A framework for characterizing drug information sources.

PubMed

Sharp, Mark; Bodenreider, Olivier; Wacholder, Nina

2008-11-06

Drug information is complex, voluminous, heterogeneous, and dynamic. Multiple sources are available, each providing some elements of information about drugs (usually for a given purpose), but there exists no integrated view or directory that could be used to locate sources appropriate to a given purpose. We examined 23 sources that provide drug information in the pharmacy, chemistry, biology, and clinical medicine domains. Their drug information content could be categorized with 39 dimensions. We propose this list of dimensions as a framework for characterizing drug information sources. As an evaluation, we show that this framework is useful for comparing drug information sources and selecting sources most relevant to a given use case.

21 CFR 20.117 - New drug information.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false New drug information. 20.117 Section 20.117 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.117 New drug information. (a) The following...

21 CFR 20.117 - New drug information.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false New drug information. 20.117 Section 20.117 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.117 New drug information. (a) The following...

21 CFR 20.117 - New drug information.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false New drug information. 20.117 Section 20.117 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.117 New drug information. (a) The following...

21 CFR 20.117 - New drug information.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false New drug information. 20.117 Section 20.117 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.117 New drug information. (a) The following...

Consumers' preferences for the communication of risk information in drug advertising.

PubMed

Davis, Joel J

2007-01-01

Research was conducted to identify consumers' preferences regarding the form, content, and placement of drug side-effect information in direct-to-consumer (DTC) advertising. Specific questions explored preferences for the presence or absence of numeric information, the use of placebo and discontinuation groups as a context for understanding drug risk, the sequence in which side effects are presented, and the placement of side-effect statements on DTC Web sites. Consumers prefer detailed, readily accessible risk information--preferences that are a major departure from current advertiser practices and from what current and proposed Food and Drug Administration (FDA) regulations require.

National Clearinghouse for Drug Abuse Information Report Series, Series 16, No. 1.

ERIC Educational Resources Information Center

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

Concerned with clarifying some of the more complex issues in drug abuse, the National Clearinghouse for Drug Abuse Information has prepared this special report on psilocybin. Background information is provided through a summary of its history, legal status, and the opinions of authorities in the field. Significant research on the subject is…

National Clearinghouse for Drug Abuse Information Report Series, Series 18, No. 1.

ERIC Educational Resources Information Center

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

Concerned with clarifying some of the more complex issues in drug abuse, the National Clearinghouse for Drug Abuse Information has prepared this special report on methaqualone. Background information is provided through a summary of its history, legal status, and the opinions of authorities in the field. Significant research on the subject is…

Accuracy and completeness of drug information in Wikipedia medication monographs.

PubMed

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

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

Adverse drug events and the Freedom of Information Act: an apple in Eden.

PubMed

Stang, P E; Fox, J L

1992-02-01

To review some of the abuses and proper uses of the Food and Drug Administration's (FDA's) spontaneous adverse-reaction reporting system, as a way of educating the reader to its strengths and limitations. Published literature and reports based on information obtained from the FDA's database of spontaneous adverse drug-event reports. The Freedom of Information Act has increased public access to the FDA's database of spontaneous adverse drug reaction reports. As these reports are voluntarily received and reported to the FDA, their use for comparisons of drug safety is severely limited. Despite these limitations and the FDA's caveats for use of these data, consumer advocacy groups, researchers, and various pharmaceutical marketing groups have used this source to project the incidence of adverse drug reactions. The FDA's spontaneous adverse-event reporting system is designed to generate signals of unexpected adverse drug events. Use of the data gathered by this system to make drug safety comparisons is beyond their credible scope because many factors influence the reporting of adverse events. Researchers and peer reviewers should place these data in the proper perspective and support sound research into questions of drug safety.

21 CFR 50.24 - Exception from informed consent requirements for emergency research.

Code of Federal Regulations, 2010 CFR

2010-04-01

... emergency research. 50.24 Section 50.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Informed Consent of Human Subjects § 50.24 Exception from informed consent requirements for emergency research. (a) The IRB responsible for the review...

Drug Abuse Information, Teacher Resource Material.

ERIC Educational Resources Information Center

Bowen, Haskell, Comp.

This informational publication is to be used as an aid for teachers, bringing them basic facts regarding drugs and drug abuse. Its purpose is to (1) give additional teacher background information and (2) enrich any course of study that has been developed on drug abuse. To use the material most effectively, it is suggested the teacher have an…

Mental models in risk assessment: informing people about drugs.

PubMed

Jungermann, H; Schütz, H; Thüring, M

1988-03-01

One way to communicate about the risks of drugs is through the use of package inserts. The problems associated with this medium of informing patients have been investigated by several researchers who found that people require information about drugs they are using, including extensive risk information, and that they are willing to take this information into account in their usage of drugs. But empirical results also show that people easily misinterpret the information given. A conceptual framework is proposed that might be used for better understanding the cognitive processes involved in such a type of risk assessment and communication. It is based on the idea that people develop, through experience, a mental model of how a drug works, which effects it might produce, that contraindications have to be considered, etc. This mental model is "run" when a specific package insert has been read and a specific question arises such as, for example, whether certain symptoms can be explained as normal or whether they require special attention and action. We argue that the mental model approach offers a useful perspective for examining how people understand package inserts, and consequently for improving their content and design. The approach promises to be equally useful for other aspects of risk analysis that are dependent upon human judgment and decision making, e.g., threat diagnosis and human reliability analysis.

Drug Information Services Today: Current Role and Future Perspectives in Rational Drug Therapy.

PubMed

Amundstuen Reppe, Linda; Spigset, Olav; Schjøtt, Jan

2016-02-01

Polypharmacy and complex drug treatment regimens are becoming increasingly common, which may lead to adverse drug reactions, drug interactions, medication nonadherence, and increasing costs and thus challenge the rational use of drugs. At the same time, the accessibility of drug information increases, and health care professionals may have limited opportunities and capabilities to search and critically evaluate drug information. Clinicians have reported difficulties in searching the best evidence and translating study findings into clinically meaningful information applicable to specific patients. Consequently, it remains a challenge to ensure the rational use of drugs in the years to come. Drug information centers (DICs) have been established to promote the rational use of drugs. One of the most important tasks of DICs is the question and answer services for health care professionals posing drug-related questions. DICs staffed by pharmacists and clinical pharmacologists hold expertise in searching for drug information and critical evaluation of the literature. The uniqueness in this service lies not only in the identification and interpretation of the scientific literature but also in the adaptation of the findings into specific clinical situations and the discussion of possible solutions with the enquirer. Thus, DICs could provide valuable decision support to the clinic. Taking into account the increasing number of possible drug-related questions that will arise today and in the future, the DICs will remain highly relevant in the years to come. However, the DICs must follow the developments in health information technology to disseminate relevant, unbiased drug information to old and new users of the service. Moreover, the DICs are important tools to counterbalance the drug information published by the pharmaceutical industry. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

A compilation of research working groups on drug utilisation across Europe

PubMed Central

2014-01-01

Background The assessment of the benefit-risk of medicines needs careful consideration concerning their patterns of utilization. Systems for the monitoring of medicines consumption have been established in many European countries, and several international groups have identified and described them. No other compilation of European working groups has been published. As part of the PROTECT project, as a first step in searching for European data sources on the consumption of five selected groups of medicines, we aimed to identify and describe the main characteristics of the existing collaborative European working groups. Findings Google and bibliographic searches (PubMed) of articles containing information on databases and other sources of drug consumption data were conducted. For each working group the main characteristics were recorded. Nineteen selected groups were identified, focusing on: a) general drug utilisation (DU) research (EuroDURG, CNC, ISPE’S SIG-DUR, EURO-MED-STAT, PIPERSKA Group, NorPEN, ENCePP, DURQUIM), b) specific DU research: b.1) antimicrobial drugs (ARPAC, ESAC, ARPEC, ESGAP, HAPPY AUDIT), b.2) cardiovascular disease (ARITMO, EUROASPIRE), b.3) paediatrics (TEDDY), and b.4) mental health/central nervous system effects (ESEMeD, DRUID, TUPP/EUPoMMe). Information on their aims, methods and activities is presented. Conclusions We assembled and updated information on European working groups in DU research and in the utilisation of five selected groups of drugs for the PROTECT project. This information should be useful for academic researchers, regulatory and health authorities, and pharmaceutical companies conducting and interpreting post-authorisation and safety studies. European health authorities should encourage national research and collaborations in this important field for public health. PMID:24625054

Scope, completeness, and accuracy of drug information in Wikipedia.

PubMed

Clauson, Kevin A; Polen, Hyla H; Boulos, Maged N Kamel; Dzenowagis, Joan H

2008-12-01

With the advent of Web 2.0 technologies, user-edited online resources such as Wikipedia are increasingly tapped for information. However, there is little research on the quality of health information found in Wikipedia. To compare the scope, completeness, and accuracy of drug information in Wikipedia with that of a free, online, traditionally edited database (Medscape Drug Reference [MDR]). Wikipedia and MDR were assessed on 8 categories of drug information. Questions were constructed and answers were verified with authoritative resources. Wikipedia and MDR were evaluated according to scope (breadth of coverage) and completeness. Accuracy was tracked by factual errors and errors of omission. Descriptive statistics were used to summarize the components. Fisher's exact test was used to compare scope and paired Student's t-test was used to compare current results in Wikipedia with entries 90 days prior to the current access. Wikipedia was able to answer significantly fewer drug information questions (40.0%) compared with MDR (82.5%; p < 0.001). Wikipedia performed poorly regarding information on dosing, with a score of 0% versus the MDR score of 90.0%. Answers found in Wikipedia were 76.0% complete, while MDR provided answers that were 95.5% complete; overall, Wikipedia answers were less complete than those in Medscape (p < 0.001). No factual errors were found in Wikipedia, whereas 4 answers in Medscape conflicted with the answer key; errors of omission were higher in Wikipedia (n = 48) than in MDR (n = 14). There was a marked improvement in Wikipedia over time, as current entries were superior to those 90 days prior (p = 0.024). Wikipedia has a more narrow scope, is less complete, and has more errors of omission than the comparator database. Wikipedia may be a useful point of engagement for consumers, but is not authoritative and should only be a supplemental source of drug information.

The HIV and Drug Abuse Prevention Research Ethics Training Institute: Training Early-Career Scientists to Conduct Research on Research Ethics

PubMed Central

Fisher, Celia B.; Yuko, Elizabeth

2018-01-01

The responsible conduct of HIV/drug abuse prevention research requires investigators with both the knowledge of and ability to generate empirical data that can enhance global ethical practices and policies. This article describes a multidisciplinary program offering early-career professionals a 2-year intensive summer curriculum along with funding to conduct a mentored research study on a wide variety of HIV/drug abuse research ethics topics. Now in its fifth year, the program has admitted 29 trainees who have to date demonstrated increased knowledge of research ethics, produced 17 peer-reviewed publications, 46 professional presentations, and submitted or been awarded five related federal grants. The institute also hosts a global information platform providing general and HIV/drug abuse relevant research ethics educational and research resources that have had more than 38,800 unique visitors from more than 150 countries. PMID:26564944

Researcher liability for negligence in human subject research: informed consent and researcher malpractice actions.

PubMed

Jansson, Roger L

2003-02-01

Two sets of federal regulations, the "Common Rule" and Food and Drug Administration (FDA) regulations, govern human subject research that is either federally-funded or involves FDA regulated products. These regulations require, inter alia, that: (1) researchers obtain informed consent from human subjects, and (2) that an Institutional Review Board (IRB) independently review and approve the research protocol. Although the federal regulations do not provide an express cause of action against researchers, research subjects should be able to bring informed consent and malpractice actions against researchers by establishing a duty of care and standard of care. Researchers owe human subjects a duty of care analogous to the special relationship between physicians and patients. The federal regulations should provide the minimum standard of care for informed consent in human subject research, and complying with them should be a partial defense. In contrast, expert testimony should establish the standard of care for researcher malpractice, and IRB approval should be a partial defense.

Caveat emptor: Erroneous safety information about opioids in online drug-information compendia.

PubMed

Talwar, Sonia R; Randhawa, Amarita S; Dankiewicz, Erica H; Crudele, Nancy T; Haddox, J David

2016-01-01

Healthcare professionals and consumers refer to online drug-information compendia (eg, Epocrates and WebMD) to learn about prescription medications, including opioid analgesics. With the significant risks associated with opioids, including abuse, misuse, and addiction, any of which can result in life-threatening overdose, it is important for those seeking information from online compendia to have access to current, accurate, and complete drug information to help support clinical treatment decisions. Although compendia are informative, readily available, and user friendly, studies have shown that they may contain errors. To review and identify misinformation in drug summaries of online drug-information compendia for selected opioid analgesic products and submit content corrections to the respective editors. Between 2011 and 2013, drug summaries for Purdue's prescription opioid analgesic products from seven leading online drug-information compendia were systematically reviewed, and the requests for corrections were retrospectively categorized and classified. At least 2 months following requests, the same compendia were then reexamined to assess the degree of error resolution. A total of 859 errors were identified, with the greatest percentage in Safety and Patient Education categories. Across the seven compendia, the complete or partial resolution of errors was 34 percent; therefore, nearly two thirds of the identified errors remain. The results of this analysis, consistent with past studies, demonstrate that online drug-information compendia may contain inaccurate information. Healthcare professionals and consumers must be informed of potential misinformation so they may consider using multiple resources to obtain accurate and current drug information, thereby helping to ensure safer use of prescription medications, such as opioids.

Tobacco regulatory science: research to inform regulatory action at the Food and Drug Administration's Center for Tobacco Products.

PubMed

Ashley, David L; Backinger, Cathy L; van Bemmel, Dana M; Neveleff, Deborah J

2014-08-01

The U.S. Food and Drug Administration (FDA) promotes the development of regulatory science to ensure that a strong evidence base informs all of its regulatory activities related to the manufacture, marketing, and distribution of tobacco products as well as public education about tobacco product constituents and effects. Toward that end, the FDA's Center for Tobacco Products (CTP) provides funding for research studies with scientific aims that fall within its defined regulatory authority. However, given their traditional biomedical focus on basic and applied research, some researchers may not understand the principles of regulatory science or the types of studies CTP funds. The purpose of this paper is (1) to clarify the definition of regulatory science as a distinct scientific discipline, (2) to explore the role of tobacco regulatory science in order to help researchers understand the parameters and types of research that can be funded by CTP, and (3) to describe the types of research efforts that will inform the FDA's public health framework for tobacco product regulation. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco 2014. This work is written by (a) US Government employee(s) and is in the public domain in the US.

Multi-target drugs: the trend of drug research and development.

PubMed

Lu, Jin-Jian; Pan, Wei; Hu, Yuan-Jia; Wang, Yi-Tao

2012-01-01

Summarizing the status of drugs in the market and examining the trend of drug research and development is important in drug discovery. In this study, we compared the drug targets and the market sales of the new molecular entities approved by the U.S. Food and Drug Administration from January 2000 to December 2009. Two networks, namely, the target-target and drug-drug networks, have been set up using the network analysis tools. The multi-target drugs have much more potential, as shown by the network visualization and the market trends. We discussed the possible reasons and proposed the rational strategies for drug research and development in the future.

The role of insurance claims databases in drug therapy outcomes research.

PubMed

Lewis, N J; Patwell, J T; Briesacher, B A

1993-11-01

The use of insurance claims databases in drug therapy outcomes research holds great promise as a cost-effective alternative to post-marketing clinical trials. Claims databases uniquely capture information about episodes of care across healthcare services and settings. They also facilitate the examination of drug therapy effects on cohorts of patients and specific patient subpopulations. However, there are limitations to the use of insurance claims databases including incomplete diagnostic and provider identification data. The characteristics of the population included in the insurance plan, the plan benefit design, and the variables of the database itself can influence the research results. Given the current concerns regarding the completeness of insurance claims databases, and the validity of their data, outcomes research usually requires original data to validate claims data or to obtain additional information. Improvements to claims databases such as standardisation of claims information reporting, addition of pertinent clinical and economic variables, and inclusion of information relative to patient severity of illness, quality of life, and satisfaction with provided care will enhance the benefit of such databases for outcomes research.

Hallucinogens and Dissociative Drugs, Including LSD, PCP, Ketamine, Dextromethorphan. National Institute on Drug Abuse Research Report Series.

ERIC Educational Resources Information Center

National Inst. on Drug Abuse (DHHS/PHS), Rockville, MD.

Research is developing a clearer picture of the dangers of mind-altering drugs. The goal of this report is to present the latest information to providers to help them strengthen their prevention and treatment efforts. A description is presented of dissociative drugs, and consideration is given as to why people take hallucinogens. The physical…

Automatic indexing in a drug information portal.

PubMed

Sakji, Saoussen; Letord, Catherine; Dahamna, Badisse; Kergourlay, Ivan; Pereira, Suzanne; Joubert, Michel; Darmoni, Stéfan

2009-01-01

The objective of this work is to create a bilingual (French/English) Drug Information Portal (DIP), in a multi-terminological context and to emphasize its exploitation by an ATC automatic indexing allowing having more pertinent information about substances, organs or systems on which drugs act and their therapeutic and chemical characteristics. The development of the DIP was based on the CISMeF portal, which catalogues and indexes the most important and quality-controlled sources of institutional health information in French. DIP has created specific functionalities and uses specific drugs terminologies such as the ATC classification which used to automatic index the DIP resources. DIP is the result of collaboration between the CISMeF team and the VIDAL Company, specialized in drug information. DIP is conceived to facilitate the user information retrieval. The ATC automatic indexing provided relevant results in 76% of cases. Using multi-terminological context and in the framework of the drug field, indexing drugs with the appropriate codes or/and terms revealed to be very important to have the appropriate information storage and retrieval. The main challenge in the coming year is to increase the accuracy of the approach.

21 CFR 20.117 - New drug information.

Code of Federal Regulations, 2011 CFR

2011-04-01

... covered by such applications. (b) Other computer printouts containing IND and NDA information are... computer printouts are available for public inspection in the Food and Drug Administration's Freedom of Information Public Room: (1) A numerical listing of all new drug applications and abbreviated new drug...

The Hospital-Based Drug Information Center.

ERIC Educational Resources Information Center

Hopkins, Leigh

1982-01-01

Discusses the rise of drug information centers in hospitals and medical centers, highlighting staffing, functions, typical categories of questions received by centers, and sources used. An appendix of drug information sources included in texts, updated services, journals, and computer databases is provided. Thirteen references are listed. (EJS)

The HIV and Drug Abuse Prevention Research Ethics Training Institute: Training Early-Career Scientists to Conduct Research on Research Ethics.

PubMed

Fisher, Celia B; Yuko, Elizabeth

2015-12-01

The responsible conduct of HIV/drug abuse prevention research requires investigators with both the knowledge of and ability to generate empirical data that can enhance global ethical practices and policies. This article describes a multidisciplinary program offering early-career professionals a 2-year intensive summer curriculum along with funding to conduct a mentored research study on a wide variety of HIV/drug abuse research ethics topics. Now in its fifth year, the program has admitted 29 trainees who have to date demonstrated increased knowledge of research ethics, produced 17 peer-reviewed publications, 46 professional presentations, and submitted or been awarded five related federal grants. The institute also hosts a global information platform providing general and HIV/drug abuse relevant research ethics educational and research resources that have had more than 38,800 unique visitors from more than 150 countries. © The Author(s) 2015.

[Activity of NTDs Drug-discovery Research Consortium].

PubMed

Namatame, Ichiji

2016-01-01

Neglected tropical diseases (NTDs) are an extremely important issue facing global health care. To improve "access to health" where people are unable to access adequate medical care due to poverty and weak healthcare systems, we have established two consortiums: the NTD drug discovery research consortium, and the pediatric praziquantel consortium. The NTD drug discovery research consortium, which involves six institutions from industry, government, and academia, as well as an international non-profit organization, is committed to developing anti-protozoan active compounds for three NTDs (Leishmaniasis, Chagas disease, and African sleeping sickness). Each participating institute will contribute their efforts to accomplish the following: selection of drug targets based on information technology, and drug discovery by three different approaches (in silico drug discovery, "fragment evolution" which is a unique drug designing method of Astellas Pharma, and phenotypic screening with Astellas' compound library). The consortium has established a brand new database (Integrated Neglected Tropical Disease Database; iNTRODB), and has selected target proteins for the in silico and fragment evolution drug discovery approaches. Thus far, we have identified a number of promising compounds that inhibit the target protein, and we are currently trying to improve the anti-protozoan activity of these compounds. The pediatric praziquantel consortium was founded in July 2012 to develop and register a new praziquantel pediatric formulation for the treatment of schistosomiasis. Astellas Pharma has been a core member in this consortium since its establishment, and has provided expertise and technology in the area of pediatric formulation development and clinical development.

21 CFR 201.129 - Drugs; exemption for radioactive drugs for research use.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drugs; exemption for radioactive drugs for research use. 201.129 Section 201.129 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... Drugs; exemption for radioactive drugs for research use. A radioactive drug intended for administration...

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

PubMed

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

2017-12-01

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

Pharmacogenomic biomarker information in drug labels approved by the United States food and drug administration: prevalence of related drug use.

PubMed

Frueh, Felix W; Amur, Shashi; Mummaneni, Padmaja; Epstein, Robert S; Aubert, Ronald E; DeLuca, Teresa M; Verbrugge, Robert R; Burckart, Gilbert J; Lesko, Lawrence J

2008-08-01

To review the labels of United States Food and Drug Administration (FDA)-approved drugs to identify those that contain pharmacogenomic biomarker information, and to collect prevalence information on the use of those drugs for which pharmacogenomic information is included in the drug labeling. Retrospective analysis. The Physicians' Desk Reference Web site, Drugs@FDA Web site, and manufacturers' Web sites were used to identify drug labels containing pharmacogenomic information, and the prescription claims database of a large pharmacy benefits manager (insuring > 55 million individuals in the United States) was used to obtain drug utilization data. Pharmacogenomic biomarkers were defined, FDA-approved drug labels containing this information were identified, and utilization of these drugs was determined. Of 1200 drug labels reviewed for the years 1945-2005, 121 drug labels contained pharmacogenomic information based on a key word search and follow-up screening. Of those, 69 labels referred to human genomic biomarkers, and 52 referred to microbial genomic biomarkers. Of the labels referring to human biomarkers, 43 (62%) pertained to polymorphisms in cytochrome P450 (CYP) enzyme metabolism, with CYP2D6 being most common. Of 36.1 million patients whose prescriptions were processed by a large pharmacy benefits manager in 2006, about 8.8 million (24.3%) received one or more drugs with human genomic biomarker information in the drug label. Nearly one fourth of all outpatients received one or more drugs that have pharmacogenomic information in the label for that drug. The incorporation and appropriate use of pharmacogenomic information in drug labels should be tested for its ability to improve drug use and safety in the United States.

Illicit drugs and the media: models of media effects for use in drug policy research.

PubMed

Lancaster, Kari; Hughes, Caitlin E; Spicer, Bridget; Matthew-Simmons, Francis; Dillon, Paul

2011-07-01

Illicit drugs are never far from the media gaze and although identified almost a decade ago as 'a new battleground' for the alcohol and other drug (AOD) field there has been limited research examining the role of the news media and its effects on audiences and policy. This paper draws together media theories from communication literature to examine media functions. We illustrate how each function is relevant for media and drugs research by drawing upon the existing literature examining Australian media coverage during the late 1990s of escalating heroin-related problems and proposed solutions. Media can influence audiences in four key ways: by setting the agenda and defining public interest; framing issues through selection and salience; indirectly shaping individual and community attitudes towards risk; and feeding into political debate and decision making. Each has relevance for the AOD field. For example, media coverage of the escalating heroin-related problems in Australia played a strong role in generating interest in heroin overdoses, framing public discourse in terms of a health and/or criminal issue and affecting political decisions. Implications AND CONCLUSION: Media coverage in relation to illicit drugs can have multifarious effects. Incorporating media communication theories into future research and actions is critical to facilitate understanding of the short- and long-term impacts of media coverage on illicit drugs and the avenues by which the AOD field can mitigate or inform future media debates on illicit drugs. © 2010 Australasian Professional Society on Alcohol and other Drugs.

Neonatal Safety Information Reported to the FDA During Drug Development Studies

PubMed Central

Avant, Debbie; Baer, Gerri; Moore, Jason; Zheng, Panli; Sorbello, Alfred; Ariagno, Ron; Yao, Lynne; Burckart, Gilbert J.; Wang, Jian

2017-01-01

Background Relatively few neonatal drug development studies have been conducted, but an increase is expected with the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA). Understanding the safety of drugs studied in neonates is complicated by the unique nature of the population and the level of illness. The objective of this study was to examine neonatal safety data submitted to the FDA in studies pursuant to the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) between 1998 and 2015. Methods FDA databases were searched for BPCA and/or PREA studies that enrolled neonates. Studies that enrolled a minimum of 3 neonates were analyzed for the presence and content of neonatal safety data. Results The analysis identified 40 drugs that were studied in 3 or more neonates. Of the 40 drugs, 36 drugs received a pediatric labeling change as a result of studies between 1998 and 2015, that included information from studies including neonates. Fourteen drugs were approved for use in neonates. Clinical trials for 20 of the drugs reported serious adverse events (SAEs) in neonates. The SAEs primarily involved cardiovascular events such as bradycardia and/or hypotension or laboratory abnormalities such as anemia, neutropenia, and electrolyte disturbances. Deaths were reported during studies of 9 drugs. Conclusions Our analysis revealed that SAEs were reported in studies involving 20 of the 40 drugs evaluated in neonates, with deaths identified in 9 of those studies. Patients enrolled in studies were often critically ill, which complicated determination of whether an adverse event was drug-related. We conclude that the traditional means for collecting safety information in drug development trials needs to be adjusted for neonates and will require the collaboration of regulators, industry, and the clinical and research communities to establish appropriate definitions and reporting strategies for the neonatal

Postmarket Drug Safety Information for Patients and Providers

MedlinePlus

... Information for Patients and Providers Postmarket Drug Safety Information for Patients and Providers Share Tweet Linkedin Pin ... communication to patients and healthcare providers. Latest Safety Information Index to Drug-Specific Information For patients, consumers, ...

[Current situation and development trend of Chinese medicine information research].

PubMed

Dong, Yan; Cui, Meng

2013-04-01

Literature resource service was the main service that Chinese medicine (CM) information offered. But in recent years users have started to request the health information knowledge service. The CM information researches and application service mainly included: (1) the need of strength studies on theory, application of technology, information retrieval, and information standard development; (2) Information studies need to support clinical decision making, new drug research; (3) Quick response based on the network monitoring and support to emergency countermeasures. CM information researches have the following treads: (1) developing the theory system structure of CM information; (2) studying the methodology system of CM information; (3) knowledge discovery and knowledge innovation.

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

PubMed

Kiyosawa, Naoki; Manabe, Sunao

2016-01-01

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

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

PubMed

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

2014-05-01

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

Setting priorities for a research agenda to combat drug-resistant tuberculosis in children.

PubMed

Velayutham, B; Nair, D; Ramalingam, S; Perez-Velez, C M; Becerra, M C; Swaminathan, S

2015-12-21

Numerous knowledge gaps hamper the prevention and treatment of childhood drug-resistant tuberculosis (TB). Identifying research priorities is vital to inform and develop strategies to address this neglected problem. To systematically identify and rank research priorities in childhood drug-resistant TB. Adapting the Child Health and Nutrition Research Initiative (CHNRI) methodology, we compiled 53 research questions in four research areas, then classified the questions into three research types. We invited experts in childhood drug-resistant TB to score these questions through an online survey. A total of 81 respondents participated in the survey. The top-ranked research question was to identify the best combination of existing diagnostic tools for early diagnosis. Highly ranked treatment-related questions centred on the reasons for and interventions to improve treatment outcomes, adverse effects of drugs and optimal treatment duration. The prevalence of drug-resistant TB was the highest-ranked question in the epidemiology area. The development type questions that ranked highest focused on interventions for optimal diagnosis, treatment and modalities for treatment delivery. This is the first effort to identify and rank research priorities for childhood drug-resistant TB. The result is a resource to guide research to improve prevention and treatment of drug-resistant TB in children.

Drug Information Education in Doctor of Pharmacy Programs

PubMed Central

Wang, Fei; Troutman, William G.; Seo, Teresa; Peak, Amy; Rosenberg, Jack M.

2006-01-01

Objective To characterize pharmacy program standards and trends in drug information education. Methods A questionnaire containing 34 questions addressing general demographic characteristics, organization, and content of drug information education was distributed to 86 colleges and schools of pharmacy in the United States using a Web-based survey system. Results Sixty colleges responded (73% response rate). All colleges offered a campus-based 6-year first-professional degree PharmD program. Didactic drug information was a required course in over 70% of these schools. Only 51 of the 60 colleges offered an advanced pharmacy practice experience (APPE) in drug information, and 62% of these did so only on an elective basis. Conclusion Although almost all of the PharmD programs in the US include a required course in drug information, the majority do not have a required APPE in this important area. PMID:17136172

United States National Library of Medicine Drug Information Portal.

PubMed

Hochstein, Colette; Goshorn, Jeanne; Chang, Florence

2009-01-01

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

Addiction research centres and the nurturing of creativity. Monitoring the European drug situation: the ongoing challenge for the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA).

PubMed

Griffiths, Paul; Mounteney, Jane; Lopez, Dominique; Zobel, Frank; Götz, Wolfgang

2012-02-01

The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) is the designated hub for drug-related information in the European Union. The organization's role is to provide the European Union (EU) and its Member States with a factual overview of European drug problems and a common information framework to support the drugs debate. In order to achieve its mission, the EMCDDA coordinates and relies on a network of 30 national monitoring centres, the Reitox National Focal Points. The Centre publishes on a wide range of drug-related topics, across epidemiology, interventions, laws and policies. Every November, the EMCDDA publishes its Annual Report, providing a yearly update on the European drug situation, translated into 23 EU languages. In line with its founding regulation, the EMCDDA has a role acting as an interface between the worlds of science and policy. While not a research centre in the formal sense, the results the Centre generates serve as catalysts for new research questions and help to identify priorities. Current challenges facing the agency include continuing to increase scientific standards while maintaining a strong institutional role, as well as supporting European efforts to identify, share and codify best practice in the drugs field. © 2011 EMCDDA.

