title: Sentinel site active surveillance of safety of first-line antiretroviral medicines in Namibia.
abstract: 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.
  
  
  
  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 naïve to ART were enrolled. Physicians recorded ART and health information during each follow-up visit, including presence or absence of AEs.
  
  
  
  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.
  
  
  
  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 © 2016 John Wiley & Sons, Ltd.
authors.affiliation: Department of Pharmacy, University of Washington, Seattle, WA, USA.
authors.forename: Marita
authors.initials: M
authors.lastname: Mann
authors.affiliation: Therapeutics Information and Pharmacovigilance Centre, Windhoek, Namibia.
authors.forename: Assegid
authors.initials: A
authors.lastname: Mengistu
authors.affiliation: Ministry of Health and Social Services, Windhoek, Namibia.
authors.forename: Johannes
authors.initials: J
authors.lastname: Gaeseb
authors.affiliation: Systems for Improved Access to Pharmaceutical and Services (SIAPS/Namibia), Management Sciences for Health, Windhoek, Namibia.
authors.forename: Evans
authors.initials: E
authors.lastname: Sagwa
authors.affiliation: Systems for Improved Access to Pharmaceutical and Services (SIAPS/Namibia), Management Sciences for Health, Windhoek, Namibia.
authors.forename: Greatjoy
authors.initials: G
authors.lastname: Mazibuko
authors.affiliation: Department of Medicine, University of Washington, Seattle, WA, USA.|Department of Epidemiology, University of Washington, Seattle, WA, USA.|Department of Global Health, University of Washington, Seattle, WA, USA.
authors.forename: Jared M
authors.initials: JM
authors.lastname: Baeten
authors.affiliation: Department of Global Health, University of Washington, Seattle, WA, USA.
authors.forename: Joseph B
authors.initials: JB
authors.lastname: Babigumira
authors.affiliation: Department of Pharmacy, University of Washington, Seattle, WA, USA.
authors.forename: Louis P
authors.initials: LP
authors.lastname: Garrison
authors.affiliation: Department of Pharmacy, University of Washington, Seattle, WA, USA.|Department of Global Health, University of Washington, Seattle, WA, USA.
authors.forename: Andy
authors.initials: A
authors.lastname: Stergachis
mesh_terms: D000328:Adult; D000553:Ambulatory Care; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects*; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects / Q000379:methods; D018791:CD4 Lymphocyte Count; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009276:Namibia; D060735:Pharmacovigilance; D010865:Pilot Projects; D018571:Sentinel Surveillance
chemical_list: D019380:Anti-HIV Agents
keywords: ART; HIV; Namibia; active surveillance; pharmacoepidemiology; pharmacovigilance