"THERAPEUTIC ORPHANS" AND THE PACKAGE INSERT

PEDIATRICS ◽  
1970 ◽  
Vol 46 (5) ◽  
pp. 811-813
Author(s):  
Keyword(s):  
Chemical Structure ◽  
Adverse Reactions ◽  
Package Insert ◽  
Drug Manufacturer ◽  
Full Disclosure ◽  
Package Inserts ◽  
Federal Food ◽  
The Status ◽  
Definition Of ◽  
Official Information

In the practice of pediatrics, drugs which are not approved by the Food and Drug Administration (FDA)* as safe and effective in children are prescribed daily. This is due in part to the fact that many drugs released since 1962 carry an "orphaning clause" in the package insert such as, "not to be used in children, since clinical studies have been insufficient to establish recommendations for its use." What is the status of the package insert? Is it a legal directive to the physician, or is it intended as a guide for the physician in prescribing a drug? The package insert, by legal definition of the Federal Food, Drug and Cosmetic Law, is the official information piece for a drug. The information it contains is derived from data supplied by investigators and submitted by the pharmaceutical firm to the FDA. The insert is written and printed by the drug manufacturer, but its contents must be approved by the FDA. The Food, Drug and Cosmetic Law, as amended in 1962, requires full disclosure of all known facts pertaining to the use of the drug. Therefore, a great deal of information is included in the insert, including the chemical structure of the drug, a summary of its pharmacological and toxicological action, its clinical indications and contraindications, precautions, reported adverse reactions, dosage recommendations, and available dosage forms. Many drugs have package inserts approved by the FDA before the Drug Amendments of 1962 when manufacturers were required to show the safety but not the effectiveness of their products.

scholarly journals Ontological Organization and Bioinformatic Analysis of Adverse Drug Reactions From Package Inserts: Development and Usability Study

10.2196/20443 ◽  
2020 ◽  
Vol 22 (7) ◽  
pp. e20443
Author(s):  
Xiaoying Li ◽  
Xin Lin ◽  
Huiling Ren ◽  
Jinjing Guo
Keyword(s):  
Language Processing ◽  
Adverse Reactions ◽  
Package Insert ◽  
Bioinformatic Analysis ◽  
Two Dimensions ◽  
Semantic Relations ◽  
Semantic Retrieval ◽  
Formal Representation ◽  
Package Inserts ◽  
Drug Databases

Background Licensed drugs may cause unexpected adverse reactions in patients, resulting in morbidity, risk of mortality, therapy disruptions, and prolonged hospital stays. Officially approved drug package inserts list the adverse reactions identified from randomized controlled clinical trials with high evidence levels and worldwide postmarketing surveillance. Formal representation of the adverse drug reaction (ADR) enclosed in semistructured package inserts will enable deep recognition of side effects and rational drug use, substantially reduce morbidity, and decrease societal costs. Objective This paper aims to present an ontological organization of traceable ADR information extracted from licensed package inserts. In addition, it will provide machine-understandable knowledge for bioinformatics analysis, semantic retrieval, and intelligent clinical applications. Methods Based on the essential content of package inserts, a generic ADR ontology model is proposed from two dimensions (and nine subdimensions), covering the ADR information and medication instructions. This is followed by a customized natural language processing method programmed with Python to retrieve the relevant information enclosed in package inserts. After the biocuration and identification of retrieved data from the package insert, an ADR ontology is automatically built for further bioinformatic analysis. Results We collected 165 package inserts of quinolone drugs from the National Medical Products Administration and other drug databases in China, and built a specialized ADR ontology containing 2879 classes and 15,711 semantic relations. For each quinolone drug, the reported ADR information and medication instructions have been logically represented and formally organized in an ADR ontology. To demonstrate its usage, the source data were further bioinformatically analyzed. For example, the number of drug-ADR triples and major ADRs associated with each active ingredient were recorded. The 10 ADRs most frequently observed among quinolones were identified and categorized based on the 18 categories defined in the proposal. The occurrence frequency, severity, and ADR mitigation method explicitly stated in package inserts were also analyzed, as well as the top 5 specific populations with contraindications for quinolone drugs. Conclusions Ontological representation and organization using officially approved information from drug package inserts enables the identification and bioinformatic analysis of adverse reactions caused by a specific drug with regard to predefined ADR ontology classes and semantic relations. The resulting ontology-based ADR knowledge source classifies drug-specific adverse reactions, and supports a better understanding of ADRs and safer prescription of medications.

scholarly journals Status of package insert guidelines for drugs accessible as over the counter drugs