Drug-Induced Nephrotoxicity and Dose Adjustment Recommendations: Agreement Among Four Drug Information Sources.

PubMed

Bicalho, Millena Drumond; Soares, Danielly Botelho; Botoni, Fernando Antonio; Reis, Adriano Max Moreira; Martins, Maria Auxiliadora Parreiras

2015-09-09

: Hospitalized patients require the use of a variety of drugs, many of which individually or in combination have the potential to cause kidney damage. The use of potentially nephrotoxic drugs is often unavoidable, and the need for dose adjustment should be evaluated. This study is aimed at assessing concordance in information on drug-induced nephrotoxicity and dose adjustment recommendations by comparing four drug information sources (DRUGDEX(®), UpToDate(®), Medscape(®) and the Brazilian Therapeutic Formulary) using the formulary of a Brazilian public hospital. A total of 218 drugs were investigated. The global Fleiss' kappa coefficient was 0.265 for nephrotoxicity (p < 0.001; CI 95%, 0.211-0.319) and 0.346 for recommendations (p < 0.001; CI 95%, 0.292-0.401), indicating fair concordance among the sources. Anti-infectives and anti-hypertensives were the main drugs cited as nephrotoxic by the different sources. There were no clear definitions for qualitative data or quantitative values for dose adjustments among the four information sources. There was no advice for dosing for a large number of the drugs in the international databases. The National Therapeutic Formulary offered imprecise dose adjustment recommendations for many nephrotoxic drugs. Discrepancies among information sources may have a clinical impact on patient care and contribute to drug-related morbidity and mortality.

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

PubMed

Davis, Lindsay E

2014-12-15

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

Health economics in drug development: efficient research to inform healthcare funding decisions.

PubMed

Hall, Peter S; McCabe, Christopher; Brown, Julia M; Cameron, David A

2010-10-01

In order to decide whether a new treatment should be used in patients, a robust estimate of efficacy and toxicity is no longer sufficient. As a result of increasing healthcare costs across the globe healthcare payers and providers now seek estimates of cost-effectiveness as well. Most trials currently being designed still only consider the need for prospective efficacy and toxicity data during the development life-cycle of a new intervention. Hence the cost-effectiveness estimates are inevitably less precise than the clinical data on which they are based. Methods based on decision theory are being developed by health economists that can contribute to the design of clinical trials in such a way that they can more effectively lead to better informed drug funding decisions on the basis of cost-effectiveness in addition to clinical outcomes. There is an opportunity to apply these techniques prospectively in the design of future clinical trials. This article describes the problems encountered by those responsible for drug reimbursement decisions as a consequence of the current drug development pathway. The potential for decision theoretic methods to help overcome these problems is introduced and potential obstacles in implementation are highlighted. Copyright © 2010 Elsevier Ltd. All rights reserved.

Drug Information Residency Rotation with Pharmaceutical Industry.

ERIC Educational Resources Information Center

Cramer, Richard L.

1986-01-01

Program objectives of a drug information rotation at the Upjohn Company include improving communication between the pharmaceutical industry and hospital pharmacy/academia, exposing the resident to the challenges the industry encounters, improving proficiency in drug information practice, and providing insight into the working relationships of…

NeuroAIDS, drug abuse, and inflammation: building collaborative research activities.

PubMed

Berman, Joan W; Carson, Monica J; Chang, Linda; Cox, Brian M; Fox, Howard S; Gonzalez, R Gilberto; Hanson, Glen R; Hauser, Kurt F; Ho, Wen-Zhe; Hong, Jau-Shyong; Major, Eugene O; Maragos, William F; Masliah, Eliezer; McArthur, Justin C; Miller, Diane B; Nath, Avindra; O'Callaghan, James P; Persidsky, Yuri; Power, Christopher; Rogers, Thomas J; Royal, Walter

2006-12-01

Neurological complications of human immunodeficiency virus (HIV) infection are a public health problem despite the availability of active antiretroviral therapies. The neuropathogenesis of HIV infection revolves around a complex cascade of events that include viral infection and glial immune activation, monocyte-macrophage brain infiltration, and secretion of a host of viral and cellular inflammatory and neurotoxic molecules. Although there is evidence that HIV-infected drug abusers experience more severe neurological disease, the biological basis for this finding is unknown. A scientific workshop organized by the National Institute on Drug Abuse (NIDA) was held on March 23-24, 2006 to address this question. The goal of the meeting was to bring together basic science and clinical researchers who are experts in NeuroAIDS, glial immunity, drugs of abuse, and/or pharmacology in order to find new approaches to understanding interactions between drug abuse and neuroAIDS. The format of the meeting was designed to stimulate open discussion and forge new multidisciplinary research collaborations. This report includes transcripts of active discussions and short presentations from invited participants. The presentations were separated into sections that included: Glial Biology, Inflammation, and HIV; Pharmacology, Neurotoxicology, and Neuroprotection; NeuroAIDS and Virology; and Virus-Drug and Immune-Drug Interactions. Research priorities were identified. Additional information about this meeting is available through links from the NIDA AIDS Research Program website ( http://www.nida.nih.gov/about/organization/arp/arp-websites.htm ).

21 CFR 20.116 - Drug and device listing information.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Drug and device listing information. 20.116 Section 20.116 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC INFORMATION Availability of Specific Categories of Records § 20.116 Drug and device listing...

Evaluation of drug information for cardiology patients.

PubMed Central

Baker, D; Roberts, D E; Newcombe, R G; Fox, K A

1991-01-01

1. Cardiologists and pharmacists at the University Hospital of Wales collaborated to write 20 individual leaflets incorporating guidelines for a range of drugs used in the treatment of cardiology patients. The Plain English Campaign advised on the intelligibility and presentation of the information. 2. One hundred and twenty-five patients from the Regional Cardiology Unit, University Hospital of Wales were randomly allocated to receive usual verbal counselling about their drug treatment with or without an individualised drug information wallet. Two weeks after discharge from hospital patients completed a postal questionnaire to determine their satisfaction with the information about their drug treatment and their understanding of it. Forty-nine questionnaires were returned from the leaflet group and 52 from the control group. 3. The provision of written guidelines resulted in significant improvements in patients' satisfaction with their drug treatment (chi 2 = 33.3, P less than 0.001) and their understanding of it (P less than 0.001, Mann-Whitney test). Overall, patients who received leaflets were more likely to be aware of the potential side effects of their drugs but less likely to be apprehensive about them. Succinct guidelines concerning drug therapy can be assimilated by cardiology patients and provide them with a permanent record for future reference. PMID:1888619

21 CFR 207.31 - Additional drug listing information.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Additional drug listing information. 207.31 Section 207.31 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION...

21 CFR 207.30 - Updating drug listing information.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Updating drug listing information. 207.30 Section 207.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION...

21 CFR 207.30 - Updating drug listing information.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Updating drug listing information. 207.30 Section 207.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION...

21 CFR 207.30 - Updating drug listing information.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Updating drug listing information. 207.30 Section 207.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION...

21 CFR 207.31 - Additional drug listing information.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Additional drug listing information. 207.31 Section 207.31 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION...

21 CFR 207.31 - Additional drug listing information.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Additional drug listing information. 207.31 Section 207.31 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION...

21 CFR 207.31 - Additional drug listing information.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Additional drug listing information. 207.31 Section 207.31 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION...

21 CFR 207.30 - Updating drug listing information.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Updating drug listing information. 207.30 Section 207.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION...

Information contents of drug advertisements: an Indian experience.

PubMed

Lal, A

1998-11-01

To critically analyze the drug information contained in Indian pharmaceutical advertisements. Analysis of pharmaceutical advertisements supplied by drug representatives (DRs) to prescribers from July 1, 1995, to June 30, 1996. A university-affiliated urban teaching hospital in India. 585 pharmaceutical ad pamphlets. The ads supplied by DRs to physicians in different clinical departments of the hospital were collected. These were distributed to different systems/categories and a special reference to fixed-dose drug combinations was given. The drug information contained in these ads was evaluated by using a checklist, framed by incorporating the World Health Organization ethical guidelines for medicinal drug promotion and some relevant items from other studies. The most frequently occurring ads were for antimicrobial agents. The ads on fixed-dose drug combinations constituted 37.9% of the total. More than 85% of the ads mentioned the generic name, brand name, contents, and pharmaceutical dosage forms, as well as the name and address of the company. The information concerning adverse effects, precautions, contraindications, warnings, major interactions, ingredients known to cause problems, pharmacology, drug overdose, references, drug storage, and cost was present in less than 40% of these ads. There has been inadequate information in pharmaceutical ads supplied by DRs to the physicians in India. The current scenario could be improved by formulating some definite legislative guidelines for the minimum level of information to be included in pharmaceutical ads and adhering to that legislation.

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

ERIC Educational Resources Information Center

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

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

Availability of drug information on community pharmacy websites in Tennessee.

PubMed

Borja-Hart, Nancy; Hohmeier, Kenneth C

2017-06-01

This study reports the availability and type of drug information resources on community pharmacy websites in Tennessee. A list of pharmacies was obtained from the Tennessee Board of Pharmacy. All community pharmacies located in Tennessee with a website were evaluated. Community pharmacy websites that listed a drug information resource were further analysed into pharmacy type and drug information provider. One hundred and sixty-nine websites were evaluated. Thirty-six websites listed a drug information resource. Fifty per cent of those sites used the drug information provider RxWiki. Other providers included drugs.com, First Data Bank, A.D.A.M., RxList, Gold Standard Multimedia and Express Scripts. Community pharmacy websites are underutilized as a provider for credible drug information for the public. © 2017 Royal Pharmaceutical Society.

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

PubMed

Lee, Annisa Lai

2009-06-01

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

[6-year experience with a drug information service for patients].

PubMed

Huber, Martin; Kullak-Ublick, Gerd A; Kirch, Wilhelm

2009-03-15

Many patients are inadequately informed about their drug therapy. There is thus a need for providing additional drug information to patients. The authors here report on a 6-year experience with a drug information service for patients. The information service was available by telephone, e-mail or regular mail and was addressed initially to patients in Saxony and since 2005 to patients throughout Germany. Demographic and drug therapy data of the patients were registered and analyzed using a relational database. All enquiries to the information service between August 2001 and January 2007 were evaluated. 5,587 enquiries were registered. 61.4% of the persons calling were female and 33.8% male (sex was unknown in 4.8% by anonymous calls). The most frequent reasons for an enquiry were a general need for information about drugs and therapy (27.5%) and adverse drug reactions (24.7%). The drug group most frequently enquired about were cardiovascular drugs, accounting for 34.4%, followed by neuropsychiatric drugs (15.1%). The results of this analysis show an evident need for a drug information service for patients. This need is possibly caused by the shortage of time that physicians can devote to patients. An independent and competent drug information service may improve the quality of medical care and the satisfaction of the patients involved.

An evaluation of the completeness of drug-drug interaction-related information in package inserts.

PubMed

Ng, Giok Qin; Sklar, Grant Edward; Chng, Hui Ting

2017-02-01

The project aimed to evaluate the completeness of drug-drug interaction (DDI)-related information in package inserts (PIs) and develop a systematic approach to conduct the evaluation. DDI-related information in the branded PIs of statins, macrolides, protease inhibitors and selected drugs of narrow therapeutic index (DNTI) were evaluated against the criteria distilled from the Food and Drug Administration (FDA) labelling recommendation guidance document. Decision trees were crafted and employed in the evaluation process. Scores were computed to give each PI an overall completeness score and individual criterion completeness score. The Kruskal-Wallis test and Dunn's multiple comparison test were used to assess the differences in the completeness scores. The mean overall completeness score of the 21 PIs was 35.7 ± 13.4 % (range 12.2-62 %). Eight out of the 11 individual evaluation criterion had a mean completeness score below 50 %. A subclass analysis conducted revealed that PIs from the different drug classes differed in the type of DDI-related information, such that they are more complete or less complete. The completeness score of DDI-related information in the PIs varied extensively amongst and within drug classes. A consensus between the authorities and drug companies on the type and quality of DDI-related information to be included could improve their completeness in PIs and make PIs a valuable source of DDI reference. Decision trees, albeit not validated yet, lay the groundwork for a valuable tool to evaluate DDI-related or other drug information.

Informed consent needed for sterilization or research.

PubMed

Barnett, B

1998-01-01

Informed choice involves enabling family planning clients to base their decisions about contraceptive use upon adequate information. It is a process in which clients give their permission to undergo a procedure, take a medication, or participate in a study after being fully informed. Informed consent protects an individual's freedom of choice, respects his or her autonomy, is important in both family planning programs and reproductive health research, and should always be available to clients seeking health services. Although written informed consent is not needed for most reproductive health services, it should be obtained from men and women who undergo sterilization, since that involves surgery and is considered permanent. In addition, people who volunteer to participate in contraceptive studies need to be fully informed of the risks and benefits of any new drugs or devices they receive. Volunteers should understand the potential effects of methods upon their physical health and other aspects of their lives. Ethical reviews need to be conducted before research begins.

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

PubMed

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

Guidelines for research on drugged driving

PubMed Central

Walsh, J. Michael; Verstraete, Alain G.; Huestis, Marilyn A.; Mørland, Jørg

2009-01-01

Aim A major problem in assessing the true public health impact of drug-use on driving and overall traffic safety is that the variables being measured across studies vary significantly. In studies reported in a growing global literature, basic parameters assessed, analytical techniques and drugs tested are simply not comparable due to lack of standardization in the field. These shortcomings severely limit the value of this research to add knowledge to the field. A set of standards to harmonize research findings is sorely needed. This project was initiated by several international organizations to develop guidelines for research on drugged driving. Methods A September 2006 meeting of international experts discussed the harmonization of protocols for future research on drugged driving. The principal objective of the meeting was to develop a consensus report setting guidelines, standards, core data variables and other controls that would form the basis for future international research. A modified Delphi method was utilized to develop draft guidelines. Subsequently, these draft guidelines were posted on the internet for global review, and comments received were integrated into the final document. Results The Guidelines Document is divided into three major sections, each focusing upon different aspects of drugged driving research (e.g. roadside surveys, prevalence studies, hospital studies, fatality and crash investigations, etc.) within the critical issue areas of ‘behavior’, ‘epidemiology’ and ‘toxicology’. The behavioral section contains 32 specific recommendations; (2) epidemiology 40 recommendations; and (3) toxicology 64 recommendations. Conclusions It is anticipated that these guidelines will improve significantly the overall quality of drugged driving research and facilitate future cross-study comparisons nationally and globally. PMID:18855814

The Drug Facts Box: Improving the communication of prescription drug information.

PubMed

Schwartz, Lisa M; Woloshin, Steven

2013-08-20

Communication about prescription drugs ought to be a paragon of public science communication. Unfortunately, it is not. Consumers see $4 billion of direct-to-consumer advertising annually, which typically fails to present data about how well drugs work. The professional label--the Food and Drug Administration's (FDA) mechanism to get physicians information needed for appropriate prescribing--may also fail to present benefit data. FDA labeling guidance, in fact, suggests that industry omit benefit data for new drugs in an existing class and for drugs approved on the basis of unfamiliar outcomes (such as depression rating scales). The medical literature is also problematic: there is selective reporting of favorable trials, favorable outcomes within trials, and "spinning" unfavorable results to maximize benefit and minimize harm. In contrast, publicly available FDA reviews always include the phase 3 trial data on benefit and harm, which are the basis of drug approval. However, these reviews are practically inaccessible: lengthy, poorly organized, and weakly summarized. To improve accessibility, we developed the Drug Facts Box: a one-page summary of benefit and harm data for each indication of a drug. A series of studies--including national randomized trials--demonstrates that most consumers understand the Drug Facts Box and that it improves decision-making. Despite calls from their own Risk Communication Advisory Committee and Congress (in the Affordable Care Act) to consider implementing boxes, the FDA announced it needs at least 3-5 y more to make a decision. Given its potential public health impact, physicians and the public should not have to wait that long for better drug information.

The regional drug information service: a factor in health care?

PubMed Central

Leach, F N

1978-01-01

Most regional health authorities throughout the United Kingdom have established drug information units to provide health service staff with a wide range of information about drugs and drug use. The units, which are staffed by drug information pharmacists, provide their service mainly by answering inquiries, although some disseminate information more positively through lectures and bulletins. An analysis of inquiries received by regional information units during 1976 showed that most were submitted by hospital doctors or pharmacists; comparatively few were received from general practitioners. Topics of inquiry included adverse effects of drugs, source of supply and identification, current treatment, dosage, route, precautions, and pharmaceutical problems such as stability or formulation of drug preparations. A more detailed analysis of the inquiries received by the North-western Regional Drug Information Service at Manchester over three years showed that the number of inquiries gradually increased and that more were received from general practitioners after a programme of lectures had been introduced to tell them about the service. The North-western service also received more requests from hospital pharmacists than other units, though many originated from clinicians. The regional drug information units consulted widely with clinical and other specialists in answering questions, but about a quarter of all inquiries were pharmaceutical, relating to stability and incompatibility. A multidisciplinary approach therefore seems necessary to provide a comprehensive and advisory drug information service. PMID:630339

Toward a complete dataset of drug-drug interaction information from publicly available sources.

PubMed

Ayvaz, Serkan; Horn, John; Hassanzadeh, Oktie; Zhu, Qian; Stan, Johann; Tatonetti, Nicholas P; Vilar, Santiago; Brochhausen, Mathias; Samwald, Matthias; Rastegar-Mojarad, Majid; Dumontier, Michel; Boyce, Richard D

2015-06-01

Although potential drug-drug interactions (PDDIs) are a significant source of preventable drug-related harm, there is currently no single complete source of PDDI information. In the current study, all publically available sources of PDDI information that could be identified using a comprehensive and broad search were combined into a single dataset. The combined dataset merged fourteen different sources including 5 clinically-oriented information sources, 4 Natural Language Processing (NLP) Corpora, and 5 Bioinformatics/Pharmacovigilance information sources. As a comprehensive PDDI source, the merged dataset might benefit the pharmacovigilance text mining community by making it possible to compare the representativeness of NLP corpora for PDDI text extraction tasks, and specifying elements that can be useful for future PDDI extraction purposes. An analysis of the overlap between and across the data sources showed that there was little overlap. Even comprehensive PDDI lists such as DrugBank, KEGG, and the NDF-RT had less than 50% overlap with each other. Moreover, all of the comprehensive lists had incomplete coverage of two data sources that focus on PDDIs of interest in most clinical settings. Based on this information, we think that systems that provide access to the comprehensive lists, such as APIs into RxNorm, should be careful to inform users that the lists may be incomplete with respect to PDDIs that drug experts suggest clinicians be aware of. In spite of the low degree of overlap, several dozen cases were identified where PDDI information provided in drug product labeling might be augmented by the merged dataset. Moreover, the combined dataset was also shown to improve the performance of an existing PDDI NLP pipeline and a recently published PDDI pharmacovigilance protocol. Future work will focus on improvement of the methods for mapping between PDDI information sources, identifying methods to improve the use of the merged dataset in PDDI NLP algorithms

RFDT: A Rotation Forest-based Predictor for Predicting Drug-Target Interactions Using Drug Structure and Protein Sequence Information.

PubMed

Wang, Lei; You, Zhu-Hong; Chen, Xing; Yan, Xin; Liu, Gang; Zhang, Wei

2018-01-01

Identification of interaction between drugs and target proteins plays an important role in discovering new drug candidates. However, through the experimental method to identify the drug-target interactions remain to be extremely time-consuming, expensive and challenging even nowadays. Therefore, it is urgent to develop new computational methods to predict potential drugtarget interactions (DTI). In this article, a novel computational model is developed for predicting potential drug-target interactions under the theory that each drug-target interaction pair can be represented by the structural properties from drugs and evolutionary information derived from proteins. Specifically, the protein sequences are encoded as Position-Specific Scoring Matrix (PSSM) descriptor which contains information of biological evolutionary and the drug molecules are encoded as fingerprint feature vector which represents the existence of certain functional groups or fragments. Four benchmark datasets involving enzymes, ion channels, GPCRs and nuclear receptors, are independently used for establishing predictive models with Rotation Forest (RF) model. The proposed method achieved the prediction accuracy of 91.3%, 89.1%, 84.1% and 71.1% for four datasets respectively. In order to make our method more persuasive, we compared our classifier with the state-of-theart Support Vector Machine (SVM) classifier. We also compared the proposed method with other excellent methods. Experimental results demonstrate that the proposed method is effective in the prediction of DTI, and can provide assistance for new drug research and development. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Malaysians' Preferences and Concerns Regarding Seeking Information About Illegal Drugs.

PubMed

Chie, Qiu Ting; Tam, Cai Lian; Bonn, Gregory

2018-01-01

A brief survey asked Malaysians if they had searched for information about illegal drugs and their thoughts about the information available. Two hundred and eighty participants from four states: Selangor, Penang, Malacca, and Johor filled out a paper-and-pencil survey including both multiple choice and open-ended written questions. Quantitative analyses of closed-ended, and thematic analyses of open-ended data indicated the following: Half of participants had, at some point, actively searched for information about drug use; 28% reported searching at least once per month. Participants generally (79%) preferred to obtain information online, but 62% also reported sharing and obtaining information about drugs in face-to-face interactions with friends and others. Concerns regarding the reliability of information, such as the presence of conflicting or contradictory messages from multiple sources, was a common theme in open ended responses. Of those who searched for information, about 70% reported desiring more detailed information about different drugs, in particular about their various side effects and risks. It is suggested that drug information campaigns, particularly those aimed at university students, might better focus on providing accurate, detailed information about the risks and other issues involved in various types of drug use, rather than one-size-fits-all messages. Given the varied and confusing nature of information already available, overly simplistic anti-drug messages may be ineffective, if not counterproductive.

Malaysians' Preferences and Concerns Regarding Seeking Information About Illegal Drugs

PubMed Central

Chie, Qiu Ting; Tam, Cai Lian; Bonn, Gregory

2018-01-01

A brief survey asked Malaysians if they had searched for information about illegal drugs and their thoughts about the information available. Two hundred and eighty participants from four states: Selangor, Penang, Malacca, and Johor filled out a paper-and-pencil survey including both multiple choice and open-ended written questions. Quantitative analyses of closed-ended, and thematic analyses of open-ended data indicated the following: Half of participants had, at some point, actively searched for information about drug use; 28% reported searching at least once per month. Participants generally (79%) preferred to obtain information online, but 62% also reported sharing and obtaining information about drugs in face-to-face interactions with friends and others. Concerns regarding the reliability of information, such as the presence of conflicting or contradictory messages from multiple sources, was a common theme in open ended responses. Of those who searched for information, about 70% reported desiring more detailed information about different drugs, in particular about their various side effects and risks. It is suggested that drug information campaigns, particularly those aimed at university students, might better focus on providing accurate, detailed information about the risks and other issues involved in various types of drug use, rather than one-size-fits-all messages. Given the varied and confusing nature of information already available, overly simplistic anti-drug messages may be ineffective, if not counterproductive. PMID:29868548

Student-peer mentoring on a drug information response.

PubMed

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

2014-03-12

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

The Drug Facts Box: Improving the communication of prescription drug information

PubMed Central

Schwartz, Lisa M.; Woloshin, Steven

2013-01-01

Communication about prescription drugs ought to be a paragon of public science communication. Unfortunately, it is not. Consumers see $4 billion of direct-to-consumer advertising annually, which typically fails to present data about how well drugs work. The professional label—the Food and Drug Administration's (FDA) mechanism to get physicians information needed for appropriate prescribing—may also fail to present benefit data. FDA labeling guidance, in fact, suggests that industry omit benefit data for new drugs in an existing class and for drugs approved on the basis of unfamiliar outcomes (such as depression rating scales). The medical literature is also problematic: there is selective reporting of favorable trials, favorable outcomes within trials, and “spinning” unfavorable results to maximize benefit and minimize harm. In contrast, publicly available FDA reviews always include the phase 3 trial data on benefit and harm, which are the basis of drug approval. However, these reviews are practically inaccessible: lengthy, poorly organized, and weakly summarized. To improve accessibility, we developed the Drug Facts Box: a one-page summary of benefit and harm data for each indication of a drug. A series of studies—including national randomized trials—demonstrates that most consumers understand the Drug Facts Box and that it improves decision-making. Despite calls from their own Risk Communication Advisory Committee and Congress (in the Affordable Care Act) to consider implementing boxes, the FDA announced it needs at least 3–5 y more to make a decision. Given its potential public health impact, physicians and the public should not have to wait that long for better drug information. PMID:23942130

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

PubMed

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

2018-06-01

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

Addiction research centres and the nurturing of creativity. The Centre for Alcohol and Drug Research: social science alcohol and drug research in Denmark.

PubMed

Pedersen, Mads U; Elmeland, Karen; Frank, Vibeke A

2011-12-01

The purpose of this paper is to introduce the social science alcohol and drug research undertaken by the Centre for Alcohol and Drug Research (CRF) and at the same time offer an insight into the development in Danish alcohol and drug research throughout the past 15-20 years. A review of articles, books and reports published by researcher from CRF from the mid-1990s until today and an analysis of the policy-making in the Danish substance use and misuse area. CRF is a result of the discussions surrounding social, health and allocation policy questions since the mid-1980s. Among other things, these discussions led to the formal establishment of the Centre in 1991 under the Aarhus University, the Faculty of Social Science. Since 2001 the Centre has received a permanent basic allocation, which has made it possible to appoint tenured senior researchers; to work under a more long-term research strategy; to function as a milieu for educating PhD students; and to diversify from commissioned research tasks to initiating projects involving more fundamental research. Research at the Centre is today pivoted around four core areas: consumption, policy, prevention and treatment. The emergence, continuation, financing and character of the research taking place at CRF can be linked closely to the specific Danish drug and alcohol discourse and to the division of the responsibility for alcohol and drug research into separate Ministries. © 2010 The Authors, Addiction © 2010 Society for the Study of Addiction.

Analysis of questions about use of drugs in breastfeeding to Norwegian drug information centres.

PubMed

Jahnsen, Jan Anker; Widnes, Sofia Frost; Schjøtt, Jan

2018-01-01

Health professionals may advise women to either stop breastfeeding or drug treatment due to restrictive advice in drug monographs. Regional medicines information and pharmacovigilance centres in Norway (RELIS) provide free and industry-independent answers to questions about drugs and breastfeeding documented in a full-text, searchable database (RELIS database). We used the RELIS database to describe which health care practitioners sought information about medication safety in lactation, most common drugs involved, advice provided and which resources were used to provide the advice. A random selection of 100 question-answer pairs (QAPs) from the RELIS database indexed with "BREASTFEEDING" in the period from January 2011 to December 2015 was analysed. Inclusion criteria were queries from health professionals about drugs. Questions about herbal supplements and other exposures not classified as drugs were excluded. The QAPs were manually analysed for compatibility of one or several drugs with breastfeeding, health care profession and workplace of enquirer in addition to advice and search strategy used. In the 100 QAPs there were enquires about 152 drugs. Seventy-four questions concerned a single drug, but the number of drugs evaluated varied between 1 and 16. Fifty-nine questions were from physicians, 34 from nurses or midwives, two from pharmacists and two from other health professionals. Questions from physicians contained 93 drug evaluations (61%), nurses or midwives 47 (31%) and pharmacists seven (5%). The most frequent categories of drugs were antidepressants, antiepileptics and immunosuppressants. The most asked about drugs were lamotrigine, codeine, quetiapine and escitalopram. Fifty-nine percent of the drugs were deemed safe while breastfeeding, 16% if precautions were taken and 12% not recommended. Thirty-nine percent of the drug evaluations used an advanced literature search strategy, and this was significantly ( p  < 0.05) more likely when the enquirer

How do researchers categorize drugs, and how do drug users categorize them?

PubMed Central

Lee, Juliet P.; Antin, Tamar M.J.

2011-01-01

This paper considers drug classifications and terms widely used in US survey research, and compares these to classifications and terms used by drug users. We begin with a critical review of drug classification systems, including those oriented to public policy and health services as well as survey research. We then consider the results of a pile sort exercise we conducted with 76 respondents within a mixed method study of Southeast Asian American adolescent and young adult drug users in urban Northern California, USA. We included the pile sort to clarify how respondents handled specific terms which we understood to be related to Ecstasy and methamphetamines. Results of the pile sort were analyzed using graphic layout algorithms as well as content analysis of pile labels. Similar to the national surveys, our respondents consistently differentiated Ecstasy terms from methamphetamine terms. We found high agreement between some specific local terms (thizz, crystal) and popular drug terms, while other terms thought to be mainstream (crank, speed) were reported as unknown by many respondents. In labeling piles, respondents created taxonomies based on consumption method (in particular, pill) as well as the social contexts of use. We conclude by proposing that divergences between drug terms utilized in survey research and those used by drug users may reflect two opposing tendencies: the tendency of survey researchers to utilize standardized language that constructs persons and experiences as relatively homogeneous, varying only within measurable degrees, and the tendency of drug users to utilize specialized language (argot) that reflects their understandings of their experiences as hybrid and diverse. The findings problematize the validity of drug terms and categories used in survey research. PMID:24431475

How do researchers categorize drugs, and how do drug users categorize them?

PubMed

Lee, Juliet P; Antin, Tamar M J

2012-01-01

This paper considers drug classifications and terms widely used in US survey research, and compares these to classifications and terms used by drug users. We begin with a critical review of drug classification systems, including those oriented to public policy and health services as well as survey research. We then consider the results of a pile sort exercise we conducted with 76 respondents within a mixed method study of Southeast Asian American adolescent and young adult drug users in urban Northern California, USA. We included the pile sort to clarify how respondents handled specific terms which we understood to be related to Ecstasy and methamphetamines. Results of the pile sort were analyzed using graphic layout algorithms as well as content analysis of pile labels. Similar to the national surveys, our respondents consistently differentiated Ecstasy terms from methamphetamine terms. We found high agreement between some specific local terms ( thizz , crystal ) and popular drug terms, while other terms thought to be mainstream ( crank , speed ) were reported as unknown by many respondents. In labeling piles, respondents created taxonomies based on consumption method (in particular, pill ) as well as the social contexts of use. We conclude by proposing that divergences between drug terms utilized in survey research and those used by drug users may reflect two opposing tendencies: the tendency of survey researchers to utilize standardized language that constructs persons and experiences as relatively homogeneous, varying only within measurable degrees, and the tendency of drug users to utilize specialized language (argot) that reflects their understandings of their experiences as hybrid and diverse. The findings problematize the validity of drug terms and categories used in survey research.

