative issues that are properly political (for example, about the relative weight to be accorded to different kinds of harm and benefit). It concludes by supporting calls for a more nuanced understanding of the relationship between evidence, engagement and politics than is implicit in the term 'evidence based policy'. It also argues that we should view the inherent contestability of drug policy not as something that can or should be resolved by 'objective' evidence, but as a source of vitality and creativity in policy development and evaluation. Copyright © 2014 Elsevier B.V. All rights reserved.

Complication with intraosseous access

DEFF Research Database (Denmark)

Hallas, Peter; Brabrand, Mikkel; Folkestad, Lars

2013-01-01

with aspiration of bone marrow (12.3%), and bended/broken needle (4.0%). When using an established IO access the reported complications were difficulties with injection fluid and drugs after IO insertion (7.4%), slow infusion (despite use of pressure bag) (8.8%), displacement after insertion (8...

Constraints and challenges in access to insulin: a global perspective.

Science.gov (United States)

Beran, David; Ewen, Margaret; Laing, Richard

2016-03-01

Substantial attention has been given to the issue of access to medicines for communicable diseases; however, access to essential medicines for diabetes, especially insulin, has had insufficient focus. Although insulin was discovered in 1921, the drug is unattainable to many globally, and this Review aims to highlight the range and complexity of factors that contribute to this unattainability. Manufacturers' selling prices of various insulin formulations and presentations, duties, taxes, mark-ups, and other supply chain costs affect the price of insulin and hence the drug's affordability to health systems and individuals. Unlike drugs for HIV and AIDS, the production of generic or biosimilar insulin has not had an effect on the overall market. Other factors contributing to poor availability of insulin include its quantification at the national level, in-country distribution, and determination of needs at lower levels of the health system. Although insulin is essential for the survival of people with type 1 diabetes and is needed for improved management of diabetes for some people with type 2 diabetes, very little has been done globally to address the issue of access, despite the UN's political commitment to address non-communicable diseases and ensure universal access to drugs for these disorders. Copyright © 2016 Elsevier Ltd. All rights reserved.

[Economic sustainability of therapies: considerations following the introduction of new drugs for hepatitis C virus].

Science.gov (United States)

Spandonaro, Federico

2014-06-01

The availability of new drugs potentially able to drastically reduce the burden of very common infectious diseases like hepatitis C requires the national health services to take a different decision-making process. On the one hand, there is an evident financial issue; on the other hand, low budgets may undermine a system that provides universal access to healthcare. It is unrealistic to expect retrieving the financial resources needed from negotiating prices with pharmaceutical companies, resource reallocation or a reduction in economic waste. The national health systems need a new priority setting and a National fund for healthcare innovation should be built. Novel drugs should be evaluated balancing availability and opportunity, forcing to rethink the decision-making processes. Macro- (re-prioritization of interventions) and micro-policies (the introduction of financial aspects in the process of pricing) are needed, trying to combine welfare and industrial policies.

The politics behind the implementation of the WTO Paragraph 6 Decision in Canada to increase global drug access.

Science.gov (United States)

Esmail, Laura C; Kohler, Jillian Clare

2012-04-03

The reform of pharmaceutical policy can often involve trade-offs between competing social and commercial goals. Canada's Access to Medicines Regime (CAMR), a legislative amendment that permits compulsory licensing for the production and export of medicines to developing countries, aimed to reconcile these goals. Since it was passed in 2004, only two orders of antiretroviral drugs, enough for 21,000 HIV/AIDS patients in Rwanda have been exported. Future use of the regime appears unlikely. This research aimed to examine the politics of CAMR. Parliamentary Committee hearing transcripts from CAMR's legislative development (2004) and legislative review (2007) were analysed using a content analysis technique to identify how stakeholders who participated in the debates framed the issues. These findings were subsequently analysed using a framework of framing, institutions and interests to determine how these three dimensions shaped CAMR. In 2004, policy debates in Canada were dominated by two themes: intellectual property rights and the TRIPS Agreement. The right to medicines as a basic human right and CAMR's potential impact on innovation were hardly discussed. With the Departments of Industry Canada and International Trade as the lead institutions, the goals of protecting intellectual property and ensuring good trade relations with the United States appear to have taken priority over encouraging generic competition to achieve drug affordability. The result was a more limited interpretation of patent flexibilities under the WTO Paragraph 6 Decision. The most striking finding is the minimal discussion over the potential barriers developing country beneficiaries might face when attempting to use compulsory licensing, including their reluctance to use TRIPS flexibilities, their desire to pursue technological development and the constraints inherent in the WTO Paragraph 6 Decision. Instead, these issues were raised in 2007, which can be partly accounted for by experience in

The politics behind the implementation of the WTO Paragraph 6 Decision in Canada to increase global drug access

Directory of Open Access Journals (Sweden)

Esmail Laura C

2012-04-01

Full Text Available Abstract Background The reform of pharmaceutical policy can often involve trade-offs between competing social and commercial goals. Canada's Access to Medicines Regime (CAMR, a legislative amendment that permits compulsory licensing for the production and export of medicines to developing countries, aimed to reconcile these goals. Since it was passed in 2004, only two orders of antiretroviral drugs, enough for 21,000 HIV/AIDS patients in Rwanda have been exported. Future use of the regime appears unlikely. This research aimed to examine the politics of CAMR. Methods Parliamentary Committee hearing transcripts from CAMR's legislative development (2004 and legislative review (2007 were analysed using a content analysis technique to identify how stakeholders who participated in the debates framed the issues. These findings were subsequently analysed using a framework of framing, institutions and interests to determine how these three dimensions shaped CAMR. Results In 2004, policy debates in Canada were dominated by two themes: intellectual property rights and the TRIPS Agreement. The right to medicines as a basic human right and CAMR's potential impact on innovation were hardly discussed. With the Departments of Industry Canada and International Trade as the lead institutions, the goals of protecting intellectual property and ensuring good trade relations with the United States appear to have taken priority over encouraging generic competition to achieve drug affordability. The result was a more limited interpretation of patent flexibilities under the WTO Paragraph 6 Decision. The most striking finding is the minimal discussion over the potential barriers developing country beneficiaries might face when attempting to use compulsory licensing, including their reluctance to use TRIPS flexibilities, their desire to pursue technological development and the constraints inherent in the WTO Paragraph 6 Decision. Instead, these issues were raised in 2007

Open access

CERN Document Server

Suber, Peter

2012-01-01

The Internet lets us share perfect copies of our work with a worldwide audience at virtually no cost. We take advantage of this revolutionary opportunity when we make our work "open access": digital, online, free of charge, and free of most copyright and licensing restrictions. Open access is made possible by the Internet and copyright-holder consent, and many authors, musicians, filmmakers, and other creators who depend on royalties are understandably unwilling to give their consent. But for 350 years, scholars have written peer-reviewed journal articles for impact, not for money, and are free to consent to open access without losing revenue. In this concise introduction, Peter Suber tells us what open access is and isn't, how it benefits authors and readers of research, how we pay for it, how it avoids copyright problems, how it has moved from the periphery to the mainstream, and what its future may hold. Distilling a decade of Suber's influential writing and thinking about open access, this is the indispe...

Medication abortion: Potential for improved patient access through pharmacies.

Science.gov (United States)

Raifman, Sarah; Orlando, Megan; Rafie, Sally; Grossman, Daniel

2018-05-08

To discuss the potential for improving access to early abortion care through pharmacies in the United States. Despite the growing use of medications to induce termination of early pregnancy, pharmacist involvement in abortion care is currently limited. The Food and Drug Administration's Risk Evaluation and Mitigation Strategy (REMS) for Mifeprex® (mifepristone 200 mg), the principal drug used in early medication abortion, prohibits the dispensing of the drug by prescription at pharmacies. This commentary reviews the pharmacology of medication abortion with the use of mifepristone and misoprostol, as well as aspects of service delivery and data on safety, efficacy, and acceptability. Given its safety record, mifepristone no longer fits the profile of a drug that requires an REMS. The recent implementation of pharmacy dispensing of mifepristone in community pharmacies in Australia and some provinces of Canada has improved access to medication abortion by increasing the number of medication abortion providers, particularly in rural areas. Provision of mifepristone in pharmacies, which involves dispensing and patient counseling, would likely improve access to early abortion in the United States without increasing risks to women. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Evaluating drug prices, availability, affordability, and price components: implications for access to drugs in Malaysia.

Science.gov (United States)

Babar, Zaheer Ud Din; Ibrahim, Mohamed Izham Mohamed; Singh, Harpal; Bukahri, Nadeem Irfan; Creese, Andrew

2007-03-27

Malaysia's stable health care system is facing challenges with increasing medicine costs. To investigate these issues a survey was carried out to evaluate medicine prices, availability, affordability, and the structure of price components. The methodology developed by the World Health Organization (WHO) and Health Action International (HAI) was used. Price and availability data for 48 medicines was collected from 20 public sector facilities, 32 private sector retail pharmacies and 20 dispensing doctors in four geographical regions of West Malaysia. Medicine prices were compared with international reference prices (IRPs) to obtain a median price ratio. The daily wage of the lowest paid unskilled government worker was used to gauge the affordability of medicines. Price component data were collected throughout the supply chain, and markups, taxes, and other distribution costs were identified. In private pharmacies, innovator brand (IB) prices were 16 times higher than the IRPs, while generics were 6.6 times higher. In dispensing doctor clinics, the figures were 15 times higher for innovator brands and 7.5 for generics. Dispensing doctors applied high markups of 50%-76% for IBs, and up to 316% for generics. Retail pharmacy markups were also high-25%-38% and 100%-140% for IBs and generics, respectively. In the public sector, where medicines are free, availability was low even for medicines on the National Essential Drugs List. For a month's treatment for peptic ulcer disease and hypertension people have to pay about a week's wages in the private sector. The free market by definition does not control medicine prices, necessitating price monitoring and control mechanisms. Markups for generic products are greater than for IBs. Reducing the base price without controlling markups may increase profits for retailers and dispensing doctors without reducing the price paid by end users. To increase access and affordability, promotion of generic medicines and improved availability

Evolution of antiretroviral drug costs in Brazil in the context of free and universal access to AIDS treatment.

Science.gov (United States)

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

Evolution of antiretroviral drug costs in Brazil in the context of free and universal access to AIDS treatment.

Directory of Open Access Journals (Sweden)

Amy S Nunn

2007-11-01

Full Text Available 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

Hidden Wholesale: The drug diffusing capacity of online drug cryptomarkets

OpenAIRE

Aldridge, Judith A; Décary-Hétu, David

2016-01-01

Background: In spite of globalizing processes ‘offline’ retail drug markets remain localized and – in recent decades – typically ‘closed’, in which dealers sell primarily to known customers. We characterize drug cryptomarkets as ‘anonymous open’ marketplaces that allow the diffusion of drugs across locales. Where cryptomarket customers make stock-sourcing purchases for offline distribution, the cryptomarket may indirectly serve drug users who are not themselves cryptomarket customers, thereby...

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

Science.gov (United States)

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

2017-02-22

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

Barriers to accessing substance abuse treatment in Mexico: national comparative analysis by migration status

Science.gov (United States)

2014-01-01

Background We examined Mexican migrants’ perceived barriers to entering substance abuse treatment and potential differences by gender. Methods This study analyzed a subset of household data collected in Mexico in 2011 via the Encuesta Nacional de Adicciones (National Survey of Addictions). A sample of 1,143 individuals who reported using illicit drugs was analyzed using multivariate negative binomial models to determine direct and moderated relationships of gender, migrant status, and drug dependence with perceived barriers to accessing treatment. Results Significant findings included disparities in drug dependence by migrant status. Compared with non-migrant men, women who have traveled to the United States was associated with fewer (1.3) barriers to access treatment. Fewer barriers to access care were associated with individuals residing in other regions of the country, compared to those living in Mexico City. Conclusions Drug dependence, gender, migration status and regional location are factors associated with access to needed treatment. Implications for health care policy to develop treatment services infrastructure and for future research are discussed in the context of ongoing drug policy reform in Mexico. PMID:25074067

Making ambulatory blood pressure monitoring accessible in pharmacies.

Science.gov (United States)

James, Kirstyn; Dolan, Eamon; O'Brien, Eoin

2014-06-01

characteristics of patients with ABPMs recorded in pharmacies are similar to those recorded in primary care practices. It is feasible, therefore, to perform ABPM in pharmacies, which can be utilized to make ABPM more accessible to the large number of patients in the population with hypertension.

Medication/Drug Allergy

Science.gov (United States)

... Training Home Conditions Medication/Drug Allergy Medication/Drug Allergy Make an Appointment Find a Doctor Ask a ... risk for adverse reactions to medications. Facts about Allergies The tendency to develop allergies may be inherited. ...

'You've got m@il: fluoxetine coming soon!': accessibility and quality of a prescription drug sold on the web.

Science.gov (United States)

Gelatti, U; Pedrazzani, R; Marcantoni, C; Mascaretti, S; Repice, C; Filippucci, L; Zerbini, I; Dal Grande, M; Orizio, G; Feretti, D

2013-09-01

The increasing phenomenon of online pharmacies has potential for serious public health problems. This study aimed to evaluate the possibility of accessing a prescription drug in the absence of a prescription for an Italian purchaser. Fluoxetine pills were ordered from several online pharmacies. The study included website analysis, and the quality of the received product including packaging, chemical and microbiological analyses. Orders could be placed correctly on 61 of the 98 selected websites, and a sales transaction was concluded successfully on 17 websites. Thirteen drug samples were eventually received. In one case it was necessary to fill in a questionnaire before ordering the drugs. All websites displayed aggressive marketing strategies. There was wide variation in terms of domain registration, company base (when declared) and manufacturer's location (mostly India). All pills were delivered in sealed blister packs showing the lot number and manufacturer's details. A leaflet was enclosed in one case only. In three cases we received more pills than ordered, and in one case Viagra pills as a free gift. Pharmacopoeia microbiological requirements were satisfied. Chemical analysis revealed that the active principle was always present, although many samples did not meet the Pharmacopoeia "other impurities" or "total impurities" criteria. Heavy metals and solvents regulated by the Pharmacopoeia did not exceed the set limits; some of the non-regulated ones were also assessed, in some cases with a positive result (e.g. styrene). About 20% of purchase attempts resulted in delivery of the drugs, even in the absence of a medical prescription. Traceability was poor and drug quality was generally worse compared to conventional pharmacy-purchased products. Based on all these broad-spectrum results, user safety appears not to be globally guaranteed. Copyright © 2013 Elsevier B.V. All rights reserved.

Cathepsin B Cleavage of vcMMAE-Based Antibody-Drug Conjugate Is Not Drug Location or Monoclonal Antibody Carrier Specific.

Science.gov (United States)

Gikanga, Benson; Adeniji, Nia S; Patapoff, Thomas W; Chih, Hung-Wei; Yi, Li

2016-04-20

Antibody-drug conjugates (ADCs) require thorough characterization and understanding of product quality attributes. The framework of many ADCs comprises one molecule of antibody that is usually conjugated with multiple drug molecules at various locations. It is unknown whether the drug release rate from the ADC is dependent on drug location, and/or local environment, dictated by the sequence and structure of the antibody carrier. This study addresses these issues with valine-citrulline-monomethylauristatin E (vc-MMAE)-based ADC molecules conjugated at reduced disulfide bonds, by evaluating the cathepsin B catalyzed drug release rate of ADC molecules with different drug distributions or antibody carriers. MMAE drug release rates at different locations on ADC I were compared to evaluate the impact of drug location. No difference in rates was observed for drug released from the V(H), V(L), or C(H)2 domains of ADC I. Furthermore, four vc-MMAE ADC molecules were chosen as substrates for cathepsin B for evaluation of Michaelis-Menten parameters. There was no significant difference in K(M) or k(cat) values, suggesting that different sequences of the antibody carrier do not result in different drug release rates. Comparison between ADCs and small molecules containing vc-MMAE moieties as substrates for cathepsin B suggests that the presence of IgG1 antibody carrier, regardless of its bulkiness, does not impact drug release rate. Finally, a molecular dynamics simulation on ADC II revealed that the val-cit moiety at each of the eight possible conjugation sites was, on average, solvent accessible over 50% of its maximum solvent accessible surface area (SASA) during a 500 ns trajectory. Combined, these results suggest that the cathepsin cleavage sites for conjugated drugs are exposed enough for the enzyme to access and that the drug release rate is rather independent of drug location or monoclonal antibody carrier. Therefore, the distribution of drug conjugation at different

Integrating Attributes into Role-Based Access Control

DEFF Research Database (Denmark)

Mahmood Rajpoot, Qasim; Jensen, Christian D.; Krishnan, Ram

2015-01-01

of research recently. We propose an access control model that combines the two models in a novel way in order to unify their benefits. Our approach provides a fine-grained access control mechanism that takes into account the current contextual information while making the access control decisions....

Let us make impact assessment more accessible

International Nuclear Information System (INIS)

Alton, Charles C.; Underwood, P. Benjamin

2003-01-01

Impact assessment professionals have traditionally written documents for themselves. Often, their work appears to be received with indifference by business professionals and decision makers who have different needs and interests. The two groups conflict when they should be thinking and planning together at the 'big picture' level (including the understanding of the social factors at work in environmental impact assessment) and developing related and workable 'site-specific' implementation that characterizes socially acceptable decision making. To achieve this goal, the IA professional needs to rethink the approach. IA professionals often focus on the traditional 'physical' environment, confining the assessment to facts and figures about hard aspects of the environment. Reams of detailed data are compiled to demonstrate impact assessment and to achieve a degree of certainty and precision. However, the sheer bulk of data assures that it will not be read by those who most need to use it. The IA professional must learn to prepare assessments that effectively consider less quantifiable, 'softer' aspects of the environment. We advocate preparation of an impact analysis that management decision makers and environmental stewards can use as a reference tool. The goal is to reduce or eliminate the hundreds of unread pages containing lengthy modeling runs and obscure details, and instead to prepare documents that are useful in both courtroom and boardroom. This convenient and quick-study 'consumer report' style combines with a tiered decision making process that assures broad long-term thinking and planning, and focused short-term detailed implementation, using a level of detail appropriate to the decision at hand. This methodology integrates social factors into decision making, so as to provide meaningful discussion and analysis. These principles, which have been proven in US boardrooms and courtrooms, will be illustrated with actual examples from broad policy-level impact

Medicamentos: o preço da saúde / Drugs: The Health Price

Directory of Open Access Journals (Sweden)

Joedson de Souza Delgado

2016-05-01

Full Text Available Purpose – This paper analyzes the structure of government control in drug prices between sector agents, to facilitate its reach to the population in the face of fierce competition for brand positioning in relation to generic manufacturers produced and developed in Brazil. Methodology – Based on empirical data and making use of a literature review, the paper discusses the model of maximum pricing in pharmacies, records the changes of the regulatory environment of the Brazilian pharmaceutical industry, describes the branded drug access policy and discusses the effectiveness and efficiency of intervention. Findings – The state interference in the drug market denotes the search for the containment of economic and social disparities by expanding the opportunity of choice and the offer of prices that are more competitive. Even so, there are still discussions about the quantum to be paid for effective and innovative drugs under patent protection. Practical implications – The critical discussion reveals the need for good sectorial regulation in order to maximize the welfare of society and consumers by increasing competition between laboratories.

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

Science.gov (United States)

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.…

Rapid assessment response (RAR study: drug use and health risk - Pretoria, South Africa

Directory of Open Access Journals (Sweden)

Trautmann Franz

2011-06-01

Full Text Available Abstract Background Within a ten year period South Africa has developed a substantial illicit drug market. Data on HIV risk among drug using populations clearly indicate high levels of HIV risk behaviour due to the sharing of injecting equipment and/or drug-related unprotected sex. While there is international evidence on and experience with adequate responses, limited responses addressing drug use and drug-use-related HIV and other health risks are witnessed in South Africa. This study aimed to explore the emerging problem of drug-related HIV transmission and to stimulate the development of adequate health services for the drug users, by linking international expertise and local research. Methods A Rapid Assessment and Response (RAR methodology was adopted for the study. For individual and focus group interviews a semi-structured questionnaire was utilised that addressed key issues. Interviews were conducted with a total of 84 key informant (KI participants, 63 drug user KI participants (49 males, 14 females and 21 KI service providers (8 male, 13 female. Results and Discussion Adverse living conditions and poor education levels were cited as making access to treatment harder, especially for those living in disadvantaged areas. Heroin was found to be the substance most available and used in a problematic way within the Pretoria area. Participants were not fully aware of the concrete health risks involved in drug use, and the vague ideas held appear not to allow for concrete measures to protect themselves. Knowledge with regards to substance related HIV/AIDS transmission is not yet widespread, with some information sources disseminating incorrect or unspecific information. Conclusions The implementation of pragmatic harm-reduction and other evidence-based public health care policies that are designed to reduce the harmful consequences associated with substance use and HIV/AIDS should be considered. HIV testing and treatment services also need to

Telecentres, Access and Development: Experience and Lessons ...

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

Universal access to ICTs has in recent years become a policy goal for many national ... is able to make use of a publicly available resource, such as information and ... access centres (public telephones, cybercafes, telecentres, business centres, etc.) ... The book examines the relationship between shared access centres, the ...

[Innovative medicines and market access agreements].