2018 ◽  
Vol 7 (2) ◽  
pp. 298
Author(s):  
Anuja Jha ◽  
Usha Joshi ◽  
Rajesh Hishikar ◽  
Manju Agrawal ◽  
Ajay Halwai
Keyword(s):  
Drug Administration ◽  
Package Insert ◽  
Sole Source ◽  
Over The Counter ◽  
Safety And Efficacy ◽  
Package Inserts ◽  
Otc Drugs ◽  
The Status ◽  
Effective Use ◽  
Source Of Information

Background: As per Indian pharmacopoeia, package inserts are part of a label that provides information on the article. It may be the sole source of information for drugs, which are available in the pharmacies without the prescription and it may include both prescription and over the counter (OTC) drugs. So, to aid in safety and efficacy of these drugs, package inserts must follow the standard guidelines (The Drugs and Cosmetics rule, 1945). The objective of this study was to observe the status of the standard guidelines for package insert in drugs accessible as OTC drugs.Methods: Based on the inquiries made with pharmacies, list of drugs commonly bought without prescription was made. 256 drugs were evaluated. Their package inserts were observed for the extent to which the guidelines given by The Drugs and Cosmetics rule 1945, section 6.2 and 6.3 are being followed. Secondary objectives were made to assess if package inserts are physician friendly or patients friendly.Results: Package inserts were missing in 180 (70%) of the drugs.  Therapeutic indications were present in 71% of the available package inserts (76). Pharmaceutical information was given in 57% of the package inserts. English was the preferred language and medicinal terms were used. Only one package insert was patient friendly.Conclusions: Package inserts should be made available in every drug. There should be a separate patient oriented package insert guideline, as per US food and drug administration (FDA), in India as well. This will aid in their safe and effective use.

scholarly journals Ontological Organization and Bioinformatic Analysis of Adverse Drug Reactions From Package Inserts: Development and Usability Study (Preprint)

2020 ◽  
Author(s):  
Xiaoying Li ◽  
Xin Lin ◽  
Huiling Ren ◽  
Jinjing Guo
Keyword(s):  
Language Processing ◽  
Adverse Reactions ◽  
Package Insert ◽  
Bioinformatic Analysis ◽  
Two Dimensions ◽  
Semantic Relations ◽  
Semantic Retrieval ◽  
Formal Representation ◽  
Package Inserts ◽  
Drug Databases

BACKGROUND Licensed drugs may cause unexpected adverse reactions in patients, resulting in morbidity, risk of mortality, therapy disruptions, and prolonged hospital stays. Officially approved drug package inserts list the adverse reactions identified from randomized controlled clinical trials with high evidence levels and worldwide postmarketing surveillance. Formal representation of the adverse drug reaction (ADR) enclosed in semistructured package inserts will enable deep recognition of side effects and rational drug use, substantially reduce morbidity, and decrease societal costs. OBJECTIVE This paper aims to present an ontological organization of traceable ADR information extracted from licensed package inserts. In addition, it will provide machine-understandable knowledge for bioinformatics analysis, semantic retrieval, and intelligent clinical applications. METHODS Based on the essential content of package inserts, a generic ADR ontology model is proposed from two dimensions (and nine subdimensions), covering the ADR information and medication instructions. This is followed by a customized natural language processing method programmed with Python to retrieve the relevant information enclosed in package inserts. After the biocuration and identification of retrieved data from the package insert, an ADR ontology is automatically built for further bioinformatic analysis. RESULTS We collected 165 package inserts of quinolone drugs from the National Medical Products Administration and other drug databases in China, and built a specialized ADR ontology containing 2879 classes and 15,711 semantic relations. For each quinolone drug, the reported ADR information and medication instructions have been logically represented and formally organized in an ADR ontology. To demonstrate its usage, the source data were further bioinformatically analyzed. For example, the number of drug-ADR triples and major ADRs associated with each active ingredient were recorded. The 10 ADRs most frequently observed among quinolones were identified and categorized based on the 18 categories defined in the proposal. The occurrence frequency, severity, and ADR mitigation method explicitly stated in package inserts were also analyzed, as well as the top 5 specific populations with contraindications for quinolone drugs. CONCLUSIONS Ontological representation and organization using officially approved information from drug package inserts enables the identification and bioinformatic analysis of adverse reactions caused by a specific drug with regard to predefined ADR ontology classes and semantic relations. The resulting ontology-based ADR knowledge source classifies drug-specific adverse reactions, and supports a better understanding of ADRs and safer prescription of medications.