Current Research into Chemical and Textual Information Retrieval at the Department of Information Studies, University of Sheffield.

ERIC Educational Resources Information Center

Lynch, Michael F.; Willett, Peter

1987-01-01

Discusses research into chemical information and document retrieval systems at the University of Sheffield. Highlights include the use of cluster analysis methods for document retrieval and drug design, representation and searching of files of generic chemical structures, and the application of parallel computer hardware to information retrieval.…

Do drug advertisements provide therapeutic information?

PubMed Central

Stimson, G V

1977-01-01

In this study of advertisements appearing in medical periodicals and by direct mail advertising to general practitioners, Dr. Stimson, a sociologist, concludes that from what is intended to provide therapeutic information hardly any therapeutic information is provided. He reminds the reader of the safeguards which surround all drug advertising by law and by the code of practice of the Association of the British Pharmaceutical Industry but these safeguards do not appear to control real or potential sins of omission. Frequently in these advertisements the literature relating to the drug is quoted but Dr. Stimson found that it was difficult to trace all the papers quoted in different types of medical library. (Some references quoted were to unpublished papers but surely the blame should be shared in this situation?) Dr. Stimson also gives a vivid and fascinating glimpse of what he calls the 'images and stereotypes' of the patients who, it is claimed, would benefit from the drug being advertised. Certainly most general practitioners must be aware that when they prescribe that image is displaced by an individual but the portrait gallery is indeed depressing. However, to balance these advertisements drug companies issue data sheets which must be more informative than advertisements and conform to regulations in their format. Unfortunately data sheets are only issued every 15 months whereas the 'average general practitioner is potentially exposed to 1,300 advertisements every month'. In other words, the data sheet and not the advertisement should be the guideline but it arrives too infrequently to offset the lack of therapeutic information contained in advertisements. PMID:870694

Personal digital assistant-based drug information sources: potential to improve medication safety.

PubMed

Galt, Kimberly A; Rule, Ann M; Houghton, Bruce; Young, Daniel O; Remington, Gina

2005-04-01

This study compared the potential for personal digital assistant (PDA)-based drug information sources to minimize potential medication errors dependent on accurate and complete drug information at the point of care. A quality and safety framework for drug information resources was developed to evaluate 11 PDA-based drug information sources. Three drug information sources met the criteria of the framework: Eprocrates Rx Pro, Lexi-Drugs, and mobileMICROMEDEX. Medication error types related to drug information at the point of care were then determined. Forty-seven questions were developed to test the potential of the sources to prevent these error types. Pharmacists and physician experts from Creighton University created these questions based on the most common types of questions asked by primary care providers. Three physicians evaluated the drug information sources, rating the source for each question: 1=no information available, 2=some information available, or 3 = adequate amount of information available. The mean ratings for the drug information sources were: 2.0 (Eprocrates Rx Pro), 2.5 (Lexi-Drugs), and 2.03 (mobileMICROMEDEX). Lexi-Drugs was significantly better (mobileMICROMEDEX t test; P=0.05; Eprocrates Rx Pro t test; P=0.01). Lexi-Drugs was found to be the most specific and complete PDA resource available to optimize medication safety by reducing potential errors associated with drug information. No resource was sufficient to address the patient safety information needs for all cases.

Analyzing research trends on drug safety using topic modeling.

PubMed

Zou, Chen

2018-06-01

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

Microfluidic cell culture systems for drug research.

PubMed

Wu, Min-Hsien; Huang, Song-Bin; Lee, Gwo-Bin

2010-04-21

In pharmaceutical research, an adequate cell-based assay scheme to efficiently screen and to validate potential drug candidates in the initial stage of drug discovery is crucial. In order to better predict the clinical response to drug compounds, a cell culture model that is faithful to in vivo behavior is required. With the recent advances in microfluidic technology, the utilization of a microfluidic-based cell culture has several advantages, making it a promising alternative to the conventional cell culture methods. This review starts with a comprehensive discussion on the general process for drug discovery and development, the role of cell culture in drug research, and the characteristics of the cell culture formats commonly used in current microfluidic-based, cell-culture practices. Due to the significant differences in several physical phenomena between microscale and macroscale devices, microfluidic technology provides unique functionality, which is not previously possible by using traditional techniques. In a subsequent section, the niches for using microfluidic-based cell culture systems for drug research are discussed. Moreover, some critical issues such as cell immobilization, medium pumping or gradient generation in microfluidic-based, cell-culture systems are also reviewed. Finally, some practical applications of microfluidic-based, cell-culture systems in drug research particularly those pertaining to drug toxicity testing and those with a high-throughput capability are highlighted.

Open source drug discovery--a new paradigm of collaborative research in tuberculosis drug development.

PubMed

Bhardwaj, Anshu; Scaria, Vinod; Raghava, Gajendra Pal Singh; Lynn, Andrew Michael; Chandra, Nagasuma; Banerjee, Sulagna; Raghunandanan, Muthukurussi V; Pandey, Vikas; Taneja, Bhupesh; Yadav, Jyoti; Dash, Debasis; Bhattacharya, Jaijit; Misra, Amit; Kumar, Anil; Ramachandran, Srinivasan; Thomas, Zakir; Brahmachari, Samir K

2011-09-01

It is being realized that the traditional closed-door and market driven approaches for drug discovery may not be the best suited model for the diseases of the developing world such as tuberculosis and malaria, because most patients suffering from these diseases have poor paying capacity. To ensure that new drugs are created for patients suffering from these diseases, it is necessary to formulate an alternate paradigm of drug discovery process. The current model constrained by limitations for collaboration and for sharing of resources with confidentiality hampers the opportunities for bringing expertise from diverse fields. These limitations hinder the possibilities of lowering the cost of drug discovery. The Open Source Drug Discovery project initiated by Council of Scientific and Industrial Research, India has adopted an open source model to power wide participation across geographical borders. Open Source Drug Discovery emphasizes integrative science through collaboration, open-sharing, taking up multi-faceted approaches and accruing benefits from advances on different fronts of new drug discovery. Because the open source model is based on community participation, it has the potential to self-sustain continuous development by generating a storehouse of alternatives towards continued pursuit for new drug discovery. Since the inventions are community generated, the new chemical entities developed by Open Source Drug Discovery will be taken up for clinical trial in a non-exclusive manner by participation of multiple companies with majority funding from Open Source Drug Discovery. This will ensure availability of drugs through a lower cost community driven drug discovery process for diseases afflicting people with poor paying capacity. Hopefully what LINUX the World Wide Web have done for the information technology, Open Source Drug Discovery will do for drug discovery. Copyright © 2011 Elsevier Ltd. All rights reserved.

Drugs in the Workplace: Research and Evaluation Data. Volume II. Research Monograph 100.

ERIC Educational Resources Information Center

Gust, Steven W., Ed.; And Others

This monograph presents 14 articles on the topics of the nature and extent of drug use by the workforce; drug use and job performance indicators; and drug free workplace program research. These articles are included: (1) Research on Drugs and the Workplace: Introduction and Summary (Steven Gust, Dennis Crouch, J. Michael Walsh); (2) Drug Use…

Drug Information Units Project: A Resource Directory of Available Drug Education Information at Ashland Community College.

ERIC Educational Resources Information Center

Ashland Community Coll., KY.

This bibliography provides a list of print and nonprint materials available at Ashland Community College (ACC) that deal with drug abuse education and prevention, along with information on other resources. Information on title, vendor, purchase price, and author is available for 10 books; 18 booklets; 2 audiocassette programs; 13 miscellaneous…

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

PubMed

Puteanus, U

2000-10-01

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

21 CFR 361.1 - Radioactive drugs for certain research uses.

Code of Federal Regulations, 2011 CFR

2011-04-01

... reproducible quality as to give significance to the research study conducted. The Radioactive Drug Research... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Radioactive drugs for certain research uses. 361.1... AND NOT MISBRANDED: DRUGS USED IN RESEARCH § 361.1 Radioactive drugs for certain research uses. (a...

Infovigilance: reporting errors in official drug information sources.

PubMed

Fusier, Isabelle; Tollier, Corinne; Husson, Marie-Caroline

2005-06-01

The French drug database Thériaque (http://www.theriaque.org) developed by the (Centre National Hospitalier d'Information sur le Médicament) (CNHIM), is responsible for the dissemination of independent information about all drugs available in France. Each month the CNHIM pharmacists report problems due to inaccuracies in these sources to the French drug agency. In daily practice we devised the term "infovigilance": "Activity of error or inaccuracy notification in information sources which could be responsible for medication errors". The aim of this study was to evaluate the impact of CNHIM infovigilance on the contents of the Summary of Product Characteristics (SPCs). The study was a prospective study from 09/11/2001 to 31/12/2002. The problems related to the quality of information were classified into four types (inaccuracy/confusion, error/lack of information, discordance between SPC sections and discordance between generic SPCs). (1) Number of notifications and number of SPCs integrated into the database during the study period. (2) Percentage of notifications for each type: with or without potential patient impact, with or without later correction of the SPC, per section. 2.7% (85/3151) of SPCs integrated into the database were concerned by a notification of a problem. Notifications according to type of problem were inaccuracy/confusion (32%), error/lack of information (13%), discordance between SPC sections (27%) and discordance between generic SPCs (28%). 55% of problems were evaluated as 'likely to have an impact on the patient' and 45% as 'unlikely to have an impact on the patient'. 22 of problems which have been reported to the French drug agency were corrected and new updated SPCs were published with the corrections. Our efforts to improve the quality of drug information sources through a continuous "infovigilance" process need to be continued and extended to other information sources.

A Collaborative Assessment Among 11 Pharmaceutical Companies of Misinformation in Commonly Used Online Drug Information Compendia.

PubMed

Randhawa, Amarita S; Babalola, Olakiitan; Henney, Zachary; Miller, Michele; Nelson, Tanya; Oza, Meerat; Patel, Chandni; Randhawa, Anupma S; Riley, Joyce; Snyder, Scott; So, Sherri

2016-05-01

Online drug information compendia (ODIC) are valuable tools that health care professionals (HCPs) and consumers use to educate themselves on pharmaceutical products. Research suggests that these resources, although informative and easily accessible, may contain misinformation, posing risk for product misuse and patient harm. Evaluate drug summaries within ODIC for accuracy and completeness and identify product-specific misinformation. Between August 2014 and January 2015, medical information (MI) specialists from 11 pharmaceutical/biotechnology companies systematically evaluated 270 drug summaries within 5 commonly used ODIC for misinformation. Using a standardized approach, errors were identified; classified as inaccurate, incomplete, or omitted; and categorized per sections of the Full Prescribing Information (FPI). On review of each drug summary, content-correction requests were proposed and supported by the respective product's FPI. Across the 270 drug summaries reviewed within the 5 compendia, the median of the total number of errors identified was 782, with the greatest number of errors occurring in the categories of Dosage and Administration, Patient Education, and Warnings and Precautions. The majority of errors were classified as incomplete, followed by inaccurate and omitted. This analysis demonstrates that ODIC may contain misinformation. HCPs and consumers should be aware of the potential for misinformation and consider more than 1 drug information resource, including the FPI and Medication Guide as well as pharmaceutical/biotechnology companies' MI departments, to obtain unbiased, accurate, and complete product-specific drug information to help support the safe and effective use of prescription drug products. © The Author(s) 2016.

Drug-target interaction prediction from PSSM based evolutionary information.

PubMed

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

2016-01-01

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

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

PubMed

Zhang, Wen; Chen, Yanlin; Li, Dingfang

2017-11-25

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

Predicting Drug-Target Interactions With Multi-Information Fusion.

PubMed

Peng, Lihong; Liao, Bo; Zhu, Wen; Li, Zejun; Li, Keqin

2017-03-01

Identifying potential associations between drugs and targets is a critical prerequisite for modern drug discovery and repurposing. However, predicting these associations is difficult because of the limitations of existing computational methods. Most models only consider chemical structures and protein sequences, and other models are oversimplified. Moreover, datasets used for analysis contain only true-positive interactions, and experimentally validated negative samples are unavailable. To overcome these limitations, we developed a semi-supervised based learning framework called NormMulInf through collaborative filtering theory by using labeled and unlabeled interaction information. The proposed method initially determines similarity measures, such as similarities among samples and local correlations among the labels of the samples, by integrating biological information. The similarity information is then integrated into a robust principal component analysis model, which is solved using augmented Lagrange multipliers. Experimental results on four classes of drug-target interaction networks suggest that the proposed approach can accurately classify and predict drug-target interactions. Part of the predicted interactions are reported in public databases. The proposed method can also predict possible targets for new drugs and can be used to determine whether atropine may interact with alpha1B- and beta1- adrenergic receptors. Furthermore, the developed technique identifies potential drugs for new targets and can be used to assess whether olanzapine and propiomazine may target 5HT2B. Finally, the proposed method can potentially address limitations on studies of multitarget drugs and multidrug targets.

[Psychoactive drug advertising: analysis of scientific information].

PubMed

Mastroianni, Patrícia C; Noto, Ana Regina; Galduróz, José Carlos F

2008-06-01

According to the World Health Organization, medicinal drug promotion should be reliable, accurate, truthful, informative, balanced, up-to-date and capable of substantiation. The objective of the present study was to review psychoactive drug advertisements to physicians as for information consistency with the related references and accessibility of the cited references. Data was collected in the city of Araraquara, Southeastern Brazil, in 2005. There were collected and reviewed 152 drug advertisements, a total of 304 references. References were requested directly from pharmaceutical companies' customer services and searched in UNESP (Ibict, Athenas) and BIREME (SciELO, PubMed, free-access indexed journals) library network and CAPES journals. Advertisement statements were checked against references using content analysis. Of all references cited in the advertisements studied, 66.7% were accessed. Of 639 promotional statements identified, 346 (54%) were analyzed. The analysis showed that 67.7% of promotional statements in the advertisements were consistent with their references, while the remaining was either partially consistent or inconsistent. Of the material analyzed, an average 2.5 (1-28) references was cited per advertisement. In the text body, there were identified 639 pieces of information clearly associated with at least one cited reference (average 3.5 pieces of information per advertisement). The study results evidenced difficult access to the references. Messages on efficacy, safety and cost, among others, are not always supported by scientific studies. There is a need for regulation changes and effective monitoring of drug promotional materials.

[Post-authorization research, registries, and drug development].

PubMed

Patarnello, Francesca; Recchia, Giuseppe

2013-06-01

In the last decade regulators, payers and health care providers tried to react to three major problems in drug development and drug use in clinical practice: the pharmaceutical R&D productivity crisis, the immaturity of benefit-risk profile for several newly approved drugs and the overall impact on economic sustainability of reimbursing new high cost drugs in their systems. The potentiality of create a continuum between the evidence requirements relevant for registration, for reimbursement and for post authorization research is clear. All different parties involved, like regulators, HTA agencies, scientific communities and manufacturers, are working to improve the knowledge profile of new drugs in order to anticipate the patient access to innovation, limiting or preventing the clinical and economical risks deriving from an incomplete safety and effectiveness profile. The Italian example of "New Drugs AIFA Registries", with or without the application of risk sharing schemes (cost sharing, pay for performance, etc.), introduced a new process and increased the sensitivity on this topic. However this might probably represents only a partial answer to the problem of how to set up the governance of coverage with evidence, drug utilization monitoring, comparative effectiveness research, outcome research programs and may be how to link them to access, pricing and reimbursement. The step change in post authorization research could be to "integrate" different sources and stakeholders in a wider and continuous approach, in a well designed and inclusive "second generation" HTA approach, where all resources (competencies, data, funding) will concur to increase the evidence profile and reduce the risks, and where any "evidence generation approach" is really compliant with the standard and rules of best research practices.

The issue of consent in research that administers drugs of addiction to addicted persons.

PubMed

Carter, Adrian; Hall, Wayne

2008-01-01

In addiction, impaired control over drug use raises questions about the capacity of addicted persons to consent to participate in research studies in which they are given their drug of addiction. We review the case for doing such research, and the arguments that addiction does, and does not, prevent addicted persons from consenting to such research. We argue for a more nuanced view that acknowledges that while in some situations addiction impairs decision-making capacity, it does not eliminate such capacity. We conclude with some suggestions for recruiting addicted subjects and designing experiments in ways to obtain free and informed consent.

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

PubMed

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

2007-01-01

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

Drug repurposing for aging research using model organisms.

PubMed

Ziehm, Matthias; Kaur, Satwant; Ivanov, Dobril K; Ballester, Pedro J; Marcus, David; Partridge, Linda; Thornton, Janet M

2017-10-01

Many increasingly prevalent diseases share a common risk factor: age. However, little is known about pharmaceutical interventions against aging, despite many genes and pathways shown to be important in the aging process and numerous studies demonstrating that genetic interventions can lead to a healthier aging phenotype. An important challenge is to assess the potential to repurpose existing drugs for initial testing on model organisms, where such experiments are possible. To this end, we present a new approach to rank drug-like compounds with known mammalian targets according to their likelihood to modulate aging in the invertebrates Caenorhabditis elegans and Drosophila. Our approach combines information on genetic effects on aging, orthology relationships and sequence conservation, 3D protein structures, drug binding and bioavailability. Overall, we rank 743 different drug-like compounds for their likelihood to modulate aging. We provide various lines of evidence for the successful enrichment of our ranking for compounds modulating aging, despite sparse public data suitable for validation. The top ranked compounds are thus prime candidates for in vivo testing of their effects on lifespan in C. elegans or Drosophila. As such, these compounds are promising as research tools and ultimately a step towards identifying drugs for a healthier human aging. © 2017 The Authors. Aging Cell published by the Anatomical Society and John Wiley & Sons Ltd.

75 FR 45130 - Guidance for Industry and Researchers on the Radioactive Drug Research Committee: Human Research...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-02

... and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver... products could be used. First, the Agency terminated a 1963 order from the Commissioner of Food and Drugs.... Today, research studies with a radioactive drug or biological product may be conducted in a number of...

Retrieving Online Information on Drugs: An Analysis of Four Databases.

ERIC Educational Resources Information Center

Lavengood, Kathryn A.

This study examines the indexing of drugs in the literature and compares actual drug indexing to stated indexing policies in selected databases. The goal is to aid health science information specialists, end-users, and/or non-subject experts to improve recall and comprehensiveness when searching for drug information by identifying the most useful…

24 CFR 960.205 - Drug use by applicants: Obtaining information from drug treatment facility.

Code of Federal Regulations, 2012 CFR

2012-04-01

.... This section addresses a PHA's authority to request and obtain information from drug abuse treatment... household member. (2) Drug abuse treatment facility. An entity: (i) That holds itself out as providing, and... consent forms signed by such household member that: (i) Requests any drug abuse treatment facility to...

24 CFR 960.205 - Drug use by applicants: Obtaining information from drug treatment facility.

Code of Federal Regulations, 2011 CFR

2011-04-01

.... This section addresses a PHA's authority to request and obtain information from drug abuse treatment... household member. (2) Drug abuse treatment facility. An entity: (i) That holds itself out as providing, and... consent forms signed by such household member that: (i) Requests any drug abuse treatment facility to...

24 CFR 960.205 - Drug use by applicants: Obtaining information from drug treatment facility.

Code of Federal Regulations, 2010 CFR

2010-04-01

.... This section addresses a PHA's authority to request and obtain information from drug abuse treatment... household member. (2) Drug abuse treatment facility. An entity: (i) That holds itself out as providing, and... consent forms signed by such household member that: (i) Requests any drug abuse treatment facility to...

24 CFR 960.205 - Drug use by applicants: Obtaining information from drug treatment facility.

Code of Federal Regulations, 2013 CFR

2013-04-01

.... This section addresses a PHA's authority to request and obtain information from drug abuse treatment... household member. (2) Drug abuse treatment facility. An entity: (i) That holds itself out as providing, and... consent forms signed by such household member that: (i) Requests any drug abuse treatment facility to...

24 CFR 960.205 - Drug use by applicants: Obtaining information from drug treatment facility.

Code of Federal Regulations, 2014 CFR

2014-04-01

.... This section addresses a PHA's authority to request and obtain information from drug abuse treatment... household member. (2) Drug abuse treatment facility. An entity: (i) That holds itself out as providing, and... consent forms signed by such household member that: (i) Requests any drug abuse treatment facility to...

A Guide to Drug Abuse Education and Information Materials.

ERIC Educational Resources Information Center

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

Drug-abuse-prevention materials developed by and available from the National Institute of Mental Health, National Clearinghouse for Drug Abuse Information are described in this guide. The materials are television and radio spots, print ads, posters, a federal source book, flyers, special audience publications, information for the professional,…

Creating a drug law enforcement research agenda.

PubMed

Reuter, Peter

2017-03-01

Drug law enforcement (DLE) research has been poorly funded relative to drug treatment research. The literature is slight in volume and not yet very insightful. Taking the lack of funding to represent a chronic lack of public interest in the effects of DLE, the article offers a set of suggestions for how to create of a stronger DLE research community. Copyright © 2017 Elsevier B.V. All rights reserved.

Alcohol and Drug Research in California 1987.

ERIC Educational Resources Information Center

Lowe, Lois L., Comp.

Abstracts of 130 research projects in alcohol and drug programs in California are presented in this document. The projects described in this directory show the extent and diversity of current alcohol and drug research within the state. Each abstract lists the principal investigator with his or her title, institution, and address; co-principal…

Drugs and Sex. The Nonmedical Use of Drugs and Sexual Behavior. National Institute on Drugs Research Issues 2.

ERIC Educational Resources Information Center

Ferguson, Patricia, Ed.; And Others

This report represents the second in a series intended to summarize the empirical research findings and major theoretical approaches relating to the issues of drug use and abuse. This volume reviews some of the major research findings which explore the relationship between nonmedical drug use and sexual behavior. The research is summarized and…

Presence and Accuracy of Drug Dosage Recommendations for Continuous Renal Replacement Therapy in Tertiary Drug Information References

PubMed Central

Gorman, Sean K; Slavik, Richard S; Lam, Stefanie

2012-01-01

Background: Clinicians commonly rely on tertiary drug information references to guide drug dosages for patients who are receiving continuous renal replacement therapy (CRRT). It is unknown whether the dosage recommendations in these frequently used references reflect the most current evidence. Objective: To determine the presence and accuracy of drug dosage recommendations for patients undergoing CRRT in 4 drug information references. Methods: Medications commonly prescribed during CRRT were identified from an institutional medication inventory database, and evidence-based dosage recommendations for this setting were developed from the primary and secondary literature. The American Hospital Formulary System—Drug Information (AHFS–DI), Micromedex 2.0 (specifically the DRUGDEX and Martindale databases), and the 5th edition of Drug Prescribing in Renal Failure (DPRF5) were assessed for the presence of drug dosage recommendations in the CRRT setting. The dosage recommendations in these tertiary references were compared with the recommendations derived from the primary and secondary literature to determine concordance. Results: Evidence-based drug dosage recommendations were developed for 33 medications administered in patients undergoing CRRT. The AHFS–DI provided no dosage recommendations specific to CRRT, whereas the DPRF5 provided recommendations for 27 (82%) of the medications and the Micromedex 2.0 application for 20 (61%) (13 [39%] in the DRUGDEX database and 16 [48%] in the Martindale database, with 9 medications covered by both). The dosage recommendations were in concordance with evidence-based recommendations for 12 (92%) of the 13 medications in the DRUGDEX database, 26 (96%) of the 27 in the DPRF5, and all 16 (100%) of those in the Martindale database. Conclusions: One prominent tertiary drug information resource provided no drug dosage recommendations for patients undergoing CRRT. However, 2 of the databases in an Internet-based medical information

Drug testing in Europe: monitoring results of the Trans European Drug Information (TEDI) project.

PubMed

Brunt, Tibor M; Nagy, Constanze; Bücheli, Alexander; Martins, Daniel; Ugarte, Miren; Beduwe, Cécile; Ventura Vilamala, Mireia

2017-02-01

Drug testing is a harm reduction strategy that has been adopted by certain countries in Europe. Drug users are able to hand in their drugs voluntarily for chemical analysis of composition and dose. Drug users will be alerted about dangerous test results by the drug testing systems directly and through warning campaigns. An international collaborative effort was launched to combine data of drug testing systems, called the Trans European Drug Information (TEDI) project. Drug testing systems of Spain, Switzerland, Belgium, Austria, Portugal, and the Netherlands participated in this project. This study presents results of some of the main illicit drugs encountered: cocaine, ecstasy and amphetamine and also comments on new psychoactive substances (NPS) detected between 2008 and 2013. A total of 45 859 different drug samples were analyzed by TEDI. The drug markets of the distinct European areas showed similarities, but also some interesting differences. For instance, purity of cocaine and amphetamine powders was generally low in Austria, whilst high in Spain and the Netherlands. And the market for ecstasy showed a contrast: whereas in the Netherlands and Switzerland there was predominantly a market for ecstasy tablets, in Portugal and Spain MDMA (3,4-methylenedioxymethamphetamine) crystals were much more prevalent. Also, some NPS appearing in ecstasy seemed more specific for one country than another. In general, prevalence of NPS clearly increased between 2008 and 2013. Drug testing can be used to generate a global picture of drug markets and provides information about the pharmacological contents of drugs for the population at risk. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Human Disease Insight: An integrated knowledge-based platform for disease-gene-drug information.

PubMed

Tasleem, Munazzah; Ishrat, Romana; Islam, Asimul; Ahmad, Faizan; Hassan, Md Imtaiyaz

2016-01-01

The scope of the Human Disease Insight (HDI) database is not limited to researchers or physicians as it also provides basic information to non-professionals and creates disease awareness, thereby reducing the chances of patient suffering due to ignorance. HDI is a knowledge-based resource providing information on human diseases to both scientists and the general public. Here, our mission is to provide a comprehensive human disease database containing most of the available useful information, with extensive cross-referencing. HDI is a knowledge management system that acts as a central hub to access information about human diseases and associated drugs and genes. In addition, HDI contains well-classified bioinformatics tools with helpful descriptions. These integrated bioinformatics tools enable researchers to annotate disease-specific genes and perform protein analysis, search for biomarkers and identify potential vaccine candidates. Eventually, these tools will facilitate the analysis of disease-associated data. The HDI provides two types of search capabilities and includes provisions for downloading, uploading and searching disease/gene/drug-related information. The logistical design of the HDI allows for regular updating. The database is designed to work best with Mozilla Firefox and Google Chrome and is freely accessible at http://humandiseaseinsight.com. Copyright © 2015 King Saud Bin Abdulaziz University for Health Sciences. Published by Elsevier Ltd. All rights reserved.

Drug utilization research in primary health care as exemplified by physicians' quality assessment groups.

PubMed

von Ferber, L; Luciano, A; Köster, I; Krappweis, J

1992-11-01

Drugs in primary health care are often prescribed for nonrational reasons. Drug utilization research investigates the prescription of drugs with an eye to medical, social and economic causes and consequences of the prescribed drug's utilization. The results of this research show distinct differences in drug utilization in different age groups and between men and women. Indication and dosage appear irrational from a textbook point of view. This indicates nonpharmacological causes of drug utilization. To advice successfully changes for the better quality assessment groups of primary health care physicians get information about their established behavior by analysis of their prescriptions. The discussion and the comparisons in the group allow them to recognize their irrational prescribing and the social, psychological and economic reasons behind it. Guidelines for treatment are worked out which take into account the primary health care physician's situation. After a year with 6 meetings of the quality assessment groups the education process is evaluated by another drug utilization analysis on the basis of the physicians prescription. The evaluation shows a remarkable improvement of quality and cost effectiveness of the drug therapy of the participating physicians.

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

PubMed

Cresswell, Kathrin M; Sheikh, Aziz

2008-05-01

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

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

PubMed

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

2017-10-16

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

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

PubMed Central

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

2017-01-01

In this study, we evaluate the role of information anxiety and information load on the intention to read information from prescription drug information leaflets (PILs). These PILs were developed based on the principals of information load and consumer information processing. This was an experimental prospective repeated measures study conducted in the United States where 360 (62% response rate) university students (>18 years old) participated. Participants were presented with a scenario followed by exposure to the three drug product information sources used to operationalize information load. The three sources were: (i) current practice; (ii) pre-existing one-page text only; and (iii) interventional one-page prototype PILs designed for the study. Information anxiety was measured as anxiety experienced by the individual when encountering information. The outcome variable of intention to read PILs was defined as the likelihood that the patient will read the information provided in the leaflets. A survey questionnaire was used to capture the data and the objectives were analyzed by performing a repeated measures MANOVA using SAS version 9.3. When compared to current practice and one-page text only leaflets, one-page PILs had significantly lower scores on information anxiety (p < 0.001) and information load (p < 0.001). The intention to read was highest and significantly different (p < 0.001) for PILs as compared to current practice or text only leaflets. Information anxiety and information load significantly impacted intention to read (p < 0.001). Newly developed PILs increased patient’s intention to read and can help in improving the counseling services provided by pharmacists. PMID:29035337

21 CFR 201.129 - Drugs; exemption for radioactive drugs for research use.

Code of Federal Regulations, 2011 CFR

2011-04-01

... to human research subjects during the course of a research project intended to obtain basic research... labeled drug or regarding human physiology, pathophysiology, or biochemistry (but not intended for...

