PMID- 27134056
OWN - NLM
STAT- MEDLINE
DCOM- 20170928
LR  - 20180622
IS  - 1099-1557 (Electronic)
IS  - 1053-8569 (Linking)
VI  - 25
IP  - 9
DP  - 2016 Sep
TI  - Sentinel site active surveillance of safety of first-line antiretroviral 
      medicines in Namibia.
PG  - 1052-60
LID - 10.1002/pds.4022 [doi]
AB  - PURPOSE: Active surveillance pharmacovigilance systems better estimate the burden 
      of adverse events (AEs) and can generate useful information on risk factors of 
      AEs for more effective medicine use, especially in conjunction with introduction 
      of new medicines and/or changes in treatment guidelines. This project aimed to 
      implement an active surveillance pilot program for first-line antiretroviral 
      therapy (ART) at sentinel sites in Namibia. METHODS: Sentinel sites were 
      outpatient ART clinics at the Windhoek Central Hospital and Katutura Intermediate 
      Hospital. An active surveillance data collection form was developed and placed 
      into patient charts. HIV+ adults naive to ART were enrolled. Physicians recorded 
      ART and health information during each follow-up visit, including presence or 
      absence of AEs. RESULTS: A total of 413 patients were included from August 2012 
      to April 2013. Average age was 37 years; 51% of patients were at WHO clinical 
      stage 1; and mean baseline CD4 count was 216. The most common ART regimen was 
      tenofovir/lamivudine/nevirapine. Presence or absence of AEs was recorded in 
      active surveillance forms for 94% of first follow-up visits. In total, 66 
      patients experienced 119 AEs of any severity. Incidence of experiencing at least 
      one AE was 33/100 person-years. Most common AEs were rash and abdominal pain. On 
      active surveillance forms, demographic variables were missing in 14% of patients, 
      and follow-up visits were recorded for 82% of patients. CONCLUSIONS: Completeness 
      of AE recording on active surveillance forms was high. With improved logistical 
      considerations, such as incorporation of active surveillance forms into medical 
      records, long-term active surveillance programs could be successful. Copyright (c) 
      2016 John Wiley & Sons, Ltd.
CI  - Copyright (c) 2016 John Wiley & Sons, Ltd.
FAU - Mann, Marita
AU  - Mann M
AD  - Department of Pharmacy, University of Washington, Seattle, WA, USA.
FAU - Mengistu, Assegid
AU  - Mengistu A
AD  - Therapeutics Information and Pharmacovigilance Centre, Windhoek, Namibia.
FAU - Gaeseb, Johannes
AU  - Gaeseb J
AD  - Ministry of Health and Social Services, Windhoek, Namibia.
FAU - Sagwa, Evans
AU  - Sagwa E
AD  - Systems for Improved Access to Pharmaceutical and Services (SIAPS/Namibia), 
      Management Sciences for Health, Windhoek, Namibia.
FAU - Mazibuko, Greatjoy
AU  - Mazibuko G
AD  - Systems for Improved Access to Pharmaceutical and Services (SIAPS/Namibia), 
      Management Sciences for Health, Windhoek, Namibia.
FAU - Baeten, Jared M
AU  - Baeten JM
AD  - Department of Medicine, University of Washington, Seattle, WA, USA.
AD  - Department of Epidemiology, University of Washington, Seattle, WA, USA.
AD  - Department of Global Health, University of Washington, Seattle, WA, USA.
FAU - Babigumira, Joseph B
AU  - Babigumira JB
AD  - Department of Global Health, University of Washington, Seattle, WA, USA.
FAU - Garrison, Louis P
AU  - Garrison LP
AD  - Department of Pharmacy, University of Washington, Seattle, WA, USA.
FAU - Stergachis, Andy
AU  - Stergachis A
AD  - Department of Pharmacy, University of Washington, Seattle, WA, USA.
AD  - Department of Global Health, University of Washington, Seattle, WA, USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, U.S. Gov't, Non-P.H.S.
DEP - 20160502
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
RN  - 0 (Anti-HIV Agents)
SB  - IM
MH  - Adult
MH  - Ambulatory Care
MH  - Anti-HIV Agents/administration & dosage/*adverse effects
MH  - Antiretroviral Therapy, Highly Active/adverse effects/methods
MH  - CD4 Lymphocyte Count
MH  - Female
MH  - Follow-Up Studies
MH  - HIV Infections/*drug therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Namibia
MH  - *Pharmacovigilance
MH  - Pilot Projects
MH  - *Sentinel Surveillance
OTO - NOTNLM
OT  - ART
OT  - HIV
OT  - Namibia
OT  - active surveillance
OT  - pharmacoepidemiology
OT  - pharmacovigilance
EDAT- 2016/05/03 06:00
MHDA- 2017/09/29 06:00
CRDT- 2016/05/03 06:00
PHST- 2015/10/29 00:00 [received]
PHST- 2016/03/31 00:00 [revised]
PHST- 2016/04/04 00:00 [accepted]
PHST- 2016/05/03 06:00 [entrez]
PHST- 2016/05/03 06:00 [pubmed]
PHST- 2017/09/29 06:00 [medline]
AID - 10.1002/pds.4022 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2016 Sep;25(9):1052-60. doi: 10.1002/pds.4022. Epub 
      2016 May 2.