Science.gov (United States)

Toumi, M; Zard, J; Duvillard, R; Jommi, C

2013-09-01

Market Access Agreements (MAA) for drugs have emerged in response to the need to control health expenditures, as well as to the uncertainty about the true benefit of a drug. It is possible to group MAA in two types of agreements: financial agreements and outcome-based agreements. MAA is a growing trend and is shifting towards conditional access. However, the willingness to use these contracts and their implementation differ across countries, and some are still resistant to put them in place. The MAA challenges to overcome encompass the complexity of the schemes, the administrative burden and the difficulty of evaluating MAA. It is likely that these agreements might experience further evolution in the future to become a faster pathway for therapeutic innovations, at a fair price. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

Making Mechanization Accessible to Smallholder Farmers in Sub-Saharan Africa

Directory of Open Access Journals (Sweden)

Brian Sims

2016-04-01

Full Text Available This paper summarizes the deliberations at a meeting convened by the Bill & Melinda Gates Foundation held in Beijing in October 2015. Farm power and mechanization are agricultural production inputs that will be essential to raise the labor and land productivity required if Sustainable Development Goals 1 and 2 (ending poverty and hunger are to be achieved. The smallholder farm sector demand for mechanization needs to be raised to stimulate the product value chain and activate input supply (that is to raise farm productivity, stimulate value addition, and encourage private sector custom hire service provision. The sustainability of mechanization from a natural resource conservation point of view is discussed with reference to conservation agriculture principles. Mechanization appropriate for the smallholder sector covers the range of possible power sources human, draft animal and motorized. The key is to engage all the stakeholders in the supply chain and offer a range of suitable options from which the user can select. Sustainability of mechanization includes financial and social, as well as environmental factors. Local manufacturers should be supported where feasible as they can provide implements and machines adapted to local conditions—and better technical service and replacement part supply. The public sector role in providing access to mechanization should be restricted to promulgating enabling policies, building technical and business management skills and stimulating demand. The lessons to be learnt from Chinese experience in making mechanization available to smallholder farmers include subsidies, strong extension services, infrastructure development and a solid manufacturing sector that prioritizes the smallholder sector. The implications for sub-Saharan Africa appear to be that group ownership and custom hire service provision are the models to follow. Finally, the relevance of an African Center for Sustainable Agricultural

21 CFR 312.305 - Requirements for all expanded access uses.

Science.gov (United States)

2010-04-01

... options; (iii) The criteria for patient selection or, for an individual patient, a description of the... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Requirements for all expanded access uses. 312.305 Section 312.305 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

Making out in English (English phrasebook)

CERN Document Server

Crownover, Richard

2011-01-01

Making Out in English is a fun, accessible and thorough English phrase book and guide to the English language as it's really spoken. If you are a student, businessman or tourist traveling to the English speaking world and would like to have an authentic and meaningful experience, the key is being able to speak like a local. This friendly and easy-to-use English phrasebook makes this possible. Making Out in English has been revised and redesigned to act as a guide to modern colloquial English for use in everyday informal interactions—giving access to the sort of catchy English expressions that

An Exploratory Qualitative Assessment of Self-Reported Treatment Outcomes and Satisfaction Among Patients Accessing an Innovative Voluntary Drug Treatment Centre in Malaysia

Science.gov (United States)

Ghani, Mansur A.; Brown, Shan-Estelle; Khan, Farrah; Wickersham, Jeffrey A.; Lim, Sin How; Dhaliwal, Sangeeth K.; Kamarulzaman, Adeeba; Altice, Frederick L.

2014-01-01

Background In Malaysia, compulsory drug detention centres (CDDCs) hold suspected drug users for two years without adjudication. Acute detoxification without healthcare access has been documented. CDDCs are criticized globally due to ineffectiveness in treating addiction and human rights violations. In response, the Malaysian government began transitioning these facilities into voluntary drug treatment centres known as “Cure and Care” (C&C) centres that embrace a holistic treatment-based approach to drug addiction rehabilitation. Methods An explorative qualitative study was undertaken to explore patient perspectives and satisfaction regarding treatment and services at the new Cure and Care centre in Kota Bharu, Malaysia. A convenience sample of 20 patients was recruited to participate in semi-structured in-depth interviews. Content analysis approach was used to identify the salient themes. Results Patients identified methadone treatment, psychosocial programs, religious instruction, and recreational activities as important factors contributing to treatment success for addressing both health and addiction needs. Though many had previously been in a CDDC, adherence to treatment in the C&C centre was perceived to be facilitated by the degree of social support, the voluntary nature and the array of new programs available for selection. Conclusion C&Cs represents a dramatic shift in the Malaysian government’s approach to drug addiction. Our findings demonstrate positive patient experiences associated with the holistic treatment-based approach of these centres. This exploratory study provides additional evidence to document this ongoing policy transition and may guide continued expansion of new holistic drug treatment programs across the country. PMID:25577322

An exploratory qualitative assessment of self-reported treatment outcomes and satisfaction among patients accessing an innovative voluntary drug treatment centre in Malaysia.

Science.gov (United States)

Ghani, Mansur A; Brown, Shan-Estelle; Khan, Farrah; Wickersham, Jeffrey A; Lim, Sin How; Dhaliwal, Sangeeth K; Kamarulzaman, Adeeba; Altice, Frederick L

2015-02-01

In Malaysia, compulsory drug detention centres (CDDCs) hold suspected drug users for two years without adjudication. Acute detoxification without healthcare access has been documented. CDDCs are criticized globally due to ineffectiveness in treating addiction and human rights violations. In response, the Malaysian government began transitioning these facilities into voluntary drug treatment centres known as "Cure and Care" (C&C) centres that embrace a holistic treatment-based approach to drug addiction rehabilitation. An explorative qualitative study was undertaken to explore patient perspectives and satisfaction regarding treatment and services at the new Cure and Care centre in Kota Bharu, Malaysia. A convenience sample of 20 patients was recruited to participate in semi-structured in-depth interviews. Content analysis was used to identify the salient themes. Patients identified methadone treatment, psychosocial programs, religious instruction, and recreational activities as important factors contributing to treatment success for addressing both health and addiction needs. Though many had previously been in a CDDC, adherence to treatment in the C&C centre was perceived to be facilitated by the degree of social support, the voluntary nature and the array of new programs available for selection. C&Cs represents a dramatic shift in the Malaysian government's approach to drug addiction. Our findings demonstrate positive patient experiences associated with the holistic treatment-based approach of these centres. This exploratory study provides additional evidence to document this ongoing policy transition and may guide continued expansion of new holistic drug treatment programs across the country. Copyright © 2014 Elsevier B.V. All rights reserved.

Experiences with urine drug testing by police among people who inject drugs in Bangkok, Thailand.

Science.gov (United States)

Hayashi, Kanna; Ti, Lianping; Buxton, Jane A; Kaplan, Karyn; Suwannawong, Paisan; Wood, Evan; Kerr, Thomas

2014-03-01

Thailand has relied on drug law enforcement in an effort to curb illicit drug use. While anecdotal reports suggest that Thai police frequently use urine toxicology to identify drug users, little is known about the prevalence or impacts of this practice among people who inject drugs (IDU). Therefore, we sought to examine experiences with urine drug testing by police among IDU in Bangkok. Data were derived from a community-recruited sample of IDU in Bangkok participating in the Mitsampan Community Research Project between July and October 2011. We assessed the prevalence and correlates of being subjected to urine toxicology testing by police using multivariate Poisson regression. In total, 438 IDU participated in this study, with 293 (66.9%) participants reporting having been tested for illicit drugs by police. In multivariate analyses, reports of drug testing by police were independently and positively associated with younger age (adjusted prevalence ratio [APR]: 1.28), a history of methamphetamine injection (APR: 1.22), a history of incarceration (APR: 1.21), having been in compulsory drug detention (APR: 1.43), avoiding healthcare (APR: 1.15), and HIV seropositivity (APR: 1.19), and negatively associated with access to voluntary drug treatment (APR: 0.82) (all p<0.05). A high proportion of IDU in Bangkok were subjected to drug testing by police. Young people and methamphetamine injectors were more likely to have been tested. The findings indicate that drug testing by police is associated with the compulsory drug detention system and may be interfering with IDU's access to healthcare and voluntary drug treatment. These findings raise concern about the widespread practice of drug testing by police and its associated impacts. Copyright © 2013 Elsevier B.V. All rights reserved.

Exploiting the potential of intranet for managing drug spectrum a web base publication in a Tertiary Care Hospital in Mumbai

Directory of Open Access Journals (Sweden)

Yashashri Chandrakant Shetty

2015-01-01

Full Text Available Objective: The study surveyed the availability of the intranet in campus and also the knowledge related to drug spectrum an intranet publication. Materials and Methods: Institutional ethics committee permission was obtained. Verbal consent was taken from the faculty and resident doctors of departments where all the facilities were available. Universal sampling method was used for recruitment. Pre-validated questionnaires were given to approximately 100 faculty and 500 resident doctors in the year 2012-2013. The questionnaire contained 15 items. Content analysis was done. The study questionnaire focused on a survey to obtain participants feedback on the use of the intranet and to evaluate the use of intranet as a source of knowledge. It also dealt on the relevance of the drug spectrum in the context of their subject. The responses were taken after giving the participants sufficient time. Data was entered into an Excel 2003 spread sheet and analyzed by using descriptive statistics. Results: The total number of respondents who participated in our study was 134 including faculty and residents from various departments. A total of 117 (89.66% respondents stated that their departments have access to the internet. Departments having access to intranet was 103 (76.29%. 67 (49.62% respondents have accessed. 67 (49.62% did not have the time to visit intranet site whereas 67 (49.62% have not accessed intranet. 89 (65.92% respondents were not aware of the drug spectrum. 101 (74.81% respondents felt that drug spectrum is a useful activity on intranet. 45 (33.33% knew about the intranet periodical drug spectrum, but most of the respondents (33.33% explained the meaning of the word drug spectrum according to their understanding, but never knew about the online intranet journal drug spectrum. Conclusion: The study found that the intranet is available in the campus, but it is not being utilized. The awareness and knowledge regarding drug spectrum is lacking, but

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

Directory of Open Access Journals (Sweden)

Gill PS

2013-02-01

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

Cognitive Access to TVWS in India

DEFF Research Database (Denmark)

Patil, Kishor P.; Skouby, Knud Erik; Prasad, Ramjee

2013-01-01

The digital transition of TV transmission will make available some TV frequencies which are to be geographically unused called as TV White Spaces. The important regulatory trend in the context of Dynamic Spectrum Access (DSA) is the Cognitive access of TV white Spaces. In this context, we have pe...... of India, we have proposed wireless broadband access to rural areas using TV White Spaces (TVWSs). This will help in bridging the digital divide by offering governance, banking, and health services online in the rural areas.......The digital transition of TV transmission will make available some TV frequencies which are to be geographically unused called as TV White Spaces. The important regulatory trend in the context of Dynamic Spectrum Access (DSA) is the Cognitive access of TV white Spaces. In this context, we have...... performed spectrum measurements of TV band in Pune, India. Our result shows poor spectrum utilization in TV band, and good potential for Cognitive radio operation. Digital switchover in India will generate golden opportunity for empowering rural India. As majority of India’s population lives in rural part...

Accessing remote data bases using microcomputers

OpenAIRE

Saul, Peter D.

1985-01-01

General practitioners' access to remote data bases using microcomputers is increasing, making even the most obscure information readily available. Some of the systems available to general practitioners in the UK are described and the methods of access are outlined. General practitioners should be aware of the advances in technology; data bases are increasing in size, the cost of access is falling and their use is becoming easier.

Making Patron Data Work Harder: User Search Terms as Access Points?

Directory of Open Access Journals (Sweden)

Jason A. Clark

2008-06-01

Full Text Available Montana State University (MSU Libraries are experimenting with re-using patron-generated data to create browseable access points for the Electronic Theses and Dissertations (ETD collection. A beta QueryCatcher module logs recent search terms and the number of associated hits. These terms are used to create browseable lists and tagclouds which enhance access to the ETD collection. Gathering and reusing information about user behavior is an emerging trend in web application development. This article outlines MSU Libraries' reasoning for moving towards a user-generated model and provides a complete walkthrough of the steps in building the application and example code.

Access to the internet for knowledge dissemination: agricultural ...

African Journals Online (AJOL)

Access to agricultural information is a prerequisite for agricultural development. However, information on how agricultural scientists make use of the Internet to access agricultural information is limited. This study therefore investigated access to the Internet for knowledge dissemination by agricultural researchers in ...

Restrictions in Availability of Drugs Used for Suicide

DEFF Research Database (Denmark)

Nordentoft, Merete

2007-01-01

Availability of drugs with high lethality has been hypothesized to increase the risk of self-poisoning suicides. A literature search concerning deliberate self-poisoning and the effect of restricting access to drugs was conducted, and the effect of restrictions in availability of barbiturates, tr...... in availability of drugs with high case fatality should be a part of suicide prevention strategies.......Availability of drugs with high lethality has been hypothesized to increase the risk of self-poisoning suicides. A literature search concerning deliberate self-poisoning and the effect of restricting access to drugs was conducted, and the effect of restrictions in availability of barbiturates......, tricyclic antidepressants, dextropropoxyphene, and weak analgesics was reviewed. The correlations between method-specific and overall suicide rates and sales figures for barbiturates, dextropropoxyphene, weak analgesics, and tricyclic antidepressants were reviewed. It is concluded that restriction...

Comparison of minipig, dog, monkey and human drug metabolism and disposition.

Science.gov (United States)

Dalgaard, Lars

2015-01-01

This article gives an overview of the drug metabolism and disposition (ADME) characteristics of the most common non-rodent species used in toxicity testing of drugs (minipigs, dogs, and monkeys) and compares these to human characteristics with regard to enzymes mediating the metabolism of drugs and the transport proteins which contribute to the absorption, distribution and excretion of drugs. Literature on ADME and regulatory guidelines of relevance in drug development of small molecules has been gathered. Non-human primates (monkeys) are the species that is closest to humans in terms of genetic homology. Dogs have an advantage due to the ready availability of comprehensive background data for toxicological safety assessment and dogs are easy to handle. Pigs have been used less than dogs and monkeys as a model in safety assessment of drug candidates. However, when a drug candidate is metabolised by aldehyde oxidase (AOX1), N-acetyltransferases (NAT1 and NAT2) or cytochrome (CYP2C9-like) enzymes which are not expressed in dogs, but are present in pigs, this species may be a better choice than dogs, provided that adequate exposure can be obtained in pigs. Conversely, pigs might not be the right choice if sulfation, involving 3-phospho-adenosyl-5-phosphosulphate sulphotransferase (PAPS) is an important pathway in the human metabolism of a drug candidate. In general, the species selection should be based on comparison between in vitro studies with human cell-based systems and animal-cell-based systems. Results from pharmacokinetic studies are also important for decision-making by establishing the obtainable exposure level in the species. Access to genetically humanized mouse models and highly sensitive analytical methods (accelerator mass spectrometry) makes it possible to improve the chance of finding all metabolites relevant for humans before clinical trials have been initiated and, if necessary, to include another animal species before long term toxicity studies are

Ethnographic research in immigrant-specific drug abuse recovery houses.

Science.gov (United States)

Pagano, Anna; Lee, Juliet P; García, Victor; Recarte, Carlos

2018-01-01

Access to study populations is a major concern for drug use and treatment researchers. Spaces related to drug use and treatment have varying levels of researcher accessibility based on several issues, including legality, public versus private settings, and insider/outsider status. Ethnographic research methods are indispensable for gaining and maintaining access to hidden or "hard-to-reach" populations. Here, we discuss our long-term ethnographic research on drug abuse recovery houses created by and for Latino migrants and immigrants in Northern California. We take our field work experiences as a case study to examine the problem of researcher access and how ethnographic strategies can be successfully applied to address it, focusing especially on issues of entrée, building rapport, and navigating field-specific challenges related to legality, public/private settings, and insider/outsider status. We conclude that continued funding support for ethnography is essential for promoting health disparities research focused on diverse populations in recovery from substance use disorders.

Perti Net-Based Workflow Access Control Model

Institute of Scientific and Technical Information of China (English)

陈卓; 骆婷; 石磊; 洪帆

2004-01-01

Access control is an important protection mechanism for information systems. This paper shows how to make access control in workflow system. We give a workflow access control model (WACM) based on several current access control models. The model supports roles assignment and dynamic authorization. The paper defines the workflow using Petri net. It firstly gives the definition and description of the workflow, and then analyzes the architecture of the workflow access control model (WACM). Finally, an example of an e-commerce workflow access control model is discussed in detail.

Disparities in Alcohol, Drug Use, and Mental Health Condition Prevalence and Access to Care in Rural, Isolated, and Reservation Areas: Findings From the South Dakota Health Survey.

Science.gov (United States)

Davis, Melinda M; Spurlock, Margaret; Dulacki, Kristen; Meath, Thomas; Li, Hsin-Fang Grace; McCarty, Dennis; Warne, Donald; Wright, Bill; McConnell, K John

2016-06-01

Research on urban/rural disparities in alcohol, drug use, and mental health (ADM) conditions is inconsistent. This study describes ADM condition prevalence and access to care across diverse geographies in a predominantly rural state. Multimodal cross-sectional survey in South Dakota from November 2013 to October 2014, with oversampling in rural areas and American Indian reservations. Measures assessed demographic characteristics, ADM condition prevalence using clinical screenings and participant self-report, perceived need for treatment, health service usage, and barriers to obtaining care. We tested for differences among urban, rural, isolated, and reservation geographic areas, controlling for participant age and gender. We analyzed 7,675 surveys (48% response rate). Generally, ADM condition prevalence rates were not significantly different across geographies. However, respondents in isolated and reservation areas were significantly less likely to have access to primary care. Knowledge of treatment options was significantly lower in isolated regions and individuals in reservation areas had significantly lower odds of reporting receipt of all needed care. Across the sample there was substantial discordance between ADM clinical screenings and participant self-reported need; 98.1% of respondents who screened positive for alcohol or drug misuse and 63.8% of respondents who screened positive for a mental health condition did not perceive a need for care. In a predominantly rural state, geographic disparities in ADM conditions are related to differences in access as opposed to prevalence, particularly for individuals in isolated and reservation areas. Educational interventions about ADM condition characteristics may be as important as improving access to care. © 2015 National Rural Health Association.

Can Walmart make us healthier? Prescription drug prices and health care utilization.

Science.gov (United States)

Borrescio-Higa, Florencia

2015-12-01

This paper analyzes how prices in the retail pharmaceutical market affect health care utilization. Specifically, I study the impact of Walmart's $4 Prescription Drug Program on utilization of antihypertensive drugs and on hospitalizations for conditions amenable to drug therapy. Identification relies on the change in the availability of cheap drugs introduced by Walmart's program, exploiting variation in the distance to the nearest Walmart across ZIP codes in a difference-in-differences framework. I find that living close to a source of cheap drugs increases utilization of antihypertensive medications by 7 percent and decreases the probability of an avoidable hospitalization by 6.2 percent. Copyright © 2015 Elsevier B.V. All rights reserved.

Making basic health care accessible to rural communities: a case study of Kiang West district in rural Gambia.

Science.gov (United States)

Sanneh, Edward Saja; Hu, Allen H; Njai, Modou; Ceesay, Omar Malleh; Manjang, Buba

2014-01-01

This study focuses on lack of access to basic health care, which is one of the hindrances to the development of the poor, and subjects them to the poverty penalty. It also focuses on contributing to the Bottom of the Pyramid in a general sense, in addition to meeting the health needs of communities where people live on less than $1 a day. Strengthened multistakeholder responses and better-targeted, low-cost prevention, and care strategies within health systems are suggested to address the health burdens of poverty-stricken communities. In this study, a multistakeholder model which includes the government, World Health Organization, United Nations Children Emergency Fund, and the Medical Research Council was created to highlight the collaborative approach in rural Gambia. The result shows infant immunization and antenatal care coverage were greatly improved which contributes to the reduction in mortality. This case study also finds that strategies addressing health problems in rural communities are required to achieve 'Millennium Development Goals'. In particular, actual community visits to satellite villages within a district (area of study) are extremely vital to making health care accessible. © 2013 Wiley Periodicals, Inc.

What is a new drug worth? An innovative model for performance-based pricing.

Science.gov (United States)

Dranitsaris, G; Dorward, K; Owens, R C; Schipper, H

2015-05-01

This article focuses on a novel method to derive prices for new pharmaceuticals by making price a function of drug performance. We briefly review current models for determining price for a new product and discuss alternatives that have historically been favoured by various funding bodies. The progressive approach to drug pricing, proposed herein, may better address the views and concerns of multiple stakeholders in a developed healthcare system by acknowledging and incorporating input from disparate parties via comprehensive and successive negotiation stages. In proposing a valid construct for performance-based pricing, the following model seeks to achieve several crucial objectives: earlier and wider access to new treatments; improved transparency in drug pricing; multi-stakeholder involvement through phased pricing negotiations; recognition of innovative product performance and latent changes in value; an earlier and more predictable return for developers without sacrificing total return on investment (ROI); more involved and informed risk sharing by the end-user. © 2014 John Wiley & Sons Ltd.

A Novel Fuzzy Algorithm to Introduce New Variables in the Drug Supply Decision-Making Process in Medicine

Directory of Open Access Journals (Sweden)

Jose M. Gonzalez-Cava

2018-01-01

Full Text Available One of the main challenges in medicine is to guarantee an appropriate drug supply according to the real needs of patients. Closed-loop strategies have been widely used to develop automatic solutions based on feedback variables. However, when the variable of interest cannot be directly measured or there is a lack of knowledge behind the process, it turns into a difficult issue to solve. In this research, a novel algorithm to approach this problem is presented. The main objective of this study is to provide a new general algorithm capable of determining the influence of a certain clinical variable in the decision making process for drug supply and then defining an automatic system able to guide the process considering this information. Thus, this new technique will provide a way to validate a given physiological signal as a feedback variable for drug titration. In addition, the result of the algorithm in terms of fuzzy rules and membership functions will define a fuzzy-based decision system for the drug delivery process. The method proposed is based on a Fuzzy Inference System whose structure is obtained through a decision tree algorithm. A four-step methodology is then developed: data collection, preprocessing, Fuzzy Inference System generation, and the validation of results. To test this methodology, the analgesia control scenario was analysed. Specifically, the viability of the Analgesia Nociception Index (ANI as a guiding variable for the analgesic process during surgical interventions was studied. Real data was obtained from fifteen patients undergoing cholecystectomy surgery.