Research influence on antimalarial drug policy change in Tanzania: case study of replacing chloroquine with sulfadoxine-pyrimethamine as the first-line drug

PubMed Central

Mubyazi, Godfrey M; Gonzalez-Block, Miguel A

2005-01-01

, the need for a more effective drug was indispensable but for an interim 5–10 year period it was justifiable to recommend SP that was relatively more cost-effective than CQ and AQ. The government launched the policy change considering that studies (ethically approved by the Ministry of Health) on therapeutic efficacy and cost-effectiveness of artemisinin drug combination therapies were underway. Nevertheless, the process of communicating research results and recommendations to policy-making authorities involved critical debates between policy makers and researchers, among the researchers themselves and between the researchers and general practitioners, the speculative media reports on SP side-effects and reservations by the general public concerning the rationale for policy change, when to change, and to which drug of choice. Conclusion Changing national drug policy will remain a sensitive issue that cannot be done overnight. However, to ensure that research findings are recognised and the recommendations emanating from such findings are effectively utilized, a systematic involvement of all the key stakeholders (including policy-makers, drug manufacturers, media, practitioners and the general public) at all stages of research is crucial. It also matters how and when research information is communicated to the stakeholders. Professional organizations such as the East African Network on Malaria Treatment have potential to bring together malaria researchers, policy-makers and other stakeholders in the research-to-drug policy change interface. PMID:16242017

Evaluation of personal digital assistant drug information databases for the managed care pharmacist.

PubMed

Lowry, Colleen M; Kostka-Rokosz, Maria D; McCloskey, William W

2003-01-01

Personal digital assistants (PDAs) are becoming a necessity for practicing pharmacists. They offer a time-saving and convenient way to obtain current drug information. Several software companies now offer general drug information databases for use on hand held computers. PDAs priced less than 200 US dollars often have limited memory capacity; therefore, the user must choose from a growing list of general drug information database options in order to maximize utility without exceeding memory capacity. This paper reviews the attributes of available general drug information software databases for the PDA. It provides information on the content, advantages, limitations, pricing, memory requirements, and accessibility of drug information software databases. Ten drug information databases were subjectively analyzed and evaluated based on information from the product.s Web site, vendor Web sites, and from our experience. Some of these databases have attractive auxiliary features such as kinetics calculators, disease references, drug-drug and drug-herb interaction tools, and clinical guidelines, which may make them more useful to the PDA user. Not all drug information databases are equal with regard to content, author credentials, frequency of updates, and memory requirements. The user must therefore evaluate databases for completeness, currency, and cost effectiveness before purchase. In addition, consideration should be given to the ease of use and flexibility of individual programs.

Associations Between Long-Term Gang Membership and Informal Social Control Processes, Drug Use, and Delinquent Behavior Among Mexican American Youth

PubMed Central

Cepeda, Alice; Saint Onge, Jarron M.; Nowotny, Kathryn M.; Valdez, Avelardo

2018-01-01

Research has found that among juveniles weak ties to informal social control entities such as parents, school, and conventional peers increase the probability of the initiation and continuation of deviant behaviors such as drug use and crime. Given the weak ties of formal social control mechanisms in highly disadvantaged communities, informal social control mechanisms are often an important deterrent that reduce or moderate engagement in deviant behaviors among serious and persistent offenders. This analysis examines the association between long-term gang membership and adolescent informal social control processes, drug use, and delinquency. This research is based on data from a study of 160 Mexican American male gang members between the ages of 16 and 20. Findings suggest that among gang members in this context, commonly studied informal control mechanisms such as the family and schools do not function to deter long-term gang membership that is associated with serious criminal and violent behavior and drug use. The implications for future research on desistance or continuation of antisocial behavior across the life course are discussed. PMID:25979430

[Topics from "Overseas Drug Safety Information" in the past five years].

PubMed

Amanuma, Kimiko

2013-01-01

The Drug Safety Information Section of the Division of Safety Information on Drug, Food and Chemicals has been providing bulletins titled "Overseas Drug Safety Information" in Japanese since 2003. These bulletins comprise summarized and translated reports of important post-marketing drug safety information that are published by foreign regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medical Agency. A new issue of the bulletin is posted every two weeks on the website of the National Institute of Health Sciences, Japan; to date (May 2013), a total of 280 issues have been posted, covering approximately 2400 foreign news items and articles since its inception. Recently, visits to the bulletin website have been increasing: the number of hits for each issue totaled 570,000 in fiscal 2012. Among the "Overseas Drug Safety Information" issued in the past five years, I briefly describe here several topics which interested me: erythropoietin-stimulating agents in chronic kidney disease and their cardiovascular risk; bisphosphonates and atypical femur fracture; effectiveness of oral liquid cough medicines containing codeine in children; bevacizumab for metastatic breast cancer; and congenital abnormality associated with the use of antiepileptic drugs by pregnant women. I also describe the potential safety signals identified by FDA using its Adverse Event Reporting System, and their importance in ensuring the safe use of drugs in the post-marketing phase.

Drug Abuse Treatment in Prisons. Treatment Research Report.

ERIC Educational Resources Information Center

National Inst. for Advanced Studies, Washington, DC.

This report, based on a 1979 national survey of drug abuse treatment programs in the prisons of the 50 states and the District of Columbia, presents data on 160 operational programs. Descriptive information on the identification of drug-dependent inmates and the provision of drug abuse treatment by state adult correctional institutions is…

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-05

...] Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration... an educational conference co-sponsored with the Society of Clinical Research Associates (SOCRA). The...: 510-287-2739; or Society of Clinical Research Associates (SOCRA), 530 West Butler Ave., Suite 109...

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

DTIC Science & Technology

2017-06-08

currently on the market and for which drug-protein interaction information is available . These predictions are publicly accessible at http://avoid...associated with these ADRs via DDIs. We made the predictions publicly available via internet access. Keywords: Drug-drug interactions, Adverse drug reactions...ˆDeceased Department of Defense Biotechnology High Performance Computing Software Applications Institute, Telemedicine and Advanced Technology Research

A survey of patients' receipt of prescription drug information

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

Morris, L.A.

1982-06-01

A nationwide telephone survey of 1,223 individuals investigated the nature and source of information provided to patients regarding prescription drugs. About half of the respondents said that they had received information from their doctor about the purpose and directions for use for their most recent prescription. Only a few people (11 per cent) said that they had been informed about the drug's side effects and 19 per cent said that they had been told nothing by their doctor. Most (72 per cent) related that nothing had been said to them at the pharmacy. Written information (stickers on the medicine container,more » leaflets or brochures) were said to be infrequently provided at the pharmacy. About 12 per cent of the respondents said they had expected they might get a drug side effect, but only 9 per cent said that they had experienced one. The most frequently cited action in response to side effects was to consult the physician (40 per cent); however, a sizeable percentage of people stopped the medicine completely or temporarily (36 per cent) or kept on taking the drug as prescribed (32 per cent).« less

21 CFR 20.30 - Food and Drug Administration Freedom of Information Staff.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Food and Drug Administration Freedom of... HUMAN SERVICES GENERAL PUBLIC INFORMATION General Policy § 20.30 Food and Drug Administration Freedom of Information Staff. (a) The Office responsible for agency compliance with the Freedom of Information Act and...

Placement and Format of Risk Information on Direct-to-Consumer Prescription Drug Websites.

PubMed

Sullivan, Helen W; O'Donoghue, Amie C; Rupert, Douglas J; Willoughby, Jessica Fitts; Aikin, Kathryn J

2017-02-01

We investigated whether the location and format of risk information on branded prescription drug websites influence consumers' knowledge and perceptions of the drug's risks. Participants (Internet panelists with high cholesterol [n = 2,609] or seasonal allergies [n = 2,637]) were randomly assigned to view a website promoting a fictitious prescription drug for their condition. The website presented risk information at the bottom of the homepage, or at the bottom of the homepage with a signal above indicating that the risk information was located below, or on a linked secondary page. We also varied the format of risk information (paragraph, checklist, bulleted list, highlighted box). Participants then answered questions on risk recall and perceptions. Participants recalled fewer drug risks when the risks were placed on a secondary page. The signal had little effect, and risk information format did not affect outcomes. The location of risk information on prescription drug websites can affect consumer knowledge of drug risks; however, signals and special formatting may not be necessary for websites to adequately inform consumers about drug risks. We recommend that prescription drug websites maintain risk information on their homepages to achieve "fair balance" as required by the U.S. Food and Drug Administration.

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

PubMed

Hammad, Eman A

2016-01-01

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

International Drug Use; Research Issues 23.

ERIC Educational Resources Information Center

Austin, Gregory A., Ed.; And Others

This collection of resources contains 95 summaries of research conducted on drug use in countries other than the United States, and is designed to be an introductory set of readings which provide a basic familiarity with drug use patterns in foreign countries. The first section contains 23 studies on the United Kingdom while the second section…

Beyond post-marketing research and MedWatch: Long-term studies of drug risks.

PubMed

Resnik, David B

2007-10-01

Critics of the drug safety system have discussed many different potential reforms, ranging from mandatory registration of clinical trials to increasing the power of regulatory agencies, but few have discussed one of the most important ways of enhancing safety: increasing the number of long-term studies of medications. Long-term studies of the risks and benefits of drugs can provide useful information for regulators, healthcare professionals, and patients. Government funding agencies should lead the effort to conduct long-term studies of drugs, but private companies should also be required to lend financial support. Because cost-effectiveness is likely to be an important consideration in conducting this research, funding agencies should focus, at first, on drugs that are used to treat common, chronic conditions.

Beyond post-marketing research and MedWatch: Long-term studies of drug risks

PubMed Central

Resnik, David B

2007-01-01

Critics of the drug safety system have discussed many different potential reforms, ranging from mandatory registration of clinical trials to increasing the power of regulatory agencies, but few have discussed one of the most important ways of enhancing safety: increasing the number of long-term studies of medications. Long-term studies of the risks and benefits of drugs can provide useful information for regulators, healthcare professionals, and patients. Government funding agencies should lead the effort to conduct long-term studies of drugs, but private companies should also be required to lend financial support. Because cost-effectiveness is likely to be an important consideration in conducting this research, funding agencies should focus, at first, on drugs that are used to treat common, chronic conditions. PMID:19727333

Health Services Research for Drug and Alcohol Treatment and Prevention.

PubMed

McCarty, Dennis; Roman, Paul M; Sorensen, James; Weisner, Constance

2009-01-01

Health services research is a multidisciplinary field that examines ways to organize, manage, finance, and deliver high-quality care. This specialty within substance abuse research developed from policy analyses and needs assessments that shaped federal policy and promoted system development in the 1970s. After the authorization of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the National Institute on Drug Abuse (NIDA), patient information systems supported studies of treatment processes and outcomes. Health services research grew substantially in the 1990s when NIAAA and NIDA moved into the National Institutes of Health and legislation allocated 15% of their research portfolio to services research. The next decade will emphasize research on quality of care, adoption and use of evidence-based practices (including medication), financing reforms and integration of substance abuse treatment with primary care and mental health services.

Using constrained information entropy to detect rare adverse drug reactions from medical forums.

PubMed

Yi Zheng; Chaowang Lan; Hui Peng; Jinyan Li

2016-08-01

Adverse drug reactions (ADRs) detection is critical to avoid malpractices yet challenging due to its uncertainty in pre-marketing review and the underreporting in post-marketing surveillance. To conquer this predicament, social media based ADRs detection methods have been proposed recently. However, existing researches are mostly co-occurrence based methods and face several issues, in particularly, leaving out the rare ADRs and unable to distinguish irrelevant ADRs. In this work, we introduce a constrained information entropy (CIE) method to solve these problems. CIE first recognizes the drug-related adverse reactions using a predefined keyword dictionary and then captures high- and low-frequency (rare) ADRs by information entropy. Extensive experiments on medical forums dataset demonstrate that CIE outperforms the state-of-the-art co-occurrence based methods, especially in rare ADRs detection.

Evaluation of health information systems research in information systems research: A meta-analysis.

PubMed

Haried, Peter; Claybaugh, Craig; Dai, Hua

2017-04-01

Given the importance of the health-care industry and the promise of health information systems, researchers are encouraged to build on the shoulders of giants as the saying goes. The health information systems field has a unique opportunity to learn from and extend the work that has already been done by the highly correlated information systems field. As a result, this research article presents a past, present and future meta-analysis of health information systems research in information systems journals over the 2000-2015 time period. Our analysis reviewed 126 articles on a variety of topics related to health information systems research published in the "Senior Scholars" list of the top eight ranked information systems academic journals. Across the selected information systems academic journals, our findings compare research methodologies applied, health information systems topic areas investigated and research trends. Interesting results emerge in the range and evolution of health information systems research and opportunities for health information systems researchers and practitioners to consider moving forward.

Post-marketing studies: the work of the Drug Safety Research Unit.

PubMed

Mackay, F J

1998-11-01

The Drug Safety Research Unit (DSRU) is the centre for prescription-event monitoring (PEM) in England. PEM studies are noninterventional observational cohort studies which monitor the safety of newly marketed drugs. The need for post-marketing surveillance is well recognised in the UK and general practice is an ideal source of data. PEM studies are general practitioner (community)-based and exposure is based on dispensed prescription data in England. To date, 65 PEM studies have been completed with a mean cohort size of 10 979 patients and the DSRU database has clinical information on over 700000 patients prescribed new drugs. Unlike spontaneous reporting schemes, PEM produces incidence rates for events reported during treatment. Comparative studies can be conducted for drugs in the same class. The DSRU aggregates outcome data for pregnancies exposed to new drugs. Data for children and the elderly can also be specifically examined. PEM data have a number of advantages over data from computerised general practice databases in the UK. PEM is the only technique within the UK capable of monitoring newly marketed drugs in such a comprehensive and systematic way.

78 FR 55728 - Society of Clinical Research Associates-Food and Drug Administration: Food and Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-11

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

The utilization of Arabic online drug information among adults in Saudi Arabia.

PubMed

Abanmy, Norah O; Al-Quait, Nouf A; Alami, Amani H; Al-Juhani, Meshaal H; Al-Aqeel, Sinaa

2012-10-01

In Saudi Arabia, the utilization of the world wide web has become increasingly popular. However, the exact figure of such use is unknown. This study aimed to determine the percentage of, and experience with, online Arabic drug information by Arabic-speaking adults in Saudi Arabia. A web based questionnaire was used. The questionnaire language was Arabic. Public were invited to participate in the survey through e-mails, Twitter, WhatsApp and Facebook in March 2012. The survey included 17 items examining the types of accessed Arabic drug information, the respondent's demographics, their ability to easily find and understand Arabic drug-related information, and their trustfulness and dependency on such information websites. Of the 422 Arabic speaking adults who answered the questionnaire, 88% stated that they used Arabic websites to answer drug-related questions. Of the respondents, 50% had a bachelor's degree, 44% were young adults, over half were female (60%), and 72% of them have a chronic disease. The ease of retrieving online information was the most common reason (69%) for consulting such websites. Google as a search engine was the most frequently (86%) accessible website. Although respondents reported different drug-related topics in their online searching, the search for adverse effects was the most common (68%). Respondents claimed that they could easily find (65%) and understand (49%) the drug-related information. Although a good number of respondents qualified this type of information as good, double-checking of information on other websites was highly recommended. Trustfulness was one of the important parameters to measure and 205 respondents (55%) claimed that they only trusted half of the information cited. Moreover, around 48% of respondents considered that finding the same information on more than one website increased its trustfulness. Surprisingly, 54% of respondents did not depend on Arabic information websites when making decisions on drug use

Medicare prescription drug coverage: Consumer information and preferences

PubMed Central

Winter, Joachim; Balza, Rowilma; Caro, Frank; Heiss, Florian; Jun, Byung-hill; Matzkin, Rosa; McFadden, Daniel

2006-01-01

We investigate prescription drug use, and information and enrollment intentions for the new Medicare Part D drug insurance program, using a sample of Medicare-eligible subjects surveyed before open enrollment began for this program. We find that, despite the complexity of competing plans offered by private insurers under Part D, a majority of the Medicare population had information on this program and a substantial majority planned to enroll. We find that virtually all elderly, even those with no current prescription drug use, can expect to benefit from enrollment in a Part D Standard plan at the low premiums available in the current market. However, there is a significant risk that many eligible seniors, particularly low-income elderly with poor health or cognitive impairment, will make poor enrollment and plan choices. PMID:16682629

Drugs and driving : a research review

DOT National Transportation Integrated Search

1977-01-01

The report presents the results of a study of the relationship between drugs (other than alcohol alone) and highway safety. The state of the art of current research is examined. Conclusions and recommendations for future action and research are made....

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

PubMed

Knoben, James E; Phillips, Steven J

2014-01-01

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

Whom do older adults trust most to provide information about prescription drugs?

PubMed

Donohue, Julie M; Huskamp, Haiden A; Wilson, Ira B; Weissman, Joel

2009-04-01

Cost-related nonadherence to medieations is common among older adults, yet physician-patient communication about medication cost concerns is infrequent. One factor affecting communication and adherence may be older adults' confidence in the information about prescription drugs provided by physicians and other sources. This study was conducted to identify which source older adults most trust to provide information on drugs and to examine the relationship between older patients' trust in physicians to provide price information and the occurrence of cost-related nonadherence. We conducted a cross-sectional national telephone survey of individuals aged > or =50 years who were taking at least 1 prescription medication. Respondents were asked how much they would trust various sources (physician, pharmacist, nurse, insurance plan, the Internet, consumer groups, friends and family) to provide helpful information on "the price of the prescription medicine compared to others like it" and on "how well the prescription medicine will work for you compared to other medicines like it." The response options were a lot, somewhat, and not at all. Other measures of interest were respondents' beliefs concerning physicians' ability to lower drug costs and patient activation. We also evaluated the potential association between trust in physicians to deliver drug price information and cost-related medication nonadherence. Compared with the other sources of information studied, doctors and pharmacists were the sources that respondents were most likely to trust "a lot" to provide information on drug prices (55.6% and 61.7%, respectively) and to provide information on drug effectiveness (79.9% and 66.4%). Less than half (42.3%) of respondents who said that they trusted their doctor to provide drug price information "somewhat" or "not at all" agreed that there are ways doctors could lower drug costs (P = 0.01 vs those who trusted their doctor "a lot"). Adults aged > or =65 years were more

Drug Information to Patient Care Areas via Television: Preliminary Evaluation of Two Years' Experience

ERIC Educational Resources Information Center

Springer, Sandra J.; And Others

1978-01-01

The research project described was undertaken to study the impact of the use of a closed circuit television system to deliver information about drugs, chemicals, and poisons from a central resource location to health professionals in patient care areas. Evaluation techniques included questionnaires, interviews with users, and extramural…

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

PubMed

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

2009-01-01

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

Research, public policy and drug abuse: current approaches and new directions.

PubMed

Smith, J P

This article examines current U.S. research policy in the drug abuse field and comments on future directions. It discusses three main themes: (1) the relationship of national policy and research on drug abuse; (2) how research is planned and priorities are set at the National Institute on Drug Abuse; and (3) the need for a variety of policy studies on drug abuse to help develop more effective national prevention and control efforts. Examination of national policy statements on drug abuse supply and demand reduction issued by administrations from John F. Kennedy to Ronald W. Reagan suggests a lack of appreciation of the potential that research offers to aid public policy and an underutilization of research as a response to gaps in our knowledge of how to deal with drug problems. This paper proposes development of a National Research Strategy on Drug Abuse to identify research goals that reflect national policy needs. The importance and contribution of policy studies, as part of the National Research Strategy, are discussed with a plea for research to improve policy analysis and development.

Treatment dynamics of newly marketed drugs and implications for comparative effectiveness research.

PubMed

Gagne, Joshua J; Bykov, Katsiaryna; Willke, Richard J; Kahler, Kristijan H; Subedi, Prasun; Schneeweiss, Sebastian

2013-01-01

Clinicians and payers require rapid comparative effectiveness (CE) evidence generation to inform decisions for new drugs. We empirically assessed treatment dynamics of newly marked drugs and their implications for conducting CE research. We used claims data to evaluate five drug-outcome pairs: 1) raloxifene (vs. alendronate) and fracture; 2) risedronate (vs. alendronate) and fracture; 3) simvastatin plus ezetimibe fixed-dose combination (simvastatin + ezetimibe) (vs. simvastatin alone) and cardiovascular events; 4) rofecoxib (vs. nonselective nonsteroidal anti-inflammatory drugs [ns-NSAIDs]) and myocardial infarction; and 5) rofecoxib (vs. ns-NSAIDS) and gastrointestinal bleed. We examined utilization dynamics in the early marketing period, including evolving utilization patterns, outcome risk among those treated with new versus established drugs, and prior treatment patterns that may indicate treatment resistance or intolerance. We addressed these challenges by replicating active CE monitoring with sequential matched cohort analysis. Patients initiating new drugs were more likely to have used other drugs for the same indication in the past, but the majority of patients in all new drug cohorts were treatment naive (82.0% overall). Patients initiating rofecoxib had higher predicted baseline risk of gastrointestinal bleed than did patients initiating ns-NSAIDs. Patients initiating risedronate and alendronate had similar predicted baseline risks of fracture, while those initiating raloxifene and simvastatin + ezetimibe had lower risks of outcomes of interest relative to their comparators. Prospective monitoring yielded results consistent with expectation for each example. Many challenges to assessing the CE of new drugs are borne out in empirical data. Attention to these challenges can yield valid CE results. Copyright © 2013, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc.

Collaboration for rare disease drug discovery research.

PubMed

Litterman, Nadia K; Rhee, Michele; Swinney, David C; Ekins, Sean

2014-01-01

Rare disease research has reached a tipping point, with the confluence of scientific and technologic developments that if appropriately harnessed, could lead to key breakthroughs and treatments for this set of devastating disorders. Industry-wide trends have revealed that the traditional drug discovery research and development (R&D) model is no longer viable, and drug companies are evolving their approach. Rather than only pursue blockbuster therapeutics for heterogeneous, common diseases, drug companies have increasingly begun to shift their focus to rare diseases. In academia, advances in genetics analyses and disease mechanisms have allowed scientific understanding to mature, but the lack of funding and translational capability severely limits the rare disease research that leads to clinical trials. Simultaneously, there is a movement towards increased research collaboration, more data sharing, and heightened engagement and active involvement by patients, advocates, and foundations. The growth in networks and social networking tools presents an opportunity to help reach other patients but also find researchers and build collaborations. The growth of collaborative software that can enable researchers to share their data could also enable rare disease patients and foundations to manage their portfolio of funded projects for developing new therapeutics and suggest drug repurposing opportunities. Still there are many thousands of diseases without treatments and with only fragmented research efforts. We will describe some recent progress in several rare diseases used as examples and propose how collaborations could be facilitated. We propose that the development of a center of excellence that integrates and shares informatics resources for rare diseases sponsored by all of the stakeholders would help foster these initiatives.

Collaboration for rare disease drug discovery research

PubMed Central

Litterman, Nadia K.; Rhee, Michele; Swinney, David C.; Ekins, Sean

2014-01-01

Rare disease research has reached a tipping point, with the confluence of scientific and technologic developments that if appropriately harnessed, could lead to key breakthroughs and treatments for this set of devastating disorders. Industry-wide trends have revealed that the traditional drug discovery research and development (R&D) model is no longer viable, and drug companies are evolving their approach. Rather than only pursue blockbuster therapeutics for heterogeneous, common diseases, drug companies have increasingly begun to shift their focus to rare diseases. In academia, advances in genetics analyses and disease mechanisms have allowed scientific understanding to mature, but the lack of funding and translational capability severely limits the rare disease research that leads to clinical trials. Simultaneously, there is a movement towards increased research collaboration, more data sharing, and heightened engagement and active involvement by patients, advocates, and foundations. The growth in networks and social networking tools presents an opportunity to help reach other patients but also find researchers and build collaborations. The growth of collaborative software that can enable researchers to share their data could also enable rare disease patients and foundations to manage their portfolio of funded projects for developing new therapeutics and suggest drug repurposing opportunities. Still there are many thousands of diseases without treatments and with only fragmented research efforts. We will describe some recent progress in several rare diseases used as examples and propose how collaborations could be facilitated. We propose that the development of a center of excellence that integrates and shares informatics resources for rare diseases sponsored by all of the stakeholders would help foster these initiatives. PMID:25685324

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

PubMed

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.

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

PubMed Central

Grenard, Jerry L.; Uy, Vsith; Pagán, José A.; Frosch, Dominick L.

2014-01-01

Objective 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. Methods 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. Results 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. Conclusions 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. Practical Implications 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. PMID:21044826

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

ERIC Educational Resources Information Center

Moreno, Steve

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

An ethical exploration of barriers to research on controlled drugs

PubMed Central

ANDREAE, Michael H; RHODES, Evelyn; BOURGOISE, Tylor; CARTER, George; WHITE, Robert S.; INDYK, Debbie; SACKS, Henry; RHODES, Rosamond

2016-01-01

We examine the ethical, social and regulatory barriers that may hamper research on therapeutic potential of certain controversial controlled substances like marijuana, heroin or ketamine. Hazards for individuals and society, and their potential adverse effects on communities may be good reasons for limiting access and justify careful monitoring of certain substances. Overly strict regulations, fear of legal consequences, stigma associated with abuse and populations using illicit drugs, and lack of funding may hinder research on their considerable therapeutic potential. We review the surprisingly sparse literature and address the particular ethical concerns of undue inducement, informed consent, risk to participants, researchers and institutions, justice and liberty germane to the research with illicit and addictive substances. We debate the disparate research stakeholder perspectives and why they are likely to be infected with bias. We propose an empirical research agenda to provide a more evidentiary basis for ethical reasoning. PMID:26982922

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-19

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

An exploratory research on the role of family in youth's drug addiction.

PubMed

Masood, Sobia; Us Sahar, Najam

2014-01-01

Most of the researches in Pakistan are concerned with the aetiological factors of drug addiction among the youth. However, few studies seek to explore the social aspects of this phenomenon. The present study aimed to explore the role of family, the influence of parental involvement, and communication styles in youth's drug addiction in a qualitative manner. Twenty drug addicts (age range 18-28 years) were taken as a sample from drug rehabilitation centres in Rawalpindi and Islamabad, Pakistan. A structured interview guide was administered comprising questions related to the individual's habits, relationship with family and friends, and modes of communication within the family. Case profiles of the participants were also taken. The rehabilitation centres offered family therapy and the researcher, as a non-participant, observed these sessions as part of the analysis. The demographic information revealed that majority of the participants were poly-substance abusers (80%) and the significant reasons for starting drugs were the company of peers and curiosity. The thematic analysis revealed parental involvement and emotional expressiveness as two major components in family communication. It was found that parents were concerned about their children, but were not assertive in the implementation of family rules. It was also found that the major life decisions of the participants were taken by their parents, which is a characteristic of collectivist Pakistani society.

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

PubMed

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

2018-01-23

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

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

PubMed

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

2012-07-01

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

Effect of drug reminder packaging on medication adherence: a systematic review revealing research gaps

PubMed Central

2014-01-01

Background This was a systematic review of the literature in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Evidence mapping was used to reveal the effect of drug reminder packaging on medication adherence, to identify research gaps and to make suggestions for future research. Methods PubMed, Embase, CINAHL and PsycINFO were searched with an end date of September 2013 using the Medical Subject Headings (MeSH) term ‘medication adherence’ and 20 different search terms for ‘drug reminder packaging’, limited to the English and German languages. Additional references were identified through cross-referencing. All prospective controlled trials with an intervention using drug reminder packaging for patients taking at least one medication without the assistance of a health-care professional were included in the evidence mapping of the effect of drug reminder packaging on adherence and outcomes according to the Economic, Clinical and Humanistic Outcomes (ECHO) model. Results A total of 30 studies met the inclusion criteria: 10 randomized controlled trials, 19 controlled clinical trials and 1 cohort study. Drug reminder packaging had a significant effect on at least one adherence parameter in 17 studies (57%). The methodological quality was strong in five studies. Two studies provided complete information. Clear research gaps emerged. Conclusions Overall, the studies showed a positive effect of drug reminder packaging on adherence and clinical outcomes. However, poor reporting and important gaps like missing humanistic and economic outcomes and neglected safety issues limit the drawing of firm conclusions. Suggestions are made for future research. PMID:24661495

DrugBank 4.0: shedding new light on drug metabolism.

PubMed

Law, Vivian; Knox, Craig; Djoumbou, Yannick; Jewison, Tim; Guo, An Chi; Liu, Yifeng; Maciejewski, Adam; Arndt, David; Wilson, Michael; Neveu, Vanessa; Tang, Alexandra; Gabriel, Geraldine; Ly, Carol; Adamjee, Sakina; Dame, Zerihun T; Han, Beomsoo; Zhou, You; Wishart, David S

2014-01-01

DrugBank (http://www.drugbank.ca) is a comprehensive online database containing extensive biochemical and pharmacological information about drugs, their mechanisms and their targets. Since it was first described in 2006, DrugBank has rapidly evolved, both in response to user requests and in response to changing trends in drug research and development. Previous versions of DrugBank have been widely used to facilitate drug and in silico drug target discovery. The latest update, DrugBank 4.0, has been further expanded to contain data on drug metabolism, absorption, distribution, metabolism, excretion and toxicity (ADMET) and other kinds of quantitative structure activity relationships (QSAR) information. These enhancements are intended to facilitate research in xenobiotic metabolism (both prediction and characterization), pharmacokinetics, pharmacodynamics and drug design/discovery. For this release, >1200 drug metabolites (including their structures, names, activity, abundance and other detailed data) have been added along with >1300 drug metabolism reactions (including metabolizing enzymes and reaction types) and dozens of drug metabolism pathways. Another 30 predicted or measured ADMET parameters have been added to each DrugCard, bringing the average number of quantitative ADMET values for Food and Drug Administration-approved drugs close to 40. Referential nuclear magnetic resonance and MS spectra have been added for almost 400 drugs as well as spectral and mass matching tools to facilitate compound identification. This expanded collection of drug information is complemented by a number of new or improved search tools, including one that provides a simple analyses of drug-target, -enzyme and -transporter associations to provide insight on drug-drug interactions.

Randomized trial of risk information formats in direct-to-consumer prescription drug advertisements.

