NDLI: Adverse event management in mass drug administration for neglected tropical diseases.

Please wait, while we are loading the content...

A randomized, placebo-controlled study of a new sublingual formulation of fentanyl citrate (fentanyl ethypharm) for breakthrough pain in opioid-treated patients with cancer.

Economic evaluation of primary prevention of cardiovascular diseases in mild hypertension: a scenario analysis for the Netherlands.

Anemia management trends in hospital-based dialysis centers (HBDCs), 2010 to 2013.

Is splenectomy necessary for immune thrombocytopenic purpura? The role of rituximab in patients with corticosteroid resistance in a single-center experience.

Methotrexate in rheumatoid arthritis: optimizing therapy among different formulations. Current and emerging paradigms.

Administration of anticancer drugs: exposure in hospital nurses.

Adverse event management in mass drug administration for neglected tropical diseases.

A population pharmacokinetic analysis of the influence of nutritional status of digoxin in hospitalized Korean patients.

Trans fatty acids: are its cardiovascular risks fully appreciated?

FDA's proposed ban on trans fats: How do the costs and benefits stack up?

Overview of local, state, and national government legislation restricting trans fats.

First time compliance inspections to evaluate an artificial trans fat ban in Nassau County.

Effect of combined systemic and local morpholino treatment on the spinal muscular atrophy Δ7 mouse model phenotype.

From bench to bedside: An overview of rotigotine for the treatment of restless legs syndrome.

Year: 2014 Volume: 36 Issue: 2

Year: 2014 Volume: 36 Issue: 1

Year: 2013 Volume: 35

Year: 2012 Volume: 34

Year: 2011 Volume: 33

Year: 2010 Volume: 32

Year: 2009 Volume: 31

Year: 2008 Volume: 30

Year: 2008 Volume: 30 Spec No

Year: 2008 Volume: 30 Pt 2

Year: 2007 Volume: 29

Adverse event management in mass drug administration for neglected tropical diseases.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Caplan, Arthur Zink, Amanda
Description	Author Affiliation: Caplan A ( NYU, Langone Medical Center, New York, New York. Electronic address: Arthur.caplan@nyumc.org.); Zink A ( NYU, Langone Medical Center, New York, New York.)
Abstract	The ethical challenges of reporting and managing adverse events (AEs) and serious AEs (SAEs) in the context of mass drug administration (MDA) for the treatment of neglected tropical diseases (NTDs) require reassessment of domestic and international policies on a global scale. Although the World Health Organization has set forth AE/SAE guidelines specifically for NTD MDA that incorporate suspected causality, and recommends that only SAEs get reported in this setting, most regulatory agencies continue to require the reporting of all SAEs exhibiting even a merely temporal relationship to activities associated with an MDA program. This greatly increases the potential for excess 'noise' and undue risk aversion and is not only impractical but arguably unethical where huge proportions of populations are being treated for devastating diseases, and no good baseline exists against which to compare possible AE/SAE reports. Other population-specific variables that might change the way drug safety ought to be assessed include differing efficacy rates of a drug, background morbidity/mortality rates of the target disease in question, the growth rate of the incidence of disease, the availability of rescue or salvage therapies, and the willingness of local populations to take risks that other populations might not. The fact that NTDs are controllable and potentially eradicable with well-tolerated, effective, existing drugs might further alter our assessment of MDA safety and AE/SAE tolerability. At the same time, diffuseness of population, communication barriers, lack of resources, and other difficult surveillance challenges may present in NTD-affected settings. These limitations could impair the ability to monitor an MDA program's success, as well as hinder efforts to obtain informed consent or provide rescue therapy. Denying beneficial research interventions and MDA programs intended to benefit millions requires sound ethical justification based on more than the identification of and rote response to AEs and SAEs.
File Format	HTM / HTML
ISSN	01492918
Issue Number	3
Volume Number	36
e-ISSN	1879114X
Journal	Clinical Therapeutics
Language	English
Publisher	Elsevier
Publisher Date	2014-03-01
Publisher Place	United States
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Disease Management Drug Therapy Methods Drug-related Side Effects And Adverse Reactions Neglected Diseases Tropical Climate Drug Administration Schedule Female Humans Vaccination World Health Organization Journal Article
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical)

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

Medication therapy management for adverse drug event preventive care.

Why pharmacology matters.

Anticipating REMS.

Assessment of a new instrument for detecting preventable adverse drug reactions.

Drug absorption in celiac disease.

Wonder vigilance.

Medications in Parkinson's disease.

Pharmacovigilance activities in Nepal.

African heat.

Adverse event management in mass drug administration for neglected tropical diseases.

Similar Documents

Medication therapy management for adverse drug event preventive care.

Why pharmacology matters.

Anticipating REMS.

Assessment of a new instrument for detecting preventable adverse drug reactions.

Drug absorption in celiac disease.

Wonder vigilance.

Medications in Parkinson's disease.

Pharmacovigilance activities in Nepal.

African heat.

Adverse event management in mass drug administration for neglected tropical diseases.