Public Health and International Drug Policy

Science.gov (United States)

Csete, Joanne; Kamarulzaman, Adeeba; Kazatchkine, Michel; Altice, Frederick; Balicki, Marek; Buxton, Julia; Cepeda, Javier; Comfort, Megan; Goosby, Eric; Goulão, João; Hart, Carl; Horton, Richard; Kerr, Thomas; Lajous, Alejandro Madrazo; Lewis, Stephen; Martin, Natasha; Mejía, Daniel; Mathiesson, David; Obot, Isidore; Ogunrombi, Adeolu; Sherman, Susan; Stone, Jack; Vallath, Nandini; Vickerman, Peter; Zábranský, Tomáš; Beyrer, Chris

2016-01-01

for PWUD and OST coverage is relatively high in prison, an estimated 54% of incident HCV infection occurs in prison, but as much as 21% may occur in the high-risk post-release period. These results underscore the importance of alternatives to prison for minor drug offences, ensuring access to OST in prison, and a seamless link from prison services to OST in the community. The evidence also clearly demonstrates that drug law enforcement has been applied in a discriminatory way against racial and ethnic minorities in a number of countries. The US is perhaps the best documented but not the only case of racial biases in policing, arrest, and sentencing. In 2014, African American men were more than five times more likely than whites to be incarcerated in their lifetime, though there is no significant difference in rates of drug use among these populations. The impact of this bias on communities of people of color is inter-generational and socially and economically devastating. The Commission also found significant gender biases in current drug policies. Of women in prison and pretrial detention around the world, a higher percentage are detained because of drug infractions than is the case for men. Women involved in drug markets are often on the bottom rungs – as couriers or drivers – and may not have information about major traffickers to trade as leverage with prosecutors. Gender and racial biases have marked overlap, making this an intersectional threat to women of color, their children, families, and communities. In both prison and the community, HIV, HCV and TB programmes for PWUD – including testing, prevention and treatment – are gravely underfunded at the cost of preventable death and disease. In a number of middle-income countries where large numbers of PWUD live, HIV and TB programmes for PWUD that were expanded with support from the Global Fund to Fight AIDS, TB and Malaria have lost funding due to changes in the Fund’s eligibility criteria. There is an

Breaking the Cycle of Drug Abuse. 1993 Interim National Drug Control Strategy.

Science.gov (United States)

Office of National Drug Control Policy, Washington, DC.

This Interim Drug Strategy is intended to give a new sense of direction and to reinvigorate the nation's efforts against drug trafficking and abuse. The preface to the report lists eight new strategies that the Administration will implement: (1) make drug policy a cornerstone of domestic and social policy; (2) target pregnant women, children, and…

Evaluating Drug Prices, Availability, Affordability, and Price Components: Implications for Access to Drugs in Malaysia

Science.gov (United States)

Babar, Zaheer Ud Din; Ibrahim, Mohamed Izham Mohamed; Singh, Harpal; Bukahri, Nadeem Irfan; Creese, Andrew

2007-01-01

Background Malaysia's stable health care system is facing challenges with increasing medicine costs. To investigate these issues a survey was carried out to evaluate medicine prices, availability, affordability, and the structure of price components. Methods and Findings The methodology developed by the World Health Organization (WHO) and Health Action International (HAI) was used. Price and availability data for 48 medicines was collected from 20 public sector facilities, 32 private sector retail pharmacies and 20 dispensing doctors in four geographical regions of West Malaysia. Medicine prices were compared with international reference prices (IRPs) to obtain a median price ratio. The daily wage of the lowest paid unskilled government worker was used to gauge the affordability of medicines. Price component data were collected throughout the supply chain, and markups, taxes, and other distribution costs were identified. In private pharmacies, innovator brand (IB) prices were 16 times higher than the IRPs, while generics were 6.6 times higher. In dispensing doctor clinics, the figures were 15 times higher for innovator brands and 7.5 for generics. Dispensing doctors applied high markups of 50%–76% for IBs, and up to 316% for generics. Retail pharmacy markups were also high—25%–38% and 100%–140% for IBs and generics, respectively. In the public sector, where medicines are free, availability was low even for medicines on the National Essential Drugs List. For a month's treatment for peptic ulcer disease and hypertension people have to pay about a week's wages in the private sector. Conclusions The free market by definition does not control medicine prices, necessitating price monitoring and control mechanisms. Markups for generic products are greater than for IBs. Reducing the base price without controlling markups may increase profits for retailers and dispensing doctors without reducing the price paid by end users. To increase access and affordability

Evaluating drug prices, availability, affordability, and price components: implications for access to drugs in Malaysia.

Directory of Open Access Journals (Sweden)

Zaheer Ud Din Babar

2007-03-01

Full Text Available BACKGROUND: Malaysia's stable health care system is facing challenges with increasing medicine costs. To investigate these issues a survey was carried out to evaluate medicine prices, availability, affordability, and the structure of price components. METHODS AND FINDINGS: The methodology developed by the World Health Organization (WHO and Health Action International (HAI was used. Price and availability data for 48 medicines was collected from 20 public sector facilities, 32 private sector retail pharmacies and 20 dispensing doctors in four geographical regions of West Malaysia. Medicine prices were compared with international reference prices (IRPs to obtain a median price ratio. The daily wage of the lowest paid unskilled government worker was used to gauge the affordability of medicines. Price component data were collected throughout the supply chain, and markups, taxes, and other distribution costs were identified. In private pharmacies, innovator brand (IB prices were 16 times higher than the IRPs, while generics were 6.6 times higher. In dispensing doctor clinics, the figures were 15 times higher for innovator brands and 7.5 for generics. Dispensing doctors applied high markups of 50%-76% for IBs, and up to 316% for generics. Retail pharmacy markups were also high-25%-38% and 100%-140% for IBs and generics, respectively. In the public sector, where medicines are free, availability was low even for medicines on the National Essential Drugs List. For a month's treatment for peptic ulcer disease and hypertension people have to pay about a week's wages in the private sector. CONCLUSIONS: The free market by definition does not control medicine prices, necessitating price monitoring and control mechanisms. Markups for generic products are greater than for IBs. Reducing the base price without controlling markups may increase profits for retailers and dispensing doctors without reducing the price paid by end users. To increase access and

Reforming voluntary drug insurance in Russian healthcare: does social solidarity matter?

Science.gov (United States)

Gerry, Christopher J; Kaneva, Maria; Zasimova, Liudmila

2017-11-01

With low take-up of both private health insurance and the existing public drug reimbursement scheme, it is thought that less than 5% of the Russian population have access to free outpatient drug treatment. This represents a major policy challenge for a country grappling with reforms of its healthcare system and experiencing low or no economic growth and significant associated reductions in spending on social services. In this paper, we draw on data from a 2011 Levada-Center survey to examine the attitudes and social solidarity of the Russian population towards drug policies in general and towards the introduction of a proposed voluntary drug insurance system in particular. In addition to being among the first to explore these important questions in the post-Communist setting, we make three important contributions to the emerging policy debates. First, we find that, if introduced immediately and without careful planning and preparation, Russia's voluntary drug insurance scheme is likely to collapse financially due to the over-representation of high-risk unhealthy individuals opting in to the scheme. Second, the negative attitude of higher income groups towards the redistribution of wealth to the poor may further impede government efforts to introduce voluntary drug insurance. Finally, we argue that Russia currently lacks the breadth and depth of social solidarity necessary for implementing this form of health financing. Copyright © 2017 Elsevier B.V. All rights reserved.

Accessible Collaborative Learning Using Mobile Devices

Science.gov (United States)

Wald, Mike; Li, Yunjia; Draffan, E. A.

2014-01-01

This paper describes accessible collaborative learning using mobile devices with mobile enhancements to Synote, the freely available, award winning, open source, web based application that makes web hosted recordings easier to access, search, manage, and exploit for all learners, teachers and other users. Notes taken live during lectures using…

Designing Out the Play: Accessibility and Playfulness in Inclusive Play.

Science.gov (United States)

Holt, Raymond; Beckett, Angharad

2017-01-01

Play is an important part of child development, yet disabled children are often excluded from the opportunity to play, either due to lack of accessible toys and games, or social pressures. This paper presents a case study reflecting on the development of Button Bash: a switch accessible game intended to encourage inclusive play between disabled and non-disabled children. In particular, the paper focuses on how changes intended to make the game more accessible tended to make it less playful, and reflects on the relationship between playfulness and accessibility.

Attributes Enhanced Role-Based Access Control Model

DEFF Research Database (Denmark)

Mahmood Rajpoot, Qasim; Jensen, Christian D.; Krishnan, Ram

2015-01-01

as an important area of research. In this paper, we propose an access control model that combines the two models in a novel way in order to unify their benefits. Our approach provides a fine-grained access control mechanism that not only takes contextual information into account while making the access control...... decisions but is also suitable for applications where access to resources is controlled by exploiting contents of the resources in the policy....

Factors associated with patterns of mobile technology use among persons who inject drugs.

Science.gov (United States)

Collins, Kelly M; Armenta, Richard F; Cuevas-Mota, Jazmine; Liu, Lin; Strathdee, Steffanie A; Garfein, Richard S

2016-01-01

New and innovative methods of delivering interventions are needed to further reduce risky behaviors and increase overall health among persons who inject drugs (PWID). Mobile health (mHealth) interventions have potential for reaching PWID; however, little is known about mobile technology use (MTU) in this population. In this study, the authors identify patterns of MTU and identified factors associated with MTU among a cohort of PWID. Data were collected through a longitudinal cohort study examining drug use, risk behaviors, and health status among PWID in San Diego, California. Latent class analysis (LCA) was used to define patterns of MTU (i.e., making voice calls, text messaging, and mobile Internet access). Multinomial logistic regression was then used to identify demographic characteristics, risk behaviors, and health indicators associated with mobile technology use class. In LCA, a 4-class solution fit the data best. Class 1 was defined by low MTU (22%, n = 100); class 2, by PWID who accessed the Internet using a mobile device but did not use voice or text messaging (20%, n = 95); class 3, by primarily voice, text, and connected Internet use (17%, n = 91); and class 4, by high MTU (41%, n = 175). Compared with low MTU, high MTU class members were more likely to be younger, have higher socioeconomic status, sell drugs, and inject methamphetamine daily. The majority of PWID in San Diego use mobile technology for voice, text, and/or Internet access, indicating that rapid uptake of mHealth interventions may be possible in this population. However, low ownership and use of mobile technology among older and/or homeless individuals will need to be considered when implementing mHealth interventions among PWID.

Serotonin and decision making processes.

NARCIS (Netherlands)

Homberg, J.R.

2012-01-01

Serotonin (5-HT) is an important player in decision making. Serotonergic antidepressant, anxiolytic and antipsychotic drugs are extensively used in the treatment of neuropsychiatric disorders characterized by impaired decision making, and exert both beneficial and harmful effects in patients.

77 FR 65198 - Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, and Drug...

Science.gov (United States)

2012-10-25

..., U.S. postal money order, or wire transfer. FDA has partnered with the U.S. Department of the... money order and make payable to the order of the Food and Drug Administration. Your payment can be mailed to: Food and Drug Administration, P.O. Box 979108, St. Louis, MO 63197-9000. If checks are to be...

One day access to a running wheel reduces self-administration of d-methamphetamine, MDMA and Methylone

Science.gov (United States)

Aarde, Shawn M.; Miller, Michelle L.; Creehan, Kevin M.; Vandewater, Sophia A.; Taffe, Michael A.

2015-01-01

Background Exercise influences drug craving and consumption in humans and drug self-administration in laboratory animals, but the effects can be variable. Improved understanding of how exercise affects drug intake or craving would enhance applications of exercise programs to human drug users attempting cessation. Methods Rats were trained in the intravenous self-administration (IVSA) of d-methamphetamine (METH; 0.05 mg/kg/inf), 3,4-methylenedioxymethamphetamine (MDMA; 0.5 mg/kg/inf) or methylone (0.5 mg/kg/inf). Once IVSA was established, the effect of ~22 hrs of wheel access in the home cage on subsequent drug taking was assessed in a two cohort crossover design. Results Provision of home cage wheel access during the day prior to IVSA sessions significantly decreased the self-administration of METH, MDMA and methylone. At the individual level, there was no correlation between the amount a rat used the wheel and the size of the individual’s decrease in drug intake. Conclusions Wheel access can reduce self-administration of a variety of psychomotor stimulants. It does so immediately, i.e., without a need for weeks of exercise prior to drug access. This study therefore indicates that future mechanistic investigations should focus on acute effects of exercise. In sum, the results predict that exercise programs can be used to decrease stimulant drug use in individuals even with no exercise history and an established drug taking pattern. PMID:25863714

Ethical framework for resource allocation during a drug supply shortage.

Science.gov (United States)

Gibson, Jennifer L; Bean, Sally; Chidwick, Paula; Godkin, Dianne; Sibbald, Robert W; Wagner, Frank

2012-01-01

Drug supply shortages are common in health systems due to manufacturing and other delays. Frequently, shortages are successfully addressed through conservation and redistribution efforts, with limited impact on patient care. However, when Sandoz Canada Inc. announced in February 2012 that it was reducing production of a number of generic injectable drugs at its Quebec facility, the scope and magnitude of the drug supply shortage were unprecedented in Canada. The potential for an extreme scarcity of some drugs raised ethical concerns about patient care, including the need to limit access to some health services. In this article, the authors describe the development and implementation of an ethical framework to promote equitable access to drugs and healthcare services in the context of a drug supply shortage within and across health systems.

AN AUTOMATIC AND METHODOLOGICAL APPROACH FOR ACCESSIBLE WEB APPLICATIONS

Directory of Open Access Journals (Sweden)

Lourdes Moreno

2007-06-01

Full Text Available Semantic Web approaches try to get the interoperability and communication among technologies and organizations. Nevertheless, sometimes it is forgotten that the Web must be useful for every user, consequently it is necessary to include tools and techniques doing Semantic Web be accessible. Accessibility and usability are two usually joined concepts widely used in web application development, however their meaning are different. Usability means the way to make easy the use but accessibility is referred to the access possibility. For the first one, there are many well proved approaches in real cases. However, accessibility field requires a deeper research that will make feasible the access to disable people and also the access to novel non-disable people due to the cost to automate and maintain accessible applications. In this paper, we propose one architecture to achieve the accessibility in web-environments dealing with the WAI accessibility standard and the Universal Design paradigm. This architecture tries to control the accessibility in web applications development life-cycle following a methodology starting from a semantic conceptual model and leans on description languages and controlled vocabularies.

Accessing patient-centered care using the advanced access model.

Science.gov (United States)

Tantau, Catherine

2009-01-01

Waits and delays for healthcare are legendary. These delays are not only frustrating and potentially hazardous for patients and providers but also represent significant cost to office practices. The traditional medical model that defines urgent care versus routine care is a vain and futile attempt to sort demand. This approach is at constant odds with patients' definition of urgency. Trusting patients to determine when and how they want to access care makes sense from a customer service perspective. If approached systematically using the principles of Advanced Access, patient demand patterns can be tracked to forecast demand. These demand patterns become the template for deploying the resources necessary to meet patients' needs. Although not a simple journey, the transformation to Advanced Access provides an entree to patient-centered care where patients can say, "I get exactly the care I want and need, when I want and need it."

Drug therapy for hereditary cancers

Directory of Open Access Journals (Sweden)

Imyanitov Evgeny N

2011-08-01

Full Text Available Abstract Tumors arising in patients with hereditary cancer syndromes may have distinct drug sensitivity as compared to their sporadic counterparts. Breast and ovarian neoplasms from BRCA1 or BRCA2 mutation carriers are characterized by deficient homologous recombination (HR of DNA, that makes them particularly sensitive to platinum compounds or inhibitors of poly (ADP-ribose polymerase (PARP. Outstandingly durable complete responses to high dose chemotherapy have been observed in several cases of BRCA-related metastatic breast cancer (BC. Multiple lines of evidence indicate that women with BRCA1-related BC may derive less benefit from taxane-based treatment than other categories of BC patients. There is virtually no reports directly assessing drug response in hereditary colorectal cancer (CRC patients; studies involving non-selected (i.e., both sporadic and hereditary CRC with high-level microsatellite instability (MSI-H suggest therapeutic advantage of irinotecan. Celecoxib has been approved for the treatment of familial adenomatous polyposis (FAP. Hereditary medullary thyroid cancers (MTC have been shown to be highly responsive to a multitargeted tyrosine kinase inhibitor vandetanib, which exerts specific activity towards mutated RET receptor. Given the rapidly improving accessibility of DNA analysis, it is foreseen that the potential predictive value of cancer-associated germ-line mutations will be increasingly considered in the future studies.

Pharmacodynamics and common drug-drug interactions of the third-generation antiepileptic drugs.

Science.gov (United States)

Stefanović, Srđan; Janković, Slobodan M; Novaković, Milan; Milosavljević, Marko; Folić, Marko

2018-02-01

Anticonvulsants that belong to the third generation are considered as 'newer' antiepileptic drugs, including: eslicarbazepine acetate, lacosamide, perampanel, brivaracetam, rufinamide and stiripentol. Areas covered: This article reviews pharmacodynamics (i.e. mechanisms of action) and clinically relevant drug-drug interactions of the third-generation antiepileptic drugs. Expert opinion: Newer antiepileptic drugs have mechanisms of action which are not shared with the first and the second generation anticonvulsants, like inhibition of neurotransmitters release, blocking receptors for excitatory amino acids and new ways of sodium channel inactivation. New mechanisms of action increase chances of controlling forms of epilepsy resistant to older anticonvulsants. Important advantage of the third-generation anticonvulsants could be their little propensity for interactions with both antiepileptic and other drugs observed until now, making prescribing much easier and safer. However, this may change with new studies specifically designed to discover drug-drug interactions. Although the third-generation antiepileptic drugs enlarged therapeutic palette against epilepsy, 20-30% of patients with epilepsy is still treatment-resistant and need new pharmacological approach. There is great need to explore all molecular targets that may directly or indirectly be involved in generation of seizures, so a number of candidate compounds for even newer anticonvulsants could be generated.

Making science accessible through collaborative science teacher action research on feminist pedagogy

Science.gov (United States)

Capobianco, Brenda M.

research. This study revealed that there are no uniform solutions or standard methods to address issues of equity and accessibility in science education. This study recommends teachers be given time, support, and freedom to collaborate with other teacher-researchers, enact decisions for change, and reflect on and make public the results of their work. Additional implications suggest science teacher educators collaborate with practicing science teachers to devise practical applications and feasible resources for a wider audience.

Perceived barriers in accessing dental care among patients attending dental institute using decision-making trial and evaluation laboratory method

Directory of Open Access Journals (Sweden)

Ravneet Malhi

2015-01-01

Full Text Available Introduction: Utilization of dental service is a concept of expressing the extent of interaction between the service provider and the people for whom it is indented. However, one of the major issues in social welfare is the equitable provision of these services to the population. Aim: To determine the perceived barriers affecting access to the dental services in the dental institute. Materials and Methods: A cross-sectional survey was conducted in the dental institute during the month of February in the year 2014 using decision-making trial and evaluation laboratory (DEMATEL method. The study sample included the 364 subjects. The required data were collected using a specially designed and pretested questionnaire. The data were analyzed using SPSS 18.0 (SPSS Inc., Chicago, IL, USA and MATLAB 7.6.0. The mean, standard deviations were used to describe the data, and inferential statistics included one-way ANOVA and DEMATEL. Results: The five determinants of cost, inconvenience, fear, organization, and patient-dentist relationship were determined as barriers to access dental services. Based on subjects′ responses to the questions, the cost (54.75% agreed or strongly agreed was identified as the most important factor affecting the access to dental health care followed by dentist-patient relationship (48.57%, inconvenience (36.55%, fear (23.70%, and organization (14.02%. The difference was found to be statistically significant (P = 0.0001. When the hierarchy of the affecting and affected factors was calculated, based on the factor analysis by using DEMATEL method, the cost (R−J = 0.16 and organization (R−J = 1.15, were certain affecting determinant which influenced the access to dental services and inconvenience. Conclusion: The major barriers to oral health care utilization among our patients were cost, fear, and organization. Policymakers, administrators, and insurance organizations have a major role. Hence, the policies should be fair and

Pharmaceutical companies vs. the State: who is responsible for post-trial provision of drugs in Brazil?

Science.gov (United States)

Wang, Daniel Wei L; Ferraz, Octavio Luiz Motta

2012-01-01

This paper discusses the post-trial access to drugs for patients who participated in clinical trials in Brazil. The ethical guidance for clinical trials in Brazil is arguably one of the clearest in the world in attributing to research sponsors the responsibility for providing post-trial drugs to patients who participated in their experiments. The Federal Constitution recognizes health as a fundamental right to be fulfilled by the State. Based on the Brazilian constitution and on the National Health Council resolutions, courts have been accepting patients' claims and ordering the State and the pharmaceutical companies to provide these patients with the tested treatment in the quantity and duration they need it. This generous interpretation of the duties of the pharmaceutical companies and the State makes the Brazilian model for post-trial access unique when compared to the experience of other countries and thus should be followed with attention by future research in order to assess its consequences for patients, research sponsors, and the public health system. © 2012 American Society of Law, Medicine & Ethics, Inc.

Prediction methods and databases within chemoinformatics: emphasis on drugs and drug candidates

DEFF Research Database (Denmark)

Jonsdottir, Svava Osk; Jorgensen, FS; Brunak, Søren

2005-01-01

about drugs and drug candidates, and of databases with relevant properties. Access to experimental data and numerical methods for selecting and utilizing these data is crucial for developing accurate predictive in silico models. Many interesting predictive methods for classifying the suitability......MOTIVATION: To gather information about available databases and chemoinformatics methods for prediction of properties relevant to the drug discovery and optimization process. RESULTS: We present an overview of the most important databases with 2-dimensional and 3-dimensional structural information...... of chemical compounds as potential drugs, as well as for predicting their physico-chemical and ADMET properties have been proposed in recent years. These methods are discussed, and some possible future directions in this rapidly developing field are described....

Temperament and character modify risk of drug addiction and influence choice of drugs.