PubMed

Aikin, Kathryn J; O'Donoghue, Amie C; Swasy, John L; Sullivan, Helen W

2011-01-01

Federal regulations specify that print advertisements for prescription drugs and biological products must provide a true statement of information "in brief summary" about each advertised product's "side effects, contraindications, and effectiveness." Some of the current approaches to fulfilling the brief summary requirement, although adequate from a regulatory perspective, result in ads that may be difficult to read and understand when used in consumer-directed promotion. . To explore ways in which the brief summary might be improved. . The authors conducted an experimental study that examined 300 consumers' (mall visitors ever told that they were overweight) understanding of and preference for 4 different brief summary formats: traditional (a plain-language version of the risk sections from professional labeling), question and answer (Q&A; with headings framed in the form of questions), highlights (a summary section from revised professional labeling), and prescription drug facts box (similar to the current over-the-counter drug facts label). . The format had several effects. For instance, participants who viewed the drug facts format were better able to recall risks (P < .01) and reported greater confidence to perform the tasks (P < .01) than those who saw the traditional format. Differences in preference were noted; for example, the drug facts format was ranked highest, followed by the Q&A format, the traditional format, and finally the highlights format, P < 0.001. . Taken together, these data suggest that the traditional method of conveying information in the brief summary is neither the most comprehensible nor the most preferred by consumers. These data provide policy makers and researchers with important information regarding the role of format in consumers' understanding of the brief summary.

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

PubMed

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

2014-05-01

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

Future technology insight: mass spectrometry imaging as a tool in drug research and development

PubMed Central

Cobice, D F; Goodwin, R J A; Andren, P E; Nilsson, A; Mackay, C L; Andrew, R

2015-01-01

In pharmaceutical research, understanding the biodistribution, accumulation and metabolism of drugs in tissue plays a key role during drug discovery and development. In particular, information regarding pharmacokinetics, pharmacodynamics and transport properties of compounds in tissues is crucial during early screening. Historically, the abundance and distribution of drugs have been assessed by well-established techniques such as quantitative whole-body autoradiography (WBA) or tissue homogenization with LC/MS analysis. However, WBA does not distinguish active drug from its metabolites and LC/MS, while highly sensitive, does not report spatial distribution. Mass spectrometry imaging (MSI) can discriminate drug and its metabolites and endogenous compounds, while simultaneously reporting their distribution. MSI data are influencing drug development and currently used in investigational studies in areas such as compound toxicity. In in vivo studies MSI results may soon be used to support new drug regulatory applications, although clinical trial MSI data will take longer to be validated for incorporation into submissions. We review the current and future applications of MSI, focussing on applications for drug discovery and development, with examples to highlight the impact of this promising technique in early drug screening. Recent sample preparation and analysis methods that enable effective MSI, including quantitative analysis of drugs from tissue sections will be summarized and key aspects of methodological protocols to increase the effectiveness of MSI analysis for previously undetectable targets addressed. These examples highlight how MSI has become a powerful tool in drug research and development and offers great potential in streamlining the drug discovery process. PMID:25766375

Improving postapproval drug safety surveillance: getting better information sooner.

PubMed

Hennessy, Sean; Strom, Brian L

2015-01-01

Adverse drug events (ADEs) are an important public health concern, accounting for 5% of all hospital admissions and two-thirds of all complications occurring shortly after hospital discharge. There are often long delays between when a drug is approved and when serious ADEs are identified. Recent and ongoing advances in drug safety surveillance include the establishment of government-sponsored networks of population databases, the use of data mining approaches, and the formal integration of diverse sources of drug safety information. These advances promise to reduce delays in identifying drug-related risks and in providing reassurance about the absence of such risks.

DrugBank 4.0: shedding new light on drug metabolism

PubMed Central

Law, Vivian; Knox, Craig; Djoumbou, Yannick; Jewison, Tim; Guo, An Chi; Liu, Yifeng; Maciejewski, Adam; Arndt, David; Wilson, Michael; Neveu, Vanessa; Tang, Alexandra; Gabriel, Geraldine; Ly, Carol; Adamjee, Sakina; Dame, Zerihun T.; Han, Beomsoo; Zhou, You; Wishart, David S.

2014-01-01

DrugBank (http://www.drugbank.ca) is a comprehensive online database containing extensive biochemical and pharmacological information about drugs, their mechanisms and their targets. Since it was first described in 2006, DrugBank has rapidly evolved, both in response to user requests and in response to changing trends in drug research and development. Previous versions of DrugBank have been widely used to facilitate drug and in silico drug target discovery. The latest update, DrugBank 4.0, has been further expanded to contain data on drug metabolism, absorption, distribution, metabolism, excretion and toxicity (ADMET) and other kinds of quantitative structure activity relationships (QSAR) information. These enhancements are intended to facilitate research in xenobiotic metabolism (both prediction and characterization), pharmacokinetics, pharmacodynamics and drug design/discovery. For this release, >1200 drug metabolites (including their structures, names, activity, abundance and other detailed data) have been added along with >1300 drug metabolism reactions (including metabolizing enzymes and reaction types) and dozens of drug metabolism pathways. Another 30 predicted or measured ADMET parameters have been added to each DrugCard, bringing the average number of quantitative ADMET values for Food and Drug Administration-approved drugs close to 40. Referential nuclear magnetic resonance and MS spectra have been added for almost 400 drugs as well as spectral and mass matching tools to facilitate compound identification. This expanded collection of drug information is complemented by a number of new or improved search tools, including one that provides a simple analyses of drug–target, –enzyme and –transporter associations to provide insight on drug–drug interactions. PMID:24203711

76 FR 60505 - Center for Drug Evaluation and Research, Approach to Addressing Drug Shortage; Public Workshop...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-29

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0690] Center for Drug Evaluation and Research, Approach to Addressing Drug Shortage; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug...

78 FR 8446 - Center for Drug Evaluation and Research; Prescription Drug Labeling Improvement and Enhancement...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-06

... products. \\5\\ Ibid. \\6\\ See http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 201, 314, and 601 [Docket No. FDA-2013-N-0059] Center for Drug Evaluation and Research; Prescription Drug Labeling...

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

PubMed

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.

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

Code of Federal Regulations, 2010 CFR

2010-04-01

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

Managing confidentiality in illicit drugs research: ethical and legal lessons from studies in remote Aboriginal communities.

PubMed

Clough, A; Conigrave, K

2008-01-01

Assuring participant confidentiality in illicit drugs research has raised legal questions and challenges both for researchers and ethics committees. There are similar challenges for clinicians. To study cannabis use in Aboriginal people in Arnhem Land (Northern Territory), a risk-management approach was successful. Aboriginal participants were informed in their own language that confidentiality could not be assured if they disclosed information about illegal behaviours. Researchers avoided questions of intrinsic interest to law enforcement. Relationships between researchers and study participants and the integrity of the study were preserved. These considerations have relevance for clinicians as well as researchers dealing with the influence of illicit behaviours on health.

Urine Testing for Drugs of Abuse. NIDA Research Monograph Series 73.

ERIC Educational Resources Information Center

Hawks, Richard L., Ed.; Chiang, C. Nora, Ed.

In the past 5 years, a growing concern over the use of illicit drugs in the workplace has led to an interest in urinalysis as a way to detect and deter drug use. This monograph provides information that will assist those involved in the planning or implementation of drug testing programs in making informed choices. Articles include: (1)…

GPs' opinions of public and industrial information regarding drugs: a cross-sectional study

PubMed Central

2011-01-01

Background General Practitioners {GP} in Sweden prescribe more than 50% of all prescriptions. Scientific knowledge on the opinions of GPs regarding drug information has been sparse. Such knowledge could be valuable when designing evidence-based drug information to GPs. GPs' opinions on public- and industry-provided drug information are presented in this article. Methods A cross-sectional study using a questionnaire was answered by 368 GPs at 97 primary-health care centres {PHCC}. The centres were invited to participate by eight out of 29 drug and therapeutic committees {DTCs}. A multilevel model was used to analyse associations between opinions of GPs regarding drug information and whether the GPs worked in public sector or in a private enterprise, their age, sex, and work experience. PHCC and geographical area were included as random effects. Results About 85% of the GPs perceived they received too much information from the industry, that the quality of public information was high and useful, and that the main task of public authorities was to increase the GPs' knowledge of drugs. Female GPs valued information from public authorities to a much greater extent than male GPs. Out of the GPs, 93% considered the main task of the industry was to promote sales. Differences between the GPs' opinions between PHCCs were generally more visible than differences between areas. Conclusions Some kind of incentives could be considered for PHCCs that actively reduce drug promotion from the industry. That female GPs valued information from public authorities to a much greater extent than male GPs should be taken into consideration when designing evidence-based drug information from public authorities to make implementation easier. PMID:21867497

Accelerating Alzheimer's disease drug innovations from the research pipeline to patients.

PubMed

Goldman, Dana P; Fillit, Howard; Neumann, Peter

2018-03-23

In June 2017, a diverse group of experts in Alzheimer's disease convened to discuss how to accelerate getting new drugs to patients to both prevent and treat the disease. Participants concluded that we need a more robust, diversified drug development pipeline. Strategic policy measures can help keep new Alzheimer's disease therapies (whether to treat symptoms, prevent onset, or cure) affordable for patients while supporting innovation and facilitating greater information sharing among payers, providers, researchers, and the public, including a postmarket surveillance study system, disease registries, innovative payment approaches, harmonizing federal agency review requirements, allowing conditional coverage for promising therapeutics and technology while additional data are collected, and opening up channels for drug companies to communicate with payers (and each other) about data and outcomes. To combat reimbursement issues, policy makers should address the latency time between potential treatment-which may be costly and fall on private payers-and societal benefits that accrue elsewhere. Copyright © 2018 the Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2002-01-01

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-16

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

[Drug information for patients (Package Leaflets), and user testing in EU].

PubMed

Yamamoto, Michiko; Doi, Hirohisa; Furukawa, Aya

2015-01-01

Patients and consumers have desired high quality drug information in their pharmacotherapy, and are entitled to receive it. It is desirable that the information should be aimed at shared decision-making between patients and healthcare professionals about medications. The quality of drug information available to patients should also be assured. With an aim to improve the quality of "Drug Guide for Patients", we investigated Patient Information Leaflets (PILs) which are approved by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (UK) with regard to the criteria of development and user testing for assuring the quality of the PILs. In the European Union (EU), these are called Package Leaflets (PLs). PILs have been a legal requirement in the UK since 1999 for all medications. The user testing of PILs has been implemented as evidence since 2005 so that people can rely on the information provided in the leaflet. Execution of PILs which follow the guidance of the user testing, according to the guidance of this user testing, would reflect the views of patients. Here, we introduce the development process and implementation of user testing of PILs. In terms of readability, accessibility and understandability of drug information for patients, we need to discuss involving the public in decisions on how its quality should be assured and how it can be made easily be comprehensible for patients, in order to make effective use of "Drug Guide for Patients" in the future in Japan.

Content and Usability Evaluation of Patient Oriented Drug-Drug Interaction Websites.

PubMed

Adam, Terrence J; Vang, Joseph

Drug-Drug Interactions (DDI) are an important source of preventable adverse drug events and a common reason for hospitalization among patients on multiple drug therapy regimens. DDI information systems are important patient safety tools with the capacity to identify and warn health professionals of clinically significant DDI risk. While substantial research has been completed on DDI information systems in professional settings such as community, hospital, and independent pharmacies; there has been limited research on DDI systems offered through online websites directly for use by ambulatory patients. The focus of this project is to test patient oriented website capacity to correctly identify drug interactions among well established and clinically significant medication combinations and convey clinical risk data to patients. The patient education capability was assessed by evaluating website Information Capacity, Patient Usability and Readability. The study results indicate that the majority of websites identified which met the inclusion and exclusion criteria operated similarly, but vary in risk severity assessment and are not optimally patient oriented to effectively deliver risk information. The limited quality of information and complex medical term content complicate DDI risk data conveyance and the sites may not provide optimal information delivery to allow medication consumers to understand and manage their medication regimens.

Evaluation of adverse drug event information in US manufacturer labels.

PubMed

Harrington, Catherine A; Garcia, Angela S; Sircar-Ramsewak, Feroza

2011-02-01

Pharmaceutical manufacturer labels are an important source of adverse drug event (ADE) information. The study objective was to determine the sufficiency of ADE reporting in US drug labels. A sample of 50 labels was evaluated from the top 200 drugs dispensed in the US. Electronic copies of labels were obtained and reviewed by 2 pharmacists for ADE incidence and discontinuation data. ADE incidence data were provided in 86% of labels. However, discontinuation rates due to ADEs and ADE incidence by dose were only reported in 60%. ADE incidence reporting by age (46%) or gender (18%) was also low. ADEs that occurred in less than 2% of the population were rarely reported. Incidence rates were based on small populations (median of 794) and short term studies (median of 84 days for chronic conditions). Labels for 19 drugs used chronically had no long term study data. Methods for collecting ADE data were stated in only 12% of labels. Adverse drug event and drug discontinuation data is under-reported in US labels. More information on adverse events causing discontinuation (especially serious events) and those related to dose, age, and gender is needed in labels to ensure safe prescribing and dispensing of drugs.

Assessment of drug information resource preferences of pharmacy students and faculty

PubMed Central

Hanrahan, Conor T.; Cole, Sabrina W.

2014-01-01

A 39-item survey instrument was distributed to faculty and students at Wingate University School of Pharmacy to assess student and faculty drug information (DI) resource use and access preferences. The response rate was 81% (n = 289). Faculty and professional year 2 to 4 students preferred access on laptop or desktop computers (67% and 75%, respectively), followed by smartphones (27% and 22%, respectively). Most faculty and students preferred using Lexicomp Online for drug information (53% and 74%, respectively). Results indicate that DI resources use is similar between students and faculty; laptop or desktop computers are the preferred platforms for accessing drug information. PMID:24860270

Research on Substance Abuse: Alcohol, Drugs, Tobacco. Matrix No. 14.

ERIC Educational Resources Information Center

Robins, Lee N.

In the last few years, a vast amount of research has accumulated with respect to American children's use of legal and illicit drugs. This research has included cross-sectional studies (which have attempted to determine current drug usage, age of onset for each drug used, and maximum frequency of use in the lifetime); longitudinal studies (which…

Advances in drug metabolism and pharmacogenetics research in Australia.

PubMed

Mackenzie, Peter I; Somogyi, Andrew A; Miners, John O

2017-02-01

Metabolism facilitates the elimination, detoxification and excretion in urine or bile (as biotransformation products) of a myriad of structurally diverse drugs and other chemicals. The metabolism of drugs, non-drug xenobiotics and many endogenous compounds is catalyzed by families of drug metabolizing enzymes (DMEs). These include the hemoprotein-containing cytochromes P450, which function predominantly as monooxygenases, and conjugation enzymes that transfer a sugar, sulfate, acetate or glutathione moiety to substrates containing a suitable acceptor functional group. Drug and chemical metabolism, especially the enzymes that catalyse these reactions, has been the research focus of several groups in Australia for over four decades. In this review, we highlight the role of recent and current drug metabolism research in Australia, including elucidation of the structure and function of enzymes from the various DME families, factors that modulate enzyme activity in humans (e.g. drug-drug interactions, gene expression and genetic polymorphism) and the application of in vitro approaches for the prediction of drug metabolism parameters in humans, along with the broader pharmacological/clinical pharmacological and toxicological significance of drug metabolism and DMEs and their relevance to drug discovery and development, and to clinical practice. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

PubMed

Tsao, J C

1997-01-01

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

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

PubMed

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

1990-04-01

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

Drugs and Addict Lifestyles. National Institute on Drug Abuse Research Issues 7.

ERIC Educational Resources Information Center

Ferguson, Patricia, Ed.; And Others

This report is the seventh in a series intended to summarize the empirical research findings and major theoretical approaches relating to the issues of drug use and abuse. This volume reviews the research undertaken to describe the lifestyle histories of heroin users. These research findings are formulated and detailed to provide the reader with…

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

PubMed

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

2016-05-01

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

Perceptions of financial payment for research participation among African-American drug users in HIV studies.

PubMed

Slomka, Jacquelyn; McCurdy, Sheryl; Ratliff, Eric A; Timpson, Sandra; Williams, Mark L

2007-10-01

Financial compensation for participating in research is controversial, especially when participants are recruited from economically disadvantaged and/or marginalized populations such as drug users. Little is known about these participants' own views regarding payment for research participation. The objective of the study was to elicit underserved minority drug users' views about monetary payments for participating in research. Semi-structured in-depth interview study of motivations for and perceptions of participation in research was used. Thirty-seven adult, economically disadvantaged African-American crack cocaine smokers were the participants of the study. Participants were recruited from among those taking part in three HIV prevention studies. Interviews were conducted at one of 2 research field offices located in underserved minority neighborhoods in Houston, Texas. Interviews lasting 30-45 min were recorded, transcribed, coded, and analyzed for categories and themes using both conventional and directed qualitative content analysis. This report addresses themes under the broad category of financial motivations for participating in research. Participants viewed monetary payment for research as essential to attract participation and desirable to provide optional income. Payment for research participation was perceived as one potential income source among others. Participants considered self-determination a prerogative for themselves and others. They rejected the notion of payment for participation as encouraging drug use or as inducing risk taking. Research regulators should consider participants' views of their desires and capacity for autonomous decisions about financial compensation for research rather than assume participants' diminished capacity due to poverty and/or drug use. Payment for research participation appears to be part of the "informal economy" that has been observed in underserved communities.

Ethnographic research in immigrant-specific drug abuse recovery houses.

PubMed

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.

Healthcare Databases for Drug Safety Research: Data Validity Assessment Remains Crucial.

PubMed

Rawson, Nigel S B; D'Arcy, Carl

2018-04-30

Administrative healthcare utilization databases are frequently used either individually or as a component of aggregated data for evaluating drug safety issues without taking into account their known deficiencies. All too often insufficient evidence is provided about their validity for the purposes for which they are used. The assessment of data validity is a key constituent that should be included in drug safety research studies and should take a broad multifaceted approach that encompasses both diagnostic and drug exposure data. Drug safety researchers need to continue advancing their knowledge of the data resources they use and to ensure that they and the users of their research understand the limitations of the data that are the foundation on which their research is built. Fundamental issues regarding data validity should be addressed in each use of administrative data for drug safety research.

Gore offers to help drug companies pursue research.

PubMed

1996-03-08

A meeting convened between Vice President Al Gore and executives of leading pharmaceutical companies to determine means of accelerating efforts to develop vaccines, therapeutics, and microbicides for people with HIV. Gore explained that the administration will work with pharmaceutical companies to determine the long-term effectiveness of drugs approved by the Food and Drug Administration (FDA), work with international groups to increase investment in vaccine development, help develop new microbicides for women with HIV, and identify promising areas of AIDS research. According to advocates, the Clinton Administration has made great strides in improving and accelerating the FDA's drug approval process. The next goal of the pharmaceutical research agenda should be to include consumer advocates in the decision-making process.

Pharmacogenomic Testing for Neuropsychiatric Drugs: Current Status of Drug Labeling, Guidelines for Using Genetic Information, and Test Options

PubMed Central

Drozda, Katarzyna; Müller, Daniel J.; Bishop, Jeffrey R.

2014-01-01

Advancements in pharmacogenomics have introduced an increasing number of opportunities to bring personalized medicine into clinical practice. Understanding how and when to use this technology to help guide pharmacotherapy used to treat neuropsychiatric conditions remains a challenge for many clinicians. Currently, guidelines exist to assist clinicians in the use of genetic information for drug selection and/or dosing for the tricyclic antidepressants, carbamazepine, and phenytoin. Additional language in the product labeling suggests that genetic information may also be useful for assessing the starting and target doses, as well as drug interaction potential, for a number of other medications used to treat psychiatric and neurological conditions. In this review, we outline the current status of pharmacogenomic testing for neuropsychiatric drugs as it pertains to information contained in drug labeling, consensus guidelines, and test panels, as well as considerations related to obtaining tests for patients. PMID:24523097

The Needs and Resources of Drug Information at Community Pharmacies in Gondar Town, Northwest Ethiopia.

PubMed

Asmelashe Gelayee, Dessalegn; Binega Mekonnen, Gashaw; Birarra, Mequanent Kassa

2017-01-01

Community pharmacists are in a key position to provide information on drugs and thus promote the rational use of drugs. The present study was designed to determine the needs and resources of drug information in community pharmacies. A prospective institution based cross-sectional study was carried out and data were collected on 48 community pharmacists in Gondar, Northwest Ethiopia, using interviewer administered structured questionnaire. Almost all pharmacists ( N = 47, 97.9%) often receive drug related queries and these were mainly from consumers ( N = 41, 85.4%). While most questions relate to drug price ( N = 29, 60.4%) and dosage ( N = 21, 43.8%), the information resources mainly referred to were drug package inserts and national standard treatment guidelines. However, limited availability of information resources as well as limited ability to retrieve relevant information influenced the practice of pharmacists. Female pharmacists claimed better use of different information resources than males ( P < 0.05). Community pharmacists in Gondar, Northwest Ethiopia, are often accessed for drug related information. But there are limitations in using up to date and most reliable resources. Therefore, intervention aimed at improving pharmacists' access to and evaluation of drug information is urgently needed.

Provincial drug plan officials' views of the Canadian drug safety system.

PubMed

Lexchin, Joel; Wiktorowicz, Mary; Moscou, Kathy; Eggertson, Laura

2013-06-01

The Canadian constitution divides the responsibility for pharmaceuticals between the federal and provincial governments. While the provincial governments are responsible for establishing public formularies, the majority of the safety and efficacy information that the provinces use comes from the federal government. We interviewed drug plan officials from eight of the ten provinces and two of three territories regarding their views on the Canadian drug safety system. Here we report on the following categories: the federal drug approval system; the strengths and weaknesses of the federal system of postmarket pharmaceutical safety (i.e., pharmacosurveillance); resources available to support provincial formulary decision making; provincial roles in pharmacosurveillance; how the drug safety system could be improved; and the role of the Drug Safety and Effectiveness Network, a recently established virtual network designed to connect researchers throughout Canada who conduct postmarket drug research. Next, we place the Canadian system within an international context by comparing informational asymmetry between government institutions in the United States and the European Union and by looking at how institutions support each other's roles in sharing information and in jointly developing policy through the International Conference on Harmonization. Finally, we draw on international experiences and suggest potential solutions to the concerns that our key informants have identified.

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

PubMed

Tyrawski, Jennifer; DeAndrea, David C

2015-06-01

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

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

PubMed Central

2015-01-01

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

Emergence of Chinese drug discovery research: impact of hit and lead identification.

PubMed

Zhou, Caihong; Zhou, Yan; Wang, Jia; Zhu, Yue; Deng, Jiejie; Wang, Ming-Wei

2015-03-01

The identification of hits and the generation of viable leads is an early and yet crucial step in drug discovery. In the West, the main players of drug discovery are pharmaceutical and biotechnology companies, while in China, academic institutions remain central in the field of drug discovery. There has been a tremendous amount of investment from the public as well as private sectors to support infrastructure buildup and expertise consolidation relative to drug discovery and development in the past two decades. A large-scale compound library has been established in China, and a series of high-impact discoveries of lead compounds have been made by integrating information obtained from different technology-based strategies. Natural products are a major source in China's drug discovery efforts. Knowledge has been enhanced via disruptive breakthroughs such as the discovery of Boc5 as a nonpeptidic agonist of glucagon-like peptide 1 receptor (GLP-1R), one of the class B G protein-coupled receptors (GPCRs). Most of the original hit identification and lead generation were carried out by academic institutions, including universities and specialized research institutes. The Chinese pharmaceutical industry is gradually transforming itself from manufacturing low-end generics and active pharmaceutical ingredients to inventing new drugs. © 2014 Society for Laboratory Automation and Screening.

A Review of Alcohol and Other Drug Control Policy Research

PubMed Central

Treno, Andrew J.; Marzell, Miesha; Gruenewald, Paul J.; Holder, Harold

2014-01-01

Objective: This article provides a historical review of alcohol and other drug policy research and its impact on public health over the past 75 years. We begin our summary with the state of the field circa 1940 and trace the development across the subsequent decades. We summarize current thinking and suggest possible future directions the field of alcohol and other drug policy may take. Specific topics discussed include the minimum legal drinking age, pricing and taxation, hours and days of sale, outlet density, and privatization effects. The future of drug policy research is also considered. Method: A comprehensive search of the literature identified empirical studies, reviews, and commentaries of alcohol and other drug policy research published from 1940 to 2013 that contributed to the current state of the field. Results: Our review demonstrates the historical emergence of alcohol problems as a public health issue over the early part of the 20th century, the public health policy response to this issue, subsequent research, and current and future research trends. Conclusions: Alcohol and other drug policy research over the last several decades has made great strides in its empirical and theoretical sophistication of evaluating alcohol policy effects. This history is not only remarkable for its analytic complexity, but also for its conceptual sophistication. PMID:24565316

Drug abuse in Vietnam: a critical review of the literature and implications for future research.

PubMed

Nguyen, Van T; Scannapieco, Maria

2008-04-01

To provide an overall picture of drug abuse in Vietnam, its prevalence, correlates and patterns. Studies addressing the drug abuse problem in Vietnam are reviewed. Attention is paid to studies conducted from 1993 onwards. The reviewed studies were collected from both refereed and non-refereed sources. Drug abuse is rising sharply in Vietnam: almost threefold over the past 10 years. From a predominantly rural-mountainous phenomenon, illicit drug abuse spread rapidly to urban areas. Meanwhile, the average age of drug users has declined and more women have been engaging in drug consumption. At the same time, heroin has replaced opium as the most preferred drug in the country's illicit drug market, especially among young users in urban areas. At the national level, the second main route of drug administration, injecting, has exceeded smoking and taken precedence in the country's drug abuse culture, especially among heroin users. Drug abuse in Vietnam has changed radically over the past decade, which has implications for the national and international community and requires further research to fill the knowledge gap and to inform intervention policy for better drug control policy.

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

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Data and information about Food and Drug... Data and information about Food and Drug Administration employees. (a) The name, title, grade, position... are available for public disclosure. The home address and home telephone number of any such employee...

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

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Data and information about Food and Drug... Data and information about Food and Drug Administration employees. (a) The name, title, grade, position... are available for public disclosure. The home address and home telephone number of any such employee...

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

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Data and information about Food and Drug... Data and information about Food and Drug Administration employees. (a) The name, title, grade, position... are available for public disclosure. The home address and home telephone number of any such employee...

Drugs and Pregnancy: The Effects of Nonmedical Use of Drugs on Pregnancy, Childbirth, and Neonates. National Institute on Drug Abuse Research Issues 5.

ERIC Educational Resources Information Center

Ferguson, Patricia, Ed.; And Others

The National Institute on Drug Abuse presents this report as the fifth in a series intended to summarize the empirical research findings and major theoretical approaches relating to the the issues of drug use and abuse. Included in this volume are summaries of the major research findings concerning the effects of nonmedical drug use on pregnancy.…

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

DOT National Transportation Integrated Search

1980-03-01

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

Drugs and Crime: The Relationship of Drug Use and Concomitant Criminal Behavior. Research Issues 17.

ERIC Educational Resources Information Center

Austin, Gregory A., Ed.; Lettieri, Dan J., Ed.

This volume of abstracts of major research and theoretical studies dealing with the relationship between drug use, criminal behavior and the law is concerned with criminal acts other than the possession of, or trafficking in, illicit drugs. Included are 107 selected studies categorized into seven major topic areas: Reviews and Theories, Drug Use…

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

ERIC Educational Resources Information Center

Santa Cruz County Superintendent of Schools, CA.

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

The role of public-sector research in the discovery of drugs and vaccines.

PubMed

Stevens, Ashley J; Jensen, Jonathan J; Wyller, Katrine; Kilgore, Patrick C; Chatterjee, Sabarni; Rohrbaugh, Mark L

2011-02-10

Historically, public-sector researchers have performed the upstream, basic research that elucidated the underlying mechanisms of disease and identified promising points of intervention, whereas corporate researchers have performed the downstream, applied research resulting in the discovery of drugs for the treatment of diseases and have carried out development activities to bring them to market. However, the boundaries between the roles of the public and private sectors have shifted substantially since the dawn of the biotechnology era, and the public sector now has a much more direct role in the applied-research phase of drug discovery. We identified new drugs and vaccines approved by the Food and Drug Administration (FDA) that were discovered by public-sector research institutions (PSRIs) and classified them according to their therapeutic category and potential therapeutic effect. We found that during the past 40 years, 153 new FDA-approved drugs, vaccines, or new indications for existing drugs were discovered through research carried out in PSRIs. These drugs included 93 small-molecule drugs, 36 biologic agents, 15 vaccines, 8 in vivo diagnostic materials, and 1 over-the-counter drug. More than half of these drugs have been used in the treatment or prevention of cancer or infectious diseases. PSRI-discovered drugs are expected to have a disproportionately large therapeutic effect. Public-sector research has had a more immediate effect on improving public health than was previously realized.

Alcohol and Other Drug Use: The Connection to Youth Suicide. Abstracts of Selected Research.

ERIC Educational Resources Information Center

Laws, Kathy; Turner, Amy

This publication provides the reader with an overview of the research done on the connection between the use of alcohol and other drugs and the ideation and/or completion of suicide among adolescents. It also provides information and resources on how to develop a youth suicide prevention program. The introduction gives a brief overview of the…

The Needs and Resources of Drug Information at Community Pharmacies in Gondar Town, Northwest Ethiopia

PubMed Central

Birarra, Mequanent Kassa

2017-01-01

Background Community pharmacists are in a key position to provide information on drugs and thus promote the rational use of drugs. Objectives The present study was designed to determine the needs and resources of drug information in community pharmacies. Methods A prospective institution based cross-sectional study was carried out and data were collected on 48 community pharmacists in Gondar, Northwest Ethiopia, using interviewer administered structured questionnaire. Results Almost all pharmacists (N = 47, 97.9%) often receive drug related queries and these were mainly from consumers (N = 41, 85.4%). While most questions relate to drug price (N = 29, 60.4%) and dosage (N = 21, 43.8%), the information resources mainly referred to were drug package inserts and national standard treatment guidelines. However, limited availability of information resources as well as limited ability to retrieve relevant information influenced the practice of pharmacists. Female pharmacists claimed better use of different information resources than males (P < 0.05). Conclusions Community pharmacists in Gondar, Northwest Ethiopia, are often accessed for drug related information. But there are limitations in using up to date and most reliable resources. Therefore, intervention aimed at improving pharmacists' access to and evaluation of drug information is urgently needed. PMID:28951876

Use of comparative effectiveness research in drug coverage and pricing decisions: a six-country comparison.

