PMID- 24612943
OWN - NLM
STAT- MEDLINE
DCOM- 20160215
LR  - 20181202
IS  - 1879-114X (Electronic)
IS  - 0149-2918 (Linking)
VI  - 36
IP  - 3
DP  - 2014 Mar 1
TI  - Adverse event management in mass drug administration for neglected tropical 
      diseases.
PG  - 421-4
LID - S0149-2918(14)00059-9 [pii]
LID - 10.1016/j.clinthera.2014.02.002 [doi]
AB  - 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.
CI  - Copyright (c) 2014 Elsevier HS Journals, Inc. All rights reserved.
FAU - Caplan, Arthur
AU  - Caplan A
AD  - NYU, Langone Medical Center, New York, New York. Electronic address: 
      Arthur.caplan@nyumc.org.
FAU - Zink, Amanda
AU  - Zink A
AD  - NYU, Langone Medical Center, New York, New York.
LA  - eng
PT  - Journal Article
DEP - 20140306
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
SB  - IM
MH  - *Disease Management
MH  - Drug Administration Schedule
MH  - Drug Therapy/*methods
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - Female
MH  - Humans
MH  - Neglected Diseases/*drug therapy
MH  - *Tropical Climate
MH  - Vaccination
MH  - World Health Organization
OTO - NOTNLM
OT  - adverse events
OT  - benefit
OT  - developing nation
OT  - research ethics
OT  - risk
EDAT- 2014/03/13 06:00
MHDA- 2016/02/16 06:00
CRDT- 2014/03/12 06:00
PHST- 2013/05/13 00:00 [received]
PHST- 2014/02/03 00:00 [revised]
PHST- 2014/02/03 00:00 [accepted]
PHST- 2014/03/12 06:00 [entrez]
PHST- 2014/03/13 06:00 [pubmed]
PHST- 2016/02/16 06:00 [medline]
AID - S0149-2918(14)00059-9 [pii]
AID - 10.1016/j.clinthera.2014.02.002 [doi]
PST - ppublish
SO  - Clin Ther. 2014 Mar 1;36(3):421-4. doi: 10.1016/j.clinthera.2014.02.002. Epub 
      2014 Mar 6.