Science.gov (United States)

Milivojevic, Dragan; Milovanovic, Srdjan D; Jovanovic, Minja; Svrakic, Dragan M; Svrakic, Nenad M; Svrakic, Slobodan M; Cloninger, C Robert

2012-01-01

Drug addiction and alcoholism involve a complex etiopathogenesis with a variable degree of risk contributions from the host (person), environment, and addictive substances. In this work, temperament and character features of individuals addicted to opiates or alcohol are compared with normal controls to study personality factors in the overall risk for drug addiction. The study was done in a permissive environment, with easy access to alcohol and heroin, which facilitated analyses of personality factors in drug choice. Participants included 412 consecutive patients (312 opiate addicts, 100 alcohol addicts) treated at the Specialized Hospital for Chemical Dependency in Belgrade, Serbia, and a community sample of 346 controls. Opiate addicts manifested antisocial temperament configuration (high Novelty Seeking, low Reward Dependence) coupled with high Self-transcendence (ie, susceptibility to fantasy and imagination). Alcohol addicts manifested sensitive temperament configuration (high Novelty Seeking coexisting with high Harm Avoidance). Immature personality was observed far more frequently in opiate addicts than in alcoholics or normals. Novelty Seeking appears to be a general risk factor for drug addiction. High Harm Avoidance appears to channel individuals with high Novelty Seeking towards alcoholism. Immature character traits and probable Personality Disorder increase the risk of illegal drugs. Based on equivalent research in nonpermissive environments, at least a portion of our opiate addicts could have developed alcoholism instead in environments with more limited access to opiates. Personality factors provide useful guidelines for preventive work with young individuals with personality risk factors for drug addiction. Copyright © American Academy of Addiction Psychiatry.

Free software to analyse the clinical relevance of drug interactions with antiretroviral agents (SIMARV®) in patients with HIV/AIDS.

Science.gov (United States)

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.

Making accessibility analyses accessible: A tool to facilitate the public review of the effects of regional transportation plans on accessibility

OpenAIRE

Golub, Aaron; Robinson, Glenn; Brendan Nee, Brendan Nee

2013-01-01

The regional transportation planning process in the United States has not been easily opened to public oversight even after strengthened requirements for public participation and civil rights considerations. In the effort to improve the public review of regional transportation plans, this paper describes the construction of a proof-of concept web-based tool designed to analyze the effects of regional transportation plans on accessibility to jobs and other essential destinations. The tool allo...

People who use drugs, HIV, and human rights.

Science.gov (United States)

Jürgens, Ralf; Csete, Joanne; Amon, Joseph J; Baral, Stefan; Beyrer, Chris

2010-08-07

We reviewed evidence from more than 900 studies and reports on the link between human rights abuses experienced by people who use drugs and vulnerability to HIV infection and access to services. Published work documents widespread abuses of human rights, which increase vulnerability to HIV infection and negatively affect delivery of HIV programmes. These abuses include denial of harm-reduction services, discriminatory access to antiretroviral therapy, abusive law enforcement practices, and coercion in the guise of treatment for drug dependence. Protection of the human rights of people who use drugs therefore is important not only because their rights must be respected, protected, and fulfilled, but also because it is an essential precondition to improving the health of people who use drugs. Rights-based responses to HIV and drug use have had good outcomes where they have been implemented, and they should be replicated in other countries. Copyright 2010 Elsevier Ltd. All rights reserved.

Are essential medicines in Malaysia accessible, affordable and available?

Science.gov (United States)

Saleh, Kamaruzaman; Ibrahim, Mohamed I M

2005-12-01

To assess the pharmaceutical sector to know whether people have access to essential medicines. The study was conducted in 20 public health clinics, five public district drug stores and 20 private retail pharmacies selected randomly in five different areas randomly selected (four states and a federal territory). The methodology used was adopted from the World Health Organization study protocol. The degree of attainment of the strategic pharmaceutical objectives of improved access is measured by a list of tested indicators. Access is measured in terms of the availability and affordability of essential medicines, especially to the poor and in the public sector. The first survey in the public health clinics and public district drug stores gathered information about current availability of essential medicines, prevalence of stock-outs and affordability of treatment (except drug stores). The second survey assessed affordability of treatment in public health clinics and private retail pharmacies. Availability, stock-out duration, percent of medicines dispensed, accessibility and affordability of key medicines. The average availability of key medicines in the public health clinics for the country was 95.4%. The average stock-out duration of key medicines was 6.5 days. However, average availability of key medicines in the public district drug stores was 89.2%; with an average stock-out duration of 32.4 days. Medicines prescribed were 100% dispensed to the patients. Average affordability for public health clinics was 1.5 weeks salary and for the private pharmacies, 3.7 weeks salary. The present pharmaceutical situation in the context of essential medicines list implementation reflected that the majority of the population in Malaysia had access to affordable essential medicines. If medicines need to be obtained from the private sector, they are hardly affordable. Although the average availability of essential medicines in Malaysia was high being more than 95.0%, in certain

Human drug metabolism: an introduction

National Research Council Canada - National Science Library

Coleman, Michael D

2010-01-01

Human Drug Metabolism, An Introduction, Second Edition provides an accessible introduction to the subject and will be particularly invaluable to those who already have some understanding of the life sciences...

Poor access to basic services | IDRC - International Development ...

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

2015-10-28

Oct 28, 2015 ... Poor access to basic services can foster competition and fuel conflict between groups. ... Make clean water, sanitation, electricity, and other services accessible ... Poverty, inequality, and violence in urban India: Towards more ...

Marine Corps Drug Prevention Review

National Research Council Canada - National Science Library

Stander, Valerie A; Reed, Cheryl; Olson, Cheryl B; Johnson, Judy; Merrill, Lex L; Clapp, John; Elder, John; Lawson, Gary; Mangual, George; Lowe, Nate

2003-01-01

.... Some of the common components were information on the consequences of drug use, decision-making skill training, public pledges not to use drugs, values clarification, goal setting, stress management...

Improving access to shared decision-making for Hispanics/Latinos with inadequately controlled type 2 diabetes mellitus.

Science.gov (United States)

Davidson, Jaime A; Rosales, Aracely; Shillington, Alicia C; Bailey, Robert A; Kabir, Chris; Umpierrez, Guillermo E

2015-01-01

To describe the cultural and linguistic adaptation and Spanish translation of an English-language patient decision aid (PDA) for use in supporting shared decision-making in Hispanics/Latinos with type 2 diabetes mellitus (T2DM), a group at a high risk for complications. A steering committee of endocrinologists, a primary care physician, a certified diabetes educator, and a dietician, each with extensive experience in providing care to Hispanics/Latinos was convened to assess a PDA developed for English-speaking patients with T2DM. English content was reviewed for cultural sensitivity and appropriateness for a Hispanic/Latino population. A consensus-building process and iterative version edits incorporated clinician perspectives. The content was adapted to be consistent with traditional Hispanic/Latino cultural communication precepts (eg, avoidance of hostile confrontation; value for warm interaction; respect for authority; value of family support for decisions). The PDA was translated by native-speaking individuals with diabetes expertise. The PDA underwent testing during cognitive interviews with ten Spanish-speaking Hispanics/Latinos with T2DM to ensure that the content is reflective of the experience, understanding, and language Hispanic/Latino patients use to describe diabetes and treatment. Content edits were made to assure a literacy level appropriate to the audience, and the PDA was produced for online video dissemination. High-quality, well-developed tools to facilitate shared decision-making in populations with limited access to culturally sensitive information can narrow gaps and align care with individual patient preferences. A newly developed PDA is available for shared decision-making that provides culturally appropriate treatment information for inadequately controlled Hispanics/Latinos with T2DM. The impact on the overall health of patients and care management of T2DM requires further study.

Evidence for Policy Making: Health Services Access and Regional Disparities in Kerman

Directory of Open Access Journals (Sweden)

Mina Anjomshoa

2013-12-01

Full Text Available Background and purpose: Health indices, regarding to their role in the development of society, are one of the most important indices at national level. Success of national development programs is largely dependent on the establishment of appropriate goals at the health sector, among which access to healthcare facilities is an essential requirement. The aim of this study was to examine the disparities in health services access across the Kerman province. Materials and Methods: This was a cross-sectional study. Study sample included the cities of Kerman province, ranked based on 15 health indices. Data was collected from statistical yearbook. The indices were weighted using Shannon entropy, then using the TOPSIS technique and the result were classified into three categories in terms of the level of development across towns. Results: The findings showed distinct regional disparities in health services across Kerman province and the significant difference was observed between the cities in terms of development. Shannon entropy introduced the number of pharmacologist per 10 thousand people as the most important indicator and the number of rural active health center per 1000 people as the less important indicator. According to TOPSIS, Kerman town (0.719 and Fahraj (0.1151 ranked the first and last in terms of access to health services respectively. Conclusion: There are significant differences between cities of Kerman province in terms of access to health care facilities and services. Therefore, it is recommended that officials and policy-makers determine resource allocation priorities according to the degree of development for a balanced and equitable distribution of health care facilities.

Insurance companies' perspectives on the orphan drug pipeline.

Science.gov (United States)

Handfield, Robert; Feldstein, Josh

2013-11-01

costs, and two thirds are relying on prior authorization as a means to control costs. More than 80% of the companies are not using cost-effectiveness methodologies with regard to rare diseases, generally because of a lack of the availability of medicines to facilitate such comparisons. CEA is used by less than 20% of our study sample of payers in dealing with orphan drug policies. Evaluating cost-effectiveness is a valuable strategy for payers seeking to facilitate appropriate access and coverage decision-making related to orphan drugs, but it is not well understood or adapted by private insurance companies. Health economists, along with providers and payers, must work together to design rational methodologies to evaluate the value of orphan drugs, perhaps by adopting cost-effectiveness methodologies to consider a compound's total research and development and commercialization demands relative to its cost-effectiveness.

Assessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: a cohort study.

Science.gov (United States)

Larochelle, Matthieu; Downing, Nicholas S; Ross, Joseph S; David, Frank S

2017-02-08

To quantify the potential effect of reciprocal approval legislation on access to clinically impactful therapeutics in the USA. A cohort study. New therapeutics approved by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and/or Health Canada between 2000 and 2010. Characteristics of new therapeutics approved by the EMA and/or Health Canada before the FDA, including mechanistic novelty, likely clinical impact, size of the affected population and FDA review outcome. From 2001 to 2010, 282 drugs were approved in the USA, Europe or Canada, including 172 (61%) first approved in the USA, 24 (9%) never approved in the USA, and 86 (30%) approved in the USA after Europe and/or Canada. Of the 110 new drugs approved in Europe and/or Canada before the USA, 37 (34%) had a novel mechanisms of action compared with drugs already approved by the FDA, but only 10 (9%) were for conditions lacking alternate available therapies in the USA at the time of ex-US approval-of which the majority (9/10; 90%) were indicated for rare diseases. 12 of the 37 agents with novel mechanisms of action approved first in Europe and/or Canada (32%) had their initial FDA submissions rejected for safety reasons-including 2 drugs that were ultimately withdrawn from the market in Europe due to safety concerns. If enacted, reciprocal approval legislation would most likely benefit only a small number of US patients receiving treatment for rare diseases, and the benefit may be somewhat mitigated by an increased exposure to harms. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Drug allergy passport and other documentation for patients with drug hypersensitivity

DEFF Research Database (Denmark)

Brockow, Knut; Aberer, Werner; Atanaskovic-Markovic, M

2016-01-01

The strongest and best-documented risk factor for drug hypersensitivity (DH) is the history of a previous reaction. Accidental exposures to drugs may lead to severe or even fatal reactions in sensitized patients. Preventable prescription errors are common. They are often due to inadequate medical...... history or poor risk assessment of recurrence of drug reaction. Proper documentation is essential information for the doctor to make sound therapeutic decision. The European Network on Drug Allergy and Drug Allergy Interest Group of the European Academy of Allergy and Clinical Immunology have formed...... a task force and developed a drug allergy passport as well as general guidelines of drug allergy documentation. A drug allergy passport, a drug allergy alert card, a certificate, and a discharge letter after medical evaluation are adequate means to document DH in a patient. They are to be handed...

Recommendation Techniques for Drug-Target Interaction Prediction and Drug Repositioning.

Science.gov (United States)

Alaimo, Salvatore; Giugno, Rosalba; Pulvirenti, Alfredo

2016-01-01

The usage of computational methods in drug discovery is a common practice. More recently, by exploiting the wealth of biological knowledge bases, a novel approach called drug repositioning has raised. Several computational methods are available, and these try to make a high-level integration of all the knowledge in order to discover unknown mechanisms. In this chapter, we review drug-target interaction prediction methods based on a recommendation system. We also give some extensions which go beyond the bipartite network case.

SWS: accessing SRS sites contents through Web Services.

Science.gov (United States)

Romano, Paolo; Marra, Domenico

2008-03-26

Web Services and Workflow Management Systems can support creation and deployment of network systems, able to automate data analysis and retrieval processes in biomedical research. Web Services have been implemented at bioinformatics centres and workflow systems have been proposed for biological data analysis. New databanks are often developed by taking into account these technologies, but many existing databases do not allow a programmatic access. Only a fraction of available databanks can thus be queried through programmatic interfaces. SRS is a well know indexing and search engine for biomedical databanks offering public access to many databanks and analysis tools. Unfortunately, these data are not easily and efficiently accessible through Web Services. We have developed 'SRS by WS' (SWS), a tool that makes information available in SRS sites accessible through Web Services. Information on known sites is maintained in a database, srsdb. SWS consists in a suite of WS that can query both srsdb, for information on sites and databases, and SRS sites. SWS returns results in a text-only format and can be accessed through a WSDL compliant client. SWS enables interoperability between workflow systems and SRS implementations, by also managing access to alternative sites, in order to cope with network and maintenance problems, and selecting the most up-to-date among available systems. Development and implementation of Web Services, allowing to make a programmatic access to an exhaustive set of biomedical databases can significantly improve automation of in-silico analysis. SWS supports this activity by making biological databanks that are managed in public SRS sites available through a programmatic interface.

DRUG MANAGEMENT REVIEWS IN DISTRICT DRUG MANAGEMENT UNIT AND GENERAL HOSPITAL

Directory of Open Access Journals (Sweden)

Max Joseph Herman

2009-12-01

Full Text Available Drug is one of the essential elements in healthcare that should be effectively and efficiently managed. Following thedecentralization in 2001 in Indonesia, drug management has changed in district drug management units and also in District General Hospitals. Certainly this condition influences the sustainability of drug access in primary health care such as in Community Health Center and District General Hospital, especially in drug financing policy. A cross sectional descriptive study to obtain information on drug management in public healthcare in district had been carried out between July and December 2006 in 10 District Public Drug Management Units from 10 district health offices and 9 district general hospitals as samples. Data were collected by interviewing heads of Drug Section in District Health Offices and heads of Hospital Pharmacies using structured questionnaires and observing drug storage in District Drug Management Units, Community Health Centers, and Hospital Pharmacies. Results of the study show that drug planning in District Health Offices and General Hospitals did not meet the basic real need in some districts nor District Hospitals. The minimum health service standards had no been achieved yet. Furthermore, drug procurement, storage and recording as well as reporting was not good enough either, such as shown by the existence of expired drugs. Lead time for drug delivery to community health centers in some districts was longer than the average of lead time in the past 3 years.

Structural Genomics and Drug Discovery for Infectious Diseases

International Nuclear Information System (INIS)

Anderson, W.F.

2009-01-01

The application of structural genomics methods and approaches to proteins from organisms causing infectious diseases is making available the three dimensional structures of many proteins that are potential drug targets and laying the groundwork for structure aided drug discovery efforts. There are a number of structural genomics projects with a focus on pathogens that have been initiated worldwide. The Center for Structural Genomics of Infectious Diseases (CSGID) was recently established to apply state-of-the-art high throughput structural biology technologies to the characterization of proteins from the National Institute for Allergy and Infectious Diseases (NIAID) category A-C pathogens and organisms causing emerging, or re-emerging infectious diseases. The target selection process emphasizes potential biomedical benefits. Selected proteins include known drug targets and their homologs, essential enzymes, virulence factors and vaccine candidates. The Center also provides a structure determination service for the infectious disease scientific community. The ultimate goal is to generate a library of structures that are available to the scientific community and can serve as a starting point for further research and structure aided drug discovery for infectious diseases. To achieve this goal, the CSGID will determine protein crystal structures of 400 proteins and protein-ligand complexes using proven, rapid, highly integrated, and cost-effective methods for such determination, primarily by X-ray crystallography. High throughput crystallographic structure determination is greatly aided by frequent, convenient access to high-performance beamlines at third-generation synchrotron X-ray sources.

Open Access e-books come into play

CERN Multimedia

Tullio Basaglia

2015-01-01

According to the Directory of Open Access Journals, more than 10,000 journals are available on an open access (OA) basis. Building on this success, e-books are also now becoming available under this popular publishing scheme, proving that open access is steadily gaining momentum in scholarly scientific communication.   The economic model is largely inspired by well-established experience in the publishing of articles, and several publishers have expanded their OA programmes to include books. Today, negotiations with such publishers make it possible for books to be available with an appropriate licence, according to which the authors retain copyright while the content can be freely shared and reused, provided the author is credited appropriately. The introduction of e-books, in addition to expanding the diffusion of the written word and the relevant content, helps avoid the costs of the production and distribution of paper books that result in high prices for titles, making them accessible only to li...

Achieving open access to conservation science.

Science.gov (United States)

Fuller, Richard A; Lee, Jasmine R; Watson, James E M

2014-12-01

Conservation science is a crisis discipline in which the results of scientific enquiry must be made available quickly to those implementing management. We assessed the extent to which scientific research published since the year 2000 in 20 conservation science journals is publicly available. Of the 19,207 papers published, 1,667 (8.68%) are freely downloadable from an official repository. Moreover, only 938 papers (4.88%) meet the standard definition of open access in which material can be freely reused providing attribution to the authors is given. This compares poorly with a comparable set of 20 evolutionary biology journals, where 31.93% of papers are freely downloadable and 7.49% are open access. Seventeen of the 20 conservation journals offer an open access option, but fewer than 5% of the papers are available through open access. The cost of accessing the full body of conservation science runs into tens of thousands of dollars per year for institutional subscribers, and many conservation practitioners cannot access pay-per-view science through their workplace. However, important initiatives such as Research4Life are making science available to organizations in developing countries. We urge authors of conservation science to pay for open access on a per-article basis or to choose publication in open access journals, taking care to ensure the license allows reuse for any purpose providing attribution is given. Currently, it would cost $51 million to make all conservation science published since 2000 freely available by paying the open access fees currently levied to authors. Publishers of conservation journals might consider more cost effective models for open access and conservation-oriented organizations running journals could consider a broader range of options for open access to nonmembers such as sponsorship of open access via membership fees. © 2014 The Authors. Conservation Biology published by Wiley Periodicals, Inc., on behalf of the Society for

Prescription for trouble: Medicare Part D and patterns of computer and internet access among the elderly.

Science.gov (United States)

Wright, David W; Hill, Twyla J

2009-01-01

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 specifically encourages Medicare enrollees to use the Internet to obtain information regarding the new prescription drug insurance plans and to enroll in a plan. This reliance on computer technology and the Internet leads to practical questions regarding implementation of the insurance coverage. For example, it seems unlikely that all Medicare enrollees have access to computers and the Internet or that they are all computer literate. This study uses the 2003 Current Population Survey to examine the effects of disability and income on computer access and Internet use among the elderly. Internet access declines with age and is exacerbated by disabilities. Also, decreases in income lead to decreases in computer ownership and use. Therefore, providing prescription drug coverage primarily through the Internet seems likely to maintain or increase stratification of access to health care, especially for low-income, disabled elderly, who are also a group most in need of health care access.

78 FR 23684 - Personnel Access Authorization Requirements for Nuclear Power Plants

Science.gov (United States)

2013-04-22

... an employee's unescorted access at their facility. The petitioner seeks to ensure that such decisions... is solely responsible for making final unescorted access decisions, and to prescribe a clearly... #0;notices is to give interested persons an opportunity to participate in #0;the rule making prior to...

Planning for Accessibility.

Science.gov (United States)

Spoor, Dana L.

1997-01-01

Argues that barrier-free designs should be incorporated in the first steps of school facility planning to avoid the difficulties in meeting Americans with Disabilities Act (ADA) guidelines during renovations. Explains why not all barriers need be removed to make a facility accessible to everyone. Discusses issues involving ADA guidelines and child…

Optimizing clinical drug product performance

DEFF Research Database (Denmark)

Dickinson, Paul A.; Kesisoglou, Filippos; Flanagan, Talia

2016-01-01

The aim of Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid is to facilitate optimization of clinical performance of drug products. BioRAM strategy relies on therapy-driven drug delivery and follows an integrated systems approach for formulating and addressing critical...... questions and decision-making (J Pharm Sci. 2014,103(11): 3777-97). In BioRAM, risk is defined as not achieving the intended in vivo drug product performance, and success is assessed by time to decision-making and action. Emphasis on time to decision-making and time to action highlights the value of well....... Application of the BioRAM Scoring Grid is illustrated using published literature. Organizational considerations for implementing BioRAM strategy, including the interactions, function, and skillsets of the BioRAM group members, are also reviewed. As a creative and innovative systems approach, we believe...

The "Darknet": The new street for street drugs.

Science.gov (United States)

Pergolizzi, J V; LeQuang, J A; Taylor, R; Raffa, R B

2017-12-01

The "Darknet" ("dark web") has emerged as a means by which illegal drug buys and deliveries can be arranged with apparent anonymity and impunity. Healthcare providers should be aware of this growing source of illicit drugs. The "Darknet" refers to networks isolated from the Internet that cannot be accessed via conventional search engines. They require special software that is protected by special encryption. The initial legitimate use of a "Darknet" to conceal personal information against misuse or political reprisal is being exploited to conceal the identity of buyers and sellers in illegal drug transactions. Instructions on how to obtain access to the "Darknet" are readily available on conventional Internet web pages. The "Darknet" has changed the paradigm of illegal drug importation and distribution by providing a difficult-to-trace transaction, and delivery via legitimate couriers directly to the home. © 2017 John Wiley & Sons Ltd.