PubMed

Sorenson, Corinna

2010-07-01

Comparative effectiveness research (CER) has assumed an increasing role in drug coverage and, in some cases, pricing decisions in Europe, as decision-makers seek to obtain better value for money. This issue brief comparatively examines the use of CER across six countries--Denmark, England, France, Germany, the Netherlands, and Sweden. With CER gaining traction in the United States, these international experiences offer insights and potential lessons. Investing in CER can help address the current gap in publicly available, credible, up-to-date, and scientifically based comparative information on the effectiveness of drugs and other health interventions. This information can be used to base coverage and pricing decisions on evidence of value, thereby facilitating access to and public and private investment in the most beneficial new drugs and technologies. In turn, use of CER creates incentives for more efficient, high-quality health care and encourages development of innovative products that offer measurable value to patients.

Management Information Systems Research.

DTIC Science & Technology

Research on management information systems is illusive in many respects. Part of the basic research problem in MIS stems from the absence of standard...decision making. But the transition from these results to the realization of ’satisfactory’ management information systems remains difficult indeed. The...paper discusses several aspects of research on management information systems and reviews a selection of efforts that appear significant for future progress. (Author)

Drug-resistant tuberculosis in Mumbai, India: An agenda for operations research

PubMed Central

Mistry, Nerges; Tolani, Monica; Osrin, David

2012-01-01

Operations research (OR) is well established in India and is also a prominent feature of the global and local agendas for tuberculosis (TB) control. India accounts for a quarter of the global burden of TB and of new cases. Multidrug-resistant TB is a significant problem in Mumbai, India’s most populous city, and there have been recent reports of totally resistant TB. Much thought has been given to the role of OR in addressing programmatic challenges, by both international partnerships and India’s Revised National TB Control Programme. We attempt to summarize the major challenges to TB control in Mumbai, with an emphasis on drug resistance. Specific challenges include diagnosis of TB and defining cure, detecting drug resistant TB, multiple sources of health care in the private, public and informal sectors, co-infection with human immunodeficiency virus (HIV) and a concurrent epidemic of non-communicable diseases, suboptimal prescribing practices, and infection control. We propose a local agenda for OR: modeling the effects of newer technologies, active case detection, and changes in timing of activities, and mapping hotspots and contact networks; modeling the effects of drug control, changing the balance of ambulatory and inpatient care, and adverse drug reactions; modeling the effects of integration of TB and HIV diagnosis and management, and preventive drug therapy; and modeling the effects of initiatives to improve infection control. PMID:24501697

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-18

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

A Cross-Comparative Survey of Information Seeking and Scanning About Drug-Related Sources and Topics Among U.S. and Israeli College Students.

PubMed

Cheng, Ying; Ahn, Jisoo; Lewis, Nehama; Martinez, Lourdes S

2017-08-01

There is an increasing amount of drug-related information that is easily accessible from media and interpersonal sources. Recent research shows significant positive associations between information acquisition and nonmedical drug use intentions among college students. This study examines information about amphetamines and marijuana that was actively searched ("seeking") as well as information that was encountered during routine media use ("scanning"). Data are drawn from a cross-national comparative survey of college students in the United States (N = 734) and in Israel (N = 800). U.S. participants reported seeking and scanning information about marijuana across a broader range of sources than Israeli participants. Among U.S. and Israeli participants, the most frequently searched marijuana-related topics included the benefits of marijuana, negative effects of marijuana use, and political reasons why marijuana should be legal. Participants from both countries reported the benefits of amphetamines, and the negative effects of amphetamine use as the most frequently searched topics about amphetamines. Participants in both countries identified the internet and friends as the most popular sources of drug-related information and noted that physicians, friends, and the internet were the most trusted sources. Implications for research on information seeking and health communication are discussed.

Drug Themes in Science Fiction. National Institute on Drug Abuse Research Issues 9.

ERIC Educational Resources Information Center

Silverberg, Robert

This booklet is part of a series most of which focus on empirical research findings and major theoretical approaches in the area of drug usage. In this volume, the author has compiled a group of English-language short stories and novels which deal with the use of mind-altering drugs, all written since 1900 and falling within the literary category…

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

PubMed

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

2016-12-01

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

Drug information-seeking intention and behavior after exposure to direct-to-consumer advertisement of prescription drugs.

PubMed

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

2005-06-01

Concerns about direct-to-consumer advertisement's (DTCA's) information quality have raised interest in patients' drug information-seeking after DTCA exposure. To identify predictors of patients' intentions and behaviors to seek drug information from physicians, pharmacists, and the Internet after DTCA exposure, using theories of planned behavior and self-efficacy. One thousand patients were randomly selected from 3,000 nationwide osteoarthritic patients. A self-administered survey examined predictors of intention including measurements of attitude toward behavior, subjective norm, perceived difficulty, self-efficacy, controllability, self-identity, intention, exposure to ads, and control variables. After 6 weeks, another survey measured respondents' information-seeking behavior. For patients exposed to DTCA, 6 multiple regressions were performed for information-seeking intention and behavior for 3 information sources: physicians, pharmacists, and the Internet. The response rates were 61.9% and 80.1% for the first survey and the second survey, respectively. Four hundred and fifty-four participants reported exposure to DTCA about arthritis prescription medicines in the previous month. Over 41% of the variance in intention and over 18% of the variance in behavior were explained by the regression procedures. The consistent positive predictors of intention were attitude toward behavior, self-identity, attitude toward DTCAs of arthritis medication, and osteoarthritis pain; while the consistent positive predictors of behavior were intention and osteoarthritis pain. The strongest predictors of intention were self-identity for physicians, subjective norm for pharmacists, and attitude toward behavior for the Internet. Perceived difficulty and self-efficacy did not predict intention, and self-efficacy and controllability did not predict behavior. DTCA-prompted drug information-seeking may be under patients' complete volitional control. To promote information searching

Patient and Physician Perceptions of Drug Safety Information for Sleep Aids: A Qualitative Study.

PubMed

Kesselheim, Aaron S; McGraw, Sarah A; Dejene, Sara Z; Rausch, Paula; Dal Pan, Gerald J; Lappin, Brian M; Zhou, Esther H; Avorn, Jerry; Campbell, Eric G

2017-06-01

The US Food and Drug Administration uses drug safety communications (DSCs) to release emerging information regarding post-market safety issues, but it is unclear the extent of awareness by patients and providers of these communications and their specific recommendations. We conducted semi-structured interviews with patients and physicians to evaluate their awareness and understanding of emerging drug safety information related to two sleep aids: zolpidem or eszopiclone. We conducted interviews with 40 patients and ten physicians recruited from a combination of insurer claims databases and online sources. We evaluated (1) sources of drug safety information; (2) discussions between patients and physicians about the two medications; (3) their knowledge of the DSC; and (4) preferences for learning about future drug safety information. Interviews were transcribed and analyzed thematically. Patients cited their physicians, pharmacy inserts, and the Internet as sources of drug safety information. Physicians often referred to medical journals and online medical sources. Most patients reported being aware of information contained in the DSC summaries they were read. Almost all patients and physicians reported discussing side effects during patient-provider conversations, but almost no patients mentioned that physicians had communicated with them key messaging from the DSCs at issue: the risk of next-morning impairment with zolpidem and the lower recommended initial dose for women. Some risks of medications are effectively communicated to patients and physicians; however, there is still a noticeable gap between information issued by the Food and Drug Administration and patient and physician awareness of this knowledge, as well as patients' decisions to act on this information. Disseminators of emerging drug safety information should explore ways of providing user-friendly resources to patients and healthcare professionals that can update them on new risks in a timely manner.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-27

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

Evaluation of DILearn: An Interactive Computer-Assisted Learning Program for Drug Information.

ERIC Educational Resources Information Center

Tunget, Cynthia L.; And Others

1993-01-01

Use of an interactive computer-assisted learning program to teach basic skills in obtaining drug information was investigated with 26 doctoral pharmacy students and a control group of 25 students receiving lecture instruction. Findings indicated no significant differences in short-term retention of drug information between groups and that students…

Herb-drug, food-drug, nutrient-drug, and drug-drug interactions: mechanisms involved and their medical implications.

PubMed

Sørensen, Janina Maria

2002-06-01

Adverse drug reactions (ADRs) and iatrogenic diseases have been identified as significant factors responsible for patient morbidity and mortality. Significant studies on drug metabolism in humans have been published during the last few years, offering a deeper comprehension of the mechanisms underlying adverse drug reactions and interactions. More understanding of these mechanisms, and of recent advances in laboratory technology, can help to evaluate potential drug interactions when drugs are prescribed concurrently. Increasing knowledge of interindividual variation in drug breakdown capacity and recent findings concerning the influence of environment, diet, nutrients, and herbal products can be used to reduce ADRs and iatrogenic diseases. Reviewed data suggest that drug treatment should be increasingly custom tailored to suit the individual patient and that appropriately co-prescribed diet and herbal remedies, could increase drug efficacy and lessen drug toxicity. This review focuses mainly on recently published research material. The cytochrome p450 enzymes, their role in metabolism, and their mechanisms of action are reviewed, and their role in drug-drug interactions are discussed. Drug-food and drug-herb interactions have garnered attention. Interdisciplinary communication among medical herbalists, medical doctors, and dietetic experts needs to be improved and encouraged. Internet resources for obtaining current information regarding drug-drug, drug-herb, and drug-nutrient interactions are provided.

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

PubMed

Costerison, Emily C; Graham, Angie S

2008-04-01

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

Remote Sensing Information Sciences Research Group: Santa Barbara Information Sciences Research Group, year 4

NASA Technical Reports Server (NTRS)

Estes, John E.; Smith, Terence; Star, Jeffrey L.

1987-01-01

Information Sciences Research Group (ISRG) research continues to focus on improving the type, quantity, and quality of information which can be derived from remotely sensed data. Particular focus in on the needs of the remote sensing research and application science community which will be served by the Earth Observing System (EOS) and Space Station, including associated polar and co-orbiting platforms. The areas of georeferenced information systems, machine assisted information extraction from image data, artificial intelligence and both natural and cultural vegetation analysis and modeling research will be expanded.

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

PubMed

Farrugia, Adrian; Fraser, Suzanne

2017-11-01

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

Drug and poison information centres: An emergent need for health care professionals in Pakistan.

PubMed

Khaliq, Asif; Sayed, Sayeeda Amber

2016-06-01

To determine the need of drug and poison information centres in public and private hospitals of Karachi. The cross-sectional study was conducted at 3 public and 3 private tertiary care hospitals of Karachi, from July 2013 to April 2014, using a self-administered, multi-item questionnaire. Non-probability convenient sampling was used to select the participants. SPSS 18 was used to analyse data. Of the 307 physicians, 282(92%) highlighted the need for a 24/7 drug and poison information centre and 206(67%) suggested opening a drug information centre at the hospital. Besides, 215(70%) respondents said they took at least 15 minutes for searching information about the drug while managing a case. Regarding the poisoning case management, 160(52%) physicians complained about the unavailability of medicines in hospitals. Provision of 24 /7 drug information centres with specialised staff are necessary to reduce treatment delays and to ensure provision of quality healthcare.

Planning for management information systems in drug treatment organizations.

PubMed

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

1979-02-01

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

Drugs and the Elderly Adult. Research Issues 32.

ERIC Educational Resources Information Center

Glantz, Meyer D., Ed.; And Others

This book, on the nature and problems of inappropriate drug use by older adults, provides researchers and health practitioners with an up-to-date survey and overview of the literature on drug use, misuse, and abuse among the elderly. The volume provides abstracts of 100 selected scientific articles on the major topic areas in the field. The…

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

PubMed

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

2016-04-01

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

Tools, information sources, and methods used in deciding on drug availability in HMOs.

PubMed

Barner, J C; Thomas, J

1998-01-01

The use and importance of specific decision-making tools, information sources, and drug-use management methods in determining drug availability and use in HMOs were studied. A questionnaire was sent to 303 randomly selected HMOs. Respondents were asked to rate their use of each of four formal decision-making tools and its relative importance, as well as the use and importance of eight information sources and 11 methods for managing drug availability and use, on a 5-point scale. The survey response rate was 28%. Approximately half of the respondents reported that their HMOs used decision analysis or multiattribute analysis in deciding on drug availability. If used, these tools were rated as very important. There were significant differences in levels of use by HMO type, membership size, and age. Journal articles and reference books were reported most often as information sources. Retrospective drug-use review was used very often and perceived to be very important in managing drug use. Other management methods were used only occasionally, but the importance placed on these tools when used ranged from moderately to very important. Older organizations used most of the management methods more often than did other HMOs. Decision analysis and multiattribute analysis were the most commonly used tools for deciding on which drugs to make available to HMO members, and reference books and journal articles were the most commonly used information sources. Retrospective and prospective drug-use reviews were the most commonly applied methods for managing HMO members' access to drugs.

A research framework for pharmacovigilance in health social media: Identification and evaluation of patient adverse drug event reports.

PubMed

Liu, Xiao; Chen, Hsinchun

2015-12-01

Social media offer insights of patients' medical problems such as drug side effects and treatment failures. Patient reports of adverse drug events from social media have great potential to improve current practice of pharmacovigilance. However, extracting patient adverse drug event reports from social media continues to be an important challenge for health informatics research. In this study, we develop a research framework with advanced natural language processing techniques for integrated and high-performance patient reported adverse drug event extraction. The framework consists of medical entity extraction for recognizing patient discussions of drug and events, adverse drug event extraction with shortest dependency path kernel based statistical learning method and semantic filtering with information from medical knowledge bases, and report source classification to tease out noise. To evaluate the proposed framework, a series of experiments were conducted on a test bed encompassing about postings from major diabetes and heart disease forums in the United States. The results reveal that each component of the framework significantly contributes to its overall effectiveness. Our framework significantly outperforms prior work. Published by Elsevier Inc.

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

PubMed Central

Oshikoya, Kazeem A.; Senbanjo, Idowu O.; Soipe, Ayo

2008-01-01

Pharmaceutical advertisement of drugs is a means of advocating drug use and their selling but not a substitute for drug formulary to guide physicians in safe prescribing. Objectives: To evaluate drug advertisements in Nigerian and other African medical journals for their adequacy of pharmacological information. Methods: Twenty four issues from each of West African Journal of Medicine (WAJM), East African Medical Journal (EAMJ), South African Medical Journal (SAMJ), Nigerian Medical Practitioner (NMP), Nigerian Quarterly Journal of Hospital Medicine (NQJHM) and Nigerian Postgraduate Medical Journal (NPMJ) were reviewed. While EAMJ, SAMJ and NMP are published monthly, the WAJM, NQJHM and NPMJ are published quarterly. The monthly journals were reviewed between January 2005 and December 2006, and the quarterly journals between January 2001 and December 2006. The drug information with regards to brand/non-proprietary name, pharmacological data, clinical information, pharmaceutical information and legal aspects was evaluated as per World Health Organisation (WHO) criteria. Counts in all categories were collated for each advertiser. Results: Forty one pharmaceutical companies made 192 advertisements. 112 (58.3%) of these advertisements were made in the African medical journals. Pfizer (20.3%) and Swipha (12.5%) topped the list of the advertising companies. Four (2.1%) adverts mentioned generic names only, 157 (81.8%) mentioned clinical indications. Adults and children dosage (39.6%), use in special situations such as pregnancy and renal or liver problems (36.5%), adverse effects (30.2%), average duration of treatment (26.0%), and potential for interaction with other drugs (18.7%) were less discussed. Pharmaceutical information such as available dosage forms and product and package information {summary of the generic and proprietary names, the formulation strength, active ingredient, route of administration, batch number, manufactured and expiry dates, and the manufacturer

Values in a Science of Social Work: Values-Informed Research and Research-Informed Values

ERIC Educational Resources Information Center

Longhofer, Jeffrey; Floersch, Jerry

2014-01-01

While social work must be evaluative in relation to its diverse areas of practice and research (i.e., values-informed research), the purpose of this article is to propose that values are within the scope of research and therefore research on practice should make values a legitimate object of investigation (i.e., research-informed values). In this…

Bayesian Models Leveraging Bioactivity and Cytotoxicity Information for Drug Discovery

PubMed Central

Ekins, Sean; Reynolds, Robert C.; Kim, Hiyun; Koo, Mi-Sun; Ekonomidis, Marilyn; Talaue, Meliza; Paget, Steve D.; Woolhiser, Lisa K.; Lenaerts, Anne J.; Bunin, Barry A.; Connell, Nancy; Freundlich, Joel S.

2013-01-01

SUMMARY Identification of unique leads represents a significant challenge in drug discovery. This hurdle is magnified in neglected diseases such as tuberculosis. We have leveraged public high-throughput screening (HTS) data, to experimentally validate virtual screening approach employing Bayesian models built with bioactivity information (single-event model) as well as bioactivity and cytotoxicity information (dual-event model). We virtually screen a commercial library and experimentally confirm actives with hit rates exceeding typical HTS results by 1-2 orders of magnitude. The first dual-event Bayesian model identified compounds with antitubercular whole-cell activity and low mammalian cell cytotoxicity from a published set of antimalarials. The most potent hit exhibits the in vitro activity and in vitro/in vivo safety profile of a drug lead. These Bayesian models offer significant economies in time and cost to drug discovery. PMID:23521795

Evaluation of Drug Abuse Treatment Effectiveness: Summary of the DARP Followup Research. Treatment Research Report.

ERIC Educational Resources Information Center

Simpson, D. Dwayne; Sells, S. B.

The Drug Abuse Reporting Program (DARP) was initiated in 1969 as a federally supported client reporting system for community-based drug abuse treatment programs. Posttreatment follow-up interviews were conducted with over 4,000 persons from 34 treatment agencies to describe major findings from the drug abuse treatment research of the DARP relating…

Benefit and risk information in prescription drug advertising: review of empirical studies and marketing implications.

PubMed

Kopp, S W; Bang, H K

2000-01-01

As pharmaceutical companies began to advertise prescription drugs directly to consumers as well as to physicians, understanding the impact of benefit and risk information in drug advertising on physicians and consumers has become more critical. This paper reviews previous empirical studies that examined the content of benefit and risk information in drug advertising and its potential effects on physicians' subsequent prescribing behaviors. It also reviews studies that investigated how consumers process information on a drug's efficacy and side effects. Based on the findings of these studies, implications are discussed for effective marketing information development as well as for government regulation.

Drugs and Minorities. Research Issues 21.

ERIC Educational Resources Information Center

Austin, Gregory A., Ed.; And Others

This volume contains summaries of the latest research focusing on the issue of the extent of drug use and abuse among racial and ethnic minorities and the factors influencing it. Taken into consideration are age and sex differences among users, narcotics addiction, socioeconomic influences, cultural factors, racial factors, demographic factors,…

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-19

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

Interactions of dendrimers with biological drug targets: reality or mystery - a gap in drug delivery and development research.

PubMed

Ahmed, Shaimaa; Vepuri, Suresh B; Kalhapure, Rahul S; Govender, Thirumala

2016-07-21

Dendrimers have emerged as novel and efficient materials that can be used as therapeutic agents/drugs or as drug delivery carriers to enhance therapeutic outcomes. Molecular dendrimer interactions are central to their applications and realising their potential. The molecular interactions of dendrimers with drugs or other materials in drug delivery systems or drug conjugates have been extensively reported in the literature. However, despite the growing application of dendrimers as biologically active materials, research focusing on the mechanistic analysis of dendrimer interactions with therapeutic biological targets is currently lacking in the literature. This comprehensive review on dendrimers over the last 15 years therefore attempts to identify the reasons behind the apparent lack of dendrimer-receptor research and proposes approaches to address this issue. The structure, hierarchy and applications of dendrimers are briefly highlighted, followed by a review of their various applications, specifically as biologically active materials, with a focus on their interactions at the target site. It concludes with a technical guide to assist researchers on how to employ various molecular modelling and computational approaches for research on dendrimer interactions with biological targets at a molecular level. This review highlights the impact of a mechanistic analysis of dendrimer interactions on a molecular level, serves to guide and optimise their discovery as medicinal agents, and hopes to stimulate multidisciplinary research between scientific, experimental and molecular modelling research teams.

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

PubMed

Frost Widnes, Sofia K; Schjøtt, Jan

2008-01-01

Safety regarding use in pregnancy is not established for many drugs. Inconsistencies between sources providing drug information can give rise to confusion with possible therapeutic consequences. Therefore, it is important to measure clinically important differences between drug information sources. The objective of this study was to compare two easily accessible Norwegian sources providing advice on drug safety in pregnancy - the product monographs in the Felleskatalog (FK), published by the pharmaceutical companies, and the five regional Drug Information Centres (DICs) in Norway - in addition to assessing the frequency of questions regarding drug safety in pregnancy made to the DICs according to the Anatomical Therapeutic Chemical (ATC) classification system. Advice on drug use in pregnancy provided by the DICs in 2003 and 2005 were compared with advice in the product monographs for the respective drugs in the FK. Comparison of advice was based on categorization to one of four categories: can be used, benefit-risk assessment, should not be used, or no available information. A total of 443 drug advice were categorized. Seven out of ten of drugs frequently enquired about, according to the ATC system, were drugs acting on the nervous system (group N). For 208 (47%) of the drugs, advice differed between the DICs and FK. Advice from the FK was significantly (p < 0.01) more restrictive than advice from the DICs. There were no differences in the level of consistency of advice between drugs that were newly introduced and those that had been on the market for a longer time, advice regarding use of drugs in the first trimester and advice regarding use of drugs in the second or third trimester, or between advice provided during 2003 and during 2005. The results of this study show considerable differences between two Norwegian sources providing advice on the use of drugs in pregnancy. Based on the knowledge that healthcare providers choose sources of information in a random

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

DOT National Transportation Integrated Search

1980-06-01

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

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

PubMed

Gooblar, Jonathan; Carpenter, Brian D

2013-06-01

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

Optimising research to speed up availability of paediatric antiretroviral drugs and formulations

PubMed Central

Penazzato, M; Gnanashanmugam, D; Rojo, P; Lallemant, M; Lewis, L; Rocchi, F; Saint Raymond, A; Ford, N; Hazra, R; Giaquinto, C; Gibb, D; Abrams, Elaine J

2018-01-01

Globally 1.8 million children are estimated to be living with HIV, yet only 51% of those eligible actually start treatment. The completion of research and development (R&D) for paediatric antiretrovirals (ARVs) is a lengthy process and licensing of new paediatric ARVs continues to lag considerably behind adults. Providing safe, effective, and well-tolerated drugs for children remains critical to ensuring scale-up of paediatric treatment globally. In this manuscript we review current approaches to R&D for paediatric ARVs and suggest innovations to enable simplified, faster, and more comprehensive strategies to develop optimal formulations. Several approaches could be adopted, including enrolment of multiple age-cohorts concurrently and the early introduction of dosing approaches for both single and fixed-dose combination (FDC) drug formulations (preferably scored and dispersible) that match WHO weight-bands. Efforts to speed up development of optimal drugs and formulations for children should focus on a limited number of prioritised formulations. This work should build upon existing partnerships and collaborations to ensure that paediatric investigation plans are developed early in the drug development process but can be modified in a streamlined manner as more information becomes available. In addition, simplified and more efficient mechanisms to undertake R&D need to be put in place, and financing mechanisms must be made more efficient and sustainable. Registration, implementation, and strategic use of drugs should not be seen as a sequential process, with research designed to address multiple questions simultaneously to respond to the needs of HIV-infected children where they live. It is imperative that lessons learned from HIV should be shared to support progress in developing paediatric formulations for other diseases with similar treatment challenges, including tuberculosis and viral hepatitis. PMID:29190337

Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness.

PubMed

Boyce, Richard D; Horn, John R; Hassanzadeh, Oktie; Waard, Anita de; Schneider, Jodi; Luciano, Joanne S; Rastegar-Mojarad, Majid; Liakata, Maria

2013-01-26

Out-of-date or incomplete drug product labeling information may increase the risk of otherwise preventable adverse drug events. In recognition of these concerns, the United States Federal Drug Administration (FDA) requires drug product labels to include specific information. Unfortunately, several studies have found that drug product labeling fails to keep current with the scientific literature. We present a novel approach to addressing this issue. The primary goal of this novel approach is to better meet the information needs of persons who consult the drug product label for information on a drug's efficacy, effectiveness, and safety. Using FDA product label regulations as a guide, the approach links drug claims present in drug information sources available on the Semantic Web with specific product label sections. Here we report on pilot work that establishes the baseline performance characteristics of a proof-of-concept system implementing the novel approach. Claims from three drug information sources were linked to the Clinical Studies, Drug Interactions, and Clinical Pharmacology sections of the labels for drug products that contain one of 29 psychotropic drugs. The resulting Linked Data set maps 409 efficacy/effectiveness study results, 784 drug-drug interactions, and 112 metabolic pathway assertions derived from three clinically-oriented drug information sources (ClinicalTrials.gov, the National Drug File - Reference Terminology, and the Drug Interaction Knowledge Base) to the sections of 1,102 product labels. Proof-of-concept web pages were created for all 1,102 drug product labels that demonstrate one possible approach to presenting information that dynamically enhances drug product labeling. We found that approximately one in five efficacy/effectiveness claims were relevant to the Clinical Studies section of a psychotropic drug product, with most relevant claims providing new information. We also identified several cases where all of the drug-drug

Futurescapes: evidence expectations in the USA for comparative effectiveness research for drugs in 2020.

PubMed

Messner, Donna A; Mohr, Penny; Towse, Adrian

2015-08-01

Explore key factors influencing future expectations for the production of evidence from comparative effectiveness research for drugs in the USA in 2020 and construct three plausible future scenarios. Semistructured key informant interviews and three rounds of modified Delphi with systematic scenario-building methods. Most influential key factors were: health delivery system integration; electronic health record development; exploitation of very large databases and mixed data sources; and proactive patient engagement in research. The scenario deemed most likely entailed uneven development of large integrated health systems with pockets of increased provider risk for patient care, enhanced data collection systems, changing incentives to do comparative effectiveness research and new opportunities for evidence generation partnerships.

Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness

PubMed Central

2013-01-01

Out-of-date or incomplete drug product labeling information may increase the risk of otherwise preventable adverse drug events. In recognition of these concerns, the United States Federal Drug Administration (FDA) requires drug product labels to include specific information. Unfortunately, several studies have found that drug product labeling fails to keep current with the scientific literature. We present a novel approach to addressing this issue. The primary goal of this novel approach is to better meet the information needs of persons who consult the drug product label for information on a drug’s efficacy, effectiveness, and safety. Using FDA product label regulations as a guide, the approach links drug claims present in drug information sources available on the Semantic Web with specific product label sections. Here we report on pilot work that establishes the baseline performance characteristics of a proof-of-concept system implementing the novel approach. Claims from three drug information sources were linked to the Clinical Studies, Drug Interactions, and Clinical Pharmacology sections of the labels for drug products that contain one of 29 psychotropic drugs. The resulting Linked Data set maps 409 efficacy/effectiveness study results, 784 drug-drug interactions, and 112 metabolic pathway assertions derived from three clinically-oriented drug information sources (ClinicalTrials.gov, the National Drug File – Reference Terminology, and the Drug Interaction Knowledge Base) to the sections of 1,102 product labels. Proof-of-concept web pages were created for all 1,102 drug product labels that demonstrate one possible approach to presenting information that dynamically enhances drug product labeling. We found that approximately one in five efficacy/effectiveness claims were relevant to the Clinical Studies section of a psychotropic drug product, with most relevant claims providing new information. We also identified several cases where all of the drug-drug

Research Informing Practice--Practice Informing Research: Innovative Teaching Methologies for World Language Teachers. Research in Second Language Learning

ERIC Educational Resources Information Center

Schwarzer, David, Ed.; Petron, Mary, Ed.; Luke, Christopher, Ed.

2011-01-01

"Research Informing Practice--Practice Informing Research: Innovative Teaching Methodologies for World Language Educators" is an edited volume that focuses on innovative, nontraditional methods of teaching and learning world languages. Using teacher-research projects, each author in the volume guides readers through their own personal…

Curcumin and dietary polyphenol research: beyond drug discovery.

PubMed

Jin, Tian-Ru

2018-05-01

Numerous natural products available over the counter are commonly consumed by healthy, sub-healthy or ill people for the treatment and prevention of various chronic diseases. Among them, a few dietary polyphenols, including the curry compound curcumin, have been attracting the most attention from biomedical researchers and drug developers. Unlike many so-called "good drug candidates", curcumin and several other dietary polyphenols do not have a single known therapeutic target or defined receptor. In addition, the bioavailability of these polyphenols is usually very low due to their poor absorption in the gut. These recently debated features have created enormous difficulties for drug developers. In this review, I do not discuss how to develop curcumin, other dietary polyphenols or their derivatives into pharmaceutical agents. Instead, I comment on how curcumin and dietary polyphenol research has enriched our knowledge of insulin signaling, including the presentation of my perspectives on how these studies will add to our understanding of the famous hepatic insulin function paradox.

Annual Report of Drug and Poison Information in Iran From March 2012 to March 2013.

PubMed

Ghane, Talat; Behmanesh, Yasna; Khazei, Fardin

2016-08-01

Drug and Poison Information Centers (DPICs) have a critical role in the fulfillment of rational drug use programs and provide services to the scientific community with the aim of improving the health and safety of drug use. This was a retrospective study on recorded calls of DPICs in Iran from March 2012 to March 2013. Data consisted of general information; drug and poisoning information, medical history and also the distribution of a number of calls collected by DPICs in Iran. The centers received a total of 171769 calls. Most calls were made by the patients (56.1%) and then the patients' relatives (38%). Also, 67% of the patients were determined as female. The calls mostly were focused on Adverse Drug Reactions (ADR) (15.3%), indications (14.0%) and drug evaluations (11.8%). Anti-infective agents, non-steroidal anti-inflammatory drugs (NSAIDs) and vitamins with 9.6%, 7%, and 6.8% frequencies were the highest frequently asked questions, respectively. Based on the results, patients do not receive enough information about their medications, from physicians and pharmacists. The DPICs have an important role to guide the people and provide the accurate drug and poison information and fill the absence of information that is not provided by medical staff. So, based on the important role of these centers, it is worth the Iran DPICs being introduced more to people, and we need more advertising around the country.