The Use of Prescription Drugs and Drugs of Abuse for Neuroenhancement in Europe

2015 ◽  
Vol 20 (3) ◽  
pp. 155-166 ◽  
Author(s):  
Larissa J. Maier ◽  
Michael P. Schaub
Keyword(s):  
Prescription Drugs ◽  
Illicit Drugs ◽  
Adverse Reactions ◽  
Low Dose ◽  
Drugs Of Abuse ◽  
Mental Performance ◽  
Or Education ◽  
Learning Techniques ◽  
Monitoring The Future ◽  
Definition Of

Abstract. Pharmacological neuroenhancement, defined as the misuse of prescription drugs, illicit drugs, or alcohol for the purpose of enhancing cognition, mood, or prosocial behavior, is not widespread in Europe – nevertheless, it does occur. Thus far, no drug has been proven as safe and effective for cognitive enhancement in otherwise healthy individuals. European studies have investigated the misuse of prescription and illicit stimulants to increase cognitive performance as well as the use of tranquilizers, alcohol, and cannabis to cope with stress related to work or education. Young people in educational settings report pharmacological neuroenhancement more frequently than those in other settings. Although the regular use of drugs for neuroenhancement is not common in Europe, the irregular and low-dose usage of neuroenhancers might cause adverse reactions. Previous studies have revealed that obtaining adequate amounts of sleep and using successful learning techniques effectively improve mental performance, whereas pharmacological neuroenhancement is associated with ambiguous effects. Therefore, non-substance-related alternatives should be promoted to cope with stressful situations. This paper reviews the recent research on pharmacological neuroenhancement in Europe, develops a clear definition of the substances used, and formulates recommendations for practitioners regarding how to react to requests for neuroenhancement drug prescriptions. We conclude that monitoring the future development of pharmacological neuroenhancement in Europe is important to provide effective preventive measures when required. Furthermore, substance use to cope with stress related to work or education should be studied in depth because it is likely more prevalent and dangerous than direct neuroenhancement.

Slave Women and Their Descendants among the Upper Classes in Tetouan, Morocco (1859–1956): Between Recognition and Conflict

2020 ◽  
pp. 036319902096739
Author(s):  
Josep Lluís Mateo Dieste
Keyword(s):  
Skin Color ◽  
Arab World ◽  
Family Members ◽  
Negative Stereotypes ◽  
The Social ◽  
Form Part ◽  
Slave Women ◽  
The Status ◽  
Definition Of ◽  
Determinant Factor

In the Arab world, the recognized children of elite men and slave women could adopt the status of their father, ignoring the slave origin of the mother, owing to a system of patrilineal transmission. This regime co-existed with negative stereotypes toward slaves and blackness, despite the very fact that—as this study of notable families in Tetouan between 1859 and 1956 demonstrates—skin color was not the determinant factor to form part of this group. Rather, it was based on the social definition of filiation, leading to legal disputes between family members to delineate the boundaries of kinship.

scholarly journals Rethinking Southern Europe: Society, Networks and Politics

2021 ◽  
pp. 1-10
Author(s):  
Alan Granadino ◽  
Eirini Karamouzi ◽  
Rinna Kullaa
Keyword(s):  
Cold War ◽  
Southern Europe ◽  
Eurozone Crisis ◽  
Development Education ◽  
Family Structures ◽  
Conceptual Clarity ◽  
Welfare Systems ◽  
The Status ◽  
Nineteenth And Twentieth Centuries ◽  
Definition Of

Writing and researching Southern Europe as a symbiotic area has always presented a challenging task. Historians and political scientists such as Stanley Payne, Edward Malefakis, Giulio Sapelli, and Roberto Aliboni have studied the concept of Southern Europe and its difficult paths to modernity. They have been joined by sociologists and anthropologists who have debated the existence of a Southern European paradigm in the nineteenth and twentieth centuries and the arduous transformation of the region's welfare systems, economic development, education and family structures. These scholarly attempts to understand the specificities of Southern Europe date back to the concerns of Western European Cold War strategists in the 1970s, many of whom were worried about the status quo of the region in the aftermath of the fall of the dictatorships. But this geographical and geopolitical definition of the area did not necessarily follow existing cultural, political and economic patterns. Once the Eurozone crisis hit in the 2000s these questions came back with renewed force but with even less conceptual clarity, as journalists and pundits frequently gestured towards vague notions of what they considered to be ‘Southern Europe’.

Grammatik der Narration

2020 ◽  
Vol 48 (3) ◽  
pp. 457-494
Author(s):  
Sonja Zeman
Keyword(s):  
Narrative Discourse ◽  
Linguistic Theory ◽  
Second Step ◽  
Narrative Fiction ◽  
The Status ◽  
Definition Of ◽  
Narrative Syntax

AbstractIs there a ‚narrative syntax‘, i. e. a special grammar restricted to narrative fiction? Starting from this question which has been investigated since early structuralism, the paper focusses on grammatical characteristics of narrative discourse mode and their implications for a linguistic theory of narration. Its goal is two-fold: In a first step, the traditional accounts by Benveniste, Hamburger, Kuroda and recent typological studies are brought together in order to support the claim that the distinction between narrative and non-narrative discourse mode is a fundamental one that has consequences for the use of grammar. In a second step, I discuss three central questions within the intersection between narrative micro- and macro-structures, namely (i) the definition of narrativity, (ii) the status of the narrator, and (iii) the relation between narration and fictionality. In sum, the article argues that investigations on the ‘grammar of narration’ do not just offer insights into a specific text configuration next to others, but are deeply linked to fundamental theoretical questions concerning the architecture of language – and that the comparison between linguistic and narratological categories offers a potential for addressing them.