Open Access and ORCID poster presentation

DEFF Research Database (Denmark)

Elbæk, Mikael Karstensen; Ekstrøm, Jeannette

2014-01-01

and related topics such as copyright, DTU Orbit, Open Access journals, APCs, Vouchers etc. ORCID ORCID – Open Research & Contributor ID – is an internationally recognized and widely used researcher-ID. ORCID makes it easy to reuse your data across disciplines, publishers and databases – all you need to do......Open Access Open Access is high on the agenda in Denmark and internationally. Denmark has announced a national strategy for Open Access that aims to achieve Open Access to 80% in 2017 and 100% in 2022 to peer review research articles. All public Danish funders as well as H2020 requires that all...... peer review articles that is an outcome of their funding will be Open Access. Uploading your full texts (your final author manuscript after review ) to DTU Orbit is a fundamental part of providing Open Access to your research. We are here to answer all your questions with regards to Open Access...

Making detailed predictions makes (some) predictions worse

Science.gov (United States)

Kelly, Theresa F.

In this paper, we investigate whether making detailed predictions about an event makes other predictions worse. Across 19 experiments, 10,895 participants, and 415,960 predictions about 724 professional sports games, we find that people who made detailed predictions about sporting events (e.g., how many hits each baseball team would get) made worse predictions about more general outcomes (e.g., which team would win). We rule out that this effect is caused by inattention or fatigue, thinking too hard, or a differential reliance on holistic information about the teams. Instead, we find that thinking about game-relevant details before predicting winning teams causes people to give less weight to predictive information, presumably because predicting details makes information that is relatively useless for predicting the winning team more readily accessible in memory and therefore incorporated into forecasts. Furthermore, we show that this differential use of information can be used to predict what kinds of games will and will not be susceptible to the negative effect of making detailed predictions.

Education Scholars' Perceptions and Practices toward Open Access Publishing

Science.gov (United States)

Ellingford, Lori Michelle

2012-01-01

Although open access publishing has been available since 1998, we know little regarding scholars' perceptions and practices toward publishing in open access outlets, especially in the social science community. Open access publishing has been slow to penetrate the field of education, yet the potential impact of open access could make this…

Quantitative prediction of drug side effects based on drug-related features.

Science.gov (United States)

Niu, Yanqing; Zhang, Wen

2017-09-01

Unexpected side effects of drugs are great concern in the drug development, and the identification of side effects is an important task. Recently, machine learning methods are proposed to predict the presence or absence of interested side effects for drugs, but it is difficult to make the accurate prediction for all of them. In this paper, we transform side effect profiles of drugs as their quantitative scores, by summing up their side effects with weights. The quantitative scores may measure the dangers of drugs, and thus help to compare the risk of different drugs. Here, we attempt to predict quantitative scores of drugs, namely the quantitative prediction. Specifically, we explore a variety of drug-related features and evaluate their discriminative powers for the quantitative prediction. Then, we consider several feature combination strategies (direct combination, average scoring ensemble combination) to integrate three informative features: chemical substructures, targets, and treatment indications. Finally, the average scoring ensemble model which produces the better performances is used as the final quantitative prediction model. Since weights for side effects are empirical values, we randomly generate different weights in the simulation experiments. The experimental results show that the quantitative method is robust to different weights, and produces satisfying results. Although other state-of-the-art methods cannot make the quantitative prediction directly, the prediction results can be transformed as the quantitative scores. By indirect comparison, the proposed method produces much better results than benchmark methods in the quantitative prediction. In conclusion, the proposed method is promising for the quantitative prediction of side effects, which may work cooperatively with existing state-of-the-art methods to reveal dangers of drugs.

Accessible Electronic and Information Technology

Science.gov (United States)

This Policy establishes EPA's responsibilities and procedures for making its Electronic and Information Technology (EIT) products accessible to all people, including people with disabilities, in accordance with Section 508 of the Rehabilitation Act.

Accessible Website Content Guidelines for Users with Intellectual Disabilities

NARCIS (Netherlands)

Karreman, Joyce; van der Geest, Thea; Buursink, Esmee

2007-01-01

Background: The W3C Web Accessibility Initiative has issued guidelines for making websites better and easier to access for people with various disabilities (W3C Web Accessibility Initiative guidelines 1999). - Method: The usability of two versions of a website (a non-adapted site and a site that was

Significant differences between the Nordic laws on public access to documents

DEFF Research Database (Denmark)

Jørgensen, Oluf

2017-01-01

Transparency and public access to information work as a check on the exercise of power and the existence of corruption. In Sweden the constitutional right of access to documents is justified precisely by its contribution to democracy, the rule of law and efficiency in the public administration....... The wide access to information in today’s world also makes possible the publication of personal information about individuals’ private life in an unprecedented way. Does this mean that the relative importance of the protection of privacy has to be strengthened at the cost of access to information? What...... will be the impact of the developing information and communication technology on access to information? The right of access to documents has traditionally been discussed on the level of domestic administration but when public administration is internationalised the issue of access to documents makes itself felt also...

Factors influencing access to education, decision making, and receipt of preferred dialysis modality in unplanned dialysis start patients.

Science.gov (United States)

Machowska, Anna; Alscher, Mark Dominik; Reddy Vanga, Satyanarayana; Koch, Michael; Aarup, Michael; Qureshi, Abdul Rashid; Lindholm, Bengt; Rutherford, Peter A

2016-01-01

Unplanned dialysis start (UPS) leads to worse clinical outcomes than planned start, and only a minority of patients ever receive education on this topic and are able to make a modality choice, particularly for home dialysis. This study aimed to determine the predictive factors for patients receiving education, making a decision, and receiving their preferred modality choice in UPS patients following a UPS educational program (UPS-EP). The Offering Patients Therapy Options in Unplanned Start (OPTiONS) study examined the impact of the implementation of a specific UPS-EP, including decision support tools and pathway improvement on dialysis modality choice. Linear regression models were used to examine the factors predicting three key steps: referral and receipt of UPS-EP, modality decision making, and actual delivery of preferred modality choice. A simple economic assessment was performed to examine the potential benefit of implementing UPS-EP in terms of dialysis costs. The majority of UPS patients could receive UPS-EP (214/270 patients) and were able to make a decision (177/214), although not all patients received their preferred choice (159/177). Regression analysis demonstrated that the initial dialysis modality was a predictive factor for referral and receipt of UPS-EP and modality decision making. In contrast, age was a predictor for referral and receipt of UPS-EP only, and comorbidity was not a predictor for any step, except for myocardial infarction, which was a weak predictor for lower likelihood of receiving preferred modality. Country practices predicted UPS-EP receipt and decision making. Economic analysis demonstrated the potential benefit of UPS-EP implementation because dialysis modality costs were associated with modality distribution driven by patient preference. Education and decision support can allow UPS patients to understand their options and choose dialysis modality, and attention needs to be focused on ensuring equity of access to educational

Drugs + HIV, Learn the Link

Medline Plus

Full Text Available ... HIV Learn the Link - Drugs and HIV ... Drugs can change the way the brain works, disrupting the parts of the brain that people use to weigh risks and benefits when making decisions. ...

Indian aspects of drug information resources and impact of drug information centre on community.

Science.gov (United States)

Chauhan, Nitesh; Moin, Sabeeya; Pandey, Anushree; Mittal, Ashu; Bajaj, Umakant

2013-04-01

Drug information centre refer to facility specially set aside for, and specializing in the provision of drug information and related issues. The purpose of drug information center is to provide authentic individualized, accurate, relevant and unbiased drug information to the consumers and healthcare professionals regarding medication related inquiries to the nation for health care and drug safety aspects by answering their call regarding the all critical problems on drug information, their uses and their side effects. Apart from that the center also provides in-depth, impartial source of crucial drug information to meet the needs of the practicing physicians, pharmacists and other health care professionals to safeguard the health, financial and legal interests of the patient and to broaden the pharmacist role visible in the society and community. The service should include collecting, reviewing, evaluating, indexing and distributing information on drugs to health workers. Drug and poisons information centers are best established within major teaching hospitals. This allows access to clinical experience, libraries, research facilities and educational activities. Information present in the current paper will not only enlighten the role of drug information center but also focused on the rational use of drug.

Indian aspects of drug information resources and impact of drug information centre on community

Directory of Open Access Journals (Sweden)

Nitesh Chauhan

2013-01-01

Full Text Available Drug information centre refer to facility specially set aside for, and specializing in the provision of drug information and related issues. The purpose of drug information center is to provide authentic individualized, accurate, relevant and unbiased drug information to the consumers and healthcare professionals regarding medication related inquiries to the nation for health care and drug safety aspects by answering their call regarding the all critical problems on drug information, their uses and their side effects. Apart from that the center also provides in-depth, impartial source of crucial drug information to meet the needs of the practicing physicians, pharmacists and other health care professionals to safeguard the health, financial and legal interests of the patient and to broaden the pharmacist role visible in the society and community. The service should include collecting, reviewing, evaluating, indexing and distributing information on drugs to health workers. Drug and poisons information centers are best established within major teaching hospitals. This allows access to clinical experience, libraries, research facilities and educational activities. Information present in the current paper will not only enlighten the role of drug information center but also focused on the rational use of drug.

Access 2010 All-in-One For Dummies

CERN Document Server

Barrows, Alison; Stockman, Joseph C

2010-01-01

The all-in-one reference to all aspects of Microsoft Access 2010. If you want to learn Microsoft Access inside and out, the nine minibooks in this easy-access reference are exactly what you need. Read the book cover to cover, or jump into any of the minibooks for the instruction and topics you need most. Learn how to connect Access to SQL Server, manipulate your data locally, use nifty new features from Office 2010 such as the enhanced Ribbon, create queries and macros like a champ, and much more. From the basics to advanced functions, it's what you need to make Access more accesssible.:; Show

Physician awareness of drug cost: a systematic review.

Science.gov (United States)

Allan, G Michael; Lexchin, Joel; Wiebe, Natasha

2007-09-01

lack of appreciation of the large difference in cost between inexpensive and expensive drugs. This discrepancy in turn could have profound implications for overall drug expenditures. Much more focus is required in the education of physicians about costs and the access to cost information. Future research should focus on the accessibility and reliability of medical cost information and whether the provision of this information is used by doctors and makes a difference to physician prescribing. Additionally, future work should strive for higher methodological standards to avoid the biases we found in the current literature, including attention to the method of assessing accuracy that allows larger absolute estimation ranges for expensive drugs.

76 FR 17064 - Shared Use Path Accessibility Guidelines

Science.gov (United States)

2011-03-28

...] RIN 3014-AA41 Shared Use Path Accessibility Guidelines AGENCY: Architectural and Transportation... (ANPRM) to develop accessibility guidelines for shared use paths. Shared use paths are designed for both... users. The guidelines will include technical provisions for making newly constructed and altered shared...

Freeing up access to CERN technology

CERN Multimedia

Joannah Caborn Wengler

2012-01-01

In line with CERN’s principle of maximising the dissemination of knowledge to society, the Knowledge Transfer (KT) Group has launched a new collaborative initiative to share the products of CERN’s scientific and technological labours: Easy Access IP, where IP stands for intellectual property.   CERN has a whole portfolio of dissemination channels designed and implemented by the KT Group, with Easy Access IP being the latest addition. “Inspired by the UK’s Easy Access Innovation initiative, our scheme involves making some of CERN's technologies available royalty-free and through a more agile licensing process,” explains Giovanni Anelli, head of the Group. “This approach seems to be an appropriate model for CERN, where the ultimate goal of technology transfer is not to generate income but to transfer knowledge to external partners.” The new scheme, as the name suggests, is designed to make it easier for industry and othe...

West African Journal of Pharmacology and Drug Research

African Journals Online (AJOL)

(Journal Ouest Africain de Pharmacologie de Recherche sur les Medicaments). Papers on all aspects of drug action and related topics including chemotherapy and toxicology will be considered for publication. Vol 31, No 1 (2016). DOWNLOAD FULL TEXT Open Access DOWNLOAD FULL TEXT Subscription or Fee Access ...

The National Access to Antiretroviral Program for PHA (NAPHA) in Thailand.

Science.gov (United States)

Chasombat, Sanchai; Lertpiriyasuwat, Cheewanan; Thanprasertsuk, Sombat; Suebsaeng, Laksami; Lo, Ying Ru

2006-07-01

To describe the development, components, initial results and lessons learned from Thailand's National Access to Antiretroviral Program for People living with HIV/AIDS (NAPHA), a historical review was conducted and program monitoring was analyzed. The national antiretroviral therapy program at different levels of the public health system was implemented with all major program components; ARV protocol development, health care professional training, drug supply chain management, laboratory network formation, monitoring and evaluation, and multi-sector and PHA involvement since 2001, which was based on elements of research, pilot projects, training, national guideline development, experiences and policy making. A national monitoring system was developed to monitor the progress of the program. From February 2001 to December 2004, the monitoring reports received from implementing hospitals showed that 58,133 cases had received antiretroviral therapy (ART), and 85% (49,477) of them were continuing to take ARV drugs. In conclusion, the NAPHA was implemented nationwide with comprehensive systems. The reports indicate achievement of expansion of the ART program. Lessons learned from the program initiation and scaling up show local leadership, comprehensive training, adherence, and coordination are essential to program effectiveness and sustainability.

Novel Polymeric Prodrugs of Valproic Acid as Anti- Epilepsy Drugs ...

African Journals Online (AJOL)

Epilepsy Drugs: Synthesis, Characterization and In-vitro ... The release of VPA from polymeric prodrugs was studied using cellophane ... pharmacokinetics and accessibility in market [8]. ..... between the drug and polymer chain can affect.

Web Accessibility and Guidelines

Science.gov (United States)

Harper, Simon; Yesilada, Yeliz

Access to, and movement around, complex online environments, of which the World Wide Web (Web) is the most popular example, has long been considered an important and major issue in the Web design and usability field. The commonly used slang phrase ‘surfing the Web’ implies rapid and free access, pointing to its importance among designers and users alike. It has also been long established that this potentially complex and difficult access is further complicated, and becomes neither rapid nor free, if the user is disabled. There are millions of people who have disabilities that affect their use of the Web. Web accessibility aims to help these people to perceive, understand, navigate, and interact with, as well as contribute to, the Web, and thereby the society in general. This accessibility is, in part, facilitated by the Web Content Accessibility Guidelines (WCAG) currently moving from version one to two. These guidelines are intended to encourage designers to make sure their sites conform to specifications, and in that conformance enable the assistive technologies of disabled users to better interact with the page content. In this way, it was hoped that accessibility could be supported. While this is in part true, guidelines do not solve all problems and the new WCAG version two guidelines are surrounded by controversy and intrigue. This chapter aims to establish the published literature related to Web accessibility and Web accessibility guidelines, and discuss limitations of the current guidelines and future directions.

Drug Policy in Poland.

Science.gov (United States)

Jahnz-Różyk, Karina; Kawalec, Pawel; Malinowski, Krzysztof; Czok, Katarzyna

2017-09-01

We presented a general overview of the health care system as well as the pricing and reimbursement environment in Poland. Poland aims to ensure proper access to safe and effective medicines while reducing patients' share in treatment costs. Nevertheless, the co-payment for pharmacotherapy is still high (more than 60%). The key policymaker and regulator in the system is the Ministry of Health, which is supported by the Polish Agency for Health Technology Assessment and Tariff System (Agencja Oceny Technologii Medycznych i Taryfikacji), responsible for evaluating applicant drugs, and the Economic Commission, responsible for negotiating the official sales prices and conditions for reimbursement with pharmaceutical companies (e.g., level of reimbursement and risk-sharing scheme agreements). The Agency for Health Technology Assessment and Tariff System dossier is obligatory for reimbursement application and includes the analysis of clinical effectiveness, economic analysis (with the threshold of quality-adjusted life-year established as no more than 3 times the gross domestic product per capita), and the analysis of budget impact. In Poland, only a positive list of reimbursed drugs is published and it is updated every 2 months. The following levels of reimbursement are in use: 100%, 70%, 50%, and lump sum (about €0.8). The first reimbursement decision is given for a period of 2 years only, the second for 3 years, and the third for 5 years. There is no separate budget or special legal regulations for orphan drugs. Generic substitution of drugs is desired but not mandatory. Physicians are not assigned with pharmaceutical budgets. The access to real-world data is limited; the only registers available are for drugs used in drug programs. Copyright © 2017. Published by Elsevier Inc.

The role of health technology assessment bodies in shaping drug development

Directory of Open Access Journals (Sweden)

Ciani O

2014-11-01

Full Text Available Oriana Ciani,1,3 Claudio Jommi1,2 1Centre for Research on Health and Social Care Management (CERGAS, Bocconi University, Milan, Italy; 2Department of Pharmaceutical Sciences, Università del Piemonte Orientale, Novara, Italy; 3University of Exeter Medical School, Exeter, UK Abstract: The use of health technology assessment (HTA to inform policy-making is established in most developed countries. Compared to licensing agencies, HTA agencies have different interests and, therefore, different evidence requirements. Criteria for coverage or reimbursement decisions on pharmaceutical compounds vary; however, it is common to include, as part of the HTA, a comparative effectiveness evaluation. This type of clinical data might go beyond that required for market authorization, thus creating an additional evidence gap between the regulatory and the reimbursement submission. The relevance of submissions to HTA agencies is consistently increasing in a pharmaceutical company’s perspective, as market prospects are strongly influenced by third-party payers’ coverage. In this study, we aim to describe current HTA activities with a potential impact throughout the drug development process of pharmaceuticals, with a comparative emphasis on the systems in place in Italy and in the UK. Based on an extensive literature and website review, we identified three major classes of HTA activities, beyond mainstream HTA, with the potential to influence the drug development program: 1 horizon scanning and early HTA; 2 bipartite and tripartite early dialogue between manufacturers, regulators, and HTA assessors; and 3 managed market entry agreements. From early stages of clinical research up to postauthorization studies, there is a trend toward increased collaboration between parties, anticipation of market access evidence collection, and postmarketing risk-sharing. Heterogeneity of HTA practices increases the complexity of the market access environment. Overall, there are

A win-win solution?: A critical analysis of tiered pricing to improve access to medicines in developing countries

Science.gov (United States)

2011-01-01

Background Tiered pricing - the concept of selling drugs and vaccines in developing countries at prices systematically lower than in industrialized countries - has received widespread support from industry, policymakers, civil society, and academics as a way to improve access to medicines for the poor. We carried out case studies based on a review of international drug price developments for antiretrovirals, artemisinin combination therapies, drug-resistant tuberculosis medicines, liposomal amphotericin B (for visceral leishmaniasis), and pneumococcal vaccines. Discussion We found several critical shortcomings to tiered pricing: it is inferior to competition for achieving the lowest sustainable prices; it often involves arbitrary divisions between markets and/or countries, which can lead to very high prices for middle-income markets; and it leaves a disproportionate amount of decision-making power in the hands of sellers vis-à-vis consumers. In many developing countries, resources are often stretched so tight that affordability can only be approached by selling medicines at or near the cost of production. Policies that "de-link" the financing of R&D from the price of medicines merit further attention, since they can reward innovation while exploiting robust competition in production to generate the lowest sustainable prices. However, in special cases - such as when market volumes are very small or multi-source production capacity is lacking - tiered pricing may offer the only practical option to meet short-term needs for access to a product. In such cases, steps should be taken to ensure affordability and availability in the longer-term. Summary To ensure access to medicines for populations in need, alternate strategies should be explored that harness the power of competition, avoid arbitrary market segmentation, and/or recognize government responsibilities. Competition should generally be the default option for achieving affordability, as it has proven superior

A win-win solution?: A critical analysis of tiered pricing to improve access to medicines in developing countries.

Science.gov (United States)

Moon, Suerie; Jambert, Elodie; Childs, Michelle; von Schoen-Angerer, Tido

2011-10-12

Tiered pricing - the concept of selling drugs and vaccines in developing countries at prices systematically lower than in industrialized countries - has received widespread support from industry, policymakers, civil society, and academics as a way to improve access to medicines for the poor. We carried out case studies based on a review of international drug price developments for antiretrovirals, artemisinin combination therapies, drug-resistant tuberculosis medicines, liposomal amphotericin B (for visceral leishmaniasis), and pneumococcal vaccines. We found several critical shortcomings to tiered pricing: it is inferior to competition for achieving the lowest sustainable prices; it often involves arbitrary divisions between markets and/or countries, which can lead to very high prices for middle-income markets; and it leaves a disproportionate amount of decision-making power in the hands of sellers vis-à-vis consumers. In many developing countries, resources are often stretched so tight that affordability can only be approached by selling medicines at or near the cost of production. Policies that "de-link" the financing of R&D from the price of medicines merit further attention, since they can reward innovation while exploiting robust competition in production to generate the lowest sustainable prices. However, in special cases - such as when market volumes are very small or multi-source production capacity is lacking - tiered pricing may offer the only practical option to meet short-term needs for access to a product. In such cases, steps should be taken to ensure affordability and availability in the longer-term. To ensure access to medicines for populations in need, alternate strategies should be explored that harness the power of competition, avoid arbitrary market segmentation, and/or recognize government responsibilities. Competition should generally be the default option for achieving affordability, as it has proven superior to tiered pricing for reliably

A win-win solution?: A critical analysis of tiered pricing to improve access to medicines in developing countries

Directory of Open Access Journals (Sweden)

Childs Michelle

2011-10-01

Full Text Available Abstract Background Tiered pricing - the concept of selling drugs and vaccines in developing countries at prices systematically lower than in industrialized countries - has received widespread support from industry, policymakers, civil society, and academics as a way to improve access to medicines for the poor. We carried out case studies based on a review of international drug price developments for antiretrovirals, artemisinin combination therapies, drug-resistant tuberculosis medicines, liposomal amphotericin B (for visceral leishmaniasis, and pneumococcal vaccines. Discussion We found several critical shortcomings to tiered pricing: it is inferior to competition for achieving the lowest sustainable prices; it often involves arbitrary divisions between markets and/or countries, which can lead to very high prices for middle-income markets; and it leaves a disproportionate amount of decision-making power in the hands of sellers vis-à-vis consumers. In many developing countries, resources are often stretched so tight that affordability can only be approached by selling medicines at or near the cost of production. Policies that "de-link" the financing of R&D from the price of medicines merit further attention, since they can reward innovation while exploiting robust competition in production to generate the lowest sustainable prices. However, in special cases - such as when market volumes are very small or multi-source production capacity is lacking - tiered pricing may offer the only practical option to meet short-term needs for access to a product. In such cases, steps should be taken to ensure affordability and availability in the longer-term. Summary To ensure access to medicines for populations in need, alternate strategies should be explored that harness the power of competition, avoid arbitrary market segmentation, and/or recognize government responsibilities. Competition should generally be the default option for achieving affordability

[Hepatox: database on hepatotoxic drugs].