DrugBank 5.0: a major update to the DrugBank database for 2018.

PubMed

Wishart, David S; Feunang, Yannick D; Guo, An C; Lo, Elvis J; Marcu, Ana; Grant, Jason R; Sajed, Tanvir; Johnson, Daniel; Li, Carin; Sayeeda, Zinat; Assempour, Nazanin; Iynkkaran, Ithayavani; Liu, Yifeng; Maciejewski, Adam; Gale, Nicola; Wilson, Alex; Chin, Lucy; Cummings, Ryan; Le, Diana; Pon, Allison; Knox, Craig; Wilson, Michael

2018-01-04

DrugBank (www.drugbank.ca) is a web-enabled database containing comprehensive molecular information about drugs, their mechanisms, their interactions and their targets. First described in 2006, DrugBank has continued to evolve over the past 12 years in response to marked improvements to web standards and changing needs for drug research and development. This year's update, DrugBank 5.0, represents the most significant upgrade to the database in more than 10 years. In many cases, existing data content has grown by 100% or more over the last update. For instance, the total number of investigational drugs in the database has grown by almost 300%, the number of drug-drug interactions has grown by nearly 600% and the number of SNP-associated drug effects has grown more than 3000%. Significant improvements have been made to the quantity, quality and consistency of drug indications, drug binding data as well as drug-drug and drug-food interactions. A great deal of brand new data have also been added to DrugBank 5.0. This includes information on the influence of hundreds of drugs on metabolite levels (pharmacometabolomics), gene expression levels (pharmacotranscriptomics) and protein expression levels (pharmacoprotoemics). New data have also been added on the status of hundreds of new drug clinical trials and existing drug repurposing trials. Many other important improvements in the content, interface and performance of the DrugBank website have been made and these should greatly enhance its ease of use, utility and potential applications in many areas of pharmacological research, pharmaceutical science and drug education. © The Author(s) 2017. Published by Oxford University Press on behalf of Nucleic Acids Research.

Problem-oriented drug information: physicians' expectations and impact on clinical practice.

PubMed

Hedegaard, U; Damkier, P

2009-05-01

Problem-oriented drug information (POD) is a service in which health professionals provide evidence-based answers to clinical questions posed by physicians. The objective of this study was to evaluate the user satisfaction and clinical impact of POD, to investigate predictors for use and to examine the kind of sources physicians search before applying for POD. To evaluate POD, a questionnaire was distributed with problem-oriented answers sent from a drug information centre to physicians during the period of April 2006 to March 2007. Of 197 questionnaires, 183 (93%) were returned. The information from the POD service was highly valued by the physicians, and 90% of the answers led to reported impact on clinical practice in the specific clinical situation. Furthermore, 74% of the answers were intended to be used in a wider context either for future patients (67%) or for dissemination to colleagues (51%). Secondary-care physicians more often than general practitioners (GPs) used the information for dissemination to colleagues (63 vs. 39%, P = 0.0008), while GPs more often used the answer to support patient information (88 vs. 70%, P = 0.0029). The most prominent motive for applying for POD was a request for evidence-based information (78%), and the service was used to overcome barriers to practicing evidence-based medicine such as lack of time (36%), skills for searching (26%), and appraising the literature (13%). Before inquiring, 74% of the physicians had tried other information sources; the most frequent sources used were a drug reference (68%) and consulting a colleague (24%). Secondary-care physicians reported fewer barriers than GPs when seeking information, and secondary-care physicians searched other sources more often than GPs before contacting the service (81 vs. 67%, P = 0.031). POD represents a useful source for acquiring evidence-based drug information by physicians. POD is highly valued by the users. It was reported to have an impact on clinical practice

Stage Theory and Research on Tobacco, Alcohol, and Other Drug Use.

ERIC Educational Resources Information Center

Werch, Chudley E.; Anzalone, Debra

1995-01-01

Examines the conceptual and empirical foundations of individual drug use stage development and progression related to tobacco, alcohol, and other drugs. Research examining interdrug use progression among youths supports the idea of a generally invariant sequence, involving nonuse to legal drug use, marijuana, and finally other illegal drug use.…

21 CFR 201.125 - Drugs for use in teaching, law enforcement, research, and analysis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Drugs for use in teaching, law enforcement, research, and analysis. 201.125 Section 201.125 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... § 201.125 Drugs for use in teaching, law enforcement, research, and analysis. A drug subject to § 201...

21 CFR 201.125 - Drugs for use in teaching, law enforcement, research, and analysis.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Drugs for use in teaching, law enforcement, research, and analysis. 201.125 Section 201.125 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... § 201.125 Drugs for use in teaching, law enforcement, research, and analysis. A drug subject to § 201...

21 CFR 201.125 - Drugs for use in teaching, law enforcement, research, and analysis.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Drugs for use in teaching, law enforcement, research, and analysis. 201.125 Section 201.125 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... § 201.125 Drugs for use in teaching, law enforcement, research, and analysis. A drug subject to § 201...

21 CFR 201.125 - Drugs for use in teaching, law enforcement, research, and analysis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drugs for use in teaching, law enforcement, research, and analysis. 201.125 Section 201.125 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... § 201.125 Drugs for use in teaching, law enforcement, research, and analysis. A drug subject to § 201...

21 CFR 201.125 - Drugs for use in teaching, law enforcement, research, and analysis.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Drugs for use in teaching, law enforcement, research, and analysis. 201.125 Section 201.125 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... § 201.125 Drugs for use in teaching, law enforcement, research, and analysis. A drug subject to § 201...

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

PubMed

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

2010-09-01

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

75 FR 47604 - Guidance for Industry on Drug Substance Chemistry, Manufacturing, and Controls Information...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-06

...] (formerly 2003D-0571) Guidance for Industry on Drug Substance Chemistry, Manufacturing, and Controls... Substance Chemistry, Manufacturing, and Controls Information.'' This guidance provides recommendations on the chemistry, manufacturing, and controls (CMC) information for drug substances that should be...

Illicit Drug Users in the Tanzanian Hinterland: Population Size Estimation Through Key Informant-Driven Hot Spot Mapping.

PubMed

Ndayongeje, Joel; Msami, Amani; Laurent, Yovin Ivo; Mwankemwa, Syangu; Makumbuli, Moza; Ngonyani, Alois M; Tiberio, Jenny; Welty, Susie; Said, Christen; Morris, Meghan D; McFarland, Willi

2018-02-12

We mapped hot spots and estimated the numbers of people who use drugs (PWUD) and who inject drugs (PWID) in 12 regions of Tanzania. Primary (ie, current and past PWUD) and secondary (eg, police, service providers) key informants identified potential hot spots, which we visited to verify and count the number of PWUD and PWID present. Adjustments to counts and extrapolation to regional estimates were done by local experts through iterative rounds of discussion. Drug use, specifically cocaine and heroin, occurred in all regions. Tanga had the largest numbers of PWUD and PWID (5190 and 540, respectively), followed by Mwanza (3300 and 300, respectively). Findings highlight the need to strengthen awareness of drug use and develop prevention and harm reduction programs with broader reach in Tanzania. This exercise provides a foundation for understanding the extent and locations of drug use, a baseline for future size estimations, and a sampling frame for future research.

Prevention Research: Deterring Drug Abuse among Children and Adolescents. NIDA Research Monograph 63. A RAUS Review Report.

ERIC Educational Resources Information Center

Bell, Catherine S., Ed.; Battjes, Robert, Ed.

Papers from the meeting "Prevention Research: Deterring Drug Abuse Among Children and Adolescents" which focused on social skills and social inoculation approaches and also included a contrasting cognitive-developmental approach are presented in this document. These papers are included: (1) "Overview of Drug Abuse Prevention Research," (Catherine…

Future Challenges and Opportunities in Online Prescription Drug Promotion Research

PubMed Central

Southwell, Brian G.; Rupert, Douglas J.

2016-01-01

Despite increased availability of online promotional tools for prescription drug marketers, evidence on online prescription drug promotion is far from settled or conclusive. We highlight ways in which online prescription drug promotion is similar to conventional broadcast and print advertising and ways in which it differs. We also highlight five key areas for future research: branded drug website influence on consumer knowledge and behavior, interactive features on branded drug websites, mobile viewing of branded websites and mobile advertisements, online promotion and non-US audiences, and social media and medication decisions. PMID:26927597

Research and development of anti-Alzheimer's disease drugs: an update from the perspective of technology flows.

PubMed

Liu, Kunmeng; Lin, Hui-Heng; Pi, Rongbiao; Mak, Shinghung; Han, Yifan; Hu, Yuanjia

2018-04-01

Today, over 20 million people suffer from Alzheimer's disease (AD) worldwide. AD has become a critical issue to human health, especially in aging societies, and therefore it is a research hotspot in the global scientific community. The technology flow method differs from traditional reviews generating an informative overview of the research and development (R&D) landscape in a specific technological area. We need such an updated method to get a general overview of the R&D of anti-AD drugs in light of the dramatic developments in this area in recent years. Areas covered: This study collects patent data from the Integrity database. A total of 399 patents with 821 internal citation pairs in the US from 1978 to 2017 were analyzed. Patent citation network analysis was used to visualize the technology relationship. Expert opinion: For better production of anti-AD drugs, governments should emphasize the multi-target drug design, provide policy support for private companies, and encourage multilateral cooperation. The β-amyloid peptide (Aβ) theory leaves much to be desired; neurotransmitter and tau protein hypotheses are worth further examination. The use of old drugs for new indications is promising, as are traditional herbal medicines.

Interdisciplinary Research and Information Overload.

ERIC Educational Resources Information Center

Wilson, Patrick

1996-01-01

Discusses information overload and examines several ways in which actual and potential overload affects research choices for the solo researcher in interdisciplinary areas. Topics include information overload and teamwork; entry barriers to certain specialties, including necessary background knowledge; and information utilization and knowledge…

[Does the public sector have an independent research role in the development of drugs?].

PubMed

Poulsen, Henrik Enghusen; Grønlykke, Thor Buch

2003-04-14

Exclusively private companies do drug development. The State contributes with education of academics and basic research constituting the basis of half of the drugs developed by the private companies. The Danish private drug research amounts to six billion DKK per year, corresponding to the estimated price of the development of one new drug. The development shows a negative tendency. There are doubts about the scientific credibility, the number of new drugs is declining, drug development costs are rising, and the competitiveness in Europe is declining compared with the one of The United States. Continued improvement of Danish drug development can be achieved by stimulation of the public research related to drug development.

Research Costs Investigated: A Study Into the Budgets of Dutch Publicly Funded Drug-Related Research.

PubMed

van Asselt, Thea; Ramaekers, Bram; Corro Ramos, Isaac; Joore, Manuela; Al, Maiwenn; Lesman-Leegte, Ivonne; Postma, Maarten; Vemer, Pepijn; Feenstra, Talitha

2018-01-01

The costs of performing research are an important input in value of information (VOI) analyses but are difficult to assess. The aim of this study was to investigate the costs of research, serving two purposes: (1) estimating research costs for use in VOI analyses; and (2) developing a costing tool to support reviewers of grant proposals in assessing whether the proposed budget is realistic. For granted study proposals from the Netherlands Organization for Health Research and Development (ZonMw), type of study, potential cost drivers, proposed budget, and general characteristics were extracted. Regression analysis was conducted in an attempt to generate a 'predicted budget' for certain combinations of cost drivers, for implementation in the costing tool. Of 133 drug-related research grant proposals, 74 were included for complete data extraction. Because an association between cost drivers and budgets was not confirmed, we could not generate a predicted budget based on regression analysis, but only historic reference budgets given certain study characteristics. The costing tool was designed accordingly, i.e. with given selection criteria the tool returns the range of budgets in comparable studies. This range can be used in VOI analysis to estimate whether the expected net benefit of sampling will be positive to decide upon the net value of future research. The absence of association between study characteristics and budgets may indicate inconsistencies in the budgeting or granting process. Nonetheless, the tool generates useful information on historical budgets, and the option to formally relate VOI to budgets. To our knowledge, this is the first attempt at creating such a tool, which can be complemented with new studies being granted, enlarging the underlying database and keeping estimates up to date.

Monetary Incentives Improve Recall of Research Consent Information: A Randomized Pilot Study

PubMed Central

Festinger, David S.; Marlowe, Douglas B.; Croft, Jason R.; Dugosh, Karen L.; Arabia, Patricia L.; Benasutti, Kathleen M.

2011-01-01

Research participants often fail to recall substantial amounts of informed consent information after delays of only a few days. Numerous interventions have proven effective at improving consent recall; however, virtually all have focused on compensating for potential cognitive deficits and have ignored motivational factors. In this pilot study, we randomly assigned 31 drug court clients participating in a clinical research trial to a standard consent procedure or to the same procedure plus incentives for correctly recalling consent information. The incentive group was told they would receive $5 for each of the 15 consent items they could answer correctly 1-week later. At the follow-up, the incentive group recalled a significantly greater percentage of consent information overall than the standard group (65% vs. 42%; p < .01). Similar findings were observed for specific categories of consent information, including study purpose and design, risks and benefits, and human subject protections. Effect sizes were all large (d = 0.89 to 1.25). Findings suggest that motivation plays a key role in recall of consent information and should be considered in the development of future interventions. PMID:19331486

Commercial speech and off-label drug uses: what role for wide acceptance, general recognition and research incentives?

PubMed

Gilhooley, Margaret

2011-01-01

approval. Distributions of information about unapproved uses should not be acceptable unless experts consider the expanded use to be generally recognized as safe and effective based on adequate studies. The last part of this paper considers the need to develop better research incentives to encourage more testing and post-market risk surveillance by drug makers on off-label uses of their drugs. Violations of the Federal Food Drug and Cosmetic Act (FFDCA) can be considered violations of the False Claims Act, which opens the way to fraud and abuse suits. The scale of penalties involved in these suits may lead to more examination of the scope of FDA regulation and commercial speech protections. Thus this symposium's consideration of these issues is timely and important.

The determinants of physician attitudes and subjective norms toward drug information sources: modification and test of the theory of reasoned action.

PubMed

Gaither, C A; Bagozzi, R P; Ascione, F J; Kirking, D M

1997-10-01

To improve upon the theory of reasoned action and apply it to pharmaceutical research, we investigated the effects of relevant appraisals attributes, and past behavior of physicians on the use of drug information sources. We also examined the moderating effects of practice characteristics. A mail questionnaire asked HMO physicians to evaluate seven common sources of drug information on general appraisals (degree of usefulness and ease of use), specific attributes (availability, quality of information on harmful effects and on drug efficacy), and past behavior when searching for information on a new, simulated H2 antagonist agent. Semantic differential scales were used to measure each appraisal, attribute and past behavior. Information was also collected on practice characteristics. Findings from 108/200 respondents indicated that appraisals and attributes were useful determinants of attitudes and subjective norms toward use. Degree of usefulness and quality of information on harmful effects were important predictors of attitudes toward use for several sources of information. Ease of use and degree of usefulness were important predictors of subjective norms toward use. In many cases, moderating effects of practice characteristics were in opposing directions. Past behavior had significant direct effects on attitudes toward the PDR. The findings suggest ways to improve the usefulness of the theory of reasoned action as a model of decision-making. We also propose practical guidelines that can be used to improve the types of drug information sources used by physicians.

Coffee shops and clinics: the give and take of doing HIV/AIDS research with injecting drug users.

PubMed

Marsh, A; Loxley, W

1992-06-01

We discuss recruiting and interviewing injecting drug users and using research as health promotion in the context of collecting information related to human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) from a convenience sample of 200 injecting drug users, half in treatment and half not, in 1989 and 1990 in Perth, Western Australia. A variety of recruiting methods were used including advertising, referral by agency staff, 'snowballing' and approaches to personal contacts and others known to inject by the interviewer. Snowballing and personal contacts were the most successful means of recruiting those not in treatment, while advertising was comparatively unsuccessful with this group because of the importance of establishing the credibility of the study and the interviewer among injecting drug users before they will volunteer to be involved. The promotion of behavioural risk reduction among respondents during the interview is detailed. We argue that the traditionally rigid separation between research and intervention is inappropriate in the HIV/AIDS context. When lives are potentially at stake, any contact with injecting drug users, especially those not in treatment (where may receive HIV/AIDS education), must be used as an HIV/AIDS prevention opportunity, and the interview is an ideal opportunity. The employment of research as community intervention is also discussed.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-15

..., Human Resources Division, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152... Administrator, Human Resources Division, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield... Administration (DEA) will be submitting the following information collection request to the Office of Management...

Experimental evaluation of the effects of drug information on antibiotic prescribing: a study in outpatient care in an area of Sri lanka.

PubMed

Angunawela, I I; Diwan, V K; Tomson, G

1991-06-01

The intervention level of epidemiology is useful for studying effects in health systems research. Due to practical and ethical reasons, it is often difficult to apply experimental methods such as classical randomized clinical trials in the field. However with alternative approaches such as 'randomization by group' some of these problems can be overcome. Drug information has since long been considered as an instrument to influence physicians, however evaluation of its effects is a new field of research. In the present study the impact of drug information on prescribing behaviour was evaluated in an outpatient setting in Sri Lanka. The study included 15 state health institutions (45 prescribers) with a common drug formulary. Groups of prescribers were randomized into two interventions; newsletters and newsletters reinforced by a group seminar, and one control group. The target topic was 'rational prescribing of antibiotics'. Some 18,766 randomly selected outpatient drug prescriptions were studied. Antibiotics (and sulphonamides) were prescribed to 33.2% of the patients. An overall trend towards a decrease in proportion of patients prescribed antibiotics in the two intervention groups was seen, although the difference was not significant (p greater than 0.05) compared to the control group. This is similar to the effect of written information on prescribing in other studies. A mean difference of -7.4% in written, -7.3% in written + seminar and -0.4% in the control group was shown. The general antibiotic prescribing pattern did not change in any of the three groups. Penicillin was the most commonly prescribed antibiotic and tetracycline was only rarely prescribed to children. This experiment indicates the feasibility of drug information intervention studies in developing countries.(ABSTRACT TRUNCATED AT 250 WORDS)

Drug Use Forecasting. 1993 Annual Report on Juvenile Arrestees/Detainees: Drugs and Crime in American Cities. Research in Brief.

ERIC Educational Resources Information Center

Department of Justice, Washington, DC. National Inst. of Justice.

This report offers data on juvenile drug use and crime so as to increase understanding of the dimensions of drug use among youthful offenders. The report includes information from collaborative efforts at both the Federal and the local levels. Data on male juvenile arrestees and detainees were collected in 12 Drug Use Forecasting (DUF) sites…

75 FR 77906 - Agency Information Collection Activities: Proposed Collection; Comments Requested: Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-14

..., Human Resources Division, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152... collection: Form number: DEA Form 341. Component: Human Resources Division, Drug Enforcement Administration... Administration (DEA), will be submitting the following information collection request to the Office of Management...

A review of geographic variation and Geographic Information Systems (GIS) applications in prescription drug use research.

PubMed

Wangia, Victoria; Shireman, Theresa I

2013-01-01

While understanding geography's role in healthcare has been an area of research for over 40 years, the application of geography-based analyses to prescription medication use is limited. The body of literature was reviewed to assess the current state of such studies to demonstrate the scale and scope of projects in order to highlight potential research opportunities. To review systematically how researchers have applied geography-based analyses to medication use data. Empiric, English language research articles were identified through PubMed and bibliographies. Original research articles were independently reviewed as to the medications or classes studied, data sources, measures of medication exposure, geographic units of analysis, geospatial measures, and statistical approaches. From 145 publications matching key search terms, forty publications met the inclusion criteria. Cardiovascular and psychotropic classes accounted for the largest proportion of studies. Prescription drug claims were the primary source, and medication exposure was frequently captured as period prevalence. Medication exposure was documented across a variety of geopolitical units such as countries, provinces, regions, states, and postal codes. Most results were descriptive and formal statistical modeling capitalizing on geospatial techniques was rare. Despite the extensive research on small area variation analysis in healthcare, there are a limited number of studies that have examined geographic variation in medication use. Clearly, there is opportunity to collaborate with geographers and GIS professionals to harness the power of GIS technologies and to strengthen future medication studies by applying more robust geospatial statistical methods. Copyright © 2013 Elsevier Inc. All rights reserved.

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

PubMed Central

Doran, Evan

2016-01-01

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

Medical consequences of drug abuse and co-occurring infections: research at the National Institute on Drug Abuse.

PubMed

Khalsa, Jag H; Treisman, Glenn; McCance-Katz, Elinore; Tedaldi, Ellen

2008-01-01

Substance abuse still remains one of the major problems in the world today, with millions of people abusing legal and illegal drugs. In addition, a billion people may also be infected with one or more infections. Both drugs of abuse and infections are associated with enormous burden of social, economic, and health consequences. This article briefly discusses a few medical consequences of drugs of abuse and infections such as human immunodeficiency virus, hepatitis C virus, psychiatric complications in hepatitis C infection, pharmacokinetic drug-drug interactions among medications used in the treatment of addiction and infections, and new drugs in development for the treatment of infections. Research is encouraged to study interactions between infections, drugs of abuse, and underlying pathophysiologic and molecular/genetic mechanisms of these interactions.

Linked open drug data for pharmaceutical research and development

PubMed Central

2011-01-01

There is an abundance of information about drugs available on the Web. Data sources range from medicinal chemistry results, over the impact of drugs on gene expression, to the outcomes of drugs in clinical trials. These data are typically not connected together, which reduces the ease with which insights can be gained. Linking Open Drug Data (LODD) is a task force within the World Wide Web Consortium's (W3C) Health Care and Life Sciences Interest Group (HCLS IG). LODD has surveyed publicly available data about drugs, created Linked Data representations of the data sets, and identified interesting scientific and business questions that can be answered once the data sets are connected. The task force provides recommendations for the best practices of exposing data in a Linked Data representation. In this paper, we present past and ongoing work of LODD and discuss the growing importance of Linked Data as a foundation for pharmaceutical R&D data sharing. PMID:21575203

7 CFR 1220.230 - Promotion, research, consumer information, and industry information.

Code of Federal Regulations, 2014 CFR

2014-01-01

... industry information. 1220.230 Section 1220.230 Agriculture Regulations of the Department of Agriculture... Research Order Expenses and Assessments § 1220.230 Promotion, research, consumer information, and industry..., research, consumer information, and industry information activities with respect to soybean and soybean...

7 CFR 1220.230 - Promotion, research, consumer information, and industry information.

Code of Federal Regulations, 2011 CFR

2011-01-01

... industry information. 1220.230 Section 1220.230 Agriculture Regulations of the Department of Agriculture... Research Order Expenses and Assessments § 1220.230 Promotion, research, consumer information, and industry..., research, consumer information, and industry information activities with respect to soybean and soybean...

7 CFR 1220.230 - Promotion, research, consumer information, and industry information.

Code of Federal Regulations, 2012 CFR

2012-01-01

... industry information. 1220.230 Section 1220.230 Agriculture Regulations of the Department of Agriculture... Research Order Expenses and Assessments § 1220.230 Promotion, research, consumer information, and industry..., research, consumer information, and industry information activities with respect to soybean and soybean...

7 CFR 1220.230 - Promotion, research, consumer information, and industry information.

Code of Federal Regulations, 2013 CFR

2013-01-01

... industry information. 1220.230 Section 1220.230 Agriculture Regulations of the Department of Agriculture... Research Order Expenses and Assessments § 1220.230 Promotion, research, consumer information, and industry..., research, consumer information, and industry information activities with respect to soybean and soybean...

How research in behavioral pharmacology informs behavioral science.

PubMed

Branch, Marc N

2006-05-01

Behavioral pharmacology is a maturing science that has made significant contributions to the study of drug effects on behavior, especially in the domain of drug-behavior interactions. Less appreciated is that research in behavioral pharmacology can have, and has had, implications for the experimental analysis of behavior, especially its conceptualizations and theory. In this article, I outline three general strategies in behavioral pharmacology research that have been employed to increase understanding of behavioral processes. Examples are provided of the general characteristics of the strategies and of implications of previous research for behavior theory. Behavior analysis will advance as its theories are challenged.

21 CFR 207.37 - Inspection of registrations and drug listings.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Management Team (HFD-095), Office of Information Technology, Center for Drug Evaluation and Research, Food... information submitted under the drug listing requirements will be available for public disclosure when...) Information that has become a matter of public knowledge. (x) A list of drug products containing a particular...

Computer-aided drug discovery research at a global contract research organization

NASA Astrophysics Data System (ADS)

Kitchen, Douglas B.

2017-03-01

Computer-aided drug discovery started at Albany Molecular Research, Inc in 1997. Over nearly 20 years the role of cheminformatics and computational chemistry has grown throughout the pharmaceutical industry and at AMRI. This paper will describe the infrastructure and roles of CADD throughout drug discovery and some of the lessons learned regarding the success of several methods. Various contributions provided by computational chemistry and cheminformatics in chemical library design, hit triage, hit-to-lead and lead optimization are discussed. Some frequently used computational chemistry techniques are described. The ways in which they may contribute to discovery projects are presented based on a few examples from recent publications.

Computer-aided drug discovery research at a global contract research organization.

PubMed

Kitchen, Douglas B

2017-03-01

Computer-aided drug discovery started at Albany Molecular Research, Inc in 1997. Over nearly 20 years the role of cheminformatics and computational chemistry has grown throughout the pharmaceutical industry and at AMRI. This paper will describe the infrastructure and roles of CADD throughout drug discovery and some of the lessons learned regarding the success of several methods. Various contributions provided by computational chemistry and cheminformatics in chemical library design, hit triage, hit-to-lead and lead optimization are discussed. Some frequently used computational chemistry techniques are described. The ways in which they may contribute to discovery projects are presented based on a few examples from recent publications.

7 CFR 1220.230 - Promotion, research, consumer information, and industry information.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 10 2010-01-01 2010-01-01 false Promotion, research, consumer information, and...), DEPARTMENT OF AGRICULTURE SOYBEAN PROMOTION, RESEARCH, AND CONSUMER INFORMATION Soybean Promotion and Research Order Expenses and Assessments § 1220.230 Promotion, research, consumer information, and industry...

Patients' consent preferences for research uses of information in electronic medical records: interview and survey data.

PubMed

Willison, Donald J; Keshavjee, Karim; Nair, Kalpana; Goldsmith, Charlie; Holbrook, Anne M

2003-02-15

To assess patients' preferred method of consent for the use of information from electronic medical records for research. Interviews and a structured survey of patients in practices with electronic medical records. Family practices in southern Ontario, Canada. 123 patients: 17 were interviewed and 106 completed a survey. Patients' opinions and concerns on use of information from their medical records for research and their preferences for method of consent. Most interviewees were willing to allow the use of their information for research purposes, although the majority preferred that consent was sought first. The seeking of consent was considered an important element of respect for the individual. Most interviewees made little distinction between identifiable and anonymised data. Research sponsored by private insurance firms generated the greatest concern, and research sponsored by foundation the least. Sponsorship by drug companies evoked negative responses during interview and positive responses in the survey. Patients are willing to allow information from their medical records to be used for research, but most prefer to be asked for consent either verbally or in writing.

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

PubMed

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

2013-08-01

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

Research review for information management

NASA Technical Reports Server (NTRS)

Bishop, Peter C.

1988-01-01

The goal of RICIS research in information management is to apply currently available technology to existing problems in information management. Research projects include the following: the Space Business Research Center (SBRC), the Management Information and Decision Support Environment (MIDSE), and the investigation of visual interface technology. Several additional projects issued reports. New projects include the following: (1) the AdaNET project to develop a technology transfer network for software engineering and the Ada programming language; and (2) work on designing a communication system for the Space Station Project Office at JSC. The central aim of all projects is to use information technology to help people work more productively.

The Application of the Open Pharmacological Concepts Triple Store (Open PHACTS) to Support Drug Discovery Research

PubMed Central

Ratnam, Joseline; Zdrazil, Barbara; Digles, Daniela; Cuadrado-Rodriguez, Emiliano; Neefs, Jean-Marc; Tipney, Hannah; Siebes, Ronald; Waagmeester, Andra; Bradley, Glyn; Chau, Chau Han; Richter, Lars; Brea, Jose; Evelo, Chris T.; Jacoby, Edgar; Senger, Stefan; Loza, Maria Isabel; Ecker, Gerhard F.; Chichester, Christine

2014-01-01

Integration of open access, curated, high-quality information from multiple disciplines in the Life and Biomedical Sciences provides a holistic understanding of the domain. Additionally, the effective linking of diverse data sources can unearth hidden relationships and guide potential research strategies. However, given the lack of consistency between descriptors and identifiers used in different resources and the absence of a simple mechanism to link them, gathering and combining relevant, comprehensive information from diverse databases remains a challenge. The Open Pharmacological Concepts Triple Store (Open PHACTS) is an Innovative Medicines Initiative project that uses semantic web technology approaches to enable scientists to easily access and process data from multiple sources to solve real-world drug discovery problems. The project draws together sources of publicly-available pharmacological, physicochemical and biomolecular data, represents it in a stable infrastructure and provides well-defined information exploration and retrieval methods. Here, we highlight the utility of this platform in conjunction with workflow tools to solve pharmacological research questions that require interoperability between target, compound, and pathway data. Use cases presented herein cover 1) the comprehensive identification of chemical matter for a dopamine receptor drug discovery program 2) the identification of compounds active against all targets in the Epidermal growth factor receptor (ErbB) signaling pathway that have a relevance to disease and 3) the evaluation of established targets in the Vitamin D metabolism pathway to aid novel Vitamin D analogue design. The example workflows presented illustrate how the Open PHACTS Discovery Platform can be used to exploit existing knowledge and generate new hypotheses in the process of drug discovery. PMID:25522365

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-19

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

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

PubMed

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

2016-04-01

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

Norms for healthy adults aged 18-87 years for the Cognitive Drug Research System: An automated set of tests of attention, information processing and memory for use in clinical trials.