The Humdrum Use of Ultimate Authority: Defining and Analysing Chapter VII Resolutions

2009 ◽  
Vol 78 (3) ◽  
pp. 309-342 ◽  
Author(s):  
Patrik Johansson
Keyword(s):  
Cold War ◽  
United Nations ◽  
Security Council ◽  
Security Council Resolution ◽  
Post Cold War ◽  
Standard Definition ◽  
The Status ◽  
Definition Of ◽  
The Cold War ◽  
Business As Usual

AbstractUnder Chapter VII of the Charter of the United Nations, the Security Council has the unique authority to make decisions that are binding on member states. However, the lack of a standard definition of what makes a Security Council resolution "a Chapter VII resolution" has caused disagreement regarding the status of several resolutions. This is unfortunate as the international community should never have to doubt whether a Security Council resolution is in fact adopted under Chapter VII or not. It is also unnecessary. This article addresses this problem by proposing a definition of Chapter VII resolutions, based on two criteria referred to as "Article 39 determinations" and "Chapter VII decisions". On the basis of the proposed definition, the article describes and analyses a dramatic increase in the use of Chapter VII during the post-Cold War era. It concludes that as Chapter VII has come to constitute the majority of Security Council resolutions in recent years, the resort to Chapter VII no longer signifies exceptional determination and resolve, which it did during the Cold War; instead Chapter VII today implies business as usual. An appendix lists all Chapter VII resolutions from 1946–2008.

Diversity, Equity, and Inclusion (DEI) Statements in the U. S. Creative Sector: Progress, or More Bullshit?

2021 ◽  
Vol 5 (2) ◽  
pp. 33-46
Author(s):  
Antonio C. Cuyler
Keyword(s):  
Content Analysis ◽  
Research Question ◽  
Theoretical Framework ◽  
Status Quo ◽  
Arts Organizations ◽  
The Public ◽  
Cultural Organizations ◽  
The Status ◽  
Definition Of ◽  
Equity And Inclusion

This article represents a snapshot and analysis of U. S. service arts organizations’ DEI statements and activities in 2018. At that time, many primarily White-serving U. S. cultural organizations responded defensively to accusations of elitism and a harmful rigged funding system that maintained the status quo by awarding most cultural funding to these organizations while undermining the health and vitality of cultural organizations by and for historically oppressed communities (Sidford, 2011). Furthermore, Helicon Collaborative (2017) found that even with a host of cultural equity, “diversity” projects (Tseng 2016), and public-facing DEI statements, little had changed within six years. Therefore, this study uses directed and summative content analysis to investigate the research question “what do cultural equity and diversity statements communicate about cultural organizations’ positions on DEI?” This study also uses Frankfurt’s (2005) essay On Bullshit and Laing’s (2016) two-prong definition of accountability as a theoretical framework to examine if and how cultural organizations hold themselves accountable for achieving DEI in the creative sector. Lastly, readers should keep in mind that the public murder of Geor-ge Floyd in 2020 has hastened all of the service arts organizations’ access, diversity, equity, and inclusion (ADEI) work examined in this study.

Si può parlare di un’arte femminista queer?

2020 ◽  
Vol 7 (1) ◽  
Author(s):  
Ilenia Caleo
Keyword(s):  
Cultural Appropriation ◽  
Feminist Art ◽  
Bell Hooks ◽  
The Status ◽  
Definition Of ◽  
Work Up ◽  
Eccentric Work ◽  
The Relationship

Language "is a place of struggle," says bell hooks. The relationship between art and feminism is complex and stratified, for this reason the definition of "feminist art" is tricky. I attempt here a recognition of theoretical landmarks and epistemologies come forth in the debate that examined the intersection between artistic practices and experiments of feminist policies, from the historical speeches of Nochlin, Pollock, Phelan to the Italian anomaly marked by Carla Lonzi’s eccentric work, up to to the most recent openings. From this scheme, questions active at present appear, relating to the patriarchal myth of authorship, to the status of the work, to the invisibility of material processes and to cultural appropriation. The prospect is one of a thought of practices destabilizing the canon through strategies of decolonization, countercultural practices, "positional geographies" and new epistemologies.

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