Science.gov (United States)

Quinton, A; Latry, P; Biour, M

1993-01-01

Hepatox is a data base on the hepatotoxic drugs file published every year in Gastroentérologie Clinique et Biologique. The program was developed under Omnis 7 for Apple computers, and under Visual Basic Professional Toolkit and Code Base for IBM PC and compatibles computers. The data base includes forms of 866 drugs identified by their approved name and those of their 1,300 corresponding proprietary names in France; drugs are distributed among 104 pharmacological classes. It is possible to have instantaneously access to the card of a drug identified by its approved name. Acceding to a drug identified by its proprietary name gives a list of the approved name of its components; going from a name of this list to the correspondent card of hepatoxicity is immediate. It is easy to extract lists of drugs responsible of a type of hepatic injury, and a table of types of hepatic injuries induced by the drugs of a pharmacological class.

Unemployment, drugs and attitudes among European youth.

Science.gov (United States)

Ayllón, Sara; Ferreira-Batista, Natalia N

2018-01-01

This paper studies changes in the patterns of drug consumption and attitudes towards drugs in relation to sky-high (youth) unemployment rates brought about by the Great Recession. Our analysis is based on data for 28 European countries that refer to young people. We find that the consumption of cannabis and 'new substances' is positively related to increasing unemployment rates. An increase of 1% in the regional unemployment rate is associated with an increase of 0.7 percentage points in the ratio of young people who state that they have consumed cannabis at some point in time. Our findings also indicate that higher unemployment may be associated with more young people perceiving that access to drugs has become more difficult, particularly access to ecstasy, cocaine and heroin. According to young Europeans, when the economy worsens, anti-drug policies should focus on the reduction of poverty and unemployment, and not on implementing tougher measures against users. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

[Shift of focus in the financing of Hungarian drugs. Reimbursement for orphan drugs for treating rare diseases: financing of enzyme replacement therapy in Hungary].

Science.gov (United States)

Szegedi, Márta; Molnár, Mária Judit; Boncz, Imre; Kosztolányi, György

2014-11-02

Focusing on the benefits of patients with rare disease the authors analysed the aspects of orphan medicines financed in the frame of the Hungarian social insurance system in 2012 in order to make the consumption more rational, transparent and predictable. Most of the orphan drugs were financed in the frame of compassionate use by the reimbursement system. Consequently, a great deal of crucial problems occurred in relation to the unconventional subsidized method, especially in the case of the highest cost enzyme replacement therapies. On the base of the findings, proposals of the authors are presented for access to orphan drugs, fitting to the specific professional, economical and ethical aspects of this unique field of the health care system. The primary goal is to provide a suitable subsidized method for the treatment of rare disease patients with unmet medical needs. The financial modification of orphans became indispensible in Hungary. Professionals from numerous fields dealing with rare disease patients' care expressed agreement on the issue. Transforming the orphan medicines' financial structure has been initiated according to internationally shared principles.

A Novel Design for Drug-Drug Interaction Alerts Improves Prescribing Efficiency.

Science.gov (United States)

Russ, Alissa L; Chen, Siying; Melton, Brittany L; Johnson, Elizabette G; Spina, Jeffrey R; Weiner, Michael; Zillich, Alan J

2015-09-01

Drug-drug interactions (DDIs) are common in clinical care and pose serious risks for patients. Electronic health records display DDI alerts that can influence prescribers, but the interface design of DDI alerts has largely been unstudied. In this study, the objective was to apply human factors engineering principles to alert design. It was hypothesized that redesigned DDI alerts would significantly improve prescribers' efficiency and reduce prescribing errors. In a counterbalanced, crossover study with prescribers, two DDI alert designs were evaluated. Department of Veterans Affairs (VA) prescribers were video recorded as they completed fictitious patient scenarios, which included DDI alerts of varying severity. Efficiency was measured from time-stamped recordings. Prescribing errors were evaluated against predefined criteria. Efficiency and prescribing errors were analyzed with the Wilcoxon signed-rank test. Other usability data were collected on the adequacy of alert content, prescribers' use of the DDI monograph, and alert navigation. Twenty prescribers completed patient scenarios for both designs. Prescribers resolved redesigned alerts in about half the time (redesign: 52 seconds versus original design: 97 seconds; p<.001). Prescribing errors were not significantly different between the two designs. Usability results indicate that DDI alerts might be enhanced by facilitating easier access to laboratory data and dosing information and by allowing prescribers to cancel either interacting medication directly from the alert. Results also suggest that neither design provided adequate information for decision making via the primary interface. Applying human factors principles to DDI alerts improved overall efficiency. Aspects of DDI alert design that could be further enhanced prior to implementation were also identified.

It’s the workflows, stupid! What is required to make ‘offsetting’ work for the open access transition

Directory of Open Access Journals (Sweden)

Kai Geschuhn

2017-11-01

Full Text Available This paper makes the case for stronger engagement of libraries and consortia when it comes to negotiating and drafting offsetting agreements. Two workshops organized by the Efficiencies and Standards for Article Charges (ESAC initiative in 2016 and 2017 have shown a clear need for an improvement of the current workflows and processes between academic institutions (and libraries and the publishers they use in terms of author identification, metadata exchange and invoicing. Publishers need to invest in their editorial systems, while institutions need to get a clearer understanding of the strategic goal of offsetting. To this purpose, strategic and practical elements, which should be included in the agreements, will be introduced. Firstly, the 'Joint Understanding of Offsetting', launched in 2016, will be discussed. This introduces the ‘pay-as-you-publish’ model as a transitional pathway for the agreements. Secondly, this paper proposes a set of recommendations for article workflows and services between institutions and publishers, based on a draft document which was produced as part of the 2nd ESAC Offsetting Workshop in March 2017. These recommendations should be seen as a minimum set of practical and formal requirements for offsetting agreements and are necessary to make any publication-based open access business model work.

Digitisation for access to preserved documents

Directory of Open Access Journals (Sweden)

Majlis Bremer-Laamanen

2003-06-01

Full Text Available Today the digitisation of our collections is a goal for libraries all over Europe. The choices we make in digitisation and preservation now will have a significant impact on the future. Do we only emphasise access? How do we enable access and preserve our originals in a qualitative and productive way? What will actually be left of our cultural heritage in the next millennium? In this paper I am going to look at promoting access to preserved originals mirrored by the experience at the Helsinki University Library, the National Library of Finland: · Preservation activities as platform for digitisation and OCR · Processing access to collections · The future - looking ahead

Delivery dilemmas: How drug cryptomarket users identify and seek to reduce their risk of detection by law enforcement.

Science.gov (United States)

Aldridge, Judith; Askew, Rebecca

2017-03-01

Cryptomarkets represent an important drug market innovation by bringing buyers and sellers of illegal drugs together in a 'hidden' yet public online marketplace. We ask: How do cryptomarket drug sellers and buyers perceive the risks of detection and arrest, and attempt to limit them? We analyse selected texts produced by vendors operating on the first major drug cryptomarket, Silk Road (N=600) alongside data extracted from the marketplace discussion forum that include buyer perspectives. We apply Fader's (2016) framework for understanding how drug dealers operating 'offline' attempt to reduce the risk of detection and arrest: visibility reduction, charge reduction and risk distribution. We characterize drug transactions on cryptomarkets as 'stretched' across time, virtual and physical space, and handlers, changing the location and nature of risks faced by cryptomarket users. The key locations of risk of detection and arrest by law enforcement were found in 'offline' activities of cryptomarket vendors (packaging and delivery drop-offs) and buyers (receiving deliveries). Strategies in response involved either creating or disrupting routine activities in line with a non-offending identity. Use of encrypted communication was seen as 'good practice' but often not employed. 'Drop shipping' allowed some Silk Road vendors to sell illegal drugs without the necessity of handling them. Silk Road participants neither viewed themselves as immune to, nor passively accepting of, the risk of detection and arrest. Rational choice theorists have viewed offending decisions as constrained by limited access to relevant information. Cryptomarkets as 'illicit capital' sharing communities provide expanded and low-cost access to information enabling drug market participants to make more accurate assessments of the risk of apprehension. The abundance of drug market intelligence available to those on both sides of the law may function to speed up innovation in illegal drug markets, as well

TargetNet: a web service for predicting potential drug-target interaction profiling via multi-target SAR models

Science.gov (United States)

Yao, Zhi-Jiang; Dong, Jie; Che, Yu-Jing; Zhu, Min-Feng; Wen, Ming; Wang, Ning-Ning; Wang, Shan; Lu, Ai-Ping; Cao, Dong-Sheng

2016-05-01

Drug-target interactions (DTIs) are central to current drug discovery processes and public health fields. Analyzing the DTI profiling of the drugs helps to infer drug indications, adverse drug reactions, drug-drug interactions, and drug mode of actions. Therefore, it is of high importance to reliably and fast predict DTI profiling of the drugs on a genome-scale level. Here, we develop the TargetNet server, which can make real-time DTI predictions based only on molecular structures, following the spirit of multi-target SAR methodology. Naïve Bayes models together with various molecular fingerprints were employed to construct prediction models. Ensemble learning from these fingerprints was also provided to improve the prediction ability. When the user submits a molecule, the server will predict the activity of the user's molecule across 623 human proteins by the established high quality SAR model, thus generating a DTI profiling that can be used as a feature vector of chemicals for wide applications. The 623 SAR models related to 623 human proteins were strictly evaluated and validated by several model validation strategies, resulting in the AUC scores of 75-100 %. We applied the generated DTI profiling to successfully predict potential targets, toxicity classification, drug-drug interactions, and drug mode of action, which sufficiently demonstrated the wide application value of the potential DTI profiling. The TargetNet webserver is designed based on the Django framework in Python, and is freely accessible at http://targetnet.scbdd.com.

TargetNet: a web service for predicting potential drug-target interaction profiling via multi-target SAR models.

Science.gov (United States)

Yao, Zhi-Jiang; Dong, Jie; Che, Yu-Jing; Zhu, Min-Feng; Wen, Ming; Wang, Ning-Ning; Wang, Shan; Lu, Ai-Ping; Cao, Dong-Sheng

2016-05-01

Drug-target interactions (DTIs) are central to current drug discovery processes and public health fields. Analyzing the DTI profiling of the drugs helps to infer drug indications, adverse drug reactions, drug-drug interactions, and drug mode of actions. Therefore, it is of high importance to reliably and fast predict DTI profiling of the drugs on a genome-scale level. Here, we develop the TargetNet server, which can make real-time DTI predictions based only on molecular structures, following the spirit of multi-target SAR methodology. Naïve Bayes models together with various molecular fingerprints were employed to construct prediction models. Ensemble learning from these fingerprints was also provided to improve the prediction ability. When the user submits a molecule, the server will predict the activity of the user's molecule across 623 human proteins by the established high quality SAR model, thus generating a DTI profiling that can be used as a feature vector of chemicals for wide applications. The 623 SAR models related to 623 human proteins were strictly evaluated and validated by several model validation strategies, resulting in the AUC scores of 75-100 %. We applied the generated DTI profiling to successfully predict potential targets, toxicity classification, drug-drug interactions, and drug mode of action, which sufficiently demonstrated the wide application value of the potential DTI profiling. The TargetNet webserver is designed based on the Django framework in Python, and is freely accessible at http://targetnet.scbdd.com .

Establishing a compulsory drug treatment prison: Therapeutic policy, principles, and practices in addressing offender rights and rehabilitation.

Science.gov (United States)

Birgden, Astrid; Grant, Luke

2010-01-01

A Compulsory Drug Treatment Correctional Center (CDTCC) was established in Australia in 2006 for repeat drug-related male offenders. Compulsory treatment law is inconsistent with a therapeutic jurisprudence approach. Despite the compulsory law, a normative offender rehabilitation framework has been established based on offender moral rights. Within moral rights, the offender rehabilitation framework addresses the core values of freedom (supporting autonomous decision-making) and well-being (supporting support physical, social, and psychological needs). Moral rights are underpinned by a theory or principle which, in this instance, is a humane approach to offender rehabilitation. While a law that permits offenders to choose drug treatment and rehabilitation is preferable, the article discusses the establishment of a prison based on therapeutic policy, principles, and practices that respond to participants as both rights-violators and rights-holders. The opportunity for accelerated community access and a therapeutic alliance with staff has resulted in offenders actively seeking to be ordered into compulsory drug treatment and rehabilitation. Crown Copyright © 2010. Published by Elsevier Ltd. All rights reserved.

Identification of designer drug 2C-E (4-ethyl-2, 5-dimethoxy-phenethylamine) in urine following a drug overdose

OpenAIRE

Van Vrancken, Michael J.; Benavides, Raul; Wians, Frank H.

2013-01-01

In recent years, access to information regarding acquisition and synthesis of newer designer drugs has been at an all-time high due largely to the Internet. As these drugs have become more prevalent, laboratory techniques have been developed and refined to identify and screen for this burgeoning population of drugs. This provides a unique opportunity for learning about many of these methods. Laboratory testing techniques and instrumentation are obscure to many health care professionals, yet t...

Center for Drug Evaluation and Research

Data.gov (United States)

Federal Laboratory Consortium — The Center for Drug Evaluation and Research(CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the...

Anticoagulant Medicine: Potential for Drug-Food Interactions

Science.gov (United States)

... Medications Anticoagulants and Drug-Food Interactions Anticoagulants and Drug-Food Interactions Make an Appointment Ask a Question Refer Patient ... Jewish Health wants you to be aware these drug-food interactions when taking anticoagulant medicine. Ask your health care ...

Drug Facts

Medline Plus

Full Text Available ... 800-662-HELP (4357) at any time to find drug treatment centers near you. I want my ... is making positive changes in her life. She finds support from family and friends who don't ...

Drug Facts

Medline Plus

Full Text Available ... prescription drugs. The addiction slowly took over his life. I need different people around me. To stop ... marijuana, "Cristina" is making positive changes in her life. She finds support from family and friends who ...

Biometrics: Accessibility challenge or opportunity?

Science.gov (United States)

Blanco-Gonzalo, Ramon; Lunerti, Chiara; Sanchez-Reillo, Raul; Guest, Richard Michael

2018-01-01

Biometric recognition is currently implemented in several authentication contexts, most recently in mobile devices where it is expected to complement or even replace traditional authentication modalities such as PIN (Personal Identification Number) or passwords. The assumed convenience characteristics of biometrics are transparency, reliability and ease-of-use, however, the question of whether biometric recognition is as intuitive and straightforward to use is open to debate. Can biometric systems make some tasks easier for people with accessibility concerns? To investigate this question, an accessibility evaluation of a mobile app was conducted where test subjects withdraw money from a fictitious ATM (Automated Teller Machine) scenario. The biometric authentication mechanisms used include face, voice, and fingerprint. Furthermore, we employed traditional modalities of PIN and pattern in order to check if biometric recognition is indeed a real improvement. The trial test subjects within this work were people with real-life accessibility concerns. A group of people without accessibility concerns also participated, providing a baseline performance. Experimental results are presented concerning performance, HCI (Human-Computer Interaction) and accessibility, grouped according to category of accessibility concern. Our results reveal links between individual modalities and user category establishing guidelines for future accessible biometric products.

Biometrics: Accessibility challenge or opportunity?

Science.gov (United States)

Lunerti, Chiara; Sanchez-Reillo, Raul; Guest, Richard Michael

2018-01-01

Biometric recognition is currently implemented in several authentication contexts, most recently in mobile devices where it is expected to complement or even replace traditional authentication modalities such as PIN (Personal Identification Number) or passwords. The assumed convenience characteristics of biometrics are transparency, reliability and ease-of-use, however, the question of whether biometric recognition is as intuitive and straightforward to use is open to debate. Can biometric systems make some tasks easier for people with accessibility concerns? To investigate this question, an accessibility evaluation of a mobile app was conducted where test subjects withdraw money from a fictitious ATM (Automated Teller Machine) scenario. The biometric authentication mechanisms used include face, voice, and fingerprint. Furthermore, we employed traditional modalities of PIN and pattern in order to check if biometric recognition is indeed a real improvement. The trial test subjects within this work were people with real-life accessibility concerns. A group of people without accessibility concerns also participated, providing a baseline performance. Experimental results are presented concerning performance, HCI (Human-Computer Interaction) and accessibility, grouped according to category of accessibility concern. Our results reveal links between individual modalities and user category establishing guidelines for future accessible biometric products. PMID:29565989

Assessing the role of syringe dispensing machines and mobile van outlets in reaching hard-to-reach and high-risk groups of injecting drug users (IDUs: a review

Directory of Open Access Journals (Sweden)

Islam Md Mofizul

2007-10-01

Full Text Available Abstract Reaching hard-to-reach and high-risk injecting drug users (IDUs is one of the most important challenges for contemporary needle syringe programs (NSPs. The aim of this review is to examine, based upon the available international experience, the effectiveness of syringe vending machines and mobile van/bus based NSPs in making services more accessible to these hard-to-reach and high-risk groups of IDUs. A literature search revealed 40 papers/reports, of which 18 were on dispensing machines (including vending and exchange machines and 22 on mobile vans. The findings demonstrate that syringe dispensing machines and mobile vans are promising modalities of NSPs, which can make services more accessible to the target group and in particular to the harder-to-reach and higher-risk groups of IDUs. Their anonymous and confidential approaches make services attractive, accessible and acceptable to these groups. These two outlets were found to be complementary to each other and to other modes of NSPs. Services through dispensing machines and mobile vans in strategically important sites are crucial elements in continuing efforts in reducing the spread of HIV and other blood borne viruses among IDUs.

A user-friendly mathematical modelling web interface to assist local decision making in the fight against drug-resistant tuberculosis.

Science.gov (United States)

Ragonnet, Romain; Trauer, James M; Denholm, Justin T; Marais, Ben J; McBryde, Emma S

2017-05-30

Multidrug-resistant and rifampicin-resistant tuberculosis (MDR/RR-TB) represent an important challenge for global tuberculosis (TB) control. The high rates of MDR/RR-TB observed among re-treatment cases can arise from diverse pathways: de novo amplification during initial treatment, inappropriate treatment of undiagnosed MDR/RR-TB, relapse despite appropriate treatment, or reinfection with MDR/RR-TB. Mathematical modelling allows quantification of the contribution made by these pathways in different settings. This information provides valuable insights for TB policy-makers, allowing better contextualised solutions. However, mathematical modelling outputs need to consider local data and be easily accessible to decision makers in order to improve their usefulness. We present a user-friendly web-based modelling interface, which can be used by people without technical knowledge. Users can input their own parameter values and produce estimates for their specific setting. This innovative tool provides easy access to mathematical modelling outputs that are highly relevant to national TB control programs. In future, the same approach could be applied to a variety of modelling applications, enhancing local decision making.

The make or buy debate: Considering the limitations of domestic production in Tanzania

Directory of Open Access Journals (Sweden)

Wilson Kinsley

2012-06-01

Full Text Available Abstract Background In order to ensure their population’s regular access to essential medicines, many least developed countries and developing countries are faced with the policy question of whether to import or manufacture drugs locally, in particular for life-saving antiretroviral medicines for HIV/AIDS patients. In order for domestic manufacturing to be viable and cost-effective, the local industry must be able to compete with international suppliers of medicines by producing sufficiently low cost ARVs. Methods This paper considers the ‘make-or-buy’ dilemma by using Tanzania as a case study. Key informant interviews, event-driven observation, and purposive sampling of documents were used to evaluate the case study. The case study focused on Tanzania’s imitation technology transfer agreement to locally manufacture a first-line ARV (3TC + d4T + NVP, reverse engineering the ARV. Results Tanzania is limited by weak political support for the use of TRIPS flexibilities, limited production capacity for ARVs and limited competitiveness in both domestic and regional markets. The Ministry of Health and Social Welfare encourages the use of flexibilities while others push for increased IP protection. Insufficient production capacity and lack of access to donor-financed tenders make it difficult to obtain economies of scale and provide competitive prices. Conclusions Within the “make-or-buy” context, it was determined that there are significant limitations in domestic manufacturing for developing countries. The case study highlights the difficulty of governments to make use of economies of scale and produce low-cost medicines, attract technology transfer, and utilize the flexibilities of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS. The results demonstrate the importance of evaluating barriers to the use of TRIPS flexibilities and long-term planning across sectors in future technology transfer and

The make or buy debate: considering the limitations of domestic production in Tanzania.

Science.gov (United States)

Wilson, Kinsley Rose; Kohler, Jillian Clare; Ovtcharenko, Natalia

2012-06-29

In order to ensure their population's regular access to essential medicines, many least developed countries and developing countries are faced with the policy question of whether to import or manufacture drugs locally, in particular for life-saving antiretroviral medicines for HIV/AIDS patients. In order for domestic manufacturing to be viable and cost-effective, the local industry must be able to compete with international suppliers of medicines by producing sufficiently low cost ARVs. This paper considers the 'make-or-buy' dilemma by using Tanzania as a case study. Key informant interviews, event-driven observation, and purposive sampling of documents were used to evaluate the case study. The case study focused on Tanzania's imitation technology transfer agreement to locally manufacture a first-line ARV (3TC + d4T + NVP), reverse engineering the ARV. Tanzania is limited by weak political support for the use of TRIPS flexibilities, limited production capacity for ARVs and limited competitiveness in both domestic and regional markets. The Ministry of Health and Social Welfare encourages the use of flexibilities while others push for increased IP protection. Insufficient production capacity and lack of access to donor-financed tenders make it difficult to obtain economies of scale and provide competitive prices. Within the "make-or-buy" context, it was determined that there are significant limitations in domestic manufacturing for developing countries. The case study highlights the difficulty of governments to make use of economies of scale and produce low-cost medicines, attract technology transfer, and utilize the flexibilities of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The results demonstrate the importance of evaluating barriers to the use of TRIPS flexibilities and long-term planning across sectors in future technology transfer and manufacturing initiatives.