PubMed

Wesnes, Keith A; McNamara, Cynthia; Annas, Peter

2016-03-01

The Cognitive Drug Research (CDR) System is a set of nine computerized tests of attention, information processing, working memory, executive control and episodic memory which was designed for repeated assessments in research projects. The CDR System has been used extensively in clinical trials involving healthy volunteers for over 30 years, and a database of 7751 individuals aged 18-87 years has been accumulated for pre-treatment data from these studies. This database has been analysed, and the relationships between the various scores with factors, including age, gender and years of full-time education, have been identified. These analyses are reported in this paper, along with tables of norms for the various key measures from the core tasks stratified by age and gender. These norms can be used for a variety of purposes, including the determination of eligibility for participation in clinical trials and the everyday relevance of research findings from the system. In addition, these norms provide valuable information on gender differences and the effects of normal ageing on major aspects of human cognitive function. © The Author(s) 2016.

Exploration of Heterogeneity in Distributed Research Network Drug Safety Analyses

ERIC Educational Resources Information Center

Hansen, Richard A.; Zeng, Peng; Ryan, Patrick; Gao, Juan; Sonawane, Kalyani; Teeter, Benjamin; Westrich, Kimberly; Dubois, Robert W.

2014-01-01

Distributed data networks representing large diverse populations are an expanding focus of drug safety research. However, interpreting results is difficult when treatment effect estimates vary across datasets (i.e., heterogeneity). In a previous study, risk estimates were generated for selected drugs and potential adverse outcomes. Analyses were…

21 CFR 20.111 - Data and information submitted voluntarily to the Food and Drug Administration.

Code of Federal Regulations, 2011 CFR

2011-04-01

... in a way that does not reveal data or information which is not available for public disclosure under... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Data and information submitted voluntarily to the... Records § 20.111 Data and information submitted voluntarily to the Food and Drug Administration. (a) The...

[New drug development by innovative drug administration--"change" in pharmaceutical field].

PubMed

Nagai, T

1997-11-01

New drug development can be made by providing products of higher "selectivity for the drug" for medical treatment. There are two ways for the approach to get higher "selectivity of drug": 1) discovery of new compounds with high selectivity of drug; 2) innovation of new drug administration, that is new formulation and/or method with high selectivity of drug by integration and harmonization of various hard/soft technologies. An extensive increase of biological information and advancement of surrounding science and technology may modify the situation as the latter overcomes the former in the 21 century. As the science and technology in the 21 century is said to be formed on "3H", that is, 1. hybrid; 2. hi-quality; 3. husbandry, the new drug development by innovative drug administration is exactly based on the science and technology of 3H. Its characteristic points are interdisciplinary/interfusion, international, of philosophy/ethics, and systems of hard/hard/heart. From these points of view, not only the advance of unit technology but also a revolution in thinking way should be "must" subjects. To organize this type of research well, a total research activity such as ROR (research on research) might take an important and efficient role. Here the key words are the "Optimization technology" and "Change in Pharmaceutical Fields." As some examples of new drug innovation, our trials on several topical mucosal adhesive dosage forms and parenteral administration of peptide drugs such as insulin and erythropoietin will be described.

77 FR 72869 - Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in Center for Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-06

... and Research-Regulated Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION... guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug... INFORMATION CONTACT: Laurie Muldowney, Center for Drug Evaluation and Research (HFD-003), Food and Drug...

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

ERIC Educational Resources Information Center

Hanneman, Gerhard J.; And Others

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

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

PubMed Central

Gooblar, Jonathan; Carpenter, Brian D.

2014-01-01

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

How Research in Behavioral Pharmacology Informs Behavioral Science

ERIC Educational Resources Information Center

Branch, Marc N.

2006-01-01

Behavioral pharmacology is a maturing science that has made significant contributions to the study of drug effects on behavior, especially in the domain of drug-behavior interactions. Less appreciated is that research in behavioral pharmacology can have, and has had, implications for the experimental analysis of behavior, especially its…

Beyond 'Doing Gender': Incorporating Race, Class, Place, and Life Transitions into Feminist Drug Research.

PubMed

Miller, Jody; Carbone-Lopez, Kristin

2015-05-01

This essay draws from our research with US rural women methamphetamine users in 2009 to offer strategies for "revisioning" the drug use(r) field to better understand the impact of gender on drug use and drug market participation. We highlight the insights and limitations of a popular strategy in feminist research that conceptualizes gender as performance- commonly referred to as "doing gender"-using illustrations from our research. We encourage scholars to move beyond a primarily normative orientation in studying gender, and investigate gendered organizational features of social life including their intersections with other aspects of social inequality such as those of race, class, and place. In addition, we suggest that feminist scholars can integrate gender in a rigorous way into theoretical perspectives that are typically inattentive to its import, as a means of challenging, enriching, and refining research on drug use, drug users, and drug market participation.

Reasons Why Post-Trial Access to Trial Drugs Should, or Need not be Ensured to Research Participants: A Systematic Review

PubMed Central

Sofaer, Neema; Strech, Daniel

2011-01-01

Background: researchers and sponsors increasingly confront the issue of whether participants in a clinical trial should have post-trial access (PTA) to the trial drug. Legislation and guidelines are inconsistent, ambiguous or silent about many aspects of PTA. Recent research highlights the potential importance of systematic reviews (SRs) of reason-based literatures in informing decision-making in medicine, medical research and health policy. Purpose: to systematically review reasons why drug trial participants should, or need not be ensured PTA to the trial drug and the uses of such reasons. Data sources: databases in science/medicine, law and ethics, thesis databases, bibliographies, research ethics books and included publications’ notes/bibliographies. Publication selection: a publication was included if it included a reason as above. See article for detailed inclusion conditions. Data extraction and analysis: two reviewers extracted and analyzed data on publications and reasons. Results: of 2060 publications identified, 75 were included. These mentioned reasons based on morality, legality, interests/incentives, or practicality, comprising 36 broad (235 narrow) types of reason. None of the included publications, which included informal reviews and reports by official bodies, mentioned more than 22 broad (59 narrow) types. For many reasons, publications differed about the reason’s interpretation, implications and/or persuasiveness. Publications differed also regarding costs, feasibility and legality of PTA. Limitations: reason types could be applied differently. The quality of reasons was not measured. Conclusion: this review captured a greater variety of reasons and of their uses than any included publication. Decisions based on informal reviews or sub-sets of literature are likely to be biased. Research is needed on PTA ethics, costs, feasibility and legality and on assessing the quality of reason-based literature. PMID:21754950

7 CFR 1260.169 - Promotion, research, consumer information and industry information.

Code of Federal Regulations, 2013 CFR

2013-01-01

... industry information. 1260.169 Section 1260.169 Agriculture Regulations of the Department of Agriculture... Operating Committee § 1260.169 Promotion, research, consumer information and industry information. The... approval any plans and projects for promotion, research, consumer information and industry information...

7 CFR 1260.169 - Promotion, research, consumer information and industry information.

Code of Federal Regulations, 2011 CFR

2011-01-01

... industry information. 1260.169 Section 1260.169 Agriculture Regulations of the Department of Agriculture... Operating Committee § 1260.169 Promotion, research, consumer information and industry information. The... approval any plans and projects for promotion, research, consumer information and industry information...

7 CFR 1260.169 - Promotion, research, consumer information and industry information.

Code of Federal Regulations, 2012 CFR

2012-01-01

... industry information. 1260.169 Section 1260.169 Agriculture Regulations of the Department of Agriculture... Operating Committee § 1260.169 Promotion, research, consumer information and industry information. The... approval any plans and projects for promotion, research, consumer information and industry information...

7 CFR 1260.169 - Promotion, research, consumer information and industry information.

Code of Federal Regulations, 2014 CFR

2014-01-01

... industry information. 1260.169 Section 1260.169 Agriculture Regulations of the Department of Agriculture... Operating Committee § 1260.169 Promotion, research, consumer information and industry information. The... approval any plans and projects for promotion, research, consumer information and industry information...

Nanoinformatics knowledge infrastructures: bringing efficient information management to nanomedical research

NASA Astrophysics Data System (ADS)

de la Iglesia, D.; Cachau, R. E.; García-Remesal, M.; Maojo, V.

2013-01-01

Nanotechnology represents an area of particular promise and significant opportunity across multiple scientific disciplines. Ongoing nanotechnology research ranges from the characterization of nanoparticles and nanomaterials to the analysis and processing of experimental data seeking correlations between nanoparticles and their functionalities and side effects. Due to their special properties, nanoparticles are suitable for cellular-level diagnostics and therapy, offering numerous applications in medicine, e.g. development of biomedical devices, tissue repair, drug delivery systems and biosensors. In nanomedicine, recent studies are producing large amounts of structural and property data, highlighting the role for computational approaches in information management. While in vitro and in vivo assays are expensive, the cost of computing is falling. Furthermore, improvements in the accuracy of computational methods (e.g. data mining, knowledge discovery, modeling and simulation) have enabled effective tools to automate the extraction, management and storage of these vast data volumes. Since this information is widely distributed, one major issue is how to locate and access data where it resides (which also poses data-sharing limitations). The novel discipline of nanoinformatics addresses the information challenges related to nanotechnology research. In this paper, we summarize the needs and challenges in the field and present an overview of extant initiatives and efforts.

Nanoinformatics knowledge infrastructures: bringing efficient information management to nanomedical research.

PubMed

de la Iglesia, D; Cachau, R E; García-Remesal, M; Maojo, V

2013-11-27

Nanotechnology represents an area of particular promise and significant opportunity across multiple scientific disciplines. Ongoing nanotechnology research ranges from the characterization of nanoparticles and nanomaterials to the analysis and processing of experimental data seeking correlations between nanoparticles and their functionalities and side effects. Due to their special properties, nanoparticles are suitable for cellular-level diagnostics and therapy, offering numerous applications in medicine, e.g. development of biomedical devices, tissue repair, drug delivery systems and biosensors. In nanomedicine, recent studies are producing large amounts of structural and property data, highlighting the role for computational approaches in information management. While in vitro and in vivo assays are expensive, the cost of computing is falling. Furthermore, improvements in the accuracy of computational methods (e.g. data mining, knowledge discovery, modeling and simulation) have enabled effective tools to automate the extraction, management and storage of these vast data volumes. Since this information is widely distributed, one major issue is how to locate and access data where it resides (which also poses data-sharing limitations). The novel discipline of nanoinformatics addresses the information challenges related to nanotechnology research. In this paper, we summarize the needs and challenges in the field and present an overview of extant initiatives and efforts.

Nanoinformatics knowledge infrastructures: bringing efficient information management to nanomedical research

PubMed Central

de la Iglesia, D; Cachau, R E; García-Remesal, M; Maojo, V

2014-01-01

Nanotechnology represents an area of particular promise and significant opportunity across multiple scientific disciplines. Ongoing nanotechnology research ranges from the characterization of nanoparticles and nanomaterials to the analysis and processing of experimental data seeking correlations between nanoparticles and their functionalities and side effects. Due to their special properties, nanoparticles are suitable for cellular-level diagnostics and therapy, offering numerous applications in medicine, e.g. development of biomedical devices, tissue repair, drug delivery systems and biosensors. In nanomedicine, recent studies are producing large amounts of structural and property data, highlighting the role for computational approaches in information management. While in vitro and in vivo assays are expensive, the cost of computing is falling. Furthermore, improvements in the accuracy of computational methods (e.g. data mining, knowledge discovery, modeling and simulation) have enabled effective tools to automate the extraction, management and storage of these vast data volumes. Since this information is widely distributed, one major issue is how to locate and access data where it resides (which also poses data-sharing limitations). The novel discipline of nanoinformatics addresses the information challenges related to nanotechnology research. In this paper, we summarize the needs and challenges in the field and present an overview of extant initiatives and efforts. PMID:24932210

Return of results in translational iPS cell research: considerations for donor informed consent

PubMed Central

2013-01-01

Efforts have emerged internationally to recruit donors with specific disease indications and to derive induced pluripotent cell lines. These disease-specific induced pluripotent stem cell lines have the potential to accelerate translational goals such as drug discovery and testing. One consideration for donor recruitment and informed consent is the possibility that research will result in findings that are clinically relevant to the cell donor. Management protocols for such findings should be developed a priori and disclosed during the informed consent process. The California Institute for Regenerative Medicine has developed recommendations for informing donors in sponsored research. These recommendations include obtaining consent to recontact tissue donors for a range of scientific, medical and ethical considerations. This article reviews the basis for these recommendations and suggests conditions that may be appropriate when reporting findings to donors. PMID:23336317

Correction of misleading information in prescription drug television advertising: The roles of advertisement similarity and time delay.

PubMed

Aikin, Kathryn J; Southwell, Brian G; Paquin, Ryan S; Rupert, Douglas J; O'Donoghue, Amie C; Betts, Kevin R; Lee, Philip K

Prescription drug television advertisements containing potentially consequential misinformation sometimes appear in the United States. When that happens, the U.S. Food and Drug Administration can request that companies distribute corrective advertisements to address misinformation and inaccurate claims. Previous research has demonstrated effectiveness in corrective advertising for various products. The present article builds on that work with a randomized experimental study (n = 6454) of corrective advertising investigating the extent to which visual similarity matters between violative and corrective ads and the extent to which time delay matters between violative and corrective advertisement exposure. Our study sample included overweight or obese U.S. adults recruited from an existing online consumer panel representative of the U.S. adult population. We created a brand for a fictitious prescription weight-loss drug and produced corresponding direct-to-consumer (DTC) television ads. All participants viewed the same violative ad, but were randomly assigned to view corrective ads with different levels of visual similarity and exposure time delay using a 4 × 4 between-subjects factorial design. Results suggest corrective ad exposure can influence consumer perceptions of drug efficacy, risks, and benefits previously established by violative ads that overstated drug efficacy, broadened drug indication, and omitted important risk information. Corrective ads also can weaken consumer intentions to consider and investigate a drug. However, ad similarity does not appear to affect consumer perceptions and preferences. Although we found that the effects of violative ad exposure tend to diminish over time, the length of the delay between violative and corrective ad exposure has limited influence. An exception to this was observed with regard to recall of drug benefits and risks, where the impact of corrective ad exposure increases with greater time delay. These results

A Collection of NIDA Notes: Articles That Address Research on Club Drugs.

ERIC Educational Resources Information Center

National Inst. on Drug Abuse (DHHS/PHS), Bethesda, MD.

Included in this document are selections of topic-specific articles on club drug research reprinted from the National Institute on Drug Abuse's (NIDA) research newsletter, NIDA Notes. The collection features articles originally published from 1996 through 2002. Topics include the effects of ecstasy and methamphetamine on the brain and body,…

Remote Sensing Information Sciences Research Group, Santa Barbara Information Sciences Research Group, year 3

NASA Technical Reports Server (NTRS)

Estes, J. E.; Smith, T.; Star, J. L.

1986-01-01

Research continues to focus on improving the type, quantity, and quality of information which can be derived from remotely sensed data. The focus is on remote sensing and application for the Earth Observing System (Eos) and Space Station, including associated polar and co-orbiting platforms. The remote sensing research activities are being expanded, integrated, and extended into the areas of global science, georeferenced information systems, machine assissted information extraction from image data, and artificial intelligence. The accomplishments in these areas are examined.

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

PubMed

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

2013-12-01

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-09

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

Closing the information gap: informing better medical decisionmaking through the use of post-market safety and comparative effectiveness information.

PubMed

Fox, Bethany

2012-01-01

While FDA gathers vast amounts of data about prescription drugs prior to their marketing approval, important information about the relative effectiveness and long term safety of products is not required for approval, and often is never collected. Increased postmarket research on the safety and comparative effectiveness of products would improve medical decisionmaking and lead to better clinical outcomes. Fortunately, Congress has recognized the value of this information for healthcare professionals. In response to a congressional mandate in the FDA Amendments Act (FDAAA), FDA is developing the Sentinel Initiative, an active surveillance system for monitoring postmarket drug safety issues. FDAAA also authorized FDA to require a drug sponsor to conduct postmarket safety studies or clinical trials to address a specific safety concern. To increase the repository of comparative effectiveness information, Congress established the Patient-Centered Outcomes Research Institute (PCORI) in the Patient Protection and Affordable Care Act (PPACA), directing it to manage comparative effectiveness research (CER). This article discusses the need for better safety and comparative effectiveness information and outlines methods to efficiently conduct the research and communicate it effectively to healthcare professionals. Coordination between FDA and the PCORI in gathering and communicating postmarket information is recommended. Medical source data collected by the Sentinel Initiative should be used for CER in addition to postmarket safety surveillance, and FDA and the PCORI should adopt identical standards for the distribution and communication of CER. Coordination between the two entities is recommended to save costs, reduce duplication of efforts, and to generate and communicate more information on prescription drugs for medical decisionmakers.

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

PubMed

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

2014-01-01

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

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

PubMed Central

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

2014-01-01

The online resource Wikipedia is increasingly used by students for knowledge acquisition and learning. However, the lack of a formal editorial review and the heterogeneous expertise of contributors often results in skepticism by educators whether Wikipedia should be recommended to students as an information source. In this study we systematically analyzed the accuracy and completeness of drug information in the German and English language versions of Wikipedia in comparison to standard textbooks of pharmacology. In addition, references, revision history and readability were evaluated. Analysis of readability was performed using the Amstad readability index and the Erste Wiener Sachtextformel. The data on indication, mechanism of action, pharmacokinetics, adverse effects and contraindications for 100 curricular drugs were retrieved from standard German textbooks of general pharmacology and compared with the corresponding articles in the German language version of Wikipedia. Quantitative analysis revealed that accuracy of drug information in Wikipedia was 99.7%±0.2% when compared to the textbook data. The overall completeness of drug information in Wikipedia was 83.8±1.5% (p<0.001). Completeness varied in-between categories, and was lowest in the category “pharmacokinetics” (68.0%±4.2%; p<0.001) and highest in the category “indication” (91.3%±2.0%) when compared to the textbook data overlap. Similar results were obtained for the English language version of Wikipedia. Of the drug information missing in Wikipedia, 62.5% was rated as didactically non-relevant in a qualitative re-evaluation study. Drug articles in Wikipedia had an average of 14.6±1.6 references and 262.8±37.4 edits performed by 142.7±17.6 editors. Both Wikipedia and textbooks samples had comparable, low readability. Our study suggests that Wikipedia is an accurate and comprehensive source of drug-related information for undergraduate medical education. PMID:25250889

The state of support for research on the epidemiology, prevention, and treatment of drug use and drug use disorders in the USA.

PubMed

Sloboda, Zili

2012-01-01

This article describes the challenge of sustaining a balanced agenda for drug use research in the USA to advance understanding of the nature and extent of drug use and drug use disorders in a population; the processes and mechanisms that underlie onset, continuing, and stopping drug dependence; how to effectively prevent the onset of and early drug use as well as the social and health consequences of such use; and how to treat and maintain those with drug use disorders. This review concludes with recommendations to achieve sustained stability of funding for and to promote the progress of epidemiologic, prevention, and treatment policy research.

A practical approach to risk-benefit estimation in pediatric drug research.

PubMed

Koren, Gideon

2015-02-01

One of the most difficult challenges in pediatric drug research is in exposing children to risk, often without a balanced chance of benefits. While the concept of risk is similar in adult research, the adult patient can decide for himself/herself on an acceptable level of risk, whereas children have to accept the decisions of their guardians. This paper attempts to put the complexities of estimating risk in pediatric drug research into their practical perspective, and to familiarize the reader with the way such processes are conducted in different parts of the world. Although there are regional differences, all authorities typically quantify risks of pediatric research in general, and drug research in particular, in three levels: those experienced in day-to-day life; risks slightly above this 'baseline' risk; and risks substantially above 'baseline risk'. Proportionally, the diligence of the ethics process depends on these levels, as well as on the potential benefits (or lack of) to the child involved in the research. Importantly, risk is context dependent, and a particular intervention may be effective or safe in one setting but not in another, based on local experience, staffing levels, and similar variabilities.

Research Progress in Reversal of Tumor Multi-drug Resistance via Natural Products.

PubMed

Guo, Qi; Cao, Hongyan; Qi, Xianghui; Li, Huikai; Ye, Peizhi; Wang, Zhiguo; Wang, Danqiao; Sun, Mingyu

2017-11-24

Multidrug resistance occurs when a tumor develops resistance to multiple chemotherapeutic drugs, which may include antitumor drugs with different chemical structures and mechanisms. Multidrug resistance limits the treatment effects of antitumor drugs, and is the main cause of chemotherapy failure. Multidrug resistance is caused by numerous factors including changes in ATP-binding cassette transporters, target proteins, detoxification, deoxyribonucleic acid repair, drug metabolic enzymes, and signal pathways of apoptosis. Clinical research indicates that natural products have great potential to treat tumors and reverse multidrug resistance. Natural products, which often have multiple targets, could play an important role in tumor treatment, have beneficial effects on tumor inhibition, improve symptoms, reduce radiotherapy and chemotherapy side effects, enhance immunity, and prolong survival. Because natural products often have few adverse reactions and less drug resistance, the antitumor activities of natural products have attracted extensive research. We aimed to review the basic research and clinical application of natural products in the reversal of multidrug resistance. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Ethical issues in HIV prevention research with people who inject drugs.

PubMed

Sugarman, Jeremy; Rose, Scott M; Metzger, David

2014-04-01

Injection drug use continues to significantly contribute to new infections with HIV. Moreover, conducting HIV prevention research with people who inject drugs (PWIDs) can be complicated for an array of practical, social, legal, and ethical reasons. It is critical that these research efforts are sensitive to the particular vulnerabilities associated with injection drug use as well as those related to being at risk of acquiring HIV so as to minimize harm to participants in research. To describe how we addressed some of these ethical challenges during the course of a large-scale multinational randomized HIV prevention trial involving PWIDs, which was successfully completed. The ethical issues encountered during the life cycle of the trial were cataloged by the principal investigator, study coordinator, and ethicist working on the trial. Relevant study documents were then reviewed to provide pertinent details. The ethical issues unique to the trial were then described. Before implementation, the trial faced particularly complex challenges related to the vulnerability of PWIDs, where HIV seroincidence rates in the population were high and legal policies and stigma regarding injection drug use was severe. Accordingly, a rapid policy assessment was commissioned, and a series of community engagement activities were conducted. During the trial, in addition to using careful standard operating procedures regarding all aspects of trial conduct and extensive staff training, the trial standardized informed consent procedures and assessed them. Furthermore, social harms were monitored along with physical harms and adverse events. Following the decision to close the study, it was critical to develop an orderly and safe process for closing it. The issue of post-trial access to the study medication and a complex intervention also surfaced for consideration. The issues described in this article are necessarily limited to how they manifested themselves within the context of a

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

PubMed

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

2016-09-01

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

Incorporating a Drug Information Consult into a Pharmacy Practice Course to Build Literature Search and Evaluation Skills Through a 3-Stage Model.

PubMed

Wittman, Deborah; Kovera, Craig; Sullivan, Maureen; Rumore, Martha M

2017-06-01

Pharmacy students need to be equipped with skills to research and evaluate literature to effectively apply evidence-based medicine (EBM) in practice. To prepare them, a 3-stage approach to writing a drug information consult (3sDIC) was incorporated into a pharmacy course. The primary objective was to assess students' abilities to retrieve and analyze literature pursuant to a drug information consult. Secondary objectives were to examine feasibility of faculty participation and continuation of the assignment. Ninety students were given a clinical scenario about a patient. The assignment consisted of 3 stages incorporating use of the Population, Intervention, Comparison intervention, Outcome (PICO) method and modified systematic approach (MSA) for stage 1, evaluation of primary literature to write a draft for stage 2, and stage 3, the final consult. All 3 stages were reviewed and graded by faculty. All students completed the 3sDIC, with no grade failures. The rubric employed by faculty was effective, providing students the opportunity to improve the consult. The 3sDIC was found to be feasible with adequate faculty support. The 3sDIC, although not a substitute for a complete drug information course, demonstrated a streamlined approach for Pharmacy year 2 (P2) students to acquire and develop drug information skills.

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

DOT National Transportation Integrated Search

1980-06-01

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

The effect of the European Clinical Trials Directive on published drug research in anaesthesia.

PubMed

Walker, E; Hankins, M C; White, S M

2009-09-01

The clinical indications for anaesthetic drugs are developed through peer-reviewed publication of clinical trials. We performed a bibliometric analysis of all human research papers reported in nine general anaesthesia journals over 6 years (n = 6489), to determine any effects of the 2004 European Clinical Trials Directive on reported drug research in anaesthesia originating from Europe and the United Kingdom. We found 89% studies involved patients and 11% volunteers. Of 3234 (50%) drug studies, 96% were phase IV (post-marketing) trials. Worldwide, the number of research papers fell by 3.6% (p < 0.004) in the 3 years following introduction of the European Clinical Trials Directive (5% Europe, 18% United Kingdom), and drug research papers fell by 12% (p < 0.001; 15% Europe, 29% United Kingdom). The introduction of the Clinical Trials Directive has therefore coincided with a decline in European drug research, particularly that originating from the United Kingdom. We suggest a number of measures researchers could take in response, and we propose a simplification of the application process for phase IV clinical trials, emphasising patient risk assessment.

The Aging Process and Psychoactive Drug Use. Services Research Monograph Series.

ERIC Educational Resources Information Center

Stanford Research Inst., Menlo Park, CA.

This three-phase literature review focusses on the dangers of drug misuse or abuse by the elderly, and seeks to assist in the development of prevention and treatment strategies. The first phase focusses on the aging process and psychoactive drug use in clinical treatment. The second phase identifies and synthesizes information on the patterns of…

78 FR 70069 - Agency Information Collection Activities; Proposed New Collection; Comments Requested: Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-22

... Collection; Comments Requested: Drug Endangered Children Tracking System User Survey ACTION: 60-day notice... technological collection techniques or other forms of information technology, e.g., permitting electronic... new collection; comments requested. (2) Title of the Form/Collection: Drug Endangered Children...

21 CFR 312.160 - Drugs for investigational use in laboratory research animals or in vitro tests.

Code of Federal Regulations, 2010 CFR

2010-04-01

... research animals or in vitro tests. 312.160 Section 312.160 Food and Drugs FOOD AND DRUG ADMINISTRATION... Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests § 312.160 Drugs for investigational use in laboratory research animals or in vitro tests. (a) Authorization to ship. (1)(i) A person...

21 CFR 312.160 - Drugs for investigational use in laboratory research animals or in vitro tests.

Code of Federal Regulations, 2013 CFR

2013-04-01

... research animals or in vitro tests. 312.160 Section 312.160 Food and Drugs FOOD AND DRUG ADMINISTRATION... Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests § 312.160 Drugs for investigational use in laboratory research animals or in vitro tests. (a) Authorization to ship. (1)(i) A person...

21 CFR 312.160 - Drugs for investigational use in laboratory research animals or in vitro tests.

Code of Federal Regulations, 2014 CFR

2014-04-01

... research animals or in vitro tests. 312.160 Section 312.160 Food and Drugs FOOD AND DRUG ADMINISTRATION... Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests § 312.160 Drugs for investigational use in laboratory research animals or in vitro tests. (a) Authorization to ship. (1)(i) A person...

21 CFR 312.160 - Drugs for investigational use in laboratory research animals or in vitro tests.

Code of Federal Regulations, 2012 CFR

2012-04-01

... research animals or in vitro tests. 312.160 Section 312.160 Food and Drugs FOOD AND DRUG ADMINISTRATION... Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests § 312.160 Drugs for investigational use in laboratory research animals or in vitro tests. (a) Authorization to ship. (1)(i) A person...

21 CFR 312.160 - Drugs for investigational use in laboratory research animals or in vitro tests.

Code of Federal Regulations, 2011 CFR

2011-04-01

... research animals or in vitro tests. 312.160 Section 312.160 Food and Drugs FOOD AND DRUG ADMINISTRATION... Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests § 312.160 Drugs for investigational use in laboratory research animals or in vitro tests. (a) Authorization to ship. (1)(i) A person...

Drug Information Training and Experience at U.S. Schools of Pharmacy.

ERIC Educational Resources Information Center

Davis, Sharon K.; Krucke, Lynn B.

1994-01-01

A survey of 56 pharmacy schools gathered information on current content of drug information courses and clerkships and plans to change training methods as the Doctor of Pharmacy becomes the sole entry-level degree. Some schools will modify course or clerkship content, by omitting or shifting objectives within the curriculum. (Author/MSE)

The reinstatement model of drug relapse: recent neurobiological findings, emerging research topics, and translational research

PubMed Central

Bossert, Jennifer M.; Marchant, Nathan J.; Calu, Donna J.; Shaham, Yavin

2013-01-01

Background and Rationale Results from many clinical studies suggest that drug relapse and craving are often provoked by acute exposure to the self-administered drug or related drugs, drug-associated cues or contexts, or certain stressors. During the last two decades, this clinical scenario has been studied in laboratory animals by using the reinstatement model. In this model, reinstatement of drug seeking by drug priming, drug cues or contexts, or certain stressors is assessed following drug self-administration training and subsequent extinction of the drug-reinforced responding. Objective In this review, we first summarize recent (2009-present) neurobiological findings from studies using the reinstatement model. We then discuss emerging research topics, including the impact of interfering with putative reconsolidation processes on cue- and context-induced reinstatement of drug seeking, and similarities and differences in mechanisms of reinstatement across drug classes. We conclude by discussing results from recent human studies that were inspired by results from rat studies using the reinstatement model. Conclusions Main conclusions from the studies reviewed highlight: (1) the ventral subiculum and lateral hypothalamus as emerging brain areas important for reinstatement of drug seeking, (2) the existence of differences in brain mechanisms controlling reinstatement of drug seeking across drug classes, (3) the utility of the reinstatement model for assessing the effect of reconsolidation-related manipulations on cue-induced drug seeking, and (4) the encouraging pharmacological concordance between results from rat studies using the reinstatement model and human laboratory studies on cue- and stress-induced drug craving. PMID:23685858