Impact of economic sanctions on access to noncommunicable diseases medicines in the Islamic Republic of Iran.

Science.gov (United States)

Kheirandish, Mehrnaz; Varahrami, Vida; Kebriaeezade, Abbas; Cheraghali, Abdol Majid

2018-04-05

It has been argued that economic sanctions and the economic crisis have adversely affected access to drugs. To assess the impact of economic sanctions on the Iranian banking system in 2011 and Central Bank in 2012 on access to and use of drugs for noncommunicable diseases (NCDs). An interrupted time series study assessed the effects of sanctions on drugs for diabetes (5 drug groups), asthma (5 drug groups), cancer (14 drugs) and multiple sclerosis (2 drugs). We extracted data from national reference databases on the list of drugs on the Iranian pharmaceutical market before 2011 for each selected NCD and their monthly sales. For cancer drugs, we used stratified random sampling by volume and value of sales, and source of supply (domestic or imported). Data were analysed monthly from 2008 to 2013. Market availability of 13 of 26 drugs was significantly reduced. Ten other drugs showed nonsignificant reductions in their market availability. Interferon α2b usage reduced from 0.014 defined daily doses per 1000 inhabitants per day (DID) in 2010 to 0.008 in 2013; and cytarabine from 1.40 mg per 1000 population per day in 2010 to 0.96 in 2013. Selective β2-adrenoreceptor agonists usage reduced from 8.4 to 6.8 DID in the same time period. There is strong evidence that sanctions have had a negative effect on access to drugs, particularly those that depended on the import of their raw material or finished products. Copyright © World Health Organization (WHO) 2018. Some rights reserved. This work is available under the CC BY-NC-SA 3.0 IGO license (https://creativecommons.org/licenses/by-nc-sa/3.0/igo).

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

Science.gov (United States)

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

2013-01-01

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

Drug problems in contemporary China: a profile of Chinese drug users in a metropolitan area.

Science.gov (United States)

Huang, Kaicheng; Zhang, Lening; Liu, Jianhong

2011-03-01

Drug problems are reemerging in China since the nation implemented economic reform and an "open door" policy in the early 1980s. This is causing both national and international concern. However, knowledge and understanding of the Chinese drug problem is fairly limited because of the nation's unique social and political history. In response to this shortage of information, our study presents a profile of Chinese drug users. Data were collected from a survey of drug users attending mandatory treatment centres in a large city in 2009. We present a demographic profile of the drug users, describe their patterns of drug use, their access to drugs and their history of drug treatment. Chinese drug users, like those from the U.S., are likely to be unemployed and have a low level of education. However, they are more likely than those in the U.S. to use heroin, Bingdu (methamphetamine) and Maguo (a derivative of methamphetamine), and they pay less for their drugs. This profile of drug users is informative and valuable for drug prevention, intervention, and treatment in the Chinese setting because knowing and understanding the drug population is essential for effective control. Copyright © 2010 Elsevier B.V. All rights reserved.

How Parents of Teens Store and Monitor Prescription Drugs in the Home

Science.gov (United States)

Friese, Bettina; Moore, Roland S.; Grube, Joel W.; Jennings, Vanessa K.

2013-01-01

Qualitative interviews were conducted with parents of teens to explore how parents store and monitor prescription drugs in the home. Most parents had prescription drugs in the house, but took few precautions against teens accessing these drugs. Strategies for monitoring included moving the drugs to different locations, remembering how many pills…

Video Game Accessibility: A Legal Approach

Directory of Open Access Journals (Sweden)

George Powers

2015-02-01

Full Text Available Video game accessibility may not seem of significance to some, and it may sound trivial to anyone who does not play video games. This assumption is false. With the digitalization of our culture, video games are an ever increasing part of our life. They contribute to peer to peer interactions, education, music and the arts. A video game can be created by hundreds of musicians and artists, and they can have production budgets that exceed modern blockbuster films. Inaccessible video games are analogous to movie theaters without closed captioning or accessible facilities. The movement to have accessible video games is small, unorganized and misdirected. Just like the other battles to make society accessible were accomplished through legislation and law, the battle for video game accessibility must be focused toward the law and not the market.

No Special Equipment Required: The Accessibility Features Built into the Windows and Macintosh Operating Systems make Computers Accessible for Students with Special Needs

Science.gov (United States)

Kimball,Walter H.; Cohen,Libby G.; Dimmick,Deb; Mills,Rick

2003-01-01

The proliferation of computers and other electronic learning devices has made knowledge and communication accessible to people with a wide range of abilities. Both Windows and Macintosh computers have accessibility options to help with many different special needs. This documents discusses solutions for: (1) visual impairments; (2) hearing…

Biological therapy in inflammatory bowel diseases: Access in Central and Eastern Europe

Science.gov (United States)

Rencz, Fanni; Péntek, Márta; Bortlik, Martin; Zagorowicz, Edyta; Hlavaty, Tibor; Śliwczyński, Andrzej; Diculescu, Mihai M; Kupcinskas, Limas; Gecse, Krisztina B; Gulácsi, László; Lakatos, Peter L

2015-01-01

Biological drugs opened up new horizons in the management of inflammatory bowel diseases (IBD). This study focuses on access to biological therapy in IBD patients across 9 selected Central and Eastern European (CEE) countries, namely Bulgaria, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania and Slovakia. Literature data on the epidemiology and disease burden of IBD in CEE countries was systematically reviewed. Moreover, we provide an estimation on prevalence of IBD as well as biological treatment rates. In all countries with the exception of Romania, lower biological treatment rates were observed in ulcerative colitis (UC) compared to Crohn’s disease despite the higher prevalence of UC. Great heterogeneity (up to 96-fold) was found in access to biologicals across the CEE countries. Poland, Bulgaria, Romania and the Baltic States are lagging behind Hungary, Slovakia and the Czech Republic in their access to biologicals. Variations of reimbursement policy may be one of the factors explaining the differences to a certain extent in Bulgaria, Latvia, Lithuania, and Poland, but association with other possible determinants (differences in prevalence and incidence, price of biologicals, total expenditure on health, geographical access, and cost-effectiveness results) was not proven. We assume, nevertheless, that health deterioration linked to IBD might be valued differently against other systemic inflammatory conditions in distinct countries and which may contribute to the immense diversity in the utilization of biological drugs for IBD. In conclusion, access to biologicals varies widely among CEE countries and this difference cannot be explained by epidemiological factors, drug prices or total health expenditure. Changes in reimbursement policy could contribute to better access to biologicals in some countries. PMID:25684937

Multi-criteria decision analysis for assessment and appraisal of orphan drugs

Directory of Open Access Journals (Sweden)

Georgi Iskrov

2016-09-01

Full Text Available Background: Limited resources and expanding expectations push all countries and types of health systems to adopt new approaches in priority setting and resources allocation. Despite best efforts, it is difficult to reconcile all competing interests and trade-offs are inevitable. This is why multi-criteria decision analysis (MCDA has played a major role in recent uptake of value-based reimbursement. MCDA framework enables exploration of stakeholders’ preferences, as well as explicit organization of broad range of criteria on which real-world decisions are made.Assessment and appraisal of orphan drugs tend to be one of the most complicated health technology assessment (HTA tasks. Access to market approved orphan therapies remains an issue. Early constructive dialogue among rare disease stakeholders and elaboration of orphan drug-tailored decision support tools could set the scene for ongoing accumulation of evidence, as well as for proper reimbursement decision-making.Objective: The objective of this study was to create a MCDA value measurement model to assess and appraise orphan drugs. This was achieved by exploring the preferences on decision criteria’s weights and performance scores through a stakeholder-representative survey and a focus group discussion that were both organized in Bulgaria.Results/Conclusions: Decision criteria that describe the health technology’s characteristics were unanimously agreed as the most important group of reimbursement considerations. This outcome, combined with the high individual weight of disease severity and disease burden criteria underlined some of the fundamental principles of healthcare – equity and fairness. Our study proved that strength of evidence may be a key criterion in orphan drug assessment and appraisal. Evidence is not only used to shape reimbursement decision-making, but also to lend legitimacy to policies pursued. The need for real-world data on orphan drugs was largely stressed

ACOG Committee Opinion Number 542: Access to emergency contraception.

Science.gov (United States)

2012-11-01

Emergency contraception includes contraceptive methods used to prevent pregnancy in the first few days after unprotected intercourse, sexual assault, or contraceptive failure. Although the U.S. Food and Drug Administration approved the first dedicated product for emergency contraception in 1998, numerous barriers to access to emergency contraception remain. The purpose of this Committee Opinion is to examine the barriers to the use of oral emergency contraception methods and to highlight the importance of increasing access.

Computational prediction of multidisciplinary team decision-making for adjuvant breast cancer drug therapies: a machine learning approach.

Science.gov (United States)

Lin, Frank P Y; Pokorny, Adrian; Teng, Christina; Dear, Rachel; Epstein, Richard J

2016-12-01

Multidisciplinary team (MDT) meetings are used to optimise expert decision-making about treatment options, but such expertise is not digitally transferable between centres. To help standardise medical decision-making, we developed a machine learning model designed to predict MDT decisions about adjuvant breast cancer treatments. We analysed MDT decisions regarding adjuvant systemic therapy for 1065 breast cancer cases over eight years. Machine learning classifiers with and without bootstrap aggregation were correlated with MDT decisions (recommended, not recommended, or discussable) regarding adjuvant cytotoxic, endocrine and biologic/targeted therapies, then tested for predictability using stratified ten-fold cross-validations. The predictions so derived were duly compared with those based on published (ESMO and NCCN) cancer guidelines. Machine learning more accurately predicted adjuvant chemotherapy MDT decisions than did simple application of guidelines. No differences were found between MDT- vs. ESMO/NCCN- based decisions to prescribe either adjuvant endocrine (97%, p = 0.44/0.74) or biologic/targeted therapies (98%, p = 0.82/0.59). In contrast, significant discrepancies were evident between MDT- and guideline-based decisions to prescribe chemotherapy (87%, p machine learning models. A machine learning approach based on clinicopathologic characteristics can predict MDT decisions about adjuvant breast cancer drug therapies. The discrepancy between MDT- and guideline-based decisions regarding adjuvant chemotherapy implies that certain non-clincopathologic criteria, such as patient preference and resource availability, are factored into clinical decision-making by local experts but not captured by guidelines.

Recidivism among High-Risk Drug Felons: A Longitudinal Analysis following Residential Treatment

Science.gov (United States)

Belenko, Steven; Foltz, Carol; Lang, Michelle A.; Sung, Hung-En

2004-01-01

Recent interest in increasing access to substance abuse treatment for drug-involved offenders has been spurred by concerns over expanding prison and jail populations, high recidivism rates for drug-involved offenders, and the close link between illegal drug use and criminal activity. Chronic untreated drug and alcohol abuse is likely to result in…

Pharma Pricing & Market Access Europe 2016--Health Network Communications' Tenth Annual Conference (February 23-25, 2016--London, UK).

Science.gov (United States)

D'Souza, P

2016-03-01

Tighter national budgets and escalating drug prices continue to present challenges for pharmaceutical market access strategies and societal cost of care. As pharmaceutical companies and medical governmental advisory organizations enter tougher negotiations, hospital trusts and other dispensary firms face barriers to receiving the best medical treatment, and as a result patient access is limited. The 2016 HealthNetwork Communications' Pharma Pricing & Market Access Europe meeting brought together pharmaceutical, medical governmental advisory and stakeholders and market access/pricing consultants, to encourage discussions and negotiations into how to improve the drug pricing system and consequential market access strategies while achieving the respective reimbursement and affordability objectives. Copyright 2016 Prous Science, S.A.U. or its licensors. All rights reserved.

Drugs + HIV, Learn the Link

Medline Plus

Full Text Available ... projects/learn-link-drugs-hiv . 120x90 460x80 486x60 Social Media Send the message to young people and ... the Party" "Text Message" NIDA Home Site Map Accessibility Privacy FOIA(NIH) Working at NIDA FAQs Contact ...

Critical thinking about adverse drug effects: lessons from the psychology of risk and medical decision-making for clinical psychopharmacology.

Science.gov (United States)

Nierenberg, Andrew A; Smoller, Jordan W; Eidelman, Polina; Wu, Yelena P; Tilley, Claire A

2008-01-01

Systematic biases in decision-making have been well characterized in medical and nonmedical fields but mostly ignored in clinical psychopharmacology. The purpose of this paper is to sensitize clinicians who prescribe psychiatric drugs to the issues of the psychology of risk, especially as they pertain to the risk of side effects. Specifically, the present analysis focuses on heuristic organization and framing effects that create cognitive biases in medical practice. Our purpose is to increase the awareness of how pharmaceutical companies may influence physicians by framing the risk of medication side effects to favor their products. (c) 2008 S. Karger AG, Basel.

Efficient Access Control in Multimedia Social Networks

Science.gov (United States)

Sachan, Amit; Emmanuel, Sabu

Multimedia social networks (MMSNs) have provided a convenient way to share multimedia contents such as images, videos, blogs, etc. Contents shared by a person can be easily accessed by anybody else over the Internet. However, due to various privacy, security, and legal concerns people often want to selectively share the contents only with their friends, family, colleagues, etc. Access control mechanisms play an important role in this situation. With access control mechanisms one can decide the persons who can access a shared content and who cannot. But continuously growing content uploads and accesses, fine grained access control requirements (e.g. different access control parameters for different parts in a picture), and specific access control requirements for multimedia contents can make the time complexity of access control to be very large. So, it is important to study an efficient access control mechanism suitable for MMSNs. In this chapter we present an efficient bit-vector transform based access control mechanism for MMSNs. The proposed approach is also compatible with other requirements of MMSNs, such as access rights modification, content deletion, etc. Mathematical analysis and experimental results show the effectiveness and efficiency of our proposed approach.

Navigating the poverty of heroin addiction treatment and recovery opportunity in Kenya: access work, self-care and rationed expectations.

Science.gov (United States)

Rhodes, Tim; Ndimbii, James; Guise, Andy; Cullen, Lucy; Ayon, Sylvia

2015-01-01

Drawing on the analyses of qualitative interview accounts of people who inject heroin in Kenya, we describe the narration of addiction treatment access and recovery desire in conditions characterised by a 'poverty of drug treatment opportunity'. We observe the performance of addiction recovery narrative in the face of heavy social constraints limiting access to care. Fee-based residential rehabilitation ('rehab') is the only treatment locally available and inaccessible to most. Its recovery potential is doubted, given normative expectations of relapse. Treating drug use is a product of tightly bounded agency. Individuals enact strategies to maximise their slim chances of treatment access ('access work'), develop self-care alternatives when these fail to materialise and ration their care expectations. The use of rehab as a primary means of respite and harm reduction rather than recovery and the individuation of care in the absence of an enabling recovery environment are key characteristics of drug treatment experience. The recent incorporation of 'harm reduction' into policy discourses may trouble the primacy of recovery narrative in addiction treatment and in how treatment desires are voiced. The diversification of drug treatments in combination with social interventions enabling their access are fundamental.

International Drug Discovery Science and Technology--BIT's Seventh Annual Congress.

Science.gov (United States)

Bodovitz, Steven

2010-01-01

BIT's Seventh Annual International Drug Discovery Science and Technology Congress, held in Shanghai, included topics covering new therapeutic and technological developments in the field of drug discovery. This conference report highlights selected presentations on open-access approaches to R&D, novel and multifactorial targets, and technologies that assist drug discovery. Investigational drugs discussed include the anticancer agents astuprotimut-r (GlaxoSmithKline plc) and AS-1411 (Antisoma plc).

An Overview of the Reimbursement Decision-Making Processes in Bulgaria As a Reference Country for the Middle-Income European Countries

Directory of Open Access Journals (Sweden)

Maria Kamusheva

2018-03-01

Full Text Available BackgroundPolicy makers face a lot of challenges in the process of drug reimbursement decision-making, especially in the context of entering the market of more and more innovative medicinal products (MPs. The aim of the current study is to make an overview of the reimbursement system development and to evaluate the access of innovative medicines, which have entered the EU-market in the period 2015–2017, in Bulgaria as reference example for middle-income European country.MethodsA literature and a legislative systematic review regarding the Bulgarian reimbursement system as well as a defining the number of available innovative reimbursed MPs in 2017 in Bulgaria was made.ResultsThe reimbursement legislation in Bulgaria is quite unstable due to constant changes, which have been made, especially in the recent years. Despite this fact, the reimbursement process in Bulgaria is in accordance with the Transparency Directive. Bulgarian patients have a relatively delayed access to innovative medicines as only 5% of centrally authorized MPs in 2017 are available in the positive drug list (PDL, 16% of all in 2016 and 18%—in 2015. This could be explained by the long procedure for their appraisal in Bulgaria: the first step is issuing an opinion by the HTA Committee, followed by negotiation of discounts between the marketing authorization holder and the National Health Insurance Fund and making a final decision by the National Council on Prices and Reimbursement (NCPR for the inclusion into the PDL.ConclusionOptimization of the procedure for issuing reimbursement status for innovative MPs is needed, such as improvements in the process of conducting HTA reports and their appraisal, incorporation of adequate systems for following the effectiveness and safety of MPs in the real-world conditions, value-based pricing implementation, and increasing the financial control over the health insurance system.

An Overview of the Reimbursement Decision-Making Processes in Bulgaria As a Reference Country for the Middle-Income European Countries.

Science.gov (United States)

Kamusheva, Maria; Vassileva, Mariya; Savova, Alexandra; Manova, Manoela; Petrova, Guenka

2018-01-01

Policy makers face a lot of challenges in the process of drug reimbursement decision-making, especially in the context of entering the market of more and more innovative medicinal products (MPs). The aim of the current study is to make an overview of the reimbursement system development and to evaluate the access of innovative medicines, which have entered the EU-market in the period 2015-2017, in Bulgaria as reference example for middle-income European country. A literature and a legislative systematic review regarding the Bulgarian reimbursement system as well as a defining the number of available innovative reimbursed MPs in 2017 in Bulgaria was made. The reimbursement legislation in Bulgaria is quite unstable due to constant changes, which have been made, especially in the recent years. Despite this fact, the reimbursement process in Bulgaria is in accordance with the Transparency Directive. Bulgarian patients have a relatively delayed access to innovative medicines as only 5% of centrally authorized MPs in 2017 are available in the positive drug list (PDL), 16% of all in 2016 and 18%-in 2015. This could be explained by the long procedure for their appraisal in Bulgaria: the first step is issuing an opinion by the HTA Committee, followed by negotiation of discounts between the marketing authorization holder and the National Health Insurance Fund and making a final decision by the National Council on Prices and Reimbursement (NCPR) for the inclusion into the PDL. Optimization of the procedure for issuing reimbursement status for innovative MPs is needed, such as improvements in the process of conducting HTA reports and their appraisal, incorporation of adequate systems for following the effectiveness and safety of MPs in the real-world conditions, value-based pricing implementation, and increasing the financial control over the health insurance system.

Delays by people living with HIV/AIDS in accessing antiretroviral ...

African Journals Online (AJOL)

Objective: To understand, by qualitative enquiry, the underlying reasons and narratives ... denial, practical clinic constraints and appropriate types of health education. Keywords: qualitative research, delays, access, antiretroviral drugs, ARVs ...

A survey of causes of the drugs abuse tendency and psychoactive drugs from viewpoint of Lorestan University of Medical Sciences Students

Directory of Open Access Journals (Sweden)

Davod Kordestani

2017-06-01

Full Text Available Background : The following study is done to recognize causes of the drugs abuse tendency and psychoactive drugs from viewpoint of Lorestan University of Medical Sciences students. Materials and Methods: The method of the following study is descriptive survey with purpose. The statistic groups are the university students of medical university of Lorestan and its colleges between 2014 and 2015. To take samples we used the Morgan table and the numbers of participants is 335 in a random order. In this study, to analysis the data, we use the descriptive statistics in two ways. The first part is descriptive statistics, like use of frequency tables, charts, and in second part the analysis is done by inferential descriptive statistics (sample test one. The data were analyzed using SPSS version 19. Results: The results showed that, personal، social and interpersonal factors has effects on student tendency toward using drugs (p<0/01. According to the findings among personal factors positive attitude toward drugs 23/3 depression 20/8 and not being able to intolerance of  failure have the most possible mean and curiosity and aggression with 13/58 has the least possible mean among interpersonal and environmental factors related to family with the mean of 30/96 has the most possible mean and school related factors has the least possible mean 17/67.Also in social factors in accessibility to systems of services، support systems and consultative systems had the most possible mean with 34/27 and drug market in Iran has the least possible mean with 20/67.Among following factors interpersonal factor had the most impression with 122/62. Conclusion: It seems that running comprehensive educational programs and increasing awareness ،enriching the leisure times can increase awareness of students and finally leads to prevention drugs, furthermore educating the students will make them more aware and keeps them away from drugs.

Scaling predictive modeling in drug development with cloud computing.

Science.gov (United States)

Moghadam, Behrooz Torabi; Alvarsson, Jonathan; Holm, Marcus; Eklund, Martin; Carlsson, Lars; Spjuth, Ola

2015-01-26

Growing data sets with increased time for analysis is hampering predictive modeling in drug discovery. Model building can be carried out on high-performance computer clusters, but these can be expensive to purchase and maintain. We have evaluated ligand-based modeling on cloud computing resources where computations are parallelized and run on the Amazon Elastic Cloud. We trained models on open data sets of varying sizes for the end points logP and Ames mutagenicity and compare with model building parallelized on a traditional high-performance computing cluster. We show that while high-performance computing results in faster model building, the use of cloud computing resources is feasible for large data sets and scales well within cloud instances. An additional advantage of cloud computing is that the costs of predictive models can be easily quantified, and a choice can be made between speed and economy. The easy access to computational resources with no up-front investments makes cloud computing an attractive alternative for scientists, especially for those without access to a supercomputer, and our study shows that it enables cost-efficient modeling of large data sets on demand within reasonable time.

The crisis in access to essential medicines in India: key issues which call for action.

Science.gov (United States)

Bhargava, Anurag; Kalantri, S P

2013-01-01

The government is planning to introduce free generic and essential medicines in public health facilities. Most people in India buy healthcare from the private sector, a compulsion that accounts for a high proportion of healthcare-related expenditure. To reduce the burden of healthcare costs, the government must improve availability and affordability of generic and essential medicines in the market. It can do so because India's large pharmaceutical industry is a major source of generic medicines worldwide. In this article, we discuss three factors that have impeded access to generic and essential medicines: (1) mistaken notions among policymakers, prescribers and patients about branded drugs and generic drugs in India; (2) high prices of medicines due to the progressive dismantling of the system of regulation of medicine prices, and (3) a drug approval and regulatory system that allows medicines (including fixed dose combinations) of doubtful efficacy, rationale, safety and public health relevance to dominate the market at the cost of access to affordable generic and essential medicines. The consequences of ill-health and wasted expenditure on drugs raise issues of public health ethics.Improving access to essential medicines in India is an urgent public health and ethical imperative. This should include improved public provisioning, a system of regulation of drug prices, and an evidence-based drug approval process.

Changes in access to health care in China, 1989-1997.

Science.gov (United States)

Akin, John S; Dow, William H; Lance, Peter M; Loh, Chung-Ping A

2005-03-01

The post-1979 period in China has seen the implementation of reforms that dismantled much of the Maoist era social welfare system and permitted a significant reallocation of society's resources. The result has been rapid but uneven economic development that has profoundly altered the environment within which consumers make health investment decisions. Many studies report significant and apparently non-random reductions in health care utilization during this period. Scholars have tended to focus on the loss of insurance coverage and the growth of fees for services in explaining such reductions. An alternative explanation is growing inequality in access to care. This possibility has not received much research attention. As a result, our understanding of the patterns of changes in health care access, and of the types of populations that have been most adversely affected, has been rather limited. This research examines the distribution of the changes in several indicators of access to health care across communities during the period 1989 to 1997. We find evidence of relatively uneven changes to these indicators. Money charges for routine services increased consistently, though this trend was less pronounced in lower-income communities. Most communities experienced reductions in travel distance to clinics but increases in distance to hospitals. There were major improvements to the quality of care in wealthier rural areas, but not in poorer villages. Wealthier villages experienced less improvement in waiting time and drug availability. These trends appear to be closely associated with changing economic circumstances during the reform era.

[Costly drugs: analysis and proposals for the Mercosur countries].

Science.gov (United States)

Marín, Gustavo H; Polach, María Andrea

2011-08-01

Determine how the Mercosur countries access, regulate, and finance costly drugs and propose joint selection and financing strategies at the subregional level. Qualitative design, using content analyses of primary and secondary sources, document reviews, interviews, focus groups, and case studies. The variables selected included: selection criteria, access, financing, and regulations in the various countries. Costly drugs were divided into those that do not alter the natural course of the disease and those with demonstrated efficacy, using the defined daily dose to compare the costs of classical treatments and those involving costly drugs. The Mercosur countries generally lack formal strategies for dealing with the demand for costly drugs, and governments and insurers wind up financing them by court order. The case studies show that there are costly drugs whose efficacy has not been established but that nonetheless generate demand. The fragmentation of procurement, international commitments with regard to intellectual property, and low negotiating power exponentially increase the price of costly drugs, putting health system finances in jeopardy. Costly drugs must be regulated and rationally selected so that only those that substantively benefit people are accepted. To finance the drugs so selected, common country strategies are needed that include such options as flexible in trade agreements, the creation of national resource funds, or joint procurement by countries to enhance their negotiating power.

An Authentication Gateway for Integrated Grid and Cloud Access

International Nuclear Information System (INIS)

Ciaschini, V; Salomoni, D

2011-01-01

The WNoDeS architecture, providing distributed, integrated access to both Cloud and Grid resources through virtualization technologies, makes use of an Authentication Gateway to support diverse authentication mechanisms. Three main use cases are foreseen, covering access via X.509 digital certificates, federated services like Shibboleth or Kerberos, and credit-based access. In this paper, we describe the structure of the WNoDeS authentication gateway.

The Relationship between of Rural Accessibility and Development

Directory of Open Access Journals (Sweden)

Thomas Soseco

2016-09-01

Full Text Available Rural accessibility has been an important situation to enhance people living. Lack of access limiting people’s opportunity to not only economic choices but also educational and health aspects. Various studies found that there was a positive relationship between better accessibility and poverty, health, and educational measurements. One indicator to measure accessibility is Rural Access Index (RAI, which developed by The Worldbank. Eventhough Indonesia has quite high RAI, but in realty Indonesia still experience large disparity of road condition in its regions. Accessibility became big problems because it may cause worse effect on wider aspects, for instance health. Health, which proxied by infant mortality rate, is worse in villages with poor acessibility. Thus, government must do adequate efforts to enhance accessibility and at the same time make sure that more villages can gain better access.

Personalized medicine and access to genetic technologies.

Science.gov (United States)

den Exter, André

2010-01-01

Personalized medicine started after the Human Genome Project and is a relatively new concept that will dramatically change clinical practice. It offers clear clinical advantages by applying genetic diagnostic tests and then treating the patient with targeted medicines based on his or her genetic make-up. Its potential seems promising but there are quite a few legal concerns. One of these questions deals with the right to health care and access to genetic technologies. In this paper, the author explains the meaning of such a right to health care under international human rights law, its relevance for making genetic services eligible for public funding, how to cope with quality concerns of commercial testing, and finally, the patentability controversy and clinical access to genetic information. Apart from more traditional human rights concerns (consent, privacy, confidentiality) and genetics, States should be aware of the meaning of the equal access concept under international law and its consequences when introducing new technologies such genetic testing and services.

Architectures for a quantum random access memory

OpenAIRE

Giovannetti, Vittorio; Lloyd, Seth; Maccone, Lorenzo

2008-01-01

A random access memory, or RAM, is a device that, when interrogated, returns the content of a memory location in a memory array. A quantum RAM, or qRAM, allows one to access superpositions of memory sites, which may contain either quantum or classical information. RAMs and qRAMs with n-bit addresses can access 2^n memory sites. Any design for a RAM or qRAM then requires O(2^n) two-bit logic gates. At first sight this requirement might seem to make large scale quantum versions of such devices ...

Buccal bioadhesive drug delivery--a promising option for orally less efficient drugs.

Science.gov (United States)

Sudhakar, Yajaman; Kuotsu, Ketousetuo; Bandyopadhyay, A K

2006-08-10

Rapid developments in the field of molecular biology and gene technology resulted in generation of many macromolecular drugs including peptides, proteins, polysaccharides and nucleic acids in great number possessing superior pharmacological efficacy with site specificity and devoid of untoward and toxic effects. However, the main impediment for the oral delivery of these drugs as potential therapeutic agents is their extensive presystemic metabolism, instability in acidic environment resulting into inadequate and erratic oral absorption. Parenteral route of administration is the only established route that overcomes all these drawbacks associated with these orally less/inefficient drugs. But, these formulations are costly, have least patient compliance, require repeated administration, in addition to the other hazardous effects associated with this route. Over the last few decades' pharmaceutical scientists throughout the world are trying to explore transdermal and transmucosal routes as an alternative to injections. Among the various transmucosal sites available, mucosa of the buccal cavity was found to be the most convenient and easily accessible site for the delivery of therapeutic agents for both local and systemic delivery as retentive dosage forms, because it has expanse of smooth muscle which is relatively immobile, abundant vascularization, rapid recovery time after exposure to stress and the near absence of langerhans cells. Direct access to the systemic circulation through the internal jugular vein bypasses drugs from the hepatic first pass metabolism leading to high bioavailability. Further, these dosage forms are self-administrable, cheap and have superior patient compliance. Developing a dosage form with the optimum pharmacokinetics is a promising area for continued research as it is enormously important and intellectually challenging. With the right dosage form design, local environment of the mucosa can be controlled and manipulated in order to

Spanish Clinical Guidelines on Vascular Access for Haemodialysis.

Science.gov (United States)

Ibeas, José; Roca-Tey, Ramon; Vallespín, Joaquín; Moreno, Teresa; Moñux, Guillermo; Martí-Monrós, Anna; Del Pozo, José Luis; Gruss, Enrique; Ramírez de Arellano, Manel; Fontseré, Néstor; Arenas, María Dolores; Merino, José Luis; García-Revillo, José; Caro, Pilar; López-Espada, Cristina; Giménez-Gaibar, Antonio; Fernández-Lucas, Milagros; Valdés, Pablo; Fernández-Quesada, Fidel; de la Fuente, Natalia; Hernán, David; Arribas, Patricia; Sánchez de la Nieta, María Dolores; Martínez, María Teresa; Barba, Ángel

2017-11-01

Vascular access for haemodialysis is key in renal patients both due to its associated morbidity and mortality and due to its impact on quality of life. The process, from the creation and maintenance of vascular access to the treatment of its complications, represents a challenge when it comes to decision-making, due to the complexity of the existing disease and the diversity of the specialities involved. With a view to finding a common approach, the Spanish Multidisciplinary Group on Vascular Access (GEMAV), which includes experts from the five scientific societies involved (nephrology [S.E.N.], vascular surgery [SEACV], vascular and interventional radiology [SERAM-SERVEI], infectious diseases [SEIMC] and nephrology nursing [SEDEN]), along with the methodological support of the Cochrane Center, has updated the Guidelines on Vascular Access for Haemodialysis, published in 2005. These guidelines maintain a similar structure, in that they review the evidence without compromising the educational aspects. However, on one hand, they provide an update to methodology development following the guidelines of the GRADE system in order to translate this systematic review of evidence into recommendations that facilitate decision-making in routine clinical practice, and, on the other hand, the guidelines establish quality indicators which make it possible to monitor the quality of healthcare. Copyright © 2017 Sociedad Española de Nefrología. Published by Elsevier España, S.L.U. All rights reserved.

Accessible engineering drawings for visually impaired machine operators.

Science.gov (United States)

Ramteke, Deepak; Kansal, Gayatri; Madhab, Benu

2014-01-01

An engineering drawing provides manufacturing information to a machine operator. An operator plans and executes machining operations based on this information. A visually impaired (VI) operator does not have direct access to the drawings. Drawing information is provided to them verbally or by using sample parts. Both methods have limitations that affect the quality of output. Use of engineering drawings is a standard practice for every industry; this hampers employment of a VI operator. Accessible engineering drawings are required to increase both independence, as well as, employability of VI operators. Today, Computer Aided Design (CAD) software is used for making engineering drawings, which are saved in CAD files. Required information is extracted from the CAD files and converted into Braille or voice. The authors of this article propose a method to make engineering drawings information directly accessible to a VI operator.

Biometrics: Accessibility challenge or opportunity?

Directory of Open Access Journals (Sweden)

Ramon Blanco-Gonzalo

Full Text Available Biometric recognition is currently implemented in several authentication contexts, most recently in mobile devices where it is expected to complement or even replace traditional authentication modalities such as PIN (Personal Identification Number or passwords. The assumed convenience characteristics of biometrics are transparency, reliability and ease-of-use, however, the question of whether biometric recognition is as intuitive and straightforward to use is open to debate. Can biometric systems make some tasks easier for people with accessibility concerns? To investigate this question, an accessibility evaluation of a mobile app was conducted where test subjects withdraw money from a fictitious ATM (Automated Teller Machine scenario. The biometric authentication mechanisms used include face, voice, and fingerprint. Furthermore, we employed traditional modalities of PIN and pattern in order to check if biometric recognition is indeed a real improvement. The trial test subjects within this work were people with real-life accessibility concerns. A group of people without accessibility concerns also participated, providing a baseline performance. Experimental results are presented concerning performance, HCI (Human-Computer Interaction and accessibility, grouped according to category of accessibility concern. Our results reveal links between individual modalities and user category establishing guidelines for future accessible biometric products.

Vascular access: a never-ending story.

Science.gov (United States)

Hedin, U

2014-12-01

Vascular surgeons are more and more becoming responsible for "life-line" creation well functioning and maintenance of hemodialysis patients and to provide a well functioning and multidisciplinary access service together with nefrologists, dialysis staff, and interventional radiology. For many, this sometimes arduous surgery with associated complicated clinical decision making, becomes a constant and challenging burden but much through the appearance of national and international guidelines and especially the endovascular technology, feasible solutions are easily at hand and the life as an access surgeon more pleasant. Here, basics in dialysis access care are presented together with some examples of novel available solutions to troublesome clinical problems.

The Family and Federal Drug Abuse Policies--Programs: Toward Making the Invisible Family Visible.

Science.gov (United States)

Clayton, Richard R.

1979-01-01

Notes why the family is not considered in drug policy and programing and asserts that existing conditions demand conscious consideration of the family in efforts of federal drug agencies. Data show changing parameters of drug use-abuse. A research and prevention agenda that integrates the family is presented. (Author/BEF)

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

Science.gov (United States)

2013-03-08

... benefit and risk considerations that make up a regulatory decision will help to facilitate balanced and... and the role of those factors in the regulatory decision-making process for human drug and biological... communication of its decisions by making clear the important considerations in the Agency's decision-making...

A Method for Automated Planning of FTTH Access Network Infrastructures

DEFF Research Database (Denmark)

Riaz, Muhammad Tahir; Pedersen, Jens Myrup; Madsen, Ole Brun

2005-01-01

In this paper a method for automated planning of Fiber to the Home (FTTH) access networks is proposed. We introduced a systematic approach for planning access network infrastructure. The GIS data and a set of algorithms were employed to make the planning process more automatic. The method explains...... method. The method, however, does not fully automate the planning but make the planning process significantly fast. The results and discussion are presented and conclusion is given in the end....

Public Access ICT across Cultures

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

3 Impact of Public Access to ICT Skills on Job Prospects in Rwanda ... reform and information and communication technology (ICT) policies, particularly in developing countries. ... (From internal memoranda prepared by Amy Mahan, 2008) ..... little decision-making autonomy, power, or financial control within the household.

Wheelchair accessibility to public buildings in the Kumasi metropolis, Ghana

Directory of Open Access Journals (Sweden)

Cosmos Yarfi

2017-09-01

Conclusion: The results of this study show that public buildings in the Kumasi metropolis are not wheelchair accessible. An important observation made during this study was that there is an intention to improve accessibility when buildings are being constructed or renovated, but there are no laid down guidelines as how to make the buildings accessible for wheelchair users.

StaySafe: A self-administered android tablet application for helping individuals on probation make better decisions pertaining to health risk behaviors

Directory of Open Access Journals (Sweden)

Wayne E.K. Lehman

2018-06-01

Full Text Available This paper describes the development and protocol for feasibility and efficacy testing of a risk reduction intervention designed to improve behavioral health outcomes among drug offenders on probation under community supervision or in residential substance abuse treatment centers. StaySafe is a self-administered tablet-based intervention for teaching better decision-making skills regarding health risk behaviors, especially those involving HIV risks. We are using pre/post, experimental/control group randomized clinical trial (RCT in both community and residential probation settings with goals to 1 assess the feasibility and acceptance of StaySafe by examining participation rates and satisfaction measures, and 2 examine the impact of StaySafe on decision-making skills, confidence and motivation to avoid sex and drug risks, willingness to discuss health risks and concerns with helpful others, and engagement in health risk behaviors.StaySafe consists of 12 brief sessions and utilizes an evidence-based decision-making schema, called WORKIT, which guides participants through steps for identifying the problem and options, evaluating the options and making a decision about which option to carry out. Multiple sessions of StaySafe provide a practice effect so that the WORKIT steps become easily accessible to participants when making decisions. Three of the sessions provide participants a choice of activities designed to provide additional information about HIV and reinforce lessons learned during the WORKIT sessions. Preliminary data demonstrate feasibility and high levels of satisfaction with StaySafe. Keywords: Clinical trial, HIV, Probation, Tablet-based intervention, Decision-making

Medicamentos y transnacionales farmacéuticas: impacto en el acceso a los medicamentos para los países subdesarrollados The drugs and the pharmaceutical transnationals: impact on the drugs access for developing countries

Directory of Open Access Journals (Sweden)

Amarilys Torres Domínguez

2010-03-01

Full Text Available Este trabajo tiene como objetivo realizar una presentación general acerca de la situación de salud a nivel mundial, relacionar esta con la problemática del acceso a los medicamentos y vincular ambos factores a las características que tipifican la diversidad de intereses alrededor de las empresas farmacéuticas transnacionales. La explosión en la producción y comercialización de los medicamentos durante los últimos años han convertido al sector farmacéutico en líder mundial. No obstante, actualmente ¾ partes de la población mundial tienen poca o ninguna posibilidad de adquirir los medicamentos esenciales. La situación actual es insostenible y, por lo tanto, se trata de ir a alternativas diferentes de las que hoy existen.The aim of present paper is to perform a general presentation about the worldwide health situation, to relates it with the problem of drugs access ant to link both factors with features typifying the diversity of interests around the transnational pharmaceutical enterprises. The boom in drugs production and marketing over past years becomes the pharmaceutical sector in the world leader. However, nowadays the ¾ of world population has not much or neither possibility to acquires the essential drugs. Present situation is untenable and therefore, it is necessary tolook for alternatives difeferent to available nowadays.

M2M massive wireless access

DEFF Research Database (Denmark)

Zanella, Andrea; Zorzi, Michele; Santos, André F.

2013-01-01

In order to make the Internet of Things a reality, ubiquitous coverage and low-complexity connectivity are required. Cellular networks are hence the most straightforward and realistic solution to enable a massive deployment of always connected Machines around the globe. Nevertheless, a paradigm...... shift in the conception and design of future cellular networks is called for. Massive access attempts, low-complexity and cheap machines, sporadic transmission and correlated signals are among the main properties of this new reality, whose main consequence is the disruption of the development...... Access Reservation, Coded Random Access and the exploitation of multiuser detection in random access. Additionally, we will show how the properties of machine originated signals, such as sparsity and spatial/time correlation can be exploited. The end goal of this paper is to provide motivation...

Drugs + HIV, Learn the Link

Medline Plus

Full Text Available ... brain that people use to weigh risks and benefits when making decisions. This page connects you to information about the ... brain that people use to weigh risks and benefits when making decisions. Watch the "Send the Message About Drugs and ...

Viral leads for chemokine-modulatory drugs

DEFF Research Database (Denmark)

Lindow, Morten; Lüttichau, Hans Rudolf; Schwartz, Thue W

2003-01-01

The chemokine system, which controls leukocyte trafficking, provides several potentially very attractive anti-inflammatory drug targets. However, the complexity and redundancy of this system makes it very difficult to exploit through classical drug discovery. Despite this, viruses have millions...

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

Science.gov (United States)

2010-07-01

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

Brand-name drug, generic drug, orphan drug. Pharmacological therapy with biosimilar drugs - provision of due diligence in the treatment process.

Science.gov (United States)

Zajdel, Justyna; Zajdel, Radosław

2013-01-01

Due diligence in the process of provision of healthcare services refers, among other elements, to the application of pharmacological therapy at a time which offers the greatest chance for a successful outcome of treatment, i.e. for achieving the optimum expected effect understood as an improvement in the patient's health, reduction of health risks or elimination of the disease. However, due diligence may also refer to actions aimed at ensuring that neither the patient nor the healthcare payer is required to incur unreasonable costs in the process of treatment. The validity of that statement stems not only from normative acts but also from ethical standards laid down in the Medical Code of Ethics (Article 57 section 2). It often happens that the provision of optimal treatment calls for deviations from the formal provisions included in Summary Product Characteristics (SPCs), and the application of drugs that are bioequivalent to reference drugs, which translates into a significant reduction of costs. The present study addresses the problem of acceptability of a specific form of drug substitution consisting in the replacement of a reference drug with a generic drug. Also explored are legal aspects associated with the possibility of therapy based on "off-label use". The study reviews normative acts existing in the Polish and EU legislation. It also provides a clear definition of orphan drug, which has made it possible to make a distinction and investigate mutual relations between the concepts of brand-name (reference) drug, orphan drug and generic drug.

[Three types of brand name loyalty strategies set up by drug manufacturers].

Science.gov (United States)

PréMont, Marie-Claude; Gagnon, Marc-André

2014-11-01

The recent restructuring of the pharmaceutical industry has led to three new types of promotional strategies to build patient loyalty to brand name drugs: loyalty through rebates, patient support, and compassion programs. Loyalty through rebates seeks to keep patients on a brand name drug and prevent their switch to the generic equivalent. Loyalty through patient support provides aftersales services to help and support patients (by phone or home visits) in order to improve adherence to their treatments. Finally, compassion programs offer patients access to drugs still awaiting regulatory approval or reimbursement by insurers. When and if the approval process is successful, the manufacturer puts an end to the compassion program and benefits from a significant cohort of patients already taking a very expensive drug for which reimbursement is assured. The impact of these programs on public policies and patients' rights raises numerous concerns, among which the direct access to patients and their health information by drug manufacturers and upward pressure on costs for drug insurance plans.

Making Healthy Decisions About Sex

Science.gov (United States)

... For Teens: How to Make Healthy Decisions About Sex Page Content Article Body Before you decide to ... alcohol or use drugs. Are You Ready for Sex? Sex can change your life and relationships. Having ...

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

Science.gov (United States)

2013-02-06

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

Making working memory work: the effects of extended practice on focus capacity and the processes of updating, forward access, and random access.

Science.gov (United States)

Price, John M; Colflesh, Gregory J H; Cerella, John; Verhaeghen, Paul

2014-05-01

We investigated the effects of 10h of practice on variations of the N-Back task to investigate the processes underlying possible expansion of the focus of attention within working memory. Using subtractive logic, we showed that random access (i.e., Sternberg-like search) yielded a modest effect (a 50% increase in speed) whereas the processes of forward access (i.e., retrieval in order, as in a standard N-Back task) and updating (i.e., changing the contents of working memory) were executed about 5 times faster after extended practice. We additionally found that extended practice increased working memory capacity as measured by the size of the focus of attention for the forward-access task, but not for variations where probing was in random order. This suggests that working memory capacity may depend on the type of search process engaged, and that certain working-memory-related cognitive processes are more amenable to practice than others. Copyright © 2014 Elsevier B.V. All rights reserved.

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